chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Vaccine: DTAP
Symptoms: Product storage error
Clinical narrative: INFANRIX was exposed to 5 excursions in 2024 and 2025 (4 of 5 were in 2024); This non-serious case was reported by a other health professional via call center representative and described the occurrence of incorrect storage of drug in a patient who received DTPa (Infanrix) for prophylaxis.   On an unknown date, the patient received Infanrix. On an unknown date, an unknown time after receiving Infanrix, the patient experienced incorrect storage of drug (Verbatim: INFANRIX was exposed to 5 excursions in 2024 and 2025 (4 of 5 were in 2024)). 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-JUN-2025 Medical assistant reported that Infanrix was exposed to 5 excursions in 2024 and 2025 (4 of 5 were in 2024) which led to incorrect storage of drug. Highest temperature reached was 9.76C and they were above range for 1 hour and 15 minutes in total 75 minutes. No other excursions had occurred.  The majority of all vaccines reported were administered to patients. healthcare professional did not have patient, product, other adverse event details available during call. This was 1 of 6 linked cases reported by same reporter, different suspect.; Sender's Comments:  US-GSK-US2025071798:Same reporter, Different suspect US-GSK-US2025071804:Same reporter, Different suspect US-GSK-US2025071799:Same reporter, Different suspect US-GSK-US2025071800:Same reporter, Different suspect US-GSK-US2025071801:Same reporter, Different suspect US-GSK-US2025071802:Same reporter, Different suspect US-GSK-US2025071803:Same reporter, Different suspect US-GSK-US2025071805:Same reporter, Different suspect US-GSK-US2025071800:Same reporter, Different suspect
Vaccine: HEP
Symptoms: Product storage error
Clinical narrative: ENGERIX-B was exposed to 5 excursions in 2024 and 2025  (4 of 5 were in 2024). Highest temperature reached was9.76C and they were above range for 1 hour and 15 minutes in total (5x15 minutes). No other excursions; This non-serious case was reported by a other health professional via call center representative and described the occurrence of incorrect storage of drug in a patient who received HBV (Engerix B) for prophylaxis.   On an unknown date, the patient received Engerix B. On an unknown date, an unknown time after receiving Engerix B, the patient experienced incorrect storage of drug (Verbatim: ENGERIX-B was exposed to 5 excursions in 2024 and 2025 (4 of 5 were in 2024). Highest temperature reached was9.76C and they were above range for 1 hour and 15 minutes in total (5x15 minutes). No other excursions). The outcome of the incorrect storage of drug was not applicable.   Additional Information: GSK Receipt Date: 06-JUN-2025 MA reports that Engerix-B was exposed to 5 excursions in 2024 and 2025 (4 of 5 were in 2024). Highest temperature reached was 9.76C and they were above range for 1 hour and 15 minutes in total (5 into15 minutes). No other excursions. The majority of all vaccines reported were administered to patients, which led to incorrect storage of vaccine.; Sender's Comments:  US-GSK-US2025071799:Same reporter, Different suspect US-GSK-US2025071804:Same reporter, Different suspect GSK-US2025071798:Same reporter, Different suspect US-GSK-US2025071801:Same reporter, Different suspect US-GSK-US2025071800:Same reporter, Different suspect US-GSK-US2025071802:Same reporter, Different suspect US-GSK-US2025071803:Same reporter, Different suspect GSK-US2025071802:Same reporter, Different suspect US-GSK-US2025071804:Same reporter, Different suspect
Age: 1.0
Sex: M
Vaccine: DTAP
Symptoms: Expired product administered
Clinical narrative: gave an expired infanrix to a patient; 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 19-month-old male patient who received DTPa (Infanrix) (batch number GG39D, expiry date 07-JUN-2025) for prophylaxis.   On 09-JUN-2025, the patient received Infanrix. On 09-JUN-2025, an unknown time after receiving Infanrix, the patient experienced expired vaccine used (Verbatim: gave an expired infanrix to a patient). 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: 09-JUN-2025 Medical Assistant reported that we gave an expired infanrix to a patient, which led to expired vaccine used and reporter wanted to know if need to re-dose or not. The reporter was consented to follow up.
Age: 63.0
Sex: F
Vaccine: HEPAB
Symptoms: Expired product administered
Clinical narrative: patient received this expire dose; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of expired vaccine used in a 64-year-old female patient who received HAB (Twinrix) (batch number 4KS75, expiry date 03-JAN-2025) for prophylaxis.   On 06-JUN-2025, the patient received Twinrix. On 06-JUN-2025, an unknown time after receiving Twinrix, the patient experienced expired vaccine used (Verbatim: patient received this expire dose). 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: 09-JUN-2025 The pharmacist was called and reported the following he /she was just called to see if had any extended stability information on the Twinrix vaccine or not. The reporter asked about if the product was exposed to a temperature excursion on that pharmacist answered no, it was expired.  They need to know how long after the expiration date was good. The reporter asked if any patient received this expire dose on that pharmacist said yes.  During the call, reported that the vaccine was administered last Friday and set this as 06-Jun-2025, which led to expired vaccine used. The reporter was consented to follow up.  The Vaccine Administration Facility was the same as Primary Reporter.
