chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: MMR
Symptoms: Antibody test negative
Clinical narrative: the patient developed an Alpha-Gal allergy at an unknown point in time; but it is not showing when they ran titers; This spontaneous report was received from a Nurse and refers to an 60-year-old female patient.   The patient's medical history was not reported. The patient's concurrent conditions included Prednisone allergy, Penicillin allergy, and Alpha-Gal allergy. Historical drugs included Prednisone (Prednisone), and Penicillin (Penicillin nos). Concomitant therapies were not reported.   On an unknown date, it was stated that the patient was vaccinated with the series of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II), injection 0.5 mL, administered as prophylaxis (Lot Numbers, expiration dates, dose numbers, exact dose quantity volumes, routes and anatomical locations of administrations and vaccination scheme frequencies were not provided); that were reconstituted with sterile diluent (Lot No, expiration date and indication were not provided). On an unknown date, the patient developed an alpha-Gal allergy (food allergy) and also it was stated that she received the measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (MMR II) series (dates unknown) but it is not showing when they ran titers (antibody test negative) At the reporting time, the outcome of both events was not provided. The causal relationship between the both events with measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) and the sterile diluent was not provided.
Age: 55.0
Sex: M
Vaccine: PNC21
Symptoms: Pyrexia
Clinical narrative: fever; This spontaneous report was received from non-health proffesional and refers to 55-year-old male patient.   The patient's medical history was not reported. The patient's concurrent conditions included Environmenta allergies (pollen). Concomitant therapies were not reported.   On 17-Jun-2025 at 08:40, the patient was vaccinated with Pneumococcal 21-valent Conjugate Vaccine (CAPVAXIVE) Injection, (dose, lot # and expiration date were not reported) as routine vaccination.  On 17-Jun-2025 at 23:00, the patient experienced fever. It lasted through the night. The patient took 2 - 350 mg acetaminophen on 18-JUN-2025 at 2:00 am. The patient was fine on 18-JUN-2025 at 11:00. The patient recovered from the event of fever on 18-Jun-2025 at 11:00. The action taken with Pneumococcal 21-valent Conjugate Vaccine (CAPVAXIVE) was not applicable.   The causal relationship between the event of fever and Pneumococcal 21-valent Conjugate Vaccine (CAPVAXIVE) was not reported.  Lot # is being requested and will be submitted if received.
Sex: M
Vaccine: VARZOS
Symptoms: Death
Clinical narrative: My friend's son just died from taking a shingles/He passed away last week from the syndrome; This serious case was reported by a consumer via interactive digital media and described the occurrence of unknown cause of death in a male patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. In JUN-2025, an unknown time after receiving Shingles vaccine, the patient experienced unknown cause of death (Verbatim: My friend's son just died from taking a shingles/He passed away last week from the syndrome) (serious criteria death and GSK medically significant). The patient died in JUN-2025. The reported cause of death was unknown.   The reporter considered the unknown cause of death to be related to Shingles vaccine.     The company considered the unknown cause of death to be unrelated to Shingles vaccine.   Additional Information: GSK receipt date: 16-JUN-2025 This case was reported by a patient via interactive digital media. The reporter reported his/her friend's son just died from taking a shingles shot. He passed away last week from the syndrome that it sent him into.; Sender's Comments: Death is an unlisted event which is considered unrelated to GSK vaccine Shingles vaccine; Reported Cause(s) of Death: Unknown cause of death
Age: 65.0
Sex: M
Vaccine: VARZOS
Symptoms: Arthralgia, Lip swelling, Oral herpes, Tenderness
Clinical narrative: lip swelling; cold sore on his lower lip; shoulder was sore from the injection/tenderness in shoulder; This non-serious case was reported by a consumer via call center representative and described the occurrence of shoulder soreness in a 65-year-old male patient who received Herpes zoster (Shingrix) (batch number A5T73, expiry date 28-MAR-2027) for prophylaxis.   The patient's past medical history included cold sores (had cold sores all his life). Previously administered products included multi vitamin and loratadine (allergy pill).   On 29-MAY-2025, the patient received the 1st dose of Shingrix (left arm). On 30-MAY-2025, 1 days after receiving Shingrix, the patient experienced shoulder soreness (Verbatim: shoulder was sore from the injection/tenderness in shoulder). On 04-JUN-2025, the patient experienced cold sores lip (Verbatim: cold sore on his lower lip). On 06-JUN-2025, the patient experienced lip swelling (Verbatim: lip swelling). The patient was treated with docosanol. The outcome of the shoulder soreness was resolved and the outcome of the cold sores lip and lip swelling were not resolved.   The reporter considered the shoulder soreness to be related to Shingrix. It was unknown if the reporter considered the cold sores lip and lip swelling to be related to Shingrix.     The company considered the shoulder soreness to be related to Shingrix. It was unknown if the company considered the cold sores lip and lip swelling to be related to Shingrix.   Additional Information: GSK Receipt Date: 10-JUN-2025 Patient received his first dose of Shingrix in his left arm on 29-MAY-2025 from his Physician, and reports that starting on 30-MAY-2025, his shoulder was sore from the injection. The patient reported that he felt mild tenderness in his shoulder for the next day or two (no specific dates provided) that was 0.5 on a scale of 1 to 10.  The patient reported that on 4-JUN-2025, he developed a cold sore on his lower lip, but he has had cold sores all his life.  The patient used Over the Counter Docosanol Cream on the cold sore from 4-JUN-2025 through 6-JUN-2025, and the cold sore was diminishing.  The patient reported that on the evening on 6-JUN-2025, through the morning of 7-JUN-2025, the cold sore spread to the right side of his lower lip and swelled up enormously.  The patient reported that his lip was three times the normal size and he could not put his teeth together, the swelling went down by half over the next 24 hours, and on 10-JUN-2025, the swelling has gone down by half again.  The patient stated he has never had an outbreak like this in his entire life and the patient did not know if the vaccine was given as an IM injection.  The patient reported that he takes a Multi Vitamin and over the counter allergy pill, Loratadine, but did not take concurrently with Shingrix.
