chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: HPV9
Symptoms: Seizure, Unresponsive to stimuli
Clinical narrative: This spontaneous report was received from a physician, referring to an unspecified number of patients. Concomitant medications were not provided. The patients were vaccinated with unknown doses of GARDASIL 9, intramuscularly (lot # and expiration date not reported) for prevention of HPV on an unspecified dates. On the same date of vaccination, the patients' experienced head lag, were unresponsive and had mental status changes. Also the had seizures. During the seizures, the patients' whole faces turned white, their lips turned blue, and they started to make a groaning sound and seemed like they were awake but were not able to comprehend anything or communicate (cognitive disorder) (communication disorder). Furthermore, the patients' experienced decreased blood pressure.  The outcome of the events was not provided. The reporter considered seizures to be a life threatening.  The causal relationship between vaccination with GARDASIL 9 and the events was not provided.  This is one of two reports received from the same source.
Age: 63.0
Sex: M
Vaccine: TDAP, VARCEL
Symptoms: No adverse event, Wrong drug administered
Clinical narrative: This spontaneous report was received from a medical assistant regarding a patient of unknown age and gender. The patient's medical history, current conditions and concomitant medications were not reported. On 22-AUG-2017, the patient was scheduled to receive one dose of ZOSTAVAX (route, lot number and expiry date were not reported). When the patient came to the office on 22-AUG-2017, one dose of VARIVAX diluted with sterile diluent was administered instead of the ZOSTAVAX. There were no adverse effects reported. No additional information was provided. No product quality complaint was involved.
Sex: U
Vaccine: HPV9
Symptoms: Product storage error
Clinical narrative: This spontaneous report as received from a healthcare worker referring to unspecified number of patients of unknown age and gender. Information about concurrent condition, concomitant medication and medical history was not provided. On an unknown date the patients received improperly stored doses of GARDASIL 9 lot # M023169, expiration date 13-JUN-2018 (dose, route and frequency unknown) for prophylaxis. The temperature and time frame was reported as 31 degree Fahrenheit) (F) or colder (30.8 F) for 5 days. There was no previous temperature excursion and it was not because of a data logger.; Sender's Comments: US-009507513-1708USA010417:
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: Information has been received from a registered nurse concerning unspecified patients of unknown age and gender. The patients' concurrent conditions, medical histories and concomitant therapies were not reported. From 28-JUL-2017 to 22-AUG-2017, the patients were vaccinated with improperly stored VARIVAX (lot # N002204 with expiration date 19-JAN-2019; dose and route were unknown, for prophylaxis) which were exposed to temperature excursion of -14 to -10 degrees Celsius for 11 hours 29 minutes. There were no previous temperature excursions. Data logger was involved. No adverse reactions were reported. This is one of several reports received from the same reporter. Sender's Comments: US-009507513-1708USA010404: US-009507513-1708USA010405: US-009507513-1708USA010406: US-009507513-1708USA010407: US-009507513-1708USA010408.
Sex: U
Vaccine: MMR
Symptoms: No adverse event, Product storage error
Clinical narrative: Information has been received from a medical assistant concerning an unspecified number of patients of unknown age and gender. The patients' concurrent conditions, medical histories and concomitant therapies were not reported. On unknown dates, the patient were vaccinated with improperly stored M-M-R II (lot # M011666 with expiration date  08-MAR-2018; dose and route were unknown; for prophylaxis) that was reconstituted with properly stored STERILE WATER DILUENT which was exposed to temperature excursion of 47 to 77 (46.9) degrees Fahrenheit for 13 hours and 30 minutes. The previous temperature excursions was 47 to 77 (62) degrees Fahrenheit for 2 hours and 30 minutes and 47 to 77 (48) degrees Fahrenheit for 30 minutes. Data logger was not involved. No adverse effects were reported.
Age: 19.0
Sex: F
Vaccine: HPV4
Symptoms: Urticaria
Clinical narrative: This spontaneous report as received from a other health professional refers to a female patient of unknown age. On 15-JUL-2010 the patient was vaccinated with GARDASIL for prophylaxis. On an unknown date the patient experienced urticaria. The outcome of urticaria was reported as resolved.