Sex: F
Vaccine: TDAP, VARZOS
Symptoms: Product storage error
Clinical narrative: A 52 years old female patient received a dose of Boostrix and a dose of Shingrix after a temperature excursion.; This non-serious case was reported by a other health professional via call center representative and described the occurrence of incorrect storage of drug in a 52-year-old female patient who received Herpes zoster (Shingrix) (batch number 27LR2, expiry date 25-MAR-2027) for prophylaxis.   Co-suspect products included DTPa (Reduced antigen) (Boostrix) (batch number KR75K, expiry date 27-AUG-2027) for prophylaxis.   On an unknown date, the patient received Shingrix and Boostrix. On an unknown date, an unknown time after receiving Shingrix and Boostrix, the patient experienced incorrect storage of drug (Verbatim: A 52 years old female patient received a dose of Boostrix and a dose of Shingrix after a temperature excursion.). 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: 11-JUN-2025  The office manager called to ask about the stability of Boostrix and Shingrix, after a temperature excursion of minus 14 degree C for 24 hours. No prior excursion. Office Manager mentioned that they administered 1 dose of Boostrix and 1 dose of Shingrix to a 52 years old female patient after this temperature excursion, which led to Incorrect storage of drug.
Age: 2.0
Sex: M
Vaccine: TDAP
Symptoms: Wrong product administered
Clinical narrative: inadvertently administered dose; This non-serious case was reported by a nurse via call center representative and described the occurrence of wrong vaccine administered in a 2-year-old male patient who received DTPa (Reduced antigen) (Boostrix) (batch number 3RE73, expiry date 16-NOV-2026) for prophylaxis.   Co-suspect products included DTPa (Infanrix) for prophylaxis.   On 12-JUN-2025, the patient received Boostrix. On an unknown date, the patient received Infanrix. On 12-JUN-2025, immediately after receiving Boostrix and not applicable after receiving Infanrix, the patient experienced wrong vaccine administered (Verbatim: inadvertently administered dose). The outcome of the wrong vaccine administered 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: 12-JUN-2025 On 12 June 2025, a licensed practical nurse had called to report that she had inadvertently administered a dose of Boostrix to a 2-year-old patient instead of the scheduled dose of Infanrix earlier that same day, which led to wrong vaccine administered. She had asked how to proceed following the incorrect administration.
Age: 75.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Heart rate, Heart rate abnormal, Palpitations, Paraesthesia
Clinical narrative: Day she woke up and was exhausted "it felt like I had ran a marathon; Her heart seemed to be racing; Her hands and feet began to tingle; This spontaneous case was reported by a consumer and describes the occurrence of PALPITATIONS (Her heart seemed to be racing), PARAESTHESIA (Her hands and feet began to tingle) and FATIGUE (Day she woke up and was exhausted "it felt like I had ran a marathon) in a 75-year-old female patient who received mRNA-1273.712 (SPIKEVAX 2024-2025 PFS) (batch no. 3046731) for COVID-19 prophylaxis.     The patient's past medical history included Heart attack (Between 2010-2016, experienced several "broken heart" heart attacks due to stress.) and Stress.    On 03-May-2025, the patient received dose of mRNA-1273.712 (SPIKEVAX 2024-2025 PFS) (Intramuscular use) .5 milliliter. On 03-May-2025, the patient experienced PALPITATIONS (Her heart seemed to be racing) and PARAESTHESIA (Her hands and feet began to tingle). On 04-May-2025, the patient experienced FATIGUE (Day she woke up and was exhausted "it felt like I had ran a marathon). At the time of the report, PALPITATIONS (Her heart seemed to be racing), PARAESTHESIA (Her hands and feet began to tingle) and FATIGUE (Day she woke up and was exhausted "it felt like I had ran a marathon) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Heart rate: heart rate was 122 bpm and heart rate was down to the 50s. On an unknown date, Heart rate abnormal: heart rate continued to go up and down for 5 hours..     For mRNA-1273.712 (SPIKEVAX 2024-2025 PFS) (Intramuscular use), the reporter did not provide any causality assessments.   Concomitant medication was not provided.  Reporter causality was not reported.  Patient took no other vaccines within the past 4 weeks.  It was reported that the patient tends to have alternate reactions with her COVID vaccines. She stated that she did not had anything that day at all, but 7 to 8 hours after receiving the vaccine, she sat down after dinner and noticed her heart seemed to be racing and her heart rate was 122 bpm on her fit bit which seemed a little high for her and within a minute later, her hands and feet began to tingle and her heart rate was down to the 50s. She stated that her heart rate continued to go up and down for 5 hours. Around midnight her heart rate seemed to have settled and the next day she woke up and was exhausted and it felt to her like she had ran a marathon. It was reported that 2 months before she received a comprehensive cardiac checkup and everything was normal. She filed an adverse reaction within the CDC online and had discussed this and future vaccines with her family physician and pharmacist and she will be seeing her cardiologist that next day.  Treatment information was not reported.
