chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: DTAPIPV
Symptoms: Product administered to patient of inappropriate age, Wrong product administered
Clinical narrative: Kinrix instead of Pediarix administration; Kinrix under age administration; This non-serious case was reported by a nurse via call center representative and described the occurrence of wrong vaccine administered in a infant female patient who received DTPa-IPV (Kinrix) for prophylaxis.   On an unknown date, the patient received Kinrix. On an unknown date, an unknown time after receiving Kinrix, the patient experienced wrong vaccine administered (Verbatim: Kinrix instead of Pediarix administration) and inappropriate age at vaccine administration (Verbatim: Kinrix under age administration). The outcome of the wrong vaccine administered and inappropriate age at vaccine administration were unknown.   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: 24-JAN-2024 The nurse reported that from March 2023 to December 2023, 8 kids under 4 years received Kinrix instead of Pediarix. The patient received Kinrix instead of Pediarix, below than the recommended age limit, which led to wrong vaccine administered and inappropriate age at vaccine administration. No adverse reactions has been reported.  The reporter consented to follow up. This was 1 of the 8 cases, reported by the same reporter.; Sender's Comments:  US-GSK-US2024011346:Same reporter US-GSK-US2024011349:Same reporter US-GSK-US2024011355:Same reporter US-GSK-US2024011343:Same reporter US-GSK-US2024011352:Same reporter US-GSK-US2024011347:Same reporter US-GSK-US2024011353:Same reporter
Sex: M
Vaccine: DTAPIPV
Symptoms: Product administered to patient of inappropriate age, Wrong product administered
Clinical narrative: Kinrix under age administration; Kinrix instead of Pediarix administration; This non-serious case was reported by a nurse via call center representative and described the occurrence of inappropriate age at vaccine administration in a 9-month-old male patient who received DTPa-IPV (Kinrix) for prophylaxis.   On an unknown date, the patient received Kinrix. On an unknown date, an unknown time after receiving Kinrix, the patient experienced inappropriate age at vaccine administration (Verbatim: Kinrix under age administration) and wrong vaccine administered (Verbatim: Kinrix instead of Pediarix administration). The outcome of the inappropriate age at vaccine administration and wrong vaccine administered were unknown.   This report is made by RA without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: RA Receipt Date: 24-Jan-2024 The reporter reported that from March 2023 to December 2023, 8 patients under age 4 years received Kinrix vaccine instead of Pediarix, which led to wrong vaccine administered.  The reporter stated that no adverse reactions had been reported. The patient received Kinirix who was younger than the indicated age which led to inappropriate age at vaccine administration. The reporter consented to follow up. This case was 1 of 8 cases for the patient reported by same reporter.; Sender's Comments:  US-GSK-US2024011349:Diferent Patient US-GSK-US2024011329:Diferent Patient US-GSK-US2024011355:Diferent Patient US-GSK-US2024011353:Diferent Patient US-GSK-US2024011352:Diferent Patient US-GSK-US2024011347:Diferent Patient US-GSK-US2024011346:Diferent Patient
Sex: F
Vaccine: DTAPIPV
Symptoms: Product administered to patient of inappropriate age, Wrong product administered
Clinical narrative: Kinrix instead of Pediarix administration; Kinrix under age administration; This non-serious case was reported by a nurse via call center representative and described the occurrence of wrong vaccine administered in a infant female patient who received DTPa-IPV (Kinrix) for prophylaxis.   On an unknown date, the patient received Kinrix. On an unknown date, an unknown time after receiving Kinrix, the patient experienced wrong vaccine administered (Verbatim: Kinrix instead of Pediarix administration) and inappropriate age at vaccine administration (Verbatim: Kinrix under age administration). The outcome of the wrong vaccine administered and inappropriate age at vaccine administration were unknown.   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: 24-JAN-2024 The nurse reported that from March 2023 to December 2023, 8 kids under 4 years received Kinrix instead of Pediarix. The patient received Kinrix instead of Pediarix below than the recommended age limit, which led to wrong vaccine administered and inappropriate age at vaccine administration. No adverse reactions has been reported.  The reporter consented to follow up. This was 1 of the 8 cases, reported by the same reporter.; Sender's Comments:  US-GSK-US2024011355:Diferent Patient US-GSK-US2024011349:Diferent Patient US-GSK-US2024011343:Diferent Patient US-GSK-US2024011353:Diferent Patient US-GSK-US2024011352:Diferent Patient US-GSK-US2024011347:Diferent Patient US-GSK-US2024011329:Diferent Patient
Age: 66.0
Sex: F
Vaccine: RSV
Symptoms: Injection site erythema
Clinical narrative: redness at injection site, left arm, deltoid; This non-serious case was reported by a other health professional via call center representative and described the occurrence of injection site erythema in a 66-year-old female patient who received RSVPreF3 adjuvanted (Arexvy) (batch number L5C22, expiry date 18-AUG-2025) for prophylaxis.   On 23-JAN-2024, the patient received Arexvy (left deltoid). On 23-JAN-2024, less than a day after receiving Arexvy, the patient experienced injection site erythema (Verbatim: redness at injection site, left arm, deltoid). The outcome of the injection site erythema was unknown.   It was unknown if the reporter considered the injection site erythema to be related to Arexvy.     It was unknown if the company considered the injection site erythema to be related to Arexvy.   Additional Information: GSK Receipt Date: 25-JAN-2024 The pharmacy intern reported that the patient experienced redness at injection site on left arm, deltoid after received the Arexvy vaccine.  The patient was seeking medical attention. There was no additional information available. The reporter consented to follow up.
