chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Blood test, Chest X-ray, Chest discomfort, Chills, Computerised tomogram
Clinical narrative: This spontaneous case was reported by a consumer and describes the occurrence of HYPERHIDROSIS (Broke fever in pool of sweat for 4 nights which kept getting worse), HEAD DISCOMFORT (Massive pressure in head), INSOMNIA (Insomnia), COUGH (Developed a cold cough) and DYSPNOEA (Major breathing issues/Shortness of breath) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 045J21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. The patient's past medical history included COVID-19 (Neurological) in November 2020.Concurrent medical conditions included Asthma (asthma attack once a year.) and Wolff-Parkinson-White syndrome (not medicated). On 21-Dec-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 03-Jan-2022, the patient experienced PULMONARY CALCIFICATION (Calcified nodule of lung). On an unknown date, the patient experienced HYPERHIDROSIS (Broke fever in pool of sweat for 4 nights which kept getting worse), HEAD DISCOMFORT (Massive pressure in head), INSOMNIA (Insomnia), COUGH (Developed a cold cough), DYSPNOEA (Major breathing issues/Shortness of breath), CHEST DISCOMFORT (Chest congestion), LOWER RESPIRATORY TRACT INFECTION (Chest cold for 14 day), PYREXIA (Fever), CHILLS (Hot chills), HEADACHE (Headaches) and FATIGUE (Fatigued). The patient was treated with PREDNISONE at an unspecified dose and frequency. At the time of the report, HYPERHIDROSIS (Broke fever in pool of sweat for 4 nights which kept getting worse), HEAD DISCOMFORT (Massive pressure in head), INSOMNIA (Insomnia), COUGH (Developed a cold cough), DYSPNOEA (Major breathing issues/Shortness of breath), PULMONARY CALCIFICATION (Calcified nodule of lung), CHEST DISCOMFORT (Chest congestion), PYREXIA (Fever), CHILLS (Hot chills), HEADACHE (Headaches) and FATIGUE (Fatigued) outcome was unknown and LOWER RESPIRATORY TRACT INFECTION (Chest cold for 14 day) had resolved. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available):On 03-Jan-2022, Chest X-ray: abnormal (abnormal) calcified nodule of lung.On 14-Jan-2022, Computerised tomogram: results not reported at 04:30 pm , Results not reported.On an unknown date, Blood test: results not reported Results not reported. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. Concomitant medication included inhaler(unspecified). Treatment medications also included nebulizer (5 times a day) and inhaler(not specified.) Patient stated she would be going to a cardiologist and pulmonologist on the day of reporting.
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Cough, Dyspnoea, Fatigue, Head discomfort, Headache
Clinical narrative: This spontaneous case was reported by a consumer and describes the occurrence of HYPERHIDROSIS (Broke fever in pool of sweat for 4 nights which kept getting worse), HEAD DISCOMFORT (Massive pressure in head), INSOMNIA (Insomnia), COUGH (Developed a cold cough) and DYSPNOEA (Major breathing issues/Shortness of breath) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 045J21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. The patient's past medical history included COVID-19 (Neurological) in November 2020.Concurrent medical conditions included Asthma (asthma attack once a year.) and Wolff-Parkinson-White syndrome (not medicated). On 21-Dec-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 03-Jan-2022, the patient experienced PULMONARY CALCIFICATION (Calcified nodule of lung). On an unknown date, the patient experienced HYPERHIDROSIS (Broke fever in pool of sweat for 4 nights which kept getting worse), HEAD DISCOMFORT (Massive pressure in head), INSOMNIA (Insomnia), COUGH (Developed a cold cough), DYSPNOEA (Major breathing issues/Shortness of breath), CHEST DISCOMFORT (Chest congestion), LOWER RESPIRATORY TRACT INFECTION (Chest cold for 14 day), PYREXIA (Fever), CHILLS (Hot chills), HEADACHE (Headaches) and FATIGUE (Fatigued). The patient was treated with PREDNISONE at an unspecified dose and frequency. At the time of the report, HYPERHIDROSIS (Broke fever in pool of sweat for 4 nights which kept getting worse), HEAD DISCOMFORT (Massive pressure in head), INSOMNIA (Insomnia), COUGH (Developed a cold cough), DYSPNOEA (Major breathing issues/Shortness of breath), PULMONARY CALCIFICATION (Calcified nodule of lung), CHEST DISCOMFORT (Chest congestion), PYREXIA (Fever), CHILLS (Hot chills), HEADACHE (Headaches) and FATIGUE (Fatigued) outcome was unknown and LOWER RESPIRATORY TRACT INFECTION (Chest cold for 14 day) had resolved. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available):On 03-Jan-2022, Chest X-ray: abnormal (abnormal) calcified nodule of lung.On 14-Jan-2022, Computerised tomogram: results not reported at 04:30 pm , Results not reported.On an unknown date, Blood test: results not reported Results not reported. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. Concomitant medication included inhaler(unspecified). Treatment medications also included nebulizer (5 times a day) and inhaler(not specified.) Patient stated she would be going to a cardiologist and pulmonologist on the day of reporting.
