chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 1.02
Sex: M
Vaccine: FLU3, HIBV, MMR, PPV, VARCEL
Symptoms: Immediate post-injection reaction, Injection site erythema, Injection site rash, Injection site reaction, Injection site urticaria
Clinical narrative: Immediately after child received his varicella vaccine in his R upper thigh, he developed 4-5 raised pink lesions that coalesced into one larger lesion; I was called in to re-examine patient at 11:10 am; child in good spirits and no acute distress; had a single 1.75 cm raised pink blanching urticarial lesion on his R upper thigh; no other rashes or hives present; no shortness of breath; no vomiting; applied cold compress to site x 15 min and upon re-examination, lesion was smaller and no new lesions; child was observed in office an additional 15 min after which time the hive had resolved (there was some faint residual pinkness to site); child discharged home to parents; on 11/27/12 child developed a new rash at same site of R upper thigh; started as single raised bump with surrounding redness; by next day, had 5-6 similar lesions;  seen in office on 11/29/12 and diagnosed with immunization reaction from varicella (had a cluster of small papulovesicular lesions on R upper thigh on a base of erythema); not indurated, warm, or tender; no pustules.
Age: 1.02
Sex: M
Vaccine: FLU3, HIBV, MMR, PPV, VARCEL
Symptoms: Pallor, Rash erythematous, Rash papular
Clinical narrative: Immediately after child received his varicella vaccine in his R upper thigh, he developed 4-5 raised pink lesions that coalesced into one larger lesion; I was called in to re-examine patient at 11:10 am; child in good spirits and no acute distress; had a single 1.75 cm raised pink blanching urticarial lesion on his R upper thigh; no other rashes or hives present; no shortness of breath; no vomiting; applied cold compress to site x 15 min and upon re-examination, lesion was smaller and no new lesions; child was observed in office an additional 15 min after which time the hive had resolved (there was some faint residual pinkness to site); child discharged home to parents; on 11/27/12 child developed a new rash at same site of R upper thigh; started as single raised bump with surrounding redness; by next day, had 5-6 similar lesions;  seen in office on 11/29/12 and diagnosed with immunization reaction from varicella (had a cluster of small papulovesicular lesions on R upper thigh on a base of erythema); not indurated, warm, or tender; no pustules.
Age: 1.01
Sex: M
Vaccine: FLU3, HIBV, MMR, PPV, VARCEL
Symptoms: Immediate post-injection reaction, Injection site erythema, Injection site reaction, Local reaction, Rash macular
Clinical narrative: Immediately after receiving his varicella vaccine in his L thigh, child broke out in redness around administration site; when I re-evaluated him, he had a 9 cm area of flat splotchy erythema involving his L upper thigh; not itchy; no hives; no swelling; no SOB; no vomiting; otherwise acting fine; appeared consistent with a localized reaction; of note, this was the second child who had a reaction to varicella vaccine in my clinic this day.
Age: 36.0
Sex: F
Vaccine: HEPAB, MMR
Symptoms: Arthralgia, Headache, Myalgia, Rash generalised
Clinical narrative: Headache, joints and muscles pains, rush from tummy and neck spreading out everywhere else.
Age: 9.0
Sex: M
Vaccine: FLUN3
Symptoms: Cough, Oropharyngeal pain, Pyrexia
Clinical narrative: High fever, cough, sore throat.
Age: 54.0
Sex: F
Vaccine: FLUX, FLU3
Symptoms: Insomnia, Muscle spasms, Muscle tightness, Muscle twitching, Myalgia
Clinical narrative: My voluntary muscles became spasmodic.  My muscles were tight as if in continuous firing. I had twitches in my muscles; arms, hamstrings, calves, shoulders..painful couldn't get my muscles to relax all night. I took aleve, I took Valerian an herb for muscle spasms at 4am.  I took 4 Ibuprofen 200mg at 6AM.  I didn't sleep all night.
Age: 54.0
Sex: F
Vaccine: FLUX, FLU3
Symptoms: Muscle spasms, Muscle tightness, Neurological examination normal
Clinical narrative: My voluntary muscles became spasmodic.  My muscles were tight as if in continuous firing. I had twitches in my muscles; arms, hamstrings, calves, shoulders..painful couldn't get my muscles to relax all night. I took aleve, I took Valerian an herb for muscle spasms at 4am.  I took 4 Ibuprofen 200mg at 6AM.  I didn't sleep all night.
Age: 35.0
Sex: F
Vaccine: FLU3, TDAP
Symptoms: Guillain-Barre syndrome
Clinical narrative: Was told by patient on 11/30/2012 that she was admitted to hospital (I think that she said on 10/31) and was diagnosed with Guillain-Barre due to vaccination.
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Headache, Injection site mass, Pyrexia, Swelling
Clinical narrative: Redness and swelling at side. With a lump at injection site. Pt complained of fever and headache.
Age: 53.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site pain, Injection site pruritus, Mobility decreased, Sleep disorder
Clinical narrative: My left upper arm started to get really sore almost like a bruise. It was itching. It aches most of the time and I am unable to reach behind my back or to stretch to the side of me. I am unable to sleep on left side.  As of this time, I am applying heat and taking Advil. It just hurts for no reason and I still have soreness where the shot was given.
Age: 40.0
Sex: F
Vaccine: FLU3
Symptoms: Fatigue, Injection site pain, Lymphoedema, Nausea
Clinical narrative: I was unaware that there was latex in the syringe when the vaccine was administered. Over the period of two weeks I developed pain at the injection site, nausea, fatigue, and lymphedema in my breast. It took approximately six weeks to figure out and track back the cause to the flu shot and the latex. Treatment was Benadryl and ranitadine.
