chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: HPV4
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a healthcare professional refers to unspecified patients of unknown age and gender. Patient's pertinent medical history and drug reactions or allergies were not reported. On an unknown date, patients were vaccinated with the improperly stored doses of GARDASIL (lot number K006960 and expiration date 19-FEB-2017) (dose and route of administration were not reported). Concomitant therapy was not reported. No adverse effect was reported. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: MMRV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a physician referring to multiple patients of unknown age and gender. On unknown dates the patients were vaccinated with improperly stored doses of PROQUAD (Merck) (lot #K009470, expiration date 03-JAN-2016, dose and route were unknown). No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HIBV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a Licensed Practical Nurse referring to an unspecified number of patients of unknown age and gender. Information about medical history, concurrent condition and concomitant medication. On unknown dates the patients were vaccinated with doses of improperly stored PEDVAXHIB (lot # L004740 with expiration date of 16-NOV-2017; strength, dosage, frequency and route unspecified) (incorrect product storage). No symptoms were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Age: 0.57
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage
Clinical narrative: Information has been received from a registered nurse referring to a 6 month old patient of unknown gender. On 03-AUG-2015 the patient was vaccinated with ROTATEQ (oral, lot # K022990, expiration date and dose were unknown) which excursed the storage temperature. No reaction was 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
Clinical narrative: Information has been received from a pharmacist referring to 4 newborns (numbered 170, 171, 172, 173). Background: Since June 2015, there had been  1645 times (30 minutes each time-=822.5 hours0 that the temperature dropped below 36F. Of course, there was 144 times (30 minutes each time=72 hours) that temperature was below 32F, the lowest being 29.7F. On 04-JUL-2015, there was a low temperature of 30.2F. On 06-SEP-2015 the patients were vaccinated with the improperly stored RECOMBIVAX HB strength 2.5/0.6 (units not provided) (lot number K020216 and expiration date of 17-SEP-2016 (dose and route of administration were not reported) (incorrect product storage). There was no product quality complaint (PQC). This is one of several reports received from the same reporter. Additional information has been requested.
Age: 0.41
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a registered nurse referring to a 4 month old patient of unknown gender. On 01-JUL-2015 the patient was vaccinated with ROTATEQ (oral, lot # K017573, expiration date and dose were unknown) which was excursion the storage temperature. No reaction was reported. This is one of several reports received 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 unspecified patients of unknown age and gender. Patient's pertinent medical history and drug reactions or allergies were not reported. On an unknown date, patients were vaccinated with the improperly stored doses of (Oka/Merck) VARIVAX (lot number L000453 and expiration date 06-JAN-2017) (dose and route of administration were not reported). Concomitant therapy was not reported. No adverse effect was reported. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a physician referring to multiple patients of unknown age and gender. On unknown dates the patients were vaccinated with improperly stored doses of (Oka/Merck) VARIVAX (lot # L008271, expiration date 11-MAR-2017; Lot # K005428, expiration date: 15-APR-2016; lot#: K016131, expiration date 24-SEP-2016, dose and route were unknown). No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Age: 15.0
Sex: U
Vaccine: HPV4
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a registered nurse referring to a 15 year old patient of unknown gender. On 30-JUN-2015 the patient was vaccinated with GARDASIL (lot # K008931, intramuscular, expiration date and dose were unknown) which excursed the storage temperature (incorrect product storage). No reaction was reported. This is one of several reports received from the same reporter. Additional information has been requested.
Age: 0.51
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a registered nurse referring to a 6 month old patient of unknown gender. On 01-JUL-2015 the patient was vaccinated with ROTATEQ (oral, lot # K017573, expiration date and dose were unknown) which was excursion the storage temperature. No reaction was 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
Clinical narrative: Information has been received from a pharmacist referring to 3 newborns (numbered 174, 175 and 176). Background: Since June 2015, there had been 1645 times (30 minutes each time=822.5 hours) that the temperature dropped below 36F. Of course, there was 144 times (30 minutes each time=72 hours) that temperature was below 32F, the lowest being 29.7F. On 04-JUL-2015, there was a low temperature of 30.2F. On 07-SEP-2015 the patients were vaccinated with the improperly stored RECOMBIVAX HB strength 2.5/0.5 (units not provided) (lot number K020216 and expiration date of 17-SEP-2016) (dose and route of administration were not reported). There was no product quality complaint (PQC). This is one of several reports received from the same reporter. Additional information has been requested.
