chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 29.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Protein C deficiency, Protein deficiency, Pulmonary embolism, Pulmonary thrombosis, Rash
Clinical narrative: Was pregnant at time of vaccination. Only in 1st trimester, Maybe 6 weeks. After the shot I had extreme diarrhea till I was 16/17 weeks. Then I had a sever rash all over my face in the second trimester. All things I never experienced with my first pregnancy. I had extremely low potassium and magnesium to the point of needing medication at the ER. Delivered and she was 7.7 pounds. I was pregnant again, found out 1/20/2023 and went into cardiac arrest 1/21/2023. Confirmed non viable 2/9/2023 and took miscarriage medication 2/11/2023. I?ve never had a miscarriage before. Drs don?t know if I already had a PE on my lungs prior or from CPR my husband administered during my SCA. I?ve seen many drs and still cannot determine why this happened to me. I?m a perfectly healthy 30 year old with no family history of LQTS.
Age: 29.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Resuscitation
Clinical narrative: Was pregnant at time of vaccination. Only in 1st trimester, Maybe 6 weeks. After the shot I had extreme diarrhea till I was 16/17 weeks. Then I had a sever rash all over my face in the second trimester. All things I never experienced with my first pregnancy. I had extremely low potassium and magnesium to the point of needing medication at the ER. Delivered and she was 7.7 pounds. I was pregnant again, found out 1/20/2023 and went into cardiac arrest 1/21/2023. Confirmed non viable 2/9/2023 and took miscarriage medication 2/11/2023. I?ve never had a miscarriage before. Drs don?t know if I already had a PE on my lungs prior or from CPR my husband administered during my SCA. I?ve seen many drs and still cannot determine why this happened to me. I?m a perfectly healthy 30 year old with no family history of LQTS.
Age: 49.0
Sex: F
Vaccine: COVID19
Symptoms: Pain
Clinical narrative: the next day and for the next 3-4 days my body was in intense pain all over. it hurt to move at all.
Age: 49.0
Sex: F
Vaccine: COVID19
Symptoms: Mobility decreased, Musculoskeletal pain
Clinical narrative: same as the first....for 3-4 days after i suffered from intense musculoskeletal pain all over my body that made it difficult to move.
Age: 52.0
Sex: F
Vaccine: VARZOS
Symptoms: Asthenia, Cough, Dyspnoea, Feeling abnormal, Influenza like illness
Clinical narrative: Location of shot left arm tight and sore, fever of 102, heart palpitations, difficultly breathing, extremely painful, and itchy sores. Deep cough, Weak, flu like symptoms. Went to ER twice. Contacted doctor 7 days after shot. Message on chart to doctor:  Apr 26, 2023 Hi. I'm not feeling very good. I started the zpak last night. This cough is really bad. Is this a side effect from the vaccine? It's really bad Dr. I feel weak,nausea and my breathing.   No response from the doctor. I scheduled a follow up appt. Doctor kept telling me no its not from vaccine. That's wrong. I was not sick prior to shot. I was dealing with a staph infection and doctor insisted on shingrex vaccine while I had an active staph infection.    Every time I was seen after vaccination I would tell doctors and nurses, is this from the vaccine!? They all said it's possible or no. Their wrong. It is. Period. I know my body and the way I felt after this shot. It's going on 4 months now
Age: 52.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site discomfort, Injection site pain, Laboratory test, Malaise, Nausea
Clinical narrative: Location of shot left arm tight and sore, fever of 102, heart palpitations, difficultly breathing, extremely painful, and itchy sores. Deep cough, Weak, flu like symptoms. Went to ER twice. Contacted doctor 7 days after shot. Message on chart to doctor:  Apr 26, 2023 Hi. I'm not feeling very good. I started the zpak last night. This cough is really bad. Is this a side effect from the vaccine? It's really bad Dr. I feel weak,nausea and my breathing.   No response from the doctor. I scheduled a follow up appt. Doctor kept telling me no its not from vaccine. That's wrong. I was not sick prior to shot. I was dealing with a staph infection and doctor insisted on shingrex vaccine while I had an active staph infection.    Every time I was seen after vaccination I would tell doctors and nurses, is this from the vaccine!? They all said it's possible or no. Their wrong. It is. Period. I know my body and the way I felt after this shot. It's going on 4 months now
Age: 52.0
Sex: F
Vaccine: VARZOS
Symptoms: Pain, Palpitations, Pyrexia, Skin lesion
Clinical narrative: Location of shot left arm tight and sore, fever of 102, heart palpitations, difficultly breathing, extremely painful, and itchy sores. Deep cough, Weak, flu like symptoms. Went to ER twice. Contacted doctor 7 days after shot. Message on chart to doctor:  Apr 26, 2023 Hi. I'm not feeling very good. I started the zpak last night. This cough is really bad. Is this a side effect from the vaccine? It's really bad Dr. I feel weak,nausea and my breathing.   No response from the doctor. I scheduled a follow up appt. Doctor kept telling me no its not from vaccine. That's wrong. I was not sick prior to shot. I was dealing with a staph infection and doctor insisted on shingrex vaccine while I had an active staph infection.    Every time I was seen after vaccination I would tell doctors and nurses, is this from the vaccine!? They all said it's possible or no. Their wrong. It is. Period. I know my body and the way I felt after this shot. It's going on 4 months now
