chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: HPV9
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a licensed practical nurse refers to multiple unspecified patients of unknown age and gender. There was no information about the patients' concurrent conditions, concomitant therapies or medical histories provided. On unknown dates in approximately 2016, the patients were vaccinated with improperly stored doses of GARDASIL 9 lot # L016429, expiration date 09-AUG-2017 or lot # L024993, expiration date 17-OCT-2017 (dose and route of administration were not reported). There was no adverse effect reported. Administered doses of GARDASIL 9 lot # L016429 experienced a temperature excursion of 14.2 degrees Celsius for 1 hour 40 minutes on 03-FEB-2016, 9.4 degrees Celsius for 40 minutes on 23-FEB-2016, 8.5 degrees Celsius for 1 hour on 11-MAR-2016, 8.5 degrees Celsius for 30 minutes on 16-MAR-2016, 10.6 degrees Celsius for 1 hour 50 minutes on 23-MAR-2016, 17.2 degrees Celsius for 5 hours 40 minutes on 05-APR-2016 and 9 degrees Celsius for 4 hours 50 minutes on 19-APR-2016. Administered doses of GARDASIL 9 lot # L024993 experienced a temperature excursion of 17.2 degrees Celsius for 5 hours 40 minutes on 05-APR-2016 and 9 degrees Celsius for 4 hours 50 minutes on 19-APR-2016. Data logger was involved. This is one of several reports received from the same reporter. Additional information has been requested. Sender's Comments: US-009507513-1612USA009026: US-009507513-1612USA009027.
Sex: F
Vaccine: VARCEL
Symptoms: Allergy to vaccine, Contraindication to vaccination, Pyrexia
Clinical narrative: Information has been received from a health care professional via Pfizer (MFR control# 2016538484) referring to a currently 64 year old female patient. Information about concurrent condition, medical history and concomitant medication was unspecified. On an unknown date the patient was vaccinated with a dose of varicella virus vaccine live (oka/merck) (manufacturer unknown) (dose, lot#, expiration date and route unknown) for prophylaxis. On an unknown date the patient had allergy to varicella virus vaccine live (oka/merck) (manufacturer unknown) and experienced unspecified contraindication. The outcome of the events was unknown. The reporter considered the events to be related to varicella virus vaccine live (oka/merck) (manufacturer unknown). The patient also had allergy to pneumococcal vaccine, polyvalent (23-valent) (manufacturer unknown) and experienced fever (captured in MARRS# 1612USA004206). Additional information has been requested. Sender's Comments: US-009507513-1612USA004206.
Age: 69.0
Sex: U
Vaccine: PPV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a nurse and refers to a 69 year old patient of an unknown gender. The patient's pertinent medical history, concurrent conditions and concomitant medications were not reported. On 07-OCT-2016, the patient was vaccinated with improperly stored dose of PNEUMOVAX 23 lot # M000592 and expiry date: 12-OCT-2017 (volume/dose reported as 0.5 (units not provided), (route was not reported) for prophylaxis. The vaccine was exposed to temperature of 49 Fahrenheit for 30 minutes. No previous temperature excursion was reported. The patient was vaccinated with private funds. No adverse effects and no product quality complaint (PQC) were reported. No further information provided. This is one of several reports received from the same reporter. Additional information has been requested. Sender's Comments: US-009507513-1610USA004378: US-009507513-1610USA004376: US-009507513-1610USA003097: US-009507513-1610USA004377: US-009507513-1612USA006597: US-009507513-1612USA006599.
Age: 19.0
Sex: U
Vaccine: HEPA
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a nurse referring to a 19 year old patient of unknown gender. The patient's pertinent medical history, concurrent conditions and concomitant medications were not reported. On 14-OCT-2016, the patient was vaccinated with improperly stored dose of VAQTA (dose and route were not reported) lot #M012261 and expiry date: 01-FEB-2018, (volume/dose reported as 1 (units not provided)) for prophylaxis. The vaccine was exposed to temperature of 49 Fahrenheit for 30 minutes. No previous temperature excursion was reported. The patient was vaccinated with private funds. No adverse effects and no product quality complaint (PQC) were reported. No further information provided. This is one of several reports received from the same reporter. Additional information has been requested. Sender's Comments: US-009507513-1610USA004376: US-009507513-1610USA003097: US-009507513-1610USA004377: US-009507513-1610USA004378: US-009507513-1612USA006634.
Age: 0.17
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a nurse referring to a 8 weeks old patient of unknown gender. The patients' pertinent medical history, current conditions and concomitant medications were not reported. On 20-OCT-2016, the patients was vaccinated with improperly stored dose of ROTATEQ lot # M006112 expiration date 16-NOV-2016 (volume/dose reported as 2) for prophylaxis. The vaccine was exposed to temperature of 49 Fahrenheit for 30 minutes. No previous temperature excursion was reported. No adverse effects and no product quality complaint (PQC) was reported. No further information provided The vaccine was purchased with private pay insurance. This is one of the 4 reports from the same reporter. Additional information is not expected because all information required has been received. Sender's Comments: US-009507513-1610USA004378: US-009507513-1610USA004376: US-009507513-1610USA004377: US-009507513-1612USA006675: US-009507513-1612USA006674: US-009507513-1610USA003097: US-009507513-1612USA006676: US-009507513-1612USA006672.
