chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report received from a nurse refers to a patient of unknown age. Information on pertinent medical history and concurrent condition was not provided. Information on pertinent medical history and concurrent condition was not provided. On an unknown date, the patient was vaccinated with VARIVAX lot # M038856 for prophylaxis. The Nurse reported that the vaccine administered was improperly stored. No adverse event reported. The outcome of incorrect product storage and no adverse event was unknown.  Lot M038856 was stored in the range of -14°C to-10°C for 483 hours and in the range of -9°C to 8°C for 28 hours No previous temperature excursion The call was not because of a "data logger". Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report received from a nurse refers to a patient of unknown age. Information on pertinent medical history and concurrent condition was not provided. Information on pertinent medical history and concurrent condition was not provided. On an unknown date, the patient was vaccinated with VARIVAX lot # M038856 for prophylaxis. The Nurse reported that the vaccine administered was improperly stored. No adverse event reported. The outcome of incorrect product storage and no adverse event was unknown. Lot M038856 was stored in the range of -14°C to-10°C for 483 hours and in the range of -9°C to 8°C for 28 hours No previous temperature excursion The call was not because of a "data logger" Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report received from a nurse refers to a patient of unknown age. Information on pertinent medical history and concurrent condition was not provided. Information on pertinent medical history and concurrent condition was not provided. On an unknown date, the patient was vaccinated with VARIVAX lot # M038856 for prophylaxis. The Nurse reported that the vaccine administered was improperly stored. No adverse event reported. The outcome of incorrect product storage and no adverse event was unknown. Lot M038856 was stored in the range of -14°C to-10°C for 483 hours and in the range of -9°C to 8°C for 28 hours. No previous temperature excursion The call was not because of a "data logger". Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report received from a nurse refers to a patient of unknown age. Information on pertinent medical history and concurrent condition was not provided. Information on pertinent medical history and concurrent condition was not provided. On an unknown date, the patient was vaccinated with VARIVAX lot # M005971 for prophylaxis. The Nurse reported that the vaccine administered was improperly stored. No adverse event reported. The outcome of incorrect product storage and no adverse event was unknown. Lot M005971 was stored at 12°C for 63 hours, and in the range of -14°C to-10°C for 487.5 hours. No previous temperature excursion. The call was not because of a "data logger". Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report received from a nurse refers to a patient of unknown age. Information on pertinent medical history and concurrent condition was not provided. Information on pertinent medical history and concurrent condition was not provided. On an unknown date, the patient was vaccinated with VARIVAX lot # M005971 for prophylaxis. The Nurse reported that the vaccine administered was improperly stored. No adverse event reported. The outcome of incorrect product storage and no adverse event was unknown. Lot M005971 was stored at 12°C for 63 hours, and in the range of -14°C to-10°C for 487.5 hours. No previous temperature excursion. The call was not because of a "data logger" Additional information has been requested.
Sex: U
Vaccine: MMRV
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report as received from a other health professional refers to a patient of unknown age with prophylaxis. On an unknown date the patient was vaccinated with PROQUAD for prophylaxis. Concomitant therapies included sterile diluent. On an unknown date the patient experienced incorrect product storage and no adverse event. The outcome of incorrect product storage and no adverse event is unknown. The reporter considered incorrect product storage and no adverse event to be not related to PROQUAD. This is one of two reports received from the same reporter. Sender's Comments: US-009507513-1707USA011253.
Age: 12.0
Sex: F
Vaccine: HPV9
Symptoms: Contusion, Fall, Syncope
Clinical narrative: This spontaneous report as received from a physician refers to a 12 year old female patient. On 07-JUL-2017 the patient was vaccinated with GARDASIL 9 dose 1, intramuscular for prophylaxis. On 07-JUL-2017, 1 day after onset of therapy the patient experienced syncope and contusion. The outcome of syncope and contusion was unknown.
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a certified medical assistant and refers to unspecified number of patients of unknown age and gender. The patients' pertinent medical history, drug reactions/allergies and concomitant medication were not reported. Since 04-MAY-2017, the patients were vaccinated with improperly stored doses of VARIVAX lot # M025869, expiration date 24-MAY-2018 (dose and route were not reported) for prophylaxis, which were exposed to temperature excursion of -9°C to 8°C (-6°C) for 8 hours. There was a previous temperature excursion. Additionally, there was no data logger. The outcome of the vaccine was reported as supported. No adverse effected were reported. The information regarding the sterile diluent (manufacturer unknown) used to reconstitute the vaccine, was not reported. This is one of the several reports from the same reporter. Sender's Comments: US-009507513-1707USA012032.
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report as received from a other health professional refers to a patient of unknown age with prophylaxis. On an unknown date the patient was vaccinated with VARIVAX lot # N002204 for prophylaxis. Concomitant therapies included sterile diluent(STERILE DILUENT). On an unknown date the patient experienced incorrect product storage and no adverse event. The outcome of incorrect product storage and no adverse event is unknown. The reporter considered incorrect product storage and no adverse event to be not related to VARIVAX.; Sender's Comments: US-009507513-1707USA011165:
Sex: U
Vaccine: VARZOS
Symptoms: Extra dose administered, No adverse event
Clinical narrative: This spontaneous report as received from a pharmacist refers to a patient of unknown gender and age. Information regarding the patient's medical history, concurrent conditions, drug reactions/allergies and concomitant medications were not provided. Pharmacist reported that on 21-MAR-2017, the patient was vaccinated with first dose of ZOSTAVAX (lot # m035691, expiry date: 17-NOV-2017) for prophylaxis. The patient received their second vaccine dose on 30-APR-2017 (lot # m038864, expiry date: 12-DEC-2017). Pharmacist mentioned that each ZOSTAVAX dose was reconstituted with a new, separate dose of sterile diluent (Manufacturer unknown) (lot # m020944, expiry date: 24-OCT-2018). No adverse effects were reported. Additional information has been requested.
