chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 37.0
Sex: F
Vaccine: TDAP
Symptoms: Chills, Injection site mass, Lymphadenopathy, Pyrexia
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of fever in a 37-year-old female patient who received BOOSTRIX (batch number 9ZS2S, expiry date 11th February 2019). On 17th December 2016, the patient received BOOSTRIX (intramuscular) .5 ml. On 17th December 2016, less than a day after receiving BOOSTRIX, the patient experienced fever, injection site lump, lymphadenopathy cervical and chills. On 18th December 2016, the outcome of the fever was recovered/resolved. On an unknown date, the outcome of the injection site lump and lymphadenopathy cervical were not recovered/not resolved and the outcome of the chills was unknown. The reporter considered the fever, injection site lump, lymphadenopathy cervical and chills to be probably related to BOOSTRIX. Additional details were provided as follows: The concomitant medication included birth control pills. After vaccination with BOOSTRIX (left deltoid) the patient experienced fever which resolved in a day, but the patient still had a golf-ball sized lump at the injection site and on the glands of her neck on the side of the vaccination. The call was transferred to medical information.
Age: 57.0
Sex: M
Vaccine: FLU4, FLUX
Symptoms: Rash
Clinical narrative: Skin Rash, started on forearms back of hands and back and buttocks. Treatment Tanning booth. Same thing happened last time with flu shot in 2013.
Age: 1.25
Sex: F
Vaccine: HIBV, IPV
Symptoms: Retching, Vomiting
Clinical narrative: Vomiting. She threw up 3 substantial times and then 4 more with an empty stomach, so more of dry heaving. This went on until 3:30 am. no fever and no other symptoms.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Rash pruritic, Urticaria
Clinical narrative: Hive-like rash that was itchy woke me up in early AM. It was on my buttocks. Bothered me less during day. the next morning (01/05/2017, today) I again woke w/ hive-like rash itching on my knees, ankles, trunk of body, arms.
Sex: U
Vaccine: HPV9
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a healthcare worker (medical assistant) and refers to multiple unspecified patients of unknown age and gender. There was no information regarding the patients' pertinent medical history, drug reactions, allergies or concomitant therapies. On unknown dates, the patients might have been vaccinated with improperly stored doses GARDASIL 9 (lot # M007764 and expiration date 30-JAN-2018, lot # M021407 and expiration date 30-APR-2018, lot # M018810 and expiration date 28-MAY-2018; site, doses and route of administration were not reported) for prophylaxis. The reason of the call was temperature alarm received via Digital Data Logger. It was reported that the vaccines were exposed to temperature between 8.4 and 14.5 Celsius degrees for 368 hours. No previous temperature excursion was reported. No adverse effects were reported. The reporter stated that after she became aware of the temperature excursion, no vaccines were administered to the patients that were improperly stored. This is one of the several reports received from the same source. The attempt to contact the reporter on 22-DEC-2016 has been unsuccessful. Additional information is not expected as no further information is available. Reporter information and narrative were updated. Sender's Comments: US-009507513-1611USA001675: US-009507513-1611USA001676: US-009507513-1611USA001677: US-009507513-1611USA001674: US-009507513-1611USA000940: MERCK 1611USA001678: Mfr number.
Sex: U
Vaccine: PPV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a Registered Nurse concerning a patient of unknown age and gender. Patient's pertinent medical history, drug reactions/allergies and concomitant medications were not reported. On 08-DEC-2016, the patient was vaccinated with an improperly stored dose of PNEUMOVAX 23 (Lot #M038359 and expiration date: 13-MAY-2018; however, dose and route of administration were not reported) for prophylaxis. The temperature was 35.2 F, time frame was unknown, and there was no previous temperature excursion. The call was due to a data logger. No adverse symptoms reported and no further information was provided. There was no product quality complaint involved. Additional information has been requested.
