chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 16.0
Sex: F
Vaccine: MEN, MENB
Symptoms: Dehydration, Dyskinesia, Nausea, Peripheral coldness
Clinical narrative: Nausea; she presented cold toes; body jerking; presented dehydration; This non-serious case was reported by a physician via call center representative and described the occurrence of nausea in a 16-year-old female patient who received Men B NVS (Bexsero) (batch number DD72H, expiry date 30-NOV-2027) for prophylaxis.   Co-suspect products included MENINGOCOCCAL VACCINE A/C/Y/W CONJ (TET TOX) (MENQUADFI) for prophylaxis.   On 05-MAR-2025, the patient received Bexsero and MENQUADFI. In MAR-2025, less than 2 weeks after receiving Bexsero, the patient experienced nausea (Verbatim: Nausea), cold feet (Verbatim: she presented cold toes), jerkiness (Verbatim: body jerking) and dehydration (Verbatim: presented dehydration). The patient was treated with diphenhydramine hydrochloride (Benadryl). The outcome of the nausea, cold feet, jerkiness and dehydration were unknown.   It was unknown if the reporter considered the nausea, cold feet, jerkiness and dehydration to be related to Bexsero and Bexsero Pre-Filled Syringe Device.     It was unknown if the company considered the nausea, cold feet, jerkiness and dehydration to be related to Bexsero and Bexsero Pre-Filled Syringe Device.   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: 13-MAR-2025 The Vaccine Administration Facility is the same as Primary Reporter A sales representative communicated on behalf of the health care provider in charge of the case to report an adverse event with Bexsero vaccine.  The doctor did not fully believed what patient was presenting, but the patient went to the Emergency Room and the situation was really dramatic The patient presented cold toes, body jerking, nausea and although she was with body jerking, she was able to talk and being normally. The father of the patient pulled over on the side of the road because the patient started presenting these symptoms and took her to the Emergency Room where, she received 2 doses of Benadryl and presented dehydration. The father of the patient was blaming the doctor for giving Bexsero and Menquadfi at the same time. The sales representative only wanted to the report the case and agent asked for a phone number to contact the health care provider and also asking if she was ok to being contacted, to which sales representative replied that would be great, providing her office phone number. Then, the agent called the health care provider and confirmed the information provided by the sales representative and gather the essential information to create the adverse event report.  The health care provider did not share any more symptoms. It was unknown if the reporter considered the adverse events to be related to Menquadfi.
Age: 15.0
Sex: M
Vaccine: HEP
Symptoms: Incorrect dose administered, Product administered to patient of inappropriate age
Clinical narrative: Maladministration of Adult Dose on an Pediatric Patient; Overdose; This non-serious case was reported by a other health professional via call center representative and described the occurrence of adult product administered to child in a 15-year-old male patient who received HBV (Engerix B adult) (batch number CT3Z7, expiry date 13-FEB-2027) for prophylaxis.   On 12-MAR-2025, the patient received the 3rd dose of Engerix B adult. On 12-MAR-2025, an unknown time after receiving Engerix B adult, the patient experienced adult product administered to child (Verbatim: Maladministration of Adult Dose on an Pediatric Patient) and overdose (Verbatim: Overdose). The outcome of the adult product administered to child and overdose were not applicable.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK Receipt Date: 14-MAR-2025 The patient came and was due to the Engerix-B third dose, and adult dose was given to the pediatric patient, which led adult product administered to child and overdose.  The reporter consented to follow up.
Sex: F
Vaccine: HEPAB
Symptoms: Incomplete course of vaccination
Clinical narrative: Patient did not not receive the second dose yet; 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 HAB (Twinrix) for prophylaxis.   Previously administered products included Twinrix (1st dose received on 14th September 2024).   On an unknown date, the patient did not receive the 2nd dose of Twinrix. On an unknown date, an unknown time after receiving Twinrix, the patient experienced incomplete course of vaccination (Verbatim: Patient did not not receive the second dose yet). 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: 14-MAR-2025 The pharmacist stated that a patient received their first dose of Twinrix on 14th September 2024 and they have not received their second dose yet. This was the first dose of a Hepatitis A or Hepatitis B vaccine so far for this patient.  Till the time of reporting, the patient did not receive 2nd dose of Twinrix, which led to incomplete course of vaccination.
