chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: PPV
Symptoms: Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Information has been received from a physician via a company representative referring to two female patients in their seventies. The patients' medical history, concurrent condition and concomitant therapy were unknown. On unknown dates, the patients received PNEUMOVAX 23 injection (lot#, expiration date, dose and route were unknown). On unknown dates, both patients experienced injection site swelling as well as pain and erythema. The patients did not seek any medical attention. No treatment was given for the events. The events lasted for 4 days and the outcome was reported as fine. The causality assessment between the events and PNEUMOVAX 23 was not reported. Additional information has been requested.
Age: 19.0
Sex: F
Vaccine: HPV4
Symptoms: Gastrooesophageal reflux disease, Hair growth abnormal, Hypomenorrhoea, Menstrual disorder, Menstruation irregular
Clinical narrative: Information has been received from a 19 years old female patient referring to herself, who had drug allergies to sulfur, ibuprofen and BACTRIM. The patient had no pertinent medical history. Concomitant therapies included VIORELE, and DEXILANT. On an unknown date, the patient started therapy with 3 dose series GARDASIL 9 injection (dose, frequency and route were unknown). On an unknown date in June 2012, the patient was administered her final dose of GARDASIL 9. In late September 2012, the patient was diagnosed with Poly Cystic Ovary Syndrome (PCOS) by a most recently retired physician. The patient began experiencing hair growth above the upper lip area, and she also began having changes in her menstrual cycle (periods became very light and also less frequent). The patient sought for medical attention and reported to a physician who was treating her for PCOS. On an unknown date in the 2013, the patient began having an acid reflux issue. The outcome of the events PCOS and acid reflux issue was unknown. The causality assessment between the events and GARDASIL 9 was not reported. Additional information has been requested.
Age: 19.0
Sex: F
Vaccine: HPV4
Symptoms: Polycystic ovaries
Clinical narrative: Information has been received from a 19 years old female patient referring to herself, who had drug allergies to sulfur, ibuprofen and BACTRIM. The patient had no pertinent medical history. Concomitant therapies included VIORELE, and DEXILANT. On an unknown date, the patient started therapy with 3 dose series GARDASIL 9 injection (dose, frequency and route were unknown). On an unknown date in June 2012, the patient was administered her final dose of GARDASIL 9. In late September 2012, the patient was diagnosed with Poly Cystic Ovary Syndrome (PCOS) by a most recently retired physician. The patient began experiencing hair growth above the upper lip area, and she also began having changes in her menstrual cycle (periods became very light and also less frequent). The patient sought for medical attention and reported to a physician who was treating her for PCOS. On an unknown date in the 2013, the patient began having an acid reflux issue. The outcome of the events PCOS and acid reflux issue was unknown. The causality assessment between the events and GARDASIL 9 was not reported. 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 physician via an other company and refers to a patient of unknown age and gender. Relevant medical history, drug history and concomitant medication information was unknown. On an unknown date, the patient was given with GARDASIL 9 lot # reported as 36301, expiration date December 2017 (strength, dose, dose number and route of administration were not provided) that underwent a temperature excursion and had been exposed to a temperature of 32.1 Fahrenheit degrees for 7 hours on an unknown date. The patient did not experience any adverse events. It was unknown if any relevant tests were done. This is one of 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 consumer, via company representative, refers to an unspecified patients of unknown age and gender. She reported that her husband (unspecified physician) mentioned that unspecified vaccines that may have been improperly stored on unspecified dates and may have been administered to unspecified patients on unspecified dates. No adverse effects were reported. Additional information is not expected, due to lack of contact details. It has been determined that the case 1608USA005743 belongs to a batch of reports that are not being processed by the DMC. Therefore, case # 1608USA005743 is being deleted from our files on generic Hepatitis B Vaccine (Recombinant). All information from this case was was consolidated in case 1610USA004920.
Age: 88.0
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: Information has been received from a pharmacist referring to a 88 years old female patient. The patient's medical history, concurrent condition and concomitant therapy were not reported. On unknown dates in 2014 (reported as "two years ago"), the patient was vaccinated with 2 doses of ZOSTAVAX 19400 PFU (dose, lot # and expiration date not reported) subcutaneously on two separate occasions. On unknown dates in 2014, following the administration of ZOSTAVAX, the patient developed shingles on two separate occasions. The outcome of the event was unknown. The causality between ZOSTAVAX and the event was not provided. Additional information is not expected as there was no consent to contact the reporter.
Sex: U
Vaccine: VARZOS
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a pharmacist referring to multiple patients of unknown age and gender. The patients' pertinent medical history, drug reactions/allergies and concomitant medications were not reported. On unknown dates, the patients were vaccinated with improperly stored ZOSTAVAX (lot # L046897, expiration date 23-FEB-2016; dose and route were unknown). No adverse effects were reported. The temperature excursion included 30 minutes at -11.6 Celsius degree, 2 hours and 30 minutes at -8.7 Celsius degree, 1 hour and 30 minutes at -9.2 Celsius degree, 1 hour and 15 minutes at -9.8 Celsius degree. Data logger was involved. There was no previous temperature excursion. This is one of several reports received from the same reporter. Additional information has been requested.
