chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 26.0
Sex: F
Vaccine: COVID19
Symptoms: Heavy menstrual bleeding, Immunisation, Menstrual disorder, SARS-CoV-2 test
Clinical narrative: bleeding heavy; my menstrual cycle came early; booster; This is a spontaneous report from a contactable other HCP.     A 26-years-old female Non pregnant patient received bnt162b2 (BNT162B2 PFIZER BIOTECH MRNA COVID 19 SOLUTION FOR INJECTION, (Batch/Lot Number: EW0172), dose 3 via an unspecified route of administration, administered in Arm Left on 03Nov2021 13:00 as dose 3 (booster), single for covid-19 immunisation. Medical history included hypertension, food allergy. Concomitant medication(s) included lisdexamfetamine mesilate (VYVANSE); hydrochlorothiazide (HYDROCHLOROTHIAZIDE); lamotrigine (LAMICTAL); buspirone hydrochloride (BUSPAR). patient previously took bnt162b2 for covid-19 immunisation, bnt162b2 for covid-19 immunisation, phenergan [promethazine] and experienced drug hypersensitivity. Patient was not Pregnant at the time of vaccination. The patient had not received any other vaccine within 4 weeks, Patient had not been diagnosed with COVID-19 prior to vaccination and had not been tested since the vaccination patient receive other medications the patient received within 2 weeks of vaccination:Vyvanse, hydroclothized, lamictal, buspar.It was Reported that, The patient experienced booster on 03Nov2021 13:00 with outcome of unknown, bleeding heavy, my menstrual cycle came early on 05Nov2021 07:45 with outcome of unknown. The patient underwent lab tests and procedures which included sars-cov-2 test: negative on 29Sep2021 Nasal Swab.  Follow-Up (10Nov2021): Follow-up attempts are completed. No further information is expected.
Age: 40.0
Sex: F
Vaccine: COVID19
Symptoms: Body height, Immunisation, Vaccination site pain, Weight
Clinical narrative: Received third shot of COMIRNATY on 05Nov2021; Soreness in arm where vaccine was administered; This is a spontaneous report from a contactable consumer. A 40-year-old female patient received the third dose of BNT162b2 (COMIRNATY; Lot Number: UNKNOWN) on 05Nov2021 via an unspecified route of administration as a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. On the date of Nov2021 patient experienced soreness in arm where vaccine was administered and on 05Nov2021 the patient received third shot of COMIRNATY. The patient underwent lab tests and procedures which included body height: 6 feet and weight: 157. The outcome of the events was not reported.   The lot number for the vaccine [BNT162B2], was not provided and will be requested during follow up.
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Cough, Dyspnoea, Heart rate increased, Immunisation, Pain in extremity
Clinical narrative: booster; Left arm really hurts; heart rate is 116 currently; cough; short of breath; Keeps clearing throat; This is a spontaneous report from a contactable consumer (patient). A 63-year-old female patient received bnt162b2 (COMIRNATY- formulation: solution for injection, Batch/Lot Number: FH8020), dose 3 via an unspecified route of administration, administered in Arm Left on 09Nov20211, (at the age of 63-year-old) as DOSE 3 (BOOSTER), SINGLE for covid-19 immunisation. The patient medical history and concomitant medications reported as none. The patient's historical vaccine included first dose of bnt162b2 (COMIRNATY- formulation: solution for injection, Batch/Lot Number: EN6206), dose 1 via an unspecified route of administration, on 05Mar2021, as DOSE 1, SINGLE for covid-19 immunisation and second dose of bnt162b2 (COMIRNATY- formulation: solution for injection, Batch/Lot Number: EN6204), dose 2 via an unspecified route of administration, on 26Mar2021, as DOSE 2, SINGLE for covid-19 immunisation. The patient experienced cough, short of breath, keeps clearing throat on 10Nov2021, and left arm really hurts, heart rate is 116 currently and booster on an unspecified date. Caller (patient) reported that, her Pfizer COVID-19 vaccine booster dose yesterday on 09Nov20211, around 14:30 she is complaining of a deep cough and having to clear her throat and while on the phone looked at her watch and her resting heart rate is 116 currently and since she is coughing so much right now is starting to get short of breath. She is wondering if this could be a possible side effect of the booster. She said she is just wondering, because she hasn't read it anywhere, if these are possible side effects. Patient denies any other medications, medical conditions, labs, testing, or treatments relevant to events. Patient stated that she does take medications, she doesn't think they are relevant because she took them before. Caller states that these symptoms started today. The patient underwent lab tests and procedures which included heart rate increased: 116 on an unspecified date. No therapeutic measures were taken as a result of the events. The outcome of the events was reported as unknown.  Follow-up attempts are completed. No further information is expected.