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Hyperhidrosis, Insomnia, Lower respiratory tract infection, Pulmonary calcification, Pyrexia
Clinical narrative: This spontaneous case was reported by a consumer and describes the occurrence of HYPERHIDROSIS (Broke fever in pool of sweat for 4 nights which kept getting worse), HEAD DISCOMFORT (Massive pressure in head), INSOMNIA (Insomnia), COUGH (Developed a cold cough) and DYSPNOEA (Major breathing issues/Shortness of breath) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 045J21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. The patient's past medical history included COVID-19 (Neurological) in November 2020.Concurrent medical conditions included Asthma (asthma attack once a year.) and Wolff-Parkinson-White syndrome (not medicated). On 21-Dec-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 03-Jan-2022, the patient experienced PULMONARY CALCIFICATION (Calcified nodule of lung). On an unknown date, the patient experienced HYPERHIDROSIS (Broke fever in pool of sweat for 4 nights which kept getting worse), HEAD DISCOMFORT (Massive pressure in head), INSOMNIA (Insomnia), COUGH (Developed a cold cough), DYSPNOEA (Major breathing issues/Shortness of breath), CHEST DISCOMFORT (Chest congestion), LOWER RESPIRATORY TRACT INFECTION (Chest cold for 14 day), PYREXIA (Fever), CHILLS (Hot chills), HEADACHE (Headaches) and FATIGUE (Fatigued). The patient was treated with PREDNISONE at an unspecified dose and frequency. At the time of the report, HYPERHIDROSIS (Broke fever in pool of sweat for 4 nights which kept getting worse), HEAD DISCOMFORT (Massive pressure in head), INSOMNIA (Insomnia), COUGH (Developed a cold cough), DYSPNOEA (Major breathing issues/Shortness of breath), PULMONARY CALCIFICATION (Calcified nodule of lung), CHEST DISCOMFORT (Chest congestion), PYREXIA (Fever), CHILLS (Hot chills), HEADACHE (Headaches) and FATIGUE (Fatigued) outcome was unknown and LOWER RESPIRATORY TRACT INFECTION (Chest cold for 14 day) had resolved. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available):On 03-Jan-2022, Chest X-ray: abnormal (abnormal) calcified nodule of lung.On 14-Jan-2022, Computerised tomogram: results not reported at 04:30 pm , Results not reported.On an unknown date, Blood test: results not reported Results not reported. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. Concomitant medication included inhaler(unspecified). Treatment medications also included nebulizer (5 times a day) and inhaler(not specified.) Patient stated she would be going to a cardiologist and pulmonologist on the day of reporting.
Age: 32.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Head discomfort, Headache, Immunisation, SARS-CoV-2 test
Clinical narrative: Fatigue, severe headache, headache continued to intensify (causing vision to become blurry), chills.
Age: 32.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Chills, Fatigue, Headache, Vision blurred
Clinical narrative: Fatigue, severe headache, headache continued to intensify (causing vision to become blurry), chills.
Sex: U
Vaccine: COVID19, COVID19
Symptoms: Pruritus, Rash, Rash erythematous, Type IV hypersensitivity reaction, Urticaria
Clinical narrative: I received my booster 12/29/21 and 13 days later I developed hives and rashes on my body; I received my booster 12/29/21 and 13 days later I developed hives and rashes on my body.This spontaneous case was reported by a nurse and describes the occurrence of URTICARIA (I received my booster 12/29/21 and 13 days later I developed hives and rashes on my body) and RASH (I received my booster 12/29/21 and 13 days later I developed hives and rashes on my body.) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 29-Dec-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In January 2022, the patient experienced URTICARIA (I received my booster 12/29/21 and 13 days later I developed hives and rashes on my body) and RASH (I received my booster 12/29/21 and 13 days later I developed hives and rashes on my body.). At the time of the report, URTICARIA (I received my booster 12/29/21 and 13 days later I developed hives and rashes on my body) and RASH (I received my booster 12/29/21 and 13 days later I developed hives and rashes on my body.) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medications details were not reported by the reporter. Treatment details was not reported by the reporter.
