chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 43.0
Sex: F
Vaccine: COVID19, FLU3
Symptoms: Pain, Pregnancy test urine positive, Ultrasound antenatal screen abnormal, Vaginal discharge
Clinical narrative: Pt began having lower abdominal pain about 8 hours after vaccines. Took tylenol, did not help. Started having some vaginal discharge the next morning, Felt vaguely unwell until 1/15/2025 when increasing pain and cramping and pt had miscarriage. Pt was approximately 11 weeks pregnant and Due Aug 15, 2025. Pt denies having prior episodes of spotting, cramping during this pregnancy.
Age: 64.0
Sex: M
Vaccine: VARZOS
Symptoms: Headache, Myalgia, Nausea
Clinical narrative: Muscle ache, nausea, headache
Age: 77.0
Sex: F
Vaccine: COVID19
Symptoms: Atrial fibrillation
Clinical narrative: Pt called 6 days later stating that she experienced about 14 hours of Afib after the vaccine but did not go to her MD's office nor seek medical attention. stated that she was familiar with the feeling and assumed it would go away. Pt had no record of prior reporting to pharmacy that she had history of AFib. rph added to  pt's profile today 01/16/2025.
Age: 74.0
Sex: F
Vaccine: TDAP
Symptoms: Arthralgia, Joint stiffness, Joint swelling, Pain in extremity, Peripheral swelling
Clinical narrative: Pt called pharmacy to report that he had both of his hands and wrist swell about 2 days after the vaccine admin day. he stated that they feel very stiff and there is some pain. counseled pt to take Ibuprofen but he stated he had renal issues so he may not take those NSAIDs. advised pt to see his PCP if it doesn't get better. Per facts and comparisons it is already listed that s/e may include myalgia, joint swelling, and arthralgia.
Age: 2.0
Sex: F
Vaccine: FLU3, HEPA
Symptoms: Incorrect dose administered, No adverse event
Clinical narrative: I accidentally administered adult dose of Havrix rather than pediatric dose. I called mom this afternoon (1/16) to see how patient was doing and let her know what occurred. Mom states she is doing well and hasn't had any side effects. I let her know that patient may be at an increased risk for decreased appetite, nausea, vomiting, and fevers (as per GSK documentation), and requested she let us know if patient has any of these reactions.
Age: 9.0
Sex: M
Vaccine: COVID19
Symptoms: Incorrect dose administered, No adverse event
Clinical narrative: The pt was given the Comirnaty vaccine (12 years and older), and the pt is 6 years old. No side effects seen.
Sex: F
Vaccine: MMRV
Symptoms: Expired product administered, No adverse event
Clinical narrative: no adverese event; Vaccine was administered to a patient one day after expiration date; This spontaneous report was received from a nurse, referring to a 4-year-old female patient.  The patient's medical history, concurrent conditions, drug reactions/allergies, and concomitant therapies were not reported.  On 07-JAN-2025, the patient was vaccinated with expired vaccine of measles, mumps, rubella and varicella (oka-merck) virus vaccine live (recombinant human albumin [rHA]) (PROQUAD) injection, lot #X018732, expiration date: 06-JAN-2025, administered for prophylaxis (strength, dose, and route of administration were not provided) (expired product administered). Expired dose never experienced a temperature excursion. No side effects or symptoms reported (no adverse event).
Age: 32.0
Sex: M
Vaccine: HPV9
Symptoms: Device connection issue, Exposure via skin contact, No adverse event, Syringe issue, Underdose
Clinical narrative: No additional adverse event was reported; medicine leaked down patients arm from syringe while injected; medicine leaked down patients arm from syringe while injected; medicine leaked down patients arm from syringe while injected; medicine leaked down patients arm from syringe while injected; medicine leaked down patients arm from syringe while injected; This spontaneous report was received from Other Health Professional and refers to a 32-year-old male.  The patient's medical history was not reported. The patient's concurrent conditions were not reported. Concomitant therapies were not reported.  On 10-OCT-2024, the patient was vaccinated with third dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) injection, unk, lot #1965046, expiration date: 22-JAN-2026, administered intramuscularly for prophylaxis (strength was not provided). While administerin the vaccine, the medicine leaked aownd patients arm from the connection between syringe hub or luer lock and syringe needle (Accidental exposure to product, exposure via skin contact, accidental underdose, device leakage and poor quality device used). No additional adverse events were reported. ; Sender's Comments:  US-009507513-2412USA005429:
Age: 35.0
Sex: M
Vaccine: HPV9
Symptoms: Device connection issue, Exposure via skin contact, No adverse event, Syringe issue, Underdose
