chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: FLU3
Symptoms: Pain in extremity, Peripheral swelling
Clinical narrative: she had limited range of motion with her left arm; can't shave, no ponytails; still feeling sore and stiff; remained swollen; hurt like crazy; Initial information received on 23-Jul-2025 regarding an unsolicited valid  non-serious case received from a patient.  This case involves an unknown age female patient who had limited range of motion with her left arm, can't shave, no ponytails, still feeling sore and stiff, remained swollen and hurt like crazy after receiving  Influenza Quadrivalent Recombinant Vaccine [Flublok].  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On 03-Nov-2018, the patient received 0.5 ml dose of suspect Influenza Quadrivalent Recombinant Vaccine, unknown formulation, lot QFA1818, expiry date:30-Jun-2019, strength not reported via unknown route in the left deltoid for influenza.  On 03-Nov-2018 the patient hurt like crazy (vaccination site pain) (latency :same day).  On an unknown date the patient had limited range of motion with her left arm (vaccination site movement impairment), can't shave, no ponytails (loss of personal independence in daily activities), still feeling sore and stiff (musculoskeletal stiffness) and remained swollen (vaccination site swelling) (unknown latency).   Reportedly,Patient said that she was not taking any pain meds such as Meloxicam, she used some ointments and ice packs. Through the years, she said that she had physical therapies, MRIs [Magnetic resonance imaging], she had seen multiple nice doctors.On one of her MRIs, she mentioned that she was informed that a little bursitis was seen,her doctor suggested surgery, but he did not guarantee that the swelling would go down.  Action taken was not applicable.  It was not reported if the patient received a corrective treatment for all the events.  At time of reporting, the outcome was Not Recovered / Not Resolved for all the events.
Age: 17.0
Sex: F
Vaccine: FLU3, MENB, MNQ
Symptoms: Fall, Head injury, Imaging procedure, Loss of consciousness, Presyncope
Clinical narrative: Pt fell from chair after immunization given, hit her forehead. her body jerked a couple of times and then she regained consciousness  after 10 seconds.  Pt was fully aware within seconds of reawakening, not postictal, remembered the vaccination being administered. EMS was called to site for evaluation, mom was at pt's side the entire time. After evaluation by EMS. Mom acknowledged concern for life-threatening risk d/t her head injury, and agreed to take the pt directly to the ER for full evaluation.  Pt left via ambulation with a steady gait accompanied by her mother. Mother drove her to a nearby ER. Later spoke with mom over the phone and they said she was evaluated in ER for head injury, no apparent TBI or brain bleed/swelling. Pt discharged home to follow up with Neuro. It was believed to be a vasovagal event
Age: 45.0
Sex: F
Vaccine: PNC21
Symptoms: Product storage error
Clinical narrative: the patient did not report any adverse issues or side effects from the administered dose; CAPVAXIVE  was exposed to a minimum temperature of 0C and a maximum of 9C / The HCP also stated the CAPVAXIVE was administered to a  patient; This spontaneous report was received from a medical assistant and refers to a) 45-year-old female patient.   The patient's medical, concurrent conditions and concomitant therapies were not reported.   The reporter stated that sometime during 27-Jun-2025 through 09-Jul-2025 the Pneumococcal 21-valent Conjugate Vaccine (CAPVAXIVE)  was exposed to a minimum temperature of 0C and a maximum of 9C, but the reporter was unable to confirm when the excursions occurred, and it was unknown if the vaccine had any prior excursions. On 01-Jul-2025, the patient was vaccinated with the improper storage vaccine Pneumococcal 21-valent Conjugate Vaccine (CAPVAXIVE) 168 mcg/ml, lot #Z002626, expiration date: 04-Sep-2026, 0.5 mL once administered by Unknown route as prophylaxis.  The reporter confirmed the patient did not report any adverse issues or side effects from the administered dose.  This is one of several cases from the same source.
Vaccine: HEPA
Symptoms: Underdose
Clinical narrative: No additional AE; HCP reported that an adult patient received a pediatric dose of VAQTA.; HCP reported that an adult patient received a pediatric dose of VAQTA. No symptoms reported. No additional information provided. No additional AE/no PQC.; This spontaneous report was received from nurse regarding a 63-year-old patient of unknown gender. The patient's medical history, concurrent conditions, and concomitant therapies were not reported.   On 17-JUL-2025, the adult patient was vaccinated with a pediatric dose of Hepatitis A Vaccine, Inactivated, 0.5 mL administered as prophylaxis (lot number reported as Y015910, which has been verified as valid, expiration date reported and validated as 06-FEB-2026) (vaccination scheme, route of administration, and anatomical site of injection were not reported) (Product administered to patient of inappropriate age, Underdose).  No symptoms were reported in the patient.
Sex: F
Vaccine: HEP
Symptoms: Inappropriate schedule of product administration, No adverse event
Clinical narrative: The patient did not experience any symptoms; patient accidentally received their third dose of RECOMBIVAXHB prior to the suggested 6 months of age; HCP called to report that a patient accidentally received their third dose of RECOMBIVAXHB prior to the suggested 6 months of age; This spontaneous report was received from a healthcare professional regarding a 4-month-old female patient. The patient's medical, concurrent conditions, and concomitant therapies were not reported.   On 11-JUL-2025, the patient was accidentally vaccinated with the third dose of Hepatitis B Vaccine (Recombinant) (RECOMBIVAX HB) injection, 0.5 mL administered intramuscularly as prophylaxis (lot number reported as Y014090, which has been verified as valid, expiration date reported and validated as 01-JUN-2027) (anatomical site of injection was not reported).   This vaccine was administered prior to the suggested 6 months of age (Inappropriate schedule of product administration, Product administered to patient of inappropriate age). The patient did not experience any symptoms.
