chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 48.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Diarrhoea, Feeling hot, Headache, Pain in extremity, Throat tightness
Clinical narrative: Tight throat; Right arm pain that was expected;; Diarrhea for two full days; continuous headache (still!); ringing in ears; Hot legs (as if icy hot applied to lower half of my body).; This is a spontaneous report from a contactable other healthcare professional (patient). A 48-years-old female patient (Pregnant: No) received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration, administered in right arm on 08Nov2021 at 14:45 (Batch/Lot Number: FF2589) as dose 1, single for covid-19 immunisation. Medical history included seasonal allergies from an unknown date. There were no concomitant medications. The patient experienced tight throat on 08Nov2021 at 22:00, right arm pain that was expected on 08Nov2021 at 22:00, diarrhea for two full days on 08Nov2021 at 22:00, continuous headache (still) on 08Nov2021 at 22:00, ringing in ears on 08Nov2021 at 22:00, hot legs (as if icy hot applied to lower half of my body) on 08Nov2021 at 22:00. The events were reported as serious due to medically significant. The adverse events resulted in Doctor or other healthcare professional office/clinic visit. Treatment received for the adverse events included: Tylenol; albuterol HFA, nose spray -per FP. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The outcome of the events was not recovered.; Sender's Comments: Based on the available information in the case, the causal association between the events throat tightness, pain in extremity, diarrhoea, headache, tinnitus, feeling hot and the suspect drug BNT162B2 cannot be excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
Age: 48.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Tinnitus, Urticaria
Clinical narrative: Tight throat; Right arm pain that was expected;; Diarrhea for two full days; continuous headache (still!); ringing in ears; Hot legs (as if icy hot applied to lower half of my body).; This is a spontaneous report from a contactable other healthcare professional (patient). A 48-years-old female patient (Pregnant: No) received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration, administered in right arm on 08Nov2021 at 14:45 (Batch/Lot Number: FF2589) as dose 1, single for covid-19 immunisation. Medical history included seasonal allergies from an unknown date. There were no concomitant medications. The patient experienced tight throat on 08Nov2021 at 22:00, right arm pain that was expected on 08Nov2021 at 22:00, diarrhea for two full days on 08Nov2021 at 22:00, continuous headache (still) on 08Nov2021 at 22:00, ringing in ears on 08Nov2021 at 22:00, hot legs (as if icy hot applied to lower half of my body) on 08Nov2021 at 22:00. The events were reported as serious due to medically significant. The adverse events resulted in Doctor or other healthcare professional office/clinic visit. Treatment received for the adverse events included: Tylenol; albuterol HFA, nose spray -per FP. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The outcome of the events was not recovered.; Sender's Comments: Based on the available information in the case, the causal association between the events throat tightness, pain in extremity, diarrhoea, headache, tinnitus, feeling hot and the suspect drug BNT162B2 cannot be excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
Age: 48.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Tinnitus
Clinical narrative: Tight throat; Right arm pain that was expected;; Diarrhea for two full days; continuous headache (still!); ringing in ears; Hot legs (as if icy hot applied to lower half of my body).; This is a spontaneous report from a contactable other healthcare professional (patient). A 48-years-old female patient (Pregnant: No) received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration, administered in right arm on 08Nov2021 at 14:45 (Batch/Lot Number: FF2589) as dose 1, single for covid-19 immunisation. Medical history included seasonal allergies from an unknown date. There were no concomitant medications. The patient experienced tight throat on 08Nov2021 at 22:00, right arm pain that was expected on 08Nov2021 at 22:00, diarrhea for two full days on 08Nov2021 at 22:00, continuous headache (still) on 08Nov2021 at 22:00, ringing in ears on 08Nov2021 at 22:00, hot legs (as if icy hot applied to lower half of my body) on 08Nov2021 at 22:00. The events were reported as serious due to medically significant. The adverse events resulted in Doctor or other healthcare professional office/clinic visit. Treatment received for the adverse events included: Tylenol; albuterol HFA, nose spray -per FP. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The outcome of the events was not recovered.; Sender's Comments: Based on the available information in the case, the causal association between the events throat tightness, pain in extremity, diarrhoea, headache, tinnitus, feeling hot and the suspect drug BNT162B2 cannot be excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
Age: 27.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Expired product administered
Clinical narrative: ADMINISTERED AN ALREADY EXPIRED VACCINE; This spontaneous report received from a pharmacist concerned a 27 year old male. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 042A21A expiry: 19-SEP-2021) dose was not reported, administered on 21-OCT-2021 for prophylactic vaccination. No concomitant medications were reported. On 21-OCT-2021, the patient experienced administered an already expired vaccine. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of administered an already expired vaccine was not reported. This report was non-serious. This case, from the same reporter is linked to 20211152016.