Sex: F
Vaccine: COVID19
Symptoms: Herpes zoster
Clinical narrative: shingles; This is a spontaneous report received from a Consumer or other non HCP from medical information team.  A female patient received BNT162b2 (BNT162B2 NOS), as dose 2, single for covid-19 immunisation. The patient's relevant medical history included: "cardiac issues" (unspecified if ongoing). The patient's concomitant medications were not reported. Vaccination history included: Bnt162b2 (DOSE 1, SINGLE), for covid-19 immunization. The following information was reported: HERPES ZOSTER (non-serious), outcome "unknown", described as "shingles".  Additional information: Patient mentioned that around the year 2021 - 2022 she got the 2nd shot Pfizer Covid 19 Vaccine and got Shingles afterwards and she said that shingles were terrible.  No follow-up attempts are possible.
Sex: F
Vaccine: COVID19
Symptoms: Breast cancer recurrent, Computerised tomogram, Magnetic resonance imaging, Positron emission tomogram, Thymic carcinoma
Clinical narrative: thymic carcinoma; recurrent breast cancer; This is a spontaneous report received from a Consumer or other non HCP from medical information team.  A 76-year-old female 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 included: "Breast cancer female" (ongoing). The patient's concomitant medications were not reported. Vaccination history included: moderna COVID-19 vaccine (DOSE 1, SINGLE, lot number: 006M2014, IM), administration date: 12Feb2021, for COVID-19 immunisation, reaction(s): "Drug ineffective", "Interchange of vaccine products", "COVID-19"; moderna COVID-19 vaccine (DOSE 2, SINGLE, lot number: 0016219, IM), administration date: 12Mar2021, for COVID-19 immunisation; moderna COVID-19 vaccine (DOSE 3 (BOOSTER), SINGLE,  lot number: 047C2114, IM), administration date: 22Oct2021, for COVID-19 immunisation, reaction(s): "Drug ineffective", "Interchange of vaccine products", "COVID-19"; BNT162b2 (DOSE 4 (BOOSTER), SINGLE, lot number: FK9895, IM), administration date: 30Mar2022, for COVID-19 immunisation, reaction(s): "Drug ineffective", "Interchange of vaccine products", "COVID-19"; BNT162b2, BNT162b2 omi ba.4-5 (DOSE 5 (BOOSTER), SINGLE), administration date: 09Sep2022, for COVID-19 immunisation, reaction(s): "cold", "sore arm". The following information was reported: THYMIC CARCINOMA (medically significant), outcome "unknown"; BREAST CANCER RECURRENT (medically significant), outcome "unknown", described as "recurrent breast cancer". The patient underwent the following laboratory tests and procedures: Computerised tomogram: Unknown Results; Magnetic resonance imaging: Unknown Results; Positron emission tomogram: thymic carcinoma, notes: thymic carcinoma was identified during PET scan. Therapeutic measures were taken as a result of thymic carcinoma.  Clinical course: Caller stated that she had her thymus removed due to a rare form of cancer known as "thymic carcinoma". According to the caller, thymic carcinoma was identified during PET scan, which was performed due to the caller's "recurrent breast cancer", along with an MRI and CAT scan. Caller was informed, by HCP, that "vaccines would not be as effective" with her thymus removed. Caller added that she has received "all eight shots" and that she is 76 years of age. In conclusion, caller was interested in information regarding whether the "potency" of the Pfizer COVID-19 vaccine would be affected due to her thymus having been removed.  No follow-up attempts are possible. Batch/lot number is not provided, and it cannot be obtained.
Vaccine: COVID19, COVID19
Symptoms: Immunisation reaction, Pain, Pyrexia
Clinical narrative: serious adverse effects; sick afterwards, like a fever and body aches; sick afterwards, like a fever and body aches; This is a spontaneous report received from a Physician.  A patient (age and gender not provided) received BNT162b2 (BNT162B2 NOS), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation; elasomeran (SPIKEVAX), as dose number unknown, single) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: IMMUNISATION REACTION (medically significant), outcome "unknown", described as "serious adverse effects"; PYREXIA (non-serious), PAIN (non-serious), outcome "unknown" and all described as "sick afterwards, like a fever and body aches".  The patient reported she would usually take them on the weekend because she knew she was going to be sick afterwards, like a fever and body aches, etc.   Company Comment: The causality of the event Immunisation reaction, Pain and Pyrexia was assessed conservatively as related, due to the unknown temporal association and limited information provided.   No follow-up attempts are possible. Batch/lot number is not provided, and it cannot be obtained.; Sender's Comments: A possible contributory role of the suspect products cannot be excluded for the reported event immunization reaction based on the known safety profile and temporal association.  The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees, and Investigators as appropriate.
