chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 40.0
Sex: F
Vaccine: COVID19
Symptoms: Axillary pain, Hypoaesthesia, Immunisation, Paraesthesia, Peripheral swelling
Clinical narrative: Significant L armpit swelling with pain; Significant L armpit swelling with pain; numbness, and tingling in neck, shoulder, arm, and hand; numbness, and tingling in neck, shoulder, arm, and hand; booster; This is a spontaneous report from a contactable other hcp (Patient).  A 40-years-old non pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number: 30145BA), dose 3 via an unspecified route of administration, administered in Arm Left on 28Sep2021 at 11:15 as DOSE 3 (BOOSTER), SINGLE (Age at vaccination: 40 years) for covid-19 immunisation . Medical history included, seasonal allergy from an unknown date and unknown if ongoing, asthma from an unknown date and unknown if ongoing, drug hypersensitivity had allergies: Sulfa Antibiotics. Concomitant medications included cetirizine hydrochloride (ZYRTEC [CETIRIZINE HYDROCHLO-RIDE]); Ibuprofen; diphenhydramine hydrochloride (BENADRYL) taken for an unspecified indication, start and stop date were not reported; calcium carbonate, magnesium carbonate, magnesium trisilicate (TUMS [CALCIUM CARBONATE; MAGNESIUM CARBONATE; MAGNESIUM TRISILICATE]).  Historical vaccine included bnt162b2 (COMIRNATY, solution for injection, lot number: EC8982) as dose 2 in left arm on 26Jan2021 (Age at vaccination: 39 years) for covid-19 immunisation, and dose 1 with lot number Batch/Lot No: EK9231, in left arm on 05Jan2021(Age at vaccination: 39 years) for Covid-19 immunization. Patient did not have other vaccinations in 4 weeks. Patient did not have Covid prior vaccination. Patient did not test Covid post vaccination. The patient reported booster on 28Sep2021 at 11:15, significant l armpit swelling with pain, numbness, and tingling in neck, shoulder, arm, and hand on 29Sep2021 at 08:30. No treatment was received for the events. The outcome of the events was recovering.   Follow-up attempts are completed. No further information is expected.
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Headache, Immunisation, Lethargy, Myalgia
Clinical narrative: dose number=3; Sore arm muscles / arm/muscle extremely sore; Sore arm muscles / arm/muscle extremely sore; Extreme fatigue; Nausea; Lethargic; Headache; arm/muscle extremely sore/rash.; arm/muscle extremely sore/rash.; This is a spontaneous report from a contactable consumer (patient). A 73-year-old female non-pregnant patient received BNT162B2 (COMIRNATY, Formulation: Solution for injection, Batch/Lot number: FF2587, Expiration date was not reported), via intramuscular in arm left on 05Oct2021 at 15:30 (at the age of 73-year-old) as a dose 3 (booster), single for COVID-19 immunization. The patient's medical history included Lupus. The patient had known allergies were reported as none. Past drug events included corticosteroids, high-dose of corticosteroids, cyclosporine, methotrexate, azathioprine, rituximab, etanercept and experienced weakened immune system. The patient's concomitant medications in two weeks included hydroxychloroquine, citalopram, methotrexate, Atvo, all were taken for an unspecified indication. The patient had received other vaccines within four weeks prior to the COVID-19 vaccine that included influenza vaccine inact sag 4v (FLUAD QUAD, Batch/Lot number: 70461-0121-03), via an unspecified route of administration in arm left on 16Sep2021 as a dose 1, single for an unspecified indication. Historical vaccine included BNT162B2 (COMIRNATY, Formulation: Solution for injection, Batch/Lot number: EL9262, Expiration date was not reported), via intramuscular in arm left on 28Jan2021 (reported as at noon) as a dose 1, single and the patient received BNT162B2 (COMIRNATY, Formulation: Solution for injection, Batch/Lot number: EN6200, Expiration date was not reported), via intramuscular in arm left on 18Feb2021 at 11:30 AM as a dose 2, single for COVID-19 immunization. The patient was not pregnant at the time of vaccination. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On 05Oct2021, the patient experienced sore arm muscles / arm/muscle extremely sore, extreme fatigue, lethargic, nausea, headache, arm/muscle extremely sore/rash. Stated that, on an unspecified date in Oct2021, the patient experienced side effects of booster shot 3-4 days, lethargic, headache, arm/muscle extremely sore/rash and dose number=3, nausea on 05Oct2021. Stated that, weakened immune system, use of medications that suppress the immune system (e.g., high dose of corticosteroids, cyclosporine, methotrexate, azathioprine and biologic therapies like rituximab and etanercept). Treatment was not received for the events. The specific relevant test for thromboembolic events with thrombocytopenia was reported as none. The outcome of the events sore arm muscles / arm/muscle extremely sore, extreme fatigue, nausea was recovered on an unspecified date in Oct2021 and for lethargic, headache, arm/muscle extremely sore/rash was recovered on an unspecified date in 2021 while for the other event was unknown.  Follow-up attempts are completed. No further information is expected.