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a medical assistant referring to multiple patients of unknown age and gender. Information about concurrent condition, concomitant medication and medical history was not provided. On unknown dates, the patients were vaccinated with improperly stored ROTATEQ (dose unknown) (lot# M004544, expiration date 18-OCT-2017) orally for prophylaxis. The vaccine was exposed to temperature excursion of 35Fahrenheit degree (F) for 6 hours. There was no previous temperature excursion. No data logger was involved. No adverse effects was reported. This is one of several reports received from the same reporter. Additional information has been requested.; Sender's Comments: US-009507513-1701USA001893: US-009507513-1701USA001894: US-009507513-1701USA001895:
Sex: U
Vaccine: VARZOS
Symptoms: Injection site hypoaesthesia, Injection site paraesthesia, Injection site pruritus
Clinical narrative: This spontaneous report was received from a pharmacist referring to a multiple patients of unknown age and gender. Patient's pertinent medical history, drug reactions/allergies, concurrent conditions or concomitants medications were not reported. On unknown dates, the patients were vaccinated with ZOSTAVAX Vial, Lot # M019646 and expiration date: 18-JUL-2017 (dose and route of administration were not provided) for prophylaxis. On unknown dates, the pharmacist reported multiple patient complaints as itching, tingling, numbness and a ring around the injection site from the ZOSTAVAX administered from the Lot # above mentioned.  The reporter also asked whether she could have the remaining box replaced, because she did not feel comfortable giving those vaccinations. She was adviced to not discard the 4 vials still available from that box because more information about it might be needed. The outcome of  itching, tingling, numbness and a ring around the injection site was unknown. The reporter did not report the causality between the events and ZOSTAVAX. 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 concerning unspecified patients of unknown age and gender. The patients' concomitant medications, pertinent medical history, and drug reactions and allergies have not been provided. On unspecified dates, improperly stored doses of PROQUAD (rHA) (dose, strength, frequency and route were unknown, lot # M003435 with expiration date 19-JUL-2017, Lot # L046506 with 17-MAY-2017) were administered to the unspecified patients for prophylaxis. The PROQUAD was exposed 7 Fahrenheit for a time frame of 7 days. No adverse effects were reported. This is one of several reports from the same reporter. Additional information is not expected since there is no consent for follow up. Sender's Comments: US-009507513-1612USA008812.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a registered nurse referring to multiple unspecified patients. The patients' concurrent condition, medical history and concomitant therapy were not provided. On unknown dates, the patients were vaccinated with improperly stored VARIVAX (lot # M024702, expiration date: 18-MAY-2018; lot # L028278, expiration date: 28-JUL-2017; lot # L042264, expiration date: 26-OCT-2017; dose and route were unknown) for prophylaxis. No adverse effects were reported. The temperature for the vaccine stored was 10 Fahrenheit degree with 35 minutes time frame. Previous temperature excursion was reported as exposure to 35.6 Fahrenheit for 8 hours and 53 minutes, 13.3 Fahrenheit for 3 hours and 22 minutes, 32.9 Fahrenheit for 24 hours and 34.5 Fahrenheit for 24 hours (cumulative 60 hours and 15 minutes). Data logger was involved.  This is one of several reports received from the same reporter. Additional information has been requested.; Sender's Comments:  US-009507513-1701USA001053:
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 condition, medical history and concomitant therapy were not provided. On unspecified dates during the time period of 06-DEC-2016 to 13-DEC2016, the patients were vaccinated with improperly stored VARIVAX (lot # M028553, expiration date: 07-JUN-2018; lot # M030138, expiration date: 15-JUN-2018; lot # M014908, expiration date: 25-MAR-2018; lot # M034586, expiration date: 27-JUL-2018; dose and route were unknown) for prophylaxis. The detail of the storage was a temperature excursion of 22.5 Fahrenheit for 2 hours 36 minutes for the freezer vaccine VARIVAX. No adverse effect was reported.  This is one of several reports received from the same reporter. Additional information is not expected as follow up with the reporter is not permitted.; Sender's Comments: US-009507513-1701USA001925: US-009507513-1701USA001926: US-009507513-1701USA001927:
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Pain, Peripheral swelling
Clinical narrative: This spontaneous report was received from a consumer as part of the Market Research Program conducted by Research Group referring to an about 60 year old female patient. The patient's medical history, concurrent conditions and concomitant therapy were not provided. On an unknown day in 2016, the patient received a shot of ZOSTAVAX injection for shingles. (Strength, dose, route, lot number and expiration date were not provided). The reporter stated that she sat next to a women who told her that "2-3 days" after getting the shot (reported as sometime in June/ July 2016) her arm got swollen and turned red. Also mentioned it really hurt and had to put ice on it. The patient said she went back to her doctor and doctor said it was one of the side effects she could get with this vaccine. Back on an unspecified date in 2016, the reporter saw this woman again and by then her arm was getting better (was a little swollen and her skin was pink), so believe it was starting to resolve them, but not sure if the events was completely resolved; however the outcome of arm redness was unknown. The reporter relate the events with ZOSTAVAX. Additional information is not expected as there was no contact details provided.
Sex: U
Vaccine: HPV9
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a medical assistant referring to an unspecified number of patients of unknown age and gender. Pertinent medical history, concurrent conditions, drug reactions/allergies and concomitant medications of the patients were not provided. On unspecified dates, the patients received improperly stored dose of GARDASIL 9 Lot # M017983 and expiration date: 30-MAY-2018 (dose numbers, dose and route of administration were not reported) for prophylaxis. The vaccine underwent a temperature of 35.6 Fahrenheit during 10 minutes, detected by data logger. No previous temperature excursions 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 medical assistant refers to a patient of unknown age and gender. There was no information on concomitant medications, medical history and concurrent conditions. On 13-DEC-2016, the patient was inadvertently administered GARDASIL 9 that had been improperly stored (lot # M032650, expiry date: 31-MAR-2019, intramuscular route) for prophylaxis. No adverse effects were reported. The vaccine was stored at -4.2 F for 15 minutes. There was no previous temperature excursion. Data logger was involved. The outcome was unknown. No product quality complaint was involved. Additional information is not expected as the reporter did not wish further contact.