Sex: U
Vaccine: HPV9
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report as received from a medical assistant refers to a 14 year old patient. On 21-NOV-2015 the patient received the first dose of GARDASIL 9 (dose, route, lot # and expiration date were unknown) for prophylaxis. On 26-JUL-2017, the patient returned to the clinic for the second dose of GARDASIL 9 (inappropriate schedule of drug administration). No adverse effect was reported.
Age: 4.0
Sex: U
Vaccine: MMR
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report as received from an office manager refers to a 4 year old patient. The patient's pertinent medical history, concurrent conditions and concomitant medications were not reported. On 16-MAY-2017 the patient was vaccinated with first dose of improperly stored M-M-R II (lot # M029230, expiry date: 08-JUN-2018) for prophylaxis (incorrect product stored). The product had undergone a temperature excursion at a temperature of 47 to 77 F for 11 days. The sterile diluent did not undergo a temperature excursion. The lot number and expiration date of the sterile diluent is unknown by reporter. No previous temperature excursion were reported. No adverse effects reported. A call was made due to data logger. No additional information provided. No product quality complaint involved.
Sex: U
Vaccine: HEPA
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report as received from a registered nurse refers to an unspecified number of patients of unknown age and gender. No information regarding the patient's medical history or concurrent conditions was provided. On unknown date, the patients were vaccinated with improperly stored doses of VAQTA injection (exact dose, route of administration, lot number and expiry date were not reported). There were no concomitant therapies reported. The administered doses of the vaccine were exposed to a temperature between 32 degrees Fahrenheit to 35 degrees Fahrenheit (33.9 degrees Fahrenheit) on an unspecified date, for a time frame of 40.5 hours. A digital data logger was involved. There were no previous temperature excursions recorded. No adverse experiences were reported. There was no product quality complaint involved. This is one of the several reports received from the same reporter.; Sender's Comments: US-009507513-1707USA012404: US-009507513-1707USA012403: US-009507513-1707USA012405:
Sex: U
Vaccine: HIBV
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report as received from a other health professional refers to a patient of unknown age. On 2017 the patient was vaccinated with LIQUID PEDVAXHIB (lot # M027884, exp 19-APR-2019; lot #M034188, exp 20-MAY-2019) for prophylaxis. On 2017 the patient experienced incorrect product storage. On an unknown date the patient experienced no adverse event. This is one of several reports received from the same source. ; Sender's Comments:  US-009507513-1707USA011495: US-009507513-1707USA011496: US-009507513-1707USA011494:
Sex: U
Vaccine: HEP
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report as received from a other health professional refers to a patient of unknown age. On 2017 the patient was vaccinated with RECOMBIVAX HB (lot # L039660, exp 02-FEB-2018) for prophylaxis. On 2017 the patient experienced incorrect product storage.  On an unknown date the patient experienced no adverse event. This is one of several reports received from the same source. ; Sender's Comments: US-009507513-1707USA011495: US-009507513-1707USA011496: US-009507513-1707USA011478:
Sex: U
Vaccine: RV5
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report as received from a other health professional refers to a patient of unknown age. On 2017 the patient was vaccinated with ROTATEQ (lot # M033337, exp 13-APR-2018) for prophylaxis. On 2017 the patient experienced incorrect product storage.  On an unknown date the patient experienced no adverse event. This is one of several reports received from the same source. ;sender's Comments: US-009507513-1707USA011478: US-009507513-1707USA011496: US-009507513-1707USA011494:
Sex: U
Vaccine: HEPA
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report as received from a other health professional refers to a patient of unknown age. On 2017 the patient was vaccinated with VAQTA (lot # M036459, exp 18-JAN-2018, lot # M047658, exp 28-OCT-2017) for prophylaxis. On 2017 the patient experienced incorrect product storage. On an unknown date the patient experienced no adverse event. This is one of several reports received from the same source.; Sender's Comments: US-009507513-1707USA011495: US-009507513-1707USA011478: US-009507513-1707USA011494:
Age: 19.0
Sex: F
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a registered nurse and refers to a 19 year old female patient. The patient's concurrent conditions and medical history were not reported. On 06-JAN-2017, the patient was vaccinated with an improperly stored dose of varicella virus vaccine live (oka/merck)(manufacturer unknown) lot # M018436 with expiration date of 13-APR-2018 (dose, route and frequency were not reported) reconstituted with properly stored sterile diluent (MRK) for prophylaxis. No adverse effects were reported. It was stated that the vaccine underwent a temperature excursion of 6 degrees Fahrenheit to 14 degrees Fahrenheit for 101 days. It was reported that there was no need to repeat vaccine. No previous temperature excursion. The call was not because of a "data logger". There was no Product Quality Complaint (PQC) involved in this case. No further information was provided. This is one of the several reports received from the same reporter. Sender's Comments: US-009507513-1705USA014053.
