chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: MMRV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a medical assistant referring to a patient of unknown age and gender. The patient's medical history, concomitant therapy, drug reactions and allergies were not provided. On an unknown date, the patient was vaccinated with improperly stored PROQUAD (rHA) (dose not reported) lot # M011664 with expiration date 08-SEP-2017, subcutaneously for prophylaxis. No adverse effects were reported. No product quality complaint was involved. Follow-up information has been received on 30-NOV-2016 from the medical assistant. The patient was vaccinated with improperly stored doses of PROQUAD on 18-DEC-2011 and on 15-SEP-2016. This is one of several reports received from the same source. Additional information has been requested. Sender's Comments: US-009507513-1610USA008441: US-009507513-1610USA008442: US-009507513-1610USA008443: US-009507513-1610USA008444: US-009507513-1610USA008445: US-009507513-1610USA008446: US-009507513-1610USA008447: US-009507513-1610USA008448: US-009507513-1610USA008449: MERCK 1609USA010309:Mfr number.
Sex: U
Vaccine: HPV9
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a nurse referring to multiple patients of unknown age and gender. The patients' medical histories, concurrent conditions and concomitant therapies were not reported. On unknown dates, the patients were vaccinated with improperly stored doses of GARDASIL 9 (lot # M004116, expiration date 12-OCT-2017, dose and route not reported) for prophylaxis. No adverse effects were reported. This is one of two reports received from the same reporter. As of 30-NOV-2016, all telephone attempts to obtain follow-up information have been unsuccessful. Additional information is not expected as the reporter could be not located. Sender's Comments:  US-009507513-1610USA005976: MERCK 1609USA013613:Mfr number.
Age: 4.0
Sex: U
Vaccine: MMRV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a medical assistant referring to an unspecified number of patients of unknown age and gender. Information regarding concomitant medication, medical history and drug reactions/allergies was not reported. On unspecified dates in 2016 (reported as "since 19-AUG-2016"), the patients received improperly stored doses of PROQUAD (lot # M006105 with expiration date 01-AUG-2017, therapy type rHA; lot # M010478 with expiration date 01-SEP-2017, therapy type HSA; lot # M012987, expiration date 12-SEP-2017, therapy type HSA; lot# M015695 with expiration date 26-SEP-2017, therapy type rHA; lot # M021427 with expiration date 29-OCT-2017, therapy type rHA; dose and route were not reported) for prophylaxis. It was reported that the vaccine was improperly stored at -3.5 Celsius for 1 hour and 6 minutes. There was no previous temperature excursion. Data logger was involved. No symptoms were reported. This is one of two reports received from the same reporter. Telephone attempt on 19-DEC-2016 to obtain follow-up information had been unsuccessful. Additional information has been requested. Narrative was updated. Sender's Comments: US-009507513-1610USA011133: MERCK 1610USA011245:Mfr number.
Sex: U
Vaccine: PPV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from an office administrator refers to a patient of unknown age and gender. No information regarding the patient's concurrent conditions, pertinent medical history, concomitant medications, drug reactions or allergies was provided. On 28-NOV-2016, the patient was vaccinated with a dose of improperly stored PNEUMOVAX 23, injection (lot# M042599, expiration date: 17-JUN-2016; dose and route of administration were not provided). The vaccine was exposed to temperature: 99 degrees Fahrenheit for 9 hours. The temperature information was not logged with a digital data logger and there were no previous excursions. No adverse effect was reported. No product quality complaint was involved. Additional information has been requested.
Sex: F
Vaccine: PPV
Symptoms: Erythema, Skin warm
Clinical narrative: This spontaneous report was received from a female healthcare worker (an administrator) of unknown age, who was referring to herself. No information regarding the patient's pertinent medical history, drug reactions or allergies and concomitant therapies was provided. On an unknown date (reported as "over 10 years ago"), the patient was vaccinated with a dose of unspecified pneumococcal vaccine (dose and route of administration were not reported). The patient could not confirm whether she received PNEUMOVAX 23 or PREVNAR 13 (also reported as "unspecified manufacturer/lot/expiration date"). On an unknown date (reported as "when she had an unspecified pneumococcal vaccination"), the patient experienced a "hot and red pocket". The patient recovered from the events on an unspecified date. The relatedness between the events and the unspecified pneumococcal vaccine was not reported. This is one of two reports received from the same reporter. Additional information has been requested. Sender's Comments: US-009507513-1611USA013795.
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a medical assistant referring to 10 unspecified patients of unknown age and gender. The patients' medical histories, concurrent conditions and concomitant therapies were not reported. In November 2016 (reported as "either 22-NOV-2016 or 28-NOV-2016"), the patients were vaccinated with improperly stored ROTATEQ (lot # M018957, expiration date 22-NOV-2017, dose not reported) orally for prophylaxis. The doses of vaccine were improperly stored at 49 degree Fahrenheit for 1.75 hours on 22-NOV-2016 and 49 degree Fahrenheit for 1.75 hours on 28-NOV-2016. There was no previous temperature excursion. 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. Sender's Comments: US-009507513-1612USA009766.