Sex: F
Vaccine: VARZOS
Symptoms: Inappropriate schedule of product administration
Clinical narrative: Inappropriate schedule of vaccine administered; This non-serious case was reported by a consumer via call center representative and described the occurrence of drug dose administration interval too long in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st dose in 2022).   In MAR-2025, the patient received the 2nd dose of Shingrix. In MAR-2025, an unknown time after receiving Shingrix, the patient experienced drug dose administration interval too long (Verbatim: Inappropriate schedule of vaccine administered). In MAR-2025, the outcome of the drug dose administration interval too long was not applicable.   Additional Information: GSK Receipt Date: 11-JUN-2025 The patient received 2nd dose at longer interval than recommended which led to lengthening of vaccination schedule.
Vaccine: VARZOS
Symptoms: Pain
Clinical narrative: Took shingle shots it hurt patient; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of pain in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received the 2nd dose of Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine, the patient experienced pain (Verbatim: Took shingle shots it hurt patient). The outcome of the pain was not reported.   It was unknown if the reporter considered the pain to be related to Shingles vaccine.     It was unknown if the company considered the pain to be related to Shingles vaccine.   Linked case(s) involving the same patient:  US2025AMR076144   Additional Information: GSK Receipt Date: 12-JUN-2025 This case was reported by a patient via interactive digital media. The patient reported that he/she took second shingles shot and it hurt patient but will get over it as having shingles was horrible and it was worth taking the shots.; Sender's Comments:  US-GSK-US2025AMR076144:1 st dose
Vaccine: VARZOS
Symptoms: Malaise
Clinical narrative: That second shingles shot did me in sick; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of sickness in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received the 2nd dose of Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine, the patient experienced sickness (Verbatim: That second shingles shot did me in sick). The outcome of the sickness was not reported.   The reporter considered the sickness to be related to Shingles vaccine.     The company considered the sickness to be related to Shingles vaccine.   Additional Information: GSK Receipt Date: 13-JUN-2025 This case was reported by a consumer via interactive digital media. The second shingles shot did him/her sick.
Vaccine: VARZOS, VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: Suspected vaccination failure; am dealing shingles now from my spine around the right to my navel; This serious case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Co-suspect products included Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received the 2nd dose of Shingles vaccine and the 1st dose of Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine and Shingles vaccine, the patient experienced vaccination failure (Verbatim: Suspected vaccination failure) (serious criteria GSK medically significant) and shingles (Verbatim: am dealing shingles now from my spine around the right to my navel). The outcome of the vaccination failure was not reported and the outcome of the shingles was not resolved.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine and Shingles vaccine.     The company considered the vaccination failure to be unrelated to Shingles vaccine and Shingles vaccine. It was unknown if the company considered the shingles to be related to Shingles vaccine and Shingles vaccine.   Additional Information: GSK Receipt Date: 11-JUN-2025 This case was reported by a patient via interactive digital media. Consumer reported that he/she got the shots two years ago and dealing with shingles now from spine around the right to navel. This case was considered as suspected vaccination failure as details regarding time to onset and laboratory test confirming shingles were unknown at the time of reporting. The follow-up could not be possible as no contact details were available.; Sender's Comments: Vaccination failure is a listed event which, due to the following criteria (insufficient information provided about the clinical description, details regarding time to onset and laboratory confirmation of disease) is considered unrelated to GSK Shingles vaccine (Dose 1 and Dose 2).
Vaccine: VARZOS
Symptoms: Erythema, Injection site swelling
Clinical narrative: swelling on my arm; redness on my arm; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of swelling arm in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On 13-JUN-2025, the patient received the 2nd dose of Shingles vaccine. In JUN-2025, an unknown time after receiving Shingles vaccine, the patient experienced swelling arm (Verbatim: swelling on my arm) and erythema of extremities (Verbatim: redness on my arm). The outcome of the swelling arm and erythema of extremities were not reported.   It was unknown if the reporter considered the swelling arm and erythema of extremities to be related to Shingles vaccine.     It was unknown if the company considered the swelling arm and erythema of extremities to be related to Shingles vaccine.   Additional Information: GSK Receipt Date: 14-JUN-2025 The patient self-reported this case for himself/herself. The patient had his/her 2nd Shingles vaccination shot yesterday (day before reporting). The patient had swelling and redness on his/her arm.
