chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 20.0
Sex: F
Vaccine: COVID19-2
Symptoms: Body temperature, Dizziness, Injection site induration, Malaise, Presyncope
Clinical narrative: This spontaneous case was reported by a patient family member or friend and describes the occurrence of DIZZINESS (Felt dizzy all day long), MALAISE (Not feeling well/feels unwell), PRESYNCOPE (Almost fainted, she felt like she would pass out), PYREXIA (103.5 Fahrenheit degrees fever/99-100 Fahrenheit degrees fever) and VACCINATION SITE SWELLING (This morning (13Sep2022) her arm on the site of injection is double its size) in a 20-year-old female patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. A57145B) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. Patient was never tested positive for Covid-19. Concurrent medical conditions included Adhesive tape allergy. Concomitant products included ELAGOLIX SODIUM (ORILISSA) and ESTROGENS CONJUGATED (PREMARIN) for an unknown indication. On 10-Sep-2022, the patient received fourth dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On 10-Sep-2022, the patient experienced PRESYNCOPE (Almost fainted, she felt like she would pass out) and PYREXIA (103.5 Fahrenheit degrees fever/99-100 Fahrenheit degrees fever). On 11-Sep-2022, the patient experienced DIZZINESS (Felt dizzy all day long). On 12-Sep-2022, the patient experienced MALAISE (Not feeling well/feels unwell). On 13-Sep-2022, the patient experienced VACCINATION SITE SWELLING (This morning (13Sep2022) her arm on the site of injection is double its size) and INJECTION SITE INDURATION (Site of injection swollen and hard). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency and IBUPROFEN (MOTRIN [IBUPROFEN]) at an unspecified dose and frequency. At the time of the report, DIZZINESS (Felt dizzy all day long), MALAISE (Not feeling well/feels unwell), PRESYNCOPE (Almost fainted, she felt like she would pass out), PYREXIA (103.5 Fahrenheit degrees fever/99-100 Fahrenheit degrees fever), VACCINATION SITE SWELLING (This morning (13Sep2022) her arm on the site of injection is double its size) and INJECTION SITE INDURATION (Site of injection swollen and hard) outcome was unknown.    DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 10-Sep-2022, Body temperature: 103.5 103.5 Fahrenheit degrees fever. On 12-Sep-2022, Body temperature: 99-100 Fahrenheit degrees fever. Patient took Moderna first dose on 16-Feb-2021 (lot number 011M20A), Moderna second dose on 16-Mar-2021 (047A21A), Moderna 1st booster dose on 12-Nov-2021 (lot number 033F21A). Concomitant medication reported as Hormonal IUD with description Progesterone. The patient visited the hospital, where some tests were conducted. The tests were normal. The patient was released midnight from the hospital. This case was linked to MOD-2022-645021 (Patient Link).
Age: 20.0
Sex: F
Vaccine: COVID19-2
Symptoms: Pyrexia, Vaccination site swelling
Clinical narrative: This spontaneous case was reported by a patient family member or friend and describes the occurrence of DIZZINESS (Felt dizzy all day long), MALAISE (Not feeling well/feels unwell), PRESYNCOPE (Almost fainted, she felt like she would pass out), PYREXIA (103.5 Fahrenheit degrees fever/99-100 Fahrenheit degrees fever) and VACCINATION SITE SWELLING (This morning (13Sep2022) her arm on the site of injection is double its size) in a 20-year-old female patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. A57145B) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. Patient was never tested positive for Covid-19. Concurrent medical conditions included Adhesive tape allergy. Concomitant products included ELAGOLIX SODIUM (ORILISSA) and ESTROGENS CONJUGATED (PREMARIN) for an unknown indication. On 10-Sep-2022, the patient received fourth dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On 10-Sep-2022, the patient experienced PRESYNCOPE (Almost fainted, she felt like she would pass out) and PYREXIA (103.5 Fahrenheit degrees fever/99-100 Fahrenheit degrees fever). On 11-Sep-2022, the patient experienced DIZZINESS (Felt dizzy all day long). On 12-Sep-2022, the patient experienced MALAISE (Not feeling well/feels unwell). On 13-Sep-2022, the patient experienced VACCINATION SITE SWELLING (This morning (13Sep2022) her arm on the site of injection is double its size) and INJECTION SITE INDURATION (Site of injection swollen and hard). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency and IBUPROFEN (MOTRIN [IBUPROFEN]) at an unspecified dose and frequency. At the time of the report, DIZZINESS (Felt dizzy all day long), MALAISE (Not feeling well/feels unwell), PRESYNCOPE (Almost fainted, she felt like she would pass out), PYREXIA (103.5 Fahrenheit degrees fever/99-100 Fahrenheit degrees fever), VACCINATION SITE SWELLING (This morning (13Sep2022) her arm on the site of injection is double its size) and INJECTION SITE INDURATION (Site of injection swollen and hard) outcome was unknown.    DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 10-Sep-2022, Body temperature: 103.5 103.5 Fahrenheit degrees fever. On 12-Sep-2022, Body temperature: 99-100 Fahrenheit degrees fever. Patient took Moderna first dose on 16-Feb-2021 (lot number 011M20A), Moderna second dose on 16-Mar-2021 (047A21A), Moderna 1st booster dose on 12-Nov-2021 (lot number 033F21A). Concomitant medication reported as Hormonal IUD with description Progesterone. The patient visited the hospital, where some tests were conducted. The tests were normal. The patient was released midnight from the hospital. This case was linked to MOD-2022-645021 (Patient Link).