Sex: U
Vaccine: HEP
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a nurse referring to multiple patients of unknown age and gender. The patients' concurrent condition, medical history and concomitant therapy were not provided. On  multiple unknown dates, the patients were vaccinated with improperly stored RECOMBIVAX HB (lot # M010671, expiration date: 02-JUN-2018; lot # M020926, expiration date: 11-AUG-2018; dose and route were unknown) for prophylaxis. No adverse effects were reported. The vaccines were exposed to temperature excursion of 35.6 Fahrenheit five times (7 hours each time). There was no previous temperature excursion. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Wrong drug administered
Clinical narrative: Information has been received from a healthcare worker referring to an adult patient of unknown age and gender. The patient's medical history and concomitant medication were unknown. On 02-DEC-2016, the patient with Sjogren's syndrome was vaccinated with VARIVAX (dose and route unknown, lot # L025210, expiration date: 07-JUL-2017) for prophylaxis rather than ZOSTAVAX. No adverse effect was reported. Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a health care professional refers to a patient of unknown demographics. On an unknown date the patient was vaccinated with improperly stored ZOSTAVAX (dosing regimen unspecified) (lot M005972, expiry 02-FEB-2018) (dose, route and frequency unspecified) for prophylaxis. Excursion details are as follows: which were exposed to the following conditions, were administered to unspecified patients: temperature: 5.9 F, Time frame: 2 hours, there was previous temperature excursion:18F for 17 hours, 16F for 3 hours and 15.3F for 2 hours and 3 minutes. It was a call because of a data logger. No adverse effect reported. No further information was provided. Additional information has been requested.
Sex: U
Vaccine: HEP
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a nurse concerning unspecified patients of unknown age and gender. The patients' concomitant medications, pertinent medical history, and drug reactions and allergies have not been provided. On unspecified dates, improperly stored doses of RECOMBIVAX HB (dose, strength, frequency, route, lot # and expiration date were unknown) were administered to the unspecified patients for prophylaxis. The RECOMBIVAX HB were exposed to following temperatures: from 35 Fahrenheit to 49 Fahrenheit, 32 Fahrenheit, 35 Fahrenheit, 35 Fahrenheit, 35 Fahrenheit and 35 Fahrenheit for a time frame of 24 hours, respectively. No adverse effects were reported. Data logger was involved, but no previous temperature excursion was reported. This is one of several reports from the same reporter. Additional information has been requested. Sender's Comments: US-009507513-1612USA003951: US-009507513-1612USA003952: US-009507513-1612USA003950.
Sex: U
Vaccine: PPV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a nurse concerning unspecified patients of unknown age and gender. The patients' concomitant medications, pertinent medical history, and drug reactions and allergies have not been provided. On unspecified dates, improperly stored doses of PNEUMOVAX 23 (dose, strength, frequency, route, lot # and expiration date were unknown) were administered to the unspecified patients for prophylaxis. The PNEUMOVAX 23 were exposed to following temperatures: from 35 Fahrenheit to 49 Fahrenheit, 32 Fahrenheit, 35 Fahrenheit, 35 Fahrenheit, 35 Fahrenheit and 35 Fahrenheit for a time frame of 24 hours respectively. No adverse effects were reported. Data logger was involved, but no previous temperature excursion was reported. This is one of several reports from the same reporter. Additional information has been requested. Sender's Comments: US-009507513-1612USA003951: US-009507513-1612USA003952: US-009507513-1612USA003579.
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a nurse concerning unspecified patients of unknown age and gender. The patients' concomitant medications, pertinent medical history, and drug reactions and allergies have not been provided. On unspecified dates, improperly stored doses of ROTATEQ (dose, strength, frequency, lot # and expiration date were unknown) were orally administered to the unspecified patients for prophylaxis. The ROTATEQ were exposed to following temperatures: from 35 Fahrenheit to 49 Fahrenheit, 32 Fahrenheit, 35 Fahrenheit, 35 Fahrenheit, 35 Fahrenheit and 35 Fahrenheit for a time frame of 24 hours respectively. No adverse effects were reported. Data logger was involved, but no previous temperature excursion was reported. This is one of several reports from the same reporter. Additional information has been requested. Sender's Comments: US-009507513-1612USA003579: US-009507513-1612USA003952: US-009507513-1612USA003950.
Sex: U
Vaccine: MMR
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a nurse concerning unspecified patients of unknown age and gender.  The patients' concomitant medications, pertinent medical history, and drug reactions and allergies have not been provided. On unspecified dates, improperly stored doses of M-M-R II (dose, strength, frequency, route, lot # and expiration date were unknown) were administered to the unspecified patients for prophylaxis. The M-M-R II were exposed to following temperatures: from 35 Fahrenheit to 49 Fahrenheit, 32 Fahrenheit, 35 Fahrenheit, 35 Fahrenheit, 35 Fahrenheit and 35 Fahrenheit for a time frame of 24 hours respectively. No adverse effects were reported. Data logger was involved, but no previous temperature excursion was reported. This is one of several reports from the same reporter. Additional information has been requested.; Sender's Comments: US-009507513-1612USA003579: US-009507513-1612USA003951: US-009507513-1612USA003950.
