chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: VARCEL
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 a child of unknown gender. The patients' concurrent conditions, medical history, allergies and concomitant therapies were not reported.  On 12-JUL-2022, 40 doses of the vaccine varicella virus vaccine live (oka/merck) (VARIVAX) (lot # U029621with expiration date 20-SEP-2023) underwent a temperature excursion during storage.   On an unknown date, the patient was one of 40 patients vaccinated with vaccine varicella virus vaccine live (oka/merck) (VARIVAX) (lot # U029621, expiration date 20-SEP-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: VARCEL
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 to children in community. No further information provided. No add; This spontaneous report was received from a nurse and refers a child of unknown gender. The patients' concurrent conditions, medical history, allergies and concomitant therapies were not reported.  On 12-JUL-2022, 40 doses of the vaccine varicella virus vaccine live (oka/merck) (VARIVAX) (lot # U029621with expiration date 20-SEP-2023) 0.5 ml once underwent a temperature excursion during storage.   On an unknown date, the patient was one of 40 patients vaccinated with vaccine varicella virus vaccine live (oka/merck) (VARIVAX) (lot # U029621, expiration date 20-SEP-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: VARCEL
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 to children in community. No further information provided. No add; This spontaneous report was received from a nurse and refers a child of unknown gender. The patients' concurrent conditions, medical history, allergies and concomitant therapies were not reported.  On 12-JUL-2022, 40 doses of the vaccine varicella virus vaccine live (oka/merck) (VARIVAX) (lot # U029621with expiration date 20-SEP-2023) 0.5 ml once underwent a temperature excursion during storage.   On an unknown date, the patient was one of 40 patients vaccinated with vaccine varicella virus vaccine live (oka/merck) (VARIVAX) (lot # U029621, expiration date 20-SEP-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: VARCEL
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 a child of unknown gender. The patients' concurrent conditions, medical history, allergies and concomitant therapies were not reported.  On 12-JUL-2022, 40 doses of the vaccine varicella virus vaccine live (oka/merck) (VARIVAX) (lot # U029621with expiration date 20-SEP-2023) 0.5 ml once underwent a temperature excursion during storage.   On an unknown date, the patient was one of 40 patients vaccinated with vaccine varicella virus vaccine live (oka/merck) (VARIVAX) (lot # U029621, expiration date 20-SEP-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: VARCEL
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 to children in community. No further information provided. No add; This spontaneous report was received from a nurse and refers a child of unknown gender. The patients' concurrent conditions, medical history, allergies and concomitant therapies were not reported.  On 12-JUL-2022, 40 doses of the vaccine varicella virus vaccine live (oka/merck) (VARIVAX) (lot # U029621with expiration date 20-SEP-2023) underwent a temperature excursion during storage.   On an unknown date, the patient was one of 40 patients vaccinated with vaccine varicella virus vaccine live (oka/merck) (VARIVAX) (lot # U029621, expiration date 20-SEP-2023) 0.5 milliliter once, 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: VARCEL
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 to children in community. No further information provided. No add; This spontaneous report was received from a nurse and refers a child of unknown gender. The patients' concurrent conditions, medical history, allergies and concomitant therapies were not reported.  On 12-JUL-2022, 40 doses of the vaccine varicella virus vaccine live (oka/merck) (VARIVAX) (lot # U029621with expiration date 20-SEP-2023) underwent a temperature excursion during storage.   On an unknown date, the patient was one of 40 patients vaccinated with vaccine varicella virus vaccine live (oka/merck) (VARIVAX) (lot # U029621, expiration date 20-SEP-2023) 0.5 ML once, 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: VARCEL
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 to children in community. No further information provided. No add; This spontaneous report was received from a nurse and refers a child of unknown gender. The patients' concurrent conditions, medical history, allergies and concomitant therapies were not reported.  On 12-JUL-2022, 40 doses of the vaccine varicella virus vaccine live (oka/merck) (VARIVAX) (lot # U029621with expiration date 20-SEP-2023) underwent a temperature excursion during storage.   On an unknown date, the patient was one of 40 patients vaccinated with vaccine varicella virus vaccine live (oka/merck) (VARIVAX) (lot # U029621, expiration date 20-SEP-2023) 0.5 ml once 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: VARCEL