Sex: M
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: minor side effects/minor soreness at the injection site; This spontaneous case was reported by a patient and describes the occurrence of VACCINATION SITE PAIN (minor side effects/minor soreness at the injection site) in a male patient of an unknown age who received SPIKEVAX NOS (SPIKEVAX NOS) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received dose of SPIKEVAX NOS (SPIKEVAX NOS) (unknown route) 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE PAIN (minor side effects/minor soreness at the injection site). At the time of the report, VACCINATION SITE PAIN (minor side effects/minor soreness at the injection site) outcome was unknown. Not Provided      The action taken with SPIKEVAX NOS (SPIKEVAX NOS) (Unknown) was unknown.       It was unknown if the patient experienced any additional symptoms or events. No concomitant medication was reported. No treatment medication was reported. Reporter causality was not reported.   This case was linked to US-MODERNATX, INC.-MOD-2025-783390 (E2B Linked Report).   Reporter did not allow further contact; Sender's Comments:  US-MODERNATX, INC.-MOD-2025-783390:Same patient but different product
Sex: M
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: minor side effects/minor soreness at the injection site; This spontaneous case was reported by a patient and describes the occurrence of VACCINATION SITE PAIN (minor side effects/minor soreness at the injection site) in a male patient of an unknown age who received mRNA-1273.712 (SPIKEVAX 2024-2025 PFS) for COVID-19 prophylaxis.     No Medical History information was reported.    In 2024, the patient received dose of mRNA-1273.712 (SPIKEVAX 2024-2025 PFS) (Intramuscular use) 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE PAIN (minor side effects/minor soreness at the injection site). At the time of the report, VACCINATION SITE PAIN (minor side effects/minor soreness at the injection site) had resolved.            The concomitant medication was not reported by reporter. Patient had all of the COVID vaccinations and all of the COVID vaccinations he had were Moderna vaccinations and he was satisfied with the outcome and the side effects. It was unknown if the patient experienced any additional symptoms/events. The treatment medication was not reported by reporter.   This case was linked to US-MODERNATX, INC.-MOD-2025-783399 (E2B Linked Report).   Reporter did not allow further contact; Sender's Comments:  US-MODERNATX, INC.-MOD-2025-783399:Same patient but different product
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Fatigue, Impaired work ability, Platelet count, Thrombocytosis
Clinical narrative: I developed thrombocytosis [high platelets] that has caused permanent injuries; chronic fatigue and weakness; persistent impaired vision; these conditions have severely impacted my daily life, overall well-being and my ability to work; chronic fatigue; This spontaneous case was reported by a patient and describes the occurrence of THROMBOCYTOSIS (I developed thrombocytosis [high platelets] that has caused permanent injuries), ASTHENIA (chronic fatigue and weakness), VISUAL IMPAIRMENT (persistent impaired vision), IMPAIRED WORK ABILITY (these conditions have severely impacted my daily life, overall well-being and my ability to work) and FATIGUE (chronic fatigue) in a 73-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 023m20A and 016B21A) for COVID-19 vaccination.     No Medical History information was reported.   On 26-Feb-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular use) dosage was changed to .5 milliliter. On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular use) .5 milliliter. On an unknown date, the patient experienced THROMBOCYTOSIS (I developed thrombocytosis [high platelets] that has caused permanent injuries), ASTHENIA (chronic fatigue and weakness), VISUAL IMPAIRMENT (persistent impaired vision), IMPAIRED WORK ABILITY (these conditions have severely impacted my daily life, overall well-being and my ability to work) and FATIGUE (chronic fatigue). At the time of the report, THROMBOCYTOSIS (I developed thrombocytosis [high platelets] that has caused permanent injuries), ASTHENIA (chronic fatigue and weakness), VISUAL IMPAIRMENT (persistent impaired vision), IMPAIRED WORK ABILITY (these conditions have severely impacted my daily life, overall well-being and my ability to work) and FATIGUE (chronic fatigue) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Platelet count: High (caused permanent injuries).         No concomitant medications were reported.  The patient had to take hydroxy urea for the rest of my life, that had side effects as well.
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Visual impairment
Clinical narrative: I developed thrombocytosis [high platelets] that has caused permanent injuries; chronic fatigue and weakness; persistent impaired vision; these conditions have severely impacted my daily life, overall well-being and my ability to work; chronic fatigue; This spontaneous case was reported by a patient and describes the occurrence of THROMBOCYTOSIS (I developed thrombocytosis [high platelets] that has caused permanent injuries), ASTHENIA (chronic fatigue and weakness), VISUAL IMPAIRMENT (persistent impaired vision), IMPAIRED WORK ABILITY (these conditions have severely impacted my daily life, overall well-being and my ability to work) and FATIGUE (chronic fatigue) in a 73-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 023m20A and 016B21A) for COVID-19 vaccination.     No Medical History information was reported.   On 26-Feb-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular use) dosage was changed to .5 milliliter. On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular use) .5 milliliter. On an unknown date, the patient experienced THROMBOCYTOSIS (I developed thrombocytosis [high platelets] that has caused permanent injuries), ASTHENIA (chronic fatigue and weakness), VISUAL IMPAIRMENT (persistent impaired vision), IMPAIRED WORK ABILITY (these conditions have severely impacted my daily life, overall well-being and my ability to work) and FATIGUE (chronic fatigue). At the time of the report, THROMBOCYTOSIS (I developed thrombocytosis [high platelets] that has caused permanent injuries), ASTHENIA (chronic fatigue and weakness), VISUAL IMPAIRMENT (persistent impaired vision), IMPAIRED WORK ABILITY (these conditions have severely impacted my daily life, overall well-being and my ability to work) and FATIGUE (chronic fatigue) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Platelet count: High (caused permanent injuries).         No concomitant medications were reported.  The patient had to take hydroxy urea for the rest of my life, that had side effects as well.