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a licensed practical nurse referring to an unspecified patient of unknown demographics. On 07-DEC-2015, the patients were vaccinated with improperly stored ROTATEQ (lot # M029252, expiry: 14-MAR-2018) for prophylaxis (dose and route unspecified) which were exposed to temperatures outside of the recommended range. No adverse effects have been reported. There was no product quality complaint involved. No additional information was provided. The outcome of incorrect product storage was unknown.  Temperature: 72 F Time frame: 1.5 Hours Was it administered (AE)? Yes Was previous temperature excursion? No Was call because of a "data logger"? Yes 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 medical assistant referring to a patient of unknown age and gender. Information about concurrent condition, medical history, drug reaction/allergies and concomitant therapy were not provided. The patient was vaccinated with the first dose of VAQTA on 18-JUL-2016 and the second dose on 08-DEC-2016 (strength, dose, lot # and expiration date was unknown) intramuscularly for prophylaxis, which was shorter than the recommended interval between doses. No adverse effect was reported by the patient. Additional information has been requested.
Sex: U
Vaccine: UNK
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a medical assistant referring to a patient of unknown age and gender. Information about concurrent condition, medical history, drug reaction/allergies and concomitant therapy were not provided. On an unknown date, the patient might be vaccinated with a dose of improperly stored either GARDASIL 9 (strength, dose and route were unknown, lot # M016193 with expiration date 24-APR-2018), RECOMBIVAX HB (strength, dose and route were unknown, lot # M023718 with expiration date 09-AUG-2018), M-M-R II recombinant human albumin (rHA) (strength, dose and route were unknown, lot # M008588 with expiration date 16-FEB-2018), PROQUAD recombinant human albumin (rHA) (strength, dose and route were unknown, lot # M031567 with expiration date 24-DEC-2017) or VARIVAX (strength, dose and route were unknown, lot # M027347 with expiration date 11-MAY-2018) for prophylaxis. No adverse effect was reported. The vaccines had been exposed under temperature 49.7 Fahrenheit for 2 hours and 10.6 Fahrenheit for 3 hours and 30 minutes, but did not undergo previous excursion. Data logger was used. Additional information has been requested.
Sex: U
Vaccine: PPV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a Licensed Practical Nurse (LPN) referring to an unspecified number of patients of unknown age and gender. The patient's concurrent conditions, medical history drug reactions, allergies and concomitant medications were not reported. It was reported that on 09-DEC-2016, the patients were vaccinated with improperly stored dose of PNEUMOVAX 23 (lot # M022086, expiration date 09-OCT-2017) (strength, dose and route of administration were not reported) for prophylaxis. It was reported that the temperature excursion was for 30 minutes at 8.4 degrees C, according to the data logger. There was no previous temperature excursion. No adverse effects were reported. This is one of several reports from the same source. Additional information has been requested. Sender's Comments: US-009507513-1612USA005657.
Sex: U
Vaccine: HPV9
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report received from a medical assistant referred to unspecified patients of unknown age and gender. The patients' medical history, concurrent conditions and concomitant medications were not reported. The medical assistant reported that unspecified patients were administered improperly stored vaccines GARDASIL 9 (lot: M018810; expiry date: 28-MAY-2018) on an unspecified date. No adverse effects were reported. The vaccine was stored at 35.52F for 8 hours and 2 minutes. There was no previous temperature excursion and the call was because of digital data logger. This is one of the several reports received from the same reporter. Additional information has been requested. Sender's Comments: US-009507513-1612USA006359: same reporter.
Sex: U
Vaccine: HPV9
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' medical history, current conditions and concomitant medications were unknown. On unknown dates, the patients were vaccinated with improperly stored GARDASIL 9 (dose, route, lot number and expiry date were not reported) for prophylaxis. The reporter did not have any information about the excursion details. No adverse events were reported. There was no product quality complaint involved. This is one of the several reports from the same reporter. Additional information has been requested. Sender's Comments: US-009507513-1612USA009619: US-009507513-1612USA009620: US-009507513-1612USA009621.
Sex: U
Vaccine: VARZOS
Symptoms: Injection site swelling, Injection site warmth
Clinical narrative: This spontaneous report received from the pharmacist referred to a patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant medications were not reported. On 13-DEC-2016, the patient was administered ZOSTAVAX (lot number and expiration date unknown). The pharmacist reported that on 15-DEC-2016, the patient presented with warmth and swelling at the injection site. The symptoms were still present but it was unknown if they have improved. Causality assessment was not reported for the events.  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 refers to multiple patients of unknown age and gender. The patients' medical history, current conditions and concomitant medications were unknown. On unknown dates, the patients were vaccinated with improperly stored VAQTA (dose, route, lot number and expiry date were not reported) for prophylaxis. The reporter did not have any information about the excursion details. No adverse events were reported. There was no product quality complaint involved. This is one of the several reports from the same reporter. Additional information has been requested. Sender's Comments: US-009507513-1612USA009621: US-009507513-1612USA008828: US-009507513-1612USA009620.
Sex: U
Vaccine: RV5
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' medical history, current conditions and concomitant medications were unknown. On unknown dates, the patients were vaccinated with improperly stored ROTATEQ (dose, route, lot number and expiry date were not reported)for prophylaxis. The reporter did not have any information about the excursion details. No adverse events were reported. There was no product quality complaint involved. This is one of the several reports from the same reporter. Additional information has been requested. Sender's Comments: US-009507513-1612USA009621: US-009507513-1612USA008828: US-009507513-1612USA009619.