Vaccine: PNC20
Symptoms: Product quality issue
Clinical narrative: The last one from a box has plastic in the vaccine; This is a spontaneous report received from a Pharmacist from product quality group.  This report involves pneumococcal 20-val conj vac (dipht CRM197 protein) (PREVNAR 20), as dose number unknown, single (Lot number: LN4931, Expiration Date: 31Jul2026) for immunisation. The following information was reported: PRODUCT CONTAMINATION (non-serious), outcome "unknown", described as "The last one from a box has plastic in the vaccine".  Additional information: NDC number of Prevnar 20 is 0005200010. The sample of the product is available to be returned.   Causality for "the last one from a box has plastic in the vaccine" was determined associated to device constituent of pneumococcal 20-val conj vac (dipht CRM197 protein) (malfunction).
Sex: F
Vaccine: COVID19
Symptoms: Acne, Hypersensitivity, Myocarditis, Pericarditis
Clinical narrative: myocarditis; pericarditis; resurfacing acne; vaccine caused an allergic reaction; This is a spontaneous report received from a Consumer or other non HCP.  A 35-year-old female patient (not pregnant) received BNT162b2 omicron (kp.2) (COMIRNATY (2024-2025 FORMULA)), on 01Dec2024 as dose 1, single (Batch/Lot number: unknown), in right arm for covid-19 immunisation. The patient's relevant medical history included: "Endocarditis" (unspecified if ongoing), notes: pre-existing condition that is under yearly review and check up; "Staph" (unspecified if ongoing); "Hepatitis C" (unspecified if ongoing); "MRSA" (unspecified if ongoing); "Allergy to poison oak and ivy" (unspecified if ongoing); "Chickenpox" (unspecified if ongoing), notes: never fully disappeared causing a domino effect with a series of medical complications, chronic acne; "Chronic acne" (unspecified if ongoing), notes: her dermatologist should have put her on Accutane for one year and she had not had a pimple since then. The patient's concomitant medications were not reported. The following information was reported: HYPERSENSITIVITY (non-serious) with onset 29Jul2025, outcome "unknown", described as "vaccine caused an allergic reaction"; MYOCARDITIS (medically significant, life threatening), outcome "unknown"; PERICARDITIS (medically significant, life threatening), outcome "not recovered"; ACNE (non-serious), outcome "unknown", described as "resurfacing acne".  Clinical course: The patient has a pre-existing condition that is under yearly review and check up. She has a health condition called endocarditis and has scheduled heart surgeries to replace pulmonary valve mechanically. She is allergic to poison oak and ivy, also her chicken pox never fully disappeared causing a domino effect with a series of medical complications, chronic acne (which she doesn't think really was acne at the time) when she was super young and didn't know any better when her dermatologist should have put her on Accutane for one year and she had not had a pimple since then, coincidentally typing this. She was concerned about resurfacing acne starting 29Jul2025, the vaccine caused an allergic reaction. Myocarditis dangers include pre-existing heart condition, inflammation of the heart muscle condition, and pericarditis has been persisting up until now, she has many concerns and not only had bad side effects but her life is in danger when these adverse side effects, affect her vital organs.
Age: 46.0
Sex: M
Vaccine: HEP, HEP, HEP
Symptoms: Extra dose administered, Inappropriate schedule of product administration
Clinical narrative: Late 3rd dose; Overdose; Late 2nd dose; This non-serious case was reported by a nurse via call center representative and described the occurrence of drug dose administration interval too long in a 46-year-old male patient who received HBV (Engerix B) for prophylaxis.   Co-suspect products included HBV (Engerix B) (batch number 9K34M) for prophylaxis and HBV (Engerix B) (batch number 9K34M) for prophylaxis.   Previously administered products included Shingrix (received the 1st dose on 22-Oct-2013).   On 03-SEP-2014, the patient received the 2nd dose of Engerix B. On 15-JUL-2024, the patient received the 3rd dose of Engerix B. On 15-JUL-2025, the patient received the 4th dose of Engerix B. On 03-SEP-2014, an unknown time after receiving Engerix B and not applicable after receiving Engerix B and Engerix B, the patient experienced drug dose administration interval too long (Verbatim: Late 2nd dose). On 15-JUL-2025, the patient experienced drug dose administration interval too long (Verbatim: Late 3rd dose) and overdose (Verbatim: Overdose). The outcome of the drug dose administration interval too long, drug dose administration interval too long and overdose 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: 15-JUL-2025 Other HCP reported that they accidentally administered a 2nd dose of the Hep B (Engerix-B) vaccine to an adult in the same day. Reporter mentioned that the PX received the 1st dose on 22nd October 20213, and the 2nd on 03rd September 2014, which led to drug dose administration interval too long. And on 15th July 2024 the patient received the 3rd and 4th dose (on the same day), which led to drug dose administration interval too long and accidental overdose. The lot number that HCP provide was for the 3rd and 4th dose.