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Nausea, Pain in extremity, Rash
Clinical narrative: dose number=3; Sore arm muscles / arm/muscle extremely sore; Sore arm muscles / arm/muscle extremely sore; Extreme fatigue; Nausea; Lethargic; Headache; arm/muscle extremely sore/rash.; arm/muscle extremely sore/rash.; This is a spontaneous report from a contactable consumer (patient). A 73-year-old female non-pregnant patient received BNT162B2 (COMIRNATY, Formulation: Solution for injection, Batch/Lot number: FF2587, Expiration date was not reported), via intramuscular in arm left on 05Oct2021 at 15:30 (at the age of 73-year-old) as a dose 3 (booster), single for COVID-19 immunization. The patient's medical history included Lupus. The patient had known allergies were reported as none. Past drug events included corticosteroids, high-dose of corticosteroids, cyclosporine, methotrexate, azathioprine, rituximab, etanercept and experienced weakened immune system. The patient's concomitant medications in two weeks included hydroxychloroquine, citalopram, methotrexate, Atvo, all were taken for an unspecified indication. The patient had received other vaccines within four weeks prior to the COVID-19 vaccine that included influenza vaccine inact sag 4v (FLUAD QUAD, Batch/Lot number: 70461-0121-03), via an unspecified route of administration in arm left on 16Sep2021 as a dose 1, single for an unspecified indication. Historical vaccine included BNT162B2 (COMIRNATY, Formulation: Solution for injection, Batch/Lot number: EL9262, Expiration date was not reported), via intramuscular in arm left on 28Jan2021 (reported as at noon) as a dose 1, single and the patient received BNT162B2 (COMIRNATY, Formulation: Solution for injection, Batch/Lot number: EN6200, Expiration date was not reported), via intramuscular in arm left on 18Feb2021 at 11:30 AM as a dose 2, single for COVID-19 immunization. The patient was not pregnant at the time of vaccination. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On 05Oct2021, the patient experienced sore arm muscles / arm/muscle extremely sore, extreme fatigue, lethargic, nausea, headache, arm/muscle extremely sore/rash. Stated that, on an unspecified date in Oct2021, the patient experienced side effects of booster shot 3-4 days, lethargic, headache, arm/muscle extremely sore/rash and dose number=3, nausea on 05Oct2021. Stated that, weakened immune system, use of medications that suppress the immune system (e.g., high dose of corticosteroids, cyclosporine, methotrexate, azathioprine and biologic therapies like rituximab and etanercept). Treatment was not received for the events. The specific relevant test for thromboembolic events with thrombocytopenia was reported as none. The outcome of the events sore arm muscles / arm/muscle extremely sore, extreme fatigue, nausea was recovered on an unspecified date in Oct2021 and for lethargic, headache, arm/muscle extremely sore/rash was recovered on an unspecified date in 2021 while for the other event was unknown.  Follow-up attempts are completed. No further information is expected.
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Axillary pain, Fatigue, Immunisation, Swelling, Tenderness
Clinical narrative: fatigue; localized tenderness; significant left axillary swelling and tenderness; significant left axillary swelling and tenderness; Dose 3 (booster), single; This is a spontaneous report from a contactable nurse. This 50-year-old female nurse reported for herself that:  A 50-years-old non-pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot Number: FF88-39) via an unspecified route of administration in arm left on 06Oct2021 12:15 (at the age of 50-year-old) as DOSE 3 (BOOSTER), SINGLE for COVID-19 immunization. The patient medical history was not reported. Concomitant medications included aspirin [acetylsalicylic acid] (ASPIRIN [ACETYLSALICYLIC ACID]) taken 81 mg, ascorbic acid (VIT C), vit d [vitamin d nos] (VIT D [VITAMIN D NOS]), birth control pills and all taken within 2 weeks of vaccination. Patient had no known allergies. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient was not diagnosed with COVID-19 prior to vaccination. The patient was not tested for COVID-19 since the vaccination. Patient previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot Number: EJ1685) via an unspecified route of administration in arm left on 20Dec2020 (at the age of 50-year-old) as DOSE 1, SINGLE and second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot Number: EK9231) via an unspecified route of administration in arm left on 10Jan2021 (at the age of 50-year-old) as DOSE 2, SINGLE for COVID-19 immunization. On 08Oct2021 in general with all injections: fatigue, and localized tenderness With Booster (#3 in series) I have had significant left axillary swelling and tenderness. Adverse event treatment hydration fluids and stiches. Patient didn't received treatment. The clinical outcome of the events was not recovered.   Follow-Up (13Oct2021): Follow-up attempts are completed. No further information is expected.