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Loss of personal independence in daily activities, Pain
Clinical narrative: all over body pain for 3-4 days after. made it difficult to do anything
Age: 11.0
Sex: F
Vaccine: MNQ
Symptoms: Incorrect dose administered, Product preparation issue
Clinical narrative: Menveo administration of liquid portion; Menveo administration of liquid portion; This non-serious case was reported by a nurse via call center representative and described the occurrence of inappropriate preparation of medication in a 11-year-old female patient who received Men ACWY-CRM NVS (Menveo) (batch number AMXA955a, expiry date MAY-2025) for prophylaxis.   On 16-JUN-2023, the patient received Menveo. On 16-JUN-2023, an unknown time after receiving Menveo, the patient experienced inappropriate preparation of medication (Verbatim: Menveo administration of liquid portion) and inappropriate dose of vaccine administered (Verbatim: Menveo administration of liquid portion). The outcome of the inappropriate preparation of medication and inappropriate dose of vaccine administered were unknown.   Additional Information: GSK Receipt Date: 16-JUN-2023 The nurse called in to report the administration of only the liquid component of Menveo to a patient.  The healthcare professional asked how to proceed with this patient. The reporter mentioned that expiration date of the dose administered was May 2025. The reporter consented to follow up. The patient received only liquid component of Menveo which led to inappropriate preparation of medication and inappropriate dose of vaccine administered.
Age: 0.83
Sex: M
Vaccine: UNK
Symptoms: Expired product administered, Medication error, Pyrexia
Clinical narrative: fever; patient received a dose of pentacel that expired; Initial information received on 30-Sep-2022 regarding an unsolicited valid non-serious case received from a physician.  This case involves a 10 months old male patient who was having fever and patient received a dose of pentacel (DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(VERO)/HIB(PRP/T) VACCINE [PENTACEL (VERO)] that expired.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On 29-Sep-2022, the patient received 0.5 ml third dose of suspect DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(VERO)/HIB(PRP/T) VACCINE (formulation, strength: unknown) lot number: UJ496AAA, expiration date: 09-Jul-2022, via intramuscular route in right vastus lateralis as Immunization  On 29-Sep-2022 the patient received a dose of pentacel that expired (expired product administered) (same day) following the administration of DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(VERO)/HIB(PRP/T) VACCINE.  On an unknown date the patient had fever (pyrexia) (unknown latency) following the administration of DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(VERO)/HIB(PRP/T) VACCINE.  Action taken was not applicable.  It was not reported if the patient received a corrective treatment for the events (fever, patient received a dose of pentacel that expired).  At time of reporting, the outcome was Unknown for all.  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.  Additional information received on 30-Sep-2022 from other health care professional: therapy details, therapy start date, batch number and expiry date updated for the suspect, event onset date updated for expired product administered, text amended accordingly
Age: 58.0
Sex: F
Vaccine: FLUR3
Symptoms: Erythema, Urticaria
Clinical narrative: Her shoulder and deltoid became red; Her shoulder and deltoid became red and welted; the welt measures about 10x 10 cm; Initial information received on 05-Oct-2022 regarding an unsolicited valid non-serious case received from a healthcare professional.  This case involves a 58-year-old female patient whose shoulder and deltoid became red and welted; the welt measures about 10x 10 cm while receiving vaccine INFLUENZA QUADRIVALENT RECOMBINANT VACCINE [FLUBLOK].  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  On an unknown date, the patient received suspect INFLUENZA QUADRIVALENT RECOMBINANT VACCINE (strength, formulation, dose, route, frequency: unknown) (lot number: UJ888AA and expiry date: 09-Jun-2023) in unknown administration site for Immunization.  On 04-Oct-2022, the patient developed non-serious events of, her shoulder and deltoid became red (erythema) and welted; the welt measures about 10x 10 cm (urticaria) (unknown latency) following the administration of INFLUENZA QUADRIVALENT RECOMBINANT VACCINE.  It was reported, she has the LOT and EXP for a product but is not sure what the product name is. Reporter mentioned that the product does not contain any egg which would make the product the FLUBLOK vaccine. Caller mentioned that an employee had a reaction to a preservative containing flu product last year, unknown which product manufacturer, and would like to know if the flu product they currently have has any preservative in it. Reported, that the employee received the product on 4Oct2022 and developed a localized reaction. It has not spread or gotten any worse. Caller also asked what other flu products if any does? She would like to know if a patient is greater than 50 years old which product should they receive? She would like to know if any other of the flu products are a preservative free product?   Action taken with QUADRIVALENT RECOMBINANT INFLUENZA VACCINE (FLUBLOK) was not applicable.  Corrective treatment: They are putting warm compresses for the events.  At time of reporting, the outcome was Unknown for both events.
