chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 47.0
Sex: M
Vaccine: VARZOS
Symptoms: Product preparation issue
Clinical narrative: given a vaccine diluent of Shingrix without being reconstituted; given a vaccine diluent of Shingrix without being reconstituted; This non-serious case was reported by a other health professional via call center representative and described the occurrence of inappropriate preparation of medication in a 47-year-old male patient who received Herpes zoster (Shingrix) (batch number EY253, expiry date 16-JUL-2026) for prophylaxis.   On 18-FEB-2025, the patient received Shingrix. On 18-FEB-2025, an unknown time after receiving Shingrix, the patient experienced inappropriate preparation of medication (Verbatim: given a vaccine diluent of Shingrix without being reconstituted) and inappropriate dose of vaccine administered (Verbatim: given a vaccine diluent of Shingrix without being reconstituted). The outcome of the inappropriate preparation of medication and inappropriate dose of vaccine administered were not applicable.   Additional Information: GSK Receipt Date: 05-MAR-2025 Reporter had a patient who was given a vaccine diluent (Shingrix) without being reconstituted, which led to Inappropriate preparation of medication and Inappropriate dose of vaccine administered. Reporter was enquiring if he/she can revaccinate at any time and are there any potential concerns he should be notified if he only received diluent.
Age: 28.0
Sex: F
Vaccine: HEPA
Symptoms: Underdose
Clinical narrative: Pediatric dose to an adult patient; Pediatric dose to an adult patient; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of adult use of a child product in a 28-year-old female patient who received HAV (Havrix pediatric) (batch number 232Z3, expiry date 14-NOV-2025) for prophylaxis.   On 04-MAR-2025, the patient received the 2nd dose of Havrix pediatric. On 04-MAR-2025, an unknown time after receiving Havrix pediatric, the patient experienced adult use of a child product (Verbatim: Pediatric dose to an adult patient) and underdose (Verbatim: Pediatric dose to an adult patient). The outcome of the adult use of a child product and underdose 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: 05-MAR-2025 The registered pharmacist reported that they had a adult patient came for Havrix vaccine and they were given the 2nd pediatric dose, which led to adult use of a child product and underdose. The Vaccine Administration Facility was the same as Primary Reporter.
Sex: M
Vaccine: COVID19
Symptoms: Biopsy brain, Investigation, Vasculitis
Clinical narrative: Vasculitis; This is a spontaneous report received from a Consumer or other non HCP.  An 83-year-old male patient received BNT162b2 (BNT162B2), in Oct2021 as dose 3 (booster), single (Lot number: FF8841), in arm for covid-19 immunisation. The patient's relevant medical history included: "Known allergies: penicillin" (unspecified if ongoing); "Thyroid" (unspecified if ongoing); "Polymyalgia" (unspecified if ongoing). Concomitant medication(s) included: SYNTHROID. Vaccination history included: BNT162b2 (DOSE 2; EM9809, administered in arm), administration date: 05Feb2021, for Covid-19 Immunization; Covid-19 vaccine (DOSE 1; MANUFACTURER UNKNOWN), for Covid-19 Immunization. The following information was reported: VASCULITIS (death, prolonged hospitalization, life threatening) with onset Nov2021, outcome "fatal". The clinical course was reported as follows: The patient died from vasculitis on 03Jul2022 after suffering a debilitating death. Treatment included unspecified medication. He ran a thriving auto agency 5 days a week and cut wood and grew a huge garden on weekends. He was a very active, healthy man prior to the vaccine.  The patient underwent the following laboratory tests and procedures: Biopsy brain: unknown results; many test: unknown results. Therapeutic measures were taken as a result of vasculitis. The patient date of death was 03Jul2022. Reported cause of death: "Vasculitis". It was not reported if an autopsy was performed.; Reported Cause(s) of Death: Vasculitis
Vaccine: COVID19
Symptoms: Death
Clinical narrative: killed 23 of my friends with your covid hoax vaccine; This is a spontaneous report received from a Consumer or other non HCP, Program ID.  A patient (age and gender not provided) received BNT162b2 (BNT162B2 NOS), as dose number unknown, 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: DEATH (death, medically significant), outcome "fatal", described as "killed 23 of my friends with your covid hoax vaccine". The date and cause of death for the patient were unknown. It was not reported if an autopsy was performed.  Batch/lot number is not provided, and it cannot be obtained.; Sender's Comments: Linked Report(s) : US-PFIZER INC-PV202500025640 Same reporter/product/event, different patients.;; Reported Cause(s) of Death: Unknown cause of death
Age: 67.0
Sex: M
Vaccine: COVID19
Symptoms: Death, Eyeball avulsion, Mobility decreased, Peritonitis bacterial
Clinical narrative: Bacterial peritonitis; Lost an eye; Lost full-body mobility; Died; This is a spontaneous report received from a consumer.  