chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Vaccine: VARZOS, VARZOS
Symptoms: Incomplete course of vaccination, Malaise
Clinical narrative: received my first Shingrix shot in July 2024 and I have been sick; have not gotten my second shot, is it too late; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of sickness in a patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient did not receive the 2nd dose of Shingrix. In JUL-2024, the patient received the 1st dose of Shingrix. On an unknown date, not applicable after receiving Shingrix and an unknown time after receiving Shingrix, the patient experienced sickness (Verbatim: received my first Shingrix shot in July 2024 and I have been sick) and incomplete course of vaccination (Verbatim: have not gotten my second shot, is it too late). The outcome of the sickness was not reported and the outcome of the incomplete course of vaccination was unknown.   It was unknown if the reporter considered the sickness to be related to Shingrix.     It was unknown if the company considered the sickness to be related to Shingrix.   Additional Information: GSK Receipt Date: 13-FEB-2025 This case was reported by a patient via interactive digital media. The patient received first Shingrix shot and had been sick on and off and have not got the second shot, was it too late to get it now or did have to start over. Till the time of reporting, the patient did not receive 2nd dose of Shingrix, which led to incomplete course of vaccination.
Vaccine: VARZOS, 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 patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Co-suspect products included Herpes zoster (Shingles vaccine) for prophylaxis.   The patient's past medical history included shingles.   On an unknown date, the patient received the 2nd dose of Shingles vaccine and the 1st dose of Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine and Shingles vaccine, the patient experienced vaccination failure (Verbatim: 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 resolving.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine and Shingles vaccine.     The company considered the vaccination failure to be unrelated to Shingles vaccine and Shingles vaccine. It was unknown if the company considered the shingles to be related to Shingles vaccine and Shingles vaccine.   Additional Information: GSK Receipt Date: 15-FEB-2025 This case was reported by a patient via interactive digital media. The patient had both shingles vaccines and continue to get shingles.  The patient also stated that vaccines have not protected them at all and was just getting over the worst outbreak so far.  This case was considered as suspected vaccination failure as details regarding time to onset for shingles and laboratory confirmation regarding shingles were unknown at the time of reporting.; Sender's Comments: Vaccination failure is a listed event which, due to the following criteria (insufficient information provided about the clinical description, details regarding completion of primary vaccination schedule, time to onset and laboratory confirmation of disease) is considered unrelated to GSK vaccine Shingles vaccine (1st and 2nd dose)
Vaccine: VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: Suspected Vaccination failure; Everyone I know got shingles from the vaccination; This serious case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine, the patient experienced vaccination failure (Verbatim: Suspected Vaccination failure) (serious criteria GSK medically significant) and shingles (Verbatim: Everyone I know got shingles from the vaccination). The outcome of the vaccination failure and shingles were not reported.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine.     The company considered the vaccination failure and shingles to be unrelated to Shingles vaccine.   Additional Information: GSK Receipt Date 14-FEB-2025 This case was reported by a patient via interactive digital media. Reporter reported that he/she got shingles from the vaccination.  Sorry he/she will take chances. Zinc had helped me ward off viruses. 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.; 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 Shingles vaccine. Herpes zoster is an unlisted event which is considered unrelated to GSK Shingles vaccine.
Vaccine: VARZOS, VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: Suspected vaccination failure; diagnosed with shingles last week; This serious case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Co-suspect products included Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received the 2nd dose of Shingles vaccine and the 1st dose of Shingles vaccine. In FEB-2025, an unknown time after receiving Shingles vaccine and Shingles vaccine, the patient experienced vaccination failure (Verbatim: Suspected vaccination failure) (serious criteria GSK medically significant) and shingles (Verbatim: diagnosed with shingles last week). The outcome of the vaccination failure and shingles were not reported.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine and Shingles vaccine.     The company considered the vaccination failure and shingles to be unrelated to Shingles vaccine and Shingles vaccine.   Additional Information: GSK Receipt Date: 20-FEB-2025 This case was reported by a patient via interactive digital media. The patient just had the vaccine last year in 2024 and was a two part shot and was just diagnosed with shingles last week. The patient didn't knew what to think about any vaccines as they were shooting in everyone's bodies. This case was considered as suspected vaccination failure since the details regarding the time to onset and lanboratory confirmation of shingles were unknown at the time of reporting.; Sender's Comments: Vaccination failure is a listed event which, due to the following criteria (insufficient information provided about the clinical description,  time to onset and laboratory confirmation of disease) is considered unrelated to GSK Shingles vaccine.  Herpes zoster is an unlisted event which is considered unrelated to GSK Shingles vaccine.