Age: 0.16
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a registered nurse referring to an 8 week old patient of unknown gender. On 06-JUL-2015 the patient was vaccinated with ROTATEQ (oral, lot # K017573, expiration date and dose were unknown) which excursed the storage temperature. No reaction was reported. This is one of several reports received from the same reporter. Additional information has been requested.
Age: 0.58
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a registered nurse referring to a 7 month old patient of unknown gender. On 27-JUL-2015 the patient was vaccinated with ROTATEQ (oral, lot # K011952, expiration date and dose were unknown) which excursed the storage temperature. No reaction was reported. This is one of several reports received from the same reporter. Additional information has been requested.
Age: 81.0
Sex: F
Vaccine: PPV
Symptoms: Injection site pain, Mobility decreased
Clinical narrative: Information has been received from an 81 year old female patient referring to herself. Concurrent condition and medical history were not reported. On 03-AUG-2015 the patient was vaccinated with PNEUMOVAX 23 (lot # L003228, expiration date 30-JUL-2016, dose was unknown) intramuscularly for prevention of pneumococcal disease. On 03-AUG-2015, with a few minutes after the vaccination, the patient experienced continuous pain at injection site. The patient stated that the pain had made it difficulty for her to lift things and move her arm. The patient sought medical attention by calling the provider. The patient stated provider gave her MOTRIN (Dosage unknown) for the pain, but after more than a month, she continued to have pain and difficulty with her arm (not recovered). Additional information is not expected as the physician asked not to be contacted and lack of contact information.
Age: 4.0
Sex: U
Vaccine: MMR, VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a healthcare worker referring to a 5 year old patient of unknown gender. There was no medical history or concurrent condition reported. On 17-SEP-2015, doses of VARIVAX (Merck) (lot # K010437, expiry date 22-JUL-2016) (dosage, strength and route were not reported) and M-M-R II (lot # K018965, expiry date 15-OCT-2016) (dosage, strength and route were not reported), which were exposed to a temperature excursion, were administered to the patient. At the time of the report, the patient had not experienced an adverse effect. 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 unspecified patients of unknown age and gender. Patients' pertinent medical history and drug reactions or allergies were not reported. On an unknown date, patients were vaccinated with the improperly stored doses of (Merck) PROQUAD (lot number K019102 and expiration date 15-APR-2016) (dose and route of administration were not reported). Concomitant therapy was not reported. No adverse effect was reported. This is one of several reports received from the same reporter. Additional information has been requested.
Age: 11.0
Sex: U
Vaccine: HPV4
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a registered nurse referring to a 11 year old patient of unknown gender. On 30-JUN-2015 the patient was vaccinated with GARDASIL (lot # K008931, intramuscular, expiration date and dose were unknown) which excursed the storage temperature. No reaction was reported. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: F
Vaccine: MMR
Symptoms: Adverse event
Clinical narrative: Information has been received from a consumer referring to her daughter, a female patient of unknown age. No relevant medical history or concurrent conditions were reported. On an unknown date the patient was vaccinated with MMR II (strength, dose, frequency, lot# and expiration date not reported) via subcutaneous to against MMR II. On an unknown date the patient experienced adverse event. The outcome of the event was unknown. Causality assessment was not reported. Additional information is not expected due to lack of contact information.
Sex: U
Vaccine: HPV9
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a Licensed Practical Nurse referring to an unspecified number of patients of unknown age and gender. Information about medical history, concurrent condition and concomitant medication. On unknown dates the patients were vaccinated with doses of improperly stored GARDASIL 9 (lot # L000610 with expiration date 21-JAN-2017; strength, dosage, frequency and route unspecified). No symptoms were reported. This is one of 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: Information has been received from a Licensed Practical Nurse referring to an unspecified number of patients of unknown age and gender. Information about medical history, concurrent condition and concomitant medication. On an unknown dates the patients were vaccinated with doses of improperly stored ROTATEQ (lot # K020181 with expiration date of 24-JUN-2016; strength, dosage, frequency and route unspecified). No symptoms were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: MMRV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a nurse referring to unspecified number of patients of unknown age and gender. On unknown dates the patients were vaccinated with improperly stored (Merck) PROQUAD injection (lot # L026728, expiration date 15-JAN-2017) (dose and route were not reported). No adverse effects were reported. This is one of several reports received from the same source. Additional information has been requested.
Age: 1.38
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a registered nurse referring to a 16 month old patient of unknown gender. On 30-JUN-2015 the patient was vaccinated with ROTATEQ (oral, lot # K011952, expiration date and dose were unknown) which was excursion the storage temperature. No reaction was reported. This is one of several reports received from the same reporter. Additional information has been requested.
