chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Vaccine: VARZOS
Symptoms: Inappropriate schedule of product administration
Clinical narrative: had Shingrix vaccination in 2022 and again today March 8 2025; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of drug dose administration interval too long in a patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (Received 1st dose of vaccine in 2022).   On 08-MAR-2025, the patient received the 2nd dose of Shingrix. On 08-MAR-2025, an unknown time after receiving Shingrix, the patient experienced drug dose administration interval too long (Verbatim: had Shingrix vaccination in 2022 and again today March 8 2025). The outcome of the drug dose administration interval too long was not applicable.   Additional Information: GSK Receipt Date: 08-MAR-2025 This case was reported by a patient via (chatbot) interactive digital media. The patient received 2nd dose of Shingrix vaccine later than the recommended schedule, which led to lengthening of vaccination schedule.. The reporter wanted to know if a third dose was necessary for efficacy.
Sex: M
Vaccine: COVID19
Symptoms: Dizziness, Dyspnoea
Clinical narrative: Shortness of breath; Dizziness; This is a spontaneous report received from a Consumer or other non HCP from medical information team.  A male patient received BNT162b2 omicron (kp.2) (COMIRNATY (2024-2025 FORMULA)), as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DYSPNOEA (non-serious), outcome "unknown", described as "Shortness of breath"; DIZZINESS (non-serious), outcome "unknown".  The information on the batch/lot number for BNT162b2 omicron (kp.2) will be requested and submitted if and when received.
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, Influenza virus test, SARS-CoV-2 test
Clinical narrative: COVID; COVID; This is a spontaneous report received from a Consumer or other non HCP, Program ID.  A 64-year-old male patient received BNT162b2 omicron (kp.2) (COMIRNATY (2024-2025 FORMULA)), as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Primary Immunization series complete; unknown manufacturer), for Immunisation; Covid-19 vaccine (DOSE NUMBER UNKNOWN (BOOSTER)), for Immunisation. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID". The event "covid" required physician office visit. Clinical course: the patient stated he was leaving to go out of the country, and he thought he had a little bit of a cold. The patient thought he should get tested for the flu, which was negative. The results, however, found that he had COVID. The patient stated that he had all the "past vaccinations and boosters and everything I had had, but the very last one back about a year ago I didn't get, and they diagnosed me with that, and so the doctor said you need to start taking (nirmatrelvir, ritonavir) PAXLOVID today, because if you take it today then by the time you leave Monday it will run the course." The patient then stated he didn't feel bad at all, but he was told he was positive for COVID, and they were calling in a prescription for nirmatrelvir, ritonavir.  Later, the patient then confirmed they had taken "all the vaccinations" (as reported). The patient was seen by a nurse practitioner; however, he spoke to a doctor and the patient was told he definitely need to take nirmatrelvir, ritonavir."  The patient underwent the following laboratory tests and procedures: Influenza virus test: Negative; SARS-CoV-2 test: Positive.  No follow-up attempts are possible. Batch/lot number is not provided, and it cannot be obtained.
Sex: M
Vaccine: COVID19
Symptoms: COVID-19
Clinical narrative: Covid; This is a spontaneous report received from a Consumer or other non HCP, Program ID.  An elderly male patient received BNT162b2 omicron (kp.2) (COMIRNATY (2024-2025 FORMULA)), on 09Mar2025 as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "pneumonia" (unspecified if ongoing). The patient took concomitant medications. The following information was reported: COVID-19 (non-serious) with onset 12Mar2025, outcome "unknown", described as "Covid". Additional information: The reporter is calling on behalf of her husband which had Covid yesterday (12Mar2025). She mentioned that he had a Pfizer Covid shot which he is fine when he got this but three days later, he got covid. She also mentioned that he is a high risk because he is older and had pneumonia a couple of times. She was told to buy Paxlovid but it will cost them which they need help for it. The patient had (health insurance name redacted) and he has supplement with (redacted).   No follow-up attempts are possible. Batch/lot number is not provided, and it cannot be obtained.
Age: 1.0
Sex: F
Vaccine: DTAPIPVHIB
Symptoms: Product preparation issue
Clinical narrative: PENTACEL was administered but only the liquid portion containing the DTap-IPV with no reported AE; Initial information received on 12-Mar-2025 (with live follow up process together with CSD: 12-Mar-2025) regarding an unsolicited valid non-serious case received from an other health professional.  This case involves a 1 years 2 month old female patient whom  diphtheria/tetanus/5 hybrid AC pertussis/IPV(VERO)/HIB(PRP/T) vaccine [Pentacel (Vero)] pentacel was administered but only the liquid portion containing the dtap-ipv with no reported AE.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included pneumococcal vaccine conj 15V (CRM197) (Vaxneuvance) for Prophylactic vaccination (Immunisation).  On 05-Mar-2025, the patient received an unknown dose (0.5ml) of suspect diphtheria/tetanus/5 hybrid AC pertussis/IPV(VERO)/HIB(PRP/T) vaccine; Suspension for injection with unknown strength (lot UK107AA with expiry date 30-Sep-2025) via intramuscular route in unknown administration site for Immunization.  On 05-Mar-2025 the patient developed pentacel was administered but only the liquid portion containing the dtap-ipv with no reported ae (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.   Additional information was received on 12-Mar-2025
Age: 0.17
Sex: F
Vaccine: DTPPVHBHPB, IPV, PNC20, RV5
Symptoms: Extra dose administered, No adverse event
Clinical narrative: Administration error. I gave both Vaxelis and IPOC polio vaccines. Neither I nor the person who verified realized that Vaxelis contained a dose of polio vaccine. I immediately called facility and spoke to a representative who advised me that it "should be okay."  Called pt's mom and informed her of the error, asked her to monitor patient for any adverse reactions and bring her back to the clinic if she had any concerns. She stated that patient had not has any adverse reactions.