A 67-year-old male patient received BNT162b2 Omicron (kp.2) (COMIRNATY (2024-2025 FORMULA)), on 30Aug2024 at 14:00 as dose 1, single (Batch/Lot number: unknown) at the age of 67 years, in arm for COVID-19 immunisation. The patient's relevant medical history included: "Diabetes" (unspecified if ongoing); "Liver cirrhosis" (unspecified if ongoing); "Liver cancer" (unspecified if ongoing); "Immunocompromised" (unspecified if ongoing). The patient took concomitant medications. Vaccination history included: COVID-19 vaccine (DOSE 1; MANUFACTURER UNKNOWN), for COVID-19 immunization; COVID-19 vaccine (DOSE 2; MANUFACTURER UNKNOWN), for COVID-19 immunization; COVID-19 vaccine (DOSE 3 (BOOSTER); MANUFACTURER UNKNOWN), for COVID-19 immunization. No other vaccine was administered in four weeks and on the same date with the Pfizer suspect vaccine. The facility where the vaccine was administered was in a pharmacy or drugstore. The following information was reported: PERITONITIS BACTERIAL (hospitalization, disability, life threatening) with onset 31Aug2024, outcome "not recovered", described as "Bacterial peritonitis"; EYEBALL AVULSION (hospitalization, disability, life threatening) with onset 31Aug2024, outcome "not recovered", described as "Lost an eye"; MOBILITY DECREASED (hospitalization, disability, life threatening) with onset 31Aug2024, outcome "not recovered", described as "Lost full-body mobility"; DEATH (death) with onset 21Feb2025, outcome "fatal", described as "Died". After receiving the vaccine (fourth COVID-19 vaccine), the patient felt ill in less than 24 hours. The symptoms were similar to those reported for a COVID-19 reaction but, when they became worse after 4 days, turned out to be spontaneous bacterial peritonitis. The patient had diabetes related liver cirrhosis and liver cancer. The patient was admitted to a hospital, but was med flighted to another place. The patient lost an eye and full-body mobility to the infection. The patient was referred to hospice and died on 21Feb2025. Some doctors thought the COVID-19 vaccine triggered the peritonitis in this immunocompromised patient. The patient was hospitalized for peritonitis bacterial, eyeball avulsion, mobility decreased (hospitalization duration: 40 day(s)). Therapeutic measures were taken as a result of peritonitis bacterial, avulsion of eye, and mobility decreased (various). The patient date of death was 21Feb2025. The reported cause of death was unknown. It was not reported if an autopsy was performed.  Batch/lot number is not provided, and it cannot be obtained.; Reported Cause(s) of Death: Died
Vaccine: COVID19
Symptoms: Death
Clinical narrative: killed 23 of my friends with your covid hoax vaccine; This is a spontaneous report received from a Consumer or other non HCP, Program ID.  A patient (age and gender not provided) received BNT162b2 (BNT162B2 NOS), as dose number unknown, 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: DEATH (death, medically significant), outcome "fatal", described as "killed 23 of my friends with your covid hoax vaccine". The date and cause of death for the patient were unknown. It was not reported if an autopsy was performed.  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-202500050283 Same reporter/product/event, different patients;US-PFIZER INC-202500051107 Same reporter/product/event, different patients.;US-PFIZER INC-202500051103 Same reporter/product/event, different patients.;US-PFIZER INC-202500051111 Same reporter/product/event, different patients.;US-PFIZER INC-202500051100 Same reporter/product/event, different patients.;US-PFIZER INC-202500051110 Same reporter/product/event, different patients.;US-PFIZER INC-202500051102 Same reporter/product/event, different patients.;US-PFIZER INC-202500051118 Same reporter/product/event, different patients.;US-PFIZER INC-202500051108 Same reporter/product/event, different patients.;US-PFIZER INC-202500051120 Same reporter/product/event, different patients.;US-PFIZER INC-202500051104 Same reporter/product/event, different patients.;US-PFIZER INC-202500051117 Same reporter/product/event, different patients.;US-PFIZER INC-202500051116 Same reporter/product/event, different patients.;US-PFIZER INC-202500051105 Same reporter/product/event, different patients.;US-PFIZER INC-202500051113 Same reporter/product/event, different patients.;US-PFIZER INC-202500051109 Same reporter/product/event, different patients.;US-PFIZER INC-202500051112 Same reporter/product/event, different patients.;US-PFIZER INC-202500051106 Same reporter/product/event, different patients.;US-PFIZER INC-202500051119 Same reporter/product/event, different patients.;US-PFIZER INC-202500051114 Same reporter/product/event, different patients.;US-PFIZER INC-202500051115 Same reporter/product/event, different patients.;US-PFIZER INC-202500051101 Same reporter/product/event, different patients.;; Reported Cause(s) of Death: Unknown cause of death
Sex: M
Vaccine: MEN
Symptoms: Loss of consciousness, Seizure
Clinical narrative: passed out 3 separate times; 3 separate seizure; Initial information received on 02-Mar-2025 regarding an unsolicited valid Social Media serious case received from a consumer/non-hcp.  This case involves Adolescent male patient who had passed out 3 separate times and 3 separate seizure after receiving  meningococcal A-C-Y-W135 (T CONJ) vaccine [MenquadfI].  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On an unknown date, the patient received an unknown dose of suspect lot number meningococcal A-C-Y-W135 (T CONJ) vaccine Solution for injection (lot number, strength, expiry date-unknown) via unknown route in unknown administration site for prophylactic vaccination (Immunisation).  Information on the batch number was requested corresponding to the one at time of event occurrence.  On an unknown date the patient developed a serious passed out 3 separate times (loss of consciousness), 3 separate seizure (seizure) (unknown latency).  Reportedly- lingering neurological problems, passed out on the pediatricians floor.  Action taken was not applicable.  It was not reported if the patient received a corrective treatment for both the events.  At time of reporting, the outcome was Unknown for both the events.  Seriousness criteria: These events are medically significant.; Sender's Comments: Sanofi company comment dated 03-Feb-2025: This case involves Adolescent male patient who had passed out 3 separate times and 3 separate seizure after receiving  meningococcal A-C-Y-W135 (T CONJ) vaccine [MenquadfI]. The clinical course of the event was not provided. Furthermore, information regarding condition at the time of vaccination, role of medical history, lab data excluding other predisposing etiologies would be needed for complete assessment of the case. Based upon the reported information, the role of the suspect vaccine cannot be assessed.