Age: 25.0
Sex: M
Vaccine: HEP, MMR, VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report received from a medical assistant referred to a patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant medications were not reported. The medical assistant reported that the patient received three improperly stored vaccines: VARIVAX (unspecified lot and expiry date), RECOMBIVAX HB (unspecified lot and expiry date) and M-M-R II (lot: M027637 expiry: 02-JUN-2018) on 12-DEC-2016. No adverse effects reported. The VARIVAX (lot: M005972, expiry: 02-FEB-2018, lot: M034583, expiry: 27-JUL-2018, lot: M028552  expiry: 07-JUL-2018) was stored at 0C for 6.5 hours. There was no previous temperature excursion. The vaccines RECOMBIVAX HB (lot: M026309, 11-NOV-2018, lot: M039642 expiry: 03-JUL-2019) and M-M-R II (lot: M027637 expiry: 02-JUN-2018) were stored at 18C for 6.5 hours. Additional information has been requested.
Age: 1.0
Sex: F
Vaccine: MMRV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a medical assistant, and refers to a patient of unknown age and gender. No pertinent medical history, drug reactions, allergies or concurrent conditions were reported. On 08-DEC-2016 the patient was vaccinated with an improperly stored dose of PROQUAD for prophylaxis (dose and route of administration were not reported; lot # M022402, expiry 01-NOV-2017). No other suspect and concomitant medications were provided. On unspecified dates, the administered dose of vaccine experienced the temperature excursion of -12 degrees Celsius for 3 hours 43 minutes, and second excursion of -10 degrees Celsius for 7 hours 38 minutes. A digital data logger was involved. There had been no previous temperature excursions. There was no adverse effect reported. No product quality complaint was involved. Additional information has been requested.
Age: 4.0
Sex: U
Vaccine: MMRV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a Licensed Practical Nurse on 13-DEC-2016, concerning a 4 years old patient of unknown gender. On 14-APR-2016, the patient was vaccinated with an improperly stored dose of PROQUAD for prophylaxis (lot number L050907) (dose number, frequency, route of administration and anatomical location were not reported). No adverse events were reported. This is one of several reports received from the same reporter. Additional information has been requested. Sender's Comments: US-009507513-1610USA013756: US-009507513-1610USA013820: US-009507513-1610USA013819: US-009507513-1610USA010040: US-009507513-1612USA008582: US-009507513-1612USA008583: US-009507513-1612USA008584: US-009507513-1612USA008585: US-009507513-1610USA010040.
Age: 6.0
Sex: U
Vaccine: MMRV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a Licensed Practical Nurse on 13-DEC-2016, concerning a 7 years old patient of unknown gender. No information regarding the patient's medical history, concurrent conditions or concomitant therapies was provided. On 08-APR-2016, the patient was vaccinated with an improperly stored dose of PROQUAD for prophylaxis (lot number: L050907) (dose number, frequency, route of administration and anatomical location were not reported). No adverse event was reported. This is one of two reports received from the same reporter. Additional information has been requested. Sender's Comments: US-009507513-1610USA013756: US-009507513-1610USA013820: US-009507513-1610USA013819: US-009507513-1610USA010040: US-009507513-1612USA008581: US-009507513-1612USA008583: US-009507513-1612USA008584: US-009507513-1612USA008585: US-009507513-1610USA013756.
Age: 4.0
Sex: U
Vaccine: MMRV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a licensed Practical Nurse on 13-DEC-2016, concerning a 4 years old patient of unknown gender. No information regarding the patient's medical history, concurrent conditions or concomitant therapies was provided. On 20-OCT-2016, the patient was vaccinated with an improperly stored dose of PROQUAD for prophylaxis (lot number reported as: M015699) (dose number, frequency, route of administration and anatomical location were not reported). No adverse events were reported. This is one of several reports received from the same reporter. Additional information has been requested. Sender's Comments: US-009507513-1610USA013756: US-009507513-1610USA013820: US-009507513-1610USA013819: US-009507513-1612USA008581: US-009507513-1612USA008582: US-009507513-1610USA010040: US-009507513-1612USA008584: US-009507513-1612USA008585.
Age: 4.0
Sex: U
Vaccine: MMRV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a licensed Practical Nurse on 13-DEC-2016, concerning a 4 years old patient of unknown gender. No information regarding the patient's medical history, concurrent conditions or concomitant therapies was provided. On 20-SEP-2016, the patient was vaccinated with an improperly stored dose of PROQUAD for prophylaxis (lot number reported as: M015699) (dose number, frequency, route of administration and anatomical location were not reported). No adverse events were reported. This is one of several reports received from the same reporter. Additional information has been requested. Sender's Comments: US-009507513-1610USA013756: US-009507513-1610USA013820: US-009507513-1610USA013819: US-009507513-1612USA008581: US-009507513-1612USA008582: US-009507513-1612USA008583: US-009507513-1610USA010040: US-009507513-1612USA008585
Age: 4.0
Sex: U
Vaccine: MMRV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a licensed practical nurse refers to the three patients of unknown age and gender. No information on the patients' concomitant medications, concurrent conditions, pertinent medical history, drug reactions or allergies was reported. On unknown dates, the patients were vaccinated with improperly stored doses of PROQUAD injection (lot # M021428 with expiry date on 19-OCT-2017, albumin status: recombinant human albumin (rHA); dose was not reported) for prophylaxis. No adverse effects were reported. Additional information has been requested. Sender's Comments: US-009507513-1610USA013756: US-009507513-1610USA013820: US-009507513-1610USA013819: US-009507513-1612USA008581: US-009507513-1612USA008582: US-009507513-1612USA008583: US-009507513-1612USA008584: US-009507513-1610USA010040.
