chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 2.0
Vaccine: HPV9
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: no adverse event; the 2 year old patient was given GARDASIL 9 in error; This spontaneous report was received from a Consumer referring to a 2-year-old patient of unknown gender.   The patient's medical history, concurrent conditions, concomitant therapies, and drug reactions/allergies were not reported.   On 01-Jul-2025, the patient was vaccinated with Human Papillomavirus 9-valent Vaccine, Recombinant (GARDASIL 9) in error, administered by Health Professional as prophylaxis (dose, route of administration, lot #, and expiration date were not reported) (Product administered to patient of inappropriate age). No symptoms were reported (no adverse event).   Lot # is being requested and will be submitted if received.
Vaccine: FLUN3
Symptoms: Nervousness, Panic attack, Presyncope
Clinical narrative: Almost passed out after receiving a COVID vaccine; Terrible case of nerves; Pure panic; A report has been received from a non-health professional, regarding a subject enrolled in study (withheld). The report concerns a male patient (age not provided).  The patient's past and current medical history included coronavirus test (dates not reported).  No concomitant products were reported.     On an unknown date, the patient experienced almost passed out after receiving a covid vaccine (preferred term: Near death experience), pure panic (preferred term: Panic attack) and terrible case of nerves (preferred term: Neuralgia).     The dose of Flumist (flumist, influenza virus vaccine polyvalent, q/laiv) was not changed.  The outcome of the event(s) of almost passed out after receiving a covid vaccine, pure panic and terrible case of nerves was unknown.      The following event(s) were considered serious due to medically significant:almost passed out after receiving a covid vaccine.  The following events were considered non-serious:pure panic and terrible case of nerves.  The reporter did not consider that there was a reasonable possibility of a causal relationship between Accuspray Single Dose and the following event(s): almost passed out after receiving a covid vaccine, pure panic and terrible case of nerves. The reporter did not consider that there was a reasonable possibility of a causal relationship between Flumist and the following event(s): almost passed out after receiving a covid vaccine, pure panic and terrible case of nerves.  The company physician did not consider that there was a reasonable possibility of a causal relationship between Accuspray Single Dose and the following event(s): almost passed out after receiving a covid vaccine, pure panic and terrible case of nerves. The company physician did not consider that there was a reasonable possibility of a causal relationship between Flumist and the following event(s): almost passed out after receiving a covid vaccine, pure panic and terrible case of nerves.      Device Information:  Combination Product Report: Yes  Product As Reported: Flumist Brand Name: FLUENZ TETRA, FLUENZ TETRA Product Role:Suspect Manufacturer Name:ASTRAZENECA Labeled for single use:No; Sender's Comments: Presyncope is not a listed event for the core data sheet for Q/LAIV. Due to limited information on patient demographics, underlying comorbidities, past medical history and concomitant medications, suspect product start date, indication, and action taken, circumstances leading to event, details of the event including onset date and outcome, risk factors, treatment details, clinical course, detailed etiological, diagnostic workup as clinical examination, complete blood workup, the evaluation did not find evidence to suggest a causal relationship between event and suspect drug.
Vaccine: VARZOS
Symptoms: Rheumatoid arthritis
Clinical narrative: rheumatoid arthritis; This serious case was reported by a consumer via interactive digital media and described the occurrence of rheumatoid arthritis in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine, the patient experienced rheumatoid arthritis (Verbatim: rheumatoid arthritis) (serious criteria GSK medically significant). The outcome of the rheumatoid arthritis was not resolved.   The reporter considered the rheumatoid arthritis to be related to Shingles vaccine.     The company considered the rheumatoid arthritis to be unrelated to Shingles vaccine.   Additional Information: GSK Receipt Date: 25-JUN-2025 This case was reported by a patient via interactive digital media. The patient reported this was damn vaccine. Two years ago (from the date of reporting), the patient almost died and developed rheumatoid arthritis. Further patient stated after taking several medications until today (till the day of reporting) and the patient never had support from anyone at the laboratory. The patient mentioned not to take it.  The patient was suffering every day because of the vaccine.; Sender's Comments: Rheumatoid arthritis is an unlisted event which is considered unrelated to GSK Shingles vaccine.