Sex: U
Vaccine: VARZOS
Symptoms: Pruritus, Rash, Skin irritation
Clinical narrative: Spots on my backside; Itching; Irritation; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of rash in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine, the patient experienced rash (Verbatim: Spots on my backside), pruritus (Verbatim: Itching) and skin irritation (Verbatim: Irritation). The outcome of the rash, pruritus and skin irritation were not resolved.   It was unknown if the reporter considered the rash, pruritus and skin irritation to be related to Shingles vaccine.     It was unknown if the company considered the rash, pruritus and skin irritation to be related to Shingles vaccine.   Additional Information: GSK Receipt Date: 15-JUN-2023 This case was reported by a patient via interactive digital media. The patient got the shots and still got spots on backside/ 3 times now. Patient experienced just itching at first and then irritation and stated it will take forever to go away. Patient did not experienced pain. The follow-up could not be possible as no contact details were available.
Sex: U
Vaccine: COVID19-2
Symptoms: Expired product administered, No adverse event
Clinical narrative: No adverse event; Pharmacist is calling to report that several nursing home patients received expired Bivalent booster dose of Moderna COVID-19 vaccine; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Pharmacist is calling to report that several nursing home patients received expired Bivalent booster dose of Moderna COVID-19 vaccine) and NO ADVERSE EVENT (No adverse event) in an elderly patient of an unknown gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. AS7147B) for COVID-19 prophylaxis.     No Medical History information was reported.    On 31-May-2023, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On 31-May-2023, the patient experienced EXPIRED PRODUCT ADMINISTERED (Pharmacist is calling to report that several nursing home patients received expired Bivalent booster dose of Moderna COVID-19 vaccine). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Pharmacist is calling to report that several nursing home patients received expired Bivalent booster dose of Moderna COVID-19 vaccine) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for EXPIRED PRODUCT ADMINISTERED (Pharmacist is calling to report that several nursing home patients received expired Bivalent booster dose of Moderna COVID-19 vaccine).    This case was created for 11th patient of the 20 patients involved. Concomitant medication was not provided. Pharmacist called to report that several nursing home patients received expired Bivalent booster dose of Moderna COVID-19 vaccine, located in the freezer thawed.  They were all in intact carton. Vial size was 2.5 ml and had not underwent any temperature excursions. Treatment information was not reported.   This case was linked to US-MODERNATX, INC.-MOD-2023-727268 (Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-727268:Patient 3 out of 20
Age: 7.0
Sex: M
Vaccine: FLUR3
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: FLUBLOK being administered to 7 years old child, with no reported adverse event; Initial information received on 27-Sep-2022 regarding an unsolicited valid  non-serious case received from a other health professional.  This case involves a 7 years old male patient and it was reported that flublok(INFLUENZA QUADRIVALENT RECOMBINANT VACCINE) being administered to 7 years old child, with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On 23-Sep-2022, the patient received a  dose of 0.5 ml of suspect INFLUENZA QUADRIVALENT RECOMBINANT VACCINE, injection (strength: unknown) lot UJ887AA, expiry date: 09-Jun-2023, via intramuscular route in the right deltoid as Immunization.  On 23-SEP-2022 the flublok being administered to 7 years old child, with no reported adverse event (product administered to patient of inappropriate age) same day following the administration of INFLUENZA QUADRIVALENT RECOMBINANT VACCINE.  Action taken was not applicable.  It was not reported if the patient received a corrective treatment for the event (FLUBLOK being administered to 7 years old child, with no reported adverse event).  At time of reporting, the outcome was Unknown for the 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: 7.0
Sex: F
Vaccine: COVID19-2, HEP, IPV, MMRV, TDAP
Symptoms: Expired product administered
Clinical narrative: COVID-19 - MODERNA BIVALENT LOT #045H22A IM - LD - MEDICATION ERROR -  COVID VACCINE ADMINISTERED 3 DAYS past expiration date (Expiration Date-6/12/23) DOH and manufacturer MODERNA NOTIFIED ON - 6-15-2023 A response from the manufacturer (MODERNA) was received on 6/20/2023 An analysis of lot # 045H22A - showed that the vaccine was protective against (covid 19) virus at time of administration on 6/15/2023
Age: 7.0
Sex: F
Vaccine: COVID19-2, DTAPHEPBIP, MMRV
Symptoms: Expired product administered, Medication error
Clinical narrative: COVID 19 MODERNA BIVALENT VACCINE - LOT # 045H22A - MED ERROR - VACCINE ADMINISTERED 3 DAYS PAST - (EXPIRATION DATE - 6-12-23). STATE DOH AND MANUFACTURER NOTIFIED (MODERNA) ON - 6-15-2023.
