chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: COVID19
Symptoms: Cardiac disorder, Gait disturbance, Postural orthostatic tachycardia syndrome, Urinary tract infection
Clinical narrative: UTI; POTS; heart was not behaving properly; could not walk; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the parent.  A female patient received BNT162b2 (BNT162B2), as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: URINARY TRACT INFECTION (non-serious), 14 days after the suspect product(s) administration, outcome "unknown", described as "UTI"; POSTURAL ORTHOSTATIC TACHYCARDIA SYNDROME (non-serious), outcome "unknown", described as "POTS"; CARDIAC DISORDER (non-serious), outcome "recovered", described as "heart was not behaving properly"; GAIT DISTURBANCE (non-serious), outcome "unknown", described as "could not walk". Therapeutic measures were taken as a result of cardiac disorder.  Additional information: The reporter's sister was in withheld and the caller has a daughter in another city a few hours away from the caller and they all including the caller herself, received the Pfizer Covid vaccine 1st dose on the same day and 14 days later they all had UTIs. Stated they each had a different lot of the Pfizer Covid vaccine that day. She, her sister, and her daughter all had the UTI 14 days after the 1st dose of their Pfizer Covid vaccine. Stated she had no information on her daughter or her sister to provide and no lots, expiry dates, NDC numbers or dates of their Pfizer Covid vaccines to provide. She, her sister, and her daughter all had the UTI 14 days after the 1st dose of their Pfizer Covid vaccine. Her daughter now has POTS and her sister and daughter had to wear heart monitors for six weeks after because their hearts were not behaving properly and that issue with the sister and daughter's hearts seems to have rectified and that has resolved for them. Her daughter ended up in the hospital for five days and could not walk.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Sex: M
Vaccine: COVID19
Symptoms: Crohn's disease, Diarrhoea, Disease recurrence, Vomiting
Clinical narrative: reoccurrence of pre-existing crohn's disease; reoccurrence of pre-existing crohn's disease; diarrhea; vomiting; This is a spontaneous report received from a contactable reporter (Consumer or other non HCP). The reporter is the patient.  A 75-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), as dose number unknown (booster), single (Batch/Lot number: unknown) for COVID-19 immunisation. The patient's relevant medical history included: "Crohn's Disease" (unspecified if ongoing). The patient's concomitant medications were not reported. Vaccination history included: Bnt162b2 (DOSE 3 (BOOSTER), SINGLE), for COVID-19 immunization, reaction: "reoccurance of my pre-existing Chron's Disease"; Covid-19 vaccine (Primary immunization, manufacturer unknown), for COVID-19 immunisation. The following information was reported: CROHN'S DISEASE (medically significant), DISEASE RECURRENCE (medically significant), outcome "recovering" and all described as "reoccurrence of pre-existing crohn's disease"; DIARRHOEA (non-serious), outcome "recovering", described as "diarrhea"; VOMITING (non-serious), outcome "recovering". Clinical course: With the first booster, there was a reoccurrence of my pre-existing Crohn's disease characterized by Chronic pain in the ileocecal intenstinal area. It was painful enough to require my taking prednisolone (starting at 20mg) for about 6 weeks. With the next booster, the reaction has more severe about 12 hours following the shot. I also got diarrhea and vomiting lasting about a half hour. Then I improved over the next several hours. The latest booster also caused a worsening of arthritis in my hands along with the run-down feeling.  The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5 has been requested and will be submitted if and when received.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300080872 same patient and suspect drug/different booster # and AE;US-PFIZER INC-PV202300035909 same patient and suspect drug/different dose # and AE;US-PFIZER INC-202300006841 same patient and suspect drug/different booster # and AE;
Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity, Vaccination site pain