Sex: U
Vaccine: HIBV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report received from a nurse referred to an unknown number of patients of unknown age and gender. The patients' medical history, concurrent conditions and concomitant medications were not reported. Since an unknown date in DEC-2016, the patients had been administered PEDVAX HIB (lot: K025005; expiry: 21-JUL-2017 and lot: L014427; 09-MAR-2018) which were improperly stored. No adverse effects were reported. The vaccines were stored at 34F for 48 hours. The call was because of a data logger. This is one of the several reports received from the same reporter. Additional information has been requested. Sender's Comments: US-009507513-1612USA010417: same reporter US-009507513-1612USA010418: same reporter US-009507513-1612USA010419: same reporter US-009507513-1612USA010420: same reporter US-009507513-1612USA010421: same reporter.
Sex: U
Vaccine: HEPA
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report received from a nurse referred to an unknown number of patients of unknown age and gender. The patients' medical history, concurrent conditions and concomitant medications were not reported. Since an unknown date in DEC-2016, the patients had been administered VAQTA (lot: L046953; expiry: 14-JAN-2017) which were improperly stored. No adverse effects were reported. The vaccines were stored at 34F for 48 hours. The call was because of a data logger.  This is one of the several reports received from the same reporter.  Additional information has been requested.; Sender's Comments:  US-009507513-1612USA010325:same reporter.
Sex: U
Vaccine: HEP
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report received from a nurse referred to an unknown number of patients of unknown age and gender. The patients' medical history, concurrent conditions and concomitant medications were not reported. Since an unknown date in DEC-2016, the patients had been administered RECOMBIVAX HB (lot: L029631; expiry: 14-AUG-2017 and lot: M000442; 31-MAR-2018 and lot: L029631; expiry: 14-AUG-2017) which were improperly stored. No adverse effects were reported. The vaccines were stored at 34F for 48 hours. The call was because of a data logger. This is one of the several reports received from the same reporter. Additional information has been requested.; Sender's Comments: US-009507513-1612USA010325:same reporter.
Sex: U
Vaccine: PPV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report received from a nurse referred to an unknown number of patients of unknown age and gender. The patients' medical history, concurrent conditions and concomitant medications were not reported. Since an unknown date in DEC-2016, the patients had been administered PNEUMOVAX 23 (lot: M026317; expiry:11-JAN-2018 and lot: M029680; 17-JAN-2018) which were improperly stored. No adverse effects were reported. The vaccines were stored at 34F for 48 hours. The call was because of a data logger. This is one of the several reports received from the same reporter. Additional information has been requested. Sender's Comments: US-009507513-1612USA010325: same reporter.
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report received from a nurse referred to an unknown number of patients of unknown age and gender. The patients' medical history, concurrent conditions and concomitant medications were not reported. Since an unknown date in DEC-2016, the patients had been administered ROTATEQ (lot: L013206; expiry: 29-JAN-2017) which were improperly stored. No adverse effects were reported. The vaccines were stored at 34F for 48 hours. The call was because of a data logger.  This is one of the several reports received from the same reporter.  Additional information has been requested.; Sender's Comments:  US-009507513-1612USA010325:same reporter.
Sex: F
Vaccine: FLUX
Symptoms: Lymphadenopathy
Clinical narrative: Initial unsolicited report received from a consumeron 10 December 2016. This case involves a female patient (age not reported) who was vaccinated with INFLUENZA VACCINE (Flu shot) (dose, dose in series, batch number, expiry date of product, route and site of administration were not reported) on an unspecified date (reported as this week). It was reported that the patient never had a low blood sugar. No further information regarding the patient's medical history was reported. Concomitant medications included METFORMIN HYDROCHLORIDE (Metformin), SITAGLIPTIN PHOSPHATE (Januvia) and glimiperide. On an unspecified date and duration following the vaccination the patient had enlarged lymph nodes. Laboratory data and corrective treatment were not reported. The patient had not recovered from the event at the time of reporting. List of documents held by sender: none.
Age: 5.0
Sex: F
Vaccine: MMR
Symptoms: Pyrexia, Urticaria
Clinical narrative: 2 weeks after immunization child developed fever t0 102 degrees F. and hives.  Since that time child develops hives when overheated--bathing, fever, waking up from nap or in am (heat induced urticarial).