Sex: M
Vaccine: COVID19, UNK
Symptoms: Cough, Fatigue, Nasal congestion, SARS-CoV-2 test positive, Vaccination failure
Clinical narrative: Product lack efficiacy/ did not work as expected; Coughing; Fatigue; Congestion; COVID antigen home test positive; This spontaneous case, initially received on 24-Feb-2025, was reported by a non health professional and concerns an adult male patient.  No any medical history, chronic condition to report. Drug history included Covid-19 Pfizer (Booster, left deltoid, Lot number: 6J6739)  Covid-19 Pfizer (Booster, left deltoid, Lot number: HF9298) No any allergic to this vaccination.  Concomitant medication: refer to appropriate report section.  Administration of company suspect drug(s): On 03-Oct-2024, the patient received Flucelvax (TIV) for Indication not reported, Dose regimen: 0.5 ml, Route of administration: Intramuscular,  annual booster, Anatomical location: Right Deltoid, Lot number: 94612. CSL batch number unable to match.   Non-company suspect drugs: On 03-Oct-2024, the patient received Pfizer BioNTech COVID-19 vaccine (Tozinameran) for Indication not reported, booster dose , Anatomical location: Left upper deltoid, Lot number: LM2210  Adverse reactions/events and outcomes: On 01-Jan-2025, the patient experienced Coughing (outcome: Recovered / Resolved), Fatigue (outcome: Recovered / Resolved), Congestion (outcome: Recovered / Resolved). On an unknown date, the patient experienced Product lack efficiacy/ did not work as expected (Medically Significant, outcome: Not Reported)   On 01-Jan-2025, patient had COVID positive (outcome: Not Reported)  Patient did not received any other vaccine within 4 weeks prior to the first administration of suspect vaccine. Primary infection site was not known. There were no any predisposing factors. Culture was not performed. No any antipyretic product used around the date of vaccination. Adverse event did not required to visit emergency room.. No physician office visit.   On 01-Jan-2025,  LUCIRA by Pfizer COVID-19 & Flu Home Test shows COVID positive, Flu A, Flu B  negative.  On 05-Jan-2025, COVID antigen home test: COVID positive. On 08-Jan-2025, COVID antigen home test: COVID positive. On 15-Jan-2025,  Flowflex COVID antigen home test: COVID negative.    Flucelvax (TIV) action taken: Not Applicable Treatment medication: Dayquil As needed, Nyquil As needed  Reporter assessment: The reporter considered the event as non serious and did not report the causality assessment for the events.; Reporter's Comments: Due to the spontaneous nature of the case, it is considered related for reporting purposes. However, the reported symptoms coughing, fatigue and congestion are attributed to covid antigen test positive. Hence, Vaccination failure is more plausibly explained by covid antigen positive and attributed to non-company Covid-19 vaccine.
Age: 56.0
Sex: F
Vaccine: HEPA, PNC21
Symptoms: Chills, Injection site erythema, Injection site pain
Clinical narrative: Patient received  the havrix  (2nd dose)and capvaxine on the same arm as pt has a hormonal patch on the other arm. Two vaccines were given IM spaced at least 1'' apart. Before giving the vaccine, pharmacist already counseled patient over potential side effects (sore arm, redness, body aches, mild fever, or chills) and what to do to help with it (massaging, icepack  to relieve soreness, and tylenol if fever). Patient called again on 3/7/25 to report red pump, soreness on injected area and chills. Patient told that the soreness and redness was subsidized and getting better. patient doesn't have trouble breathing, and pt is doing well. Patient just wants to call and let the pharmacy know. Pharmacist already counseled patient again such as using icepacks to soothe the soreness and redness.
Age: 66.0
Sex: F
Vaccine: VARZOS
Symptoms: Pain in extremity, Radiotherapy
Clinical narrative: Patient called the pharmacy seven days following administration complaining  of pain in the arm that radiates to the neck which has not subsided. Pain started three days after administration.
Age: 14.0
Sex: M
Vaccine: COVID19, FLU3, HPV9
Symptoms: Blepharospasm, Feeling abnormal, Loss of consciousness, Musculoskeletal stiffness, Seizure
Clinical narrative: after giving all vaccines, he stated that the last one HPV felt a little weird he laid his head against the wall and his eyes started twitching, body got tense, had a mini seizure the whole thing lasted 15-20 seconds. Once he gained conciseness he laid down and we got his Pulse and oxygen levels and gave him water and he asked for pretzels. He stayed in clinic for 10 extra minutes so we can keep an eye out and after Dr. saw him again she said it was ok for him to go as he was feeling better.
Age: 70.0
Sex: F
Vaccine: RSV
Symptoms: Extra dose administered, No adverse event
Clinical narrative: Patient received a second dose of the Arexvy on 9/8/24, no AE at this time
Age: 11.0
Sex: M
Vaccine: COVID19, FLU3
Symptoms: Pyrexia
Clinical narrative: Per patient's mom, patient had a fever that lasted 30 minutes after vaccination, and now fully recovered from it.
Age: 48.0
Sex: F
Vaccine: TDAP
Symptoms: Erythema, Induration, Pain, Peripheral swelling, Pyrexia
Clinical narrative: PATIENT'S ARM WAS SWOLLEN, RED, AND HARD.  SHE SAYS SHE ALSO HAD A FEVER. PATIENT WAS ADVISED TO TAKE IBUPROFEN TO HELD WITH FEVER  AND PAIN/SWELLING AND TO APPLY A COLD COMPRESS.  PATIENT DID NOT EXPERIENCE ANY SWELLING IN THE MOUTH, TONGUE, OR THROAT OR HAVE ANY PROBLEMS BREATHING.