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 a child of unknown gender. The patients' concurrent conditions, medical history, allergies and concomitant therapies were not reported.  On 12-JUL-2022, 40 doses of the vaccine varicella virus vaccine live (oka/merck) (VARIVAX) (lot # U029621with expiration date 20-SEP-2023) underwent a temperature excursion during storage.   On an unknown date, the patient was one of 40 patients vaccinated with vaccine varicella virus vaccine live (oka/merck) (VARIVAX) (lot # U029621, expiration date 20-SEP-2023) 0.5 ml once 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: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional adverse event information reported; Medical assistant reporting AE for improperly stored vaccine administered. No additional AE information reported. No PQC reported.; This spontaneous report has been received from a medical assistant concerning to a patient of unknown age and gender. No information regarding the patient's pertinent medical history, concurrent conditions, previous drug reactions or allergies and concomitant medications was provided.  On 22-AUG-2022, the patient was vaccinated with one improperly stored dose of varicella virus vaccine live (Oka/Merck) (VARIVAX) (strength, dose, vaccination scheme frequency, route of administration and anatomical site of injection were not provided; lot number U015685 which has been verified to be valid, expiration date reported as 03-NOV-2022 but upon internal validation established as 18-MAY-2023) as prophylaxis. It was reported that the vaccine was stored at a temperature of 9.3 degrees Fahrenheit (F), during a time frame of 0 hour with 5 minutes and 0 seconds, there was a previous temperature excursion of 14 degrees F up to 46 degrees F (25.9 F) for 1 hour with 20 minutes and 0 seconds (product storage error).   No additional adverse event was reported (no adverse event).  This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-2209USA004839: US-009507513-2209USA004559: US-009507513- 2209USA004342:
Sex: U
Vaccine: MMRV
Symptoms: No adverse event, Product storage error
Clinical narrative: No adverse event; Inbound call from HCP reporting a PROQUAD was inadvertently administered after a supported temp excursion.; This spontaneous report has been received from a health care professional, concerning a patient of unknown age and gender. The patient's medical history, concurrent conditions, concomitant medications, previous drug reactions, and allergies were not provided.  On 12-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) (product storage error), diluted with sterile diluent, for prophylaxis (lot number W010061 has been verified to be valid; expiration date reported and established as 20-SEP-2023) (dosage, vaccination scheme, frequency, route of administration, and anatomical site of injection were not provided). The administered dose of the vaccine was stored at a temperature of 7.9 degrees Fahrenheit (F), during a time frame of 37 minutes. There was no previous temperature excursion. There was no adverse effect reported.
Sex: U
Vaccine: MMR
Symptoms: Expired product administered, No adverse event
Clinical narrative: No additional AE reported.; Customer called and reported that a dose of MMR-II expired on 18AUG2022 and was administered on 13SEP2022. Customer reported that the MMR-II had no temperature excursions through date of administration.; This spontaneous report was received from the customer and refers to a patient of unknown age, and gender. The patient's medical history, concurrent conditions, and concomitant therapies were not provided.  On 13-SEP-2022, the patient was vaccinated with expired measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II), recombinant Human albumin, subcutaneous injection, lot #T027937, expiration date: 18-AUG-2022, administered for prophylaxis (strength, and route of administration were not provided). The suspect therapy had no temperature excursions through date of administration. No additional adverse event was reported.
Sex: U
Vaccine: MMR
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional AE's and no PQC's were reported; A physician stated that an improperly stored dose of MMR II pursuant to a temperature excursion was administered to a patient.          ?; This spontaneous report was received from a physician referring to a patient of unreported age and gender. There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided.  On 30-AUG-2022, the patient was vaccinated with an improperly stored dose of  measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live(M-M-R II) rHA, U014656 (also reported as: W014656), expiration date: 07-MAY-2023, to prevent measles, mumps and rubella infection (dose, route and site of administration were not reported).   The administered dose of the vaccine experienced a temperature excursion of 13.8F and 51F for 25 hours and 100 hours respectively (product storage error). The vaccines had not had any previous temperature excursions.  There was no adverse effect reported. No product quality complaint was involved.     Lot Number W014656 is NOT valid for measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live(M-M-R II), and does not match any company product.
