chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a healthcare worker concerning an unspecified number of patients of unknown age and gender. Pertinent medical history, concurrent conditions, drug reactions or allergies were not reported. On an unknown date, the unspecified patients were vaccinated with improperly stored doses of ROTATEQ oral liquid (dose, dose number, lot number and expiration date were unspecified). No adverse effects reported. Concomitant therapies were not reported. Thi sis one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HBHEPB
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a healthcare worker concerning an unspecified number of patients of unknown age and gender. Pertinent medical history, concurrent conditions, drug reactions or allergies were not reported. On an unknown date, the unspecified patients were vaccinated with improperly stored doses of COMVAX (dose, dose number, route, anatomical location, lot number and expiration date were unspecified). No adverse effects reported. Concomitant therapies were not reported. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HEP
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a healthcare worker concerning an unspecified number of patients of unknown age and gender. Pertinent medical history, concurrent conditions, drug reactions or allergies were not reported. On an unknown date, the unspecified patients were vaccinated with improperly stored doses of RECOMBIVAX HB (dose, dose number, route, anatomical location, lot number and expiration date were unspecified). No adverse effects reported. Concomitant therapies were not reported. This is one of several reports received from the same reporter. Additional information has been requested.
Age: 15.0
Sex: U
Vaccine: VARCEL
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse refers to a 15 year old patient of unknown gender. The patient's medical history, concurrent conditions and concomitant medications were not reported. On 30-JUL-2015, the patient was vaccinated with an expired dose of (Oka/Merck) VARIVAX, lot number reported as J008026, expiration date: 30-JUN-2015, (dose, route of administration and injection site were not reported). It was the patient's second dose in the series of (Oka/Merck) VARIVAX. No adverse effects were reported. Additional information has been requested.
Sex: U
Vaccine: HIBV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a healthcare worker concerning an unspecified number of patients of unknown age and gender. Pertinent medical history, concurrent conditions, drug reactions or allergies were not reported. On an unknown date, the unspecified patients were vaccinated with improperly stored doses of PEDVAXHIB (dose, dose number, route, anatomical location, lot number and expiration date were unspecified). No adverse effects reported. Concomitant therapies were not reported. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: PPV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a healthcare worker concerning an unspecified number of patients of unkonwn age and gender. Pertinent medical history, concurrent conditions, drug reactions or allergies were not reported. On an unknown date, the unspecified patients were vaccinated with improperly stored doses of PNEUMOVAX23 (dose, dose number, route, anatomica location, lot number and expiration date were unspecified). No adverse effects reported. Concomitant therapies were not reported. This is one of several reports received from the same reporter. Additional information has been requested.
Age: 16.0
Sex: F
Vaccine: HPV4
Symptoms: Dizziness, Feeling abnormal
Clinical narrative: This spontaneous report was received from a physician refers to a female patient of unknown age. Patient's concurrent condition included anxiety. Her relevant medical history and drug reactions/allergies were not reported. On 06-MAY-2015 and 07-JUL-2015, the patient was vaccinated with first and second dose of GARDASIL (lot # L007531, expiry date: not provided and lot # L009964, expiry date: not provided) respectively, intramuscular for prophylaxis (reported as HPV vaccination). Concomitant therapies included ZOLOFT. Reporting physician stated that the patient experienced dizziness and felt like jelly everywhere in her body except in her feet, on an unspecified date in July 2015 (reported as about a week) after receiving both her first and second doses of GARDASIL. Patient sought medical attention and visited the physician on an unspecified date. Reporting physician stated that the patient could not clarify about her experience of feeling like jelly everywhere in her body except in her feet, but physician thought this could mean numbness. No treatment was given for the adverse events. Outcome of the events, hypoaesthesia and dizziness was reported as not recovered. Reporting physician did not assessed the causality of the events with respect to vaccination with GARDASIL. Additional information has been requested.
Sex: U
Vaccine: HPV9
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a healthcare worker concerning an unspecified number of patients of unknown age and gender. Pertinent medical history, concurrent conditions, drug reactions or allergies were not reported. On an unknown date, the unspecified patients were vaccinated with improperly stored doses of GARDASIL 9 (dose, dose number, route, anatomical location, lot number and expiration date were unspecified). No adverse effects reported. Concomitant therapies were not reported. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Wrong drug administered
Clinical narrative: This spontaneous report as received from a Registered Nurse refers to a patient of unknown age and gender. Concurrent conditions and other medical history were not reported. The nurse reported that on 22-JUL-2015, the patient was inadvertently vaccinated with a dose of (Oka/Merck) VARIVAX Subcutaneous injection (0.5 mL, subcutaneously, lot # K003411, expiration date 06-MAR-2015), instead of the intended dose of ZOSTAVAX. No adverse experience was reported. Additional information has been requested.