Age: 63.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: COVID-19, SARS-CoV-2 test positive, Vaccine breakthrough infection
Clinical narrative: BREAKTHROUGH CASE
Age: 55.0
Sex: F
Vaccine: UNK, VARZOS
Symptoms: Chills, Fatigue, Inflammation, Influenza virus test negative, Injection site erythema
Clinical narrative: Redness, swelling, and itching at injection site for the past 7 days since administration of vaccine (11/19/21). The patient went to urgent care on 11/24/21. The patient was tested for flu, strep, and COVID. All tests were negative. The nurse at urgent care hypothesized that she had a reaction to a component of the vaccine or that she may have a staph infection during administration of the vaccine. The patient was prescribed steroid and antibiotic treatment. She has taken both medications for the past 3 days and reports some improvement. She has been instructed to follow up with her PCP by both the urgent care nurse and the pharmacist she reported to.
Age: 55.0
Sex: F
Vaccine: UNK, VARZOS
Symptoms: Injection site pruritus, Injection site swelling, Injection site warmth, Oropharyngeal pain, Respiratory tract congestion
Clinical narrative: Redness, swelling, and itching at injection site for the past 7 days since administration of vaccine (11/19/21). The patient went to urgent care on 11/24/21. The patient was tested for flu, strep, and COVID. All tests were negative. The nurse at urgent care hypothesized that she had a reaction to a component of the vaccine or that she may have a staph infection during administration of the vaccine. The patient was prescribed steroid and antibiotic treatment. She has taken both medications for the past 3 days and reports some improvement. She has been instructed to follow up with her PCP by both the urgent care nurse and the pharmacist she reported to.
Age: 55.0
Sex: F
Vaccine: UNK, VARZOS
Symptoms: SARS-CoV-2 test, Streptococcus test negative
Clinical narrative: Redness, swelling, and itching at injection site for the past 7 days since administration of vaccine (11/19/21). The patient went to urgent care on 11/24/21. The patient was tested for flu, strep, and COVID. All tests were negative. The nurse at urgent care hypothesized that she had a reaction to a component of the vaccine or that she may have a staph infection during administration of the vaccine. The patient was prescribed steroid and antibiotic treatment. She has taken both medications for the past 3 days and reports some improvement. She has been instructed to follow up with her PCP by both the urgent care nurse and the pharmacist she reported to.
Age: 55.0
Sex: F
Vaccine: UNK, VARZOS
Symptoms: Influenza virus test negative, Injection site erythema, Injection site pruritus, Injection site swelling, SARS-CoV-2 test negative
Clinical narrative: Redness, swelling, and itching at injection site for the past 7 days since administration of vaccine (11/19/21). The patient went to urgent care on 11/24/21. The patient was tested for flu, strep, and COVID. All tests were negative. The nurse at urgent care hypothesized that she had a reaction to a component of the vaccine or that she may have a staph infection during administration of the vaccine. The patient was prescribed steroid and antibiotic treatment. She has taken both medications for the past 3 days and reports some improvement. She has been instructed to follow up with her PCP by both the urgent care nurse and the pharmacist she reported to.
Age: 55.0
Sex: F
Vaccine: UNK, VARZOS
Symptoms: Streptococcus test negative
Clinical narrative: Redness, swelling, and itching at injection site for the past 7 days since administration of vaccine (11/19/21). The patient went to urgent care on 11/24/21. The patient was tested for flu, strep, and COVID. All tests were negative. The nurse at urgent care hypothesized that she had a reaction to a component of the vaccine or that she may have a staph infection during administration of the vaccine. The patient was prescribed steroid and antibiotic treatment. She has taken both medications for the past 3 days and reports some improvement. She has been instructed to follow up with her PCP by both the urgent care nurse and the pharmacist she reported to.