Vaccine: VARZOS
Symptoms: Hypersensitivity
Clinical narrative: I had a allergic reaction; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of allergic reaction in a 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 allergic reaction (Verbatim: I had a allergic reaction). The outcome of the allergic reaction was resolved.   The reporter considered the allergic reaction to be related to Shingrix.     The company considered the allergic reaction to be related to Shingrix.   Additional Information: GSK Receipt Date: 20-FEB-2025 The reporter reported that he/she had an allergic reaction to what they suspect was the vaccine, and would be available for questions if anyone was interested. The reporter saw that allergic reactions were rare with this vaccine, and thought the reporter would offer if interested. All was well now.
Sex: F
Vaccine: HEPAB
Symptoms: Incomplete course of vaccination
Clinical narrative: patient received a dose of Twinrix and then she came back two months later for the second dose; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in a 54-year-old female patient who received HAB (Twinrix) for prophylaxis.   Concomitant products included HEPATITIS A VACCINE INACT;HEPATITIS B VACCINE RHBSAG (YEAST) (TWINRIX).   On an unknown date, the patient did not receive the 2nd dose of Twinrix. On an unknown date, an unknown time after receiving Twinrix, the patient experienced incomplete course of vaccination (Verbatim: patient received a dose of Twinrix and then she came back two months later for the second dose). The outcome of the incomplete course of vaccination 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: 28-JAN-2025 The reporter called to report that a patient received a dose of Twinrix and then she came back two months later for the second dose.  The reporter enquired does the patient needs a booster dose. The reporter consented to follow up. Till the time of reporting, the patient did not receive the 2nd dose, which led to incomplete course of vaccination.
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Headache, Hyperhidrosis, Oral mucosal eruption, Pain
Clinical narrative: body ache; Headache; broke out with a rash in the mouth; Chills; Sweating; This non-serious case was reported by a consumer via call center representative and described the occurrence of chills in a 75-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Zostavax (Had vaccine 12 years ago). Concurrent medical conditions included diabetes. Additional patient notes included The patient had sensitive system and react bad to all vaccines/medications. She takes medications for diabetes..   On 03-AUG-2024, the patient received the 1st dose of Shingrix (left arm). On an unknown date, an unknown time after receiving Shingrix, the patient experienced chills (Verbatim: Chills), sweating (Verbatim: Sweating), general body pain (Verbatim: body ache), headache (Verbatim: Headache) and rash mouth (Verbatim: broke out with a rash in the mouth). The outcome of the chills and sweating were resolved (duration 1 week) and the outcome of the general body pain and headache were resolved and the outcome of the rash mouth was not resolved.   It was unknown if the reporter considered the chills, sweating, general body pain, headache and rash mouth to be related to Shingrix.     It was unknown if the company considered the chills, sweating, general body pain, headache and rash mouth to be related to Shingrix.   Additional Information: GSK Receipt Date: 28-JAN-2025 The patient was diabetic and that takes medications for diabetes. She had the Zostavax vaccine 12 years ago.  She reported that she got her 1st dose of Shingrix on 03 August 2024. The patient received the vaccine at a local pharmacy, and it was administered in the left arm. The patient reported that she had headache and body aches. She had sweating and chills that lasted for a week. These events have been resolved. The patient concerned about getting the 2nd dose because had a sensitive system and react bad to all vaccines/medications.  The patient inquired Shingrix related to Likens planus. She broke out with a rash in the mouth a few days ago. The patient was not sure what it was and was concerned about getting the 2nd dose of Shingrix because she was told that this condition and Shingrix were related. No additional events were reported. Did not given consent to follow up.
Vaccine: DTAP, DTAPHEPBIP, FLU3, MNQ, RV1, TDAP
Symptoms: Product storage error
Clinical narrative: Vaccines administered after above and below temperature excursion; This non-serious case was reported by a physician via call center representative and described the occurrence of incorrect storage of drug in an unspecified number of patients who received DTPa (Reduced antigen) (Boostrix) (batch number 3335K, expiry date 28-SEP-2025) for prophylaxis.   Co-suspect products included DTPa (Infanrix) (batch number M52GG, expiry date 07-SEP-2026) for prophylaxis, Rota (Rotarix liquid formulation) (batch number HP495, expiry date 17-MAY-2026) for prophylaxis, DTPa-HBV-IPV (Pediarix) (batch number 2G273, expiry date 15-APR-2027) for prophylaxis, Flu Seasonal TIV Quebec (FluLaval 2024-2025 season) (batch number J5T9Z, expiry date 06-JUN-2025) for prophylaxis and Men ACWY-CRM NVS (Menveo) (batch number 9M2R7, expiry date 31-DEC-2025) for prophylaxis.   On an unknown date, the patient received Boostrix, Infanrix, Rotarix liquid formulation, Pediarix, FluLaval 2024-2025 season and Menveo. On an unknown date, an unknown time after receiving Boostrix, Infanrix, Rotarix liquid formulation, Pediarix, FluLaval 2024-2025 season and Menveo, the patient experienced incorrect storage of drug (Verbatim: Vaccines administered after above and below 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: 07-FEB-2025 The physician called to report a temperature excursion that happened during 22 hours 50 minutes with a maximum temperature of 10.22 degree Celsius for Bexsero, Boostrix, Engerix-B, FluLaval, Havrix, Infanrix, Kinrix, Menveo (1-vial), Pediarix and Rotarix (liquid).  Those vaccines experienced two prior excursions, one of them during 32 hours 6 minutes with maximum temperature of 21.92 degree Celsius, and the other one during 9 hours 45 minutes with a minimum temperature of 1.53 degree Celsius.  Physician mentioned that after those temperature excursions, some of the vaccines were administered to patients 1 dose of Menveo (1-vial presentation), 2 doses of FluLaval, 3 doses of Pediarix, 3 doses of Rotarix (liquid presentation), 2 doses of Infanrix, and 1 dose of Boostrix, which led incorrect storage of drug. The reporter did not have any patient demographics, but mentioned that vaccines were administered between February 3rd and 4th 2025.  The reporter consented to follow up.