Age: 1.25
Sex: U
Vaccine: HIBV
Symptoms: Incorrect dose administered, No adverse event, Product preparation issue
Clinical narrative: No Additional Adverse Event; Have accidentally been given PEDVAXHIB vaccine that was diluted.; the person administering the product was diluting the PEDVAXHIB with 0.5ml of normal saline and then drawing up 0.5 and administering it to patients; This spontaneous report has been received from a nurse, concerning a 15- months old patient of unknown gender. The patient's pertinent medical history, concurrent conditions, previous drug reactions, allergies, and concomitant medications were not provided.  On 16-SEP-2022, the patient was accidentally vaccinated with a booster of haemophilus b conjugate vaccine (meningococcal protein conjugate) (LIQUID PEDVAXHIB) intramuscular injection, 0.5 milliliter (ml) (valid lot number W002453 [expiration date 24-JUN-2024]) (vaccination scheme, and frequency were not provided) for prophylaxis, that was diluted, the healthcare provider (HCP) stated that the person administering the product was diluting the haemophilus b conjugate vaccine (meningococcal protein conjugate) (LIQUID PEDVAXHIB) with 0.5 ml of normal saline and then drawing up 0.5ml and administering it to patients (product preparation issue, incorrect dose administered).  No additional adverse event (AE) information provided.   This is one of several reports received from the same reporter.
Sex: U
Vaccine: HPV9
Symptoms: Expired product administered
Clinical narrative: No additional AE's and no PQC's were reported.; A nurse reported that an expired dose of GARDASIL 9 was administered to a patient.; This spontaneous report was received from  nurse and refers to a patient of an unknown age and gender.  The patient's medical history, concurrent conditions previous drugs reaction or allergies and concomitant therapies were not reported.  07-SEP-2022, the patient was vaccinated  with an expired vaccine of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) (Expired product administered) use as directed to prevent human papilloma virus infection, lot #T007024, expiration date: 23-APR-2022, administered for prophylaxis (strength, and route of administration were not provided). No additional adverse event were reported.
Age: 0.33
Sex: U
Vaccine: RV5
Symptoms: No adverse event, Product storage error
Clinical narrative: No other adverse event; Vaccines were administered following a temperature excursion.; This spontaneous report was received from a state vaccine coordinator regarding a 4-month-old patient of an unknown gender. The patient's medical history, concurrent conditions, and concomitant therapies were not reported.  On 27-SEP-2022, the patient was vaccinated with an improperly stored dose of rotavirus vaccine, live, oral, pentavalent (ROTATEQ) lot #W004501, expiration date: 20-APR-2023, taken orally (strength was not provided) as prophylaxis (Product storage error).  The improperly stored vaccine underwent a temperature excursion of 8.6 degrees Celsius (C) for 18 minutes with previous excursions of 11.5C for 1 hour and 6 minutes; 8.8C for 21 minutes; and 9.6C for 6 hours and 41 minutes. No adverse events were reported.  This is one of nine cases received from the same reporter.; Sender's Comments:  US-009507513-2209USA010833: US-009507513-2209USA010884: US-009507513-2209USA010940: US-009507513-2209USA010983: US-009507513-2209USA010910: US-009507513-2209USA010935: US-009507513-2209USA010872:
Age: 0.5
Sex: U
Vaccine: RV5
Symptoms: No adverse event, Product storage error
Clinical narrative: No other adverse event; Vaccines were administered following a temperature excursion.; This spontaneous report was received from a state vaccine coordinator regarding a 6-month-old patient. The patient's medical history, concurrent conditions, and concomitant therapies were not reported.  On 27-SEP-2022, the patient was vaccinated with an improperly stored dose of rotavirus vaccine, live, oral, pentavalent (ROTATEQ) lot #W004501, expiration date: 20-APR-2023, taken orally (strength was not provided) as prophylaxis (Product storage error).  The improperly stored vaccine underwent a temperature excursion of 8.6 degrees Celsius (C) for 18 minutes with previous excursions of 11.5C for 1 hour and 6 minutes; 8.8C for 21 minutes; and 9.6C for 6 hours and 41 minutes. No adverse events were reported.  This is one of nine cases received from the same reporter.; Sender's Comments:  US-009507513-2209USA010833: US-009507513-2209USA010884: US-009507513-2209USA010940: US-009507513-2209USA010983: US-009507513-2209USA010910: US-009507513-2209USA010935: US-009507513-2209USA010872:
Age: 2.0
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: no additional AEs; patients received doses of VARIVAX vaccine on 8/9/22 while improperly stored outside recommended storage temperature range; This spontaneous report has been received from a registered nurse regarding a 2 years-old patient of unknown gender. The patient's concomitant medications, pertinent medical history, and drug reactions/ allergies were not reported.  On 03-AUG-2022, varicella virus vaccine live (oka/merck) (VARIVAX) was exposed to -14 Fahrenheit (F) up to 46 F (14F) for 4 hours (h) 15 minutes (min). On 09-AUG-2022, the vaccine was exposed to 14 F up to 46 F (45F) for 4 h 45 min. On the same day, the patient was vaccinated with one dose of a stored outside the recommended storage temperature range of varicella virus vaccine live (oka/merck) (VARIVAX) subcutaneous injection, subcutaneously, on the left vastus lateralis at a dose of 0.5 milliliters (ml), once (lot number: W011626, which was verified to be valid, with an expiration date: 06-APR-2024; strength was not reported) (product storage error). The reporter called for an evaluation of vaccine temperature stability. There was no additional adverse event (AE) reported, and no further information was provided.  This is one of several reports from the same reporter.