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Blood test, Brain fog, Cough, Fatigue
Clinical narrative: Got blood in his stools and his cough; Fatigue; Muscle pain; Joint pain; Cough; Brain fog; Sleep disturbance; sluggish; skin rashes, rashes on his face; Got Inflammation in his body; Got blood in his stools and his cough; This is a spontaneous report received from a Consumer or other non HCP.  A 44-year-old male patient received BNT162b2 (BNT162B2 NOS), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history was not reported. The patient took concomitant medications.  The following information was reported: HAEMATOCHEZIA (medically significant), HAEMOPTYSIS (non-serious), outcome "unknown" and all described as "Got blood in his stools and his cough"; FATIGUE (non-serious), outcome "unknown"; MYALGIA (non-serious), outcome "unknown", described as "Muscle pain"; ARTHRALGIA (non-serious), outcome "unknown", described as "Joint pain"; COUGH (non-serious), outcome "unknown"; BRAIN FOG (non-serious), outcome "unknown"; SLEEP DISORDER (non-serious), outcome "unknown", described as "Sleep disturbance"; SLUGGISHNESS (non-serious), outcome "unknown", described as "sluggish"; RASH (non-serious), outcome "unknown", described as "skin rashes, rashes on his face"; INFLAMMATION (non-serious), outcome "unknown", described as "Got Inflammation in his body". The events "got blood in his stools and his cough", "fatigue", "muscle pain", "joint pain", "cough", "brain fog", "sleep disturbance", "sluggish", "skin rashes, rashes on his face" and "got inflammation in his body" required physician office visit. Clinical course: the patient took the Pfizer Covid Vaccine and he got crazy side effects: It is fatigue, muscle and joint pain, cough, brain fog, sleep disturbance, he can't get worked out, he is feeling rest of the time, he is very sluggish, he has got blood in his stools and his cough, he has got skin rashes, rashes on his face, 'when he eats' he has got inflammation in his body.  Regarding the treatment for side effects, it was reported as yes, he has been to several doctors. Do not know which one per say exactly, but he has been to psychologist, he is going to blood specialist, he is seeing so many doctors, he is waiting for people being reviewed for almost over 3 years. It has been over 3 years and he is terrible. For the patient age, it was reported probably 44 or 45. Maybe 44, event start: probably around 44 years of age, so maybe 4 years before 20Mar2025. Concomitant medications or other medical conditions reported as several medications on daily basis, but do not know which ones. Treatment: He is taking medication now but he never used to have to take medication, like the way he is doing it now. The patient underwent the following laboratory tests and procedures: Blood test: Unknown results. Therapeutic measures were taken as a result of haematochezia, fatigue, myalgia, arthralgia, cough, brain fog, sleep disorder, sluggishness, rash, inflammation, haemoptysis. The information on the batch/lot number for BNT162b2 will be requested and submitted if and when received.
Sex: M
Vaccine: COVID19
Symptoms: Haematochezia, Haemoptysis, Inflammation, Myalgia, Rash
Clinical narrative: Got blood in his stools and his cough; Fatigue; Muscle pain; Joint pain; Cough; Brain fog; Sleep disturbance; sluggish; skin rashes, rashes on his face; Got Inflammation in his body; Got blood in his stools and his cough; This is a spontaneous report received from a Consumer or other non HCP.  A 44-year-old male patient received BNT162b2 (BNT162B2 NOS), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history was not reported. The patient took concomitant medications.  The following information was reported: HAEMATOCHEZIA (medically significant), HAEMOPTYSIS (non-serious), outcome "unknown" and all described as "Got blood in his stools and his cough"; FATIGUE (non-serious), outcome "unknown"; MYALGIA (non-serious), outcome "unknown", described as "Muscle pain"; ARTHRALGIA (non-serious), outcome "unknown", described as "Joint pain"; COUGH (non-serious), outcome "unknown"; BRAIN FOG (non-serious), outcome "unknown"; SLEEP DISORDER (non-serious), outcome "unknown", described as "Sleep disturbance"; SLUGGISHNESS (non-serious), outcome "unknown", described as "sluggish"; RASH (non-serious), outcome "unknown", described as "skin rashes, rashes on his face"; INFLAMMATION (non-serious), outcome "unknown", described as "Got Inflammation in his body". The events "got blood in his stools and his cough", "fatigue", "muscle pain", "joint pain", "cough", "brain fog", "sleep disturbance", "sluggish", "skin rashes, rashes on his face" and "got inflammation in his body" required physician office visit. Clinical course: the patient took the Pfizer Covid Vaccine and he got crazy side effects: It is fatigue, muscle and joint pain, cough, brain fog, sleep disturbance, he can't get worked out, he is feeling rest of the time, he is very sluggish, he has got blood in his stools and his cough, he has got skin rashes, rashes on his face, 'when he eats' he has got inflammation in his body.  Regarding the treatment for side effects, it was reported as yes, he has been to several doctors. Do not know which one per say exactly, but he has been to psychologist, he is going to blood specialist, he is seeing so many doctors, he is waiting for people being reviewed for almost over 3 years. It has been over 3 years and he is terrible. For the patient age, it was reported probably 44 or 45. Maybe 44, event start: probably around 44 years of age, so maybe 4 years before 20Mar2025. Concomitant medications or other medical conditions reported as several medications on daily basis, but do not know which ones. Treatment: He is taking medication now but he never used to have to take medication, like the way he is doing it now. The patient underwent the following laboratory tests and procedures: Blood test: Unknown results. Therapeutic measures were taken as a result of haematochezia, fatigue, myalgia, arthralgia, cough, brain fog, sleep disorder, sluggishness, rash, inflammation, haemoptysis. The information on the batch/lot number for BNT162b2 will be requested and submitted if and when received.