Sex: U
Vaccine: HPV9
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a vaccine coordinator (non-health care professional) and refers to an unspecified number of patients of unknown age and gender. No information regarding the patients' pertinent medical history, concomitant medication and drug reactions or allergies was reported. On unknown dates in 2016, the patients were vaccinated with improperly stored doses of GARDASIL 9 lot # L038917, expiration date 20-FEB-2018 and lot # M009378 expiration date 23-APR-2018 (dose, route of administration and anatomical location were not provided). The vaccines were refrigerated and exposed to the following temperatures and time frames out of range: 1 Celsius degree for 165 hours between 01-JUL-2016 and 07-JUL-2016, 1 Celsius degree for 126.75 hours between 14-JUL-2016 and 19-JUL-2016, -2 Celsius degrees for 70.5 hours between 22-JUL-2016 and 25-JUL-2016, 1 Celsius degree for 191.5 hours between 28-JUL-2016 and 05-AUG-2016, 1 Celsius degree for 77 hours between 06-AUG-2016 and 09-AUG-2016, 1 Celsius degree for 166 hours between 12-AUG-2016 and 18-AUG-2016, 10 Celsius degrees for 79.5 hours between 19-AUG-2016 and 22-AUG-2016, 9 Celsius degrees for 22 hours between 23-AUG-2016 and 24-AUG-2016, 1 Celsius degree for 71 hours between 26-AUG-2016 and 29-AUG-2016, 1 Celsius degree for 53 hours between 30-AUG-2016 and 31-AUG-2016, 0 Celsius degrees for 168 hours between 15-SEP-2016 and 21-SEP-2016, 0 Celsius degrees for 218 hours between 22-SEP-2016 and 30-SEP-2016 and 1 Celsius degree for 92 hours between 01-OCT-2016 and 05-OCT-2016 (summary time of excursions 1500.25 hours). There were no adverse effects reported. There were no data logger and no prior excursions. This is one of several reports received from the same reporter. Follow-up information was received on 16-DEC-2016: all telephone attempts to obtain follow-up information have been unsuccessful. Additional information has been requested. Sender's Comments: US-009507513-1610USA013015: US-009507513-1610USA013016: US-009507513-1610USA013017: US-009507513-1610USA013018: US-009507513-1610USA013019: US-009507513-1610USA013020: US-009507513-1610USA013021: MERCK 1610USA004014:Mfr number.
Sex: U
Vaccine: HPV9
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a healthcare worker refers to an unspecified number of patients of unknown age and gender. No medical history and concurrent conditions were reported. On an unknown date the patients were vaccinated with a dose of improperly stored GARDASIL 9 (incorrect product storage) (lot number and expiry date unknown) (dosing regimen and frequency unknown) for prophylaxis. No concomitant medications were reported. No adverse effects were reported. It was reported that the temperatures had reached below recommended temperatures. Specific temperature excursion details were unavailable at the time. This case is linked to case number 1610USA011174 and 1610USA011175 via same reporter link. All telephone attempts to obtain follow up information have been unsuccessful. Additional information has been requested. Narrative updated. Sender's Comments: US-009507513-1610USA011175: US-009507513-1610USA011174: MERCK 1610USA009568:Mfr number.
Sex: M
Vaccine: VARZOS
Symptoms: Vomiting
Clinical narrative: This spontaneous report was received from a consumer (the patient's wife) and refers to a male patient of unknown age. No information about the patient's medical history, drug reactions, allergies and concurrent conditions was provided. On 26-NOV-2016, the patient was vaccinated with ZOSTAVAX (lot#, expiration date, dose and site of injection were not reported). On 28-NOV-2016 (also reported as 18-NOV-2016), 2 days after receiving the ZOSTAVAX, the patient had started vomiting. Information about the concomitant therapies was not provided. The outcome of the event and causality between ZOSTAVAX and the event of vomiting were unknown. Product quality complaint was not involved. Additional information is not expected as there were no contact details provided.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a nurse, referring to unspecified number of patients of unknown ages and genders. The patients' medical history, concurrent conditions and concomitant therapies were not reported. On 28-NOV-2016, the unspecified number of patients were vaccinated with an improperly stored doses of VARIVAX lot # reported as M100673, expiration date 09-FEB-2018 (strength, dose, administration route and anatomical location were not provided) for prophylaxis. No adverse effects were reported. The vaccine had two temperature excursions one of 29.9 Fahrenheit (F) for 2 hours 30 minutes and the other of 47.7 (F) for 30 minutes; with a data logger involved. Also it was reported no previously excursions. This is one of several reports received from the same source. Lot number [M100673] is an invalid lot number for varicella virus vaccine live (oka/merck). Additional information is not expected because the reporter do not want to be contacted. Sender's Comments: US-009507513-1612USA000346: US-009507513-1612USA000347: US-009507513-1612USA000348: US-009507513-1612USA000349: US-009507513-1612USA000351: US-009507513-1611USA013515.
Sex: U
Vaccine: MMR
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a nurse, referring to unspecified number of patients of unknown ages and genders. The patients' medical history, concurrent conditions and concomitant therapies were not reported. On 28-NOV-2016, the unspecified number of patients were vaccinated with an improperly stored doses of M-M-R II lot # L015282, expiration date 30-APR-2017 (strength, dose, administration route and anatomical location were not provided) for prophylaxis. No adverse effects were reported. The vaccine had one temperature excursion of 47.4 Fahrenheit (F) for 30 minutes; with a data logger involved. Also it was reported no previously excursions. This is one of several reports received from the same source. Additional information is not expected because the reporter do not want to be contacted. Sender's Comments:  US-009507513-1612USA000346: US-009507513-1612USA000347: US-009507513-1612USA000348: US-009507513-1612USA000349: US-009507513-1612USA000350: US-009507513-1611USA013515.
Sex: U
Vaccine: PPV
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 regarding the patients' pertinent medical history, drug reactions or allergies and concomitant therapies was reported. On an unknown dates, the patients were vaccinated with improperly stored doses of PNEUMOVAX 23 (lot # M035104, expiration date 06-MAY-2018) for prophylaxis (exact dose and route of administration were not reported). Administered doses of vaccines experienced the temperature excursions of 10.73 degrees Celsius for 15 minutes and 10.8 degrees Celsius for 30 minutes. The call was because of data logger. No previous temperature excursion was reported. No adverse symptoms were reported. This is one of two reports received from the same reporter. Additional information has been requested. Sender's Comments: US-009507513-1612USA010734.
