chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 37.0
Sex: F
Vaccine: COVID19
Symptoms: Aphasia, Asthenia, Cerebrovascular accident, Dizziness, Dysarthria
Clinical narrative: My first stroke i didn't know that i had it, it was on my right side. And when i found out that had multiple strokes on 05/15/2023, that you learned about the first stroke. The first doctor he told me that it looked like i got hit in the head but there was a language barrier, and this was in (redacted). My face was numb and i could not speak and slurring my words. Another doctor gave me medication after i was getting migraines but he didn't see anything about the stoke. Later on in 2023 on 05/18 they did a MRI, that's when they told me that it was a stroke. They did an x ray on my mouth and they broke my tooth and i was not supposed to have go under after a stroke but they still did.  When i moved to (redacted) i started seeing the doctor. I went to Regional Hospital 01/2025 - because i thought i was having another stoke they did another MRI. But my arm was numb on the left side from hand to shoulder. I am having weakness in my whole body and i am shaking and feeling nauseous and dizzy.
Age: 37.0
Sex: F
Vaccine: COVID19
Symptoms: Hypoaesthesia, Magnetic resonance imaging abnormal, Migraine, Nausea, Tooth fracture
Clinical narrative: My first stroke i didn't know that i had it, it was on my right side. And when i found out that had multiple strokes on 05/15/2023, that you learned about the first stroke. The first doctor he told me that it looked like i got hit in the head but there was a language barrier, and this was in (redacted). My face was numb and i could not speak and slurring my words. Another doctor gave me medication after i was getting migraines but he didn't see anything about the stoke. Later on in 2023 on 05/18 they did a MRI, that's when they told me that it was a stroke. They did an x ray on my mouth and they broke my tooth and i was not supposed to have go under after a stroke but they still did.  When i moved to (redacted) i started seeing the doctor. I went to Regional Hospital 01/2025 - because i thought i was having another stoke they did another MRI. But my arm was numb on the left side from hand to shoulder. I am having weakness in my whole body and i am shaking and feeling nauseous and dizzy.
Age: 37.0
Sex: F
Vaccine: COVID19
Symptoms: Tremor
Clinical narrative: My first stroke i didn't know that i had it, it was on my right side. And when i found out that had multiple strokes on 05/15/2023, that you learned about the first stroke. The first doctor he told me that it looked like i got hit in the head but there was a language barrier, and this was in (redacted). My face was numb and i could not speak and slurring my words. Another doctor gave me medication after i was getting migraines but he didn't see anything about the stoke. Later on in 2023 on 05/18 they did a MRI, that's when they told me that it was a stroke. They did an x ray on my mouth and they broke my tooth and i was not supposed to have go under after a stroke but they still did.  When i moved to (redacted) i started seeing the doctor. I went to Regional Hospital 01/2025 - because i thought i was having another stoke they did another MRI. But my arm was numb on the left side from hand to shoulder. I am having weakness in my whole body and i am shaking and feeling nauseous and dizzy.
Age: 51.0
Sex: F
Vaccine: PNC20
Symptoms: Chills, Decreased appetite, Diarrhoea, Injection site erythema, Injection site pain
Clinical narrative: site reaction with pain, swelling, hyperthermia, firmness, erythema and white blanching, nerve pain. Systemic: body aches, diarrhea, felt chills. sweating. decreased appetite.
Age: 51.0
Sex: F
Vaccine: PNC20
Symptoms: Injection site pallor, Injection site swelling, Injection site warmth, Neuralgia, Pain
Clinical narrative: site reaction with pain, swelling, hyperthermia, firmness, erythema and white blanching, nerve pain. Systemic: body aches, diarrhea, felt chills. sweating. decreased appetite.
Age: 69.0
Sex: M
Vaccine: FLU3
Symptoms: Atrial fibrillation, Blood pressure decreased, Blood test, Cardioversion, Dizziness
Clinical narrative: Awoke to dizziness at ~3:30am.  Returned to sleep and arose to same feeling at ~7:30am.  Took ECG with smart Watch at 7:59am and discovered I was in A-fib for the first time in my life.  My pulse rate was erratic between 142 and 92 BPM.  My BP was also generally low and unstable.  My historic BP is !118-128/72-78 with a resting pulse rate of 68-78.  I have and have never had any caridac, repsiratory or other infirmity and live a healthy lifestyle.    I went to Hospital and was admitted for 3 days in cardiac observation.  During that time a variety of drug therapies were used to force conversion.  I was taken on day 3 to do a cardio-converion but converted on my own seconds after the removal of the Ultrasound tool inserted in my esophagus to check for clots in the atrial appendage and before the doctor pressed the button to shock me into can attempt at conversion.  I was released with a regimen of blood thinner (Eloquis) 5mg 2xday, anti-arrhythmic (Propafenone HCL) 150mg, and blood pressure regulator (Metoprolol Tartrate) 25mg.  I stopped the drug therapy after 2 weeks of non-recurrence and my personal health history.  My heart rate, bp and pulse-ox were tracking normally and historically.  I did experience a recurrence wand was subsequently hospitalized again on 02/10/2025 at the same hospital under the care of the same physician.  I corrected once again using Amiodarone intravenously and was discharged on 02/12/2025 with only Amiodarone HCL 200mg (2xday) which was reduced by the physician 4weeks later to 200mg (1xday) and a referral to Dr, an electro-physiologist at facility for a planned Atrial Ablation. (*The referred physician has yet to respond with a schedule for the procedure.)
