chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Underdose
Clinical narrative: Patient was given a 0.25 mL of Moderna Bivalent Booster dose on 9/15/2022. Patient documentation shows the lot number for bivalent.  The information was presented to hospital staff on 9/27/22. The patient was called on 9/28/22. Patient made aware received a 0.25 mL of Moderna Bivalent Booster dose. Patient verbalized understanding. Patient denies having distress at the time of call. Patient denied having to go to the Emergency room or Primary Care provider. Informed the patient according to Moderna the recommendation was to re vaccinate with full dose in 8 weeks from 9/15/2022. Patient stated would like to be re vaccinated. Patient made aware will reach out to patient regarding receiving full vaccination. Patient
Age: 7.0
Sex: F
Vaccine: COVID19-2
Symptoms: Incorrect dose administered
Clinical narrative: Patient was given a Pfizer Bivalent Booster on 9/15/2022. The information was presented to staff on 9/27/22. The patient mother was called on 9/27/22.   Patient mother made aware child received incorrect Bivalent Pfizer vaccine. Patient mother verbalized understanding.  Patient mother denied that the patient was currently having any distress.  Patient mother denied having to take child to Emergency Room or Primary Care provider.  The patient mother was informed that according to committee there is no need to administer an additional Covid Pfizer booster. Patient mother verbalized understanding. Patient mother encourage to reach out to primary care physician regarding medical needs. I reviewed side effects and serve allergic reactions with parent.  Encouraged parent to seek emergency services for severe allergic reactions by calling 911 or going to the nearest hospital. Patient mother verbalized understanding.
Age: 61.0
Sex: M
Vaccine: COVID19
Symptoms: Underdose
Clinical narrative: Patient was given a 0.25 mL of Moderna Bivalent Booster dose on 9/15/2022. Patient documentation shows the lot number for bivalent.  The information was presented to staff on 9/27/22. The patient was called on 9/28/22. Patient made aware received a 0.25 mL of Moderna Bivalent Booster dose. Patient verbalized understanding. Patient denies having distress at the time of call. Patient denied having to go to the Emergency room or Primary Care provider. Informed the patient according to Moderna the recommendation was to re vaccinate with full dose in 8 weeks from 9/15/2022. Patient stated would like to be re vaccinated. Patient made aware will reach out to patient regarding receiving full vaccination. Patient Verbalized understanding.
Age: 37.0
Sex: M
Vaccine: COVID19
Symptoms: Abdominal discomfort, Abdominal pain, Appendicitis perforated, Blood test abnormal, Computerised tomogram abdomen abnormal
Clinical narrative: Abdominal pain began the morning of April 2nd, followed by a sharp increase in pain in the overnight hours of April 2-3. Appendix ruptured at approximately 3am April 3rd (88 hours post vaccine administration). Blood present in stool on April 6th (first bowel movement post-rupture).  Due to nausea and abdominal discomfort as possible side effect of vaccine, did not seek medical attention immediately. Was hospitalized on April 8th, discharged April 13th.  Second vaccine given May 18th. Abdominal pain followed on May 22nd and I was taken to the Emergency Room.
Age: 37.0
Sex: M
Vaccine: COVID19
Symptoms: Gastrointestinal inflammation, Haematochezia, Infection, Nausea, Sepsis
Clinical narrative: Abdominal pain began the morning of April 2nd, followed by a sharp increase in pain in the overnight hours of April 2-3. Appendix ruptured at approximately 3am April 3rd (88 hours post vaccine administration). Blood present in stool on April 6th (first bowel movement post-rupture).  Due to nausea and abdominal discomfort as possible side effect of vaccine, did not seek medical attention immediately. Was hospitalized on April 8th, discharged April 13th.  Second vaccine given May 18th. Abdominal pain followed on May 22nd and I was taken to the Emergency Room.
Age: 59.0
Sex: F
Vaccine: COVID19-2
Symptoms: Incorrect dose administered
Clinical narrative: Patient was given a 0.25 mL of Moderna Bivalent Booster dose on 9/15/2022.The information was presented to the staff on 9/27/22. The patient was called on 9/28/22. Patient made aware received a  0.25 mL of Moderna Bivalent Booster dose. Patient verbalized understanding. Patient denies having distress at this time. Patient denied having to go to the Emergency room or Primary Care provider. Informed the patient according to Moderna the recommendation was to re vaccinate with full dose in 8 weeks from 9/15/2022. Patient stated would like to be re vaccinated. Patient made aware will reach out to patient regarding receiving full vaccination. Patient verbalized understanding. Patient encouraged to reach out to primary care physician regarding medical needs. I reviewed side effects and serve allergic reactions with parent.  Encouraged patient to seek emergency services for severe allergic reactions by calling 911 or going to the nearest hospital. Patient verbalized understanding.