Sex: M
Vaccine: HEPAB
Symptoms: Incomplete course of vaccination
Clinical narrative: Inappropriate schedule of vaccine; This non-serious case was reported by a consumer via call center representative and described the occurrence of incomplete course of vaccination in a male patient.  The patient did not receive Twinrix. The patient experienced incomplete course of vaccination (Verbatim: Inappropriate schedule of vaccine). The outcome of the incomplete course of vaccination was not applicable.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK Receipt Date: 27-JUN-2025 The patient received the accelerated dosing of Twinrix in 2013/2014.  The reporter does not believe the patient received the 4th dose. Till the time of reporting the patient did not receive the booster dose of Twinrix, which led to incomplete course of vaccination. This case is linked with case US2025081315, reported by the same reporter.; Sender's Comments:  US-GSK-US2025081315:Same reporter,Different patient
Vaccine: VARZOS, VARZOS
Symptoms: Herpes zoster, Stress, Vaccination failure
Clinical narrative: Suspected Vaccination failure; I have been going through a small outbreak for the last few weeks; Currently dealing with 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 84-year-old 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 have been going through a small outbreak for the last few weeks) and stress (Verbatim: Currently dealing with a lot of stress). The outcome of the vaccination failure and shingles were not reported and the outcome of the stress was not 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: 28-JUN-2025 This case was reported by a patient via interactive digital media. Reporter was vaccinated twice for shingles but he/she had been going through a small outbreak for the last few weeks.  Fortunately it did not seemed to be spreading.  Reporter was 84 years old and currently dealing with a lot of stress. 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 vaccine (dose 1 and 2)
Vaccine: VARZOS, VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: Suspected vaccination failure; diagnosed with shingles; 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: diagnosed with 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 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: 27-JUN-2025 This case was reported by a patient via interactive digital media. The patient too had the shingles vaccine and have just been diagnosed with shingles.  The patient mentioned that he/she had both doses of vaccine. 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 time to onset for shingles and laboratory confirmation regarding shingles) is considered unrelated to GSK's Shingles vaccine (Dose 1 & 2).
Vaccine: VARZOS, VARZOS
Symptoms: Herpes zoster, Post herpetic neuralgia, Vaccination failure
Clinical narrative: Suspected vaccination failure; still got shingles a year ago; still have chronic nerve pain; 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), shingles (Verbatim: still got shingles a year ago) and post herpetic neuralgia (Verbatim: still have chronic nerve pain). The outcome of the vaccination failure and shingles were not reported and the outcome of the post herpetic neuralgia was not resolved.   It was unknown if the reporter considered the vaccination failure, shingles and post herpetic neuralgia 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 post herpetic neuralgia to be related to Shingles vaccine and Shingles vaccine.   Additional Information: GSK Receipt Date: 30-JUN-2025 This case was reported by a patient via interactive digital media. The patient mentioned he/she had both shots of Shingles vaccine and still got shingles a year ago.  The patient reported he/she still have chronic nerve pain. 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 Shingles vaccine
Vaccine: VARZOS, VARZOS, VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: Suspected vaccination failure; still got shingles; had more than two vaccines for it; This serious case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Co-suspect products included Herpes zoster (Shingles vaccine) for prophylaxis and Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received the 2nd dose of Shingles vaccine, the 1st dose of Shingles vaccine and Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine, Shingles vaccine and Shingles vaccine, the patient experienced vaccination failure (Verbatim: Suspected vaccination failure) (serious criteria GSK medically significant), shingles (Verbatim: still got shingles) and extra dose administered (Verbatim: had more than two vaccines for it). The outcome of the vaccination failure and shingles were not reported and the outcome of the extra dose administered was not applicable.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine, Shingles vaccine and Shingles vaccine.     The company considered the vaccination failure to be unrelated to Shingles vaccine, Shingles vaccine and Shingles vaccine. It was unknown if the company considered the shingles to be related to Shingles vaccine, Shingles vaccine and Shingles vaccine.   Additional Information: GSK Receipt Date: 30-JUN-2025 This case was reported by a patient via interactive digital media. It was reported as not necessarily true. The patient never had chicken pox but had more than two vaccines for it which led to extra dose administered and still got shingles. 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 time to onset for shingles and laboratory confirmation regarding shingles) is considered unrelated to GSK's Shingles vaccine (Dose 1, 2 & 3).