Sex: M
Vaccine: COVID19
Symptoms: Swelling, Vaccination site pain
Clinical narrative: [after previous doses] swelling; [after previous doses] pain at the injection site/[after previous doses] soreness; This spontaneous case was reported by a consumer and describes the occurrence of SWELLING ([after previous doses] swelling) and VACCINATION SITE PAIN ([after previous doses] pain at the injection site/[after previous doses] soreness) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 016M20A and 012L20A) for COVID-19 vaccination.     No Medical History information was reported.   On 20-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 17-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced SWELLING ([after previous doses] swelling) and VACCINATION SITE PAIN ([after previous doses] pain at the injection site/[after previous doses] soreness). At the time of the report, SWELLING ([after previous doses] swelling) outcome was unknown and VACCINATION SITE PAIN ([after previous doses] pain at the injection site/[after previous doses] soreness) had resolved.            No concomitant medication information was provided. No treatment information was provided.   This case was linked to MOD-2022-647145, MOD-2021-015968 (Patient Link).
Age: 32.0
Sex: F
Vaccine: HEP
Symptoms: Pruritus, Urticaria
Clinical narrative: Patient has complaints of hives all over her body and itching. Patient has not taken any medication as of right now,
Sex: U
Vaccine: VARCEL
Symptoms: Accidental overdose, No adverse event, Product storage error
Clinical narrative: no addtional AE; inadvertently administered improperly stored vaccine; inadvertentlyadministered for 2 doses to the same patient; This spontaneous report was received from a registered nurse, referring to a patient of unknown age and gender. The patient's medical history, concurrent condition, drug allergies/reactions were not provided. Concomitant therapy included sterile diluent.  Two doses of improperly stored varicella virus vaccine live (oka/merck) (VARIVAX) (lot # U025205, expiration date 13-AUG-2023; strength, dose and route were unknown) may have been administered to the patient inadvertently(product storage error, accidental overdose) on 07-AUG-2022 (also reported as on 07-AUG-2022 and "two months later").   Temperature excursion of this vaccine was minus 80 Fahrenheit degrees for 264 hours. There was no previous temperature excursion. No additional adverse event or product quality compliant was reported.
Sex: F
Vaccine: HPV9
Symptoms: Off label use
Clinical narrative: A 60-year old female patient was prescribed GARDASIL 9 by her physician. Vaccine has not been administered to the patient. Agent is filing a near miss AE due to the off label prescription of GARDASIL 9.; No additional AE reported. No PQC reported.; This spontaneous report was received from a pharmacist concerning a 60-year-old female patient. The patient's concomitant medications, pertinent medical history, and drug reactions/allergies were not reported.  On an unspecified date, the patient was prescribed with off label HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast) (GARDASIL 9) by her physician for prophylaxis (off label use). It was confirmed that the vaccine had not been administered to the patient. No additional adverse event (AE) was reported.
Sex: U
Vaccine: PPV
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional AE reported.; HCP reported PNEUMOVAX 23 (PFS) was administered after a temperature excursion to a patient.; This spontaneous report was received from a medical assistant referring to a patient of unknown age and gender. The patient's concurrent conditions, medical history, drug reactions/allergies and concomitant therapies were not reported.  On 14-JUN-2022, the patient was vaccinated with pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) once (strength, dose and route of administration were not provided), lot #U003306, expiration date: 15-OCT-2022, administered for prophylaxis, after a temperature excursion (Product storage error) occurred on 12-APR-2022 in 62 degrees Fahrenheit for 5 hours 12 minutes. No previous temperature excursion. No additional adverse event (AE) reported.   This is one of four reports received from the same reporter. ; Sender's Comments:  US-009507513-2208USA010861: US-009507513-2209USA000715: US-009507513-2209USA000730:
Sex: U
Vaccine: RV5
Symptoms: Product storage error
Clinical narrative: No additional AEs were reported; The healthcare worker reported that a patient received improperly stored vaccine (storage temperature: 11.3 C); This spontaneous report as received from an other health professional refers to a 4-month-old patient of unknown gender. No information regarding the patient's concurrent conditions, medical history, drug reactions or allergies and concomitant medications was provided.     On 29-AUG-2022, the patient was vaccinated with one dose of improperly stored rotavirus vaccine, live, oral, pentavalent (ROTATEQ) lot# W002562 (was verified to be valid), expiration date: 12-OCT-2023 or lot# w004504, expiration date: 16-JUN-2023, administered orally (exact dose was not reported) for prophylaxis. Administered dose of vaccine has been stored in the temperature of 11.3 degrees Celsius for 34 minutes (LLT: Product storage error temperature too high). There were no previous temperature excursions reported. No adverse event was reported.