Vaccine: COVID19
Symptoms: Therapeutic response unexpected
Clinical narrative: had "virago"/always needed a walker/had bad allergies/got a nail fungus; after the second shot, wasn't dizzy/walked without a walker/allergies and nail fungus cleared up/asthma got better; This is a spontaneous report received from a Consumer or other non HCP, Program ID.  A patient (age and gender not provided) received BNT162b2 (BNT162B2), as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Virago" (unspecified if ongoing), notes: always needed a walker; "always needed a walker" (unspecified if ongoing); "bad allergies" (unspecified if ongoing), notes: couldn't be outside; "nail fungus" (unspecified if ongoing), notes: was in 70's had first manicure, got nail fungus so bad/thought about getting thumb nails removed; "Dizzy" (unspecified if ongoing); "asthma" (ongoing). The patient's concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (DOSE 1, SINGLE), for COVID-19 Immunisation. The following information was reported: THERAPEUTIC RESPONSE UNEXPECTED (non-serious), outcome "unknown", described as "had "virago"/always needed a walker/had bad allergies/got a nail fungus; after the second shot, wasn't dizzy/walked without a walker/allergies and nail fungus cleared up/asthma got better".  Additional information: The patient reported it was a miracle what Pfizer COVID-19 original vaccine did. The patient had vertigo/'virago" (as reported) and always needed a walker. The patient had bad allergies couldn't be outside. In the patient's 70's, the patient had their first manicure got a nail fungus so bad they thought about getting thumb nails removed. About 6 or 7 days after the second shot, the patient woke up, sat up and wasn't dizzy. Vertigo was gone. The patient walked around house without a walker. The patient could walk outside. The patient's allergies and nail fungus cleared up. Asthma got so much better and all the patient has to do was carry an inhaler. It worked for year 2 but with the changes, vertigo, allergies and asthma were coming back. The patient stated, "I need the original vaccine" as all was coming back.  The information on the batch/lot number for BNT162b2 will be requested and submitted if and when received.
Age: 54.0
Sex: F
Vaccine: YF
Symptoms: Product preparation error
Clinical narrative: the vaccine was mixed with the incorrect diluent of sterile water with no reported AE; Initial information received on 11-Jun-2025 regarding an unsolicited valid non-serious case received from a pharmacist.  This case involves a 54 years old female patient who was administered yellowfever vaccine- [YF-VAX] that was mixed with the incorrect diluent of sterile water with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On 09-Jun-2025, the patient received a dose of 0.5 ml of suspect yellowfever vaccine- solution for injection (lot UK134AA, strength: standard and frequency: once) (expiry date not reported) via unknown route in the left arm for immunization and was mixed with the incorrect diluent of sterile water with no reported adverse event (product preparation error) (Latency: same day).  Reportedly, The pharmacist reported that 2 consumers received a medication error with the YF vaccine, that the consumers are family members.  Action taken was not applicable.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.; Sender's Comments:  US-SA-2025SA166823:consumer 2
Vaccine: FLU3
Symptoms: Vaccination error
Clinical narrative: whether there had been any specific instances of one Sanofi flu vaccine being mistaken for another and administered to a patient, she said that historically there may have been with no reported adverse event; Initial information received on 12-Jun-2025 regarding an unsolicited valid non-serious case received from a nurse.  This case involves an unknown age and unknown gender patient for whom influenza usp trival a-b subvirion no preservative vaccine [Fluzone], there had been any specific instances of one sanofi flu vaccine being mistaken for another and administered to a patient, she said that historically there may have been with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  On an unknown date, the patient received an unknown dose of suspect influenza usp trival a-b subvirion no preservative vaccine; Suspension for injection (lot number, strength and expiry date not reported) via unknown route in unknown administration site for Immunization; whether there had been any specific instances of one sanofi flu vaccine being mistaken for another and administered to a patient, she said that historically there may have been with no reported adverse event (wrong product administered) (latency: same day)  Reportedly: She states that they have some new staff that is coming on board in the near future, and they are putting together training materials for them related to flu vaccination. When the nurse was asked whether there had been any specific instances of one Sanofi flu vaccine being mistaken for another and administered to a patient, she said that historically there may have been, but she cannot say for sure, and she does not have any information on any specific instances  Action taken was not applicable.  Information on the batch number was requested corresponding to the one at time of event occurrence.  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.
Vaccine: YF
Symptoms: No adverse event, Product preparation error
Clinical narrative: suspects pharmacist reconstituted using sterile water with no reported adverse event; Initial information received on 13-Jun-2025 regarding an unsolicited valid non-serious case received from a pharmacist.  This case involves an unknown age and unknown gender patient for whom yellow fever vaccine - [YF-VAX] pharmacist reconstituted using sterile water with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On an unknown date, the patient received an unknown dose of suspect yellow fever vaccine; Solution for injection with unknown strength (lot UK137AA with expiry date 31-JAN-2026) via unknown route in unknown administration site for Immunization; pharmacist reconstituted using sterile water with no reported adverse event (product preparation error) (latency: same day).  Action taken was not applicable.  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: 18.0
Sex: M
Vaccine: VARCEL
Symptoms: Product storage error
Clinical narrative: No additional AE; Inbound call received from a nurse who said improperly stored doses of VARIVAX were administered to at least one patient.; This spontaneous report was received from a Nurse and refers to a(n) 18-year-old male patient.   The patient's medical history was not reported. The patient's concurrent conditions included seizure disorder. Concomitant medications included Tdap (Diphtheria vaccine toxoid;Pertussis vaccine acellular;Tetanus vaccine toxoid), Hbhepb (Hepatitis b vaccine;HIB vaccine) .  On 05-May-2025, the patient was vaccinated with an improperly stored Varicella Virus Vaccine Live (Oka-Merck) (VARIVAX), Injection (lot #X028612, expiration date: 13-Dec-2025), dose number 1, diluted in sterile diluent (MERCK STERILE DILUENT), Solution for injection (indication, expiration date, and lot # were not reported) and were administered by Subcutaneous route in the Left Arm for prophylaxis. The vaccine had been exposed to a temperature of -11.31 C for 28 minutes. There were no previous temperature excursions. No adverse event was reported.  This is one of two reports from the same reporter.