Age: 4.0
Sex: U
Vaccine: MMR
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a physician's office manage refers to a 4 year old patient of unknown gender. Pertinent medical history, drug reactions or allergies were not reported. On 01-JUN-2015 the patient was vaccinated with an improperly stored dose of M-M-R II lot # K014833, expiration date 14-SEP-2016 (dose, dose number, route and anatomical location were unspecified). Concomitant therapies were not reported. No adverse effects reported. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HEP
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report as received from a medical assistant refers to a patient of unknown age and gender. The patient's medical history and concurrent conditions were not reported. On 31-DEC-2014, the patient was vaccinated with the first dose of RECOMBIVAX HB (dose, route, lot number and expiration date were not reported). On 21-JAN-2015, the patient received the second dose of RECOMBIVAX HB (dose, route, lot number and expiration date were not reported). No adverse effects reported. Additional information has been requested.
Sex: U
Vaccine: RV5
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: Information has been received from a healthcare professional concerning a 7.5 month old infant who on an unknown date was vaccinated with a dose of ROTATEQ (dose and route not reported). The reporter stated that he patient received the vaccine "outside of the recommendations of ROTATEQ) prescribing information". No adverse effect was reported. Additional information is not expected as no contact information is available.
Sex: U
Vaccine: HPV4
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a registered nurse and refers to an unspecified number of patients of unknown age or gender. Pertinent medical history or drug allergies/drug reactions were not reported. On an unknown date, the patients were vaccinated with improperly stored doses of GARDASIL (lot 1 # K008931, expiration date 04-MAR-2017; lot 2 # K009482, expiration date 06-MAR-2017) (dose, strength, frequency and route of administration were not reported). There was no concomitant medication reported and there were no adverse effects reported. Additional information has been requested.
Age: 66.0
Sex: M
Vaccine: PPV
Symptoms: Peripheral swelling, Pyrexia
Clinical narrative: Vaccine administered 2/28/13. Per CPRS patient called clinic to report reaction to 'shot in right arm' in February (swelling of right arm, fever). He states he had to get medication from private doctor to 'counteract reaction'.
Sex: U
Vaccine: HPV9
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a medical assistant and refers to two unspecified patients of unknown age or gender. Pertinent medical history or drug allergies/drug reactions were not reported. On an unknown date, the patients were vaccinated with improperly stored doses of GARDASIL 9 (lot reported as K006960, expiration date 19-FEB-2017) (dose, strength and route of administration were not reported). There was not concomitant medication reported. No adverse experiences were reported. Additional information has been requested. Lot number K006960 is an invalid lot number for GARDASIL 9.
Sex: U
Vaccine: VARZOS
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse refers to a patient of unknown age and gender. On an unknown date, the patient was vaccinated with an expired dose of ZOSTAVAX (lot # K000328 exp date 06-MAR-2015). No adverse effects were reported. Additional information has been requested.
Sex: F
Vaccine: HPV4
Symptoms: Human papilloma virus test positive
Clinical narrative: This spontaneous report was received from a physician via company representative unspecified number of female patients of unknown age. The patients pertinent medical history and drug allergies were unspecified. On an unknown date, the unspecified number of patients were vaccinated with GARDASIL (dose, frequency, lot# and route were not reported). On an unknown date, the unspecified number of patients had abnormal Papanicolaou (PAP) smear test results. The outcome of the event was unknown. The causality of the event was not reported. Additional information has been requested.
Sex: U
Vaccine: HPV9
Symptoms: Incorrect product storage, 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. No information on patients medical history or concurrent conditions was provided. Between the dates of 05-JUN-2015 and 27-JUL-2015, the patients were vaccinated with unspecified doses of GARDASIL 9, lot # K026246, expiration date 28-JAN-2017 (dose, strength and route of administration were not reported) which were improperly stored. No information on patients concomitant medication was provided. No adverse events were reported. This is one of several reports from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HEPA
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a medical assistant on 02-JUL-2015 concerning a patient of an unknown age and gender. On 01-APR-2015, the patient was vaccinated with a dose of VAQTA (lot # K007827) 0.5 ml (expiration date, route and site of administration were not reported) that underwent temperature excursion. No adverse effects had been observed or reported. This is one of several reports from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HEPA
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a medical assistant on 02-JUL-2015 concerning a patient of an unknown age and gender. On 02-APR-2015, the patient was vaccinated with a dose of VAQTA (lot # K007827) 0.5 ml (expiration date, route and site of administration were not reported) that underwent temperature excursion. No adverse effects had been observed or reported. This is one of several reports from the same reporter. Additonal information has been requested.
