chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 0.16
Sex: U
Vaccine: RV5
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a register nurse refers to a 3 months infant, of unknown gender. Medical history and concurrent conditions were not reported. On 17-MAR-2014, the patient was vaccinated with second dose of ROTATEQ, lot #J008735; expiration date: 24-MAR-2015 (dose and strength were not reported. Secondary and concomitant therapies were not reported. Nurse called and stated that improperly stored ROTATEQ was administered to patient. No adverse effects reported. The nurse reported that vaccine dose received by patient was a vaccine improperly stored as follows: On 13-JAN-2014, ROTATEQ was stored outside of recommended temperatures for 2 hours (2 pm - 4 pm) the temperature recorded was 50 degrees F. On 18-JAN-2014, ROTATEQ was stored outside of recommended temperatures for 2 hours (2 pm - 4 pm) the temperature recorded was 49.1 degrees F. On 10-FEB-2014, ROTATEQ was stored outside of recommended temperatures for 6 hours (12 pm - 6 pm) the temperature recorded was 51.8 degrees F. On 16-FEB-2014, ROTATEQ was stored outside of recommended temperatures for 5 hours (12 pm - 5 pm) the temperature recorded was 51.8 degrees F. On 22-FEB-2014, ROTATEQ was stored outside of recommended temperatures for 4 hours (2 pm - 6 pm) the temperature recorded was 52.7 degrees F. On 09-MAR-2014, ROTATEQ was stored outside of recommended temperatures for 2 hours (12 pm - 10 pm) the temperature recorded was 55.4 degrees F. On 15-MAR-2014, ROTATEQ was stored outside of recommended temperatures for 6 hours (8 am - 2 pm) the temperature recorded was 50 degrees F. On 16-MAR-2014, ROTATEQ was stored outside of recommended temperatures for 20 hours (2 am - 10 pm) the temperature recorded was 64.4 degrees F. On 17-MAR-2014, ROTATEQ the temperature reading on the morning was 64.8 degrees F. The total of hours stored outside of recommended temperatures was 55 hours. This is one of several reports from the same reporter. Additional information has been requested.
Age: 0.52
Sex: U
Vaccine: RV5
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a register nurse refers to a 6 months infant, of unknown gender. Medical history and concurrent conditions were not reported. On 17-MAR-2014, the patient was vaccinated with third dose of ROTATEQ, lot #J008735; expiration date: 24-MAR-2015 (dose and strength were not reported. Secondary and concomitant therapies were not reported. Nurse called and stated that improperly stored ROTATEQ was administered to patient. No adverse effects reported. The nurse reported that vaccine dose received by patient was a vaccine improperly stored as follows: On 13-JAN-2014, ROTATEQ was stored outside of recommended temperatures for 2 hours (2 pm - 4 pm) the temperature recorded was 50 degrees F. On 18-JAN-2014, ROTATEQ was stored outside of recommended temperatures for 2 hours (2 pm - 4 pm) the temperature recorded was 49.1 degrees F. On 10-FEB-2014, ROTATEQ was stored outside of recommended temperatures for 6 hours (12 pm - 6 pm) the temperature recorded was 51.8 degrees F. On 16-FEB-2014, ROTATEQ was stored outside of recommended temperatures for 5 hours (12 pm - 5 pm) the temperature recorded was 51.8 degrees F. On 22-FEB-2014, ROTATEQ was stored outside of recommended temperatures for 4 hours (2 pm - 6 pm) the temperature recorded was 52.7 degrees F. On 09-MAR-2014, ROTATEQ was stored outside of recommended temperatures for 2 hours (12 pm - 10 pm) the temperature recorded was 55.4 degrees F. On 15-MAR-2014, ROTATEQ was stored outside of recommended temperatures for 6 hours (8 am - 2 pm) the temperature recorded was 50 degrees F. On 16-MAR-2014, ROTATEQ was stored outside of recommended temperatures for 20 hours (2 am - 10 pm) the temperature recorded was 64.4 degrees F. On 17-MAR-2014, ROTATEQ the temperature reading on the morning was 64.8 degrees F. The total of hours stored outside of recommended temperatures was 55 hours. This is one of several reports from the same reporter. Additional information has been requested.
Age: 0.14
Sex: U
Vaccine: RV5
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a register nurse refers to a 1 month infant, of unknown gender. Medical history and concurrent conditions were not reported. On 17-MAR-2014, the patient was vaccinated with first dose of ROTATEQ, lot #J008735; expiration date: 24-MAR-2015 (dose and strength were not reported. Secondary and concomitant therapies were not reported. Nurse called and stated that improperly stored ROTATEQ was administered to patient. No adverse effects reported. The nurse reported that vaccine dose received by patient was a vaccine improperly stored as follows: On 13-JAN-2014, ROTATEQ was stored outside of recommended temperatures for 2 hours (2 pm - 4 pm) the temperature recorded was 50 degrees F. On 18-JAN-2014, ROTATEQ was stored outside of recommended temperatures for 2 hours (2 pm - 4 pm) the temperature recorded was 49.1 degrees F. On 10-FEB-2014, ROTATEQ was stored outside of recommended temperatures for 6 hours (12 pm - 6 pm) the temperature recorded was 51.8 degrees F. On 16-FEB-2014, ROTATEQ was stored outside of recommended temperatures for 5 hours (12 pm - 5 pm) the temperature recorded was 51.8 degrees F. On 22-FEB-2014, ROTATEQ was stored outside of recommended temperatures for 4 hours (2 pm - 6 pm) the temperature recorded was 52.7 degrees F. On 09-MAR-2014, ROTATEQ was stored outside of recommended temperatures for 2 hours (12 pm - 10 pm) the temperature recorded was 55.4 degrees F. On 15-MAR-2014, ROTATEQ was stored outside of recommended temperatures for 6 hours (8 am - 2 pm) the temperature recorded was 50 degrees F. On 16-MAR-2014, ROTATEQ was stored outside of recommended temperatures for 20 hours (2 am - 10 pm) the temperature recorded was 64.4 degrees F. On 17-MAR-2014, ROTATEQ the temperature reading on the morning was 64.8 degrees F. The total of hours stored outside of recommended temperatures was 55 hours. This is one of several reports from the same reporter. Additional information has been requested.