Age: 16.0
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: no additional AEs; patients received doses of VARIVAX vaccine on 8/9/22 while improperly stored outside recommended storage temperature range; This spontaneous report has been received from a registered nurse regarding a 16 years-old patient of unknown gender. The patient's concomitant medications, pertinent medical history, and drug reactions/ allergies were not reported.  On 03-AUG-2022, varicella virus vaccine live (oka/merck) (VARIVAX) was exposed to -14 Fahrenheit (F) up to 46 F (14F) for 4 hours (h) 15 minutes (min). On 09-AUG-2022, the vaccine was exposed to 14 F up to 46 F (45F) for 4 h 45 min. On the same day, the patient was vaccinated with one dose of a stored outside the recommended storage temperature range of varicella virus vaccine live (oka/merck) (VARIVAX) subcutaneous injection, subcutaneously, on the right deltoid at a dose of 0.5 milliliters (ml), once (lot number: W002596, which was verified to be valid, with an expiration date: 24-JAN-2024; strength was not reported) (product storage error). The reporter called for an evaluation of vaccine temperature stability. There was no additional adverse event (AE) reported, and no further information was provided.  This is one of several reports from the same reporter.
Age: 5.0
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: no additional AEs; patients received doses of VARIVAX vaccine on 8/9/22 while improperly stored outside recommended storage temperature range; This spontaneous report has been received from a registered nurse regarding a 5 years-old patient of unknown gender. The patient's concomitant medications, pertinent medical history, and drug reactions/ allergies were not reported.  On 03-AUG-2022, varicella virus vaccine live (oka/merck) (VARIVAX) was exposed to -14 Fahrenheit (F) up to 46 F (14F) for 4 hours (h) 15 minutes (min). On 09-AUG-2022, the vaccine was exposed to 14 F up to 46 F (45F) for 4 h 45 min. On the same day, the patient was vaccinated with one dose of a stored outside the recommended storage temperature range of varicella virus vaccine live (oka/merck) (VARIVAX) subcutaneous injection, subcutaneously, on the left deltoid at a dose of 0.5 milliliters (ml), once (lot number: W011626, which was verified to be valid, with an expiration date: 06-APR-2024; strength was not reported) (product storage error). The reporter called for an evaluation of vaccine temperature stability. There was no additional adverse event (AE) reported, and no further information was provided.  This is one of several reports from the same reporter.
Age: 3.0
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: no additional AEs; patients received doses of VARIVAX vaccine on 8/9/22 while improperly stored outside recommended storage temperature range; This spontaneous report has been received from a registered nurse regarding a 3 years-old patient of unknown gender. The patient's concomitant medications, pertinent medical history, and drug reactions/ allergies were not reported.  On 03-AUG-2022, varicella virus vaccine live (oka/merck) (VARIVAX) was exposed to -14 Fahrenheit (F) up to 46 F (14F) for 4 hours (h) 15 minutes (min). On 09-AUG-2022, the vaccine was exposed to 14 F up to 46 F (45F) for 4 h 45 min. On the same day, the patient was vaccinated with one dose of a stored outside the recommended storage temperature range of varicella virus vaccine live (oka/merck) (VARIVAX) subcutaneous injection, subcutaneously, on the left deltoid at a dose of 0.5 milliliters (ml), once (lot number: W011626, which was verified to be valid, with an expiration date: 06-APR-2024; strength was not reported) (product storage error). The reporter called for an evaluation of vaccine temperature stability. There was no additional adverse event (AE) reported, and no further information was provided.  This is one of several reports from the same reporter.