Age: 69.0
Sex: M
Vaccine: FLU3
Symptoms: Echocardiogram, Electrocardiogram, Electrocardiogram ambulatory abnormal, Heart rate irregular, Sleep disorder
Clinical narrative: Awoke to dizziness at ~3:30am.  Returned to sleep and arose to same feeling at ~7:30am.  Took ECG with smart Watch at 7:59am and discovered I was in A-fib for the first time in my life.  My pulse rate was erratic between 142 and 92 BPM.  My BP was also generally low and unstable.  My historic BP is !118-128/72-78 with a resting pulse rate of 68-78.  I have and have never had any caridac, repsiratory or other infirmity and live a healthy lifestyle.    I went to Hospital and was admitted for 3 days in cardiac observation.  During that time a variety of drug therapies were used to force conversion.  I was taken on day 3 to do a cardio-converion but converted on my own seconds after the removal of the Ultrasound tool inserted in my esophagus to check for clots in the atrial appendage and before the doctor pressed the button to shock me into can attempt at conversion.  I was released with a regimen of blood thinner (Eloquis) 5mg 2xday, anti-arrhythmic (Propafenone HCL) 150mg, and blood pressure regulator (Metoprolol Tartrate) 25mg.  I stopped the drug therapy after 2 weeks of non-recurrence and my personal health history.  My heart rate, bp and pulse-ox were tracking normally and historically.  I did experience a recurrence wand was subsequently hospitalized again on 02/10/2025 at the same hospital under the care of the same physician.  I corrected once again using Amiodarone intravenously and was discharged on 02/12/2025 with only Amiodarone HCL 200mg (2xday) which was reduced by the physician 4weeks later to 200mg (1xday) and a referral to Dr, an electro-physiologist at facility for a planned Atrial Ablation. (*The referred physician has yet to respond with a schedule for the procedure.)
Age: 65.0
Sex: F
Vaccine: PNC20
Symptoms: Injection site erythema, Injection site infection, Injection site pain, Injection site swelling
Clinical narrative: pain at injection site, swelling, redness, inflammation at injection site,
Age: 67.0
Sex: F
Vaccine: TDAP, VARZOS
Symptoms: Dizziness, Injection site mass, Vomiting
Clinical narrative: VOMITING NIGHT OF SHOTS, DIZZINESS  FROM DAY OF SHOT 3/26/25 UNTIL TODAY 4/9/25, KNOTS ON EACH ARM WHERE SHOT ADMINISTERED.
Age: 46.0
Sex: M
Vaccine: TD
Symptoms: Chills, Injection site erythema, Injection site pain, Injection site swelling, Pyrexia
Clinical narrative: pt reports tenderness, redness, and swelling to site of infection, fevers/chills
Age: 6.0
Sex: F
Vaccine: MMRV
Symptoms: Rash
Clinical narrative: Pt was given second dose of MMRV,   around 10 mins after admin.  she started to develop a rash..  provider went in to see patient.  she was given children's Benadryl and solu medrol
Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: Computerised tomogram, Magnetic resonance imaging, Migraine, Scan with contrast
Clinical narrative: Started getting migraines 2 months after the vaccine. Have been  and still being treated for migraines
Vaccine: VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: Suspected vaccination failure; got shot but still got it; This serious case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine, the patient experienced vaccination failure (Verbatim: Suspected vaccination failure) (serious criteria GSK medically significant) and shingles (Verbatim: got shot but still got it). The outcome of the vaccination failure and shingles were not reported.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine.     The company considered the vaccination failure and shingles to be unrelated to Shingles vaccine.   Additional Information: GSK Receipt Date: 02-APR-2025 This case was reported by a patient via interactive digital media. The patient got the shot and still got it (shingles). This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule, time to onset for shingles and laboratory confirmation regarding shingles were unknown at the time of reporting.; Sender's Comments: "Vaccination failure is a listed event which, due to the following criteria (insufficient information provided about the clinical description, details regarding the completion of primary vaccination schedule, time to onset and laboratory confirmation of disease) is considered unrelated to GSK Shingles vaccine. Herpes zoster is an unlisted event which is considered unrelated to GSK Shingles vaccine."
Age: 1.0
Sex: M
Vaccine: MMRV, VARCEL
Symptoms: Extra dose administered, No adverse event
Clinical narrative: Patient had no visual signs or symptoms while in the office for more than 30 minutes. Adverse event was that patient was given Varicella and Proquad on the same day.