Age: 65.0
Sex: M
Vaccine: VARZOS
Symptoms: Unevaluable event
Clinical narrative: Information has been received from a 65 year old male patient referring to himself. The patient had a weakened immune system. The patient's medical history included heart transplant. The patient did not have any drug reactions/allergies. On 01-OCT-2016, the patient had a headache. Concomitant therapies included TYLENOL, tacrolimus and mycophenolate sodium. On 03-OCT-2016, the patient was vaccinated with ZOSTAVAX (one time vaccination, dose and route unknown) (product use in unapproved population). At time of the vaccination, the headache was persisted. No treatments or labs were performed. Additional information has been requested.
Age: 61.0
Sex: F
Vaccine: FLU3, PPV, VARZOS
Symptoms: Injection site induration, Injection site pain, Injection site rash, Injection site warmth, Pyrexia
Clinical narrative: Information has been received from a pharmacist referring to a 61 years old female patient who was not pregnant. The patient had no pertinent medical history nor drug reactions/allergies. Concomitant therapies included fish oil, daily multi-vitamins and OS-CAL. On 20-SEP-2016, the patient started a prescription for amoxicillin and PROAIR for respiratory congestion. The patient was not running fever at the time she was prescribed the amoxicillin and PROAIR. On 20-SEP-2016, the patient was vaccinated with ZOSTAVAX (0.65 ml, lot # reported as M030140, expiration date 18-AUG-2017) subcutaneously in the right arm. On the same day, the patient also received PNEUMOVAX 23 (dose, lot #, expiration date and route not reported) at physician's practice. When the patient was vaccinated with ZOSTAVAX, the patient also vaccinated with AFLURIA during the same vaccination session. In the evening of 20-SEP-2016, the patient experienced ZOSTAVAX injection site pain. In the evening of 21-SEP-2016, the patient noticed that her ZOSTAVAX injection site was silver-dollar sized. On 22-SEP-2016, the ZOSTAVAX injection site was 4 inches in diameter, warm, indurated, but not itching. The patient was experiencing a fever of 101 degree Fahrenheit. The pharmacist stated that the injection site area appeared to be developing white bumps inside the pink area and the pharmacist referred to these bumps as a rash. On the same day, the patient called her physician who referred her to the pharmacy for treatment guidance. No treatment was given for the events. No laboratory test was performed. The outcome of the events was reported as not resolved. The causality between suspect therapies and the events was not provided. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a registered nurse referring to multiple unspecified patients (age and gender unknown). The patients' concurrent conditions, medical history and concomitant therapies were not reported. On unknown dates, the patients were administered improperly stored doses of VARIVAX (lot # L049536 with expiration date of 12-AUG-2017, lot # M009764 with expiration date of 23-FEB-2018, lot # L044524 with expiration date of 09-NOV-2017, lot # M025867 with expiration date of 24-MAY-2018, lot # M017291 with expiration date of 07-APR-2018, dose and route unknown). The vaccines were exposed to 10.9 Fahrenheit (F) for 24 hours, 14.7 F for 24 hours, 6.1 F for 72 hours, 6.0 F for 120 hours, 8.1 F for 48 hours, 6.1 F for 24 hours, 10.9 F for 192 hours, 10.2 F for 48 hours, 11.8 F for 192 hours, and 9.1 F for 48 hours. 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 registered nurse referring to multiple unspecified patients (age and gender unknown). The patients' concurrent conditions, medical history and concomitant therapies were not reported. On unknown dates, the patients were administered improperly stored doses of GARDASIL 9 (lot # M009378 with expiration date of 23-APR-2018, lot # M013636 with expiration date of 15-FEB-2018, dose and route unknown). The vaccines were exposed to 55 Fahrenheit (F) for 24 hours, 49 F for 24 hours, and 49.6 F for 24 hours. No adverse effects were reported. 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: Information has been received from a registered nurse referring to multiple patients (age and gender unknown). The patients' concurrent conditions, medical history and concomitant therapies were not reported. On unknown dates, the patients were administered improperly stored doses of ROTATEQ (lot # M019691 with expiration date of 02-NOV-2017, lot # M031802 with expiration date of 09-NOV-2017, dose unknown) orally. The vaccines were exposed to 55 Fahrenheit (F) for 24 hours, 49 F for 24 hours, and 49.6 F for 24 hours. No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Rash pruritic
Clinical narrative: Information has been received from a pharmacist referring to herself, a female patient of unknown age. The patient's medical history, concurrent condition and concomitant medication were unknown. On an unknown date, the patient was vaccinated with a dose of ZOSTAVAX (strength, dose and route unknown). On an unknown date, the patient developed a rash on her (unspecified if left or right) arm. The rash became itchy. The outcome of the events was unknown. The causal relationship between the events and ZOSTAVAX was unknown. Additional information has been requested.
Age: 56.0
Sex: M
Vaccine: FLU3, PPV
Symptoms: Axillary pain, Injection site erythema, Injection site nodule, Injection site swelling, Injection site warmth
Clinical narrative: This spontaneous report as received from a pharmacist refers to a 56 year old male patient with diabetes. The patient had no allergies. On 04-OCT-2016, the patient was vaccinated with a dose of PNEUMOVAX 23, lot # reported as M033086, expiration date reported as 05-MAY-2018, intramuscular (dose was not reported). Concomitant therapies included glimepiride, LOTREL, metformin and NASONEX. On 04-OCT-2016, the injection site had redness and a large baseball size knot. There was redness and swelling around the arm and down to the elbow with pain in the armpit. On 06-OCT-2016, the injection site was red, warm and raised less than baseball size knot. The patient did not seek medical attention. No laboratory diagnostics studies were performed and no treatment was given. The outcome of events was reports as recovering/resolving. The relatedness between the events and PNEUMOVAX 23 was not reported. Additional information has been requested.