Age: 75.0
Sex: M
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: Patient received two covid vaccines. 1 on 1/24 and 1 on 3/5. Patient only complained of sore arm
Age: 65.0
Sex: F
Vaccine: VARZOS
Symptoms: Cough, Feeling abnormal, Feeling of body temperature change, Pain, Pyrexia
Clinical narrative: About 12 hours after receiving the shot I had bodyaches. Body aches the whole next day in the evening 99.9° fever slight cough. I feel bad. Hot, then cold
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Asthenia, Chills, Cough, Gait disturbance, Headache
Clinical narrative: Started with chills and fever. Advil every 4 hours did not work. Fever continued to climb along with nausea (took Pepto Bismol which did not help,  Diarrhea - took immodium which did not work. Severe weakness, muscle aches, body aches, difficulty walking and thinking clearly. Headache, dry nose, sore throat. Fever climbed to 103.2 at 4:00AM.  I considered calling an ambulance. I got into a cool bath and my temperature slowly declined. This was WAY worse than my first Shingles shot.
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Myalgia, Nausea, Oropharyngeal pain, Pain, Pyrexia
Clinical narrative: Started with chills and fever. Advil every 4 hours did not work. Fever continued to climb along with nausea (took Pepto Bismol which did not help,  Diarrhea - took immodium which did not work. Severe weakness, muscle aches, body aches, difficulty walking and thinking clearly. Headache, dry nose, sore throat. Fever climbed to 103.2 at 4:00AM.  I considered calling an ambulance. I got into a cool bath and my temperature slowly declined. This was WAY worse than my first Shingles shot.
Age: 16.0
Sex: F
Vaccine: MENB
Symptoms: Injection site urticaria
Clinical narrative: Hives at vaccine site - Took Benadryl with relief. Patient/Parent then stated pt had hives after first Men-B vaccine but did not think it was related.
Age: 66.0
Sex: F
Vaccine: PNC20
Symptoms: Erythema, Infection, Pain, Skin warm
Clinical narrative: Vaccine administered 2-27-2027 few days later adverse event started area Red + Hot to touch swollen, pain. Patient went to doctor and was pescribed steroids and abx for infection on 3-5-2025.
Vaccine: FLU3
Symptoms: Contusion, Dizziness, Fatigue, Malaise
Clinical narrative: lightheadedness; phantom bruising all over the body; severe fatigue; malaise; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of light headedness in a patient who received Flu Seasonal TIV Dresden (Fluarix 2024-2025 season) (batch number 72RF2, expiry date 30-JUN-2025) for prophylaxis.   On an unknown date, the patient received Fluarix 2024-2025 season. On an unknown date, an unknown time after receiving Fluarix 2024-2025 season, the patient experienced light headedness (Verbatim: lightheadedness), contusion (Verbatim: phantom bruising all over the body), fatigue (Verbatim: severe fatigue) and malaise (Verbatim: malaise). The outcome of the light headedness, contusion, fatigue and malaise were not reported.   The reporter considered the light headedness, contusion, fatigue and malaise to be related to Fluarix 2024-2025 season and Fluarix Pre-Filled Syringe Device.     The company considered the light headedness, contusion, fatigue and malaise to be related to Fluarix 2024-2025 season and Fluarix 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: 21-OCT-2024 and 28-OCT-2024 The health care professional reported that a patient received Fluarix and had phantom bruising all over the body, severe fatigue, malaise and lightheadedness and patient went to emergency department. The reporter stated that particular batch (Lot: 72RF2) was causing the adverse events. This case was one of the four linked cases, reported by the same reporter for different patient.   Follow up information received on 04-NOV-2024 The case reported was an human safety information only with no defined quality defect and therefore this case does not qualify as a customer complaint as per GQP 8203 definitions and scope.  Summary of changes: Event deleted and narrative were updated.   Upon internal review case was updated on: 06-MAR-2025 The suspect was coded as Fluarix 2024-2025. Summary of changes: Product tab, event details and narrative were updated.; Sender's Comments:  US-GSK-US2024AMR131526:Original Case : US2024129463 US-GSK-US2024AMR131525:Original Case : US2024129463 US-GSK-US2024133757:Same reporter
Vaccine: HEP
Symptoms: No adverse event, Underdose
Clinical narrative: No adverse side effects were reported.; HCP calling to inquire about a pediatric RECOMBIVAX HB vaccine that was administered to an adult, and if they can revaccinate with another pediatric dose, see request case 02752180. HCP refused to provide patient information at the time of the call.; This spontaneous report was received from a nurse practitioner concerning an adult patient of unspecified gender.   The patient's medical history, concurrent conditions, concomitant therapies and drug reactions/allergies were not reported.   On 11-FEB-2025, the patient was vaccinated with Hepatitis B Vaccine (Recombinant) (RECOMBIVAX HB), Injection, batch# reported as X01182 which is an invalid batch/lot number for Hepatitis B Vaccine (Recombinant), expiration date reported as 01-OCT-2025) 1 dosage form (pediatric dose) (dosage regimen, anatomical location and route of administration were not provided) administered as prophylaxis (underdose.)  The reporter inquired if they could revaccinate with another pediatric dose. No adverse side effects were reported (no adverse event).  No additional information available.
Age: 5.0
Vaccine: MMRV
Symptoms: No adverse event, Wrong product administered
Clinical narrative: Patient is asymptomatic.  No additional AE; a 5 year old patient was inadvertently administered a dose of PROQUAD instead of MMRII on 02/20/2025.; This spontaneous report was received from an office manager and refers to a 5-year-old patient of unknown gender.   The patient's medical history, concurrent conditions and concomitant therapies were not reported.  On 20-Feb-2025, the patient was inadvertently administered a dose of Measles, Mumps, Rubella and Varicella (Oka-Merck) Virus Vaccine Live (PROQUAD), (lot #Y003880, expiration date: 05-Aug-2025) (dose, route of administration and anatomical location were not provided) which was diluted with sterile diluent, (expiration date, and lot # were not reported) instead of Measles, Mumps, and Rubella (Wistar RA 27-3) Virus Vaccine, Live (MMR II) (wrong product administered). The patient was asymptomatic, no additional adverse event and no additional details were reported.