Age: 34.0
Sex: F
Vaccine: VARCEL
Symptoms: Product storage error
Clinical narrative: This spontaneous report was received from a registered nurse and refers to a 34 year old female patient. The patient's concurrent conditions, medical history and concomitant therapies were not reported. The stock of vaccine was received on 17-FEB-2017. On 02-MAR-2017, the patient was vaccinated with an improperly stored dose of varicella virus vaccine live (oka/merck)(manufacturer unknown), lot # M039318 with expiration date of 20-SEP-2018 (dose, route and frequency were not reported) for prophylaxis. It was stated that the vaccine underwent a temperature excursion of 6 degrees Fahrenheit to 14 degrees Fahrenheit for 13 days. It was reported that there was no need to repeat vaccine. This is one of the several reports received from the same reporter.; Sender's Comments: US-009507513-1705USA014053:
Age: 5.0
Sex: F
Vaccine: VARCEL
Symptoms: Product storage error
Clinical narrative: This spontaneous report was received from a registered nurse and refers to a 5 year old female patient. The patient's concurrent conditions, medical history and concomitant therapies were not reported. The stock of vaccine was received in summer 2017. On 01-DEC-2016, the patient was vaccinated with an improperly stored dose of VARIVAX, lot # L016124 with expiration date of 06-MAY-2017 (dose, route and frequency were not reported) for prophylaxis. It was stated that the vaccine underwent a temperature excursion of 6 degrees Fahrenheit to 14 degrees Fahrenheit for 65 days. It was reported that there was no need to repeat vaccine. This is one of the several reports received from the same reporter.; Sender's Comments: US-009507513-1705USA014053:
Age: 10.0
Sex: F
Vaccine: VARCEL
Symptoms: Product storage error
Clinical narrative: This spontaneous report was received from a registered nurse and refers to a 10 year old female patient. The patient's concurrent conditions, medical history and concomitant therapies were not reported. The stock of vaccine was received in summer 2017. On 08-NOV-2016, the patient was vaccinated with an improperly stored dose of VARIVAX, lot # L016124 with expiration date of 06-MAY-2017 (dose, route and frequency were not reported) for prophylaxis. It was stated that the vaccine underwent a temperature excursion of 6 degrees Fahrenheit to 14 degrees Fahrenheit for 42 days. It was reported that there was no need to repeat vaccine. This is one of the several reports received from the same reporter.; Sender's Comments: US-009507513-1705USA014053:
Age: 9.0
Sex: M
Vaccine: VARCEL
Symptoms: Product storage error
Clinical narrative: This spontaneous report was received from a registered nurse and refers to a 9 year old male patient. The patient's concurrent conditions, medical history and concomitant therapies were not reported. On 23-NOV-2016, the patient was vaccinated with an improperly stored dose of VARIVAX, lot # L016124 with expiration date of 06-MAY-2017 (dose, route and frequency were not reported) for prophylaxis. It was stated that the vaccine underwent a temperature excursion of 6 degrees Fahrenheit to 14 degrees Fahrenheit for 57 days. It was reported that there was no need to repeat vaccine. This is one of the several reports received from the same reporter.; Sender's Comments: US-009507513-1705USA014053:
Age: 5.0
Sex: F
Vaccine: VARCEL
Symptoms: Product storage error
Clinical narrative: This spontaneous report was received from a registered nurse and refers to a 5 year old female patient. The patient's concurrent conditions, medical history and concomitant therapies were not reported. On 23-NOV-2016, the patient was vaccinated with an improperly stored dose of VARIVAX, lot # L016124 with expiration date of 06-MAY-2017 (dose, route and frequency were not reported) for prophylaxis. It was stated that the vaccine underwent a temperature excursion of 6 degrees Fahrenheit to 14 degrees Fahrenheit for 57 days. It was reported that there was no need to repeat vaccine. This is one of the several reports received from the same reporter. ; Sender's Comments: US-009507513-1705USA014053:
Age: 11.0
Sex: F
Vaccine: VARCEL
Symptoms: Product storage error
Clinical narrative: This spontaneous report was received from a registered nurse and refers to a 11 year old female patient. The patient's concurrent conditions, medical history and concomitant therapies were not reported. On 17-NOV-2016, the patient was vaccinated with an improperly stored dose of VARIVAX, lot # L016124 with expiration date of 06-MAY-2017 (dose, route and frequency were not reported) for prophylaxis. It was stated that the vaccine underwent a temperature excursion of 6 degrees Fahrenheit to 14 degrees Fahrenheit for 51 days. It was reported that there was no need to repeat vaccine. This is one of the several reports received from the same reporter.; Sender's Comments: US-009507513-1705USA014053:
Age: 6.0
Sex: M
Vaccine: VARCEL
Symptoms: Product storage error
Clinical narrative: This spontaneous report was received from a registered nurse and refers to a 6 year old male patient. The patient's concurrent conditions, medical history and concomitant therapies were not reported. On 03-JAN-2017, the patient was vaccinated with an improperly stored dose of VARIVAX, lot # L037559 with expiration date of 29-SEP-2017 (dose, route and frequency were not reported) for prophylaxis. It was stated that the vaccine underwent a temperature excursion of 6 degrees Fahrenheit to 14 degrees Fahrenheit for 98 days. It was reported that there was no need to repeat vaccine. This is one of the several reports received from the same reporter.; Sender's Comments:  US-009507513-1705USA014053:
