chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 59.0
Sex: F
Vaccine: COVID19, COVID19, COVID19, COVID19
Symptoms: Malaise, Pulmonary embolism
Clinical narrative: Pulmonary Embolism; did not feel well; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A 59 year-old female patient received bnt162b2 (BNT162B2), administered in arm, administration date 28Dec2021 (Lot number: 33130BA) at the age of 59 years as dose 3 (booster), single for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. Vaccination history included: Bnt162b2 (DOSE 1, SINGLE, Anatomical Location:  Arm, unknown if right or left arm), administration date: Apr2021, when the patient was 58 years old, for COVID-19 immunization, reaction(s): "sore arm"; Bnt162b2 (DOSE 2, SINGLE, Anatomical Location:  Arm, unknown if right or left arm), for COVID-19 immunization, reaction(s): "sore arm ". The following information was reported: PULMONARY EMBOLISM (death, medically significant), outcome "fatal", described as "Pulmonary Embolism"; MALAISE (non-serious), outcome "unknown", described as "did not feel well". The patient date of death was 01Jan2022. The reported cause of death was pulmonary embolism. The patient had not received any other vaccines within 4 weeks prior to the COVID vaccine.Vaccination facility type was clinic.  The patient was back to work and working and active until receiving third dose. The patient had no other condition. The patient had no investigations. The reporter reported that the patient received the booster dose on 28Dec2021. The patient just did not feel well after receiving the booster dose and the reporter was told this by the patient's son who lived with the patient at the time. The reporter did not know exactly what it meant that the patient did not feel well, except that the patient postponed a Christmas gathering with family and friends. The patient passed away on 01Jan2022. The caller stated the cause of death was pulmonary Embolism. The reporter reported The reporter did not believe additional vaccines administered on same date of the Pfizer Suspect. The reporter did not visit Emergency Room or Physician Office. The patient had no relevant tests.  No follow-up attempts are possible. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202200474100 Same reporter/patient, different dose/events; Reported Cause(s) of Death: Pulmonary Embolism
Age: 59.0
Sex: F
Vaccine: COVID19, COVID19, COVID19, COVID19
Symptoms: Pain in extremity
Clinical narrative: Pulmonary Embolism; did not feel well; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A 59 year-old female patient received bnt162b2 (BNT162B2), administered in arm, administration date 28Dec2021 (Lot number: 33130BA) at the age of 59 years as dose 3 (booster), single for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. Vaccination history included: Bnt162b2 (DOSE 1, SINGLE, Anatomical Location:  Arm, unknown if right or left arm), administration date: Apr2021, when the patient was 58 years old, for COVID-19 immunization, reaction(s): "sore arm"; Bnt162b2 (DOSE 2, SINGLE, Anatomical Location:  Arm, unknown if right or left arm), for COVID-19 immunization, reaction(s): "sore arm ". The following information was reported: PULMONARY EMBOLISM (death, medically significant), outcome "fatal", described as "Pulmonary Embolism"; MALAISE (non-serious), outcome "unknown", described as "did not feel well". The patient date of death was 01Jan2022. The reported cause of death was pulmonary embolism. The patient had not received any other vaccines within 4 weeks prior to the COVID vaccine.Vaccination facility type was clinic.  The patient was back to work and working and active until receiving third dose. The patient had no other condition. The patient had no investigations. The reporter reported that the patient received the booster dose on 28Dec2021. The patient just did not feel well after receiving the booster dose and the reporter was told this by the patient's son who lived with the patient at the time. The reporter did not know exactly what it meant that the patient did not feel well, except that the patient postponed a Christmas gathering with family and friends. The patient passed away on 01Jan2022. The caller stated the cause of death was pulmonary Embolism. The reporter reported The reporter did not believe additional vaccines administered on same date of the Pfizer Suspect. The reporter did not visit Emergency Room or Physician Office. The patient had no relevant tests.  No follow-up attempts are possible. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202200474100 Same reporter/patient, different dose/events; Reported Cause(s) of Death: Pulmonary Embolism
Age: 59.0
Sex: F
Vaccine: COVID19, COVID19, COVID19, COVID19
Symptoms: Headache, Hip arthroplasty, Pain in extremity, SARS-CoV-2 test