Sex: U
Vaccine: PPV
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report as received from a nurse refers to a patient of unknown age and gender. Patient's pertinent medical history, concurrent condition, drug reactions/allergies and concomitant medications were not specified. On 08-DEC-2016, the patient was vaccinated with an expired dose of PNEUMOVAX 23 injection (lot # L022795, expiry date: 05-NOV-2016, dosage regimen not reported) intramuscularly for prophylaxis (expired product administered). No side effects reported. No further information was available. No product quality complaint (PQC) was involved. Additional information has been requested.
Age: 0.17
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a nurse referring to a 9 weeks old patient of an unknown gender. The patient's pertinent medical history, concurrent conditions and concomitant medications were not reported. On 14-OCT-2016, the patient was vaccinated with improperly stored dose of ROTATEQ lot # M006112 expiration date of 16-NOV-2017, (volume/dose reported as 2 (units not provided)) for prophylaxis. The vaccine was exposed to temperature of 49 Fahrenheit for 30 minutes. No previous temperature excursion was reported. The patient was vaccinated with private funds. No adverse effects and no product quality complaint (PQC) were reported. No further information provided. This is one of several reports received from the same reporter. Additional information has been requested. Sender's Comments: US-009507513-1610USA004378: US-009507513-1610USA004376: US-009507513-1610USA004377: US-009507513-1610USA003097: US-009507513-1612USA006674: US-009507513-1612USA006673: US-009507513-1612USA006676: US-009507513-1612USA006672.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a nurse regarding multiple unspecified patients with unknown demographics. Information on pertinent medical history, drug reactions/allergies and concomitant medications were not reported. On unknown dates, unspecified multiple patients were vaccinated with improperly stored VARIVAX lot# M028551 with expiry date 07-JUN-2018 for prophylaxis (dosing details not reported). No adverse effects were reported. Temperature was 68F, time frame was 1 hour, no previous excursion and no data logger involvement. No product quality complaint was involved. This is one of the three linked reports. 1612USA010738 (Same Reporter Link) and 1612USA010737 (Same Reporter Link). Additional information has been requested.
Sex: U
Vaccine: HEP
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a nurse and refers to an unspecified number of patients of unknown age and gender. No information regarding the patients' pertinent medical history, drug reactions or allergies and concomitant therapies were reported. On an unknown dates, the patients were vaccinated with improperly stored doses of RECOMBIVAX HB (lot # L027733, expiration date 13-SEP-2017) for prophylaxis (exact dose and route of administration were not reported). Administered doses of vaccines experienced the temperature excursions of 10.73 degrees Celsius for 15 minutes and 10.8 degrees Celsius for 30 minutes. The call was because of data logger. No previous temperature excursion was reported. No adverse symptoms were reported. This is one of two reports received from the same reporter. Additional information has been requested. Sender's Comments: US-009507513-1612USA002466.
Sex: U
Vaccine: MMRV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a nurse regarding multiple unspecified patients with unknown demographics. Information on pertinent medical history, drug reactions/allergies and concomitant medications were not reported. On unknown dates, unspecified multiple patients were vaccinated with improperly stored PROQUAD lot# M032497, expiry date: 02-JAN-2018 for prophylaxis (dosing details not reported). No adverse effects were reported. Temperature was 68F, time frame was 1 hour, no previous excursion and no data logger involvement. No product quality complaint was involved. This is one of the three linked reports. 1612USA009515 (Same Reporter Link) and 1612USA010738 (Same Reporter Link). Additional information has been requested.
Sex: U
Vaccine: MMR
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a nurse regarding multiple unspecified patients with unknown demographics. Information on pertinent medical history, drug reactions/allergies and concomitant medications were not reported. On unknown dates, unspecified multiple patients were vaccinated with improperly stored M-M-R II lot# M015931, expiry date: 30-MAR-2018 for prophylaxis (dosing details not reported). No adverse effects were reported. Temperature was 68F, time frame was 1 hour, no previous excursion and no data logger involvement. No product quality complaint was involved. This is one of the three linked reports. 1612USA010737 (Same Reporter Link) and 1612USA009515 (Same Reporter Link). Additional information has been requested.
Age: 65.0
Sex: M
Vaccine: FLU3, PPV
Symptoms: Rash
Clinical narrative: Skin rash.
Age: 54.0
Sex: F
Vaccine: FLU4
Symptoms: Pain in extremity
Clinical narrative: Extreme pain of left arm persisting for 2 months.
Age: 68.0
Sex: F
Vaccine: PNC13
Symptoms: Ear swelling, Injection site rash, Local swelling
Clinical narrative: RASH AT SITE ON RIGHT ARM LATER SPREAD DOWN ARM, SOME SWELLING OF/AROUND THE EAR/NECK, CALLED MD, PATIENT TAKING ZYRTEC AND ZANTAC AS WELL AS RX TRIAMCINOLONE 0.025% CREAM.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Cellulitis, Injection site erythema, Injection site mass, Injection site swelling, Injection site warmth
Clinical narrative: Redness at site that expanded, warmth at site, fever of 100.8 and 101.6, lump noted at site and swelling at site. Cefdinir 300 mg 1 capsule PO BID X 10 days for cellulitis.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Pyrexia
Clinical narrative: Redness at site that expanded, warmth at site, fever of 100.8 and 101.6, lump noted at site and swelling at site. Cefdinir 300 mg 1 capsule PO BID X 10 days for cellulitis.