Sex: M
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site warmth
Clinical narrative: injection site warm to the touch; Red around injection site; This non-serious case was reported by a consumer via call center representative and described the occurrence of injection site warmth in a adult male patient who received Herpes zoster (Shingrix) for prophylaxis.   On 22-JAN-2024, the patient received the 2nd dose of Shingrix (intramuscular, left arm). In JAN-2024, an unknown time after receiving Shingrix, the patient experienced injection site warmth (Verbatim: injection site warm to the touch) and injection site erythema (Verbatim: Red around injection site). The outcome of the injection site warmth and injection site erythema were unknown.   It was unknown if the reporter considered the injection site warmth and injection site erythema to be related to Shingrix.     It was unknown if the company considered the injection site warmth and injection site erythema to be related to Shingrix.   Additional Information: GSK Receipt Date: 25-JAN-2024 The patient reported that he received his 2nd dose and when the band aid was removed, the patient noticed a red round patch at the injection site which was warm to the touch. The size was about 1 1/2 to 2 inches with a small section extending slightly downward. The reporter consented to follow up.
Sex: F
Vaccine: HEPA
Symptoms: Inappropriate schedule of product administration, Product prescribing error
Clinical narrative: Pharmacist calls today 1-25-2024 to report a patient received the first dose of Havrix in 11-14-2023 then after two months a second dose was administered as prescribed by patient´s physician; after two months a second dose was administered as prescribed by patient´s physician; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of drug dose administration interval too short in a 77-year-old female patient who received HAV (Havrix) (batch number T9TL9, expiry date 05-DEC-2025) for prophylaxis.   Concomitant products included Hepatitis a vaccine inact (Havrix).   On 14-NOV-2023, the patient received the 2nd dose of Havrix. On 14-NOV-2023, an unknown time after receiving Havrix, the patient experienced drug dose administration interval too short (Verbatim: Pharmacist calls today 1-25-2024 to report a patient received the first dose of Havrix in 11-14-2023 then after two months a second dose was administered as prescribed by patient´s physician) and drug prescribing error (Verbatim: after two months a second dose was administered as prescribed by patient´s physician). The outcome of the drug dose administration interval too short and drug prescribing error were unknown.   Additional Information: GSK Receipt Date: 25-JAN-2024 The patient was administered after two months a second dose of Havrix as prescribed by patient´s physician, which led to drug prescribing error. The reporter consented to follow up via email. The patient received 2nd dose of Havrix earlier than the recommended schedule, which led to shortening of vaccination schedule.
Sex: U
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: never received 2nd dose; This non-serious case was reported by a physician via call center representative and described the occurrence of incomplete course of vaccination in a patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st dose 3 years ago).   On an unknown date, the patient did not receive Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced incomplete course of vaccination (Verbatim: never received 2nd dose). The outcome of the incomplete course of vaccination was unknown.   Additional Information: GSK Receipt Date: 25-JAN-2024 The reporter stated that If a patient got the Shingrix shot about 3 years ago and never got the second shot can they get the second shot now or do they have to start all over again. Till the time of reporting, the patient did not receive 2nd dose of Shingrix, which led to incomplete course of vaccination.
Age: 0.5
Sex: M
Vaccine: HIBV
Symptoms: Expired product administered
Clinical narrative: inadvertently administered an expired Hiberix; This non-serious case was reported by a nurse via call center representative and described the occurrence of expired vaccine used in a 6-month-old male patient who received Hib (Hiberix) (batch number 9X2TS, expiry date 30-DEC-2023) for prophylaxis.   On 25-JAN-2024, the patient received Hiberix (left thigh). On 25-JAN-2024, an unknown time after receiving Hiberix, the patient experienced expired vaccine used (Verbatim: inadvertently administered an expired Hiberix). The outcome of the expired vaccine used was unknown.   Additional Information: GSK Receipt date: 25-JAN-2024 A nurse reported that they inadvertently administered an expired Hiberix dose to a patient today on 25 January 2024 which led to expired vaccine used. Nurse wanted to know how to proceed.  The reporter did not consent to follow-up.
Age: 20.0
Sex: F
Vaccine: HEP
Symptoms: Underdose
Clinical narrative: Adult patient received the ENGERIX-B peds instead of adult vaccine; Adult patient received the ENGERIX-B peds instead of adult vaccine; This non-serious case was reported by a other health professional via call center representative and described the occurrence of adult use of a child product in a 20-year-old female patient who received HBV (Engerix B pediatric) for prophylaxis.   On 16-OCT-2023, the patient received Engerix B pediatric. On 16-OCT-2023, an unknown time after receiving Engerix B pediatric, the patient experienced adult use of a child product (Verbatim: Adult patient received the ENGERIX-B peds instead of adult vaccine) and underdose (Verbatim: Adult patient received the ENGERIX-B peds instead of adult vaccine). The outcome of the adult use of a child product and underdose were unknown.   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: 25-JAN-2024 An HCP reported that a patient received the Engerix-B peds instead of adult vaccine which led to Underdose and Adult use of child product. No other information provided.  Patient wanted to know what she needs to do next.  The reporter consented to follow up.