Age: 63.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Pain, Peripheral swelling, Product preparation issue, Pyrexia
Clinical narrative: body ache; fever; arm  swelling; Adjuvant administered alone; gave just the adjuvant component alone; This non-serious case was reported by a nurse via call center representative and described the occurrence of general body pain in a 63-year-old female patient who received Herpes zoster (Shingrix) (batch number N77J2, expiry date 23-OCT-2026) and (batch number 7ZM55, expiry date 15-NOV-2026) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis.   On 07-FEB-2025, the patient received the 2nd dose of Shingrix. On 06-DEC-2024, the patient received the 1st dose of Shingrix. On 07-FEB-2025, an unknown time after receiving Shingrix and not applicable after receiving Shingrix, the patient experienced inappropriate preparation of medication (Verbatim: Adjuvant administered alone) and inappropriate dose of vaccine administered (Verbatim: gave just the adjuvant component alone). On an unknown date, the patient experienced general body pain (Verbatim: body ache), fever (Verbatim: fever) and swelling arm (Verbatim: arm  swelling). The outcome of the general body pain, fever and swelling arm were resolving and the outcome of the inappropriate preparation of medication and inappropriate dose of vaccine administered were unknown.   It was unknown if the reporter considered the general body pain, fever and swelling arm to be related to Shingrix.     It was unknown if the company considered the general body pain, fever and swelling arm to be related to Shingrix.   Additional Information: GSK Receipt Date : 12-FEB-2025 Registered Nurse mentioned that a patient got a first dose of Shingrix on December 6th 2024 and they came to get a second dose on February 7th 2025 but they accidentally gave just the adjuvant component alone which led to Inappropriate preparation of medication and Inappropriate dose of vaccine administered. So when they realized of the error, they discussed with the patient and decided to give another dose properly mixed on the other arm that same day. Reporter mentioned that after the first dose the patient experienced body aches, fever and arm swelling, and they recommended patient to took Tylenol or Benadryl if needed after the second dose if they feel symptoms, but mentioned that patient was feeling fine so far.; Sender's Comments:  US-GSK-US2025018343:same reporter
Sex: M
Vaccine: TDAP
Symptoms: Pruritus
Clinical narrative: whole body itching/Systemic and general itching reaction; This non-serious case was reported by a consumer via call center representative and described the occurrence of generalized pruritus in a 59-year-old male patient who received DTPa (Reduced antigen) (Boostrix) for prophylaxis.   On an unknown date, the patient received Boostrix. On an unknown date, an unknown time after receiving Boostrix, the patient experienced generalized pruritus (Verbatim: whole body itching/Systemic and general itching reaction). The patient was treated with diphenhydramine hydrochloride (Benadryl) and valaciclovir. The outcome of the generalized pruritus was resolved (duration 1 week).   It was unknown if the reporter considered the generalized pruritus to be related to Boostrix and Boostrix Pre-Filled Syringe Device.     It was unknown if the company considered the generalized pruritus to be related to Boostrix and Boostrix Pre-Filled Syringe Device.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK Receipt Date: 14-FEB-2025 The patient wife reported that a patient had a whole body itching systemic and general itching reaction for one week. The patient had been taking Benadryl and Valaciclovir. The wife wants to know which ingredient had to do with this adverse event. No specific vaccination date given but wife said it was about two weeks ago in Jan 2025, no vaccine detail were obtained in this call. Patient demographics were obtained in this call. No further information was obtained in this call.
Vaccine: HEP
Symptoms: Intercepted product prescribing error
Clinical narrative: Prescription of 1 mL dose to 18 year old patient; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of drug prescribing error in a 18-year-old patient who received HBV (Engerix B) for prophylaxis.   On an unknown date, the patient did not receive Engerix B 1 ml. On an unknown date, an unknown time after receiving Engerix B, the patient experienced drug prescribing error (Verbatim: Prescription of 1 mL dose to 18 year old patient). The outcome of the drug prescribing 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: 18-FEB-2025 The pharmacist called to inform that one of their patients was an 18-year-old that needs the 1 mL dosing of Engerix-B. Reporter mentioned that the doctor had prescribed this 18-year-old patient a 20 year-old dosing which led to Drug prescribing error. No more details were provided by reporter.