Age: 50.0
Sex: F
Vaccine: PNC20, TYP, VARZOS
Symptoms: Asthenia, Chills, Hyperhidrosis, Immediate post-injection reaction, Loss of personal independence in daily activities
Clinical narrative: Immediate pain with admin of second vaccine (I do not know which order they were administered ).  This was not just pain from needle. Arm continued to hurt more and turned warm & red  in a roundish welt the size of a small grapefruit.  By the next morning I was exhausted and began getting chills and ended up in a fever cycle of chills/sweating and slept restlessly most of the day & night taking 2 advil every 4-8h. By midday Thursday the fever broke but still fatigued and arm is still swollen, hot , red & painful.  It is Friday morning & I canceled my scheduled yoga class because my arm is still swollen, hot, red & painful and I lack energy
Age: 50.0
Sex: F
Vaccine: PNC20, TYP, VARZOS
Symptoms: Pain in extremity, Peripheral swelling, Poor quality sleep, Pyrexia, Skin warm
Clinical narrative: Immediate pain with admin of second vaccine (I do not know which order they were administered ).  This was not just pain from needle. Arm continued to hurt more and turned warm & red  in a roundish welt the size of a small grapefruit.  By the next morning I was exhausted and began getting chills and ended up in a fever cycle of chills/sweating and slept restlessly most of the day & night taking 2 advil every 4-8h. By midday Thursday the fever broke but still fatigued and arm is still swollen, hot , red & painful.  It is Friday morning & I canceled my scheduled yoga class because my arm is still swollen, hot, red & painful and I lack energy
Age: 50.0
Sex: F
Vaccine: PNC20, TYP, VARZOS
Symptoms: Urticaria
Clinical narrative: Immediate pain with admin of second vaccine (I do not know which order they were administered ).  This was not just pain from needle. Arm continued to hurt more and turned warm & red  in a roundish welt the size of a small grapefruit.  By the next morning I was exhausted and began getting chills and ended up in a fever cycle of chills/sweating and slept restlessly most of the day & night taking 2 advil every 4-8h. By midday Thursday the fever broke but still fatigued and arm is still swollen, hot , red & painful.  It is Friday morning & I canceled my scheduled yoga class because my arm is still swollen, hot, red & painful and I lack energy
Age: 0.33
Sex: F
Vaccine: DTPPVHBHPB, PNC20, RV5
Symptoms: Blood test, Computerised tomogram head, Intussusception, Ultrasound abdomen
Clinical narrative: Patient with an intussusception 19 days after receiving rotateq vaccine
Age: 72.0
Sex: F
Vaccine: FLU3
Symptoms: Dizziness, Tunnel vision
Clinical narrative: dizziness and tunnel vision
Age: 73.0
Sex: M
Vaccine: COVID19
Symptoms: Hypoaesthesia
Clinical narrative: Patient reports numbness in all 10 of his fingers the day after vaccine administration.
Age: 19.0
Sex: F
Vaccine: FLU3, MNQ
Symptoms: Blood glucose, Fatigue, Pallor, Pupillary disorder, Syncope
Clinical narrative: A  female19 year old patient got fainting  on the floor  4-5 minutes after getting the vaccines,  with pale face, change in color of the eye pupils but got consciousness back in 2-3 minutes with normal breathing . She got fatigue and shakiness on both hands. Patient , patient caregiver, and patient's mom all refused getting a dose of Epipen on scene when it happened and reported that she has history of anxiety. Provided water, and a bottle of milk. Patient was feeling better after 5 minutes. When EMS arrived and performed the fingerstick blood glucose test, patient fainted again for  another 2 minutes. She got consciousness back and got taken to the Hospital.
Age: 19.0
Sex: F
Vaccine: FLU3, MNQ
Symptoms: Tremor
Clinical narrative: A  female19 year old patient got fainting  on the floor  4-5 minutes after getting the vaccines,  with pale face, change in color of the eye pupils but got consciousness back in 2-3 minutes with normal breathing . She got fatigue and shakiness on both hands. Patient , patient caregiver, and patient's mom all refused getting a dose of Epipen on scene when it happened and reported that she has history of anxiety. Provided water, and a bottle of milk. Patient was feeling better after 5 minutes. When EMS arrived and performed the fingerstick blood glucose test, patient fainted again for  another 2 minutes. She got consciousness back and got taken to the Hospital.
Age: 18.0
Sex: M
Vaccine: MNQ
Symptoms: Generalised tonic-clonic seizure, Headache, Malaise, Staring
Clinical narrative: within seconds of administering vaccine patient stated he didn't feel good, witnessed pt with eyes open and blank stare have a mild tonic/clonic type seizure activity that lasted about 5-6 seconds, pt came to and asked what happened and asked for water and was fine thereafter, stated he had a headache that resolved in office while completing visit information and waiting for mother to come pick him up
Age: 17.0
Sex: M
Vaccine: COVID19
Symptoms: Chest X-ray normal, Chest pain, Drug screen negative, Electrocardiogram normal, Laboratory test normal
Clinical narrative: NO PREVIOUS MEDICAL ISSUES OR DIAGNOSES. NOW HAS DEVELOPED PERICARDITIS AFTER COVID VACCINATIONS. UNKNOWN WHEN PERICARDITIS STARTED EXACTLY BUT WENT TO THE ER WITH CHEST PAINS AND ELEVATED TROPONIN LEVEL ON 8/1/25 AND WAS PREVIOUSLY HEALTHY, NO MEDS, NO OTHER DIAGNOSES, NO HEART ISSUES PRIOR TO COVID VACCINATIONS.