Age: 46.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Immunisation
Clinical narrative: it knocked her out for 2 days; booster; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A 46 year-old female patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) at the age of 46 years as dose 3 (booster), single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (1st Dose, lot unknown), when the patient was 46 years old, for Covid-19 immunization; Bnt162b2 (2nd Dose lot unknown), when the patient was 46 years old, for Covid-19 Immunization. The following information was reported: FATIGUE (non-serious), outcome "unknown", described as "it knocked her out for 2 days"; IMMUNISATION (non-serious), outcome "unknown", described as "booster". Additional information: the reporter is patient's neighbor.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Headache, Insomnia
Clinical narrative: Headache; Can't sleep; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A female patient received bnt162b2 (COMIRNATY) (Batch/Lot number: unknown) as dose 2, single for covid-19 immunisation. Relevant medical history included: "Pertussis", start date: 2016 (unspecified if ongoing), notes: she and her other 2 sons got the pertussis back 5 years ago. The patient's concomitant medications were not reported. Vaccination history included: Bnt162b2 (1st dose), for COVID-19 immunization. The following information was reported: HEADACHE (non-serious), outcome "unknown", described as "Headache"; INSOMNIA (non-serious), outcome "unknown", described as "Can't sleep".  Additional Information: The patient had a headache since her second vaccine of the BioTech. The clinic people told her to give another 2 weeks before she gets worried. If it's not better by then she will go back. It's just a bad headache and bad enough to where she could not sleep. If this was all she gets to save her life than that's okay. She was totally an anti-vaxxer and questions vaccines because she and her other 2 sons got the pertussis back 5 years ago and was very upset about that. She reported that she was in quarantine right now. Reporter did not specify the seriousness for headache. Investigation Assessment was not provided.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202101432469 same reporter, differet patient
Age: 63.0
Sex: M
Vaccine: COVID19
Symptoms: Airway peak pressure increased, Drug hypersensitivity, Eye pruritus, Immunisation, Lacrimation increased
Clinical narrative: Significant histimine reaction; minor tightness of airways; nasal flow; sneezing; itchy/watery eyes; itchy/watery eyes; dose 3 (Booster); This is a spontaneous report from a contactable consumer (patient).  A 63-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; solution for injection; Lot Number: FE3590), dose 3 via an unspecified route of administration, administered in left arm on 20Oct2021 at 13:00 (at the age of 63-year-old) as DOSE 3 (BOOSTER), SINGLE for covid-19 immunization at Pharmacy or Drug Store. Medical history included allergic reaction to cats, some pollens (not applicable since Booster vaccine). There were no concomitant medications. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient did not receive other medications within 2 weeks of vaccination. Patient previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; solution for injection), via an unspecified route of administration, administered in left arm on 27Mar2021 (Lot Number: FE3590) at 13:00 as DOSE 1, SIGLE and second dose via an unspecified route of administration, administered in left arm on 19Apr2021 (Lot Number: ER8731) at 13:00 as DOSE 2, SIGLE both for covid-19 immunization. The patient received dose 3 (Booster) on 20Oct2021 at 13:00 and experienced significant histamine reaction, minor tightness of airways, nasal flow, sneezing, and itchy/watery eyes 21Oct2021 at 14:00. The patient did not receive any treatment as a result of events significant histamine reaction, minor tightness of airways, nasal flow, sneezing, and itchy/watery eyes. The outcome of the event significant histamine reaction, minor tightness of airways, nasal flow, sneezing, and itchy/watery eyes was not resolved.  Follow-up attempts are completed. No further information is expected.
Age: 63.0
Sex: M
Vaccine: COVID19
Symptoms: Rhinorrhoea, Sneezing
Clinical narrative: Significant histimine reaction; minor tightness of airways; nasal flow; sneezing; itchy/watery eyes; itchy/watery eyes; dose 3 (Booster); This is a spontaneous report from a contactable consumer (patient).  A 63-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; solution for injection; Lot Number: FE3590), dose 3 via an unspecified route of administration, administered in left arm on 20Oct2021 at 13:00 (at the age of 63-year-old) as DOSE 3 (BOOSTER), SINGLE for covid-19 immunization at Pharmacy or Drug Store. Medical history included allergic reaction to cats, some pollens (not applicable since Booster vaccine). There were no concomitant medications. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient did not receive other medications within 2 weeks of vaccination. Patient previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; solution for injection), via an unspecified route of administration, administered in left arm on 27Mar2021 (Lot Number: FE3590) at 13:00 as DOSE 1, SIGLE and second dose via an unspecified route of administration, administered in left arm on 19Apr2021 (Lot Number: ER8731) at 13:00 as DOSE 2, SIGLE both for covid-19 immunization. The patient received dose 3 (Booster) on 20Oct2021 at 13:00 and experienced significant histamine reaction, minor tightness of airways, nasal flow, sneezing, and itchy/watery eyes 21Oct2021 at 14:00. The patient did not receive any treatment as a result of events significant histamine reaction, minor tightness of airways, nasal flow, sneezing, and itchy/watery eyes. The outcome of the event significant histamine reaction, minor tightness of airways, nasal flow, sneezing, and itchy/watery eyes was not resolved.  Follow-up attempts are completed. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Asthenia, Diarrhoea, Nausea, Vomiting