Sex: U
Vaccine: HEP
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a medical assistant on 02-JUL-2015, concerning a patient of an unknown age and gender. On 13-APR-2015, the patient was vaccinated with a dose of RECOMBIVAX HB 0.5 ml, lot # K010535, (expiration date, route and site of administration were not reported) that underwent 72 hours temperature excursion outside of the recommended range. No adverse effects had been observed or reported. This is one of several reports from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HEPA
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a medical assistant on 02-JUL-2015 concerning a patient of an unknown age and gender. On 06-APR-2015, the patient was vaccinated with a dose of VAQTA (lot # K007827) 0.5 ml (expiration date, route and site of administration were not reported) that underwent temperature excursion. No adverse effects had been observed or reported. This is one of several reports from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HEP
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a medical assistant on 02-JUL-2015, concerning a patient of an unknown age and gender. On 10-APR-2015, the patient was vaccinated with a dose of RECOMBIVAX HB 0.5 ml, lot # K010535, (expiration date, route and site of administration were not reported) that underwent 72 hours temperature excursion outside of the recommended range. No adverse effects had been observed or reported. This is one of several reports from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HEP
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a medical assistant on 02-JUL-2015, concerning a patient of an unknown age and gender. On 10-APR-2015, the patient was vaccinated with a dose of RECOMBIVAX HB 0.5 ml, lot # K010535, (expiration date, route and site of administration were not reported) that underwent 72 hours temperature excursion outside of the recommended range. No adverse effects had been observed or reported. This is one of several reports from the same reporter. Additional informatino has been requested.
Sex: U
Vaccine: HEP
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a medical assistant on 02-JUL-2015, concerning a patient of an unknown age and gender. On 08-APR-2015, the patient was vaccinated with a dose of RECOMBIVAX HB 0.5 ml, lot # K010535, (expiration date, route and site of administration were not reported) that underwent 72 hours temperature excursion outside of the recommended range. No adverse effects had been observed or reported. This is one of several reports from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a health care professional refers to an unspecified patients of unknown demographics. On 20-JUL-2015 the patients were vaccinated with GARDASIL (lot # K011562, expiry: 08-APR-2017; K010215, expiry: 05-MAY-2015; K016966, expiry 10-MAY-2017) (dose and route unspecified) which were exposed to temperatures outside of the recommended range. No adverse effects have been reported. There was no product quality complaint involved. No additional information was provided. The outcome of incorrect product storage was unknown. Additional information has been requested.
Sex: U
Vaccine: MMR
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a health care professional refers to an unspecified patients of unknown demographics. ON 20-JUL-2015 the patients were vaccinated with M-M-R II (lot #K002285, expiry: 12-NOV-2015; L005291, expiry: 17-FEB-2016; L008684, exp 13-MAR-2017) (dose and route  unspecified) which were exposed to temperatures outside of the recommended range. No adverse effects have been reported. There was no product quality complaint involved. No additional information was provided. The outcome of incorrect product storage was unknown. This is one of several reports received from the same source. Additional information has been requested.
Sex: U
Vaccine: MMRV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a healthcare professional refers to an unspecified number of patients of unknown gender and age. The patient's medical history and concurrent conditions were not reported. In 2015, between 20-MAY-2015 and 14-JUL-2015 the patients were vaccinated with improperly stored doses of PROQUAD (Merck), 0.5 ml, subcutaneous, lot number K004860, expiration date 04-OCT-2015. There was no concomitant medication reported. No adverse effects were reported. This is one of two reports from the same reporter (case # 1507USA007010). Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Hyperthyroidism, Pyrexia, Weight decreased
Clinical narrative: This spontaneous report was received from a physician via a company representative and refers to a female patient of unknown age. The patient's medical history included hypothyroidism. No concurrent conditions or concomitant therapies were reported. In approximately May 2015 (reported as "about two months ago"), the patient was vaccinated with ZOSTAVAX (lot #, expiration date, dose, route and anatomical location were not reported). On approximately 13-JUL-2015 (reported as "about 2 weeks ago"), the patient visited the office where she presented with fever and weight loss. The patient also mentioned, that she had hyperthyroidism after receiving treatment with ZOSTAVAX, but it was unspecified if this was an official diagnosis from a physician or simply a statement offered by patient. The patient sought medical attention, she visited the office. The outcome of the events was unknown. The relatedness between the events and ZOSTAVAX was not reported. Additional information has been requested.