Age: 58.0
Sex: M
Vaccine: PPV
Symptoms: Injection site erythema, Injection site pain
Clinical narrative: Redness and pain at injection site. Diphenhydramine 1 cap q6 hours PRN.
Age: 64.0
Sex: M
Vaccine: PPV
Symptoms: Erythema, Peripheral swelling, Pruritus, Skin warm
Clinical narrative: Patient returns call states he received a pneumonia vaccine today. Now his arm is swollen, red and hot. States it is about baseball size. States it is now getting itchy as well.
Age: 17.0
Sex: F
Vaccine: VARCEL
Symptoms: Fatigue, Injection site erythema, Injection site swelling
Clinical narrative: Two days after vaccine (9-30) noted red swollen area size of small apple at site of inject. Had chic pox at 4 yrs of age. No fever, no breathing problems, tired after current Varicella inject.
Age: 1.01
Sex: M
Vaccine: MMR, VARCEL
Symptoms: Expired product administered
Clinical narrative: MMR vaccine was expired (4 days) and check expiration date was missed at time that vaccine was given, then on documentation of administration, date was noted as expired.
Age: 1.05
Sex: F
Vaccine: HIBV, MMRV, PNC13, VARCEL
Symptoms: Extra dose administered, Product label confusion, Wrong drug administered
Clinical narrative: Patient given additional dose of varicella with MMR vaccine due o close proximity to and resemblance to MMRV/MMR vaccines in storage area.
Age: 73.0
Sex: F
Vaccine: PNC13
Symptoms: Musculoskeletal pain, Skin warm, Swelling
Clinical narrative: 5 days after receiving PREVNAR shoulder swelled up, got "hot", and was painful. Swelling is approx. 4" x 4".
Age: 50.0
Sex: F
Vaccine: PPV
Symptoms: Erythema, Injection site pain, Pain in extremity, Peripheral swelling, Pyrexia
Clinical narrative: Vaccinatino was Sat 10/10/15 - patient had pain at site, but Sun. Had swelling, redness, fever and soreness down arm. By Tuesday better. (MOTRIN relieved fever/pain).
Age: 3.0
Sex: F
Vaccine: HEP
Symptoms: Injection site erythema, Injection site warmth
Clinical narrative: Area around injection site is red and hot to the touch per mother's statement. Denies pain or other symptoms. Declined appointment to evaluate area.
Age: 39.0
Sex: F
Vaccine: PPV
Symptoms: Drug administered to patient of inappropriate age
Clinical narrative: None stated.
Sex: U
Vaccine: HEP
Symptoms: Incorrect product storage
Clinical narrative: Information has been received from a pharmacist referring to 2 newborns (numbered 181 and 182). Background: Since June 2015, there had been 1645 times (30 minutes each time=822.5 hours) that the temperature dropped below 36F. Of course, there was 144 times (30 minutes each time=72 hours) that temperature was below 32F, the lowest being 29.7F. On 04-JUL-2015, there was a low temperature of 30.2F. On 10-SEP-2015 the patients were vaccinated with the improperly stored RECOMBIVAX HB strength 2.5/0.5 (units not provided) (lot number K020216 and expiration date of 17-SEP-2016) (dose and route of administration were not reported). There was no product quality complaint (PQC). This is one of several reports received from the same reporter. Additional information has been requested.
Age: 11.0
Sex: U
Vaccine: HPV9
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a registered nurse referring to an 11 year old patient of unknown gender. On 03-AUG-2015 the patient was vaccinated with GARDASIL 9 (lot # L006547, intramuscular, expiration date and dose were unknown) which excursed the storage temperature. No reaction was reported. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Inappropriate schedule of drug administration
Clinical narrative: Information has been received from a pharmacist via a company representative referring to some patients of unknown gender. On unknown dates these patients were vaccinated with doses of ZOSTAVAX (dose and frequency were not reported) before they were 50 years of age (Inappropriate schedule of vaccine administered). This is one of several cases 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 was received from a nurse and refers to an unspecified number of patients of unknown age and gender. No information about the patients' pertinent medical history, concomitant medications, drug reactions or allergies was provided. On an unknown date in 2015 (reported as "between 01-SEP-2015 and 09-OCT-2015"), the patients received an unspecified doses in the immunization series of PROQUAD (Merck) (lot # L019994, expiration date 02-DEC-2016) (dose and route of administration were not reported) that were improperly stored. No adverse effects were reported. This is one of two reports received from the same reporter. Additional information has been requested.