Clinical narrative: Pulmonary Embolism; did not feel well; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A 59 year-old female patient received bnt162b2 (BNT162B2), administered in arm, administration date 28Dec2021 (Lot number: 33130BA) at the age of 59 years as dose 3 (booster), single for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. Vaccination history included: Bnt162b2 (DOSE 1, SINGLE, Anatomical Location:  Arm, unknown if right or left arm), administration date: Apr2021, when the patient was 58 years old, for COVID-19 immunization, reaction(s): "sore arm"; Bnt162b2 (DOSE 2, SINGLE, Anatomical Location:  Arm, unknown if right or left arm), for COVID-19 immunization, reaction(s): "sore arm ". The following information was reported: PULMONARY EMBOLISM (death, medically significant), outcome "fatal", described as "Pulmonary Embolism"; MALAISE (non-serious), outcome "unknown", described as "did not feel well". The patient date of death was 01Jan2022. The reported cause of death was pulmonary embolism. The patient had not received any other vaccines within 4 weeks prior to the COVID vaccine.Vaccination facility type was clinic.  The patient was back to work and working and active until receiving third dose. The patient had no other condition. The patient had no investigations. The reporter reported that the patient received the booster dose on 28Dec2021. The patient just did not feel well after receiving the booster dose and the reporter was told this by the patient's son who lived with the patient at the time. The reporter did not know exactly what it meant that the patient did not feel well, except that the patient postponed a Christmas gathering with family and friends. The patient passed away on 01Jan2022. The caller stated the cause of death was pulmonary Embolism. The reporter reported The reporter did not believe additional vaccines administered on same date of the Pfizer Suspect. The reporter did not visit Emergency Room or Physician Office. The patient had no relevant tests.  No follow-up attempts are possible. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202200474100 Same reporter/patient, different dose/events; Reported Cause(s) of Death: Pulmonary Embolism
Age: 45.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Pruritus, Rash
Clinical narrative: Skin Rash; itching; This is a spontaneous report received from a contactable reporter(s) (Other HCP). The reporter is the patient.  A 45 year-old female patient received bnt162b2 (BNT162B2), intramuscular, administered in arm left, administration date 05Feb2022 (Lot number: FL3209) at the age of 45 years as dose 3 (booster), single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (1st Dose, Date: 10Aug2021, Anatomical site of injection: left arm, Route of administration: Intramuscular, Batch/Lot number: FA7485), administration date: 10Aug2021, when the patient was 45 years old, for Covid-19 immunization, reaction(s): "Flu like symptoms", "skin rash"; Bnt162b2 (2nd Dose, Date: 31Aug2021, Anatomical site of injection: left arm , Route of administration: Intramuscular, Batch/Lot number: FP8448), administration date: 31Aug2021, when the patient was 45 years old, for Covid-19 Immunization, reaction(s): "skin rash itchy only", "skin rash itchy only". The following information was reported: RASH (non-serious) with onset 06Feb2022, outcome "recovered" (2022), described as "Skin Rash"; PRURITUS (non-serious) with onset 06Feb2022, outcome "recovered" (2022), described as "itching". Therapeutic measures were taken as a result of rash, pruritus.  Additional information: The patient was treated with Hydrocortisone cream over the counter.  No follow-up attempts are possible. No further information is expected.
Age: 73.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Fatigue
Clinical narrative: This spontaneous case was reported by a consumer and describes the occurrence of SYNCOPE (after the booster got up and fainted) and FATIGUE (each time she got the Moderna Covid19 vaccine she got wiped out the next day) in a 73-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 939909, 013L20A and 016M20A) for COVID-19 vaccination. Concurrent medical conditions included Allergy to antibiotic (clindamycin). Concomitant products included Amlodipine Besylate for an unknown indication. On 14-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 11-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 12-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 13-Nov-2021, after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced FATIGUE (each time she got the Moderna covid19 vaccine she got wipe out the next day,). In November 2021, the patient experienced SYNCOPE (after the booster got up and fainted). At the time of the report, SYNCOPE (after the booster got up and fainted) and FATIGUE (each time she got the Moderna Covid19 vaccine she got wipe out the next day,) had resolved. The patient did not have a COVID and test or diagnosis. The patient did not have history relating to mentioned AE or both Acute and Chronic illnesses at the time of vaccination. It was reported that no other vaccines were given within 1 month prior to Moderna COVID-19 vaccine. The patient reported that she was potentially getting another booster and each time she got the Moderna Covid19 vaccine she got wipe out the next day, and was not uncommon, and was not supposed to happened to old people, and after the booster got up and fainted, on the next day of the shoot, she did thought she was desiderated. The patient also wanted to know if it was normal to faint, if it happened to other people. Due to adverse event patient did not to seek medical care. Patient did not experience a similar event in the past. No treatment drug was reported.