Age: 78.0
Sex: F
Vaccine: PNC20
Symptoms: Inappropriate schedule of product administration
Clinical narrative: Prevnar20 pneumococcal vaccine given on 5/14/24 and 3/13/25 which exceeds recommendation interval
Age: 47.0
Sex: M
Vaccine: FLU3
Symptoms: Rash
Clinical narrative: Pt came to clinic with rash covering trunk, back and arms on 03/12/25 that started on 03/07/25 after getting vaccines on 02/26/25.  Provider contributed rash to reaction from vaccines. Unknown which vaccine.
Age: 84.0
Sex: M
Vaccine: PNC21
Symptoms: Bell's palsy, Facial paralysis
Clinical narrative: Patient developed left facial eyelid and lip drooping two days after vaccine administration and was diagnosed with Bell's palsy.
Age: 54.0
Sex: M
Vaccine: HEP
Symptoms: No adverse event, Underdose
Clinical narrative: No adverse event.   Patient was administered the pediatric dose of Hep B instead of the Adult dose of HEP B Energix.  No complications
Age: 37.0
Sex: M
Vaccine: HPV9
Symptoms: Chest pain, Myalgia
Clinical narrative: severe chest pain started on the evening on day of vaccination.  Called today (Monday 3/17/2025) and reported that he still has chest pain and muscle pain all over the body.  The pain was less intense than the night of vaccination.  He took ibuprofen but did not help with the pain.  I referred him to see his PCP.
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site erythema, Injection site pain
Clinical narrative: Patient developed red spots and soreness around injection site on the day following immunization (03/16/25). Two days after immunization (03/17/25), the redness spread and there is a larger red spot around injection site with continued soreness. Patient denied hives, swelling, difficulty breathing, or anaphylactic reaction.
Age: 36.0
Sex: M
Vaccine: PNC20, VARZOS
Symptoms: Herpes zoster
Clinical narrative: Patients states he developed a shingles outbreak today 03/17/2025 on his lower back, He saw a doctor virtually and was prescribed Valacyclovir 1 gram 1 tablet three times a day for 7 days
Age: 67.0
Sex: F
Vaccine: UNK
Symptoms: Urticaria
Clinical narrative: Hives
Age: 21.0
Sex: M
Vaccine: COVID19
Symptoms: Syncope, Vomiting
Clinical narrative: Patient informed pharmacist and technician that patient has a tendency to faint after vaccines or blood draws. Pharmacist and staff were alerted before giving a COVID vaccine. COVID vaccine was delivered by pharmacy technician, and patient fainted after the vaccination. Pharmacist was present checking for pulse, and breath. Patient was still breathing and responding when name was called. After drinking water, patient stated he was getting better. Then, patient had a second episode. Patient was still conscious at the moment. Patient vomited, and mentioned patient has not had any food after breakfast. Patient felt better after drinking more water and eating chocolate. Patient was escorted out after feeling better.
Age: 4.0
Sex: M
Vaccine: PPV
Symptoms: Urticaria
Clinical narrative: Hives. Lasting13+ weeks. (Still has them)
Age: 45.0
Sex: M
Vaccine: PNC20
Symptoms: Extra dose administered
Clinical narrative: Patient received vaccination on on 8-2-24 and received it again on 3-15-25
Age: 0.33
Sex: F
Vaccine: UNK, UNK
Symptoms: Diarrhoea, Faeces discoloured
Clinical narrative: Diarrhea lasted for 4 weeks. 3-6 watery green-gray colored bowel movements a day. Mostly in the middle of the night.  about 36 hrs after 4 month shots. No dehydration symptoms. Occasional cramping but baby was overall content.b was seen for a cold 10 days in and pediatrician said if it lasted a month out would Be concerning, unless there was signs of dehydration. Probiotic was given after about a week. One dose Every day. Didn?t help.
