chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: MMR
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional AE details provided.; Nurse calling in to report an AE for a patient that received MMR-II that was improperly stored. No additional AE details provided. No PQC.  Names of vaccines involved (including lot/exp): MMR-II (U006486  2/26/2023;  U019290 6/18/2023)  Temperature; This spontaneous report was received from a nurse and refers to a patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant therapies were not provided.  On an unknown date, the patient was vaccinated with measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (albumin status rHA) (M-M-R II) 5 milliliter, subcutaneously, lot# U006486, expiration date 26-FEB-2023 (dose number and vaccination schedule were not provided) for prophylaxis. This vaccine and the other vaccine measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (albumin status rHA) (M-M-R II) lot#U019290, expiration date 18-JUN-2023 had been improperly stored in the temperature of 61.5 Fahrenheit degrees (F) for 9 hours 20 minutes with no previous temperature excursion (product storage error). It was unknown if digital data logger was involved. No additional adverse events were reported.
Age: 1.0
Sex: F
Vaccine: HIBV, MMR, VARCEL
Symptoms: Accidental overdose, Incorrect route of product administration, No adverse event, Product preparation error
Clinical narrative: The patient has had no side effects at this time.; PEDVAX HIB was accidently used as the diluent for MMR-II and VARIVAX instead of the Merck sterile diluent; Because of the PEDVAX HIB being used as the diluent for both MMR-II and VARIVAX, the patient received 1mL of PEDVAX HIB instead of the recommended dose of 0.5mL therefore receiving double the recommended dose of PEDVAX HIB.; Also, the PEDVAX HIB was given subcutaneously instead of intramuscularly since it was mixed as diluent with MMR-II and VARIVAX.; This spontaneous report was received from physician and refers to a 12-month-old female patient. The patient's concomitant therapy included pneumococcal vaccine conj 13v (crm197) (PREVENAR 13). The patient's concurrent conditions, medical history, allergies and drug reactions were not provided.  On 30-JUN-2022, the patient was vaccinated with measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) , 0.5 ml, administered subcutaneously, lot #U011995, expiration date: 15-APR-2023 (strength and dose number was not provided), and varicella virus vaccine live (oka/merck) (VARIVAX), 0.5 ml, administered subcutaneously, lot #U039726, expiration date: 15-DEC-2023 (strength and dose number were not provided) for prophylaxis. Haemophilus b conjugate vaccine (meningococcal protein conjugate) (LIQUID PEDVAXHIB) lot #U039951, expiration date: 22-JUN-2024 was accidentally used as the diluent for both measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) and varicella virus vaccine live (oka/merck) (VARIVAX) instead of Merck sterile diluen (product preparation error). Because haemophilus b conjugate vaccine (meningococcal protein conjugate) (LIQUID PEDVAXHIB) being used as the diluent for both measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) and varicella virus vaccine live (oka/merck) (VARIVAX), the patient received 1 ml of haemophilus b conjugate vaccine (meningococcal protein conjugate) (LIQUID PEDVAXHIB) instead of recommended dose of 0.5 ml, therefore receiving double the recommended dose of haemophilus b conjugate vaccine (meningococcal protein conjugate) (LIQUID PEDVAXHIB) (accidental overdose). Also, the haemophilus b conjugate vaccine (meningococcal protein conjugate) (LIQUID PEDVAXHIB) was given subcutaneously instead of intramuscularly since it was mixed as diluent with measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) and varicella virus vaccine live (oka/merck) (VARIVAX) (incorrect route of product administration). The patient has had no side effects at this time (no adverse event).
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional AE details available.; states 10 total doses of VARIVAX (6 doses) and PROQUAD (4 doses) that have been stored outside of recommended range have been administered to patients; This spontaneous report was received from an office manager in charge of vaccine storage and refers to a patient of unknown age and gender. The patient's medical history and concurrent conditions were not provided. The concomitant therapies included sterile diluent used for vaccine reconstitution.   On 28-JUN-2022, the patient was vaccinated with an improperly stored varicella virus vaccine live (oka/merck) (VARIVAX) subcutaneous injection, lot # U039722, expiration date 15-DEC-2023 (dose, strength, route of administration and anatomical location were not provided) for prophylaxis (product storage error). The administered vaccine underwent temperature excursion of 6 Fahrenheit degrees up tp 14 Fahrenheit degrees for 50 minutes and 14 Fahrenheit degrees up to 46 Fahrenheit degrees  (15 Fahrenheit degrees) for 30 minutes on 28-JUN-2022. There was no previous temperature excursion. No additional adverse event details were available (no adverse event).  This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-2207USA000680: US-009507513-2207USA000544: US-009507513-2207USA000552: US-009507513-2207USA000553: US-009507513-2207USA000561: US-009507513-2207USA000563: US-009507513-2207USA000765: US-009507513-2207USA000771: US-009507513-2207USA000775:
Sex: U
Vaccine: MMRV
Symptoms: Product administered to patient of inappropriate age, Wrong product administered
Clinical narrative: HCP reporting a patient older than 13 years of age was administered PROQUAD instead of MMR II and VARIVAX; HCP reporting a patient older than 13 years of age was administered PROQUAD instead of MMR II and VARIVAX; This spontaneous report was received from a licensed vocational nurse and refers to a patient older than 13 years of age and of unknown gender. The exact age of the patient was not provided. The patient's medical history, concurrent conditions, and concomitant therapies were not reported.  On 24-JUN-2022, the patient was vaccinated with measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) subcutaneous injection (strength, dose, lot #, expiry date, anatomical site, and route of administration were not provided) for prophylaxis (product administered to patient of inappropriate age). The vaccine was administrated instead of Measles, Mumps, and Rubella (Wistar RA 27-3) Virus Vaccine, Live (M-M-R II); and varicella virus vaccine live (Oka/Merck) (VARIVAX) (wrong product administered).