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pruritus, Vaccination site rash
Clinical narrative: Red-itchy rash at vaccine site.
Age: 65.0
Sex: F
Vaccine: FLU4
Symptoms: Mobility decreased
Clinical narrative: Low grade temp 99 degrees for 2 weeks. Inability to move left arm. I was given an order for NAPROSYN which did not help. Physical therapy started 12-9-16 with some improvement.
Age: 78.0
Sex: U
Vaccine: PNC13
Symptoms: Pyrexia, Swelling
Clinical narrative: Pt experienced swelling. Pt has a fever 102 F. No treatment.
Age: 54.0
Sex: F
Vaccine: FLU4
Symptoms: Injected limb mobility decreased
Clinical narrative: Pt called me on 12-20-16 to inform me she has had decreased mobility of her arm since the evening after her flu shot administration on 12-4-16, I advised pt to seek urgent care.
Age: 56.0
Sex: F
Vaccine: FLU4
Symptoms: Urticaria
Clinical narrative: Patient states that she woke up the next morning with hives around her waist and ankles. States the symptoms lasted about 1 week.
Age: 70.0
Sex: F
Vaccine: PPV
Symptoms: Erythema, Peripheral swelling, Swelling
Clinical narrative: Patient experienced swollen, red arm to elbow up to base of her neck. As day went on, she experienced a swollen, tight, hot red arm to elbow up to base of neck.
Age: 5.0
Sex: F
Vaccine: FLU4
Symptoms: Injection site discomfort, Injection site erythema, Injection site oedema, Injection site pain, Injection site warmth
Clinical narrative: Erythema, edema, warmth, tenderness on (R) thigh-began evening of appt increased size and discomfort over 24 hours. TX: symptomatic care -> BENADRYL/warm/cool compress.
Age: 77.0
Sex: U
Vaccine: FLU3
Symptoms: Arthralgia, Asthenia, Chills, Influenza, Myalgia
Clinical narrative: Sore throat within 20 mins. Chills within 3 hrs. along with muscle ache, severe soreness of all joints, back, neck, etc. Severe flu symptoms, cont'd. for 2 1/2 days then 1 day of weakness.
Age: 77.0
Sex: U
Vaccine: FLU3
Symptoms: Oropharyngeal pain
Clinical narrative: Sore throat within 20 mins. Chills within 3 hrs. along with muscle ache, severe soreness of all joints, back, neck, etc. Severe flu symptoms, cont'd. for 2 1/2 days then 1 day of weakness.
Age: 4.0
Sex: M
Vaccine: DTAPIPV, MMR, VARCEL
Symptoms: Body temperature increased, Injection site erythema, Injection site induration, Injection site pain, Injection site pruritus
Clinical narrative: Pt. stated on 12/20/16 left arm hurt during the night had significant itching and swelling. Had temp. 101 F and Mom gave ADVIL. On 12/21/16 office visit progressing upper arm lightly erythematous, mildly indurated, non tender, child is scratching during visit. Meds - Betamethasone cream, BENADRYL 2.
Age: 4.0
Sex: M
Vaccine: DTAPIPV, MMR, VARCEL
Symptoms: Injection site swelling
Clinical narrative: Pt. stated on 12/20/16 left arm hurt during the night had significant itching and swelling. Had temp. 101 F and Mom gave ADVIL. On 12/21/16 office visit progressing upper arm lightly erythematous, mildly indurated, non tender, child is scratching during visit. Meds - Betamethasone cream, BENADRYL 2.
Age: 54.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site pruritus
Clinical narrative: Itchy sensation at site on (L) posterior upper arm. Site approximately 4 cm long x 3 cm wide. Itchy sensation began 12-20-16. Denies any systemic reactions. Nurse placed BAND-AID over site. Advised pt. to take BENADRYL for itchy sensation. Keep area covered until reaction subsides.
Age: 74.0
Sex: M
Vaccine: PNC13
Symptoms: Hypoaesthesia, Paraesthesia
Clinical narrative: PATIENT DESCRIBED "TINGLING/NUMBNESS" ALL THROUGHOUT LEFT ARM, WHICH IS THE INJECTION SITE OF IMMUNIZATION. DID NOT RESOLVE WITH REGULAR USE OF IBUPROFEN.
Age: 44.0
Sex: M
Vaccine: FLUX
Symptoms: Asthenia, Back pain, Decreased appetite, Disorientation, Dysgeusia
Clinical narrative: Legs were numb 12/15/2016 PM, arms were sore 12/14/2016 till present day, couldn't catch my breath without coughing for 10 min 12/15/2016 AM, arms and feet tingled 12/15/2016 to present day, lower back pain 12/15/2016 AM, and couldn't get my bearings for 5 min 12/15/2016 occurs randomly now. No real appetite, things taste funny, 12/14/2016 PM, feeling drained of energy 12/16/2016 PM, went from 5 hours of sleep to 2.5 maybe 3, can't stay asleep, migraine like head aches everyday since 12/15/2016.
