chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 0.5
Vaccine: HPV9
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: no AE; GARDASIL 9 was administered to a 6-month-old patient; This spontaneous report was received from a Physician and refers to a 6-month-old patient of unknown gender.   The patient's medical history was not reported. The patient's concurrent conditions were not reported. Concomitant therapies were not reported.   On 19-Feb-2025, the patient started therapy with Human Papillomavirus 9-valent Vaccine, Recombinant (GARDASIL 9) (lot #Y000206, expiration date: 23-Sep-2026) 0.5 mL for prophylaxis.  On 19-Feb-2025, the patient was vaccinated GARDASIL 9 (inappropriate age at vaccination). No adverse events reported.
Age: 1.0
Sex: M
Vaccine: HEPA, HIBV, MMR, VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: no adverse event; Caller reported VARIVAX administered after temperature excursion.  No other information provided.          ?    Names of vaccines involved (including lot/exp) VARIVAX  Y015108  9/6/2026        ?    Temperature (-2.1C)         ?    Time frame  6; This spontaneous report was received from a Other health professional and refers to a patient of unknown age and gender.   The patient's medical history was not reported. The patient's concurrent conditions were not reported. Concomitant therapies were not reported.   On 06-Feb-2025, the patient started therapy with Varicella Virus Vaccine Live (Oka-Merck) (VARIVAX), (lot #Y015108, expiration date: 06-Sep-2026) for prophylaxis. On 06-Feb-2025, the patient started therapy with sterile diluent (BAXTER STERILE DILUENT), for prophylaxis (lot # and expiration date were not reported). This vaccine underwent temperature excursion in -2.1 degree Celsius for 6 hours 45 minutes (Product storage error).  Follow up information has been received on 06-FEB-2025. The patient experienced no adverse event. The route of administration for Varicella Virus Vaccine Live (Oka-Merck) (VARIVAX) was subcutaneously in the right arm. On the same date, the subject was vaccinated with improperly stored doses of Measles, Mumps, and Rubella (Wistar RA 27-3) Virus Vaccine, Live lyophilisate (MMR-II) injection, subcutaneously in the left arm, lot number Y008290 which has been verified to be valid, expiration date reported and validated as 24-APR-2026 (doe, scheme, strength not provided). The patient was vaccinated with HIB vaccine conj (tet tox) (HIBERIX), intramuscular , left thigh, lot number 437EK, expiration date reported as 13-JUL-2026. Consequently, the patient was vaccinated with Hepatitis A vaccine (HARVIX) intramuscularly in the right thigh, lot number T5727, expiration date 05-MAY-2026 (doses, formulations, strengths not provided).
Age: 4.0
Sex: M
Vaccine: UNK
Symptoms: No adverse event, Product storage error
Clinical narrative: no additional AE; received improperly stored PROQUAD since it "was stored in the refrigerator for months" instead of the freezer; This spontaneous report was received from a Nurse and refers to a(n) 4-year-old male patient.   The patient's medical history was not reported. The patient's concurrent conditions were not reported. Concomitant medications included Diphtheria and Tetanus Toxoids and Acellular Pertussis Vaccine Adsorbed, Inactivated Poliovirus (VAXELIS) Havrix (Hepatitis a vaccine inact), Fluarix quadrivalent (Influenza vaccine inact split 4v).  On 02-Dec-2024, the patient was vaccinated with improperly stored Measles, Mumps, Rubella and Varicella (Oka-Merck) Virus Vaccine Live (PROQUAD), Injection (lot #Y013583, expiration date: 03-Feb-2026), dose number 2, administered by subcutaneous route in Left Thigh together with sterile diluent (MERCK STERILE DILUENT) (expiration date, and lot # were not reported) as prophylaxis.   The suspect vaccine "was stored in the refrigerator for months" instead of the freezer (incorrect product storage). There was no additional AE (no adverse event). Temperature excursion was reported as "Total time in the range 15°F to 46°F (-9°C to 8°C): 1488" (time units not reported).; Sender's Comments: Priority : 5 , Is case serious : No , Index user : @merck.com , Index date : 2025-02-26 , MNSC number : , CLIC number : , ESTAR number : , IRMS number : 10/xx/2020 , Central date : 2025-02-20 , Classification : DMC, Attachment description : Post Marketing Basic , Safety case number :
Age: 4.0
Sex: F
Vaccine: MMR
Symptoms: Device connection issue, Granuloma skin, Needle issue