Sex: M
Vaccine: MMR
Symptoms: Pallor, Urticaria
Clinical narrative: A FBE called to report an AE on behalf of an HCP for MMR II. The FBE stated she spoke with the HCP last Tuesday, 06/10/2025, then went out of town, and was just getting back to town and wanted to call and report the AE but the HCP also told the FBE t; This spontaneous report was received from a Physician and refers to a 4-year-old male patient.   The patient's medical history was not reported. The patient's concurrent conditions included rash. Historical drugs included COVID-19 vaccine (COVID-19 vaccine). Concomitant therapies were not reported.   On an unknown date, the patient started therapy with Measles, Mumps, and Rubella (Wistar RA 27-3) Virus Vaccine, Live (M-M-R II), administered by Unknown route (lot # and expiration date were not reported) reconstituted with sterile diluent (MERCK STERILE DILUENT), (lot # and expiration date were not reported).  On an unknown date, the patient experienced hives on his shoulder and back that "blanched" within an unknown time-frame after the injection. The HCP stated she administered an antihistamine which improved the reaction of hives but when the antihistamine wore off, the hives would return until the hives resolved and got better all together on an unknown date or time-frame.  The patient recovered/resolved from the event on an unspecified date.   The action taken with Measles, Mumps, and Rubella (Wistar RA 27-3) Virus Vaccine, Live and sterile diluent was reported as not applicable.   The reporter considered the event to be related to Measles, Mumps, and Rubella (Wistar RA 27-3) Virus Vaccine, Live and sterile diluent (reported as reaction from MMR II).; Reporter's Comments:
Sex: M
Vaccine: YF
Symptoms: Pain, Pharyngitis, Pyrexia
Clinical narrative: body aches; throat infection; high fever; Initial information received on 12-Jun-2025 regarding an unsolicited valid non-serious case received from a consumer/non-hcp (health care professional).  This case involves an unknown age male patient who had high fever, body aches and throat infection after receiving yellow fever vaccine - [YF-VAX].  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On 09-Jun-2025, the patient received an unknown  dose of suspect yellow fever vaccine, Solution for injection (lot number, strength and expiry date not reported) via unknown route in unknown administration site for prophylactic vaccination (Immunisation). Information on the batch number was requested corresponding to the one at time of event occurrence.  On 12-Jun-2025 the patient developed high fever (pyrexia), body aches (pain) and throat infection (pharyngitis) (Latency: 3 days).  Action taken was not applicable.  It was not reported if the patient received a corrective treatment for all the events.  At time of reporting, the outcome was Unknown for all the events.
Age: 5.0
Sex: F
Vaccine: DTAPIPVHIB
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: a 5 year and 1-day old patient was given PENTACEL with no reported adverse event; Initial information received on 11-Jun-2025 regarding an unsolicited valid non-serious case received from a other health professional.  This case involves a 5 years and 1 day old female patient who received diphtheria/tetanus/5 hybrid AC pertussis/IPV(VERO)/HIB(PRP/T) vaccine [Pentacel (vero)] with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included measles vaccine live (enders-edmonston), mumps vaccine live (jeryl lynn), rubella vaccine live (wistar ra 27/3), varicella zoster vaccine live (oka/merck) (Proquad) for prophylactic vaccination (Immunisation).  On 11-Jun-2025, the patient received a dose of 0.5 ml (dose 5) of suspect diphtheria/tetanus/5 hybrid AC pertussis/IPV(VERO)/HIB(PRP/T) vaccine, suspension for injection (lot UK224AC and expiry date 31-Jul-2026) (strength: standard and frequency: once) via intramuscular route in the left thigh for immunization with no reported adverse event (product administered to patient of inappropriate age) (Latency: same day).  Action taken was not applicable.   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: 16.0
Sex: F
Vaccine: HPV9
Symptoms: Extra dose administered
Clinical narrative: Pt given Gardasil injection IM to L deltoid, was not ordered (previous Gardasil vaccines given 6/16/20 and 8/2/21)
Age: 61.0
Sex: F
Vaccine: HEPAB
Symptoms: Chills, Dark circles under eyes, Decreased appetite, Diarrhoea, Headache
Clinical narrative: Patient experienced severe flu-like symptoms such as fever, chills, body aches, excessive diarrhea, loss of appetite, black circles under her eyes, and severe  headache. Patient has taken ibuprofen for the body aches and has been rehydrating with plenty of water and gatorade
Age: 61.0
Sex: F
Vaccine: HEPAB
Symptoms: Influenza like illness, Pain, Pyrexia
Clinical narrative: Patient experienced severe flu-like symptoms such as fever, chills, body aches, excessive diarrhea, loss of appetite, black circles under her eyes, and severe  headache. Patient has taken ibuprofen for the body aches and has been rehydrating with plenty of water and gatorade
Age: 1.0
Sex: M
Vaccine: HEPA, HIBV, MMRV, PNC20, VARCEL
Symptoms: Extra dose administered
Clinical narrative: Patient came to immunizations clinic for vaccines. Pt was given a dose of MMRII and Varicella along with Hep A, Hib, Prevnar 20,. Patient was informed and was spoken to by the provider about adverse affects. Reports were made.