Sex: U
Vaccine: COVID19, COVID19
Symptoms: Rash, Urticaria
Clinical narrative: I received my booster 12/29/21 and 13 days later I developed hives and rashes on my body; I received my booster 12/29/21 and 13 days later I developed hives and rashes on my body.This spontaneous case was reported by a nurse and describes the occurrence of URTICARIA (I received my booster 12/29/21 and 13 days later I developed hives and rashes on my body) and RASH (I received my booster 12/29/21 and 13 days later I developed hives and rashes on my body.) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 29-Dec-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In January 2022, the patient experienced URTICARIA (I received my booster 12/29/21 and 13 days later I developed hives and rashes on my body) and RASH (I received my booster 12/29/21 and 13 days later I developed hives and rashes on my body.). At the time of the report, URTICARIA (I received my booster 12/29/21 and 13 days later I developed hives and rashes on my body) and RASH (I received my booster 12/29/21 and 13 days later I developed hives and rashes on my body.) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medications details were not reported by the reporter. Treatment details was not reported by the reporter.
Sex: F
Vaccine: COVID19
Symptoms: Chills, Discomfort, Fatigue, Feeling hot, Nausea
Clinical narrative: fever; the back of my neck and chest felt warm; nausea; chills; tiredness in the neck; very intense heaviness in the nape.; had general tiredness; This is a spontaneous report from a contactable consumer or other non hcp. Received from Pfizer Colleague. A 37-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, (Batch/Lot Number: AW0198)), dose 2 unknown, administered in the left arm on 23Jul2021 at 15:15 as dose 2, single for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. On 23Jul2021 at 15:35, the patient experienced tiredness, very intense heaviness in the nape. On 23Jul2021, the patient had general tiredness. On 23Jul2021 at 20:00, the patient had, chills, fever. On 24Jul2021 at 11:00, the patient had fever, the back of my neck and chest felt warm. About 20 minutes later I started to feel very heavy / tired on the back of my neck. The sensation disappeared 20 minutes later. In the late evening the patient had general tiredness and around 20:00 the patient had nausea and chills. The next day, at 11 a.m. The patient started to feel a fever, the patient did not measure my temperature, but my neck and chest felt warm, so the patient took a 500 mg Tylenol tablet. The fever sensation disappeared at about 13:30 pm. Therapeutic measures were taken as a result of, fever (pyrexia), the back of my neck and chest felt warm (feeling hot). The outcome of the events tiredness, very intense heaviness in the nape recovered on 23Jul2021 at 15:55, had general tiredness, nausea, chills, was unknown, fever and the back of my neck and chest felt warm was recovered on 24Jul2021 at 13:30. Additional information: My second dose of Comirnaty was administered to my left arm on July 23, 2021 at 3:15 PM. About 20 minutes later I started to feel very heavy / tired on the back of my neck. The sensation disappeared 20 minutes later. In the late evening I had general tiredness and around 8 I had nausea and chills. The next day (July 24), at 11 a.m. I started to feel a fever, I did not measure my temperature but my neck and chest felt hot, so I took a 500 mg Tylenol tablet. The fever sensation disappeared at about 1:30 pm.  Follow-up attempts are possible; information about batch number will be obtained.  Follow-up (25Oct2021) new information received from same contactable consumer via email included: Lot and clinical information was updated.  Follow-up attempts completed and no further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: fever; the back of my neck and chest felt warm; nausea; chills; tiredness in the neck; very intense heaviness in the nape.; had general tiredness; This is a spontaneous report from a contactable consumer or other non hcp. Received from Pfizer Colleague. A 37-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, (Batch/Lot Number: AW0198)), dose 2 unknown, administered in the left arm on 23Jul2021 at 15:15 as dose 2, single for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. On 23Jul2021 at 15:35, the patient experienced tiredness, very intense heaviness in the nape. On 23Jul2021, the patient had general tiredness. On 23Jul2021 at 20:00, the patient had, chills, fever. On 24Jul2021 at 11:00, the patient had fever, the back of my neck and chest felt warm. About 20 minutes later I started to feel very heavy / tired on the back of my neck. The sensation disappeared 20 minutes later. In the late evening the patient had general tiredness and around 20:00 the patient had nausea and chills. The next day, at 11 a.m. The patient started to feel a fever, the patient did not measure my temperature, but my neck and chest felt warm, so the patient took a 500 mg Tylenol tablet. The fever sensation disappeared at about 13:30 pm. Therapeutic measures were taken as a result of, fever (pyrexia), the back of my neck and chest felt warm (feeling hot). The outcome of the events tiredness, very intense heaviness in the nape recovered on 23Jul2021 at 15:55, had general tiredness, nausea, chills, was unknown, fever and the back of my neck and chest felt warm was recovered on 24Jul2021 at 13:30. Additional information: My second dose of Comirnaty was administered to my left arm on July 23, 2021 at 3:15 PM. About 20 minutes later I started to feel very heavy / tired on the back of my neck. The sensation disappeared 20 minutes later. In the late evening I had general tiredness and around 8 I had nausea and chills. The next day (July 24), at 11 a.m. I started to feel a fever, I did not measure my temperature but my neck and chest felt hot, so I took a 500 mg Tylenol tablet. The fever sensation disappeared at about 1:30 pm.  Follow-up attempts are possible; information about batch number will be obtained.  Follow-up (25Oct2021) new information received from same contactable consumer via email included: Lot and clinical information was updated.  Follow-up attempts completed and no further information is expected.
