chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 69.0
Sex: F
Vaccine: TDAP
Symptoms: Rash generalised
Clinical narrative: This case was reported by a pharmacist via other manufacturer and described the occurrence of generalized rash in a 69-year-old male patient who received BOOSTRIX (batch number 3Z27B, expiry date unknown). On 22nd September 2016, the patient received BOOSTRIX (intramuscular) .5 ml. On 25th September 2016, 3 days after receiving BOOSTRIX, the patient experienced generalized rash. On an unknown date, the outcome of the generalized rash was unknown. It was unknown if the reporter considered the generalized rash to be related to BOOSTRIX. Additional details were provided as follows: This case was reported by a registered pharmacist. The age at vaccination was not reported. The patient's medical history, diagnosed allergies, compromised immune status, respiratory illness, genetic or chromosomal abnormalities, endocrine abnormalities and obesity were not reported. No any adverse event reported previously. There was no illness at the time of vaccination. The patient did not receive any concomitant medications. At 1:58 pm, the patient received BOOSTRIX in left arm. After receiving BOOSTRIX, the patient experienced rash on trunk and on body. The adverse events did not require an emergency room or physician visit. The patient was not hospitalized. No treatment or tests were required. The event did not occur after re-administration.
Sex: F
Vaccine: PPV
Symptoms: Decreased appetite, Fatigue, Headache, Nausea, Oropharyngeal pain
Clinical narrative: This spontaneous report as received from a consumer refers to herself a 74 year female with a medical history of thyroid disorder, blood cholesterol increased and drug allergies ("many allergies if there is a 1% chance of a side effect, I will be in the 1% that gets it"). On 04-OCT-2016 the patient was vaccinated with PNEUMOVAX 23, route of administration "with a syringe". This was the first time she had ever been vaccinated with PNEUMOVAX 23. Concomitant therapies included ZOCOR, unspecified thyroid medication, Diazepam and LEXAPRO. On 04-OCT-2016, within hours of receiving the vaccine, she began to feel soreness in her arm. She lost her appetite and felt queasy after that. Three days later her arm was very sore and she started taking extra strength TYLENOL for the pain. She then got a sore throat, felt tired and was "headachy". The patient reported feeling better and was almost back to normal (date not specified). Additional information is not expected.
Sex: F
Vaccine: PPV
Symptoms: Pain in extremity
Clinical narrative: This spontaneous report as received from a consumer refers to herself a 74 year female with a medical history of thyroid disorder, blood cholesterol increased and drug allergies ("many allergies if there is a 1% chance of a side effect, I will be in the 1% that gets it"). On 04-OCT-2016 the patient was vaccinated with PNEUMOVAX 23, route of administration "with a syringe". This was the first time she had ever been vaccinated with PNEUMOVAX 23. Concomitant therapies included ZOCOR, unspecified thyroid medication, Diazepam and LEXAPRO. On 04-OCT-2016, within hours of receiving the vaccine, she began to feel soreness in her arm. She lost her appetite and felt queasy after that. Three days later her arm was very sore and she started taking extra strength TYLENOL for the pain. She then got a sore throat, felt tired and was "headachy". The patient reported feeling better and was almost back to normal (date not specified). Additional information is not expected.
Sex: U
Vaccine: HEP
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a Medical Assistant regarding a case involving VAQTA lot # M001815, expiration date 20-SEP-2017 (MARRS # 1610USA001301) who refers to multiple unknown patients of unknown age and gender. The patient's pertinent medical history, current conditions and concomitant medications were not reported. On an unknown date the patients were administered improperly stored doses of RECOMBIVAX HB lot # M010212, expiration date 21-JAN-2019. The vaccines were exposed to temperatures ranging from 33F to 35F for cumulative total time frame of 72 hours out of recommended storage range. There were no previous excursions reported. The data logger was reported as yes. No adverse effects were reported. There was no product quality complaint involved. No further information was provided. This is one of the several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HPV9
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a Medical Assistant regarding a case involving VAQTA lot # M001815, expiration date 20-SEP-2017 (MARRS # 1610USA001301) who refers to multiple unknown patients of unknown age and gender. The patients' pertinent medical history, current conditions and concomitant medications were not reported. On an unknown date the patients were administered improperly stored doses of GARDASIL 9 lot # M007764, expiration date 30-JAN-2018 (dosing details were not reported). The vaccines were exposed to temperatures ranging from 33F to 35F for cumulative total time frame of 72 hours out of recommended storage range. There were no previous excursions reported. The data logger was reported as yes. No adverse effects were reported. There was no product quality complaint involved. No further information was provided. This is one of the several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HIBV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a certified medical assistant, referring to an unspecified number of patients of unknown age and gender. Information about patients' medical history, concurrent conditions and concomitant medication were not reported. On unspecified dates, the patients were administered doses of improperly stored PEDVAXHIB (lot # M014926, expiration date 17-FEB-2019; lot # M020102, expiration date 08-MAR-2019); which were exposed to temperature of 49F for 1 hour and 48 F for 1 additional hour. There was not previous temperature excursion and the call was because of a data logger. No adverse effects were reported. This is one of the several reports received from the same reporter. Additional information has been requested.