Age: 60.0
Sex: F
Vaccine: FLU3, VARZOS
Symptoms: Abasia, CSF test, Computerised tomogram, Guillain-Barre syndrome, Hypoaesthesia
Clinical narrative: 10/04/2012 Swelling and redness in left arm (vaccine area). 10/06/2012 Patient was in hospital and received antibiotics and cortisone. 10/14/2012 Patient inform she was hospitalized because of numbness in arms and legs and she can't walk. 10/16/2012 Patient notify she was diagnosed with Guillain-Barre Syndrome.
Age: 60.0
Sex: F
Vaccine: FLU3, VARZOS
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: 10/04/2012 Swelling and redness in left arm (vaccine area). 10/06/2012 Patient was in hospital and received antibiotics and cortisone. 10/14/2012 Patient inform she was hospitalized because of numbness in arms and legs and she can't walk. 10/16/2012 Patient notify she was diagnosed with Guillain-Barre Syndrome.
Age: 68.0
Sex: F
Vaccine: PPV
Symptoms: Discomfort, Injection site pain, Pain in extremity
Clinical narrative: Left deltoid injection site was sore 2 days afterward. When patient puts weight on left arm, she doesn't feel it at first, then it hurts. Discomfort experienced when putting arm back. No external sign of problem.
Age: 36.0
Sex: M
Vaccine: PPV
Symptoms: Axillary pain, Dizziness, Pain, Pyrexia
Clinical narrative: This spontaneous report was received from a physician refers to a 36 year old male patient. The patient was vaccinated with a dose of 0.5 ml PNEUMOVAX 23. On an unknown date, the patient experienced high fever of 104 degrees, aches and pain, dizziness and excruciating pain in the armpit area after receiving the vaccine. The outcome of the events were unknown at the time of this report. This is one of the several reports received by the same reporter. Additional information has been requested.
Sex: F
Vaccine: HEP
Symptoms: Incorrect storage of drug
Clinical narrative: This spontaneous report as received from a pharmacist refers to a newborn female patient of unknown age. On 14-OCT-2012 13:48, the patient was vaccinated with RECOMBIVAX HB that had been exposed to temperatures below 32F for 6 hours. During that 6 hour time period, the vaccine was exposed to 28.8F for 1.5 hours. Administration route was not reported. Two lot# were involved and the lot# were reported as: 0294AE, expiry date on 06-SEP-2014; and 0385AE, expiry date on 08-NOV-2014. It was unspecified which lot# the patient was administered. The outcome of event was unknown. It was unspecified if the patient sought medical attention. This is one of several reports received from the same source. Additional information has been requested.
Sex: M
Vaccine: HEP
Symptoms: Incorrect storage of drug
Clinical narrative: This spontaneous report as received from a pharmacist refers to a newborn male patient of unknown age. On 11-OCT-2012 09:21, the patient was vaccinated with RECOMBIVAX HB that had been exposed to temperatures below 32F for 6 hours. During that 6 hour time period, the vaccine was exposed to 28.8F for 1.5 hours. Administration route was not reported. Two lot# were involved and the lot# were reported as: 0294AE, expiry date on 06-SEP-2014; and 0385AE, expiry date on 08-NOV-2014. It was unspecified which lot# the patient was administered. The outcome of event was unknown. It was unspecified if the patient sought medical attention. This is one of several reports received from the same source. Additional information has been requested.
Sex: M
Vaccine: HEP
Symptoms: Incorrect storage of drug
Clinical narrative: This spontaneous report as received from a pharmacist refers to a newborn male patient of unknown age. On 12-OCT-2012 14:52, the patient was vaccinated with RECOMBIVAX HB that had been exposed to temperatures below 32F for 6 hours. During that 6 hour time period, the vaccine was exposed to 28.8F for 1.5 hours. Administration route was not reported. Two lot # were involved and the lot # were reported as; 0294AE, expiry date on 06-SEP-2014; and 0385AE, expiry date on 08-NOV-2014. IT was unspecified which lot # the patient was administered. The outcome of event was unknown. It was unspecified if the patient sought medical attention. this is one of several reports received from the same source. Additional information has been requested.
Sex: F
Vaccine: HEP
Symptoms: Incorrect storage of drug
Clinical narrative: This spontaneous report as received from a pharmacist refers to a newborn female patient of unknown age. On 12-OCT-2012 12:54, the patient was vaccinated with RECOMBIVAX HB that had been exposed to temperatures below 32F for 6 hours. During that 6 hour time period, the vaccine was exposed to 28.8F for 1.5 hours. Administration route was not reported. Two lot# were involved and the lot# were reported as: 0294AE, expiry date on 06-SEP-2014; and 0385AE, expiry date on 08-NOV-2014. It was unspecified which lot# the patient was administered. The outcome of event was unknown. It was unspecified if the patient sought medical attention. This is one of several reports received from the same source. Additional information has been requested.
Sex: M
Vaccine: HEP
Symptoms: Incorrect storage of drug
Clinical narrative: This spontaneous report as received from a pharmacist refers to a newborn male patient of unknown age. On 10-OCT-2012 16:58, the patient was vaccinated with RECOMBIVAX HB that had been exposed to temperatures below 32F for 6 hours. During that 6 hour time period, the vaccine was exposed to 28.8F for 1.5 hours. Administration route was not reported. Two lot # were involved and the lot # were reported as; 0294AE, expiry date on 06-SEP-2014; and 0385AE, expiry date on 08-NOV-2014. IT was unspecified which lot # the patient was administered. The outcome of event was unknown. It was unspecified if the patient sought medical attention. this is one of several reports received from the same source. Additional information has been requested.