Age: 0.26
Sex: U
Vaccine: RV5
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a register nurse refers to a 3 months infant, of unknown gender. Medical history and concurrent conditions were not reported. On 10-MAR-2014, the patient was vaccinated with first dose of ROTATEQ, lot #J007283; expiration date: 27-SEP-2014 (dose and strength were not reported. Secondary and concomitant therapies were not reported. Nurse called and stated that improperly stored ROTATEQ was administered to patient. No adverse effects reported. The nurse reported that vaccine dose received by patient was a vaccine improperly stored as follows: On 13-JAN-2014, ROTATEQ was stored outside of recommended temperatures for 2 hours (2 pm - 4 pm) the temperature recorded was 50 degrees F. On 18-JAN-2014, ROTATEQ was stored outside of recommended temperatures for 2 hours (2 pm - 4 pm) the temperature recorded was 49.1 degrees F. On 10-FEB-2014, ROTATEQ was stored outside of recommended temperatures for 6 hours (12 pm - 6 pm) the temperature recorded was 51.8 degrees F. On 16-FEB-2014, ROTATEQ was stored outside of recommended temperatures for 5 hours (12 pm - 5 pm) the temperature recorded was 51.8 degrees F. On 22-FEB-2014, ROTATEQ was stored outside of recommended temperatures for 4 hours (2 pm - 6 pm) the temperature recorded was 52.7 degrees F. On 09-MAR-2014, ROTATEQ was stored outside of recommended temperatures for 2 hours (12 pm - 10 pm) the temperature recorded was 55.4 degrees F. On 15-MAR-2014, ROTATEQ was stored outside of recommended temperatures for 6 hours (8 am - 2 pm) the temperature recorded was 50 degrees F. On 16-MAR-2014, ROTATEQ was stored outside of recommended temperatures for 20 hours (2 am - 10 pm) the temperature recorded was 64.4 degrees F. On 17-MAR-2014, ROTATEQ the temperature reading on the morning was 64.8 degrees F. The total of hours stored outside of recommended temperatures was 55 hours. This is one of several reports from the same reporter. Additional information has been requested.
Age: 11.0
Sex: U
Vaccine: MMRV
Symptoms: Expired drug administered, No adverse event
Clinical narrative: This spontaneous report as received from a unspecified healthcare provider refers to a 11 year old patient. On an unknown date, the patient was vaccinated with expired PROQUAD (Merck) (lot # and expiry date not provided) by an unspecified healthcare provider. No concomitant medication was reported. It was reported that PROQUAD (Merck) had an expiration date of over two months ago. No adverse effects reported. No product quality complaint filed. Outcome of the event was unknown. Additional information is not expected.
Age: 0.18
Sex: U
Vaccine: RV5
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse refers to a 2 months old patient of unknown gender. The nurse reported that on 29-JAN-2014, the patient was vaccinated with the first dose of ROTATEQ, (lot #J005073) expiration date: 17-SEP-2014. Route and dose were not reported. On 14-MAR-2014, the patient received the second dose of ROTATEQ, (Lot # J008735), expiration date: 24-MAR-2015. No other co-suspect or concomitant medications were reported. The nurse reported that both doses received by patient were vaccines improperly stored as follows: On 13-JAN-2014, ROTATEQ was stored outside of recommended temperatures for 2 hours (2 pm - 4 pm) the temperature recorded was 50 degrees F. On 18-JAN-2014, ROTATEQ was stored outside of recommended temperatures for 2 hours (2 pm - 4 pm) the temperature recorded was 49.1 degrees F. On 10-FEB-2014, ROTATEQ was stored outside of recommended temperatures for 6 hours (12 pm - 6 pm) the temperature recorded was 51.8 degrees F. On 16-FEB-2014, ROTATEQ was stored outside of recommended temperatures for 5 hours (12 pm - 5 pm) the temperature recorded was 51.8 degrees F. On 22-FEB-2014, ROTATEQ was stored outside of recommended temperatures for 4 hours (2 pm - 6 pm) the temperature recorded was 52.7 degrees F. On 09-MAR-2014, ROTATEQ was stored outside of recommended temperatures for 2 hours (12 pm - 10 pm) the temperature recorded was 55.4 degrees F. On 15-MAR-2014, ROTATEQ was stored outside of recommended temperatures for 6 hours (8 am - 2 pm) the temperature recorded was 50 degrees F. On 16-MAR-2014, ROTATEQ was stored outside of recommended temperatures for 20 hours (2 am - 10 pm) the temperature recorded was 64.4 degrees F. On 17-MAR-2014, ROTATEQ the temperature reading on the morning was 64.8 degrees F. The total of hours stored outside of recommended temperatures was 55 hours. No adverse effects reported. This is one of several reports received from the same source. Additional information is not expected.
Age: 0.34
Sex: M
Vaccine: RV5
Symptoms: Oral administration complication, Vomiting
Clinical narrative: This spontaneous report as received from a certified medical assistant refers to a 4 month old male patient with no pertinent medical history. On 26-FEB-2014, the patient was vaccinated with a dose of ROTATEQ (dose and lot # not reported) orally and on 25-APR-2014, the patient inadvertently received an incomplete dose of ROTATEQ (dose and lot # not reported) orally, due to vomiting immediately after administration. The outcome of vomiting was unknown. Additional information has been requested.