Clinical narrative: Nausea; Diarrhea; Weakness; Vomited; This is a spontaneous report from a contactable consumer reporting for a patient (reporter's friend).  A male patient of unspecified age received second dose of BNT162B2 (PFIZER-BIONTEC COVID-19 mRNA VACCINE, Solution for injection, lot number and expiry date were not reported), via an unspecified route of administration, on an unspecified date in Sep2021, as DOSE 2, SINGLE for COVID-19 immunization. The patient medical history and concomitant medications were not reported. Historical vaccine included first dose of BNT162B2 (PFIZER-BIONTEC COVID-19 mRNA VACCINE, Solution for injection, lot number and expiry date were not reported), via an unspecified route of administration, on an unspecified date, as DOSE 1, SINGLE for COVID-19 immunization and no events reported. On an unspecified date in Sep2021, the patient experienced nausea, diarrhea, weakness and vomited. Received call from consumer (patient friend) regarding the second dose of Pfizer COVDI 19 shot on Saturday. While reporting for himself, caller stated that he had a friend (patient) that said he experienced the same thing after his second dose. He did not have his friend information to complete a report on. He had his done two weeks before his. He received the Pfizer COVID vaccine as well. He is over his symptoms. No further details provided. Outcome of the events were recovered on an unspecified date in Sep2021.  The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202101426803 same reporter/product/event, different patient
Age: 39.0
Sex: F
Vaccine: COVID19
Symptoms: Lip swelling, Mouth swelling, Nasal congestion, Obstructive airways disorder, Panic attack
Clinical narrative: Swelling of face nose and throat; Swelling of face nose and throat; Severe panic bc of lack of air; Severe panic bc of lack of air; swelled lips mouth and nose; swelled lips mouth and nose; swelled lips mouth and nose; This is a spontaneous report from a contactable consumer or other non hcp. A 39-years-old non-pregnant female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, Solution for injection, Batch/Lot number was not reported), via an unspecified route of administration on 25Oct2021 at 09:00 (at the age of 39-years-old) as dose 2, single for covid-19 immunisation. The medical history was not reported. Concomitant medications included buprenorphine hydrochloride, naloxone hydrochloride (SUBOXONE), fluoxetine hydrochloride (PROZAC) buspirone hydrochloride (BUSPAR). The patient did not have covid prior to the vaccination. The patient was not tested for COVID post vaccination. The patient had no Known allergies and no other medical history. The patient did not receive any other vaccine in four weeks. The patient received first dose of BNT162B2 on 04Oct2021 (Location: Arm Right) at 09:15 AM for covid-19 immunisation. On 29Oct2021 at 22:00 the patient experienced swelling of face nose and throat, severe panic bc of lack of air and swelled lips mouth and nose. Therapeutic measures were taken as a result of swelled lips mouth and nose. No treatment received for swelling of face nose and throat and severe panic bc of lack of air. The patient reported swelling of face nose and throat Severe panic bc of lack of air Mainly, swelled lips mouth and nose Took Benadryl and seemed to help some No new foods ingested. The outcome of all the events was resolving. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 39.0
Sex: F
Vaccine: COVID19
Symptoms: Pharyngeal swelling, Swelling face
Clinical narrative: Swelling of face nose and throat; Swelling of face nose and throat; Severe panic bc of lack of air; Severe panic bc of lack of air; swelled lips mouth and nose; swelled lips mouth and nose; swelled lips mouth and nose; This is a spontaneous report from a contactable consumer or other non hcp. A 39-years-old non-pregnant female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, Solution for injection, Batch/Lot number was not reported), via an unspecified route of administration on 25Oct2021 at 09:00 (at the age of 39-years-old) as dose 2, single for covid-19 immunisation. The medical history was not reported. Concomitant medications included buprenorphine hydrochloride, naloxone hydrochloride (SUBOXONE), fluoxetine hydrochloride (PROZAC) buspirone hydrochloride (BUSPAR). The patient did not have covid prior to the vaccination. The patient was not tested for COVID post vaccination. The patient had no Known allergies and no other medical history. The patient did not receive any other vaccine in four weeks. The patient received first dose of BNT162B2 on 04Oct2021 (Location: Arm Right) at 09:15 AM for covid-19 immunisation. On 29Oct2021 at 22:00 the patient experienced swelling of face nose and throat, severe panic bc of lack of air and swelled lips mouth and nose. Therapeutic measures were taken as a result of swelled lips mouth and nose. No treatment received for swelling of face nose and throat and severe panic bc of lack of air. The patient reported swelling of face nose and throat Severe panic bc of lack of air Mainly, swelled lips mouth and nose Took Benadryl and seemed to help some No new foods ingested. The outcome of all the events was resolving. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Dyspnoea, Erythema, Inflammation, Nuchal rigidity