Age: 63.0
Sex: F
Vaccine: VARZOS
Symptoms: Rash, Rash pruritic
Clinical narrative: New onset rash on face reported at PCP visit 5/6/24- small round raised area on right cheek area some itching, pcp notes state patient was weeding leading up to rash and pcp did not document rash may be related to vaccine that was given the week prior- however, patient believes they may be related. Rash treated with 6 day oral course of medrol dose pack and then a week later given clobetasol propionate cream 0.05% applied twice daily. Office visit 6/4/24 reports rash present on left side upper back that has been present for a week and patient indicated she had been working in her yard. Once again, no mention in pcp documentation that this may have been caused by vaccine; ketoconazole cream 2% once daily started.
Age: 47.0
Sex: M
Vaccine: COVID19
Symptoms: Injection site pain
Clinical narrative: Following vaccine patient report persistent left lower deltoid pain. He suspects the vaccine was administered low in his deltoid and that is leading to the persistent discomfort.
Age: 4.0
Sex: M
Vaccine: VARCEL
Symptoms: Pyrexia, Urticaria
Clinical narrative: Hives, and high temperature
Age: 76.0
Sex: M
Vaccine: COVID19
Symptoms: Acute respiratory failure, COVID-19, Chronic obstructive pulmonary disease, Condition aggravated, Dyspnoea
Clinical narrative: Name:   Age:  76 y.o.  DOB: 9/XX/1948  Admit date: 4/5/2025   Discharge date: 04/07/2025  Attending Physician at the Time of Discharge: MD  Primary Care Physician: MD  Reason for Admission: Acute on chronic hypoxic respiratory failure due to COVID-19   Brief Summary of Hospital Stay:   Patient is a 76 y.o. M with NSCLC, COPD, ongoing tobacco abuse, Chronic respiratory failure on 2L NC. He presented for evaluation of shortness of breath. He was diagnosed with acute on chronic hypoxic respiratory failure and acute COPD exacerbation due to COVID-19. He was treated with steroids, remdesivir, and scheduled duoneb. He had rapid improvement in symptoms and was weaned to his baseline 2L NC. Continued to improve and was discharged home at his baseline. Will continue prednisone on discharge to complete a 5 day course. Follow-up with PCP.  The patient was discharged in stable condition with improvement of symptoms and appropriate follow up planned.  Issues Requiring Follow Up: Follow-up with PCP. Follow-up with oncology and pulmonology as previously scheduled.  Discharged to Home.
Age: 76.0
Sex: M
Vaccine: COVID19
Symptoms: Respiratory failure
Clinical narrative: Name:   Age:  76 y.o.  DOB: 9/XX/1948  Admit date: 4/5/2025   Discharge date: 04/07/2025  Attending Physician at the Time of Discharge: MD  Primary Care Physician: MD  Reason for Admission: Acute on chronic hypoxic respiratory failure due to COVID-19   Brief Summary of Hospital Stay:   Patient is a 76 y.o. M with NSCLC, COPD, ongoing tobacco abuse, Chronic respiratory failure on 2L NC. He presented for evaluation of shortness of breath. He was diagnosed with acute on chronic hypoxic respiratory failure and acute COPD exacerbation due to COVID-19. He was treated with steroids, remdesivir, and scheduled duoneb. He had rapid improvement in symptoms and was weaned to his baseline 2L NC. Continued to improve and was discharged home at his baseline. Will continue prednisone on discharge to complete a 5 day course. Follow-up with PCP.  The patient was discharged in stable condition with improvement of symptoms and appropriate follow up planned.  Issues Requiring Follow Up: Follow-up with PCP. Follow-up with oncology and pulmonology as previously scheduled.  Discharged to Home.
Age: 60.0
Sex: F
Vaccine: PNC21
Symptoms: Rash
Clinical narrative: Pt. stated she broke out in a rash on her torso, shoulders, and back - pt. was instructed by her physician to take famotidine and cetirizine by mouth until resolved
Age: 67.0
Sex: F
Vaccine: TDAP
Symptoms: Contusion, Immediate post-injection reaction, Peripheral swelling
Clinical narrative: She had immediate swelling and bruising in right arm. No other symptoms. I notified provider immediately and she examined the patient. We applied a cooling pack and had the patient wait in office for 20 minutes. Patient was instructed to call us immediately if she has any other reactions.
Age: 11.0
Sex: M
Vaccine: HPV9, MNQ, TDAP
Symptoms: Erythema, Peripheral swelling
Clinical narrative: Left Arm: Redness and swelling, 3x2 inches. Will observe the swollen area and note any increase
Age: 44.0
Sex: F
Vaccine: HEPA
Symptoms: Arthralgia, Pain in extremity
Clinical narrative: pt has had sore arm/shoulder since vaccination
Age: 69.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pruritus, Injection site swelling
Clinical narrative: "my arm is red, swollen and very itchy at the injection site (like a bad allergic reaction) and spreading down toward my elbow"
Age: 63.0
Sex: F
Vaccine: PNC21
Symptoms: Fatigue, Injection site erythema, Injection site warmth, Pain, Pyrexia
Clinical narrative: Pt developed fever, fatigue, body aches starting the next day and lasting 24-36hr.  Developed rubor/calor near injection site three days later, as well as hives on the left side of her trunk and left lower extremity that same day.