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Throat irritation
Clinical narrative: booster; Left arm really hurts; heart rate is 116 currently; cough; short of breath; Keeps clearing throat; This is a spontaneous report from a contactable consumer (patient). A 63-year-old female patient received bnt162b2 (COMIRNATY- formulation: solution for injection, Batch/Lot Number: FH8020), dose 3 via an unspecified route of administration, administered in Arm Left on 09Nov20211, (at the age of 63-year-old) as DOSE 3 (BOOSTER), SINGLE for covid-19 immunisation. The patient medical history and concomitant medications reported as none. The patient's historical vaccine included first dose of bnt162b2 (COMIRNATY- formulation: solution for injection, Batch/Lot Number: EN6206), dose 1 via an unspecified route of administration, on 05Mar2021, as DOSE 1, SINGLE for covid-19 immunisation and second dose of bnt162b2 (COMIRNATY- formulation: solution for injection, Batch/Lot Number: EN6204), dose 2 via an unspecified route of administration, on 26Mar2021, as DOSE 2, SINGLE for covid-19 immunisation. The patient experienced cough, short of breath, keeps clearing throat on 10Nov2021, and left arm really hurts, heart rate is 116 currently and booster on an unspecified date. Caller (patient) reported that, her Pfizer COVID-19 vaccine booster dose yesterday on 09Nov20211, around 14:30 she is complaining of a deep cough and having to clear her throat and while on the phone looked at her watch and her resting heart rate is 116 currently and since she is coughing so much right now is starting to get short of breath. She is wondering if this could be a possible side effect of the booster. She said she is just wondering, because she hasn't read it anywhere, if these are possible side effects. Patient denies any other medications, medical conditions, labs, testing, or treatments relevant to events. Patient stated that she does take medications, she doesn't think they are relevant because she took them before. Caller states that these symptoms started today. The patient underwent lab tests and procedures which included heart rate increased: 116 on an unspecified date. No therapeutic measures were taken as a result of the events. The outcome of the events was reported as unknown.  Follow-up attempts are completed. No further information is expected.
Age: 11.0
Sex: M
Vaccine: COVID19
Symptoms: Asthenia, Chest pain, Dizziness, Feeling hot, Hyperhidrosis
Clinical narrative: Trembling of limbs (hands); Numbness in palms/fingers; Burning in chest; Hot forehead; Sweating; Weakness; Dizziness; This is a spontaneous report from a contactable consumer or other non hcp. A 11-years-old male patient received bnt162b2 (BNT162B2, Solution for injection, Batch/Lot Number: FK5127), via an unspecified route of administration, administered in Arm Left on 09Nov2021 18:45 as(Age at vaccination 11 Years) DOSE 1, SINGLE for covid-19 immunisation. Medical history were none and there were no concomitant medications. No other vaccines were received within 4 weeks prior to the COVID vaccine and No other medications were received within 2 weeks of vaccination. Prior to vaccination, the patient was not diagnosed with COVID-19 and Since the vaccination, the patient was not tested for COVID-19. On 09Nov2021 18:55, The patient experienced trembling of limbs, numbness in palms/fingers, burning in chest, hot forehead, sweating, weakness, dizziness. Therapeutic measures were taken as a result of trembling of limbs (hands) (tremor), numbness in palms/fingers, burning in chest, hot forehead, sweating, weakness, dizziness. Hydroxyzine treatment received for the adverse event. The outcome of the events was recovered on unspecified date in 2021.  Follow-up attempts are completed. No further information is expected.
Age: 11.0
Sex: M
Vaccine: COVID19
Symptoms: Hypoaesthesia, Tremor
Clinical narrative: Trembling of limbs (hands); Numbness in palms/fingers; Burning in chest; Hot forehead; Sweating; Weakness; Dizziness; This is a spontaneous report from a contactable consumer or other non hcp. A 11-years-old male patient received bnt162b2 (BNT162B2, Solution for injection, Batch/Lot Number: FK5127), via an unspecified route of administration, administered in Arm Left on 09Nov2021 18:45 as(Age at vaccination 11 Years) DOSE 1, SINGLE for covid-19 immunisation. Medical history were none and there were no concomitant medications. No other vaccines were received within 4 weeks prior to the COVID vaccine and No other medications were received within 2 weeks of vaccination. Prior to vaccination, the patient was not diagnosed with COVID-19 and Since the vaccination, the patient was not tested for COVID-19. On 09Nov2021 18:55, The patient experienced trembling of limbs, numbness in palms/fingers, burning in chest, hot forehead, sweating, weakness, dizziness. Therapeutic measures were taken as a result of trembling of limbs (hands) (tremor), numbness in palms/fingers, burning in chest, hot forehead, sweating, weakness, dizziness. Hydroxyzine treatment received for the adverse event. The outcome of the events was recovered on unspecified date in 2021.  Follow-up attempts are completed. No further information is expected.