Sex: U
Vaccine: HEP
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' medical history, current conditions and concomitant medications were unknown. On unknown dates, the patients were vaccinated with improperly stored RECOMBIVAX HB (dose, route, lot number and expiry date were not reported) for prophylaxis. The reporter did not have any information about the excursion details. No adverse events were reported. There was no product quality complaint involved. This is one of the several reports from the same reporter. Additional information has been requested. Sender's Comments: US-009507513-1612USA008828: US-009507513-1612USA008828: US-009507513-1612USA009620.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a healthcare worker referring to three unspecified patients of unknown age and gender. The three patients' medical history, concurrent conditions and concomitant medications were not provided. On multiple unspecified dates the three unspecified patients were vaccinated with improperly stored doses of VARIVAX (lot #, expiration date, dose, route and site of administration were not reported) for prophylaxis. The vaccines were exposed to 33.8 degrees Fahrenheit for 327 hours. The temperatures were logged with a data logger and there was no previous excursion.  No adverse effect was reported. Additional information has been requested.
Sex: U
Vaccine: HEPA
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a medical assistant referring to 10 unspecified patients of unknown age and gender. The patients' medical histories, concurrent conditions and concomitant therapies were not reported. In November 2016 (reported as "either 22-NOV-2016 or 28-NOV-2016"), the patients were vaccinated with improperly stored VAQTA (lot # M027879, expiration date 24-JAN-2018, dose and route not reported) for prophylaxis. The doses of vaccine were improperly stored at 49 degree Fahrenheit for 1.75 hours on 22-NOV-2016 and 49 degree Fahrenheit for 1.75 hours on 28-NOV-2016. There was no previous temperature excursion. 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.; Sender's Comments: US-009507513-1612USA001319:
Age: 67.0
Sex: M
Vaccine: FLU3
Symptoms: Blepharospasm, Dizziness, Dysgeusia, Facial paralysis, Fall
Clinical narrative: Initial unsolicited report received from a consumer on 07 Dec 2016. This case involves a 67 years old male patient who was vaccinated with a dose of FLUZONE HD (batch number, expiry date, dose, and dose in series were unknown) via intramuscular route in left deltoid on 25 Nov 2016. Illness at time of vaccination was reported as no and Pre-existing physician diagnosed allergies, birth defects, medical conditions were allergies to strawberries and codeine. Any other vaccinations within 4 weeks of vaccination was not reported. The patient concomitant medications were not reported. On 25 Nov 2016, on the same day by evening following vaccination, the patient experienced soreness at the injection site, the next day his left arm became sore. Over the next few days, the soreness traveled up to his shoulder, to the back of his neck, to the top of his head. The patient had a dizzy feeling that would come and go and this lasted for 3-4 days. On 05 Dec 2016, after riding his bicycle, the patient fell to the ground, his left eye started twitching, left side of his face drooped, his face felt numb, he had a bad taste in his mouth, and could barely talk. The patient also suffered from headache, which was not usual for him. Laboratory investigations were not reported. The patient required ER doctor visit, where it was diagnosed as Bell's Palsy. The patient corrective treatment were reported as steroids and antivirals. The outcome of the events was not recovered. Upon internal review, the company decided to consider the event serious because of important medical event Bell's Palsy. List of documents held by sender: none. Sender's Comments: Bell's Palsy is listed with INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE. This is poorly documented case. However, investigation results ruling out a concurrent condition and other etiologies would be helpful to further assess this case.
Age: 67.0
Sex: M
Vaccine: FLU3
Symptoms: Headache, Hypoaesthesia, Injection site pain, Neck pain, Pain in extremity
Clinical narrative: Initial unsolicited report received from a consumer on 07 Dec 2016. This case involves a 67 years old male patient who was vaccinated with a dose of FLUZONE HD (batch number, expiry date, dose, and dose in series were unknown) via intramuscular route in left deltoid on 25 Nov 2016. Illness at time of vaccination was reported as no and Pre-existing physician diagnosed allergies, birth defects, medical conditions were allergies to strawberries and codeine. Any other vaccinations within 4 weeks of vaccination was not reported. The patient concomitant medications were not reported. On 25 Nov 2016, on the same day by evening following vaccination, the patient experienced soreness at the injection site, the next day his left arm became sore. Over the next few days, the soreness traveled up to his shoulder, to the back of his neck, to the top of his head. The patient had a dizzy feeling that would come and go and this lasted for 3-4 days. On 05 Dec 2016, after riding his bicycle, the patient fell to the ground, his left eye started twitching, left side of his face drooped, his face felt numb, he had a bad taste in his mouth, and could barely talk. The patient also suffered from headache, which was not usual for him. Laboratory investigations were not reported. The patient required ER doctor visit, where it was diagnosed as Bell's Palsy. The patient corrective treatment were reported as steroids and antivirals. The outcome of the events was not recovered. Upon internal review, the company decided to consider the event serious because of important medical event Bell's Palsy. List of documents held by sender: none. Sender's Comments: Bell's Palsy is listed with INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE. This is poorly documented case. However, investigation results ruling out a concurrent condition and other etiologies would be helpful to further assess this case.