Sex: M
Vaccine: COVID19
Symptoms: Sleep disorder, Sluggishness
Clinical narrative: Got blood in his stools and his cough; Fatigue; Muscle pain; Joint pain; Cough; Brain fog; Sleep disturbance; sluggish; skin rashes, rashes on his face; Got Inflammation in his body; Got blood in his stools and his cough; This is a spontaneous report received from a Consumer or other non HCP.  A 44-year-old male patient received BNT162b2 (BNT162B2 NOS), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history was not reported. The patient took concomitant medications.  The following information was reported: HAEMATOCHEZIA (medically significant), HAEMOPTYSIS (non-serious), outcome "unknown" and all described as "Got blood in his stools and his cough"; FATIGUE (non-serious), outcome "unknown"; MYALGIA (non-serious), outcome "unknown", described as "Muscle pain"; ARTHRALGIA (non-serious), outcome "unknown", described as "Joint pain"; COUGH (non-serious), outcome "unknown"; BRAIN FOG (non-serious), outcome "unknown"; SLEEP DISORDER (non-serious), outcome "unknown", described as "Sleep disturbance"; SLUGGISHNESS (non-serious), outcome "unknown", described as "sluggish"; RASH (non-serious), outcome "unknown", described as "skin rashes, rashes on his face"; INFLAMMATION (non-serious), outcome "unknown", described as "Got Inflammation in his body". The events "got blood in his stools and his cough", "fatigue", "muscle pain", "joint pain", "cough", "brain fog", "sleep disturbance", "sluggish", "skin rashes, rashes on his face" and "got inflammation in his body" required physician office visit. Clinical course: the patient took the Pfizer Covid Vaccine and he got crazy side effects: It is fatigue, muscle and joint pain, cough, brain fog, sleep disturbance, he can't get worked out, he is feeling rest of the time, he is very sluggish, he has got blood in his stools and his cough, he has got skin rashes, rashes on his face, 'when he eats' he has got inflammation in his body.  Regarding the treatment for side effects, it was reported as yes, he has been to several doctors. Do not know which one per say exactly, but he has been to psychologist, he is going to blood specialist, he is seeing so many doctors, he is waiting for people being reviewed for almost over 3 years. It has been over 3 years and he is terrible. For the patient age, it was reported probably 44 or 45. Maybe 44, event start: probably around 44 years of age, so maybe 4 years before 20Mar2025. Concomitant medications or other medical conditions reported as several medications on daily basis, but do not know which ones. Treatment: He is taking medication now but he never used to have to take medication, like the way he is doing it now. The patient underwent the following laboratory tests and procedures: Blood test: Unknown results. Therapeutic measures were taken as a result of haematochezia, fatigue, myalgia, arthralgia, cough, brain fog, sleep disorder, sluggishness, rash, inflammation, haemoptysis. The information on the batch/lot number for BNT162b2 will be requested and submitted if and when received.
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Disease recurrence, Drug ineffective, SARS-CoV-2 test
Clinical narrative: Covid/had it again; COVID; COVID; This is a spontaneous report received from a Consumer or other non HCP, Program ID.  An 83-year-old male patient received BNT162b2 (BNT162B2 NOS), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 2022, outcome "recovering" and all described as "COVID"; DISEASE RECURRENCE (medically significant) with onset 21Feb2024, outcome "not recovered", described as "Covid/had it again". The event "covid/had it again" required physician office visit. The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (21Feb2024) positive. Clinical course: During an inbound call the caller stated "Last night (21Feb2024) I went to the doctor, I had got COVID I tested positive yesterday went to the doctor last night told them I had used the Paxlovid about 2 years ago when I had umm, and I had gotten the shots the COVID shots first, second and the booster but that was prior that's going back to 2019 and 2020 whenever they did the shots but then I still got the COVID and I had the used the Paxlovid it helped me get out of the symptoms" So just yesterday I found out I had it again" Later during the call, the caller was asked if they had previously taken Paxlovid and the caller replied "Yes it was about 2 year I want to say it was 2 years ago last fall I was up in (Withheld) I know it wasn't this past fall probably the October prior to that. "2022" "It could've been 22, 21 or 22".  The information on the batch/lot number for BNT162B2 will be requested and submitted if and when received.