Age: 63.0
Sex: F
Vaccine: PNC21
Symptoms: Urticaria
Clinical narrative: Pt developed fever, fatigue, body aches starting the next day and lasting 24-36hr.  Developed rubor/calor near injection site three days later, as well as hives on the left side of her trunk and left lower extremity that same day.
Age: 64.0
Sex: F
Vaccine: PNC21
Symptoms: Injection site bruising, Injection site erythema
Clinical narrative: redness ,and bruising  at the site of injection
Age: 11.0
Sex: M
Vaccine: MNQ
Symptoms: Erythema, Pain in extremity, Peripheral swelling
Clinical narrative: RT ARM SWELLING, REDNESS AND PAIN; PT GIVEN ZYRTEC 10 MG IN OUR OFFICE ON 4/2/2025. FATHER ADVISED TO CONTINUE ZYRTEC 10 MG BID UNTIL SWELLING DECREASED; MOTRIN PRN FOR PAIN. PATIENT DUE SECOND DOSE OF MENVEO AT AGE 16 YR; DAD ADVISED TO GIVE PATIENT ZYRTEC 10 MG PRIOR TO APPOINTMENT DATE.
Age: 57.0
Sex: F
Vaccine: COVID19, VARZOS
Symptoms: Expired product administered, No adverse event
Clinical narrative: Patient came in to receive both her updated Covid vaccine and her 2nd dose Shingles. Upon inputting the information into the system after the patient received both vaccines we noticed the expiration date of the Covid vaccine was expired(03/11/2025). The patient has been talked to and she is coming back to get a in date Covid vaccine and has not experience any adverse reactions thus far. Pfizer was contacted, as was the CDC.
Age: 54.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Arthralgia, Asthenia, Brain fog, Depression, Fatigue
Clinical narrative: After the first dose, that night,  I developed terrible brain fog and headaches that still have not went away.  I was never a headache person at all prior to this.  My doctor at the time said my brain fog was age related.   Within a week after the second dose I developed the worst muscle pain along with severe tinnitus.  Followed by SEVERE fatigue, weakness, depression, joint pain.  I was having trouble sleeping. I went to a doctor and found out I have sleep apnea and continually have several symptoms that appear after ANY type of exertion.  None of the doctors in my healthcare system will say this is related to the vaccine but it all started within a week of having the second dose.
Age: 54.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Headache, Insomnia, Laboratory test normal, Myalgia, Sleep apnoea syndrome
Clinical narrative: After the first dose, that night,  I developed terrible brain fog and headaches that still have not went away.  I was never a headache person at all prior to this.  My doctor at the time said my brain fog was age related.   Within a week after the second dose I developed the worst muscle pain along with severe tinnitus.  Followed by SEVERE fatigue, weakness, depression, joint pain.  I was having trouble sleeping. I went to a doctor and found out I have sleep apnea and continually have several symptoms that appear after ANY type of exertion.  None of the doctors in my healthcare system will say this is related to the vaccine but it all started within a week of having the second dose.
Age: 54.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Tinnitus
Clinical narrative: After the first dose, that night,  I developed terrible brain fog and headaches that still have not went away.  I was never a headache person at all prior to this.  My doctor at the time said my brain fog was age related.   Within a week after the second dose I developed the worst muscle pain along with severe tinnitus.  Followed by SEVERE fatigue, weakness, depression, joint pain.  I was having trouble sleeping. I went to a doctor and found out I have sleep apnea and continually have several symptoms that appear after ANY type of exertion.  None of the doctors in my healthcare system will say this is related to the vaccine but it all started within a week of having the second dose.
Age: 80.0
Sex: F
Vaccine: RSV
Symptoms: Injection site erythema, Injection site pain, Injection site reaction, Musculoskeletal stiffness
Clinical narrative: Patient reports redness at the injection site "size of tennis ball" without improvement after 6 days. Also reports pain/stiffness at the injection site.
Age: 86.0
Sex: F
Vaccine: PNC21
Symptoms: Pruritus, Rash
Clinical narrative: about 24 hours after the shot a rash developed on the shoulder down to the elbow on anterior and lateral arm. Patient reported itching deep under the skin but not topically. rash still present 7 days post immunization but is receding and itching has subsided.
Age: 0.17
Sex: M
Vaccine: DTAPHEPBIP, HEP
Symptoms: Extra dose administered
Clinical narrative: Patient was given Hep B vaccine in two different forms at the same time-Pediarix (DTaP, IPV, Hep B) and Engerix-B (Hep B)
Age: 41.0
Sex: F
Vaccine: MENB, PNC20
Symptoms: Arthralgia, Injection site pain, Injection site swelling, X-ray limb
Clinical narrative: Acute pain of right shoulder - Right upper arm and shoulder pain post-vaccination x 1 week - Pain deep in shoulder joint, extending into deltoid muscle insertion with swelling and tenderness - Icing and ibuprofen provide some relief - Prescribed meloxicam 15 mg once daily for pain management - Prescribed methocarbamol, starting with half dose at night for muscle relaxation and sleep - full DUR performed including discussion regarding use, possible side effects, and all questions answered. - Advised against operating machinery or driving taking muscle relaxer  - initial x-ray of right shoulder given reduce ROM and TTP over anterior AC joint -  US of upper arm given ongoing swelling and tenderness near insertion of deltoid muscle - r/o hematoma, abscess,   - Will continue to monitor symptoms; red flag precautions given for when to seek immediate medical attention.  Orders:    meloxicam (MOBIC) 7.5 mg tablet; Take 1 tablet by mouth Daily as needed for Pain.    methocarbamol (ROBAXIN) 750 mg tablet; Take 1-2 tablets by mouth every 6 hours as needed for Muscle spasms for up to 3 days.