Clinical narrative: My arm where it was administered has been painful to touch/Sometimes just sitting I feel pain in the arm.; My arm where it was administered has been painful to touch; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non-HCP), Program ID: The reporter is the patient.  A 51-year-old female patient received BNT162b2 (BNT162B2), on 16Oct2021 at 10:30 as dose 3 (booster), single (Lot number: FH8027) at the age of 51 years, in arm for covid-19 immunisation. The patient had no relevant medical history. The patient's concomitant medications were not reported. Vaccination history included: BNT162b2 (Dose 1st, Time (24hr): 11:30 AM, Batch/Lot number: Not available / Provided at time of report completion), administration date: 13Mar2021, when the patient was 50-year-old, for COVID-19 Immunization; BNT162b2 (Dose 2nd, Time (24hr): 11:00 AM, Batch/Lot number: Not available / Provided at time of report completion), administration date: 10Apr2021, when the patient was 50-year-old, for COVID-19 Immunization. The following information was reported: VACCINATION SITE PAIN (non-serious) with onset Oct2021, outcome "unknown", described as "My arm where it was administered has been painful to touch"; PAIN IN EXTREMITY (non-serious) with onset Oct2021, outcome "unknown", described as "My arm where it was administered has been painful to touch/Sometimes just sitting I feel pain in the arm.".  Additional information: Ever since the third dose (Booster) on 16Oct2021, her arm where it was administered has been painful to touch as well as whenever she carries anything heavy in that hand/arm. Sometimes just sitting she feel pain in the arm. In addition, 6 weeks after the 4th booster of 10Nov2022 she tested positive for COVID-19.
Sex: M
Vaccine: COVID19-2
Symptoms: Pain
Clinical narrative: Bad my currently suffering some pains after getting a booster short of Pfizer.; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non-HCP), Program ID:  The reporter is the patient.  An adult male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), as dose number unknown (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Primary Immunization series complete, unknown manufacturer.), for COVID-19 Immunization. The following information was reported: PAIN (non-serious), outcome "unknown", described as "Bad my currently suffering some pains after getting a booster short of Pfizer.". No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Feeling abnormal, Influenza like illness, Malaise, Pyrexia
Clinical narrative: malaise; feeling run down; fever; comparable to getting the flu; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 75-year-old male patient received BNT162b2 (BNT162B2), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Flu years before" (unspecified if ongoing); "Crohns disease" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: MALAISE (non-serious), outcome "unknown"; FEELING ABNORMAL (non-serious), outcome "unknown", described as "feeling run down"; PYREXIA (non-serious), outcome "unknown", described as "fever"; INFLUENZA LIKE ILLNESS (non-serious), outcome "unknown", described as "comparable to getting the flu". Reporter stated "Common to all the vaccinations (with involves all the booster shots) has been a general malaise, specifically, feeling run down with an accompanying fever. In that sense, it has been comparable to getting the flu."  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 65.0
Sex: F
Vaccine: COVID19, FLU4
Symptoms: Decreased immune responsiveness, Hepatitis C antibody, Nucleic acid test
Clinical narrative: weakened immune system; Hepatitis C antibody test reactive; Initial information received on 22-Feb-2023 regarding an unsolicited valid non-serious courtesy case received from Partner Pfizer.  This case involves a 64 years old female patient (165 cm and 68 kg) who experienced hepatitis c antibody test reactive, nucleic acid test is nonreactive and weakened immune system while receiving vaccines influenza quadrival A-B high dose HV vaccine [fluzone high-dose quadrivalent] and pfizer biontech covid-19 vaccine.  The patient's past medical history included Occupational exposure to toxic agent. The patient's past vaccination(s) included INFLUENZA VACCINE on 05-NOV-2021 and PFIZER BIONTECH COVID-19 VACCINE with Dose 1- 10-Mar-2021 with Lot number lot EM6204  Dose 2- 31-Mar-2021 with Lot number lot ER8737  Dose 3- 22-oct-2021 with Lot number lot FE3590  Dose 4- 10-Jun-2022 with Lot number lot FM7553 All in the left arm. The patient's past medical treatment(s) and family history were not provided. Concomitant medications included PNEUMOCOCCAL VACCINE CONJ 20V (CRM197) (PREVNAR 20) for Prophylactic vaccination.  On 12-Oct-2022, the patient received a  dose of suspect influenza quadrival A-B high dose HV vaccine (lot UJ919AB, expiry date, strength, form and dose was unknown) via unknown route in unknown administration site as prophylactic vaccination. On 22-Nov-2022, the patient received a dose 5  of suspect pfizer biontech covid-19 vaccine not produced by Sanofi Pasteur (lot GJ6796, with unknown expiry date, strength, form and dose) via unknown route in the left arm as prophylactic vaccination.  