Vaccine: VARZOS, VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: Suspected vaccination failure; I currently have Shingles; 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 (Shingrix) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 2nd dose of Shingrix and the 1st dose of Shingrix. 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: I currently have Shingles). 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: 25-JUN-2025 This case was reported by a patient via interactive digital media. Patient received both doses of shingrix vaccine 3 years ago and he/she currently have shingles. Patient could confirm it was the most painful thing he/she had ever experienced.  The itching, the burning, and the pain was indescribable. He/she was really hoping the antiviral medication and steroid cream helps. 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, details regarding completion of primary vaccination schedule and laboratory confirmation of disease) is considered unrelated to GSK vaccine Shingrix (dose 1 and 2)
Age: 16.0
Sex: F
Vaccine: FLU3
Symptoms: Expired product administered
Clinical narrative: received an expired dose of Flulaval; 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 16-year-old female patient who received Flu Seasonal TIV Quebec (FluLaval 2024-2025 season) (batch number AE2J7, expiry date 16-JUN-2025) for prophylaxis.   On 17-JUN-2025, the patient received FluLaval 2024-2025 season. On 17-JUN-2025, an unknown time after receiving FluLaval 2024-2025 season, the patient experienced expired vaccine used (Verbatim: received an expired dose of Flulaval). 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: 17-JUN-2025 The patient received an expired dose of Flulaval on the day of reporting morning, which led expired vaccine used. The reporter consented to follow up.
Vaccine: TDAP
Symptoms: Expired product administered
Clinical narrative: Maladministration of an expired dose; 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 patient who received DTPa (Reduced antigen) (Boostrix) (batch number B32NG, expiry date 13-JUN-2025) for prophylaxis.   On 26-JUN-2025, the patient received Boostrix. On 26-JUN-2025, an unknown time after receiving Boostrix, the patient experienced expired vaccine used (Verbatim: Maladministration of an expired dose). 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: 26-JUN-2025 Medical Assistant called to ask for further steps regarding the maladministration of an expired dose of Boostrix which led to expired vaccine use. Vaccination date and vaccine detail were obtained in this call (these were reactively mentioned from the Medical Assistant´s end). No patient demographics were obtained in this call. No further information was obtained in this call.
Sex: F
Vaccine: MENB, MENB
Symptoms: Interchange of vaccine products
Clinical narrative: received a dose of Trumemba instead of a dose of Bexsero as a second dose; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of interchange of vaccine products in a 19-year-old female patient who received Men B NVS (Bexsero) (batch number ES49H, expiry date 31-MAY-2027) for prophylaxis.   Co-suspect products included Meningococcal vaccine B rfHbpA/fHbpB (Trumenba) for prophylaxis.   On 26-JUL-2024, the patient received the 1st dose of Bexsero. On an unknown date, the patient received the 2nd dose of Trumenba. On an unknown date, an unknown time after receiving Bexsero and Trumenba, the patient experienced interchange of vaccine products (Verbatim: received a dose of Trumemba instead of a dose of Bexsero as a second dose). The outcome of the interchange of vaccine products 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: 27-JUN-2025 A pharmacist called asking advice regarding a 19-year-old female patient dosing schedule. Patient received Bexsero 1st dose on 26th July 2024. Then the patient received Trumenba by mistake instead of Bexsero which led to interchange of vaccine products. Reporter questioned that did the patient had to get the next dose of Bexsero.