Age: 1.25
Sex: F
Vaccine: DTAPIPVHIB
Symptoms: No adverse event, Product preparation issue
Clinical narrative: administered pentacel to a patient yesterday but only the dtap-ipv component was given. the hib component was not reconstituted with no reported ae; Initial information received on 11-Mar-2025 regarding an unsolicited valid  non-serious case received from a other health professional.  This case involves a 15 months old female patient who was administered Diphtheria/tetanus/5 hybrid AC pertussis/IPV(VERO)/HIB(PRP/T) vaccine [Pentacel (VERO)] but only the DTAP-IPV component was given the HIB component was not reconstituted with no reported AE (adverse event).  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided Concomitant medications included Pneumococcal vaccine for Immunisation.  On 10-Mar-2025, the patient received a 0.5ml dose which was of suspect Diphtheria/tetanus/5 hybrid AC pertussis/IPV(VERO)/HIB(PRP/T) vaccine Powder and suspension for suspension for injection standard strength (frequency-once) (lot UK040AA) (expiry date-31-Jul-2025) intramuscular route in the left thigh for immunization and only the dtap-ipv component was given. the hib component was not reconstituted with no reported AE (single component of a two-component product administered) (latency-same day).  Reportedly- It was supposed to be a final series  Action taken was not applicable.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Age: 77.0
Sex: F
Vaccine: PNC21
Symptoms: Injection site bruising, Injection site pain
Clinical narrative: 02/27/2025 at her pharmacy. The caller stated that she noticed a bruise forming underneath the bandage. The next day on 02/28/2025, she removed the bandage and there was a large bruise at the injection site.; On 03/04/2025, the caller took a photo of her arm and stated that the bruise was still "huge" and tender.; This spontaneous report was received from a patient reporting on herself as a 77-year-old female patient.   Her medical history, concurrent conditions and drug reactions/allergies were not reported. Concomitant medications included Xarelto (Rivaroxaban.)  On 27-Feb-2025, at her pharmacy, the patient was vaccinated with Pneumococcal 21-valent Conjugate Vaccine solution for injection (CAPVAXIVE) 1 dosage form (dosage regimen, anatomical location, route of administration, lot # and expiration date were not reported) administered as prophylaxis.  On the same date, the patient noticed a bruise forming underneath the bandage (vaccination site bruising). The next day on 28-FEB-2025, she removed the bandage and there was a large bruise at the injection site. On unspecified date in 2025, she experienced vaccination site pain. On 04-MAR-2025, she took a photo of her arm and stated that the bruise was still "huge" and tender. On 11-MAR-2025, (also reported as "yesterday"), she stated that she went back to the pharmacy to show the pharmacist. It was also stated that she read that this was only supposed to last for a few days, but it had been 2 weeks at that point. She had not spoken to her health care professional (HCP) about this. No further details provided.  She had not recovered from the events, as at the reporting time (reported as "today"), her arm was still very bruised and tender at the injection site.   The reporter considered vaccination site bruising and vaccination site pain to be related to Pneumococcal 21-valent Conjugate Vaccine (CAPVAXIVE), considering that she had had many vaccines before including a flu shot about a month ago, and she had never had this reaction before and believed that she was having a reaction to Pneumococcal 21-valent Conjugate Vaccine (CAPVAXIVE) vaccine itself.  Lot # is being requested and will be submitted if received.
Sex: F
Vaccine: PNC21
Symptoms: Pyrexia, Rash pruritic, Urticaria
Clinical narrative: fever; itchy rash; welts; This spontaneous report was received from a health professional referring to a 56-year-old female patient. The patient's medical history, concurrent conditions and concomitant therapies were not reported.   On 14-Mar-2025, the patient was vaccinated with Pneumococcal 21-valent Conjugate Vaccine (CAPVAXIVE) for prophylaxis, lot number Y013009, which has been verified to be valid, expiration date reported and validated as 17-NOV-2025. (formulation, strength, dose, scheme, route of administration and anatomical location not provided).  On the same date the patient developed itchy rash that was hot to touch, welts and fever. The reporter stated that the fever was currently resolved, but the patient was still experiencing the rash and itchiness.   The causal relationship between the events and the suspect vaccine was unknown.
Vaccine: VARZOS
Symptoms: Therapeutic response unexpected
Clinical narrative: this was above 90 percent accuracy /they have not had a recurrence of shingles; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of unexpected therapeutic effect in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   The patient's past medical history included pain (the pain was still just as bad). Previously administered products included Shingles vaccine with an associated reaction of herpes zoster (got shingles 7 months after getting the first Shingles shot).   On an unknown date, the patient received Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine, the patient experienced unexpected therapeutic effect (Verbatim: this was above 90 percent accuracy /they have not had a recurrence of shingles). The outcome of the unexpected therapeutic effect was not applicable.   Additional Information: GSK Receipt Date: 16-MAR-2025 This case was reported by a patient via interactive digital media. The got shingles 7 months after getting the first Shingles shot, it was not as bad as far as breaking out, but the pain was still just as bad.  In 2017, the patient received a second set of the new shingles vaccine.  The pharmacist informed the patient that this vaccine had over 90 percent accuracy.  The patient confirmed that the pharmacist was right, and 8 years later, they have not had a recurrence of shingles.