Age: 34.0
Sex: F
Vaccine: COVID19
Symptoms: Immunisation, Ventricular extrasystoles
Clinical narrative: PVCs; dose number=3; This is a spontaneous report from a contactable consumer (Patient). A non-pregnant 34-years-old female patient received third dose of bnt162b2 (COMIRNATY, solution for injection) (Batch/Lot Number: FH8020), dose 3 via an unspecified route of administration, administered in Arm Right on 21Oct2021 as dose 3 (booster), single (age at vaccination: 34-year-old) for covid-19 immunization. The patient medical history was not reported. The patient was not pregnant at Time of Vaccination. There was no other vaccine in four weeks. Concomitant medications in two weeks included vitamin c [ascorbic acid] (VITAMIN C [ASCORBIC ACID]); melatonin (MELATONIN); cetirizine hydrochloride (ZYRTEC [CETIRIZINE HYDROCHLORIDE]) taken for an unspecified indication, start and stop date were not reported. Reportedly, patient was not diagnosed with COVID-19 prior to vaccination. Patient had not been tested for COVID-19 since the vaccination. Historical vaccine included first dose of BNT162B2 (PFIZER-BIONTEC COVID-19 mRNA VACCINE; Lot Number: EN6207), via an unspecified route of administration in the right arm on 12Mar2021 and second dose of BNT162B2 (PFIZER-BIONTEC COVID-19 mRNA VACCINE; Lot Number: EN6206), via an unspecified route of administration in the right arm on 31Mar2021, single for COVID-19 immunization. On 22Oct2021, patient experienced PVCs (Premature ventricular contractions). Therapeutic measures were taken as a result of pvcs. The patient has not had covid prior vaccination and not tested for covid post vaccination. The event resulted in doctor or other healthcare professional office/clinic visit. The treatment for event included Magnesium, beta blocker. The outcome of event pvcs was not recovered.  Follow-up attempts are completed. No further information is expected.
Age: 23.0
Sex: F
Vaccine: COVID19
Symptoms: Ageusia, Immunisation, Weight, Weight increased
Clinical narrative: weight little heavier between 190-200lbs; muted taste, can still taste, but seems less; Had the vaccine at 10:00AM today, 11Nov2021; This is a spontaneous report from a contactable consumer (patient) or other non hcp. A 23-years-old female patient received bnt162b2 (COMIRNATY), dose 3 via an unspecified route of administration, administered in Arm Left on 11Nov2021 10:00 (at the age of 23-year-old) (Lot Number: FH8028) as DOSE 3 (BOOSTER), SINGLE for covid-19 immunisation. Medical history included, from an unknown date and unknown if ongoing Patient's Medical History: None, from an unknown date and unknown if ongoing Family Medical History Relevant to AE(s): None. There were no concomitant medications.  The patient previously received first doses of BNT162B2, lot number was not reported) via an unspecified route of administration on 26Feb2021 dose 1, single and second dose of BNT162B2, lot number was not reported) via an unspecified route of administration on 26Mar2021  respectively for covid-19 immunisation. The patient had the vaccine at 10:00 am today, 11nov2021 and patient experienced muted taste, can still taste, but seems less on 11Nov2021 12:00. It was reported that there is currently no information on "muted taste". Patient experiencing this a little bit. When she is trying to eat some things, the taste is a little off. Could be the things she's eating. She did get the vaccine today. Wondering if it's the vaccine or if she should go get tested. States she's a little heavier between 190-200lbs. Patient did not received treatment for muted taste, can still taste, but seems less. Patient underwent lab test and procedures included weight little heavier between 190-200lbs. The outcome of event muted taste, can still taste, but seems less was recovering and for weight little heavier between 190-200lbs was Unknown.    No follow-up attempts are needed. No further information is expected.
Sex: U
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: tested positive for COVID; tested positive for COVID; This is a spontaneous report from a non-contactable consumer (patient). A patient of an unspecified age and gender received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE Solution for injection), via an unspecified route of administration, on an unspecified date (lot number unknown), as dose 1, single, for COVID-19 immunisation. Relevant medical history and concomitant medications were not reported. The patient received her first COVID-19 shot recently (unspecified date) and tested positive for COVID-19 on 10Nov2021. The outcome of the events was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: patient had what was described as "the virus" (implying the corona virus); patient had what was described as "the virus" (implying the corona virus); This is a spontaneous report from a contactable consumer via a Pfizer colleague.  An adult male patient received bnt162b2 (BNT162B2), dose 2 via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as DOSE 2, SINGLE; dose 1 via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as DOSE 1, SINGLE for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. It was reported that the patient had what was described as "the virus" (implying the corona virus) and was recovering. At the time of the report, the patient was still congested from the disease. Outcome of the events was recovering.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected
Age: 35.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Chest pain, Chills, Headache, Immunisation
Clinical narrative: Fever 103; headache; swollen/very painful lymph node under armpit; swollen/very painful lymph node under armpit; pain irradiated into chest; body aches; chills; booster; This is a spontaneous report from a contactable consumer. This 35-year-old female consumer (patient) reported that she received 3rd dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, FH8020) booster dose single on 09Nov2021 02:30 PM at left arm for COVID-19 immunization at the age of 35 years old. Medical history included known allergies; Sulfa meds. Historical vaccine included 1st dose of BNT162B2 (lot EN6202) on 02Mar2021 at 07:00 AM at left arm and 2nd dose of BNT162B2 (lot EN6203) on 23Mar2021 07:30 AM at left arm both for COVID-19 immunization at the age of 34 years old.  Concomitant drugs included diazepam, isopropamide iodide (VALTRAX), ethinylestradiol, norethisterone acetate (JUNEL) and cetirizine hydrochloride (ZYRTEC ALLERGY). The patient experienced fever 103, swollen/very painful lymph node under armpit, pain irradiated into chest, body aches, chills, headache on 09Nov2021 08:00 PM. No treatment was received for the events. The outcome of the events was not resolved.   Follow-up attempts are completed. No further information is expected.