Sex: U
Vaccine: MMR
Symptoms: Mumps
Clinical narrative: This spontaneous report was received from  an administrator concerning to unspecified number of patients of unknown age and gender. Concurrent conditions, medical history, historical drugs and concomitant therapies were not reported. On unknown dates, some patients had been vaccinated with M-M-R-II (dose, route, lot number and expiration date were not reported) for prophylaxis. On unknown dates, the reporter stated that she knew of "outbreak of mumps" in several unspecified regions, additionally, the reporter indicated that some unspecified doses of properly stored M-M-R-II had been moved from  her geographic area to unspecified counties where the mumps outbreak had occurred. The reporter did not specify if any of these patients had been previously vaccinated with M-M-R-II. No additional information available. A product quality complaint was not involved.  The outcome of the event was unknown. The causal relationship between the event and M-M-R-II was not reported. Additional information is not expected as there is no consent to contact the reporter.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a registered nurse referring to multiple unspecified patients. The patients' concurrent condition, medical history and concomitant therapy were not provided. On an unknown date, the patients were vaccinated with improperly stored VARIVAX (lot # M033904, expiration date: 20-JUL-2018; lot # M025867, expiration date: 24-MAY-2018; lot # M023382, expiration date: 11-MAY-2018; lot # M017292, expiration date: 07-APR-2018; lot # L046887, expiration date: 23-NOV-2017; lot # L010148, expiration date: 24-MAR-2017;dose and route were unknown) for prophylaxis. The nurse reported no adverse effects noted. The temperature for the vaccine stored was 12.9 Fahrenheit degree with 2 hours 10 minutes time frame. Previous temperature excursion was reported as exposure to 13.8 Fahrenheit for 3 hours. Data logger was involved.  This is one of several reports received from the same reporter. Additional information has been requested.; Sender's Comments:  US-009507513-1701USA001204: US-009507513-1701USA001205:
Age: 1.0
Sex: F
Vaccine: HEPA, MMR, PNC13, VARCEL
Symptoms: Expired product administered, No adverse event
Clinical narrative: Information has been received from a medical assistant referring to a 12 month old patient of unknown gender. There was no information about concurrent condition, concomitant medication and medical history. On 15-DEC-2016, the patient was vaccinated with a dose of M-M-R II (lot # K020188, expiration date 22-OCT-2016) (therapy type, dose and route unknown) for prophylaxis (expired vaccine used). No adverse effect was reported. Additional information has been requested.
Sex: M
Vaccine: FLUX, PPV, FLUX, PPV
Symptoms: Fatigue
Clinical narrative: The information was received from a pharmacist via Pfizer referring to three adult male patients under the age of 65. The reporter did not know of any concomitant medication, other medical conditions or if any tests were performed. On an unknown date, the patients received PNEUMOVAX 23 (lot number and dose unknown) and influenza virus vaccine (Flu vaccine) (manufacturer unknown) (lot number and dose unknown). All the three patients received the influenza virus vaccine (manufacturer unknown) at the same time. The indication for the influenza virus vaccine (manufacturer unknown) was assumed to be for protection against the flu and PNEUMOVAX 23 for protection against pneumococcal pneumonia. On an unspecified date and time, post administration of PNEUMOVAX 23 and influenza virus vaccine (manufacturer unknown), the patients experienced fatigue. The outcome of the event fatigue was unknown. The reporter considered the event was related to PNEUMOVAX 23 and the causality for influenza virus vaccine (manufacturer unknown) was unknown. Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Peripheral swelling
Clinical narrative: This solicited report was received from a consumer (patient's friend) regarding a 58 year old female patient, as part of a market research program by Research Group. The patient's concurrent conditions, medical history and concomitant medications have not been reported.  On an unknown date (also reported as 2 years ago), the patient was vaccinated with a dose of ZOSTAVAX injection (lot#, expiration date, dose and route of administration were not reported) for shingles prophylaxis. On an unknown date (also reported as on the day of vaccine, in the evening), it was reported that the patient's arm blew up and she had to go to the emergency room. The outcome of the event was reported as recovered on an unspecified date (also reported as 2-3 days from the time of injection). The action taken with ZOSTAVAX was reported as not applicable. The reporter considered the event to be related to ZOSTAVAX. Additional information is not expected as the consent to contact the physician was not given.