Age: 90.0
Sex: F
Vaccine: PNC21, RSV, VARZOS
Symptoms: Hypersensitivity
Clinical narrative: PATIENT HAD ALLERGIC REACTION TO THE VACCINES AND  WAS TAKEN THE ER.  PATIENT WAS IN THE HOSPITAL FOR 2 DAYS WAS DISCHARGED
Age: 71.0
Sex: M
Vaccine: UNK
Symptoms: Deep vein thrombosis, Pulmonary embolism
Clinical narrative: Patient received RSV vaccine approximately 6 weeks prior to ED visit for bilateral pulmonary embolism with saddle, and bilateral lower extremity DVT. No other obvious causes for development of blood clots. Specific vaccine unknown.
Age: 69.0
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Rash pruritic, Rash vesicular
Clinical narrative: pt says a day or two after getting 1st dose he started itching on his lower back just around the waist line. It developed into a rash like a bunch of mosquito bites and after a few days it spread to both buttocks. This lasted for a week to ten days. They diminished slowly and and finally disappeared. He no longer has any symptoms. He is not sure weather to get the second shot or not.
Age: 69.0
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Rash, Rash pruritic
Clinical narrative: pt says a day or two after getting 1st dose he started itching on his lower back just around the waist line. It developed into a rash like a bunch of mosquito bites and after a few days it spread to both buttocks. This lasted for a week to ten days. They diminished slowly and and finally disappeared. He no longer has any symptoms. He is not sure weather to get the second shot or not.
Vaccine: COVID19, COVID19
Symptoms: Aspiration bone marrow, Blood iron, Blood uric acid, Full blood count, Janus kinase 2 mutation
Clinical narrative: Thrombocytopenia; tested positive for the JAK2 gene; platelet count started rising; This is a spontaneous report received from a Consumer or other non HCP from medical information team, Program ID.  A patient (age and gender not provided) received BNT162b2 (BNT162B2), on 18Jul2022 as dose 4 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (DOSE 1, SINGLE; Lot number: unknown), for Covid-19 immunization; Bnt162b2 (DOSE 2, SINGLE; Lot number: unknown), for Covid-19 immunization; Bnt162b2 (DOSE 3 (BOOSTER), SINGLE; Lot number: unknown), for Covid-19 immunization. The following information was reported: PLATELET COUNT INCREASED (non-serious) with onset 2023, outcome "unknown", described as "platelet count started rising"; THROMBOCYTOPENIA (medically significant) with onset Apr2024, outcome "unknown"; GENE MUTATION IDENTIFICATION TEST POSITIVE (non-serious) with onset Apr2024, outcome "unknown", described as "tested positive for the JAK2 gene". The patient underwent the following laboratory tests and procedures: Janus kinase 2 mutation: (Apr2024) Positive, notes: tested positive for the JAK2 gene; Platelet count: (Jul2023) rising.  Clinical course: The patient had 4 Pfizer covid vaccines with the last one being administered on 18Jul2022. Exactly one year later, the patient's platelet count started rising. In Apr2024, the patient was diagnosed with essential thrombocytopenia and tested positive for the JAK2 gene. The patient would like to know if anyone else had reported this condition to Pfizer after having the Pfizer covid vaccine.  The information on the batch/lot number for BNT162b2 will be requested and submitted if and when received.
Vaccine: COVID19, COVID19
Symptoms: Metabolic function test, Platelet count increased, Serum ferritin, Thrombocytopenia
Clinical narrative: Thrombocytopenia; tested positive for the JAK2 gene; platelet count started rising; This is a spontaneous report received from a Consumer or other non HCP from medical information team, Program ID.  A patient (age and gender not provided) received BNT162b2 (BNT162B2), on 18Jul2022 as dose 4 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (DOSE 1, SINGLE; Lot number: unknown), for Covid-19 immunization; Bnt162b2 (DOSE 2, SINGLE; Lot number: unknown), for Covid-19 immunization; Bnt162b2 (DOSE 3 (BOOSTER), SINGLE; Lot number: unknown), for Covid-19 immunization. The following information was reported: PLATELET COUNT INCREASED (non-serious) with onset 2023, outcome "unknown", described as "platelet count started rising"; THROMBOCYTOPENIA (medically significant) with onset Apr2024, outcome "unknown"; GENE MUTATION IDENTIFICATION TEST POSITIVE (non-serious) with onset Apr2024, outcome "unknown", described as "tested positive for the JAK2 gene". The patient underwent the following laboratory tests and procedures: Janus kinase 2 mutation: (Apr2024) Positive, notes: tested positive for the JAK2 gene; Platelet count: (Jul2023) rising.  Clinical course: The patient had 4 Pfizer covid vaccines with the last one being administered on 18Jul2022. Exactly one year later, the patient's platelet count started rising. In Apr2024, the patient was diagnosed with essential thrombocytopenia and tested positive for the JAK2 gene. The patient would like to know if anyone else had reported this condition to Pfizer after having the Pfizer covid vaccine.  The information on the batch/lot number for BNT162b2 will be requested and submitted if and when received.