Age: 7.0
Sex: M
Vaccine: DTAPIPV
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: 7 year old male patient was administered a dose of Kinrix on 17Jan2024; This non-serious case was reported by a nurse via call center representative and described the occurrence of inappropriate age at vaccine administration in a 7-year-old male patient who received DTPa-IPV (Kinrix) (batch number 34MF9, expiry date 13-FEB-2026) for prophylaxis.   On 17-JAN-2024, the patient received Kinrix. On 17-JAN-2024, an unknown time after receiving Kinrix, the patient experienced inappropriate age at vaccine administration (Verbatim: 7 year old male patient was administered a dose of Kinrix on 17Jan2024). The outcome of the inappropriate age at vaccine administration was unknown.   This report is made by RA without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: RA Receipt Date: 25-JAN-2024 The 7 year old patient was administered a dose of Kinrix, which led to inappropriate age at vaccine administration.        This was the patient's 5th DTaP and 4th IPV dose.  The vaccine administration facility was the same as primary reporter. The reporter consented to follow up.
Sex: M
Vaccine: MNQ
Symptoms: Product use in unapproved indication
Clinical narrative: Use in asplenic patient; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of drug use for unapproved indication in a 55-year-old male patient who received Men ACWY-CRM NVS (Menveo) (batch number 3CB9L, expiry date 30-NOV-2024) for prophylaxis.   Concurrent medical conditions included asplenia.   On 24-SEP-2023, the patient received Menveo. On 24-SEP-2023, an unknown time after receiving Menveo, the patient experienced drug use for unapproved indication (Verbatim: Use in asplenic patient). The outcome of the drug use for unapproved indication was unknown.   Additional Information: GSK Receipt Date: 25-JAN-2024 The reporter contacted GSK via phone and inquired about Menveo and what information was available about any information for the administration of Menveo in a splenic patient after 1 month. Information about patient, vaccine and event was given. The reporter consented to follow-up. Reporter reported that the Menveo administered for use in a splenic patient, which led to drug use for unapproved indication.
Sex: U
Vaccine: COVID19
Symptoms: Death
Clinical narrative: DEATH; This solicited report received from a patient via Agency concerned a patient of unspecified age and sex. The patient's weight, height, and medical history were not reported. No past medical history or concurrent conditions were reported. The patient received vaccination with covid-19 vaccine ad26.cov2.s (Dose number in series 1) (suspension for injection, intramuscular, batch number was not reported) dose, start therapy date were not reported for covid-19 prophylaxis. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported. On an unspecified date, the patient experienced death (Dose number in series 1). The cause of death was not reported. It was unknown if an autopsy was performed. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The reporter provided no causality assessment. Company causality between covid-19 vaccine ad26.cov2.s, and death was not related. This report was serious (Death).; Sender's Comments: V0: Death. The event(s) has an unknown/unclear temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event(s) than the drug. Specifically: NATURE OF EVENT. Therefore, this event(s) is considered not related.; Reported Cause(s) of Death: UNKNOWN CAUSE OF DEATH
Age: 50.0
Sex: M
Vaccine: COVID19
Symptoms: Cerebrovascular accident
Clinical narrative: Stroke; This spontaneous case was reported by a non-healthcare professional and describes the occurrence of CEREBROVASCULAR ACCIDENT (Stroke) in a 50-year-old male patient who received mRNA-1273.815 (SPIKEVAX 2023-2024) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273.815 (SPIKEVAX 2023-2024) (unknown route) 1 dosage form. On an unknown date, the patient experienced CEREBROVASCULAR ACCIDENT (Stroke) (seriousness criterion medically significant). At the time of the report, CEREBROVASCULAR ACCIDENT (Stroke) outcome was unknown.            Concomitant medication was not provided. Patient was a top-fit man. He was currently learning to speak again and was battling paralysis on the right side of his body. Treatment information was not reported.  Company comment: This spontaneous case concerns a 50-year-old, male patient with no relevant medical history reported (described as top fit man), who experienced the unexpected serious (medically significant) AESI of cerebrovascular accident. The event occurred on an unknown date. Temporal relation to a dose of mRNA-1273 is unclear. The patient was battling paralysis on right side of body and learning to speak again. No further information about the events was provided. The benefit-risk relationship of mRNA-1273 is not affected by this report.