Age: 73.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Fatigue, Syncope
Clinical narrative: This spontaneous case was reported by a consumer and describes the occurrence of SYNCOPE (after the booster got up and fainted) and FATIGUE (each time she got the Moderna Covid19 vaccine she got wiped out the next day) in a 73-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 939909, 013L20A and 016M20A) for COVID-19 vaccination. Concurrent medical conditions included Allergy to antibiotic (clindamycin). Concomitant products included Amlodipine Besylate for an unknown indication. On 14-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 11-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 12-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 13-Nov-2021, after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced FATIGUE (each time she got the Moderna covid19 vaccine she got wipe out the next day,). In November 2021, the patient experienced SYNCOPE (after the booster got up and fainted). At the time of the report, SYNCOPE (after the booster got up and fainted) and FATIGUE (each time she got the Moderna Covid19 vaccine she got wipe out the next day,) had resolved. The patient did not have a COVID and test or diagnosis. The patient did not have history relating to mentioned AE or both Acute and Chronic illnesses at the time of vaccination. It was reported that no other vaccines were given within 1 month prior to Moderna COVID-19 vaccine. The patient reported that she was potentially getting another booster and each time she got the Moderna Covid19 vaccine she got wipe out the next day, and was not uncommon, and was not supposed to happened to old people, and after the booster got up and fainted, on the next day of the shoot, she did thought she was desiderated. The patient also wanted to know if it was normal to faint, if it happened to other people. Due to adverse event patient did not to seek medical care. Patient did not experience a similar event in the past. No treatment drug was reported.
Sex: U
Vaccine: COVID19, COVID19
Symptoms: Amnesia, Computerised tomogram head normal, Condition aggravated, Feeling abnormal, Memory impairment
Clinical narrative: SHARP, NEAR PHOTOGRAPHIC MEMORY BEGAN TO GET FUZZY, REMEMBERED EVERYTHING PRIOR TO VACCINE AND EVERYTHING WITHIN LAST 2 MONTHS; This spontaneous report received from a patient concerned a patient of unspecified age and sex. 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, and batch number were not reported) dose was not reported, administered on DEC-2020 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On an unspecified date, the patient experienced sharp, near photographic memory began to get fuzzy, remembered everything prior to vaccine and everything within last 2 months. Laboratory data (dates unspecified) included: COVID-19 virus test (NR: not provided) Negative. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of sharp, near photographic memory began to get fuzzy, remembered everything prior to vaccine and everything within last 2 months was not reported. This report was non-serious. This case, involving the same patient is linked to 20220361912.
Sex: U
Vaccine: COVID19, COVID19
Symptoms: Memory impairment, SARS-CoV-2 test
Clinical narrative: SHARP, NEAR PHOTOGRAPHIC MEMORY BEGAN TO GET FUZZY, REMEMBERED EVERYTHING PRIOR TO VACCINE AND EVERYTHING WITHIN LAST 2 MONTHS; This spontaneous report received from a patient concerned a patient of unspecified age and sex. 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, and batch number were not reported) dose was not reported, administered on DEC-2020 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On an unspecified date, the patient experienced sharp, near photographic memory began to get fuzzy, remembered everything prior to vaccine and everything within last 2 months. Laboratory data (dates unspecified) included: COVID-19 virus test (NR: not provided) Negative. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of sharp, near photographic memory began to get fuzzy, remembered everything prior to vaccine and everything within last 2 months was not reported. This report was non-serious. This case, involving the same patient is linked to 20220361912.
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Myalgia, Skin infection, Swelling
Clinical narrative: Two days after my Pfizer booster, my muscles started feeling really sore, and my belly button became swollen and a previous scar started to look infected. I went to the ER and was admitted to the local hospital for 2 days and I was given an IV of antibiotics.
Age: 34.0
Sex: F
Vaccine: DTAP
Symptoms: Exposure during pregnancy, Injected limb mobility decreased, Injection site erythema, Injection site induration, Injection site mass
Clinical narrative: 36 week pregnant, Edd 29 April, hard red tender lump at injection site, impacting range of motion with no pain, warm to touch, quarter sized.
Age: 34.0
Sex: F
Vaccine: DTAP
Symptoms: Injection site pain, Injection site warmth
Clinical narrative: 36 week pregnant, Edd 29 April, hard red tender lump at injection site, impacting range of motion with no pain, warm to touch, quarter sized.