On an unknown date in Jan-2023, the patient developed hepatitis c antibody test reactive, nucleic acid test is nonreactive (hepatitis c antibody positive) and on an unknown date developed weakened immune system (decreased immune responsiveness) (unknown latency) following the administration of influenza quadrival A-B high dose HV vaccine and pfizer biontech covid-19 vaccine.   Relevant laboratory test results included: Hepatitis C antibody - On an unknown date: Positive Nucleic acid test - On an unknown date: Negative  Action taken: not applicable.  It was not reported if the patient received a corrective treatment for the events.  At time of reporting, the outcome was Unknown for the events.   Hepatitis c was assessed as medically significant. Sender's Comments: Sanofi Company Comment dated 27-Feb-2023: This case involves a 64 years old female patient (165 cm and 68 kg) who experienced hepatitis c antibody test reactive, nucleic acid test is nonreactive and weakened immune system while receiving vaccines influenza quadrival A-B high dose HV vaccine [fluzone high-dose quadrivalent] and pfizer biontech covid-19 vaccine. Based on the limited information provided, the causal role of the company suspect product cannot be excluded in occurrence of the events. However, lack of information regarding any concurrent conditions, any family history precludes the comprehensive case assessment.
Sex: U
Vaccine: DTAPIPVHIB
Symptoms: Medication error, No adverse event, Product preparation error
Clinical narrative: In the office gave the DTAP-IPV mixed with sterile water to two patients but did not give the HIB portion of the vaccine at all/ medication error due to not mixing the vaccine as prescribed with no reported adverse event; Initial information received on 22-Feb-2023 regarding an unsolicited valid  non-serious case received from a physician.  This case involves 2 patient with unknown demographics who reported in the office gave the diphtheria/tetanus/5 hybrid AC pertussis/IPV(MRC5)/HIB(PRP/T) Vaccine [Pentacel] mixed with sterile water to two patients but did not give the hib portion of the vaccine at all/ medication error due to not mixing the vaccine as prescribed with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  On an unknown date, the patient received a  dose of suspect diphtheria/tetanus/5 hybrid AC pertussis/IPV(MRC5)/HIB(PRP/T) Vaccine Suspension for injection strength, dose, expiry date: unknown lot U7311AA via unknown route in unknown administration site for prophylactic vaccination.  On an unknown date the patient developed a non-serious event "In the office gave the dtap-ipv mixed with sterile water to two patients but did not give the hib portion of the vaccine at all/ medication error due to not mixing the vaccine as prescribed with no reported adverse event" (product preparation error) (unknown latency) following the administration of diphtheria/tetanus/5 hybrid AC pertussis/IPV(MRC5)/HIB(PRP/T) Vaccine.  Action taken was not applicable.  At time of reporting, the outcome was Unknown for the event in the office gave the dtap-ipv mixed with sterile water to two patients but did not give the hib portion of the vaccine at all/ medication error due to not mixing the vaccine as prescribed with no reported adverse event.   This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the guidelines. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Age: 18.0
Sex: F
Vaccine: MNQ
Symptoms: Medication error, Poor quality product administered, Product storage error
Clinical narrative: temperature dropped down to -30 degrees outside causing the building temperature and refrigerators to drop, temperature reached was 32.2F for a total excursion time of 39 hours, with no reported adverse event; patient to receive menquadfi post-excursion with no reported adverse event; Initial information received on 23-Feb-2023 regarding an unsolicited valid non-serious case received from a physician.  This case involves an 18-year-old female patient who receives MENINGOCOCCAL A-C-Y-W135 (T CONJ) VACCINE [MENQUADFI] post-excursion and temperature dropped down to -30 degrees outside causing the building temperature and refrigerators to drop, temperature reached was 32.2f for a total excursion time of 39 hours, with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On 06-Feb-2023, the patient received dose 1, at 0.5ml total dose of suspect MENINGOCOCCAL A-C-Y-W135 (T CONJ) VACCINE Solution for injection (strength: standard) (lot number: U7576AB and expiry date: 28-Feb-2025) via intramuscular route in the left deltoid for Immunization and on the same day patient received menquadfi post-excursion with no reported adverse event (poor quality product administered).  On an unknown date, a non-serious event reported, temperature dropped down to -30 degrees outside causing the building temperature and refrigerators to drop, temperature reached was 32.2f for a total excursion time of 39 hours, with no reported adverse event (product storage error).  It was reported, Caller reporting a temperature excursion at their facility. The caller requested stability data. Extended stability data covers the excursion with the exception of the MENQUADFI.    Action taken with MENINGOCOCCAL VACCINE (MENQUADFI) was not applicable.  At time of reporting, the outcome was Unknown for both events.   This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the guidelines. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Age: 11.0