Sex: M
Vaccine: HEP
Symptoms: Incorrect storage of drug
Clinical narrative: This spontaneous report as received from a pharmacist refers to a newborn male patient of unknown age. On 11-OCT-2012 13:35, the patient was vaccinated with RECOMBIVAX HB that had been exposed to temperatures below 32F for 6 hours. During that 6 hour time period, the vaccine was exposed to 28.8F for 1.5 hours. Administration route was not reported. Two lot# were involved and the lot# were reported as: 0294AE, expiry date on 06-SEP-2014; and 0385AE, expiry date on 08-NOV-2014. It was unspecified which lot# the patient was administered. The outcome of event was unknown. It was unspecified if the patient sought medical attention. This is one of several reports received from the same source. Additional information has been requested.
Sex: M
Vaccine: HEP
Symptoms: Incorrect storage of drug
Clinical narrative: This spontaneous report as received from a pharmacist refers to a newborn male patient of unknown age. On 12-OCT-2012 01:42, the patient was vaccinated with RECOMBIVAX HB that had been exposed to temperatures below 32F for 6 hours. During that 6 hour time period, the vaccine was exposed to 28.8F for 1.5 hours. Administration route was not reported. Two lot# were involved and the lot# were reported as: 0294AE, expiry date on 06-SEP-2014; and 0385AE, expiry date on 08-NOV-2014. It was unspecified which lot# the patient was administered. The outcome of event was unknown. It was unspecified if the patient sought medical attention. This is one of several reports received from the same source. Additional information has been requested.
Sex: F
Vaccine: HEP
Symptoms: Incorrect storage of drug
Clinical narrative: This spontaneous report as received from a pharmacist refers to a newborn female patient of unknown age. On 12-OCT-2012 08:19, the patient was vaccinated with RECOMBIVAX HB that had been exposed to temperatures below 32F for 6 hours. During that 6 hour time period, the vaccine was exposed to 28.8F for 1.5 hours. Administration route was not reported. Two lot# were involved and the lot# were reported as: 0294AE, expiry date on 06-SEP-2014; and 0385AE, expiry date on 08-NOV-2014. It was unspecified which lot# the patient was administered. The outcome of event was unknown. It was unspecified if the patient sought medical attention. This is one of several reports received from the same source. Additional information has been requested.
Sex: M
Vaccine: HEP
Symptoms: Incorrect storage of drug
Clinical narrative: This spontaneous report as received from a pharmacist refers to a newborn male patient of unknown age. On 14-OCT-2012 19:58, the patient was vaccinated with RECOMBIVAX HB that had been exposed to temperatures below 32F for 6 hours. During that 6 hour time period, the vaccine was exposed to 28.8F for 1.5 hours. Administration route was not reported. Two lot# were involved and the lot# were reported as: 0294AE, expiry date on 06-SEP-2014; and 0385AE, expiry date on 08-NOV-2014. It was unspecified which lot# the patient was administered. The outcome of event was unknown. It was unspecified if the patient sought medical attention. This is one of several reports received from the same source. Additional information has been requested.
Sex: M
Vaccine: HEP
Symptoms: Incorrect storage of drug
Clinical narrative: This spontaneous report as received from a pharmacist refers to a newborn male patient of unknown age. On 14-OCT-2012 18:22, the patient was vaccinated with RECOMBIVAX HB that had been exposed to temperatures below 32F for 6 hours. During that 6 hour time period, the vaccine was exposed to 28.8F for 1.5 hours. Administration route was not reported. Two lot# were involved and the lot# were reported as: 0294AE, expiry date on 06-SEP-2014; and 0385AE, expiry date on 08-NOV-2014. It was unspecified which lot# the patient was administered. The outcome of event was unknown. It was unspecified if the patient sought medical attention. This is one of several reports received from the same source. Additional information has been requested.
Sex: M
Vaccine: HEP
Symptoms: Incorrect storage of drug
Clinical narrative: This spontaneous report as received from a pharmacist refers to a newborn male patient of unknown age. On 14-OCT-2012 18:57, the patient was vaccinated with RECOMBIVAX HB that had been exposed to temperatures below 32F for 6 hours. During that 6 hour time period, the vaccine was exposed to 28.8F for 1.5 hours. Administration route was not reported. Two lot# were involved and the lot# were reported as: 0294AE, expiry date on 06-SEP-2014; and 0385AE, expiry date on 08-NOV-2014. It was unspecified which lot# the patient was administered. The outcome of event was unknown. It was unspecified if the patient sought medical attention. This is one of several reports received from the same source. Additional information has been requested.
Sex: F
Vaccine: HEP
Symptoms: Incorrect storage of drug
Clinical narrative: This spontaneous report as received from a pharmacist refers to a newborn female patient of unknown age. On 14-OCT-2012 11:31, the patient was vaccinated with RECOMBIVAX HB that had been exposed to temperatures below 32F for 6 hours. During that 6 hour time period, the vaccine was exposed to 28.8F for 1.5 hours. Administration route was not reported. Two lot# were involved and the lot# were reported as: 0294AE, expiry date on 06-SEP-2014; and 0385AE, expiry date on 08-NOV-2014. It was unspecified which lot# the patient was administered. The outcome of event was unknown. It was unspecified if the patient sought medical attention. This is one of several reports received from the same source. Additional information has been requested.