Vaccine: PNC20
Symptoms: Device connection issue
Clinical narrative: the whole top section of the luer lock broke off the syringe; This is a spontaneous report received from an Other HCP from product quality group.  A patient (age and gender not provided) received pneumococcal 20-valent conjugate vaccine (diphtheria CRM197 protein) (PREVNAR 20), as dose number unknown, single (Lot number: LC5484, Expiration Date: 31Jan2026) for immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: SYRINGE ISSUE (non-serious), outcome "unknown", described as "the whole top section of the luer lock broke off the syringe".  Additional information: The reporter said that while opening a box, a medical assistant grabbed a dose, and the whole top section of the luer lock has broken off the syringe. The reporter mentioned that this is not her first rodeo with this issue. The luer lock breaking off the syringe has occurred with other pneumococcal 20-valent conjugate vaccine (diphtheria CRM197 protein) (PREVNAR 20) vaccines. No patients were involved with any of the PREVNAR 20 vaccines that had this issue.  Causality for "the whole top section of the luer lock broke off the syringe" was determined associated to device constituent of pneumococcal 20-valent conjugate vaccine (diphtheria CRM197 protein) (malfunction).; Sender's Comments: Linked Report(s) : US-PFIZER INC-202400237868 same reporter/product/PC, different lots;US-PFIZER INC-202400266262 same reporter/product/PC, different lots;US-PFIZER INC-202400272234 same reporter/product/PC, different lots;
Sex: F
Vaccine: RSV
Symptoms: Foetal exposure during pregnancy, Respiratory syncytial virus infection
Clinical narrative: the baby was diagnosed with RSV when she was 9 months old; the baby was diagnosed with RSV when she was 9 months old; This is a spontaneous report received from a Pharmacist.  A 9-month-old female patient received rsv vaccine prot.subunit pref 2v (ABRYSVO), in 2023 as dose number unknown, single (Batch/Lot number: unknown) other for maternal immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: RESPIRATORY SYNCYTIAL VIRUS INFECTION (medically significant), DRUG INEFFECTIVE (medically significant), outcome "recovered" and all described as "the baby was diagnosed with RSV when she was 9 months old". It was unknown if therapeutic measures were taken as a result of respiratory syncytial virus infection, drug ineffective. The information on the batch/lot number for rsv vaccine prot.subunit pref 2v will be requested and submitted if and when received.; Sender's Comments: The 9-month-old infant received one dose of ABRYSVO for maternal immunization then was diagnosed with RSV; a lack of efficacy with the vaccine ABRYSVO therefore cannot be completely excluded.  The patient's predispositions such as young age and underlying conditions may also contribute to suboptimal response after vaccination.
Vaccine: COVID19
Symptoms: Chills, Headache, Insomnia
Clinical narrative: headaches; chills; insomnia; This is a spontaneous report received from a Consumer or other non HCP, Program ID.  A patient (age and gender not provided) received BNT162b2 (BNT162B2), in Apr2021 as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (DOSE 1, SINGLE; Lot number: unknown), administration date: Apr2021, for Covid-19 Immunization. The following information was reported: HEADACHE (non-serious), outcome "unknown", described as "headaches"; CHILLS (non-serious), outcome "unknown"; INSOMNIA (non-serious), outcome "unknown".  Additional information: The patient took 2 Covid vaccine shots in Apr2021 and it's been an absolute nightmare experience. The patient had side effects like  headaches, chills, insomnia & many other side effects. The patient wanted a settlement of some kind and $100,000 would be perfect.
Age: 85.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Vaccination failure
Clinical narrative: I have Covid; I have Covid; This is a spontaneous report received from a Consumer or other non HCP, Program ID.  An 85-year-old female patient received BNT162b2 omicron (kp.2) (COMIRNATY (2024-2025 FORMULA)), in Oct2024 as dose 1, single (Batch/Lot number: unknown) at the age of 85 years for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (Primary immunization completed.), for COVID-19 immunization; Bnt162b2 (DOSE NUMBER UNKNOWN (BOOSTER), SINGLE), for COVID-19 immunization; Comirnaty (2023-2024 formula) (DOSE 1, SINGLE), for COVID-19 immunization. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "I have Covid". Therapeutic measures were taken as a result of vaccination failure, covid-19. Patient has got all the patient has had all of the Pfizer COVID Vaccines. The last one  got was in October of this previous year. The information on the batch/lot number for BNT162b2 omicron (kp.2) will be requested and submitted if and when received.
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, COVID-19, Drug ineffective
Clinical narrative: Covid after Vaccine/3rd time with Covid; Covid after Vaccine/3rd time with Covid; This is a spontaneous report received from a Consumer or other non HCP, Program ID.  A 65-year-old female patient received BNT162b2 omicron (kp.2) (COMIRNATY (2024-2025 FORMULA)), as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "pre-diabetic" (unspecified if ongoing); "COVID" (unspecified if ongoing), notes: previous 2 times. The patient's concomitant medications were not reported. Vaccination history included: Fully vaccinated (Primary immunization completed, MANUFACTURER UNKNOWN), for COVID-19 immunization; Boostered (BOOSTER, MANUFACTURER UNKNOWN), for COVID-19 immunization. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "Covid after Vaccine/3rd time with Covid". The patient underwent the following laboratory tests and procedures: Body temperature: 103. Clinical course: During this inbound call for financial assistance, the caller stated she did have Covid, her temperature is 103, and her primary care doctor ordered it but it did not go through". The caller was then asked to confirm the reason for the call and that they were prescribed the medication and what the name was, and the caller stated "Paxlovid, and it was denied this is my 3rd time with Covid, and I think this time I'm the worst and I am fully vaccinated and boostered." The caller stated she didn't understand with Covid right now, even the test, they're telling her its not covered by the insurance any longer. Near the end of the call, the caller stated they denied the entire prescription. If she can't get it she won't get it, she'll just bear with it you know? The caller then stated her doctors approved her for Wegovy and, and with all the things she have medically they didn't cover it. She's not diabetic, she's pre-diabetic.   The information on the batch/lot number for BNT162b2 omicron (kp.2) will be requested and submitted if and when received.