Age: 11.0
Sex: U
Vaccine: HPV4
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a registered nurse referring to an 11 year old patient of unknown gender. On 16-JUL-2015 the patient was vaccinated with GARDASIL (lot # K008931, intramuscular, expiration date and dose were unknown) which excursed the storage temperature (incorrect product storage). No reaction was reported. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: PPV
Symptoms: Extra dose administered, No adverse event
Clinical narrative: This spontaneous report was received from a pharmacist and refers to a patient of unknown age and gender. The patient's pertinent medical history and drug reactions or allergies were not reported. On 28-SEP-2014, the patient was vaccinated with a first dose of PNEUMOVAX 23 (dose, route of administration, lot#, expiration date and indication were not reported). Concomitant therapy was not provided. On 04-OCT-2015, the patient was inadvertently vaccinated with another dose of PNEUMOVAX 23 (lot # L022795, expiration date 05-NOV-2016; dose, route of administration and indication were not reported). No adverse effect was reported. Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Drug administered to patient of inappropriate age
Clinical narrative: Information has been received from a female patient less than 50 years of age, who was also a pharmacist, via a company representative referring to the patient herself. On an unknown date the patient was vaccinated with a dose of ZOSTAVAX (dose and frequency were not reported) (Inappropriate schedule of vaccine administered). This is one of several cases received from the same source. Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a female nurse practitioner of unknown age referring to herself. There was no information about the patient's medical history and concurrent condition. On 28-SEP-2015, the patient was vaccinated with a dose of improperly stored ZOSTAVAX vial 19400 plaque-forming unit (PFU) (lot # K026365, expiration date: 15-MAR-2016, dose and route unknown) (incorrect product storage). There was no information about concomitant therapy. No adverse effects were reported. Additional information has been requested.
Age: 0.4
Sex: M
Vaccine: HPV9
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: Information has been received from a physician assistant referring to a 4 months old male patient. Pertinent medical history and drug reactions/allergies were not reported. On 02-SEP-2015 the patient was vaccinated with a dose of GARDASIL 9 (dose, route, lot# and expiration date were not reported). Concomitant drug was not reported. No adverse effect was reported. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a nurse and refers to an unspecified number of patients of unknown age and gender. No information about the patient's pertinent medical history, concomitant medications, drug reactions or allergies was provided. On an unknown dates in 2015 (reported as "between 01-SEP-2015 and 09-OCT-2015"), the patients received an unspecified doses in the immunization series of VARIVAX (Merck) (lot # L016127, expiration date 06-MAY-2017) (dose and route of administration were not reported) that were improperly stored. No adverse effects were reported. This is one of two reports received from the same reporter. Additional information has been requested.
Age: 15.0
Sex: U
Vaccine: HPV4
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a registered nurse referring to a 15 year old patient of unknown gender. On 16-JUL-2015 the patient was vaccinated with GARDASIL (lot # K008931, intramuscular, expiration date and dose were unknown) which excursed the storage temperature (incorrect product storage). No reaction was reported. This is one of several reports received from the same reporter. Additional information has been requested.
Age: 13.0
Sex: U
Vaccine: HPV4
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a registered nurse referring to a 13 year old patient of unknown gender. On 16-JUL-2015 the patient was vaccinated with GARDASIL (lot # K008931, intramuscular, expiration date and dose was unknown) which excursed the storage temperature (incorrect product storage). No reaction was 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
Clinical narrative: Information has been received from a pharmacist referring to 3 newborns (numbered 183, 184 and 185). Background: Since June 2015, there had been 1645 times (30 minutes each time=822.5 hours) that the temperature dropped below 36F. Of course, there was 144 times (30 minutes each time=72 hours) that temperature was below 32F, the lowest being 29.7F. On 04-JUL-2015, there was a low temperature of 30.2F. On 11-SEP-2015 the patients were vaccinated with the improperly stored RECOMBIVAX HB strength 2.5/0.5 (units not provided) (lot number K020216 and expiration date of 17-SEP-2016) (dose and route of administration were not reported). There was no product quality complaint (PQC). This is one of several reports received from the same reporter. Additional information has been requested.