Sex: U
Vaccine: VARCEL
Symptoms: Expired product administered, No adverse event
Clinical narrative: No additional AE/PQC; patient inadvertently received a dose of VARlVAX on 26-OCT-2021 with a labeled expiry of 25-JUN-2021; This spontaneous report was received from a nurse, referring to a patient of unknown age and gender. The patient's pertinent medical history, drugs reactions or allergies and concomitant medications were not reported.  On 26-OCT-2021, the patient inadvertently received a dose of varicella virus vaccine live (Oka/Merck) (VARIVAX) with a labeled expiry (strength, dose, frequency, route of administration, anatomical injection site were not provided; lot number S019583 has been verify to be a valid lot number for varicella virus vaccine live (Oka/Merck) with expiration date on 25-JUN-2021) for prophylaxis. There was no known temperature excursion. No additional adverse event.
Sex: U
Vaccine: MMRV, VARCEL
Symptoms: No adverse event
Clinical narrative: no additional AEs were reported; received both PROQUAD nad VARIVAX today/ due to a human error; This spontaneous report was received from a registered nurse and refers to a patient of unknown age and gender. The patient's medical history, concurrent conditions, concomitant medications, previous drug reactions or allergies were not reported.  On 29-OCT-2021, the patient was vaccinated with measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) rHA, lot # T034614, expiration date was provided and also validated as 10-APR-2022, at the dose of 0.5 milliliter, once; and also with varicella virus vaccine live (oka/merck)(VARIVAX) 0.5 ml, once, lot # T022315, expiration date was reported and also validated as 30-JUN-2022 for prophylaxis (strength, route of administration and anatomical location were not provided for both).  The patient supposed to get only measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) but also received varicella virus vaccine live (oka/merck)(VARIVAX) due to a human error (accidental overdose). No additional adverse events (AEs) were reported (no adverse event).
Sex: U
Vaccine: HEP
Symptoms: Expired product administered
Clinical narrative: Medical assistant calling to request stability information on RECOMBIVAX HB vaccine after it was administered one day post expiration; This spontaneous report was received from a certified medical assistant and refers to patient of unknown age and gender. No information regarding the patients' medical history, concurrent conditions or concomitant medications was provided.  On 01-NOV-2021, the patient was vaccinated with an expired dose of Hepatitis B Vaccine (Recombinant) (RECOMBIVAX HB) expiration date 31-OCT-2021, for prophylaxis (dose, lot #, route and site of administration were not reported). It was confirmed that the vaccine had never undergone temperature excursion.
Sex: U
Vaccine: HEP, RV5
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional AE; Patient was administered both improperly stored RECOMBIVAX HB and improperly stored ROTATEQ on 11/01/2021; This spontaneous report was received from a certified medical assistant and refers to patient of unknown age and gender. No information regarding the patients' medical history, concurrent conditions or concomitant medications was provided. On 01-NOV-2021, the patient was vaccinated with improperly stored doses of the following vaccines: Rotavirus Vaccine, Live, Oral, Pentavalent (ROTATEQ) orally, lot # 1742078 was confirmed to be valid, expiration date 06-JUL-2022 (dose and was not reported) and Hepatitis B Vaccine (Recombinant) (RECOMBIVAX HB) lot # T032918 was confirmed to be valid, expiration date 12-NOV-2022 (dose, route and site of administration were not reported), both for prophylaxis. The administered doses were exposed to the temperature of 62.2 degrees Fahrenheit (F) for 6 hours. There was also previous temperature excursion reported as 36 F to 46 F (46.07 F) for 15 minutes. No additional adverse event was provided.; Sender's Comments:  US-009507513-2111USA000921:
Sex: F
Vaccine: MMRV
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: Customer does not report any symptoms or issues at this time; Customer reports that she is 31 years old and received PROQUAD 4 weeks; This spontaneous report has been received from the consumer, referring about herself, a 31-year-old female patient. Information about her pertinent medical history, concurrent conditions, concomitant medications and previous drug reactions and allergies were not provided.  On 06-OCT-2021 (reported also as "4 weeks ago"), the patient was vaccinated at a clinic with measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) for prophylaxis (strength, dose, frequency, route of information, anatomical injection site, lot number, and expiration date were not provided) (product administered to patient of inappropriate age).   She also received on 01-NOV-2021 ("Monday"), varicella virus vaccine live (Oka/Merck) (VARIVAX), from pharmacy. Customer did not report any symptoms or issues at the time. No adverse event reported.