Sex: U
Vaccine: HIBV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a medical assistant referring to multiple unspecified patients of unknown age and gender. The patients' concomitant medication, medical history and drug/allergies were not reported. On unknown dates, the patients were vaccinated with improperly stored doses of PEDVAXHIB (lot # M014937 with expiration date 18-FEB-2019; dose and route were not reported). It was reported that the vaccine was improperly stored at 31.8 Fahrenheit for 4 hours. There was no prior temperature excursion. It was unknown if 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: HPV9
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a medical assistant referring to multiple unspecified patients of unknown age and gender. The patients' concomitant medication, medical history and drug reaction/allergies were not reported. On unknown dates, the patients were vaccinated with improperly stored doses of GARDASIL 9 (lot # L038503 with expiration date 18-DEC-2017; dose and route were not reported). It was reported that the vaccine was improperly stored at 31.8 Fahrenheit for 4 hours. There was no prior temperature excursion. It was unknown if 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: MMR
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report as received from a medical assistant refers to a 2 year old patient. On an unknown dates, the patient was vaccinated with M-M-R II (dose, route of administration, lot # and expiration date were not reported) at 1 and 2 years old which was not included in the prescribing information. No adverse effects were reported. Additional information is not expected as there is no consent to contact the reporter.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a medical assistant referring to an unspecified number of patients (age and gender unknown). The patients' concurrent conditions, medical history and concomitant therapies were not reported. The patients received unspecified doses in VARIVAX (lot # M000756, expiration date 06-JAN-2018, dose and route unknown) immunization series that were improperly were improperly stored. The vaccines were exposed at minus 10 degrees Celsius for 24 hours. The excursion occurred on 08-JUN-2016 and the vaccinations occurred from that point through 07-OCT-2016. No adverse effects were reported. This is one of two 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 medical assistant referring to an unspecified number of patients (age and gender unknown). The patient's concurrent conditions, medical history and concomitant therapies were not reported. The patients received unspecified doses in PROQUAD (lot # M029595 with expiration date of 10-DEC-2017, and lot # M004892 with expiration date of 25-JUL-2017, dose and route unknown) immunization series that were improperly stored. The vaccines were exposed at minus 10 degrees Celsius for 24 hours. The excursion occurred on 08-JUN-2016 and the vaccinations occurred from that point through 07-OCT-2016. No adverse effects were reported. This is one of two reports received from the same reporter. 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 concerning multiple unspecified patients of unknown age and gender. The patients' concurrent conditions, medical histories and concomitant therapies were not reported. On unknown dates, the patients were vaccinated improperly stored RECOMBIVAX HB (lot # L038018 with expiration date 13-SEP-2017; dose and route were unknown). The vaccines were exposed to temperature excursion of minimum (Min) -0.5 degrees centigrade for 3 hours 39 minutes and maximum (Max) 15.9 degrees centigrade for 16 minutes on 28-SEP-2016; Min 0.8 degrees centigrade for 5 hours 19 minutes on 29-SEP-2016; Min 0.7 degrees centigrade for 5 hours 37 minutes on 30-SEP-2016 and Min 1 degrees centigrade for 2 hours 26 minutes on 01-OCT-2016. There were no previous temperature excursions. Data logger was involved. No adverse effects were reported. No product quality complaint (PQC) was involved. 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: Information has been received from a registered nurse concerning multiple unspecified patients of unknown age and gender. The patients' concurrent conditions, medical histories and concomitant therapies were not reported. On unknown dates, the patients were vaccinated improperly stored ROTATEQ (lot # M025568 with expiration date 07-NOV-2017; dose and route were unknown). The vaccines were exposed to temperature excursion of minimum (Min) -0.5 degrees centigrade for 3 hours 39 minutes and maximum (Max) 15.9 degrees centigrade for 16 minutes on 28-SEP-2016; Min 0.8 degrees centigrade for 5 hours 19 minutes on 29-SEP-2016; Min 0.7 degrees centigrade for 5 hours 37 minutes on 30-SEP-2016 and Min 1 degrees centigrade for 2 hours 26 minutes on 01-OCT-2016. There were no previous temperature excursions. Data logger was involved. No adverse effects were reported. No product quality complaint (PQC) was involved. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a registered nurse referring to unspecified patients of unknown age and gender. The patients' pertinent medical history, drug reactions/allergies and concomitant medication were not provided. On unknown dates, the patients were vaccinated with doses of improperly stored ZOSTAVAX (lot # L035506, expiration date 16-DEC-2016, lot # L044529, expiration date 09-FEB-2017; dose and route were unknown). No adverse effects had been reported. The temperature excursion included 6.3 Fahrenheit degree for 2 hours and 48 minutes, 9.2 Fahrenheit degree for 13 hours and 57 minutes, 20 Fahrenheit degree for 8 hours and 24 minutes, 18 Fahrenheit degree for 1 hour and 28 minutes, 5.2 Fahrenheit degree for 6 minutes, 19.8 Fahrenheit degree for 11 hours and 13 minutes, 9 Fahrenheit degree for 7 hours and 37 minutes, 15.8 Fahrenheit degree for 1 hour and 19 minutes, 23.8 Fahrenheit degree for 4 hours and 52 minutes, 13.7 Fahrenheit degree for 9 hours and 18 minutes, 8.5 Fahrenheit degree for 20 hours and 27 minutes, 7.7 Fahrenheit degree for 24 hours. Data logger was involved. This is one of two reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HIBV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a registered nurse concerning multiple unspecified patients of unknown age and gender. The patients' concomitant conditions, medical histories and concomitant therapies were not reported. On unknown dates, the patient were vaccinated improperly stored PEDVAXHIB (lot # M020101 with expiration date 07-MAR-2019; dose and route were unknown). The vaccines were exposed to temperature excursion of minimum (Min) -0.5 degrees centigrade for 3 hours 39 minutes and maximum (Max) 15.9 degrees centigrade for 16 minutes on 28-SEP-2016; Min 0.8 degrees centigrade for 5 hours 19 minutes on 29-SEP-2016; Min 0.7 degrees centigrade for 5 hours 37 minutes on 30-SEP-2016 and Min 1 degrees centigrade for 2 hours 26 minutes on 01-OCT-2016. There were no previous temperature excursions. Data logger was involved. No adverse effects were reported. No product complaint (PQC) was involved. This is one of several reports received from the same reporter.
