Administered by: Private Purchased by: Private Symptoms: Culture stool negative, Diarrhoea, Faeces discoloured, Flatulence, Irritability, Occult blood positive SMQs:, Haemorrhage laboratory terms (narrow), Pseudomembranous colitis (broad), Gastrointestinal haemorrhage (narrow), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Hostility/aggression (broad), Noninfectious diarrhoea (narrow) Write-up: Baby was fussy and very gassy for 2 days following vaccine. It was reported that on 21-JAN-2009 the patient presented in office with rash under left arm. All stool studies were negative. There was no other concomitant medication. The area affected was dermatome L1. The reporter noted that this was a “classic shingles”. In the middle of the night, he was taken to the hospital by ambulance.
Additional information has been requested. Documents held by sender: none. She felt kind of tired, though no specific complains. The reporting physician felt that pneumonia was definitely related to PNEUMOVAX 23. In this group, 8 subjects had no extremity involvement, 8 had proximal extremity involvement, and 9 had distal extremity involvement. Unlike all the other reports, our patient was diagnosed with SIADH in the prodromic phase, three days prior to the visible rash eruption, compared to several days after the rash in other reported cases(1,2). The term spinal nerve generally refers to the mixed spinal nerve, which is formed from the dorsal and ventral roots that come out of the spinal cord.
Source: The physician via BISC. 4.9). S3 through S5 are perianal. A less likely possibility is contact dermatitis, given her recent gardening. Source: The physician on an interview card. Reportability: reportable as an individual case report (combined with Ver 001). Received date: 19-JAN-2009.
Follow-up information: AE term was changed from “urinary pneumococcal capsular antigen positive” and “respiratory discomfort” to “pneumonia”, and the seriousness was assessed as “serious due to life-threatening”. During ten treatments, no side effects were reported. Administered by: Unknown Purchased by: Unknown Symptoms: C-reactive protein increased, Chest X-ray abnormal, Dyspnoea, Pleurisy, Pneumonia SMQs:, Anaphylactic reaction (broad), Systemic lupus erythematosus (broad), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Cardiomyopathy (broad), Eosinophilic pneumonia (broad) Write-up: Information has been received from a physician concerning an 83 year old female patient who on 09-DEC-2008 was subcutaneously vaccinated with PNEUMOVAX (dose unknown). The affected dermatomes are shown in Table 1. All spinous processes from the cervical to the sacral segment were examined for tenderness. In the areas of skin affected by inflammatory changes and demyelination of the affected peripheral nerve, an alteration in skin infrared emission might be expected. On 20-DEC-2008, therapy with levofloxacin hydrate was discontinued.
The aim of this study was to determine the thermal patterns of different zoster localizations. After thorough clinical examination and history, the diagnosis of herpes zoster duplex bilateralis was presumed. On 13-JAN-2009, the patient visited the reporting physician. (b) Two conducting electrodes are applied to the surface of the skin: an anode directly over the corresponding nerve, and a cathode on the other side of the same dermatome, as far away from the anode as possible. Although the shadow of pneumonia became thinner, pleurisy was suspected. These responses are weak and are apparently not fully protective against further infection with the same virus genotype . She is currently being treated with oral Sawacilun 1g, twice a day and flomaxef sodium 1g, twice a day.
173 TACTILE DERMATOMES OF THE DOG and cats, concluded that rootlets were distributed according to their cranio-caudal position in the root rather than coexensively with the entire dermtaome, particularly in the cat. The treatment is experiencing difficulties. At the time of this report, the patient had not recovered from pleurisy. The reporting physician felt that pneumonia and pleurisy were definitely related to PNEUMOVAX. From that day, the VAS score was maintained within the range of 2-3 for the next 2 weeks. No further information is available. Stenosis is typically caused by degenerative change (arthritis) within and around the structures that border the motion segment holes.
Very quickly after vaccination (exact latency not documented), the patient experienced fever at about 40 C with convulsion. In herpes affections below the girdle–the most common condition being herpes genitalis by which both the vagina and the penis or the surrounding areas (herpes progenitalis) can be afflicted–the anode is transcutaneously applied in a paravertebral position on the right or left side of the second sacral dermatome. When contracted, the levator ani muscles squeeze the vagina, urethra, and rectum closed by compressing them against the pubic bone and lifting the pelvic floor and visceral organs cephalad. Follow-up information was received from the physician on 15-JAN-2009: The patient was 2 to 3 years old at the time of events. The patient experienced high fever and intense asthenia 3 to 5 days after vaccination. Experienced no difficulty breathing. The physician examined the patient “today” and described the patient having a macularpapular rash on both cheeks, some on the forehead, there was burning and the patient was uncomfortable.
The reporter did not mention the case seriousness. She could not provide further information. The events were considered to be other important medical events. After the fifth treatment, the VAS score was 3/10 and T-PRI on the SF-MPQ was 5/45. There was mild dysarthria with frequent paraphasic errors. PRF at the DRG L1 and L2 resulted in partial pain relief during 6 weeks. Patient symptoms: Herpes zoster, Shingles: zoster right leg.
The patient received an injection of ANAHELP. Urticaria stopped spreading after 10 minutes, 45 minutes later, papules and erythema regressed significantly; a few erythematous plaques persisted. No other associated signs were found, ie no respiratory discomfort, no oedema and no reaction at the site of injection. The physician suggested diagnosis of anaphylactic reaction. The outcome was not reported. It was also reported that the patient had received the first dose of MMR II (batch number not reported)0 on 28-APR-2008 and did not experience any adverse reaction following this first injection (vaccine was well tolerated). Anaphylactic reaction was determined to be an other important medical event due to injection of adrenalin.