Age: 7.0
Sex: F
Vaccine: UNK
Symptoms: No adverse event, Product storage error
Clinical narrative: Improper storage of produc in use; No additional AE; This spontaneous report was received from a registered nurse referring to a 7-year-old female patient. The patient's medical history was not reported. The patient's concurrent conditions were not reported. Concomitant medications included Hepatitis a vaccine inact (HAVRIX), Elasomeran (MODERNA COVID-19 VACCINE), Hepatitis b vaccine rHBsAg (yeast) (ENGERIX), Influenza vaccine inact split 4v (FLUARIX QUADRIVALENT), Iodinated glycerol (IPOL) and Diphtheria vaccine toxoid;Pertussis vaccine acellular 3-  On 01-OCT-2024, the facility received a shipment of COVID vaccine that needed to be stored in the freezer. There was no room in the freezer to accommodate the shipment. It was assumed that the Measles, Mumps, Rubella and Varicella (Oka-Merck) Virus Vaccine Live (PROQUAD) received could be stored in both the freezer and refrigerator and both state and private Measles, Mumps, Rubella and Varicella (Oka-Merck) Virus Vaccine Live (PROQUAD) were moved to the refrigerators where they remained within normal refrigerated temperature range until administration.   On 08-JAN-2025, the patient was vaccinated with the second dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) injection, lot#: Y013579, expiration date: 03-FEB-2026, that was verified to be valid vial, administered subcutaneously with sterile diluent in the left thigh for prophylaxis (strength and dose were not reported) (product storage error). The administered dose of Measles, Mumps, Rubella and Varicella (Oka-Merck) Virus Vaccine Live (PROQUAD) was received and stored in the refrigerator that experienced a temperature excursion (on 13-NOV-2024) for a Total time of 1344 in the range 15°Fto 46°F. No additional adverse event (AE) (No adverse event).  This case was one of several reports received from the same reporter with the case US-009507513-2254349.; Sender's Comments: Priority : 5 , Is case serious : No , Index user : , Index date : 2025-02-26 , MNSC number : , CLIC number : , ESTAR number : , IRMS number : 04/16/2017 , Central date : 2025-02-20 , Classification : DMC, Attachment description : Post Marketing Basic , Safety case number :
Vaccine: MMRV, MMRV
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional AE; inadvertent administration of PROQUAD during a temperature excursion.; This spontaneous report was received from a Registered Nurse and refers to a patient of unspecified age and gender.   The patient's concurrent conditions, medical history, previous drug reactions, drug allergies and concomitant therapies were not reported.  On 24-Feb-2025, the patient was vaccinated with an improperly stored dose of Measles, Mumps, Rubella and Varicella (Oka-Merck) Virus Vaccine Live (PROQUAD) (involved lot # Y012075, expiration date: 05-Jan-2026) reconstituted with sterile diluent, and administered as prophylaxis (strength, route, and site of administration were not provided) (Product storage error).  The administered dose of the vaccine experienced a temperature excursion of 42.83 Fahrenheit degrees for 720 hours 0 minutes 0 seconds. No previous temperature excursion was reported. There was no adverse event reported. No product quality complaint was involved.
Sex: F
Vaccine: MMR, MMRV
Symptoms: Antibody test negative
Clinical narrative: The HCP reports that one of her staff members recently had a titer test and showed no immunity to Rubella; This spontaneous Prospective pregnancy report was received from a medical assistant regarding a female patient of unknown age.   The patient's medical history, concurrent conditions, concomitant therapies, past drug reactions and allergies were unknown by the reporter.    On an unknown date, the patient may have been vaccinated with Measles, Mumps, Rubella and Varicella (Oka-Merck) Virus Vaccine Live (PROQUAD), injection, 0.5 mL/series, reconstituted with sterile diluent (MERCK STERILE DILUENT) (dose, formulation, route of administration, lot number, and expiration date were not reported) or may have been vaccinated with Measles, Mumps, and Rubella (Wistar RA 27-3) Virus Vaccine, Live (M-M-R II), Injection 0.5 mL (0.5 ml/series) (vaccination scheme frequency, lot number, expiration date, route of administration and anatomical site of injection were not reported for any of the vaccines), which was reconstituted with sterile diluent (MERCK STERILE DILUENT) (dose, formulation, route of administration, lot number, and expiration date were not reported); both vaccines indicated as prophylaxis.   On an unknown date, the patient became pregnant. Her last menstrual period was estimated as 23-DEC-2024 and her pregnancy due date was estimated as 29-SEP-2025. The pregnancy and fetal outcome were not provided. She was 10 weeks pregnant at the time of the report.   The reporter stated that on an unknown date (reported as recently), the patient had a titer test that showed no immunity to Rubella (Rubella antibody negative). It was reported that the patient´s vaccination history is unknown, but the physician mentioned Measles, Mumps, Rubella and Varicella (Oka-Merck) Virus Vaccine Live (PROQUAD) and Measles, Mumps, and Rubella (Wistar RA 27-3) Virus Vaccine, Live (M-M-R II) because they contain rubella. The reporter also stated that it could not be confirmed if the patient received any vaccines/medications during her pregnancy.   At the reporting time, the outcome of the event Rubella antibody negative was unknown.   The causal relationship between the suspect vaccines and sterile diluents, regarding the event was not provided.