Sex: F
Vaccine: TDAP
Symptoms: Circumstance or information capable of leading to medication error, Extra dose administered
Clinical narrative: second dose of Boostrix will be administered today; second dose of Boostrix will be administered today June 10, 2025; A female patient received the first dose of Boostrix on April 24, 2025 and is intended to get the second dose on June 10, 2025.; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of circumstance or information capable of leading to medication error in a 37-year-old female patient who did not receive DTPa (Reduced antigen) (Boostrix) for prophylaxis.   Concomitant products included Diphtheria vaccine toxoid, Pertussis vaccine acellular 3-component, Tetanus vaccine toxoid (Boostrix).   The patient did not receive Boostrix. On an unknown date, an unknown time after receiving Boostrix, the patient experienced circumstance or information capable of leading to medication error (Verbatim: second dose of Boostrix will be administered today), extra dose administered (Verbatim: second dose of Boostrix will be administered today June 10, 2025) and drug prescribing error (Verbatim: A female patient received the first dose of Boostrix on April 24, 2025 and is intended to get the second dose on June 10, 2025.). The outcome of the circumstance or information capable of leading to medication error, extra dose administered and drug prescribing error 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: 10-JUN-2025 On 10/ June/2025 a pharmacist called to ask two questions for two different patients: The first patient is a female and received Boostrix on April 24, 2025. Physician prescribed a 3 dose series of Boostrix which led to drug prescribing error and because the patient never had Boostrix before. The second dose of Boostrix will be administered today June 10, 2025, and 3rd dose will be administered 6 months later, this led to circumstance or information capable of leading to medication error and extra dose administered. Is there any information of primary series of Boostrix for unvaccinated adults.
Sex: M
Vaccine: HEP, HEP
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: inadvertent administration of 1st dose; inadvertent administration of 2nd dose; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of inappropriate age at vaccine administration in a 17-year-old male patient who received HBV (Engerix B) (batch number T5D73, expiry date 10-APR-2027) for prophylaxis.   Co-suspect products included HBV (Engerix B) for prophylaxis.   On 24-JAN-2025, the patient received the 2nd dose of Engerix B. On an unknown date, the patient received the 1st dose of Engerix B. On 24-JAN-2025, an unknown time after receiving Engerix B and Engerix B, the patient experienced inappropriate age at vaccine administration (Verbatim: inadvertent administration of 2nd dose). On an unknown date, the patient experienced inappropriate age at vaccine administration (Verbatim: inadvertent administration of 1st dose). The outcome of the inappropriate age at vaccine administration and inappropriate age at vaccine administration were not applicable.   Additional Information: GSK receipt date: 13-JUN-2025 Other HCP reported that the inadvertent administration of two adult doses to a 17-year-old male patient, which led to inappropriate age at vaccine administration. He wanted to know how to proceed, and if the same vaccine could be used or a vaccine change is needed for completing the third dose. Second dose was administered on 24 January 2025, and third dose is scheduled as for 24 June 2025.
Sex: F
Vaccine: VARZOS
Symptoms: Extra dose administered
Clinical narrative: a patient that was accidentally given 2 shingrix shots in one day (in January); This non-serious case was reported by a pharmacist via call center representative and described the occurrence of accidental overdose in a adult female patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis.   In JAN-2025, the patient received the 2nd dose of Shingrix and the 1st dose of Shingrix. In JAN-2025, an unknown time after receiving Shingrix and Shingrix, the patient experienced accidental overdose (Verbatim: a patient that was accidentally given 2 shingrix shots in one day (in January)). The outcome of the accidental overdose was not applicable.   Additional Information: GSK Receipt Date: 17-JUN-2025 Pharmacist had a patient that was accidentally given 2 Shingrix shots in one day (in January) which led to accidental overdose Pharmacist questioned that did you had any data on whether she should receive another shot after 60 days or was she complete. Pharmacist could share some of the patient information, but pharmacist did not have the vaccine information.
Sex: M
Vaccine: PNC20
Symptoms: Pneumonia, Pneumothorax
Clinical narrative: Pneumonia; Pneumothorax; A hole in the lung; This is a spontaneous report received from a Physician.  A male patient received pneumococcal 20-val conj vac (dipht CRM197 protein) (PREVNAR 20), as dose number unknown, single (Batch/Lot number: unknown) for immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: PNEUMONIA (medically significant), 48 hrs after the suspect product(s) administration, outcome "unknown"; PNEUMOTHORAX (medically significant), 48 hrs after the suspect product(s) administration, outcome "unknown", described as "Pneumothorax; A hole in the lung".  No follow-up attempts are possible. Batch/lot number is not provided, and it cannot be obtained.; Sender's Comments: A possible contributory role of the suspect products cannot be excluded for the reported event pneumonia and pneumothorax based on the known safety profile  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.