Sex: U
Vaccine: HEPA
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a State Immunization Official and refers to multiple patients (exact number unspecified) of unknown age and gender. The patients' concurrent conditions, drug reactions or allergies, concomitant therapies and medical histories were not provided. On multiple unspecified dates, the patients might have been vaccinated with improperly stored doses of VAQTA injection, lot # M015290 and expiration date 20-SEP-2017, lot # M017982 and expiration date 13-SEP-2017, lot # M022924 and expiration date 24-JAN-2018 (doses and routes of administration were not reported) for prophylaxis. Administered doses of vaccines experienced the temperature excursion of 29.3 degrees Fahrenheit (F) for 2 hours 56 minutes, 28.8 F for 7 hours 6 minutes, 34.7 F for 26 minutes, 34.5 F for 27 minutes, 33.6 F for 1 hour 13 minutes , 30.6 F for 5 hours 55 minutes, 31 F for 3 hours 30 minutes, 33 F for 1 hour 59 minutes, 33.4 F for 2 hours 20 minutes, 32 F for 4 hours 15 minutes, 32 F for 3 hours 52 minutes, 32 F for 4 hours 4 minutes, 30.1 F for 4 hours 53 minutes, 31.7 F for 4 hours 5 minutes, 32.5 F for 2 hours 21 minutes, 33.2 F for 2 hours 16 minutes and 33 F for 1 hour 23 minutes. Data logger was involved. There were no previous excursions reported. There was no adverse effect reported. Product quality complaint (PQC) was not involved. This is one of several reports received from the same reporter. Additional information has been requested.; Sender's Comments: US-009507513-1612USA009918: US-009507513-1612USA014168: US-009507513-1612USA014170:
Sex: U
Vaccine: MMRV
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. Information about concomitant medication and medical history was not provided. On unknown dates, the patients received improperly stored PROQUAD (rHA, injection, lot # L032760, expiration date 24-FEB-2018, dose and route unknown) for prophylaxis. The vaccines were exposed to temperature excursion of minus 10.2 degrees centigrade(C) for 37 hours and 29 minutes. Data logger was involved. There was previous temperature excursion of minus 12.9 degrees centigrade(C) for 11 hours and 24 minutes. No adverse effect had been reported. No product quality complaint was involved. Additional information has been requested.
Sex: U
Vaccine: HPV9
Symptoms: Inappropriate schedule of drug administration, Interchange of vaccine products, No adverse event
Clinical narrative: Information has been received from a medical assistant referring to a patient of unknown age and gender. Information about concurrent condition, concomitant medication and medical history was not provided. On 25-NOV-2013 the patient was vaccinated with GARDASIL(confirmed not GARDASIL 9) for prophylaxis.  On 13-SEP-2016, the patient received GARDASIL 9 (confirmed not GARDASIL quadrivalent). Information of treatment was not provided. At the time of this report, no adverse symptoms was reported. Additional information has been requested.
Age: 26.0
Sex: F
Vaccine: MMRV
Symptoms: No adverse event, Wrong drug administered
Clinical narrative: This spontaneous report as received from a medical assistant refers to a 26 year old patient of an unknown gender. The patient's medical history, concurrent conditions and concomitant medications were not reported. On 29-DEC-2016, the patient was inadvertently vaccinated with a dose of PROQUAD (albumin status rHA, lot # L041629, expiration date 22-APR-2017, for prophylaxis; dose and route were not reported) instead of M-M-R II. No adverse effects were reported. Additional information has been requested.
Sex: U
Vaccine: UNK
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a registered nurse and refers to a patient of unknown age and gender. There was no information about the patient's concurrent conditions, concomitant therapy, medical history, drug reactions or allergies provided. On an unknown date, the patient was vaccinated with a dose of one of improperly stored vaccines. The improperly stored vaccines were as follows: GARDASIL 9 injection, lot# M016193 with expiration date 24-APR-2018, lot# M020103 with expiration date 15-FEB-2018, lot# M011840 with expiration date 01-FEB-2018, lot# L037554 with expiration date 25-DEC-2017, lot# M007764 with expiration date 30-JAN-2018 or lot# M009362 with expiration date 13-JUN-2018 (dose and route of administration were not reported), VAQTA injection, lot# L023936 with expiration date 15-MAR-2017, lot# M036459 with expiration date 18-JAN-2018, lot# L015460 with expiration date 20-JUL-2017, lot# L046953 with expiration date 14-JAN-2017, lot# L045713 with expiration date 14-JAN-2017 or lot# L041676 with expiration date 15-MAR-2017 (dose and route of administration were not reported), RECOMBIVAX HB injection, lot# L014418 with expiration date 13-APR-2017, lot# reported as M011671 with expiration date 02-JUN-2018, lot# M029026 with expiration date 18-NOV-2018, lot# L027733 with expiration date 13-SEP-2017, lot# L039660 with expiration date 04-FEB-2018, lot# M000442 with expiration date 31-MAR-2018, lot# L029631 with expiration date 14-AUG-2018 (dose and route of administration were not reported), PEDVAXHIB injection, lot# M006710 with expiration date 06-DEC-18, lot# L004740 with expiration date 16-NOV-2017, lot# M001811 with expiration date 04-NOV-2018, lot# M014927 with expiration date 18-FEB-2019, lot# M027882 with expiration date 14-APR-2019, lot# L014427 with expiration date 09-MAR-2018, or lot# K025005 with expiration date 21-JUL-2017 (dose and route of administration were not reported), ROTATEQ taken orally, lot# M014318 with expiration date 30-SEP-2017, lot# M007307 with expiration date 30-NOV-2017, or lot# L013206 with expiration date 29-JAN-2017 (dose was not reported), PNEUMOVAX 23 vials, lot# M029680 with expiration date 17-JAN-2018 or lot# M026317 with expiration date 11-JAN-2018 (dose and route of administration were not reported). Reporting nurse was not sure which of the vaccines the patient received. There was no adverse effects reported. Product quality complaint (PQC) was not involved. The vaccines were exposed to the temperature between 32 and 36 degrees Fahrenheit for 9 days (date unspecified). A digital data logger was not involved. There were no previous temperature excursions. Additional information has been requested.