Age: 18.0
Sex: M
Vaccine: MENB
Symptoms: Generalised tonic-clonic seizure
Clinical narrative: tonic-clonic seizure lasting a few minutes
Age: 39.0
Sex: M
Vaccine: COVID19
Symptoms: Autoimmune disorder, Colonoscopy, Computerised tomogram, Crohn's disease, Malaise
Clinical narrative: I became ill about 18 months later and was diagnosed with Crohn's Disease
Age: 39.0
Sex: M
Vaccine: COVID19
Symptoms: Sigmoidoscopy, Stool analysis
Clinical narrative: I became ill about 18 months later and was diagnosed with Crohn's Disease
Age: 74.0
Sex: F
Vaccine: PNC20
Symptoms: Extra dose administered, No adverse event
Clinical narrative: Patient was given a second dose of Prevnar 20. It was not noticed that the patient had already received this vaccine on 5/22/23. Patient did not report any adverse events
Age: 11.0
Sex: F
Vaccine: MMRV
Symptoms: Injection site discolouration, Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Per mom and patient, patient received HPV & MMRV on Wed 3/5/25. On Thur 3/6 patient noticed localized redness and swelling, increased pain at injection site (back of L arm) but did not tell anyone. Friday 3/7 it became worse & per patient she noticed a small white dot at injection site so she alerted her mother and older sister. Patient denies any known insect stings or bites. Sister applied hydrocortisone 1% cream that night after patient applied warm water.    Today, mother and patient report swelling & redness is reduced. Minimal redness & swelling noted at injection site. No discharge present. Patient reports 8/10 pain when touched at injection site. Oral temp 98.5 F.
Age: 75.0
Sex: M
Vaccine: PNC20
Symptoms: Extra dose administered, No adverse event
Clinical narrative: Discovered this was a vaccine duplications pt also received Prevnar 20 on 9/1/22. Patient has not experiences any symptoms or side effects from dose administered.
Age: 1.0
Sex: M
Vaccine: HEPA, MMR, PNC20
Symptoms: Ear infection, Seizure
Clinical narrative: Unprovoked seizure (afebrile) and reported to ER on 3/1/2025. On 3/1/2025 child reported to also have ear infection at hospital and treated with amoxicillin for 7 days. Then had another myoclonic seizure (unprovoked/afebrile) on 3/6/2025 and reported to the hospital in good state of health no symptoms other than the seizure at this time. Given a loading dose of keppra and started on maintenance keppra and given Diastat for rescue until able to be seen by Neurology. There is no family history of seizure.
Age: 0.5
Sex: M
Vaccine: DTPPVHBHPB, PNC20, RV5
Symptoms: Febrile convulsion, Seizure
Clinical narrative: Reported to the ER on 8/18/2025 with seizure activity. Diagnosed with a feeble seizure
Age: 40.0
Sex: F
Vaccine: FLU3
Symptoms: Arthralgia, Hypoaesthesia, Immediate post-injection reaction, Muscular weakness, Musculoskeletal stiffness
Clinical narrative: Upon injection, a sharp pain was felt in the left arm. A few minutes after the vaccine, left arm began to feel numb, pins and needles. The next day, most of the left arm was numb down through the fingers. Was seen in occupational health clinic on 11/1, advised to go to occupational health provider to be seen. Was seen 11/1 and asked to come back in 1 week. Was seen again the next week with no resolution in symptoms. Referred to orthopedic MD/hand/shoulder specialist .Saw specialist on 11/19/24 who recommended PT for 4-6 weeks and commented he felt the axillary nerve may have been damaged. Completed PT with no significant improvement. Continue to have pain, weakness and stiffness in the left shoulder, arm and hand up until now.
Age: 40.0
Sex: F
Vaccine: FLU3
Symptoms: Pain in extremity, Paraesthesia
Clinical narrative: Upon injection, a sharp pain was felt in the left arm. A few minutes after the vaccine, left arm began to feel numb, pins and needles. The next day, most of the left arm was numb down through the fingers. Was seen in occupational health clinic on 11/1, advised to go to occupational health provider to be seen. Was seen 11/1 and asked to come back in 1 week. Was seen again the next week with no resolution in symptoms. Referred to orthopedic MD/hand/shoulder specialist .Saw specialist on 11/19/24 who recommended PT for 4-6 weeks and commented he felt the axillary nerve may have been damaged. Completed PT with no significant improvement. Continue to have pain, weakness and stiffness in the left shoulder, arm and hand up until now.
Age: 11.0
Sex: F
Vaccine: HPV9, HPV9, HPV9
Symptoms: Blood test, Electroencephalogram, Epilepsy, Generalised tonic-clonic seizure, Laboratory test
Clinical narrative: Beginning with absence seizures in 2015 during school  which were undiagnosed until presentation of grand mal seizures starting in 2017.  Patient continues with Generalized Seizures Refractory to Medications.
Age: 11.0
Sex: F
Vaccine: HPV9, HPV9, HPV9
Symptoms: Magnetic resonance imaging, Petit mal epilepsy, Scan with contrast
Clinical narrative: Beginning with absence seizures in 2015 during school  which were undiagnosed until presentation of grand mal seizures starting in 2017.  Patient continues with Generalized Seizures Refractory to Medications.
Age: 65.0
Sex: F
Vaccine: TDAP
Symptoms: Injection site erythema, Injection site pain
Clinical narrative: Patient complains o f redness and pain in her arm at injection site.
Age: 41.0
Sex: M
Vaccine: COVID19
Symptoms: Computerised tomogram neck abnormal, Diagnostic aspiration, Pathology test, Sinusitis, Thyroid mass
Clinical narrative: 5+cm abnormal nodule on right thyroid,
Age: 41.0
Sex: M
Vaccine: COVID19
Symptoms: Ultrasound neck
Clinical narrative: 5+cm abnormal nodule on right thyroid,
Age: 6.0
Sex: F
Vaccine: TDAP
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: Tdap given to a 6 year old for 3rd dose.
Age: 51.0
Sex: M
Vaccine: MMR, VARCEL
Symptoms: Arthralgia, Fall, Gait disturbance, Headache, Impaired work ability
Clinical narrative: On 3/4/25, patient stated he had vertigo, tipped backwards and fell around 3pm. Also, reported mild headache (general pressure headache) later in the evening. Vertigo has been continuous but getting better (not to the point of falling). Did not go to work on 3/5/25. Patient had rotated cuff surgery on right arm on 12/10/2024. It is tough to tell if the soreness is injection related or from surgery. Left shoulder is still sore but mild.