Sex: U
Vaccine: HEP
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report as received from a Nurse refers to multiple unspecified patients. On unknown dates the patients were vaccinated with improperly stored RECOMBIVAX HB (lot number, expiration date, dose and route unknown) for prophylaxis. No adverse effects reported. The vaccine was exposed to 47 Fahrenheit (F) to 77 F (47.5F) for 888 hours. This is one of several reports received from the same reporter.; Sender's Comments: US-009507513-1708USA010403: US-009507513-1708USA010402: US-009507513-1708USA010400: US-009507513-1708USA010401:
Sex: U
Vaccine: MMR
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report as received from a Nurse refers to multiple unspecified patients. On unknown dates the patients were vaccinated with improperly stored M-M-R II (lot number, expiration date, dose and route unknown) for prophylaxis. No adverse effects reported. The vaccine was exposed to 47 Fahrenheit (F) to 77 F (47.5F) for 888 hours. This is one of several reports received from the same reporter.; Sender's Comments: US-009507513-1708USA010403: US-009507513-1708USA010402: US-009507513-1708USA010320: US-009507513-1708USA010401:
Sex: U
Vaccine: HPV9
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report as received from a Nurse refers to multiple unspecified patients. On unknown dates the patients were vaccinated with improperly stored GARDASIL 9 (lot number, expiration date, dose and route unknown) for prophylaxis. No adverse effects reported. The vaccine was exposed to 47 Fahrenheit (F) to 77 F (47.5F) for 888 hours. This is one of several reports received from the same reporter. ; Sender's Comments: US-009507513-1708USA010403: US-009507513-1708USA010402: US-009507513-1708USA010400: US-009507513-1708USA010320:
Sex: U
Vaccine: HEPA
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report as received from a Nurse refers to multiple unspecified patients. On unknown dates the patients were vaccinated with improperly stored VAQTA (lot number, expiration date, dose and route unknown) for prophylaxis. No adverse effects reported. The vaccine was exposed to 47 Fahrenheit (F) to 77 F (47.5F) for 888 hours. This is one of several reports received from the same reporter.; Sender's Comments: US-009507513-1708USA010403: US-009507513-1708USA010320: US-009507513-1708USA010400: US-009507513-1708USA010401:
Sex: U
Vaccine: RV5
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report as received from a Nurse refers to multiple unspecified patients. On unknown dates the patients were vaccinated with improperly stored ROTATEQ (lot number, expiration date and dose unknown, oral) for prophylaxis. No adverse effects reported. The vaccine was exposed to 47 Fahrenheit (F) to 77 F (47.5F) for 888 hours. This is one of several reports received from the same reporter.; Sender's Comments: US-009507513-1708USA010320: US-009507513-1708USA010402: US-009507513-1708USA010400: US-009507513-1708USA010401:
Sex: U
Vaccine: HEPA
Symptoms: No adverse event, Product storage error
Clinical narrative: Information has been received from a registered nurse concerning unspecified patients of unknown age and gender. The patients' concurrent conditions, medical histories and concomitant therapies were not reported. From 08-AUG-2017 to 22-AUG-2017, the patients were vaccinated with improperly stored VAQTA (lot # N008823 with expiration date 26-MAY-2018; dose and route were unknown, for prophylaxis) which were  exposed to temperature excursion of 9 to 25 degrees Celsius for 1 hours 34 minutes. There were no previous temperature excursions. Data logger was involved. No adverse reactions were reported. This is one of several reports received from the same reporter.; Sender's Comments: US-009507513-1708USA010405: US-009507513-1708USA010242: US-009507513-1708USA010408: US-009507513-1708USA010406: US-009507513-1708USA010407:
Sex: U
Vaccine: HEP
Symptoms: No adverse event, Product storage error
Clinical narrative: Information has been received from a registered nurse concerning unspecified patients of unknown age and gender. The patients' concurrent conditions, medical histories and concomitant therapies were not reported. From 08-AUG-2017 to 22-AUG-2017, the patients were vaccinated with improperly stored RECOMBIVAX HB (lot # N002202 with expiration date 04-NOV-2019; dose and route were unknown, for prophylaxis) which were exposed to temperature excursion of 9 to 25 degrees Celsius for 1 hours 34 minutes. There were no previous temperature excursions. Data logger was involved. No adverse reactions were reported. This is one of several reports received from the same reporter.; Sender's Comments: US-009507513-1708USA010242: US-009507513-1708USA010404: US-009507513-1708USA010408: US-009507513-1708USA010406: US-009507513-1708USA010407:
Sex: U
Vaccine: HPV9
Symptoms: No adverse event, Product storage error
Clinical narrative: Information has been received from a registered nurse concerning unspecified patients of unknown age and gender. The patients' concurrent conditions, medical histories and concomitant therapies were not reported. From 08-AUG-2017 to 22-AUG-2017, the patients were vaccinated with improperly stored GARDASIL 9 (lot # M034780 with expiration date 15-APR-2019; dose and route were unknown, for prophylaxis) which were exposed to temperature excursion of 9 to 25 degrees Celsius for 1 hours 34 minutes. There were no previous temperature excursions. Data logger was involved. No adverse reactions were reported. This is one of several reports received from the same reporter.; Sender's Comments: US-009507513-1708USA010405: US-009507513-1708USA010404: US-009507513-1708USA010408:  US-009507513-1708USA010242: US-009507513-1708USA010407:
Sex: U
Vaccine: MMR
Symptoms: No adverse event, Product storage error
Clinical narrative: Information has been received from a registered nurse concerning unspecified patients of unknown age and gender. The patients' concurrent conditions, medical histories and concomitant therapies were not reported. From 08-AUG-2017 to 22-AUG-2017, the patients were vaccinated with improperly stored  M-M-R II (lot # M044351 with expiration date 04-NOV-2018; dose and route were unknown, for prophylaxis) which were  exposed to temperature excursion of 9 to 25 degrees Celsius for 1 hours 34 minutes. There were no previous temperature excursions. Data logger was involved. No adverse reactions were reported. This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-1708USA010405: US-009507513-1708USA010404: US-009507513-1708USA010408: US-009507513-1708USA010406: US-009507513-1708USA010242:
Sex: U
Vaccine: RV5
Symptoms: No adverse event, Product storage error
Clinical narrative: Information has been received from a registered nurse concerning unspecified patients of unknown age and gender. The patients' concurrent conditions, medical histories and concomitant therapies were not reported. From 08-AUG-2017 to 22-AUG-2017, the patients were vaccinated with improperly stored ROTATEQ (lot # M041181 with expiration date 31-MAY-2018, oral; dose was unknown, for prophylaxis) which were exposed to temperature excursion of 9 to 25 degrees Celsius for 1 hours 34 minutes. There were no previous temperature excursions. Data logger was involved. No adverse reactions were reported. This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-1708USA010405: US-009507513-1708USA010404: US-009507513-1708USA010242: US-009507513-1708USA010406: US-009507513-1708USA010407:
Sex: U
Vaccine: HIBV
Symptoms: Product storage error
Clinical narrative: This spontaneous report as received from a healthcare worker referring to unspecified number of patients of unknown age and gender. Information about concurrent condition, concomitant medication and medical history was not provided. On an unknown date the patients received improperly stored doses of LIQUID PEDVAXHIB lot # L042836, expiration date 24-AUG-2018 (dose, route and frequency unknown) for prophylaxis. The temperature and time frame was reported as 32 degree Fahrenheit) (F) to 35 F for 10 days. There was no previous temperature excursion and it was not because of a data logger.; Sender's Comments: US-009507513-1708USA010211:
Sex: U
Vaccine: HEP
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report as received from a healthcare worker refers to multiple unspecified patients of unknown age and gender. The patient's pertinent medical history, drug reaction or allergies and concomitant therapies were not reported. On an unknown date, the patient was vaccinated with improperly stored doses of RECOMBIVAX HB (lot # M023718, Expiry date: 09-AUG-2018). On an unknown date, the vaccine was exposed to temperature of 47 degrees F to 77 degrees F for 108 hours. No adverse effects reported. Previous temperature excursion occurred on an unknown date between temperatures of 47 degrees F to 77 degrees F for 28 hours. This case was reported because of a data logger. No product quality complaint (PQC) was reported. No further information to report. This is one of several reports received from the same reporter.; Sender's Comments: US-009507513-1708USA009652:
Sex: M
Vaccine: TDAP
Symptoms: Injection site erythema, Lymph node pain, Pain in extremity, Pyrexia, Ultrasound scan abnormal
Clinical narrative: Initial unsolicited report received from a physician on 16-Aug-2017. This case involves a male patient (age not reported) who was vaccinated with a dose of ADACEL (Batch number: U5459AA, expiry date, route and site of administration was not reported), on an unknown date. The patient's medical history and concomitant medications were not reported. On an unknown date, following the vaccination, the patient developed redness at injection site larger than ink circle and fever of 99.9 F and pain in arm. Ultrasound performed and findings were multiple small lymph nodes inferior axillary region of pain- (no sonographic abnormality in the vaccination site). The patient's other laboratory data and corrective treatment were not reported. The outcome of events was not reported. List of documents held by sender: none.
Age: 12.0
Sex: M
Vaccine: TDAP
Symptoms: Hyperhidrosis, Hypoacusis, Hypotension, Nausea, Palpitations
Clinical narrative: Child stated he felt like his eyes were blurry, hearing was off, sweaty, racing heart. States he felt nauseous for a few seconds. Low blood pressure 80/62. Stayed with child. Gave Orange juice. After 10 min. child felt much better. After mom and child left, mom states that she and spouse remember child feeling faint after sight of blood. She was questioning if this is what happened.
Age: 12.0
Sex: M
Vaccine: TDAP
Symptoms: Vision blurred
Clinical narrative: Child stated he felt like his eyes were blurry, hearing was off, sweaty, racing heart. States he felt nauseous for a few seconds. Low blood pressure 80/62. Stayed with child. Gave Orange juice. After 10 min. child felt much better. After mom and child left, mom states that she and spouse remember child feeling faint after sight of blood. She was questioning if this is what happened.
Age: 12.0
Sex: M
Vaccine: HPV9, MNQ, TDAP
Symptoms: Feeling hot, Pallor, Thirst
Clinical narrative: Client and family waiting for 15 minutes after vaccine per policy. Client told mother he was hot and wanted water. Client noted to be very pale, advised to lay down, and assisted to ground. No loss of consciousness noted. Client given snacks and drink, color improved, went home with parent.
Age: 12.0
Sex: F
Vaccine: HPV9, MNQ, TDAP
Symptoms: Fall, Pallor, Syncope
Clinical narrative: Prior to vaccines, client was very apprehensive, pulling away from nurse. While discussing vaccine info. with mother following administration, client fainted and fell to floor. Vital signs stable (BP 110/70, HR 84) EMS called. When EMS arrived, client was sitting up, eating and drinking, color improved. EMS did not transport. Mother states client has HX of fainting with needles. No injuries noted.
Age: 16.0
Sex: F
Vaccine: MENB
Symptoms: Swelling face, Urticaria
Clinical narrative: Hives to the face and swelling of the face per guardian.
Age: 1.0
Sex: M
Vaccine: HEPA, MMR, PNC13
Symptoms: Decreased appetite, Injection site swelling, Irritability, Poor quality sleep, Pyrexia
Clinical narrative: Irritable, child would not eat, could not sleep comfortably, swelling at injection site of left leg, fever climbing to 102.7 despite MOTRIN/TYLENOL given. ER visit. This lasted 3 days.
Age: 80.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Erythema, Injection site pruritus, Skin warm
Clinical narrative: Pt developed itching at injection site afternoon after receiving injection, by next day (8/23/2017) entire arm was red and hot. Pt saw primary care Dr who administered SOLU-MEDROL.