Age: 35.0
Sex: F
Vaccine: COVID19
Symptoms: Lymph node pain, Lymphadenopathy, Pain, Pyrexia
Clinical narrative: Fever 103; headache; swollen/very painful lymph node under armpit; swollen/very painful lymph node under armpit; pain irradiated into chest; body aches; chills; booster; This is a spontaneous report from a contactable consumer. This 35-year-old female consumer (patient) reported that she received 3rd dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, FH8020) booster dose single on 09Nov2021 02:30 PM at left arm for COVID-19 immunization at the age of 35 years old. Medical history included known allergies; Sulfa meds. Historical vaccine included 1st dose of BNT162B2 (lot EN6202) on 02Mar2021 at 07:00 AM at left arm and 2nd dose of BNT162B2 (lot EN6203) on 23Mar2021 07:30 AM at left arm both for COVID-19 immunization at the age of 34 years old.  Concomitant drugs included diazepam, isopropamide iodide (VALTRAX), ethinylestradiol, norethisterone acetate (JUNEL) and cetirizine hydrochloride (ZYRTEC ALLERGY). The patient experienced fever 103, swollen/very painful lymph node under armpit, pain irradiated into chest, body aches, chills, headache on 09Nov2021 08:00 PM. No treatment was received for the events. The outcome of the events was not resolved.   Follow-up attempts are completed. No further information is expected.
Age: 58.0
Sex: M
Vaccine: COVID19
Symptoms: Joint swelling, Psoriatic arthropathy
Clinical narrative: PSA has flared; Knees are constantly swollen; This is a spontaneous report from a contactable consumer (patient). A 58-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 2 via an unspecified route of administration on 16Aug2021 (Lot Number: FC3180) at age of 58-year-old as DOSE 2, SINGLE for COVID-19 immunization.  Medical history included Psoriatic arthritis (PSA) (Humira is not effective anymore). There were no concomitant medications. No other vaccine in four weeks and no other medications in two weeks. Historical vaccine included first dose of COVID19 Vaccine (dose brand name unknown) for COVID-19 immunization. Since receiving vaccine, his PSA has flared. Humira was not effective anymore. Knees were constantly swollen after years of being under control with Humira. No covid prior vaccination. No covid tested post vaccination. No known allergies. The outcome of the events was not recovered.  No follow-up attempts are possible. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Drug ineffective, Suspected COVID-19
Clinical narrative: had 1st dose of covid vaccine. After vaccine had gotten covid; had 1st dose of covid vaccine. After vaccine had gotten covid; This is a spontaneous report from Pfizer-sponsored program, from a non-contactable consumer (patient). A male patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on an unspecified date (lot number and expiry date: unknown) as dose 1, single, for Covid-19 immunization. The patient's medical history and concomitant medications were not reported. On unspecified date, after the first vaccine, the patient experienced Covid. Patient wanted to know if he can get the 2nd dose. Outcome of the events was unknown.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Cognitive disorder, Dementia
Clinical narrative: Dementia; cognitive decline; This is a spontaneous report from a contactable consumer (patient). A 67-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), vaccinated at age of 67 years old, dose 2 via an unspecified route of administration, administered in Arm Left on 02Jun2021 (Batch/Lot Number: EW0185) as DOSE 2, SINGLE for covid-19 immunisation. Medical history included rheumatoid arthritis and allergies Sulfa. Concomitant medications included atenolol; methotrexate sodium; and leucovorin [folinic acid]. The patient previously took first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/Lot No: EW0108) in arm left on 12May2021 at age of 67 years old for covid-19 immunisation; erythromycin, and clarithromycin (MACROBID) and experienced allergy. Patient experienced cognitive decline, rapid onset and moderate, concerning. Memory, recall, concentration. "Dementia" like symptoms, previously nonexistent. No treatment was received for both events. Events onset date was 14Jul2021. The outcomes of events were not recovered.   Follow-up attempts are completed. No further information is expected.