Age: 44.0
Sex: M
Vaccine: FLUX
Symptoms: Dyspnoea, Hypoaesthesia, Insomnia, Migraine, Pain in extremity
Clinical narrative: Legs were numb 12/15/2016 PM, arms were sore 12/14/2016 till present day, couldn't catch my breath without coughing for 10 min 12/15/2016 AM, arms and feet tingled 12/15/2016 to present day, lower back pain 12/15/2016 AM, and couldn't get my bearings for 5 min 12/15/2016 occurs randomly now. No real appetite, things taste funny, 12/14/2016 PM, feeling drained of energy 12/16/2016 PM, went from 5 hours of sleep to 2.5 maybe 3, can't stay asleep, migraine like head aches everyday since 12/15/2016.
Age: 44.0
Sex: M
Vaccine: FLUX
Symptoms: Paraesthesia
Clinical narrative: Legs were numb 12/15/2016 PM, arms were sore 12/14/2016 till present day, couldn't catch my breath without coughing for 10 min 12/15/2016 AM, arms and feet tingled 12/15/2016 to present day, lower back pain 12/15/2016 AM, and couldn't get my bearings for 5 min 12/15/2016 occurs randomly now. No real appetite, things taste funny, 12/14/2016 PM, feeling drained of energy 12/16/2016 PM, went from 5 hours of sleep to 2.5 maybe 3, can't stay asleep, migraine like head aches everyday since 12/15/2016.
Age: 24.0
Sex: F
Vaccine: VARCEL
Symptoms: Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Dark red, swollen, sore to touch 40 mm X65mm area around injection site.
Age: 33.0
Sex: F
Vaccine: MMR
Symptoms: Arthralgia, Headache, Myalgia, Oropharyngeal pain, Pyrexia
Clinical narrative: 11/8/16 C/O headache, fever and muscle aches. 11-17-16 presented with macular itchy rash over entire body, sore throat and joint pain. 11-25-16 increased rash/on body, lesions over lower extremities.
Age: 33.0
Sex: F
Vaccine: MMR
Symptoms: Rash generalised, Rash macular, Rash pruritic
Clinical narrative: 11/8/16 C/O headache, fever and muscle aches. 11-17-16 presented with macular itchy rash over entire body, sore throat and joint pain. 11-25-16 increased rash/on body, lesions over lower extremities.
Age: 72.0
Sex: F
Vaccine: FLU3, PNC13
Symptoms: Disorientation, Dizziness, Impaired driving ability, Nausea, Presyncope
Clinical narrative: Patient felt dizzy and nauseated a few hours after receiving the vaccine. She was dizzy to the point of near syncope. She felt very disoriented and needed someone to drive her home.
Age: 39.0
Sex: F
Vaccine: FLU4
Symptoms: Headache, Impaired work ability, Meningitis aseptic, Meningitis viral, Neck pain
Clinical narrative: Began having neck pain that gradually progressed into headache that worsened over several days and began having severe vomiting, admitted to Medical Center on 10/24/2016 with a diagnosis of Aseptic Viral Meningitis and treated with narcotic pain medications, antiemetics, and fluids. Discharged from hospital on 10/29/2016 and was absent from work with continuing headache and neck pain until 12/2/2016.
Age: 39.0
Sex: F
Vaccine: FLU4
Symptoms: Vomiting
Clinical narrative: Began having neck pain that gradually progressed into headache that worsened over several days and began having severe vomiting, admitted to Medical Center on 10/24/2016 with a diagnosis of Aseptic Viral Meningitis and treated with narcotic pain medications, antiemetics, and fluids. Discharged from hospital on 10/29/2016 and was absent from work with continuing headache and neck pain until 12/2/2016.
Age: 45.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site pain, Rotator cuff syndrome
Clinical narrative: Pain in upper left section of arm. Shot out from place of injection-being the center point.
Age: 16.0
Sex: F
Vaccine: MMRV
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: No adverse outcomes reported.
Sex: F
Vaccine: FLU4
Symptoms: Bursitis, Drug administered at inappropriate site, Injection site pain, Wrong technique in product usage process
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of injection site pain in a female patient who received FLUARIX QUADRIVALENT. On 18th November 2016, the patient received FLUARIX QUADRIVALENT .5 ml. On 18th November 2016, less than a day after receiving FLUARIX QUADRIVALENT, the patient experienced injection site pain (serious criteria disability), bursitis (serious criteria disability), wrong injection technique and vaccine administered at inappropriate site. On an unknown date, the outcome of the injection site pain and bursitis were recovering/resolving and the outcome of the wrong injection technique and vaccine administered at inappropriate site were unknown. It was unknown if the reporter considered the injection site pain and bursitis to be related to FLUARIX QUADRIVALENT. Additional details were provided as follows: The age at vaccination was not reported. The patient received an unknown concomitant medication. The patient received FLUARIX QUADRIVALENT on an unknown arm. The patient complained about pain and bursitis in her arm after receiving FLUARIX. The patient thought that the injection was too high in her arm, and it was administered in her tendon instead of the muscle which led to wrong injection technique and vaccine administered at inappropriate site.