Age: 1.0
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a medical assistant refers to a 12 month old patient of unknown gender. No information regarding the patient's pertinent medical history, concomitant medications and drug reactions or allergies was reported. On 12-SEP-2016, the patient received improperly stored dose of VARIVAX injection, lot # M009768, expiration date: 23-FEB-2018 (dose, route of administration and anatomical location were not reported). It was reported that the administered dose of VARIVAX was improperly stored at -3.5 degrees Celsius (C) for 1 hour and 6 minutes. There was no previous temperature excursion. Data logger was involved. No symptoms were reported. This is one of several reports received from the same reporter. Additional information is not expected as all relevant information has been received.; Sender's Comments: US-009507513-1610USA011133:
Age: 1.0
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a medical assistant refers to a 12 month old patient of unknown gender. No information regarding the patient's pertinent medical history, concomitant medications and drug reactions or allergies was reported. On 09-SEP-2016, the patient received improperly stored dose of VARIVAX injection, lot # M009768, expiration date: 23-FEB-2018 (dose, route of administration and anatomical location were not reported). It was reported that the administered dose of VARIVAX was improperly stored at -3.5 degrees Celsius (C) for 1 hour and 6 minutes. There was no previous temperature excursion. Data logger was involved. No symptoms were reported. This is one of several reports received from the same reporter. Additional information is not expected as all relevant information has been received.; Sender's Comments: US-009507513-1610USA011133:
Age: 1.0
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a medical assistant refers to a 12 month old patient of unknown gender. No information regarding the patient's pertinent medical history, concomitant medications and drug reactions or allergies was reported. On 08-SEP-2016, the patient received improperly stored dose of VARIVAX injection, lot # M009768, expiration date: 23-FEB-2018 (dose, route of administration and anatomical location were not reported). It was reported that the administered dose of VARIVAX was improperly stored at -3.5 degrees Celsius (C) for 1 hour and 6 minutes. There was no previous temperature excursion. Data logger was involved. No symptoms were reported. This is one of several reports received from the same reporter. Additional information is not expected as all relevant information has been received.; Sender's Comments: US-009507513-1610USA011133:
Age: 1.0
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a medical assistant refers to a 12 month old patient of unknown gender. No information regarding the patient's pertinent medical history, concomitant medications and drug reactions or allergies was reported. On 07-SEP-2016, the patient received improperly stored dose of VARIVAX injection, lot # M004328, expiration date: 26-JAN-2018 (dose, route of administration and anatomical location were not reported). It was reported that the administered dose of VARIVAX was improperly stored at -3.5 degrees Celsius (C) for 1 hour and 6 minutes. There was no previous temperature excursion. Data logger was involved. No symptoms were reported. This is one of several reports received from the same reporter. Additional information is not expected as all relevant information has been received.; Sender's Comments: US-009507513-1610USA011133:
Age: 14.0
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a medical assistant refers to a 14 year old patient of unknown gender. No information regarding the patient's pertinent medical history, concomitant medications and drug reactions or allergies was reported. On 01-SEP-2016, the patient received improperly stored dose of VARIVAX injection, lot # M004328, expiration date: 26-JAN-2018 (dose, route of administration and anatomical location were not reported). It was reported that the administered dose of VARIVAX was improperly stored at -3.5 degrees Celsius (C) for 1 hour and 6 minutes. There was no previous temperature excursion. Data logger was involved. No symptoms were reported. This is one of several reports received from the same reporter. Additional information is not expected as all relevant information has been received.; Sender's Comments: US-009507513-1610USA011133:
Age: 1.25
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a medical assistant refers to a 15 month old patient of unknown gender. No information regarding the patient's pertinent medical history, concomitant medications and drug reactions or allergies was reported. On 01-SEP-2016, the patient received improperly stored dose of VARIVAX injection, lot # M004328, expiration date: 26-JAN-2018 (dose, route of administration and anatomical location were not reported). It was reported that the administered dose of VARIVAX was improperly stored at -3.5 degrees Celsius (C) for 1 hour and 6 minutes. There was no previous temperature excursion. Data logger was involved. No symptoms were reported. This is one of several reports received from the same reporter. Additional information is not expected as all relevant information has been received.; Sender's Comments: US-009507513-1610USA011133:
Age: 1.0
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a medical assistant and refers to a 12-month-old patient of unknown gender. The patient's pertinent medical history, concomitant medications and drug reactions or allergies were not reported. On 26-SEP-2016, the patient received an improperly stored dose of VARIVAX (exact dose and route of administration were not reported, lot # M009768, expiration date: 23-FEB-2018). It was reported that the administered dose of VARIVAX was improperly stored at -3.5 degrees Celsius (C) for 1 hour and 6 minutes. There was no previous temperature excursion. Data logger was involved. No symptoms were reported. This is one of several reports received from the same reporter. Additional information is not expected as all relevant information has been received.; Sender's Comments:  US-009507513-1610USA011133:
Age: 1.0
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a medical assistant and refers to a 12-month-old patient of unknown gender. The patient's pertinent medical history, concomitant medications and drug reactions or allergies were not reported. On 23-SEP-2016, the patient received an improperly stored dose of VARIVAX (exact dose and route of administration were not reported, lot # M009768, expiration date: 23-FEB-2018). It was reported that the administered dose of VARIVAX was improperly stored at -3.5 degrees Celsius (C) for 1 hour and 6 minutes. There was no previous temperature excursion. Data logger was involved. No symptoms were reported. This is one of several reports received from the same reporter. Additional information is not expected as all relevant information has been received.; Sender's Comments:  US-009507513-1610USA011133:
Age: 1.0
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a medical assistant and refers to a 12-month-old patient of unknown gender. The patient's pertinent medical history, concomitant medications and drug reactions or allergies were not reported. On 22-SEP-2016, the patient received an improperly stored dose of VARIVAX (exact dose and route of administration were not reported, lot # M009768, expiration date: 23-FEB-2018). It was reported that the administered dose of VARIVAX was improperly stored at -3.5 degrees Celsius (C) for 1 hour and 6 minutes. There was no previous temperature excursion. Data logger was involved. No symptoms were reported. This is one of several reports received from the same reporter. Additional information is not expected as all relevant information has been received.; Sender's Comments:  US-009507513-1610USA011133:
Sex: U
Vaccine: VARZOS
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a nurse referring to multiple unspecified patients. The patients' concurrent condition, medical history and concomitant therapy were not provided. On an unknown date, the patients were vaccinated with improperly stored ZOSTAVAX (lot # M032638, expiration date: 04-OCT-2017; lot # L035283, expiration date: 15-DEC-2016; dose and route were unknown) for prophylaxis. The nurse reported no adverse effects noted. The temperature for the vaccine stored was 12.9 Fahrenheit degree with 2 hours 10 minutes time frame. Previous temperature excursion was reported as exposure to 13.8 Fahrenheit for 3 hours. Data logger was involved. This is one of several reports received from the same reporter. Additional information has been requested.; Sender's Comments: US-009507513-1612USA008934: US-009507513-1701USA001205:
Sex: U
Vaccine: VARZOS
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a nurse referring to multiple unspecified patients. The patients' concurrent condition, medical history and concomitant therapy were not provided. On an unknown date, the patients were vaccinated with improperly stored ZOSTAVAX (lot # M007964, expiration date: 15-AUG-2017; lot # L046508, expiration date: 17-MAY-2017; dose and route were unknown) for prophylaxis. The nurse reported no adverse effects noted. The temperature for the vaccine stored was 12.9 Fahrenheit degree with 2 hours 10 minutes time frame. Previous temperature excursion was reported as exposure to 13.8 Fahrenheit for 3 hours. Data logger was involved. This is one of several reports received from the same reporter. Additional information has been requested. Sender's Comments: US-009507513-1612USA008934: US-009507513-1701USA001204.
Sex: U
Vaccine: HEPA
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a medical assistant referring to multiple patients of unknown age and gender. Information about concurrent condition, concomitant medication and medical history was not provided. On unknown dates, the patients were vaccinated with improperly stored VAQTA (dose and route unknown) (lot# M022924 with expiration date 24-JAN-2018, lot# M027879 with expiration date 24-JAN-2018) for prophylaxis. The vaccine was exposed to temperature excursion of 35Fahrenheit degree (F) for 6 hours. There was no previous temperature excursion. No data logger was involved. No adverse effect was reported. This is one of several reports received from the same reporter. Additional information has been requested.; Sender's Comments: US-009507513-1612USA005918: US-009507513-1701USA001894: US-009507513-1701USA001895:
Sex: U
Vaccine: HEP
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a medical assistant referring to multiple patients of unknown age and gender. Information about concurrent condition, concomitant medication and medical history was not provided. On unknown dates, the patients were vaccinated with improperly stored RECOMBIVAX HB (dose and route unknown) (lot# M023718 with expiration date 09-AUG-2018, lot# reported as M024261 with expiration date 30-JUL-2018) for prophylaxis. The vaccine was exposed to temperature excursion of 35 Fahrenheit degree (F) for 6 hours. There was no previous temperature excursion. No data logger was involved. No adverse effect was reported. This is one of several reports received from the same reporter. Additional information has been requested. Sender's Comments: US-009507513-1612USA005918: US-009507513-1701USA001893: US-009507513-1701USA001895.
Sex: U
Vaccine: PPV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a medical assistant referring to multiple patients of unknown age and gender. Information about concurrent condition, concomitant medication and medical history was not provided. On unknown dates, the patients were vaccinated with improperly stored PNEUMOVAX 23 (dose and route unknown) (lot# reported as M037533 with expiration date 17-MAY-2018) for prophylaxis. The vaccine was exposed to temperature excursion of 35 Fahrenheit degree (F) for 6 hours. There was no previous temperature excursion. No data logger was involved. No adverse effect was reported. This is one of several reports received from the same reporter. Additional information has been requested. Sender's Comments: US-009507513-1612USA005918: US-009507513-1701USA001893: US-009507513-1701USA001894.