Age: 11.0
Sex: M
Vaccine: COVID19
Symptoms: Product administered to patient of inappropriate age, Seizure
Clinical narrative: patient had seizure the evening of receiving the vaccine; 11-Year-Old male patient; This is a spontaneous report from a contactable consumer or other non hcp. A 11-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), vaccinated at the of 11 years old, dose 1 via an unspecified route of administration on 11Nov2021 as DOSE 1, SINGLE for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient had seizure the evening of receiving the vaccine on 11Nov2021 with outcome of unknown.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Immunisation, Off label use, Vomiting
Clinical narrative: off label use; Booster; Vomiting; This is a non-interventional study report from contactable consumer (patient himself) received via the marketing program by Regulatory Authority. This is a solicited report based on the information received by Pfizer from Regulatory Authority, manufacturer control number: 21K-163-4149632-00.  A 77-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, solution for injection, lot number was not reported) via an intramuscular route on unspecified date in 2021 (age at the time of vaccination was 77 years old) as Dose 3 (Booster), Single for Covid-19 immunization (reported as Covid-19 vaccination) and upadacitinib (RINVOQ) via oral route from 03Mar2021 to 03Mar2021 for unknown dose taken for an unspecified indication. The patient's medical history and concomitant medications were not reported. It was unknown if patient was enrolled in a COVID-19 Vaccine Trial. The patient previously received historical vaccine bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot number was not reported) via intramuscular route on 03Mar2021 (age at the time of vaccination was 77 years old) as Dose 1, Single and received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot number was not reported) via intramuscular route on 20Apr2021 (age at the time of vaccination was 77 years old) as Dose 2, Single, both doses for Covid-19 immunization. On unknown date in 2021, the patient had experienced vomiting after he had booster shot. Action taken with upadacitinib (RINVOQ) was reported as unknown. The outcome of the event vomiting was unknown.  The reporter's assessment of the causal relationship of vomiting with Rinvoq (Upadacitinib) was not provided.  The reporter's assessment of the causal relationship of vomiting with the suspect bnt162b2 was reported as Possible.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Based on available information and the drug temporal relationship, the causality between the events immunisation, off label use, vomiting and the suspect drug "BNT162B2" cannot be completely excluded.
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Bronchoscopy, Cough, Increased viscosity of bronchial secretion, Pneumonitis, Respiratory disorder
Clinical narrative: Dx with eosinophilic pneumonitis; Breathing problems; cough; thick phlegm, waxing and waning; This is a spontaneous report from a contactable physician. This physician reported for a 59-years-old non-pregnant female patient received bnt162b2 (BNT162B2), dose 1 via an unspecified route of administration on 26Aug2021 (Batch/Lot number was not reported) as DOSE 1, SINGLE for COVID-19 immunisation at the age of 59 years old.  Medical history included known allergies: Penicillins. No COVID prior vaccination. There were no concomitant medications.  The patient previously took doxycycline and experienced allergies. On 30Aug2021, the patient experienced Breathing problems with cough and thick phlegm, waxing and waning infiltrates not responsive to several rounds of antibiotics. Dx with eosinophilic pneumonitis 20Oct by bronchoscopy. Events resulted in Doctor or other healthcare professional office/clinic visit, Emergency room/department or urgent care. Treatment included: prednisone prolonged Rx course. Patient had Nasal Swab Covid tested post on 18Oct2021 with unknown results. The outcome of events was Recovering.   The lot number for the vaccine BNT162B2 was not provided and will be requested during follow up.; Sender's Comments: As per available information in the case provided, the causal association between the event pneumonitis and the suspect drug cannot be excluded. The impact of this report on the benefit-risk profile of the Pfizer product and on the conduct of the study 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: 59.0
Sex: F
Vaccine: COVID19
Symptoms: SARS-CoV-2 test
Clinical narrative: Dx with eosinophilic pneumonitis; Breathing problems; cough; thick phlegm, waxing and waning; This is a spontaneous report from a contactable physician. This physician reported for a 59-years-old non-pregnant female patient received bnt162b2 (BNT162B2), dose 1 via an unspecified route of administration on 26Aug2021 (Batch/Lot number was not reported) as DOSE 1, SINGLE for COVID-19 immunisation at the age of 59 years old.  Medical history included known allergies: Penicillins. No COVID prior vaccination. There were no concomitant medications.  The patient previously took doxycycline and experienced allergies. On 30Aug2021, the patient experienced Breathing problems with cough and thick phlegm, waxing and waning infiltrates not responsive to several rounds of antibiotics. Dx with eosinophilic pneumonitis 20Oct by bronchoscopy. Events resulted in Doctor or other healthcare professional office/clinic visit, Emergency room/department or urgent care. Treatment included: prednisone prolonged Rx course. Patient had Nasal Swab Covid tested post on 18Oct2021 with unknown results. The outcome of events was Recovering.   The lot number for the vaccine BNT162B2 was not provided and will be requested during follow up.; Sender's Comments: As per available information in the case provided, the causal association between the event pneumonitis and the suspect drug cannot be excluded. The impact of this report on the benefit-risk profile of the Pfizer product and on the conduct of the study 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: 72.0
Sex: F
Vaccine: COVID19
Symptoms: Chest discomfort, Chills, Immunisation, Insomnia, Nausea
Clinical narrative: Arm had shooting pains at injection site; experienced 12 hours straight of constant chills and terrible nausea; experienced 12 hours straight of constant chills and terrible nausea; Slept on and off all day the day after shot.; Night of shot felt as if someone was standing on center of my chest; Booster; This is a spontaneous report from a contactable consumer or other non hcp (Patient). A 72-years-old non-pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot Number: 30145BA), dose 3 via an unspecified route of administration, administered in Arm Right on 10Nov2021 09:00 as dose 3 (booster), single for covid-19 immunisation (at the age of 72-years-old). Medical history included, high cholesterol, pre-diabetic, drug hypersensitivity from an unknown date and allergic to some meds but never vaccinations. Concomitant medication included simvastatin. Historical Vaccine included BNT162B2 (lot number:EN6201) as dose 1 on 17Feb2021 and BNT162B2 (lot number:EN6204) as dose 2 on 08Mar2021 for COVID-19 immunization. Both the vaccination was done at the age of 71-years-old. After both the doses the patient had soreness in arm. On 10Nov2021 at 18:00, the patient experienced arm had shooting pains at injection site, experienced 12 hours straight of constant chills and terrible nausea, slept on and off all day the day after shot, night of shot felt as if someone was standing on center of my chest. The event chills was on and off for another six hours as well as some nausea. Facility where the most recent COVID-19 vaccine was administered was a Hospital. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID. Since the vaccination, the patient has not been tested for COVID-19. The events were reported as non-serious. Outcome of the events was recovering.   Follow-up attempts are completed. No further information is expected.
Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: Arm had shooting pains at injection site; experienced 12 hours straight of constant chills and terrible nausea; experienced 12 hours straight of constant chills and terrible nausea; Slept on and off all day the day after shot.; Night of shot felt as if someone was standing on center of my chest; Booster; This is a spontaneous report from a contactable consumer or other non hcp (Patient). A 72-years-old non-pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot Number: 30145BA), dose 3 via an unspecified route of administration, administered in Arm Right on 10Nov2021 09:00 as dose 3 (booster), single for covid-19 immunisation (at the age of 72-years-old). Medical history included, high cholesterol, pre-diabetic, drug hypersensitivity from an unknown date and allergic to some meds but never vaccinations. Concomitant medication included simvastatin. Historical Vaccine included BNT162B2 (lot number:EN6201) as dose 1 on 17Feb2021 and BNT162B2 (lot number:EN6204) as dose 2 on 08Mar2021 for COVID-19 immunization. Both the vaccination was done at the age of 71-years-old. After both the doses the patient had soreness in arm. On 10Nov2021 at 18:00, the patient experienced arm had shooting pains at injection site, experienced 12 hours straight of constant chills and terrible nausea, slept on and off all day the day after shot, night of shot felt as if someone was standing on center of my chest. The event chills was on and off for another six hours as well as some nausea. Facility where the most recent COVID-19 vaccine was administered was a Hospital. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID. Since the vaccination, the patient has not been tested for COVID-19. The events were reported as non-serious. Outcome of the events was recovering.   Follow-up attempts are completed. No further information is expected.
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Cerebrovascular accident, Electrocardiogram, Fall, Movement disorder, SARS-CoV-2 test
Clinical narrative: Thinking I was having a stroke; I collapsed to the floor and could not get up for 10 minutes.; I had no response from my legs or arms or hands; This is a spontaneous report from a contactable consumer (patient). A 72-year-old non-pregnant female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number was not reported, Expiry date was not reported) via an unspecified route of administration, administered in Arm Right on 06Apr2021 at 12:00 (at the age of 71 years old) as DOSE 1, SINGLE for covid-19 immunisation. The patient was not pregnant at the time of vaccination. Medical history included Cancer from an unknown date and unknown if ongoing, Known allergies: sulpha from an unknown date and unknown if ongoing. Concomitant medication(s) included alprazolam (ALPRAZOLAM) taken for an unspecified indication, start and stop date were not reported; sertraline (SERTRALINE) taken for an unspecified indication, start and stop date were not reported; hydrochlorothiazide (HYDROCHLOROTHIAZIDE) taken for an unspecified indication, start and stop date were not reported. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has been tested for COVID-19. The patient had not received any other vaccine within 4 weeks. List of other medications the patient received within 2 weeks of vaccination was Alprazolam, Sertraline, Hydrochlorothiazide. The reporter reported that, 2 weeks after first dose (on 20Apr2021 16:00), I collapsed to the floor and could not get up for 10 minutes. I had no response from my legs or arms or hands. I layed on the floor for 10 minutes, thinking I was having a stroke, and got up with no problem after 10 minutes. Was checked at the drs afterward and EKG was fine. The same happened on 02Nov2021. I fell to the floor and couldn't get up for approx. 10 minutes. The case was assessed as non-serious by the reporter. The patient was not hospitalized for the events. The events resulted in doctor or other healthcare professional office/clinic visit. No treatment was received for the events (thinking I was having a stroke and I had no response from my legs or arms or hands). The patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number was not reported, Expiry date was not reported) via an unspecified route of administration, administered in Arm Right on 29Apr2021 at 10:45, as DOSE 2, SINGLE for covid-19 immunisation. The patient underwent lab tests and procedures which included electrocardiogram which results as fine on unspecified date of 2021, sars-cov-2 test (Nasal Swab) which results negative on 28Oct2021. The outcome for the events thinking I was having a stroke and I had no response from my legs or arms, or hands was recovering and for the event I collapsed to the floor and could not get up for 10 minutes was unknown.  The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.