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional AE details available; have been stored outside of recommended range have been administered to patients; This spontaneous report has been received from the office manager referring a patient of an unknown age and gender. The patient's medical history, concurrent conditions, and previous drug reactions or allergies were not reported. Concomitant medications included sterile diluent.  On an unknown date in 2022, reported as between 28-JUN-2022 and 01-JUL-2022, the patient was vaccinated with an improperly stored varicella virus vaccine live (Oka/Merck) (VARIVAX), lot number U039722, expiration date: 15-DEC-2023, as prophylaxis (vaccination scheme, dose, anatomical location and route of administration were not provided) following a temperature excursion of 6 up to 14 Fahrenheit degrees (F) for 0 hours 50 minutes 0 seconds; 14 up to 46 Fahrenheit degrees (F) (15F) for 0 hours 30 minutes 0 seconds, which occured on 28-JUN-2022 (product storage error). There was stated that no previous temperature excursion occurred. No additional adverse event were reported.  This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-2207USA000680: US-009507513-2207USA000470: US-009507513-2207USA000552: US-009507513-2207USA000553: US-009507513-2207USA000561: US-009507513-2207USA000563: US-009507513-2207USA000765: US-009507513-2207USA000771: US-009507513-2207USA000775:
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional AE details available.; have been stored outside of recommended range have been administered to patient; This spontaneous report has been received from the office manager referring a patient of an unknown age and gender. The patient's medical history, concurrent conditions, and previous drug reactions or allergies were not reported. Concomitant medications included sterile diluent.  On an unknown date in 2022, reported as between 28-JUN-2022 and 01-JUL-2022, the patient was vaccinated with an improperly stored varicella virus vaccine live (Oka/Merck) (VARIVAX), lot number U039722, expiration date: 15-DEC-2023, as prophylaxis (vaccination scheme, dose, anatomical location and route of administration were not provided) following a temperature excursion of 6 up to 14 Fahrenheit degrees (F) for 0 hours 50 minutes 0 seconds; 14 up to 46 Fahrenheit degrees (F) (15F) for 0 hours 30 minutes 0 seconds, which occurred on 28-JUN-2022 (product storage error). There was stated that no previous temperature excursion occurred. No additional adverse event were reported.  This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-2207USA000680: US-009507513-2207USA000544: US-009507513-2207USA000470: US-009507513-2207USA000552: US-009507513-2207USA000553: US-009507513-2207USA000561: US-009507513-2207USA000765: US-009507513-2207USA000771: US-009507513-2207USA000775:
Sex: U
Vaccine: MMRV
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional AE details available; stored outside of recommended range have been administered to patient; This spontaneous report was received from an office manager referring to a patient of unknown age and gender.  The patient's medical history was not reported. The patient's concurrent conditions were not reported. Concomitant medications included sterile diluent (MERCK STERILE DILUENT).   On an unknown date between 28-JUN-2022 and 01-JUL-2022, the patient was vaccinated with measles, mumps, rubella and varicella (oka-merck) virus vaccine live recombinant human albumin (rHA) (PROQUAD) subcutaneous injection, administered for prophylaxis (lot #W006585, expiration date: 23-AUG-2023; strength, dose and route of administration were not provided). On 28-JUN-2022, excursion occurred, the vaccine had been stored outside of recommended range at 6 F up to 14 F for 50 mins and 14 F up to 46 F (15 F) for 30 mins. There was no previous temperature excursion. No additional adverse event (AE) was available.  This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-2207USA000680: US-009507513-2207USA000553: US-009507513-2207USA000470: US-009507513-2207USA000775: US-009507513-2207USA000561: US-009507513-2207USA000544: US-009507513-2207USA000552: US-009507513-2207USA000563: US-009507513-2207USA000765:
Sex: U
Vaccine: HEPA
Symptoms: Product storage error