Age: 51.0
Sex: M
Vaccine: MMR, VARCEL
Symptoms: Pain, Rotator cuff repair, Vertigo
Clinical narrative: On 3/4/25, patient stated he had vertigo, tipped backwards and fell around 3pm. Also, reported mild headache (general pressure headache) later in the evening. Vertigo has been continuous but getting better (not to the point of falling). Did not go to work on 3/5/25. Patient had rotated cuff surgery on right arm on 12/10/2024. It is tough to tell if the soreness is injection related or from surgery. Left shoulder is still sore but mild.
Age: 77.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pain, Injection site pruritus, Injection site swelling
Clinical narrative: Patient reported injection-site symptoms, which included pain /tenderness/swelling/redness / a  little itchy (comes and goes). Symptoms started the day after injection on 3/4/25. Patient stated she used hydrocortisone the first day and icing off and on since. Itchiness has gone down but other symptoms look about the same / but not worsen since started.
Age: 63.0
Sex: M
Vaccine: COVID19
Symptoms: Extra dose administered, No adverse event
Clinical narrative: Patient was supposed to receive mResvia, RSV vaccine, but the pharmacist administered Spikevax instead.  Pharmacist mistakenly pulled 2 vaccines from the Spikevax box in the freezer instead of the mRsevia. Corrective action has been taken to label bins and separate the vaccines.  Both boxes are white and say Moderna.  The syringes are the same size and the small font does not aid in identification.  This error was also reported to ISMP. The error was discovered one week later after the vaccine inventory count. Patients reported no AE.
Age: 61.0
Sex: M
Vaccine: COVID19
Symptoms: Extra dose administered, No adverse event
Clinical narrative: Patient was supposed to receive mResvia, RSV vaccine, but the pharmacist administered Spikevax instead.  Pharmacist mistakenly pulled 2 vaccines from the Spikevax box in the freezer instead of the mRsevia. Corrective action has been taken to label bins and separate the vaccines.  Both boxes are white and say Moderna.  The syringes are the same size and the small font does not aid in identification.  This error was also reported to ISMP. The error was discovered one week later after the vaccine inventory count. Patients reported no AE.
Age: 72.0
Sex: F
Vaccine: PNC21
Symptoms: Injection site erythema, Injection site pruritus, Injection site swelling
Clinical narrative: Pt presented to pharmacy 2 days after vaccine was given with red, swollen itchy deltoid. Discussed using OTC treatments to help with symptoms and directed patient to contact pharmacy if not improving.
Age: 50.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site warmth, Pyrexia
Clinical narrative: Redness to the right arm at the inject site with fever and warm to touch per patient , she went to the ER and got antibiotic , Amoxil 500 mg
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Brain fog, Dysarthria, Dysgraphia, Essential tremor, Fatigue
Clinical narrative: Shortly after receiving the shots my handwriting became illegible. I lost control when writing and it progressed to being illegible.  My speech then became slurred, and the tremors started. My head started shaking uncontrollably and I was unable to eat or drink without my hands shaking. Simple tasks have become difficult. During a routine check-up, my nurse practitioner noticed and said the word tremor.   My days are filled with brain fog and exhaustion.  The tremor is progressing day-be-day.  There is no cure or treatment.
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Head titubation, Loss of personal independence in daily activities, Tremor
Clinical narrative: Shortly after receiving the shots my handwriting became illegible. I lost control when writing and it progressed to being illegible.  My speech then became slurred, and the tremors started. My head started shaking uncontrollably and I was unable to eat or drink without my hands shaking. Simple tasks have become difficult. During a routine check-up, my nurse practitioner noticed and said the word tremor.   My days are filled with brain fog and exhaustion.  The tremor is progressing day-be-day.  There is no cure or treatment.
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Dysphonia
Clinical narrative: caught Covid-19  in March of 2022 after the virus ran its course my voice was hoarse and I was unable to project there was no pain.  I have been to my general practitioner and multiple ear nose and throat doctors they can not find any definitive reason for my voice to be hoarse or for me to not be able to project without it sounding like I am out of breath.
Age: 17.0
Sex: F
Vaccine: MENB
Symptoms: Chest pain, Loss of consciousness, Throat tightness, Urticaria
Clinical narrative: Patient reports that she began to develop hives/welts to her buttocks bilaterally, left abdomen, and "entire back" at 1800 last night. Patient took a Benadryl capsule at 1900 last night. Patient reports a "brief five second" loss of consciousness at 1243AM on 3/8/25. She reports remembering "passing out" and calling her mother shortly afterwards. Patient reports mild persistent 3/10 throat tightness since 0700 this AM, 3/8/25 and intermittent bilaterally upper chest pain since 0700 this AM.
Age: 77.0
Sex: M
Vaccine: VARZOS
Symptoms: Hypoaesthesia, Injection site erythema, Injection site induration, Injection site swelling, Paraesthesia
Clinical narrative: pt's wife reported he had some redness and swelling at the site of the injection, and that it felt hard to the touch. Pt started to have some numbness/tingling in fingers on that arm so decided to go to the ER.  They said they thought it was likely an immune response to the vaccine, but gave him cephalexin 500mg to prevent any cellulitis.  The numbness had since resolved itself by the time the rx was picked up.  It was still red and swollen, but pt had not yet started the cephalexin.
Age: 22.0
Sex: F
Vaccine: TDAP
Symptoms: Dizziness
Clinical narrative: pt came to get two vaccines. In about 15 minutes after got the vaccines, pt stated that pt felt dizzy.