Age: 17.0
Sex: M
Vaccine: COVID19
Symptoms: Pericarditis, Troponin increased
Clinical narrative: NO PREVIOUS MEDICAL ISSUES OR DIAGNOSES. NOW HAS DEVELOPED PERICARDITIS AFTER COVID VACCINATIONS. UNKNOWN WHEN PERICARDITIS STARTED EXACTLY BUT WENT TO THE ER WITH CHEST PAINS AND ELEVATED TROPONIN LEVEL ON 8/1/25 AND WAS PREVIOUSLY HEALTHY, NO MEDS, NO OTHER DIAGNOSES, NO HEART ISSUES PRIOR TO COVID VACCINATIONS.
Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: Pain of skin, Vomiting
Clinical narrative: COVID PFIZER VACCINE (every piece of skin hurt, could not sit, vomiting, felt like she was gonna die, lasted for about 3 days),
Age: 76.0
Sex: M
Vaccine: FLU3
Symptoms: Dehydration, Pyrexia
Clinical narrative: Patient's wife said he ended up in the hospital with a fever of 103 and dehydration after getting vaccinated.
Age: 18.0
Sex: M
Vaccine: HPV9
Symptoms: Expired product administered
Clinical narrative: vaccine administered past expiration date; soreness at vaccine site; This spontaneous report was received from a Physician Assistant and refers to a patient of unknown age and gender.   The patient's medical history was not reported. The patient's concurrent conditions were not reported. Concomitant therapies were not reported.   On 04-Jun-2025, the patient was vaccinated with an expired dose of Human Papillomavirus 9-valent Vaccine, Recombinant (GARDASIL®9), (lot #W033612, expiration date: 03-Mar-2025, dose not reported), dose number 1, for prophylaxis (expired product administered). No adverse event was reported.  Follow up information has been received from the reporter on 02-Jul-2025 referring to an 18 year-old male patient.  The patient's concurrent conditions included attention deficit hyperactivity disorder (ADHD). Historical drugs included Meningococcal vaccine (Meningococcal vaccine). Concomitant medications included Adderall (Amfetamine aspartate;Amfetamine sulfate;Dexamfetamine saccharate;Dexamfetamine sulfate) .  On 04-Jun-2025, the patient was vaccinated with Human Papillomavirus 9-valent Vaccine, Recombinant (GARDASIL®9) past expiration date in Left Arm, by a trained healthcare professional at private doctor's office. The vaccine was purchased with private funds.  The vaccine had been properly stored loading up to administration. Error discovered shortly after, patient was notified. Followed up via phone, no unexpected adverse outcomes. On an unspecified date in 2025, the patient experienced soreness at vaccine site (Vaccination site pain), consistent with expected response to vaccine. At the reporting time, the outcome of Vaccination site pain was unknown. The action taken with Human Papillomavirus 9-valent Vaccine, Recombinant was not applicable.   The causal relationship between the event of Vaccination site pain and Human Papillomavirus 9-valent Vaccine, Recombinant was not reported.
Vaccine: HEPA
Symptoms: Expired product administered, No adverse event
Clinical narrative: No additional AE/PQC.; HCP calling to check the expiration date for a VAQTA with lot number h012673. Caller stated that upon checking the past immunization record for a patient, it appeared that someone might have mistyped the expiration date of the product as 2/27/2013 an; This spontaneous report was received from a consumer or other non-health professional and refers to a patient of unknown age and gender.   The patient's pertinent medical history, concurrent conditions, previous drug reactions or allergies and concomitant medications were not reported.  On 14-Jun-2013, the patient was vaccinated with an expired dose of Hepatitis A Vaccine, Inactivated (VAQTA), lot #H012673 has been verified to be a valid lot number, expiration date: 27-Feb-2015 (conflicting information, upon checking the past immunization record for the patient, it appeared that someone might have mistyped the expiration date of the product as 27-Feb-2013), administered for prophylaxis (dose, route of administration and anatomical site of injection were not provided) (Expired product administered). No additional adverse event was reported (No adverse event).
Sex: F
Vaccine: VARZOS
Symptoms: Guillain-Barre syndrome
Clinical narrative: she developed Guillain Barre Syndrome; This serious case was reported by a consumer via interactive digital media and described the occurrence of guillain barre syndrome in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   The patient's past medical history included shingles (had twice). Previously administered products included Shingles vaccine (received 1st dose on an unknown date).   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced guillain barre syndrome (Verbatim: she developed Guillain Barre Syndrome) (serious criteria GSK medically significant). The outcome of the guillain barre syndrome was not reported.   The reporter considered the guillain barre syndrome to be related to Shingrix.     The company considered the guillain barre syndrome to be unrelated to Shingrix.   Additional Information: GSK Receipt Date: 19-JUL-2025 This case was reported by a consumer via interactive digital media. The second one was Shingrix, and she developed Guillain barre syndrome form the vaccine. Now patient had trouble walking and could not take most vaccines. The reporter was 50 but the reporter scared to get it after seeing what it did to her.; Sender's Comments: A case of Guillain-Barre syndrome, an unknown time after receiving Shingrix, in a female patient. Based on the available information, a possible causality that the event(s) was caused by the GSK product cannot be ascertained. Consent for further follow up has not been received.