Sex: F
Vaccine: COVID19
Symptoms: Dysgeusia, Hypersensitivity, Pain in extremity, Pyrexia, Tongue discomfort
Clinical narrative: Tongue started burning; Typical side effects of a sore arm and a little bit of a fever; Metal taste in her mouth; Progressively worse allergic reactions; Typical side effects of a sore arm and a little bit of a fever; Rash at the injection site; This spontaneous case was reported by a patient and describes the occurrence of TONGUE DISCOMFORT (Tongue started burning), PAIN IN EXTREMITY (Typical side effects of a sore arm and a little bit of a fever), DYSGEUSIA (Metal taste in her mouth), HYPERSENSITIVITY (Progressively worse allergic reactions) and PYREXIA (Typical side effects of a sore arm and a little bit of a fever) in a female patient of an unknown age who received SPIKEVAX NOS (SPIKEVAX NOS) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Cancer (patient had Post cancer treatment).   On an unknown date, the patient received first dose of SPIKEVAX NOS (SPIKEVAX NOS) (unknown route) 1 dosage form. On an unknown date, received second dose of SPIKEVAX NOS (SPIKEVAX NOS) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced TONGUE DISCOMFORT (Tongue started burning), PAIN IN EXTREMITY (Typical side effects of a sore arm and a little bit of a fever), DYSGEUSIA (Metal taste in her mouth), HYPERSENSITIVITY (Progressively worse allergic reactions) and PYREXIA (Typical side effects of a sore arm and a little bit of a fever). an unknown date, the patient experienced VACCINATION SITE RASH (Rash at the injection site). At the time of the report, TONGUE DISCOMFORT (Tongue started burning), PAIN IN EXTREMITY (Typical side effects of a sore arm and a little bit of a fever), DYSGEUSIA (Metal taste in her mouth), HYPERSENSITIVITY (Progressively worse allergic reactions), PYREXIA (Typical side effects of a sore arm and a little bit of a fever) and VACCINATION SITE RASH (Rash at the injection site) outcome was unknown.            No concomitant and treatment medications were reported.  It was reported that the patient started treatment with first and second doses of Moderna COVID-19 vaccine. The patient reported that she got it because she was also just post-cancer treatment. It was reported that with each shot, the patient got progressively worse allergic reactions. With dose 1, she got the typical side effects of a sore arm and a little bit of a fever. But 9 days after the initial shot, she got COVID-19 arm, as so she got a rash at the injection site. The patient reported it was not terrible and she did not feel bad. As soon as the patient got second dose, her tongue started burning. She got a metal taste in her mouth and had a really burning hot tongue.
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site rash
Clinical narrative: Tongue started burning; Typical side effects of a sore arm and a little bit of a fever; Metal taste in her mouth; Progressively worse allergic reactions; Typical side effects of a sore arm and a little bit of a fever; Rash at the injection site; This spontaneous case was reported by a patient and describes the occurrence of TONGUE DISCOMFORT (Tongue started burning), PAIN IN EXTREMITY (Typical side effects of a sore arm and a little bit of a fever), DYSGEUSIA (Metal taste in her mouth), HYPERSENSITIVITY (Progressively worse allergic reactions) and PYREXIA (Typical side effects of a sore arm and a little bit of a fever) in a female patient of an unknown age who received SPIKEVAX NOS (SPIKEVAX NOS) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Cancer (patient had Post cancer treatment).   On an unknown date, the patient received first dose of SPIKEVAX NOS (SPIKEVAX NOS) (unknown route) 1 dosage form. On an unknown date, received second dose of SPIKEVAX NOS (SPIKEVAX NOS) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced TONGUE DISCOMFORT (Tongue started burning), PAIN IN EXTREMITY (Typical side effects of a sore arm and a little bit of a fever), DYSGEUSIA (Metal taste in her mouth), HYPERSENSITIVITY (Progressively worse allergic reactions) and PYREXIA (Typical side effects of a sore arm and a little bit of a fever). an unknown date, the patient experienced VACCINATION SITE RASH (Rash at the injection site). At the time of the report, TONGUE DISCOMFORT (Tongue started burning), PAIN IN EXTREMITY (Typical side effects of a sore arm and a little bit of a fever), DYSGEUSIA (Metal taste in her mouth), HYPERSENSITIVITY (Progressively worse allergic reactions), PYREXIA (Typical side effects of a sore arm and a little bit of a fever) and VACCINATION SITE RASH (Rash at the injection site) outcome was unknown.            No concomitant and treatment medications were reported.  It was reported that the patient started treatment with first and second doses of Moderna COVID-19 vaccine. The patient reported that she got it because she was also just post-cancer treatment. It was reported that with each shot, the patient got progressively worse allergic reactions. With dose 1, she got the typical side effects of a sore arm and a little bit of a fever. But 9 days after the initial shot, she got COVID-19 arm, as so she got a rash at the injection site. The patient reported it was not terrible and she did not feel bad. As soon as the patient got second dose, her tongue started burning. She got a metal taste in her mouth and had a really burning hot tongue.