Clinical narrative: No additional adverse events.; multiple doses of VAQTA administered since temperature excursion that occurred 16JUN202; This spontaneous report was received from a consumer and refers to a patient of unknown age and gender. The patient's medical history, concomitant therapies and concurrent conditions were not provided.  On 30-JUN-2022, the patient was vaccinated with 1 dose of improperly stored hepatitis a vaccine, inactivated (VAQTA) intramuscular injection, prefilled syringe, lot # U012678, expiration date 18-JAN-2023 (exact dose, dose number, strength, route of administration and anatomical location were not provided) for prophylaxis (product storage error). The administered hepatitis a vaccine, inactivated (VAQTA) underwent temperature excursion that took place on 16-JUN-2022 with 8.5 Celsius degrees for 10 minutes. Previous temperature excursion took place on an unknown date in May 2022 with 8.8 Celsius degrees for 11 minutes. No additional adverse events were reported (no adverse event).  This is one of several reports received from the same reporter. ; Sender's Comments:  US-009507513-2207USA004234: US-009507513-2207USA004244: US-009507513-2207USA004679: US-009507513-2207USA004710: US-009507513-2207USA004698: US-009507513-2207USA004707: US-009507513-2207USA004709: US-009507513-2207USA004695: US-009507513-2207USA004690: US-009507513-2207USA004697: US-009507513-2207USA004715: US-009507513-2207USA004700: US-009507513-2207USA004691: US-009507513-2207USA004688: US-009507513-2207USA004712: US-009507513-2207USA004714:
Age: 15.0
Sex: M
Vaccine: HPV9
Symptoms: Dizziness, Hyperhidrosis, Nausea
Clinical narrative: Caller is physician reporting that a patient received first dose of GARDASIL 9 yesterday 05JUL2022. Within 10 minutes of vaccine administration, patient was nauseated, diaphoretic and dizzy.; Caller is physician reporting that a patient received first dose of GARDASIL 9 yesterday 05JUL2022. Within 10 minutes of vaccine administration, patient was nauseated, diaphoretic and dizzy.; Caller is physician reporting that a patient received first dose of GARDASIL 9 yesterday 05JUL2022. Within 10 minutes of vaccine administration, patient was nauseated, diaphoretic and dizzy.; This spontaneous report was received from a physician and refers to a 15-year-old male patient. The patient's medical history and concurrent conditions were not reported. The patient was not receiving concomitant medications.   On 05-JUL-2022 (reported also as yesterday), the patient was vaccinated with a first dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) syringe, lot #: U019413, expiration date: 01-NOV-2023 (exact dose, strength, site and route of administration were not provided) for prophylaxis. Within 10 minutes of vaccine administration, the patient was nauseated, diaphoretic and dizzy. No intervention was necessary other than additional monitoring. The patient recovered from the events on the same day.  The relatedness between the events and hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) was not provided.
Sex: U
Vaccine: MMRV, UNK
Symptoms: Expired product administered, No adverse event
Clinical narrative: Patient had no symptoms or adverse effects/ No other adverse event; An expired dose of PROQUAD was given to a patient.; This vial had a different lot number and expiration date than all other vials of PROQUAD in the box./a box of PROQUAD came from Merck with one vial having a different lot number.; This spontaneous report was received from a medical assistant referring to a 4-year-old. child of unknown gender. The patient's pertinent medical history, drugs reactions or allergies and concomitant medications were not provided.  On 08-JUL-2022, the patient was vaccinated with an expired dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live recombinant Human albumin (rHA) (PROQUAD) subcutaneous injection, at the dose of 0.5 milliliter (mL), once (route of administration was not provided; lot number T030761 has been verified to be a valid lot number with expiration date on 08-MAR-2022) and was reconstituted with sterile diluent (MRK) at the dose of 0.5 milliliter (mL), once, both given as prophylaxis (lot number T025911 has been verified to be a valid lot number with expiration date on 08-MAR-2023).   The vial had a different lot number and expiration date than all other vials of measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) in the box (product lot number issue) It was attempted to clarified whether the caller has mixed lots/expiration dates because of storage procedures at the clinic or whether she was reporting that a box of measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) came from Merck with one vial having a different lot number. Caller stated she was unsure; she initially stated that she thought that this was a human error, but then later stated that "maybe it came from Merck this way". She stated that the vials were in the original Merck box and came to the clinic as part of a vaccines for children shipment but did not want to provide any further information. It was reported that measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) had no history of temperature excursions. No other information and no other adverse event reported. .