Age: 65.0
Sex: U
Vaccine: FLU4
Symptoms: Back pain, Insomnia, Mobility decreased, Musculoskeletal pain, Myalgia
Clinical narrative: Initial unsolicited report received from a consumer on 26 December 2016. This case involves a 65-year-old patient (gender not reported) who was vaccinated with a dose of FLUZONE (batch number, expiry date, dose, route and site of administration were not reported) on 28 November 2016 (reported as Nov 28TH). Patient's medical history and concomitant medications were not reported. On unspecified date, two to three weeks following the vaccination, shoulder muscle of patient was decriped, imobile and patient felt like hit with a baseball bat. On specified date (reported as a week or so later from previous event), following the vaccination patient felt that it moved accross patient's back and in the other shoulder muscle with sore and imobile feeling in entire muscle system , legs,hands, every where and patient also felt like beaten with baseball bats. On unspecified date, following the vaccination the patient couldn't sleep. Lab data was not reported. Patient received corrective treatment with ibuprophen and acetaminophen. The outcome of the events was not reported. Upon internal review the case was considered as serious because of important medical event: Immobile. List of documents held by sender: none.; Sender's Comments: This case concerns 65 year old patient who received INFLUENZA QUADRIVAL A-B VACCINE and developed muscle pain immobile feeling, muscle wasting and cant sleep. Time to onset was not compatible with the role of vaccination. Further information regarding etiological work up, concurrent condition at the time of vaccination, concomitant medication, and more investigation results to rule out the alternative cause are needed for complete assessment of the case. Based upon available information role of vaccine cannot be judged.
Age: 72.0
Sex: M
Vaccine: FLU3
Symptoms: Cardiac stress test, Cough, Muscle spasms, Scan, Wheezing
Clinical narrative: Initial unsolicited report received from a consumer on 27-Dec-2016. Additional information was received from the reporter on 29-Dec-2016. This case involves a 72 year old male patient who was vaccinated with a dose of FLUZONE HD (Batch number, expiration date, dose, dose in series, site and route of administration were not reported) on Sep-2016 (date not reported). Pre-existing physician diagnosed allergies, birth defects, medical conditions (specify) was reported to have allergy with Sodium Benzoid. Illness at the time of vaccination was none. Any other vaccinations within four weeks of vaccinations were also not reported. On Oct-2016, about 3 weeks after vaccination experienced involuntary spasms from the base of his neck to his stomach muscles, wheezing and coughing. It was reported that for both 2014 and 2015 reactions he was hospitalized for possible heart problem, but all studies had been negative. It was reported that for 2014 and 2015, symptoms resolved after several months. It was reported that scans and another stress test was conducted which ruled out any heart disease. It was reported that patient received FLUZONE HD in Oct-2014 and Oct-2015 (unspecified date). It was reported that patient required ER/Doctor visit. Other laboratory data were not reported. Corrective treatment were not reported. The outcome of event was reported as unknown. List of documents held by sender: none.
Age: 79.0
Sex: M
Vaccine: FLU4
Symptoms: Carpal tunnel syndrome, Hypoaesthesia, Laboratory test abnormal, Pain, Pain in extremity
Clinical narrative: Initial unsolicited case received from a consumer (patient himself) on 29 Dec 2016. This case involves a 79 year old male patient who was vaccinated with a dose of FLUZONE QIV (Batch number: UI673AC, Expiry date: 30 Jun 2016) administered intramuscularly in left deltoid on 14 Oct 2016. The patient had no illness at time of vaccination and preexisting physician diagnosed allergies, birth defects, medical conditions were reported as glaucoma. The patient's concomitant medications were unknown. On 21 Oct 2016, one week after vaccination the patient began having numbness and tingling in his right hand, which then began to occur in his left hand a few days later. On an unknown date, post vaccination the patients fingers and hands were swollen and at night the patient experienced shooting pain in both arms. On an unspecified date, post vaccination the patient was seen by primary care physician (PCP), the patient had an appointment scheduled with a neurologist and the patient had a test for carpel tunnel syndrome which was positive. The patient's other lab tests were not provided. The patient was advised to take Ibuprofen which helped to decrease the swelling and shooting pain in his arms at night. The outcome of the events were reported as not recovered (it was reported as the numbness and tingling are still present in patient hands and fingers). List of documents held by sender: none.