Sex: M
Vaccine: HEP
Symptoms: Incorrect storage of drug
Clinical narrative: This spontaneous report as received from a pharmacist refers to a newborn male patient of unknown age. On 13-OCT-2012 12:17, the patient was vaccinated with RECOMBIVAX HB that had been exposed to temperatures below 32F for 6 hours. During that 6 hour time period, the vaccine was exposed to 28.8F for 1.5 hours. Administration route was not reported. Two lot# were involved and the lot# were reported as: 0294AE, expiry date on 06-SEP-2014; and 0385AE, expiry date on 08-NOV-2014. It was unspecified which lot# the patient was administered. The outcome of event was unknown. It was unspecified if the patient sought medical attention. This is one of several reports received from the same source. Additional information has been requested.
Sex: M
Vaccine: HEP
Symptoms: Incorrect storage of drug
Clinical narrative: This spontaneous report as received from a pharmacist refers to a newborn male patient of unknown age. On 14-OCT-2012 08:58, the patient was vaccinated with RECOMBIVAX HB that had been exposed to temperatures below 32F for 6 hours. During that 6 hour time period, the vaccine was exposed to 28.8F for 1.5 hours. Administration route was not reported. Two lot# were involved and the lot# were reported as: 0294AE, expiry date on 06-SEP-2014; and 0385AE, expiry date on 08-NOV-2014. It was unspecified which lot# the patient was administered. The outcome of event was unknown. It was unspecified if the patient sought medical attention. This is one of several reports received from the same source. Additional information has been requested.
Sex: M
Vaccine: HEP
Symptoms: Incorrect storage of drug
Clinical narrative: This spontaneous report as received from a pharmacist refers to a newborn male patient of unknown age. On 14-OCT-2012 10:49, the patient was vaccinated with RECOMBIVAX HB that had been exposed to temperatures below 32F for 6 hours. During that 6 hour time period, the vaccine was exposed to 28.8F for 1.5 hours. Administration route was not reported. Two lot# were involved and the lot# were reported as: 0294AE, expiry date on 06-SEP-2014; and 0385AE, expiry date on 08-NOV-2014. It was unspecified which lot# the patient was administered. The outcome of event was unknown. It was unspecified if the patient sought medical attention. This is one of several reports received from the same source. Additional information has been requested.
Sex: F
Vaccine: HEP
Symptoms: Incorrect storage of drug
Clinical narrative: This spontaneous report as received from a pharmacist refers to a newborn female patient of unknown age. On 14-OCT-2012 09:13, the patient was vaccinated with RECOMBIVAX HB that had been exposed to temperatures below 32F for 6 hours. During that 6 hour time period, the vaccine was exposed to 28.8F for 1.5 hours. Administration route was not reported. Two lot# were involved and the lot# were reported as: 0294AE, expiry date on 06-SEP-2014; and 0385AE, expiry date on 08-NOV-2014. It was unspecified which lot# the patient was administered. The outcome of event was unknown. It was unspecified if the patient sought medical attention. This is one of several reports received from the same source. Additional information has been requested.
Sex: M
Vaccine: HEP
Symptoms: Incorrect storage of drug
Clinical narrative: This spontaneous report as received from a pharmacist refers to a newborn male patient of unknown age. On 13-OCT-2012 10:46, the patient was vaccinated with RECOMBIVAX HB that had been exposed to temperatures below 32F for 6 hours. During that 6 hour time period, the vaccine was exposed to 28.8F for 1.5 hours. Administration route was not reported. Two lot # were involved and the lot # were reported as; 0294AE, expiry date on 06-SEP-2014; and 0385AE, expiry date on 08-NOV-2014. IT was unspecified which lot # the patient was administered. The outcome of event was unknown. It was unspecified if the patient sought medical attention. this is one of several reports received from the same source. Additional information has been requested.
Sex: F
Vaccine: HEP
Symptoms: Incorrect storage of drug
Clinical narrative: This spontaneous report as received from a pharmacist refers to a newborn female patient of unknown age. On 13-OCT-2012 05:33, the patient was vaccinated with RECOMBIVAX HB that had been exposed to temperatures below 32F for 6 hours. During that 6 hour time period, the vaccine was exposed to 28.8F for 1.5 hours. Administration route was not reported. Two lot# were involved and the lot# were reported as: 0294AE, expiry date on 06-SEP-2014; and 0385AE, expiry date on 08-NOV-2014. It was unspecified which lot# the patient was administered. The outcome of event was unknown. It was unspecified if the patient sought medical attention. This is one of several reports received from the same source. Additional information has been requested.
Sex: F
Vaccine: HEP
Symptoms: Incorrect storage of drug
Clinical narrative: This spontaneous report as received from a pharmacist refers to a newborn female patient of unknown age. On 13-OCT-2012 01:24, the patient was vaccinated with RECOMBIVAX HB that had been exposed to temperatures below 32F for 6 hours. During that 6 hour time period, the vaccine was exposed to 28.8F for 1.5 hours. Administration route was not reported. Two lot# were involved and the lot# were reported as: 0294AE, expiry date on 06-SEP-2014; and 0385AE, expiry date on 08-NOV-2014. It was unspecified which lot# the patient was administered. The outcome of event was unknown. It was unspecified if the patient sought medical attention. This is one of several reports received from the same source. Additional information has been requested.