Sex: U
Vaccine: VARCEL
Symptoms: Expired product administered, No adverse event, Product storage error
Clinical narrative: no additional AE reported; expired dose of VARIVAX was administered to a patient on 11JUL2022; X expired on 30JUN2022 and did experience a temperature excursion on 1APR2022.; This spontaneous report was received from the Office Manager and refers to a patient of an unknown age and gender. The patient's medical history, concurrent conditions, and concomitant therapies were not reported.  On 11-JUL-2022, the patient was vaccinated with varicella virus vaccine live (oka/merck) (VARIVAX) subcutaneous injection, 0.5 ml, lot #T022312, expiration date: 30-JUN-2022, administered for prophylaxis (dose number, strength, an anatomical location and route of administration were not provided). The vaccine experienced a temperature excursion on 1-APR-2022 (product storage error), and additionally did expire on 30-JUN-2022 (expired product administered). No other adverse event reported.
Sex: U
Vaccine: MMRV
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional AE reported; HCP reported PROQUAD was administered to patient after a temperature excursion. Date of administration was Mar 23, 2022.; This spontaneous report was received from a nurse and refers to a patient of unknown age and gender. No information regarding the patient's concurrent conditions, medical history and concomitant medications was provided.  On 23-MAR-2022, the patient was vaccinated with improperly stored (product storage error) dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live (recombinant Human albumin) (PROQUAD) lot #: U010745, expiration date: 03-OCT-2022 (exact dose, strength, site and route of administration were not provided) for prophylaxis. Temperature excursion information: -8.3 degree Celsius for 1 hour 1 minute. No previous temperature excursion. There was no additional adverse event reported.
Sex: U
Vaccine: HPV9
Symptoms: Cerebrovascular accident
Clinical narrative: Patient experienced a stroke 8 days after receiving GARDASIL 9.; This spontaneous report was received from a physician via company representative and refers to an adult patient ("in early 40s") of unknown gender. No information regarding the patient's concurrent conditions, medical history and concomitant medications was provided.  On an unknown date, the patient was vaccinated with hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) (exact dose, strength, lot #, expiration date, site and route of administration were not provided) for prophylaxis.  On an unknown date, 8 days after receiving hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9), the patient experienced a stroke. On an unknown date, the patient recovered from the event. It was unknown whether the patient received any treatment for the event.  The causal relationship between the event and hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) was not provided.  Upon internal review, the event of stroke was determined to be medically significant.
Sex: U
Vaccine: HEPA
Symptoms: Expired product administered
Clinical narrative: no other AE occurred.; The caller said they inadvertently administered an expired dose of VAQTA today, 7/12/2022, to a patient.; This spontaneous report was received from the Medical Assistant and refers to a patient of an unknown age and gender. The patient's medical history, concurrent conditions, and concomitant therapies were not reported.  On 12-JUL-2022, the patient was inadvertently vaccinated with an expired hepatitis a vaccine, inactivated (VAQTA) intramuscular injection, 1 dosage form, lot #t040581, expiration date: 28-MAR-2022, administered for prophylaxis (dose number, strength, an anatomical location and route of administration were not provided) (expired product administered). No further information provided.
Sex: F
Vaccine: PPV
Symptoms: Blood culture negative, Bone pain, Chills, Culture urine negative, Erythema
Clinical narrative: muscle and bone pain; teeth chattering, like she was cold; nausea; dry heaving; headache; fever of 103; muscle and bone pain; According, to the consumer the doctors from the hospital told her she was being treated for sepsis; arm started to blow up like a red balloon and spread everywhere; arm started to blow up like a red balloon and spread everywhere; injection site pain; This spontaneous report was received from a 67-year-old female, referring to herself.  The patient's medical history included COVID-19 and kidney stones. The patient's concurrent conditions were not reported. Historical drugs included codeine (causes nausea) and benadryl (causes somnolence). Concomitant medications included gabapentin, montelukast, escitalopram oxalate (LEXAPRO) and omeprazole (PRILOSEC).   On 07-JUL-2022, the patient was vaccinated with first dose of pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) injection, administered for prophylaxis (reported as "to stay out of the hospital with pneumonia") in upper right arm (strength, exact dose, lot #, expiry date and route of administration were not provided).  On 07-JUL-2022, the patient experienced injection site pain. On 08-JUL-2022, the patient experienced teeth chattering, like she was cold, which quickly led to a headache, muscle and bone pain, nausea and dry heaving and a fever of 103. On 08-JUL-2022, the patient was admitted to the hospital and reported the hospital performed urine and blood cultures, COVID testing and a viral screen; all of these tests came back negative or clear according to the patient. The patient was administered pain medication and an antibiotic. On 09-JUL-2022, the arm she received the pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) in, started to "blow up like a red balloon and spread everywhere". According to the patient, the doctors from the hospital told her, she was being treated for sepsis and would not listen to her regarding a reaction to the vaccine, stating "there was a lot of paperwork involved." The patient reports, that she was home now and was still red and swollen, "just not as bad as before". On 11-JUL-2022, the patient was discharged from the hospital. At the time of reporting, the patient had not recovered from the events.  The reporter considered events of teeth chattering, headache, muscle and bone pain, nausea, dry heaving, fever, injection site pain and arm started to blow up like a red balloon and spread everywhere to be related to pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23). The causal relationship between sepsis and pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) was not reported.  Upon the internal review, the event of sepsis was considered to be medically significant.