Sex: F
Vaccine: COVID19
Symptoms: Blood pressure measurement, Death, Dizziness, Dyspnoea, Fatigue
Clinical narrative: developed high blood pressure; dizziness; shortness of breath; persistent tiredness; who has since passed away; lung cancer; This is a spontaneous report received from a Consumer or other non HCP.  A 78-year-old female patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), in Oct2022 as dose number unknown (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Rheumatoid arthritis" (unspecified if ongoing). Concomitant medication(s) included: AZATHIOPRINE. Vaccination history included: Covid-19 vaccine (Primary Immunization series complete; Unknown manufacturer), for Covid-19 immunization. The following information was reported: LUNG NEOPLASM MALIGNANT (disability, life threatening) with onset 2023, 9 months after the suspect product(s) administration, outcome "not recovered", described as "lung cancer"; DEATH (death), outcome "fatal", described as "who has since passed away"; HYPERTENSION (disability, life threatening), outcome "not recovered", described as "developed high blood pressure"; DIZZINESS (disability, life threatening), outcome "not recovered"; DYSPNOEA (disability, life threatening), outcome "not recovered", described as "shortness of breath"; FATIGUE (disability, life threatening), outcome "not recovered", described as "persistent tiredness". Clinical course: The patient had passed away. Soon after taking the Covid vaccine booster (Pfizer), she developed high blood pressure that had never been seen in her lifetime. She experienced dizziness and shortness of breath. This led to reduced activity level and persistent tiredness. 9 months after the vaccine, she was detected with lung cancer even though all her previous assessments were clean. The patient underwent the following laboratory tests and procedures: Blood pressure measurement: high. Therapeutic measures were not taken as a result of death, lung neoplasm malignant, hypertension, dizziness, dyspnoea, fatigue. The date and cause of death for the patient were unknown. It was not reported if an autopsy was performed. The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5 will be requested and submitted if and when received.; Reported Cause(s) of Death: who has since passed away
Sex: F
Vaccine: COVID19
Symptoms: Hypertension, Lung neoplasm malignant
Clinical narrative: developed high blood pressure; dizziness; shortness of breath; persistent tiredness; who has since passed away; lung cancer; This is a spontaneous report received from a Consumer or other non HCP.  A 78-year-old female patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), in Oct2022 as dose number unknown (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Rheumatoid arthritis" (unspecified if ongoing). Concomitant medication(s) included: AZATHIOPRINE. Vaccination history included: Covid-19 vaccine (Primary Immunization series complete; Unknown manufacturer), for Covid-19 immunization. The following information was reported: LUNG NEOPLASM MALIGNANT (disability, life threatening) with onset 2023, 9 months after the suspect product(s) administration, outcome "not recovered", described as "lung cancer"; DEATH (death), outcome "fatal", described as "who has since passed away"; HYPERTENSION (disability, life threatening), outcome "not recovered", described as "developed high blood pressure"; DIZZINESS (disability, life threatening), outcome "not recovered"; DYSPNOEA (disability, life threatening), outcome "not recovered", described as "shortness of breath"; FATIGUE (disability, life threatening), outcome "not recovered", described as "persistent tiredness". Clinical course: The patient had passed away. Soon after taking the Covid vaccine booster (Pfizer), she developed high blood pressure that had never been seen in her lifetime. She experienced dizziness and shortness of breath. This led to reduced activity level and persistent tiredness. 9 months after the vaccine, she was detected with lung cancer even though all her previous assessments were clean. The patient underwent the following laboratory tests and procedures: Blood pressure measurement: high. Therapeutic measures were not taken as a result of death, lung neoplasm malignant, hypertension, dizziness, dyspnoea, fatigue. The date and cause of death for the patient were unknown. It was not reported if an autopsy was performed. The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5 will be requested and submitted if and when received.; Reported Cause(s) of Death: who has since passed away
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Vaccination failure
Clinical narrative: came down with COVID two weeks ago; came down with COVID two weeks ago; This is a spontaneous report received from a Consumer or other non HCP, Program ID.  A 74-year-old male patient received BNT162b2 omicron (kp.2) (COMIRNATY (2024-2025 FORMULA)), in Jan2025 as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Past drug history included: Paxlovid for COVID. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset May2025, outcome "unknown" and all described as "came down with COVID two weeks ago". Therapeutic measures were taken as a result of vaccination failure, covid-19. Clinical course: The patient's wife stated "My husband came down with COVID two weeks ago and the doctor provided or prescribed Paxlovid because he's got an upcoming surgery. When asked when the medication was picked up, patient's wife stated, "29May, just last month, so just over 2 weeks ago." "we were in such shock, but it was like 'Oh, we have to do this so he can have his surgery'." "When it's COVID you're just in a hurry to get the medication on the Paxlovid cause he had a upcoming heart procedure"...and we're spoiled, cause we all got it, my family, like a year or so ago (that was like almost 2 years ago), and the Paxlovid was free...it's kind of like a fast reaction, well we got to get this." When asked if Paxlovid was previously taken for COVID, patient's wife replied, "Yes, yes, and then we've had all our vacc-Pfizer, we get the Pfizer vaccinations regularly. We got it in Jan, just this year..." Later she said, "Thankfully I didn't get it I kept testing".  The information on the batch/lot number for BNT162b2 omicron (kp.2) will be requested and submitted if and when received.