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: Incomplete course of vaccination/not received the second dose; This non-serious case was reported by a nurse via call center representative and described the occurrence of incomplete course of vaccination in a patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received first dose of Shingrix on 03 Oct 2023).   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: Incomplete course of vaccination/not received the second dose). The outcome of the incomplete course of vaccination was not applicable.   Additional Information: GSK Receipt Date: 19-FEB-2025 The registered nurse mentioned If a person received their first dose of Shingrix on 03 Oct 2023 and had not received the second dose would they just need to complete the second series or would they need to restart. The health care professional reject to provide any other information. Till the time of reporting, the patients did not receive second dose of Shingrix, which led to incomplete course of vaccination.
Age: 0.67
Sex: M
Vaccine: RV1
Symptoms: Extra dose administered
Clinical narrative: Third dose given; This non-serious case was reported by a other health professional via call center representative and described the occurrence of extra dose administered in a 8-month-old male patient who received Rota (Rotarix lyophilized formulation) (batch number 5N2AN) for prophylaxis.   Previously administered products included Rotarix (received first dose of Rotarix on an unknown date) and Rotarix (received second dose of Rotarix on an unknown date).   On 18-FEB-2025, the patient received the 3rd dose of Rotarix lyophilized formulation. On 18-FEB-2025, an unknown time after receiving Rotarix lyophilized formulation, the patient experienced extra dose administered (Verbatim: Third dose given). The outcome of the extra dose 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: 20-FEB-2025 The other health professional reported that third vaccines dose in an 8 month old patient which led to extra dose administered.  The Vaccine Administration Facility was the same as Primary Reporter.
Sex: M
Vaccine: DTAPIPV
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: underage; wrong dose in schedule; This non-serious case was reported by a physician via call center representative and described the occurrence of inappropriate age at vaccine administration in a 9-month-old male patient who received DTPa-IPV (Kinrix) for prophylaxis.   On 20-FEB-2025, the patient received the 3rd dose of Kinrix. On 20-FEB-2025, an unknown time after receiving Kinrix, the patient experienced inappropriate age at vaccine administration (Verbatim: underage) and wrong vaccine administered (Verbatim: wrong dose in schedule). The outcome of the inappropriate age at vaccine administration and wrong vaccine administered were 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: 21-FEB-2025 The physician reported that a 9 month old patient received Kinrix in error, which led to inappropriate age at vaccine administration. Patient was due for DTaP and IPV, which led to wrong vaccine administered. Kinrix was the patient's 3rd dose of each.   The patient received their 2nd dose of a DTaP and an IPV on 19-NOV-2024(no mention of brand).
Vaccine: MENB, MENB
Symptoms: Interchange of vaccine products
Clinical narrative: Patient had received a dose of Trumenba and one dose of Bexsero; This non-serious case was reported by a other health professional via call center representative and described the occurrence of interchange of vaccine products in a patient who received Men B NVS (Bexsero) for prophylaxis.   Co-suspect products included Meningococcal vaccine B rfHbpA/fHbpB (Trumenba) for prophylaxis.   On an unknown date, the patient received Bexsero and Trumenba. On an unknown date, an unknown time after receiving Bexsero, the patient experienced interchange of vaccine products (Verbatim: Patient had received a dose of Trumenba and one dose of Bexsero). The outcome of the interchange of vaccine products 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: 21-FEB-2025 The reporter mentioned that a patient had received a dose of Trumenba and one dose of Bexsero , which led to interchange of vaccine products. They wanted to know if the patient still need another Bexsero dose in order to complete the series. The reporter did not provide further details.
Vaccine: COVID19
Symptoms: Chest pain
Clinical narrative: chest pains; 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.  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 and frequency not reported, administered on Jun-2021, additional dosage information included: Dose series 1, for covid-19 prophylaxis. The batch number was not reported. Company was unable to perform follow-up to request batch/lot numbers.  No concomitant medications were reported.  On Jun-2021, the patient experienced chest pains. (Dose series: 1). The patient had chest pains immediately after the Covid vaccine in June 2021 for 12weeks.  The action taken with janssen covid-19 vaccine was not applicable.  The outcome of chest pains was not reported.  This report was non-serious.
Age: 76.0
Sex: F
Vaccine: COVID19
Symptoms: Eczema
Clinical narrative: I developed eczema; This spontaneous case was reported by a patient and describes the occurrence of ECZEMA (I developed eczema) in a 76-year-old female patient 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) (Intramuscular use) 1 dosage form. On an unknown date, the patient experienced ECZEMA (I developed eczema). At the time of the report, ECZEMA (I developed eczema) had not resolved.        The action taken with SPIKEVAX NOS (SPIKEVAX NOS) (Intramuscular use) was unknown.       No concomitant medication was reported. It was unknown if the patient experienced any additional symptoms/events. No treatment medication was reported. Reporter causality was not reported.