Clinical narrative: The HCP stated the needle stayed in the patient; No other adverse issues or side effects were reported related to the incident.; It was unknown if the patient got the full dose and the physician plans to check titers going forward; This spontaneous report was received from a Nurse and refers to a 4-year-old female patient.   The patient's medical history was not reported. The patient's concurrent conditions were not reported. Concomitant therapies were not reported.  On 20-Feb-2025, the patient was vaccinated with Measles, Mumps, and Rubella (Wistar RA 27-3) Virus Vaccine, Live (M-M-R II), (lot #Y011709, expiration date: 02-Jul-2026) 0.5 mL (0.5mL / once), with sterile diluent (lot #2050911, expiration date: 11-Feb-2027) 0.5 mL (0.5mL / once), injection administered by Unknown route. This was a routine vaccination for 4-year check up. The nurse reported that the hub/luer lock on the sterile diluent syringe became loose causing the needle to fall off. She stated when trying to screw the needle on tight, it caused the hub to become loose and detach (captured in Case# 2260119).  The nurse stated the needle stayed in the patient after she administered the injection (Needle issue) and a "few drops" splattered in her (nurse's) face, in which she had to flush her face and eyes (Nurse's report captured in Case# 2260119). It was unknown if the patient got the full dose and it was reported that the physician planned to check titers going forward (Underdose). It was also unknown what amount splattered onto the HCP (nurse's) face/eyes. The nurse and patient were not injured during the incident, the needle was removed easily and quickly without concern of sanitation issues, and no other medical attention was required. No other adverse issues or side effects were reported related to the incident (No adverse event).;
Age: 14.0
Sex: F
Vaccine: MMRV
Symptoms: No adverse event, Product storage error
Clinical narrative: No adverse event; A HCP called to report a TE for PROQUAD that occurred on 02/23/2025 and was also inadvertently administered on 02/25/2025. The HCP stated the patient did not experience any adverse issues or side effects related to the administered dose.  Please also; This spontaneous report has been received from a registered nurse (R.N), regarding a 12-year-old female patient.  The patient's pertinent medical history, concurrent conditions, concomitant therapies, and previous drug reactions or allergies were not reported. On 23-FEB-2025, it was stated that a temperature excursion occurred for measles, mumps, rubella and varicella (oka-merck) virus vaccine live lyophilisate and solvent for solution for injection (PROQUAD), after a temperature excursion of 54 degree Fahrenheit (F) during a time frame of 13 hours with 10 minutes; thus on 25-FEB-2025 the patient was inadvertently vaccinated with an improperly stored dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live lyophilisate and solvent for solution for injection (rHA [recombinant Human albumin])  (PROQUAD) 0.5 mL, administered as prophylaxis (Lot No. Y010292 has been verified to be a valid lot number for [measles, mumps, rubella and varicella (oka-merck) virus vaccine live lyophilisate and solvent for solution for injection], expiration date reported and upon internal validation established as 01-DEC-2025) (strength, dose number, route and anatomical location of administration and vaccination scheme frequency were not provided) that was reconstituted with sterile diluent solution for injection (BAXTER STERILE DILUENT) (Lot No., expiration date and route of administration were not provided) (product storage error). Previous temperature excursions were not provided. No additional adverse event was reported (no adverse event).
Vaccine: HEP
Symptoms: Needle issue
Clinical narrative: no additional AE; was preparing 1 RECOMBIVAX HB (NDC 0006-4094-02) prefilled syringe for administration when the luer lock detached while trying to attach the needle to the syringe.; Medical assistant called stating another medical assistant at their facility was preparing 1 RECOMBIVAX HB (NDC 0006-4094-02) prefilled syringe for administration when the luer lock detached while trying to attach the needle to the syringe. Caller an; Event Medical assistant called stating another medical assistant at their facility was preparing 1 RECOMBIVAX HB (NDC 0006-4094-02) prefilled syringe for administration when the luer lock detached while trying to attach the needle to the syringe.; Medical assistant called stating another medical assistant at their facility was preparing 1 RECOMBIVAX HB (NDC 0006-4094-02) prefilled syringe for administration when the luer lock detached while trying to attach the needle to the syringe.; This spontaneous report was received from a medical assistant and refers to a patient of unknown age and gender. The patient's medical history, concurrent conditions, concomitant therapies, drug reactions or allergies were not reported.   On 12-MAR-2025, the patient was vaccinated with one dose of Hepatitis B Vaccine (Recombinant) (RECOMBIVAX) (valid lot number Y009436, expiration date: 12-FEB-2027) for prophylaxis (dose, dose number, anatomical location, route of administration was not provided). Medical assistant called stating another medical assistant at their facility was preparing one of Hepatitis B Vaccine (Recombinant) (RECOMBIVAX) prefilled syringe for administration (product preparation issue) when the luer lock detached while trying to attach the needle to the syringe (syringe issue, device issue). Caller stated the medical assistant attached a new needle to the syringe without the luer lock and administered the product to the patient without further issue (poor quality device used). Caller stated no patient symptoms have been reported. Caller stated the product was discarded after use so was not available for return however pictures were taken which they would send in. Caller declined needing a replacement for this product.  No additional adverse event (AE) reported.