Sex: F
Vaccine: HEPAB
Symptoms: Incomplete course of vaccination
Clinical narrative: back today to start the completion of the series; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in a 67-year-old female patient who received HAB (Twinrix) for prophylaxis.   Previously administered products included Twinrix (received 1st dose on 20-FEB-2019).   On an unknown date, the patient did not receive the 2nd dose of Twinrix. The patient experienced incomplete course of vaccination (Verbatim: back today to start the completion of the series). The outcome of the incomplete course of vaccination was not applicable.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK Receipt Date: 22-JUL-2025 The pharmacist reported that the patient received 1st dose of Twinrix on 20-FEB-2019 and was back on the day of reporting to start the completion of the series.  The pharmacist was unsure if patient had received 2 doses or just the 1 dose, how should they proceed with completing the series for the patient. Patient had not received next dose of Twinrix at the time of the reporting. Till the time of reporting, the patient did not receive 2nd dose of Twinrix vaccine, which led to incomplete course of vaccination.
Age: 7.0
Sex: F
Vaccine: MMR
Symptoms: Incorrect route of product administration
Clinical narrative: Subcutaneous injection formulation administered intramuscularly;  This non-serious case was reported by a nurse via call center representative and described the occurrence of subcutaneous injection formulation administered by other route in a 7-year-old female patient who received MMR (Priorix) (batch number 4ZC23, expiry date 01-SEP-2025) for prophylaxis.   Previously administered products included Priorix (patient received 1st dose on unknown date).   On 18-JUL-2025, the patient received the 2nd dose of Priorix (intramuscular). On 18-JUL-2025, an unknown time after receiving Priorix, the patient experienced subcutaneous injection formulation administered by other route (Verbatim: Subcutaneous injection formulation administered intramuscularly). The outcome of the subcutaneous injection formulation administered by other route was not applicable.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK receipt date: 23-JUL-2025 Other HCP informed that a Priorix dose was given by the intramuscular route instead of subcutaneous one to a 7-year-old female patient, which led to subcutaneous injection formulation administered by other route. Vaccine was administered on 18 July 2025 as second dose. She wanted to know how to proceed after this incident.
Sex: F
Vaccine: HEP
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: They administered an adult dose of Engerix-B (1 mL dose) to a patient who is 18 years old.; They administered an adult dose of Engerix-B (1 mL dose) to a patient who is 18 years old.; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of adult product administered to child in a 18-year-old female patient who received HBV (Engerix B adult) (batch number T5D73, expiry date 10-APR-2027) for prophylaxis.   On an unknown date, the patient received the 1st dose of Engerix B adult 1 ml. On an unknown date, an unknown time after receiving Engerix B adult, the patient experienced adult product administered to child (Verbatim: They administered an adult dose of Engerix-B (1 mL dose) to a patient who is 18 years old.) and accidental overdose (Verbatim: They administered an adult dose of Engerix-B (1 mL dose) to a patient who is 18 years old.). The outcome of the adult product administered to child and accidental overdose 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: 24-JUL-2025 The reporter called to report a vaccination error. They administered an adult dose of Engerix-B (1 mL dose) to a patient who was 18 years old, which led to adult product administered to child and accidental overdose.
Sex: M
Vaccine: COVID19
Symptoms: Schizophrenia
Clinical narrative: mental health problems/ schizophrenic now/ hearing voices in his head, like, how scary; This spontaneous case was reported by a consumer and describes the occurrence of SCHIZOPHRENIA (mental health problems/ schizophrenic now/ hearing voices in his head, like, how scary) in a male patient of an unknown age who received SPIKEVAX NOS (SPIKEVAX NOS) for COVID-19 prophylaxis.     No Medical History information was reported.   On an unknown date, the patient received first dose of SPIKEVAX NOS (SPIKEVAX NOS) (unknown route) 1 dosage form. On an unknown date, received second dose of SPIKEVAX NOS (SPIKEVAX NOS) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced SCHIZOPHRENIA (mental health problems/ schizophrenic now/ hearing voices in his head, like, how scary) (seriousness criteria disability and medically significant). At the time of the report, SCHIZOPHRENIA (mental health problems/ schizophrenic now/ hearing voices in his head, like, how scary) outcome was unknown.            No concomitant medication was reported.  Patient took 2 shots and felt sick. He was permanently disabled. He had mental health problems because the shots cross the blood-brain barrier. He was schizophrenic at the time of reporting. Before taking the shot, he had never had any signs of mental health issues. Then he was like hearing voices in his head, like scary.  No treatment medication was reported.   This case was linked to US-MODERNATX, INC.-MOD-2025-787428 (E2B Linked Report).   Reporter did not allow further contact   Most recent FOLLOW-UP information incorporated above includes: On 10-Jun-2025: Upon internal review on 31-Jul-2025, significant correction was performed to remove the classification of Invalid, Updated suspect product coding from Unspecified Moderna vaccine to Spikevax NOS.; Reporter's Comments: Company Comment: The benefit-risk relationship of product is not affected by this report.; Sender's Comments:  US-MODERNATX, INC.-MOD-2025-787428:For nephew
Sex: F
Vaccine: COVID19
Symptoms: Neoplasm malignant