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test
Clinical narrative: Patient tested positive for Covid about a week after the dose of Spikevax.; This spontaneous case was reported by a nurse and describes the occurrence of COVID-19 (Patient tested positive for Covid about a week after the dose of Spikevax.) in a female patient of an unknown age who received SPIKEVAX NOS (SPIKEVAX NOS) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received dose of SPIKEVAX NOS (SPIKEVAX NOS) (unknown route) 1 dosage form. On an unknown date, the patient experienced COVID-19 (Patient tested positive for Covid about a week after the dose of Spikevax.). At the time of the report, COVID-19 (Patient tested positive for Covid about a week after the dose of Spikevax.) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, SARS-CoV-2 test: Positive.     The action taken with SPIKEVAX NOS (SPIKEVAX NOS) (Unknown) was unknown.   For SPIKEVAX NOS (SPIKEVAX NOS) (Unknown), the reporter did not provide any causality assessments.   It was unknown if patient receive any other vaccines in the 4 weeks prior to COVID-19 vaccine.  The concomitant medication was not reported by reporter.   Dosage text for suspect product was reported as unknown.  The patient lived in a living facility and got a dose of Spikevax vaccine, and she was to get a second dose in 4 weeks. She tested positive for Covid about a week after the dose of Spikevax. She had an exposure to Covid. It was not her first dose of a covid vaccine.  The treatment medication was not reported by reporter.
Age: 78.0
Sex: M
Vaccine: COVID19
Symptoms: Ischaemic stroke
Clinical narrative: ischemic stroke; This spontaneous case was reported by a patient and describes the occurrence of ISCHAEMIC STROKE (ischemic stroke) in a 78-year-old male patient 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) (Intramuscular use) 1 dosage form. On 04-Nov-2023, the patient experienced ISCHAEMIC STROKE (ischemic stroke) (seriousness criterion medically significant). At the time of the report, ISCHAEMIC STROKE (ischemic stroke) had not resolved.        The action taken with SPIKEVAX NOS (SPIKEVAX NOS) (Intramuscular use) was unknown.   For SPIKEVAX NOS (SPIKEVAX NOS) (Intramuscular use), the reporter did not provide any causality assessments.   No concomitant medications were reported.  It was unknown if the patient experienced any additional symptoms/events.  No treatment information was provided. Company comment-This is a spontaneous case concerning a 78-year-old male patient with no reported medical history, who experienced the serious (medically significant) unexpected AESI ischaemic stroke. A dose of SPIKEVAX NOS vaccine was administered on an unknown date. Temporal association cannot be assessed due to lack of information on vaccination date. No further details were provided for medical review. Patient´s age and gender remain as contributory risk factors for the event. The benefit-risk relationship of SPIKEVAX NOS vaccine is not affected by this report.
Age: 65.0
Sex: M
Vaccine: RSV, RSV
Symptoms: Headache, Rash
Clinical narrative: -pt had extreme headaches  3 days w/no relief from medication - chills/cold hands -rash that presented like shingles/poison ivy down arm but not itchy or painful
Age: 65.0
Sex: M
Vaccine: RSV, RSV
Symptoms: Chills, Headache, Peripheral coldness, Rash
Clinical narrative: -pt had extreme headaches  3 days w/no relief from medication - chills/cold hands -rash that presented like shingles/poison ivy down arm but not itchy or painful
Age: 44.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Arthralgia, Asthenia, Asthma, Blood immunoglobulin G, Cardiac failure congestive
Clinical narrative: Started as extreme flu, nausea, weakness dizzy fatique for 3 months would not go away, kept getting much worse, I developed shorness of breath, I usually run 7 to 10 miles a day every day, stopped running, joint pain, chest pain, headaches.  Went to my dr was sent to specialist, diagnosed with common variable immune defiency, asthma, congestive heart failure.  I have not recovered, I cannot even remember the person I was before this vaccine.  I was so healthy before this vaccine. I used to be a person that never sat still, I was the best at my job, now I cannot no longer focus. I have no energy, constant chest pains, and now I am on cuvitru for immune defiency for the rest of my life
Age: 44.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Chest pain, Disturbance in attention, Dizziness, Dyspnoea, Electrocardiogram
Clinical narrative: Started as extreme flu, nausea, weakness dizzy fatique for 3 months would not go away, kept getting much worse, I developed shorness of breath, I usually run 7 to 10 miles a day every day, stopped running, joint pain, chest pain, headaches.  Went to my dr was sent to specialist, diagnosed with common variable immune defiency, asthma, congestive heart failure.  I have not recovered, I cannot even remember the person I was before this vaccine.  I was so healthy before this vaccine. I used to be a person that never sat still, I was the best at my job, now I cannot no longer focus. I have no energy, constant chest pains, and now I am on cuvitru for immune defiency for the rest of my life