Clinical narrative: With the second one, she just had her arm get red and inflamed; With the second one, she just had her arm get red and inflamed; difficulty breathing; light headed; rope around my neck; Dizzy; This is a spontaneous report from a contactable consumer. This 61-year-old female consumer(patient) reported that: A 61-years-old female patient received second dose of bnt162b2 (PFIZER BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot Number: EN5318), via intramuscular, administered in left arm on 30Jan2021 (at the age of 61-years-old) as DOSE 2, SINGLE for covid-19 immunization. Vaccination facility type: Nursing home/Senior living facility. Medical history included allergic reaction from an unknown date and unknown if ongoing. Concomitant medication(s) included methylprednisolone (MEDROL) taken for hypersensitivity from 19Oct2021 to 25Oct2021; cortisone (CORTISONE) taken for allergic reaction from 18Oct2021 to 18Oct2021; methylprednisolone acetate (MEDROL [METHYLPREDNISOLONE ACETATE]) taken for allergic reaction from 27Oct2021 to 02Nov2021 and amoxicillin, clavulanate potassium (AUGMENTIN [AMOXICILLIN; CLAVULANATE POTASSIUM]) taken for allergic reaction from 27Oct2021 to 02Nov2021. Prior vaccination, the patient had not received any other vaccine within four weeks. The patient had previously received first dose of bnt162b2 (PFIZER BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot Number: EK5730), via intramuscular, administered in right arm on 09Jan2021 (at the age of 61-years-old) as DOSE 1, SINGLE for covid-19 immunization. On an unspecified date, the patient experienced with the second one, she just had her arm get red and inflamed, difficulty breathing, light-headed, rope around my neck and dizzy. It was reported that, 1st vaccine fine 2nd vaccine arm red swollen booster. The patient had difficulty breathing, light-headed and dizzy. It felt like there was a rope around her neck. Went to family Doctor. Dr. said it was a severe allergic reaction. He gave a shot of cortisone a prescription for Medrol 4mg (methyl prednisone) went back to Dr. on 27Oct2021 because symptoms were better but not gone. He prescribed another Medrol pack and Augmentin 875 mg. Did a chest x ray which was good. On 27Oct2021, the patient underwent lab tests and procedures which included X-ray result was good. The patient required to visit Physician office for the adverse events. The patient had received treatment for the adverse events. The outcome of events was recovering at the time of this report.  Follow-up attempts are completed. No further information is expected
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: X-ray
Clinical narrative: With the second one, she just had her arm get red and inflamed; With the second one, she just had her arm get red and inflamed; difficulty breathing; light headed; rope around my neck; Dizzy; This is a spontaneous report from a contactable consumer. This 61-year-old female consumer(patient) reported that: A 61-years-old female patient received second dose of bnt162b2 (PFIZER BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot Number: EN5318), via intramuscular, administered in left arm on 30Jan2021 (at the age of 61-years-old) as DOSE 2, SINGLE for covid-19 immunization. Vaccination facility type: Nursing home/Senior living facility. Medical history included allergic reaction from an unknown date and unknown if ongoing. Concomitant medication(s) included methylprednisolone (MEDROL) taken for hypersensitivity from 19Oct2021 to 25Oct2021; cortisone (CORTISONE) taken for allergic reaction from 18Oct2021 to 18Oct2021; methylprednisolone acetate (MEDROL [METHYLPREDNISOLONE ACETATE]) taken for allergic reaction from 27Oct2021 to 02Nov2021 and amoxicillin, clavulanate potassium (AUGMENTIN [AMOXICILLIN; CLAVULANATE POTASSIUM]) taken for allergic reaction from 27Oct2021 to 02Nov2021. Prior vaccination, the patient had not received any other vaccine within four weeks. The patient had previously received first dose of bnt162b2 (PFIZER BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot Number: EK5730), via intramuscular, administered in right arm on 09Jan2021 (at the age of 61-years-old) as DOSE 1, SINGLE for covid-19 immunization. On an unspecified date, the patient experienced with the second one, she just had her arm get red and inflamed, difficulty breathing, light-headed, rope around my neck and dizzy. It was reported that, 1st vaccine fine 2nd vaccine arm red swollen booster. The patient had difficulty breathing, light-headed and dizzy. It felt like there was a rope around her neck. Went to family Doctor. Dr. said it was a severe allergic reaction. He gave a shot of cortisone a prescription for Medrol 4mg (methyl prednisone) went back to Dr. on 27Oct2021 because symptoms were better but not gone. He prescribed another Medrol pack and Augmentin 875 mg. Did a chest x ray which was good. On 27Oct2021, the patient underwent lab tests and procedures which included X-ray result was good. The patient required to visit Physician office for the adverse events. The patient had received treatment for the adverse events. The outcome of events was recovering at the time of this report.  Follow-up attempts are completed. No further information is expected
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Condition aggravated, Tinnitus
Clinical narrative: Extreme exacerbation of bilateral tinnitus; Extreme exacerbation of bilateral tinnitus; This is a spontaneous report from a contactable Nurse. A 59-year-old non-pregnant female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID -19 VACCINE, solution for injection, Lot Number: no reported, Expiry date: not reported) via an unspecified route of administration, administered in right arm on 31Mar2021 at 13:15 (59-year-old at the time of vaccination) as dose 1, single for COVID-19 immunization. Patient was not pregnant at the time of vaccination. Medical history included hypothyroidism, irritable bowel syndrome and constipation. Concomitant medication included lithium (LITHIUM), quetiapine (QUETIAPINE), gabapentin (GABAPENTIN), levothyroxine sodium (SYNTHROID), linaclotide (LINZESS). The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient was not diagnosed with COVID-19 prior to vaccination and not tested covid post vaccination. Since the vaccination, the patient has not been tested for COVID-19. The patient previously took Resperidone and experienced hypersensitivity. On 31Mar2021 at 12:00, the patient experienced extreme exacerbation of bilateral tinnitus. The patient did not receive any treatment for the event. The clinical outcome of the events was not recovered at the time of this report.  The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up; Sender's Comments: Based on the information provided and plausible temporal association, the causality between BNT162B2 and Tinnitus, Condition aggravated cannot be completely excluded.  The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