Age: 34.0
Sex: M
Vaccine: FLU4
Symptoms: Dizziness
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of dizziness in a 34-year-old male patient who received FLUARIX QUADRIVALENT (batch number 9Z429, expiry date 30th June 2016). On 5th December 2015, the patient received FLUARIX QUADRIVALENT. In December 2015, less than a month after receiving FLUARIX QUADRIVALENT, the patient experienced dizziness. On an unknown date, the outcome of the dizziness was recovered/resolved. It was unknown if the reporter considered the dizziness to be related to FLUARIX QUADRIVALENT. Additional details were provided as follows: The patient mentioned to the pharmacist that he had experienced dizziness last year after receiving FLUARIX QUADRIVALENT, but it was not as severe which he experienced in the reporting year (refer case US2016156941).
Sex: U
Vaccine: HEPA
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a certified medical assistant who reported that three unspecified patients were vaccinated with VAQTA, lot # L015460, exp. 20-JUL-2017 and three unspecified patients were vaccinated with VAQTA, lot # M011839, exp. 13-SEP-2017 and one unspecified patient received improperly stored RECOMBIVAX, lot # L038018, exp. 13-SEP-2017 (1611USA000313), on unspecified dates. It was reported the vaccines were improperly stored. Temperature was reported as 35 degrees Fahrenheit. Time frame was reported as 15.5 hours. No adverse effects were reported. This is one of several reports received from the same source. Additional information has been requested.
Age: 0.67
Sex: M
Vaccine: PNC13
Symptoms: Pyrexia, Vomiting
Clinical narrative: Fever 103, vomited.
Age: 16.0
Sex: M
Vaccine: MENB, MNQ
Symptoms: Eye swelling, Injection site erythema, Injection site swelling, Urticaria
Clinical narrative: Full body hive. Redness and swelling at injection site. Right eye swelling.
Age: 12.0
Sex: F
Vaccine: HEPA, HPV9
Symptoms: Rash papular, Rash pruritic
Clinical narrative: This spontaneous report was received from a licensed nurse referring to a 12 year old female patient. The patient had no pertinent medical history. Concomitant medication was not reported. On 12-AUG-2016, the patient was vaccinated with the first dose of GARDASIL 9 (lot # M004116, expiration date 12-OCT-2017); dose, route and anatomical location were not reported, and a dose of VAQTA (dose, route, dose number, lot# and expiration date were not reported). Approximately in August 2016 (reported as following administration), the patient experienced rash in her upper extremities, arms, face and chest, which was not raised but was itchy, spotty. No treatment was provided to the patient after this reaction. The patient fully recovered on an unspecified date in 2016. On 14-OCT-2016, the patient was administered the second dose of GARDASIL 9 (lot # M013636, expiration date 15-FEB-2018); dose, route and anatomical location were not reported) and developed a worse rash. The rash was raised, appeared on the upper extremities and face, and was more pronounced than the first time. The reporter stated that no other vaccine was administered on that date. The patient was given a couple of doses of BENADRYL 50mg for treatment which did not provide much relief. The nurse reported that the patient completely recovered from the second reaction after a few days. The patient sought medical attention and called to physicians office. No laboratory test were performed. The reporter did not assessed the relatedness between the suspect therapies and the events. Additional information has been requested.
Age: 73.0
Sex: F
Vaccine: PNC13
Symptoms: Pain in extremity, Peripheral swelling
Clinical narrative: Severe swelling and pain  of upper right arm. Still very noticeable after 6 days.