Clinical narrative: her sister, got cancer after taking a bunch of the shots, really bizarre cancer, two different cancers in the same area. She had never heard of anybody having two cancers at the same time; This spontaneous case was reported by a consumer and describes the occurrence of NEOPLASM MALIGNANT (her sister, got cancer after taking a bunch of the shots, really bizarre cancer, two different cancers in the same area. She had never heard of anybody having two cancers at the same time) in a female patient of an unknown age who received SPIKEVAX NOS (SPIKEVAX NOS) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received dose of SPIKEVAX NOS (SPIKEVAX NOS) (unknown route) 1 dosage form. On an unknown date, the patient experienced NEOPLASM MALIGNANT (her sister, got cancer after taking a bunch of the shots, really bizarre cancer, two different cancers in the same area. She had never heard of anybody having two cancers at the same time) (seriousness criterion medically significant). At the time of the report, NEOPLASM MALIGNANT (her sister, got cancer after taking a bunch of the shots, really bizarre cancer, two different cancers in the same area. She had never heard of anybody having two cancers at the same time) outcome was unknown.            No concomitant medication was reported.  Patient got cancer after taking a bunch of the shots, really bizarre cancer, two different cancers in the same area.  Reporter stated that her neighbor across the street, her sister, got cancer after taking a bunch of the shots, really bizarre cancer, two different cancers in the same area. She had never heard of anybody having two cancers at the same time.   No treatment medication was reported.   This case was linked to US-MODERNATX, INC.-MOD-2025-787428 (E2B Linked Report).   Reporter did not allow further contact   Most recent FOLLOW-UP information incorporated above includes: On 10-Jun-2025: Upon internal review on 31-Jul-2025, significant correction was performed to remove the classification of Invalid, updated suspect product coding from Unspecified Moderna vaccine to Spikevax NOS.; Reporter's Comments: Company Comment: The benefit-risk relationship of product is not affected by this report.; Sender's Comments:  US-MODERNATX, INC.-MOD-2025-787428:Master case
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: Discomfort, Hypoaesthesia, Vaccination site pain
Clinical narrative: very localized discomfort; Arm turned numb; still have a sore spot where the shot was administered; This spontaneous case was reported by a consumer and describes the occurrence of DISCOMFORT (very localized discomfort), HYPOAESTHESIA (Arm turned numb) and VACCINATION SITE PAIN (still have a sore spot where the shot was administered) in a 54-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 040C21A) for COVID-19 prophylaxis.     No Medical History information was reported.  On 07-Sep-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular use) 1 dosage form. On an unknown date, the patient experienced DISCOMFORT (very localized discomfort), HYPOAESTHESIA (Arm turned numb) and VACCINATION SITE PAIN (still have a sore spot where the shot was administered). At the time of the report, DISCOMFORT (very localized discomfort), HYPOAESTHESIA (Arm turned numb) and VACCINATION SITE PAIN (still have a sore spot where the shot was administered) had not resolved.      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular use) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular use), the reporter did not provide any causality assessments.   Concomitant medication was not reported.  It was reported that the patient still had a sore spot where the shot was administered 4 years later. It was unknown if the patient experienced any additional symptoms/events. The patient had no medical history, concomitant disease, or risk factor.  Treatment medication was not reported.
Vaccine: COVID19
Symptoms: Pancreatic failure
Clinical narrative: EPI; This is a spontaneous report received from a Consumer or other non HCP from medical information team.  A patient (age and gender not provided) received BNT162b2 omicron (kp.2) (BNT162B2 OMICRON (KP.2)), as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: PANCREATIC FAILURE (medically significant), outcome "unknown", described as "EPI".  Clinical course: Patient was diagnosed with EPI just after getting the covid shots.  The information on the batch/lot number for BNT162b2 omicron (kp.2) will be requested and submitted if and when received.
Age: 16.0
Sex: F
Vaccine: MENB
Symptoms: Face injury, Fall, Syncope
Clinical narrative: severe fainting episode/single severe syncope episode/syncopy; collapsed; This is a spontaneous report received from a Physician and a Consumer or other non HCP from medical information team.  A 16-year-old female patient received meningococcal group b Rlp2086 (TRUMENBA), on 28Jul2025 as dose 1, 0.5 ml single (Lot number: LX2636, Expiration Date: 31Jan2027) at the age of 16 years intramuscular, in left deltoid for immunisation, Device Lot Number: LX2636, Device Expiration Date: 31Jan2027. The patient's relevant medical history included: "Scoliosis" (unspecified if ongoing). There were no concomitant medications (The patient was not on any medication). The patient did not have any allergic to anything, had not had an illness in the month or got any other vaccines. The following information was reported: CIRCULATORY COLLAPSE (medically significant) with onset 28Jul2025, outcome "unknown", described as "collapsed"; SYNCOPE (medically significant) with onset 28Jul2025, outcome "unknown", described as "severe fainting episode/single severe syncope episode/syncopy". Clinical course: The patient had collapsed and get single severe syncope episode/severe fainting episode, and fell down in the room within like a minute later after due to syncopy and got hurt near the eye, they did not let her go and observed her for 0-40 minutes, she came to baseline, she was able to walk, everything so they let her go home. The physician had been using it for three years now and never had problems like this before. Physician expressed concern of this particular of lot of Trumenba, since he recognized the adverse reaction of two patients to same lot of vaccine as "uncommon". The physician wanted to return whole lot# LX2636 due to concern that the next patient will also get the same reaction. Had 14 remaining doses of this lot.; Sender's Comments: Based on known drug safety profile, and close temporal association the event syncope is assessed as related to the suspect drug MENINGOCOCCAL GROUP B RLP2086.  The event circulatory collapse is conservatively assessed as related to the suspect drug based on plausible temporal association but consider also possible contributory effects from medical history of the patient and/or concomitant medications. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees, and Investigators, as appropriate.