Age: 1.83
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: no additional AEs; patients received doses of VARIVAX vaccine on 8/9/22 while improperly stored outside recommended storage temperature range; This spontaneous report has been received from a registered nurse regarding a 22 months-old patient of unknown gender. The patient's concomitant medications, pertinent medical history, and drug reactions/ allergies were not reported.  On 03-AUG-2022, varicella virus vaccine live (oka/merck) (VARIVAX) was exposed to -14 Fahrenheit (F) up to 46 F (14F) for 4 hours (h) 15 minutes (min). On 09-AUG-2022, the vaccine was exposed to 14 F up to 46 F (45F) for 4 h 45 min. On the same day, the patient was vaccinated with one dose of a stored outside the recommended storage temperature range of varicella virus vaccine live (oka/merck) (VARIVAX) subcutaneous injection, subcutaneously, on the left deltoid at a dose of 0.5 milliliters (ml), once (lot number: W011626, which was verified to be valid, with an expiration date: 06-APR-2024; strength was not reported) (product storage error). The reporter called for an evaluation of vaccine temperature stability. There was no additional adverse event (AE) reported, and no further information was provided.  This is one of several reports from the same reporter.
Age: 9.0
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: no additional AEs; patients received doses of VARIVAX vaccine on 8/9/22 while improperly stored outside recommended storage temperature range; This spontaneous report has been received from a registered nurse regarding a 9 years-old patient of unknown gender. The patient's concomitant medications, pertinent medical history, and drug reactions/ allergies were not reported.  On 03-AUG-2022, varicella virus vaccine live (oka/merck) (VARIVAX) was exposed to -14 Fahrenheit (F) up to 46 F (14F) for 4 hours (h) 15 minutes (min). On 09-AUG-2022, the vaccine was exposed to 14 F up to 46 F (45F) for 4 h 45 min. On the same day, the patient was vaccinated with one dose of a stored outside the recommended storage temperature range of varicella virus vaccine live (oka/merck) (VARIVAX) subcutaneous injection, subcutaneously, on the right deltoid at a dose of 0.5 milliliters (ml), once (lot number: W002596, which was verified to be valid, with an expiration date: 24-JAN-2024; strength was not reported) (product storage error). The reporter called for an evaluation of vaccine temperature stability. There was no additional adverse event (AE) reported, and no further information was provided.  This is one of several reports from the same reporter.
Age: 8.0
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: no additional AEs; patients received doses of VARIVAX vaccine on 8/9/22 while improperly stored outside recommended storage temperature range; This spontaneous report has been received from a registered nurse regarding a 8 years-old patient of unknown gender. The patient's concomitant medications, pertinent medical history, and drug reactions/ allergies were not reported.  On 03-AUG-2022, varicella virus vaccine live (oka/merck) (VARIVAX) was exposed to -14 Fahrenheit (F) up to 46 F (14F) for 4 hours (h) 15 minutes (min). On 09-AUG-2022, the vaccine was exposed to 14 F up to 46 F (45F) for 4 h 45 min. On the same day, the patient was vaccinated with one dose of a stored outside the recommended storage temperature range of varicella virus vaccine live (oka/merck) (VARIVAX) subcutaneous injection, subcutaneously, on the left deltoid at a dose of 0.5 milliliters (ml), once (lot number: W011626, which was verified to be valid, with an expiration date: 06-APR-2024; strength was not reported) (product storage error). The reporter called for an evaluation of vaccine temperature stability. There was no additional adverse event (AE) reported, and no further information was provided.  This is one of several reports from the same reporter.
Sex: U
Vaccine: PPV
Symptoms: Expired product administered, No adverse event
Clinical narrative: No additional AEs or PQC reported; Caller reported expired dose of PNEUMOVAX 23 was administered.  No other information is provided.  No additional AEs or PQC reported.; This spontaneous report was received from a pharmacist referring to a patient of unknown age and gender. The patient's pertinent medical history, drug reactions/allergies, concurrent conditions and concomitant medications were not reported.      On 30-SEP-2022, the patient was vaccinated with an expired dose of pneumococcal vaccine, polyvalent (23-valent)(PNEUMOVAX23)  0.5 mL, intramuscularly, lot # T040202 wth expiration date 11-SEP-2022, for prophylaxis (strength and anatomical location were not reported). No other information was provided. No additional adverse events (AEs) were reported.