Sex: U
Vaccine: MENB
Symptoms: Injection site mass, Injection site swelling
Clinical narrative: This case was reported by a other health professional via sales rep and described the occurrence of injection site swelling in a patient who received BEXSERO. On an unknown date, the patient received BEXSERO at an unknown dose. On an unknown date, less than a week after receiving BEXSERO, the patient experienced injection site swelling and injection site lump. On an unknown date, the outcome of the injection site swelling and injection site lump were not recovered/not resolved. The reporter considered the injection site swelling and injection site lump were not recovered/not resolved. The reporter considered the injection site swelling and injection site lump to be probably related to BEXSERO. Additional detail were provided as follows: This case was reported by a medical assistant. The age at vaccination was not reported. The patient received the BEXSERO vaccine approximately one week ago from the date of reporting and was still experiencing swelling and a lump at the injection site at the time of reporting. On the date of reporting, the field representative received and email with the above information. She was unable to provide any additional details at the time of the call. The field representative did not know the last name of the medical assistant.
Age: 65.0
Sex: F
Vaccine: PNC13
Symptoms: Blood immunoglobulin G, Blood test, Computerised tomogram normal, Electromyogram abnormal, Hypoaesthesia
Clinical narrative: Paralyzed from waist down-over course of approx. 2 1/2 hrs. 8:30AM began w/(R) foot tingling then (R) leg became weak and wouldn't hold up body. Progressed to spastic muscles, then (L) Leg then complete numbness. Body temp normal. Diagnosis: Transverse myelitis. Treatment: IV Steroids 5 days; rehab.
Age: 65.0
Sex: F
Vaccine: PNC13
Symptoms: Lumbar puncture normal, Muscle spasticity, Muscular weakness, Myelitis transverse, Nuclear magnetic resonance imaging normal
Clinical narrative: Paralyzed from waist down-over course of approx. 2 1/2 hrs. 8:30AM began w/(R) foot tingling then (R) leg became weak and wouldn't hold up body. Progressed to spastic muscles, then (L) Leg then complete numbness. Body temp normal. Diagnosis: Transverse myelitis. Treatment: IV Steroids 5 days; rehab.
Age: 65.0
Sex: F
Vaccine: PNC13
Symptoms: Paraesthesia, Paralysis, Somatosensory evoked potentials abnormal
Clinical narrative: Paralyzed from waist down-over course of approx. 2 1/2 hrs. 8:30AM began w/(R) foot tingling then (R) leg became weak and wouldn't hold up body. Progressed to spastic muscles, then (L) Leg then complete numbness. Body temp normal. Diagnosis: Transverse myelitis. Treatment: IV Steroids 5 days; rehab.
Sex: M
Vaccine: RV1
Symptoms: Dehydration, Haematochezia, Intussusception
Clinical narrative: This case was reported by a physician via sales rep and described the occurrence of intussusception in a 4-month-old male patient who received ROTARIX. On an unknown date, the patient received the 2nd dose of ROTARIX (oral) 1 ml. On an unknown date, an unknown time after receiving ROTARIX oral suspension, the patient experienced intussusception (serious criteria GSK medically significant), blood in stool (serious criteria GSK medically significant) and dehydration. On an unknown date, the outcome of the intussusception, blood in stool and dehydration were unknown. The reporter considered the intussusception, blood in stool and dehydration to be possibly related to ROTARIX oral suspension. Additional details were provided as follows: The age at vaccination was not provided. Limited information was provided by the sales representative from the physician. The sales representative reported that the other vaccines were given to the patient at the time of the ROTARIX, but the vaccines were unknown. The patient went to the physician's office and to the hospital. The patient did not have surgery.
Sex: U
Vaccine: MMRV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a registered nurse and refers to an unspecified number of patients of unknown age and gender. The patients' medical history, concurrent conditions and concomitant medications were not reported. On multiple unknown dates, the patients were vaccinated with improperly stored PROQUAD (recombinant human albumin) lot # M015698, expiration date 26-SEP-2017 and lot # L051102, expiration date 17-JUN-2017 (dose, route of administration were not reported not reported) for prophylaxis. No adverse effects were reported. This is one of the two reports received from the same reporter. Follow up information was received on 07-DEC-2016. All telephone attempts to obtain follow up have been unsuccessful. Additional information has been requested. Sender's Comments: US-009507513-1610USA008848: MERCK 1610USA009745:Mfr number.
Sex: F
Vaccine: VARZOS
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: This spontaneous report as received from a pharmacist refers to a currently less than 50 year old female patient (also reported as "she was in her thirties and forties"). There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided. It was reported that in 1997, the patient might have been vaccinated with ZOSTAVAX injection (exact dose, route of administration, lot #, expiration date and anatomical location were unspecified) (Product use issue). There were no adverse effect reported. Additional information is not expected because there was no consent to contact the pharmacist.
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a registered nurse concerning on multiple unspecified patients. The patients' medical history, concurrent conditions and concomitant therapies were not reported. On an unknown date, the multiple unspecified patients received improperly stored doses of ROTATEQ orally (lot # M007307; expiration date: 30-NOV-2017), (strength and dose were not reported) for prophylaxis. The temperature excursion with ROTATEQ was at 58 Fahrenheit degrees for 28 hours. The temperature excursion was detected by a data logger. There were no prior excursions. No adverse effects were reported and no product quality complaint (PQC) was involved. This is one of several reports from the same reporter. Additional information has been requested. Sender's Comments:  US-009507513-1612USA010295: US-009507513-1612USA010293: US-009507513-1612USA010294: US-009507513-1612USA010291: US-009507513-1612USA010292.