Sex: U
Vaccine: MMRV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a healthcare worker and refers to two unspecified patients of unknown age and gender. No information about patients' pertinent medical history, concurrent conditions, concomitant medications, drug reactions or allergies was provided. On 29-JUL-2015, the patients were each vaccinated with one dose of improperly stored PROQUAD (Merck) lot# L005293, expiration date 17-AUG-2016 (strength, dose and route of administration were not reported). No adverse effect reported. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a medical assistant refers to unspecified number of patients of unknown age and gender. The reporter was not sure of the  number of patients involved but she thought 3 patients were vaccinated with the improperly stored (Oka/Merck) VARIVAX. Patient's medical history concurrent conditions and concomitant therapy were not reported. On an unknown date, the patients were vaccinated with doses of improperly stored (Oka/Merck) VARIVAX (lot # L001334, expiry date: 13-JUN-2017; lot # L004655, Expiry date: 11-FEB-2017), (dose and route were not reported). No symptoms were reported. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a medical assistant on 02-JUL-2015 concerning a patient of an unknown age and gender. On 31-MAR-2015, the patient was vaccinated with a dose of VAQTA (lot # K007827) 0.5 ml (expiration date, route and site of administration were not reported) that underwent temperature excursion. No adverse effects had been observed or reported. This is one of several reports from the same reporter. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a healthcare professional refers to an unspecified number of patients of unknown gender and age. The patient's medical history and concurrent conditions were not reported. In 2015, between 20-MAY-2015 and 14-JUL-2015 the patients were vaccinated with improperly stored doses of (Oka/Merck) VARIVAX, 0.5 ml, subcutaneous, lot number J012818, expiration date 10-OCT-2015 (also0 reported 24-JUL-2015). There was no concomitant medication reported. No adverse effects were reported. This is one of two reports from the same reporter (case # 1507USA013304). Additional information has been requested.
Sex: U
Vaccine: PPV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a pharmacist and a pharmacist student and refers to an unspecified patient of unknown age or gender. Pertinent medical history or drug allergies/drug reactions were not reported. On 15-JUL-2015, the patient was vaccinated with an improperly stored PNEUMOVAX23 (lot number reported as L010598, expiration date 06-AUG-2016) (dose, strength, frequency and route of admministration were not reported) (incorrect product storage). There was no concmitant medication was reported. No adverse effects were reported. Additional information has been requested.
Sex: U
Vaccine: HEPA
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a medical assistant on 02-JUL-2015 concerning a patient of an unknown age and gender. On 27-MAR-2015, the patient was vaccinated with a dose of VAQTA (lot # K007827) 0.5 ml (expiration date, route and site of administration were not reported) that underwent temperature excursion. No adverse effects had been observed or reported. This is one of several reports from the same reporter. Additional information has been requested.
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a health care professional refers to an unspecified patients of unknown demographics. On 20-JUL-2015 the patients were vaccinated with ROTATEQ (lot # K013661, expiry: 26-MAY-2016; K016261, expiry: 23-JUN-2016; K023159, expiry 26-JUL-2016; K019372, expiry: 16-JUL-2016) (dose and route unspecified) which were exposed to temperatures outside of the recommended range. NO adverse effects have been reported. There was no product quality complaint involved. No additional information was provided. The outcome of incorrect product storage was unknown. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse refers to an unspecified number of patients of unknown age and gender. Concurrent conditions and medical history were not reported. On 21-JUL-2015, the nurse provided details on to vaccine stability revaluated for (Oka/Merck) VARIVAX and reported that on 21-JUL-2015, the patients were vaccinated with an improperly stored doses of (Oka/Merck) VARIVAX (lot number, expiration date, dose and route were not reported). Concomitant medications were not reported. No adverse symptoms were reported. Additional information has been requested.
Sex: U
Vaccine: HEPA
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a medical assistant on 02-JUL-2015 concerning a patient of an unknown age and gender. On 26-MAR-2015, the patient was vaccinated with a dose of VAQTA (lot # K007827) 0.5 ml (expiration date, route and site of administration were not reported) that underwent temperature excursion. No adverse effects had bee observed or reported. This is one of several reports from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HIBV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a healthcare worker refers to a patient of unknown age and gender. There were no concomitant medications, concurrent conditions and medical history reported. On 30-JUL-2015, the patient was vaccinated with PEDVAXHIB 0.5 ml, once, intramuscular. The PEDVAXHIB was improperly stored. The reporter could not specify which lot of PEDVAXHIB was administered to the patient: lot # K026533 expiration date 07-AUG-2015 or lot # reported as L004740 expiration date 16-NOV-2015. There was no adverse effects reported. Additional information has been requested.