Vaccine: COVID19, COVID19
Symptoms: Gene mutation identification test positive, Janus kinase 2 mutation, Platelet count, Platelet count increased, Thrombocytopenia
Clinical narrative: Thrombocytopenia; tested positive for the JAK2 gene; platelet count started rising; This is a spontaneous report received from a Consumer or other non HCP from medical information team, Program ID.  A patient (age and gender not provided) received BNT162b2 (BNT162B2), on 18Jul2022 as dose 4 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (DOSE 1, SINGLE; Lot number: unknown), for Covid-19 immunization; Bnt162b2 (DOSE 2, SINGLE; Lot number: unknown), for Covid-19 immunization; Bnt162b2 (DOSE 3 (BOOSTER), SINGLE; Lot number: unknown), for Covid-19 immunization. The following information was reported: PLATELET COUNT INCREASED (non-serious) with onset 2023, outcome "unknown", described as "platelet count started rising"; THROMBOCYTOPENIA (medically significant) with onset Apr2024, outcome "unknown"; GENE MUTATION IDENTIFICATION TEST POSITIVE (non-serious) with onset Apr2024, outcome "unknown", described as "tested positive for the JAK2 gene". The patient underwent the following laboratory tests and procedures: Janus kinase 2 mutation: (Apr2024) Positive, notes: tested positive for the JAK2 gene; Platelet count: (Jul2023) rising.  Clinical course: The patient had 4 Pfizer covid vaccines with the last one being administered on 18Jul2022. Exactly one year later, the patient's platelet count started rising. In Apr2024, the patient was diagnosed with essential thrombocytopenia and tested positive for the JAK2 gene. The patient would like to know if anyone else had reported this condition to Pfizer after having the Pfizer covid vaccine.  The information on the batch/lot number for BNT162b2 will be requested and submitted if and when received.
Age: 1.0
Sex: M
Vaccine: HEPA, MMRV, PNC20, VARCEL, HEPA, MMRV, PNC20, VARCEL
Symptoms: Wrong patient
Clinical narrative: patient was dosed with ProQuad vaccine and Varicella
Age: 1.0
Sex: M
Vaccine: HEPA, MMRV, PNC20, VARCEL, HEPA, MMRV, PNC20, VARCEL
Symptoms: Wrong product administered
Clinical narrative: patient was dosed with ProQuad vaccine and Varicella
Sex: F
Vaccine: PPV
Symptoms: Allergy to vaccine, Epistaxis
Clinical narrative: Allergy to pneumovax; This spontaneous report was received from a consumer referring to an 80-year-old female patient. The patient's Historical drugs included Phenoxymethylpenicillin potassium (PENICILLIN VK), Influenza vaccine rHA 3v (baculovirus) (FLUBLOK), Chlorpheniramine, Morphine sulfate, Acetaminophen (Paracetamol), Acyclovir, Chlorphenamine maleate (+) Paracetamol (+) Phenylephrine hydrochloride (DRISTAN COLD MULTI-SYMPTOM FORMULA), Xylometazoline hydrochloride (SUDAFED), Pethidine hydrochloride (MEPERIDINE HCl), and Sulfamethoxazole (+) Trimethoprim (SULFAMETHOPRIM). Concurrent condition was not reported.   On an unknown date, the patient was vaccinated with a dose of Pneumococcal Vaccine, Polyvalent (23-valent) (PNEUMOVAX 23) solution for injection (Lot #, expiration date, dose, strength, anatomical location of vaccine and route of administration were not reported) for prophylaxis.   On an unknown date, the patient experienced Allergy to pneumovax. At the reporting time, the outcome of Allergy to pneumovax was unknown.   On an unknown date in 2024, the patient started therapy with sotatercept (WINREVAIR) injection (strength, dose, frequency, lot#, expiry date, route and indication were not reported). On an unknown date in 2024, the patient experienced nosebleed (Captured on Case # 2055804).  The reporter considered the event of Allergy to pneumovax to be related to Pneumococcal Vaccine, Polyvalent (23-valent).  Lot # is being requested and will be submitted if reported.   This is one of the two reports from the same reporter.