Sex: U
Vaccine: HEP
Symptoms: Incorrect product storage
Clinical narrative: This spontaneous report was received from an unspecified healthcare professional, referring to multiple unspecified patients of unknown age and gender. Information about patients' medical history, concurrent conditions and concomitant medication were not reported. On unspecified dates, the patients were administered doses of improperly stored RECOMBIVAX HB that were exposed to a fridge excursion on 21-JUL-2017 (lot # M001578 expiration date 21-NOV-2018, lot # K012875 expiration date 27-AUG-2016, lot # L048209 expiration date 31-MAY-2018, lot # 042826 expiration date 15-SEP-2017, lot # L010595 expiration date 12-NOV-2016, lot # L027733 expiration date 13-SEP-2017, lot # L040458 expiration date 04-FEB-2016). Lot # 042826 is an invalid lot number for hepatitis B vaccine (recombinant). This is one of the several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HEPA
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a Medical Assistant who refers to multiple unknown patients of unknown age and gender. The patient's pertinent medical history, current conditions and concomitant medications were not reported. On an unknown date the patients were administered multiple unspecified vaccines of improperly stored doses of VAQTA lot # M001815, expiration date 20-SEP-2017 (dosing details were not reported), GARDASIL 9 lot # M007764, expiration date 30-JAN-2018 (dosing details were not reported) (refer to MARRS # 1611USA000221 and RECOMBIVAX HB lot # M001578, expiration date 21-NOV-2018 (refer to MARRS # 1611USA000222) and lot # M010212, expiration date 21-JAN-2019 (refer to MARRS # 1611USA000223) (dosing details were not reported). The vaccines were exposed to temperatures ranging from 33F to 35F for cumulative total time frame of 72 hours out of recommended storage range. There were no previous excursions reported. The data logger was reported as yes. No adverse effects were reported. There was no product quality complaint involved. No further information was provided. This is one of the several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HEP
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a certified medical assistant who reported that on unspecified dates one unspecified patient received improperly stored RECOMBIVAX, lot # L038018/exp. 13-SEP-2017; three unspecified patients were vaccinated with VAQTA, lot # L015460/exp. 20-JUL-2017 and three unspecified patients were vaccinated with VAQTA, lot # M011839/exp. 13-SEP-2017 (MARRS# 1610USA003123). It was reported the vaccines were improperly stored. Temperature was reported as 35 degrees Fahrenheit. Time frame was reported as 15.5 hours. No adverse effects were reported. This is one of several reports received from the same source. Additional information has been requested.
Age: 78.0
Sex: F
Vaccine: PNC13
Symptoms: Injection site cellulitis, Injection site erythema, Injection site swelling
Clinical narrative: Redness, swelling from injection site to shoulder (cellulitis).
Sex: U
Vaccine: HPV9
Symptoms: Malaise
Clinical narrative: Information has been received from a patient's mother referring to the patient of unknown age and gender. No medical history or concurrent condition was provided. On an unknown date the patient was vaccinated with GARDASIL 9 (lot#, expiration date and dose unspecified), intramuscularly. On an unknown date, after received the GARDASIL 9, the patient got sick from the shot. The outcome of the event was unknown. Additional information is not expected because no consent to contact.
Age: 0.33
Sex: U
Vaccine: HIBV, RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a other health professional refers to unspecified number of patient of unknown age and gender. The patient's medical history, drug reactions and allergies were not reported. On an unknown date, the patients were vaccinated with improperly stored PEDVAXHIB (dose and route were not reported), lot # M025192 and expiry date: 21-MAR-2019, lot # M020102 and expiry date: 08-MAR-2019, lot # M025194 and expiry date: 22-MAR-2019. No concomitant medications were reported. The vaccine was exposed to a temperature frame of 34.5 Fahrenheit for 100 minutes. A data logger was involved. There were no previous excursions. No adverse events were reported. No product quality complaint was involved. This is one of the several reports from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HIBV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a medical assistant refers to multiple patients of unknown age and gender. The patients' pertinent medical history, drug reactions and allergies and concomitant medications were not reported. On unspecified dates the patients were vaccinated with improperly stored doses of PEDVAXHIB (dose and route were not reported) lot # M020100 and expiry date: 07-MAR-2019, lot # M001811 and expiry date: 04-NOV-2018, lot # M014927 and expiry date: 18-FEB-2019. The vaccine was exposed to a temperature frame of 34.9 Fahrenheit for 336 hours. A data logger was used to record the temperatures. No adverse effects were reported. No additional information was provided. There was no product quality complaint involved. This is one of the several reports from the same reporter. Additional information has been requested.
Age: 74.0
Sex: F
Vaccine: PPV
Symptoms: Peripheral swelling, Urticaria
Clinical narrative: Swollen arm - allergic urticaria according to Urgent Care.
Age: 19.0
Sex: U
Vaccine: HEP
Symptoms: Incorrect dose administered, No adverse event
Clinical narrative: Information has been received from a pharmacist referring to a 19 years old patient. The patient's concurrent condition, medical history and concomitant therapies were not provided. On an unknown date, the patient received a booster dose RECOMBIVAX HB (strength reported as 10/1.0 microgram/ml, lot #, expiration date and route were unknown) 10 microgram instead of the 5 microgram. No adverse event was reported. No product quality complaint was involved. Additional information has been requested.