Age: 5.0
Sex: F
Vaccine: DTAPIPV, MMRV
Symptoms: No adverse event, Product preparation error
Clinical narrative: Kinrix given w/out incident. Proquad vaccine mixed w/ Menveo liquid conjugate instead of sterile diluent. Proquad then administered subcutaneously in R arm. Error noticed when entering vaccine into state registry. Manufacturer called, diluents are not interchangeable. No adverse events or side effects noted, parents made aware. Patient r/sd in 4 wks to receive right dose of Proquad.
Age: 0.17
Sex: F
Vaccine: HIBV
Symptoms: Extra dose administered, Product administered to patient of inappropriate age
Clinical narrative: Hib: 22-MAR-2004, 04-JUN-2004, 12-AUG-2004, 11-APR-2005, 18-OCT-2005; Hib: 22-MAR-2004, 04-JUN-2004, 12-AUG-2004, 11-APR-2005, 18-OCT-2005; Hib: 22-MAR-2004, 04-JUN-2004, 12-AUG-2004, 11-APR-2005, 18-OCT-2005; This spontaneous report has been received from a licensed practical nurse, via medical records from a case in litigation for quadrivalent human papillomavirus (types 6,11,16,18) recomb. vaccine (GARDASIL)(2303USA000170), concerning a 6-month-old female patient. The patient's medical history, concurrent conditions and concomitant therapies prior to vaccinations were not reported.  On 22-MAR-2004, the patient was vaccinated with the first dose of haemophilus b conjugate vaccine (meningococcal protein conjugate) (manufacturer unknown) intramuscular injection (exact dose, strength, lot #, expiration date, site and route of administration were not provided) for prophylaxis. On 04-JUN-2004, the patient was vaccinated with the second dose of haemophilus b conjugate vaccine (meningococcal protein conjugate) (manufacturer unknown) intramuscular injection (exact dose, strength, lot #, expiration date, site and route of administration were not provided) for prophylaxis. On 12-AUG-2004, the patient was vaccinated with the third dose of haemophilus b conjugate vaccine (meningococcal protein conjugate) (manufacturer unknown) intramuscular injection (exact dose, strength, lot #, expiration date, site and route of administration were not provided) for prophylaxis (product administered to patient of inappropriate age). On 11-APR-2005, the patient was vaccinated with the fourth dose of haemophilus b conjugate vaccine (meningococcal protein conjugate) (manufacturer unknown) intramuscular injection (exact dose, strength, lot #, expiration date, site and route of administration were not provided) for prophylaxis (extra dose administered). On 18-OCT-2005, the patient was vaccinated with the fifth dose of haemophilus b conjugate vaccine (meningococcal protein conjugate) (manufacturer unknown) intramuscular injection (exact dose, strength, lot #, expiration date, site and route of administration were not provided) for prophylaxis (extra dose administered).  This is one of several reports regarding the same patient.  All available medical records will be provided upon request.; Sender's Comments:  US-009507513-2303USA000170:Original case 2303USA000170 US-009507513-2306USA000601:Split report 2306USA000601 US-009507513-2306USA000599:Spit report 2306USA000599
Age: 4.0
Sex: F
Vaccine: HEPA
Symptoms: Inappropriate schedule of product administration
Clinical narrative: Hep-A: 28-AUG-2008, 25-SEP-2015 09:46; This spontaneous report has been received from a licensed practical nurse, via medical records from a case in litigation for quadrivalent human papillomavirus (types 6,11,16,18) recomb. vaccine (GARDASIL)(2303USA000170), concerning an 11-year-old female patient. The patient's medical history, concurrent conditions and concomitant therapies prior to vaccinations were not reported.  On 28-AUG-2008, the patient was vaccinated with the first dose of with hepatitis a vaccine, inactivated (manufacturer unknown) intramuscular injection for prophylaxis (exact dose, strength, lot #, expiration date, site and route of administration were not provided) for prophylaxis. On 25-SEP-2015 at 09:46, the patient was vaccinated with the second dose of hepatitis a vaccine, inactivated (manufacturer unknown) intramuscular injection for prophylaxis (exact dose, strength, lot #, expiration date, site and route of administration were not provided) for prophylaxis (inappropriate schedule of product administration).   This is one of several reports regarding the same patient.  All available medical records will be provided upon request.; Sender's Comments:  US-009507513-2303USA000170:Original Case: 2303USA000170 US-009507513-2306USA000599:Split 2306USA000599 US-009507513-2306USA000600:Split 2306USA000600
Sex: U
Vaccine: VARCEL
Symptoms: Expired product administered, No adverse event, Product storage error
Clinical narrative: No symptoms reported. No further AE; HCP called to report an expired dose of VARIVAX was administered to Multiple patients.; Date of excursion: 3/2/2023; This spontaneous report as received from a pharmacist refers to a 12-month-old patient. No information on patient's medical history, current conditions and concomitant medications was provided.   On 14-JUN-2023 the patient was vaccinated with expired and improperly stored dose of varicella virus vaccine live (oka/merck) (VARIVAX) lot # W0252273 (not valid for varicella virus vaccine live (oka/merck) (VARIVAX), 0.5 milliliter for prophylaxis (dose number and route and site of administration were not provided) (expired product administered and product storage error and no adverse event).