Vaccine: DTAPIPVHIB, DTPPVHBHPB, MMR, VARCEL
Symptoms: Product preparation issue
Clinical narrative: inadvertently reconstituted both the MMR II and VARIVAX Vaccines with the VAXELIS Vaccine instead of the STERILE DILUENT. The patient received both vaccines on the same day on 01/27/2025.; Vaccines with the VAXELIS Vaccine instead of the STERILE DILUENT. Pentacel vaccine administered the same day; inadvertently reconstituted both the MMR II and VARIVAX Vaccines with the VAXELIS Vaccine instead of the STERILE DILUENT. The patient received both vaccines on the same day on 01/27/2025.; This non-serious, spontaneous, safety report was received by partner on 30-JAN-2025 and forwarded to agency on 30-JAN-2025 from a healthcare professional.  Due to the nature of the event, the causality between the event "inadvertently reconstituted both the MMR II and VARIVAX Vaccines with the VAXELIS Vaccine instead of the STERILE DILUENT. The patient received both vaccines on the same day on 01/27/2025" and Vaxelis was not applicable.    Further information is expected  Significant follow-up information was received by the partner on 13-FEB-2025 and forwarded to agency on 13-FEB-2025, from other health professional. The case is maintained as non-serious.  Due to the nature of the event, the causality between the event "inadvertently reconstituted both the MMR II and VARIVAX Vaccines with the VAXELIS Vaccine instead of the STERILE DILUENT. The patient received both vaccines on the same day on 01/27/2025" and Vaxelis was not applicable.    Further information is not expected.
Vaccine: COVID19
Symptoms: Device breakage
Clinical narrative: One of the vials was damaged/one of the vials was broken/They have not administered it; This is a spontaneous report received from a Consumer or other non HCP from product quality group.  A patient (age and gender not provided) received BNT162b2 omicron (kp.2) (COMIRNATY (2024-2025 FORMULA)), (Lot number: LP1776, Expiration Date: 26Apr2025) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DEVICE BREAKAGE (non-serious), outcome "unknown", described as "One of the vials was damaged/one of the vials was broken/They have not administered it". The action taken for BNT162b2 omicron (kp.2) was unknown.  Additional information: One of their vaccines that they received from Pfizer, she realized that one of the vials was damaged. They have not administered it or utilized it. She just realized that one of the vials was broken when she unboxed that. The vaccine was not administered to any patient. They are looking to either return it or get it replaced or get credit.  Causality for "one of the vials was damaged/one of the vials was broken/they have not administered it" was determined associated to device constituent of BNT162b2 omicron (kp.2) (malfunction).  Product Quality Group provided investigational results on 17Feb2025 for bnt162b2 omicron (kp.2) (device constituent): The complaint for "one of the vials was broken when she unboxed that" of Comirnaty PFS was investigated. The investigation included reviewing the involved batch records, deviation investigation, a picture of the complaint sample, evaluation of retain sample and an analysis of the complaint history for the involved scope and Annual Product Review. Quantity of returned complaint sample: picture. The reported defect was present on the returned complaint sample picture. The complaint is confirmed. No root cause or CAPA were identified as all reviewed records in scope of this investigation met the established requirements at time of release. No related quality issues were identified during the investigation. There is no impact on product quality, regulatory, validation, stability and patient safety. Agency concludes that the reported defect is not representative of the quality of the batch and the batch remains acceptable. The NTM process determined that a regulatory notification was required. The final scope was determined to be the associated lots of the reported lot LP1776. The reported defect is not representative of the quality of the batch, and reported lot remains acceptable for further distribution. Device Investigation: This investigation is based on the information captured in the Complaint Description and Argus Report. The Complaint Issue "Luer Lock Detached During Prep/Use" was reported. The complaint issue is selected as per the sample. The Risk Management File was reviewed to confirm that the Hazard(s) and Hazardous Situation(s) associated with the Complaint Issue are documented in the Hazard Analysis. All complaint investigations are trended. There no current trend alert documented.