Age: 26.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered, Product storage error
Clinical narrative: administered with the vaccine from a vial which has been 1st punctured for more than 12 hours; administered with the vaccine from a vial which has been exposed to room temperature for approximately 27 hours after 1st puncture; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (administered with the vaccine from a vial which has been 1st punctured for more than 12 hours) and PRODUCT STORAGE ERROR (administered with the vaccine from a vial which has been exposed to room temperature for approximately 27 hours after 1st puncture) in a 26-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 059H21A) for COVID-19 vaccination.     No Medical History information was reported.    On 14-Jan-2022, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 14-Jan-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (administered with the vaccine from a vial which has been 1st punctured for more than 12 hours) and PRODUCT STORAGE ERROR (administered with the vaccine from a vial which has been exposed to room temperature for approximately 27 hours after 1st puncture). On 14-Jan-2022, EXPIRED PRODUCT ADMINISTERED (administered with the vaccine from a vial which has been 1st punctured for more than 12 hours) and PRODUCT STORAGE ERROR (administered with the vaccine from a vial which has been exposed to room temperature for approximately 27 hours after 1st puncture) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications reported by reporter No treatment medications provided by the reporter.   Reporter stated that vial was first punctured on 13JAN2022, 9:40 am for more than 12 hours and which has been exposed to room temperature for approximately 27 hours after 1st puncture.
Sex: U
Vaccine: MMR, MMRV
Symptoms: Incorrect dose administered, Product administered to patient of inappropriate age
Clinical narrative: Accidentally administered the M-M-R II and PROQUAD vaccines to pediatric patient at our facility; This spontaneous report was received from a medical assistance referring to a pediatric patient of unreported age and gender. The patient's medical history, current condition, and concomitant medications were not provided.    On 03-JAN-2022, the patient accidentally administered measles, mumps, and rubella (wistar RA 27-3) virus vaccine, live(M-M-R II) and measles, mumps, rubella and varicella (Oka-Merck) virus vaccine live (PROQUAD) (accidental overdose) for prophylaxis (dose, vaccination scheme frequency, route of administration, lot number, and expiration date were not reported).
Sex: U
Vaccine: RV5
Symptoms: Product storage error
Clinical narrative: Improperly stored administered vaccine; This spontaneous report was received from a physician referring to a patient of unknown age. The patient's pertinent medical history, previous drug reactions or allergies and concomitant medications were not provided.      On 23-DEC-2021, the patient was vaccinated with improperly stored rotavirus vaccine, live, oral, pentavalent (ROTATEQ) (product storage error) (lot number T040207, expiration date 18-JUL-2022; dose, dose number, vaccination scheme, route of administration, and anatomical location of vaccination were not reported) for prophylaxis.  The vaccine was exposed to a temperature of 27.4 degree Celsius (C), for a time frame of 52 hours and 30 minutes. There were no previous temperature excursions.
Sex: U
Vaccine: MMRV
Symptoms: Product storage error
Clinical narrative: This spontaneous report was received from a registered nurse referring to a patient of unknown age. Information regarding the patient's pertinent medical history, historical drugs, concurrent conditions, concomitant therapies and previous drug reactions or allergies were not provided. On 07-OCT-2021, the patient was vaccinated with measles, mumps, rubella and varicella (Oka-Merck) virus vaccine live recombinant human albumin (rHA) (PROQUAD) 0.5 milliliter (lot number T015598, expiration date 02-NOV-2022; route of administration, vaccination scheme and anatomical location of vaccination were not reported) for prophylaxis. The administration of a vaccine that was involved in temperature excursion (product storage error). The measles, mumps, rubella and varicella (Oka-Merck) virus vaccine live recombinant human albumin (rHA) (PROQUAD) underwent a temperature excursion of 23.10 degree Celsius for period of 65 hours and 25 minutes. The previous temperature excursion was unknown. No product quality complaint (PQC) and no additional adverse event (AEs) was reported.