Age: 1.42
Sex: M
Vaccine: VARCEL
Symptoms: Product storage error
Clinical narrative: This spontaneous report was received from a registered nurse and refers to a 17 month old male patient. The patient's concurrent conditions, medical history and concomitant therapies were not reported. On 08-DEC-2016, the patient was vaccinated with an improperly stored dose of VARIVAX, lot # L037559 with expiration date of 29-SEP-2017 (dose, route and frequency were not reported) for prophylaxis. It was stated that the vaccine underwent a temperature excursion of 6 degrees Fahrenheit to 14 degrees Fahrenheit for 72 days. It was reported that there was no need to repeat vaccine. This is one of the several reports received from the same reporter.; Sender's Comments:  US-009507513-1705USA014053:
Age: 6.0
Sex: F
Vaccine: VARCEL
Symptoms: Product storage error
Clinical narrative: This spontaneous report was received from a registered nurse and refers to a 6 year old female patient.. The patient's concurrent conditions, medical history and concomitant therapies were not reported. On 14-DEC-2016, the patient was vaccinated with an improperly stored dose of VARIVAX, lot # L037559 with expiration date of 29-SEP-2017 (dose, route and frequency were not reported) for prophylaxis. It was stated that the vaccine underwent a temperature excursion of 6 degrees Fahrenheit to 14 degrees Fahrenheit for 78 days. It was reported that there was no need to repeat vaccine. This is one of the several reports received from the same reporter.; Sender's Comments:  US-009507513-1705USA014053:
Sex: U
Vaccine: HPV9
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report as received from a pharmacist refers to a patient of unknown age and gender. In January 2016, the patient was vaccinated with GARDASIL 9 dose 1 for prophylaxis. In March 2016, the patient experienced inappropriate schedule of drug administration. On an unknown date the patient experienced no adverse event.
Sex: U
Vaccine: MMR
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report as received from a other health professional refers to a patients of unknown age and gender. On 27-JUL-2017, the patients were inadvertently vaccinated with improperly stored doses of M-M-R II for prophylaxis. Concomitant therapies included sterile diluent (MERCK STERILE DILUENT). No adverse effects reported.
Sex: U
Vaccine: VARZOS
Symptoms: Contraindication to vaccination
Clinical narrative: This spontaneous report as received from a physician refers to a patient of unknown age. On an unknown date the patient was vaccinated with ZOSTAVAX for prophylaxis. On an unknown date the patient experienced product use issue. The outcome of product use issue is unknown.   The reporter considered product use issue to be not related to ZOSTAVAX. {Additional information has been requested. / Additional information is not expected.}
Sex: F
Vaccine: HPV9
Symptoms: General symptom
Clinical narrative: This spontaneous report as received from a physician refers to a 14 year old female patient. On NOV-2016 the patient was vaccinated with GARDASIL 9 dose 1, intramuscular for prophylaxis. On JAN-2017 the patient experienced general symptom. Therapy with GARDASIL 9 was discontinued. The outcome of general symptom was reported as not recovered/not resolved.
Sex: U
Vaccine: MMRV
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a certified medical assistant and refers to unspecified number of patients of unknown age and gender. The patients' pertinent medical history, drug reactions/allergies and concomitant medication were not reported. Since 04-MAY-2017, the patients were vaccinated with improperly stored doses (incorrect product storage) of PROQUAD lot # M036294, expiration date 13-FEB-2018 (dose and route were not reported) for prophylaxis, which were exposed to temperature excursion of -9°C to 8°C (-6°C) for 8 hours. There was a previous temperature excursion. Additionally, there was no data logger. The outcome of the vaccine was reported as supported. No adverse effected were reported. The information regarding the sterile diluent (manufacturer unknown) used to reconstitute the vaccine, was not reported. This is one of the several reports from the same reporter. Sender's Comments: US-009507513-1707USA011222.
Sex: U
Vaccine: HPV9
Symptoms: No adverse event, Product storage error
Clinical narrative: Information was received from a nurse referring to an unknown number of unspecified patients of unknown age and gender. The patients' medical history, concurrent conditions and concomitant therapies were not reported. On unspecified dates, the patients were administered doses of improperly stored GARDASIL 9 injection (lot# M044717, expiration date 19-JUL-2019; lot# N001533, expiration date 16-OCT-2019) (Strength, dose, frequency, anatomical location and route were not reported) for prophylaxis. The vaccines were exposed to 47 to 77 Fahrenheit degree (F) for 2 hours. There was no previous temperature excursion. Digital data logger was involved. No adverse effects was reported. There was no product quality complaint involved. This is one of several reports received from the same reporter. Sender's Comments: US-009507513-1707USA012417: US-009507513-1707USA012418: US-009507513-1707USA012419: US-009507513-1707USA012416: US-009507513-1707USA012415.