Age: 53.0
Sex: F
Vaccine: TDAP
Symptoms: Eye irritation, Pruritus, Throat irritation
Clinical narrative: Patient returned with itching skin, burning eyes and "scratchy" throat. She said she was allergic to Benadryl so I gave her a 10mg dose of loratadine and monitored her for an additional 20min.
Age: 42.0
Sex: M
Vaccine: HEPA
Symptoms: Injection site pain, X-ray limb
Clinical narrative: General Soreness in left shoulder, worsened over several months.
Age: 35.0
Sex: M
Vaccine: MMR, MNQ
Symptoms: Biopsy skin, Dermatologic examination, Rash generalised, Skin exfoliation, Skin lesion
Clinical narrative: Developed rash on scalp, chest arms, legs. Small ovoid 0.5-1 cm well defined scaling lesions in a patchy distribution.
Age: 45.0
Sex: M
Vaccine: TD
Symptoms: Injection site erythema, Injection site pruritus, Injection site swelling
Clinical narrative: Large area of redness, swelling, itching at injection site.
Age: 67.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: Redness/swelling at site of injection and surrounding areas, hot to touch. Swelling increased 8/1 to approximate baseball-sized spot.
Age: 22.0
Sex: M
Vaccine: TDAP
Symptoms: Blood pressure increased, Diarrhoea, Headache, Lymphadenopathy
Clinical narrative: Patient complained of headache, diarrhea, a swollen gland and elevated blood pressure.
Age: 70.0
Sex: F
Vaccine: PNC13
Symptoms: Arthralgia, Inflammatory marker increased, Injection site pain, Joint swelling, Mobility decreased
Clinical narrative: Soreness at immunization site that spread up to shoulder, across back to other shoulder and down arm  Difficulty in raising arms, soreness and swelling of elbow, hand and hip joints, soreness in thigh and gluteal muscles.  I am now on my 4th course of prednisone - 3 short bursts and now my rheumatologist has me on a course of prednisone that will take one year to taper off of.
Age: 70.0
Sex: F
Vaccine: PNC13
Symptoms: Musculoskeletal pain, Myalgia, Pain in extremity, Peripheral swelling
Clinical narrative: Soreness at immunization site that spread up to shoulder, across back to other shoulder and down arm  Difficulty in raising arms, soreness and swelling of elbow, hand and hip joints, soreness in thigh and gluteal muscles.  I am now on my 4th course of prednisone - 3 short bursts and now my rheumatologist has me on a course of prednisone that will take one year to taper off of.
Age: 72.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site swelling, Pruritus generalised
Clinical narrative: Patient has swelling and redness at injection site.  Also reported itching "all over." No rash, SOB or fever reported.
Age: 0.17
Sex: F
Vaccine: DTAP, HEP, HIBV, IPV, PPV, RVX
Symptoms: Crying, Injection site erythema, Injection site nodule, Injection site warmth
Clinical narrative: Excessive crying with Tylenol dosages throughout 24 hours after. Knot in Left thigh at injection site for 1 week. Injection site on both legs red & warm to the touch for 3 1/2 days.
Age: 80.0
Sex: F
Vaccine: VARZOS
Symptoms: Arthralgia, Erythema, Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: 10 days swelling around injection area, bright red and raised aching pain in arm from site of injection to wrist, 4th day after injection no rash itching whole body patient took BENADRYL for 4 days then itching went away patient has had shingles: June 13, 2014 August 16, 2014 prior to vaccination.
Age: 80.0
Sex: F
Vaccine: VARZOS
Symptoms: Pain in extremity, Peripheral swelling, Pruritus generalised
Clinical narrative: 10 days swelling around injection area, bright red and raised aching pain in arm from site of injection to wrist, 4th day after injection no rash itching whole body patient took BENADRYL for 4 days then itching went away patient has had shingles: June 13, 2014 August 16, 2014 prior to vaccination.
Age: 9.0
Sex: F
Vaccine: PPV
Symptoms: Pyrexia, Urticaria
Clinical narrative: Pt received PNEUMOVAX 7/28 then began fever to 102. On 07/30/15 developed urticaria requiring ER visit with prednisone, ZOFRAN, ranitidine and diphenhydramine given. No known allergy ingestion.
Sex: F
Vaccine: VARCEL
Symptoms: Exposure during pregnancy, Pregnancy test urine positive
Clinical narrative: Information has been received from a physician for varicella virus vaccine (Merck), a Pregnancy Registry product, concerning a female patient of approximately 36 year old with no pertinent medical history and no drug reactions or allergies. On 02-JUL-2015, the patient was vaccinated with the first 0.5 ml dose of VARIVAX (Merck) (lot # not reported) subcutaneously. Concomitant therapies included prenatal vitamins. The physician reported that on 20-JUL-2015, the patient was seen in the office and a urine pregnancy test was performed which came back positive. The patient's last menstrual period (LMP) as on 18-JUN-2015 and her estimated date of delivery (EDD) would be on 24-MAR-2016. The pregnancy outcome was pending. Additional information has been requested.