Sex: M
Vaccine: HEP
Symptoms: Incorrect storage of drug
Clinical narrative: This spontaneous report as received from a pharmacist refers to a newborn male patient of unknown age. On 12-OCT-2012 11:53, the patient was vaccinated with RECOMBIVAX HB that had been exposed to temperatures below 32F for 6 hours. During that 6 hour time period, the vaccine was exposed to 28.8F for 1.5 hours. Administration route was not reported. Two lot# were involved and the lot# were reported as: 0294AE, expiry date on 06-SEP-2014; and 0385AE, expiry date on 08-NOV-2014. It was unspecified which lot# the patient was administered. The outcome of event was unknown. It was unspecified if the patient sought medical attention. This is one of several reports received from the same source. Additional information has been requested.
Sex: U
Vaccine: HEP
Symptoms: Incorrect storage of drug
Clinical narrative: This spontaneous report as received from a pharmacist refers to a newborn patient of unknown age. On 10-OCT-2012 18:27, the patient was vaccinated with RECOMBIVAX HB that had been exposed to temperatures below 32F for 6 hours. During that 6 hour time period, the vaccine was exposed to 28.8F for 1.5 hours. Administration route was not reported. Two lot# were involved and the lot# were reported as: 0294AE, expiry date on 06-SEP-2014; and 0385AE, expiry date on 08-NOV-2014. It was unspecified which lot# the patient was administered. The outcome of event was unknown. It was unspecified if the patient sought medical attention. This is one of several reports received from the same source. Additional information has been requested.
Sex: M
Vaccine: HEP
Symptoms: Incorrect storage of drug
Clinical narrative: This spontaneous report as received from a pharmacist refers to a newborn male patient of unknown age. On 11-OCT-2012 12:42, the patient was vaccinated with RECOMBIVAX HB that had been exposed to temperatures below 32F for 6 hours. During that 6 hour time period, the vaccine was exposed to 28.8F for 1.5 hours. Administration route was not reported. Two lot# were involved and the lot# were reported as: 0294AE, expiry date on 06-SEP-2014; and 0385AE, expiry date on 08-NOV-2014. It was unspecified which lot# the patient was administered. The outcome of event was unknown. It was unspecified if the patient sought medical attention. This is one of several reports received from the same source. Additional information has been requested.
Sex: M
Vaccine: HEP
Symptoms: Incorrect storage of drug
Clinical narrative: This spontaneous report as received from a pharmacist refers to a newborn male patient of unknown age. On 11-OCT-2012 13:46, the patient was vaccinated with RECOMBIVAX HB that had been exposed to temperatures below 32F for 6 hours. During that 6 hour time period, the vaccine was exposed to 28.8F for 1.5 hours. Administration route was not reported. Two lot# were involved and the lot# were reported as: 0294AE, expiry date on 06-SEP-2014; and 0385AE, expiry date on 08-NOV-2014. It was unspecified which lot# the patient was administered. The outcome of event was unknown. It was unspecified if the patient sought medical attention. This is one of several reports received from the same source. Additional information has been requested.
Sex: F
Vaccine: HEP
Symptoms: Incorrect storage of drug
Clinical narrative: This spontaneous report as received from a pharmacist refers to a newborn female patient of unknown age. On 11-OCT-2012 13:11, the patient was vaccinated with RECOMBIVAX HB that had been exposed to temperatures below 32F for 6 hours. During that 6 hour time period, the vaccine was exposed to 28.8F for 1.5 hours. Administration route was not reported. Two lot# were involved and the lot# were reported as: 0294AE, expiry date on 06-SEP-2014; and 0385AE, expiry date on 08-NOV-2014. It was unspecified which lot# the patient was administered. The outcome of event was unknown. It was unspecified if the patient sought medical attention. This is one of several reports received from the same source. Additional information has been requested.
Sex: M
Vaccine: HEP
Symptoms: Incorrect storage of drug
Clinical narrative: This spontaneous report as received from a pharmacist refers to a newborn male patient of unknown age. On 11-OCT-2012 23:50, the patient was vaccinated with RECOMBIVAX HB that had been exposed to temperatures below 32F for 6 hours. During that 6 hour time period, the vaccine was exposed to 28.8F for 1.5 hours. Administration route was not reported. Two lot# were involved and the lot# were reported as: 0294AE, expiry date on 06-SEP-2014; and 0385AE, expiry date on 08-NOV-2014. It was unspecified which lot# the patient was administered. The outcome of event was unknown. It was unspecified if the patient sought medical attention. This is one of several reports received from the same source. Additional information has been requested.
Sex: M
Vaccine: HEP
Symptoms: Incorrect storage of drug
Clinical narrative: This spontaneous report as received from a pharmacist refers to a newborn male patient of unknown age. On 10-OCT-2012 19:59, the patient was vaccinated with RECOMBIVAX HB that had been exposed to temperatures below 32F for 6 hours. During that 6 hours time period the vaccine was exposed to 28.8F for 1.5 hours. Administration route was not reported. Two lot# were involved and the lot# were reported as:0294AE, expiry date on 06-SEP-2014; and 0385AE, expiry date on 08-NOV-2014. It was unspecified which lot# the patient was administered. The outcome of event was unknown. It was unspecified if the patient sought medical attention. This is one of several reports received from the same source. Additional information has been requested.