Sex: F
Vaccine: HPV4, HPV9
Symptoms: Immediate post-injection reaction, Syncope
Clinical narrative: an adolescent female patient that was vaccinated with first dose of GARDASIL or GARDASIL 9 on unknown date, had tried to get up right after receiving it and fainted and went down; an adolescent female patient that was vaccinated with first dose of GARDASIL or GARDASIL 9 on unknown date, had tried to get up right after receiving it and fainted and went down; This spontaneous report was received from a Consumer or other non health professional and refers to an Adolescent female patient.   The patient's medical history was not reported. The patient's concurrent conditions were not reported. Concomitant therapies were not reported.   On an unknown date, the patient was vaccinated with the first dose of Quadrivalent Human Papillomavirus (Types 6, 11, 16, 18) Recombinant Vaccine (GARDASIL) or Human Papillomavirus 9-valent Vaccine, Recombinant (GARDASIL®9) (unconfirmed which one) (dose, units, route of administration, lot#, and expiration date were not reported) for prophylaxis.  The patient had tried to get up right after receiving it and fainted and went down. The outcome of the events was not reported.  The causality between the events and suspect vaccine was not provided.  Upon internal review, the event of syncope was considered to be medically significant.  Lot# is being requested and will be submitted if received.
Vaccine: HIBV
Symptoms: Inappropriate schedule of product administration, No adverse event
Clinical narrative: No symptomatic adverse events were reported; HCP called to state that the patient received a third dose of PEDVAXHIB at 6 months of age.; This spontaneous report was received from a Nurse regarding a 6-month-old patient of unknown gender.   The patient's medical history, concurrent conditions, concomitant therapies, past drug reactions and allergies were not reported.   On 16-JAN-2025, at 6 months of age, the patient was vaccinated with the third dose of Haemophilus b Conjugate Vaccine (Meningococcal Protein Conjugate) (LIQUID PEDVAX HIB) 0.5ml/series, administered as prophylaxis (lot number y003144 has been verified to be a valid number for Haemophilus b Conjugate Vaccine (Meningococcal Protein Conjugate) [LIQUID PEDVAX HIB], expiration date 11-SEP-2026; anatomical site of injection, formulation and route of administration were not reported) (Inappropriate schedule of product administration). No symptomatic adverse events were reported (no adverse event).  This is one of several reports from the same reporter.
Sex: F
Vaccine: HEP
Symptoms: Inappropriate schedule of product administration, No adverse event
Clinical narrative: Received First Dose of HEPLISAV-B on 09/10/2024 and Second Dose of the Series Engerix-B on 10/10/2024; Initial report received on 10-Mar-2025.  A pharmacist reported that a female patient received HEPLISAV-B (hepatitis B vaccine) for the first dose of hepatitis B immunization and received ENGERIX-B for the second dose of the series. Medical history included an allergy to amoxicillin (unknown reaction).  No concomitant medications were reported.     On 10-Sep-2024, the patient received dose 1 of a hepatitis B vaccine [HEPLISAV-B (lot number 943187, expiration date 30-Nov-2025, and NDC 43528-003-05)] intramuscularly in the left deltoid.   On 10-Oct-2024, 31 days after receiving HEPLISAV-B, the patient received dose 2 of a hepatitis B vaccine [ENGERIX-B (lot number, expiration date, route, and site not available)].  The patient had no side effects.  No other information was available.   Company Comment:  The company assessed the event as non-serious.; Sender's Comments: The company assessed the event as non-serious.
Sex: M
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: consumer had his first dose of SHINGRIX approximately two yaers ago; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in a 70-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (consumer had his first dose of SHINGRIX approximately two years ago).   On an unknown date, the patient did not receive the 2nd dose of Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced incomplete course of vaccination (Verbatim: consumer had his first dose of SHINGRIX approximately two yaers ago). The outcome of the incomplete course of vaccination was not applicable.   Additional Information: GSK Receipt Date : 11-MAR-2025 Reporter reported that he had his first dose of SHINGRIX approximately two years ago. Till the time of reporting, the patient did not receive 2nd dose of Shingrix, which led to incomplete course of vaccination.
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: 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 adult 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 vaccination failure (Verbatim: Suspected vaccination failure) (serious criteria GSK medically significant) and shingles (Verbatim: Shingles). The outcome of the vaccination failure was not reported and the outcome of the shingles was unknown.   The reporter considered the vaccination failure and shingles to be related to Shingrix.     The company considered the vaccination failure and shingles to be unrelated to Shingrix.   Additional Information: GSK Receipt Date: 07-MAR-2025 This case was reported by a patient via interactive digital media. Consumer reported that got the vaccine and got shingles anyway and her friends at church and discovered most who had shingles also had the vaccine. 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.; Sender's Comments: Vaccination failure is a listed event which, due to the following criteria (insufficient information provided about the clinical description, details regarding the completion of primary vaccination schedule, time to onset and laboratory confirmation of disease) is considered unrelated to GSK Shingrix.  Herpes zoster is an unlisted event which is considered unrelated to GSK Shingrix.