Age: 12.0
Sex: U
Vaccine: HPV9
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a registered nurse referring to a 12 year old patient of unknown gender. On 03-AUG-2015 the patient was vaccinated with GARDASIL 9 (lot # L006547, intramuscular, expiration date and dose were unknown) which excursed the storage temperature (incorrect product storage). No reaction was 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
Clinical narrative: Information has been received from a pharmacist referring to 3 newborns (numbered 178, 179 and 180). Background: Since June 2015, there had been 1645 times (30 minutes each time=822.5 hours) that the temperatures dropped below 36F. Of course, there was 144 times (30 minutes each time=72 hours) that temperature was below 32F, the lowest being 29.7F. On 04-JUL-20105, there was a low temperature of 30.2F. On 09-SEP-2015 the patients were vaccinated with the improperly stored RECOMBIVAX HB strength 2.5/0.5 (units not provided) (lot number K020216 and expiration date of 17-SEP-2016) (dose and route of administration were not reported). There was no product quality complaint (PQC). This is one of several reports received from the same reporter. Additional information has been requested.
Age: 13.0
Sex: U
Vaccine: HPV4
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a registered nurse referring to a 13 year old patient of unknown gender. On 16-JUL-2015 the patient was vaccinated with GARDASIL (lot # K006960, intramuscular, expiration date and dose were unknown) which excursed the storage temperature (incorrect product storage). No reaction was 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
Clinical narrative: Information has been received from a pharmacist referring to a newborns (numbered 177). Background: Since June 2015, there had been 1645 times (30 minutes each time = 822.5 hours) that the temperature dropped below 36F. Of course, there was 144 times (30 minutes each time = 72 hours) that temperature was below 32F, the lowest being 29.7F. On 04-JUL-2015, there was a low temperature of 30.2F. On 08-SEP-2015 the patients were vaccinated with the improperly stored RECOMBIVAX HB strength 2.5/0.5 (units not provided) (lot number K020216 and expiration date of 17-SEP-2016) (dose and route of administration were not reported). There was no product quality complaint (PQC). This is one of several reports received from the same reporter. Additional information has been requested.
Age: 65.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema
Clinical narrative: Right arm - site of injection reddish-pink color - almost looks like a birthmark, not bruised, swollen or warm to touch. Patient said not bothersome - she didn't even know it was there until a friend pointed it out to her the other day.
Age: 13.0
Sex: U
Vaccine: HPV4
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a registered nurse referring to a 13 year old patient of unknown gender. On 01-JUL-2015 the patient was vaccinated with GARDASIL (lot # K006960, intramuscular, expiration date and dose were unknown) which excursed the storage temperature (incorrect product storage). No reaction was reported. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: M
Vaccine: MMRV, VARCEL
Symptoms: Herpes zoster
Clinical narrative: This spontaneous report as received from a pharmacist refers to a male patient of unknown age. There was no information about patient's concomitant medications and pertinent medical history reported. On an unknown dates, the patient was vaccinated with unspecified number of doses of unspecified varicella vaccine reported as either VARIVAX (Merck) (lots#, expiry dates, routes and sites of administration, doses were not reported) or PROQUAD (Merck) (lots#, expiry dates, routes and sites of administration, doses were not reported). On an unknown date, the patient experienced "full case" of shingles an unspecified amount of times. The outcome of the event was unknown. The relatedness between the event and unspecified varicella vaccine (either VARIVAX (Merck) or PROQUAD (Merck) was not reported. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: MMRV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a licensed practical nurse referring to multiple unspecified patients of unknown age and gender. There was no medical history or concurrent condition reported. On an unknown date the patients were vaccinated with PROQUAD (Merck) (lot # L019996, expiry date: 02-DEC-2016; lot # L011079, expiry date: 01-OCT-2016) (dosage, strength and route were not reported), that were improperly stored. No adverse effects were reported. This is one of several report from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HPV4
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. The patient's pertinent medical history and drug reactions or allergies were not reported. On 09-OCT-2015, the patient was vaccinated inadvertently with the first dose in GARDASIL immunization series (lot number H020901 and expiration date 05-JUL-2015) (dose and route of administration were not reported) which was expired. Concomitant therapy was not reported. No adverse effects were 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 certified medical assistant refers to an unspecified number of patients of unknown age and gender. No information on patients' medical history or concurrent conditions was provided. On an unknown dates, the patients were vaccinated with improperly stored doses of GARDASIL 9 injection, lot# K023432 with expiration date 18-JUN-2016 and lot# K011562 with expiration date 18-APR-2017 (dose and route of administration were not reported). No information on patients' concomitant medications was provided. No adverse symptoms were reported. This is one of the several reports from the same reporter. Additional information has been requested.