Age: 67.0
Sex: M
Vaccine: FLU3
Symptoms: Speech disorder
Clinical narrative: Initial unsolicited report received from a consumer on 07 Dec 2016. This case involves a 67 years old male patient who was vaccinated with a dose of FLUZONE HD (batch number, expiry date, dose, and dose in series were unknown) via intramuscular route in left deltoid on 25 Nov 2016. Illness at time of vaccination was reported as no and Pre-existing physician diagnosed allergies, birth defects, medical conditions were allergies to strawberries and codeine. Any other vaccinations within 4 weeks of vaccination was not reported. The patient concomitant medications were not reported. On 25 Nov 2016, on the same day by evening following vaccination, the patient experienced soreness at the injection site, the next day his left arm became sore. Over the next few days, the soreness traveled up to his shoulder, to the back of his neck, to the top of his head. The patient had a dizzy feeling that would come and go and this lasted for 3-4 days. On 05 Dec 2016, after riding his bicycle, the patient fell to the ground, his left eye started twitching, left side of his face drooped, his face felt numb, he had a bad taste in his mouth, and could barely talk. The patient also suffered from headache, which was not usual for him. Laboratory investigations were not reported. The patient required ER doctor visit, where it was diagnosed as Bell's Palsy. The patient corrective treatment were reported as steroids and antivirals. The outcome of the events was not recovered. Upon internal review, the company decided to consider the event serious because of important medical event Bell's Palsy. List of documents held by sender: none. Sender's Comments: Bell's Palsy is listed with INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE. This is poorly documented case. However, investigation results ruling out a concurrent condition and other etiologies would be helpful to further assess this case.
Sex: F
Vaccine: FLU4
Symptoms: Allergy to vaccine
Clinical narrative: Initial unsolicited report received from a health care professional (nurse practitioner) via other company (Pfizer) (Manufacturer Report Number: 2016540822) on 07 Dec 2016. This case involves an adult female patient (age not reported) who was vaccinated with a dose of FLUZONE QUADRIVALENT (Batch number, expiry date, dose, route and site of administration was not reported) on an unknown date and time frame. The patient medical history and concomitant medications were not reported. It was reported as on an unknown date the patient had allergy to FLUZONE. The patient lab tests and corrective treatment was not reported. The outcome of the event was unknown. List of documents held by sender: none.
Sex: F
Vaccine: TDAP
Symptoms: Diarrhoea, Exposure during pregnancy, Tremor
Clinical narrative: Initial unsolicited pregnancy report received from a health care professional (pharmacist) on 09 December 2016. This case involves a female patient (age not reported) who was vaccinated with a one dose of ADACEL (batch number, expiration date, dose, route and site of administration were not reported) on 08 December 2016 while she was pregnant. Pregnancy information of last menstrual period (LMP), trimester and estimated delivery date was not reported. Patient's illness at time of vaccination was unknown and the patient was pregnant. Concomitant medication was not reported. On 08 December 2016, same day following the vaccination, the patient experienced shakiness and diarrhea. It was a case of vaccine exposure during pregnancy. Lab data was reported as unknown. Corrective treatment was not reported. The outcome of events was reported as unknown. Pregnancy outcome was unknown. Documents held by sender: none.
Age: 71.0
Sex: F
Vaccine: FLU3
Symptoms: Eyelid oedema, Ocular hyperaemia
Clinical narrative: Initial unsolicited report received from a pharmacist on 09-Dec-2016. This case involves 71 year old a female patient who was vaccinated with a dose of FLUZONE HD (Batch number- UI741AB, expiration date- 14-Jun-2017 (dose and dose in series not reported) intramuscularly in left deltoid on 08-Dec-2016 at 02:00 PM. Patient's medical history was reported that pre-existing physician diagnosed allergies, birth defects, medical conditions (specify) reported as none. Illness at the time of vaccination was reported as no. Concomitant medications were not reported. Any other vaccinations within four weeks of vaccinations were also not reported. On 08-Dec-2016, at 08:00 PM six hours after vaccination patient developed swollen eyelids and bloodshot eyes. Laboratory investigations reported as none. Corrective treatment were not reported. It was reported that patient was not recovered from the events. List of documents held by sender: none.
Sex: F
Vaccine: FLU4, MNQ
Symptoms: Mobility decreased, Pain in extremity, Wrong technique in product usage process
Clinical narrative: Initial unsolicited misuse report received from a Physician on 08 December 2016. This case involves female patient (onset age unknown) who was vaccinated with 0.5 ml dose of Fluzone Quadrivalent (lot number, expiration date, dose in series and route of administration not reported) and Menactra (lot number, expiration date, dose in series and route of administration not reported) in arm on an unknown date. The medical history and concomitant medications were not reported. On an unknown date, unspecified time following the vaccination patient had sore arms, inability to move and lift her arms, and reported pain. This was a case of wrong technique in product usage process. Lab data and corrective treatment was not reported. The outcome of the event sore arms, inability to move and lift her arms and pain was not reported. List of the documents held by sender: none.