Sex: U
Vaccine: HIBV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from an executive refers to unspecified number of patients of unknown age and gender. No information on concurrent conditions and medical history were provided. On unspecified dates, the patients were vaccinated with improperly stored PEDVAXHIB (unknown route, strength and dose) lot # K025005 and expiry date of 21-JUL-2017. Concomitant medications were not reported. No adverse effects were reported. The outcome of the event was unknown. There was no product quality complaint involved. This is one of the several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HEPA
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a healthcare worker refers to an unspecified number of patients of unknown age and gender. No information on concurrent conditions and medical history were not reported. Approximately in April 2015 (dates ranging from 28-APR-2015 through 29-APR-2015), the patients were vaccinated with improperly stored VAQTA (unknown dose and route) lot # K010579 and expiry date of 12-FEB-2017. Concomitant medications were not reported. No adverse effects were reported. The outcome of incorrect product storage was unknown. There was no product quality complaint involved. This is one of the several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HEP
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a healthcare worker refers to an unspecified number of patients of unknown age and gender. No information on concurrent conditions and medical history were not reported. Approximately in April 2015 (dates ranging from 28-APR-2015 through 29-APR-2015), the patients were vaccinated with improperly stored RECOMBIVAX HB (unknown dose and route) lot # K014548 and expiry date of 27-AUG-2016. Concomitant medications were not reported. No adverse effects were reported. The outcome of incorrect product storage was unknown. There was no product quality complaint involved. This is one of the several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a healthcare worker refers to an unspecified number of patients of unknown age and gender. No information on concurrent conditions and medical history were not reported. Approximately in April 2015 (dates ranging from 28-APR-2015 through 29-APR-2015), the patients were vaccinated with improperly stored ROTATEQ oral (unknown dose) lot # K010222 and expiry date of 12-MAY-2016. Concomitant medications were not reports. No adverse effects were reported. The outcome of incorrect product storage was unknown. There was no product quality complaint involved. This is one of the several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from an executive refers to unspecified number of patients of unknown age and gender. No information on concurrent conditions and medical history were provided. On unspecified dates, the patients were vaccinated with improperly stored GARDASIL (unknown route, strength and dose) lot # K023432 and expiry date of 18-JUN-2016. Concomitant medications were not reported. No adverse effects were reported. The outcome of the event was unknown. There was no product quality complaint involved. This is one of the several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HEP
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from an executive refers to unspecified number of patients of unknown age and gender. No information on concurrent conditions and medical history were provided. On unspecified dates, the patients were vaccinated with improperly stored RECOMBIVAX HB Pediatric (unknown route, strength and dose) lot # K018180 and expiry date of 17-SEP-2016. Concomitant medications were not reported. No adverse effects were reported. The outcome of the event was unknown. There was no product quality complaint involved. This is one of the several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: MMR
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a healthcare worker refers to a unspecified number of patients of unknown age and gender. No information on concurrent conditions and medical history were not reported. Approximately in April 2015 (dates ranging from 28-APR-2015  through 29-APR-2015) the patients were vaccinated with improperly stored M-M-R II (unknown dose and route) lot # K006141 and expiry dare of 28-APR-2016. Concomitant medications were not reported. No adverse effects were reported. The outcome of incorrect product storage was unknown. There was no product quality complaint involved. This is one of the several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from an executive refers to unspecified number of patients of unknown age and gender. No information on concurrent conditions and medical history were provided. On unspecified dates, the patients were vaccinated with improperly stored ROTATEQ oral (unknown strength and dose) lot # K016314 and expiry date of 05-JUN-2016. Concomitant medications were not reported. No adverse effects were reported. The outcome of the event was unknown. There was no product quality complaint involved. This is one of the several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a healthcare worker refers to a unspecified number of patients of unknown age an gender. No information on concurrent conditions and medical history were not reported. Approximately in April 2015 (dates ranging from 28-APR-2015 through 29-APR-2015), the patients were vaccinated with improperly stored GARDASIL (unknown dose and route) lot # K008931 and expiry date of 04-MAR-2017. Concomitant medications were not reported. No adverse effects were reported. The outcome of incorrect product storage was unknown. There was no product quality complaint involved. This is one of the several reports received from the same reporter. Additional information has been requested.