Age: 17.0
Sex: F
Vaccine: HPV9
Symptoms: No adverse event
Clinical narrative: No additional AE; 2nd dose was administered 2 weeks after the 1st dose; This spontaneous report was received from a pharmacist refers to a 18-year-old female patient. No information regarding the patient's medical history, concurrent conditions or concomitant medications was provided.   On 04-SEP-2021, the patient was vaccinated with first dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) (exact dose, route of administration, lot # and expiration date were unknown) and the second dose on 18-SEP-2021, only after two weeks from the first dose, ( exact dose, route of administration, lot # and expiration date were unknown) for prophylaxis.       No adverse event was reported.
Sex: F
Vaccine: VARZOS
Symptoms: Pneumothorax
Clinical narrative: holes in her lungs; This initial spontaneous report was received from a lawyer regarding a case in litigation and referring to a female patient (pt) of unknown age. The pt's concurrent conditions, medical history or concomitant medications were not reported. On an unspecified date, the pt was administered zoster vaccine live (ZOSTAVAX) (lot #, expiration date, dosage, route of administration and anatomical location were not provided) for routine health maintenance and for its intended purpose: the prevention of shingles (herpes zoster). On an unknown date after receiving zoster vaccine live (ZOSTAVAX), the patient suffered holes her in lungs, all caused by the suspect vaccine. As a direct and proximate result of zoster vaccine live (ZOSTAVAX), the pt's symptoms had resulted in physical limitations not present prior to using the Company product and caused by zoster vaccine live (ZOSTAVAX). The pt also experienced mental and emotional distress due to resulting physical limitations and seriousness of her condition. As a result of the manufacture, marketing, advertising, promotion, distribution and/or sale of zoster vaccine live ZOSTAVAX), she sustained severe and disfiguring personal injuries. Further, as a tragic consequence of Company's wrongful conduct, the pt suffered serious, progressive, and incurable injuries, as well as significant conscious pain and suffering, mental anguish, emotional distress, loss of enjoyment of life, physical impairment and injury. The pt suffered and incurred damages, including medical expenses; the loss of accumulations, and other economic and non-economic damages. The outcome of the event was considered not recovered/not resolved. The reporter considered the event to be related to zoster vaccine live (ZOSTAVAX).  The reporter considered the event of holes her in lungs to be disabling (reported as disfiguring).
Sex: U
Vaccine: VARCEL
Symptoms: Expired product administered, No adverse event
Clinical narrative: no adverse event; Expired dose of Varivax administered; This spontaneous report was received from an officer manager, referring to a patient of unknoen age and gender. The patient's historical drugs, medical history, concomitant therapies and concurrent conditions were not reported.  On 16-NOV-2021, the patient was vaccinated with an expired varicella virus vaccine live (Oka/Merck) (VARIVAX) 0.5 ml. subcutaneously, lot# S033539, expiration date 22-OCT-2021, for prophylaxis (strength and frequency were not reported) (expired product administered). No additional adverse event reported.
Age: 1.0
Sex: U
Vaccine: MMRV, VARCEL
Symptoms: Extra dose administered
Clinical narrative: The patient has had no known side effects; Extra dose of Varicella being given; Extra dose of Varicella being given; Proquad and Varivax were administered to a patient today, istead of MMR-II and Varivax; This spontaneous report has been received from a medical assistant, concerning a 12 month old patient of unknown gender. The patient's concurrent conditions, pertinent medical history, drug reactions/allergies, and concomitant medications were not reported.       The reporter stated that on 22-NOV-2021, the patient was vaccinated with an extra dose of varicella (Overdose), since she/he received a dose of varicella virus vaccine live (oka/merck)(VARIVAX), 0.5 milliliter, subcutaneous (lot # T021825, which has been verified to be a valid lot number for varicella virus vaccine live (oka/merck), expiration date of 25-JUN-2022), and also was vaccinated with a dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live(PROQUAD) 0.5 milliliter, subcutaneous (lot # U014143, which has been verified to be a valid lot number for measles, mumps, rubella and varicella (oka-merck) virus vaccine live, expiration date of 31-OCT-2022), both as prophylaxis; instead of being vaccinated with measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live(M-M-R II) and varicella virus vaccine live (oka/merck)(VARIVAX).  The patient had no known side effects.