Age: 1.0
Sex: U
Vaccine: HEPA, HEPA
Symptoms: Product storage error
Clinical narrative: No additional AEs were reported,; The healthcare worker reported that a patient received improperly./Temperature: 11.3C; This spontaneous report was received from the healthcare worker and refers to a 12-month-old patient of an unknown gender.  The patient's medical history, concurrent conditions, and concomitant therapies were not provided.  On 29-AUG-2022, the patient was vaccinated with hepatitis a vaccine, inactivated (VAQTA) intramuscular injection, lot #w003118, expiration date: 13-JUL-2023, administered for prophylaxis (strength, and route of administration were not provided); or hepatitis a vaccine, inactivated (VAQTA) intramuscular injection, lot #w015191, verified as valid lot of prefilled syringe, expiration date: 27-OCT-2023, administered for prophylaxis (strength, and route of administration were not provided). The vaccine was improperly stored before, and the patient received only one dose, but it was not specified which lot number was involved (product storage error). No further information provided.
Sex: U
Vaccine: RV5
Symptoms: Product storage error
Clinical narrative: No additional AE details; HBP in charge of vaccine storage calling for TE evaluation on refrigerated products. Products were administered to multiple patients.; This spontaneous report was received from a health business professional and refers to a patient of unspecified age and gender.  The patient's pertinent medical history, concomitant therapies, drug reactions and allergies were not reported.  a temperature excursion occurred on refrigerated products, with temperature of above 46 Fahrenheit (F) degrees at 62.8 F for 8 hours. On 06-SEP-2022, the patient was vaccinated with an improperly stored dose of rotavirus vaccine, live, oral, pentavalent (ROTATEQ) oral liquid, with lot #1879864, expiration date: 19-OCT-2023, administered orally for prophylaxis (strength dose, and vaccine scheme frequency were not provided) (Product storage error). There were no previous temperature excursions. No adverse events were reported.  This is one of several cases from the same reporter.; Sender's Comments:  US-009507513-2209USA003021:02242077 US-009507513-2209USA003055:02242082 US-009507513-2209USA002510:02242136 US-009507513-2209USA002557:02242137 US-009507513-2209USA002540:02242138 US-009507513-2209USA002566:02242139 US-009507513-2209USA002779:02242131 US-009507513-2209USA002481:02242135 US-009507513-2209USA002570:02242096 US-009507513-2209USA002469:02242101 US-009507513-2209USA002559:02242113 US-009507513-2209USA002573:02242103 US-009507513-2209USA002606:02242106 US-009507513-2209USA002532:02242109 US-009507513-2209USA002746:02242132 US-009507513-2209USA002745:02242092 US-009507513-2209USA002574:02242099
Sex: U
Vaccine: MMRV
Symptoms: No adverse event, Product storage error
Clinical narrative: No AEs; RN called to report temperature excursion that occurred on 7/12/2022. Caller states that 100 doses of PROQUAD and 94 doses of VARIVAX were administered since 7/12/2022 from mobile unit. No further information provided. No add; This spontaneous report was received from a nurse and refers to a child of unknown gender. The patient's concurrent conditions, medical history, allergies or concomitant therapies were not reported.  On 12-JUL-2022, 60 doses of Measles, Mumps, Rubella and Varicella (Oka-Merck) Virus Vaccine Live (PROQUAD) (lot # W002782 with expiration date 24-JUL-2023) underwent a temperature excursion during storage.   On an unknown date, the patient was one of 60 patients vaccinated with vaccine Measles, Mumps, Rubella and Varicella (Oka-Merck) Virus Vaccine Live (PROQUAD) (lot # W002782  with expiration date 24-JUL-2023) administered as prophylaxis (dose regimen details were not provided).   No adverse event was reported. No further information was reported.  This is one of several reports received from the same reporter.
Sex: U
Vaccine: MMRV
Symptoms: Product storage error
Clinical narrative: No AEs; RN called to report temperature excursion that occurred on 7/12/2022. Caller states that 100 doses of PROQUAD and 94 doses of VARIVAX were administered since 7/12/2022 from mobile unit. No further information provided. No add; This spontaneous report was received from a nurse and refers to a child of unknown gender. The patient's concurrent conditions, medical history, allergies or concomitant therapies were not reported.  On 12-JUL-2022, 60 doses of Measles, Mumps, Rubella and Varicella (Oka-Merck) Virus Vaccine Live (PROQUAD) (lot # W002782 with expiration date 24-JUL-2023) underwent a temperature excursion during storage.   On an unknown date, the patient was one of 60 patients vaccinated with vaccine Measles, Mumps, Rubella and Varicella (Oka-Merck) Virus Vaccine Live (PROQUAD) (lot # W002782  with expiration date 24-JUL-2023) administered as prophylaxis (dose regimen details were not provided).   No adverse event was reported. No further information was reported.  This is one of several reports received from the same reporter.