Sex: M
Vaccine: VARZOS
Symptoms: Product preparation issue
Clinical narrative: Maladministration of AS01B Adjuvant of Shingrix alone (without the Lyophilized Antigen Component); Maladministration of AS01B Adjuvant of Shingrix alone (without the Lyophilized Antigen Component); This non-serious case was reported by a nurse via call center representative and described the occurrence of inappropriate preparation of medication in a 53-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   On 01-JUL-2025, the patient received Shingrix. On 01-JUL-2025, an unknown time after receiving Shingrix, the patient experienced inappropriate preparation of medication (Verbatim: Maladministration of AS01B Adjuvant of Shingrix alone (without the Lyophilized Antigen Component)) and inappropriate dose of vaccine administered (Verbatim: Maladministration of AS01B Adjuvant of Shingrix alone (without the Lyophilized Antigen Component)). The outcome of the inappropriate preparation of medication and inappropriate dose of vaccine administered were not applicable.   Additional Information: GSK Receipt Date: 02-JUL-2025 The reporter called to ask about the specific timeframe for a valid dose of Shingrix, since a patient was administered with the adjuvant alone, which led to inappropriate preparation of medication and inappropriate dose of vaccine administered. Vaccination date and patient demographics were obtained in this call.  No vaccine detail was obtained from the Registered Nurse. No further information was obtained in this call.  The reporter consented to follow up.  The Vaccine Administration Facility was the same as Primary Reporter.
Sex: F
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: Shingrix late second dose/now wants to receive the second 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 elderly female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (04-JUN-2024, 1st dose was received).   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: Shingrix late second dose/now wants to receive the second dose). The outcome of the incomplete course of vaccination was not applicable.   Additional Information: GSK Receipt Date: 02-JUL-2025 A Health Care Provider wanted to know how to proceed after a patient received the first dose of Shingrix and now wanted to receive the second dose. The Vaccine Administration Facility is the same as Primary Reporter. No lot number nor expiration date known of the first Shingrix dose. Till the time of reporting the patients did not receive the second dose of Shingrix, which led to incomplete course of vaccination. VAERS details provided corresponding to the 1st dose and the case is an incomplete course of vaccination.
Vaccine: HEP
Symptoms: Product storage error
Clinical narrative: Vaccine stored outside recommended conditions and administered to patient; This non-serious case was reported by a other health professional via call center representative and described the occurrence of incorrect storage of drug in a patient who received HBV (Engerix B) (batch number 42B22, expiry date 07-MAR-2026) for prophylaxis.   In JUN-2025, the patient received Engerix B. On an unknown date, an unknown time after receiving Engerix B, the patient experienced incorrect storage of drug (Verbatim: Vaccine stored outside recommended conditions and administered to patient). The outcome of the incorrect storage of drug 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: 03-JUL-2025 The pharmacy technician reported that they have the Hep B vaccine in his/her refrigerator, Engerix B, and they going to need some information about temperature it went out of range for 5 minutes. And then, his/her county needs information about its use.  The reporter would tell you right now that it had already been used. The reporter did not have the patient's information and said that the administration might have administered the same day of the excursion (26-JUN-2025) or probably 2 days after that. The Engerix B vaccine stored outside recommended conditions and administered to patient, which led to an incorrect storage of drug.
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Cardiac failure
Clinical narrative: he went into heart failure; diagnosed with COVID; This spontaneous case was reported by a consumer and describes the occurrence of CARDIAC FAILURE (he went into heart failure) in a male patient of an unknown age who received SPIKEVAX NOS (SPIKEVAX NOS) for COVID-19 prophylaxis. The occurrence of additional non-serious events is detailed below.     Family history included Heart rate low (slow heart rate, mother died from heart failure).    On an unknown date, the patient received dose of SPIKEVAX NOS (SPIKEVAX NOS) (unknown route) 1 dosage form. In December 2024, the patient experienced COVID-19 (diagnosed with COVID). On an unknown date, the patient experienced CARDIAC FAILURE (he went into heart failure) (seriousness criteria death and medically significant). The patient died on an unknown date. The reported cause of death was he went into heart failure. It is unknown if an autopsy was performed. At the time of death, COVID-19 (diagnosed with COVID) had resolved.            