Sex: F
Vaccine: HEP
Symptoms: Incorrect storage of drug
Clinical narrative: This spontaneous report as received from a pharmacist refers to a newborn female patient of unknown age. On 14-OCT-2012 14:26, the patient was vaccinated with RECOMBIVAX HB that had been exposed to temperatures below 32F for 6 hours. During that 6 hour time period, the vaccine was exposed to 28.8F for 1.5 hours. Administration route was not reported. Two lot# were involved and the lot# were reported as: 0294AE, expiry date on 06-SEP-2014; and 0385AE, expiry date on 08-NOV-2014. It was unspecified which lot# the patient was administered. The outcome of event was unknown. It was unspecified if the patient sought medical attention. This is one of several reports received from the same source. Additional information has been requested.
Sex: M
Vaccine: HEP
Symptoms: Incorrect storage of drug
Clinical narrative: This spontaneous report as received from a pharmacist refers to a newborn male patient of unknown age. On 15-OCT-2012 09:12, the patient was vaccinated with RECOMBIVAX HB that had been exposed to temperatures below 32F for 6 hours. During that 6 hour time period, the vaccine was exposed to 28.8F for 1.5 hours. Administration route was not reported. Two lot# were involved and the lot# were reported as: 0294AE, expiry date on 06-SEP-2014; and 0385AE, expiry date on 08-NOV-2014. It was unspecified which lot# the patient was administered. The outcome of event was unknown. It was unspecified if the patient sought medical attention. This is one of several reports received from the same source. Additional information has been requested.
Sex: M
Vaccine: HEP
Symptoms: Incorrect storage of drug
Clinical narrative: This spontaneous report as received from a pharmacist refers to a newborn male patient of unknown age. On 11-NOV-2012 at 17:26, the patient was vaccinated with RECOMBIVAX HB that had been exposed to temperatures below 32F for 6 hours. During that 6 hour time period, the vaccine was exposed to 28.8F for 1.5 hours. Administration route was not reported. Two lot # were involved and the lot # were reported as; 0294AE, expiry date on 06-SEP-2014; and 0385AE, expiry date on 08-NOV-2014. IT was unspecified which lot # the patient was administered. The outcome of event was unknown. It was unspecified if the patient sought medical attention. this is one of several reports received from the same source. Additional information has been requested.
Sex: F
Vaccine: HEP
Symptoms: Incorrect storage of drug
Clinical narrative: This spontaneous report as received from a pharmacist refers to a newborn female patient of unknown age. On 12-NOV-2012 at 10:55, the patient was vaccinated with RECOMBIVAX HB that had been exposed to temperatures below 32F for 6 hours. During that 6 hour time period, the vaccine was exposed to 28.8F for 1.5 hours. Administration route was not reported. Two lot# were involved and the lot# were reported as: 0294AE, expiry date on 06-SEP-2014; and 0385AE, expiry date on 08-NOV-2014. It was unspecified which lot# the patient was administered. The outcome of event was unknown. It was unspecified if the patient sought medical attention. This is one of several reports received from the same source. Additional information has been requested.
Age: 6.0
Sex: F
Vaccine: VARCEL
Symptoms: Blister, Pyrexia, Rash
Clinical narrative: Information has been received for a physician (local reference number MK8901, case number US12-057036) regarding the 6 year old female patient. This physician reported currently six year old female consumer started VARIVAX, of unknown date dose and frequency, on an unknown date, when she was one year old for an unknown indication. The patient's relevant medical history included allergies and asthma. The patient had no relevant concomitant medications. The patient's relevant past drug history was unknown. On 23-NOV-2012, this physician reported that this consumer received first dose of VARIVAX (merck) when she was one year old. She possibly received the second VARIVAX (merck) dose when she was 4 years old but the physician was not sure if she received it or not. In November 2012, about two weeks ago (approximately on 09-NOV-2012), the patient received a dose of VARIVAX (merck). In November 2012, about two days after the VARIVAX (merck) injection, she developed a rash on both of her lower extremities. The rash lasted a few days and it resolved. In November 2012, about a week after vaccination with VARIVAX (merck), the consumer developed a low grade fever, which lasted over-night, and then resolved. In November 2012, a few days ago, the consumer developed blisters on her face and on her chest. There was no relevant laboratory data. As of 23-NOV-2012, it was unknown if the consumer continued to receive VARIVAX (merck), she no longer experienced fever and rash, and she continued to experience blisters on her face and her chest. The physician did not have lot number and the expiration date of VARIVAX (merck) that was administered to this patient. Additional information has been requested.
Sex: F
Vaccine: HEP
Symptoms: Incorrect storage of drug
Clinical narrative: This spontaneous report as received from a pharmacist refers to a newborn female patient of unknown age. On 12-NOV-2012 at 15:21, the patient was vaccinated with RECOMBIVAX HB that had been exposed to temperatures below 32F for 6 hours. During that 6 hour time period, the vaccine was exposed to 28.8F for 1.5 hours. Administration route was not reported. Two lot# were involved and the lot# were reported as: 0294AE, expiry date on 06-SEP-2014; and 0385AE, expiry date on 08-NOV-2014. It was unspecified which lot# the patient was administered. The outcome of event was unknown. It was unspecified if the patient sought medical attention. This is one of several reports received from the same source. Additional information has been requested.
Sex: F
Vaccine: HEP
Symptoms: Incorrect storage of drug
Clinical narrative: This spontaneous report as received from a pharmacist refers to a newborn female patient of unknown age. On 12-NOV-2012 at 14:52, the patient was vaccinated with RECOMBIVAX HB that had been exposed to temperatures below 32F for 6 hours. During that 6 hour time period, the vaccine was exposed to 28.8F for 1.5 hours. Administration route was not reported. Two lot# were involved and the lot# were reported as: 0294AE, expiry date on 06-SEP-2014; and 0385AE, expiry date on 08-NOV-2014. It was unspecified which lot# the patient was administered. The outcome of event was unknown. It was unspecified if the patient sought medical attention. This is one of several reports received from the same source. Additional information has been requested.