Sex: M
Vaccine: MNQ
Symptoms: Medication error, No adverse event, Product storage error
Clinical narrative: temperature reached was 32.2F for a total excursion time of 39 hours with no reported adverse event; patient to receive MENQUADFI post-excursion with no reported adverse event; Initial information received on 23-Feb-2023 regarding an unsolicited valid non-serious case received from a consumer/non-healthcare professional.  This case involves a 11 years old male patient who received meningococcal A-C-Y-W135 (T CONJ) vaccine [Menquadfi] post-excursion whose temperature reached 32.2f for a total excursion time of 39 hours with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included diphtheria vaccine toxoid, pertussis vaccine acellular3-component, tetanus vaccine toxoid (Boostrix) for Prophylactic vaccination.  On 17-Feb-2023, the patient received 0.5 ml dose of suspect meningococcal A-C-Y-W135 (T CONJ) vaccine, Solution for injection (frequency, once (1x), strength - standard, expiry date  - 28-Feb-2025,  lot U7576AB) via intramuscular route in right deltoid for prophylactic vaccination.  On 17-FEB-2023 meningococcal A-C-Y-W135 (T CONJ) vaccine temperature reached 32.2f for a total excursion time of 39 hours with no reported adverse event (product storage error) and patient receive dmenquadfi post-excursion with no reported adverse event (poor quality product administered) (latency: 1 day)   Reportedly, the temperature dropped down to -30 degrees outside causing the building temperature and refrigerators to drop. The products involved are MENQUADFI, PENTACEL, and FLUZONE QIV NP.  Action taken: not applicable.  At time of reporting, the outcome was Unknown for both the events.   This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.; Sender's Comments:  US-SA-2023SA065072:01504785 US-SA-2023SA064145:01504843 US-SA-2023SA065058:01504849
Age: 68.0
Sex: F
Vaccine: FLU4
Symptoms: Expired product administered, Medication error, No adverse event
Clinical narrative: Expired fluzone high-dose quadrivalent, was administered to a patient with no reported adverse event; Initial information was received on 23-Feb-2023 regarding an unsolicited valid non-serious case received from a other health professional.  This case involves a 68 years old female patient who was administered with  expired INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE [FLUZONE HIGH-DOSE QUADRIVALENT] with no reported adverse event.   The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On 22-Feb-2023, the patient received total, 0.7 ml of suspect INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE (lot UJ765AC and expiry 30-Jun-22) (expired product administered) (strength: unknown) via intramuscular route in deltoid (UNKNOWN IF RIGHT OR LEFT) for prophylactic vaccination.  Action taken with QUADRIVALENT INFLUENZA VACCINE (FLUZONE HIGH-DOSE QUADRIVALENT) was not applicable.  At time of reporting, the outcome was Unknown for the event expired fluzone high-dose quadrivalent, was administered to a patient with no reported adverse event.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Age: 39.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Granuloma annulare
Clinical narrative: Granuloma Annulare
Sex: U
Vaccine: PPV
Symptoms: Expired product administered, No adverse event
Clinical narrative: . No additional AE reported. No PQC report; Pharmacist reports administration of an expired dose of PNEUMOVAX 23 to a patient on 22FEB2023. Caller confirmed product was stored according to the recommended storage range until administered to the patient.; This spontaneous report has been received from pharmacist referring a patient of unknown age and gender. The patient's pertinent medical history, drug reactions, allergies and concomitant medications were not reported.  On 22-FEB-2023, the patient was vaccinated with an expired dose of pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23), injection, lot number U026796 that had been verified to be a valid number with expiration date 28-JAN-2023, administered for prophylaxis (strength, specific dosage, vaccination scheme, route of administration and anatomical site of application were not provided) (expired product administered). Product was stored according to the recommended storage range until administered to the patient. No additional adverse event reported.