Sex: M
Vaccine: COVID19
Symptoms: Feeling abnormal
Clinical narrative: first 3 they made me feel bad; This is a spontaneous report received from a Consumer or other non HCP from medical information team.  A 61-year-old male patient received BNT162b2 (BNT162B2), as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: FEELING ABNORMAL (non-serious), outcome "recovered", described as "first 3 they made me feel bad".  Additional information: The first three vaccines made the patient feel bad, but in 2 to 3 days, the patient went back to normal.  No follow-up attempts are possible. Batch/lot number is not provided, and it cannot be obtained.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202500040306 same reporter/patient, different dose/event;
Sex: M
Vaccine: COVID19
Symptoms: Feeling abnormal
Clinical narrative: first 3 they made me feel bad; This is a spontaneous report received from a Consumer or other non HCP from medical information team.  A 61-year-old male patient received BNT162b2 (BNT162B2), as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose 1, single), for COVID-19 immunization, reaction(s): "made me feel bad". The following information was reported: FEELING ABNORMAL (non-serious), outcome "recovered", described as "first 3 they made me feel bad". Additional information: The first three vaccines made the patient feel bad, but in 2 to 3 days, the patient went back to normal.  No follow-up attempts are possible. Batch/lot number is not provided, and it cannot be obtained.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202500040306 same reporter/patient, different dose/event;
Sex: M
Vaccine: COVID19
Symptoms: Feeling abnormal
Clinical narrative: feel bad; This is a spontaneous report received from a Consumer or other non HCP from medical information team.  An adult male patient received BNT162b2 (BNT162B2 NOS), as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (dose 1), for COVID-19 immunisation, reaction(s): "feel bad"; Bnt162b2 (dose 2), for COVID-19 immunisation, reaction(s): "feel bad". The following information was reported: FEELING ABNORMAL (non-serious), outcome "recovered", described as "feel bad". Additional information: The first 3 they made the patient feel bad but in 2 to 3 days, the patient was back to normal.  No follow-up attempts are possible. Batch/lot number is not provided, and it cannot be obtained.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202500040306 same reporter/patient, different dose/event;US-PFIZER INC-202500040789 same reporter/patient, different dose/event;US-PFIZER INC-202500040790 same reporter/patient, different dose/event;
Age: 48.0
Sex: F
Vaccine: COVID19
Symptoms: Escherichia sepsis, IgA nephropathy, Urinary tract infection
Clinical narrative: sepsis (E Coli); IGA Nephropathy; had 3 UTI's; This is a spontaneous report received from a Consumer or other non HCP.  A 51-year-old female patient received BNT162b2 (BNT162B2), on 03Mar2021 as dose 2, single (Batch/Lot number: unknown) at the age of 48 years, in arm for covid-19 immunisation. The patient's relevant medical history included: "Allergy to tree nuts" (unspecified if ongoing). There were no concomitant medications. No other vaccine on the same date. Vaccination history included: Covid-19 (DOSE 1, SINGLE; Manufacturer unknown), for COVID-19 immunization. The following information was reported: IGA NEPHROPATHY (medically significant) with onset 04Dec2023, outcome "recovered with sequelae"; URINARY TRACT INFECTION (medically significant) with onset 04Dec2023, outcome "recovered with sequelae", described as "had 3 UTI's"; ESCHERICHIA SEPSIS (hospitalization) with onset 04Dec2023, outcome "recovered with sequelae", described as "sepsis (E Coli)". The patient was hospitalized for escherichia sepsis (hospitalization duration: 4 day(s)).  Clinical course: Prior to this vaccine patient never had an kidney issues or UTI's in her life. Now in 2023 she had 3 UTI's. 2 that she been hospitalized for sepsis (e Coli). And also have been diagnosed with IGA nephropathy. Patient truly believed all this issues were from the vaccine, now she had to live with this the rest of her life. Therapeutic measures were not taken as a result of escherichia sepsis, iga nephropathy, urinary tract infection.  The information on the batch/lot number for BNT162b2 will be requested and submitted if and when received.
Age: 40.0
Sex: F
Vaccine: COVID19, FLU3
Symptoms: Vaccination site erythema, Vaccination site pruritus, Vaccination site rash, Vaginal haemorrhage
Clinical narrative: Abnormal vaginal bleeding (2.5 weeks too early for a period - have never had mid cycle bleeding); Large itchy red rash at injection site; Large itchy red rash at injection site; Large itchy red rash at injection site; This is a spontaneous report received from a Consumer or other non HCP.  A 40-year-old female patient (not pregnant) received BNT162b2 omicron (kp.2) (COMIRNATY (2024-2025 FORMULA)), on 18Feb2025 at 19:00 as dose 1, single (Batch/Lot number: unknown) at the age of 40 years, in left arm for covid-19 immunisation; influenza vaccine rha 3v (baculovirus) (FLUBLOK), on 18Feb2025 as dose 1, single (Lot number: 49281072410), in left arm for immunisation. The patient's relevant medical history included: "Ehlers-Danlos Syndrome" (unspecified if ongoing). Concomitant medication(s) included: ESCITALOPRAM, start date: 01Aug2021, stop date: 21Feb2025; PRAZOSIN, start date: 01May2023, stop date: 21Feb2025. The following information was reported: VACCINATION SITE PRURITUS (non-serious), VACCINATION SITE ERYTHEMA (non-serious), VACCINATION SITE RASH (non-serious) all with onset 19Feb2025, outcome "not recovered" and all described as "Large itchy red rash at injection site"; VAGINAL HAEMORRHAGE (non-serious) with onset 21Feb2025, outcome "not recovered", described as "Abnormal vaginal bleeding (2.5 weeks too early for a period - have never had mid cycle bleeding)". Therapeutic measures were not taken as a result of vaccination site pruritus, vaccination site erythema, vaccination site rash, vaginal haemorrhage.  Additional information: The patient did not receive any other vaccines within 4 weeks PRIOR to the vaccine(s). Large itchy red rash at injection site starting 19Feb2025. Abnormal vaginal bleeding starting 21Feb2025 (2.5 weeks too early for a period - have never had mid cycle bleeding)  The information on the batch/lot number for BNT162b2 omicron (kp.2) will be requested and submitted if and when received.