Age: 24.0
Vaccine: UNK
Symptoms: Animal bite, No adverse event, Off label use
Clinical narrative: patient who was prescribed Imovax with off label diagnosis Bitten by cat, initial encounter with no reported AE; Initial information received on 16-Jun-2025 regarding an unsolicited valid non-serious case received from a physician.  This case involves a 24 years old and unknown gender patient who was prescribed IPV (VERO) [IMOVAX] with off label diagnosis bitten by cat, initial encounter 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, patient was prescribed unknown dose of suspect IPV (VERO) with off label diagnosis for Bitten by cat, initial encounter (Animal bite) (formulation: suspension for injection) (lot number, strength and expiry date not reported) with no reported adverse event (off label use) (Latency: same day). Information on the batch number was requested corresponding to the one at time of event occurrence.  Action taken was not applicable.
Vaccine: RSV
Symptoms: Arthralgia, Arthritis, Injection site cellulitis, Injection site rash, Joint swelling
Clinical narrative: acute rheumatoid arthritis in R. thumb; rash extending 5 inches from injection site; rash turned into cellulitis; This serious case was reported by a consumer via interactive digital media and described the occurrence of rheumatoid arthritis in a patient who received RSVPreF3 adjuvanted (Arexvy) for prophylaxis.   On an unknown date, the patient received Arexvy. On an unknown date, less than a week after receiving Arexvy, the patient experienced rheumatoid arthritis (Verbatim: acute rheumatoid arthritis in R. thumb) (serious criteria GSK medically significant), injection site rash (Verbatim: rash extending 5 inches from injection site) and injection site cellulitis (Verbatim: rash turned into cellulitis). The outcome of the rheumatoid arthritis, injection site rash and injection site cellulitis were not reported.   It was unknown if the reporter considered the rheumatoid arthritis, injection site rash and injection site cellulitis to be related to Arexvy.     The company considered the rheumatoid arthritis to be unrelated to Arexvy. It was unknown if the company considered the injection site rash and injection site cellulitis to be related to Arexvy.   Additional Information: GSK Receipt Date: 13-JUN-2025 This case was reported by a patient via interactive digital media. The patient had rash extended 5 inches from injection site which appeared about 12 hours after Arexvy injection. Also, joint swelling, inflamed and extremely painful acute rheumatoid arthritis in right thumb. Then on day 5 and 6, rash turned into cellulitis.; Sender's Comments: Rheumatoid arthritis is an unlisted event which is considered unrelated to GSK vaccine Arexvy.
Vaccine: RSV
Symptoms: Rheumatoid arthritis
Clinical narrative: acute rheumatoid arthritis in R. thumb; rash extending 5 inches from injection site; rash turned into cellulitis; This serious case was reported by a consumer via interactive digital media and described the occurrence of rheumatoid arthritis in a patient who received RSVPreF3 adjuvanted (Arexvy) for prophylaxis.   On an unknown date, the patient received Arexvy. On an unknown date, less than a week after receiving Arexvy, the patient experienced rheumatoid arthritis (Verbatim: acute rheumatoid arthritis in R. thumb) (serious criteria GSK medically significant), injection site rash (Verbatim: rash extending 5 inches from injection site) and injection site cellulitis (Verbatim: rash turned into cellulitis). The outcome of the rheumatoid arthritis, injection site rash and injection site cellulitis were not reported.   It was unknown if the reporter considered the rheumatoid arthritis, injection site rash and injection site cellulitis to be related to Arexvy.     The company considered the rheumatoid arthritis to be unrelated to Arexvy. It was unknown if the company considered the injection site rash and injection site cellulitis to be related to Arexvy.   Additional Information: GSK Receipt Date: 13-JUN-2025 This case was reported by a patient via interactive digital media. The patient had rash extended 5 inches from injection site which appeared about 12 hours after Arexvy injection. Also, joint swelling, inflamed and extremely painful acute rheumatoid arthritis in right thumb. Then on day 5 and 6, rash turned into cellulitis.; Sender's Comments: Rheumatoid arthritis is an unlisted event which is considered unrelated to GSK vaccine Arexvy.
Sex: F
Vaccine: PNC13
Symptoms: Pneumonia, Vaccination failure
Clinical narrative: Vaccine was not effective; pneumonia; This is a spontaneous report received from an Other HCP.  A female patient (not pregnant) received pneumococcal 13-val conj vac (dipht CRM197 protein) (PREVNAR 13), as dose number unknown, single (Batch/Lot number: unknown) for immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (hospitalization), outcome "recovering", described as "Vaccine was not effective"; PNEUMONIA (hospitalization), outcome "recovering". The patient was hospitalized for drug ineffective, pneumonia (hospitalization duration: 10 day(s)). It was unknown if therapeutic measures were taken as a result of drug ineffective, pneumonia.  No follow-up attempts are possible. Batch/lot number is not provided, and it cannot be obtained.; Sender's Comments: Vaccine efficacy varies from person to person and is affected by many factors. The association between the event lack of effect/drug ineffective (pneumonia) with the suspect product PNEUMOCOCCAL 13-VAL CONJ VAC (DIPHT CRM197 PROTEIN) cannot be fully excluded.