Age: 0.53
Sex: U
Vaccine: RV5
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a register nurse refers to a 6 months infant, of unknown gender, Medical history and concurrent conditions were not reported. On 11-MAR-2014, the patient was vaccinate with third dose of ROTATEQ oral, lot # J008735; expiration date: 24-MAR-2015 (dose and strength were not reported). Secondary and concomitant therapies were not reported. Nurse called and stated that improperly stored ROTATEQ was administered to patient. No adverse effects reported. The nurse reported that vaccine dose received by patient was a vaccine improperly stored as follows: On 13-JAN-2014, ROTATEQ was stored outside of recommended temperatures for 2 hours (2 pm- 4 pm) the temperature recorded was 50 degrees F. On 18-JAN-2014, ROTATEQ was stored outside of recommended temperatures for 2 hours (2 pm - 4 pm) the temperature recorded was 49.1 degrees F. On 10-FEB-2014, ROTATEQ was stored outside of recommended temperatures for 6 hours (12 pm - 6 pm) the temperature recorded was 51.8 degrees F. On 16-FEB-2014, ROTATEQ was stored outside of recommended temperatures for 5 hours (12 pm - 5 pm) the temperature recorded was 51.8 degrees F. On 22-FEB-2014, ROTATEQ was stored outside of recommended temperatures for 4 hours (2 pm - 6 pm) the temperature recorded was 52.7 degrees F. On 09-MAR-2014, ROTATEQ was stored outside of recommended temperatures for 2 hours (12 pm - 10 pm) the temperature recorded was 55.4 degrees F. On 15-MAR-2014, ROTATEQ was stored outside of recommended temperatures for 6 hours (8 am - 2 pm) the temperature recorded was 50 degrees F. On 16-MAR-2014, ROTATEQ was stored outside of recommended temperatures for 20 hours (2 am - 10 pm) the temperature recorded was 64.4 degrees F. On 17-MAR-2014, ROTATEQ the temperature reading on the morning was 64.8 degrees F. The total of hours stored outside of recommended temperatures was 55 hours. This is one of several reports from the same reporter. Additional information has been requested.
Sex: U
Vaccine: MMRV
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a medical assistant refers to unknown number of patients of unknown age. The reproter reported that an unknown number of doses of PROQUAD (Merck) (lot# unspecified), which underwent temperatures outside the prescribing information (PI) and were supported, had been administered (dose, route unspecified). No adverse effects reported. The outcome of the event was unknown. This is one of two reports from the same reproter. The other report is 1404USA014365. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a medical assistant refers to unknown number of patients of unknown age. The reporter reported that an unknown number of doses of VARIVAX (Merck) (lot# unspecified), which underwent temperatures outside the prescribing information (PI) and were supported, had been administered (dose, route unspecified). No adverse effects reported. The outcome of the event was unknown. This is one of two reports from the same reporter. The other report is 1404USA014496. Additional information has been requested.
Age: 1.0
Sex: U
Vaccine: MMRV, VARCEL
Symptoms: Incorrect dose administered, No adverse event
Clinical narrative: This spontaneous report as received from a medical assistant refers to a 12 month old patient. On an unknown date the patient was vaccinated with first dose of PROQUAD (dosage information and lot number unknown) and a dose of VARIVAX (Merck) (dosage information and lot number unknown) on the same office visit. No adverse effect reported. It was unknown if the patient had sought medical attention. Additional information has been requested.
Age: 5.0
Sex: F
Vaccine: MMR, VARCEL
Symptoms: Varicella post vaccine
Clinical narrative: Developed varicella (clinical diagnosis) 19 days after vaccine administered. No adverse outcome.
Age: 0.4
Sex: U
Vaccine: MMR
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: This spontaneous report as received from a other health professional refers to a 4 month old patient of unknown gender. On an unknown date the patient was vaccinated with M-M-R II, 0.5 ml (milliliters), subcutaneous. No concomitant medication was reported. On an unknown date a 4 month old patient received a dose of M-M-R II. Medical assistant reporting that a 4-month old patient received a dose of M-M-R II. No symptoms reported. Medical assistant inquiring about what information is available for M-M-R II administered to a 4-month old patient. There was no product quality complaint (PQC) involved. The outcome of the medication error and no symptoms reported is unknown. Additional information has been requested.
Age: 4.0
Sex: F
Vaccine: VARCEL
Symptoms: Pruritus, Rash papular, Urticaria
Clinical narrative: Developed urticarial rash 4/16/14 - interm. hives and itching over next 1-2 weeks - some pressure urticaria lesions, others papular, itchy, no vesicles present; seen 4/29/14 started oral antihistamine medication.
Age: 43.0
Sex: F
Vaccine: VARCEL
Symptoms: Body temperature increased, Cellulitis, Injection site erythema
Clinical narrative: 10 hours after receiving vaccine, noticed reddened area where vaccine was administered. Next day later temp 100.5. Went to ED. Was dx with cellulitis and given clindamycin.
Age: 65.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Expired drug administered
Clinical narrative: After I administered the ZOSTAVAX vaccine, I noticed the vaccine was expired by 5 days.
Age: 65.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Expired drug administered, No adverse event
Clinical narrative: After I administered the ZOSTAVAX vaccine, I noticed the vaccine was expired by 5 days.
Age: 26.0
Sex: F
Vaccine: MMR
Symptoms: Rash generalised
Clinical narrative: Rash on eyes, chin, chest, leg starting 2 days after MMR vaccine. Treated w/ CLARITIN, triamcinolone cream.