Sex: U
Vaccine: MMR
Symptoms: No adverse event, Product dose omission issue
Clinical narrative: unable to confirm if Patient was previously administered MMR ll prior to call time; No Additional AE reported; Missed a scheduled MMR II dose; This spontaneous report was received from a consumer (office manager) referring to a patient of unreported age and gender. The patient's relevant medical history, drug reactions or allergies, and concomitant medications were not provided.       On 07-JAN-2022, the patient had missed a scheduled dose of measles, mumps, and rubella (wistar RA 27-3) virus vaccine, live (M-M-R II) for prophylaxis(product dose omission issue) (dose, dose number, vaccination scheme, route of administration, anatomical location of vaccination, lot number and expiration date were not reported). It was unable to confirm if patient was previously administered measles, mumps, and rubella (wistar RA 27-3) virus vaccine, live (M-M-R II) prior to reporting time (circumstance or information capable of leading to medication error). No product quality complaint (PQC) and no additional adverse event (AEs) (no adverse event) was reported.
Sex: M
Vaccine: HIBV
Symptoms: Extra dose administered, No adverse event
Clinical narrative: No additiona AE reported; Administered an additional dose of PEDVAX HIB to a patient; Administered an additional dose of PEDVAX HIB to a patient; This spontaneous report was received from a nurse, concerning a 4 year old male patient. Information regarding the patient's pertinent medical history, concurrent conditions and concomitant medications was not provided.   On 10-JAN-2022, the patient was accidentally administered an additional dose of haemophilus b conjugate vaccine (meningococcal protein conjugate) (LIQUID PEDVAXHIB) 1 dose for prophylaxis, lot # T037651 and expiration date 20-JUL-2023 (strength and route of administration were not provided). No additional adverse event was reported.
Sex: U
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: been 18 months since the 1st dose; 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 vaccine (1st dose received 18th months prior to the reporting date).   On an unknown date, the patient received 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 details were provided as follows: The patient self-reported this case. The age at vaccination was not applicable for this report. A patient received the 1st dose but did not return in 2 to 6 months to receive the 2nd dose. Now it had been 18 months since the 1st dose and till the time of reporting, the patient did not receive the 2nd dose, which led to incomplete course of vaccination. A patient asked did the patient have to retake the 1st dose now. The follow-up would not possible as no contact details were available.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Rash papular, Vaccination failure
Clinical narrative: This case was reported by a consumer via interactive digital media and described the occurrence of suspected vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis. On an unknown date, the patient received Shingles vaccine. In May 2021, unknown after receiving Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the patient experienced papular rash. The patient was treated with calamine, zinc oxide (Calamine Lotion), valacyclovir hcl tablet and gabapentin. On an unknown date, the outcome of the vaccination failure, shingles and papular rash were unknown. It was unknown if the reporter considered the vaccination failure, shingles and papular rash to be related to Shingles vaccine. Additional details were provided as follows: This case was reported by patient himself/herself. The age at vaccination was not reported. The patient stated he/she had shingles shot when shots first came out. Bumps did not come out until about 2 months ago of reporting date and they were not bad. Calamine lotion helps bumps. The patient stated he/she had internal shingles. The physician prescribed Valacyclovir HCL 1 GM Tablets twice a day and Gabapentin 300 MG Capsule thrice a day. The patient stated had not noticed any bad side effects from either one. The follow-up would not be possible as no contact details were available. This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule, time to onset and laboratory test confirming herpes zoster were unknown at the time of reporting.
Sex: U
Vaccine: VARZOS, VARZOS
Symptoms: Condition aggravated, Herpes zoster, Vaccination failure
Clinical narrative: This case was reported by a consumer via interactive digital media and described the occurrence of suspected vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis. Co-suspect products included Herpes zoster (Shingles vaccine) for prophylaxis. The patient's past medical history included shingles (51 times since 23rd March 2017). Previously administered products included antibiotic. On an unknown date, the patient received Shingles vaccine and Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine and Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure and shingles were unknown. It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine and Shingles vaccine. Additional details were provided as follows: This case was reported by patient himself/herself. The age at vaccination was not reported. The patient stated he/she had the Shingles shot and the booster shot. The patient had Shingles 51 times. The patient he/she taken antibiotic for several months and I still get the Shingles. The patient would give most anything to stop getting shingles. The follow-up would not possible as no contact details were available. This case was considered as suspected vaccination failure as details regarding time to onset and laboratory test confirming herpes zoster were unknown at the time of reporting.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: Had vaccine, still got Shingles\ suspected vaccination failure; shingles; This case was reported by a consumer via interactive digital media and described the occurrence of suspected 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 details were provided as follows: This case was reported by patient himself/herself. The age at vaccination was not reported. The patient stated he/she had Shingles vaccine and still got Shingles. It was a mild case and caught early. The follow-up would not possible as no contact details were available. This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule, time to onset and laboratory test confirming herpes zoster were unknown at the time of reporting.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: This case was reported by a consumer via interactive digital media and described the occurrence of suspected 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 details were provided as follows: This case was reported by patient himself/herself. The age at vaccination was not reported. The patient stated he/she had Shingles vaccine and still get shingles just as bad. The follow-up would not be possible as no contact details were available. This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule, time to onset and laboratory test confirming herpes zoster were unknown at the time of reporting.