Sex: M
Vaccine: VARCEL
Symptoms: Herpes zoster
Clinical narrative: This spontaneous report as received from a pharmacist refers to a male patient of unknown age. There was no information about patient's concurrent medications and pertinent medical history reported. On an unknown dates, the patient was vaccinated with unspecified number of doses of unspecified varicella vaccine reported as either (Merck) VARIVAX (lots#, expiry dates, routes and sites of administration, doses were not reported) or (Merck) PROQUAD (lots#, expiry dates, routes and sites of administration, doses were not reported). On an unknown date, the patient experienced shingles an unspecified amount of times. The patient developed "just a few spots". The outcome of the event was unknown. The relatedness between the event and unspecified varicella vaccine (either (Merck) VARIVAX or (Merck) PROQUAD) was not reported. This is one of several reports received from the same reporter. Additional information has been requested.
Age: 67.0
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster, Post herpetic neuralgia, Rash
Clinical narrative: Information has been received from a pharmacist referring to a 67 year old female patient. Medical history or concurrent condition was not reported. In approximately 2013 reported as "around 2 years ago", the patient was vaccinated with ZOSTAVAX (dosage, strength, route and lot # were not reported). Concomitant medication was reported. In approximately April 2015 (reported as "around 6 months ago"), the patient developed shingles on an unspecified date. The patient sought unspecified medical attention. The reporter stated that the patient had experienced a rash that "wrapped around her abdomen and back" which her unspecified physician told her was shingles. The pharmacist stated that the patient might have been prescribed an unspecified dose of acyclovir at the time to treat the rash by healthcare provider. On an unspecified date in 2015, the patient experienced post-herpetic nerve pain and the pharmacist reported that the patient continued to experience post-herpetic nerve pain. Outcome of the adverse events was not recovered. 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 certified medical assistant refers to an unspecified number of patients of unknown age and gender. No information on patients' medical history or concurrent conditions was provided. On an unknown dates, the patients were vaccinated with improperly stored doses of ROTATEQ oral liquid, lot# K023537, expiration date 22-JUN-2016 (dose not reported). No information on patients' concomitant medications was provided. No adverse symptoms were reported. This is one of the several reports from the same reporter. Additional information has been requested.
Age: 65.0
Sex: M
Vaccine: PPV
Symptoms: Erythema, Pain, Peripheral swelling, Pyrexia, Tenderness
Clinical narrative: Information has been received from a registered nurse via field representative referring to a 65 year old male patient. There was no medical history or concurrent condition reported. On an unknown date the patient was vaccinated with PNEUMOVAX 23 (dosage, strength, route and lot # were not reported). There was no concomitant medication reported. On an unknown date, the patient presented with a excessive swelling, redness, pain and tenderness in an unspecified arm 1 week after receiving the PNEUMOVAX 23. The patient also had body aches and a temperature. He went to the emergency room due to these symptoms. It was not known if he was admitted into the hospital. At the time of the report, the outcome of the events was unknown. Additional information has been requested.
Age: 57.0
Sex: F
Vaccine: VARZOS
Symptoms: Immediate post-injection reaction, Injection site pain, Injection site pruritus, Injection site rash, Injection site warmth
Clinical narrative: This spontaneous report was received from a consumer refers to herself as a 57 year old female patient. The patient current conditions included with glaucoma. The patient was allergic to sulfa drug. On 12-SEP-2015, the patient was vaccinated with ZOSTAVAX (dose, route and lot# were not reported). Concomitant therapies included unspecified doses of TRAVATAN and MICROGESTIN as well as received an unspecified flu vaccine and pneumonia vaccine in the other arm in the next few days approximately in 2015 after receiving the ZOSTAVAX. The patient stated that after receiving the ZOSTAVAX approximately on 12-SEP-2015, she had a severe reaction in her left arm where the vaccine was received. Immediately after receiving the ZOSTAVAX approximately on 12-SEP-2015, there were bumps and itching around the injection area. Within 48 hours approximately on 14-SEP-2015, these reactions went away. Then within one week of receiving the ZOSTAVAX approximately in September 2015, bumps of the same size and the accompanying itching that had surrounded the injection site appeared on the outer left arm from the wrist bone up about 5 inches toward the elbow. On an unknown date approximately in 2015, these bumps got warm, painful, and had severe itch that want to claw at although the desire to itch gone away in approximately 10 seconds. On an unknown date approximately in 2015, the bumps appeared red just under the skin that is probably blood vessel breakage but do not actually bleed. The patient was now in day 30 of the reaction. It was diminished, but still evident. Patient did not sought medical attention. The patient was self-treated with unspecified doses of BENADRYL and SOVERIGN SILVER GEL plus 10% cortisone cream to calm the itching. The outcome of events bumps of the same size and the accompanying itching that had surrounded the injection site appeared on the outer left arm from the wrist bone up about 5 inches toward the elbow, bumps got warm, painful, had severe itch and bumps appeared red was recovering/resolving. The reporter did not provide the causality between the event and the suspect therapy. Additional information is not expected as the reporter did not wish further contact.