Age: 52.0
Sex: F
Vaccine: COVID19, FLUX
Symptoms: Dizziness, Fatigue, Heart rate, Heart rate increased, Malaise
Clinical narrative: not feeling so good today; little tired/ extremely tired; BLURRED VISION/ SHE CAN'T SEE RIGHT; RAPID HEART RATE/feel like HYPERTENSION; DIZZINESS; MUSCLE ACHES; WAS UP ALL NIGHT; This case was reported by a nurse and described the occurrence of feeling unwell in a 52-year-old female patient who received Flu unspecified (Flu vaccine) for prophylaxis.   Co-suspect products included niraparib (Zejula) capsule (batch number 2057808, expiry date 30th June 2024) for ovarian cancer and COVID-19 VACCINE (COVID VACCINE) for prophylaxis.   The patient's past medical history included asthma and hysterectomy. Concurrent medical conditions included ovarian cancer.   On 15th September 2022, the patient received Flu vaccine. On 19th September 2022, the patient started Zejula (oral) 100 mg twice daily (200 mg daily). On 15th September 2022, the patient received COVID VACCINE. On 19th September 2022, 4 days after receiving Flu vaccine and less than a day after starting Zejula, the patient experienced feeling unwell, tiredness, blurred vision, heart rate increased, dizziness, muscle pain and sleep disturbance. The action taken with Zejula was unknown. On an unknown date, the outcome of the feeling unwell, tiredness, blurred vision, heart rate increased, dizziness, muscle pain and sleep disturbance were not recovered/not resolved.   It was unknown if the reporter considered the feeling unwell, tiredness, blurred vision, heart rate increased, dizziness, muscle pain and sleep disturbance to be related to Flu vaccine and Zejula.     Additional Information: GSK Receipt Date: 23-SEP-2022 Reporter's Comments:The patient stated that she was not feeling so good today. The patient got her Covid and Flu vaccine on Thursday. The patient was little tired to be honest. The patient reported that she was extremely tired, she was brought to tears when she was talking about how tired she was. The patient getting a little blurred vision stating that she could not saw right. The patient experienced little rapid heart rate, dizziness and muscle aches. The patient was up all night and she could felt liked hypertension, although she had not checked her blood pressure. The patient need to take her blood pressure . Medical physician was not aware. The patient did want to speak to pharmacist about stopping the medication. The physician was not aware. The patient had not stopped Zejula. Zejula label instructions: took 2 capsules 200 mg total daily as directed on days 1 thought 28 of your chemotherapy cycles It was unknown if the reporter considered the feeling unwell, tiredness, blurred vision, heart rate increased, dizziness, muscle pain, sleep disturbance and hypertension to be related to Covid vaccine.
Age: 52.0
Sex: F
Vaccine: COVID19, FLUX
Symptoms: Myalgia, Sleep disorder, Vision blurred
Clinical narrative: not feeling so good today; little tired/ extremely tired; BLURRED VISION/ SHE CAN'T SEE RIGHT; RAPID HEART RATE/feel like HYPERTENSION; DIZZINESS; MUSCLE ACHES; WAS UP ALL NIGHT; This case was reported by a nurse and described the occurrence of feeling unwell in a 52-year-old female patient who received Flu unspecified (Flu vaccine) for prophylaxis.   Co-suspect products included niraparib (Zejula) capsule (batch number 2057808, expiry date 30th June 2024) for ovarian cancer and COVID-19 VACCINE (COVID VACCINE) for prophylaxis.   The patient's past medical history included asthma and hysterectomy. Concurrent medical conditions included ovarian cancer.   On 15th September 2022, the patient received Flu vaccine. On 19th September 2022, the patient started Zejula (oral) 100 mg twice daily (200 mg daily). On 15th September 2022, the patient received COVID VACCINE. On 19th September 2022, 4 days after receiving Flu vaccine and less than a day after starting Zejula, the patient experienced feeling unwell, tiredness, blurred vision, heart rate increased, dizziness, muscle pain and sleep disturbance. The action taken with Zejula was unknown. On an unknown date, the outcome of the feeling unwell, tiredness, blurred vision, heart rate increased, dizziness, muscle pain and sleep disturbance were not recovered/not resolved.   It was unknown if the reporter considered the feeling unwell, tiredness, blurred vision, heart rate increased, dizziness, muscle pain and sleep disturbance to be related to Flu vaccine and Zejula.     Additional Information: GSK Receipt Date: 23-SEP-2022 Reporter's Comments:The patient stated that she was not feeling so good today. The patient got her Covid and Flu vaccine on Thursday. The patient was little tired to be honest. The patient reported that she was extremely tired, she was brought to tears when she was talking about how tired she was. The patient getting a little blurred vision stating that she could not saw right. The patient experienced little rapid heart rate, dizziness and muscle aches. The patient was up all night and she could felt liked hypertension, although she had not checked her blood pressure. The patient need to take her blood pressure . Medical physician was not aware. The patient did want to speak to pharmacist about stopping the medication. The physician was not aware. The patient had not stopped Zejula. Zejula label instructions: took 2 capsules 200 mg total daily as directed on days 1 thought 28 of your chemotherapy cycles It was unknown if the reporter considered the feeling unwell, tiredness, blurred vision, heart rate increased, dizziness, muscle pain, sleep disturbance and hypertension to be related to Covid vaccine.