Age: 79.0
Sex: M
Vaccine: FLU4
Symptoms: Paraesthesia, Peripheral swelling
Clinical narrative: Initial unsolicited case received from a consumer (patient himself) on 29 Dec 2016. This case involves a 79 year old male patient who was vaccinated with a dose of FLUZONE QIV (Batch number: UI673AC, Expiry date: 30 Jun 2016) administered intramuscularly in left deltoid on 14 Oct 2016. The patient had no illness at time of vaccination and preexisting physician diagnosed allergies, birth defects, medical conditions were reported as glaucoma. The patient's concomitant medications were unknown. On 21 Oct 2016, one week after vaccination the patient began having numbness and tingling in his right hand, which then began to occur in his left hand a few days later. On an unknown date, post vaccination the patients fingers and hands were swollen and at night the patient experienced shooting pain in both arms. On an unspecified date, post vaccination the patient was seen by primary care physician (PCP), the patient had an appointment scheduled with a neurologist and the patient had a test for carpel tunnel syndrome which was positive. The patient's other lab tests were not provided. The patient was advised to take Ibuprofen which helped to decrease the swelling and shooting pain in his arms at night. The outcome of the events were reported as not recovered (it was reported as the numbness and tingling are still present in patient hands and fingers). List of documents held by sender: none.
Age: 36.0
Sex: F
Vaccine: FLU3, MNQ, PPV
Symptoms: Erythema, Fatigue, Pain in extremity, Pyrexia, Swelling
Clinical narrative: Fever, right arm pain, redness, swelling, fatigue.
Age: 1.0
Sex: F
Vaccine: HEPA, HIBV, MMR, PNC13, VARCEL
Symptoms: Febrile convulsion, Laboratory test normal, Rash, Viral test negative
Clinical narrative: Received routine 1 yr immunizations on 12/15/2016, including MMR. Developed febrile seizure on 12/31/2016. Admitted overnight. Possible 2 brief seizures during admission. Developed rash on 1/2/2017.
Age: 36.0
Sex: F
Vaccine: FLUR3
Symptoms: Anion gap, Anxiety, Blood urea increased, Carbon dioxide decreased, Electrocardiogram T wave abnormal
Clinical narrative: Patient received flu vaccination in right deltoid.  Stated after about an hour had stroke like symtpoms that started.  Went to the ED (Patient works in a hospital setting).  Described to ED phys as having an acute onset of right sided numbness. Also, tremulous, and anxious.  Denies weakness of side. Pmhx of similar episodes with not related to vaccines. In the ED- patient appears in a sinus tach through EKG tracing.  Labs- Essentially negative.  BUN 26, CO2-20 Anion Gap 17.   Patient also had MRI with negative results of stroke.
Age: 36.0
Sex: F
Vaccine: FLUR3
Symptoms: Hypoaesthesia, Nuclear magnetic resonance imaging normal, Sinus tachycardia, Tremor
Clinical narrative: Patient received flu vaccination in right deltoid.  Stated after about an hour had stroke like symtpoms that started.  Went to the ED (Patient works in a hospital setting).  Described to ED phys as having an acute onset of right sided numbness. Also, tremulous, and anxious.  Denies weakness of side. Pmhx of similar episodes with not related to vaccines. In the ED- patient appears in a sinus tach through EKG tracing.  Labs- Essentially negative.  BUN 26, CO2-20 Anion Gap 17.   Patient also had MRI with negative results of stroke.
Age: 8.0
Sex: M
Vaccine: HEP, IPV, MMRV, TDAP
Symptoms: Erythema
Clinical narrative: A few flat red areas noted on child's arms and upper torso shortly after vaccinations. No apparent signs of distress noted. EMS called Vitals: P-84, Resp-30, BP-111/69. EMS arrived head-to-toe completed, per EMS lung sounds clear to auscultation, no wheezing or stridor. Parents declined transport to hospital, release signed. Family counseled on what signs and symptoms to seek emergency medical attention for overnight. Symptoms resolved before leaving clinic to home. Phone call to Father 1/05/2017 no further events throughout the night.
Age: 17.0
Sex: M
Vaccine: HPV4
Symptoms: Therapeutic response unexpected
Clinical narrative: Information has been received from the patient's mother concerning her 17 year old son. The patient's pertinent medical history, drug reactions and allergies were not informed. The patient's concurrent conditions included warts and anxiety. Concomitant therapies were not reported. In October of 2016, reported as "two months ago", the patient was vaccinated with the first dose of GARDASIL (lot #, expiration date and therapy route were not provided), for prophylaxis. The reporter stated that her son had an impressive crop of warts on his hands. The patient had tried various unspecified therapies, none of which worked. On an unknown date 2016 (reported as 5 weeks after injection), reported as "5 weeks after injection", the patient's hand had cleared except for one wart on his palm. The reporter was excited, thankful and amazed and she was hopeful that it would secure an indication to use GARDASIL for warts. The reported stated that GARDASIL saved her money and most importantly took her sons warts and anxiety over them. No product quality complaint (PQC) was involved. Additional information has been requested.
Sex: U
Vaccine: MMRV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from an office manager referring an unspecified number of patients of unknown age and gender. The patients' pertinent medical history, drug reaction/allergies, concurrent conditions and concomitant medications were not reported. On unspecified dates, the patients were vaccinated with a dose of improperly stored doses of PROQUAD lot # M037011, expiration date 21-FEB-2018 for prophylaxis (strength, dose and route were not provided). No adverse effects were reported. It was confirmed by a data logger that the temperature excursion was 9 to 25 Celsius degrees for 6 hours and 56 minutes. No previous temperature excursions were reported. A product quality complaint (PQC) was not involved. Additional information has been requested.