Sex: U
Vaccine: HEP
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report as received from a registered nurse refers to an unspecified number of patients of unknown age and gender. No information regarding the patient's medical history or concurrent conditions was provided. On unknown date, the patients were vaccinated with improperly stored doses of RECOMBIVAX HB injection (exact dose, route of administration, lot number and expiry date were not reported). There were no concomitant therapies reported. The administered doses of the vaccine were exposed to a temperature between 32 degrees Fahrenheit to 35 degrees Fahrenheit (33.9 degrees Fahrenheit) on an unspecified date, for a time frame of 40.5 hours. A digital data logger was involved. There were no previous temperature excursions recorded. No adverse experiences were reported. There was no product quality complaint involved. This is one of the several reports received from the same reporter.; Sender's Comments: US-009507513-1707USA012404: US-009507513-1707USA012404: US-009507513-1707USA012404:
Sex: U
Vaccine: HPV9
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report as received from a registered nurse refers to an unspecified number of patients of unknown age and gender. No information regarding the patient's medical history or concurrent conditions was provided. On unknown date, the patients were vaccinated with improperly stored doses of GARDASIL 9 injection (exact dose, route of administration, lot number and expiry date were not reported). There were no concomitant therapies reported. The administered doses of the vaccine were exposed to a temperature between 32 degrees Fahrenheit to 35 degrees Fahrenheit (33.9 degrees Fahrenheit) on an unspecified date, for a time frame of 40.5 hours. A digital data logger was involved. There were no previous temperature excursions recorded. No adverse experiences were reported. There was no product quality complaint involved. Sender's Comments: US-009507513-1707USA011460: US-009507513-1707USA012405: US-009507513-1707USA012403.
Sex: U
Vaccine: RV5
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report as received from a registered nurse refers to an unspecified number of patients of unknown age and gender. No information regarding the patient's medical history or concurrent conditions was provided. On unknown date, the patients were vaccinated with improperly stored doses of ROTATEQ injection (exact dose, route: defaulted to oral, lot number and expiry date were not reported). There were no concomitant therapies reported. The administered doses of the vaccine were exposed to a temperature between 32 degrees Fahrenheit to 35 degrees Fahrenheit (33.9 degrees Fahrenheit) on an unspecified date, for a time frame of 40.5 hours. A digital data logger was involved. There were no previous temperature excursions recorded. No adverse experiences were reported. There was no product quality complaint involved. This is one of the several reports received from the same reporter.; Sender's Comments: US-009507513-1707USA012404: US-009507513-1707USA011460: US-009507513-1707USA012403:
Sex: U
Vaccine: VARZOS
Symptoms: No adverse event, Product storage error
Clinical narrative: Information was received from a nurse referring to an unknown number of unspecified patients of unknown age and gender. The patients' medical history and concurrent conditions were not reported. On unspecified dates, the patients were administered doses of improperly stored ZOSTAVAX injection (Strength, dose, frequency, anatomical location, route, lot/batch # and expiration date were not reported) for prophylaxis. The concomitant therapy included sterile diluent which was used to reconstitute ZOSTAVAX injection, was stored properly. The vaccines were exposed to 6 to 14 Fahrenheit degree (F) for 1.5 hours. There was no previous temperature excursion. Digital data logger was involved. No adverse effects was reported. There was no product quality complaint involved. This is one of several reports received from the same reporter.; Sender's Comments: US-009507513-1707USA012152: US-009507513-1707USA012415: US-009507513-1707USA012416: US-009507513-1707USA012417: US-009507513-1707USA012418:
Age: 2.0
Sex: F
Vaccine: DTAPHEPBIP, MMR, VARCEL
Symptoms: No adverse event, Wrong drug administered
Clinical narrative: Patient came in for 2 year WCC. MA looked at record and misread what patient was due for. Patient is due for 4 year vaccines on 7/22/19, MA gave them. Patient would have been due for KINRIX, MMR, and Varicella. Patient was given PEDIARIX, MMR and Varicella. Patient did not have any symptoms from vaccines. MA was called into office and asked if she could point out what was wrong with the record. MA noticed the date and the age of the patient. MA was informed that she would need to contact mother and let her know. MA gave verbal understanding. Manager is also notified.
Age: 12.0
Sex: F
Vaccine: FLUX, MEN, TDAP
Symptoms: Discomfort, Erythema, Pyrexia, Skin disorder, Skin reaction
Clinical narrative: In the fall 2016, she had a severe skin reaction to a flu vaccine. Redness, webbing, hot to touch, swelling with low grade fever. On 7/18/2017, follow the two above vaccines, Tdap and meningiococcal, she had severe discomfort, excessive redness, swelling the size of a tennis ball, webbing in appearance, low grade fever.
Age: 12.0
Sex: F
Vaccine: FLUX, MEN, TDAP
Symptoms: Skin warm, Swelling
Clinical narrative: In the fall 2016, she had a severe skin reaction to a flu vaccine. Redness, webbing, hot to touch, swelling with low grade fever. On 7/18/2017, follow the two above vaccines, Tdap and meningiococcal, she had severe discomfort, excessive redness, swelling the size of a tennis ball, webbing in appearance, low grade fever.