Age: 1.25
Sex: F
Vaccine: DTAPIPVHIB
Symptoms: No adverse event, Product preparation issue
Clinical narrative: administering only the liquid component of Pentacel, with no reported adverse event; Initial information received on 18-Jun-2025 regarding an unsolicited valid non-serious case received from a other health professional.  This case involves a 1 years old female patient for whom diphtheria/tetanus/5 hybrid ac pertussis/ipv(vero)/hib(prp/t) vaccine [Pentacel (Vero)] administering only the liquid component of pentacel, with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included Pneumococcal vaccine conj 7v (CRM197) (Prevnar).  On 16-Jun-2025, the patient received the liquid component of dose 4 (0.5ml) of suspect diphtheria/tetanus/5 hybrid ac pertussis/ipv(vero)/hib(prp/t) vaccine; Suspension for injection with Strength = standard (lot UK043AA with expiry date 31-AUG-2025) via intramuscular route in the thigh nos for Immunization; with no reported adverse event (single component of a two-component product administered) (latency: same day).  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.
Vaccine: DTAPIPVHIB
Symptoms: No adverse event, Product preparation issue
Clinical narrative: given the PENTACEL but without the HIB component with no reported adverse event; Initial information received on 18-Jun-2025 regarding an unsolicited valid non-serious case received from a other health professional.  This case involves an unknown age and unknown gender patient gives the diphtheria/tetanus/5 hybrid ac pertussis/ipv(vero)/hib(prp/t) vaccine [Pentacel (Vero) but without the hib component 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/tetanus/5 hybrid ac pertussis/ipv(vero)/hib(prp/t) vaccine with unknown formulation and strength (lot UK225AB with expiry date 31-JUL-2026) via unknown route in unknown administration site for Immunization; without the hib component with no reported adverse event (poor quality product administered) (unknown latency).  Reportedly: The staff member may have used a sterile diluent. Caller verified that the liquid component was not administered.   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: 62.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site warmth
Clinical narrative: red, warm area on right arm more down towards the elbow on the front of the arm, not as the site of injection, told patient to use ice pack and take tylenol/ibuprofen
Age: 67.0
Sex: F
Vaccine: PNC21
Symptoms: Erythema, Mobility decreased
Clinical narrative: Patient reports numbness in the right shoulder area and decreased movement in the right shoulder area.  Patient gets all routine vaccinations at this location and symptoms began following the Capvaxive vaccine  4 months ago.
Age: 1.58
Sex: M
Vaccine: MMR, VARCEL
Symptoms: Inappropriate schedule of product administration
Clinical narrative: Patient had already received MMR and VZV given separately at visit 1/9/25.  It was not my custom to give these vaccines until 18 months.  Therefore child got 2 doses approx 3 months apart.  I sent an inquiry to CDC-INFO and received a response that although early, these shots would be valid and the child would therefore not need boosters at age 4 years.
Age: 34.0
Sex: F
Vaccine: TDAP
Symptoms: Circumstance or information capable of leading to medication error, Exposure during pregnancy
Clinical narrative: I am currently 29 weeks pregnant.  Estimated date of delivery  9/5/25. On 6/20/25, around 5:20 pm, I had a scheduled Tdap vaccine.  The pharmacist who administered the vaccine greeted me with blue gloves already on. With those same gloves, he open 2 doors so we can enter the storage room where he set up to administered the vaccine. Before administering the vaccine,  he still had the gloves on, he pulled out his personal phone,  touched it and said "I thought someone was calling me". He then put his personal phone away.  Still with the blue gloves, he open the alcohol wipe, wiped the area were he was going to administered the vaccine,  he opened the bandaid and put it on his right thigh, he administered the Tdap and some liquid spilled on my arm. When he was done administering the vaccine, he grabbed a cotton ball, wiped the spill liquid from my arm and dabbed where he administered the vaccine.  He then pulled out the bandaid from his right thigh and put it on my arm and he said "all done".
Age: 78.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Ear pain, Hypoaesthesia, Pain in extremity, Palpitations
Clinical narrative: 6/18/25: PT GOT VACCINE ON 6/13/25 DETAILS FRIDAY NIGHT: HEART POUNDING IN THE MIDDLE OF THE NIGHT, ELBOW PAIN NEXT DAY, RIGHT LEG NUMB SATURDAY NIGHT-- > BETTER NEXT 2 DAYS, SHARP PINCHING BEHINHD RIGHT EAR FOR3 TO 4 DAYS-- > GOES AWAY 6/17/25, ---- > RIGHT LEG STILL HURT, MILD ELBOWS PAIN    ; 6/20/25 FOLLOW UP, PT RIGHT LEG STILL HURT-- > SHE HAD APPT WITH EHR DOCTOR ON 6/19/25. SHE SAID DOCTOR TOLD HER SHE MAY NEED TO DO XRAY IN THE NEXT 2 WEEKS AND MAYBE SURGERY
Age: 1.5
Sex: M
Vaccine: COVID19
Symptoms: Product storage error
Clinical narrative: None reported- Symptoms COVID vaccine given over 10 weeks after thawed and storage.