Sex: U
Vaccine: HPV9, MMRV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a Nurse Practitioner concerning several unspecified patients (age and gender not specified). The nurse practitioner reported that on unspecified dates several doses of improperly stored GARDASIIL 9 (lot # M013636, expiration date 15-FEB-2108)(dosage and route not specified) and (Oka-Merck) PROQUAD (lot# M019232, expiration date 17-OCT-2017) (dosage and route not specified) were administered to unspecified patients. The storage temperature for GARDSAIL 9 was -0.1 degrees Celsius for 38 hours, 20 minutes, -1.67 Celsius for 2 minutes, and 9 Celsius for 13 minutes. The storage temperature for PROQUAD was 11 degrees Fahrenheit for 15 hours 49 minutes. No adverse effects were reported. Additional information is not available. Additional information is not expected.
Sex: U
Vaccine: HPV9
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a nurse regarding four unspecified patients (age and gender unknown). Medical history, concurrent conditions and concomitant medication use not specified. On an unknown date the patients were vaccinated with GARDASIL 9 (lot # M009378, expiration date 23-APR-2018) (total dosage and route not specified). The nurse reported that on unspecified dates, four unspecified patients received improperly stored GARDASIL 9. No adverse effects were reported. Additional information has been requested.
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a medical assistant concerning unspecified patients of unknown age and gender. Information about concurrent condition, concomitant medication and medical history was not provided. On unspecified dates since 29-SEP-2016, the patients received doses of improperly stored ROTATEQ orally (lot # M007124, expiration date 05-OCT-2017) (dose and frequency was not reported. The vaccines were stored at 31.6 F for 30 minutes. The temperature excursions were detected by a "data logger". There was no previous temperature excursion. The medical assistant was not aware of any adverse effects. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: PPV
Symptoms: Guillain-Barre syndrome, Hypersensitivity, Vaccination complication
Clinical narrative: Information has been received from a physician via Pfizer (MFC#2016286137) on 10-JUN-2016 referring to unknown number of patients of unknown age and gender. Information about concurrent condition, medical history and concomitant medication was not provided. On unknown dates the patients were vaccinated with doses of PNEUMOVAX 23 (dose, dose#, lot# and route unknown). On unknown dates the patients experienced reaction to PNEUMOVAX 23 such as Guillain's Barre syndrome and hypersensitivity, et al. The outcome of the events was unknown. Upon internal review, the event Guillain's Barre syndrome was considered to be medically significant. Additional information has been requested.
Sex: U
Vaccine: VARCEL, VARZOS
Symptoms: Wrong drug administered
Clinical narrative: This spontaneous report as received from a pharmacist refers to an unspecified number (reported as few) of child patients' of unknown demographics. Patients' pertinent medical history, concurrent condition and concomitant medication were not reported. No previous drug reactions/allergies were reported. On unknown dates these patients' were inadvertently vaccinated with ZOSTAVAX (strength, dosing details, anatomical location, lot# and expiration date were unknown), instead of (Oka/Merck) VARIVAX. Additional information has been requested.
Sex: U
Vaccine: HEP
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a healthcare worker 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 an unknown dates, since 01-MAR-2015, the patients were vaccinated with improperly stored doses of RECOMBIVAX HB, (dosing details and lot# not reported). No adverse effects were reported. The vaccine was exposed to high temperature of 10.3 degree Celsius for a cumulative time frame of 731 hours from 24-NOV-2015 through 26-OCT-2016. No further information provided. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: MMR
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a healthcare worker 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 an unknown dates, since 01-MAR-2015, the patients were vaccinated with improperly stored doses of M-M-R II, (dosing details and lot# not reported). No adverse effects were reported. The vaccine was exposed to high temperature of 10.3 degree Celsius for a cumulative time frame of 731 hours from 24-NOV-2015 through 26-OCT-2016. No further information provided. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HEPA
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a healthcare worker 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 an unknown dates, since 01-MAR-2015, the patients were vaccinated with improperly stored doses of VAQTA, (dosing details not reported). No adverse effects were reported. The vaccine was exposed to high temperature of 10.3 degree Celsius for a cumulative time frame of 731 hours from 24-NOV-2015 through 26-OCT-2016. No further information provided. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HEPA
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a registered nurse referring to an unspecified number of patients with unknown age and gender. There was no information regarding concomitant medication, medical history or drug reactions/allergies. On unknown dates, the patients were vaccinated with improperly stored doses of VAQTA 25/0.5 (unit not provided) (lot # K018181, expiration date 04-JUN-2017; dose and route were not reported). The vaccine was improperly stored at 1 Celsius (C) for 7 hours and 9 C for 5 hours. There was no previous temperature excursion. Data logger was involved. No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HEP
Symptoms: Incorrect product storage
Clinical narrative: Information has been received from a physician referring to a patient of unknown age and gender. The patient's medical history, concomitant therapy and concurrent condition were not provided. On 14-JUL-2016, the patient was vaccinated with a dose of RECOMBIVAX HB (dose, route, lot number and expiration date were unknown), which experienced temperature excursion. This is one of several reports that received from the same source. Additional information has been requested.