Age: 1.0
Sex: U
Vaccine: VARCEL
Symptoms: Expired product administered, Product storage error
Clinical narrative: No symptoms reported; HCP called to report an expired dose of VARIVAX was administered to Multiple patients.; Date of excursion: 3/2/2023; This spontaneous report was received from a pharmacist referring to 1-year-old patient of unknown gender. Information about the patient's pertinent medical history, concurrent conditions, concomitant medications and drug reactions/allergies was not provided.  On 13-JUN-2023, the patient was vaccinated with improperly stored and expired dose of varicella virus vaccine live (Oka/Merck) (VARIVAX) injection (0.5 mL, lot #W0252273 was established as not valid, expiration date was reported as 02-JUN-2023, route of administration and anatomical location were not provided) for prophylaxis (Expired vaccine used, Improper storage of product in use).  On 02-MAR-2023, the suspect vaccine experienced a temperature excursion of 70 degrees Fahrenheit for 9 minutes. No symptoms reported (No adverse event). No further adverse event (AE) details. No product quality complaint (PQC).  This is one of multiple reports from the same reporter.
Age: 32.0
Sex: F
Vaccine: HPV4
Symptoms: Exposure during pregnancy, Wrong product administered
Clinical narrative: Email received in the Mailbox on 16JUN2023 at 3:58pm from a Merck employee reporting an adverse event for GARDASIL reported via website. Some fields marked "unknown" as they were unable to be asked. No letter sent as no consumer/physician dem; Wrong vaccine administered; This spontaneous, Social-Media report was received from a consumer refers to a 32-year-old female patient. The patient's medical history, concurrent conditions were not reported. The concomitant therapies included diphtheria vaccine toxoid, pertussis vaccine acellular, tetanus vaccine toxoid (TDAP).  On 16-JUN-2023, the patient was accidentally vaccinated with quadrivalent human papillomavirus (types 6,11,16,18) recomb. vaccine (GARDASIL) (lot #, expiration date, exact dose, route of administration and anatomical location were not reported) for prophylaxis.  It was reported that the 32 weeks pregnant patient was vaccinated with quadrivalent human papillomavirus (types 6,11,16,18) recomb. vaccine (GARDASIL), instead of diphtheria vaccine toxoid, pertussis vaccine acellular, tetanus vaccine toxoid (TDAP) because someone put the vaccine in the wrong place in the fridge (exposure during pregnancy, wrong product administered).
Age: 4.0
Sex: U
Vaccine: VARCEL
Symptoms: Expired product administered, No adverse event, Product storage error
Clinical narrative: No adverse event; HCP called to report an expired dose of VARIVAX was administered to Multiple patients. Patient Demographics provided for all patients, please see notes for additional case numbers. HCP gave permission to contact. No symptoms reported. No further AE d; Improper storage of product in use; This spontaneous report was received from a pharmacist refers to a 4-year-old patient of unknown gender. The patient's medical history, concurrent conditions and concomitant therapies were not reported.  On 12-JUN-2023, the patient was vaccinated with one dose of expired and improper storage varicella virus vaccine live (oka/merck)(VARIVAX), lot#: W0252273, expiration date reported as: 02-JUN-2023, 0.5 milliliter (route of administration and anatomical location were not provided) for prophylaxis.  On 02-MAR-2023, administered dose of vaccine was exposed to the temperature excursion of 70 degrees Fahrenheit for 9 minutes. There were no additional adverse events reported (expired product administered, product storage error, no adverse event).  Lot number W0252273 has been verified to be non-valid lot number for varicella virus vaccine live (oka/merck) (VARIVAX) and does not match any Company product.  This is one of several reports received from the same reporter.