Age: 44.0
Sex: F
Vaccine: COVID19
Symptoms: Atrial fibrillation, Immunisation, SARS-CoV-2 test
Clinical narrative: Booster; Sudden onset Afib with RVR 3 days after the booster; This is a spontaneous report from a contactable physician. This physician reported for a 44-year-old female patient that:  A 44-year-old- non-pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection) (lot number: unknown), dose 3 via an unspecified route of administration on an unspecified date (age at vaccination: 44-years-old) as DOSE 3 (BOOSTER), SINGLE for covid-19 immunization. The patient was not pregnant at the time of vaccination. Relevant medical history included hypertension, obesity. It was unknown that the patient was diagnosed with COVID-19Prior to vaccination. Concomitant medication(s) included losartan (LOSARTAN); hydrochlorothiazide (HYDROCHLOROTHIAZIDE); nifedipine (NIFEDIPINE) taken for an unspecified indication, start and stop date were not reported (received within 2 weeks of vaccination). Historical vaccine included second dose of BNT162B2 (PFIZER-BIONTEC COVID-19 mRNA VACCINE; Lot Number: unknown), via an unspecified route of administration on 25Feb2021 (at the age of 44-years-old) as a DOSE 2, SINGLE for COVID-19 immunization and first dose of BNT162B2 (PFIZER-BIONTEC COVID-19 mRNA VACCINE; Lot Number: unknown), via an unspecified route of administration on 18Mar2021 (at the age of 44-years-old) as a DOSE 1, SINGLE for COVID-19 immunization and experienced Allergy. It was unknown that the patient received any other vaccines within 4 weeks prior to the COVID vaccine. On 12Nov2021, patient experienced sudden onset Afib with rvr 3 days after the booster. The patient was hospitalized for the events. Patient tested for COVID-19 after vaccination. The patient was hospitalized for sudden onset afib with rvr 3 days after the booster for 1 days. The patient underwent lab tests and procedures which included sars-cov-2 test negative on 13Nov2021 Nasal Swab. The event resulted to visit Emergency room/department or urgent care. Therapeutic measures were taken as a result of sudden onset afib with rvr 3 days after the booster with cardioversion and anticoagulation. The outcome was recovered on an unspecified date.  The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.; Sender's Comments: As there is limited information in the case provided, the causal association between the event atrial fibrillation and the suspect drug BNT162B2 cannot be excluded. The case will be reassessed once new information is available.  The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
Age: 50.0
Sex: F
Vaccine: COVID19, FLUX
Symptoms: Dermatitis contact, Drug hypersensitivity, Immunisation, Pruritus, Skin burning sensation
Clinical narrative: This is a spontaneous report from a contactable consumer (patient). A 50-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot Number: FF2593), via an unspecified route of administration, administered in arm left on 01Nov2021 10:00 (at the age of 50-years-old) as DOSE 3 (BOOSTER), SINGLE for covid-19 immunization; influenza vaccine (FLU), via an unspecified route of administration from 01Nov2021 (Lot number was not reported), at unspecified dose for an unspecified indication. The patient medical history included mitral valve prolapse, high cholesterol and anemia. Prior to vaccination, the patient was not diagnosed with COVID-19. There were no concomitant medications. The patient previously received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on 25Mar2021 11:00 AM as dose 1 (Lot number: EN6207), and on 15Apr2021 11:00 AM as dose 2 (Lot number: EW0162) both was administered in left arm for covid-19 immunization. Vaccines were administered at the Pharmacy/Drug Store. On 01Nov2021 at 10:30am, severe skin itching and burning in arms, back, butt, thighs, and legs. These were all still occurring since Booster Shot and Flu Shot on 01Nov2021. The patient was also diagnosed with contact dermatitis on 07Nov2021 by hospital. The patient does not have known allergies not until the booster shot and flu shot on 01Nov2021. The events resulted in emergency room/department. Treatment received for the events was OTC Cortisone, and an upcoming appointment for burns/itching. The outcome of the events was not recovered. Since the vaccination, the patient has not been tested for COVID-19.
Sex: U
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: ended up catching covid; ended up catching covid; This is a spontaneous report received from a contactable consumer (patient). A patient of unspecified age and gender received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as dose 1, single; the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as dose 2, single for covid-19 immunisation. The patient medical history was not reported. Concomitant medication included estrogens conjugated (PREMARIN). The patient experienced ended up catching covid on 30Aug2021 even though fully vaccinated. Outcome of the events was unknown.   The lot number for the vaccine BNT162B2, was not provided and will be requested during follow up.