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: This solicited report was received from a patient's daughter regarding her 78 year old mother as part of a Market Research Program. The patient's concurrent conditions, historical conditions and concomitant medications were not reported. Approximately on an unknown date in 2016 (reported as in the spring of this year), the patient received ZOSTAVAX subcutaneous injection (dosage details and indication were not reported). It was reported: "I don't want to know the name and three weeks later (approximately in 2016) she got the shingles, explain that to me." The outcome of the event shingles and the causality with the suspect product was unknown. Additional information is not expected as the reporter did not give consent for further follow up.
Age: 2.0
Sex: M
Vaccine: VARCEL
Symptoms: Gingival swelling, Herpes zoster, Malaise, Pyrexia, Rash pustular
Clinical narrative: Information has been received from a consumer referring to her 2 years old grandson. The patient's medical history, concomitant therapy and concurrent condition were not provided. On an unknown date in June 1996, the patient was vaccinated with an unspecified chicken pox vaccine (dose 1, dose, route, lot number and expiration date were unknown) (the patient was approximately 2 years when vaccination). On an unknown date in September 1996, after receipt of the initial unspecified chicken pox vaccine, the patient became very sick. The patient developed the following symptoms: fevers over 40 centigrade (reported as 104 degrees), swollen gums and broke out in pox all over the patient's body. The patient also developed a full blown case of shingles, which presented 3 months following the vaccination. The patient sought unspecified medical attention via office visit. No treatment was given for the adverse events. The outcome of the events was reported as recovered (date unspecified). The causal relationship between the unspecified chicken pox vaccine and the events was unknown. This is one of the two reports that received from the same source. Additional information is not expected as there is not consent to contact the physician.
Sex: U
Vaccine: HEPA
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a nurse refers to a patient of unknown age and gender. Patient's medical history, concurrent conditions and drug reactions/allergies were not reported. On 27-SEP-2016, the patient was vaccinated with an improperly stored dose of VAQTA lot # M009377, expiration date: 17-JUN-2017, (Strength was not reported), 0.5 ml, intramuscular. The administered dose of VAQTA underwent temperature excursion at 32 Fahrenheit degrees, for 13 hours and 30 minutes. No previous temperature excursions were reported. The temperature excursion was not detected by a data logger. Patient's concomitant medication was not reported. No adverse effects were reported. A product quality complaint (PQC) was not involved. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report received from a licensed practical nurse referring to a patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant therapies were not reported. On 28-SEP-2016 the patient was vaccinated with an improperly stored dose of (Oka/Merck) VARIVAX lot number M009765; expiration date 23-FEB-2018, 0.5 ml, subcutaneously, once. No adverse effects were reported. The administered vaccine experienced excursion of 33.2 degree F on 26-SEP-2016 for 9 hours 50 minutes and 30.2 degree F on 27-SEP-2016 for 7 hours 38 minutes. There were no prior excursions. Data logger was involved. There was no product quality complaint involved. Additional information has been requested.
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a medical assistant and refers to unspecified patients of unknown age and gender. The patients' concurrent conditions, medical history, and allergies were not reported. On unknown dates, the patients were vaccinated with unspecified improperly stored doses of ROTATEQ oral liquid (lot number M019706 with expiration date of 24-OCT-2017) (strength and dosage schedule were not reported). Other suspect and concomitant therapies were not reported. The administered doses experienced a temperature excursion of 46.8 degree Fahrenheit for 9 hours. No adverse events were reported and no product quality complaint was involved. Additional information has been requested.
Age: 28.0
Sex: F
Vaccine: PPV
Symptoms: Rash
Clinical narrative: Rash. Pneumococcal vaccine.