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Basophil count, Blood potassium, Full blood count, Iron binding capacity total
Clinical narrative: Day 1 and 2, shoulder was sore and left ankle was so stiff I couldn't bend it. I had broken it 13 years before but by now it was completely healed and functional. I did my rehab exercises again and those brought back flexibility. ??But then, what became so concerning that I visited the doctor about it on 4/7/21, was that, on Day 2 or 3 after the vaccine, I became so sleepy that I almost felt as though I had sleeping sickness. Would sleep for a few hours. then be up for 3-4 hours, then suddenly become so sleepy again that I could hardly even sit upright. Had to go back to sleep immediately. After a few hours, I would be up for 3-4 hours again, then have to go back to sleep. This lasted for a month.
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Joint stiffness, Mobility decreased, Serum ferritin, Somnolence, Thyroid function test
Clinical narrative: Day 1 and 2, shoulder was sore and left ankle was so stiff I couldn't bend it. I had broken it 13 years before but by now it was completely healed and functional. I did my rehab exercises again and those brought back flexibility. ??But then, what became so concerning that I visited the doctor about it on 4/7/21, was that, on Day 2 or 3 after the vaccine, I became so sleepy that I almost felt as though I had sleeping sickness. Would sleep for a few hours. then be up for 3-4 hours, then suddenly become so sleepy again that I could hardly even sit upright. Had to go back to sleep immediately. After a few hours, I would be up for 3-4 hours again, then have to go back to sleep. This lasted for a month.
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Vitamin B12, White blood cell count normal
Clinical narrative: Day 1 and 2, shoulder was sore and left ankle was so stiff I couldn't bend it. I had broken it 13 years before but by now it was completely healed and functional. I did my rehab exercises again and those brought back flexibility. ??But then, what became so concerning that I visited the doctor about it on 4/7/21, was that, on Day 2 or 3 after the vaccine, I became so sleepy that I almost felt as though I had sleeping sickness. Would sleep for a few hours. then be up for 3-4 hours, then suddenly become so sleepy again that I could hardly even sit upright. Had to go back to sleep immediately. After a few hours, I would be up for 3-4 hours again, then have to go back to sleep. This lasted for a month.
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Dizziness, Headache, Pyrexia
Clinical narrative: 103 fever, chills. Headache,  dizziness
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster, Post herpetic neuralgia
Clinical narrative: shingles; postherpetic neuralgia; This spontaneous report was received from a consumer concerning herself a female patient with currently 76-years-old. The patient's medical history and concomitant therapies were not reported. Her concurrent conditions included chronic dermatitis.   On an unknown date in 2015, the patient was vaccinated with zoster vaccine live (ZOSTAVAX) subcutaneous injection, unk (strength, lot #, expiry date, route of administration, and indication were not provided). After she had her vaccine she experienced shingles and postherpetic neuralgia off and on. On an unspecified date in October 2021, she had another vaccination with zoster vaccine live (ZOSTAVAX) subcutaneous injection, unk (strength, lot #, expiry date, route of administration, and indication were not provided) and a few weeks later she experienced again postherpetic neuralgia on the right side of her stomach that was still present. The outcome of the events was not reported.    The causal relationship between postherpetic neuralgia and shingles with zoster vaccine live (ZOSTAVAX) was not provided.
Age: 4.0
Sex: U
Vaccine: MMRV
Symptoms: Expired product administered, No adverse event
Clinical narrative: No additional AE/PQC reported; expired PROQUAD was administered to a patient yesterday 3/22/2022; This spontaneous report was received from a certified medical assistant (C.M.A.), referring to a 4-year-old patient of unknown gender. Information regarding the patient's concurrent conditions, concomitant therapies or medical history was not provided.  On 22-MAR-2022, the patient was administered expired Measles, Mumps, Rubella and Varicella (Oka-Merck) Virus Vaccine Live recombinant human albumin (rHA) (PROQUAD) lot number: T031825, expiry date: 16-MAR-2022 (dose, strength, frequency, route of administration and anatomical location were not reported) for prophylaxis (expired product administered). No additional adverse event (AE)/product quality complaint (PQC) reported (no adverse event). The reporter confirmed Measles, Mumps, Rubella and Varicella (Oka-Merck) Virus Vaccine Live (PROQUAD) had no prior temperature excursions.