No concomitant medications provided by the reporter. Patient went to attend a family wedding on Dec-2024 and patient was fully vaccinated. He had been diagnosed with COVID after the wedding. That was because some person came to the wedding that apparently was not vaccinated and COVID was spread it to everyone. There were over 100 people at that wedding. Every single person at that wedding got COVID. Reporter had no information if other attendees were vaccinated or with what vaccine. It was reported that patient had all the vaccines that recommended for COVID but despite that patient got very, very sick and he was on a very extensive antibiotic as treatment medication to get over that COVID infection. Patient was recovered with an antibiotic treatment when he did get COVID. Patient had died from heart failure. Before that patient was taken to surgery to do a pacemaker, but he did not want it. It was reported that the reason he passed away was he refused to have the pacemaker. It was also reported that patient had a genetic propensity for a slow heart rate and death was not related with COVID.   This case was linked to US-MODERNATX, INC.-MOD-2025-787904 (E2B Linked Report).; Reporter's Comments: Family history is a risk factor for the event. The benefit-risk relationship of product is not affected by this report.; Sender's Comments:  US-MODERNATX, INC.-MOD-2025-787904:Patient 2 (Brother's case); Reported Cause(s) of Death: he went into heart failure
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Binocular visual dysfunction, Visual impairment
Clinical narrative: Weird vision changes about 12 hours after vaccine administered/interference along with twinkling lights shaped like a right angle on left side of vision sphere; Margining vision; This spontaneous case was reported by a consumer and describes the occurrence of VISUAL IMPAIRMENT (Weird vision changes about 12 hours after vaccine administered/interference along with twinkling lights shaped like a right angle on left side of vision sphere) and BINOCULAR VISUAL DYSFUNCTION (Margining vision) in a 64-year-old female patient who received mRNA-1273.712 (SPIKEVAX 2024-2025 PFS) (batch no. 3046732) for COVID-19 prophylaxis.     No Medical History information was reported.    On 23-Jun-2025, the patient received dose of mRNA-1273.712 (SPIKEVAX 2024-2025 PFS) (Intramuscular use) 1 dosage form. On 23-Jun-2025, the patient experienced VISUAL IMPAIRMENT (Weird vision changes about 12 hours after vaccine administered/interference along with twinkling lights shaped like a right angle on left side of vision sphere) and BINOCULAR VISUAL DYSFUNCTION (Margining vision). In 2025, BINOCULAR VISUAL DYSFUNCTION (Margining vision) had resolved. On 23-Jun-2025, VISUAL IMPAIRMENT (Weird vision changes about 12 hours after vaccine administered/interference along with twinkling lights shaped like a right angle on left side of vision sphere) had resolved.            No concomitant medication was reported. Patient had weird vision changes about 12 hours after vaccine administered. Patient had margining vision and interference along with twinkling lights shaped like a right angle on left side of vision sphere. It was unknown if the patient experienced any additional symptoms/events.  Patient went to emergency room, and they did a CT scan of head and neck, result was unknown. No treatment medication was reported. Reporter causality was not provided.
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Heart rate, Heart rate decreased
Clinical narrative: Heart rate is very low; This spontaneous case was reported by a consumer and describes the occurrence of HEART RATE DECREASED (Heart rate is very low) in a 71-year-old female patient who received mRNA-1273.712 (SPIKEVAX 2024-2025 PFS) for COVID-19 prophylaxis.     Previously administered products included for COVID-19 prophylaxis: Spikevax NOS in 2024. Past adverse reactions to the above products included No adverse effect with Spikevax NOS. Family history included Heart failure (Mother died from heart failure) and Heart rate low (genetic propensity for a slow heart rate) since an unknown date.    In June 2025, the patient received dose of mRNA-1273.712 (SPIKEVAX 2024-2025 PFS) (Intramuscular use) 1 dosage form. In June 2025, the patient experienced HEART RATE DECREASED (Heart rate is very low). At the time of the report, HEART RATE DECREASED (Heart rate is very low) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In June 2025, Heart rate: Heart rate was very low.         Concomitant medication use information was not provided by reporter.  In September 2025, the patient's age would be 72. The patient received Spikevax two weeks ago in June 2025 and last year in 2024. All previous doses of COVID-19 vaccine were Moderna.  It was reported that there was a genetic propensity for a slow heart rate. That's all, it was not related to COVID.  It was unknown if the patient experienced any additional symptoms/events.    Treatment medication use information was not provided by reporter.   This case was linked to US-MODERNATX, INC.-MOD-2025-787905 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2025-787905:Patient 2 (Brother's case)
Sex: F
Vaccine: COVID19
Symptoms: Anaphylactic reaction, Confusional state
Clinical narrative: Full anaphylaxis; mental fog; This is a spontaneous report received from a Consumer or other non HCP from a sales representative.  An adult female patient (unknown if pregnant) received BNT162b2 omicron (kp.2) (COMIRNATY (2024-2025 FORMULA)), as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Known allergies: Yes, many" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: ANAPHYLACTIC REACTION (disability, life threatening, medically significant), outcome "unknown", described as "Full anaphylaxis"; CONFUSIONAL STATE (disability, life threatening), outcome "unknown", described as "mental fog". Therapeutic measures were taken as a result of anaphylactic reaction, confusional state.