Age: 0.22
Sex: U
Vaccine: HEP
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse refers to an 11 week old patient. On 24-MAR-2015, the patient was vaccinated with the first 0.5 ml dose of RECOMBIVAX HB (lot # not reported) intramuscularly. On 11-JUN-2015, the patient received the second 0.5 ml of RECOMBIVAX HB (lot # not reported) intramuscularly and on 30-JUL-2015, the patient received the third 0.5 ml dose of RECOMBIVAX HB (lot # K009953 exp date 03-APR-2016) intramuscularly. No adverse effect was reported. Additional information has been requested.
Age: 27.0
Sex: F
Vaccine: ANTH
Symptoms: Amnesia, Arthralgia, Fatigue, Lymphadenopathy, Malaise
Clinical narrative: Chronic conditions (see below) began in Nov 2012. She is concerned that the anthrax and smallpox immunizations had a causal association. However, there was greater than one year between last anthrax immunization and onset of symptoms. Altered mental status, Disturbance of skin sensation, Disturbance, sleep NOS, Enlargement, lymph nodes, Joint pain, Malaise and fatigue, Rash, other nonspecific skin eruption, Symptom, memory loss, Symptom, nervous/musculoskeletal NEC.
Age: 27.0
Sex: F
Vaccine: ANTH
Symptoms: Mental status changes, Neurological symptom, Paraesthesia, Rash, Sleep disorder
Clinical narrative: Chronic conditions (see below) began in Nov 2012. She is concerned that the anthrax and smallpox immunizations had a causal association. However, there was greater than one year between last anthrax immunization and onset of symptoms. Altered mental status, Disturbance of skin sensation, Disturbance, sleep NOS, Enlargement, lymph nodes, Joint pain, Malaise and fatigue, Rash, other nonspecific skin eruption, Symptom, memory loss, Symptom, nervous/musculoskeletal NEC.
Sex: U
Vaccine: HPV4
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report as received from a nurse refers to a patient of unknown age and gender with no pertinent medical history, drug reactions and allergies reported. On 01-JUL-2013, the patient was vaccinated with the first dose of GARDASIL (route, dose and lot number were not provided). Concomitant therapy was not reported. On 30-JUL-2015, the patient was vaccinated with the second dose of GARDASIL (route, dose and lot number were not provided). No adverse effects were reported. Additional information is not expected because the reporter denied consent for follow up.
Sex: U
Vaccine: HPV4
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a medical assistant refers to unspecified number of patients of unknown age and gender. No information on concurrent conditions and medical history were not reported. On unspecified dates, the patients were vaccinated with improperly stored GARDASIL (unknown strength, route and dose). Concomitant medications were not reported. No adverse effects were reported. The outcome of incorrect product storage was unknown. There was no product quality complaint involved. This is one of the three reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: MMR
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a medical assistant refers to unspecified number of patients of unknown age and gender. No information on concurrent conditions and medical history were not reported. On unspecified dates, the patients were vaccinated with improperly stored M-M-R II (unknown strength, route and dose). Concomitant medications were not reported. No adverse effects were reported. The outcome of incorrect product storage was unknown. There was no product quality complaint involved. This is one of the three reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HIBV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a medical assistant refers to unspecified number of patients of unknown age and gender. No information on concurrent conditions and medical history were not reported. On unspecified dates, the patients were vaccinated with improperly stored PEDVAXHIB (unknown strength, route and dose). Concomitant medications were not reported. No adverse effects were reported. The outcome of incorrect product storage was unknown. There was no product complaint involved. This is one of the three reports received from the same reporter. Additional information has been requested.
Age: 70.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Rash
Clinical narrative: Rash, nonspecific, migrating - duration of at least 2 months.  Red marks, possible Zoster infection.
Age: 70.0
Sex: F
Vaccine: PPV
Symptoms: Nausea
Clinical narrative: Felt sick to stomach, took usual medications with 400 mg. IB, went to bed.
Age: 70.0
Sex: F
Vaccine: PNC13
Symptoms: Erythema, Peripheral swelling
Clinical narrative: Patient came back on 7/27/2015 and said that her both hands are red and welling big.
Age: 49.0
Sex: M
Vaccine: PNC13, TDAP
Symptoms: Injection site reaction, Local reaction, Pain in extremity
Clinical narrative: Patient received 2 shots. The Prevnar caused quarter size local reaction at site of injection. The Boostrix a dime size local reaction at site of injection. Both arms sore. Told to apply cool compress and if worsens or does not improve see doctor.
Age: 70.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pruritus, Injection site warmth
Clinical narrative: Patient has red, warm skin around the injection site. Size of a silver dollar and itchy.