Sex: U
Vaccine: HPV9
Symptoms: No adverse event, Product storage error
Clinical narrative: no adverse event; vaccine stored out of recommended storage range was administered to patient; This spontaneous report was received from nurse prescriber referring to a patient of unknown age and gender. Information regarding the patient's pertinent medical history, historical drugs, concurrent conditions, concomitant therapies, and previous drug reactions or allergies was not reported.       On 04-MAR-2022, the patient was vaccinated with an improperly stored dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) lot # 1687290, expiration date 06-SEP-2022, for prophylaxis (dose, vaccination scheme frequency, route of administration and anatomical site of vaccination were not reported) (product storage error). No additional adverse event reported.
Age: 11.0
Sex: M
Vaccine: HPV9
Symptoms: Anxiety, Attention deficit hyperactivity disorder, Syncope
Clinical narrative: anxiety; ADHD; fainted; fainted; This spontaneous report aws received from a consumer (reported as "office manager") referring to a 11-year-old male patient. Information regarding the patient's pertinent medical history, historical drugs, concurrent conditions, concomitant therapies, and previous drug reactions or allergies was not reported.      On an unknown date in September 2021, the patient received the first dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) for prophylaxis (formulation, strength, dose, frequency, route of administration, indication, lot number and expiration date were not reported). The patient fainted briefly after the vaccine (syncope).   On 23-MAR-2022, the patient was vaccinated with his second dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) for prophylaxis (formulation, strength, dose, frequency, route of administration, indication, lot number and expiration date were not reported). After receiving the vaccine, the patient fainted for approximately 2 seconds (syncope). The reporter stated that the patient had also been diagnosed with anxiety and attention deficit hyperactivity disorder (ADHD) on an unknown date and was taking unspecified medications for it. The outcome of the syncope events was assesed as recovered (reported as "patient ok"). The outcome of anxiety and ADHD was unknown.   The causal relationshiop between hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) and the reported events was unknown.   Upon internal review, the events of syncope were determined to be medically significant.
Sex: U
Vaccine: RV5
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional AEs reported; expired dose of ROT ATEQ which also experienced a temperature excursion was given to a patient.; expired dose of ROT ATEQ which also experienced a temperature excursion was given to a patient.; This spontaneous report was received from a licensed practical nurse (LPN), referring to a patient of unknown age and gender. Information regarding the patient's concurrent conditions, concomitant therapies or medical history was not provided.  On 24-MAR-2022, the patient was administered with a third dose of an improperly stored and expired rotavirus vaccine, live, oral, pentavalent (ROTATEQ), route of administration defaulted to oral, lot number: 1707486, expiry date: 20-MAR-2022(dose and strength were not reported) for prophylaxis (product storage error),(expired product administered). No additional adverse events (AEs) were reported (no adverse event).   There were reported temperature excursion of the administered vaccine: 05-JAN-2022 of 8.4 degrees Celsius (C) for 7 minutes, 27-JAN-2022 of 8.5 C for 11 minutes, 28-JAN-2022 of 10.3 C for 22 minutes and 18-FEB-2022 of 8.2 C for 3 minutes. It was not reported if Logger was involved.
Age: 0.17
Sex: U
Vaccine: RV5, RV5
Symptoms: Expired product administered, No adverse event
Clinical narrative: Patient had no known side effects or reactions; an expired dose of ROTATEQ was administered to a patient; This spontaneous report was received from a Physician Assistant, referring to a 8-week-old patient of unknown gender. The patient's pertinent medical history, concurrent conditions, previous drug allergies or reactions and concomitant medications were not reported.  On 28-MAR-2022, the patient was vaccinated with an expired dose of rotavirus vaccine, live, oral, pentavalent (ROTATEQ) 2 ml, was given orally, lot # 1707593 was confirmed to be valid, expiration date not reported, but upon internal validation established as 24-MAR-2022 for prophylaxis. The patient had no known side effects or reactions. The reporter asked about revaccination but was satisfied after hearing supported disclaimer.
Sex: U
Vaccine: VARZOS
Symptoms: Feeling abnormal, Herpes zoster, Vaccination failure, Vertigo
Clinical narrative: Vertigo; Suspected vaccination failure; Very severe case of internal shingles; Haven't been the same, Really down for three months, never been so sick; This case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix. On 27th September 2021, more than 2 years after receiving Shingrix, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the patient experienced vertigo and feeling abnormal. On an unknown date, the outcome of the vaccination failure, shingles and vertigo were unknown and the outcome of the feeling abnormal was recovered/resolved.   It was unknown if the reporter considered the vaccination failure, shingles, vertigo and feeling abnormal to be related to Shingrix.     Additional Information: GSK Receipt Date: 26-Mar-2022 Reporter's Comments: This case was reported by a consumer via  interactive digital media. The reporter had the Shingrix vaccination in 2018 and ended up with a very severe case of internal shingles.  With it, the patient suffered with vertigo and was really down for three months.  The patient lost three months out of his/her life. The patient had never been so sick and had not been the same. Additional Supportive Information: This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule, time to onset and laboratory test confirming shingles were unknown at the time of reporting. Follow-up would not possible as no contact details were available.