Sex: U
Vaccine: HEP
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 age and gender. The patient's medical history, concurrent condition and concomitant medication were not reported. On 22-SEP-2016, the patient was vaccinated with one improperly stored dose of RECOMBIVAX HB (lot # M010671, expiration date 02-JUN-2018, dose and route were not reported). No adverse effects were reported. This is one of the several reports received from the same reporter. Additional information is not expected as there is no contact consent to follow up.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a registered nurse referring to unspecified patients of unknown age and gender. The patients' pertinent medical history, drug reactions/allergies and concomitant medication were not provided. On unknown dates, the patients were vaccinated with doses of improperly stored VARIVAX (lot # M006731, expiration date 09-FEB-2018, lot # M024675, expiration date 18-MAY-2018; dose and route were unknown). No adverse effects had been reported. The temperature excursion included 6.3 Fahrenheit degree for 2 hours and 48 minutes, 9.2 Fahrenheit degree for 13 hours and 57 minutes, 20 Fahrenheit degree for 8 hours and 24 minutes, 18 Fahrenheit degree for 1 hour and 28 minutes, 5.2 Fahrenheit degree for 6 minutes, 19.8 Fahrenheit degree for 11 hours and 13 minutes, 9 Fahrenheit degree for 7 hours and 37 minutes, 15.8 Fahrenheit degree for 1 hour and 19 minutes, 23.8 Fahrenheit degree for 4 hours and 52 minutes, 13.7 Fahrenheit degree for 9 hours and 18 minutes, 8.5 Fahrenheit degree for 20 hours and 27 minutes, 7.7 Fahrenheit degree for 24 hours. Data logger was involved. This is one of two reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: PPV
Symptoms: Injection site pain
Clinical narrative: Information has been received from a pharmacist referring to four to five patients (age and gender unknown). The patient's concurrent conditions, medical history and concomitant therapies were not reported. On unknown dates, the patients were vaccinated with PNEUMOVAX 23 (strength, dose, frequency and route unknown). On unknown dates, the patients experienced injection site reactions with pain and soreness. The patients sought unspecified medical attention for the event. The outcome of the event and causality assessment were unknown. Additional information has been requested.
Sex: U
Vaccine: HPV9
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a registered nurse concerning multiple unspecified patients of unknown age and gender. The patients' concurrent conditions, medical histories and concomitant therapies were not reported. On unknown dates, the patients were vaccinated improperly stored GARDASIL 9 (lot # L026602 with expiration date 19-OCT-2017; dose and route were unknown). The vaccines were exposed to temperature excursion of minimum (Min) -0.5 degrees centigrade for 3 hours and 39 minutes and maximum (Max) 15.9 degrees centigrade for 16 minutes on 28-SEP-2016; Min 0.8 degrees centigrade for 5 hours 19 minutes on 29-SEP-2016; Min 0.7 degrees centigrade for 5 hours 37 minutes on 30-SEP-2016 and Min 1 degrees centigrade for 2 hours 26 minutes on 01-OCT-2016. There were no previous temperature excursions. Data logger was involved. No adverse effects were reported. No product quality complaint (PQC) was involved. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HPV9
Symptoms: Premature menopause
Clinical narrative: Information has been received from a physician via a company referring to unspecified patients of unknown age and gender. It was informed that multiple unspecified people reported to the physician about reading "somewhere" (unspecified) about premature ovarian failure occurring with GARDASIL 9 (lot #, expiration date, dose and route were not reported). It was unknown if there were patients involved. The outcome of the event and the causality were not reported. Additional information has been requested.
Age: 21.0
Sex: F
Vaccine: RAB
Symptoms: Injection site rash, Rash maculo-papular
Clinical narrative: 9/16/16-1st rabies vaccine -> did ok. 9/23/16-pt given 2nd rabies vaccine -> rash around site-maculopapular. Cleared in a few days. 10/7/16-pt given 3rd rabies vaccine-localized RUE maculopapular rash. (-) angioedema.
Age: 62.0
Sex: F
Vaccine: TDAP
Symptoms: Mobility decreased, Pain in extremity
Clinical narrative: Pain and decreased ROM of (L) arm.
Age: 31.0
Sex: F
Vaccine: TDAP
Symptoms: Injection site erythema, Injection site pain
Clinical narrative: Patient reported redness and pain at injection site to pharmacy on 10/12/16.
Age: 59.0
Sex: M
Vaccine: VARZOS
Symptoms: Local swelling, Rash, Swelling face
Clinical narrative: Rash and swelling of face and neck. No TX reported - planned to contact MD.
Age: 71.0
Sex: F
Vaccine: PNC13
Symptoms: Diarrhoea, Dyspnoea, Pyrexia
Clinical narrative: Fever, diarrhea, difficulty breathing. Being checked for pulmonary embolism after ER trip.
Age: 48.0
Sex: F
Vaccine: UNK
Symptoms: Bursitis, Contusion, Incorrect route of drug administration
Clinical narrative: Vaccine administered into bursa per patient resulted in Dr visit and bursitis. Pt had visible bruise (10/12/16) still on arm vaccine administered too high.
Age: 0.33
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV5
Symptoms: Diarrhoea, Haematochezia, Occult blood positive
Clinical narrative: Bloody stools/diarrhea 24 hours after receiving ROTATEQ. 2nd dose given with no ill effects after first dose. No treatment advised.