Vaccine: VARZOS
Symptoms: Lethargy, Pain in extremity
Clinical narrative: sore arm; lethargy; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of pain in arm in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received the 2nd dose of Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine, the patient experienced pain in arm (Verbatim: sore arm) and lethargy (Verbatim: lethargy). The outcome of the pain in arm and lethargy were not reported.   It was unknown if the reporter considered the pain in arm and lethargy to be related to Shingles vaccine.     It was unknown if the company considered the pain in arm and lethargy to be related to Shingles vaccine.   Additional Information: GSK Receipt Date: 05-MAR-2025 This case was reported by a patient via interactive digital media. The follow-up could not be possible as no contact details were available. Patient had the second half of the vaccine and  stated that it did pack a wallop. Patient experienced sore arm, lethargic, but said it was manageable and was much less painful than getting shingles.
Vaccine: VARZOS
Symptoms: Hypersensitivity
Clinical narrative: severe allergy in the upper part of my body; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of allergy in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On 04-MAR-2025, the patient received Shingles vaccine. On 05-MAR-2025, 1 days after receiving Shingles vaccine, the patient experienced allergy (Verbatim: severe allergy in the upper part of my body). The outcome of the allergy was not reported.   It was unknown if the reporter considered the allergy to be related to Shingles vaccine.     It was unknown if the company considered the allergy to be related to Shingles vaccine.   Additional Information: GSK Receipt Date: 07-MAR-2025 This case was reported by a patient via interactive digital media. The patient got Shingles vaccine since then have had a severe allergy in the upper part of body.
Age: 75.0
Sex: F
Vaccine: VARZOS
Symptoms: Inappropriate schedule of product administration
Clinical narrative: late second dose; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of drug dose administration interval too long in a 75-year-old female patient who received Herpes zoster (Shingrix) (batch number 3334y, expiry date 25-MAR-2027) for prophylaxis.   Previously administered products included Shingrix (Patient received first dose in DEC-2020).   On 04-MAR-2025, the patient received the 2nd dose of Shingrix. On 04-MAR-2025, an unknown time after receiving Shingrix, the patient experienced drug dose administration interval too long (Verbatim: late second dose). The outcome of the drug dose administration interval too long was not applicable.   Additional Information: GSK Receipt Date: 04-MAR-2025 Pharmacist reported that patient received 1st dose of Shingrix in DEC-2020 and received 2nd dose on 4-MAR-2025. The patient received 2nd dose of Shingrix, later than the recommended interval, which led to lengthening of vaccinations schedule.
Age: 8.0
Sex: M
Vaccine: HEPA
Symptoms: Expired product administered
Clinical narrative: administered an expired dose of Havrix; This non-serious case was reported by a other health professional via call center representative and described the occurrence of expired vaccine used in a 8-year-old male patient who received HAV (Havrix) (batch number 2YS34, expiry date 02-MAR-2025) for prophylaxis.   Previously administered products included Havrix (Received 1st dose of vaccine on 27-AUG-2024 (Lot number 423NL and expiration date 16 November 2025 )).   On 04-MAR-2025, the patient received the 2nd dose of Havrix. On 04-MAR-2025, an unknown time after receiving Havrix, the patient experienced expired vaccine used (Verbatim: administered an expired dose of Havrix). The outcome of the expired vaccine used was not applicable.   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: 04-MAR-2025 Medical assistant reported that they accidentally administered an expired dose of Havrix on 04 March 2025 which led to expired vaccine administered. The dose was expired on 02 March 2025. The patient got a first dose of Havrix on 27 August 2024. Consented to follow up.
Age: 47.0
Sex: F
Vaccine: HEP
Symptoms: Underdose
Clinical narrative: a pediatric dose of Engerix-B was given to an adult patient; a pediatric dose of Engerix-B was given to an adult patient; This non-serious case was reported by a nurse via call center representative and described the occurrence of underdose in a 47-year-old female patient who received HBV (Engerix B pediatric) (batch number 95D74, expiry date 28-MAR-2025) for prophylaxis.   On 24-FEB-2025, the patient received Engerix B pediatric. On 24-FEB-2025, an unknown time after receiving Engerix B pediatric, the patient experienced underdose (Verbatim: a pediatric dose of Engerix-B was given to an adult patient) and adult use of a child product (Verbatim: a pediatric dose of Engerix-B was given to an adult patient). The outcome of the underdose and adult use of a child product were not applicable.   Additional Information: GSK Receipt Date : 05-MAR-2025 Nurse called on March 5, 2025 to report on February 24, 2025 a pediatric dose of Engerix-B was given to an adult patient which led to adult use of a child product and underdose.
Vaccine: MMR
Symptoms: Product storage error
Clinical narrative: had accidentally been exposed to 13.9 degree Fahrenheit/ accidentally administered to six pediatric patients; This non-serious case was reported by a nurse via call center representative and described the occurrence of incorrect storage of drug in specified number of pediatric patients who received MMR (Priorix) (batch number JE9GP, expiry date 01-SEP-2025) for prophylaxis.   On an unknown date, the specified number of pediatric patients received Priorix. On an unknown date, an unknown time after receiving Priorix, the patient experienced incorrect storage of drug (Verbatim: had accidentally been exposed to 13.9 degree Fahrenheit/ accidentally administered to six pediatric patients). The outcome of the incorrect storage of drug was not applicable.   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: 06-MAR-2025 A nurse practitioner contacted the GSK to report that Priorix vaccine had accidentally been exposed to 13.9 degree Fahrenheit for what would seem a period of one month but the health care professional was uncertain if this was true and accidentally administered to six pediatric patients which led to incorrect storage of drug.  The health care professional did not their age gender or initials.  Follow up was consented to for this case and they requested thermostability data and clinical recommendations, receiving the standard response letter and the contact information for the CDC immunization hotline.