Sex: U
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: 1st dose over two 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 (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st dose on an unknown date, over 2 years ago).   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 Information: Additional Information: GSK Receipt Date: 25-MAR-2022 Reporter's Comments:  The reporter asked should he/she still receive 2nd dose after close to 3 years, would it be effective.  The reporter failed to get the 2nd shot since. Additional Supportive Information: The case was reported via interactive digital media. Till the time of reporting the patient did not receive 2nd dose of vaccine, which led to incomplete course of vaccination.
Sex: U
Vaccine: VARZOS
Symptoms: Illness
Clinical narrative: made me sick; This case was reported by a consumer via interactive digital media and described the occurrence of sickness 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 sickness. On an unknown date, the outcome of the sickness was recovered/resolved.   It was unknown if the reporter considered the sickness to be related to Shingles vaccine.   Additional Information: GSK Receipt Date: 27-Mar-2022 Reporter's Comment: This case was reported consumer via interactive digital media. The case was reported by the patient. The patient got the vaccine but it made him/her sick for three days. Additional Supportive Information: The follow up would not possible, as no contact details were available.
Sex: U
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: 1st dose on september missed 2nd dose; This case was reported by a consumer via call center representative and described the occurrence of incomplete course of vaccination in a 56-year-old patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Previously administered products included Shingles vaccine (1st dose received in September 2021).   On an unknown date, the patient did not receive 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: GSK Receipt Date: 28-MAR-2022 Reporter's Comment: The patient self-reported this case. The patient asked what if it had been longer than 6 months since his/her 1st Shingles dose. Additional supportive information:  Till the time of reporting, the patient did not receive the 2nd dose of Shingles vaccine, which led to incomplete course of vaccination.
Sex: U
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: can I get second dose, it has been 7 months; 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 (1st dose received on an unknown 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: GSK receipt date: 28-Mar-2022 Reporter's comment: This case was reported via interactive digital media. The reporter wanted to know could he/she get the 2nd dose of Shingles vaccine if it had been 7 months.
Sex: U
Vaccine: VARZOS
Symptoms: COVID-19, Herpes zoster, Vaccination failure
Clinical narrative: exactly a year after shoots, got shingles/suspected vaccination failure; shingles; covid; This case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, 1 year after receiving Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant), shingles and covid-19. On an unknown date, the outcome of the vaccination failure, shingles and covid-19 were unknown.   It was unknown if the reporter considered the vaccination failure, shingles and covid-19 to be related to Shingles vaccine.   Additional Information: GSK receipt date: 26-MAR-2022 Reporter's comment: This case was reported by a consumer via interactive digital media. This case was reported by the patient. The patient was pretty sure this was a side effect of Covid because he/she had always been a healthy person but did not take medications and exactly a year after his/her shots, he/she got the shingles. Additional supportive information: This case described the occurrence of suspected vaccination failure. This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule and laboratory test confirming shingles were unknown at the time of reporting. The follow up would not possible as no contact details were available.
Sex: U
Vaccine: VARZOS, VARZOS
Symptoms: Extra dose administered
Clinical narrative: both vaccine doses two times; This case was reported by a consumer via interactive digital media and described the occurrence of extra dose administered in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Co-suspect products included Herpes zoster (Shingles vaccine) for prophylaxis.   Previously administered products included Shingles vaccine (1st and 2nd dose received on an unknown date).   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 extra dose administered. On an unknown date, the outcome of the extra dose administered was unknown.   Additional Information: GSK Receipt Date: 28-MAR-2022 Reporter's Comment: This case was reported by a consumer via interactive digital media. The reporter asked was it dangerous to have both vaccine doses two times. Additional supportive information:  The patient received both vaccine doses two times, which led to extra dose administered. The follow-up would not possible, as no contact details were available.