Sex: M
Vaccine: FLUX
Symptoms: Eczema
Clinical narrative: Eczema after 5-7 days after taking a flu vaccine; This spontaneous case, initially received on 14-Feb-2025, was reported by a non health professional and concerns a male patient with unknown age.  Drug history included morphine (Reaction: Allergy). At the time of the event the patient had allergic to cats. No concomitant medications were reported.  Administration of company suspect drug: On an unknown date, the patient received INN Flu Vaccine Seasonal for unknown indication, dose, route of administration and anatomical location: not reported. Lot number: No batch number available but will be requested upon follow-up.  No additional suspect drugs.  Adverse reactions/events and outcomes: On an unknown date, the patient experienced Eczema after 5-7 days after taking a flu vaccine (outcome: Recovered / Resolved).  Consumer inquired about adverse reaction after taking one of vaccines. He stated that after 5 to 7 days after taking the vaccine he experienced eczema, he went to his dermatologist, which gave him a shot of steroid. He mentioned that he's going to a allergologist to be tested for several allergens. He also mentioned that he's allergic to cat and morphine, but not allergic to egg. He was not sure about what vaccine he took. He wanted to check what probably caused him the eczema.  INN Flu Vaccine Seasonal action taken: Not Applicable Treatment medication: Unspecified Steroids  Reporter assessment: The reporter considered the event as non serious and did not provide a causality assessment.; Reporter's Comments: The event is related to the vaccine
Vaccine: COVID19
Symptoms: Thrombosis
Clinical narrative: I have suffered blood clots since getting the Moderna vaccines; This spontaneous case was reported by a patient and describes the occurrence of THROMBOSIS (I have suffered blood clots since getting the Moderna vaccines) in a  patient of an unknown age and gender 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) (Intramuscular use) 1 dosage form. On an unknown date, the patient experienced THROMBOSIS (I have suffered blood clots since getting the Moderna vaccines) (seriousness criterion medically significant). At the time of the report, THROMBOSIS (I have suffered blood clots since getting the Moderna vaccines) had not resolved.        The action taken with SPIKEVAX NOS (SPIKEVAX NOS) (Intramuscular use) was unknown.       No concomitant medication was reported.  The patient was on blood thinners for the rest of life.  No specified treatment medication was reported.; Reporter's Comments: The benefit-risk relationship of mRNA-1273 (Spikevax) vaccine is not affected by this report.
Age: 18.0
Sex: M
Vaccine: HEP
Symptoms: Expired product administered
Clinical narrative: An expired dose of hep B was given to a patient. It was not realized until after the vaccine was given that it was expired as our computer inventory said it expired 12/17/2025 and the vaccine expiration date on the package and the vaccine itself said 2/17/25. Call placed to GSK to inquire if vaccine is potentially still good since close to expiration date. GSK said they do in-house testing which shows the potency of the vaccine remains satisfactory for up to 30 days after expiration however they have to recommend per CDC & immunize.gov that the dose be considered invalid and be repeated ASAP. Attempted to reach patient and was not able to get a hold of them. Will continue to try and reach patient. Updated MD who was present, as well as clinic manager and clinical director.
Age: 0.42
Sex: M
Vaccine: DTAPHEPBIP
Symptoms: Urticaria
Clinical narrative: Hives
Age: 50.0
Sex: F
Vaccine: FLU3, PNC21, VARZOS
Symptoms: Fatigue, Influenza like illness, Peripheral swelling, Pyrexia
Clinical narrative: Pt got vaccines on 2/21, started to have fever on 2/22. She called pharmacy on 2/25 to report her fever is getting better, but still feel tire with flu like symptoms and right arm swelling.
Age: 81.0
Sex: M
Vaccine: UNK
Symptoms: No adverse event
Clinical narrative: NO ADVERSE REACTIONS NOTED TO.
Age: 76.0
Sex: F
Vaccine: RSV, VARZOS
Symptoms: Extra dose administered
Clinical narrative: Patient received a RSV shot on 8/28/23 and then another on 2/24/2025. She hasn't reported any issues other than maybe some headache/lightheadedness. We told the patient to call us if any issue came up.