Age: 1.0
Sex: F
Vaccine: HEPA, MMR, PNC20, VARCEL
Symptoms: Rash, Rash vesicular
Clinical narrative: On 6/11/2025, patient began to have vesicular rash that arose on legs, spread to arms, face in a widespread distribution. No other symptoms noted. Seen by Dr. on 6/16/2025, noted to have widespread blisters, no mucosal lesions. Blister on hairline leaking clear fluid.
Age: 43.0
Sex: F
Vaccine: TDAP
Symptoms: Wrong product administered
Clinical narrative: Agreed to get the Tetanus shot. Multiple nurses and the doctor said they would "update" my tetanus since its been 20 years (according to myself). Get home the next day looking at my paperwork, i was given the Tdap NOT just a regular tetanus. I was mislead. Only vaccine i have had in my life is the Tetanus so this makes me very angry and considering taking action!
Age: 64.0
Sex: F
Vaccine: PNC20, VARZOS
Symptoms: Injection site rash, Injection site swelling, Injection site warmth, Rash
Clinical narrative: Patient picked up medication on 6/16/25 for an abscess unrelated to the vaccine. At counseling, patient requested to speak to pharmacist in private. Patient reported severe swelling warm to touch at injection site for at least 4 days after administered doses of Prevnar21 and Shingrx on 6/10/2025 (about a week ago). As of 6/16/25 showed rash covering upper left arm below injection site. In addition, patient reported rash along the right side of her neck. Patient made an appointment with her PCP on 6/17/25 to look into her reaction because the rash is still present. According to patient, treatment at home included cold compress to help with the swelling around injection sites.
Age: 63.0
Sex: M
Vaccine: VARCEL
Symptoms: Wrong product administered
Clinical narrative: WE HAVE BEEN ADMINISTERED VARIVAX VACCINE INSTEAD OF MMR VACCINE
Age: 68.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Erythema, Skin indentation, Swelling, Urticaria
Clinical narrative: Rash at site of admin and across belly, arms and legs...  continuing two weeks+ after immunization.   Patient wondering if she should still have dose two.
Age: 68.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Injection site rash, Rash
Clinical narrative: Rash at site of admin and across belly, arms and legs...  continuing two weeks+ after immunization.   Patient wondering if she should still have dose two.
Age: 50.0
Sex: F
Vaccine: HEPA
Symptoms: Expired product administered
Clinical narrative: Confirmed no symptomatic adverse events reported; that an expired dose of VAQTA was inadvertently administered to a patient; This spontaneous report was received from a medical Assistant who is a Clinical supervisor and refers to a 50-year-old female patient.   The patient's medical history, concurrent conditions and concomitant therapies were not reported.   On 06-Jun-2025, the patient was vaccinated with Hepatitis A Vaccine, Inactivated (VAQTA), (lot #X024966, expiration date: 23-Mar-2025) administered by Unknown route for prophylaxis (Expired product administered). Caller also added that the patient was receiving Hepatitis A Vaccine, Inactivated (VAQTA) because she was going to be traveling out of country. Confirmed no symptomatic adverse events reported. No additional AE. No PQC.
Sex: M
Vaccine: HEPA, HEPA
Symptoms: Inappropriate schedule of product administration, No adverse event
Clinical narrative: No additional AE; the patient's initial dose was administered on 11/29/2006 and his second was administered earlier than 6-months after the initial dose on 05/18/2007; This spontaneous report was received from a nurse and refers to a 19-year-old male patient. The patient's medical history, concurrent conditions and concomitant therapies were not reported.   On 29-NOV-2006, the patient was vaccinated with the first dose of Hepatitis A Vaccine, Inactivated (VAQTA) and on 18-MAY-2007, the patient was vaccinated with the second dose of Hepatitis A Vaccine, Inactivated (VAQTA) (dose, anatomical location, route of administration, lot number and expiration date were not reported for both vaccines) for prophylaxis. The healthcare provider (HCP) wanted to know if it was safe or recommended to administer 2 doses of the pediatric formulation of Hepatitis A Vaccine, Inactivated (VAQTA) in lieu of the one adult dose formulation of Hepatitis A Vaccine, inactivated (VAQTA) because the office did not have an adult dose on hand. The HCP stated the patient needed a booster dose of Hepatitis A Vaccine, Inactivated (VAQTA) for pilot school because the patient's initial dose was administered on 29-NOV-2006 and his second was administered earlier than 6-months after the initial dose on 18-MAY-2007 (inappropriate schedule of product administration). It was unknown by the HCP if the patient had a titer drawn initiating the need of a third "booster" dose of Hepatitis A Vaccine, Inactivated (VAQTA) and the nurse was under the impression the booster was required as a standard protocol for the patient to go to pilot school, but the nurse stated the patient had not experienced any other adverse issues or side effects related to the prior administered doses.  No additional adverse event (AE).