Age: 19.0
Sex: M
Vaccine: COVID19, COVID19-2
Symptoms: Incorrect dose administered
Clinical narrative: Patient was given a 0.25 mL of Moderna Bivalent Booster dose on 9/15/2022.The information was presented to the staff on 9/27/22. The patient was called on 9/28/22. Patient made aware received a  0.25 mL of Moderna Bivalent Booster dose. Patient verbalized understanding. Patient denies having distress at this time. Patient denied having to go to the Emergency room or Primary Care provider. Informed the patient according to Moderna the recommendation was to re vaccinat with full dose in 8 weeks from 9/15/2022. Patient stated would like to be re vaccinate. Patient made aware will reach out to patient regarding receiving full vaccination. Patient verbalized understanding. Patient encouraged to reach out to primary care
Age: 19.0
Sex: M
Vaccine: COVID19, COVID19-2
Symptoms: Underdose
Clinical narrative: Patient was given a 0.25 mL of Moderna Bivalent Booster dose on 9/15/2022.The information was presented to the staff on 9/27/22. The patient was called on 9/28/22. Patient made aware received a  0.25 mL of Moderna Bivalent Booster dose. Patient verbalized understanding. Patient denies having distress at this time. Patient denied having to go to the Emergency room or Primary Care provider. Informed the patient according to Moderna the recommendation was to re vaccinat with full dose in 8 weeks from 9/15/2022. Patient stated would like to be re vaccinate. Patient made aware will reach out to patient regarding receiving full vaccination. Patient verbalized understanding. Patient encouraged to reach out to primary care
Age: 19.0
Sex: M
Vaccine: COVID19, COVID19-2
Symptoms: Incorrect dose administered
Clinical narrative: Patient was given a 0.25 mL of Moderna Bivalent Booster dose on 9/15/2022.The information was presented to MVU staff on 9/27/22. The patient was called on 9/28/22. Patient made aware received a  0.25 mL of Moderna Bivalent Booster dose. Patient verbalized understanding. Patient denies having distress at this time. Patient denied having to go to the Emergency room or Primary Care provider. Informed the patient according to Moderna the recommendation was to re vaccinat with full dose in 8 weeks from 9/15/2022. Patient stated would like to be re vaccinate. Patient made aware will reach out to patient regarding receiving full vaccination. Patient verbalized understanding. Patient encouraged to reach out to primary care physician regarding medical needs. I reviewed side effects and serve allergic reactions with parent.  Encouraged patient to seek emergency services for severe allergic reactions by calling emergency or going to the nearest hospital. Patient verbalized understanding.
Age: 19.0
Sex: M
Vaccine: COVID19, COVID19-2
Symptoms: Underdose
Clinical narrative: Patient was given a 0.25 mL of Moderna Bivalent Booster dose on 9/15/2022.The information was presented to MVU staff on 9/27/22. The patient was called on 9/28/22. Patient made aware received a  0.25 mL of Moderna Bivalent Booster dose. Patient verbalized understanding. Patient denies having distress at this time. Patient denied having to go to the Emergency room or Primary Care provider. Informed the patient according to Moderna the recommendation was to re vaccinat with full dose in 8 weeks from 9/15/2022. Patient stated would like to be re vaccinate. Patient made aware will reach out to patient regarding receiving full vaccination. Patient verbalized understanding. Patient encouraged to reach out to primary care physician regarding medical needs. I reviewed side effects and serve allergic reactions with parent.  Encouraged patient to seek emergency services for severe allergic reactions by calling emergency or going to the nearest hospital. Patient verbalized understanding.
Age: 44.0
Sex: F
Vaccine: COVID19-2
Symptoms: Incorrect dose administered
Clinical narrative: Patient was given a 0.25 mL of Moderna Bivalent Booster dose on 9/15/2022.The information was presented to medical staff on 9/27/22. The patient was called on 9/28/22. Patient made aware received a  0.25 mL of Moderna Bivalent Booster dose. Patient verbalized understanding. Patient denies having distress at this time. Patient denied having to go to the Emergency room or Primary Care provider. Informed the patient according to Moderna the recommendation was to re vaccinate with full dose in 8 weeks from 9/15/2022. Patient stated would like to be re vaccinated. Patient made aware will reach out to patient regarding receiving full vaccination. Patient verbalized understanding. Patient encouraged to reach out to primary care physician regarding medical needs. I reviewed side effects and serve allergic reactions with parent.  Encouraged patient to seek emergency services for severe allergic reactions by calling 911 or going to the nearest hospital. Patient verbalized understanding.