Sex: U
Vaccine: RV5
Symptoms: No adverse event, Product storage error
Clinical narrative: no additional adverse effect reported; temperature excursion/ was administered; This spontaneous report was received from a medical assistant and refers to a patient of unknown age and gender. No information regarding the patient's pertinent medical history, drug reactions or allergies and concomitant therapies was provided.  On an unknown date, the rotavirus vaccine, live, oral, pentavalent (ROTATEQ) lot # 1741377 experienced the temperature excursion of 36 degrees fahrenheit (F) (30.48 F) for 0 hours 45 minutes and 0 seconds. On 22-NOV-2021, the patient was vaccinated with an improperly stored dose of rotavirus vaccine, live, oral, pentavalent (ROTATEQ) lot # 1741377, expiration date 07-MAR-2022 (formulation, concentration, exact dose, dose number, route of administration and anatomical location were not reported) for prophylaxis (product storage error). There were no previous excursions reported. No adverse event was reported (no adverse event).
Sex: U
Vaccine: VARZOS
Symptoms: Blister
Clinical narrative: Vesicles on hand after vaccine; This case was reported by a consumer via(shingrix GSK chatbot) interactive digital media and described the occurrence of vesicle in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine, the patient experienced vesicle. On an unknown date, the outcome of the vesicle was unknown.   It was unknown if the reporter considered the vesicle to be related to Shingles vaccine.  Additional details were reported as follows: The age at vaccination were not reported. The patient reported that he/she experienced vesicles on hand one day after vaccine administration. No other patient details were provided.
Age: 63.0
Sex: M
Vaccine: VARZOS
Symptoms: Incorrect dose administered, Product preparation issue
Clinical narrative: Administration of diluent only, didn't include the Antigen; Administration of diluent only, didn't include the Antigen; This case was reported by a physician via sales rep and described the occurrence of inappropriate dose of vaccine administered in a 63-year-old male patient who received Herpes zoster (Shingrix) (batch number L5A35, expiry date 9th April 2023) for prophylaxis.   On 19th November 2021, the patient received Shingrix (intramuscular). On 19th November 2021, unknown after receiving Shingrix, the patient experienced inappropriate dose of vaccine administered and incorrect dose administered. On an unknown date, the outcome of the inappropriate dose of vaccine administered and incorrect dose administered were unknown.  Additional details were reported as follows: The patient had received Shingrix where only diluent was administered. Diluent was not used to reconstitute Lyophilized powder prior to administration, which led to inappropriate dose of vaccine administered and inappropriate reconstitution technique. The physician called and shared that they had an administering error in which they gave the patient the adjuvant but did not include the antigen. Patient had not reported any adverse events following administration. The health care professional agreed to follow up by GlaxoSmithKline.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: Got Shingles Vaccine and 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: The patient self-reported this case. The age at vaccination was not reported. The patient got the Shingle vaccine and still got shingles. The patient further stated that it would have been worst without vaccine. This case was considered as suspected vaccination failure since the details regarding completion of primary immunization schedule, time to onset and laboratory test confirming shingles were unknown at the time of reporting.
Sex: U
Vaccine: VARZOS
Symptoms: Feeling abnormal
Clinical narrative: felt horrible; This case was reported by a consumer via interactive digital media and described the occurrence of feels awful in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced feels awful. On an unknown date, the outcome of the feels awful was recovered/resolved.   It was unknown if the reporter considered the feels awful to be related to Shingles vaccine.  Additional details were provided as follows: The age at vaccination was not reported. The patient had reported for him/herself. The patient received Shingles vaccine after his/her sister had them. After receiving Shingles vaccine, the patient felt horrible and stated that, it was better than getting shingles. This case had been linked with case US2021AMR241370, reported by the same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021AMR241370:same patient - 2nd dose
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: shingles; 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 1st dose of Shingles vaccine. On an unknown date, unknown 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 details were reported as follows: The case was reported by the patient. The age at vaccination was not reported. The patient had the 1st shot and still got the Shingles, now they tell that the patient need a 2nd shot, the patient could not afford it. No contact details were available.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Pain, Vaccination failure
Clinical narrative: got the shot, going thru shingles/ Suspected vaccination failure; shingles; Pain is aeful; 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, more than 2 years after receiving Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant), shingles and pain. On an unknown date, the outcome of the vaccination failure was unknown and the outcome of the shingles 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 details were provided as follows: The patient self-reported this case. The age at vaccination was not reported. The patient got the shingle shot about 5 years ago and now was going through shingles. The pain was awful. This case was considered as suspected vaccination failure since the details regarding completion of primary immunization schedule and laboratory test confirming shingles were unknown at the time of reporting.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: got shingles from the vaccine/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.   The reporter considered the vaccination failure and shingles to be related to Shingles vaccine.  Additional details were provided as follows: The case was reported by patient's neighbor. The age at vaccination was not reported. The reporter stated that the patient got shingles from Shingles vaccine. 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 shingles were unknown at the time of reporting.