Sex: F
Vaccine: PPV
Symptoms: Headache, Injection site pain, Myalgia, Nausea, Peripheral swelling
Clinical narrative: muscle and bone pain; teeth chattering, like she was cold; nausea; dry heaving; headache; fever of 103; muscle and bone pain; According, to the consumer the doctors from the hospital told her she was being treated for sepsis; arm started to blow up like a red balloon and spread everywhere; arm started to blow up like a red balloon and spread everywhere; injection site pain; This spontaneous report was received from a 67-year-old female, referring to herself.  The patient's medical history included COVID-19 and kidney stones. The patient's concurrent conditions were not reported. Historical drugs included codeine (causes nausea) and benadryl (causes somnolence). Concomitant medications included gabapentin, montelukast, escitalopram oxalate (LEXAPRO) and omeprazole (PRILOSEC).   On 07-JUL-2022, the patient was vaccinated with first dose of pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) injection, administered for prophylaxis (reported as "to stay out of the hospital with pneumonia") in upper right arm (strength, exact dose, lot #, expiry date and route of administration were not provided).  On 07-JUL-2022, the patient experienced injection site pain. On 08-JUL-2022, the patient experienced teeth chattering, like she was cold, which quickly led to a headache, muscle and bone pain, nausea and dry heaving and a fever of 103. On 08-JUL-2022, the patient was admitted to the hospital and reported the hospital performed urine and blood cultures, COVID testing and a viral screen; all of these tests came back negative or clear according to the patient. The patient was administered pain medication and an antibiotic. On 09-JUL-2022, the arm she received the pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) in, started to "blow up like a red balloon and spread everywhere". According to the patient, the doctors from the hospital told her, she was being treated for sepsis and would not listen to her regarding a reaction to the vaccine, stating "there was a lot of paperwork involved." The patient reports, that she was home now and was still red and swollen, "just not as bad as before". On 11-JUL-2022, the patient was discharged from the hospital. At the time of reporting, the patient had not recovered from the events.  The reporter considered events of teeth chattering, headache, muscle and bone pain, nausea, dry heaving, fever, injection site pain and arm started to blow up like a red balloon and spread everywhere to be related to pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23). The causal relationship between sepsis and pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) was not reported.  Upon the internal review, the event of sepsis was considered to be medically significant.
Sex: F
Vaccine: PPV
Symptoms: Pyrexia, Retching, SARS-CoV-2 test negative, Sepsis, Viral test negative
Clinical narrative: muscle and bone pain; teeth chattering, like she was cold; nausea; dry heaving; headache; fever of 103; muscle and bone pain; According, to the consumer the doctors from the hospital told her she was being treated for sepsis; arm started to blow up like a red balloon and spread everywhere; arm started to blow up like a red balloon and spread everywhere; injection site pain; This spontaneous report was received from a 67-year-old female, referring to herself.  The patient's medical history included COVID-19 and kidney stones. The patient's concurrent conditions were not reported. Historical drugs included codeine (causes nausea) and benadryl (causes somnolence). Concomitant medications included gabapentin, montelukast, escitalopram oxalate (LEXAPRO) and omeprazole (PRILOSEC).   On 07-JUL-2022, the patient was vaccinated with first dose of pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) injection, administered for prophylaxis (reported as "to stay out of the hospital with pneumonia") in upper right arm (strength, exact dose, lot #, expiry date and route of administration were not provided).  On 07-JUL-2022, the patient experienced injection site pain. On 08-JUL-2022, the patient experienced teeth chattering, like she was cold, which quickly led to a headache, muscle and bone pain, nausea and dry heaving and a fever of 103. On 08-JUL-2022, the patient was admitted to the hospital and reported the hospital performed urine and blood cultures, COVID testing and a viral screen; all of these tests came back negative or clear according to the patient. The patient was administered pain medication and an antibiotic. On 09-JUL-2022, the arm she received the pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) in, started to "blow up like a red balloon and spread everywhere". According to the patient, the doctors from the hospital told her, she was being treated for sepsis and would not listen to her regarding a reaction to the vaccine, stating "there was a lot of paperwork involved." The patient reports, that she was home now and was still red and swollen, "just not as bad as before". On 11-JUL-2022, the patient was discharged from the hospital. At the time of reporting, the patient had not recovered from the events.  The reporter considered events of teeth chattering, headache, muscle and bone pain, nausea, dry heaving, fever, injection site pain and arm started to blow up like a red balloon and spread everywhere to be related to pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23). The causal relationship between sepsis and pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) was not reported.  Upon the internal review, the event of sepsis was considered to be medically significant.