Age: 31.0
Sex: F
Vaccine: FLU4, MMR
Symptoms: Injection site erythema, Injection site mass, Injection site pain, Injection site pruritus, Injection site warmth
Clinical narrative: Based on additional information received on 02-Dec-2016, this case became medically confirmed. Initial unsolicited report received from other non-health care professional on 07 Nov 2016. This case involves two female patients (age not reported) who was vaccinated with a dose of FLUZONE ID (Batch number: UT5572AA, expiry date: 30 Jun 2017, dose, and site of administration was not reported) via intradermal on an unspecified date in Nov 2016. The patient illness at time of vaccination and Pre-existing physician diagnosed allergies, birth defects, medical conditions and any other vaccinations within 4 weeks of vaccination was reported as not provided. The patient concomitant medications were not reported. It was reported as on an unspecified date in Nov 2016, following the vaccination, the patients reported an approximate 2 inch reddened area around the injection site which was tender, warm to touch and itchy. (Vaccination site inflammation and Vaccination site pruritus). The patients Laboratory investigations and corrective treatment were not reported. The outcome of the events were reported as recovered on an unknown date. Follow up information received from a physician on 02-Dec-2016: This case is linked to case number 2016SA227879 (same reporter). It was reported that a 32-year-old female patient was vaccinated with FLUZONE ID in the right arm on 03-Nov-2016 and MMR (batch number: M008588 expiry date 16-Feb-2018, dose details and route of administration not reported) in the left arm on 03-Nov-2016. On 04-Nov-2016, one day after the vaccination, it was reported that the patient discovered a lump on her right arm where she got a flu shot was very red. The patient received BENADRYL oral, cream as well as cold compress as corrective treatment. The outcome of the event vaccination site mass was unknown at the time of the report. List of documents held by sender: none.
Age: 20.0
Sex: F
Vaccine: FLU4
Symptoms: Musculoskeletal pain, Nuclear magnetic resonance imaging abnormal, Tendon disorder
Clinical narrative: Persistent shoulder pain following Fluzone immunization.  No improvement with Naproxen.  Improved with Prednisone although recurred once course completed.   Referred to physical therapy.
Sex: M
Vaccine: FLU3, MMR, PNC13, VARCEL
Symptoms: Cellulitis, Injection site erythema, Injection site swelling, Pyrexia
Clinical narrative: Pt arrived at ER 12/17/16 (9 days after vaccines given) between 4 and 5pm with redness and swelling of right distal thigh. Parents reported sx's present for approximately 24hours. No fever reported.  Pt diagnosed with cellulitis and given 7 day course of bactrim. Warm compresses multiple times daily to reduce swelling.
Age: 23.0
Sex: F
Vaccine: MENB
Symptoms: Polyarthritis, Red blood cell sedimentation rate increased
Clinical narrative: Inflammatory polyarthritis after TRUMENBA vaccine.
Age: 55.0
Sex: F
Vaccine: FLU4, PNC13
Symptoms: Local reaction, Pruritus
Clinical narrative: LARGE LOCAL REACTION 15 CM X 12 CM with itching.
Sex: U
Vaccine: HPV9
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a licensed practical nurse and refers to unspecified number of patients of unknown age and gender. The patients' pertinent medical history, drug reactions and allergies were not reported. On unspecified dates, the patients were vaccinated with improperly stored doses of GARDASIL 9 (route was not reported) lot # M009378 and expiry date: 23-APR-2018, 0.5 ml, for prophylaxis. The reporter stated that she was unaware of any adverse effects reported. The call was due to a data logger. No further information was available. There was no product quality complaint (PQC) involved. This is one of the several reports received from the same reporter. Follow-up information has been received on 07-DEC-2016. All telephone attempts to obtain follow-up information has been unsuccessful. Additional information has been requested. Sender's Comments: US-009507513-1610USA009508: US-009507513-1610USA009509: US-009507513-1610USA009510: US-009507513-1610USA009506: US-009507513-1610USA009505: US-009507513-1610USA009507: MERCK 1610USA008210:Mfr number.
Age: 61.0
Sex: U
Vaccine: VARZOS
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a pharmacist referring to a 61-year-old patient of unknown gender. The patient's concurrent conditions, medical history and concomitant therapies were not reported. On 05-NOV-2016, the patient was vaccinated with an improperly stored dose of ZOSTAVAX (lot number L034736, expiration date 09-DEC-2016; dosage and route of administration were not provided). No adverse effects were reported. The administered vaccine experienced a temperature excursion of 22F for 18 hours on an unspecified date. Data logger was not involved. The previous temperature excursion was 10F for 14 hours, 28F for 18 hours and 40F for 1 hour on an unspecified dates. A product quality complaint was not involved. This is one of several reports received from the same reporter. Additional information is not available.; Sender's Comments: US-009507513-1610USA002328:
Age: 24.0
Sex: F
Vaccine: HPV9
Symptoms: Injection site pain
Clinical narrative: Information has been received from a physician referring to a 24 years old female patient. The patient had no concomitant medication, pertinent medical history or drug allergies/reactions. On 31-OCT-2016, the patient was vaccinated with first dose of GARDASIL 9 (dose and frequency not provided; Lot# M017983, expire date 30-MAY-2018) intramuscularly (IM) as prophylaxis. After the vaccination, the patient had been experiencing persistent pain in arm where vaccinated through whole humerus region for about one month. The patient sought medical attention for the event via contacting doctor office. There was no treatment employed as yet, and no lab diagnostics study was performed. The physician stated the patient notified office on 30-NOV-2016 (reported as "yesterday") regarding the ongoing arm pain.  The physician did not believe there was any error since it was a senior nurse who gave the injection. At the time of this report, the patient had not recovered from the event. The relationship between the event and vaccine was not reported. Additional information has been requested.