Sex: U
Vaccine: VARZOS
Symptoms: Condition aggravated, Herpes zoster, Vaccination failure
Clinical narrative: 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 (Shingrix) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis.   The patient's past medical history included shingles.   On an unknown date, the patient received Shingrix and the 1st dose of Shingrix. In November 2021, unknown after receiving Shingrix and 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 and Shingrix.  Additional details were provided as follows: The patient had reported for him/herself. The age at vaccination was not reported. The patient received Shingrix shots after getting shingles the first time.  The weekend before date of reporting, the patient got shingles again.  The patient stated that, the shots did nothing. This case was considered as suspected vaccination failure, since the details regarding the time to onset and laboratory confirmation for shingles were not provided.
Sex: M
Vaccine: COVID19, VARZOS, VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: Suspected vaccination failure/Shingles, prior double dose shingles vaccine; Shingles; This case was reported by a consumer via interactive digital media and described the occurrence of suspected vaccination failure in a male patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Co-suspect products included Herpes zoster (Shingles vaccine) for prophylaxis and VIRAL VACCINES (COVID VACCINE (NOS)) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingles vaccine, the 2nd dose of Shingles vaccine and COVID VACCINE (NOS). On an unknown date, less than 2 years after receiving Shingles vaccine and Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure and shingles were unknown.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine and Shingles vaccine.  Additional details provided were as follows: The case was reported by patient's son/daughter. The age at vaccination was not reported. The patient was immunized with the double dose shingles vaccine 2 years prior from reporting date. The patient was diagnosed with shingles 3 days after the vaccination with covid vaccine. It was unknown if the reporter considered the shingles to be related to Covid vaccine. Follow-up would not be possible as no contact details available. This case was considered as suspected vaccination failure since the detail regarding laboratory test confirming shingles was unknown at the time of reporting. This case was 1 of the 3 cases reported by same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021AMR242892:Same reporter US-GLAXOSMITHKLINE-US2021AMR242893:Same reporter
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: developed shingles; This case was reported by a consumer via call center representative and described the occurrence of shingles in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix. On an unknown date, 3 days after receiving Shingrix, 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 Shingrix.  Additional details were provided as follows: The patient self-reported this case. The age at vaccination was not reported. The patient left an after hours voicemail stating that 3 days after getting Shingrix vaccine, developed shingles. No other information was available. Consent to follow up was granted
Age: 18.0
Sex: M
Vaccine: HEP
Symptoms: Accidental overdose, Product administered to patient of inappropriate age
Clinical narrative: received an adult Engerix-B/ inadvertently received an adult Engerix-B; an adolescent patient inadvertently received an adult Engerix-B; This case was reported by a other health professional via call center representative and described the occurrence of accidental overdose in a 18-year-old male patient who received HBV (Engerix B adult) for prophylaxis.   On 16th August 2021, the patient received the 1st dose of Engerix B adult. On 16th August 2021, unknown after receiving Engerix B adult, the patient experienced accidental overdose and adult product administered to child. On an unknown date, the outcome of the accidental overdose and adult product administered to child were unknown.  Additional details were provided as follows: The office manager of provider's office reported that, an adolescent patient inadvertently received an adult Engerix-B for their first dose, which led to accidental overdose and adult product administered to child. The patient received correct pediatric dose for their second dose in September 2021. The reporter consented to follow up.
Age: 43.0
Sex: M
Vaccine: MENB
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: 43 year old patient received Bexsero.; This case was reported by a pharmacist via call center representative and described the occurrence of inappropriate age at vaccine administration in a 43-year-old 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 25th September 2021, the patient received Bexsero and Bexsero Pre-Filled Syringe Device. On 25th September 2021, unknown after receiving Bexsero and Bexsero Pre-Filled Syringe Device, the patient experienced inappropriate age at vaccine administration. On 22nd November 2021, the outcome of the inappropriate age at vaccine administration 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 reported as follows: The reporter reported that a 43 year old patient received Bexsero which led to inappropriate age at vaccine administration. The health care professional did not have lot number and expiration date available.  The reporter consented to follow up.