Age: 11.0
Sex: F
Vaccine: COVID19
Symptoms: Blindness, Fatigue, Hyperhidrosis, Mydriasis, Off label use
Clinical narrative: Eyes became dilated and she said she could not see; off label use; Eyes became dilated and she said she could not see; tired; sweating; drug use in unapproved population; This is a spontaneous report from a contactable consumer (patient reported for herself). A 11-year-old non-pregnant female patient received first dose of bnt162b2 (COMIRNATY, solution for injection, Batch/Lot number: Fk5127), via unspecified route of administration, administered in arm right on 13Nov2021 at 11:45 AM (at the age of 11-year-old) as dose 1, single for COVID-19 immunization. The patient medical history included eczema and allergic to strawberries/gluten. The concomitant medications were reported as none. Patient was not pregnant at the time of vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine and did not receive any other medications within 2 weeks of vaccination. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. On 13Nov2021 at 11:45 AM, the patient experienced eyes became dilated, and she said she could not see. Lasted a couple of minutes. No other symptoms other than about 5 min after that resolved, she said she was tired and started sweating, off label use and drug use in unapproved population. Patient did not received treatment for events. At the time of this report, outcome of the events eyes became dilated, and she said she could not see was recovered on 13Nov2021 at 11:50 AM while outcome of other events was unknown. Device date was 13Nov2021.  Follow-up attempts are completed. No further information is expected.
Age: 11.0
Sex: F
Vaccine: COVID19
Symptoms: Product use issue
Clinical narrative: Eyes became dilated and she said she could not see; off label use; Eyes became dilated and she said she could not see; tired; sweating; drug use in unapproved population; This is a spontaneous report from a contactable consumer (patient reported for herself). A 11-year-old non-pregnant female patient received first dose of bnt162b2 (COMIRNATY, solution for injection, Batch/Lot number: Fk5127), via unspecified route of administration, administered in arm right on 13Nov2021 at 11:45 AM (at the age of 11-year-old) as dose 1, single for COVID-19 immunization. The patient medical history included eczema and allergic to strawberries/gluten. The concomitant medications were reported as none. Patient was not pregnant at the time of vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine and did not receive any other medications within 2 weeks of vaccination. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. On 13Nov2021 at 11:45 AM, the patient experienced eyes became dilated, and she said she could not see. Lasted a couple of minutes. No other symptoms other than about 5 min after that resolved, she said she was tired and started sweating, off label use and drug use in unapproved population. Patient did not received treatment for events. At the time of this report, outcome of the events eyes became dilated, and she said she could not see was recovered on 13Nov2021 at 11:50 AM while outcome of other events was unknown. Device date was 13Nov2021.  Follow-up attempts are completed. No further information is expected.
Age: 39.0
Sex: M
Vaccine: COVID19
Symptoms: Immunisation, Laboratory test, Myalgia, Thrombosis, Vaccination site pain
Clinical narrative: The next day, 12Nov2021, I went to my doctor and he told me it was a blood clot that I had in my armpit; the next day, 11Nov2021, I started with muscle pain in my back and legs, and by night I realized that I had a large swelling on the armpit of the same side of the vaccine; the next day, 11Nov2021, I started with muscle pain in my back and legs, and by night I realized that I had a large swelling on the armpit of the same side of the vaccine; patient received 3rd dose; On 10Nov2021, with dose 3 I felt more pain in the site of the application; This is a spontaneous report from a contactable Other HCP (patient herself). A 39 years old male patient received dose 3 of BNT162B2(PFIZER BIONTECH COVID VACCINE, solution for injection, lot number=Ff2590) via unspecified route of administration in arm left on 10Nov2021 at 14:30 PM as DOSE 3 (BOOSTER), SINGLE (age at vaccination 39 years) for covid 19 immunization. Patient had shrimp allergy from unknown date and unknown if ongoing. The concomitant medications were not reported. Patient previously received dose 2 of BNT162B2 (PFIZER BIONTECH COVID VACCINE, solution for injection, lot number: El1283) via unspecified route of administration in arm left on 10Feb2021 at 12:15 PM as dose 2, single (age at vaccination 38 years) and dose 1 of BNT162B2 (PFIZER BIONTECH COVID VACCINE, solution for injection, lot number:El1283) via unspecified route of administration in arm left on 20Jan2021 at 01:15 PM as dose 1, single (age at vaccination 38 years)for covid 19 immunization. Patient had covid prior to vaccination and Covid test result positive on 25Jan2021. Patient received 3 rd dose on 10Nov2021 at 02:30 PM (Immunisation). On 10Nov2021 patient experienced more pain in the site of the application and on next day 11Nov2021 experienced muscle pain in my back and legs, and by night I realized that I had a large swelling on the armpit of the same side of the vaccine and on 12Nov2021 patient went to his doctor and doctor told patient blood clot in his armpit, and doctor did tests on him and Patient had an appointment with the doctor for Monday 15Nov2021 to review results. Patient received treatment with aspirin. Adverse event resulted in patient Visit to doctor's office or other healthcare professional. Patient underwent covid test post vaccination: Nasal swab (sample): Negative on 17Aug2021. On 12Nov2021 patient underwent laboratory test result were was blood clot that in his armpit, and patient had an appointment with the doctor for Monday 15Nov2021 to review results. The outcome of more pain in the site of the application, muscle pain in my back and legs, and by night I realized that I had a large swelling were not recovered.