Age: 57.0
Sex: F
Vaccine: RSV
Symptoms: Pneumonia, Product administered to patient of inappropriate age
Clinical narrative: Pneumonia; Take Arevxy at 57 years; This serious case was reported by a nurse via call center representative and described the occurrence of pneumonia in a 57-year-old female patient who received RSVPreF3 adjuvanted (Arexvy) for prophylaxis.   On 30-NOV-2023, the patient received Arexvy. On 30-NOV-2023, an unknown time after receiving Arexvy, the patient experienced inappropriate age at vaccine administration (Verbatim: Take Arevxy at 57 years). On an unknown date, the patient experienced pneumonia (Verbatim: Pneumonia) (serious criteria GSK medically significant). The outcome of the pneumonia was resolved and the outcome of the inappropriate age at vaccine administration was not applicable.   It was unknown if the reporter considered the pneumonia to be related to Arexvy.     The company considered the pneumonia to be unrelated to Arexvy.   Additional Information: GSK Receipt Date: 07-MAR-2025 A registered nurse reported a patient that probably received Arexvy on 30 November 2023, at 57 years which led to Inappropriate age at vaccine administration, but there was no certainty of it due to an incomplete paperwork fulfillment. Then, the patient came back to their facility with a previous case of pneumonia (already treated) and the registered nurse wondered if she could administer Arexvy to her. The Vaccine Administration Facility was the same as Primary Reporter.; Sender's Comments: Pneumonia is an unlisted event which is considered unrelated to GSK vaccine Arexvy.
Age: 54.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Fatigue, Headache, Injection site erythema, Injection site induration
Clinical narrative: Shingrix allergic reaction to first dose; Headache; Fatigue; Chills; Soreness at the injection site; Hardness at the injection site.; Bumpy rash five inches away of the injection site; Erythema five inches away of the injection site/Rubor five inches away of the injection site; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of allergic reaction in a 54-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   The patient's past medical history included shingles (when she was 40 years prior to receipt of Shingrix).   On 21-FEB-2025, the patient received Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced allergic reaction (Verbatim: Shingrix allergic reaction to first dose), headache (Verbatim: Headache), fatigue (Verbatim: Fatigue), chills (Verbatim: Chills), injection site pain (Verbatim: Soreness at the injection site), injection site induration (Verbatim: Hardness at the injection site.), papular rash (Verbatim: Bumpy rash five inches away of the injection site) and erythema (Verbatim: Erythema five inches away of the injection site/Rubor five inches away of the injection site). The outcome of the allergic reaction, headache, fatigue, chills, injection site pain, injection site induration, papular rash and erythema were unknown.   It was unknown if the reporter considered the allergic reaction, headache, fatigue, chills, injection site pain, injection site induration, papular rash and erythema to be related to Shingrix.     It was unknown if the company considered the allergic reaction, headache, fatigue, chills, injection site pain, injection site induration, papular rash and erythema to be related to Shingrix.   Additional Information: GSK receipt date: 07-MAR-2025, 10-MAR-2025 Pharmacist asked if she could get the second dose of Shingrix after presenting an allergic reaction to the first dose of this vaccine. The health care provider did not know the vaccine lot number and expiration date. Per follow up with Pharmacist, she states she had a prior history of shingles when she was 40 years prior to receipt of Shingrix. She states she was usually not sensitive to any vaccines in the past.
Age: 54.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site pain, Injection site rash
Clinical narrative: Shingrix allergic reaction to first dose; Headache; Fatigue; Chills; Soreness at the injection site; Hardness at the injection site.; Bumpy rash five inches away of the injection site; Erythema five inches away of the injection site/Rubor five inches away of the injection site; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of allergic reaction in a 54-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   The patient's past medical history included shingles (when she was 40 years prior to receipt of Shingrix).   On 21-FEB-2025, the patient received Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced allergic reaction (Verbatim: Shingrix allergic reaction to first dose), headache (Verbatim: Headache), fatigue (Verbatim: Fatigue), chills (Verbatim: Chills), injection site pain (Verbatim: Soreness at the injection site), injection site induration (Verbatim: Hardness at the injection site.), papular rash (Verbatim: Bumpy rash five inches away of the injection site) and erythema (Verbatim: Erythema five inches away of the injection site/Rubor five inches away of the injection site). The outcome of the allergic reaction, headache, fatigue, chills, injection site pain, injection site induration, papular rash and erythema were unknown.   It was unknown if the reporter considered the allergic reaction, headache, fatigue, chills, injection site pain, injection site induration, papular rash and erythema to be related to Shingrix.     It was unknown if the company considered the allergic reaction, headache, fatigue, chills, injection site pain, injection site induration, papular rash and erythema to be related to Shingrix.   Additional Information: GSK receipt date: 07-MAR-2025, 10-MAR-2025 Pharmacist asked if she could get the second dose of Shingrix after presenting an allergic reaction to the first dose of this vaccine. The health care provider did not know the vaccine lot number and expiration date. Per follow up with Pharmacist, she states she had a prior history of shingles when she was 40 years prior to receipt of Shingrix. She states she was usually not sensitive to any vaccines in the past.