Sex: U
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: received one dose of the Shingles vaccine several years ago; 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 (Shingles vaccine) for prophylaxis.   Previously administered products included Shingles vaccine  (received 1st dose on an unknown date several years ago from reporting date).   On an unknown date, the patient received the 2nd dose of Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the incomplete course of vaccination was unknown.  Additional information were provided as follow: The patient self-reported this case. The age at vaccination was not applicable for this report. The patient stated that it was recommended that to get 2 doses of Shingles 2 to 6 months apart. Till the time of reporting, the patient did not receive 2nd dose of Shingles vaccine, which led to incomplete course of vaccination. The patient enquired if he/she should only get one more dose or start over and get 2 doses. The follow-up would not possible as no contact details were available.
Sex: M
Vaccine: MENB
Symptoms: Headache, Pain, Pain in extremity
Clinical narrative: This case was reported by a physician via sales rep and described the occurrence of headache in a male 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. On an unknown date, the patient received Bexsero and Bexsero Pre-Filled Syringe Device. On an unknown date, unknown after receiving Bexsero and Bexsero Pre-Filled Syringe Device, the patient experienced headache, general body pain and pain in arm. On an unknown date, the outcome of the headache, general body pain and pain in arm were unknown.  It was unknown if the reporter considered the headache, general body pain and pain in arm 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 details were provided follows: The age at vaccination was not reported. The physician stated that patient experience side effects with Bexsero including body aches, sore arm, and headache. The reporter was referring to her son.
Sex: U
Vaccine: FLU4
Symptoms: Anaphylactic reaction, Hypersensitivity
Clinical narrative: This case was reported by a consumer and described the occurrence of anaphylaxis in a patient who received Flu Seasonal QIV Dresden (fluarix Quadrivalent 2021-2022 season) for prophylaxis. Co-suspect products included flu seasonal qiv dresden pre-filled syringe device (fluarix Tetra Pre-Filled Syringe Device) injection syringe for prophylaxis. Previously administered products included fluarix Quadrivalent with an associated reaction of no adverse event (received dose on an unknown date in 2019), Flucelvax Quad with an associated reaction of urticaria (received dose on an unknown date in 2020) and fluarix Quad with an associated reaction of no adverse event. On an unknown date, the patient received fluarix Quadrivalent 2021-2022 season and fluarix Tetra Pre-Filled Syringe Device. On an unknown date, less than a year after receiving fluarix Quadrivalent 2021-2022 season and fluarix Tetra Pre-Filled Syringe Device, the patient experienced anaphylaxis (serious criteria GSK medically significant) and allergic reaction. On an unknown date, the outcome of the anaphylaxis and allergic reaction were unknown. It was unknown if the reporter considered the anaphylaxis and allergic reaction to be related to fluarix Quadrivalent 2021-2022 season and fluarix Tetra 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 details were provided as follows: The patient self-reported this case. The age at vaccination was not reported. The patient had received 2020 Flucelvax Quad PF flu vaccine and that year got hives after receiving that vaccine. The patient was trying to get information on the ingredients in the 2021 fluarix Quad PF and fluarix QIV PFS flu vaccines. The patient had an anaphylaxis response to the 2021 version, but no reaction to the 2019 version. The patient was working with an allergist to figure out the specific ingredient in the flu vaccine to which the patient was allergic so the patient could find a flu vaccine in fall of 2022 to which the patient was not allergic. The patient did not have a reaction to any vaccine other than flu.