Age: 11.0
Sex: M
Vaccine: MNQ
Symptoms: Burning sensation, Erythema, Immediate post-injection reaction, Mobility decreased, Pain
Clinical narrative: He had pain and burning right away. Red and hot to the touch skin plus swelling started soon after the vaccine and got so bad the next day he could not move his arm. We went to the doctor on day 2 (Saturday, March 15th) and Dr. said it was a histamine reaction.
Age: 11.0
Sex: M
Vaccine: MNQ
Symptoms: Skin warm, Swelling
Clinical narrative: He had pain and burning right away. Red and hot to the touch skin plus swelling started soon after the vaccine and got so bad the next day he could not move his arm. We went to the doctor on day 2 (Saturday, March 15th) and Dr. said it was a histamine reaction.
Age: 1.17
Sex: M
Vaccine: VARCEL
Symptoms: Herpes zoster, Varicella virus test positive
Clinical narrative: Patient developed shingles on 3/20/2025. He has required prolong hospitalization and IV acyclovir.  Pediatric ID consulted as well as Dermatology
Age: 3.0
Sex: F
Vaccine: DTPPVHBHPB, MMRV
Symptoms: Gait disturbance, Injection site erythema, Injection site swelling
Clinical narrative: Vaccinated on 3/17/2025 with Vaxelis and MMRV. Began feeling symptomatic on 3/18/2025 with redness, swelling, "bumpiness" at site and limping on left leg.  Symptomatic with fever on same day that broke on Wednesday 3/19/2025, but fever came back worse on Friday 3/21/2025. Went to Medical Center Walk-In Clinic and was prescribed antibiotics. Still symptomatic.
Age: 50.0
Sex: F
Vaccine: HEP, VARZOS
Symptoms: Axillary pain, Erythema, Pruritus
Clinical narrative: Redness, itchiness, and pain under armpit
Age: 78.0
Sex: F
Vaccine: PNC21
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Patient reports local reaction  including redness, swelling, and pain that started about 3 days after vaccination.  She said injection site became painful shortly after injection, but redness and swelling was delayed.  The redness and swelling did spread down from the injection site to the elbow.  She started applying ice to the area and hydrocortisone cream.  Condition is improving, but still present 6 days post vaccination.
Age: 19.0
Sex: F
Vaccine: FLU3, HEPAB, IPV, MMR, VARCEL
Symptoms: Dizziness, Pallor
Clinical narrative: Patient became very dizzy after administration and almost passed out. Patient looked paled. We had patient elevate legs and had patient smelled isopropyl alcohol pads. She came to and felt better after about 15 to 20 minuets.
Age: 56.0
Sex: F
Vaccine: FLU3
Symptoms: Extra dose administered
Clinical narrative: no symptoms or signs. Vaccine administration error only. Previous dose 10/02/2024
Age: 60.0
Sex: M
Vaccine: MMR
Symptoms: Measles
Clinical narrative: Breakthrough Measles for 10 days
Age: 41.0
Sex: F
Vaccine: COVID19
Symptoms: Mobility decreased, Periarthritis
Clinical narrative: Frozen shoulder, could not lift arm for over a day past a few inches; within a week could raise arm overhead. Al?s most a month later cannot fully extend or rotate without pain. Cannot bear weight when pulling overhead.
Age: 1.0
Sex: F
Vaccine: UNK, UNK, VARCEL
Symptoms: Blood test, Body temperature decreased, Chest X-ray abnormal, Crying, Influenza virus test negative
Clinical narrative: Patient had a runny nose and watery eyes with no cough. Runny nose seemed to be improving at the time of the vaccune on the 18th. Late night of the 19th and early morning hours of the 20th she began to cry and inconsolable for 3 hours. We took her to the clinic on thr 20th where her oxygen and temperature were both very low. She was taken to the ER and staying in the pediatric unit until the 23nd. She was found to have what they believed to be pneumonia. She was but on antibiotics and oxygen for several says in the hospital.  She was completely normal the night of 18th and all say on the 19th until she began to get fussy.
Age: 1.0
Sex: F
Vaccine: UNK, UNK, VARCEL
Symptoms: Irritability, Oxygen saturation decreased, Pneumonia, Respiratory syncytial virus test negative, SARS-CoV-2 test negative
Clinical narrative: Patient had a runny nose and watery eyes with no cough. Runny nose seemed to be improving at the time of the vaccune on the 18th. Late night of the 19th and early morning hours of the 20th she began to cry and inconsolable for 3 hours. We took her to the clinic on thr 20th where her oxygen and temperature were both very low. She was taken to the ER and staying in the pediatric unit until the 23nd. She was found to have what they believed to be pneumonia. She was but on antibiotics and oxygen for several says in the hospital.  She was completely normal the night of 18th and all say on the 19th until she began to get fussy.