Age: 74.0
Sex: F
Vaccine: HEPAB
Symptoms: Inappropriate schedule of product administration
Clinical narrative: came back for the 2nd dose in 11/Mar/2025; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of drug dose administration interval too long in a 74-year-old female patient who received HAB (Twinrix) (batch number M4B34, expiry date 28-SEP-2026) for prophylaxis.   Previously administered products included Twinrix (the 1st dose of Twinrix was administered to the patient back in September 2024).   On 11-MAR-2025, the patient received the 2nd dose of Twinrix. On 11-MAR-2025, an unknown time after receiving Twinrix, the patient experienced drug dose administration interval too long (Verbatim: came back for the 2nd dose in 11/Mar/2025). The outcome of the drug dose administration interval too long was not applicable.   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 : 11-MAR-2025 A pharmacist called to inform that a patient delayed their 2nd dose of Twinrix.  The patient received 2nd dose of Twinrix, later than the recommended interval, which led to lengthening of vaccination schedule.
Sex: F
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: did not receive the 2nd dose on time; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (Patient received first dose in 2019).   On an unknown date, the patient did not receive the 2nd dose of Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced incomplete course of vaccination (Verbatim: did not receive the 2nd dose on time). The outcome of the incomplete course of vaccination was not applicable.   Additional Information: GSK Receipt Date: 11-MAR-2025 Pharmacist called to inform that a patient got a vaccine, Shingrix in 2019 and did not receive the 2nd dose on time, the doctor told she should start the series over. Till the time of reporting, the patient did not receive 2nd dose of Shingrix, which led to incomplete course of vaccination
Vaccine: COVID19
Symptoms: Herpes zoster, Myocardial infarction, Neck mass
Clinical narrative: Myocardial infarction; Lump in neck; Shingles; This spontaneous report received from a patient concerned a patient of unspecified age and sex. The patient's height and weight were not reported. Age at time of vaccination was unknown. The report was received via social media (JNJ managed site - JNJNews at x.com).  No past medical history, concurrent conditions or pre-existing medical conditions were reported.  The patient received janssen covid-19 vaccine (suspension for injection, route of admin not reported, batch number: Unknown) dose, frequency and therapy dates not reported, additional dosage information included: Dose series: 1, for covid-19 prophylaxis. The batch number was not reported. The company is unable to perform follow up.  No concomitant medications were reported.  On an unspecified date, the patient experienced myocardial infarction, lump in neck, and shingles. (Dose series: 1). The patient reported patient grew a lump in my neck 10 days after and then had the shingles six times over the next couple years and a full blown MI. The action taken with janssen covid-19 vaccine was not applicable.  The outcome of myocardial infarction, lump in neck and shingles was not reported.  This report was serious (other medically important condition).; Sender's Comments: V0:  Myocardial infarction. Insufficient information is available to make a causality assessment. Therefore, this event is considered unclassifiable.
Vaccine: COVID19
Symptoms: Adverse drug reaction
Clinical narrative: mild symptoms; This spontaneous report received from a patient by a business partner (Pfizer Inc.) on 25-Feb-2025 was received by Johnson and Johnson Innovative Medicine on 25-Feb-2025 and concerned multiple unspecified age and sex patients. The patients height and weight were not reported. Age at time of vaccination was unknown.  No past medical history, concurrent conditions or pre-existing medical conditions were reported.  The patients received janssen covid-19 vaccine (suspension for injection, intramuscular, batch number not reported) dose, frequency and therapy dates not reported, additional dosage information included: Dose Series: 1, for covid-19 prophylaxis. The batch number was not reported. The company is unable to perform follow-up to request batch/lot numbers.   No concomitant medications were reported.  On an unspecified date, the patients experienced mild symptoms. Dose Series: 1  The action taken with janssen covid-19 vaccine was not applicable.  The outcome of mild symptoms was not reported.  This report was non-serious.
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: I just got COVID again; I just got COVID again; This is a spontaneous report received from a Consumer or other non HCP.  A 71-year-old male patient received BNT162b2 omicron (kp.2) (COMIRNATY (2024-2025 FORMULA)), as dose 1, 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 completed, Pfizer COVID vaccinations every year since they were released.), for Covid-19 immunization. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "I just got COVID again".  The information on the batch/lot number for BNT162b2 omicron (kp.2) will be requested and submitted if and when received.