Age: 16.0
Sex: F
Vaccine: HEP
Symptoms: No adverse event, Wrong product administered
Clinical narrative: Patient was given the wrong vaccine. No current adverse effect at this time
Age: 1.0
Sex: F
Vaccine: HEPA
Symptoms: Expired product administered
Clinical narrative: administered expired dose of Havrix; This non-serious case was reported by a nurse via call center representative and described the occurrence of expired vaccine used in a 23-month-old female patient who received HAV (Havrix) (batch number 2Y534, expiry date 02-MAR-2025) for prophylaxis.   On 27-MAR-2025, the patient received Havrix. On 27-MAR-2025, an unknown time after receiving Havrix, the patient experienced expired vaccine used (Verbatim: administered expired dose of Havrix). The outcome of the expired vaccine used was not applicable.   Additional Information: GSK receipt date: 02-APR-2025 The nurse reported that the expired dose of Havrix was administered to a patient which led to, expired vaccine used. The vaccine administration facility was the same as primary reporter.
Sex: F
Vaccine: VARZOS, VARZOS, VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: Suspected vaccination failure; I start developing shingles; This serious case was reported by a consumer via call center representative and described the occurrence of vaccination failure in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis and Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received the 2nd dose of Shingrix, the 1st dose of Shingrix and Shingles vaccine. On an unknown date, an unknown time after receiving Shingrix, Shingrix and Shingles vaccine, the patient experienced vaccination failure (Verbatim: Suspected vaccination failure) (serious criteria GSK medically significant) and shingles (Verbatim: I start developing shingles). The outcome of the vaccination failure and shingles were unknown.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingrix, Shingrix and Shingles vaccine.     The company considered the vaccination failure to be unrelated to Shingrix, Shingrix and Shingles vaccine. It was unknown if the company considered the shingles to be related to Shingrix, Shingrix and Shingles vaccine.   Additional Information: GSK receipt date: 02-APR-2025 Patient reported that she received vaccine for shingles, she got the original vaccine in 2015, and then she got both Shingrix vaccine in 2020 and 2021. Reporter stated that she started developing shingles, she thought the 1st time she had a case was in 2017, and it was never been severe. Since 2017 that she had it at least 2 or maybe 3 more times. She was trying to see if she should get another dose of Shingrix. This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule, time to onset for shingles and laboratory confirmation regarding shingles were unknown at the time of reporting.; Sender's Comments: Vaccination failure is a listed event which, due to the following criteria (insufficient information provided about the clinical description, details regarding completion of primary vaccination schedule, time to onset and laboratory confirmation of disease) is considered unrelated to GSK Shingrix Dose 1, Shingrix Dose 2 and Shingles vaccine.
Sex: M
Vaccine: HEP
Symptoms: Expired product administered
Clinical narrative: Administration of expired vaccine.; This non-serious case was reported by a nurse via call center representative and described the occurrence of expired vaccine used in a 18-year-old male patient who received HBV (Engerix B) (batch number 3T5L9, expiry date 09-MAR-2025) for prophylaxis.   On 03-APR-2025, the patient received Engerix B. On 03-APR-2025, an unknown time after receiving Engerix B, the patient experienced expired vaccine used (Verbatim: Administration of expired vaccine.). The outcome of the expired vaccine used was not applicable.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK Receipt Date: 04-APR-2025 The nurse practitioner mentioned that a patient received an expired dose of Engerix-B on 3rd April 2025 which led to expired vaccine used. The nurse asked if the patients should be re vaccinated.; Sender's Comments:  US-GSK-US2025040983:same reporter/ Different patient US-GSK-US2025040987:same reporter/ Different patient US-GSK-US2025040989:same reporter/ Different patient US-GSK-US2025040991:same reporter/ Different patient
Sex: F
Vaccine: MENB
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: Bexsero - Administration to patient older than 25 years of age; This non-serious case was reported by a nurse via call center representative and described the occurrence of inappropriate age at vaccine administration in a 31-year-old female patient who received Men B NVS (Bexsero) (batch number 52N4S, expiry date 30-NOV-2027) for prophylaxis.   On 22-JAN-2025, the patient received Bexsero. On 22-JAN-2025, an unknown time after receiving Bexsero, the patient experienced inappropriate age at vaccine administration (Verbatim: Bexsero - Administration to patient older than 25 years of age). The outcome of the inappropriate age at vaccine administration was not applicable.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK Receipt Date: 07-APR-2025 The nurse reported that the administration of Bexsero to a female patient 31 year old and the vaccine was administered by mistake. The nurse asked for safety information. The patient received a dose of Bexsero at an inappropriate age, which led to inappropriate age at vaccine administration.