Sex: U
Vaccine: HEP
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a registered nurse referring to an unspecified number of patients with unknown age and gender. There was no information regarding concomitant medication, medical history or drug reactions/allergies. On unknown dates, the patients were vaccinated with improperly stored doses of RECOMBIVAX HB (lot #L016427, expiration date 13-APR-2017; dose and route were not reported). The vaccine was improperly stored at 1 Celsius (C) for 7 hours and 9 C for 5 hours. There was no previous temperature excursion. Data logger was involved. No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HPV9
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a medical assistant concerning unspecified patients of unknown age and gender. Information about concurrent condition, concomitant medication and medical history was not provided. On unspecified dates since 29-SEP-2016, the patients received doses of improperly stored GARDASIL 9 ( lot # M016193, expiration date 24-APR-2018). The vaccines were stored at 31.6 F for 30 minutes. The temperature excursions were detected by a " data logger". There was no previous temperature excursion. The medical assistant was not aware of any adverse effects. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a healthcare worker refers to an unspecified number of patients of unknown age and gender. The patient's medical history, concurrent conditions and concomitant medications were not reported. On an unknown dates, since 01-MAR-2015, the patients were vaccinated with improperly stored doses of ROTATEQ, (dosing details and lot# not reported). No adverse effects were reporter. The vaccine was exposed to high temperature of 10.3 degree Celsius for a cumulative time frame of 731 hours from 24-NOV-2015 through 26-OCT-2016. No further information provided. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: MMRV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from medical assistant refers to a patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant medications were not reported. On 26-OCT-2016, the patient was vaccinated with improperly stored dose of (Oka-Merck) PROQUAD, lot # M031944 with expiry: 27-DEC-2017 (dosing details not reported). No adverse effects reported. Additional information has been requested.
Sex: U
Vaccine: HPVX
Symptoms: Adverse reaction
Clinical narrative: Information has been received from a reporter via social media concerning 7980 patient of unknown age and gender. Information about concurrent condition, concomitant medication and medical history was not provided. On unspecified dates, the patients received HPV vaccine (manufacturer unknown) (lot#, expire date, dose and route unknown). On unknown dates, the patients experienced adverse reactions. The outcome of the event was unknown. This is one of several reports received from the same reporter. Additional information is not expected because of lack of privately contactable information for the reporter.
Sex: U
Vaccine: HPV9
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a healthcare worker 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 an unknown dates, since 01-MAR-2015, the patients were vaccinated with improperly stored doses of GARDASIL 9, (dosing details and lot# not reported). No adverse effects were reported. The vaccine was exposed to high temperature of 10.3 degree Celsius for a cumulative time frame of 731 hours from 24-NOV-2015 through 26-OCT-2016. No further information provided. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HEPA
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a nurse referring to unspecified amount of patients of unknown age and gender. The patients' medical history, concomitant therapy and drug reactions were not reported. On unspecified dates, the patients were vaccinated with improperly stored doses of VAQTA (lot # M017982, expiration date 13-SEP-2017, dose and route were not provided), which were exposed to 50 Fahrenheit (F) for 40 minutes. It also underwent previous temperature excursion at 50.2 F for 1 hour and 10 minutes. No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: MMRV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a nurse referring to multiple unspecified patients of unknown age and gender. There was no information regarding concomitant medication, medical history or drug reaction/allergies. Since 22-SEP-2016, the patients were vaccinated with improperly stored (Oka/Merck) PROQUAD (lot # M029599 with expiration date 10-DEC-2017, therapy type rHA; Lot # M031944 with expiration date 27-DEC-2017, therapy type rHA;  Lot # M029595 with expiration date 10-DEC-2017, therapy type rHA; dose and route were not reported. The temperature excursion on an unspecified date was 6.4 Celsius (C) for 3 hours and 10 minutes. Previous temperature excursion was on 22-SEP-2016 of 4 C for 14 hours and 45 minutes. Data logger was involved. No adverse effects were reported. This is one of two reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HEPA
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: Information has been received from a Licensed Practical Nurse referring to a patient of unknown age and gender. Information about concurrent condition, medical history and concomitant medication was not provided. On 01-JUN-2016 and 24-OCT-2016 the patient was vaccinated with doses of VAQTA (lot#, dose and route unknown, respectively. No adverse symptoms reported. 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 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 an unspecified dates, the patients were vaccinated with improperly stored doses of (wistar ra 27-3) M-M-R II which had lot # L012479 with expiry: 10-APR-2017, (dosing details not reported). No adverse effects reported. The vaccine with above lot number was exposed to a temperature excursion of 72.1 degree Fahrenheit for 1 hour 42 minutes, and it had no previous temperature excursion. It was detected by data logger. No further information provided. This is one of three reports received from the same reporter. Additional information has been requested.