Age: 65.0
Sex: M
Vaccine: VARZOS
Symptoms: Injection site pain, Pain
Clinical narrative: pain at the injection site for about 3 days; body aches; This case was reported by a consumer via call center representative and described the occurrence of injection site pain in a 65-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   On 18th November 2019, the patient received the 1st dose of Shingrix .5 ml. In November 2019, 12 hrs after receiving Shingrix, the patient experienced injection site pain and general body pain. On an unknown date, the outcome of the injection site pain and general body pain were recovered/resolved.   The reporter considered the injection site pain and general body pain to be related to Shingrix.     Linked case(s) involving the same patient:  US2022006699  Additional details were reported as follows: The reporter was the patient. The patient received a dose of Shingrix and 12 hours later experienced injection site pain and body aches which resolved 3 days later. The patient wanted to know if he should restart the series. Spoke per content and patient was referred to health care professional.  Consent to follow up was denied. For tolerance to 2nd dose of Shingrix, refer case US2022006699. The case was linked to the case US2022006705, reported by the same reporter for her wife.; Sender's Comments:  US-GLAXOSMITHKLINE-US2022006705:Same reporter. US-GLAXOSMITHKLINE-US2022006699:Same Patient
Age: 4.0
Sex: M
Vaccine: TDAP
Symptoms: Product administered to patient of inappropriate age, Wrong product administered
Clinical narrative: Patient got Boostrix instead of Kinrix; 4 yo pt inadvertently given Boostrix; This case was reported by a physician via sales rep and described the occurrence of wrong vaccine administered in a 4-year-old male patient who received DTPa (Reduced antigen) (Boostrix) for prophylaxis.   On an unknown date, the patient received Boostrix. On an unknown date, unknown after receiving Boostrix, the patient experienced wrong vaccine administered and inappropriate age at vaccine administration. On an unknown date, the outcome of the wrong vaccine administered and inappropriate age at vaccine administration were unknown.  Additional details were provided as follows: The physician reported that a 4 year old boy inadvertently received Boostrix instead of Kinrix, which led wrong vaccine administered and inappropriate age at vaccine administration. The Centers for Disease Control and Prevention (CDC) guidance was provided. The reporter consented to follow-up.
Sex: U
Vaccine: MENB
Symptoms: Expired product administered
Clinical narrative: Patient was given expired booster; This case was reported by a other health professional via interactive digital media and described the occurrence of expired vaccine used in a 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.   On an unknown date, the patient received Bexsero and Bexsero Pre-Filled Syringe Device. On an unknown date, unknown after receiving Bexsero and Bexsero Pre-Filled Syringe Device, the patient experienced expired vaccine used. On an unknown date, the outcome of the expired vaccine used was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.  Additional details were provided as follows: The age at vaccination was not reported. The reporter asked for information about a patient who was administered expired booster Bexsero vaccine.
Age: 69.0
Sex: U
Vaccine: VARZOS
Symptoms: Pain
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of pain burning in a 69-year-old patient who received Herpes zoster (shingrix) for prophylaxis. In December 2021, the patient received the 1st dose of shingrix. On an unknown date, less than a month after receiving shingrix, the patient experienced pain burning. On an unknown date, the outcome of the pain burning was not recovered/not resolved. It was unknown if the reporter considered the pain burning to be related to shingrix. Additional details were provided as follows: The case was reported by the patient. The age at vaccination was not reported. The patient had had the dose of shingrix 1 month ago. The patient also had Pfizer booster recently. The patient reported that he/she had burning pain (no hives) under the skin of his/her upper back. The patient was due to get 2nd dose by 28th January 2022. The reporter wanted to know should he/she consult PCP (primary care physician).
Age: 66.0
Sex: F
Vaccine: VARZOS
Symptoms: Lymphadenopathy, Musculoskeletal stiffness, Neck pain, Sensory disturbance
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of abnormal sensation of limbs in a female patient who received Herpes zoster (shingrix) for prophylaxis. Co-suspect products included amoxicillin trihydrate (Amoxicillin) unknown for tooth extraction. The patient's past medical history included tooth extraction. On 26th December 2021, the patient received the 1st dose of shingrix. On an unknown date, the patient started Amoxicillin at an unknown dose and frequency. On an unknown date, less than 3 weeks after receiving shingrix and unknown after starting Amoxicillin, the patient experienced abnormal sensation of limbs, neck pain, enlargement of lymph nodes and stiff neck. Amoxicillin was continued with no change. On an unknown date, the outcome of the abnormal sensation of limbs, neck pain and enlargement of lymph nodes were not recovered/not resolved and the outcome of the stiff neck was unknown. It was unknown if the reporter considered the abnormal sensation of limbs, neck pain, enlargement of lymph nodes and stiff neck to be related to shingrix and Amoxicillin. Additional details were provided as follows: The patient self-reported this case. The patient stated she had been experiencing lymph node swelling, stiffness in the neck, neck pain, and her arm feels funny too, since receiving the vaccine. The patient stated she was currently taking amoxicillin for a scheduled tooth extraction. The patient was inquiring if Amoxicillin was causing these side effects or was it the shingrix vaccine. The patient was also inquiring if the vaccine was causing these side effects, what should she did about the second dose. The medical advice disclaimer was provided. The reporter did not consent to follow up.