Age: 1.39
Sex: M
Vaccine: DTAP, HIBV, VARCEL
Symptoms: Injection site rash, Pyrexia, Rash generalised, Rash vesicular
Clinical narrative: Rash started from injection site within 24 hours. Fever to 102-103 and developed vesicular all over body.
Age: 67.0
Sex: F
Vaccine: VARZOS
Symptoms: Hypersensitivity, Injection site erythema, Injection site induration, Injection site nodule, Injection site reaction
Clinical narrative: Apparent allergic reaction: 14 x 7 cm red plaque, warmth, swelling at site of admin. 4 x 2 cm hard knot in center of swollen area.
Age: 67.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site swelling, Injection site warmth, Skin plaque
Clinical narrative: Apparent allergic reaction: 14 x 7 cm red plaque, warmth, swelling at site of admin. 4 x 2 cm hard knot in center of swollen area.
Age: 0.16
Sex: F
Vaccine: DTAPIPVHIB, HEP, PNC13, RV5
Symptoms: Blood glucose normal, Breath holding, Electroencephalogram normal, Full blood count normal, General physical condition abnormal
Clinical narrative: Immediately after giving vaccines, pt appeared to have a breath holding spell (from pain and shock of shots). Mom thought she looked "out of it" but was then fine. Left office well and happy. Mom called at 245pm same day and said it occurred 3-4 more times for approx 10 secs. Mom states she "looks dead" then appears normal. Advised mom to go to ER where pt was admitted for 2 days.
Age: 0.16
Sex: F
Vaccine: DTAPIPVHIB, HEP, PNC13, RV5
Symptoms: Immediate post-injection reaction, Influenza A virus test negative, Influenza B virus test, Influenza virus test negative, Metabolic function test normal
Clinical narrative: Immediately after giving vaccines, pt appeared to have a breath holding spell (from pain and shock of shots). Mom thought she looked "out of it" but was then fine. Left office well and happy. Mom called at 245pm same day and said it occurred 3-4 more times for approx 10 secs. Mom states she "looks dead" then appears normal. Advised mom to go to ER where pt was admitted for 2 days.
Age: 0.16
Sex: F
Vaccine: DTAPIPVHIB, HEP, PNC13, RV5
Symptoms: Pain, Respiratory syncytial virus test negative, Shock
Clinical narrative: Immediately after giving vaccines, pt appeared to have a breath holding spell (from pain and shock of shots). Mom thought she looked "out of it" but was then fine. Left office well and happy. Mom called at 245pm same day and said it occurred 3-4 more times for approx 10 secs. Mom states she "looks dead" then appears normal. Advised mom to go to ER where pt was admitted for 2 days.
Age: 1.0
Sex: F
Vaccine: MMR, PNC13, VARCEL
Symptoms: Balance disorder, Bronchiolitis, Cough, Ear infection, Ear tube insertion
Clinical narrative: 4/16/14 - 1 wk of cough, intermittent fever - dxd with bronchiolitis/Rt infrahilar pneumonia - txt with ZITHROMAX - albuterol - ORAPRED better 4/17/14. 4/21/2014 - refused to walk - poor balance. 4/22 - refusal to crawl seen in ER. 4/23/14 - Adm to hospital - vaccine cerebellitis.
Age: 1.0
Sex: F
Vaccine: MMR, PNC13, VARCEL
Symptoms: Encephalitis, Gait disturbance, Inability to crawl, Lumbar puncture, Nuclear magnetic resonance imaging
Clinical narrative: 4/16/14 - 1 wk of cough, intermittent fever - dxd with bronchiolitis/Rt infrahilar pneumonia - txt with ZITHROMAX - albuterol - ORAPRED better 4/17/14. 4/21/2014 - refused to walk - poor balance. 4/22 - refusal to crawl seen in ER. 4/23/14 - Adm to hospital - vaccine cerebellitis.
Age: 1.0
Sex: F
Vaccine: MMR, PNC13, VARCEL
Symptoms: Nuclear magnetic resonance imaging brain, Pneumonia, Pyrexia, Venogram
Clinical narrative: 4/16/14 - 1 wk of cough, intermittent fever - dxd with bronchiolitis/Rt infrahilar pneumonia - txt with ZITHROMAX - albuterol - ORAPRED better 4/17/14. 4/21/2014 - refused to walk - poor balance. 4/22 - refusal to crawl seen in ER. 4/23/14 - Adm to hospital - vaccine cerebellitis.
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site hypersensitivity, Injection site swelling
Clinical narrative: This spontaneous report as received from a pharmacist refers to a 61 year old female patient. Patient's medical history was reported as red rash on face and hand after receiving unspecified cortisone injection on unspecified date. On 17-APR-2014, the patient was vaccinated with ZOSTAVAX vial 19400, plaque-forming units (PFU) (lot number J011335, expiry date 20-DEC-2014), 0.65 ml /once, subcutaneous. Concomitant therapy was unspecified. Approximately on an unknown date in April 2014, the patient experienced allergic reaction at injection site of ZOSTAVAX. Pharmacist further clarified that patient described reaction as raised area involving left deltoid area and about the size of her hand, with no pain or no itching. No medical intervention was given and patient continues to monitor site of reaction. No lab diagnostics studies were performed. No product quality complaint was involved. The outcome of allergic reaction at injection site was unknown. The reporters causality assessment for the event allergic reaction at injection site with the therapy of ZOSTAVAX was not reported. Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Syncope
Clinical narrative: This spontaneous report was received from a healthcare worker via a company representative refer to unspecified number of patients (age, gender unknown). The healthcare worker reported that unspecified number of patients may have fainted after receiving a dose of GARDASIL (dates unspecified). This is one of several reports received from the same reporter (case# 1404USA010532 and 1404USA015348). Additional information has been requested.