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: had 4 vaccinations for COVID and had covid after these vaccinations; had 4 vaccinations for COVID and had covid after these vaccinations; This is a spontaneous report received from a Consumer or other non HCP, Program ID.  A male patient received BNT162b2 (COVID-19 VACCINE NOS MANUFACTURER UNKNOWN), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown), as dose 3 (booster), single (Batch/Lot number: unknown) and as dose 4 (booster), 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: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Aug2024, outcome "unknown" and all described as "had 4 vaccinations for COVID and had covid after these vaccinations". Therapeutic measures were taken as a result of drug ineffective, covid-19. The patient's husband mentioned that he had COVID six months ago and Paxlovid was covered at that time. He recalled that they were covered for COVID previously and both had received four vaccinations. He stated that he has never had COVID. When asked if the vaccinations were Pfizer, the patient's wife responded that she did not remember which ones they had received. Both the patient and his wife had four COVID vaccinations and contracted COVID after these vaccinations. Additionally, the patient's wife was unsure of the Manufacturer and name of the vaccines they both received.; Sender's Comments: Linked Report(s) : US-PFIZER INC-PV202500029896 same reporter, drug and event, different patient;
Sex: F
Vaccine: PNC20
Symptoms: Headache, Injection site erythema, Injection site pain, Injection site swelling, Pyrexia
Clinical narrative: Redness, pain swelling at injection site; Redness, pain swelling at injection site; Redness, pain swelling at injection site; headache; fever; This is a spontaneous report received from a Consumer or other non HCP from a sales representative.  An adult female patient (unknown if pregnant) received pneumococcal 20-val conj vac (dipht CRM197 protein) (PREVNAR 20), on 03Mar2025 as dose 1, single (Batch/Lot number: unknown), in deltoid for immunisation. The patient's relevant medical history included: "Drug Allergy" (unspecified if ongoing). The patient's concomitant medications were not reported. The patient did not receive any other vaccines on the same date as Prevnar20. The following information was reported: VACCINATION SITE ERYTHEMA (non-serious), VACCINATION SITE SWELLING (non-serious), VACCINATION SITE PAIN (non-serious) all with onset 03Mar2025, outcome "recovering" and all described as "Redness, pain swelling at injection site"; PYREXIA (non-serious) with onset 03Mar2025, outcome "recovering", described as "fever"; HEADACHE (non-serious) with onset 03Mar2025, outcome "recovering". Therapeutic measures (Tylenol) were taken as a result of vaccination site erythema, vaccination site swelling, vaccination site pain, headache, pyrexia.  No follow-up attempts are possible. Batch/lot number is not provided, and it cannot be obtained.
Age: 55.0
Sex: F
Vaccine: PNC20
Symptoms: Injection site pain, Injection site reaction, Musculoskeletal stiffness
Clinical narrative: Muscle soreness/stiffness at injection site; Muscle soreness/stiffness at injection site; This is a spontaneous report received from a Consumer or other non HCP.  A 55-year-old female patient received pneumococcal 20-val conj vac (dipht CRM197 protein) (PREVNAR 20), on 12Mar2025 as dose number unknown, single (Batch/Lot number: unknown) at the age of 55 years for immunisation. The patient's relevant medical history included: "Hypertension" (unspecified if ongoing). Concomitant medication(s) included: LISINOPRIL; AMLODIPINE. The following information was reported: VACCINATION SITE PAIN (non-serious), MUSCULOSKELETAL STIFFNESS (non-serious), outcome "recovering" and all described as "Muscle soreness/stiffness at injection site". Therapeutic measures were taken as a result of vaccination site pain, musculoskeletal stiffness.  Additional information: the patient had no known allergy. The patient didn't receive any other vaccines on the same date as the vaccine or any other vaccines within 4 weeks PRIOR to the vaccine. Treatment included OTC painkillers.  No follow-up attempts are possible. Batch/lot number is not provided, and it cannot be obtained.
Sex: F
Vaccine: HPV4
Symptoms: Death
Clinical narrative: passed away shortly after receiving her third dose of Gardasil; This spontaneous report was received from a consumer or other non-health professional and refers to a 17-year-old female patient.   The patient's medical history was not reported. The patient's concurrent conditions were not reported. Concomitant therapies were not reported.   On an unknown date, the patient was vaccinated with Quadrivalent Human Papillomavirus (Types 6, 11, 16, 18) Recombinant Vaccine (GARDASIL), dose number 3, (lot # and expiration date were not reported). For prophylaxis.  On an unknown date (also reported as shortly after receiving the third dose of vaccine), the patient passed away. Cause of death was not reported. It was unknown whether an autopsy was performed.  The causal relationship between the event and Quadrivalent Human Papillomavirus (Types 6, 11, 16, 18) Recombinant Vaccine (GARDASIL) was not provided.  Additional information is not expected.