Age: 68.0
Sex: F
Vaccine: PNC20
Symptoms: Cellulitis, Injection site pain, Red blood cell count decreased, White blood cell count increased
Clinical narrative: Cellulitis in the elbow; Severe pain upon administration of Prevnar 20; White blood cell count was high; Red blood cell count was low; This is a spontaneous report received from a Nurse.  A 68-year-old female patient received pneumococcal 20-val conj vac (dipht CRM197 protein) (PREVNAR 20), on 26Jun2025 as dose number unknown, single (Lot number: LN4930, Expiration Date: 01Jul2026) at the age of 68 years intramuscular, in left deltoid for immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: RED BLOOD CELL COUNT DECREASED (non-serious) with onset 01Jul2025, outcome "unknown", described as "Red blood cell count was low"; WHITE BLOOD CELL COUNT INCREASED (non-serious) with onset 01Jul2025, outcome "unknown", described as "White blood cell count was high"; CELLULITIS (non-serious), outcome "unknown", described as "Cellulitis in the elbow"; VACCINATION SITE PAIN (non-serious), outcome "unknown", described as "Severe pain upon administration of Prevnar 20". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were taken as a result of cellulitis, white blood cell count increased, red blood cell count decreased, vaccination site pain.  Additional information: It was reported that the patient had a complaint of severe pain upon administration of Prevnar 20. The patient had seen the doctor for cellulitis and cellulitis in the elbow. The patient had been assessed by the doctor. The patient had blood work done yesterday (01Jul2025) but it was in the hospital. Her white blood cell count was high and red blood cell count was low. The reporter stated, treatment: "yes, she went to the emergency room." causality: "yes."
Vaccine: PNC20
Symptoms: Respiratory symptom
Clinical narrative: upper respiratory symptoms; This is a spontaneous report received from a Nurse.  A patient (age and gender not provided) received pneumococcal 20-val conj vac (dipht CRM197 protein) (PREVNAR 20), in Jun2025 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: RESPIRATORY SYMPTOM (non-serious) with onset Jun2025, outcome "unknown", described as "upper respiratory symptoms". Therapeutic measures were taken as a result of respiratory symptom.  Additional information: Clarified the potential adverse event is that reporter said a patient received Prevnar 20 on a Monday, on Wednesday patient had called and said patient was having some sort of upper respiratory symptoms. Reporter believes it was seasonal allergies and reporter recommended that patient take antihistamines, and that is the last reporter heard of it. Caller believes it would have been last week when this all occurred. Caller unknown if the upper respiratory symptoms are ongoing.No dates were provided to caller by reporter. Caller believes it would have been last week when this all occurred. Caller unknown if the upper respiratory symptoms are ongoing.  The information on the batch/lot number for pneumococcal 20-val conj vac (dipht CRM197 protein) will be requested and submitted if and when received.
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: This is the fifth time the patient has had COVID; This is the fifth time the patient has had COVID; This is a spontaneous report received from a Consumer or other non HCP.  A 73-year-old female patient received BNT162b2 (BNT162B2 NOS), as dose number unknown (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) included: FLU [INFLUENZA VACCINE] taken for immunisation. Vaccination history included: Bnt162b2 (Primary Immunization completed), for Covid-19 Immunization. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "This is the fifth time the patient has had COVID". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive. Therapeutic measures were taken as a result of drug ineffective, covid-19. Clinical course: The patient did not feel well and could not sleep at night. Her nose was too stuffy, so she did not sleep that night. The next day she went on with her day and then that night she kept thinking if this is a cold or allergies. She took some more drugs so she could sleep better. The second morning she woke up, she wondered if it's Covid. She did a Covid test at home, and it turned out to be Covid. She then called her doctor first thing in the morning and asked for prescription for Paxlovid, she took the Paxlovid. This is the fifth time the patient has had COVID.   Batch/lot number is not provided, and it cannot be obtained.  The information on the batch/lot number for [BNT162B2] will be requested and submitted if and when received.