Age: 11.0
Sex: F
Vaccine: HPV4
Symptoms: Acne, Pruritus generalised
Clinical narrative: This spontaneous report as received from a nurse refers to a female patient (estimated age 11 years). There was no medical history or allergies. On 17-FEB-2014 and 18-APR-2014 the patient was vaccinated with GARDASIL dose 1 and 2. There was no concomitant medication. On an unknown date in 2014 after receiving a first and second dose of GARDASIL the patient developed pimples in her ears and on her arms and neck and was itchy all over. There was no treatment. The outcome of developed pimples in her ears and on her arms and neck and itchy all over was reported as not recovered/not resolved. The nurse inquired if this patient should receive the third dose. Additional information has been requested.
Age: 1.42
Sex: M
Vaccine: DTAP
Symptoms: Diarrhoea, Frequent bowel movements
Clinical narrative: Very loose stool, milky consistency, occurring at least 5x daily for the past 7 days.
Sex: F
Vaccine: VARZOS
Symptoms: Burning sensation, Herpes zoster, Pain of skin, Rash
Clinical narrative: This spontaneous report as received from a physician (internal medicine specialist) refers to a female patient of unknown age. No information on medical history, concurrent conditions or concomitant medications was provided. On an unknown date the patient was vaccinated by a primary care physician (other than the reporting one) with ZOSTAVAX, dose, route, lot# and expiration date not reported. Two days post vaccination the patient developed burning and pain on her scalp. At the time of the report he had shingles rash on the left side of her head to her left eyebrow. The patient sought medical attention: was seen in urgent care division. The outcome of the adverse event was reported as not recovered/not resolved. Relatedness between use of ZOSTAVAX and the patient developing shingles rash was unknown. Additional information is not requested.
Sex: U
Vaccine: HEPA
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from an immunization coordinator refers to an unknown number of patients of unknown age and gender. The immunization coordinator mentioned VAQTA that was improperly stored might have been given to an unknown number of patients. VAQTA was exposed to temperatures of 32F (Fahrenheit) for 110 hours (temperature excursion not supported by stability data). No adverse effects reported. This is one of several reports from the same source (1402USA007570, 1404USA012060, 1404USA012062 and 1404USA012063). Additional information has been requested.
Sex: M
Vaccine: VARZOS
Symptoms: Hypoaesthesia, Neuropathy peripheral
Clinical narrative: This spontaneous report was received from a other health professional which refers to a male patient of unknown age. On 08-APR-2014 the patient was vaccinated with ZOSTAVAX dose 1, subcutaneous. No relevant medical history was reported. No concomitant medication was reported. On 17-APR-2014 the patient experienced numbness in his fingers, thumb, index and radial aspect of the middle finger. Patient was seen by a neurologist on 22-APR-2014 and was diagnosed with brachial plexus neuropathy. Patient received treatment with Prednisone. On 22-APR-2014, 15 days after onset of therapy the patient experienced brachial plexus neuropathy (medically significant). The outcome of brachial plexus neuropathy and numbness in his fingers, thumb, index and radial aspect of the middle finger is unknown. No further information was provided.
Sex: U
Vaccine: HBHEPB
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from an immunization coordinator refers to an unknown number of patients of unknown age and gender. The immunization coordinator mentioned COMVAX that was improperly stored might have been given to an unknown number of patients. COMVAX was exposed to temperatures of 32F (Fahrenheit) for 110 hours (temperature excursion not supported by stability data). No adverse effects reported. This is one of several reports from the same source (1402USA007570, 1404USA012061, 1404USA012062 and 1404USA012063). Additional information has been requested.
Age: 35.0
Sex: F
Vaccine: VARCEL
Symptoms: Erythema, Local swelling, Oropharyngeal pain, Pain in extremity
Clinical narrative: Varicella vaccine given 4/28/14 at approx 2:30pm. Started to have throat pain at approx 4pm on 4/29 left upper arm with redness, pain and swelling.
Sex: U
Vaccine: HEPA
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse refers to unknown number of patients of unknown age and gender whom in January 2014 were vaccinated with VAQTA (dose, route and lot# not reported) that had been improperly stored. No adverse effects reported. This is one of several reports received from same reporter. Additional information has been requested.
Sex: U
Vaccine: RV5
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a nurse refers to an unspecified number of patients of unknown age and gender. The nurse reported that an unspecified number of patients received ROTATEQ (lot number, dose, frequency, route not specified) that were exposed to 51F (Fahrenheit) for 228 hours, which was an excursion that was found to be unsupported by in-house stability data. No adverse symptoms reported. No further information provided. All telephone attempts to obtain follow-up information have been unsuccessful. Follow up was received from an immunization coordinator on 17-APR-2014. ROTATEQ was exposed to temperatures of 32F for 110 hours then 51F for 228 hours (temperature excursion not supported by stability data). No adverse effects reported. This is one of several reports from the same source (1402USA007570, 1404USA012060, 1404USA012061 and 1404USA012062). Additional information has been requested.