Sex: M
Vaccine: COVID19
Symptoms: Death
Clinical narrative: Dead; This spontaneous case was reported by a patient family member or friend and describes the occurrence of DEATH (Dead) in a male patient of an unknown age who received SPIKEVAX NOS (SPIKEVAX NOS) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received dose of SPIKEVAX NOS (SPIKEVAX NOS) (unknown route) 1 dosage form. Death occurred on an unknown date The cause of death was not reported. It is unknown if an autopsy was performed. Not Provided          No concomitant medications were reported.  Reporter stated that in 3 years, she lost 7 family members (7 people were dead from reporters' family) because of that covid vaccine. Reporter specified that the 7 people who were dead were her husband, her brother, her sister, several sister-in-laws, and several brother-in-laws.  No treatment medications were reported.  This case was created for reporter's brother.   This case was linked to US-MODERNATX, INC.-MOD-2025-784180 (E2B Linked Report).   Reporter did not allow further contact   Most recent FOLLOW-UP information incorporated above includes: On 26-Mar-2025: Upon internal review on 08-Apr-2025, significant correction was performed to remove case classification of Invalid and to update suspect product coding to Spikevax NOS.; Reporter's Comments: Very little information provided at this time. The benefit-risk relationship of product is not affected by this report.; Sender's Comments:  US-MODERNATX, INC.-MOD-2025-784180:Master Case; Reported Cause(s) of Death: Dead
Sex: F
Vaccine: COVID19
Symptoms: Death
Clinical narrative: Dead; This spontaneous case was reported by a patient family member or friend and describes the occurrence of DEATH (Dead) 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. Death occurred on an unknown date The cause of death was not reported. It is unknown if an autopsy was performed.            No concomitant medications were reported.  Reporter stated that in 3 years, she lost 7 family members (7 people were dead from reporters' family) because of that covid vaccine. Reporter specified that the 7 people who were dead were her husband, her brother, her sister, several sister-in-laws, and several brother-in-laws.  No treatment medications were reported.  This case was created for reporter's sister-in-law.   This case was linked to US-MODERNATX, INC.-MOD-2025-784180 (E2B Linked Report).   Reporter did not allow further contact   Most recent FOLLOW-UP information incorporated above includes: On 26-Mar-2025: Upon internal review on 08-Apr-2025, significant correction was performed to remove case classification of Invalid and to update suspect product coding to Spikevax NOS.; Reporter's Comments: Very little information provided at this time. The benefit-risk relationship of product is not affected by this report.; Sender's Comments:  US-MODERNATX, INC.-MOD-2025-784180:Master Case; Reported Cause(s) of Death: Dead
Sex: M
Vaccine: COVID19
Symptoms: Death
Clinical narrative: Dead; This spontaneous case was reported by a patient family member or friend and describes the occurrence of DEATH (Dead) in a male patient of an unknown age who received SPIKEVAX NOS (SPIKEVAX NOS) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received dose of SPIKEVAX NOS (SPIKEVAX NOS) (unknown route) 1 dosage form. Death occurred on an unknown date The cause of death was not reported. It is unknown if an autopsy was performed. Not Provided          No Concomitant medications provided by the reporter.  Reporter stated that in 3 years, she lost 7 family members (7 people were dead from reporter family) because of that covid vaccine. Reporter stated that the 7 people who were dead were her husband, her brother, her sister, several sister-in-laws, and several brother-in-laws.  No treatment medications provided by the reporter.  This case was created for reporter's brother-in-law.   This case was linked to US-MODERNATX, INC.-MOD-2025-784180 (E2B Linked Report).   Reporter did not allow further contact   Most recent FOLLOW-UP information incorporated above includes: On 26-Mar-2025: Upon internal review on 09-Apr-2025, significant correction was performed to remove case classification of Invalid and to update suspect product coding to Spikevax NOS.; Reporter's Comments: The benefit-risk relationship of product is not affected by this report.; Sender's Comments:  US-MODERNATX, INC.-MOD-2025-784180:Master case; Reported Cause(s) of Death: Dead
Sex: F
Vaccine: COVID19
Symptoms: Death