Age: 42.0
Sex: M
Vaccine: TYP
Symptoms: Extra dose administered, No adverse event
Clinical narrative: Pt was given TyphimVi when TyphimVi was not necessary. Pt had no advearse events as of 6 days after vaccination. Pt last Typhiiod vaccination was 2 months ago.
Age: 9.0
Sex: M
Vaccine: HEPA, MMRV
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report as received from a nurse and refers to unspecified number of patients of unknown age and gender. Information on medical history, past drugs, concurrent conditions and concomitant medications were not provided. The nurse reported that on an unknown date, the patients were vaccinated with PROQUAD, (lot # N008825, Exp date:12-SEP-2018) for prophylaxis which were improperly stored (incorrect product storage of PROQUAD). Other suspect therapies included VARIVAX, (Lot # N007930 Exp date: 08-MAR-2019) for prophylaxis (incorrect product storage of VARIVAX) which was also improperly stored (Captured in MAARS #1708USA010551), sterile diluent Merck injection. For both the products, temperature was between -9 (degree centigrade) °C to 8°C. Time frame was 4 hours and 43 minutes. Previous temperature excursion was between -9°C to 8°C for 57 hours and 40 minutes. Between -14°C to -10°C for 23 hours and 57 minutes. It was reported that call was not because of a data logger. No adverse effects were reported. No additional information was provided. No product quality compliant (PQC) was involved. Outcome of event was unknown. This is one of the several reports received from the same reporter.; Sender's Comments: US-009507513-1708USA010551:u
Age: 17.0
Sex: U
Vaccine: HEPA
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a registered nurse and refers to a 17-year-old patient of unknown gender. No information regarding the patient's pertinent medical history, concurrent conditions, concomitant medications, drug reactions or allergies was provided. On 03-AUG-2017, the patient was vaccinated with a dose of improperly stored VAQTA injection (dose, route of administration were not reported; lot # N008823, expiration date 26-MAY-2018). The vaccine underwent a temperature excursion from 9 to 25 degrees Celsius which lasted 31 minutes and was detected by a Digital Data Logger. There was no previous excursion reported. No adverse effects were reported. No product quality complaint was involved. This is one of the several reports received from the same reporter. Additional information is not expected since all relevant data have been already obtained. Sender's Comments: US-009507513-1708USA010049: US-009507513-1708USA010050: US-009507513-1708USA010051: US-009507513-1706USA002146: US-009507513-1708USA010048.
Age: 18.0
Sex: U
Vaccine: HPV9
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a registered nurse and refers to a 18-year-old patient of unknown gender. No information regarding the patient's pertinent medical history, concurrent conditions, concomitant medications, drug reactions or allergies was provided. On 08-JUN-2017, the patient was vaccinated with a dose of improperly stored GARDASIL 9 injection (dose, route of administration were not reported; lot # M040412, expiration date 30-JUN-2019). The vaccine underwent a temperature excursion from 9 to 25 degrees Celsius which lasted 31 minutes and was detected by a Digital Data Logger. There was no previous excursion reported. No adverse effects were reported. No product quality complaint was involved. This is one of several reports received from the same reporter. Additional information is not expected since all relevant data have been already obtained.; Sender's Comments: US-009507513-1708USA010049: US-009507513-1708USA010050: US-009507513-1708USA010051: US-009507513-1708USA010047: US-009507513-1706USA002146:
Age: 14.0
Sex: U
Vaccine: HEPA
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a registered nurse and refers to a 14-year-old patient of unknown gender. No information regarding the patient's pertinent medical history, concurrent conditions, concomitant medications, drug reactions or allergies was provided. On 24-JUL-2017, the patient was vaccinated with a dose of improperly stored VAQTA injection (dose, route of administration were not reported; lot # N008823, expiration date 26-MAY-2018). The vaccine underwent a temperature excursion from 9 to 25 degrees Celsius which lasted 31 minutes and was detected by a Digital Data Logger. There was no previous excursion reported. No adverse effects were reported. No product quality complaint was involved. This is one of the several reports received from the same reporter. Additional information is not expected since all relevant data have been already obtained.; Sender's Comments: US-009507513-1706USA002146: US-009507513-1708USA010050: US-009507513-1708USA010051: US-009507513-1708USA010047: US-009507513-1708USA010048:
Age: 15.0
Sex: U
Vaccine: HEPA
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a registered nurse and refers to a 15-year-old patient of unknown gender. No information regarding the patient's pertinent medical history, concurrent conditions, concomitant medications, drug reactions or allergies was provided. On 12-JUL-2017, the patient was vaccinated with a dose of improperly stored VAQTA injection (dose, route of administration were not reported; lot # N008823, expiration date 26-MAY-2018). The vaccine underwent a temperature excursion from 9 to 25 degrees Celsius which lasted 31 minutes and was detected by a Digital Data Logger. There was no previous excursion reported. No adverse effects were reported. No product quality complaint was involved. This is one of the several reports received from the same reporter. Additional information is not expected since all relevant data have been already obtained.; Sender's Comments: US-009507513-1708USA010049: US-009507513-1706USA002146: US-009507513-1708USA010051: US-009507513-1708USA010047: US-009507513-1708USA010048:
Age: 18.0
Sex: U
Vaccine: HEPA
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a registered nurse and refers to a 18-year-old patient of unknown gender. No information regarding the patient's pertinent medical history, concurrent conditions, concomitant medications, drug reactions or allergies was provided. On 16-JUN-2017, the patient was vaccinated with a dose of improperly stored VAQTA injection (dose, route of administration were not reported; lot # N008823, expiration date 26-MAY-2018). The vaccine underwent a temperature excursion from 9 to 25 degrees Celsius which lasted 31 minutes and was detected by a Digital Data Logger. There was no previous excursion reported. No adverse effects were reported. No product quality complaint was involved. This is one of the several reports received from the same reporter. Additional information is not expected since all relevant data have been already obtained.; Sender's Comments: US-009507513-1708USA010049: US-009507513-1708USA010050: US-009507513-1706USA002146: US-009507513-1708USA010047:  US-009507513-1708USA010048:
Age: 16.0
Sex: M
Vaccine: HEPA, TDAP, VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report as received from a nurse and refers to unspecified number of patients of unknown age and gender. Information on medical history, past drugs, concurrent conditions and concomitant medications were not provided. The nurse reported that on an unknown date, the patients were vaccinated with PROQUAD, (lot # N008825, Exp date:12-SEP-2018) for prophylaxis (Captured in MARRS # 1708USA009081) which were improperly stored. Other suspect therapies included VARIVAX, (Lot # N007930 Exp date: 08-MAR-2019) for prophylaxis which was also improperly stored, sterile diluent Merck injection. For both the products, temperature was between -9 (degree Centigrade) °C to 8°C. Time frame was 4 hours and 43 minutes. Previous temperature excursion was between -9°C to 8°C for 57 hours and 40 minutes. Between -14°C to -10°C for 23 hours and 57 minutes. It was reported that call was not because of a data logger. No adverse effects were reported. No additional information was provided. No product quality compliant (PQC) was involved. Outcome of event was unknown. This is one of the several reports received from the same reporter. Sender's Comments: US-009507513-1708USA009081.
Sex: M
Vaccine: MENB
Symptoms: Chills, Musculoskeletal stiffness, Pyrexia
Clinical narrative: This is a spontaneous report from a contactable physician via a Pfizer sales representative. An adolescent male patient received the first dose of TRUMENBA at single dose for immunization, on unknown date. Medical history included severe food allergies. Concomitant medications were not reported. On unknown date the patient experienced fever, chills and stiff neck. The outcome of the events was unknown. No follow-up attempts are possible. No further information is expected.
Age: 78.0
Sex: F
Vaccine: PNC13
Symptoms: Erythema, Injection site erythema, Injection site swelling, Peripheral swelling, Pruritus
Clinical narrative: This is a spontaneous report from a Pfizer-sponsored program, IBCC (Inbound Call Center for HCPs), received from a contactable pharmacist. A 78-year-old female patient received PREVNAR 13 (lot number: R12280, expiry date: 28Feb2018), via an unspecified route of administration on 12Aug2017 approximately 16:10 at single dose so the patient does not get pneumonia. The patient's medical history and concomitant medications were not reported. On an unspecified date in Aug2017, the patient reported redness and a little bit of swelling in the arm that was injected. It was reported that it goes from the injection site and then it spreads down to about half way of her lower left arm. The patient has been using hydrocortisone on it as there was some slight itching and swelling. The patient was also advised to use ice packs. The patient further reported that it has been increasing in size/ growing each day. The outcome of the events was not recovered. The reporter assessed the events 'redness and a little bit of swelling in the arm that was injected' as related to the suspect vaccine.
Age: 24.0
Sex: F
Vaccine: HPV9, TDAP
Symptoms: Erythema, Induration, Musculoskeletal stiffness, Pain in extremity, Pyrexia
Clinical narrative: Pt received vaccinations after Tdap and GARDASIL 9 on 8/16/17 from which my NP in error states both given (L) deltoid. Pt believes only Tdap on (L) approximately post vaccination pt notified. Sore and stiff arm (L) and 1 day of unmeasured low grade fever. Then soreness decreased (L) arm 6 cm induration 12x7 cm area of erythema. No SOB, Throat swelling, afebrile. Pt very certain (L) arm Tdap. Pt reseen Day 7, 80% improved. On ZYRTEC, ZANTAC and topical steroid.
Age: 92.0
Sex: F
Vaccine: FLUA3
Symptoms: Discomfort, Musculoskeletal pain, Pain in extremity
Clinical narrative: Arm/shoulder pain since administration of shot. Patient complains of discomfort for a week now.
Age: 18.0
Sex: F
Vaccine: MENB
Symptoms: Asthenia, Chest X-ray normal, Chest pain, Decreased appetite, Dizziness
Clinical narrative: Patient had immediate dizziness, nausea and felt tired after getting the vaccine. She had not eaten that morning. She progressed the next day and was seen back in the office due to worsening fatigue, "lethargic" yesterday after vaccine, eating less, nausea, slowed speech, body aches, limp yesterday, fatigue, more emotional, tingling in fingers, feeling weak, one episode of acute onset and acute resolution chest pain, emesis x1 today. She was seen in the ER for these symptoms due to her history of heart condition - no treatment. She continued with muscle aches, pain at the injection site, fatigue and chest pain intermittently for 7 days. On day #8 after vaccination, she was slowly starting to resolve with less fatigue.