Sex: F
Vaccine: HPV9
Symptoms: Papilloma viral infection
Clinical narrative: HPV infection; This spontaneous report was received from a Physician and refers to an Adult (late 20s or 30s) female patient.   The patient's medical history was not reported. The patient's concurrent conditions were not reported. Concomitant therapies were not reported.   On an unknown date, at age 10 or 11, the patient started therapy with Human Papillomavirus 9-valent Vaccine, Recombinant (GARDASIL 9), (dose, route of administration, anatomical location, lot # and expiration date were not reported).  On an unknown date, the patient experienced HPV infection.   At the reporting time, the outcome of HPV infection was unknown.   The action taken with Human Papillomavirus 9-valent Vaccine, Recombinant was reported as not applicable.   The causal relationship between the event of HPV infection and Human Papillomavirus 9-valent Vaccine, Recombinant was unknown/not reported/not provided.  This is one of two reports received from the same reporter (case # 2265116).;
Age: 11.0
Sex: F
Vaccine: UNK
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional AE; Fridge dropped below freezing over the weekend while office was closed; This spontaneous report has been received from a healthcare professional regarding a 11-year-old female patient. The patient's medical history, concurrent conditions, and concomitant therapies were not reported.   On 24-OCT-2024, the patient was vaccinated with an improperly stored dose of Human Papillomavirus 9-valent Vaccine, Recombinant (GARDASIL 9) Suspension for injection, administered intramuscularly as prophylaxis (lot number reported as X025115, which has been verified as valid, expiration date reported and validated as 19-MAY-2026).  It was reported that the fridge dropped below freezing over the weekend while office was closed (Product storage error). No additional adverse events were reported.; Sender's Comments: Priority : 4 , Is case serious : No , Index user : , Index date : 2025-03-13 , MNSC number : , CLIC number : , ESTAR number : , IRMS number : 02743778 RD , Central date : 2025-03-10 , Classification : DMC, Attachment description : Post Marketing Basic , Safety case number :
Sex: F
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: Missed dose; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st dose 3 years ago).   On an unknown date, the patient did not receive the 2nd dose of Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced incomplete course of vaccination (Verbatim: Missed dose). The outcome of the incomplete course of vaccination was not applicable.   Additional Information: GSK Receipt Date: 13-MAR-2025 The reporter stated that a patient received the first dose of Shingrix 3 years ago but never received the second dose.  No patient information was available. Till the time of reporting, the patient did not receive the 2nd dose of Shingrix, which led to incomplete course of vaccination.
Age: 1.0
Sex: M
Vaccine: HEPA
Symptoms: Expired product administered
Clinical narrative: Expired product used; This non-serious case was reported by a other health professional via call center representative and described the occurrence of expired vaccine used in a 22-month-old male patient who received HAV (Havrix) (batch number 9R5LC, expiry date 02-JAN-2024) for prophylaxis.   On 11-MAR-2025, the patient received Havrix. On 11-MAR-2025, an unknown time after receiving Havrix, the patient experienced expired vaccine used (Verbatim: Expired product used). 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: 12-MAR-2025 The office manager called to reported that one of their new staff members administered an expired dose of Havrix to a patient, which led to an expired vaccine used. The reporter wanted to know do they have to call the patient to receive a new dose. No further information was obtained in this call. The vaccine administration facility was the same as primary reporter.
Age: 13.0
Sex: F
Vaccine: HPV9
Symptoms: Blood test abnormal, Brain fog, Dizziness, Electroencephalogram abnormal, Headache
Clinical narrative: Red spot at injection site, raised knot, sore arm for 4 days, hot at touch.  3 weeks later- migraine & nausea, 4 weeks later- unexplained seizures, dizziness, loss of consciousness,  brain fog,  headache,  still lasting after 6 days.
Age: 13.0
Sex: F
Vaccine: HPV9
Symptoms: Injection site erythema, Loss of consciousness, Migraine, Nausea, Nodule
Clinical narrative: Red spot at injection site, raised knot, sore arm for 4 days, hot at touch.  3 weeks later- migraine & nausea, 4 weeks later- unexplained seizures, dizziness, loss of consciousness,  brain fog,  headache,  still lasting after 6 days.
Age: 13.0
Sex: F
Vaccine: HPV9
Symptoms: Pain in extremity, Seizure, Skin warm
Clinical narrative: Red spot at injection site, raised knot, sore arm for 4 days, hot at touch.  3 weeks later- migraine & nausea, 4 weeks later- unexplained seizures, dizziness, loss of consciousness,  brain fog,  headache,  still lasting after 6 days.
Age: 62.0
Sex: M
Vaccine: RSV
Symptoms: Abdominal pain, Angina pectoris, Dizziness, Hyperhidrosis, Pruritus
Clinical narrative: Reported Symptoms: 10000081: ABDOMINAL PAIN; 10002391: ANGINAL PAIN; 10012703: DIAPHORESIS; 10013573: DIZZINESS; 10037087: PRURITUS;  Narrative: 62 yo male with idiopathic angioedema and many medication allergies experienced allergic reaction to RSV vaccine minutes after the vaccination. The symptoms improved with treatment, then recurred several hours later, then resolved after a second dose of epi-pen in the emergency department. Other Relevant HX:  Other: diaphoresis, pruritus, abdominal pain
Age: 77.0
Sex: M
Vaccine: FLU3
Symptoms: No adverse event
Clinical narrative: Reported Symptoms: 10067481:NO ADVERSE DRUG REACTION;  Narrative: at approximately 1430 on 12/5, patient's son contacted PACT team by phone. He had questions as to if the patient had received a flu shot. he stated his father came home with a band-aid on his arm and said he thought he had gotten a flu shot. Upon review of patient's chart, there was a flu shot administered at his appt the morning of his 12/5 appt. The son stated his father is allergic to flu shots and should not receive them, due to a hx of guillian barre. RN advised the son to take his father to the ER with any s/s of reaction. At time of entry no noted reactions on patient chart after nearly 2 weeks since administration.  Other Relevant HX: Other: Pt has h/o gullian barre no reaction noted
Sex: F
Vaccine: UNK
Symptoms: Injection site pain
Clinical narrative: injection site stinging; This spontaneous report was received from an Other health professional via a company representative and refers to a female patient of unknown age.   The patient's medical history was not reported. The patient's concurrent conditions were not reported. Concomitant therapies were not reported. Drug reactions/allergies were unknown.  On an unknown date, the patient was vaccinated with Pneumococcal 21-valent Conjugate Vaccine (CAPVAXIVE) INJ 168 mcg/ml (dose, lot # and expiration date were not reported) via intramuscular (IM) route for prophylaxis.  On an unknown date, the patient experienced injection site stinging at the time of administration. At the reporting time, the outcome of injection site stinging was unknown. The causal relationship between the event of injection site stinging and Pneumococcal 21-valent Conjugate Vaccine (CAPVAXIVE) was unknown.   This is one of two cases from the same reporter.