Age: 0.76
Sex: F
Vaccine: HEP, IPV
Symptoms: Abdominal distension, Arthralgia, Diarrhoea, Feeling hot, Hypersomnia
Clinical narrative: Listless, lethargic, high body temperature, fussy, irritable, excessive sleeping, much less responsive, pain in muscles, joints, and stomach bloated and hot, diarrhea.
Age: 0.76
Sex: F
Vaccine: HEP, IPV
Symptoms: Hyporesponsive to stimuli, Irritability, Lethargy, Listless, Myalgia
Clinical narrative: Listless, lethargic, high body temperature, fussy, irritable, excessive sleeping, much less responsive, pain in muscles, joints, and stomach bloated and hot, diarrhea.
Age: 0.76
Sex: F
Vaccine: HEP, IPV
Symptoms: Pyrexia
Clinical narrative: Listless, lethargic, high body temperature, fussy, irritable, excessive sleeping, much less responsive, pain in muscles, joints, and stomach bloated and hot, diarrhea.
Age: 12.0
Sex: M
Vaccine: MNQ, TDAP
Symptoms: Headache, Hypoaesthesia, Musculoskeletal stiffness, Pain, Paraesthesia
Clinical narrative: Fever 104 with shooting pain in head, numbness and tingling in hands and feet, neck stiff, body aches.
Age: 12.0
Sex: M
Vaccine: MNQ, TDAP
Symptoms: Pyrexia
Clinical narrative: Fever 104 with shooting pain in head, numbness and tingling in hands and feet, neck stiff, body aches.
Age: 11.0
Sex: F
Vaccine: MEN
Symptoms: Axillary pain, Decreased appetite, Erythema, Headache, Injection site erythema
Clinical narrative: Localized pain. Red. Hot. Headache. Loss of appetite. Next day: Headache. Neck pain. Evening: Armpit pain. Following day: neck pain. Armpit pain. Loss of appetite. ER visit. Swollen lymph nodes on neck and armpit. Red swollen area where shot was given.
Age: 11.0
Sex: F
Vaccine: MEN
Symptoms: Injection site swelling, Lymphadenopathy, Neck pain, Pain, Skin warm
Clinical narrative: Localized pain. Red. Hot. Headache. Loss of appetite. Next day: Headache. Neck pain. Evening: Armpit pain. Following day: neck pain. Armpit pain. Loss of appetite. ER visit. Swollen lymph nodes on neck and armpit. Red swollen area where shot was given.
Age: 11.0
Sex: F
Vaccine: MEN
Symptoms: Vaccination complication
Clinical narrative: Localized pain. Red. Hot. Headache. Loss of appetite. Next day: Headache. Neck pain. Evening: Armpit pain. Following day: neck pain. Armpit pain. Loss of appetite. ER visit. Swollen lymph nodes on neck and armpit. Red swollen area where shot was given.
Age: 66.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Inflammation, Skin warm
Clinical narrative: Patient had appox. 5 in diameter red/inflamed area with approx 2 in diameter bright-dark red area, in center. She complained it felt hot. Dr. prescribed clindamycin 300mg Q.I.D. and mupirocin T.I.D.
Age: 22.0
Sex: M
Vaccine: FLU3
Symptoms: Dizziness, Hypertension, Vertigo
Clinical narrative: After receiving vaccine, patient felt dizziness, vertigo, checked BP and it showed high about 170/100 and pulse at 100, called 911 for help.
Sex: U
Vaccine: VARZOS
Symptoms: Extra dose administered, No adverse event
Clinical narrative: Information has been received from a pharmacist via a company representative referring to a friend of the pharmacist, a patient of unknown age and gender. The patient's concurrent condition and medical history were not reported. On unknown dates the patient was vaccinated with two doses of ZOSTAVAX (strength, dose, lot#, expiration date and route were unknown). No adverse effect was reported. Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Extra dose administered, No adverse event
Clinical narrative: Information has been received from a medical assistant concerning a patient of unknown gender and age. There was no medical history or drug reactions/allergies reported. On unspecified days in March 2014 and July 2015, the patient was vaccinated with two doses of ZOSTAVAX (dose, route, lot number and expiration date were unspecified) (extra dose administered). No concomitant medication was reported. No adverse experience reported. There were no product complaints (PQC) involved. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Wrong drug administered
Clinical narrative: This spontaneous report as received from a nurse refers to a patient of unknown age and gender. No concurrent condition, medical history or allergy/drug reactions were reported. On an unspecified date, the patient was inadvertently administered a dose of VARIVAX (Merck) (injection) (strength, dose, route and lot number or batch number unspecified) instead of the intended ZOSTAVAX. No concomitant medication was reported. No adverse effects were reported. The outcome of the event was unknown. There were no product quality complaints (PQC) involved. No additional information was provided. Additional information has been requested.