Age: 18.0
Sex: F
Vaccine: MENB
Symptoms: Electrocardiogram normal, Emotional disorder, Fatigue, Hypotonia, Immediate post-injection reaction
Clinical narrative: Patient had immediate dizziness, nausea and felt tired after getting the vaccine. She had not eaten that morning. She progressed the next day and was seen back in the office due to worsening fatigue, "lethargic" yesterday after vaccine, eating less, nausea, slowed speech, body aches, limp yesterday, fatigue, more emotional, tingling in fingers, feeling weak, one episode of acute onset and acute resolution chest pain, emesis x1 today. She was seen in the ER for these symptoms due to her history of heart condition - no treatment. She continued with muscle aches, pain at the injection site, fatigue and chest pain intermittently for 7 days. On day #8 after vaccination, she was slowly starting to resolve with less fatigue.
Age: 18.0
Sex: F
Vaccine: MENB
Symptoms: Injection site pain, Lethargy, Myalgia, Nausea, Pain
Clinical narrative: Patient had immediate dizziness, nausea and felt tired after getting the vaccine. She had not eaten that morning. She progressed the next day and was seen back in the office due to worsening fatigue, "lethargic" yesterday after vaccine, eating less, nausea, slowed speech, body aches, limp yesterday, fatigue, more emotional, tingling in fingers, feeling weak, one episode of acute onset and acute resolution chest pain, emesis x1 today. She was seen in the ER for these symptoms due to her history of heart condition - no treatment. She continued with muscle aches, pain at the injection site, fatigue and chest pain intermittently for 7 days. On day #8 after vaccination, she was slowly starting to resolve with less fatigue.
Age: 18.0
Sex: F
Vaccine: MENB
Symptoms: Paraesthesia, Slow speech, Vomiting
Clinical narrative: Patient had immediate dizziness, nausea and felt tired after getting the vaccine. She had not eaten that morning. She progressed the next day and was seen back in the office due to worsening fatigue, "lethargic" yesterday after vaccine, eating less, nausea, slowed speech, body aches, limp yesterday, fatigue, more emotional, tingling in fingers, feeling weak, one episode of acute onset and acute resolution chest pain, emesis x1 today. She was seen in the ER for these symptoms due to her history of heart condition - no treatment. She continued with muscle aches, pain at the injection site, fatigue and chest pain intermittently for 7 days. On day #8 after vaccination, she was slowly starting to resolve with less fatigue.
Age: 66.0
Sex: F
Vaccine: PPV
Symptoms: Injection site erythema, Injection site oedema, Injection site warmth
Clinical narrative: Patient had erythema, edema, warmth extending throughout her entire deltoid muscle on her right upper arm where the injection site had occurred. Per patient this started around 3 hours after injection.
Age: 16.0
Sex: M
Vaccine: HPV9, MENB
Symptoms: Body temperature increased, Fatigue, Headache, Nausea, Pain
Clinical narrative: Patient woke up with 102 temp, and nauseated at 4am on 8/16/17. I spoke with pts mother on 8/16 at about 5pm, he was still having all the same sx, but also included body aches, and headache, fatigue. I called his mother on 8/17/17 at 8:20 am, she stated that his temp broke, and he was starting to feel better.
Age: 0.33
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV1
Symptoms: Pyrexia
Clinical narrative: Fever of 102.8; fever comes down with TYLENOL administration.
Age: 11.0
Sex: F
Vaccine: MNQ
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: Left arm is swollen from upper shoulder area almost to elbow, red, and feverish.
Age: 13.0
Sex: M
Vaccine: TDAP
Symptoms: Abnormal behaviour, Crying, Injection site pain, Pain, Pain in extremity
Clinical narrative: When they got home after injections, their son c/o large amount of pain in right arm and shoulder. Approx. 11 Am. No redness or edema noted per parents. Unusual behavior, crying and screaming out in pain for several hours after injection per parents. Parents denied difficulty in breathing, skin color was good, no seizure activity. Parents wanted to know what they should do because their son's behavior was not normal. Discussed taking their son to ED. Parents decided that they would  monitor their son at home. Discussed giving their son a OTC pain reliever, cool compresses to the site and encourage movement of arm. If behavior continues to take their son to their doctor or ED. Parents had wrapped their son's arm with coban wrap and this nurse advised to take wrap off of arm immediately.  Parents thought compression wrap would be the best for treatment, this nurse advised them not to wrap arm up with coban. Spoke with parents at 1:30 and their son was still c/o of pain, parents had not given OTC pain reliever at this time. Encouraged parents to give OTC pain reliever and encourage movement of arm. Parents stated that site was not red or swollen. Spoke with parents by phone at 3:30 pm and their son was feeling better now, OTC pain reliever was given at 2:30 pm. Phone call to parents on 8/24/17- their sons pain was better and he was in school.
Age: 13.0
Sex: M
Vaccine: TDAP
Symptoms: Screaming
Clinical narrative: When they got home after injections, their son c/o large amount of pain in right arm and shoulder. Approx. 11 Am. No redness or edema noted per parents. Unusual behavior, crying and screaming out in pain for several hours after injection per parents. Parents denied difficulty in breathing, skin color was good, no seizure activity. Parents wanted to know what they should do because their son's behavior was not normal. Discussed taking their son to ED. Parents decided that they would  monitor their son at home. Discussed giving their son a OTC pain reliever, cool compresses to the site and encourage movement of arm. If behavior continues to take their son to their doctor or ED. Parents had wrapped their son's arm with coban wrap and this nurse advised to take wrap off of arm immediately.  Parents thought compression wrap would be the best for treatment, this nurse advised them not to wrap arm up with coban. Spoke with parents at 1:30 and their son was still c/o of pain, parents had not given OTC pain reliever at this time. Encouraged parents to give OTC pain reliever and encourage movement of arm. Parents stated that site was not red or swollen. Spoke with parents by phone at 3:30 pm and their son was feeling better now, OTC pain reliever was given at 2:30 pm. Phone call to parents on 8/24/17- their sons pain was better and he was in school.