Sex: U
Vaccine: HPV4
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a healthcare worker refers to an unspecified patients of unknown age and gender. The patients pertinent medical history and concurrent conditions were not reported. No previous drug reactions or allergies were reported. On an unknown date unspecified number of patients were vaccinated with improperly stored doses of GARDASIL (strength, dose, frequency and route of administration were not reported) (unspecified lot # and expiration date). No concomitant medications were reported. No adverse effects were reported. There was no product quality complaint. Additional information has been requested.
Sex: U
Vaccine: MMRV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a nurse referring to an unspecified patient of unknown age and gender. The patient's concurrent conditions, concomitant medication and medical history were not provided. On an unknown date the patient was vaccinated with a dose of improperly stored (Merck) PROQUAD (lot # K009891, expiration date 11-JAN-2106, dose, route and dose number were unspecified). No adverse effects were reported. 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: Information has been received from a nurse referring to four unspecified patients of unknown age and gender. The patient's concurrent conditions, concomitant medication and medical history were not provided. On unspecified dates the patients were vaccinated with doses of improperly stored (Merck) PROQUAD (lot # K008185, expiration date 05-DEC-2015, dose, route and dose number were unspecified). No adverse effects were reported. This is one of several reports received from the same source. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a nurse referring to two unspecified patients of unknown age and gender. The patients' concurrent conditions, concomitant medication and medical history were not provided. On unspecified dates the patients were vaccinated with doses of improperly stored VARIVAX (Merck) (lot # L010145, expiration date 24-MAR-2017, dose, route and dose number were unspecified). No adverse effects were reported. This is one of several reports received from the same source. Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Injection site pruritus, Injection site swelling
Clinical narrative: This spontaneous report was received from a pharmacist, referring to a female patient of unknown age. The patient's medical history and concurrent conditions were not reported. On 30-SEP-2015 (reported as "2 days ago"), the patient was vaccinated with a dose of ZOSTAVAX (dose, frequency, route, lot # and expiration date were not reported). No concomitant medications were reported. On an unspecified date in 2015, the patient developed a "2 by 5 centimeter raised", swollen area" at the injection site that was itchy. The patient sought medical attention by visiting the pharmacist. At the time of the report, the outcome of injection site swelling and injection site pruritus was unknown. The relatedness between injection site swelling and injection site pruritus and the ZOSTAVAX was not provided. No product quality complaint was involved. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a nurse referring to an unspecified number of patients of unknown age and gender. The patients' concurrent conditions, concomitant medication and medical history were not provided. On unspecified dates the patients were vaccinated with doses of improperly stored VARIVAX (Merck) (lot # K026385, expiration date 15-DEC-2016, subcutaneous, 0.5ml). No adverse effects were reported. This is one of several reports received from the same source. Additional information has been requested.
Age: 1.05
Sex: M
Vaccine: MMR
Symptoms: Erythema, Lethargy, Mobility decreased, Otitis media, Pyrexia
Clinical narrative: This spontaneous report was received from a physician (who was also the patient's mother) and refers to a 12 month old male patient. No medical history, concurrent conditions or concomitant therapies were reported. On 28-SEP-2015, the patient was vaccinated with a dose of M-M-R II (lot #, dose and route of administration were not provided). On 02-OCT-2015, the patient had a fever of 106 F and was lethargic. He was not moving around and only lying in one place. His face was red and he had some red bumpy spots on his feet. The patient was given TYLENOL, ADVIL, dextrose, Pedialyte and probiotics as a treatment for the events. The fever did not go below 102 F even with the TYLENOL, ADVIL and sponging him down in bath. On 03-OCT-2015, the patient was taken to his physician's office, where he was diagnosed with mild middle ear infection but the patient's physician did not feel the ear infection could had made the fevers go that high. The outcome of fever was recovered on 08-OCT-2015, the patient was afebrile, while the outcome of other events was unknown. The reporter did not specify whether any of the other symptoms had resolved. The relatedness between the events and M-M-R II was not reported. Additional information is not expected, as the reporter denied any further contact.