Age: 0.16
Sex: M
Vaccine: DTAPIPVHIB, PNC13, RV5
Symptoms: Crying, Discomfort, Gastrointestinal disorder, Haematochezia, Irritability
Clinical narrative: This spontaneous report was received from a physician via a field representative refers to an 8 weeks old male patient with milk protein intolerance diagnosed at one month (approximately on 15-MAR-2014). On 14-APR-2014, the patient was vaccinated with a dose of ROTATEQ 2 mg 1 standard package tube of 2, lot # J011334, expire date 13-MAY-2015, 2 ml, oral, as indicated. Other suspect therapies included PENTACEL and PREVNAR. There was no concomitant medication. On 14-APR-2014 about 5 hours after administration the patient exhibited discomfort, fussiness, and crying for about an hour after receiving ROTATEQ. The mother of the patient noted that the problem appeared to be "gastro related". It was also noted that the patient had blood in stools intermittently. It was reported that there was no blood in patient's stools prior to vaccination on 14-APR-2014. The patient visited office on 16-APR-2014, and no blood was found in stool. However, the patient's mother reported blood in stools in the evening of 16-APR-2014. The physician described this as hematochezia. Lab diagnostic studies were performed on 16-APR-2014. The patient sought medical attention by calling and visiting primary physician. At the time of this report the problem was still ongoing and had not been resolved. The outcome of the events was not recovered. The relationship between events and ROTATEQ was not reported. Additional information has been requested.
Age: 75.0
Sex: U
Vaccine: PPV
Symptoms: Expired drug administered, No adverse event
Clinical narrative: This spontaneous report was received from a nurse practitioner regarding an approximately 75 year old patient of unknown gender. On 28-APR-2014 the patient was vaccinated with PNEUMOVAX 23 lot # H020684; expiry: 17-APR-2014, 0.5 ml, intramuscular. No concomitant medications were reported. On 28-APR-2014, nurse reported that patient received an expired dose of PNEUMOVAX 23. No adverse effect was reported. There was no product quality complaint (PQC) involved. The outcome of expired vaccine administered and no adverse effect was reported is unknown. Additional information has been requested.
Age: 60.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Herpes zoster, Measles, Psoriasis
Clinical narrative: This spontaneous report was received from a consumer refers to herself as a 60 year old female patient. The patient was allergic to Penicillin (manufacturer unknown). On an unknown date in August 2013, the patient was vaccinated with ZOSTAVAX (dose, route and frequency were not reported). On an unknown date in 2013 (also reported as 2-3 weeks after) the patient experienced measles lasting about 3 weeks. On an unknown date in 2013 (also reported as about 13 days later) the patient experienced shingles lasting about 6-7 weeks. On an unknown date in 2013, the patient experienced psoriasis on her knees. The outcome of the event measles and shingles was reporting as recovering. The outcome of the event psoriasis on her knees was unknown. The reporter did not provide the causality between the events and the suspect drug. Additional information has been requested.
Age: 59.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Herpes zoster, Measles, Psoriasis
Clinical narrative: This spontaneous report as received from a 59 year old female consumer refers to herself. Patients concurrent conditions included osteoporosis and osteoarthritis. Patient medical history included penicillin allergy. On 04-AUG-2013, the patient was vaccinated with ZOSTAVAX, (dose, lot number and expiry date were unspecified), therapy route reported as injection. Concomitant therapy included multiple other medications (unspecified names, doses/frequencies and manufacturers). Approximately on an unknown date in August 2013 (reported as within an 8 days period after receiving ZOSTAVAX), the patient experienced measles, shingles and plaque psoriasis that spread to her knees. The patient has received triamcinolone for the treatment of the plaque psoriasis only. No lab diagnostics studies were performed. Patient did not seek medical attention. No product quality complaint was involved. The outcome of measles, shingles and plaque psoriasis that spread to her knees was reported as not recovered. The reporters causality assessment for the events measles, shingles and plaque psoriasis that spread to her knees with the therapy of ZOSTAVAX was not reported. No further information was provided. Additional information has been requested.
Age: 45.0
Sex: M
Vaccine: TDAP
Symptoms: Activities of daily living impaired, Crying, Injected limb mobility decreased, Injection site bruising, Injection site pain
Clinical narrative: Immunization stung more than a flu shot, she had some bruising at the injection site.  4/22/14 the deltoid was a lot more sore and became extremely painful.  4/23/14 shoulder hurt towards the back and somewhat towards the front.  By 4/25/14 the deltoid pain was resolving, but the shoulder pain has continued to get progressive worse.  Using her left arm is extremely painful in the shoulder and by this morning 4/30/14 she was in so much pain that she couldn't get out of bed and was crying.  The pain was so bad that it took her 2-3 hours to get ready for work.
Age: 19.0
Sex: U
Vaccine: HPV4
Symptoms: Incorrect storage of drug
Clinical narrative: This spontaneous report as received from a medical assistant refers to a 19 year old patient. On 21-APR-2014, the patient was vaccinated with temperature recursion experienced GARDASIL lot # J012212. No other concomitant medications were reported. The outcome of the event was not reported. The event temperature recursion experienced vaccine was considered to be not related to GARDASIL. This case is linked to the case # 1404USA010659, # 1404USA012082 and # 1404USA012090 (same reporter link). Additional information has been requested.
Age: 0.5
Sex: U
Vaccine: HEP
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report as received from a nurse refers to a 6 month old patient (gender unspecified). On 22-JAN-2014, the patient was administered the first dose of RECOMBIVAX HB injection, series, (lot number J010334 expiry date 05-DEC-2015), 0.5 ml, intramuscular. Concomitant therapy was unspecified. On 25-FEB-2014, the second dose in series of RECOMBIVAX HB (0.5 ml, intramuscular) was administered to the patient. On 25-APR-2014 (less than 16 weeks after first dose), the patient was vaccinated with the third dose of RECOMBIVAX HB (0.5 ml, intramuscular) series. The nurse was inquiring about the need of revaccination of the patient after receiving the third dose of RECOMBIVAX HB which was received earlier than recommended in the prescribing information. No adverse event was reported. No product quality complaint was involved. No further information was provided. Additional information has been requested.