Sex: U
Vaccine: VARZOS, VARZOS
Symptoms: Extra dose administered, Inappropriate schedule of product administration
Clinical narrative: received 3 doses of Shingrix; first dose in Jan 2020 and the second dose in Jan 2022; This case was reported by a nurse via sales rep and described the occurrence of drug dose administration interval too long in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (1st dose received in January 2020).   In March 2022, the patient received Shingrix. In January 2022, the patient received the 2nd dose of Shingrix. In January 2022, not applicable after receiving Shingrix and unknown after receiving Shingrix, the patient experienced drug dose administration interval too long. In March 2022, the patient experienced extra dose administered. On an unknown date, the outcome of the drug dose administration interval too long and extra dose administered were unknown.   Additional Information: GSK Receipt Date: 29-MAR-2022 Reporter's Comment: The 50 years or older aged patient received 3 doses of Shingrix. The reporter shared that they were not sure if they needed to restart the series because it had been so long since the patient had received the first dose. The reporter did not consent to follow-up. Additional supportive information: The patient received 2nd dose of Shingrix later than the recommended interval, which led to lengthening of vaccination schedule. The patient recently also received another dose of Shingrix, which led to extra dose administered.
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Herpes zoster, Incomplete course of vaccination
Clinical narrative: 1st dose 5 years ago, did not receive 2nd dose; Shingles in 2021; This case was reported by a consumer via call center representative and described the occurrence of shingles in a 88-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix and the 2nd dose of Shingrix. On 1st July 2021, more than 2 years after receiving Shingrix and not applicable after receiving Shingrix, the patient experienced shingles. On an unknown date, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the shingles was recovered/resolved and the outcome of the incomplete course of vaccination 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 the case. The age at vaccination was not reported for the 1st dose and the age at vaccination was not applicable for the 2nd dose. The patient received 1st dose of Shingrix, 5 years ago from the date of reporting.  After receiving 1st dose of Shingrix, the patient had a case of shingles, which was lasted 2 weeks and had resolved. Till the time of reporting, the patient did not receive 2nd dose of Shingrix, as she was not told there was a 2nd dose, which led to incomplete vaccination schedule. Information was provided as per content and product information, referred to health care professional and provided medical advice disclaimer. The reporter consented to follow up. Note: received 1st dose in 2017 when it was newly launched.
Age: 66.0
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster, Pain, Product administration error
Clinical narrative: administered during active case of shingles/another facility was unaware of the patient status; This case was reported by a pharmacist via call center representative and described the occurrence of drug administration error in a 66-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Concurrent medical conditions included shingles (shingles flare up) and pain.   On 21st March 2022, the patient received the 1st dose of Shingrix. On 21st March 2022, unknown after receiving Shingrix, the patient experienced drug administration error. On an unknown date, the outcome of the drug administration error was unknown.   Additional Information: GSK Receipt Date: 22-MAR-2022 Reporter's Comment: The patient was administered dose of shingrix during an active case of shingles flare up. The patient was admitted to ER (Emergency room) on 19th March 2022 for active flare up shingles and was given treatment for pain. The patient was on day 8 to 9 of active flare up of shingles.  The another facility was unaware of the patient status and administered to patient a dose of Shingrix on 21st March 2022, which led to drug administration error. The reporter consented to follow-up.
Age: 80.0
Sex: M
Vaccine: VARZOS
Symptoms: Headache, Myalgia
Clinical narrative: Experiencing muscle soreness in his arms and legs; Headache; This case was reported by a consumer via call center representative and described the occurrence of muscle soreness in a 80-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   On 24th March 2022, the patient received the 2nd dose of Shingrix. On 25th March 2022, 1 days after receiving Shingrix, the patient experienced muscle soreness and headache. On an unknown date, the outcome of the muscle soreness and headache were unknown.   It was unknown if the reporter considered the muscle soreness and headache to be related to Shingrix.     Additional Information: GSK Receipt Date: 25-MAR-2022 Reporter's Comment:  This case was reported by the patient's wife. The patient received dose of Shingrix, a day before reporting and was now experiencing muscle soreness in his arms and legs and a headache. The reporter did not consent to follow-up. Additional supportive information:  This case has been linked to the case US2022054958 reported by the same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2022054958:Same Reporter
Sex: U
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: started series in 2017, never got second dose; This case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in a patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st dose on an unknown date in 2017).   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 Information: GSK Receipt Date: 25th March 2022 Reporter's Comments: Pharmacist stated that the patient started the Shingrix series in 2017 but never got the second dose. The pharmacist did not consent to follow up from safety. Additional Supportive Information: Till the time of reporting patient did not received 2nd dose which led to incomplete course of vaccination.