Sex: F
Vaccine: HEP
Symptoms: Incorrect storage of drug
Clinical narrative: This spontaneous report as received from a pharmacist refers to a newborn female patient of unknown age. On 12-NOV-2012 at 21:01, the patient was vaccinated with RECOMBIVAX HB that had been exposed to temperatures below 32F for 6 hours. During that 6 hour time period, the vaccine was exposed to 28.8F for 1.5 hours. Administration route was not reported. Two lot# were involved and the lot# were reported as: 0294AE, expiry date on 06-SEP-2014; and 0385AE, expiry date on 08-NOV-2014. It was unspecified which lot# the patient was administered. The outcome of event was unknown. It was unspecified if the patient sought medical attention. This is one of several reports received from the same source. Additional information has been requested.
Sex: F
Vaccine: HEP
Symptoms: Incorrect storage of drug
Clinical narrative: This spontaneous report as received from a pharmacist refers to a newborn female patient of unknown age. On 12-NOV-2012 at 22:50, the patient was vaccinated with RECOMBIVAX HB that had been exposed to temperatures below 32F for 6 hours. During that 6 hour time period, the vaccine was exposed to 28.8F for 1.5 hours. Administration route was not reported. Two lot# were involved and the lot# were reported as: 0294AE, expiry date on 06-SEP-2014; and 0385AE, expiry date on 08-NOV-2014. It was unspecified which lot# the patient was administered. The outcome of event was unknown. It was unspecified if the patient sought medical attention. This is one of several reports received from the same source. Additional information has been requested.
Sex: M
Vaccine: HEP
Symptoms: Incorrect storage of drug
Clinical narrative: This spontaneous report as received from a pharmacist refers to a newborn (male) patient of unknown age. On 24-OCT-2012 05:56, the patient was vaccinated with RECOMBIVAX HB that had been exposed to temperatures below 32F for 6 hours. During that 6 hour time period, the vaccine was exposed to 28.8F for 1.5 hours. Administration route was not reported. Two lot# were involved and the lot# were reported as: 0294AE, expiry date on 06-SEP-2014; and 0385AE, expiry date on 08-NOV-2014. It was unspecified which lot# the patient was administered. The outcome of event was unknown. It was unspecified if the patient sought medical attention. This is one of several reports received from the same source. Additional information has been requested.
Sex: M
Vaccine: HEP
Symptoms: Incorrect storage of drug
Clinical narrative: This spontaneous report as received from a pharmacist refers to a newborn (male) patient of unknown age. On 24-OCT-2012 12:37, the patient was vaccinated with RECOMBIVAX HB that had been exposed to temperatures below 32F for 6 hours. During that 6 hour time period, the vaccine was exposed to 28.8F for 1.5 hours. Administration route was not reported. Two lot# were involved and the lot# were reported as: 0294AE, expiry date on 06-SEP-2014; and 0385AE, expiry date on 08-NOV-2014. It was unspecified which lot# the patient was administered. The outcome of event was unknown. It was unspecified if the patient sought medical attention. This is one of several reports received from the same source. Additional information has been requested.
Sex: F
Vaccine: HEP
Symptoms: Incorrect storage of drug
Clinical narrative: This spontaneous report as received from a pharmacist refers to a newborn (female) patient of unknown age. On 24-OCT-2012 12:43, the patient was vaccinated with RECOMBIVAX HB that had been exposed to temperatures below 32F for 6 hours. During that 6 hour time period, the vaccine was exposed to 28.8F for 1.5 hours. Administration route was not reported. Two lot# were involved and the lot# were reported as: 0294AE, expiry date on 06-SEP-2014; and 0385AE, expiry date on 08-NOV-2014. It was unspecified which lot# the patient was administered. The outcome of event was unknown. It was unspecified if the patient sought medical attention. This is one of several reports received from the same source. Additional information has been requested.
Sex: F
Vaccine: HEP
Symptoms: Incorrect storage of drug
Clinical narrative: This spontaneous report as received from a pharmacist refers to a newborn (female) patient of unknown age. On 24-OCT-2012 16:19, the patient was vaccinated with RECOMBIVAX HB that had been exposed to temperatures below 32F for 6 hours. During that 6 hour time period, the vaccine was exposed to 28.8F for 1.5 hours. Administration route was not reported. Two lot # were involved and the lot # were reported as; 0294AE, expiry date on 06-SEP-2014; and 0385AE, expiry date on 08-NOV-2014. IT was unspecified which lot # the patient was administered. The outcome of event was unknown. It was unspecified if the patient sought medical attention. this is one of several reports received from the same source. Additional information has been requested.
Age: 1.28
Sex: M
Vaccine: DTAP, FLU3, HIBV, PNC13
Symptoms: Death, Resuscitation, Unresponsive to stimuli
Clinical narrative: Was seen for 15 mo well child visit 10/28/2011 received DTaP, HIB, PCV 13 and influenza vaccines approximately 5pm exam was normal. Patient was at daycare 10/31/11 and found to be unresponsive after being put down for a nap. Brought to ER, pronounced dead after unsuccessful resuscitation attempt.