Sex: M
Vaccine: COVID19
Symptoms: Drug ineffective, Immunisation, SARS-CoV-2 test positive, Suspected COVID-19
Clinical narrative: One of the family member had the booster shot a week prior to contracting COVID-19.; One of the family member had the booster shot a week prior to contracting COVID-19.; Dose received: 3; This is a spontaneous report from a contactable consumer. This consumer reported for a male patient.  A male patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection,Batch/Lot number: Not reported) via an unspecified route of administration on an unspecified date as DOSE 3 (BOOSTER), SINGLE, via an unspecified route of administration on an unspecified date (Batch/Lot number: Not reported) as DOSE 2, SINGLE and via an unspecified route of administration on an unspecified date (Batch/Lot number: Not reported) as DOSE 1, SINGLE for COVID-19 immunisation. It was unknown if the patient took other vaccine in four weeks. It was unknown if the patient had covid prior vaccination and it was unknown if the patient was covid tested post vaccination. The patient medical history and concomitant medications were not reported. Family history included COVID-19 (youngest child did not receive the vaccine and also contracted COVID-19) start and stop date not reported. The reporter was made aware of a family who was vaccinated with the Pfizer-BioNTech vaccine and contracted COVID-19. One of the family member had the booster shot a week prior to contracting COVID-19 (unspecified date). The family was not hospitalized, and symptoms were not severe.The patient Dose received: 3 and it led to Booster on an unspecified date. Treatment taken for adverse events was unknown. The patient underwent lab test and procedure which included COVID-19 PCR test: positive on an unspecified date. Outcome of event One of the family member had the booster shot a week prior to contracting COVID-19 was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 48.0
Sex: F
Vaccine: COVID19
Symptoms: Crying, Dysmenorrhoea, Heavy menstrual bleeding, Hyperhidrosis, Mobility decreased
Clinical narrative: her cycle came on so painful and so heavy/ pain was so severe; her cycle came on so painful and so heavy and when she stood up it poured out of her which was unusual; she was throwing up and was crying; she was throwing up and was crying; her cycle came on so fierce and was so heavy and so painful that she could not move; she was sweating profusely; sore arm; This is a spontaneous report from a contactable consumer (patient reporting for herself). A 48-year-old female patient received the first dose of BNT162B2 (PFIZER BIONTECH COVID-19 VACCINE) via an unspecified route of administration, administered in the left arm, on 07Oct2021 (batch/lot number: FE359 and expiration date: 28Feb2022) at the age of 48 years old, as DOSE 1, SINGLE for COVID-19 immunization. The patient's medical history included very regular menstrual cycle. Patient can tell what day her cycle is supposed to come and has never had intermittent bleeding even when she was pregnant with her children. There is no family medical history relevant to events reported. There were no concomitant medications and no prior vaccinations (within 4 weeks). Patient reported that when she got the first vaccine on 07Oct2021, her cycle was not due until 14Oct2021 or around there. On 07Oct2021 she had a sore arm. When her cycle came on 15Oct2021, when it actually came, she was out of town and couldn't leave her hotel because her cycle came on so painful and so heavy. When she stood up, it poured out of her which was unusual. She did not associate it with the shot which occurred on 07Oct2021. She thought it was a bad cycle and the pain was so severe, she was throwing up and was crying and nothing like that had happened to her before and she never associated it with the shot because it did not click with her when her cycle came and was supposed to come. Her cycle came on so fierce and was so heavy and so painful that she could not move and to throw up from her cycle, she was sweating profusely, started crying, and the pain was so severe. She thought about going to the Emergency room, but she never went to the doctor for her cycle ever. The events did not require a visit to the Emergency Room or a Physician Office No relevant tests were performed. The outcome of the events was unknown.  Follow-up attempts completed. No further information is expected.