Age: 39.0
Sex: M
Vaccine: COVID19
Symptoms: Vaccination site swelling
Clinical narrative: The next day, 12Nov2021, I went to my doctor and he told me it was a blood clot that I had in my armpit; the next day, 11Nov2021, I started with muscle pain in my back and legs, and by night I realized that I had a large swelling on the armpit of the same side of the vaccine; the next day, 11Nov2021, I started with muscle pain in my back and legs, and by night I realized that I had a large swelling on the armpit of the same side of the vaccine; patient received 3rd dose; On 10Nov2021, with dose 3 I felt more pain in the site of the application; This is a spontaneous report from a contactable Other HCP (patient herself). A 39 years old male patient received dose 3 of BNT162B2(PFIZER BIONTECH COVID VACCINE, solution for injection, lot number=Ff2590) via unspecified route of administration in arm left on 10Nov2021 at 14:30 PM as DOSE 3 (BOOSTER), SINGLE (age at vaccination 39 years) for covid 19 immunization. Patient had shrimp allergy from unknown date and unknown if ongoing. The concomitant medications were not reported. Patient previously received dose 2 of BNT162B2 (PFIZER BIONTECH COVID VACCINE, solution for injection, lot number: El1283) via unspecified route of administration in arm left on 10Feb2021 at 12:15 PM as dose 2, single (age at vaccination 38 years) and dose 1 of BNT162B2 (PFIZER BIONTECH COVID VACCINE, solution for injection, lot number:El1283) via unspecified route of administration in arm left on 20Jan2021 at 01:15 PM as dose 1, single (age at vaccination 38 years)for covid 19 immunization. Patient had covid prior to vaccination and Covid test result positive on 25Jan2021. Patient received 3 rd dose on 10Nov2021 at 02:30 PM (Immunisation). On 10Nov2021 patient experienced more pain in the site of the application and on next day 11Nov2021 experienced muscle pain in my back and legs, and by night I realized that I had a large swelling on the armpit of the same side of the vaccine and on 12Nov2021 patient went to his doctor and doctor told patient blood clot in his armpit, and doctor did tests on him and Patient had an appointment with the doctor for Monday 15Nov2021 to review results. Patient received treatment with aspirin. Adverse event resulted in patient Visit to doctor's office or other healthcare professional. Patient underwent covid test post vaccination: Nasal swab (sample): Negative on 17Aug2021. On 12Nov2021 patient underwent laboratory test result were was blood clot that in his armpit, and patient had an appointment with the doctor for Monday 15Nov2021 to review results. The outcome of more pain in the site of the application, muscle pain in my back and legs, and by night I realized that I had a large swelling were not recovered.
Age: 36.0
Sex: M
Vaccine: COVID19
Symptoms: Immunisation, Thyroiditis subacute
Clinical narrative: Subacute thyroiditis; booster; This is a spontaneous report from a contactable physician (patient). A 36-year-old male patient received third dose of bnt162b2 (PFIZER BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch number: not reported/ Lot Number: FR2589) via an unspecified route of administration, administered in arm left (reported as left arm) on 28Sep2021 (age at the time of vaccination was 36-year-old) as dose 3 (booster), single for COVID-19 immunization administered in hospital. The patient's medical history was not reported and the patient had no known allergies. Prior to vaccination, the patient was not diagnosed with covid-19 and post vaccination, the patient was not tested for covid-19. There were no concomitant medications. The patient did not receive any other vaccine in four weeks and the patient did not receive any other medication in two weeks. Historical vaccine included, patient previously received second dose of bnt162b2 (PFIZER BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch number: not reported/ Lot Number: EL3264) via an unspecified route of administration, administered in left arm on 11Jun2021 (age at the time of vaccination was 35-year-old) as dose 2, single and received first dose of bnt162b2 (PFIZER BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch number: not reported/ Lot Number: EK5730) via an unspecified route of administration, administered in left arm on 21Dec2020 (age at the time of vaccination was 35-year-old) as dose 1, single both for covid-19 immunization. On 28Sep2021, booster was reported. On 08Oct2021, patient experienced subacute thyroiditis. Adverse event resulted in doctor or other healthcare professional office/clinic visit. The patient received NSAID (nonsteroidal anti-inflammatory drugs) and propranolol as treatment. Outcome of the event subacute thyroiditis was not recovered.  Follow-up attempts are completed. No further information is expected.