Sex: U
Vaccine: HEPA
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a medical assistant referring to unknown number of unspecified patients of unknown age and gender.   The patients' medical history, concurrent conditions and concomitant medications were not provided. On some unspecified dates the patients might have received an unknown number of doses of VAQTA (lot # M032492, expiration date 02-MAR-2018, dose, route and site of administration unknown) for prophylaxis. The vaccines were administrated after a temperature excursion to 29.29 degrees Fahrenheit for 111 hours. No adverse effect was reported in any patients. This is one of two reports received from the same source. Additional information has been requested.; Sender's Comments:  US-009507513-1612USA009633:
Sex: U
Vaccine: HPV4
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report as received from the office manager, refers to a patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant therapies were not reported.  In approximately December 2014, reported as "2 years ago", the patient received a first dose of GARDASIL (dose, lot#, expiry date and route were not reported). On 19-DEC-2016, the patient received the second dose of GARDASIL (dose, lot#, expiry date and route were not reported). No adverse symptoms reported. Additional information has been requested.
Age: 40.0
Sex: F
Vaccine: HEP
Symptoms: Headache, Malaise, Nausea, Neck pain
Clinical narrative: Onset of malaise was shortly after administration. Headache and nausea set in with worsening malaise over the next 20 minutes. Neck pain (right arm administration).
Age: 39.0
Sex: F
Vaccine: FLU4, TDAP
Symptoms: Chills, Cystitis, Kidney infection, Pain, Vomiting
Clinical narrative: Day 1: chills, body aches continued Day 4: vomiting Day 7: Hospitalized, discovered had severe bladder infection/kidney infection. Physician and Employee Health believe event was coincidental, but patient had concerns previous to hospitalization that illness was related to vaccination.
Age: 66.0
Sex: F
Vaccine: FLU4
Symptoms: Diarrhoea, Nausea, Vomiting
Clinical narrative: Patient experienced nausea, vomiting, and diarrhea.
Age: 11.0
Sex: F
Vaccine: MEN, TDAP
Symptoms: Activities of daily living impaired, Epstein-Barr virus antibody positive, Fatigue, Headache, Mononucleosis heterophile test positive
Clinical narrative: Headaches, 101 fever, missing school,positive mono, high titers with Epstein Barr, fatigue.
Age: 11.0
Sex: F
Vaccine: MEN, TDAP
Symptoms: Pyrexia
Clinical narrative: Headaches, 101 fever, missing school,positive mono, high titers with Epstein Barr, fatigue.
Age: 68.0
Sex: M
Vaccine: FLU3
Symptoms: Grip strength decreased, Injection site pain, Injection site reaction, Muscular weakness, Musculoskeletal stiffness
Clinical narrative: Right shoulder pain and arm weakness. This patient received flu shot at pharmacy 2 weeks ago and he felt burning sensation radiating down his arm during the administration of the shot. He remembers the vaccine being given high up in the arm and was infused slowly. This resolved hours later but subsequently developed pain along the right shoulder with stiffness and problems with making a grip with his right hand. He denies any neck pain and there has been no other incident that could otherwise account for his symptoms. His main concern is that this may be a permanent injury.
Age: 68.0
Sex: M
Vaccine: FLU3
Symptoms: Nuclear magnetic resonance imaging
Clinical narrative: Right shoulder pain and arm weakness. This patient received flu shot at pharmacy 2 weeks ago and he felt burning sensation radiating down his arm during the administration of the shot. He remembers the vaccine being given high up in the arm and was infused slowly. This resolved hours later but subsequently developed pain along the right shoulder with stiffness and problems with making a grip with his right hand. He denies any neck pain and there has been no other incident that could otherwise account for his symptoms. His main concern is that this may be a permanent injury.
Age: 17.0
Sex: M
Vaccine: FLU4, MENB, MNQ
Symptoms: Balance disorder, Fatigue, Injection site mass, Vaccination site induration
Clinical narrative: (1) Hard lump vaccine site. (2) Balance problems and tiredness (however patient was on Fexofenadine at the same time). Resolved balance issue in follow up isn't in 2 days after stopping Fexofenadine.
Age: 11.0
Sex: F
Vaccine: HPV9
Symptoms: Blood glucose decreased, Hyperglycaemia, Hypoglycaemia, Immediate post-injection reaction, Malaise
Clinical narrative: Pt. with IDDM, with typically significant issues with hyperglycemia, immediately (approximately 2 hrs) after vaccination with "sick" feeling and now approximately 3 week H/O hypoglycemic episodes. After received 3rd HPV.
Age: 11.0
Sex: F
Vaccine: HPV9
Symptoms: Type 1 diabetes mellitus
Clinical narrative: Pt. with IDDM, with typically significant issues with hyperglycemia, immediately (approximately 2 hrs) after vaccination with "sick" feeling and now approximately 3 week H/O hypoglycemic episodes. After received 3rd HPV.