Sex: F
Vaccine: VARZOS
Symptoms: Computerised tomogram, Condition aggravated, Magnetic resonance imaging, Sleep disorder, Tinnitus
Clinical narrative: Tinnitus got worse, fluctuating ringing and buzzing; Sleeps with a sound machine and a sound pillow; This case was reported by a consumer via call center representative and described the occurrence of tinnitus aggravated in a 68-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Concurrent medical conditions included tinnitus.   In August 2020, the patient received the 1st dose of Shingrix. On an unknown date, less than a month after receiving Shingrix, the patient experienced tinnitus aggravated and sleep disorder. The patient was treated with alprazolam (Xanax) and zolpidem tartrate (Ambien). On an unknown date, the outcome of the tinnitus aggravated and sleep disorder were not recovered/not resolved.   It was unknown if the reporter considered the tinnitus aggravated and sleep disorder to be related to Shingrix.  Additional details were provided as follows: The patient self-reported this case. The age at vaccination was not reported. The patient received dose of Shingrix vaccine and 2-3 weeks after vaccination her tinnitus became exacerbated in which it got worse, it ramped up.  The patient stated that ringing and buzzing was now mainly in her head and skull as well as her ears. It fluctuates from back to front to side. The patient said it was torture, she sleeps with a sound machine and a sound pillow.  The patient took Xanax and Ambien to help alleviate symptoms and help her sleep. The patient did MRIs and CAT scans and was waiting to follow up with a Neurologist. The patient never went back to get her second dose of Shingrix on advice from her doctor and she was very afraid to. The patient spoke per PI and content. Gave medical advise disclaimer. Referred to HCP. The patient provided limited information. The patient did not wish to give consent to contact MD. The reporter did not consent to follow-up.
Sex: F
Vaccine: HEPA
Symptoms: Expired product administered
Clinical narrative: This case was reported by a nurse via call center representative and described the occurrence of expired vaccine used in a female patient who received HAV (Havrix) (batch number E9G4E, expiry date 29th December 2021) for prophylaxis. Co-suspect products included hepatitis A vaccine pre-filled syringe device (Havrix Pre-Filled Syringe Device) injection syringe for prophylaxis. On 10th January 2022, the patient received the 1st dose of Havrix and Havrix Pre-Filled Syringe Device. On 10th January 2022, unknown after receiving Havrix and Havrix Pre-Filled Syringe Device, the patient experienced expired vaccine used. On an unknown date, the outcome of the expired vaccine used was unknown. This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences. Additional details were provided as follows: The age at vaccination was not reported. The patient received expired dose of Havrix, which led to expired vaccine used. This case was linked with case US2022005768, reported by same reporter for different patient.; Sender's Comments: US-GLAXOSMITHKLINE-US2022005768:same reporter.
Sex: F
Vaccine: VARZOS
Symptoms: Accidental exposure to product, Product complaint, Skin laceration
Clinical narrative: This case was reported by a other health professional via sales rep and described the occurrence of laceration in a female patient who received Herpes zoster (shingrix) (batch number H54CA, expiry date 18th May 2023) for prophylaxis. This case was associated with a product complaint. On an unknown date, the patient received shingrix. On an unknown date, unknown after receiving shingrix, the patient experienced laceration, inadvertent exposure to vaccine and pharmaceutical product complaint. On an unknown date, the outcome of the laceration, inadvertent exposure to vaccine and pharmaceutical product complaint were unknown. It was unknown if the reporter considered the laceration to be related to shingrix. The additional details were provided as follows: Field representative initially called to report a potential shingrix PQC on behalf of HCP. However, he did not have detailed information. GRC agent called reporter directly to obtain detailed information. The reporter reported that 1 shingrix antigen vial was cracked in the carton and all the other vials were fine, which led to pharmaceutical product complaint. The reporter did not have lot/expiry for adjuvant vial or the vaccine box as they were discarded. No patient involvement with the suspect vial. 1. The package/carton or blister tray was not damaged upon receipt. 2. There was not any evidence of leakage or product in package/carton (ex. wet PIL, powder in box). 3. There were a piece of glass is missing on the vial and was found in the carton. Since that piece of glass came off from the vial, the vial has a hole in the vial. The piece of glass that came off from the vial was discarded safely. 4.There was some product still present in the vial. 5. If cracked, it was extended and branched. 6.The crack/breakage was observed on the vial. The reporter reported that due to cracked vial, one of the staff members (who was handling the vaccine) got cut. The reporter gave a consent to follow-up with herself. The reporter provided fax number and an email address. The reporter did not have staff members date of birth. Please send 1 Single vial dose pack (1 adjuvant vial and 1 antigen vial): 704742 to replenish their stock. The reporter still had the suspect vial in possession. She would return to GlaxoSmithKline. Related PQC/AE reports completed.