Age: 48.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity, Vomiting
Clinical narrative: her cycle came on so painful and so heavy/ pain was so severe; her cycle came on so painful and so heavy and when she stood up it poured out of her which was unusual; she was throwing up and was crying; she was throwing up and was crying; her cycle came on so fierce and was so heavy and so painful that she could not move; she was sweating profusely; sore arm; This is a spontaneous report from a contactable consumer (patient reporting for herself). A 48-year-old female patient received the first dose of BNT162B2 (PFIZER BIONTECH COVID-19 VACCINE) via an unspecified route of administration, administered in the left arm, on 07Oct2021 (batch/lot number: FE359 and expiration date: 28Feb2022) at the age of 48 years old, as DOSE 1, SINGLE for COVID-19 immunization. The patient's medical history included very regular menstrual cycle. Patient can tell what day her cycle is supposed to come and has never had intermittent bleeding even when she was pregnant with her children. There is no family medical history relevant to events reported. There were no concomitant medications and no prior vaccinations (within 4 weeks). Patient reported that when she got the first vaccine on 07Oct2021, her cycle was not due until 14Oct2021 or around there. On 07Oct2021 she had a sore arm. When her cycle came on 15Oct2021, when it actually came, she was out of town and couldn't leave her hotel because her cycle came on so painful and so heavy. When she stood up, it poured out of her which was unusual. She did not associate it with the shot which occurred on 07Oct2021. She thought it was a bad cycle and the pain was so severe, she was throwing up and was crying and nothing like that had happened to her before and she never associated it with the shot because it did not click with her when her cycle came and was supposed to come. Her cycle came on so fierce and was so heavy and so painful that she could not move and to throw up from her cycle, she was sweating profusely, started crying, and the pain was so severe. She thought about going to the Emergency room, but she never went to the doctor for her cycle ever. The events did not require a visit to the Emergency Room or a Physician Office No relevant tests were performed. The outcome of the events was unknown.  Follow-up attempts completed. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Blood test, COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: test done and is positive for Covid; positive for Covid/ She was still tasted the food was dull taken as loss of taste; This is a spontaneous report from a contactable consumer (patient herself). A 73-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot Number: EW0175) via an unspecified route, administered in Left upper arm in the morning on 04May2021 (73-year-old at vaccination) as Dose 2, Single for COVID-19 immunization. The patient's medical history, family medical history relevant to AE(s) was reported as none. No concomitant medications were reported. The patient was not related to a study or programme. Vaccination facility was reported a college and not military facility. The patient had neither received any other additional vaccines within 4 weeks prior to vaccination nor on the same day of Pfizer vaccination. The patient had no Ae(s) following prior to vaccination. Historical vaccine included first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8732), via an unspecified route of administration in left upper arm on 13Apr2021 as a Dose 1, Single for COVID-19 immunization. On unspecified date, reporter stated she had two of the vaccines, and her last one was 04May2021 and then two weeks ago she had blood drawn and showed up positive for Covid, 342 u/ml on an unspecified date and SARS CoV-1 test result was positive on 28Oct2021. She does not have symptoms around that time and does not know if it was from Covid or not. She queried if it was Covid or was 342 units indicated that she had covid or was this results due to getting the vaccine in her system. The reporter also stated that she was tested negative last Thursday and asked if she needs to wait to receive the booster for a couple of months. She reported that, she was still tasted the food was dull, it does not taste the same, but other than her taste she felt like she had recovered. She took no medications. These adverse events did not result in emergency room/physician office. The outcome of the event asymptomatic Covid-19 was unknown.  Follow-up attempts are completed. No further information is expected.
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Chest pain, Dizziness, Dyspnoea, Heart rate, Heart rate decreased
Clinical narrative: shortness of breath; difficulty breathing; low heart rate; chest pain; Light headed; DOSE 3 (BOOSTER), SINGLE; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 66-year-old female patient (not pregnant) received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), administered in arm right, administration date 03Nov2021 00:30 (Lot number: 301S88A) at the age of 66 years as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included: "DVT left leg", start date: 2006 (unspecified if ongoing), notes: Other medical history: DVT left leg 2006. No other vaccine in four weeks and no other medications in two weeks. No Covid prior vaccination. There were no concomitant medications. Past drug history included: Naproxen, reaction(s): "Known allergies", notes: Known allergies: Naproxen. Vaccination history included: first dose of Bnt162b2 (lot number= EN6204) on 17Mar2021 at 10:30 AM administered in right arm, when the patient was 65 years old, for COVID-19 immunization; and second dose of Bnt162b2 (lot number= ER8737) on 07May2021 at 11:30 AM administered in right arm, when the patient was 65 years old, for COVID-19 immunization. The following information was reported: IMMUNISATION (hospitalization) with onset 03Nov2021 00:30, outcome "unknown", described as "DOSE 3 (BOOSTER), SINGLE"; DYSPNOEA (hospitalization) with onset 03Nov2021 14:30, outcome "not recovered", described as "shortness of breath"; DYSPNOEA (hospitalization) with onset 03Nov2021 14:30, outcome "not recovered", described as "difficulty breathing"; HEART RATE DECREASED (hospitalization) with onset 03Nov2021 14:30, outcome "not recovered", described as "low heart rate"; CHEST PAIN (hospitalization) with onset 03Nov2021 14:30, outcome "not recovered", described as "chest pain"; DIZZINESS (hospitalization) with onset 03Nov2021 14:30, outcome "not recovered", described as "Light headed". The patient was hospitalized for immunisation, dyspnoea, dyspnoea, heart rate decreased, chest pain, dizziness (hospitalization duration: 2 day(s)). The events "dose 3 (booster), single", "shortness of breath", "difficulty breathing", "low heart rate", "chest pain" and "light headed" were evaluated at the physician office visit and emergency room visit. The patient underwent the following laboratory tests and procedures: heart rate: (03Nov2021) low; Nasal Swab: (11Nov2021) negative, notes: covid test post vaccination. Therapeutic measures were taken as a result of immunisation, dyspnoea, dyspnoea, heart rate decreased, chest pain, dizziness included Lidocaine patch, lovanox injection, heart monitor.   Follow-up attempts are completed. No further information is expected.