Age: 27.0
Sex: F
Vaccine: FLUX, VARCEL
Symptoms: Dyspnoea, Rash
Clinical narrative: Vaccine administered sub-q and a few minutes later patient reported difficulty breathing. 911 was called and 1 dose of I.M. Diphenhydramine 50 mg administered. Pt was breathing and talking entire time until E.M.S. arrived. Rash was present on arm DF injection.
Age: 69.0
Sex: M
Vaccine: PNC13
Symptoms: Dizziness, Nausea, Vomiting
Clinical narrative: Patient stated having dizziness and nausea with one episode of vomiting. This occurred about 5 hours after the vaccine.
Age: 27.0
Sex: F
Vaccine: TYP
Symptoms: Abdominal pain, Headache, Myalgia, Pyrexia
Clinical narrative: ABD pain, headache, muscle aches, fever 101.9.
Age: 11.0
Sex: F
Vaccine: MNQ, MNQ
Symptoms: Injection site urticaria
Clinical narrative: Patient developed hives (<24 hours after injection) around injection site.
Age: 0.33
Sex: F
Vaccine: DTAPIPVHIB, PNC13
Symptoms: Injection site erythema, Injection site rash
Clinical narrative: Rash, left hip erythema, redness, Day 2, hard.
Age: 0.33
Sex: F
Vaccine: DTAPIPVHIB, PNC13
Symptoms: Injection site erythema, Injection site rash
Clinical narrative: Rash. (L) thigh erythema and redness. Eating, drinking ok.
Age: 0.08
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV5
Symptoms: Crying, Erythema, Peripheral swelling, Pyrexia
Clinical narrative: High fever, uncontrollable crying, red swollen legs.
Age: 0.33
Sex: M
Vaccine: DTAP, HIBV, IPV, PNC13
Symptoms: Injection site rash, Pyrexia, Rash macular
Clinical narrative: 10/10/16 Pt received vaccines-that night pt developed fever of 102. Mom took pt to ER. 10/11/16 mom noted 4 bumps on one leg and by end of the day rash on both legs at site of vaccines and noted red blotched on torso.
Age: 5.0
Sex: F
Vaccine: DTAPIPV, HEPA
Symptoms: Injection site erythema, Injection site induration, Injection site pain, Injection site pruritus
Clinical narrative: Left deltoid red/firm/itchy and sore for a few days.
Age: 43.0
Sex: F
Vaccine: TDAP, TDAP
Symptoms: Mobility decreased, Muscular weakness, Pain in extremity
Clinical narrative: Extreme soreness in upper arm. By 9/28/16 could not lift arm. Loss of muscle control-strength. Pain and no use of arm too 10/6/16. Still sore, hard to raise arm and hurts.
Age: 43.0
Sex: F
Vaccine: TDAP, TDAP
Symptoms: Impaired driving ability, Injected limb mobility decreased, Injection site pain, Joint range of motion decreased
Clinical narrative: Extreme soreness in upper arm. By 9/28/16 could not lift arm. Loss of muscle control-strength. Pain and no use of arm too 10/6/16. Still sore, hard to raise arm and hurts.
Sex: F
Vaccine: FLU4, TDAP
Symptoms: Erythema, Erythema nodosum, Pain in extremity, Skin warm, Ultrasound scan normal
Clinical narrative: In 24 hrs. after vaccination, she felt pain in the left leg by the ankle area. Then the next day 48 hrs. of vaccination had both hot to touch. Legs red and legs pain. He did a sonogram came back negative. Rheumatologist consult today and was diagnosed erythema nodosum post vacc TDAP.
Age: 64.0
Sex: F
Vaccine: FLU4
Symptoms: C-reactive protein, Full blood count, Injection site cellulitis, Injection site vesicles
Clinical narrative: Large fluid filled blister over injection site with numerous small blisters that encompass large area around large blister. Cellulitis that extends from lower deltoid to elbow and inner arm.
Age: 0.17
Sex: M
Vaccine: DTAPIPVHIB, PNC13
Symptoms: Injection site rash
Clinical narrative: Patient broke out in a rash to bilateral upper thighs on 8-10-16. Pt brought in by parents on 8-11-16 and noted rash to bilateral upper thighs where vaccines were administered.
Age: 70.0
Sex: F
Vaccine: PNC13, PNC13
Symptoms: Injection site erythema, Injection site induration, Injection site pruritus, Injection site swelling, Injection site warmth
Clinical narrative: This is a spontaneous report obtained from a contactable consumer and from a contactable other healthcare professional on behalf of a physician. A 70-year-old female patient of an unspecified ethnicity received on 19Apr2016 at 1:30 pm the first single dose of PREVNAR 13, (lot M56416) intramuscular in the right deltoid for immunization. The patient had a medical history of allergy (rash) to VOLTAREN with onset in 2005, concomitant medications were unknown. On 23Apr2016 the patient experienced a reaction at the injection site which included: arm swollen, hot, hard, and huge red 5 x 7 area. Cool compresses were applied. No emergency room or physician visit were needed. Clinical outcome of the events was unknown at time of this report. The reporting other healthcare professional assessed the reported events as related to pneumococcal 13-val conj vac (dipht crm197 protein).   Follow-up (25Jul2016): New information report from a contactable other healthcare professional on behalf of a physician includes: patient age, medical history, suspect vaccine details (dose number, date, time, anatomical location and route of administration), events onset date, treatment given, reporter causality assessment. Follow-up attempts are completed. No further information is expected. Follow up (11Oct2016): This is a follow up spontaneous report based on the information received by Pfizer from Novartis Pharmaceuticals Corporation (Novartis Reference # PHEH2016US019378_NS). A contactable physician and other HCP both reported for the patient who experienced red and itchy spot after the vaccination with pneumococcal 13-val conj vac (dipht crm197 protein) and not after she received diclofenac sodium.