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Transient ischaemic attack
Clinical narrative: TIA; This is a spontaneous report received from a Consumer or other non HCP.  A 71-year-old female patient received BNT162b2 (BNT162B2), on 11Dec2021 as dose 1, single (Lot number: FH8028) at the age of 71 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Diabetic", start date: 2006 (ongoing), notes: diagnosed around 2006 or somewhere around there; "Hypertension" (ongoing). There were no concomitant medications. The following information was reported: TRANSIENT ISCHAEMIC ATTACK (hospitalization) with onset 11Dec2021, outcome "unknown", described as "TIA". The patient was hospitalized for transient ischaemic attack (start date: 12Dec2021, discharge date: 13Dec2021, hospitalization duration: 2 day(s)). The event "tia" required emergency room visit. Therapeutic measures were not taken as a result of transient ischaemic attack. Clinical course: The vaccine was administered in a Pharmacy/drug store and not at a military facility. The patient did not receive any other vaccines on the same date and as the Pfizer vaccine nor within 4 weeks prior to the first administration. The patient had was a TIA, confirmed to be a transient ischemic attack.
Vaccine: VARZOS
Symptoms: Influenza like illness
Clinical narrative: felt like the flu aches; Pains; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of flu-like aching in a patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, less than a day after receiving Shingrix, the patient experienced flu-like aching (Verbatim: felt like the flu aches) and pain (Verbatim: Pains). The outcome of the flu-like aching and pain were resolved (duration 1 day).   It was unknown if the reporter considered the flu-like aching and pain to be related to Shingrix.     It was unknown if the company considered the flu-like aching and pain to be related to Shingrix.   Additional Information: GSK Receipt Date: 27-JUN-2025 This case was reported by a patient via interactive digital media. The patient only had symptoms the night of the 1st injection. It felt like the flu's aches and pains. Still better than full blown shingles. The next day patient was fine.
Sex: F
Vaccine: PNC20, TDAP
Symptoms: Urticaria
Clinical narrative: She got urticaria, hives, all over her body come and go and she's had them on and off; This is a spontaneous report received from a Nurse.  A 52-year-old female patient received pneumococcal 20-val conj vac (dipht CRM197 protein) (PREVNAR 20), on 04Feb2025 as dose number unknown, 0.5ml single (Batch/Lot number: unknown) for immunisation; diphtheria vaccine toxoid, pertussis vaccine acellular, tetanus vaccine toxoid (TDAP), on 04Feb2025 as dose number unknown, single) for immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) included: LISINOPRIL. Vaccination history included: Tdap (Unknown dose number, unknown manufacturer), for immunization. The following information was reported: URTICARIA (non-serious) with onset 05Feb2025, outcome "not recovered", described as "She got urticaria, hives, all over her body come and go and she's had them on and off". The information on the batch/lot number for pneumococcal 20-val conj vac (dipht CRM197 protein) will be requested and submitted if and when received.  Additional information: When probed about the side-effects, Pfizer Employee stated, patient got urticaria, hives, all over her body come and go and she's had them on and off since she got the vaccine on February 4th, 2025. Dose, route of administration, indication and anatomical location: Pfizer Employee stated, "The indication is for 50 and older. She received the dose that she should have got was 0.5 milliliters and she got it in her arm, but Pfizer employee do not know if it was her left arm or right arm. So, she got it in her deltoid muscle. Other medications and medical conditions: Pfizer Employee stated, "The only other medication she was taking was Lisinopril and the same day she got the Prevnar shot, she got it Tdap in the other arm. She was taking Lisinopril, the only medication she takes. The representative was trying to share that it was the same day she got Prevnar 20, she also received a Tdap (Hence suspect captured as Tdap), it is a vaccine for Tetanus diphtheria and pertussis. It is called Tdap, she received it on the same day in different arm. Product details for Tdap (LOT#, Expiration date, NDC# and UPC#): Pfizer Employee stated, patient did not give him any of that. She said she received a Tdap in the past by itself and never had a problem, that is what patient told Pfizer representative. Causality: Pfizer Employee stated, "Yes, she does and in end June, July and she still sees her, and hives come and go. She said she never got rid of them. She said they are all over the body, they come and go.Date of adverse event: Pfizer Employee stated, patient said with in 24 hours. So, patient would say February 5th, 2025. Still experiencing: Pfizer Employee stated, "Yes, she is, it comes and go." Treatment: Pfizer Employee stated, "I do not find out." Lab work: Pfizer Employee stated, "No, I do not know anything.