Clinical narrative: Dead; This spontaneous case was reported by a patient family member or friend and describes the occurrence of DEATH (Dead) 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. Death occurred on an unknown date The cause of death was not reported. It is unknown if an autopsy was performed.            No Concomitant medications provided by the reporter.  Reporter stated that in 3 years, she lost 7 family members (7 people were dead from reporter family) because of that covid vaccine. Reporter stated that the 7 people who were dead were her husband, her brother, her sister, several sister-in-laws, and several brother-in-laws.   No treatment medications provided by the reporter.  This case was created for reporter's sister-in-law.   This case was linked to US-MODERNATX, INC.-MOD-2025-784180 (E2B Linked Report).   Reporter did not allow further contact   Most recent FOLLOW-UP information incorporated above includes: On 26-Mar-2025: Upon internal review on 09-Apr-2025, significant correction was performed to remove case classification of Invalid and to update suspect product coding 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-2025-784180:Master case; Reported Cause(s) of Death: Dead
Sex: M
Vaccine: COVID19
Symptoms: Death
Clinical narrative: Dead; This spontaneous case was reported by a patient family member or friend and describes the occurrence of DEATH (Dead) in a male patient of an unknown age who received SPIKEVAX NOS (SPIKEVAX NOS) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received dose of SPIKEVAX NOS (SPIKEVAX NOS) (unknown route) 1 dosage form. Death occurred on an unknown date The cause of death was not reported. It is unknown if an autopsy was performed.            No concomitant medications were reported.  Reporter stated that in 3 years, she lost 7 family members (7 people were dead in caller's family) because of that covid vaccine. Reporter specified that the 7 people who were dead were her husband, her brother, her sister, several sister-in-laws, and several brother-in-laws.   Treatment medication was not reported.  This case was created for reporter's brother-in-law.   This case was linked to US-MODERNATX, INC.-MOD-2025-784180 (E2B Linked Report).   Reporter did not allow further contact   Most recent FOLLOW-UP information incorporated above includes: On 26-Mar-2025: Upon internal review on 09-Apr-2025, significant correction was performed to remove case classification of Invalid and to update suspect product coding to Spikevax NOS.; Reporter's Comments: The benefit -risk relationship of product is not affected by this report.; Sender's Comments:  US-MODERNATX, INC.-MOD-2025-784180:Master case; Reported Cause(s) of Death: Dead
Age: 73.0
Sex: F
Vaccine: COVID19, PNC21
Symptoms: Vaccination site erythema, Vaccination site pruritus
Clinical narrative: INJECTION SITE PRURITUS; INJECTION SITE ERYTHEMA; This spontaneous case was reported by a patient and describes the occurrence of VACCINATION SITE PRURITUS (INJECTION SITE PRURITUS) and VACCINATION SITE ERYTHEMA (INJECTION SITE ERYTHEMA) in a 73-year-old female patient who received mRNA-1273.712 (SPIKEVAX 2024-2025 PFS) (batch no. 8080799) for COVID-19 prophylaxis.    Co-suspect product included non-company product Pneumococcal vaccine conj 21v (CRM197) (Capvaxive) for an unknown indication.    Previously administered products included for Drug use for unknown indication: Codeine. Past adverse reactions to the above products included Drug allergy with Codeine. Concurrent medical conditions included Drug allergy (Codeine).   On 15-Jan-2025, the patient received dose of mRNA-1273.712 (SPIKEVAX 2024-2025 PFS) (Intramuscular use) 1 dosage form and dose of Pneumococcal vaccine conj 21v (CRM197) (Capvaxive) (Intramuscular use) 1 dosage form. On 15-Jan-2025, the patient experienced VACCINATION SITE PRURITUS (INJECTION SITE PRURITUS) and VACCINATION SITE ERYTHEMA (INJECTION SITE ERYTHEMA). At the time of the report, VACCINATION SITE PRURITUS (INJECTION SITE PRURITUS) and VACCINATION SITE ERYTHEMA (INJECTION SITE ERYTHEMA) had not resolved.            Concomitant medication was not reported.  Patient had received 2 vaccines on 15-Jan-2025 (Spikevax and Capvaxive vaccines), and since then, patient had reported of redness and itching on the injection site. Patient called and reported that, the symptoms started on evening of 15-Jan-2025 and lasted until now.  Hospitalization, emergency room or office visit was not required.  Treatment medication was not reported.