Age: 72.0
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster, Rash, Scab
Clinical narrative: Shingles disease; Still has scabbing; Rash; This case was reported by a pharmacist via call center representative and described the occurrence of shingles in a 72-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 26th October 2022, the patient received the 1st dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced shingles, scab and rash. On an unknown date, the outcome of the shingles, scab and rash were not recovered/not resolved.   It was unknown if the reporter considered the shingles, scab and rash to be related to Shingrix.     Additional Information: GSK Receipt Date: 21-FEB-2023 Reporter's Comment:  The reporter reported that the patient received dose of Shingrix vaccine. The reporter stated that after received Shingrix vaccine since then the patient experienced shingles disease and was about 2 weeks into the disease. The reporter stated that the patient still had scabbing from the rash. The reporter did consent to follow up.
Age: 26.0
Sex: F
Vaccine: COVID19
Symptoms: Chills
Clinical narrative: chills Narrative:
Sex: U
Vaccine: MMR
Symptoms: No adverse event, Underdose
Clinical narrative: administered Partial MMRII Dose specific to Corresponding 2nd MMRII Dose / '25%' MMRII Intended Dose; no adverse event; This spontaneous report was received from a nurse and refers to a patient of unknown age and gender.  The patient's pertinent medical history, concurrent conditions, drug reactions/allergies were not reported. Concomitant medications included varicella virus vaccine live (oka/merck) (VARIVAX) which the patient received on the same day as measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II).   On an unknown date, the patient was vaccinated with the first dose of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) subcutaneous injection (exact dose, strength, lot #, expiry date, route of administration) 25% intended dose, partial dose specific to corresponding second M-M-R II dose (Underdose) for prophylaxis. No additional adverse event (No adverse event) reported.
Sex: U
Vaccine: MMRV
Symptoms: Accidental underdose, No adverse event, Product administration error, Underdose
Clinical narrative: No additional AE reported; the patient moved and that caused the medication to squirt in the nurse's eye; the patient moved and that caused the medication to squirt in the nurse's eye; This spontaneous report has been received from a nurse and referring to a patient of unknown age and gender. The patient's medical history, current condition and concomitant medication were not provided.  On 16-FEB-2023, the nurse was administering measles, mumps, rubella and varicella (oka-merck) virus vaccine live (recombinant human albumin (rHA)) (PROQUAD) injection (lot number W028558, expiration date was reported as 06-MAR-2024; dose and route of administration were not reported) for prophylaxis to patient, and while the nurse was injecting the medication, patient moved and that caused the medication to squirt in the nurse's eye (product administration error, accidental underdose). Nurse stated that the patient received the full dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live (recombinant human albumin (rHA)) (PROQUAD) before it squirted out into the nurse's eye. No further information was provided. No additional adverse event (AE) or product quality complaint (PQC) were reported.  This is one of two reports from the same reporter.; Sender's Comments:  US-009507513-2302USA006030:MSD
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional AE or PQC reported.; VARIVAX was administered after a temperature excursion.; This spontaneous report was received from a nurse and referred to a patient of unknown age and gender. The patient's medical history, concurrent conditions, concomitant therapies, drug reactions and allergies were not reported.  On 02-FEB-2023, the patient was vaccinated with varicella virus vaccine live (oka/merck) (VARIVAX) subcutaneous injection, 0.5 milliliter(ml), lot #W012165, expiration date: 12-APR-2024, administered for prophylaxis (strength and route of administration were not provided). The administered varicella virus vaccine live (oka/merck) (VARIVAX) had a previous temperature excursion of minus 11.9 degree Celsus (C) for unknown time frame (product storage error). No additional adverse event (AE) was reported.