Age: 58.0
Sex: M
Vaccine: DTAP, HEPAB, IPV, HEPAB, IPV
Symptoms: Hepatitis B core antibody negative, Hepatitis B surface antigen positive
Clinical narrative: This case was reported by a consumer (also the subject) and described the occurrence of hepatitis b positive in a 58-year-old male subject who was vaccinated with TWINRIX (GlaxoSmithKline). A physician or other health care professional has not verified this report. Concurrent medical conditions included high blood pressure, house dust allergy and pre-diabetes. Concurrent vaccination included poliomyelitis vaccine inactivated (non-gsk) ;non-GSK manufacturer;unknown;unknown given on 16 December 2011. On 16 December 2011 the subject received 1st dose of TWIRIX (unknown route, left arm). On 17 December 2011, 1 day after vaccination with TWINRIX, the subject experienced hepatitis b positive. The subject's blood was drawn on 17 December 2011 and on 19 December 2011, the subject received the results indicating that he was "positive for hepatitis B". The subject planned to continue follow up with his physician. At the time of reporting the event was unresolved. Follow-up information was received on 01 May 2012 via physician. The physician reported the hepatitis b positive was attributed to the subject's medical history/ concurrent illness of chronic hepatitis B. The subject received the vaccine on 16 December 2011 and one day later gave blood showing a diagnosis of Chronic Hepatitis B; subject later recalled being contacted by a former sexual contact informing him she had hepatitis B. He had requested a full STD (sexually transmitted disease) screen prior to receiving the vaccine.
Age: 58.0
Sex: M
Vaccine: DTAP, HEPAB, IPV, HEPAB, IPV
Symptoms: Hepatitis B DNA assay negative, Hepatitis B core antibody negative, Hepatitis B e antigen negative, Hepatitis B surface antigen positive, Hepatitis B virus test positive
Clinical narrative: This case was reported by a consumer (also the subject) and described the occurrence of hepatitis b positive in a 58-year-old male subject who was vaccinated with TWINRIX (GlaxoSmithKline). A physician or other health care professional has not verified this report. Concurrent medical conditions included high blood pressure, house dust allergy and pre-diabetes. Concurrent vaccination included poliomyelitis vaccine inactivated (non-gsk) ;non-GSK manufacturer;unknown;unknown given on 16 December 2011. On 16 December 2011 the subject received 1st dose of TWIRIX (unknown route, left arm). On 17 December 2011, 1 day after vaccination with TWINRIX, the subject experienced hepatitis b positive. The subject's blood was drawn on 17 December 2011 and on 19 December 2011, the subject received the results indicating that he was "positive for hepatitis B". The subject planned to continue follow up with his physician. At the time of reporting the event was unresolved. Follow-up information was received on 01 May 2012 via physician. The physician reported the hepatitis b positive was attributed to the subject's medical history/ concurrent illness of chronic hepatitis B. The subject received the vaccine on 16 December 2011 and one day later gave blood showing a diagnosis of Chronic Hepatitis B; subject later recalled being contacted by a former sexual contact informing him she had hepatitis B. He had requested a full STD (sexually transmitted disease) screen prior to receiving the vaccine.
Age: 36.0
Sex: F
Vaccine: HEPAB, IPV, HEPAB, IPV
Symptoms: Arthralgia, Back pain, Blood creatine phosphokinase MB increased, Blood creatine phosphokinase increased, Blood creatine phosphokinase normal
Clinical narrative: This case was reported by a healthcare professional and described the occurrence of muscle weakness in a 36-year-old female subject who was vaccinated with TWINRIX (GlaxoSmithKline). Concurrent medical conditions included allergy to e-mycin and sulfa allergy. Concurrent vaccination include IPOL (non-gsk); Sanofi ;unknown; unknown given on 10 August 2012. There were no concurrent medications. On 10 August 2012 the subject received 1st dose of TWINRIX (1 ml, unknown, left arm). On 10 August 2012, less than one day after vaccination with TWINRIX, the subject experienced muscle weakness, muscle tenderness and difficulty lifting. The nurse reported the subject received the 1st dose of TWINRIX on 10 August 2012 and experienced muscle weakness, generalized muscle tenderness and difficulty lifting anything (example: subject has a hard time lifting 3-year old child). This continued through until 16 August 2012 and is unresolved. The nurse stated "she is only a tiny bit better today, but not much'. The subject was treated with ALEVE 800 mg for a couple of days, but now is taking ibuprofen (don't not specified), rest and drinking plenty of fluids. The subject had blood drawn on 16 August 2012 but results are still pending. The immunization series with TWINRIX was discontinued. At the time of reporting the events were unresolved. The healthcare professional considered the events were probably related to vaccination with TWINRIX. Follow-up information was received on 22 October 2012 via healthcare professional who reported the 36-year-old female subject who was vaccinated on 10 August 2012 with TWINRIX (1 ml, intramuscular, left deltoid). Additional medical history included postpartum depression. Additional concurrent medications included Multivitamins (OTC vitamins). and CELEXA. The subject suffered from post partum depression and took sertraline; youngest child is now 3-years old. The healthcare professional clarified that on 13 August 2012, 3 days after vaccination with TWINRIX, the subject experienced muscle weakness, muscle tenderness and difficulty lifting. The vaccination course with TWINRIX was discontinued. Subsequent vaccination with HAVRIX on 07 September 2012, she had no adverse signs/ symptoms following that dose. The reporting healthcare professional attributed the events to medical history/ concurrent illness; "the only thing we could identify was fatigue". On 17 August 2012 the subject reported complete recovery.