Age: 1.5
Sex: M
Vaccine: HIBV
Symptoms: Accidental overdose, No adverse event
Clinical narrative: No adverse events; Patient was given two dose of PedvaxHIB accidentally / Two doses given in the same day; This spontaneous report has been received from a nurse concerning a 18-month-old male patient.  The patient's medical history, concurrent conditions, historical drugs, and concomitant therapies were not reported.  On 11-JUL-2022, the patient was accidentally vaccinated with two doses of haemophilus b conjugate vaccine (meningococcal protein conjugate) (LIQUID PEDVAXHIB) 0.5 milliliter (lot number U034521 has been verified to be a valid lot number for haemophilus b conjugate vaccine (meningococcal protein conjugate) (LIQUID PEDVAXHIB), expiration date reported and confirmed as 21-JUN-2024) (formulation and route of administration were not provided) in his left thigh as prophylaxis (Accidental overdose). The patient was held for thirty minutes after these doses were given and then released by the doctor. The patient had no adverse events reported before he was discharged.
Sex: F
Vaccine: MMR
Symptoms: Expired product administered, No adverse event
Clinical narrative: no additional AE; Patient that was administered an expired dose of MMR II; This spontaneous report was received from a pharmacy intern and refers to a female patient of unknown age. No information regarding the patient's medical history, concurrent conditions or concomitant therapies was provided.  On 08-JUL-2022, the patient was vaccinated with an expired dose of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) rHA, lot #T020655, expiration date: 16-JUN-2022 (strength and route of administration were not provided) for prophylaxis (Expired product administered). No adverse events were reported (No adverse event).
Sex: U
Vaccine: HEPA
Symptoms: Product storage error
Clinical narrative: No additional adverse events.; multiple doses of VAQTA administered since temperature excursion that occurred 16JUN202; This spontaneous report was received from a consumer and refers to a patient of unknown age and gender. The patient's medical history, concomitant therapies and concurrent conditions were not provided.  On 29-JUN-2022, the patient was vaccinated with 1 dose of improperly stored hepatitis a vaccine, inactivated (VAQTA) intramuscular injection, prefilled syringe, lot # U012678, expiration date 18-JAN-2023 (exact dose, dose number, strength, route of administration and anatomical location were not provided) for prophylaxis (product storage error). The administered hepatitis a vaccine, inactivated (VAQTA) underwent temperature excursion that took place on 16-JUN-2022 with 8.5 Celsius degrees for 10 minutes. Previous temperature excursion took place on an unknown date in May 2022 with 8.8 Celsius degrees for 11 minutes. No additional adverse events were reported (no adverse event).  This is one of several reports received from the same reporter. ; Sender's Comments:  US-009507513-2207USA001345: US-009507513-2207USA004244: US-009507513-2207USA004679: US-009507513-2207USA004688: US-009507513-2207USA004690: US-009507513-2207USA004691: US-009507513-2207USA004695: US-009507513-2207USA004697: US-009507513-2207USA004698: US-009507513-2207USA004700: US-009507513-2207USA004707: US-009507513-2207USA004709: US-009507513-2207USA004710: US-009507513-2207USA004712: US-009507513-2207USA004714: US-009507513-2207USA004715:
Sex: U
Vaccine: HEPA
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional adverse events.; multiple doses of VAQTA administered since temperature excursion that occurred 16JUN202; This spontaneous report was received from a consumer and refers to a patient of unknown age and gender. The patient's medical history, concomitant therapies and concurrent conditions were not provided.  On 30-JUN-2022, the patient was vaccinated with 1 dose of improperly stored hepatitis a vaccine, inactivated (VAQTA) intramuscular injection, prefilled syringe, lot # U012678, expiration date 18-JAN-2023 (exact dose, dose number, strength, route of administration and anatomical location were not provided) for prophylaxis (product storage error). The administered hepatitis a vaccine, inactivated (VAQTA) underwent temperature excursion that took place on 16-JUN-2022 with 8.5 Celsius degrees for 10 minutes. Previous temperature excursion took place on an unknown date in May 2022 with 8.8 Celsius degrees for 11 minutes. No additional adverse events were reported (no adverse event).  This is one of several reports received from the same reporter. ; Sender's Comments:  US-009507513-2207USA004234: US-009507513-2207USA001345: US-009507513-2207USA004690: US-009507513-2207USA004691: US-009507513-2207USA004695: US-009507513-2207USA004697: US-009507513-2207USA004698: US-009507513-2207USA004700: US-009507513-2207USA004707: US-009507513-2207USA004709: US-009507513-2207USA004710: US-009507513-2207USA004712: US-009507513-2207USA004714: US-009507513-2207USA004715: US-009507513-2207USA004234:
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional AE reported; HBP reported an adverse event. Caller stated VARIVAX was administered after a temperature excursion. No additional AE or PQC reported. No additional information provided.   ?    Names of vaccines involved (including lot/exp): VARIVAX Lot U039726, E; This spontaneous report has been received from a nurse, regarding a patient of unknown age and gender. The patient's pertinent medical history, current conditions, previous drug reactions or allergies, and concomitant medications were not reported.  On 02-JUN-2022, the patient was vaccinated with improperly storage dose varicella virus vaccine live (Oka/Merck) (VARIVAX) as prophylaxis (lot number: U039726, which was determined to be valid, with an expiration date on 15-DEC-2023) (strength, dose, route and anatomical location of administration were not provided) (product storage error). Administered dose underwent a temperature excursion of -13,5 degrees Celsius (C) for 1 hour. It was reported that there was not any previous temperature excursion. No additional adverse event was provided.