Clinical narrative: No additional adverse event was reported; medicine leaked down patients arm from syringe while injected; medicine leaked down patients arm from syringe while injected; medicine leaked down patients arm from syringe while injected; medicine leaked down patients arm from syringe while injected; medicine leaked down patients arm from syringe while injected; This spontaneous report was received from Other Health Professional and refers to a 35-year-old male.  The patient's medical history was not reported. The patient's concurrent conditions were not reported. Concomitant therapies were not reported.  On 10-OCT-2024, the patient was vaccinated with third dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) injection, unk, lot #1965046, expiration date: 22-JAN-2026, administered intramuscularly for prophylaxis (strength was not provided). While administerin the vaccine, the medicine leaked aownd patients arm from the connection between syringe hub or luer lock and syringe needle (Accidental exposure to product, exposure via skin contact, accidental underdose, device leakage and poor quality device used). No additional adverse events were reported. ; Sender's Comments:  US-009507513-2412USA005429:
Sex: F
Vaccine: HEP
Symptoms: Urticaria
Clinical narrative: chronic hives after a Hep.B booster; This spontaneous report was received from Consumer and refers to a female patient of an unknown age.  The patient's medical history, concurrent conditions, previous drugs reactions or allergies and concomitant therapies were not reported.  On an unknown date, the patient was vaccinated with hepatitis b vaccine (recombinant) (RECOMBIVAX HB) intramuscular injection, booster dose administered for prophylaxis (strength, dose, lot #, expiry date, and route of administration were not provided).  On an unknown date, the patient experienced chronic hives. At the time of reporting, the outcome of the event was not known.   The causal relationship between the event and hepatitis b vaccine (recombinant) (RECOMBIVAX HB) was unknown.  Lot # is being requested and will be submitted if received.
Sex: U
Vaccine: RV5
Symptoms: Extra dose administered
Clinical narrative: No symptoms reported; Medical assistant calling to report an AE on "overvaccination" with ROTATEQ.  Per the HCP, a patient has already completed the ROTATEQ vaccine series as of Nov 2024 and was administered an additional dose on 01/14/2025; This spontaneous report was received from a medical assistant concerning to a patient of unspecified age and gender.  The patient's medical history, concurrent conditions, concomitant therapies and drug reactions/allergies were not reported.  On unknown dates, the patient was vaccinated with the 1st and 2nd doses of rotavirus vaccine, live, oral, pentavalent (ROTATEQ) oral liquid (exact dose, lot # and expiry date were not provided) administered orally (po). On an unspecified date in November 2024, the patient completed the vaccine series with the 3rd dose of rotavirus vaccine, live, oral, pentavalent (ROTATEQ) oral liquid (exact dose, lot # and expiry date were not provided) po. Then, on 14-JAN-2025, the patient received an additional dose of rotavirus vaccine, live, oral, pentavalent (ROTATEQ) oral liquid, 2 ml po once after completing 3 doses, lot # 2081735, expiration date 03-MAR-2026 (extra dose administered). All vaccine doses were administered as prophylaxis.  There were no symptoms reported (no adverse event). No further information was available.  Lot # is being requested and will be submitted if received.
Sex: F
Vaccine: SMALLMNK
Symptoms: Incomplete course of vaccination
Clinical narrative: The patient received first dose of Jynneos vaccine in October 2024 and then was beyond the recommended four weeks interval; Case reference number US-BN-2025-000006 is a spontaneous case initially received from pharmacist via Communication (reference number: USBAV25-0021) on 03-Jan-2025 and concerns a female patient of unspecified age.  The patient's medical history and concomitant medication details were not provided.  On 01-Oct-2024, the patient received first dose of Jynneos vaccine (batch number: FDP00017, expired date: Oct-2024) at unknown dose, route or site of administration for unknown indication. As reported, the patient was due for the second dose and was beyond the recommended four weeks interval (explicitly coded as 'incomplete course of vaccination').  At the time of initial report, it was unknown if the patient experienced any adverse events due Jynneos.  No further information was provided.; Reporter's Comments: A female patient of unspecified age received the first dose of Jynneos vaccine for unknown indication. As reported, the patient was due for the second dose and was beyond the recommended four weeks interval, which is considered as incomplete course of vaccination. It was unknown if the patient experienced any adverse events due Jynneos. Incomplete course of vaccination is considered as listed per company convention. The patient's medical history and concomitant medication details were not provided. Incomplete course of vaccination is not related to the suspect vaccine, but to a human actor. This case is considered as non-serious.; Sender's Comments: A female patient of unspecified age received the first dose of Jynneos vaccine for unknown indication. As reported, the patient was due for the second dose and was beyond the recommended four weeks interval, which is considered as incomplete course of vaccination. It was unknown if the patient experienced any adverse events due Jynneos. Incomplete course of vaccination is considered as listed per company convention. The patient's medical history and concomitant medication details were not provided. Incomplete course of vaccination is not related to the suspect vaccine, but to a human actor. This case is considered as non-serious.