Age: 0.5
Sex: F
Vaccine: PNC13, RV5, UNK
Symptoms: Febrile convulsion
Clinical narrative: febrile seizure; This spontaneous report has been received from a nurse practitioner and refers to a 6-month-old female patient. There was no information regarding the patient's medical history, concurrent conditions and concomitant medications provided.  On an unknown date, the patient was vaccinated with rotavirus vaccine, live, oral, pentavalent (ROTATEQ), oral liquid, administered orally (exact dose, dose number, lot # and expiration date were not reported), and diphtheria toxoid (+) hepatitis B virus vaccine rHBsAg (yeast) (+) Hib conj vaccine (OMPC) (+) pertussis acellular 5-component vaccine (+) poliovirus vaccine inactivated (Vero) (+) tetanus toxoid (VAXELIS) injection (dose, dose number, route of administration, anatomical location, lot # and expiration date were not reported), and pneumococcal vaccine conj 13V (CRM197) (PREVNAR 13) (formulation, dose, dose number, route of administration, anatomical location, lot # and expiration date were not reported), all for prophylaxis.  On an unspecified date, after vaccination, the patient experienced febrile seizure. The patient sought medical attention, she went to the emergency room the same night after receiving vaccination but did not get admitted to the hospital. The outcome of the event was not provided, however assessed as recovering as it was reported that the "patient was fine".  The causality between the event and the suspect vaccines was unknown. The reported stated that she did not know if the event was related to the suspect vaccines, a particular vaccine, or not related at all.
Age: 1.0
Sex: U
Vaccine: MMR, MMRV
Symptoms: No adverse event, Wrong product administered
Clinical narrative: No additional AE reported; Customer called and reported that they inadvertently administered PROQUAD to a 12 month old consumer when they were intending on administering MMR-II. No additional AE reported. No PQC reported. No additional information provided.; This spontaneous report was received from a medical assistant and refers to a 12-month-old patient of unknown gender. The patient's medical history, concurrent conditions, and concomitant therapies were not reported.  On 16-MAY-2023, the patient was inadvertently vaccinated with a dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) 0.5 ml, albumin status recombinant human albumin (rHA), lot #W036931, expiration date: 19-MAY-2024 (formulation, route and site of administration not provided) for prophylaxis, instead of the intended measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) vaccine (dose, formulation, route and site of administration, lot # and expiration date not provided) (wrong product administered). No additional adverse event (AE) reported (no adverse event). No product quality complaint (PQC) and no additional information provided.
Sex: U
Vaccine: VARZOS
Symptoms: Guillain-Barre syndrome, Pain
Clinical narrative: Guillain Barre; Also very painful; This serious case was reported by a consumer via interactive digital media and described the occurrence of guillain barre syndrome in an unspecified number of patients who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patients received Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine, the patient experienced guillain barre syndrome (Verbatim: Guillain Barre) (serious criteria GSK medically significant) and pain (Verbatim: Also very painful). The outcome of the guillain barre syndrome and pain were unknown.   It was unknown if the reporter considered the guillain barre syndrome and pain to be related to Shingles vaccine.     It was unknown if the company considered the guillain barre syndrome and pain to be related to Shingles vaccine.   Additional Information: GSK Receipt Date: 15-JUN-2023 This case was reported by a consumer via interactive digital media.  The reporter knew people have gotten Guillain Barre after getting the shot. Also very painful. The reporter wanted to know why get a shot that's not even keeping someone from still getting it.