Age: 48.0
Sex: F
Vaccine: COVID19-2
Symptoms: Underdose
Clinical narrative: Patient was given a 0.25 mL of Moderna Bivalent Booster dose on 9/15/2022.The information was presented to medical staff on 9/27/22. The patient was called on 9/28/22 and 9/29/22. Unable to reach patient. Will make an additional attempt to contact patient on 9/28/22.
Age: 26.0
Sex: F
Vaccine: COVID19, FLUC4
Symptoms: Chest pain, Injection site pain, Poor quality sleep
Clinical narrative: Pain at the injection site for the first couple of days which affected my sleep quality. Slight chest pain starting September 16 that lasted until September 22. On September 22, I saw a doctor virtually and they advised me to avoid intense exercise, take over the counter pain killers like advil, and monitor symptoms but didn't prescribe me any medicine.
Age: 41.0
Sex: F
Vaccine: COVID19
Symptoms: Computerised tomogram normal, Mobility decreased, Pain, Scan with contrast normal, Thunderclap headache
Clinical narrative: Thunderclap headaches. Sudden in onset after orgasm.  I needed help into bed. Extremely painful. 9 out of 10.
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Atelectasis, Chest X-ray abnormal, Computerised tomogram thorax abnormal, Lung consolidation, Pleural effusion
Clinical narrative: Pulmonary Embolism
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Pulmonary embolism
Clinical narrative: Pulmonary Embolism
Sex: U
Vaccine: VARCEL
Symptoms: Product storage error
Clinical narrative: No additional adverse events; Medical assistant reporting AE for improperly stored vaccine administered. No additional AE information reported. No PQC reported. See TE case 02244271. Names of vaccines involved: VARIVAX (U015685 11/03/2022) Temperature: 9.3F; This spontaneous report was received from a medical assistant concerning a patient of unknown age and gender.  The patient's medical history, concurrent conditions and concomitant therapies were not reported.   On 19-AUG-2022, the patient was vaccinated with an improperly stored dose of varicella virus vaccine live (oka/merck) (VARIVAX) subcutaneous injection, lot #U015685, expiration date reported as 03-NOV-2022, but upon internal validation was established as: 18-MAY-2023, administered as prophylaxis (strength, and route of administration were not provided) (product storage error).   It was reported that the vaccine was stored at a temperature of 9.3 Fahrenheit degrees (F) for 5 minutes. There was a previous temperature excursion at 14F up to 46F (25.9F) lasting 1 hour and 20 minutes.   This is one of three reports received form the same source.; Sender's Comments:  US-009507513-2209USA004839: US-009507513-2209USA004342:
Sex: U
Vaccine: MMRV
Symptoms: Expired product administered, No adverse event
Clinical narrative: No additional AE information provided; Customer states that a partial dose of expired PROQUAD vaccine (LOT U009259 exp. 9/19/2022) was accidentally administered to a patient today, 9/21/2022.; This spontaneous report has been received from a nurse concerning a patient of unknown age and gender. The patient's concurrent conditions, medical history, concomitant therapies and drug/allergy history were not reported.  On 21-SEP-2022 (also reported as "today"), the patient was accidentally administered an expired dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live(rHA) (PROQUAD) partial dose of 0.5 milliliter (ml) (lot # U009259, has been verified to be a valid lot number for measles, mumps, rubella and varicella [oka-merck] virus vaccine live[rHA] [PROQUAD], expiration date reported and upon internal validation established as 19-SEP-2022) (anatomical location and route of administration were not reported) with sterile diluent for prophylaxis (Expired product administered).  The vaccine was properly stored with no temperature excursions. No additional adverse event was reported.