Sex: U
Vaccine: MMR
Symptoms: Expired product administered, No adverse event
Clinical narrative: No additional AE reported; Caller is a physician reporting that an expired dose of M-M-R II was administered to a patient on 6SEP2022. Caller reports that the M-M-R II dose expired on 30JUL2022 and did not experience a temperature excursion prior to administration.; This spontaneous report was received from a physician and refers to a patient of unknown age and gender.  The patient's medical history, concurrent conditions and concomitant therapies were not reported.  On 06-SEP-2022, the patient was vaccinated with an expired dose of measles, mumps, and rubella (WISTAR RA 27-3) virus vaccine, live rHA (M-M-R II) 0.5 milliliter administered for prophylaxis (valid lot #T025929, expiration date: 30-JUL-2022) (strength, anatomical location and route of administration were not provided). No temperature excursion occurred prior the administration of the vaccine. No additional information or adverse event was reported.
Age: 13.0
Sex: M
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: No other AE; Caller is a nurse who reports that PROQUAD and VARIVAX may have been given after a temperature excursion that occurred in April 2022. Vaccines were then sent back so she does not have time/temperature data and does not know whether any vac; This spontaneous report was received from a registered nurse and refers to a 13-year-old male patient. Information regarding the patient's concurrent conditions, medical history, historical drugs and concomitant therapies was not provided.  On 07-JUL-2022, the patient was vaccinated with an improperly stored dose of varicella virus vaccine live (oka/merck) (VARIVAX) lot #U019291, expiration date: 28-SEP-2023, administered subcutaneously in the right deltoid for prophylaxis (product storage error), it was mentioned that there was not previous temperature excursion. No additional adverse event was reported.  Lot number U019291 is an invalid lot number for varicella virus vaccine live (oka/merck) (VARIVAX).  This is one of four reports received from the same reporter.     ; Sender's Comments:  US-009507513-2209USA003332: US-009507513-2208USA009203: US-009507513-2209USA003334: US-009507513-2208USA009203:
Age: 1.0
Sex: M
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: No other AE; Caller is a nurse who reports that PROQUAD and VARIVAX may have been given after a temperature excursion that occurred in April 2022. Vaccines were then sent back so she does not have time/temperature data and does not know whether any vac; This spontaneous report was received from a registered nurse and refers to a 12-month-old male patient. Information regarding the patient's concurrent conditions, medical history, historical drugs and concomitant therapies was not provided.  On 27-JUN-2022, the patient was vaccinated with an improperly stored dose of varicella virus vaccine live (oka/merck) (VARIVAX) lot #U030162, expiration date: 28-SEP-2023, administered subcutaneously in the right arm for prophylaxis (product storage error), it was mentioned that there was not previous temperature excursion. No additional adverse event was reported.  This is one of four reports received from the same reporter.; Sender's Comments:  US-009507513-2208USA009203: US-009507513-2209USA003332: US-009507513-2209USA003333:
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional AE; VARIVAX was administered after a temperature excursion; This spontaneous report was received from a medical assistant and refers to a patient of unknown age and gender.  The patient's medical history, concurrent conditions and concomitant therapies were not reported.  On 02-SEP-2022, the patient was vaccinated with improperly stored dose of varicella virus vaccine live (oka/merck) (VARIVAX) subcutaneous injection, lot # W011622, expiration date: 06-APR-2024, administered for prophylaxis (strength, dose, dose number and route of administration were not provided) (product storage error).  No adverse event was reported. Administered dose of vaccine experienced the temperature excursion of 1.6 degrees Celsius for 2 hours 10 minutes.
Sex: U
Vaccine: MMRV
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional AE reported; PROQUAD was administered after a temperature excursion; This spontaneous report was received from a healthcare business professional and refers to a patient of unknown age and gender.  The patient's medical history, concurrent conditions and concomitant therapies were not reported.  On an unknown date, the patient was vaccinated with improperly stored dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) subcutaneous injection, lot # W017570, expiration date: 29-NOV-2023, administered for prophylaxis (strength, dose and route of administration were not provided) (product storage error).  On 24-AUG-2022, administered dose of vaccine experienced the temperature excursion of 5.7 degrees Fahrenheit for 30 minutes; it was also reported that on 18-JUL-2022, there was previous temperature excursion of 6 degrees Fahrenheit for 1 hour and 8 minutes.  No additional adverse event was reported.