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: still got severe shingles / suspected vaccination failure; still got severe shingles; This serious 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.   Co-suspect products included Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received the 2nd dose of Shingles vaccine and the 1st dose of Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine and Shingles vaccine, the patient experienced vaccination failure (Verbatim: still got severe shingles / suspected vaccination failure) (serious criteria GSK medically significant) and shingles (Verbatim: still got severe shingles). The outcome of the vaccination failure and shingles were unknown.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine and Shingles vaccine.     It was unknown if the company considered the vaccination failure and shingles to be related to Shingles vaccine and Shingles vaccine.   Additional Information: GSK Receipt Date:15-JUN-2023. This case was reported by a consumer via interactive digital media  The reporter stated that he received both the dose of Shingles vaccine still got severe shingles. The reporter stated that vaccine did not always work. This case was considered as suspected vaccination failure since details regarding time to onset and laboratory confirmation of shingles not reported. The follow up would not be possible.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Rheumatoid arthritis, Vaccination failure
Clinical narrative: got the shingles within a few months/suspected vaccination failure; Rheumatoid arthritis; I got the shingles; This serious 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, an unknown time after receiving Shingles vaccine, the patient experienced vaccination failure (Verbatim: got the shingles within a few months/suspected vaccination failure) (serious criteria GSK medically significant), shingles (Verbatim: I got the shingles) and rheumatoid arthritis (Verbatim: Rheumatoid arthritis) (serious criteria GSK medically significant). The outcome of the vaccination failure and shingles were unknown and the outcome of the rheumatoid arthritis was not reported.   It was unknown if the reporter considered the vaccination failure, shingles and rheumatoid arthritis to be related to Shingles vaccine.  It was unknown if the company considered the vaccination failure, shingles and rheumatoid arthritis to be related to Shingles vaccine.   Additional Information: GSK Receipt Date: 17-JUN-2023 This case was reported by a patient via interactive digital media. The patient got the shingles within a few months he/she ended up with RA (rheumatoid arthritis). This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule, time to onset and laboratory test confirming shingles were unknown at the time of reporting.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: I got vaccinated, a month later I got shingles/suspected vaccination failure; I got the shingles; This serious 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 month after receiving Shingles vaccine, the patient experienced vaccination failure (Verbatim: I got vaccinated, a month later I got shingles/suspected vaccination failure) (serious criteria GSK medically significant) and shingles (Verbatim: I got the shingles). The outcome of the vaccination failure was unknown and the outcome of the shingles was not reported.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine.   It was unknown if the company considered the vaccination failure and shingles to be related to Shingles vaccine.   Additional Information: GSK Receipt Date: 17-JUN-2023 This case was reported by a patient via interactive digital media. The patient got vaccinated with shingles vaccine and a month later he/she got shingles. 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.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Immune system disorder, Vaccination failure
Clinical narrative: Suspected Vaccination failure; still got shingles; immune system is terrible; This serious 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, an unknown time after receiving Shingles vaccine, the patient experienced vaccination failure (Verbatim: Suspected Vaccination failure) (serious criteria GSK medically significant), shingles (Verbatim: still got shingles) and immune system disorder (Verbatim: immune system is terrible). The outcome of the vaccination failure was unknown and the outcome of the shingles and immune system disorder were not resolved.   It was unknown if the reporter considered the vaccination failure, shingles and immune system disorder to be related to Shingles vaccine.     It was unknown if the company considered the vaccination failure, shingles and immune system disorder to be related to Shingles vaccine.   Additional Information: GSK Receipt Date: 18-JUN-2023 The case was received from the consumer interactive digital media. The patient had the Shingles vaccines and still got shingles.  The patient stated that he/she was sitting here with shingles now and his/her immune system was terrible. This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule, time to onset for shingles and laboratory confirmation regarding shingles were unknown at the time of reporting. The follow-up could not be possible as no contact details were available.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Pain, Vaccination failure
Clinical narrative: still have shingles/suspected vaccination failure; Shingles; painful; This serious 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, an unknown time after receiving Shingles vaccine, the patient experienced vaccination failure (Verbatim: still have shingles/suspected vaccination failure) (serious criteria GSK medically significant), shingles (Verbatim: Shingles) and pain (Verbatim: painful). The outcome of the vaccination failure was unknown and the outcome of the shingles and pain were not resolved.   It was unknown if the reporter considered the vaccination failure, shingles and pain to be related to Shingles vaccine.     It was unknown if the company considered the vaccination failure, shingles and pain to be related to Shingles vaccine.   Additional Information: GSK Receipt Date: 17-JUN-2023 The case was received from the consumer interactive digital media. The patient had vaccines and still had shingles and it was very very painful. This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule, time to onset for shingles and laboratory confirmation regarding shingles were unknown at the time of reporting. The follow-up could not be possible as no contact details were available.