Vaccine: DTPPVHBHPB, DTPPVHBHPB, DTPPVHBHPB, DTPPVHBHPB, RV5, RV5, RV5, RV5
Symptoms: Extra dose administered
Clinical narrative: the patient inadvertently received a 4th dose of the ROTATEQ vaccine/ received an extra dose of VAXELIS; no adverse reaction to extra dose; This spontaneous report was received from a physician and refers to a 15-month-old patient of unknown gender.   The patient's medical history, concurrent conditions, previous drugs reactions or allergies were not provided. Concomitant medications included Pneumococcal vaccine conj 20v (CRM197) (PREVNAR 20).  On 04-JUN-2024, 05-AUG-2024, 16-SEP-2024, the patient was vaccinated with Diphtheria and Tetanus Toxoids and Acellular Pertussis Vaccine Adsorbed, Inactivated Poliovirus (VAXELIS), dose number 1-2 and 3, (doses descriptions, lot #s and expiration date were not reported), then on 08-OCT-2024, at their 6 month well check, the patient had inadvertently received an extra dose (dose number 4) of Diphtheria and Tetanus Toxoids and Acellular Pertussis Vaccine Adsorbed, Inactivated Poliovirus (VAXELIS)  (dose description, lot # and expiration date were not reported) for prophylaxis. On an unknown date, the patient was vaccinated with Rotavirus Vaccine, Live, Oral, Pentavalent (ROTATEQ) dose number 1-2 and 3 (doses description, route of administrations, lot #s and expiration dates were not reported), then,  3 weeks after completing the 3-dose series for the vaccine, on an unknown date, the patient inadvertently received a 4th dose of Rotavirus Vaccine, Live, Oral, Pentavalent (ROTATEQ) (dose description, route of administration, lot # and expiration date were not reported) for prophylaxis. The patient experienced no adverse reaction to extra dose.
Vaccine: HPV9, HPV9
Symptoms: Inappropriate schedule of product administration, No adverse event
Clinical narrative: no adverse event; 1st dose of GARDASIL 9 on 1/8/2025 and 2nd dose on 3/1/2025; This spontaneous report was received from a pharmacist and refers to a 26-year-old patient of unknown gender.   The patient's medical history, concurrent conditions and concomitant therapies were not reported.   On 08-Jan-2025, the patient was vaccinated with the first dose of Human Papillomavirus 9-valent Vaccine, Recombinant (GARDASIL®9) (dose, formulation, route of administration, injection site, lot # and expiration date were not reported). On 01-Mar-2025, the patient was vaccinated with the second dose of Human Papillomavirus 9-valent Vaccine, Recombinant (GARDASIL®9) at 0.5 mL (lot #Y014059 was verified to be a valid number, expiration date: 01-Nov-2026) (scheme, formulation, route of administration and injection site were not reported); both doses for prophylaxis (inappropriate schedule of product administration). No additional adverse event was reported.
Sex: M
Vaccine: HEP
Symptoms: Headache, Injection site pain, Nausea, Pyrexia
Clinical narrative: Pain at the Site; Low Grade Fever; Nausea; Headache; 15 year old Patient Was Given Heplisav-B; Initial report received on 07-May-2025.  Additional information received on 05-Jun-2025 included confirmation that HEPLISAV-B was given in error, information on the second dose of a hepatitis B vaccine received, and the patient's date of birth.  A physician reported that a 15-year-old male received HEPLISAV-B (hepatitis B vaccine) for hepatitis B immunization and reported pain at the site, a low-grade fever, nausea, and a headache the day following the injection.  No medical history or concomitant medications were reported.  On 09-Apr-2025, the patient received a dose of a hepatitis B vaccine HEPLISAV-B (lot number 945662, expiration date 31-Jan-2027, and NDC number 4352800301) intramuscularly in the left upper deltoid. This dose was ordered and given to the patient unintentionally. The patient was 15 years old when he received the HEPLISAV-B dose.  On 10-Apr-2025, the day after having been vaccinated with HEPLISAV-B, the patient reported pain at the injection site, a low-grade fever, nausea, and a headache.  On 07-May-2025, 29 days after receiving HEPLISAV-B, the patient received the second dose of a hepatitis B vaccine, ENGERIX-B (lot number and expiration date not provided). The patient received a pediatric dose to complete his hepatitis B series.  No additional information was reported.    Company Comment:  The company assessed the events as non-serious.; Sender's Comments: The company assessed the events as non-serious.
Age: 49.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Endotracheal intubation, Guillain-Barre syndrome, Hypoaesthesia, Intensive care, Lumbar puncture abnormal
Clinical narrative: Diagnosed with GBS (Gullaine-Barre Syndrome) after experiencing numbness and tingling to both hands/feet. The diagnosis was confirmed after a spinal tap was performed. I was intubated and in the ICU for several weeks. I was sent to a rehab to help regain my mobility, but my symptoms returned and subsequently, I was sent back to the hospital for a higher level of treatment a total of three times while in rehab. I was between the hospital and rehab for a total of three months before returning home.
Age: 49.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Mobility decreased, Paraesthesia
Clinical narrative: Diagnosed with GBS (Gullaine-Barre Syndrome) after experiencing numbness and tingling to both hands/feet. The diagnosis was confirmed after a spinal tap was performed. I was intubated and in the ICU for several weeks. I was sent to a rehab to help regain my mobility, but my symptoms returned and subsequently, I was sent back to the hospital for a higher level of treatment a total of three times while in rehab. I was between the hospital and rehab for a total of three months before returning home.