Sex: M
Vaccine: SMALLMNK
Symptoms: Incomplete course of vaccination
Clinical narrative: The patients had not come in for their second dose yet; Case reference number US-BN-2025-000016 is a spontaneous case report initially received from a pharmacist via Communication (reference number: USBAV25-0028) on 06-Jan-2025 and concerns two male patients of unspecified age (MULTI 2).  The patient's relevant medical history and concomitant medications were not provided.  On 25-Oct-2024, the second patient was vaccinated with the first dose of Jynneos vaccine (batch number: unknown) at an unknown dose, route, or site of administration for unknown indication.  On 28-Oct-2024, the first patient was vaccinated with the first dose of Jynneos vaccine (batch number: unknown) at an unknown dose, route, or site of administration for unknown indication.   As reported, the patients had not come in for their second dose of Jynneos yet (explicitly coded as 'incomplete course of vaccination').  At the time of the initial report, it was unknown if the patients experienced any adverse events due to Jynneos vaccine.  Additional information received from pharmacist via Communications (reference number: USBAV25-0029) on 08-Jan-2025: Information included reference number and confirmation there was two male patients.; Reporter's Comments: Two male patients of unspecified age did not receive the second dose of Jynneos yet in Jan-2025, after they were vaccinated with the first dose in Oct-2024, which is considered as incomplete course of vaccination. It was unknown if the patients experienced any adverse events due to Jynneos vaccine. Incomplete course of vaccination is considered as listed per company convention. The patient's medical history and concomitant medication details were not provided. Incomplete course of vaccination is not related to the suspect vaccine, but to a human factor. This case is considered as non-serious.; Sender's Comments: Two male patients of unspecified age did not receive the second dose of Jynneos yet in Jan-2025, after they were vaccinated with the first dose in Oct-2024, which is considered as incomplete course of vaccination. It was unknown if the patients experienced any adverse events due to Jynneos vaccine. Incomplete course of vaccination is considered as listed per company convention. The patient's medical history and concomitant medication details were not provided. Incomplete course of vaccination is not related to the suspect vaccine, but to a human factor. This case is considered as non-serious.
Sex: M
Vaccine: VARZOS
Symptoms: Endotracheal intubation, Pulmonary alveolar haemorrhage
Clinical narrative: critically ill with DAH; This serious case was reported by a consumer and described the occurrence of diffuse alveolar hemorrhage in a 78-year-old male patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Concurrent medical conditions included diabetes. Concomitant products included insulin degludec (Tresiba).   On 28-DEC-2024, the patient received the 1st dose of Shingles vaccine. On 01-JAN-2025, 4 days after receiving Shingles vaccine, the patient experienced diffuse alveolar hemorrhage (Verbatim: critically ill with DAH) (serious criteria hospitalization and GSK medically significant). The outcome of the diffuse alveolar hemorrhage was not resolved.   It was unknown if the reporter considered the diffuse alveolar hemorrhage to be related to Shingles vaccine.     The company considered the diffuse alveolar hemorrhage to be unrelated to Shingles vaccine.   Additional Information: GSK receipt date: 05-JAN-2025 Consumer stated that 3 days after the vaccine patient became critically ill with DAH, also stated that patient was intubated at the time of reporting. Hospitalization dates were unknown..; Sender's Comments: Pulmonary alveolar haemorrhage  is an unlisted event which is considered unrelated to GSK vaccine  Shingles vaccine.
Sex: M
Vaccine: VARZOS
Symptoms: Malaise
Clinical narrative: ill since receiving the vaccine; This serious case was reported by a consumer via sales rep and described the occurrence of illness in a male 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 illness (Verbatim: ill since receiving the vaccine) (serious criteria hospitalization). The outcome of the illness was not resolved.   It was unknown if the reporter considered the illness to be related to Shingrix.     The company considered the illness to be unrelated to Shingrix.   Additional Information: GSK Receipt Date: 06-JAN-2025 While in market research, the patient mentioned that her brother had received the Shingrix vaccine and had an adverse event.  She stated that he had been ill since receiving the vaccine and had been hospitalized (unclear whether it was the result of the vaccination or for other reasons).; Sender's Comments: Illness  is an unlisted event which is considered unrelated to GSK vaccine  Shingrix.