Age: 48.0
Sex: F
Vaccine: VARCEL
Symptoms: Antibody test negative, Inappropriate schedule of drug administration
Clinical narrative: This spontaneous report as received from registered nurse refers to a 50 year old female patient. On 25-MAR-2011 the patient received a dose of VARIVAX (Merck) (Lot #0747Z, exp. date unspecified, 0.5ml dose, subcutaneous route). Concomitant therapy was not reported. On 24-FEB-2014 the patient had a low titer of 0.91. The patient sought unspecified medical attention and received a booster of VARIVAX (Merck) on 05-MAR-2014 (Lot # J006161, exp date 20-MAY-2015). The patient's outcome was unknown. Additional information has been requested.
Age: 37.0
Sex: F
Vaccine: TDAP
Symptoms: Atypical pneumonia, Cardiac telemetry, Chest X-ray abnormal, Chest discomfort, Condition aggravated
Clinical narrative: Day following vaccine patient develops nausea, vomiting, diarrhea and fever. Thursday lungs felt tight and she started coughing - Monday she went to hospital for hydration. Tuesday ER for episode of SVT. ER by ambulance admitted to Telemetry for a day of monitoring. By noon the next day she was in the ER again for another SVT episode - and again back in ER at midnight - chest X-ray and diagnosis of walking pneumonia given. 12 hours later she was back in the ER with SVT and was admitted to Telemetry overnight in SVT. She was treated with antibiotics and symptoms slowly improved. Known Tetanus vaccine approximately 7 years ago.
Age: 37.0
Sex: F
Vaccine: TDAP
Symptoms: Cough, Diarrhoea, Electrocardiogram, Exposure during pregnancy, Foetal monitoring
Clinical narrative: Day following vaccine patient develops nausea, vomiting, diarrhea and fever. Thursday lungs felt tight and she started coughing - Monday she went to hospital for hydration. Tuesday ER for episode of SVT. ER by ambulance admitted to Telemetry for a day of monitoring. By noon the next day she was in the ER again for another SVT episode - and again back in ER at midnight - chest X-ray and diagnosis of walking pneumonia given. 12 hours later she was back in the ER with SVT and was admitted to Telemetry overnight in SVT. She was treated with antibiotics and symptoms slowly improved. Known Tetanus vaccine approximately 7 years ago.
Age: 37.0
Sex: F
Vaccine: TDAP
Symptoms: Laboratory test, Nausea, Pyrexia, Supraventricular tachycardia, Vomiting
Clinical narrative: Day following vaccine patient develops nausea, vomiting, diarrhea and fever. Thursday lungs felt tight and she started coughing - Monday she went to hospital for hydration. Tuesday ER for episode of SVT. ER by ambulance admitted to Telemetry for a day of monitoring. By noon the next day she was in the ER again for another SVT episode - and again back in ER at midnight - chest X-ray and diagnosis of walking pneumonia given. 12 hours later she was back in the ER with SVT and was admitted to Telemetry overnight in SVT. She was treated with antibiotics and symptoms slowly improved. Known Tetanus vaccine approximately 7 years ago.
Age: 2.0
Sex: F
Vaccine: HEPA
Symptoms: Eye swelling, Lip swelling, Swollen tongue, Urticaria
Clinical narrative: Swollen eyes, swollen lips, and tongue. Hives formed throughout entire body. Discovered in the early morning hours while she was asleep.
Age: 0.34
Sex: M
Vaccine: DTAPIPVHIB, PNC13, RV5
Symptoms: Crying, Injection site erythema, Pyrexia
Clinical narrative: Crying, Low grade fever, redness at site of injection. Received Tylenol.
Age: 75.0
Sex: F
Vaccine: PPV
Symptoms: Abdominal pain upper, Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: It was red (some) on the evening of the shot by the next day my arm was swelled big red to elbow and up to shoulder almost all around very painful. My stomach hurt really bad it got worse the next day. I was told to put heat compresses and keep it moving and it got better in five days was back to normal.
Age: 66.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pain, Injection site warmth
Clinical narrative: Red, hot sore injection site - checked with pt at 9am on 4-24-14 getting better.
Age: 0.16
Sex: M
Vaccine: HIBV, RV5
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a healthcare worker refers to a 1 year old female infant. On 14-APR-2014 the patient was vaccinated with a dose of PEDVAXHIB, 0.5 ml, intramuscular in the left thigh, that had been improperly stored. On the same date, the patient also received a dose of ROTATEQ, 2 ml orally, that had been improperly stored. There was no adverse effect. Additional information has been requested.
Age: 1.01
Sex: F
Vaccine: HIBV
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a healthcare worker refers to a 1 year old female infant. On 08-APR-2014 the patient was vaccinated with a dose of PEDVAXHIB, 0.5 ml, intramuscular in the left thigh, that had been improperly stored. There was no adverse effect. Additional information has been requested. This is one of several reports from the same source.
Age: 0.18
Sex: F
Vaccine: HIBV, RV5
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a healthcare worker refers to a 2 months old female infant. On 16-APR-2014 the patient was vaccinated with a dose of PEDVAXHIB, 0.5 ml, intramuscular in the left thigh, that had been improperly stored. On the same date, the patient received a dose of ROTATEQ, 2 ml, orally, that had been improperly stored. There was no adverse effect. Additional information has been requested. This is one of several reports from the same source.
Sex: U
Vaccine: VARZOS
Symptoms: Rash
Clinical narrative: This spontaneous report as received from nurse practitioner via company representative refers to a patient of unspecified demographics. Patient's medical history, drug reactions and allergies were unspecified. On an unknown date, the patient was vaccinated with ZOSTAVAX, dose, lot number and expiry date were unspecified. Concomitant therapy was unspecified. On an unknown date, the patient developed rash after receiving ZOSTAVAX vaccine. No product quality complaint was involved. The outcome of event rash was unknown. The reporters causality assessment for the event rash with the therapy of ZOSTAVAX was not provided. No further information was provided. Additional information has been requested.