Sex: U
Vaccine: MMRV
Symptoms: No adverse event, Product storage error
Clinical narrative: HBP responsible for vaccines reported a dose of PROQUAD was administered after a temperature excursion. No additional information provided. No additional AE reported.; HBP responsible for vaccines reported a dose of PROQUAD was administered after a temperature excursion. No additional information provided. No additional AE reported.; This spontaneous report was received from a HBP responsible for vaccines referring to a patient of unknown age and gender. No information about the patient's pertinent medical history, concurrent conditions, concomitant medications and drug reactions or allergies was provided.  On 01-SEP-2022, the patient was vaccinated with a dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) administered after a temperature excursion (product storage error) lot # W017570 with expiration date of 29-NOV-2023, for prophylaxis. No other event reported.      The vaccine underwent to temperature excursion as follow:  Temperature: 5.7 F (Fahrenheit); Time frame: 0 Hours 30 Minutes and 0 Seconds. The vaccine had previous temperature excursions: 6°F up to 14°F (9.1F) for 1 Hour 6 Minutes and 0 Seconds and 6°F up to 14°F (10F) for 1 Hour 8 Minutes and 0 Seconds.       No additional information provided. No additional AE reported. No PQC reported.
Sex: U
Vaccine: MMRV
Symptoms: Product storage error
Clinical narrative: No additional AE reported; HPB responsible for vacicnes reported a dose of PROQUAD was administered after temperature excursion; This spontaneous report was received from a reporter and refers to a patient of unknown age and gender.  The patient's medical history, concurrent conditions and concomitant therapies were not reported.  On 18-JUL-2022, a temperature excursion (TE) occurred to measles, mumps, rubella and varicella (OKA-MERCK) virus vaccine live rHA (PROQUAD) (valid lot #W017570, expiration date: 29-NOV-2023) at 6 Fahrenheit (F) up to 14F (10F) for 1 hour and 8 minutes. On an unspecified date, TE occurred  to the same vaccine at 6F up to 14F (9.1 F) for 1 hour and 6 minutes. Then, on an unspecified date, a TE was reported again, at 5.7F for 30 minutes. On 29-AUG-2022, the patient was vaccinated with an improperly storage with measles, mumps, rubella and varicella (OKA-MERCK) virus vaccine live rHA (PROQUAD) (valid lot #W017570, expiration date: 29-NOV-2023) (strength, anatomical location, and route of administration were not provided) for prophylaxis.
Sex: U
Vaccine: MMRV
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional AE reported.; Healthcare professional responsible for vaccines reported a dose of PROQUAD was administered after a temperature excursion.; This spontaneous report was received from a reporter and refers to a patient of unknown age and gender.  The patient's medical history, concurrent conditions and concomitant therapies were not reported.  On an unspecified date, a temperature excursion (TE) of measles, mumps, rubella, and varicella (OKA-MERCK) virus vaccine live rHA (PROQUAD) (valid lot #W017570, expiration date: 29-NOV-2023) occurred, at 6F up to 14F (9.1F) for 1 hour and 6 minutes. On 18-JUL-2022, TE occurred was reported to the same vaccine, at 6F up to 14F (10F) for 1 hour and 8 minutes. Then on an unspecified date, TE was reported again, at 5.7 Fahrenheit for 30 minutes. On 25-AUG-2022, the patient was vaccinated with an improperly storage measles, mumps, rubella, and varicella (OKA-MERCK) virus vaccine live rHA (PROQUAD) (valid lot #W017570, expiration date: 29-NOV-2023) (strength, anatomical location, and route of administration were not provided) for prophylaxis. No additional information or adverse event was provided.
Sex: U
Vaccine: MMRV
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional AE reported; a dose of PROQUAD was administered after a temperature excursion; This spontaneous report was received from an "healthcare professional" and refers to a patient of unspecified age and gender. The patient's medical history, concurrent conditions and concomitant therapies were not reported.  On 01-SEP-2022, the patient was vaccinated with an improperly stored dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live recombinant Human Albumin (rHA) (PROQUAD) lot #W017570, expiration date: 29-NOV-2023 (dosage regimen, anatomical location and route of administration were not provided) administered as prophylaxis (product storage error).  The improperly stored vaccine dose underwent a temperature excursion of 5.7 degrees Fahrenheit (F) for 0 hours, 30 minutes and 0 seconds, with previous excursions of 6 F up to 14 F (9.1F) for 1 hour 6 minutes and 0 seconds, and an additional prior excursion of 6 F up to 14 F (10 F) for 1 hour, 8 minutes, 0 seconds on 18-JUL-2022. No adverse events were reported.