Age: 81.0
Sex: F
Vaccine: VARZOS
Symptoms: Arthralgia, Chest pain, Headache, Loss of personal independence in daily activities, Muscular weakness
Clinical narrative: Weakness in legs; pain in neck; head pain; shoulder pain; chest pain; This non-serious case was reported by a consumer via call center representative and described the occurrence of muscle weakness lower limb in a 81-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 19-FEB-2025, the patient received the 1st dose of Shingrix (intramuscular, right arm). In FEB-2025, an unknown time after receiving Shingrix, the patient experienced neck pain (Verbatim: pain in neck), headache (Verbatim: head pain), shoulder pain (Verbatim: shoulder pain) and chest pain (Verbatim: chest pain). On an unknown date, the patient experienced muscle weakness lower limb (Verbatim: Weakness in legs). The patient was treated with gabapentin, baclofen and paracetamol (Tylenol). The outcome of the muscle weakness lower limb, neck pain, headache, shoulder pain and chest pain were not resolved.   It was unknown if the reporter considered the muscle weakness lower limb, neck pain, headache, shoulder pain and chest pain to be related to Shingrix.     It was unknown if the company considered the muscle weakness lower limb, neck pain, headache, shoulder pain and chest pain to be related to Shingrix.   Additional Information: GSK Receipt Date: 04-MAR-2025 Patient experienced muscle weakness in legs and pain going up both sides of head, shoulders, and chest. Patient stated the onset of muscle weakness was approximately 10-12 days following vaccination and the neck pain going up both sides of the head, shoulders, and chest presented a few days prior to the muscle weakness. The patient was self-treating the symptoms with Gabapentin, Baclofen, and Tylenol, the dose and frequency were not provided. The patient stated Gabapentin, baclofen and Tylenol were prescribed to her for a different diagnosis prior to vaccination with Shingrix. The patient had not been treated by a doctor for the adverse event after vaccination. The patient stated she was being treated by physical therapy but did not specify if the treatment was for a different diagnosis prior to vaccination with Shingrix. The vaccine was administered at Pharmacy. The patient stated she was very active and she hiked approximately 30 miles per week and she has been unable to hike due to the muscle weakness in her legs
Age: 81.0
Sex: F
Vaccine: VARZOS
Symptoms: Neck pain
Clinical narrative: Weakness in legs; pain in neck; head pain; shoulder pain; chest pain; This non-serious case was reported by a consumer via call center representative and described the occurrence of muscle weakness lower limb in a 81-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 19-FEB-2025, the patient received the 1st dose of Shingrix (intramuscular, right arm). In FEB-2025, an unknown time after receiving Shingrix, the patient experienced neck pain (Verbatim: pain in neck), headache (Verbatim: head pain), shoulder pain (Verbatim: shoulder pain) and chest pain (Verbatim: chest pain). On an unknown date, the patient experienced muscle weakness lower limb (Verbatim: Weakness in legs). The patient was treated with gabapentin, baclofen and paracetamol (Tylenol). The outcome of the muscle weakness lower limb, neck pain, headache, shoulder pain and chest pain were not resolved.   It was unknown if the reporter considered the muscle weakness lower limb, neck pain, headache, shoulder pain and chest pain to be related to Shingrix.     It was unknown if the company considered the muscle weakness lower limb, neck pain, headache, shoulder pain and chest pain to be related to Shingrix.   Additional Information: GSK Receipt Date: 04-MAR-2025 Patient experienced muscle weakness in legs and pain going up both sides of head, shoulders, and chest. Patient stated the onset of muscle weakness was approximately 10-12 days following vaccination and the neck pain going up both sides of the head, shoulders, and chest presented a few days prior to the muscle weakness. The patient was self-treating the symptoms with Gabapentin, Baclofen, and Tylenol, the dose and frequency were not provided. The patient stated Gabapentin, baclofen and Tylenol were prescribed to her for a different diagnosis prior to vaccination with Shingrix. The patient had not been treated by a doctor for the adverse event after vaccination. The patient stated she was being treated by physical therapy but did not specify if the treatment was for a different diagnosis prior to vaccination with Shingrix. The vaccine was administered at Pharmacy. The patient stated she was very active and she hiked approximately 30 miles per week and she has been unable to hike due to the muscle weakness in her legs
Vaccine: HEP, MENB
Symptoms: Incorrect dose administered
Clinical narrative: requests stability data for Bexsero, Engerix-B stored at 33.5F for 15hours; This non-serious case was reported by a nurse via call center representative and described the occurrence of incorrect product storage in unspecified number of patients who received Men B NVS (Bexsero) for prophylaxis.   Co-suspect products included HBV (Engerix B) for prophylaxis.   On an unknown date, the patient received Bexsero and Engerix B. On an unknown date, an unknown time after receiving Bexsero and Engerix B, the patient experienced product storage error (Verbatim: requests stability data for Bexsero, Engerix-B stored at 33.5F for 15hours). The outcome of the product storage error was not applicable.   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: 06-MAR-2025 A Licensed Practical Nurse requested stability data for Bexsero and Engerix B stored at 33.5 Fahrenheit  for 15 hours which led to incorrect storage of drug.  The reporter reported no prior excursions and no signs of freezing or slushing The unknown number of patients involved as excursion occurred on 05 December 2024.