Age: 16.0
Sex: F
Vaccine: HPV9, MENB, MNQ, HPV9, MENB, MNQ, HPV4, MENB, MNQ, HPV9, MENB, MNQ, HPV9, MENB, MNQ
Symptoms: Blood test, Chest pain, Dyskinesia, Dyspnoea, Electroencephalogram
Clinical narrative: This spontaneous report was received from a registered nurse via Pfizer and refers to a 16-year-old female patient. Information on the patient's concurrent conditions or medical history was not reported. On 22-JUL-2016, the patient was vaccinated intramuscularly in the left deltoid with a second dose of GARDASIL 9 (lot # M005714, expiration date and dose were not provided). Other suspect therapies included a first dose of TRUMENBA (lot# M74089, expiration date: 30-JUN-2017, 0.5 ml intramuscularly in the left deltoid, administered at 11:42) and a second dose of MENACTRA (lot# U5259AA, intramuscularly in the right deltoid, dose and expiration date were not reported); both administered on the same day. Concomitant therapies included hydroxyzine. On 22-AUG-2016, the patient experienced seizure. She was seen at an emergency department (ED) and was given an unspecified treatment for the event. At the time of reporting, the outcome of seizure was reported as ongoing. The relatedness between the event and GARDASIL 9 and MENACTRA was not reported. The reporter considered the event to be related to TRUMENBA. Upon internal review, the event of seizure was considered to be medically significant. Additional information has been requested.
Age: 16.0
Sex: F
Vaccine: HPV9, MENB, MNQ, HPV9, MENB, MNQ, HPV4, MENB, MNQ, HPV9, MENB, MNQ, HPV9, MENB, MNQ
Symptoms: Seizure
Clinical narrative: This spontaneous report was received from a registered nurse via Pfizer and refers to a 16-year-old female patient. Information on the patient's concurrent conditions or medical history was not reported. On 22-JUL-2016, the patient was vaccinated intramuscularly in the left deltoid with a second dose of GARDASIL 9 (lot # M005714, expiration date and dose were not provided). Other suspect therapies included a first dose of TRUMENBA (lot# M74089, expiration date: 30-JUN-2017, 0.5 ml intramuscularly in the left deltoid, administered at 11:42) and a second dose of MENACTRA (lot# U5259AA, intramuscularly in the right deltoid, dose and expiration date were not reported); both administered on the same day. Concomitant therapies included hydroxyzine. On 22-AUG-2016, the patient experienced seizure. She was seen at an emergency department (ED) and was given an unspecified treatment for the event. At the time of reporting, the outcome of seizure was reported as ongoing. The relatedness between the event and GARDASIL 9 and MENACTRA was not reported. The reporter considered the event to be related to TRUMENBA. Upon internal review, the event of seizure was considered to be medically significant. Additional information has been requested.
Age: 16.0
Sex: F
Vaccine: HPV9, MENB, MNQ, HPV9, MENB, MNQ, HPV4, MENB, MNQ, HPV9, MENB, MNQ, HPV9, MENB, MNQ
Symptoms: Anxiety, Dyskinesia, Electroencephalogram abnormal, Tremor
Clinical narrative: This spontaneous report was received from a registered nurse via Pfizer and refers to a 16-year-old female patient. Information on the patient's concurrent conditions or medical history was not reported. On 22-JUL-2016, the patient was vaccinated intramuscularly in the left deltoid with a second dose of GARDASIL 9 (lot # M005714, expiration date and dose were not provided). Other suspect therapies included a first dose of TRUMENBA (lot# M74089, expiration date: 30-JUN-2017, 0.5 ml intramuscularly in the left deltoid, administered at 11:42) and a second dose of MENACTRA (lot# U5259AA, intramuscularly in the right deltoid, dose and expiration date were not reported); both administered on the same day. Concomitant therapies included hydroxyzine. On 22-AUG-2016, the patient experienced seizure. She was seen at an emergency department (ED) and was given an unspecified treatment for the event. At the time of reporting, the outcome of seizure was reported as ongoing. The relatedness between the event and GARDASIL 9 and MENACTRA was not reported. The reporter considered the event to be related to TRUMENBA. Upon internal review, the event of seizure was considered to be medically significant. Additional information has been requested.