Age: 14.0
Sex: F
Vaccine: HPV9, HPV9, MNQ, TDAP
Symptoms: Injection site erythema, Injection site induration, Injection site warmth, Pruritus generalised, Urticaria
Clinical narrative: Patient presented 12/19/16 after receiving vaccine Friday before with generalized hives and a 5 x 5 cm red, hot indurated circular area around the injection site. Patient complained of generalized itching. Pt W HX of allergy to carme and did have a muffin 2 days prior to but no meds after that.
Age: 14.0
Sex: F
Vaccine: HPV9, HPV9, MNQ, TDAP
Symptoms: Muscle twitching
Clinical narrative: Patient presented 12/19/16 after receiving vaccine Friday before with generalized hives and a 5 x 5 cm red, hot indurated circular area around the injection site. Patient complained of generalized itching. Pt W HX of allergy to carme and did have a muffin 2 days prior to but no meds after that.
Age: 11.0
Sex: M
Vaccine: HPV9, HPV9, MNQ, TDAP
Symptoms: Injection site erythema, Injection site induration, Injection site warmth, Pruritus generalised, Urticaria
Clinical narrative: Mom states pt was twitching and took to the ER, which kept pt for a few hours for observation and then discharged same day in afternoon.
Age: 11.0
Sex: M
Vaccine: HPV9, HPV9, MNQ, TDAP
Symptoms: Muscle twitching
Clinical narrative: Mom states pt was twitching and took to the ER, which kept pt for a few hours for observation and then discharged same day in afternoon.
Age: 53.0
Sex: F
Vaccine: PNC13
Symptoms: Headache, Impaired driving ability, Nausea, Nervousness, Vision blurred
Clinical narrative: Received vaccine 12/17 mid morning. Awakened 12/18 with blurred vision, difficulty focusing, nausea, headaches with MOTRIN and worsening vision. Unable to drive, shaky.
Age: 19.0
Sex: F
Vaccine: TDAP
Symptoms: Fatigue, Muscle tightness, Myalgia, Pain in extremity, Peripheral swelling
Clinical narrative: 12/13/16 20 min. after leaving clinic pt states felt tight/sore muscles upper arm. Woke up next morning-entire (R) arm including hand felt sore and was swollen. Reports also feeling fatigue. Tried heat application and oral ibuprofen - 2 liquid gels every 6 hours with improvement. Warm shower helped. Worsened through day. Some relief with ice and ICY HOT applied liberally 12/15-12/16 every few hrs. 12/19 reports lingering soreness but much improved.
Age: 49.0
Sex: M
Vaccine: FLU4
Symptoms: Arthralgia, Headache, Hypoaesthesia, Muscle mass, Myalgia
Clinical narrative: LUE and LLE intermittent numbness, difficulty focusing L eye, numbness L half of face, lumps in muscles, pain/tingling R forehead, diffuse muscle pain and joint pain.
Age: 49.0
Sex: M
Vaccine: FLU4
Symptoms: Paraesthesia, Vision blurred
Clinical narrative: LUE and LLE intermittent numbness, difficulty focusing L eye, numbness L half of face, lumps in muscles, pain/tingling R forehead, diffuse muscle pain and joint pain.
Age: 50.0
Sex: F
Vaccine: MNQ, TYP, YF
Symptoms: Pruritus, Rash macular
Clinical narrative: Pt. developed non-raised red blotched with itching on lower arms, upper thighs and lower back 25 minutes, after receiving Yellow Fever vaccine. No other symptoms of allergic reaction or change in vital signs. Symptoms resolved 30 minutes after receiving oral BENADRYL.
Age: 63.0
Sex: F
Vaccine: MNQ
Symptoms: Peripheral swelling, Rash
Clinical narrative: Rash and swolleness of arms.
Sex: M
Vaccine: FLUC4
Symptoms: Immediate post-injection reaction, Seizure like phenomena
Clinical narrative: Immediately after receiving the vaccine the pt displayed seizure like activity for 3-5 seconds. We had the pt elevate his feet and monitored him for about 30 min, checking vitals frequently. We gave the pt a glucose tablet (no history of diabetes or hypoglycemia) and water.
Age: 40.0
Sex: F
Vaccine: HEP
Symptoms: Cough, Fatigue, Injected limb mobility decreased, Muscle spasms, Sensation of foreign body
Clinical narrative: Tired day receiving vaccine; 11/23/16 "lump in throat"; right sided cramping from jawline to fingertips, difficulty moving right arm, coughing and wheezing. Patient stated symptoms lasted until Monday. 11/28/16. No current symptoms. Patient states previous reaction with Hepatitis B vaccine 11/2013 of wheezing and coughing, but did not inform anyone.
Age: 40.0
Sex: F
Vaccine: HEP
Symptoms: Wheezing
Clinical narrative: Tired day receiving vaccine; 11/23/16 "lump in throat"; right sided cramping from jawline to fingertips, difficulty moving right arm, coughing and wheezing. Patient stated symptoms lasted until Monday. 11/28/16. No current symptoms. Patient states previous reaction with Hepatitis B vaccine 11/2013 of wheezing and coughing, but did not inform anyone.