Age: 30.0
Sex: F
Vaccine: COVID19, FLU4
Symptoms: Asthenia, Dizziness, Flushing, Hyperhidrosis
Clinical narrative: Dizziness/ Lightheadness; Weakness/asthenia; Flushed; Sweating/ diaphoretic/hyperhidrosis; This non-serious case was reported by a consumer via regulatory authority and described the occurrence of light headedness in a 30-year-old female patient who received Flu Seasonal QIV Quebec (FluLaval Quadrivalent 2024-2025 season) (batch number 2724I) for prophylaxis.   Co-suspect products included COVID-19 VACCINE PROT. SUBUNIT (NVX COV 2373) (NOVAVAX COVID-19 VACCINE) (batch number 6024MFO14A) for covid-19 immunization.   On 11-OCT-2024, the patient received FluLaval Quadrivalent 2024-2025 season (intramuscular, left deltoid) and the 1st dose of NOVAVAX COVID-19 VACCINE (intramuscular). On 11-OCT-2024, less than an hour after receiving FluLaval Quadrivalent 2024-2025 season, the patient experienced light headedness (Verbatim: Dizziness/ Lightheadness), weakness (Verbatim: Weakness/asthenia), flushing (Verbatim: Flushed) and diaphoresis (Verbatim: Sweating/ diaphoretic/hyperhidrosis). On 11-OCT-2024, the outcome of the light headedness, weakness, flushing and diaphoresis were resolved.   The reporter considered the light headedness, weakness, flushing and diaphoresis to be possibly related to FluLaval Quadrivalent 2024-2025 season and Flulaval Tetra Pre-Filled Syringe Device.     The company considered the light headedness, weakness, flushing and diaphoresis to be possibly related to FluLaval Quadrivalent 2024-2025 season and Flulaval Tetra 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: 18-DEC-2024 The patient received Covid and flu injections and  experienced mild dizziness/light headedness, flushed/sweating, weakness. Roughly 15 seconds after the flu shot was administered, the patient became diaphoretic and weak. The patient closed eyes for approximately 15 seconds and then her eyes reopened. She complained of weakness at that time also and Gatorade was given to the patient and stayed post vaccination for about 20 minutes. Patient's gait was checked and she was steady. She was and oriented to person, place, and time. She was escorted and left store with her boyfriend. No concomitants were used/reported. The reporter considered the light headedness, weakness, flushing and diaphoresis to be possibly related to Novavax Covid-19 Vaccine. This report was one of several cases received as part of a line-listing, each containing minimal information. No further information was expected.
Sex: U
Vaccine: RSV
Symptoms: Pyrexia
Clinical narrative: Fever; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of fever in a patient who received RSVPreF3 adjuvanted (Arexvy) for prophylaxis.   On an unknown date, the patient received Arexvy. On an unknown date, an unknown time after receiving Arexvy, the patient experienced fever (Verbatim: Fever). The outcome of the fever was not reported.   It was unknown if the reporter considered the fever to be related to Arexvy.     It was unknown if the company considered the fever to be related to Arexvy.   Additional Information: GSK Receipt Date: 17-DEC-2024 The reporter reported what about a fever
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: Suspected vaccination failure; have shingles have been supposedly Vaccinated against them; 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: have shingles have been supposedly Vaccinated against them). 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 to be unrelated to Shingles vaccine. It was unknown if the company considered the shingles to be related to Shingles vaccine.   Additional Information: GSK Receipt Date: 03-JAN-2025 This case was reported by a patient via interactive digital media. The only people the report knew that had shingles have been supposedly vaccinated against them, every case the report knew. The reporter reported that do not take the supposed shingles Vaccine. There was no such thing as a viable Vaccine. This case was considered as suspected vaccination failure since the details regarding completion of primary  vaccination schedule, time to onset and laboratory 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 regarding completion of primary vaccination schedule, time to onset for shingles and laboratory confirmation of shingles) is considered unrelated to GSK vaccine Shingles vaccine.
Sex: M
Vaccine: MEN, MNQ, MNQ
Symptoms: Extra dose administered, Interchange of vaccine products
Clinical narrative: Patient received 1st dose on 17th Oct and then again 21st nov, they received a dose of Menveo; patient received a dose of Menveo after having received a dose of MenQuadfi; This non-serious case was reported by a nurse via call center representative and described the occurrence of extra dose administered in a 16-year-old male patient who received Men ACWY-CRM NVS (Menveo) (batch number EK7DG, expiry date 31-DEC-2025) for prophylaxis.   Co-suspect products included Men ACWY-CRM NVS (Menveo) (batch number 3443E, expiry date 30-SEP-2025) for prophylaxis and meningococcal vaccine a/c/y/w conj (tet tox) (Menquadfi) (batch number U81138A, expiry date 31-JUL-2026) for prophylaxis.   On 21-NOV-2024, the patient received the 2nd dose of Menveo. On 17-OCT-2024, the patient received the 1st dose of Menveo. On 21-AUG-2024, the patient started Menquadfi. On 17-OCT-2024, not applicable after receiving Menveo and an unknown time after receiving Menveo, the patient experienced interchange of vaccine products (Verbatim: patient received a dose of Menveo after having received a dose of MenQuadfi). On 21-NOV-2024, the patient experienced extra dose administered (Verbatim: Patient received 1st dose on 17th Oct and then again 21st nov, they received a dose of Menveo). The outcome of the extra dose administered and interchange of vaccine products were unknown.   Additional Information: GSK Receipt Date: 22-NOV-2024 A registered nurse reported that they had a patient who on 21st august 2024 received a dose of MenQuadfi, and then on 17th October 2024 and then again on 21st November 2024, they received a dose of Menveo.  Patient received 1st dose on 17th October and then again on 21st November, they received a dose of Menveo, which led to Extra dose administered. Patient received a dose of Menveo after having received a dose of MenQuadfi, which led to Interchange of vaccine products. Reporter provided consent to follow up.  The Vaccine Administration Facility was the same as Primary Reporter.