Sex: M
Vaccine: PPV
Symptoms: No adverse event, Wrong product administered
Clinical narrative: the patient has not reported any additional AE; PNEUMOVAX23 was inadvertently administered to a 77 year old patient on 2/13/2023 who had previously been administered PNEUMOVAX23 on 11/5/2020; patient was intended to receive Prevnar20; This spontaneous report was received from an office manager and refers to a 77-year-old male patient. The patient's pertinent medical history, drug reaction or allergies and concomitant therapies were not reported.  On 05-NOV-2020, the patient was vaccinated with pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) injection, administered for prophylaxis (dose, lot #, expiry date, route of administration and anatomical location were not provided).  On 13-FEB-2023, the patient was inadvertently vaccinated with an extra dose of pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) injection, 0.5 mL, lot # U025499, expiration date: 07-AUG-2023,  administered for prophylaxis (route of administration and anatomical location were not provided). The patient was intended to receive Pneumococcal 20-valent Conjugate Vaccine (PREVNAR 20) (Wrong product administered).No additional adverse events reported (No adverse event).
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: both doses 2018  and shingles 2022/Suspected vaccination Failure; shingles; This case was reported by a physician via sales rep and described the occurrence of vaccination failure in a adult 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 2nd dose of Shingrix and the 1st dose of Shingrix. In November 2022, more than 2 years 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 Information: GSK Receipt date: 03-Jan-2023. Reporter's Comment: The case was reported by patient who was physician. In 2018, patient received 1st and 2nd dose of Shingrix. In November 2022 the patient experienced shingles. The reporter consent to followup. Additional Supportive Information: This case was considered as suspected vaccination failure as details regarding laboratory test confirming shingles was unknown at the time of reporting.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: Had the shingles vaccine and still got shingles/Suspected vaccination failure; Got shingles; This case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure and shingles were unknown.   The reporter considered the vaccination failure and shingles to be possibly related to Shingrix.     Additional Information: GSK Receipt Date: 21-FEB-2023 Reporter's Comment: Reporter's Comment: This case was reported by a patient via interactive digital media. The reporter reported that his/her friend received Shingles vaccine. The reporter stated that the patient still got the shingles and so much for a vaccine, just like the Covid vaccine. Additional supportive information: This case was considered as suspected vaccination failure as details regarding completion of primary schedule, time to onset for shingles and laboratory confirmation regarding shingles were unknown at the time of reporting. Follow-up would not possible as no contact details were available.