Age: 62.0
Sex: M
Vaccine: FLU4, PPV
Symptoms: Hyperhidrosis, Influenza like illness, Myalgia, Productive cough, Tremor
Clinical narrative: Patient developed severe muscle pain in right arm, and applied ice. It has lasted for 2 days, and we discussed pain relievers that would help and application of ice and heat. It is likely a direct result of having 2 vaccinations in the same arm (patient requested both due to injury to left arm). Patient experienced sweating, "shakes," and flu-like symptoms day of vaccination that has lasted for 2 days. Likely adverse reaction to vaccine due to immune response. Discussed following up with a physician if symptoms persist. Patient has developed a productive cough on day of vaccination that has lasted 2 days. Possible adverse reaction or coincidental infection. Discussed following up with a physician if symptoms do not improve.
Age: 62.0
Sex: M
Vaccine: FLU4, PPV
Symptoms: Vaccination complication
Clinical narrative: Patient developed severe muscle pain in right arm, and applied ice. It has lasted for 2 days, and we discussed pain relievers that would help and application of ice and heat. It is likely a direct result of having 2 vaccinations in the same arm (patient requested both due to injury to left arm). Patient experienced sweating, "shakes," and flu-like symptoms day of vaccination that has lasted for 2 days. Likely adverse reaction to vaccine due to immune response. Discussed following up with a physician if symptoms persist. Patient has developed a productive cough on day of vaccination that has lasted 2 days. Possible adverse reaction or coincidental infection. Discussed following up with a physician if symptoms do not improve.
Sex: U
Vaccine: MMR, VARCEL
Symptoms: Product storage error
Clinical narrative: This spontaneous report was received from a medical assistant and refers to a patient of unknown age. There was no information about the patient's concurrent condition, concomitant therapies or medical history provided. On an unknown date, was vaccinated with VARIVAX lot # M047662 with an expiration date 02-DEC-2018 (dose and route of administration were not reported) and M-M-R II lot# M039913 with an expiration date 26-SEP-2018 (dose and route of administration were not reported) both  reconstituted with sterile diluent (STERILE DILUENT)(strength, dose, route of administration, lot#, expiration date and anatomical location were not reported) and stored in a syringe at 28 degrees Fahrenheit for 35 minutes. There was no previous temperature excursion. A digital data logger was not involved. Additional information is not expected as all correspondence was returned by the post office.  It has been determined that case # US-009507513-1707USA000445 and US-009507513-1707USA000446 are a duplicates of case # US-009507513-1706USA007309. Therefore, case # US-009507513-1707USA000445 and US-009507513-1707USA000446 are being deleted from our files and the cases are consolidated into case # US-009507513-1706USA007309.; Sender's Comments:  US-009507513-1707USA000445: US-009507513-1707USA000446:
Sex: F
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a licensed practical nurse, concerning a patient of unknown age and gender. There were no concurrent conditions, medical history, drug reactions or allergies or concomitant medications reported. On an unspecified date, the patient was vaccinated with an improperly stored dose (first) of VARIVAX (dose, frequency and route were not reported) lot # M025864 with expiration date of 24-MAY-2018, for prophylaxis. The sterile diluent (manufacturer unknown) used to reconstitute the VARIVAX (lot # 020945 with expiration date of 05-DEC-2018) was properly stored. The temperature of the VARIVAX was between - 14 °C and - 10 °C for a time frame of 29 minutes. The vaccine did not have any previous temperature excursions. No adverse effects were reported and data logger was involved. Follow up information was received on 22-AUG-2017 from the licensed practical nurse. The patient was a 12 months female patient.; Sender's Comments:  US-009507513-1707USA004248:
Age: 1.0
Sex: F
Vaccine: HEP, HEPA, MMR, VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report as received from a nurse refers to a patient of unknown age and gender. On an unknown date the patient was vaccinated with VARIVAX lot # M025864 exp 24-MAY-2018 for prophylaxis. The vaccine had been stored improperly stored and experienced temperature excursion -14 °C to -10 °C for 29 minutes. The diluent lot# 020945 exp 05-DEC-2018 was stored properly. There was no adverse event. Follow up information was received on 22-AUG-2017 from the Licensed Practical Nurse referring to a 12 months female patient. On 28-JUN-2017 at 09:25 hours, the patient was vaccinated with the first dose of VARIVAX subcutaneously. Concomitant therapies included M-M-R II, VAQTA, RECOMBIVAX HB and sterile diluent (manufacturer unknown). It was confirmed no adverse events reported and data logger was involved. The reporter stated that the patient was vaccinated at private doctor's office/hospital with private funds. No illness at time of vaccination. This is one of two reports received from same source. Sender's Comments:  US-009507513-1707USA004242.