Vaccine: COVID19
Symptoms: Autoimmune disorder
Clinical narrative: Autoimmune diseases; This is a spontaneous report received from a consumer.  A patient (age and gender not provided) received BNT162b2 omicron (kp.2) (COMIRNATY (2024-2025 FORMULA)), as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Tick fever" (ongoing); "Alpha gal" (ongoing). The patient's concomitant medications were not reported. The following information was reported: AUTOIMMUNE DISORDER (medically significant), outcome "unknown", described as "Autoimmune diseases". When COVID came out, the patient kept thinking she will just keep getting COVID over and over. The patient had tick fever around 2 years before he/she was finally diagnosed. The patient took the shot not knowing he/she had tick fever, and he/she was alpha gal. The patient believed the COVID shot having tick fever and alpha gal gave the patient autoimmune diseases. The patient did not blame anyone but maybe people can all learn from this, and the patient can start feeling better. The patient had insurance, and the insurance will pay for this.  The information on the batch/lot number for BNT162b2 omicron (kp.2) will be requested and submitted if and when received.
Age: 88.0
Sex: F
Vaccine: COVID19
Symptoms: Death, Myocarditis, Pain
Clinical narrative: Died a violently painful death.  Myocarditis
Age: 67.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site erythema, Injection site pain, Neck pain, Pain
Clinical narrative: INJECTION SITE REACTION RED CIRCLE ABOUT 4 INCHES IN DIAMETER - PAIN RADIATING UP NECK
Age: 62.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site erythema, Injection site pruritus, Injection site reaction
Clinical narrative: PT REPORTED INJECTION SITE REACTION TO THE FLU VACCINE. THE SKIN WAS SLIGHTLY PINK, EXTENDING AROUND 2 INCHES IN EACH DIRECTION ABOUT THE INJECTION SITE. SHE POINTED TO THE SITE WHERE THE TECHNICIAN GAVE HER THE INJECTION WHICH WAS IN THE LOWER RIGHT DELTOID. SHE STATED IT WAS A LITTLE ITCHY, BUT SHE WAS GOING TO TAKE SOME BENADRYL. PATIENT SEEMED WELL OTHERWISE, AND STAYED TO HAVE A CONVERSATION ABOUT SOME OF HER OTHER MEDS. SHE JUST WANTED TO BE SURE TO REPORT FOR OUR RECORDS. I TOLD HER I WOULD PLACE A PT NOTE IN HER PROFILE, AND REPORT TO VAERS.
Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: Tinnitus
Clinical narrative: tinnitus
Age: 26.0
Sex: F
Vaccine: COVID19, FLU3, MMR
Symptoms: Dizziness, Gaze palsy, Posture abnormal, Seizure
Clinical narrative: PATIENT WAS GIVEN MMR LEFT ARM AND COVID AND FLU RIGHT ARM PATIENT STATED DIZZY AFTER DONE AND I TOLD HER TO STAY PUT SHE TOOK SOME DEEP BREATH LEAN TO SIDE EYES ROLLED UP AND STARTED HAVING CONVULSIONS. CALLED 911 SENT PARAMEDICS OUT WAS CHECKED DID NOT WANT TO GO TO EMERGENCY ROOM SAID WAS FINE AFTER BEING CHECKED STAYED HERE FOR HOUR I FOLLOWED UP WITH CALL . SHE STATED WAS FINE .
Vaccine: HEP
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional AE; Customer called to report TE.; This spontaneous report was received from a pharmacist, concerning to a neonate patient of unknown gender.   The patient's medical history, patient's concurrent conditions and concomitant therapies were not reported.   On an unknown date, the vaccine Hepatitis B Vaccine (Recombinant) experienced a temperature (TE) excursion at 11.5 C for 2 hours.   On 18-Jun-2025, the patient was vaccinated  with the vaccine involved in the TE, Hepatitis B Vaccine (Recombinant) (lot #X027728 has been verified to be valid as a pre-filled syringe, expiration date reported and confirmed as 16-Oct-2026) (dose and route were not provided), as prophylaxis (Product storage error).   No additional adverse event reported (No adverse event).
Vaccine: HPV9
Symptoms: Expired product administered, No adverse event
Clinical narrative: No additional AE/No PQC.; Pharmacist calling to inquire about revaccination. Pharmacist reports a patient received an expired dose of GARDASIL 9 on 28JUL2025. Pharmacist reports the GARDASIL 9 expired on 26JAN2025 and no temperature excursion ever occurred. Pharmacist did inf; This spontaneous report was received from a/an Pharmacist and refers to a(n) patient of unknown age and gender.   The patient's medical history was not reported. The patient's concurrent conditions were not reported. Concomitant therapies were not reported.   On 28-Jul-2025, the patient started therapy with Human Papillomavirus 9-valent Vaccine, Recombinant (lot #W014513, expiration date: 26-Jan-2025), dose number 3, (3rd dose (last dose)),. On an unknown date, the patient started therapy with  unknown dosage. The patient started therapy with  for the treatment of prophylaxis.  The patient started therapy with Human Papillomavirus 9-valent Vaccine, Recombinant for the treatment of prophylaxis.  On 28-Jul-2025, the patient experienced Pharmacist calling to inquire about revaccination. Pharmacist reports a patient received an expired dose of GARDASIL 9 on 28JUL2025. Pharmacist reports the GARDASIL 9 expired on 26JAN2025 and no temperature excursion ever occurred. Pharmacist did inf. On an unknown date, the patient experienced No additional AE/No PQC.  Lot # is being requested and will be submitted if received.