Age: 77.0
Sex: F
Vaccine: PNC21, TDAP
Symptoms: Injection site erythema, Injection site pain, Injection site warmth, Muscle spasms
Clinical narrative: The night she had vaccine she experienced body spasms that lasted 24 hours, pain, redness, warmth, @ injection site. The patient had never had a reaction to an injection. At todays visit, no futher spasm, still having, redness & warmth @ injection site. Left arm
Vaccine: HPV9
Symptoms: Expired product administered, No adverse event
Clinical narrative: Nurse confirmed the patient involved has not reported any medical concerns or symptoms after being administered the expired dose of GARDASIL 9. No additional AE; expired administration of a dose of GARDASIL 9; This spontaneous report was received from a Nurse and refers to a patient of unknown age and gender.   The patient's medical history, concurrent conditions, concomitant therapies, past drug reactions and allergies were not reported.   On 16-JUN-2025, the patient was inadvertently vaccinated with an expired vaccine of Human Papillomavirus 9-valent Vaccine, Recombinant (GARDASIL 9) prefilled syringe, 0.5 mL, Two or Three dose series, administered as prophylaxis (lot number X019196 has been verified to be valid for Human Papillomavirus 9-valent Vaccine, Recombinant [GARDASIL 9], expiration date 25-APR-2025; dose, formulation, anatomical site of injection, and route of administration were not reported) (Expired product administered). Nurse confirmed the patient involved has not reported any medical concerns or symptoms after being administered the expired dose of the vaccine (No adverse event).   No additional information provided.
Age: 84.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Muscle spasms, Pyrexia
Clinical narrative: Extreme fatigue, fever severe leg cramps for one hour in evening
Age: 53.0
Sex: F
Vaccine: PNC21
Symptoms: Arthralgia, Dizziness, Gait disturbance, Injection site pain, Lethargy
Clinical narrative: 0 hours: injection site pain, soreness; <12 hours muscle ache, joint pain, overall body ache, feeling of sensitive skin (i.e. skin hurts to touch); <24 hours feverish, increased overall body aches and pains, lethargy, pain lower right rib. Began 1g (2*500mg) acetaminophen Q6 hours for symptoms; <48 hours dizziness, nausea, unsteady gait, overall body pain and muscle aches (discontinue acetaminophen); >48 hours painful rash posterior to injection site on right arm, pruritis (very itchy), >72 hours pain lower right rib persists (constant, not off and on) especially if taking deep breath, pruritis on and below injection site including red rash area, placed topical salonpas patch on area to prevent scratching.
Age: 53.0
Sex: F
Vaccine: PNC21
Symptoms: Musculoskeletal chest pain, Myalgia, Nausea, Pain, Pyrexia
Clinical narrative: 0 hours: injection site pain, soreness; <12 hours muscle ache, joint pain, overall body ache, feeling of sensitive skin (i.e. skin hurts to touch); <24 hours feverish, increased overall body aches and pains, lethargy, pain lower right rib. Began 1g (2*500mg) acetaminophen Q6 hours for symptoms; <48 hours dizziness, nausea, unsteady gait, overall body pain and muscle aches (discontinue acetaminophen); >48 hours painful rash posterior to injection site on right arm, pruritis (very itchy), >72 hours pain lower right rib persists (constant, not off and on) especially if taking deep breath, pruritis on and below injection site including red rash area, placed topical salonpas patch on area to prevent scratching.
Age: 53.0
Sex: F
Vaccine: PNC21
Symptoms: Rash, Sensitive skin
Clinical narrative: 0 hours: injection site pain, soreness; <12 hours muscle ache, joint pain, overall body ache, feeling of sensitive skin (i.e. skin hurts to touch); <24 hours feverish, increased overall body aches and pains, lethargy, pain lower right rib. Began 1g (2*500mg) acetaminophen Q6 hours for symptoms; <48 hours dizziness, nausea, unsteady gait, overall body pain and muscle aches (discontinue acetaminophen); >48 hours painful rash posterior to injection site on right arm, pruritis (very itchy), >72 hours pain lower right rib persists (constant, not off and on) especially if taking deep breath, pruritis on and below injection site including red rash area, placed topical salonpas patch on area to prevent scratching.
Age: 63.0
Sex: F
Vaccine: PNC21
Symptoms: Erythema, Induration, Muscle swelling, Skin warm
Clinical narrative: Pt complained of swollen deltoid, hot to touch, hard swelling. Red "finger" marks.