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Product dose omission issue, Product preparation issue
Clinical narrative: administered the adjuvant only; missed dose; This non-serious case was reported by a pharmacist via sales rep and described the occurrence of inappropriate preparation of medication in a 64-year-old female 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 MAY-2023, 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 inappropriate preparation of medication (Verbatim: administered the adjuvant only) and incomplete course of vaccination (Verbatim: missed dose). The outcome of the inappropriate preparation of medication and incomplete course of vaccination were unknown.   Additional Information: GSK Receipt Date: 19-DEC-2024 Reporter stated that a 64-year-old female was administered the adjuvant only for Shingrix (inappropriate reconstitution technique.). Reports that this event happened in May 2023.  When the doctor's office realized the mistake, they vaccinated the patient with her first dose of Shingrix 2 months later. The patient was transferred to a pharmacy to receive her second dose of Shingrix, the pharmacy attempted to bill insurance for the second dose in 2024 (late dose,) however, received a rejection from insurance because the doctor's office submitted the first attempt at vaccinating with Shingrix to the insurance carrier, although the patient was only vaccinated with the adjuvant component. Now the insurance was under the assumption the consumer received both doses of Shingrix. Therefore, the patient was unable to have the second dose of Shingrix paid for by insurance resulting in a missed dose. The patient received only adjuvant of Shingrix, which led to inappropriate preparation of medication and inappropriate dose of vaccine administered. Till the time of reporting, the patient did not receive 2nd dose of Shingrix, which led to incomplete course of vaccination. This case is linked with case US2023133828 by the same reporter.; Sender's Comments:  US-GSK-US2023133828:same reporter
Sex: F
Vaccine: TDAP
Symptoms: Occupational exposure to product, Product complaint, Syringe issue
Clinical narrative: plunger had fallen out and the vaccine fluid had gotten her hand wet; plunger fell out of the back end and the medication leaked out; Pharmaceutical product complaint; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of occupational exposure via skin contact with product in a female patient who received DTPa (Reduced antigen) (Boostrix) (batch number 235D2, expiry date 10-JAN-2027) for prophylaxis. This case was associated with a product complaint.   On an unknown date, the patient received Boostrix. On an unknown date, an unknown time after receiving Boostrix, the patient experienced occupational exposure via skin contact with product (Verbatim: plunger had fallen out and the vaccine fluid had gotten her hand wet), syringe leak (Verbatim: plunger fell out of the back end and the medication leaked out) and pharmaceutical product complaint (Verbatim: Pharmaceutical product complaint). The outcome of the occupational exposure via skin contact with product, syringe leak and pharmaceutical product complaint were unknown.   It was unknown if the reporter considered the syringe leak to be related to Boostrix and Boostrix Pre-Filled Syringe Device.     It was unknown if the company considered the syringe leak 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: 19-DEC-2024 The pharmacist stated when she was preparing the vaccine, the plunger fell out of the back end and the medication leaked out. The suspect product was not administered. During preparation step the defect was discovered that the plunger falls out completely and she said that she put the needle on and turned the syringe in her hand so that the needle was up and then she suddenly noticed that her hand was all wet, related to accidental exposure because the plunger had fallen out and the vaccine fluid had gotten her hand wet which led to occupational exposure via skin contact with product and syringe leak. She was not wearing gloves.  She would return the suspect syringe. She had since removed the needle and the detachment happens during preparation.