Age: 16.0
Sex: F
Vaccine: HPV9, MENB, MNQ, HPV9, MENB, MNQ, HPV4, MENB, MNQ, HPV9, MENB, MNQ, HPV9, MENB, MNQ
Symptoms: Vaccination complication
Clinical narrative: This spontaneous report was received from a registered nurse via Pfizer and refers to a 16-year-old female patient. Information on the patient's concurrent conditions or medical history was not reported. On 22-JUL-2016, the patient was vaccinated intramuscularly in the left deltoid with a second dose of GARDASIL 9 (lot # M005714, expiration date and dose were not provided). Other suspect therapies included a first dose of TRUMENBA (lot# M74089, expiration date: 30-JUN-2017, 0.5 ml intramuscularly in the left deltoid, administered at 11:42) and a second dose of MENACTRA (lot# U5259AA, intramuscularly in the right deltoid, dose and expiration date were not reported); both administered on the same day. Concomitant therapies included hydroxyzine. On 22-AUG-2016, the patient experienced seizure. She was seen at an emergency department (ED) and was given an unspecified treatment for the event. At the time of reporting, the outcome of seizure was reported as ongoing. The relatedness between the event and GARDASIL 9 and MENACTRA was not reported. The reporter considered the event to be related to TRUMENBA. Upon internal review, the event of seizure was considered to be medically significant. Additional information has been requested.
Age: 12.0
Sex: M
Vaccine: HPV4, HPV4
Symptoms: Computerised tomogram head abnormal, Dizziness, Fall, Head injury, Loss of consciousness
Clinical narrative: My son was given vaccine at 9:40-9:45 am. It was HPV vaccine. Dr. also ordered x-rays for possible scoliosis. Dr did not advise of possible adverse effects. My son went and got x-rays at 10:10 am and fainted. He fractured his skull and suffered permanent deafness in right ear.
Age: 12.0
Sex: M
Vaccine: HPV4, HPV4
Symptoms: Skull fracture
Clinical narrative: My son was given vaccine at 9:40-9:45 am. It was HPV vaccine. Dr. also ordered x-rays for possible scoliosis. Dr did not advise of possible adverse effects. My son went and got x-rays at 10:10 am and fainted. He fractured his skull and suffered permanent deafness in right ear.
Age: 12.0
Sex: M
Vaccine: HPV4, HPV4
Symptoms: Deafness unilateral, Fall, Skull fracture, Spinal X-ray, Syncope
Clinical narrative: My son was given vaccine at 9:40-9:45 am. It was HPV vaccine. Dr. also ordered x-rays for possible scoliosis. Dr did not advise of possible adverse effects. My son went and got x-rays at 10:10 am and fainted. He fractured his skull and suffered permanent deafness in right ear.
Age: 82.0
Sex: F
Vaccine: FLU3, PPV, PPV
Symptoms: Contusion, Erythema
Clinical narrative: This spontaneous report was received from a pharmacist and refers to a 82 year old female patient. The patient did not have any concurrent conditions, relevant medical history or drug reactions or allergies. On 27-SEP-2016, the patient was vaccinated with PNEUMOVAX 23 intramuscularly, 0.5 ml once, lot # M027552, expiry date 04-FEB-2018. Concomitant therapies included aspirin (manufacturer unknown). On 28-SEP-2016, the patient's arm was bruised slightly by the injection site and it was red all the way down to her elbow. The reporter stated that the redness has a sunburn-like appearance. No treatment was given for the events and no laboratory diagnostic studies were performed. No product quality complain (PQC) was involved. At the reporting time, the outcome of the events was not recovered. The reporter did not provide a causality assessment between the events and the PNEUMOVAX 23. Additional information has been requested.
Age: 82.0
Sex: F
Vaccine: FLU3, PPV, PPV
Symptoms: Injection site bruising, Injection site erythema, Injection site reaction, Sunburn
Clinical narrative: This spontaneous report was received from a pharmacist and refers to a 82 year old female patient. The patient did not have any concurrent conditions, relevant medical history or drug reactions or allergies. On 27-SEP-2016, the patient was vaccinated with PNEUMOVAX 23 intramuscularly, 0.5 ml once, lot # M027552, expiry date 04-FEB-2018. Concomitant therapies included aspirin (manufacturer unknown). On 28-SEP-2016, the patient's arm was bruised slightly by the injection site and it was red all the way down to her elbow. The reporter stated that the redness has a sunburn-like appearance. No treatment was given for the events and no laboratory diagnostic studies were performed. No product quality complain (PQC) was involved. At the reporting time, the outcome of the events was not recovered. The reporter did not provide a causality assessment between the events and the PNEUMOVAX 23. Additional information has been requested.
Sex: F
Vaccine: FLU4, TDAP, FLU4, TDAP
Symptoms: Pruritus, Rash, Skin warm
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of injection site warmth in a adult female patient who received BOOSTRIX (batch number 7RJ9B, expiry date 18th November 2018). Concomitant products included FLUARIX QUADRIVALENT. On 26th September 2016, the patient received BOOSTRIX .5 ml. On 30th September 2016, 4 days after receiving BOOSTRIX and FLUARIX QUADRIVALENT, the patient experienced injection site warmth, injection site rash and injection site itching. On an unknown date, the outcome of the injection site warmth, injection site rash and injection site itching were not recovered/not resolved. It was unknown if the reporter considered the injection site warmth, injection site rash and injection site itching to be related to BOOSTRIX. Additional details were provided as follows: The pharmacists stated that this case was already reported on FDA VAERS website. The age at vaccination was not reported. The patient received BOOSTRIX in her right deltoid along with FLUARIX QUADRIVALENT in her left deltoid. The patient experienced skin hot to touch with itching and rash at injection site and surrounding area on her right arm.