Age: 14.0
Sex: F
Vaccine: UNK, UNK
Symptoms: Postural orthostatic tachycardia syndrome
Clinical narrative: POTS/autoimmune, autonomic, and neurological, injuries; Gardasil-induced autoimmune disorder; autoimmune, autonomic, and neurological injuries; Information has been received from a lawyer and refers to a female patient of 14-year-old.   The patient's medical history was not reported. The patient's concurrent conditions were not reported. Concomitant therapies were not reported.    On an unspecified date in April 2016, the patient received the first dose of Quadrivalent Human Papillomavirus (Types 6, 11, 16, 18) Recombinant Vaccine (GARDASIL) (strength, dose, lot #, and expiration date were not reported), and received the second dose of vaccine in August 2016. Patient agreed to received Quadrivalent Human Papillomavirus (Types 6, 11, 16, 18) Recombinant Vaccine (GARDASIL) by being convinced by company marketing that was very safe and prevent cancer.  Based upon her chronic and severe post- Quadrivalent Human Papillomavirus (Types 6, 11, 16, 18) Recombinant Vaccine (GARDASIL) symptoms, on an unspecified date the patient was diagnosed with various medical conditions, including but not limited to, postural orthostatic tachycardia syndrome (POTS). Her Quadrivalent Human Papillomavirus (Types 6, 11, 16, 18) Recombinant Vaccine (GARDASIL)  injections caused her to develop serious and debilitating autoimmune, autonomic, and neurological, injuries, including but not limited to POTS, as well as a constellation of adverse symptoms, complications, injuries, and other adverse events, many of which were alleged herein and all of which were caused by Gardasil or otherwise linked to her Quadrivalent Human Papillomavirus (Types 6, 11, 16, 18) Recombinant Vaccine (GARDASIL)-induced autoimmune disorder. As a result of her post-Gardasil symptoms, patient had been unable to engage in activities that a normal young person would enjoy. At the reporting time, the outcome of the events was unknown.    The reporter considered the events to be related to Quadrivalent Human Papillomavirus (Types 6, 11, 16, 18) Recombinant Vaccine (GARDASIL).   Upon internal review the event autoimmune disorder was considered as medically significant. The event POTS was considering as disabling.
Vaccine: HEPA
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: Nurse calling to report that a 15 month old patient was inadvertently administered the adult formulation of VAQTA. No symptoms reported. Caller declined to report the AE at this time.  No additional AE/No PQC.; No additional AE; This spontaneous report was received from a nurse on 17-Mar-2025 and refers to a 15-month-old patient of unknown gender.   The patient's medical history, concurrent conditions and concomitant therapies were not reported.   On an unknown date, the patient was inadvertently vaccinated with the adult formulation of Hepatitis A Vaccine, Inactivated (VAQTA), (lot # and expiration date were not reported) as prophylaxis (Product administered to patient of inappropriate age). No symptoms reported. No additional AE (no adverse event).   Lot # is being requested and will be submitted if received.