Sex: U
Vaccine: VARZOS, VARZOS
Symptoms: Herpes zoster, Pain, Vaccination failure
Clinical narrative: both shots yrs ago, got shingles on February/ suspected vaccination failure; I got shingles. They were terrible; the worst pains; 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.   Previously administered products included chemotherapy. Concurrent medical conditions included non-hodgkin's lymphoma and immunocompromised.   On an unknown date, the patient received the 2nd dose of Shingles vaccine and the 1st dose of Shingles vaccine. In February 2022, between 1 and 2 years after receiving Shingles vaccine and Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant), shingles and pain. On an unknown date, the outcome of the vaccination failure, shingles and pain were unknown.   It was unknown if the reporter considered the vaccination failure, shingles and pain to be related to Shingles vaccine and Shingles vaccine.     Additional Information: GSK Receipt Date: 26-SEP-2022 Reporter's Comment: The patient self-reported this case via interactive digital media. The reporter said shingles shots did not mean that you won't get shingles. The patient said he/she got both shots about 2 years ago and got shingles this past February.  They were terrible. He/she would still get the shots again if it would lessen the chance of getting shingles.  They really were one of the worst pains that could have.  The patient had Non-hodgkin's lymphoma and am therefore immunocompromised.  Chemotheraphy saved patient life but killed his/her immune system. The patient said not complaining he/she truly blessed to be alive. Additional supportive information: Follow up would not possible, as no contact details were available. This case was considered as suspected vaccination failure since details regarding laboratory confirmation of shingles was not reported.
Sex: F
Vaccine: VARZOS
Symptoms: Cholestasis, Malaise
Clinical narrative: shot was horrific, put me in the hospital. I have terrible reactions; This case was reported by a consumer via interactive digital media and described the occurrence of hospitalization in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   The patient's past medical history included covid-19.   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, 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 Shingrix.     Linked case(s) involving the same patient:  US2022AMR139295   Additional Information: GSK Receipt Date: 26-SEP-2022 Reporter's Comments: The pharmacist mentioned that the twin kids were sick and had Cholestasis and they advise her to did the vaccine for them agency reported by precaution as the pharmacist said that they were calling about the second dose so the twin kids already got the first dose of Rotrix. It was unknown whether this disease was related to the vaccine or not or if it was happen before the first dose or after. The second dose was not administrated yet. The pharmacist wasn't informed that he/she would report this PV case. No more information available the Rotraix formulation was unknown. The reporter did not consent to follow up.; Sender's Comments:  US-GSK-US2022AMR139295:same reporter
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Pain, Vaccination failure
Clinical narrative: Have taken the shot, now shingles/ suspected vaccination failure; shingles/Have taken the shot, now shingles; Pain is muchless; 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, several years after receiving Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant), shingles and pain. On an unknown date, the outcome of the vaccination failure was unknown and the outcome of the shingles was not recovered/not resolved and the outcome of the pain was recovering/resolving.   It was unknown if the reporter considered the vaccination failure, shingles and pain to be related to Shingles vaccine.     Additional Information: GSK Receipt Date: 26-SEP-2022 Reporter's Comment: The patient self-reported this case via interactive digital media. The patient experiencing Shingles now and certainly glad to have taken the shot a few years past. The patient would not want to have not taken the shot, the pain was much less now. 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. Follow up would not possible, as no contact details were available.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: I got the shot, and still got it/Suspected vaccination failure; Still got it/I got the shot, and still got it; 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) 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.  Additional Information: GSK Receipt Date: 26-SEP-2022 Reporter's Comment: This case was reported by a consumer via interactive digital media. The patient got the shingles shot and still got shingles. 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, VARZOS
Symptoms: Herpes zoster, Pain, Pruritus, Vaccination failure