Age: 44.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Exercise tolerance decreased, Fatigue, Full blood count, Headache, Immunodeficiency common variable
Clinical narrative: Started as extreme flu, nausea, weakness dizzy fatique for 3 months would not go away, kept getting much worse, I developed shorness of breath, I usually run 7 to 10 miles a day every day, stopped running, joint pain, chest pain, headaches.  Went to my dr was sent to specialist, diagnosed with common variable immune defiency, asthma, congestive heart failure.  I have not recovered, I cannot even remember the person I was before this vaccine.  I was so healthy before this vaccine. I used to be a person that never sat still, I was the best at my job, now I cannot no longer focus. I have no energy, constant chest pains, and now I am on cuvitru for immune defiency for the rest of my life
Age: 44.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Influenza, Lymphadenopathy, Nausea, Pulmonary function test, Ultrasound abdomen
Clinical narrative: Started as extreme flu, nausea, weakness dizzy fatique for 3 months would not go away, kept getting much worse, I developed shorness of breath, I usually run 7 to 10 miles a day every day, stopped running, joint pain, chest pain, headaches.  Went to my dr was sent to specialist, diagnosed with common variable immune defiency, asthma, congestive heart failure.  I have not recovered, I cannot even remember the person I was before this vaccine.  I was so healthy before this vaccine. I used to be a person that never sat still, I was the best at my job, now I cannot no longer focus. I have no energy, constant chest pains, and now I am on cuvitru for immune defiency for the rest of my life
Age: 44.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Ultrasound chest, Ultrasound neck
Clinical narrative: Started as extreme flu, nausea, weakness dizzy fatique for 3 months would not go away, kept getting much worse, I developed shorness of breath, I usually run 7 to 10 miles a day every day, stopped running, joint pain, chest pain, headaches.  Went to my dr was sent to specialist, diagnosed with common variable immune defiency, asthma, congestive heart failure.  I have not recovered, I cannot even remember the person I was before this vaccine.  I was so healthy before this vaccine. I used to be a person that never sat still, I was the best at my job, now I cannot no longer focus. I have no energy, constant chest pains, and now I am on cuvitru for immune defiency for the rest of my life
Age: 44.0
Sex: F
Vaccine: COVID19
Symptoms: Electrocardiogram normal, Fibrin D dimer normal, Pericarditis, Pleuritic pain, Troponin normal
Clinical narrative: Seen for annual exam on 1/30/24 and received covid booster, subsequently developed central pleuritic chest pain so sent to ER for evaluation. In ER, EKG and labs ok (including trop and Ddimer), ER advised likely pericarditis from vaccine, sent home w/ IBU prn. Per patient, pain is manageable w/ IBU 600mg Q12hrs, mild/mod pain w/ leaning forward, laughing, and deep breath. No SOB or palpitations; pain is stable over time.
Age: 68.0
Sex: M
Vaccine: VARZOS
Symptoms: Chills, Pain, Tremor
Clinical narrative: severe body pain, shaking, severe pain, shivering
Age: 49.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Death, Intensive care, Orthosis user, Pain in extremity, Thrombosis
Clinical narrative: Injection April 2021. By late March, he complained of intense foot pain. Was given a foot brace (boot) and anti-inflammatories. Was given anxiety meds.  On April 1st the giant blood clot that was in his foot, dislodged and killed him.
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Abdominal pain upper, Headache, Induration, Nausea, Peripheral swelling
Clinical narrative: swollen arm that's hot and hard, stomach pain, headache, fever, headache, nausea
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Pyrexia, Skin warm
Clinical narrative: swollen arm that's hot and hard, stomach pain, headache, fever, headache, nausea
Age: 3.0
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC13
Symptoms: Urticaria
Clinical narrative: Hives within 5-10 minuets of vaccinations. Hives only to face. No angioedema or mucosal involvement.  Hives did not spread and beagn to spontaneously resolve. Benadryl 6.25mg also given
Age: 11.0
Sex: M
Vaccine: HPV9
Symptoms: Acute disseminated encephalomyelitis, Encephalopathy, Laboratory test, Myelin oligodendrocyte glycoprotein antibody-associated disease
Clinical narrative: Was hospitalized with MOG Antibody disease about 2 weeks after receiving the vaccination.  Was diagnosed with encephalopathy and ADEM.
Age: 0.17
Sex: M
Vaccine: DTPPVHBHPB, PNC20, RV5
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Patient rced 1st dose of Vaxelis on 1/31/24 - within a few hours of recieving leg was red & swollen entire thigh down to knee. Next day-leg swelling well now.
Age: 18.0
Sex: F
Vaccine: FLU4, MENB
Symptoms: Rash, Urticaria
Clinical narrative: 1/22/24 She had some rash a few minutes after vaccine. Gave benadryl first oral then Im total 50 mg. 1/23/24 Patient came back with hives on bottom of feet, No treatment given.