Sex: U
Vaccine: VARZOS
Symptoms: Urticaria
Clinical narrative: Urticaria after 1st dose; This non-serious case was reported by a nurse via call center representative and described the occurrence of urticaria in a patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced urticaria (Verbatim: Urticaria after 1st dose). The outcome of the urticaria was unknown.   It was unknown if the reporter considered the urticaria to be related to Shingrix.     It was unknown if the company considered the urticaria to be related to Shingrix.   Additional Information: GSK Receipt Date: 19-DEC-2024 A nurse called in to request data about the incidence of urticaria after the first dose of Shingrix. They mentioned case involved one of their sister's friend but had no more information available. They stated the did not consent to receive follow up and would instruct said individual to reach out to GlaxoSmithKline.; Sender's Comments:  US-GSK-US2024125616:same reporter
Age: 0.92
Sex: M
Vaccine: DTAPIPV
Symptoms: Product administered to patient of inappropriate age, Wrong product administered
Clinical narrative: were supposed to administer Pentacel, she administered the Kinrix; she inadvertently administered an 11-month-old Kinrix; This non-serious case was reported by a nurse via call center representative and described the occurrence of wrong vaccine administered in a 11-month-old male patient who received DTPa-IPV (Kinrix) (batch number 34MF9, expiry date 13-FEB-2026) for prophylaxis.   On 24-DEC-2024, the patient received Kinrix. On 24-DEC-2024, an unknown time after receiving Kinrix, the patient experienced wrong vaccine administered (Verbatim: were supposed to administer Pentacel, she administered the Kinrix) and inappropriate age at vaccine administration (Verbatim: she inadvertently administered an 11-month-old Kinrix). The outcome of the wrong vaccine administered and inappropriate age at vaccine administration were unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK Receipt Date: 24-DEC-2024 The nurse reported that a patient inadvertently administered an 11-month-old Kinrix, they were supposed to administer Pentacel, but did not have that vaccine, so she administered the Kinrix along with the Hib vaccine, which led to wrong vaccine administered and inappropriate age at vaccine administration. The vaccine administration facility was the same as primary reporter.
Sex: U
Vaccine: MENB
Symptoms: Syringe issue, Underdose
Clinical narrative: losing too much of the vaccine trying to escape that air bubble HCP administered these vaccines; This non-serious case was reported by a other health professional via call center representative and described the occurrence of accidental underdose in an unspecified number of patients who received Men B NVS (Bexsero) for prophylaxis.   On an unknown date, the patient received Bexsero. On an unknown date, an unknown time after receiving Bexsero, the patient experienced accidental underdose (Verbatim: losing too much of the vaccine trying to escape that air bubble HCP administered these vaccines). The outcome of the accidental underdose was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK receipt date: 26-DEC-2024 The reporter reported that they were concerned if they were losing too much of the Bexsero vaccine trying to escape that air bubble, which led to accidental underdose. They had multiple syringes with that issue. Also, healthcare professional declared that she administered these vaccines and she had multiple syringes with the air bubble syringe issue.
Age: 20.0
Sex: F
Vaccine: MENB
Symptoms: Expired product administered
Clinical narrative: Bexsero expired dose; This non-serious case was reported by a nurse via call center representative and described the occurrence of expired vaccine used in a 20-year-old female patient who received Men B NVS (Bexsero) (batch number ZK9P4, expiry date 03-NOV-2024) for prophylaxis.   On 27-DEC-2024, the patient received Bexsero. On 27-DEC-2024, an unknown time after receiving Bexsero, the patient experienced expired vaccine used (Verbatim: Bexsero expired dose). The outcome of the expired vaccine used was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK Receipt Date: 02-JAN-2025 Nurse reported an expired dose of Bexsero was administered to a patient, which led expired vaccine used. The reporter consented to follow up.
Age: 84.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19
Clinical narrative: Patient and her husband got covid last October; This spontaneous case was reported by a patient family member or friend and describes the occurrence of COVID-19 (Patient and her husband got covid last October) in an 84-year-old male patient who received mRNA-1273.815 (SPIKEVAX 2023-2024) for COVID-19 prophylaxis.     Previously administered products included for COVID-19 prophylaxis: Spikevax bivalent Original / Omicron (Dose 4) on 05-Jan-2023. Past adverse reactions to the above products included No adverse effect with Spikevax bivalent Original / Omicron.    On 20-Jul-2024, the patient received dose of mRNA-1273.815 (SPIKEVAX 2023-2024) (Intramuscular use) 1 dosage form. In October 2024, the patient experienced COVID-19 (Patient and her husband got covid last October). At the time of the report, COVID-19 (Patient and her husband got covid last October) had resolved.            The concomitant medication was not reported by reporter. Patient got covid last October and lasted for 3 months.  The treatment medication was not reported by reporter.   This case was linked to US-MODERNATX, INC.-MOD-2025-781169 (E2B Linked Report).   Reporter did not allow further contact; Sender's Comments:  US-MODERNATX, INC.-MOD-2025-781169:Wife case
Sex: U
Vaccine: COVID19
Symptoms: Myocardial infarction, Myocarditis
Clinical narrative: myocarditis; Heart attack; This spontaneous case was reported by a patient and describes the occurrence of MYOCARDITIS (myocarditis) and MYOCARDIAL INFARCTION (Heart attack) 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) (unknown route) 1 dosage form. On an unknown date, received dose of SPIKEVAX NOS (SPIKEVAX NOS) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced MYOCARDITIS (myocarditis) (seriousness criterion medically significant) and MYOCARDIAL INFARCTION (Heart attack) (seriousness criterion medically significant). At the time of the report, MYOCARDITIS (myocarditis) and MYOCARDIAL INFARCTION (Heart attack) outcome was unknown.            No concomitant medication was reported.  It was reported that, patient had been vaccinated with 2 doses of Moderna and got heart attack after taking 2 shots and was being diagnosed with Myocarditis.  Reporter causality was not reported. It was unknown if the patient experienced any additional symptoms or events.  No treatment information was provided.; Reporter's Comments: Company comment: The benefit-risk relationship of product is not affected by this report.