Clinical narrative: Got shingritz series and have shingles now/suspected vaccination failure; Shingles in armpits, neck and chest; It's mostly itching; Deep 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 (Shingrix) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingles vaccine with an associated reaction of herpes zoster (on an unknown date patient had the old shot and got shingles a few months afterwards).   On an unknown date, the patient received the 2nd dose of Shingrix and the 1st dose of Shingrix. On an unknown date, unknown after receiving Shingrix and Shingrix, the patient experienced vaccination failure (serious criteria GSK medically significant), shingles, pruritus and pain. On an unknown date, the outcome of the vaccination failure, pruritus and pain were unknown and the outcome of the shingles was not recovered/not resolved.   It was unknown if the reporter considered the vaccination failure, shingles, pruritus and pain to be related to Shingrix and Shingrix.     Additional Information: GSK Receipt Date: 26-SEP-2022 Reporter's Comments: This case was reported by a patient via interactive digital media. The patient got the Shingrix series of two Shots. The patient believed he/she had shingles now in his/her armpits, chest and neck. It was mostly itching and deep pain when he/she had to wash. The patient was told that if he/she did get shingles it would not been as bad if he/she not had the vaccination. Additional supportive information: This case was considered as suspected vaccination failure as details regarding time to onset for shingles and laboratory confirmation regarding shingles were unknown at the time of reporting. Follow-up would not possible as no contact details were available.
Sex: U
Vaccine: VARZOS, VARZOS, VARZOS
Symptoms: Extra dose administered, Herpes zoster, Vaccination failure
Clinical narrative: I got all 3 shots and still had shingles/ Suspected vaccination failure; Still had shingles; I got all 3 shots; 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 and Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received the 3rd dose of Shingles vaccine, the 2nd dose of Shingles vaccine and the 1st dose of Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, Shingles vaccine and Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant), shingles and extra dose administered. On an unknown date, the outcome of the vaccination failure, shingles and extra dose administered were unknown.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine, Shingles vaccine and Shingles vaccine.     Additional Information: GSK Receipt Date: 26-SEP-2022 Reporter's Comments: The patient self-reported this case via interactive digital media. The patient got all 3 shots and still had Shingles. He/ she found out L Lysine off the shelf keeps it down. Additional Supportive Information:  This case was considered as suspected vaccination failure as time to onset and laboratory confirmation were unknown at the time of reporting. The follow-up could not be possible as no contact details were available.
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster, Pain, Vaccination failure
Clinical narrative: Shingles, got the vaccine, had a bout with it a few months go/Suspected vaccination failure; shingles; Pain is ridiculous; This case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a female 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 and pain. On an unknown date, the outcome of the vaccination failure, shingles and pain were unknown.   It was unknown if the reporter considered the vaccination failure, shingles and pain to be related to Shingles vaccine.     Additional Information: GSK receipt date :26-SEP-2022 Reporters comment: This case was reported by a patient via interactive digital media  The patient received the Shingle vaccine and had a bout with it a few months ago from reporting. The patient stated that the pain was ridiculous and if she was not already on a pain management program for something else, she could not imagine how it could be any worse. She had her husband take pictures daily to see how bad it gets. Additional Supportive information: This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule, time to onset for shingles and laboratory confirmation regarding 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: Incomplete course of vaccination
Clinical narrative: Got 1st dose, forgot the 2nd; This case was reported by a other health professional via call center representative and described the occurrence of incomplete course of vaccination in a patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (On an unknown date 1st dose received).   On an unknown date, the patient did not receive the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the incomplete course of vaccination was unknown.   Additional Information: GSK receipt date: 23-SEP-2022 Reporters comment: The patient received the first dose of shingrix and forgot to receive second dose.  The reporter stated that he/she forgot the 2nd dose. It had been a year. The reporter also asked what was the recommendation, restart the 2 injection series or just give the 2nd dose. Additional Supportive information: Till the time of reporting, the patient did not receive 2nd dose of Shingrix, which led to incomplete course of vaccination.