Sex: M
Vaccine: VARCEL, VARZOS
Symptoms: Injection site pain, Wrong drug administered
Clinical narrative: This spontaneous report as received from a pharmacist refers to a 6 year old male patient. Patient's pertinent medical history, concurrent condition and concomitant medication were not reported. No previous drug reactions/ allergies were reported. On 25-FEB-2015, the patient was vaccinated with ZOSTAVAX (strength, dosing details, anatomical location, lot# and expiration date were unknown). The reporting pharmacist stated that the patient's leg at the injection site hurt for 5 to 7 days after vaccination (approximately in FEB-2015). Four weeks after the vaccination, pharmacist was notified from the healthcare provider that the patient was inadvertently given ZOSTAVAX instead of VARIVAX. No medical attention was sought for the event. The outcome of injection site pain was unknown, causality assessment was not provided. No product quality complaint was involved. This report is linked with case# 1611USA000093, due to same reporter source. Additional information has been requested.
Sex: U
Vaccine: HEPA
Symptoms: Incorrect product storage
Clinical narrative: Information has been received from a physician referring to a patient of unknown age and gender. The patient's medical history, concomitant therapy and concurrent condition were not provided. On 16-JUL-2016, the patient was vaccinated with a dose of VAQTA (dose, route, lot number and expiration date were unknown), which experienced temperature excursion. This is one of several reports that received from the same source. Additional information has been requested.
Sex: U
Vaccine: HPV9
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a nurse 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 an unspecified dates, the patients were vaccinated with improperly stored doses of GARDASIL 9 which had lot # M003659 with expiry: 20-SEP-2017, (dosing details not reported). No adverse effects reported. The vaccine with above lot number was exposed to a temperature excursion of 72.1 degree Fahrenheit for 1 hour 42 minutes, and it had no previous temperature excursion. It was detected by data logger. No further information provided. This is one of three reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a nurse 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 an unspecified dates, the patients were vaccinated with improperly stored doses of ROTATEQ which had lot # L046320 with expiry: 29-SEP-2017, (dosing details not reported). No adverse effects reported. The vaccine with above lot number was exposed to a temperature excursion of 72.1 degree Fahrenheit for 1 hour 42 minutes, and it had no previous temperature excursion. It was detected by data logger. No further information provided. This is one of three reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a nurse (also reported as "pharmacist") referring to multiple unspecified patients of unknown age and gender. There was no information regarding concomitant medication, medical history or drug reactions/allergies. Since 22-SEP-2016, the patients were vaccinated with improperly stored VARIVAX (lot # M024683 with expiration date 18-MAY-2018; lot # M028553 with expiration date 07-JUN-2018; lot # M027885 with expiration date 03-JUN-2018; dose and route were not reported). The temperature excursion on an unspecified date was 6.4 Celsius (C) for 3 hours and 10 minutes. Previous temperature excursion was on 22-SEP-2016 of 4 C for 14 hours and 45 minutes. Data logger was involved. No adverse effects were reported. This is one of two reports received from the same reporter. Additional information has been requested.
Age: 75.0
Sex: F
Vaccine: FLUX, PPV, FLU3, PPV, FLUX, PPV, FLU4, PPV, FLU4, PPV, FLUX, PPV, FLUX, PPV, FLUX, PPV, FLUX, PPV
Symptoms: Injected limb mobility decreased, Injection site reaction, Myalgia
Clinical narrative: Initial unsolicited report received from a pharmacist via other company, Merck on 19 October 2016. This case is linked to 2016SA193123 (same vaccine, same reporter). This case involves a 75-years-old of female patient who was vaccinated with Fluzone (lot number, expiration date, dose, dose in series, route of administration and site of administration were not reported) and PNEUMOVAX 23 via intramuscularly (lot number: L03852211, expiration date: 11 August 2017, dose, dose in series and site of administration were not reported) on 6th October 2016. The medical history was reported as stomach ulcer. The concomitant medications were reported as hydrocodone for unspecified condition. On an unspecified date following vaccination, the patients developed excessive soreness, inability to left arm, arm pain and fall (reported as fallout of bed), soreness of arm and it was reported that patient was still sore. Laboratory test and the corrective treatment were not reported. The outcome of the events was reported as not recovered. List of the documents held by sender: none.