Age: 20.0
Sex: F
Vaccine: ANTH, JEV1, SMALL
Symptoms: Rash generalised, Swelling
Clinical narrative: 20 y/o female presents to clinic for swelling and rash all over body of unknown etiology. Patient reports it started at approx 8 pm last night after eating dinner. She ate grilled chicken, spinach salad with egg/tuna and french dressing, creamed corn, and peach yogurt. She has eaten these before without issue in the past. She states that as a child she was told she had a reaction (rash on face) after eating bell pepper. It is unknown if the patient came into contact with bell peppers or if the chicken was marinated in such. To note: patient received anthrax #2 and her initial smallpox on 7/6/17. After receiving these two vaccines she denies any rashes, swelling, itching or any gradual onset of symptoms.  She denies SOB, CP, difficulty breathing, angioedema, scratchy throat, excessive salivation, or NVD. Patient was given ZYRTEC, ATARAX, MEDROL Dose Pack and ZANTAC.
Age: 1.5
Sex: M
Vaccine: FLU4, HIBV, PNC13
Symptoms: Rash
Clinical narrative: A rash appeared covering his face, arms, and legs. The doctor thought it was due to something he ate, but he had eaten no new foods and has not had a reaction since then to any foods.
Age: 68.0
Sex: M
Vaccine: PPV
Symptoms: Erythema, Musculoskeletal pain, Pain in extremity, Peripheral swelling
Clinical narrative: This spontaneous report as received from a nurse refers to a 68-year-old male patient. The patient had no pertinent medical history and no drug reactions or allergies. On 27-JUN-2017, the patient was vaccinated with an unspecified dose of PNEUMOVAX 23. The patient experienced redness, pain, and swelling in the entire arm that began "within 24 hours" of receiving PNEUMOVAX 23. The pain radiated to the patient's shoulder. The patient was instructed to take an unspecified over the counter pain reliever and to apply warm compresses to the arm. The patient's symptoms lasted "at least 3 days," but at the time of reporting were resolved. The causality was not reported. The nurse reported that multiple vaccines resulted in a similar adverse event, but was unsure which patient received which vaccine. The vaccines involved were PNEUMOVAX 23 lot N001007, expiration date: 19-SEP-2018, lot #N011491, expiration date 04-NOV-22018 and lot #M047519, expiration date 04-AUG-2018. The nurse requested a lot check for PNEUMOVAX 23 lot M047519, expiration date 04-AUG-2018 and lot N011491, expiration date 04-NOV-2018. This report is one of four "Multiple Patient Reports".; Sender's Comments:  US-009507513-1707USA008579: US-009507513-1707USA008989: US-009507513-1707USA008391:
Sex: U
Vaccine: HPV9
Symptoms: Product storage error
Clinical narrative: This spontaneous report as received from a other health professional refers to a patient of unknown age. On an unknown date the patient was vaccinated with GARDASIL 9 lot # M042853 for prophylaxis. On an unknown date the patient experienced incorrect product storage. The outcome of incorrect product storage was unknown.
Sex: U
Vaccine: VARZOS
Symptoms: Discomfort, Emotional distress, Herpes zoster, Incorrect dose administered, Pain
Clinical narrative: This spontaneous report was received from a 80 year old patient of unknown gender. Information on medical history, concurrent condition, concomitant medication and drug allergies/reactions were not provided. On 23-FEB-2015, the patient was vaccinated with ZOSTAVAX subcutaneously of dose 0.85 ml (incorrect dose administered), lot # K020185 for prophylaxis. On 25-JAN-2017, the patient experienced shingles, which had effected his inner right thigh and upwards on to lower back. The patient reported that after taking the vaccine there was no side effects, like redness, pain or swelling. The pharmacist had no explanation and thought it to be very unusual. The patient stated that shingles was a serious disease and most painful and disabling than any other he had endured. Further, it also takes away weeks of productive time of the patient and close family, not to mention the physical and emotional discomfort. On an unknown date in January 2017, the patient was prescribed with VALTREX 1 gm 1X3 times for 7 days plus creams and OTC painkillers as treatment, and on 15-FEB-2017, was prescribed with Gabapentin 300mg 1 a day for prosthetic pain. The outcome of herpes zoster and incorrect dose administered were unknown. Causality assessment was not provided. The case was serious due to disability. Additional information has been requested.
Sex: F
Vaccine: HPV9
Symptoms: Loss of consciousness, Seizure
Clinical narrative: This spontaneous report has been received via a company employee from a female consumer concerning her daughter of unknown age. Information about concurrent condition, concomitant medication and medical history was not reported. On an unknown date, the patient was vaccinated with the second dose of GARDASIL 9 (dose, route, lot number and expiration data were not reported) for prophylaxis. On an unknown date, the patient passed out after vaccination. The company employee described the event as a ''seizure convulsion incident'' and the patient was ''fine'' by the evening (on an unspecified date). The reporter reported the events to the doctor's office (unspecified physician and location). Upon internal review, seizure convulsion incident was determined to be medically significant. This is one of several reports received from the same source. Sender's Comments: US-009507513-1707USA012608.