Age: 1.25
Sex: M
Vaccine: TDAP
Symptoms: Product administered to patient of inappropriate age, Wrong product administered
Clinical narrative: 15-month-old given Boostrix; given Boostrix instead of DTaP; This case was reported by a pharmacist via call center representative and described the occurrence of inappropriate age at vaccine administration in a 15-month-old male patient who received DTPa (Reduced antigen) (Boostrix) (batch number GC5NG, expiry date 1st April 2023) for prophylaxis.   On 22nd November 2021, the patient received Boostrix. On 22nd November 2021, unknown after receiving Boostrix, the patient experienced inappropriate age at vaccine administration and wrong vaccine administered. On an unknown date, the outcome of the inappropriate age at vaccine administration and wrong vaccine administered were unknown.  Additional details were reported as follows: Pharmacist reported a 15 month old patient had been given Boostrix (TDaP) instead of a dose of DTaP, which led to inappropriate age at vaccine administration and wrong vaccine administered. Reporter consent to follow up by email.
Age: 81.0
Sex: M
Vaccine: VARZOS
Symptoms: Asthenia, Fatigue
Clinical narrative: Weakness, so severe that was in hospital 3 days; Tiredness, questioning if this could be GBS; This case was reported by a consumer via call center representative and described the occurrence of weakness in a 81-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st dose 0.5ml, intramuscularly in left arm on an unknown date in June 2021).   In October 2021, the patient received the 2nd dose of Shingrix (intramuscular) .5 ml. On an unknown date, the dose was .5 ml (.5 ml daily). In October 2021, less than a month after receiving Shingrix, the patient experienced weakness (serious criteria hospitalization) and tiredness (serious criteria hospitalization). On an unknown date, the outcome of the weakness and tiredness were not recovered/not resolved.   It was unknown if the reporter considered the weakness and tiredness to be related to Shingrix.  Additional details were provided as follows: The case was reported by patient himself. The patient received his second shot in early October 2021 and by mid-October 2021 following his 2nd vaccine, he experienced weakness and tiredness.   On 31st October 2021, his weakness was so severe that he called and went to the hospital for 3 days.  The patient had no diagnosis for his symptoms and no connection had been made between his weakness and the Shingrix vaccine.  The patient was waiting for an appointment with a neurologist.   The patient's weakness/tiredness has not yet resolved.   The patient questioned whether this could be Guillain-Barre syndrome. The reporter did not consent to follow up.
Age: 0.08
Sex: F
Vaccine: RV1
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: inadvertently administered to infant who will not be turning 6 weeks old until 2 more days; This case was reported by a physician via call center representative and described the occurrence of inappropriate age at vaccine administration in a 1-month-old female patient who received Rota (Rotarix lyophilized formulation) (batch number AB3BR, expiry date 29th June 2023) for prophylaxis.   Co-suspect products included rotavirus vaccine oral applicator device (Rotarix Oral Applicator Device) oral applicator for prophylaxis.   On 23rd November 2021, the patient received the 1st dose of Rotarix lyophilized formulation (oral) and Rotarix Oral Applicator Device. On 23rd November 2021, unknown after receiving Rotarix lyophilized formulation and Rotarix Oral Applicator Device, the patient experienced inappropriate age at vaccine administration. On an unknown date, the outcome of the inappropriate age at vaccine administration 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 rotarix was inadvertently administered to infant who would not be turning 6 weeks old until 2 more days, which led to inappropriate age at vaccine administration. The reporter consented to follow up.
Sex: F
Vaccine: HEPA
Symptoms: Inappropriate schedule of product administration
Clinical narrative: patient got 2 doses of Havrix 7 weeks apart; This case was reported by a other health professional via call center representative and described the occurrence of drug dose administration interval too short in a 13-month-old female patient who received HAV (Havrix) (batch number 2K57N, expiry date 4th December 2022) for prophylaxis.   Co-suspect products included hepatitis A vaccine pre-filled syringe device (Havrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   Concomitant products included HAV (Havrix).   On an unknown date, the patient received the 2nd dose of Havrix and Havrix Pre-Filled Syringe Device. On an unknown date, unknown after receiving Havrix and Havrix Pre-Filled Syringe Device and an unknown time after receiving Havrix, the patient experienced drug dose administration interval too short. On an unknown date, the outcome of the drug dose administration interval too short 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 medical assistant reported that, a pediatric patient got 2 doses of Havrix 7 weeks apart, which led to shortening of vaccinaation schedule. The reporter consented to follow up.