Sex: M
Vaccine: COVID19
Symptoms: Myocardial infarction
Clinical narrative: HEART ATTACK;   Information was received from a Consumer/other non-health professional concerning a 67 Year(s) old Male patient, enrolled in the post marketing study who received Suspect product APIXABAN for Product used for unknown indication, lot number: Unknown; Suspect product COVID-19 VACCINE for Product used for unknown indication, lot number: Unknown. On an unknown date, the patient experienced myocardial infarction (heart attack) which was considered serious due to medical significance. The outcome of the event is unknown. The patient stated he had a heart attack due to a COVID-19 vaccine. The status of APIXABAN medication is unknown. The status of COVID-19 VACCINE medication is unknown. Concomitant medications were not reported. The reporter considered event myocardial infarction not related to product APIXABAN. The reporter considered event myocardial infarction related to product COVID-19 VACCINE. Tracking of Changes: 06-Jul-2022: Initial information was received.   Eliquis is under agreement.; Sender's Comments: Comment: This 67-year-old patient had myocardial infarction after apixaban therapy. Elderly age is a significant risk factor for the reported event and is considered not related to apixaban therapy.  A causal association between reported event and BNT162B2 cannot be excluded.  The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Laboratory test, Malaise, Pain, Vaccination failure
Clinical narrative: got the booster shot, broke out with shingles/ suspected Vaccination failure; broke out with shingles; felt so bad; hurt so bad, horrible pain; This case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, between 1 and 2 months after receiving Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant), shingles, feeling unwell and pain. On an unknown date, the outcome of the vaccination failure, shingles, feeling unwell and pain were unknown.   It was unknown if the reporter considered the vaccination failure, shingles, feeling unwell and pain to be related to Shingles vaccine.     Additional Information: GSK Receipt Date: 9-Jul-2022 Reporter's Comments: The patient self-reported the case via interactive digital media. The patient got the booster shot November 13th (year unspecified), felt so bad and hurt so bad and went to the hospital the 11th of December (year unspecified) they did all kind of heart test sent him/ her home broke out with the shingles. December 14th (year unspecified) it had been horrible pain, but they said that there was nothing in the booster shot that was related to the shingle. Additional Supportive Information:  This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule and laboratory confirmation were unknown at the time of reporting. The follow-up would not possible as no contact details were available.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Irritability, Post herpetic neuralgia, Pruritus, Skin ulcer
Clinical narrative: had them, had the vaccine; had them, had the vaccine; pruritus; nerve pain; sores; stress; irritating; This case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant), shingles, pruritus, post herpetic neuralgia, skin ulcer, stress and irritability. On an unknown date, the outcome of the vaccination failure, shingles, pruritus, post herpetic neuralgia, skin ulcer, stress and irritability were unknown.   It was unknown if the reporter considered the vaccination failure, shingles, pruritus, post herpetic neuralgia, skin ulcer, stress and irritability to be related to Shingles vaccine.     Additional Information: GSK Receipt Date: 9-Jul-2022 Reporter's Comments: The patient self-reported the case via interactive digital media. The patient had them 27 times at the time of reporting. Sometimes twice in a 6-8-week period. The patient stated that stress causes mine.  They itch till patient could not stand it, nerve pain gets worse but not much pain with the sores. The patient had the vaccine, but it did not affect it.  Each time it could last from 5 days - 2 weeks.  Very irritating and patient had been to doctor and 2 specialist and nothing had helped. Additional Supportive Information:  This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule, time to onset and laboratory test confirming shingles were unknown at the time of reporting. The follow-up would not possible as no contact details were available.
Sex: U
Vaccine: VARZOS
Symptoms: Stress, Vaccination failure
Clinical narrative: had them, had the vaccine; had them, had the vaccine; pruritus; nerve pain; sores; stress; irritating; This case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant), shingles, pruritus, post herpetic neuralgia, skin ulcer, stress and irritability. On an unknown date, the outcome of the vaccination failure, shingles, pruritus, post herpetic neuralgia, skin ulcer, stress and irritability were unknown.   It was unknown if the reporter considered the vaccination failure, shingles, pruritus, post herpetic neuralgia, skin ulcer, stress and irritability to be related to Shingles vaccine.     Additional Information: GSK Receipt Date: 9-Jul-2022 Reporter's Comments: The patient self-reported the case via interactive digital media. The patient had them 27 times at the time of reporting. Sometimes twice in a 6-8-week period. The patient stated that stress causes mine.  They itch till patient could not stand it, nerve pain gets worse but not much pain with the sores. The patient had the vaccine, but it did not affect it.  Each time it could last from 5 days - 2 weeks.  Very irritating and patient had been to doctor and 2 specialist and nothing had helped. Additional Supportive Information:  This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule, time to onset and laboratory test confirming shingles were unknown at the time of reporting. The follow-up would not possible as no contact details were available.