Age: 60.0
Sex: F
Vaccine: PNC20
Symptoms: Cellulitis, Chills, Erythema, Feeling hot, Pain in extremity
Clinical narrative: Chills redness of arm swelling of arm - arm pain- arm felt warm - redness spread everyday further down to elbow and spread side ways surrounding the arm - continue to spread for about 5-6 days.  On 6 days seek medical attention and was given Cephalexin 500mg q6h - was told for cellulitis - symptoms - subsided - finishing the 7 day course of antibiotics right now -
Age: 60.0
Sex: F
Vaccine: PNC20
Symptoms: Peripheral swelling
Clinical narrative: Chills redness of arm swelling of arm - arm pain- arm felt warm - redness spread everyday further down to elbow and spread side ways surrounding the arm - continue to spread for about 5-6 days.  On 6 days seek medical attention and was given Cephalexin 500mg q6h - was told for cellulitis - symptoms - subsided - finishing the 7 day course of antibiotics right now -
Age: 59.0
Sex: F
Vaccine: VARZOS
Symptoms: Dizziness, Lip swelling, Nausea, Syncope
Clinical narrative: The patient received her 2nd dose of Shingrix vaccine on 6/19/2025. Patient reported that 36 hours after she received the vaccination, in the early am on 6/21/2025, she woke up with a swelling upper lip, nausea, and syncope. She called the pharmacy at 10:15 am 6/21/2025 and reported her reactions with still a swollen upper lip and feeling like she was going to "black out" when she stands up. I recommended going to the emergency room, she was accompanied by her daughter at the time of the call.
Age: 51.0
Sex: F
Vaccine: PNC21
Symptoms: Injection site erythema, Injection site reaction, Injection site warmth
Clinical narrative: injection site reaction with redness swelling and heat. advised to use topical benedryl
Age: 57.0
Sex: F
Vaccine: PNC21, VARZOS
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: injection site reaction redness, swelling, heat on arm - recommended benedryl cream
Age: 79.0
Sex: F
Vaccine: RSV
Symptoms: Cough, Dyspnoea, Rhinorrhoea
Clinical narrative: cough and runny nose from the outset.....nothing helped.  On March 24, 2025. I awoke UNABLE TO BREATHE.  Managed to call EMS and was rushed to the hospital, in which  was a patient for an entire week.  When I was discharged, I came home with inhalers, nose drops AND OXYGEN!!!!   Never been on oxygen in my life!!!  Now I'm stuck with it!!!
Age: 81.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: patient was given expired vaccine
Age: 80.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: patient was given expire vaccine
Age: 79.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: patient was given expire vaccine
Age: 59.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site warmth, Joint stiffness, Mobility decreased, Musculoskeletal stiffness
Clinical narrative: After receiving the vaccine, my arm was very sore and I could not raise it above shoulder height (not too unexpected). The injection  site (left arm) has remained red and tender for 2 days. The worst (and reason I wanted to report) was the morning after the shot (Friday 6/20/25) my whole body (shoulders, arms, legs joints, etc.) was STIFF so much so that I remained in bed for about 2.5 hours after my normal wake up time (7:30am). I got up and too two Aleve (noproxen sodium 220mg) liquid gel caps and I felt much better within about one hour of taking the meds. I just wanted to report this because I didn't read "muscle stiffness" as a possible side effect. Thank you.
Age: 59.0
Sex: F
Vaccine: VARZOS
Symptoms: Pain in extremity
Clinical narrative: After receiving the vaccine, my arm was very sore and I could not raise it above shoulder height (not too unexpected). The injection  site (left arm) has remained red and tender for 2 days. The worst (and reason I wanted to report) was the morning after the shot (Friday 6/20/25) my whole body (shoulders, arms, legs joints, etc.) was STIFF so much so that I remained in bed for about 2.5 hours after my normal wake up time (7:30am). I got up and too two Aleve (noproxen sodium 220mg) liquid gel caps and I felt much better within about one hour of taking the meds. I just wanted to report this because I didn't read "muscle stiffness" as a possible side effect. Thank you.
Age: 16.0
Sex: F
Vaccine: CHIK
Symptoms: Syncope
Clinical narrative: IXIARO (LOT: JEV24B20E) WAS ADMINISTERED  TO PATIENT'S LEFT DELTOID. FOLLOWING IXIARO DOSE VIMKUNYA INJECTION WAS ADMINISTERED  INTO LEFT DELTOID BELOW IXIARO ADMINISTRATION SITE.  WITHIN ONE MINUTE OF VIMKUNYA DOSE PATIENT EXPEIRENCED VASOVAGAL SYNCOPE EPISODE .  SYNCOPE EPISODE LASTED LESS THAN ONE MINUTE AND PATIENT WAS GIVEN SODA AND WATER AND REMAINED SEATED INTO SHOT ROOM FOR 30 MINUTES.  PATIENT RECOVERED WITH SODA AND WATER.
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal pain upper, Chills, Diarrhoea, Dyspnoea, Tremor
Clinical narrative: On Saturday night, June 14, 2025, 30 hours after receiving the vaccine, I had terrible stomach cramps, vomiting, diarrhea and the most violent shivering that lasted 30 minutes.  I almost called the emergency room.  The shivering was like a seizure in that I could not control my limbs (arms and legs) which were moving very quickly and violently.  I also had difficulty breathing in that my throat seized up and I could breathe only shallowly and rapidly in an effort to control the violet shivering.