Age: 13.0
Sex: M
Vaccine: HEPA
Symptoms: Overdose, Product administered to patient of inappropriate age
Clinical narrative: 13-year-old received an adult dose; 13-year-old received an adult dose; This case was reported by a other health professional via call center representative and described the occurrence of overdose in a 13-year-old male patient who received HAV (Havrix 1440 adult) (batch number G99R4, expiry date 20th May 2022) for prophylaxis.   On 21st November 2021, the patient received Havrix 1440 adult 1 ml. On 21st November 2021, unknown after receiving Havrix 1440 adult, the patient experienced overdose and adult product administered to child. On an unknown date, the outcome of the overdose and adult product administered to child were unknown.  Additional details were provided as follows: The practice manager reported a 13 year old patient received an adult dose (1ml) of Havrix, which led to overdose and adult product administered to child. The reporter consented to follow up. The case has been linked to US2021241778, reported by the same reporter for patient's sibling.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021241778:Same reporter
Age: 0.33
Sex: F
Vaccine: RV1
Symptoms: Incorrect route of product administration
Clinical narrative: Rotarix given IM instead of orally; This case was reported by a nurse via call center representative and described the occurrence of inappropriate route of vaccination in a 4-month-old female patient who received Rota (Rotarix lyophilized formulation) (batch number AB3BR, expiry date 29th June 2023) for prophylaxis.   Co-suspect products included rotavirus vaccine oral applicator device (Rotarix Oral Applicator Device) oral applicator for prophylaxis.   On 23rd November 2021, the patient received the 2nd dose of Rotarix lyophilized formulation (intramuscular) and Rotarix Oral Applicator Device. On 23rd November 2021, unknown after receiving Rotarix lyophilized formulation and Rotarix Oral Applicator Device, the patient experienced inappropriate route of vaccination. On an unknown date, the outcome of the inappropriate route of vaccination 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 reported as follows: The nurse reported that patient received Rotarix dose by intramuscular route by error instead of oral route which led to incorrect route of vaccine administration. The nurse consented to follow up. This case had been linked with case US2021241786, reported by the same reporter for the twin patient.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021241786:same reporter. Male twin case.
Age: 37.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Back pain, Exposure during pregnancy, Heavy menstrual bleeding
Clinical narrative: UNEXPECTED POSTPARTUM RESUMPTION OF MENSTRUAL CYCLE WITH HEAVY BLEEDING; BACK PAIN; VACCINE EXPOSURE DURING PREGNANCY; This spontaneous pregnancy report received from a patient by a Business partner (Pfizer Inc.) on 12-NOV-2021 was received on 12-NOV-2021 and concerned a 37 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included: alopecia areata, and other pre-existing medical conditions included: In previous postpartum (twice) menstrual cycle began after 11 months with breakthrough bleeding prior to a full cycle. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient experienced drug allergy when treated with fluconazole, and sulfamethoxazole. The patient was gravida 3, para 3. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805025 expiry: UNKNOWN) dose was not reported, administered on 25-MAR-2021 11:00 for prophylactic vaccination. Non-company suspect vaccine included: bnt 162 ( batch number: FG3527, form of admin, route of admin, and were not reported) dose was not reported, administered on 05-NOV-2021 for prophylactic vaccination. Concomitant medications included influenza vaccine for prophylactic vaccination. On 25-MAR-2021, the patient experienced vaccine exposure during pregnancy. The date of the patient's last menstrual period and expected delivery date were not reported. On 06-NOV-2021, the patient experienced unexpected postpartum resumption of menstrual cycle with heavy bleeding. On 06-NOV-2021, the patient experienced back pain. On an unspecified date, the pregnancy resulted in a live birth. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from vaccine exposure during pregnancy, and the outcome of unexpected postpartum resumption of menstrual cycle with heavy bleeding and back pain was not reported. This report was non-serious. This parent/child case is linked to 20211137975.; Sender's Comments: V0: Medical assessment comment not required as per standard procedure as the case was assessed as non-serious.