Age: 25.0
Sex: M
Vaccine: FLU3
Symptoms: Dizziness
Clinical narrative: pt came to the pharmacy for two vaccines. in about 15-20 minutes after getting the vaccines, pt stated that pt felt dizzy
Age: 25.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Impaired work ability, Pain, Pyrexia, Tachycardia
Clinical narrative: The morning after the vaccine on Feb 6, 2025, I had a fever of 102.2, became tachycardic to 132 bpm, and had chills (I have time stamped pictures of these and I'm a medical student). I was just lying on the couch and resting so I wasn't straining myself or doing something that would cause my heart rate to spike that much. My legs were also aching like nothing I've ever experienced before and I considered going to the emergency department because I was feeling so horrible. I ultimately just rested the entire day and felt a little better on Feb 7, 2025 so I didn't go to the ER. I've never had a reaction this badly before and I have physicians in my family who said this was not normal and I should report it and not get a COVID vaccine again. This was my 4th dose, and I'd like it to be my final one because I was unable to work the day after I got it.
Age: 58.0
Sex: F
Vaccine: TDAP
Symptoms: Lymphadenopathy
Clinical narrative: TDAP Boostrix  I received TDAP on 02/27/2025 at pharmacy  Brand GlaxoSmithKline Biologicals (TDap Boostrix)  I received Boostrix TDAP on my upper left arm on February 27, 2025 within less than a week I noticed my lymph node swallowed on my lower left armpit around March 5,2025.  I reported to pharmacy on 03/06/2025 and spoke to pharmacist, he suggested to wait for two days observation then to call doctor.
Age: 50.0
Sex: M
Vaccine: VARZOS
Symptoms: Feeling hot, Hyperhidrosis, Lethargy, Musculoskeletal stiffness, Ocular discomfort
Clinical narrative: Blurred Vision, pressure in the eyes, painful left arm, chills, hot sweats, stiff muscles, extreme lethargy lasting into it's 4th day (still experiencing as of 3/9/25)
Age: 50.0
Sex: M
Vaccine: VARZOS
Symptoms: Pain in extremity, Vision blurred
Clinical narrative: Blurred Vision, pressure in the eyes, painful left arm, chills, hot sweats, stiff muscles, extreme lethargy lasting into it's 4th day (still experiencing as of 3/9/25)
Age: 51.0
Sex: F
Vaccine: DTAP
Symptoms: Arrhythmia, Electrocardiogram ambulatory abnormal, Palpitations
Clinical narrative: Heart palpitations began the day after I received the vaccine. I tested with a Holter monitor and was prescribed Propranolol.
Age: 50.0
Sex: F
Vaccine: VARZOS
Symptoms: Diarrhoea
Clinical narrative: Severe diarrhea
Age: 17.0
Sex: M
Vaccine: COVID19, FLU3, HPV9, MNQ
Symptoms: C-reactive protein increased, Chest pain, Echocardiogram normal, Electrocardiogram ST segment elevation, Inflammatory marker increased
Clinical narrative: Chest pain started the day after vaccines, presented to care with one day of chest pain, found to have diffuse ST elevation on EKG, elevated troponin, low-normal ventricular function on echo, elevated inflammatory markers - diagnosed with pericarditis with myocarditis component. Treatment with NSAIDs ongoing and patient is improving.
Age: 17.0
Sex: M
Vaccine: COVID19, FLU3, HPV9, MNQ
Symptoms: Myocarditis, Pericarditis, Troponin increased, White blood cell count increased
Clinical narrative: Chest pain started the day after vaccines, presented to care with one day of chest pain, found to have diffuse ST elevation on EKG, elevated troponin, low-normal ventricular function on echo, elevated inflammatory markers - diagnosed with pericarditis with myocarditis component. Treatment with NSAIDs ongoing and patient is improving.
Age: 68.0
Sex: F
Vaccine: PNC20
Symptoms: Extra dose administered
Clinical narrative: Vaccination error- pt did not need the vaccine (already got in 2022)
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Balance disorder, Dizziness, Magnetic resonance imaging, Vertigo, Visual impairment
Clinical narrative: Imbalance; Vision changes; Vertigo; Dizziness
Age: 49.0
Sex: M
Vaccine: PNC20, VARZOS
Symptoms: Inappropriate schedule of product administration, No adverse event
Clinical narrative: Patient received his second shingrix immunization one month after the first immunization, rather than 2 months after the first. Patient had no adverse reactions to the second vaccination.
Age: 4.0
Sex: M
Vaccine: MMR
Symptoms: Contusion, Decreased appetite, Fatigue, Vomiting
Clinical narrative: Bruise on leg still visible 6 days fter vaccine.  Child has had fatigue and not ate but a few bites in several days. Vomiting 3 days in a row. Especially at night. Yesterday at 4 am vomiting green bile.
Age: 6.0
Sex: F
Vaccine: DTAPIPV
Symptoms: Cellulitis, Injection site erythema, Injection site pain, Injection site swelling, Injection site vesicles
Clinical narrative: Swelling, erythema, tenderness, warmth and blistering at injection site, worsening over 2-3 days.   Treated with OTC Children's Tylenol,  Benadryl as well as RX Cephalexin for cellulitis.
Age: 6.0
Sex: F
Vaccine: DTAPIPV
Symptoms: Injection site warmth
Clinical narrative: Swelling, erythema, tenderness, warmth and blistering at injection site, worsening over 2-3 days.   Treated with OTC Children's Tylenol,  Benadryl as well as RX Cephalexin for cellulitis.
Age: 39.0
Sex: F
Vaccine: PNC21, VARZOS
Symptoms: Chills, Headache, Injection site erythema, Pain, Pyrexia
Clinical narrative: Patient had headache, fever, body aches/chills and a red lump at the injection site. Despite ibuprofen and ice, lump/redness continues to get larger. Patient had her spouse draw a line around the redness and it has spread beyond the drawn area.