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: had the shot have shingles now light case/suspected vaccination failure; Shingles; This serious 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, an unknown time after receiving Shingles vaccine, the patient experienced vaccination failure (Verbatim: had the shot have shingles now light case/suspected vaccination failure) (serious criteria GSK medically significant) and shingles (Verbatim: Shingles). The outcome of the vaccination failure was unknown and the outcome of the shingles was not resolved.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine.     It was unknown if the company considered the vaccination failure and shingles to be related to Shingles vaccine.   Additional Information: GSK Receipt Date: 17-JUN-2023 This case was reported by a patient via interactive digital media. The patient reported that he or she received Shingles vaccine and now experienced light case of shingles. The patient stated that Shingles vaccine did not stop you from getting the shingles but would not be as bad. 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: U
Vaccine: VARZOS, VARZOS, VARZOS
Symptoms: Extra dose administered, Herpes zoster, Vaccination failure
Clinical narrative: Suspected vaccination failure; Shingles; had 3shots; This serious 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.   Co-suspect products included Herpes zoster (Shingles vaccine) for prophylaxis and Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received the 3rd dose of Shingles vaccine, the 2nd dose of Shingles vaccine and the 1st dose of Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine, Shingles vaccine and Shingles vaccine, the patient experienced vaccination failure (Verbatim: Suspected vaccination failure) (serious criteria GSK medically significant), shingles (Verbatim: Shingles) and extra dose administered (Verbatim: had 3shots). The outcome of the vaccination failure and extra dose administered were unknown and the outcome of the shingles was not resolved.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine, Shingles vaccine and Shingles vaccine.  It was unknown if the company considered the vaccination failure and shingles to be related to Shingles vaccine, Shingles vaccine and Shingles vaccine.   Additional Information: GSK Receipt Date: 19-JUN-2023 This case was reported by a patient via interactive digital media. The reporter stated that all together he/she had the three shingles shots and he/she had shingles now. The reporter further stated that it might be more severe if he/she did not. 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. The patient had three shingles shots of shingles vaccine, which led to extra dose administered.
Sex: F
Vaccine: VARZOS
Symptoms: C-reactive protein increased, Pain, Red blood cell sedimentation rate increased, Swelling
Clinical narrative: pain; swelling; elevated KRP; elevated ESR; This non-serious case was reported by a consumer via sales rep and described the occurrence of pain in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced pain (Verbatim: pain), swelling (Verbatim: swelling), c-reactive protein increased (Verbatim: elevated KRP) and erythrocyte sedimentation rate increased (Verbatim: elevated ESR). The outcome of the pain, swelling, c-reactive protein increased and erythrocyte sedimentation rate increased were not reported.   It was unknown if the reporter considered the pain, swelling, c-reactive protein increased and erythrocyte sedimentation rate increased to be related to Shingrix.     It was unknown if the company considered the pain, swelling, c-reactive protein increased and erythrocyte sedimentation rate increased to be related to Shingrix.   Additional Information: GSK receipt date: 20-Jun-2023 The patient received Shingrix, 2nd dose 1 year prior to the reporting and reported pain, swelling and elevated C-reactive protein (CRP) and Erythrocyte sedimentation rate (ESR) The reporter did not agree to follow up from GlaxoSmithKline.
Sex: F
Vaccine: DTAPIPV
Symptoms: Expired product administered
Clinical narrative: administered an expired dose of Kinrix; This non-serious case was reported by a nurse via call center representative and described the occurrence of expired vaccine used in a female patient who received DTPa-IPV (Kinrix) (batch number H99J7) for prophylaxis.   On an unknown date, the patient received Kinrix. On an unknown date, an unknown time after receiving Kinrix, the patient experienced expired vaccine used (Verbatim: administered an expired dose of Kinrix). 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: 14-Jun-2023 A registered nurse called in to report that medical assistant accidentally administered an expired dose of Kinrix and wished to know how to proceed further. The patient was administered with expired vaccine of Kinrix, which led to expired vaccine used. The reporter consented to follow up.
Sex: U
Vaccine: VARZOS
Symptoms: Limb discomfort
Clinical narrative: have issues with my arm; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of arm discomfort in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine, the patient experienced arm discomfort (Verbatim: have issues with my arm). The outcome of the arm discomfort was not resolved.   It was unknown if the reporter considered the arm discomfort to be related to Shingles vaccine.     It was unknown if the company considered the arm discomfort to be related to Shingles vaccine.   Additional Information: GSK Receipt date:16-JUN-2023 The case was received from  the patient via interactive digital media. The patient received first Shingles vaccine over three months ago and still had issues with his/her arm.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: we had the shingles; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of shingles in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, 2 weeks after receiving Shingles vaccine, the patient experienced shingles (Verbatim: we had the shingles). The outcome of the shingles was not reported.   It was unknown if the reporter considered the shingles to be related to Shingles vaccine.     It was unknown if the company considered the shingles to be related to Shingles vaccine.   Additional Information: GSK receipt date: 16-Jun-2023 This case was reported the patient via interactive digital media. The patients got the shot, and two weeks later had the shingles, never again the patient would receive one. Follow-up not possible as no contact details provided. This case has been linked with case US2023AMR085308 reported by same reporter.; Sender's Comments:  US-GSK-US2023AMR085308:same reporter