Age: 57.0
Sex: M
Vaccine: PNC20
Symptoms: Arthralgia, Cellulitis, Injection site pain
Clinical narrative: Cellulitis in the elbow; Shoulder pain; Severe pain upon administration of Prevnar 20; This is a spontaneous report received from a Nurse.  A 57-year-old male patient received pneumococcal 20-val conj vac (dipht CRM197 protein) (PREVNAR 20), on 30Jun2025 as dose number unknown, single (Lot number: LN4930, Expiration Date: 30Jul2026) at the age of 57 years intramuscular, in left deltoid for immunisation. The patient's relevant medical history included: "Hypertension" (unspecified if ongoing), notes: Hypertension; "Diabetes" (unspecified if ongoing), notes: Diabetes. The patient's concomitant medications were not reported. The following information was reported: CELLULITIS (non-serious) with onset 2025, outcome "unknown", described as "Cellulitis in the elbow"; VACCINATION SITE PAIN (non-serious) with onset 2025, outcome "unknown", described as "Severe pain upon administration of Prevnar 20"; ARTHRALGIA (non-serious) with onset 2025, outcome "unknown", described as "Shoulder pain". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were taken as a result of arthralgia, vaccination site pain.  Additional information: Reporter stated they have had a patient complaint of severe pain upon administration of Prevnar 20. The patient visited the doctor for cellulitis/cellulitis in the elbow. That was assessed by the doctor. The patient was suffering from hypertension and diabetes like medical conditions. Reporter not preferred to reveal the details of medication for hypertension and diabetes. Reporter stated, lab work (past 2 weeks): patient did the blood work, the same day of the visit and the result was everything normal. Reporter stated, the patient called yesterday (01Jul2025) and the doctor told, he did take Tylenol and the doctor recommended he take over the counter Ibuprofen or Tylenol, to help the shoulder pain. Causality: Reporter stated, the doctor's confirm, he does not want to give any more vaccines.
Sex: F
Vaccine: COVID19
Symptoms: Thrombosis, Urticaria
Clinical narrative: Blood clot; Hives; This is a spontaneous report received from an Other HCP from a sales representative.  An adult female patient (not pregnant) received BNT162b2 (BNT162B2), on 23Jun2021 as dose number unknown, single (Lot number: EW2017) for covid-19 immunisation. The patient's relevant medical history was not reported. The patient took concomitant medications. The following information was reported: THROMBOSIS (hospitalization) with onset 01Jul2021, outcome "recovered", described as "Blood clot"; URTICARIA (hospitalization) with onset 01Jul2021, outcome "recovered", described as "Hives". The patient was hospitalized for thrombosis, urticaria (start date: 01Jul2021, hospitalization duration: 1 day(s)). Therapeutic measures were taken as a result of thrombosis, urticaria and included treatment with apixaban (ELIQUIS).; Sender's Comments: There is not a reasonable possibility that the reported events blood clot and urticaria were related to the suspect product event most likely due to patient underlying contributory factors. 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: Allergy to vaccine
Clinical narrative: had serious reactions for the last few years and has allergies; This is a spontaneous report received from a Consumer or other non HCP, Program ID.  A female patient received BNT162b2 (BNT162B2), as dose number unknown, single (Lot number: 33030BD) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: ALLERGY TO VACCINE (non-serious), outcome "unknown", described as "had serious reactions for the last few years and has allergies". Additional information: patient was asking to get the list of ingredients for Pfizer Covid vaccine with lot number 33030BD because she had serious reactions for the last few years and has allergies.