Age: 75.0
Sex: F
Vaccine: FLUX, PPV, FLU3, PPV, FLUX, PPV, FLU4, PPV, FLU4, PPV, FLUX, PPV, FLUX, PPV, FLUX, PPV, FLUX, PPV
Symptoms: Pain in extremity
Clinical narrative: Initial unsolicited report received from a pharmacist via other company, Merck on 19 October 2016. This case is linked to 2016SA193123 (same vaccine, same reporter). This case involves a 75-years-old of female patient who was vaccinated with Fluzone (lot number, expiration date, dose, dose in series, route of administration and site of administration were not reported) and PNEUMOVAX 23 via intramuscularly (lot number: L03852211, expiration date: 11 August 2017, dose, dose in series and site of administration were not reported) on 6th October 2016. The medical history was reported as stomach ulcer. The concomitant medications were reported as hydrocodone for unspecified condition. On an unspecified date following vaccination, the patients developed excessive soreness, inability to left arm, arm pain and fall (reported as fallout of bed), soreness of arm and it was reported that patient was still sore. Laboratory test and the corrective treatment were not reported. The outcome of the events was reported as not recovered. List of the documents held by sender: none.
Age: 75.0
Sex: F
Vaccine: FLUX, PPV, FLU3, PPV, FLUX, PPV, FLU4, PPV, FLU4, PPV, FLUX, PPV, FLUX, PPV, FLUX, PPV, FLUX, PPV
Symptoms: Injected limb mobility decreased, Myalgia
Clinical narrative: Initial unsolicited report received from a pharmacist via other company, Merck on 19 October 2016. This case is linked to 2016SA193123 (same vaccine, same reporter). This case involves a 75-years-old of female patient who was vaccinated with Fluzone (lot number, expiration date, dose, dose in series, route of administration and site of administration were not reported) and PNEUMOVAX 23 via intramuscularly (lot number: L03852211, expiration date: 11 August 2017, dose, dose in series and site of administration were not reported) on 6th October 2016. The medical history was reported as stomach ulcer. The concomitant medications were reported as hydrocodone for unspecified condition. On an unspecified date following vaccination, the patients developed excessive soreness, inability to left arm, arm pain and fall (reported as fallout of bed), soreness of arm and it was reported that patient was still sore. Laboratory test and the corrective treatment were not reported. The outcome of the events was reported as not recovered. List of the documents held by sender: none.
Age: 75.0
Sex: F
Vaccine: FLUX, PPV, FLU3, PPV, FLUX, PPV, FLU4, PPV, FLU4, PPV, FLUX, PPV, FLUX, PPV, FLUX, PPV, FLUX, PPV
Symptoms: Fall, Mobility decreased, Pain, Pain in extremity
Clinical narrative: Initial unsolicited report received from a pharmacist via other company, Merck on 19 October 2016. This case is linked to 2016SA193123 (same vaccine, same reporter). This case involves a 75-years-old of female patient who was vaccinated with Fluzone (lot number, expiration date, dose, dose in series, route of administration and site of administration were not reported) and PNEUMOVAX 23 via intramuscularly (lot number: L03852211, expiration date: 11 August 2017, dose, dose in series and site of administration were not reported) on 6th October 2016. The medical history was reported as stomach ulcer. The concomitant medications were reported as hydrocodone for unspecified condition. On an unspecified date following vaccination, the patients developed excessive soreness, inability to left arm, arm pain and fall (reported as fallout of bed), soreness of arm and it was reported that patient was still sore. Laboratory test and the corrective treatment were not reported. The outcome of the events was reported as not recovered. List of the documents held by sender: none.
Age: 75.0
Sex: F
Vaccine: FLUX, PPV, FLU3, PPV, FLUX, PPV, FLU4, PPV, FLU4, PPV, FLUX, PPV, FLUX, PPV, FLUX, PPV, FLUX, PPV
Symptoms: Fall, Injected limb mobility decreased, Pain in extremity
Clinical narrative: Initial unsolicited report received from a pharmacist via other company, Merck on 19 October 2016. This case is linked to 2016SA193123 (same vaccine, same reporter). This case involves a 75-years-old of female patient who was vaccinated with Fluzone (lot number, expiration date, dose, dose in series, route of administration and site of administration were not reported) and PNEUMOVAX 23 via intramuscularly (lot number: L03852211, expiration date: 11 August 2017, dose, dose in series and site of administration were not reported) on 6th October 2016. The medical history was reported as stomach ulcer. The concomitant medications were reported as hydrocodone for unspecified condition. On an unspecified date following vaccination, the patients developed excessive soreness, inability to left arm, arm pain and fall (reported as fallout of bed), soreness of arm and it was reported that patient was still sore. Laboratory test and the corrective treatment were not reported. The outcome of the events was reported as not recovered. List of the documents held by sender: none.