Age: 72.0
Sex: F
Vaccine: VARZOS
Symptoms: Abdominal discomfort, Chills, Fatigue, Headache, Mobility decreased
Clinical narrative: also began having fatigue so severe; Muscle pain; Shivering; Upset stomach; Runny nose; Nasal congestion; Headache; couldn't get out of bed; she began feeling feverish,of 101.5 degrees Fahrenheit.; This non-serious case was reported by a consumer via call center representative and described the occurrence of fever in a 72-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Concurrent medical conditions included hypertension, arthritis and pain. Concomitant products included amlodipine, tramadol and paracetamol (Tylenol).   On 01-MAR-2025, the patient received the 1st dose of Shingrix (intramuscular) .5 ml. On 01-MAR-2025, less than a day after receiving Shingrix, the patient experienced fever (Verbatim: she began feeling feverish,of 101.5 degrees Fahrenheit.). On 02-MAR-2025, the patient experienced fatigue (Verbatim: also began having fatigue so severe), muscle pain (Verbatim: Muscle pain), shivering (Verbatim: Shivering), upset stomach (Verbatim: Upset stomach), runny nose (Verbatim: Runny nose), nasal congestion (Verbatim: Nasal congestion), headache (Verbatim: Headache) and bedridden (Verbatim: couldn't get out of bed). The outcome of the fever was resolving and the outcome of the fatigue, muscle pain, shivering, upset stomach, runny nose, nasal congestion and headache were not resolved and the outcome of the bedridden was not reported.   It was unknown if the reporter considered the fever, fatigue, muscle pain, shivering, upset stomach, runny nose, nasal congestion, headache and bedridden to be related to Shingrix.     It was unknown if the company considered the fever, fatigue, muscle pain, shivering, upset stomach, runny nose, nasal congestion, headache and bedridden to be related to Shingrix.   Additional Information: GSK Receipt Date: 07-MAR-2025 The patient self-reported this case. The patient received 1st dose of Shingrix vaccine and that in the evening of vaccination day she began feeling feverish.   The following day she was having a fever of 101.5 degrees Fahrenheit.  She also began having fatigue so severe she couldn't get out of bed and other symptoms also began on that day which were  muscle pain, headache, shivering, upset stomach, runny nose and nasal congestion.   The fever has abated as of on the day of reporting and the remaining symptoms were ongoing.  She took amlodipine, Tylenol and Tramadol daily.
Age: 72.0
Sex: F
Vaccine: VARZOS
Symptoms: Myalgia, Nasal congestion, Pyrexia, Rhinorrhoea
Clinical narrative: also began having fatigue so severe; Muscle pain; Shivering; Upset stomach; Runny nose; Nasal congestion; Headache; couldn't get out of bed; she began feeling feverish,of 101.5 degrees Fahrenheit.; This non-serious case was reported by a consumer via call center representative and described the occurrence of fever in a 72-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Concurrent medical conditions included hypertension, arthritis and pain. Concomitant products included amlodipine, tramadol and paracetamol (Tylenol).   On 01-MAR-2025, the patient received the 1st dose of Shingrix (intramuscular) .5 ml. On 01-MAR-2025, less than a day after receiving Shingrix, the patient experienced fever (Verbatim: she began feeling feverish,of 101.5 degrees Fahrenheit.). On 02-MAR-2025, the patient experienced fatigue (Verbatim: also began having fatigue so severe), muscle pain (Verbatim: Muscle pain), shivering (Verbatim: Shivering), upset stomach (Verbatim: Upset stomach), runny nose (Verbatim: Runny nose), nasal congestion (Verbatim: Nasal congestion), headache (Verbatim: Headache) and bedridden (Verbatim: couldn't get out of bed). The outcome of the fever was resolving and the outcome of the fatigue, muscle pain, shivering, upset stomach, runny nose, nasal congestion and headache were not resolved and the outcome of the bedridden was not reported.   It was unknown if the reporter considered the fever, fatigue, muscle pain, shivering, upset stomach, runny nose, nasal congestion, headache and bedridden to be related to Shingrix.     It was unknown if the company considered the fever, fatigue, muscle pain, shivering, upset stomach, runny nose, nasal congestion, headache and bedridden to be related to Shingrix.   Additional Information: GSK Receipt Date: 07-MAR-2025 The patient self-reported this case. The patient received 1st dose of Shingrix vaccine and that in the evening of vaccination day she began feeling feverish.   The following day she was having a fever of 101.5 degrees Fahrenheit.  She also began having fatigue so severe she couldn't get out of bed and other symptoms also began on that day which were  muscle pain, headache, shivering, upset stomach, runny nose and nasal congestion.   The fever has abated as of on the day of reporting and the remaining symptoms were ongoing.  She took amlodipine, Tylenol and Tramadol daily.
Sex: F
Vaccine: HEP, VARZOS
Symptoms: Injection site erythema, Injection site pain, Injection site pruritus, Injection site swelling
Clinical narrative: I have a 2 inch diamter red swollen area at the injection site. Very sore, soemwhat itchy.; Injection site itchy; Injection site red; Very sore; This non-serious case was reported by a consumer and described the occurrence of injection site swelling in a 63-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Hepatitis b vaccine for prophylaxis.   On 06-MAR-2025, the patient received Shingrix .5 ml and the 2nd dose of Hepatitis b vaccine. On 07-MAR-2025, 1 days after receiving Shingrix, the patient experienced injection site swelling (Verbatim: I have a 2 inch diamter red swollen area at the injection site. Very sore, soemwhat itchy.), injection site itching (Verbatim: Injection site itchy), injection site erythema (Verbatim: Injection site red) and injection site pain (Verbatim: Very sore). The outcome of the injection site swelling, injection site itching, injection site erythema and injection site pain were unknown.   It was unknown if the reporter considered the injection site swelling, injection site itching, injection site erythema and injection site pain to be related to Shingrix.     It was unknown if the company considered the injection site swelling, injection site itching, injection site erythema and injection site pain to be related to Shingrix.   Additional Information: GSK Receipt Date: 08-MAR-2025 The reporter reported that she have a 2 inch diameter red swollen area at the injection site, very sore, somewhat itchy. The reporter reported that the she had never had this reaction to a vaccine before. but, to be clear, also got her second Hep B shot at the same time.