Age: 1.0
Sex: U
Vaccine: VARCEL
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report as received from a medical assistant refers to a 12 months old patient of unknown gender. There was no information regarding the patient's medical history, concomitant medications, drug reactions or allergies provided. On 03-AUG-2017, the patient was vaccinated with expired dose of VARIVAX lot # L021210, expiration date 10-JUN-2017, for prophylaxis (dose and route of administration were not reported). The vaccine was reconstituted with sterile diluent lot # L027293, expiration date 19-MAR-2018. No adverse effect was reported. There was no product quality complaint involved in this case.
Sex: U
Vaccine: HEP
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report as received from a other health professional refers to 15 patients of unknown age. On unknown dates the patients were vaccinated with improperly stored doses of RECOMBIVAX HB for prophylaxis. Concomitant therapies included sterile diluent. No adverse event was reported. The outcome of incorrect product storage and no adverse event is unknown. The reporter considered incorrect product storage to be not related to RECOMBIVAX HB. The reporter considered no adverse event to be not related to RECOMBIVAX HB. Additional information has been requested. Sender's Comments: US-009507513-1708USA007174: US-009507513-1708USA007175: US-009507513-1708USA007176.
Sex: U
Vaccine: HIBV
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a other health professional and refers to multiple patients of unknown age. On unknown dates, those patients were vaccinated with improperly stored doses of PEDVAXHIB lot # M045874 for prophylaxis. No adverse events were reported. This is one of several reports received from the same reporter. Additional information has been requested. Sender's Comments: US-009507513-1708USA010565: US-009507513-1708USA010566.
Sex: U
Vaccine: HPV9
Symptoms: Inappropriate schedule of drug administration, Interchange of vaccine products, No adverse event
Clinical narrative: This spontaneous report as received from a other health professional refers to a patient of unknown age. On 23-AUG-2013 and 28-OCT-2013, the patient was vaccinated with the first and second dose of GARDASIL (first dose lot # J002641, second dose lot # J007354). On 13-JUL-2017, the patient was vaccinated GARDASIL 9 (lot # N007931) reported as an "altered dosing schedule". No adverse event was reported. The outcome of inappropriate schedule of drug administration, no adverse event and interchange of vaccine products is unknown. The reporter considered inappropriate schedule of drug administration and no adverse event to be not related to GARDASIL 9 and GARDASIL. The reporter considered interchange of vaccine products to be not related to GARDASIL and GARDASIL 9. Additional information has been requested.
Age: 59.0
Sex: F
Vaccine: VARZOS
Symptoms: Arthropod bite, Herpes zoster, Pruritus, Rash
Clinical narrative: This spontaneous report was received from a pharmacist referring to a 59 year old female patient. On 03-AUG-2017, the patient was vaccinated with ZOSTAVAX lot # N014018, subcutaneous for prophylaxis. Concomitant therapies included buspirone hydrochloride, hydroxyzine, clonazepam, ENTRESTO, CYMBALTA, LAMICTAL, naltrexone, carvedilol and bumetanide. On 05-AUG-2017 (reported as "in the next couple of days"), the patient experienced herpes zoster, arthropod bite, rash and pruritus. The outcome of herpes zoster, arthropod bite, rash and pruritus was unknown.
Sex: U
Vaccine: VARZOS
Symptoms: Malaise, Secondary transmission, Varicella
Clinical narrative: This spontaneous report was received from a registered nurse referring to a neonate of unknown age and gender. On an unspecified date in February 2016 (reported as "a year and a half ago"), the grandfather was vaccinated with ZOSTAVAX for prophylaxis. On an unspecified date in 2016 (reported as "shortly after received the vaccine"), he visited his newborn grandchild and the newborn developed chicken pox. The nurse reported that the grandfather stated "his grandchild was quite sick at the time". The outcome of secondary transmission, varicella and malaise was reported as resolved.
Sex: U
Vaccine: RV5
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report as received from a healthcare worker refers to multiple unspecified patients of unknown age and gender. No concurrent conditions, medical history, allergy/drug reactions and concomitant medications were reported. On an unknown date, the patients were vaccinated with improperly stored ROTATEQ (lot#, expiry date, dosing details, anatomical location, were unknown) orally for prophylaxis. Previous temperature excursion was reported. Data logger was involved. No adverse effects were reported. There were no product quality complaints (PQC) involved. This is one of several reports received from the same reporter. Sender's Comments: US-009507513-1708USA009095.
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report as received from a healthcare worker refers to multiple unspecified patients of unknown age and gender. No concurrent conditions, medical history, allergy/drug reactions and concomitant medications were reported. On an unknown date, the patients were vaccinated with improperly stored VARIVAX (lot#, expiry date, dosing details, anatomical location, route were unknown) for prophylaxis. Previous temperature excursion was reported. Data logger was involved. No adverse effects were reported. There were no product quality complaints (PQC) involved. This is one of several reports received from the same reporter. Sender's Comments: US-009507513-1708USA009095.
Sex: U
Vaccine: MMR
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report as received from a healthcare worker refers to multiple unspecified patients of unknown age and gender. No concurrent conditions, medical history, allergy/drug reactions and concomitant medications were reported. On an unknown date, the patients were vaccinated with improperly stored M-M-R II (lot#, expiry date, dosing details, anatomical location, were unknown) for prophylaxis. Previous temperature excursion was reported. Data logger was involved. No adverse effects were reported. There were no product quality complaints (PQC) involved. This is one of several reports received from the same reporter. Sender's Comments: US-009507513-1708USA009095.