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: no other AE; Caller is a pharmacist who reports a temperature excursion involving VARIVAX. He does not know whether any doses were administered following the temperature excursion.; This spontaneous report was received from a pharmacist referring to a patient of unknown age and gender. The patient's pertinent medical history, concomitant medications, concurrent conditions, and previous drug reactions or allergies were not reported.  On an unknown date, varicella virus vaccine live (oka/merck) (VARIVAX) (lot #W011623, expiration date: 06-APR-2024) underwent a temperature excursion at minus 10 degrees Celsius for 1400 hours. There was no previous temperature excursion.  On 01-AUG-2022, the patient was vaccinated with the improperly stored varicella virus vaccine live (oka/merck) (VARIVAX) subcutaneous injection (strength, dose, and route of administration were not provided; lot #W011623, expiration date: 06-APR-2024), administered for prophylaxis (Product storage error). There was no other AE (No adverse event).  This is one of 13 reports received from the same reporter.; Sender's Comments:  US-009507513-2209USA010264: US-009507513-2209USA010265: US-009507513-2209USA005873: US-009507513-2209USA010267: US-009507513-2209USA010268: US-009507513-2209USA010269: US-009507513-2209USA010270: US-009507513-2209USA010271: US-009507513-2209USA010272: US-009507513-2209USA010273: US-009507513-2209USA010274: US-009507513-2209USA010275:
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: no other AE; Caller is a pharmacist who reports a temperature excursion involving VARIVAX. He does not know whether any doses were administered following the temperature excursion.; This spontaneous report was received from a pharmacist referring to a patient of unknown age and gender. The patient's pertinent medical history, concomitant medications, concurrent conditions, and previous drug reactions or allergies were not reported.  On an unknown date, varicella virus vaccine live (oka/merck) (VARIVAX) (lot #W011623, expiration date: 06-APR-2024) underwent a temperature excursion at minus 10 degrees Celsius for 1400 hours. There was no previous temperature excursion.  On 09-AUG-2022, the patient was vaccinated with the improperly stored varicella virus vaccine live (oka/merck) (VARIVAX) subcutaneous injection (strength, dose, and route of administration were not provided; lot #W011623, expiration date: 06-APR-2024), administered for prophylaxis (Product storage error). There was no other AE (No adverse event).  This is one of 13 reports received from the same reporter.; Sender's Comments:  US-009507513-2209USA010264: US-009507513-2209USA010265: US-009507513-2209USA010266: US-009507513-2209USA005873: US-009507513-2209USA010268: US-009507513-2209USA010269: US-009507513-2209USA010270: US-009507513-2209USA010271: US-009507513-2209USA010272: US-009507513-2209USA010273: US-009507513-2209USA010274: US-009507513-2209USA010275:
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: no other AE; Caller is a pharmacist who reports a temperature excursion involving VARIVAX. He does not know whether any doses were administered following the temperature excursion.; This spontaneous report was received from a pharmacist referring to a patient of unknown age and gender. The patient's pertinent medical history, concomitant medications, concurrent conditions, and previous drug reactions or allergies were not reported.  On an unknown date, varicella virus vaccine live (oka/merck) (VARIVAX) (lot #W011623, expiration date: 06-APR-2024) underwent a temperature excursion at minus 10 degrees Celsius for 1400 hours. There was no previous temperature excursion.  On 09-AUG-2022, the patient was vaccinated with the improperly stored varicella virus vaccine live (oka/merck) (VARIVAX) subcutaneous injection (strength, dose, and route of administration were not provided; lot #W011623, expiration date: 06-APR-2024), administered for prophylaxis (Product storage error). There was no other AE (No adverse event).  This is one of 13 reports received from the same reporter.; Sender's Comments:  US-009507513-2209USA010264: US-009507513-2209USA010265: US-009507513-2209USA010266: US-009507513-2209USA010267: US-009507513-2209USA005873: US-009507513-2209USA010269: US-009507513-2209USA010270: US-009507513-2209USA010271: US-009507513-2209USA010272: US-009507513-2209USA010273: US-009507513-2209USA010274: US-009507513-2209USA010275:
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: no other AE; Caller is a pharmacist who reports a temperature excursion involving VARIVAX. He does not know whether any doses were administered following the temperature excursion.; This spontaneous report was received from a pharmacist referring to a patient of unknown age and gender. The patient's pertinent medical history, concomitant medications, concurrent conditions, and previous drug reactions or allergies were not reported.  On an unknown date, varicella virus vaccine live (oka/merck) (VARIVAX) (lot #W011623, expiration date: 06-APR-2024) underwent a temperature excursion at minus 10 degrees Celsius for 1400 hours. There was no previous temperature excursion.  On 11-AUG-2022, the patient was vaccinated with the improperly stored varicella virus vaccine live (oka/merck) (VARIVAX) subcutaneous injection (strength, dose, and route of administration were not provided; lot #W011623, expiration date: 06-APR-2024), administered for prophylaxis (Product storage error). There was no other AE (No adverse event).  This is one of 13 reports received from the same reporter.; Sender's Comments:  US-009507513-2209USA010264: US-009507513-2209USA010265: US-009507513-2209USA010266: US-009507513-2209USA010267: US-009507513-2209USA010268: US-009507513-2209USA005873: US-009507513-2209USA010270: US-009507513-2209USA010271: US-009507513-2209USA010272: US-009507513-2209USA010273: US-009507513-2209USA010274: US-009507513-2209USA010275:
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: no other AE; Caller is a pharmacist who reports a temperature excursion involving VARIVAX. He does not know whether any doses were administered following the temperature excursion.; This spontaneous report was received from a pharmacist referring to a patient of unknown age and gender. The patient's pertinent medical history, concomitant medications, concurrent conditions, and previous drug reactions or allergies were not reported.  On an unknown date, varicella virus vaccine live (oka/merck) (VARIVAX) (lot #W011623, expiration date: 06-APR-2024) underwent a temperature excursion at minus 10 degrees Celsius for 1400 hours. There was no previous temperature excursion.  On 16-AUG-2022, the patient was vaccinated with the improperly stored varicella virus vaccine live (oka/merck) (VARIVAX) subcutaneous injection (strength, dose, and route of administration were not provided; lot #W011623, expiration date: 06-APR-2024), administered for prophylaxis (Product storage error). There was no other AE (No adverse event).  This is one of 13 reports received from the same reporter.; Sender's Comments:  US-009507513-2209USA010264: US-009507513-2209USA010265: US-009507513-2209USA010266: US-009507513-2209USA010267: US-009507513-2209USA010268: US-009507513-2209USA010269: US-009507513-2209USA005873: US-009507513-2209USA010271: US-009507513-2209USA010272: US-009507513-2209USA010273: US-009507513-2209USA010274: US-009507513-2209USA010275:
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: no other AE; Caller is a pharmacist who reports a temperature excursion involving VARIVAX. He does not know whether any doses were administered following the temperature excursion.; This spontaneous report was received from a pharmacist referring to a patient of unknown age and gender. The patient's pertinent medical history, concomitant medications, concurrent conditions, and previous drug reactions or allergies were not reported.  On an unknown date, varicella virus vaccine live (oka/merck) (VARIVAX) (lot #W011623, expiration date: 06-APR-2024) underwent a temperature excursion at minus 10 degrees Celsius for 1400 hours. There was no previous temperature excursion.  On 19-AUG-2022, the patient was vaccinated with the improperly stored varicella virus vaccine live (oka/merck) (VARIVAX) subcutaneous injection (strength, dose, and route of administration were not provided; lot #W011623, expiration date: 06-APR-2024), administered for prophylaxis (Product storage error). There was no other AE (No adverse event).  This is one of 13 reports received from the same reporter.; Sender's Comments:  US-009507513-2209USA010264: US-009507513-2209USA010265: US-009507513-2209USA010266: US-009507513-2209USA010267: US-009507513-2209USA010268: US-009507513-2209USA010269: US-009507513-2209USA010270: US-009507513-2209USA005873: US-009507513-2209USA010272: US-009507513-2209USA010273: US-009507513-2209USA010274: US-009507513-2209USA010275:
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: no other AE; Caller is a pharmacist who reports a temperature excursion involving VARIVAX. He does not know whether any doses were administered following the temperature excursion.; This spontaneous report was received from a pharmacist referring to a patient of unknown age and gender. The patient's pertinent medical history, concomitant medications, concurrent conditions, and previous drug reactions or allergies were not reported.  On an unknown date, varicella virus vaccine live (oka/merck) (VARIVAX) (lot #W011623, expiration date: 06-APR-2024) underwent a temperature excursion at minus 10 degrees Celsius for 1400 hours. There was no previous temperature excursion.  On 26-AUG-2022, the patient was vaccinated with the improperly stored varicella virus vaccine live (oka/merck) (VARIVAX) subcutaneous injection (strength, dose, and route of administration were not provided; lot #W011623, expiration date: 06-APR-2024), administered for prophylaxis (Product storage error). There was no other AE (No adverse event).  This is one of 13 reports received from the same reporter.; Sender's Comments:  US-009507513-2209USA010264: US-009507513-2209USA010265: US-009507513-2209USA010266: US-009507513-2209USA010267: US-009507513-2209USA010268: US-009507513-2209USA010269: US-009507513-2209USA010270: US-009507513-2209USA010271: US-009507513-2209USA005873: US-009507513-2209USA010273: US-009507513-2209USA010274: US-009507513-2209USA010275:
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: no other AE; Caller is a pharmacist who reports a temperature excursion involving VARIVAX. He does not know whether any doses were administered following the temperature excursion.; This spontaneous report was received from a pharmacist referring to a patient of unknown age and gender. The patient's pertinent medical history, concomitant medications, concurrent conditions, and previous drug reactions or allergies were not reported.  On an unknown date, varicella virus vaccine live (oka/merck) (VARIVAX) (lot #W011623, expiration date: 06-APR-2024) underwent a temperature excursion at minus 10 degrees Celsius for 1400 hours. There was no previous temperature excursion.  On 06-SEP-2022, the patient was vaccinated with the improperly stored varicella virus vaccine live (oka/merck) (VARIVAX) subcutaneous injection (strength, dose, and route of administration were not provided; lot #W011623, expiration date: 06-APR-2024), administered for prophylaxis (Product storage error). There was no other AE (No adverse event).  This is one of 13 reports received from the same reporter.; Sender's Comments:  US-009507513-2209USA010264: US-009507513-2209USA010265: US-009507513-2209USA010266: US-009507513-2209USA010267: US-009507513-2209USA010268: US-009507513-2209USA010269: US-009507513-2209USA010270: US-009507513-2209USA010271: US-009507513-2209USA010272: US-009507513-2209USA005873: US-009507513-2209USA010274: US-009507513-2209USA010275:
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: no other AE; Caller is a pharmacist who reports a temperature excursion involving VARIVAX. He does not know whether any doses were administered following the temperature excursion.; This spontaneous report was received from a pharmacist referring to a patient of unknown age and gender. The patient's pertinent medical history, concomitant medications, concurrent conditions, and previous drug reactions or allergies were not reported.  On an unknown date (from 16-JUL-2022 until 14-SEP-2022), varicella virus vaccine live (oka/merck) (VARIVAX) (lot #W011623, expiration date: 06-APR-2024) underwent a temperature excursion at minus 10 degrees Celsius for 1400 hours. There was no previous temperature excursion.  On 09-SEP-2022, the patient was vaccinated with the improperly stored varicella virus vaccine live (oka/merck) (VARIVAX) subcutaneous injection (strength, dose, and route of administration were not provided; lot #W011623, expiration date: 06-APR-2024), administered for prophylaxis (Product storage error). There was no other AE (No adverse event).  This is one of 13 reports received from the same reporter.; Sender's Comments:  US-009507513-2209USA010264: US-009507513-2209USA010265: US-009507513-2209USA010266: US-009507513-2209USA010267: US-009507513-2209USA010268: US-009507513-2209USA010269: US-009507513-2209USA010270: US-009507513-2209USA010271: US-009507513-2209USA010272: US-009507513-2209USA010273: US-009507513-2209USA005873: US-009507513-2209USA010275:
Sex: U
Vaccine: DTOX, HIBV, MMR, PPV, VARCEL
Symptoms: Anti-HLA antibody test positive
Clinical narrative: human leukocyte antigen (HLA) sensitization subsequent to vaccination; Literature report:   This literature marketed report has been received from authors of the literature article entitled as stated above and refers to an unspecified pediatric patient waiting for kidney transplant. No information regarding the patient's pertinent medical history, drug reactions or allergies and concomitant therapies was provided. On an unknown date, the patient was vaccinated with measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (manufacturer unknown), varicella virus vaccine live (oka/merck) (manufacturer unknown), with haemophilus b conjugate vaccine (meningococcal protein conjugate) (manufacturer unknown) with diphtheria vaccine toxoid, pertussis vaccine, tetanus vaccine toxoid and with pneumococcal vaccine conj (formulation, strength, dose, frequency, route of administration, indication, lot # and expiration date were not reported) all for prophylaxis. On an unknown date after vaccination, the patient's anti-HLA antibody test was positive; the patient experienced human leukocyte antigen (HLA) sensitization subsequent to vaccination. The outcome of the event was unknown. The authors considered the event to be related to suspect vaccines.  This is one of five reports derived from the same literature article.  A copy of the published article is attached as further documentation of the patient's experience.; Sender's Comments:  US-009507513-2209USA001761: US-009507513-2209USA010292: US-009507513-2209USA010291: US-009507513-2209USA010293:
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: shingles after doses several yrs prior/I developed shingles after having taken doses of shingrix several yrs prior. It was a mild case. My question is/ suspected vaccination failure; shingles, mild case; This case was reported by a consumer via call center representative and described the occurrence of vaccination failure in a elderly patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix. On an unknown date, several 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: 22-SEP-2022 Reporter's Comments: The patient developed shingles after having taken doses of Shingrix several years prior. The reporter reported that it was a mild case.  The reporter wanted to know should he/she took another dose of Shingrix and would it helped prevent reoccurrence. The reporter wanted to know whether patient received the first dose Shingrix or another vaccine.  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. Add Note: suspected vaccination failure coded as mentioned doses and no dose numbers reported , However patient confirmed only regarding 1st dose of Shingrix and unclear how many doses received as well information about 2nd dose and saying for scheme.