Sex: M
Vaccine: COVID19
Symptoms: Cerebral disorder, Immunisation reaction
Clinical narrative: Severe side effects to his body and brain to the extent of having to file for Disability; Severe side effects to his body and brain to the extent of having to file for Disability; This spontaneous case was reported by a patient and describes the occurrence of CEREBRAL DISORDER (Severe side effects to his body and brain to the extent of having to file for Disability) and IMMUNISATION REACTION (Severe side effects to his body and brain to the extent of having to file for Disability) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis.     The patient's past medical history included Stroke (At the age of 52.). Concurrent medical conditions included Congestive heart failure and Parkinsonism (Dealing with parkinsonism.).    In 2020, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular use) 1 dosage form. On an unknown date, the patient experienced CEREBRAL DISORDER (Severe side effects to his body and brain to the extent of having to file for Disability) (seriousness criterion disability) and IMMUNISATION REACTION (Severe side effects to his body and brain to the extent of having to file for Disability) (seriousness criterion disability). At the time of the report, CEREBRAL DISORDER (Severe side effects to his body and brain to the extent of having to file for Disability) and IMMUNISATION REACTION (Severe side effects to his body and brain to the extent of having to file for Disability) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular use) was unknown.       Concomitant medication was not provided. Patient stated that according to his doctors, the COVID-19 vaccine he received in 2020 had caused severe side effects to his body and brain to the extent of having to file for Disability. He stated that at the age of 52, he had a stroke, CHF, and was dealing with Parkinsonism. He stated that he no longer works, therefore he was researching a way to hold our company accountable in a courtroom for damages. He also stated that his lifestyle, finances, and mobility had taken a horrible turn for the worse. As soon as his research was completed, he will be filing with the court system, with a tremendous amount of evidence.  Treatment information was not reported.; Reporter's Comments: Concurrent medical conditions of Congestive heart failure and Parkinsonism could be confounders for the event. However, very limited information was provided at this time. The benefit-risk relationship of product is not affected by this report.
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Dysgeusia, Dyspepsia, Nausea, Oesophageal pain, Oropharyngeal discomfort
Clinical narrative: heartburn; burning of esophagus; throat discomfort; bitter taste; nausea; This spontaneous case was reported by a patient and describes the occurrence of DYSPEPSIA (heartburn), OESOPHAGEAL PAIN (burning of esophagus), OROPHARYNGEAL DISCOMFORT (throat discomfort), DYSGEUSIA (bitter taste) and NAUSEA (nausea) in a 63-year-old female patient who received mRNA-1273.712 (SPIKEVAX 2024-2025 PFS) for COVID-19 prophylaxis.     null Patient was diagnosed with Covid 19.  The patient's past medical history included COVID-19 (Patient was diagnosed with Covid 19) in October 2023.    On 05-Jan-2025, the patient received dose of mRNA-1273.712 (SPIKEVAX 2024-2025 PFS) (Intramuscular use) 1 dosage form. On 07-Jan-2025, the patient experienced DYSPEPSIA (heartburn), OESOPHAGEAL PAIN (burning of esophagus), OROPHARYNGEAL DISCOMFORT (throat discomfort), DYSGEUSIA (bitter taste) and NAUSEA (nausea). At the time of the report, DYSPEPSIA (heartburn), OESOPHAGEAL PAIN (burning of esophagus), OROPHARYNGEAL DISCOMFORT (throat discomfort), DYSGEUSIA (bitter taste) and NAUSEA (nausea) was resolving.        The action taken with mRNA-1273.712 (SPIKEVAX 2024-2025 PFS) (Intramuscular use) was unknown.   For mRNA-1273.712 (SPIKEVAX 2024-2025 PFS) (Intramuscular use), the reporter did not provide any causality assessments.   No concomitant medications were reported.  The patient received Gavascon.