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster, Neuralgia, Post herpetic neuralgia, Vaccination failure
Clinical narrative: nerve pain; After being vaccinated, had shingles, had the new one,Suspected vaccination Failure; Shingles an back and side, still got shingles; This case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix. In February 2022, unknown after receiving Shingrix, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the patient experienced post herpetic neuralgia. On an unknown date, the outcome of the vaccination failure was unknown and the outcome of the shingles and post herpetic neuralgia were not recovered/not resolved.   The reporter considered the vaccination failure, shingles and post herpetic neuralgia to be possibly related to Shingrix.     Additional Information: GSK Receipt Date: 21-FEB-2023 Reporter's Comments: This case was reported via interactive digital media. The patient got the shingles after getting vaccinated. The patient said she had shingles February of 2022 on her back and side, event after being vaccinated. The patient said she had new one and still got shingles. The patient still had nerve pain. Additional supportive information: This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule, time to onset and laboratory test confirming shingles were unknown at the time of reporting. Follow up would not possible, as no contact details were available.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: I've had the shots, still suffer the shingles/ Suspected Vaccination failure; Still suffer the shingles; This case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure and shingles were unknown.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine.     Additional Information: GSK Receipt date: 03-Jan-2023. Reporter's Comment: This case was reported by a consumer via interactive digital media. Patient had the shots,still suffer the shingles. Additional Supportive Information: This case was considered as suspected vaccination failure since the details regarding the completion of primary vaccination schedule, time to onset and laboratory confirmation of shingles were unknown at the time of reporting. Follow-up would not possible as no contact details were available.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: Got shots, then shingles/suspected vaccination failure; Shingles/Got shots, then shingles; This case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure and shingles were unknown.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingrix.     Additional Information: GSK Receipt Date: 22-FEB-2023 Reporter's Comment: The case was received from the patient via interactive digital media. The patient reported that shingles was what he/she got from shingrix shots. The patient stated fun times. Additional supportive information: This case was considered as suspected vaccination failure since the details regarding the completion of primary vaccination schedule, time to onset and laboratory confirmation of shingles were unknown at the time of reporting. The follow-up could not be possible as no contact details were available.
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: Took it and got it bad/suspected vaccination failure; Got it bad; This case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a male patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure and shingles were unknown.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine.     Additional Information: GSK Receipt Date: 21-FEB-2023 Reporter's comment: The case was received from the patient's wife via interactive digital media. The patient took it and got them bad. Additional supportive information: This case was considered as suspected vaccination failure as details regarding completion of primary schedule, time to onset for shingles and laboratory confirmation regarding shingles were unknown at the time of reporting. Follow-up could not be possible as no contact details were available.
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: Got shingles after the shot/Suspected vaccination failure; Got shingles after the shot for shingles event; This case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a male patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure and shingles were unknown.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine.     Additional Information: GSK Receipt Date: 23-Feb-2023 Reporter's Comments: The case was received from the consumer via interactive digital media. The reporter reported that the patient (reporter's father in law) got them after the jab, never had them before. Additional supportive information: This case was considered as suspected vaccination failure, since the details regarding primary schedule, time to onset for event and laboratory confirmation of shingles were not provided. The follow-up could not be possible as no contact details were available.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: Got shingles after Shot/Suspected vaccination failure; Shingles/Got shingles after Shot; This case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure and shingles were unknown.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine.     Additional Information: GSK receipt date: 23-Feb-2023 Reporter's comment: The case was received from the patient's friend via interactive digital media. The patient got the shingles after getting the shot. Additional supportive information: This case was considered as suspected vaccination failure since the details regarding the completion of primary vaccination schedule, time to onset and laboratory confirmation of shingles were unknown at the time of reporting. The follow-up could not be possible as no contact details were available.
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: Got shot, now shingles/Suspected vaccination failure; Shingles/ Now has shingles; This case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a female patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. In February 2023, unknown after receiving Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure and shingles were unknown.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine.     Additional Information: GSK receipt date: 23-Feb-2023 Reporter's comment: The case was received from the patient's husband via interactive digital media. The patient got the vaccine and now had shingles. Additional supportive information: This case was considered as suspected vaccination failure since the details regarding the completion of primary vaccination schedule, time to onset and laboratory confirmation of shingles were unknown at the time of reporting. The follow-up could not be possible as no contact details were available.