Age: 46.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Sudden death
Clinical narrative: Online report of sudden death in later 40's male. Image quality of vaccine card poor. Date of Dose 1 04/14/21 with Pfizer ER872? Date of DOSE 2 with Pfizer EW017? date is a guestimate as image quality as poor. Date of Death reported as 12/23/2023
Age: 57.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Creutzfeldt-Jakob disease, Death
Clinical narrative: ONLINE REPORT OF VICTIM DYING FROM CJD, creutzfeldt-jakob disease, picture of vaccine card obtained. DOSE1 1/29/2021 EN5318 DOSE2 02/20/2021 EN6202 Date of Death reported as 03/03/23. Site on card reported as MC obituary in close proximity to Medical Center, I suspect that's where the inoculations and follow up care may have occurred
Age: 44.0
Sex: U
Vaccine: COVID19, COVID19
Symptoms: Sudden death
Clinical narrative: Online report of sudden death. Online sourse was able to get a picture of information from DOSE1 on 12/18/2020 with social media made to website...DOSE2 date or subsequent booster dates-lot # unknown. Likely inoculated on the job, DATE OF DEATH reported as 11/14/23, employee as Professor
Age: 17.0
Sex: F
Vaccine: COVID19, COVID19, COVID19, COVID19, COVID19, COVID19
Symptoms: COVID-19, Death, Foreign travel, Life support, Malaise
Clinical narrative: Initial online report found with vaccine card, D1 6/7/22 FP7135 D2 6/28/22 FP7135. According to report, victim felt sick while on a sponsored school trip. Victim tested + for COVID19. At some point victim was airlifted to hospital from residence. At that point victim was on life support, may have had limbs amputated, the duration of this is unknown. Victim passed away on 08/06/22, required to be inoculated for school rip. Length of hospital stays unknown
Age: 17.0
Sex: F
Vaccine: COVID19, COVID19, COVID19, COVID19, COVID19, COVID19
Symptoms: SARS-CoV-2 test positive
Clinical narrative: Initial online report found with vaccine card, D1 6/7/22 FP7135 D2 6/28/22 FP7135. According to report, victim felt sick while on a sponsored school trip. Victim tested + for COVID19. At some point victim was airlifted to hospital from residence. At that point victim was on life support, may have had limbs amputated, the duration of this is unknown. Victim passed away on 08/06/22, required to be inoculated for school rip. Length of hospital stays unknown
Age: 17.0
Sex: F
Vaccine: COVID19, COVID19, COVID19, COVID19, COVID19, COVID19
Symptoms: Cardiac arrest, Death, Lung assist device therapy
Clinical narrative: Initial online report found with vaccine card, D1 6/7/22 FP7135 D2 6/28/22 FP7135. According to report, victim felt sick while on a sponsored school trip. Victim tested + for COVID19. At some point victim was airlifted to hospital from residence. At that point victim was on life support, may have had limbs amputated, the duration of this is unknown. Victim passed away on 08/06/22, required to be inoculated for school rip. Length of hospital stays unknown
Age: 17.0
Sex: F
Vaccine: COVID19, COVID19, COVID19, COVID19, COVID19, COVID19
Symptoms: Cardiac arrest, Death, Dizziness, Lung assist device therapy, Malaise
Clinical narrative: Initial online report found with vaccine card, D1 6/7/22 FP7135 D2 6/28/22 FP7135. According to report, victim felt sick while on a sponsored school trip. Victim tested + for COVID19. At some point victim was airlifted to hospital from residence. At that point victim was on life support, may have had limbs amputated, the duration of this is unknown. Victim passed away on 08/06/22, required to be inoculated for school rip. Length of hospital stays unknown
Age: 17.0
Sex: F
Vaccine: COVID19, COVID19, COVID19, COVID19, COVID19, COVID19
Symptoms: Multiple organ dysfunction syndrome, SARS-CoV-2 test positive, Skin discolouration, Syncope
Clinical narrative: Initial online report found with vaccine card, D1 6/7/22 FP7135 D2 6/28/22 FP7135. According to report, victim felt sick while on a sponsored school trip. Victim tested + for COVID19. At some point victim was airlifted to hospital from residence. At that point victim was on life support, may have had limbs amputated, the duration of this is unknown. Victim passed away on 08/06/22, required to be inoculated for school rip. Length of hospital stays unknown
Age: 48.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Sudden death
Clinical narrative: Online report of sudden death in working age lawyer. DOSE1 01/25/21 #EL1284 DOSE2 02/15/21 #EL9265 SITE on VAX CARD DOD 11/23/21
Age: 72.0
Sex: F
Vaccine: FLU4
Symptoms: Guillain-Barre syndrome
Clinical narrative: Guillain-Barre Syndrome
Sex: U
Vaccine: COVID19, COVID19
Symptoms: Alopecia, Anxiety, Arthritis, Balance disorder, Blood pressure increased
Clinical narrative: positive result; positive result; This is a spontaneous report received from a Consumer or other non HCP.  A 56-year-old patient received BNT162b2 (BNT162B2), on 27May2021 as dose 1, single (Lot number: EW0202), in left arm and on 17Jun2021 as dose 2, single (Batch/Lot number: unknown), in left arm, all intramuscular for covid-19 immunisation. The patient's relevant medical history included: "hypertension" (ongoing); "anxiety/depression", start date: 2020 (ongoing). The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 11Feb2023, outcome "unknown" and all described as "positive result". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (11Feb2023) positive. Clinical Course: Patient reported altered sense of smell since positive case. Both parents of the patient were having medical history of Coronary artery disease/Heart attack. Patient's mother was also having history of diabetes type 2.  The information on the batch/lot number for BNT162b2 will be requested and submitted if and when received.; Sender's Comments: Linked Report(s) : US-PFIZER INC-PV202300208833 Same patient & drug / different event and dose.;
Sex: U
Vaccine: COVID19, COVID19
Symptoms: Blood test, Bone cyst, Bone densitometry, Brain fog, Cardiac stress test