Age: 75.0
Sex: F
Vaccine: FLUX, PPV, FLU3, PPV, FLUX, PPV, FLU4, PPV, FLU4, PPV, FLUX, PPV, FLUX, PPV, FLUX, PPV, FLUX, PPV
Symptoms: Mobility decreased, Myalgia
Clinical narrative: Initial unsolicited report received from a pharmacist via other company, Merck on 19 October 2016. This case is linked to 2016SA193123 (same vaccine, same reporter). This case involves a 75-years-old of female patient who was vaccinated with Fluzone (lot number, expiration date, dose, dose in series, route of administration and site of administration were not reported) and PNEUMOVAX 23 via intramuscularly (lot number: L03852211, expiration date: 11 August 2017, dose, dose in series and site of administration were not reported) on 6th October 2016. The medical history was reported as stomach ulcer. The concomitant medications were reported as hydrocodone for unspecified condition. On an unspecified date following vaccination, the patients developed excessive soreness, inability to left arm, arm pain and fall (reported as fallout of bed), soreness of arm and it was reported that patient was still sore. Laboratory test and the corrective treatment were not reported. The outcome of the events was reported as not recovered. List of the documents held by sender: none.
Age: 75.0
Sex: F
Vaccine: FLUX, PPV, FLU3, PPV, FLUX, PPV, FLU4, PPV, FLU4, PPV, FLUX, PPV, FLUX, PPV, FLUX, PPV, FLUX, PPV
Symptoms: Disability, Mobility decreased
Clinical narrative: Initial unsolicited report received from a pharmacist via other company, Merck on 19 October 2016. This case is linked to 2016SA193123 (same vaccine, same reporter). This case involves a 75-years-old of female patient who was vaccinated with Fluzone (lot number, expiration date, dose, dose in series, route of administration and site of administration were not reported) and PNEUMOVAX 23 via intramuscularly (lot number: L03852211, expiration date: 11 August 2017, dose, dose in series and site of administration were not reported) on 6th October 2016. The medical history was reported as stomach ulcer. The concomitant medications were reported as hydrocodone for unspecified condition. On an unspecified date following vaccination, the patients developed excessive soreness, inability to left arm, arm pain and fall (reported as fallout of bed), soreness of arm and it was reported that patient was still sore. Laboratory test and the corrective treatment were not reported. The outcome of the events was reported as not recovered. List of the documents held by sender: none.
Age: 69.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Abdominal pain upper, Asthenia, Feeling abnormal, Lacrimation increased, Nausea
Clinical narrative: Initial unsolicited report received from a consumer on 20 Oct 2016. This case involves a 69 years old female patient who was vaccinated with a dose of FLUZONE HD (batch number, expiry date, dose and site of administration was not reported) via intramuscular route on 17 Oct 2016. Illness at the time of vaccination was reported as was no and pre-existing physician diagnosed allergies, birth defects, medical conditions reported as allergies to cortisone, Macrodantin, Flexoril, Kenolog, PCN, opiates, ASA and recurrent bronchitis. The patient concomitant medications were not reported. On 17 Oct 2016, same day (by the evening) following the vaccination the patient was not feeling well and had pain at injection site, nausea and vomiting. On 18 Oct 2016, 1 day following the vaccination, the patient continued to have vomiting. On an unknown date, following the vaccination, the patient had stomach pain above the navel and was not able to eat. Laboratory investigations were not performed. Corrective treatment was not reported. On 17 Oct 2016, the patient recovered from nausea (duration  30 Min). On an unknown date, the patient recovered from not able to eat (duration 2 ½ day) and recovered from other events. List of documents held by sender: none.
Age: 69.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Vomiting
Clinical narrative: Initial unsolicited report received from a consumer on 20 Oct 2016. This case involves a 69 years old female patient who was vaccinated with a dose of FLUZONE HD (batch number, expiry date, dose and site of administration was not reported) via intramuscular route on 17 Oct 2016. Illness at the time of vaccination was reported as was no and pre-existing physician diagnosed allergies, birth defects, medical conditions reported as allergies to cortisone, Macrodantin, Flexoril, Kenolog, PCN, opiates, ASA and recurrent bronchitis. The patient concomitant medications were not reported. On 17 Oct 2016, same day (by the evening) following the vaccination the patient was not feeling well and had pain at injection site, nausea and vomiting. On 18 Oct 2016, 1 day following the vaccination, the patient continued to have vomiting. On an unknown date, following the vaccination, the patient had stomach pain above the navel and was not able to eat. Laboratory investigations were not performed. Corrective treatment was not reported. On 17 Oct 2016, the patient recovered from nausea (duration  30 Min). On an unknown date, the patient recovered from not able to eat (duration 2 ½ day) and recovered from other events. List of documents held by sender: none.