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Herpes zoster, Skin disorder, Vaccination failure
Clinical narrative: second shot triggered Shingles /Suspected vaccination failure; shingles; marks on his arm; This case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a male patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis.   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 and skin disorder. On an unknown date, the outcome of the vaccination failure, shingles and skin disorder were unknown.   The reporter considered the vaccination failure, shingles and skin disorder to be possibly related to Shingrix and Shingrix.     Additional Information: GSK Receipt Date: 24-SEP-2022 Reporter's comment: This case was reported by the patient's wife via interactive digital media. The reporter stated that patient's Shingrix second shot had triggered his Shingles, the doctor said, and he would still have marks on his arm that would never go away. The reporter thought that the event might have been related to the vaccine. Additional supportive information: This case was considered as suspected vaccination failure as details regarding 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. This case had been linked with US2022AMR137779, reported by same reporter.; Sender's Comments:  US-GSK-US2022AMR137779:Same reporter
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster, Pain, Vaccination failure
Clinical narrative: get the shot and he got shingles/suspected vaccination failure; shingles/get the shot and he got shingles; still has the pain from them; This case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a male 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 was unknown and the outcome of the shingles and pain were not recovered/not resolved.   It was unknown if the reporter considered the vaccination failure, shingles and pain to be related to Shingles vaccine.     Additional Information: GSK receipt date: 21-Sept-2022 Reporter's comment: The case was received from the patient's wife via interactive digital media. The patient never had chickenpox. The patient's physician told him to get the shot and guess what he got shingles, has had them for over a year still has had the pain from them. The reporter stated that they were told that the patient should not have the shingles shot. 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.
Sex: M
Vaccine: VARZOS
Symptoms: Death, Head discomfort, Head injury
Clinical narrative: Death NOS; Was never the same/ complained of vaccine/ picked up off ground/had head hitting repeatedly; This case was reported by a consumer via interactive digital media and described the occurrence of unknown cause of death in a male patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, several months after receiving Shingles vaccine, the patient experienced unknown cause of death (serious criteria death and GSK medically significant) and head discomfort. On an unknown date, the outcome of the unknown cause of death was fatal and the outcome of the head discomfort was unknown. The reported cause of death was unknown cause of death.   The reporter considered the unknown cause of death and head discomfort to be possibly related to Shingles vaccine.     Additional Information: GSK Receipt Date: 26-SEP-2022 Reporter's comment: This case was reported by the consumer via interactive digital media. The reporter reported that his/her brother in law received a dose of Shingles vaccine and he died a few months later and complained ever since he got it. The reporter said that the patient was never the same. The reporter said that from patient's neighbors had to pick him up off the ground and took the patient inside and hit his head repeatedly. Additional Supportive Information: The follow-up would not possible as no contact details were available. Note: Suspect captured as per narrative as Shingles vaccine conservatively.; Reported Cause(s) of Death: Unknown cause of death
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: got the shots..but didn't work cause I still get it/suspected vaccination failure; I still get 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: 22-Sept-2022 Reporter's comment: The case was received from the patient via interactive digital media. The patient got the shots but did not work, he/she still got 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.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: Had shingrix in 2020, now have shingles/Suspected vaccination failure; Now have shingles; 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.   On an unknown date, the patient received Shingrix. In September 2022, more 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 was unknown and the outcome of the shingles was not recovered/not resolved.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingrix.     Additional Information: GSK receipt date: 08-Sept-2022 Reporter's comment: The case was received from the patient via interactive digital media. The patient had shingrix vaccine in 2020 and now had shingles. The patient was not happy with cost return. 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: M
Vaccine: VARZOS
Symptoms: Guillain-Barre syndrome, Near death experience
Clinical narrative: nearly died; got GBS from the shot, nearly died; This case was reported by a consumer via interactive digital media and described the occurrence of near death experience in a male 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 near death experience (serious criteria GSK medically significant and life threatening) and guillain barre syndrome (serious criteria GSK medically significant). On an unknown date, the outcome of the near death experience and guillain barre syndrome were unknown.   It was unknown if the reporter considered the near death experience to be related to Shingles vaccine. The reporter considered the guillain barre syndrome to be related to Shingles vaccine.  Additional Information: GSK Receipt Date: 25-SEP-2022 Reporter's Comment: This case was reported by a patient's wife via interactive digital media. The patient got GBS (Guillain Barre syndrome) from the Shingles shot and nearly died. Additional Supportive Information: The follow up would not possible as no contact details were available.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: Woke up with them the day after 2nd shot. Not a bad case though.; This case was reported by a consumer via interactive digital media and described the occurrence of shingles in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received the 2nd dose of Shingles vaccine. On an unknown date, 1 day after receiving Shingles vaccine, the patient experienced shingles. On an unknown date, the outcome of the shingles was unknown.   It was unknown if the reporter considered the shingles to be related to Shingles vaccine.     Additional Information: GSK Receipt Date: 19-SEP-2022 Reporter's Comment: This case was reported by a patient via interactive digital media. The patient had the shingles vaccine. The patient stated that, he/she woke up with them the day after 2nd shot of shingles vaccine but not a bad case though. Additional Supportive Information: The follow up would not possible as no contact details were available.