Sex: U
Vaccine: MMR, VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: No other adverse events occurred; The caller said these products were administered to the patient after two temperature excursions occurred.; This spontaneous report was received from a consumer concerning a patient of unknown age and gender.  The patient's medical history, concurrent conditions and concomitant therapies were not reported.   On 02-SEP-2022, the patient was vaccinated with 1 dose of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (rHA) (M-M-R II) subcutaneous injection, lot #U019291, expiration date: 18-JUN-2023 (strength, and route of administration were not provided); and 1 dose of varicella virus vaccine live (oka/merck) (VARIVAX) subcutaneous injection, lot #U028164, expiration date: 09-SEP-2023 (strength, and route of administration were not provided), both administered as prophylaxis.   The reporter stated that the vaccines experienced two temperature excursions at a temperature of 5.9 Celsius degrees (C) for 10 hours and 8.8C for 8 hours (Product storage error). There were no previous temperature excursions and no other adverse events reported.   This is one of three reports received from the same source.; Sender's Comments:  US-009507513-2209USA003954: US-009507513-2209USA004041:
Sex: U
Vaccine: MMRV, VARCEL
Symptoms: Accidental overdose, Extra dose administered, No adverse event
Clinical narrative: The patient received VARIVAX and PROQUAD (unknown lot and expiry); No addtional adverse event; Extra dose administered; This spontaneous report has been received from a nurse regarding a patient of unknown age and gender. The patient's pertinent medical history, concurrent conditions, concomitant medications, and previous drug reactions or allergies were not reported.   On 17-OCT-2016, the patient was vaccinated with varicella virus vaccine live (Oka/Merck) (VARIVAX), subcutaneous injection, then on unknown date, also, the patient received one dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live (rHA)(PROQUAD) subcutaneous injection, plus an sterile diluent, solution for injection/infusion(accidental overdose)(strengths, doses, routes of administration, anatomical sites of injection, lot numbers and expiration dates were not reported). On 20-MAY-2021, the patient received extra dose (extra dose administered) of measles, mumps, rubella and varicella (oka-merck) virus vaccine live (rHA)(PROQUAD) subcutaneous injection, plus an sterile diluent, solution for injection/infusion due to human error(lot number t037957 which has been verified to be valid, expiration date reported and validated as 09-MAY-2022) (strength, route of administration, and anatomical site of injection were not reported) All of the vaccines were administered as prophylaxis.   No additional adverse events were reported.
Age: 14.0
Sex: U
Vaccine: HPV9
Symptoms: No adverse event, Wrong product administered
Clinical narrative: No other AEs or PQC reported; Caller reports GARDASIL 9 was inadvertently administered to a 14 year old who had already completed a 2 dose series.  Caller states the patient was ordered a "Flu Vaccine" but she administered a GARDASIL 9 because that is what she "Usually administer; This spontaneous report was received from a medical assistant referring to a 14-year-old patient of unknown gender. The patient's pertinent medical history, concurrent conditions, previous drug reactions or allergies and concomitant medications were not provided.   On 09-SEP-2022, the patient was inadvertently vaccinated with hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) syringe injection, at dose 0.5 milliliter (lot number U029033 was verified to be a valid number, with an expiration date reported and established as 13-MAR-2024), administered intramuscularly for prophylaxis (strength was not provided), instead of flu vaccine (manufacturer unknown) (wrong product administered). The patient had already completed 2 doses series of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9). No additional adverse events were reported.  It was reported that the patient ordered a flu vaccine (manufacturer unknown), but received hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) because that is what the facilitator "usually administered".
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional AEs/no PQCs; HCP called in and reported that the improperly stored vaccine was administered on 09/12/2022; This spontaneous report was received from a medical assistant and refers to a patient of unknown age and gender. There was no information about the patient's concurrent conditions, concomitant therapies, drug reactions, allergies or medical history provided.  On 12-SEP-2022, the patient was administered a dose of improperly stored varicella virus vaccine live (oka/merck) (VARIVAX) subcutaneous injection, lot # W011625 with expiration date 06-APR-2024, for prophylaxis (exact dose, route of administration and anatomical site were not provided) (product storage error). The vaccine was improperly stored for 2 hours and 30 minutes in the temperature ranging from -10 degrees Celsius (C) up to 8 C (-4 C). It was unknown if data logger was used to capture the temperature excursion. There was no previous temperature excursion. No additional adverse events were reported (no adverse event).
Age: 61.0
Sex: M
Vaccine: VARZOS
Symptoms: Anaphylactoid reaction, Throat irritation
Clinical narrative: HCP reporting a patient who received ZOSTAVAX on 31MAY2012 developed an anaphylactoid reaction./Patient experienced an itchy throat; This spontaneous report was received from a registered pharmacist and refers to a currently 71-year-old male patient. The patient's medical history and concomitant therapies were not provided. The patient's concurrent conditions included egg protein allergy.   On 31-MAY-2012, the patient was vaccinated with zoster vaccine live (ZOSTAVAX) subcutaneous injection, administered as injection (dose, strength, exact route of administration, anatomical location, lot #, and expiration date were not provided) for prophylaxis.  On an unknown date, the patient developed an anaphylactoid reaction, patient experienced an itchy throat. The patient sought medical attention and received diphenhydramine (BENDARYL) as a treatment for the event. On an unknown date, the patient recovered from the event. The product was not available for agency retrieval.  The relatedness between the event and the suspect therapy was not provided.  Upon internal review, the event of anaphylactoid reaction was determined to be medically significant.