Sex: M
Vaccine: COVID19
Symptoms: Death
Clinical narrative: Dead; This spontaneous case was reported by a patient family member or friend and describes the occurrence of DEATH (Dead) in a male patient of an unknown age who received SPIKEVAX NOS (SPIKEVAX NOS) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received dose of SPIKEVAX NOS (SPIKEVAX NOS) (unknown route) 1 dosage form. Death occurred on an unknown date The cause of death was not reported. It is unknown if an autopsy was performed.            Concomitant medication was not reported. Reporter stated that in 3 years, she lost 7 family members (7 people were dead in caller's family) because of that covid vaccine. Reporter specified that the 7 people who were dead were her husband, her brother, her sister, several sister-in-laws, and several brother-in-laws.  This case was created for reporter's husband. Treatment medication was not reported.   This case was linked to US-MODERNATX, INC.-MOD-2025-784193, US-MODERNATX, INC.-MOD-2025-784202, US-MODERNATX, INC.-MOD-2025-784184, US-MODERNATX, INC.-MOD-2025-784208, US-MODERNATX, INC.-MOD-2025-784209, US-MODERNATX, INC.-MOD-2025-784211, US-MODERNATX, INC.-MOD-2025-784212 (E2B Linked Report).   Reporter did not allow further contact   Most recent FOLLOW-UP information incorporated above includes: On 26-Mar-2025: Upon internal review on 08-Apr-2025, significant correction was performed to remove case classification of Invalid and to update suspect product coding 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-2025-784184:Her brother US-MODERNATX, INC.-MOD-2025-784202:several sister-in-laws US-MODERNATX, INC.-MOD-2025-784193:Reporter's sister US-MODERNATX, INC.-MOD-2025-784208:several brother-in-laws US-MODERNATX, INC.-MOD-2025-784209:People's case US-MODERNATX, INC.-MOD-2025-784211:Several sister in Law case US-MODERNATX, INC.-MOD-2025-784212:several brother-in-laws; Reported Cause(s) of Death: Dead
Sex: M
Vaccine: COVID19
Symptoms: Polymyositis
Clinical narrative: Polymyosytis; This is a spontaneous report received from a Consumer or other non HCP from medical information team.  A 62-year-old male patient received BNT162b2 (BNT162B2 NOS), as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (manufacturer Unknown , Dose1), for Covid-19 Immunization. The following information was reported: POLYMYOSITIS (medically significant), outcome "unknown", described as "Polymyosytis". The patient was diagnosed with POLYMYOSYTIS that could have been induced by the Pfizer COVID vaccine that was administered to him 2-3 years ago.   No follow-up attempts are possible. Batch/lot number is not provided, and it cannot be obtained.
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: I still got COVID anyway; I still got COVID anyway; This is a spontaneous report received from a Consumer or other non HCP, Program ID.  A 47-year-old patient 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: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "I still got COVID anyway". Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical course: During an inbound call for financial assistance, the patient was having some trouble getting Paxlovid prescription covered. The patient had all the vaccines with Pfizer and but still got COVID anyway. The patient wanted a coupon.  No follow-up attempts are possible. Batch/lot number is not provided, and it cannot be obtained.
Vaccine: TDAP
Symptoms: Incorrect route of product administration
Clinical narrative: inadvertently administered the vaccine via SC route instead of IM to a patient with no reported adverse event; Initial information received on 03-Apr-2025 regarding an unsolicited valid  non-serious case received from a physician.  This case involves an unknown age and unknown gender patient who was administered with Diphtheria-2/Tetanus/5 AC pertussis vaccine [Adacel] via sc route instead of im to a patient with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On an unknown date, the patient received an unknown dose of suspect Diphtheria-2/Tetanus/5 AC pertussis Suspension for injection (strength, lot number, expiry date-unknown) via subcutaneous route instead of intramuscular route in unknown administration site for Prophylactic vaccination (Immunisation) with no reported adverse event (incorrect route of product administration) (latency-same day).  Information on the batch number was requested corresponding to the one at time of event occurrence  Reportedly- He inadvertently administered the vaccine via SC route instead of IM to a patient.  Action taken was not applicable.   This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Age: 75.0
Sex: F
Vaccine: RAB
Symptoms: Inappropriate schedule of product administration
Clinical narrative: patient's 4th dose was administered earlier than scheduled with no reported ae; Initial information received on 07-Apr-2025 regarding an unsolicited valid non-serious case received from a pharmacist.  This case involves a 75 year old female patient who was administered with 4th dose of Rabies (HDC) vaccine [Imovax rabies] earlier than scheduled with no reported AE (adverse event).  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On 24-Mar-2025 the patient received an unknown dose (dose 1) of suspect Rabies (HDC) vaccine Powder and solvent for suspension for injection, On 27-Mar-2025 she also received an unknown dose (dose 2), On 31-Mar-2025 received an unknown dose (dose 3) and On 04-Apr-2025, the patient received an unknown dose (dose 4) all with standard strength, frequency-once, batch number, expiry date-unknown for post exposure vaccination (Immunisation).  Information on the batch number was requested corresponding to the one at time of event occurrence.  On 04-Apr-2025 the patient was administered with 4th earlier than scheduled with no reported AE (inappropriate schedule of product administration) (latency-same day).  Reportedly-Patient has been previously vaccinated and the current dose was for post exposure.   Action taken was not applicable.   This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Age: 3.0
Sex: M
Vaccine: TDAP
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: 3 year child received Adacel with no reported ae; Initial information received on 07-Apr-2025 regarding an unsolicited valid non-serious case received from a other health professional.  This case involves a 3 years old male patient who received Diphtheria-2/tetanus/5 AC pertussis vaccine [Adacel] with no reported AE (adverse event).  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included Hepatitis A vaccine INACT (Havrix) for Immunisation.  On 07-Apr-2025, a 3 year old male patient received a 0.5ml (dose 4) of suspect Diphtheria-2/tetanus/5 ac pertussis vaccine Suspension for injection in pre-filled syringe standard strength, frequency-once (lot U8232AA, expiry date-31-May-2026) via intramuscular route in the left thigh for Immunization with no reported AE (product administered to patient of inappropriate age) (latency-same day).  Reportedly- Their office inadvertently gave the Adacel to a child, ADACEL, which is indicated for 10 years to 64 years old.  Action taken was not applicable.   This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.