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: COVID; COVID; This is a spontaneous report received from a Consumer or other non HCP.  A 72-year-old female patient received BNT162b2 omicron (kp.2) (COMIRNATY (2024-2025 FORMULA)), as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (DOSE 1-DOSE 8, SINGLE (unspecified valent)), for Covid-19 Immunization. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID". The patient reported that she was fully vaccinated and all of them was Pifizer shots, she thought she have had 9 over the last four years. Therapeutic measures were taken as a result of drug ineffective, covid-19. The patient had taken Paxlovid.  No follow-up attempts are possible. Batch/lot number is not provided, and it cannot be obtained.; Sender's Comments: Linked Report(s) : US-PFIZER INC-PV202500091010 same reporter/patient, different vaccine and event;
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Disease recurrence, Drug ineffective, SARS-CoV-2 test
Clinical narrative: has taken the Pfizer Covid-19 vaccines and has had covid 4 times; has taken the Pfizer Covid-19 vaccines and has had covid 4 times; has taken the Pfizer Covid-19 vaccines and has had covid 4 times; This is a spontaneous report received from a Consumer or other non HCP from medical information team.  A 76-year-old female patient received BNT162b2 omicron (kp.2) (COMIRNATY (2024-2025 FORMULA)), as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history was not reported. The patient took concomitant medications. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), DISEASE RECURRENCE (medically significant), outcome "unknown" and all described as "has taken the Pfizer Covid-19 vaccines and has had covid 4 times". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive.  Clinical course: Patient reported that she contracted covid and because she is on (Withheld) for Life, she apparently doesn't get to take Paxlovid. She was told by the pharmacist that Paxlovid doesn't kill the virus and as you go forward, you may fall back into symptoms. Her symptoms were mild, she was in excellent health, and does not have any underlying diseases. She was within close proximity with since testing positive for covid and she has had to cancel plans. She stated the only medications that she takes does not interact with Paxlovid and is not a contraindication. She stated that she has taken the Pfizer Covid-19 vaccines and has had covid 4 times.  No follow-up attempts are possible. Batch/lot number is not provided, and it cannot be obtained.
Age: 56.0
Sex: F
Vaccine: PNC20
Symptoms: Nausea, Pruritus
Clinical narrative: Itching; nauseated; This is a spontaneous report received from a Physician from a sales representative.  A 56-year-old female patient (not pregnant) received pneumococcal 20-val conj vac (dipht CRM197 protein) (PREVNAR 20), on 28Jul2025 as dose number unknown, single (Batch/Lot number: unknown) at the age of 56 years for immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Diphtheria, for immunization, reaction(s): "allergy"; Typhoid, for immunization, reaction(s): "allergy". The following information was reported: PRURITUS (non-serious) with onset 28Jul2025, outcome "recovered" (28Jul2025), described as "Itching"; NAUSEA (non-serious) with onset 28Jul2025, outcome "recovered" (28Jul2025), described as "nauseated". The events "itching" and "nauseated" required emergency room visit. Therapeutic measures were taken as a result of pruritus, nausea.  Additional information: The patient did not receive any other vaccines on the same date as the vaccine(s) for which they were reporting. The patient did not receive any other vaccines within 4 weeks prior to the vaccine(s) for which they were reporting. It was unknown if the patient taking any other medications within 2 weeks of the event starting. Patient had an adverse event after she was given Prevnar 20. Itching, and then feeling nauseated. She was taken to the ER. Later found out she was allergic to diphtheria typhoid and also had this reaction to tdap. Physician didn't know that a patient shouldn't receive Prevnar 20 if they were allergic to diphtheria typhoid. The patient received Prednisone and Epipen as treatment for the adverse events.  No follow-up attempts are possible. Batch/lot number is not provided, and it cannot be obtained.
Age: 40.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Facial pain, Feeling cold, Feeling hot, Infectious mononucleosis, Muscle spasms
Clinical narrative: Initial symptoms were very nerve related. Had a spot on my face the size of a medium circle that felt hot and cold constantly for several days to a week. However, symptoms followed later in the form of mono (a disease that you?re usually immune to by 40) then it was muscle spasms, not able to open my mouth, multiple specialists and continued pain today on the same side (right)
Age: 40.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Neurological symptom, Trismus
Clinical narrative: Initial symptoms were very nerve related. Had a spot on my face the size of a medium circle that felt hot and cold constantly for several days to a week. However, symptoms followed later in the form of mono (a disease that you?re usually immune to by 40) then it was muscle spasms, not able to open my mouth, multiple specialists and continued pain today on the same side (right)
Age: 77.0
Sex: M
Vaccine: COVID19
Symptoms: Brain fog, Dizziness, Fatigue, Headache, Vision blurred
Clinical narrative: Severe Headaches, Brain Fog, Dizziness, Fatigue, Blurry Vision,