Age: 6.0
Sex: M
Vaccine: VARCEL
Symptoms: Product storage error
Clinical narrative: This spontaneous report was received from a registered nurse and refers to a 6 year old male patient. The patient's concurrent conditions, medical history and concomitant therapies were not reported. On 07-DEC-201, the patient was vaccinated with an improperly stored dose of VARIVAX, lot # L037559 with expiration date of 29-SEP-2017 (dose, route and frequency were not reported) for prophylaxis. It was stated that the vaccine underwent a temperature excursion of 6 degrees Fahrenheit to 14 degrees Fahrenheit for 71 days. It was reported that there was no need to repeat vaccine. This is one of the several reports received from the same reporter.; Sender's Comments:  US-009507513-1705USA014053:
Age: 12.0
Sex: F
Vaccine: VARCEL
Symptoms: Product storage error
Clinical narrative: This spontaneous report was received from a registered nurse and refers to a 12 year old female patient. The patient's concurrent conditions, medical history and concomitant therapies were not reported. On 12-JAN-2016, the patient was vaccinated with an improperly stored dose of VARIVAX, lot # L037559 with expiration date of 29-SEP-2017 (dose, route and frequency were not reported) for prophylaxis. It was stated that the vaccine underwent a temperature excursion of 6 degrees Fahrenheit to 14 degrees Fahrenheit for 107 days. It was reported that there was no need to repeat vaccine. This is one of the several reports received from the same reporter. Sender's Comments: US-009507513-1705USA014053.
Age: 10.0
Sex: M
Vaccine: VARCEL
Symptoms: Product storage error
Clinical narrative: This spontaneous report was received from a registered nurse and refers to a 10 year old male patient. The patient's concurrent conditions, medical history and concomitant therapies were not reported. On 24-JAN-2017, the patient was vaccinated with an improperly stored dose of VARIVAX, lot # L037559 with expiration date of 29-SEP-2017 (dose, route and frequency were not reported) for prophylaxis. It was stated that the vaccine underwent a temperature excursion of 6 degrees Fahrenheit to 14 degrees Fahrenheit for 119 days. It was reported that there was no need to repeat vaccine. This is one of the several reports received from the same reporter. Sender's Comments: US-009507513-1705USA014053.
Age: 14.0
Sex: F
Vaccine: VARCEL
Symptoms: Product storage error
Clinical narrative: This spontaneous report was received from a registered nurse and refers to a 14 year old female patient. The patient's concurrent conditions, medical history and concomitant therapies were not reported. On 18-JAN-2017, the patient was vaccinated with an improperly stored dose of VARIVAX, lot # L037559 with expiration date of 29-SEP-2017 (dose, route and frequency were not reported) for prophylaxis. It was stated that the vaccine underwent a temperature excursion of 6 degrees Fahrenheit to 14 degrees Fahrenheit for 113 days. It was reported that there was no need to repeat vaccine. This is one of the several reports received from the same reporter.; Sender's Comments: US-009507513-1705USA014053:
Age: 17.0
Sex: M
Vaccine: VARCEL
Symptoms: Product storage error
Clinical narrative: This spontaneous report was received from a registered nurse and refers to a 17 year old male patient. The patient's concurrent conditions, medical history and concomitant therapies were not reported. On 20-DEC-2016, the patient was vaccinated with an improperly stored dose of VARIVAX, lot # L037559 with expiration date of 29-SEP-2017 (dose, route and frequency were not reported) for prophylaxis. It was stated that the vaccine underwent a temperature excursion of 6 degrees Fahrenheit to 14 degrees Fahrenheit for 84 days. It was reported that there was no need to repeat vaccine. This is one of the several reports received from the same reporter. ; Sender's Comments: US-009507513-1705USA014053:
Age: 8.0
Sex: F
Vaccine: VARCEL
Symptoms: Product storage error
Clinical narrative: This spontaneous report was received from a registered nurse and refers to a 8 year old female patient. The patient's concurrent conditions, medical history and concomitant therapies were not reported. On 11-JAN-2017, the patient was vaccinated with an improperly stored dose of VARIVAX, lot # L037559 with expiration date of 29-SEP-2017 (dose, route and frequency were not reported) for prophylaxis. It was stated that the vaccine underwent a temperature excursion of 6 degrees Fahrenheit to 14 degrees Fahrenheit for 106 days. It was reported that there was no need to repeat vaccine. This is one of the several reports received from the same reporter.; Sender's Comments:  US-009507513-1705USA014053:
Age: 28.0
Sex: F
Vaccine: VARCEL
Symptoms: Product storage error
Clinical narrative: This spontaneous report was received from a registered nurse and refers to a 28 year old female patient. The patient's concurrent conditions, medical history and concomitant therapies were not reported. On 05-OCT-2016, the patient was vaccinated with an improperly stored dose of VARIVAX, lot # M008173 with expiration date of 16-FEB-2018 (dose, route and frequency were not reported) for prophylaxis. It was stated that the vaccine underwent a temperature excursion of 6 degrees Fahrenheit to 14 degrees Fahrenheit for 8 days. It was reported that there was no need to repeat vaccine. This is one of the several reports received from the same reporter.; Sender's Comments:  US-009507513-1705USA014053:
Age: 31.0
Sex: M
Vaccine: VARCEL
Symptoms: Product storage error
Clinical narrative: This spontaneous report was received from a registered nurse and refers to a 31 year old male patient. The patient's concurrent conditions, medical history and concomitant therapies were not reported. On 05-OCT-2016, the patient was vaccinated with an improperly stored dose of VARIVAX, lot # M008173 with expiration date of 16-FEB-2018 (dose, route and frequency were not reported) for prophylaxis. It was stated that the vaccine underwent a temperature excursion of 6 degrees Fahrenheit to 14 degrees Fahrenheit for 8 days. It was reported that there was no need to repeat vaccine. This is one of the several reports received from the same reporter.; Sender's Comments:  US-009507513-1705USA014053:
Age: 16.0
Sex: M
Vaccine: VARCEL
Symptoms: Product storage error
Clinical narrative: This spontaneous report was received from a registered nurse and refers to a 16 year old male patient. The patient's concurrent conditions, medical history and concomitant therapies were not reported. On 30-SEP-2016, the patient was vaccinated with an improperly stored dose of VARIVAX, lot # M008173 with expiration date of 16-FEB-2018 (dose, route and frequency were not reported) for prophylaxis. It was stated that the vaccine underwent a temperature excursion of 6 degrees Fahrenheit to 14 degrees Fahrenheit for 3 days. It was reported that there was no need to repeat vaccine. This is one of the several reports received from the same reporter. Sender's Comments: US-009507513-1705USA014053.