Age: 54.0
Sex: M
Vaccine: PPV, TDAP, PPV, TDAP
Symptoms: Hypotonia, Muscular weakness, Pain
Clinical narrative: Excruciating internal pain, 2 hrs after receiving vaccination. Can't use hand to lift. Arm went limp initially.
Age: 54.0
Sex: M
Vaccine: PPV, TDAP, PPV, TDAP
Symptoms: Hypotonia, Pain in extremity
Clinical narrative: Excruciating internal pain, 2 hrs after receiving vaccination. Can't use hand to lift. Arm went limp initially.
Age: 0.17
Sex: M
Vaccine: DTAPHEPBIP, HIBV, RV5
Symptoms: Crying, Depressed mood, Pyrexia, Restlessness
Clinical narrative: When he got the shots he cried uncontrollably, about 6 pm he started crying uncontrollably and very high pitched.  This continued off and on the entire evening.  His fever spiked to 103.5 had a very hard time settling him.  Gave him Tylenol no movement on the fever. The uncontrollable crying continued for at least 24 hours. He was very unsettled and unhappy for about a week.  Prior to the shots he was a very happy boy that NEVER had cried like that!
Age: 59.0
Sex: F
Vaccine: VARZOS
Symptoms: Axillary pain, Injection site erythema, Injection site pruritus, Injection site rash, Injection site swelling
Clinical narrative: Red bullseye at injection site.  Half dollar size red circle around injection site.  Expanded pinkish red site beyond the center red circle.  Upper arm at injection site was swollen,warm to touch and itchy.  Called the pharmacist who did the injection. He instructed me to keep an eye on it.  By the end of the day I went to Urgent Care, for a doctor to look at.  The urgent care dr cited the bullseye as a rash and gave me a Cortizone shot to ease symptoms and to use ice for relief.  On 30 April, my arm had something running down it.  So I covered it with gauze.  Noticed when I go to bed at night, my armpit is sore.  1 May 14, injection site is still red spot half dollar size; is improving.
Age: 59.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site warmth, Secretion discharge
Clinical narrative: Red bullseye at injection site.  Half dollar size red circle around injection site.  Expanded pinkish red site beyond the center red circle.  Upper arm at injection site was swollen,warm to touch and itchy.  Called the pharmacist who did the injection. He instructed me to keep an eye on it.  By the end of the day I went to Urgent Care, for a doctor to look at.  The urgent care dr cited the bullseye as a rash and gave me a Cortizone shot to ease symptoms and to use ice for relief.  On 30 April, my arm had something running down it.  So I covered it with gauze.  Noticed when I go to bed at night, my armpit is sore.  1 May 14, injection site is still red spot half dollar size; is improving.
Age: 46.0
Sex: F
Vaccine: TDAP
Symptoms: Axillary mass, Axillary pain, Breast pain, Ultrasound breast
Clinical narrative: Large lump under R axilla with pain extending to R breast.
Age: 40.0
Sex: F
Vaccine: TDAP
Symptoms: Headache, Herpes zoster, Influenza, Influenza B virus test positive, Pain
Clinical narrative: Developed rash on 04/09/2014 (diagnosed as shingles on 04/14/2014). Then, 04/13/2014, developed flu symptoms of fever, body ache, headache, and was diagnosed as Influenza B positive on 04/14/2014.
Age: 40.0
Sex: F
Vaccine: TDAP
Symptoms: Pyrexia, Rash
Clinical narrative: Developed rash on 04/09/2014 (diagnosed as shingles on 04/14/2014). Then, 04/13/2014, developed flu symptoms of fever, body ache, headache, and was diagnosed as Influenza B positive on 04/14/2014.
Age: 0.51
Sex: M
Vaccine: DTAPHEPBIP, RV5
Symptoms: Abdominal distension, Nausea, Vomiting projectile
Clinical narrative: Pt developed nausea and projectile vomiting with swollen abdomen. Pt seen in local ER and was treated with anti-emetic (Zofran).
Age: 0.17
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV5
Symptoms: Crying
Clinical narrative: Inconsolable crying started at 03:45 PM, sitter called me and I thought maybe it was because he was sleepy, sitter called again, I left work early, inconsolable crying lasted until 09:00PM at which point we were getting him ready to go to the emergency room and he finally stopped, we decided not to go to the ER due to his ceased crying and the fact that the physician more than likely would not believe us.
Age: 13.0
Sex: F
Vaccine: HPV4
Symptoms: Abdominal pain upper, Activities of daily living impaired, Blood test, Chest pain, Computerised tomogram
Clinical narrative: Stomach and sternum pain fatigue vomiting lots of vomiting and has had vomiting everyday 3-4 sometime 10 times a day ever since for the past 2 years she has been to multiple hospitals and doctors and specialist she has been put on several different medications that do not calm it down she carries a bucket around at school she missed more days from school then she went all dr excused because that's how many times I have had to take her to the doctor and nothing is helping her she was a very healthy athletic girl that didn't miss school until a few days after she received the injection she has been fatigued and sick every single day since we did not finish the injections because I new that what made her sick I took her back to the same dr a few days later and told them that's what made her sick and they said it couldn't have and no one told me that I could report it and I no they didn't report it because they said I was wrong but Im not wrong I know what made my child sick Im very worried about my daughter and I want someone to give her something that reverses the injection right away because its ruining my daughters life I want someone to call me and tell me what Im supposed to do to help her now.