Sex: U
Vaccine: VARZOS
Symptoms: Unevaluable event
Clinical narrative: ended up in hospital; This case was reported by a consumer via interactive digital media and described the occurrence of hospitalization in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingles vaccine. On an unknown date, 1 day after receiving Shingles vaccine, the patient experienced hospitalization (serious criteria hospitalization). On an unknown date, the outcome of the hospitalization was unknown.   It was unknown if the reporter considered the hospitalization to be related to Shingles vaccine.     Additional Information: GSK Receipt Date: 13-JUL-2022 Reporter's Comments: This case was reported by patient via interactive digital media. The patient received first dose of Shingles vaccine and next day ended up in hospital. Additional supportive information: The follow-up would not possible as no contact details were available.
Sex: U
Vaccine: VARZOS
Symptoms: Pain
Clinical narrative: 2nd shot was painful; This case was reported by a consumer via interactive digital media and described the occurrence of pain in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received the 2nd dose of Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced pain. On an unknown date, the outcome of the pain was unknown.   It was unknown if the reporter considered the pain to be related to Shingles vaccine.     Additional Information: GSK Receipt Date: 8-Jul-2022 Reporter's Comments:  This case was received from consumer via interactive digital media. The patient had the full dosage, the 2nd shot was painful but from what he/she heard about Shingles, rather the shots The follow-up would not possible as no contact details were available.
Sex: U
Vaccine: VARZOS
Symptoms: Fatigue, Pain
Clinical narrative: little fatigued; teeny bit sore; This case was reported by a consumer via interactive digital media and described the occurrence of fatigue in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, several days after receiving Shingles vaccine, the patient experienced fatigue and pain. On an unknown date, the outcome of the fatigue and pain were not recovered/not resolved.   It was unknown if the reporter considered the fatigue and pain to be related to Shingles vaccine.     Additional Information: GSK Receipt Date: 10-JUL-2022 Reporter's Comments: This case was reported by patient via interactive digital media. The patient received a dose Shingles vaccine and still a tiny bit sore a few days later and a little fatigued. The patient reported that his/her sister in law had shingles. The patient would take the shot. Additional supportive information: The follow-up would not possible as no contact details were available.
Age: 58.0
Sex: F
Vaccine: VARZOS
Symptoms: Blister, Eye infection, Eye swelling, Paraesthesia, Swelling face
Clinical narrative: Tingling on the left side of her face; broke out into blisters/hard for the patient to open her eye, blister under the eye; nerve pain on the left side of her face; left side of her face is also swollen; her left eye is swollen shut; Eye infection; This case was reported by a consumer via call center representative and described the occurrence of tingling in a 58-year-old female patient who received Herpes zoster (Shingrix) (batch number MR75G, expiry date 13th July 2023) for prophylaxis.   On 16th June 2022, the patient received the 1st dose of Shingrix .5 ml. On an unknown date, less than 3 weeks after receiving Shingrix, the patient experienced tingling, blisters, facial neuralgia, facial swelling, eye swelling and eye infection. The patient was treated with valaciclovir hydrochloride (Valtrex), ophthalmologicals (nos) (Eye Ointment (Ingredients Or Trade Name Unknown)) and ophthalmologicals (nos) (Eye Drop (Nos)). On an unknown date, the outcome of the tingling, blisters, facial neuralgia, facial swelling and eye infection were unknown and the outcome of the eye swelling was not recovered/not resolved.   It was unknown if the reporter considered the tingling, blisters, facial neuralgia, facial swelling, eye swelling and eye infection to be related to Shingrix.     Additional Information: GSK Receipt Date: 05-JUL-2022 Reporter's comment: The patient self-reported this case. The patient received dose of Shingrix vaccine and experienced tingling and nerve pain on the left side of her face and then broke out into blisters.  The left side of her face was also swollen and her left eye was swollen shut.  The patient went to the walk-in clinic and was prescribed Valtrex. She also went to the eye doctor and was prescribed eye drops and eye ointment just in case of an infection.  The patient had another appointment with the eye doctor.  The outcome of initial visit with the eye doctor was that everything looks okay with her eye, but she needs to went back so the doctor could get a better look.  It was hard for the patient to open her eye as she had a blister under the eye. The reporter consented to follow-up.