Age: 1.05
Sex: M
Vaccine: MMR
Symptoms: Rash erythematous
Clinical narrative: This spontaneous report was received from a physician (who was also the patient's mother) and refers to a 12 month old male patient. No medical history, concurrent conditions or concomitant therapies were reported. On 28-SEP-2015, the patient was vaccinated with a dose of M-M-R II (lot #, dose and route of administration were not provided). On 02-OCT-2015, the patient had a fever of 106 F and was lethargic. He was not moving around and only lying in one place. His face was red and he had some red bumpy spots on his feet. The patient was given TYLENOL, ADVIL, dextrose, Pedialyte and probiotics as a treatment for the events. The fever did not go below 102 F even with the TYLENOL, ADVIL and sponging him down in bath. On 03-OCT-2015, the patient was taken to his physician's office, where he was diagnosed with mild middle ear infection but the patient's physician did not feel the ear infection could had made the fevers go that high. The outcome of fever was recovered on 08-OCT-2015, the patient was afebrile, while the outcome of other events was unknown. The reporter did not specify whether any of the other symptoms had resolved. The relatedness between the events and M-M-R II was not reported. Additional information is not expected, as the reporter denied any further contact.
Age: 8.0
Sex: F
Vaccine: HPV9
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: This spontaneous report was received from a healthcare worker refers to a 8 years and 10 months old female patient. On 02-OCT-2015, the patient was inadvertently vaccinated with GARDASIL 9 (Lot# L023230, 28-JUL-2017). No adverse effects were reported. 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 healthcare worker regarding unspecified number of patients of unknown age and gender. The patients' pertinent medical history and concurrent conditions were not reported. On an unknown date, the patients may have been vaccinated with doses of improperly stored GARDASIL (lot # K008931, expiry date 04-MAR-2017). Concomitant medications were not reported. No adverse events were reported. Product quality complaint was not filed. Additional information has been requested.
Sex: U
Vaccine: HEP
Symptoms: Incorrect product storage
Clinical narrative: Information has been received from a pharmacist referring to a newborns (numbered 186). Background: Since June 2015, there had been 1645 times (30 minutes each time = 822.5 hours) that the temperature dropped below 36F. Of course, there was 144 times (30 minutes each time = 72 hours) that temperature was below 32F, the lowest being 29.7F. On 04-JUL-2015, there was a low temperature of 30.2F. On 12-SEP-2015 the patients were vaccinated with the improperly stored RECOMBIVAX HB strength  (units not provided) (lot number K020216 and expiration date of 17-SEP-2016) (dose and route of administration were not reported). There was no product quality complaint (PQC). This is one of several reports received from the same reporter. Additional information has been requested.
Age: 71.0
Sex: F
Vaccine: PNC13
Symptoms: Headache, Injection site pain, Pain, Pyrexia
Clinical narrative: Body aches. Fever. Headache. Site of injection soreness.
Sex: M
Vaccine: PPV
Symptoms: Injection site pain
Clinical narrative: This spontaneous report was received from a nurse practitioner via a company representative, concerning her husband of unknown age with Diabetes. On an unknown date, the patient was vaccinated with PNEUMOVAX 23 (dose, lot No and expiration date and route were not provided). On an unknown date, about 2 to 3 days after vaccination, the patient experienced pain at injection site. The patient did not seek medical attention and no treatment was given. No product quality complaint was involved. No laboratory tests were performed. At the time of this report, the outcome of pain at injection site was reported as recovered on an unspecified date. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a medical assistant referring to multiple unspecified patients of unknown age and gender. The patient's medical history and concurrent condition were not reported. On an unknown date, the patients were vaccinated with improperly stored doses of VARIVAX (Lot# K020675; expiration date 31-OCT-2016) (dose and route of administration were not reported). No adverse effects reported. There was not a product quality complaint involved. The lot# K020675 is not valid for VARIVAX. Additional information has been requested.
Age: 73.0
Sex: M
Vaccine: VARZOS
Symptoms: Extra dose administered, No adverse event
Clinical narrative: This spontaneous report was received from a pharmacist and refers to a 73 year old male patient. Pertinent medical history or drug allergies/drug reactions were not reported. On an unspecified date in June 2013, the patient was vaccinated with the first dose of ZOSTAVAX (lot number, dose, route of administration and strength were not reported) at the pharmacy. On an unspecified date in March 2015, the patient was inadvertently vaccinated with the second dose of ZOSTAVAX (lot number, dose, route of administration and strength were not reported) at the primary care physician office (extra dose administered). Additionally, it was reported that the patient sought medical attention calling to the pharmacist (date and details were not specified). No adverse effects were noted and there was no product quality complain involved. Additional information is not expected as the reporter did not consent for new follow up attempts.