Sex: U
Vaccine: VARZOS
Symptoms: Adverse drug reaction, Anxiety, Bedridden, Fear, Illness
Clinical narrative: Completely bedridden sick as a dog; Completely bedridden sick as a dog; It's terrified me; This case was reported by a consumer via interactive digital media and described the occurrence of bedridden in a patient who received Herpes zoster (Shingrix) for prophylaxis.   On 16th September 2022, the patient received the 1st dose of Shingrix. In September 2022, less than a week after receiving Shingrix, the patient experienced bedridden, sickness and impending doom. On an unknown date, the outcome of the bedridden, sickness and impending doom were not recovered/not resolved.   It was unknown if the reporter considered the bedridden, sickness and impending doom to be related to Shingrix.     Additional Information: GSK Receipt Date: 19-SEP-2022 Reporter's Comments: This case was received from consumer via interactive digital media. The patient got the first of 2 Shingrix vaccine on Friday and had been completely bedridden sick as a dog from the side affects and was terrified to patient. The patient was not sure he/she would even get the second shot. The follow-up could not be possible as no contact details were available.
Sex: F
Vaccine: MENB
Symptoms: Extensive swelling of vaccinated limb, Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: Arm swollen (shoulder to mid forearm); Swelling was red; Swelling was hot to touch; This case was reported by a nurse via sales rep and described the occurrence of extensive swelling of vaccinated limb in a female patient who received Men B NVS (Bexsero) for prophylaxis.   Co-suspect products included meningococcal B recom vaccine + aloh + omv pre-filled syringe device (Bexsero Pre-Filled Syringe Device) injection syringe for prophylaxis.   In September 2022, the patient received the 1st dose of Bexsero .5 ml and Bexsero Pre-Filled Syringe Device. In September 2022, less than 2 weeks after receiving Bexsero and Bexsero Pre-Filled Syringe Device, the patient experienced extensive swelling of vaccinated limb, injection site erythema and injection site warmth. On an unknown date, the outcome of the extensive swelling of vaccinated limb, injection site erythema and injection site warmth were recovered/resolved.   The reporter considered the extensive swelling of vaccinated limb, injection site erythema and injection site warmth to be related to Bexsero and Bexsero Pre-Filled Syringe Device.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK Receipt Date: 20-SEP-2022 Reporter's Comment: The reporter was a licensed practical nurse. The reporter said that a patient received Bexsero in left arm deltoid muscle approximately 2 weeks ago from reporting date.  The patients arm from shoulder to mid forearm swelled.  The swelling was red and hot to touch.  The practice saw patient and treated successfully. The swelling, redness, and hot to touch symptoms all had subsided.  The practice believed this AE (Adverse events) was related to product. The reporter stated that this event was already reported to VAERS. The reporter did not agree to follow up from GSK.
Sex: U
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: 1st in October 2021, haven't had the 2nd; This case was reported by a consumer via interactive digital media and described the occurrence of incomplete course of vaccination in a patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (1st dose received in October 2021).   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: 19-SEP-2022 Reporter's comment: This case was reported by a patient via interactive digital media. The patient have not had the 2nd dose of Shingrix. The patient had asked if it was ok to get it now. Additional supportive information: Till the time of reporting, the patient did not receive the 2nd dose of Shingrix, which led to incomplete course of vaccination. The follow up would not possible as no contact details were available.
Sex: F
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: Is overdue for her 2nd SHINGRIX vaccine; This case was reported by a consumer via other manufacturer and described the occurrence of incomplete course of vaccination in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   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: 20-SEP-2022 Reporter's comment: The patient self-reported this case. The patient was overdue for her 2nd Shingrix vaccine. The patient had declined for providing her address or physician demographics. No additional information was provided. The reporter had denied to provide further contact details. Additional supportive information: Till the time of reporting, the patient did not receive the 2nd dose of Shingrix, which led to incomplete course of vaccination.
Sex: U
Vaccine: VARZOS
Symptoms: COVID-19
Clinical narrative: Still got Covid; This case was reported by a consumer via interactive digital media and described the occurrence of covid-19 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 covid-19. On an unknown date, the outcome of the covid-19 was unknown.   It was unknown if the reporter considered the covid-19 to be related to Shingles vaccine.     Additional Information: GSK Receipt Date: 20-SEP-2022 Reporter's Comments:  This case was received from patient via interactive digital media. The patient had the shots and still got Covid and patient stated was not in any pain and he/she asked what pain r u talking about. Additional supportive information: The follow-up would not possible as no contact details were available. Note: It was unaclear patient received Covid vaccine or not as said still got Covid so, as per page suspect coded as Shingle vaccine.