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: Suspected vaccination failure; she received the 2-dose series of Shingrix in 2017 and has had several flare ups of Shingles since that time; This serious case was reported by a consumer via call center representative and described the occurrence of vaccination failure in a 67-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 2nd dose of Shingrix (intramuscular) and the 1st dose of Shingrix (intramuscular). On an unknown date, an unknown time after receiving Shingrix and Shingrix, the patient experienced vaccination failure (Verbatim: Suspected vaccination failure) (serious criteria GSK medically significant) and shingles (Verbatim: she received the 2-dose series of Shingrix in 2017 and has had several flare ups of Shingles since that time). 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 Shingrix and Shingrix.     The company considered the vaccination failure to be unrelated to Shingrix and Shingrix. It was unknown if the company considered the shingles to be related to Shingrix and Shingrix.   Additional Information: GSK receipt date: 11-MAR-2025 The patient reported that she had received the 2-dose series of Shingrix in 2017 and had several flare ups of Shingles since that time. She had a case right now that affects under her right arm and to comes and goes with no warning. The batch lot number of Shingles vaccine she could not remember. The expiry date of Shingles vaccine was unknown. She was going to the doctor on Thursday, 13th March 2025. This case was considered as suspected vaccination failure since the details regarding, time to onset and laboratory confirmation of shingles were unknown at the time of reporting.; Sender's Comments: Vaccination failure is a listed event which, due to the following criteria (insufficient information provided about the clinical description, time to onset and laboratory confirmation of disease) is considered unrelated to GSK vaccine Shingrix (Dose 1 & 2).
Age: 75.0
Sex: M
Vaccine: VARZOS
Symptoms: Chills, Pyrexia
Clinical narrative: he had chills; he had fever; This non-serious case was reported by a consumer via call center representative and described the occurrence of chills in a 75-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   The patient's past medical history included shingles.   On 07-MAR-2025, the patient received the 1st dose of Shingrix (intramuscular). On 07-MAR-2025, less than a day after receiving Shingrix, the patient experienced chills (Verbatim: he had chills) and fever (Verbatim: he had fever). The outcome of the chills and fever were resolved.   It was unknown if the reporter considered the chills and fever to be related to Shingrix.     It was unknown if the company considered the chills and fever to be related to Shingrix.   Additional Information: GSK receipt date: 10-MAR-2025 The patient wife reporting on behalf of her husband. She stated that her husband received his first dose of Shingrix vaccine and experienced chills and a fever. The reporter stated that her husband was better on the day of reporting and was at the gym working out. The reporter reported that her husband had a past medical history of shingles. Reporter declines follow up for her husband or with the primary care physician for her husband. No further information was obtained/provided including what arm the husband had the vaccine administered in. The consumer was unable to locate lot number on material provided from pharmacy. Lot number may not had been provided to consumer.; Sender's Comments:  US-GSK-US2025029170:same reporter, female patient
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Herpes zoster, Stress, Vaccination failure
Clinical narrative: Suspected vaccination failure; I got the shingles; a lot of stress; This serious case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a elderly female 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), shingles (Verbatim: I got the shingles) and stress (Verbatim: a lot of stress). The outcome of the vaccination failure and stress were not reported and the outcome of the shingles was resolved.   It was unknown if the reporter considered the vaccination failure, shingles and stress 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 and stress to be related to Shingles vaccine and Shingles vaccine.   Additional Information: GSK Receipt Date: 11-MAR-2025 The case was received from the patient via interactive digital media. The patient have had both shots also but after a lot of stress got the shingles, only thankful he/she did as they are much lighter and had not lasted as long. This case was considered as suspected vaccination failure as details regarding 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, time to onset and laboratory confirmation of disease) is considered unrelated to GSK vaccine Shingles (Dose 1 & 2).
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: Suspeceted vaccination failure; I got the shingle vaccination about twenty years ago and got two more vaccinations about three years ago, but then I got the shingles; This serious case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a elderly male 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: Suspeceted vaccination failure) (serious criteria GSK medically significant) and shingles (Verbatim: I got the shingle vaccination about twenty years ago and got two more vaccinations about three years ago, but then I got the shingles). 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 and Shingles vaccine.     The company considered the vaccination failure and shingles to be unrelated to Shingles vaccine and Shingles vaccine.   Additional Information: GSK Receipt Date: 11-MAR-2025 This case was reported by a consumer via interactive digital media. The reporter got the Shingle vaccination about twenty years ago and got two more vaccinations about three years ago, but then he got the shingles and after two years the pain was still there. This case was considered as suspected vaccination failure as details regarding 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.