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: no adverse event; VARIVAX was stored in the refrigerator since 15-NOV-2021,  the refrigerator had an excursion with maximum temperautre.; This spontaneous report was received from a vaccine coordinator referring to an unknow age and gender patient. Information regarding the patient's medical history, concurrent conditions and concomitant therapies was not provided.   On 19-JAN-2022, the patient was vaccinated with improperly stored varicella virus vaccine live (oka/merck) (VARIVAX) subcutaneous injection, at a dose of 0.5 milliliter, lot #U015678, expiration date: 18-MAY-2023, administered subcutaneously for prophylaxis (strength, anatomical site injection were not provided) (Product storage error). it was mentioned that varicella virus vaccine live (oka/merck) (VARIVAX) was stored in the refrigerator since 15-NOV-2021, and the administered dose of the vaccine experienced a temperature excursion of minus 51 Degree Fahrenheit. Information regarding time frame was reported as unknown.  it was reported that no previous temperature excursion was occurred.   No additional adverse event (AE) information was provided (no adverse event).
Sex: U
Vaccine: MMRV
Symptoms: Expired product administered, No adverse event
Clinical narrative: No addtional AE.; Nurse reporting PROQUAD was administered after expiration.; This spontaneous report has been received from a nurse, regarding to a patient of unknown gender and age. The patient's pertinent medical history, concurrent conditions, concomitant medications, and previous drug reactions or allergies were not reported.   On 15-SEP-2022, the patient was vaccinated with an expired dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live (rHA)(PROQUAD) subcutaneous injection, 0.5 milliliter (ml), administered for prophylaxis (lot number U006313, which was determined to be valid, with an expiration date on 24-AUG-2022) (expired product administered)(strength, route of administration, and anatomical site of injection were not reported).   No additional adverse events were reported in the patient.
Age: 12.0
Sex: M
Vaccine: FLUX, HPV9, MNQ
Symptoms: Fall, Jaw fracture, Suture insertion, Syncope
Clinical narrative: syncope; fell and fractured his jaw; This spontaneous report was received from a physician, via a company representative, and refers to a 12-year-old male. No information was provided regarding the patient's medical history, concurrent conditions, previous drug reactions, allergies and concomitant medications.  On 27-DEC-2021, the patient was vaccinated with the first dose of with hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) lot #1775809, expiration date: 18-AUG-2023 (strength, dose, route of administration and anatomical location were not reported) for prophylaxis. The patient also received meningococcal vaccine a/c/y/w conj (dip tox) (MENACTRA) and an unspecified flu vaccine at the same visit (strengths, doses, routes of administration, anatomical locations, lot numbers and expiration dates were not reported).  On that same day, the patient did not wait 15 minutes after immunization as recommended and was standing at the checkout desk with his parent and experienced syncope. The patient fell and fractured his jaw (Jaw fracture). The patient did have to go to urgent care and received stitches. The patient also had to go to a orthodontic. The patient recovered form the events on an unknown date ("had since recovered") and curreny was okay. The action taken with hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) was not applicable.   The causal relationship between the events and hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) was not reported.  Upon internal review, the events jaw fracture and syncope were determined to be medically significant.
Sex: U
Vaccine: MMR
Symptoms: Expired product administered, No adverse event
Clinical narrative: No additional adverse events.; HCP called in and reported that an expired MMR-II vaccine was administered.; This spontaneous report was received from a nurse regarding a patient of an unknown age and gender. The patient's medical history, concurrent conditions, and concomitant therapies were not reported.  On 09-AUG-2022, the patient was vaccinated with an expired dose of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (rHA) (M-M-R II) lot #T020656, expiration date: 16-JUN-2022, (strength, dosage regimen, anatomical location, and route of administration were not provided) as prophylaxis (Expired product administered). No adverse events were reported.  .
Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: Intentional dose omission, Loss of personal independence in daily activities, Tinnitus
Clinical narrative: ringing is severe enough that it affects her daily activity; Did not go for the second dose of the vaccine because of the tinnitus; Developed tinnitus (ringing in her ears); This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of TINNITUS (Developed tinnitus (ringing in her ears)) in a 72-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Asthma and Thyroiditis. Concomitant products included LEVOTHYROXINE SODIUM (SYNTHROID) for an unknown indication.    On 27-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 02-Mar-2021, the patient experienced TINNITUS (Developed tinnitus (ringing in her ears)) (seriousness criterion medically significant). On an unknown date, the patient experienced LOSS OF PERSONAL INDEPENDENCE IN DAILY ACTIVITIES (ringing is severe enough that it affects her daily activity) and INTENTIONAL DOSE OMISSION (Did not go for the second dose of the vaccine because of the tinnitus). At the time of the report, TINNITUS (Developed tinnitus (ringing in her ears)) and LOSS OF PERSONAL INDEPENDENCE IN DAILY ACTIVITIES (ringing is severe enough that it affects her daily activity) had not resolved and INTENTIONAL DOSE OMISSION (Did not go for the second dose of the vaccine because of the tinnitus) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No treatment information was provided.   Most recent FOLLOW-UP information incorporated above includes: On 31-Mar-2021: Upon internal review on 16-SEP-2022 non significant corrections performed to update case received from field On 06-Apr-2021: The current conditions were added: asthma, thyroiditis; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of these events, a causal relationship cannot be excluded.