Age: 52.0
Sex: F
Vaccine: HEPAB
Symptoms: Expired product administered
Clinical narrative: dose has expired on February 8th 2022; This case was reported by a pharmacist via call center representative and described the occurrence of expired vaccine used in a 52-year-old female patient who received HAB (Twinrix adult) (batch number DK23D, expiry date 8th February 2022) for prophylaxis.   Co-suspect products included hepatitis A and hepatitis B vaccine pre-filled syringe device (Twinrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 25th March 2022, the patient received Twinrix adult and Twinrix Pre-Filled Syringe Device. On 25th March 2022, unknown after receiving Twinrix adult and Twinrix 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 Information: GSK Receipt Date: 28-Mar-2022 Reporter's Comments: The reporter stated that on 25th March 2022, the patient received a dose of Twinrix that had already expired on 8th February 2022. The Vaccine Administration Facility is the same as Primary Reporter. The reporter consented to follow-up. Additional Supportive Information: The patient received an expired dose of Twinrix, which led to expired vaccine used.
Age: 14.0
Sex: F
Vaccine: MNQ
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: who was 14 years of age received a booster vaccination of MENVEO; This case was reported by a other health professional via call center representative and described the occurrence of inappropriate age at vaccine administration in a 14-year-old female patient who received Men ACWY-CRM NVS (Menveo) (batch number AMVA687A, expiry date 31st October 2022) for prophylaxis.   On 25th March 2022, the patient received Menveo. On 25th March 2022, unknown after receiving Menveo, the patient experienced inappropriate age at vaccine administration. On an unknown date, the outcome of the inappropriate age at vaccine administration was unknown.   Additional Information: GSK Receipt Date: 28-Mar-2022 Reporter's comment: The patient received booster dose of Menveo at the age of 14. As per PI, booster should be given after 15 years of age once if at increased risk of meningococcal disease. The reporter wanted further guidance. The consent to follow up was given. The permission to contact healthcare professional was given. The vaccine administration facility was the same as primary reporter. Additional Supportive Information: The 14 year old patient received booster dose of Menveo, which led to inappropriate age at vaccination.
Age: 50.0
Sex: M
Vaccine: MENB
Symptoms: Expired product administered
Clinical narrative: received an expired dose; This case was reported by a nurse via call center representative and described the occurrence of expired vaccine used in a 50-year-old male patient who received Men B NVS (Bexsero) (batch number ABXA93AA, expiry date February 2022) 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.   Concurrent medical conditions included stem cell transplant.   On 23rd March 2022, the patient received the 1st dose of Bexsero and Bexsero Pre-Filled Syringe Device. On 23rd March 2022, 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 Information: GSK Receipt Date: 28-Mar-2022 Reporter's comment: The patient received an expired dose of Bexsero. The consent to follow up was given by email. The vaccine administration facility was the same as primary reporter. Additional Supportive Information: The patient received dose of Bexsero that was already got expired in February 2022, which led to expired vaccine used.
Age: 29.0
Sex: F
Vaccine: HEP
Symptoms: Dizziness, Hyperhidrosis, Paraesthesia
Clinical narrative: adverse reactions:feeling diaphoretic; adverse reactions: felt dizzy and like she was going to fainting; adverse reactions: hands started to tingling; This case was reported by a nurse via call center representative and described the occurrence of diaphoresis in a 30-year-old female patient who received HBV (Engerix B) (batch number F73DG, expiry date 3rd July 2023) for prophylaxis.   On 28th March 2022, the patient received the 1st dose of Engerix B. On 28th March 2022, less than a minute after receiving Engerix B, the patient experienced diaphoresis, felt faint and tingling of extremity. On an unknown date, the outcome of the diaphoresis, felt faint and tingling of extremity were unknown.   It was unknown if the reporter considered the diaphoresis, felt faint and tingling of extremity to be related to Engerix B.     Additional Information: GSK Receipt Date: 28-Mar-2022 Reporter's comment: The nurse reported that a patient vaccinated with Engerix-B and within seconds started feeling diaphoretic, felt dizzy and like she was going to fainting also her hands started to tingling. This was the first time that after being vaccinated had some adverse reactions. The reporter consented to follow up. Additional Supportive Information: This case is linked with case US2022055950 reported by same reporter for different patient.; Sender's Comments:  US-GLAXOSMITHKLINE-US2022055950:same reporter