Sex: F
Vaccine: VARZOS
Symptoms: Myalgia, Pain
Clinical narrative: having pain throughout her body / pain/Sitting in a comfy chair would cause pain; could barely walk; unable to get up when squatting; fatigue; shingles; headaches; joint pain; Muscle pain; This case was reported by a consumer via patient support programs and described the occurrence of general body pain in a 65-year-old female patient who received mepolizumab (Nucala) solution for injection in pre-filled pen for drug use for unknown indication.   Co-suspect products included mepolizumab autoinjector device (Nucala Autoinjector Device) administration system for drug use for unknown indication and Herpes zoster (Shingrix) for prophylaxis.   Additional patient notes included Other Conditions were unknown .   In August 2022, the patient started Nucala at an unknown dose and frequency and Nucala Autoinjector Device. In June 2022, the patient received Shingrix. In 2022, less than 5 months after starting Nucala, an unknown time after starting Nucala Autoinjector Device and less than 6 months after receiving Shingrix, the patient experienced headache, joint pain and muscle pain. On 7th January 2023, the patient experienced activities of daily living impaired and fatigue. In January 2023, the patient experienced shingles. On an unknown date, the patient experienced general body pain and walking difficulty. The patient was treated with paracetamol (Tylenol). Nucala was continued with no change. On an unknown date, the outcome of the general body pain, headache, joint pain, muscle pain, activities of daily living impaired, fatigue, shingles and walking difficulty were unknown.   It was unknown if the reporter considered the general body pain, headache, joint pain, muscle pain, activities of daily living impaired, fatigue, shingles and walking difficulty to be related to Nucala, Nucala Autoinjector Device and Shingrix. This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   GSK receipt date: 09 Feb 2023 Reporter comments: Reason for no Batch / Lot number of Nucala was Unknown. Expiry Date of Nucala was Unknown. The patient mentioned she was very active before taking Nucala. Patient scared to take medication because she was nervous she would back to having pain throughout her body. Patient stated she got the Shingrix shot in June 2022, but 4 days later she got Shingles. Patient stated she did not take the 2nd dose per Provider request. Patient received first dose of Nucala in August. Patient began to experience headaches (Tylenol) and intermittent joint/muscle pain in November/December 2022. On 07 Jan 2023, stated she was unable to get up when squatting and fatigue had been immense. Patient stated Later patient was diagnosed with Shingles again in January. In January Patient stated Sitting in a comfy chair would cause pain and could barely walk. Patient complained because she was unable to speak with a Nurse regarding the side effects. The patient stated we could follow up with her if there were additional questions. Reporter consent to contact given as Yes.; Sender's Comments:  US-GSK-US2023021101:Same reporter
Sex: U
Vaccine: VARZOS
Symptoms: Feeling cold, Headache, Pain in extremity, Pyrexia
Clinical narrative: Fever; Headhache; Too cold; Many pain in arm; This case was reported by a consumer via call center representative and described the occurrence of fever in a patient who received Herpes zoster (Shingrix) for prophylaxis.   Concurrent medical conditions included immunosuppression.   On 17th February 2023, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced fever, headache, feeling cold and pain in arm. On an unknown date, the outcome of the fever, headache, feeling cold and pain in arm were unknown.   It was unknown if the reporter considered the fever, headache, feeling cold and pain in arm to be related to Shingrix.     Additional Information: GSK Receipt Date: 18-FEB-2023 Reporter's comment: The patient got 2nd dose of Shingrix vaccine past Friday and he/she had fever and headache for two or three days, too cold and many pain in arm. The patient enquired that how many time could to be this things in him/her, how many time could he/she had the problems for the vaccine?
Sex: F
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: Received 1st shot years ago, never received 2nd; This case was reported by a consumer via call center representative and described the occurrence of incomplete course of vaccination in a female patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Previously administered products included Shingles vaccine (1st dose received on an unknown date years ago).   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: 20-FEB-2023 Reporter's comment: The reporter reported that the patient never received the second dose.  The patient wanted to know that if she need to start again. Additional Supportive Information: Till the time of reporting, the patient did not receive 2nd dose of Shingrix, which led to incomplete course of vaccination.
Sex: U
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: 1st shot last Summertime, 2nd not received; This case was reported by a consumer 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 (1st dose received on an unknown date in last summertime).   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: 18-FEB-2023 Reporter's comment: The drug store said that they would call reporter when he/she need the second shot and they never did. The reporter enquired that he/she need to start over again, or do need just the second shot. Additional supportive information: Till the time of reporting, the patient did not receive 2nd dose of Shingrix, which led to incomplete course of vaccination.