Sex: M
Vaccine: COVID19
Symptoms: COVID-19
Clinical narrative: getting Covid; This spontaneous case was reported by a non-health professional and describes the occurrence of COVID-19 (getting Covid) in a male patient of an unknown age who received SPIKEVAX NOS (SPIKEVAX NOS) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received dose of SPIKEVAX NOS (SPIKEVAX NOS) (unknown route) 1 dosage form. On an unknown date, the patient experienced COVID-19 (getting Covid). At the time of the report, COVID-19 (getting Covid) outcome was unknown.        The action taken with SPIKEVAX NOS (SPIKEVAX NOS) (Unknown) was unknown.       No concomitant medication was reported. The patient took the shots, and he kept getting Covid. No treatment medication was reported.   This case was linked to US-MODERNATX, INC.-MOD-2025-787428 (E2B Linked Report).   Reporter did not allow further contact; Sender's Comments:  US-MODERNATX, INC.-MOD-2025-787428:For landlord
Age: 0.33
Sex: F
Vaccine: HIBV, PNC20, RV5, VARCEL
Symptoms: No adverse event, Wrong product administered
Clinical narrative: VAR inadvertently given - was ordered as IPV Mother notified on 6/16/2025; mom denies any neg side effects.
Age: 0.83
Sex: F
Vaccine: MMR
Symptoms: Abdominal pain upper, Pyrexia, Rash, Rash erythematous
Clinical narrative: At 8-10 days after the immunization, she had a fever for 36-48 hours. On day 10, she developed a rash of small pink dots that spread across the whole body. On days 11-12, she has suspected stomach pains.
Age: 26.0
Sex: M
Vaccine: MMR
Symptoms: Rash
Clinical narrative: Client states he woke up with a rash covering his body two days after receiving the vaccines - client then followed up at urgent care the same day and received prednisone for treatment
Age: 36.0
Sex: M
Vaccine: PNC20
Symptoms: Wrong product administered
Clinical narrative: Patient was administered the wrong vaccine, patient was given the Prevnar20 vaccine instead of the Menveo vaccine, which was ordered. Pt was made aware of the mistake and asked to come back to receive the correct vaccine.
Age: 44.0
Sex: F
Vaccine: VARZOS
Symptoms: Feeling abnormal, Hyperhidrosis, Pyrexia
Clinical narrative: PT RECEIVED SHINGRIX 6/7/25 AROUND 12:47 PM...SAID ABOUT 4 HRS LATER, SHE DEVELOPED FEVER & COVID LIKE SYMPTOMS...HAS HAD HIGH FEVER AND SWEATS PRETTY MUCH EVER SINCE THEN.  SAID SHE IS CURRENTLY STARTING TO FEEL BETTER.  SHE IS A LUPUS PT AND GETS SAPHNELO INFUSION AND HAD ONE 6/3/25.  THIS WAS HER 2ND SHINGLES VACCINE WHICH HER PROVIDER WANTED HER TO GET IN ORDER TO  START THE INFUSIONS FOR LUPUS.  SHE WENT TO ER ON 6/8/25 BECAUSE SHE FELT SO BAD...THEY JUST GAVE HER FLUIDS AT ER AND FEEL LIKE SYMPTOMS WERE A RESULT OF THE 2ND SHINGLES VACCINE.  (SHE DID FINE WITH HER 1ST SHINGLES VACCINE WHICH SHE RECEIVED ON 2/3/25)
Age: 0.5
Sex: F
Vaccine: RV1
Symptoms: Diarrhoea, Irritability
Clinical narrative: pt was having 10 or more looser stools a day, not really soaking into the diaper not overly watery, she seems fussy more at night and not as much during the day.  She is BF well and taking her baby/table foods as usual.  Mom has rice cereal that she has been using at times.  Recommended using rice cereal to all baby foods to help bulk up stool.  BRAT diet reviewed for her age.  Unfortunately it will take time for the diarrhea to improve.  Informed mom there is nothing we can give her to stop the diarrhea.  Monitor and keep her hydrated.  Sounds like mom is keeping her hydrated, she is wetting 3-4 or more diapers a day.  No fevers. Mom will touch base in 2 days or sooner with an update or bring her into clinic for revaluation.
Age: 55.0
Sex: M
Vaccine: PNC20, TDAP
Symptoms: Wrong product administered
Clinical narrative: Provider gave verbal order for vaccine. RN administered pneumococcal vaccine. Provider intended for patient to receive T-Dap.
Age: 4.0
Sex: M
Vaccine: DTAPIPV, MMRV
Symptoms: Injection site rash
Clinical narrative: Tiny bumps on both arms at the injection site; not itchy, painful, or bothersome to patient. Parent reports the right arm is worse than the left arm. Symptoms are improving. Parent denies any fever, or any anaphylactic symptoms. Please note this is the first time patient has received the combination (DTaP-IPV) vaccine; however, patient has received four doses of the DTaP in combination vaccines and DTaP as an individual vaccine, and three doses of IPV in combination vaccines. Patient has received the Proquad vaccine previously with no adverse reactions.
Age: 12.0
Sex: M
Vaccine: MENB
Symptoms: No adverse event
Clinical narrative: PATIENT HAS HAD NO ADVERSE REACTION TO THE VACCINE