Age: 79.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19
Clinical narrative: Patient got covid last October; This spontaneous case was reported by a patient and describes the occurrence of COVID-19 (Patient got covid last October) in a 79-year-old female patient who received mRNA-1273.815 (SPIKEVAX 2023-2024) for COVID-19 prophylaxis.     Previously administered products included for COVID-19 prophylaxis: Spikevax bivalent original/omicron ba.4-5 (4th shot (but no information if it was booster or not)) on 05-Jan-2023. Past adverse reactions to the above products included No adverse effect with Spikevax bivalent original/omicron ba.4-5. Concurrent medical conditions included Asthma.    On 20-Jul-2024, the patient received dose of mRNA-1273.815 (SPIKEVAX 2023-2024) (Intramuscular use) 1 dosage form. In October 2024, the patient experienced COVID-19 (Patient got covid last October). At the time of the report, COVID-19 (Patient got covid last October) had resolved.        The action taken with mRNA-1273.815 (SPIKEVAX 2023-2024) (Intramuscular use) was unknown.       No concomitant medications were provided. It was unknown if the patient experienced any additional symptoms/events. No treatment medication was provided.   This case was linked to US-MODERNATX, INC.-MOD-2025-781172 (E2B Linked Report).   Reporter did not allow further contact; Sender's Comments:  US-MODERNATX, INC.-MOD-2025-781172:Husband case
Sex: F
Vaccine: PNC20
Symptoms: Rash
Clinical narrative: rash; This is a spontaneous report received from a Pharmacist from medical information team.  A female patient (unknown if pregnant) received pneumococcal 20-valent conjugate vaccine (diphtheria CRM197 protein) (PREVNAR 20), as dose number unknown, single (Batch/Lot number: unknown) for immunisation. The patient's relevant medical history included: "allergic to gluten" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: RASH (non-serious), outcome "unknown".  The information on the batch/lot number for pneumococcal 20-valent conjugate vaccine (diphtheria CRM197 protein) will be requested and submitted if and when received.
Sex: M
Vaccine: COVID19
Symptoms: Death
Clinical narrative: passed away; This is a spontaneous report received from a Consumer or other non HCP.  A male patient received BNT162b2 omicron (kp.2) (COMIRNATY (2024-2025 FORMULA)), as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (Primary Immunization series completed.), for Covid-19 immunization; Bnt162b2 (DOSE NUMBER UNKNOWN (BOOSTER), SINGLE), for Covid-19 immunization. The following information was reported: DEATH (death), outcome "fatal", described as "passed away". The date and cause of death for the patient were unknown. It was not reported if an autopsy was performed. The reporter stated that he had both his parents vaccinated ongoing until they passed away.  The information on the batch/lot number for BNT162b2 omicron (kp.2) will be requested and submitted if and when received.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202500007783 Same event/vaccine, different patient;; Reported Cause(s) of Death: Unknown cause of death
Sex: M
Vaccine: COVID19
Symptoms: Fatigue
Clinical narrative: a little tired; This is a spontaneous report received from a Consumer or other non HCP.  A 67-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 included: "Asthma" (ongoing), notes: Asthma approximately since age 14 years old; "Chronic lymphocytic leukemia", start date: 2022 (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: FATIGUE (non-serious), outcome "unknown", described as "a little tired".  Additional information: The patient thinks the 2nd one he had he was a little tired with but that's it and that one was definitely Pfizer. The first two he had were Pfizer.  The information on the batch/lot number for BNT162b2 will be requested and submitted if and when received.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202500007822 Same patient/suspect vaccine; different dose/events;US-PFIZER INC-202500007906 Same patient/suspect vaccine; different dose/events;
Sex: M
Vaccine: COVID19, FLUX, PPV, RVX
Symptoms: Lymphadenopathy, Peripheral swelling
Clinical narrative: swelling of the lymph nodes; swelling under his arms; This is a spontaneous report received from a Consumer or other non HCP.  A 67-year-old male patient received BNT162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation; rsv vaccine (RSV VACCINE), as dose number unknown, single) for immunisation; influenza vaccine (INFLUENZA VACCINE), as dose number unknown, single) for immunisation; pneumococcal vaccine (PNEUMOCOCCAL VACCINE), as dose number unknown, single) for immunisation. The patient's relevant medical history included: "Asthma" (ongoing), notes: approximately since age 14 years old; "Chronic lymphocytic leukemia", start date: 2022 (unspecified if ongoing); "slight food reactions" (unspecified if ongoing); "pollen allergy" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: LYMPHADENOPATHY (non-serious), outcome "unknown", described as "swelling of the lymph nodes"; PERIPHERAL SWELLING (non-serious), outcome "unknown", described as "swelling under his arms". The information on the batch/lot number for BNT162b2 omi xbb.1.5 will be requested and submitted if and when received. Additional information: Last Apr2024, the patient received a booster he believed was Pfizer last spring. With the Pfizer covid vaccine he had in Apr2024, he had swelling of the lymph nodes and swelling under his arms about two weeks which was not very much but received it with the RSV vaccine, influenza vaccine and a pneumonia vaccine; he has no manufacturer names or lot numbers to provide for the RSV vaccine, influenza vaccine and a pneumonia vaccine and there is no way to tell which he reacted to; he did not have any noticeable reaction to any other covid vaccines he had.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202500007822 Same patient/suspect vaccine; different dose/events;US-PFIZER INC-202500007905 Same patient/suspect vaccine; different dose/events;