Age: 1.0
Sex: F
Vaccine: UNK, UNK, VARCEL
Symptoms: Urine analysis
Clinical narrative: Patient had a runny nose and watery eyes with no cough. Runny nose seemed to be improving at the time of the vaccune on the 18th. Late night of the 19th and early morning hours of the 20th she began to cry and inconsolable for 3 hours. We took her to the clinic on thr 20th where her oxygen and temperature were both very low. She was taken to the ER and staying in the pediatric unit until the 23nd. She was found to have what they believed to be pneumonia. She was but on antibiotics and oxygen for several says in the hospital.  She was completely normal the night of 18th and all say on the 19th until she began to get fussy.
Age: 40.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Gait disturbance, Headache, Hypoaesthesia, Muscular weakness
Clinical narrative: Headaches, numbness on one side, fatigue, weak limbs, off balance gait
Age: 32.0
Sex: M
Vaccine: TDAP
Symptoms: Discomfort, Electrocardiogram abnormal, Palpitations, Sleep disorder, Ventricular extrasystoles
Clinical narrative: Approximately 90-120 minutes after receiving the vaccine, I began feeling heart palpitations - clusters of them. I had an idea about what they were, but never had them before so I wasn't completely sure. Beginning the day I received the vaccine, and still to this day, I get clusters of palpitations every day. Often multiple times throughout the day for anywhere between 5 mins to an hour. They are almost always guaranteed to occur during, and especially after, a stress response. As such, it seems catecholamine release induces them most often, but I still seem to get them even when at rest and not stressed and more commonly at night. They are HARD, I feel them in my chest and in the back of my throat. They are extremely uncomfortable and have prevented me from falling asleep some nights. While at work one evening, I was finally able to capture these events on an EKG and my suspicions were correct - they were Premature Ventricular Contractions. My EKG is otherwise unchanged compared to tracings before the palpitations started other than the PVCs. I've never had PVCs (at least that I've felt) before the vaccine, and now have had them every single day since getting it. Obviously I can't say with 100% certainty the Tdap vaccine caused them, but there's an extremely strong correlation because of the suspicious timing.
Age: 62.0
Sex: M
Vaccine: VARZOS
Symptoms: Chills, Migraine, Pain, Pyrexia
Clinical narrative: 103.6 Fever from 1:00 AM to 5:30 AM along with chills terrible body aches worst migrane ever. felt terrible next day that evening 101.3 Fever, migrane and body aches continued Thru day 3.
Age: 82.0
Sex: F
Vaccine: PNC20
Symptoms: Injection site erythema, Injection site induration, Injection site inflammation
Clinical narrative: I had a red inflammation from the site down to my elbow + halfway around my arm. It began to get hard in areas so I went to ER. They diagnosed possible cellulitis + put me on an antibiotic + prednisone. It continued to continue being red + inflamed until I finished antibiotic + prednisone
Age: 11.0
Sex: M
Vaccine: MNQ, TDAP
Symptoms: Injection site pruritus, Injection site swelling, Injection site warmth
Clinical narrative: 1 day post injection with erythema, swelling, pruritis  to injection site. Treated with benadryl and symptoms resolved within 2 days. No difficulty breathing or swallowing.
Age: 1.33
Sex: F
Vaccine: MMR, MMR
Symptoms: Expired product administered, No adverse event
Clinical narrative: No additional AEs/PQC reported.; Caller reported expired dose of MMR II was administered.  No other information provided.  No additional AEs/PQC reported.; This spontaneous report was received from a Nurse and refers to a 16-month-old female patient. The patient's medical history was not reported. The patient's concurrent conditions were not reported. Concomitant therapies were not reported.   On 07-Feb-2025, the patient started therapy with Measles, Mumps, and Rubella (Wistar RA 27-3) Virus Vaccine, Live (M-M-R II), (lot #X002058, expiration date: 19-Jan-2025) 0.5 mL, administered by Subcutaneous route (expired vaccine administered), as Prophylaxis. It was reported that the vaccine was administered by a healthcare professional according to the instruction leaflet. No adverse event reported. The reporter stated that they were looking to reach out the patient's family to have the patient went in 6 weeks for re-administration.
Vaccine: MMR
Symptoms: Expired product administered, No adverse event
Clinical narrative: Medical Assistant calling to report inadvertently administering an expired dose of MMRII to a patient.; no adverse event; This spontaneous report was received from a medical assistant and regarding a patient of unknown age and gender.   The patient's medical history was not reported. The patient's concurrent conditions were not reported. Concomitant therapies were not reported.   On 21-Feb-2025, the patient was inadvertently vaccinated with a dose of  Measles, Mumps, and Rubella (Wistar RA 27-3) Virus Vaccine, Live (M-M-R II) solution for injection (lot #X00178 is an invalid lot number for Measles, Mumps, and Rubella (Wistar RA 27-3) Virus Vaccine, Live) that was expired (expiration date: 02-Jan-2025) as prophylaxis along with sterile diluent (MERCK STERILE DILUENT), solution for injection (indication, expiration date, and lot # were not reported). Caller stated product did not undergo a temperature excursion and was supported per Post-Expiry Memo. No additional adverse events.