Sex: U
Vaccine: FLUX
Symptoms: Guillain-Barre syndrome
Clinical narrative: GBS after flu shot; This case was reported by a consumer via interactive digital media and described the occurrence of guillain barre syndrome in a Unknown number of patients who received Flu unspecified (Flu vaccine) for prophylaxis.   On an unknown date, the patient received Flu vaccine. On an unknown date, unknown after receiving Flu vaccine, the patient experienced guillain barre syndrome (serious criteria GSK medically significant). On an unknown date, the outcome of the guillain barre syndrome was unknown.   It was unknown if the reporter considered the guillain barre syndrome to be related to Flu vaccine.     Additional Information: GSK Receipt Date: 13-SEP-2022 Reporter's Comments: This case was reported by a patient via interactive digital media. The reporter stated that guillain barre syndrome (GBS) it was a horrible disorder.  The reporter knew a couple people who got it taking a flu shot.  Follow-up would not possible as no contact details were available.; Sender's Comments:  US-GSK-US2022AMR133022:same reporter
Sex: U
Vaccine: COVID19, COVID19, VARZOS
Symptoms: COVID-19, Herpes zoster, Vaccination failure
Clinical narrative: Had shingles vaccine got them anyway/Suspected vaccination failure; Got them anyway; got Covid anyway; 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.   Co-suspect products included COVID-19 VACCINE for prophylaxis and COVID-19 VACCINE (COVID-19 BOOSTER) for prophylaxis.   On an unknown date, the patient received Shingles vaccine, COVID-19 VACCINE and COVID-19 BOOSTER. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant), shingles and covid-19. On an unknown date, the outcome of the vaccination failure, shingles and covid-19 were unknown.   It was unknown if the reporter considered the vaccination failure, shingles and covid-19 to be related to Shingles vaccine.     Additional Information: GSK receipt date: 16-Sept-2022 Reporter's comment: The case was received from the patient via (social media) interactive digital media. The patient stated that Covid shots and boosters were useless, got covid anyway. The patient had shingles vaccine and got them anyway. The patient stated no more vaccines for him/her. Additional supportive information: It was unknown if the reporter considered the shingles and covid-19 to be related to Covid-19 vaccine and Covid-19 booster. This case was considered as suspected vaccination failure since the details regarding the completion of primary vaccination schedule, time to onset and laboratory confirmation of shingles were unknown at the time of reporting. The follow-up could not be possible as no contact details were available. In worst approach, case was kept valid and Covid shots and booster shots single Covid-19 vaccine and Covid-19 booster was coded with blank dose number as it was not clear by the reported narrative.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: Shingles again, shynrix shots 2 years ago/SUSPECTED VACINATION FAILURE; Shingles again; 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 (Shingrix) for prophylaxis.   The patient's past medical history included shingles.   On an unknown date, the patient received Shingrix. On an unknown date, less than 2 years after receiving Shingrix, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure and shingles were unknown.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingrix.     Additional Information: GSK receipt date: 16-Sept-2022 Reporter's comment: The case was received from the patient via interactive digital media. The patient got shingles again after having Shingrix shots 2 years ago. Additional supportive information: This case was considered as suspected vaccination failure since the details regarding the completion of primary vaccination schedule and laboratory confirmation of shingles were unknown at the time of reporting. The follow-up could not be possible as no contact details were available.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: Got the shot, but got shingles now/Suspected vaccination failure; Still got the shingles now for 3rd time; 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.   The patient's past medical history included shingles.   On an unknown date, the patient received Shingles vaccine. In September 2022, unknown after receiving Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure was unknown and the outcome of the shingles was recovering/resolving.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine.     Additional Information: GSK receipt date: 17-Sept-2022 Reporter's comment: The case was received from the patient via interactive digital media. The patient got the shot also but he/she still got the shingles now and it the third time just getting over them. Additional supportive information: This case was considered as suspected vaccination failure since the details regarding the completion of primary vaccination schedule, time to onset and laboratory confirmation of shingles were unknown at the time of reporting. The follow-up could not be possible as no contact details were available. As per narrative patient still got shingles now therefore partial onset date was captured as September 2022 and outcome was captured as recovering based on just getting over them.
Sex: U
Vaccine: VARZOS, VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: Had both shots, still got them 2 years later/suspected vaccination failure; Still got them; 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.   Co-suspect products included Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received the 2nd dose of Shingles vaccine and the 1st dose of Shingles vaccine. On an unknown date, 2 years after receiving Shingles vaccine and Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure and shingles were unknown.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine and Shingles vaccine.     Additional Information: GSK receipt date: 17-Sept-2022 Reporter's comment: The case was received from the patient via interactive digital media. The patient had both shots of the vaccine and still got them 2 years later. The patient would not wish this was his/her worst enemy. Additional supportive information: This case was considered as suspected vaccination failure since the details regarding the laboratory confirmation of shingles were unknown at the time of reporting. The follow-up could not be possible as no contact details were available.