Clinical narrative: positive result; positive result; This is a spontaneous report received from a Consumer or other non HCP.  A 56-year-old patient received BNT162b2 (BNT162B2), on 27May2021 as dose 1, single (Lot number: EW0202), in left arm and on 17Jun2021 as dose 2, single (Batch/Lot number: unknown), in left arm, all intramuscular for covid-19 immunisation. The patient's relevant medical history included: "hypertension" (ongoing); "anxiety/depression", start date: 2020 (ongoing). The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 11Feb2023, outcome "unknown" and all described as "positive result". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (11Feb2023) positive. Clinical Course: Patient reported altered sense of smell since positive case. Both parents of the patient were having medical history of Coronary artery disease/Heart attack. Patient's mother was also having history of diabetes type 2.  The information on the batch/lot number for BNT162b2 will be requested and submitted if and when received.; Sender's Comments: Linked Report(s) : US-PFIZER INC-PV202300208833 Same patient & drug / different event and dose.;
Sex: U
Vaccine: COVID19, COVID19
Symptoms: Chest pain, Computerised tomogram, Computerised tomogram thorax, Constipation, Depression
Clinical narrative: positive result; positive result; This is a spontaneous report received from a Consumer or other non HCP.  A 56-year-old patient received BNT162b2 (BNT162B2), on 27May2021 as dose 1, single (Lot number: EW0202), in left arm and on 17Jun2021 as dose 2, single (Batch/Lot number: unknown), in left arm, all intramuscular for covid-19 immunisation. The patient's relevant medical history included: "hypertension" (ongoing); "anxiety/depression", start date: 2020 (ongoing). The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 11Feb2023, outcome "unknown" and all described as "positive result". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (11Feb2023) positive. Clinical Course: Patient reported altered sense of smell since positive case. Both parents of the patient were having medical history of Coronary artery disease/Heart attack. Patient's mother was also having history of diabetes type 2.  The information on the batch/lot number for BNT162b2 will be requested and submitted if and when received.; Sender's Comments: Linked Report(s) : US-PFIZER INC-PV202300208833 Same patient & drug / different event and dose.;
Sex: U
Vaccine: COVID19, COVID19
Symptoms: Diarrhoea, Disturbance in attention, Dizziness, Dry eye, Echocardiogram
Clinical narrative: positive result; positive result; This is a spontaneous report received from a Consumer or other non HCP.  A 56-year-old patient received BNT162b2 (BNT162B2), on 27May2021 as dose 1, single (Lot number: EW0202), in left arm and on 17Jun2021 as dose 2, single (Batch/Lot number: unknown), in left arm, all intramuscular for covid-19 immunisation. The patient's relevant medical history included: "hypertension" (ongoing); "anxiety/depression", start date: 2020 (ongoing). The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 11Feb2023, outcome "unknown" and all described as "positive result". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (11Feb2023) positive. Clinical Course: Patient reported altered sense of smell since positive case. Both parents of the patient were having medical history of Coronary artery disease/Heart attack. Patient's mother was also having history of diabetes type 2.  The information on the batch/lot number for BNT162b2 will be requested and submitted if and when received.; Sender's Comments: Linked Report(s) : US-PFIZER INC-PV202300208833 Same patient & drug / different event and dose.;
Sex: U
Vaccine: COVID19, COVID19
Symptoms: Fatigue, Head discomfort, Headache, Heart rate increased, Heart rate irregular
Clinical narrative: positive result; positive result; This is a spontaneous report received from a Consumer or other non HCP.  A 56-year-old patient received BNT162b2 (BNT162B2), on 27May2021 as dose 1, single (Lot number: EW0202), in left arm and on 17Jun2021 as dose 2, single (Batch/Lot number: unknown), in left arm, all intramuscular for covid-19 immunisation. The patient's relevant medical history included: "hypertension" (ongoing); "anxiety/depression", start date: 2020 (ongoing). The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 11Feb2023, outcome "unknown" and all described as "positive result". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (11Feb2023) positive. Clinical Course: Patient reported altered sense of smell since positive case. Both parents of the patient were having medical history of Coronary artery disease/Heart attack. Patient's mother was also having history of diabetes type 2.  The information on the batch/lot number for BNT162b2 will be requested and submitted if and when received.; Sender's Comments: Linked Report(s) : US-PFIZER INC-PV202300208833 Same patient & drug / different event and dose.;
Sex: U
Vaccine: COVID19, COVID19
Symptoms: Magnetic resonance imaging, Muscle spasms, Muscle twitching, Nausea, Neuropathy peripheral
Clinical narrative: positive result; positive result; This is a spontaneous report received from a Consumer or other non HCP.  A 56-year-old patient received BNT162b2 (BNT162B2), on 27May2021 as dose 1, single (Lot number: EW0202), in left arm and on 17Jun2021 as dose 2, single (Batch/Lot number: unknown), in left arm, all intramuscular for covid-19 immunisation. The patient's relevant medical history included: "hypertension" (ongoing); "anxiety/depression", start date: 2020 (ongoing). The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 11Feb2023, outcome "unknown" and all described as "positive result". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (11Feb2023) positive. Clinical Course: Patient reported altered sense of smell since positive case. Both parents of the patient were having medical history of Coronary artery disease/Heart attack. Patient's mother was also having history of diabetes type 2.  The information on the batch/lot number for BNT162b2 will be requested and submitted if and when received.; Sender's Comments: Linked Report(s) : US-PFIZER INC-PV202300208833 Same patient & drug / different event and dose.;