Age: 4.0
Sex: M
Vaccine: VARCEL
Symptoms: Product storage error
Clinical narrative: This spontaneous report was received from a registered nurse and refers to a 4 year old male patient. The patient's concurrent conditions, medical history and concomitant therapies were not reported. On 28-SEP-2016, the patient was vaccinated with an improperly stored dose of VARIVAX, lot # reported as M010476 with expiration date of 01-SEP-2017 (dose, route and frequency were not reported) for prophylaxis. It was stated that the vaccine underwent a temperature excursion of 6 degrees Fahrenheit to 14 degrees Fahrenheit for 1 day. It was reported that there was no need to repeat vaccine. This is one of the several reports received from the same reporter.; Sender's Comments: US-009507513-1705USA014053:
Age: 1.08
Sex: M
Vaccine: VARCEL
Symptoms: Product storage error
Clinical narrative: This spontaneous report was received from a registered nurse and refers to a 13 month old male patient. The patient's concurrent conditions, medical history and concomitant therapies were not reported. On 18-OCT-2016, the patient was vaccinated with an improperly stored dose of VARIVAX, lot # reported as M010476 with expiration date of 01-SEP-2017 (dose, route and frequency were not reported) for prophylaxis. It was stated that the vaccine underwent a temperature excursion of 6 degrees Fahrenheit to 14 degrees Fahrenheit for 21 days. It was reported that there was no need to repeat vaccine. This is one of the several reports received from the same reporter. Sender's Comments: US-009507513-1705USA014053.
Age: 5.0
Sex: F
Vaccine: VARCEL
Symptoms: Product storage error
Clinical narrative: This spontaneous report was received from a registered nurse and refers to a 5 year old female patient. The patient's concurrent conditions, medical history and concomitant therapies were not reported. On 06-OCT-2016, the patient was vaccinated with an improperly stored dose of VARIVAX, lot # reported as M010476 with expiration date of 01-SEP-2017 (dose, route and frequency were not reported) for prophylaxis. It was stated that the vaccine underwent a temperature excursion of 6 degrees Fahrenheit to 14 degrees Fahrenheit for 9 days. It was reported that there was no need to repeat vaccine. This is one of the several reports received from the same reporter. Sender's Comments: US-009507513-1705USA014053.
Age: 4.0
Sex: F
Vaccine: VARCEL
Symptoms: Product storage error
Clinical narrative: This spontaneous report was received from a registered nurse and refers to a 4 year old female patient. The patient's concurrent conditions, medical history and concomitant therapies were not reported. On 05-OCT-2016, the patient was vaccinated with an improperly stored dose of VARIVAX, lot # reported as M010476 with expiration date of 01-SEP-2017 (dose, route and frequency were not reported) for prophylaxis. It was stated that the vaccine underwent a temperature excursion of 6 degrees Fahrenheit to 14 degrees Fahrenheit for 8 days. It was reported that there was no need to repeat vaccine. This is one of the several reports received from the same reporter.; Sender's Comments: US-009507513-1705USA014053:
Age: 1.08
Sex: M
Vaccine: VARCEL
Symptoms: Product storage error
Clinical narrative: This spontaneous report was received from a registered nurse and refers to a 13 month old male patient. The patient's concurrent conditions, medical history and concomitant therapies were not reported. On 02-DEC-2016, the patient was vaccinated with an improperly stored dose of VARIVAX, lot # reported as M010476 with expiration date of 01-SEP-2017 (dose, route and frequency were not reported) for prophylaxis. It was stated that the vaccine underwent a temperature excursion of 6 degrees Fahrenheit to 14 degrees Fahrenheit for 66 days. It was reported that there was no need to repeat vaccine. This is one of the several reports received from the same reporter.; Sender's Comments: US-009507513-1705USA014053:
Age: 37.0
Sex: M
Vaccine: VARCEL
Symptoms: Product storage error
Clinical narrative: This spontaneous report was received from a registered nurse and refers to a 37 year old male patient. The patient's concurrent conditions, medical history and concomitant therapies were not reported. On 14-DEC-2016, the patient was vaccinated with an improperly stored dose of varicella virus vaccine live (oka/merck)(manufacturer unknown), lot # M015735 with expiration date of 30-MAR-2018 (dose, route and frequency were not reported) for prophylaxis. It was stated that the vaccine underwent a temperature excursion of 6 degrees Fahrenheit to 14 degrees Fahrenheit for 78 days. It was reported that there was no need to repeat vaccine. This is one of the several reports received from the same reporter. Sender's Comments: US-009507513-1705USA014053.