It was reported that the patient had a dose of measles virus vaccine live (Enders-Edmonston) (+) mumps virus vaccine live (Jeryl Lynn) (+) rubella virus vaccine live (Wistar RA 27/3) and varicella virus vaccine live (Oka/Merck) as the initial vaccinations. On 04Nov2003 the pt presented to the Dr”s office with break through chickenpox, described as a 24 hour rash with red vesicular lesions over his trunk,arms, and body. Unspecified medical attention was sought in the office. There was no illness at the time of vaccination. Details of the patient”s medical history and concomitant medication have not been reported. The patient”s outcome was not reported. The patient was seen on 24-NOV-2008, three weeks post vaccination with behaviour changes which included insomnia, loss of appetite, tearful, anxious and lack of energy.
An electroencephalogram (EEG) and a magnetic resonance scan (MRI) were performed which were normal. It was reported that the patient was still having pain, tingling and burning where the shingles were following vaccination. The reporter considered the events to be medically significant and was not likely to be related to the vaccination. Other business partner numbers include E2009-00350. No further information is available. Administered by: Unknown Purchased by: Unknown Symptoms: Bacterial culture, Injection site abscess SMQs: Write-up: Information regarding PREVENAR was received from a healthcare professional regarding a 4-month-old male patient who experienced vaccination site abscess. The patient received the first dose on 27-Nov-2008.
There was swelling of the face especially the cheeks. The patient was hospitalized for 48 hours and underwent abscess drainage. Outcome was unknown. Results of bacterial culture were pending at the time of the report. Administered by: Unknown Purchased by: Unknown Symptoms: Body temperature increased, Depressed level of consciousness, Electroencephalogram abnormal, Epilepsy, Erythema, Eye movement disorder, Grunting, Lacrimation increased, Loss of consciousness, Lumbar puncture normal, Myoclonus, Tonic clonic movements, Viral test negative SMQs:, Torsade de pointes/QT prolongation (broad), Anaphylactic reaction (broad), Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Systemic lupus erythematosus (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Convulsions (narrow), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Lacrimal disorders (narrow), Ocular motility disorders (narrow), Hypotonic-hyporesponsive episode (broad), Generalised convulsive seizures following immunisation (narrow), Hypersensitivity (broad) Write-up: Information regarding PREVENAR was received from a healthcare professional via foreign regulatory authority regarding a 4-month-old male patient who experienced body temperature up to 38.5 C and benign childhood epilepsy. The patient received the second dose on 20-Nov-2008. The patient experienced an increase of body temperature at 38 C on 20-Nov-2008 in the evening and up to 38.5 C on 21-Nov-2008 (non serious event).
Then, the outcome was not specified. On 24-Nov-2008, the patient seemed absent and did not recognized his parents as soon as usual. Then, he experienced about 10 crisis per day manifested by redness, eyes full of tears and loss of consciousness for about 30 seconds without crying. The patient was hospitalized. On 28-Nov-2008, while an EEG was being performed, the patient experienced myoclonies of the upper limbs, winking, sometimes grumbling, and tonic contraction with flexion of the lower limbs on the trunk. The EEG trace showed a fit with focal beginning on the left, on central or temporal. The fit seemed and search of HSV1 and HSV2 returned negative.
The neurologist diagnosed benign childhood epilepsy. The patient was started on RIVOTRIL and DEPAKINE then treatment continued with RIVOTRIL and MICROPAKINE. The frequency of epileptic fits was stable but the fits seemed shorter. The patient had not recovered. No additional information was available at the time of this report. Administered by: Unknown Purchased by: Unknown Symptoms: Heart rate decreased, Neonatal hypoxia, Oxygen saturation decreased SMQs:, Arrhythmia related investigations, signs and symptoms (broad), Acute central respiratory depression (broad), Neonatal disorders (narrow), Respiratory failure (broad) Write-up: Information regarding PREVENAR was received from a healthcare professional via a regulatory authority regarding a 2-month-old female patient who experienced neonatal hypoxia, heart rate decreased and oxygen saturation decreased. The patient received the first dose on 16-Sep-2008.
Additional suspect medication included a not specified vaccine. The patient experienced neonatal hypoxia, heart rate decreased and oxygen saturation decreased on 16-Sep-2008. The patient received extra oxygen and recovered quickly. Due to the compact design of the equipment described by the invention patients with less severe herpes conditions may be treated out of the hospital or even at home with rented equipment. No additional information was available at the time of this report. This is demonstrated by the high frequency of HZ in patients who are immune suppressed . On 15-SEP-2008 the patient experienced muscular weakness, hyperreflexia and paraesthesia and was hospitalized.
It was described that the patient experienced feet weakness, bilateral weakness to knees, with weakness ascending and tingling upper extremities. The patient was treated with cortisone injection. At the time of reporting to the agency on 11-NOV-2008, the patient had recovered from muscular weakness, hyperreflexia and paraesthesia. The agency considered that muscular weakness, hyperreflexia and paraesthesia were possibly related to therapy with GARDASIL. The original reporting source was not provided by the agency. Additional information is not expected. found that 5% of men and 4% of women will develop nerve root-related sciatica at some point in there life (181).
Other suspect therapy included MICROGYNON 30 ED, tablet, one dose daily (duration and indication not reported). If dermatome 1 is also affected another cathode should be placed in front of the respective eyebrow. Neurophysiologic testing, particularly needle EMG, can be useful for identifying neurologic from nonneurologic causes of levator ani weakness. At the time of reporting to the agency on 18-NOV-2008, the patient had recovered from pancreatitis. The agency considered that pancreatitis was possibly related to therapy with GARDASIL and/or MICROGYNON. The original reporting source was not provided by the agency. Additional information is not expected.