Age: 65.0
Vaccine: HEPAB
Symptoms: Pain in extremity
Clinical narrative: pt called today stating her arm has been hurting after she got last vaccine in november. which was twinrix.
Age: 16.0
Sex: F
Vaccine: MNQ
Symptoms: Extra dose administered, No adverse event
Clinical narrative: none thus far
Age: 30.0
Sex: F
Vaccine: TDAP, TDAP
Symptoms: Arthralgia, Bone pain, Impaired work ability, Injected limb mobility decreased, Product administered at inappropriate site
Clinical narrative: On 2/23/2025 a pharmacist or technician (I?m not exactly sure what their title is) gave me a tetanus shot, right on top of my left shoulder causing me excruciating pain on my shoulder, collar bone and immobility on my left arm. Because of that, I was told by my occupational health department at my work that I can?t go back to work if I?m under restrictions because my job is unable to accommodate me. So I?m out a week at least. I work a very hands on job. I went to see a doctor the next day  (02/24/2025) because I was unable to sleep at night due to the pain getting worse. My doctor looked very appalled after I explained how the vaccine was injected; I was told Vaccines like tetanus shots are supposed to be administered in the deltoid muscle, not on top of the shoulder which is considered improper technique, violating the standard of care.
Age: 30.0
Sex: F
Vaccine: TDAP, TDAP
Symptoms: Sleep disorder, X-ray limb
Clinical narrative: On 2/23/2025 a pharmacist or technician (I?m not exactly sure what their title is) gave me a tetanus shot, right on top of my left shoulder causing me excruciating pain on my shoulder, collar bone and immobility on my left arm. Because of that, I was told by my occupational health department at my work that I can?t go back to work if I?m under restrictions because my job is unable to accommodate me. So I?m out a week at least. I work a very hands on job. I went to see a doctor the next day  (02/24/2025) because I was unable to sleep at night due to the pain getting worse. My doctor looked very appalled after I explained how the vaccine was injected; I was told Vaccines like tetanus shots are supposed to be administered in the deltoid muscle, not on top of the shoulder which is considered improper technique, violating the standard of care.
Age: 30.0
Sex: F
Vaccine: TDAP, TDAP
Symptoms: Limb injury
Clinical narrative: On 2/23/2025 a pharmacist or technician (I?m not exactly sure what their title is) gave me a tetanus shot, right on top of my left shoulder causing me excruciating pain on my shoulder, collar bone and immobility on my left arm. Because of that, I was told by my occupational health department at my work that I can?t go back to work if I?m under restrictions because my job is unable to accommodate me. So I?m out a week at least. I work a very hands on job. I went to see a doctor the next day  (02/24/2025) because I was unable to sleep at night due to the pain getting worse. My doctor looked very appalled after I explained how the vaccine was injected; I was told Vaccines like tetanus shots are supposed to be administered in the deltoid muscle, not on top of the shoulder which is considered improper technique, violating the standard of care.
Age: 63.0
Sex: F
Vaccine: PNC20, TDAP
Symptoms: Injection site erythema, Injection site pruritus
Clinical narrative: On 02/17/25, patient received Prevnar 20 IM left deltoid and Boostrix IM right deltoid. On 02/23/25, she began experiencing itchiness and redness below the injection site of left arm (Prevnar 20) and redness below injection site of right arm (Boostrix). She states both have improved since, but still has some redness on both arms. She purchased hydrocortisone cream 02/25/25 as recommended by a family member who is a physician.
Age: 11.0
Sex: F
Vaccine: HEPA, MNQ
Symptoms: Erythema, Peripheral swelling, Pyrexia, Skin warm
Clinical narrative: The next day after getting the vaccine, got fever of 102 and extreme right arm  swelling, redness and warm.
Age: 61.0
Sex: M
Vaccine: VARZOS
Symptoms: Rash
Clinical narrative: Patient started having rash on the same arm that was vaccinated a few days later after receiving vaccine -the left arm--Rash continued traveling down arm. Patient is now expiring rash on other arm.
Age: 74.0
Sex: M
Vaccine: PNC20
Symptoms: Injection site erythema, Injection site pruritus
Clinical narrative: REDNESS PRESENT AT THE INJECTION SITE A DAY AFTER THE INJECTION.  PATIENT REPORT THAT BEGIN ITCHING 9 DAYS AFTER INJECTION
Age: 32.0
Sex: M
Vaccine: COVID19
Symptoms: Chest pain, Computerised tomogram, Coordination abnormal, Dizziness, Dyspnoea
Clinical narrative: Sinus tachycardia ( diagnosed svt), therapist accelerating and deceleration if heart rate, shortness of breath, Dizziness, fainting, left side of body, legs and face numbness, vision changes, severe chest pain, palputations, complete color in skin loss, motorskills and coordination loss, memory issues.