chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: her second dose of the Pfizer COVID-19 vaccine on 11 FEB 2021 and is battling with COVID; her second dose of the Pfizer COVID-19 vaccine on 11 FEB 2021 and is battling with COVID; This is a spontaneous report from a contactable other hcp (nurse) (patient). A female patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot Number: EL3246, Expiry Date: not reported) via an unspecified route of administration on an unspecified date as DOSE 1, SINGLE and second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot Number: EL9262, Expiry Date: not reported) via an unspecified route of administration on 11Feb2021 as DOSE 2, SINGLE for COVID-19 immunization. The patient medical history was not reported. Concomitant medication included casirivimab, imdevimab (REGEN COV) on 15Sep2021 for unspecified indication. The patient had her second dose of the pfizer covid-19 vaccine on 11feb2021 and was battling with COVID on an unspecified date. Patient stated that she was not feeling well when she went to get the regeneron shot that she was battling with covid. Patient was asking when she can get her booster dose of the pfizer COVID-19 after getting regeneron. she got covid seven months after she got her pfizer covid vaccine. The patient underwent lab tests and procedures which included sars-cov-2 test: positive on an unspecified date in Sep2021. The outcome of the events was unknown.  No follow-up attempts are needed. No further information is expected.; Sender's Comments: Based on the information in the case report and a plausible temporal relationship, a possible causal association between the events and suspect drug BNT162B2 cannot be excluded.
Age: 76.0
Sex: F
Vaccine: COVID19
Symptoms: Pain
Clinical narrative: Given in the left arm in the muscle.  She is pretty sure that one was given in the muscle from the pain; This is a spontaneous report from a contactable consumer (patient). A 76-year-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection; Lot number: FC3180; expiration date: Oct2021) via an unspecified route of administration in left arm on 08Aug2021 as dose 1, single for COVID-19 immunization (at the age of 76-year-old). Medical history included immunocompromised immune because she has Rheumatoid and Osteoarthritis and was diagnosed in 2013. Patient had no family medical history relevant to ae(s) and comes from pretty health. Concomitant medication included etanercept (ENBREL) at a dose of 50mg via click injection once a week for rheumatoid arthritis. Patient did not receive any prior vaccinations (within 4 weeks) of the suspect vaccine(s). Patient previously gets regular flu vaccine every year and no issues with it. Patient will not get it this year. Reportedly, patient was given first dose in the left arm in the muscle. Patient was pretty sure that one was given in the muscle from the pain. On an unspecified date, after first dose patient experienced pain. Outcome of the event was unknown.
Age: 40.0
Sex: F
Vaccine: COVID19, UNK
Symptoms: Bladder cancer, Drug ineffective
Clinical narrative: Bladder cancer; Humira was fail medication for patient; This is a solicited report from FACILITATED COLLECT received by a contactable consumer (patient) based on information received by Pfizer. (MFR Control No. # 21K-163-4125619-00).  A 40-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number unknown), via intramuscular, on 05Aug2021 at single dose for COVID-19 immunisation. Co-suspect drug included subcutaneous adalimumab (HUMIRA, 40MG/0.4ML) taken from an unknown date at dose of 40 mg cyclic (1 in 14 D), CF (citrate free) for psoriatic arthritis/moderate to severe chronic plaque psoriasis. Historical vaccine includes the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number unknown) administered on unknown date for COVID-19 immunisation. Apart from underlying disease, no additional medical history was provided. No relevant concomitant medications were provided. On an unknown date, HUMIRA was fail medication for patient. On 04Oct2021, the patient diagnosed with bladder cancer. HUMIRA as a prior failed medication with reason for discontinuing was bladder cancer. She was switched to apremilast (OTEZLA). The last action taken with HUMIRA in response to the events was permanently discontinued on unknown date.  It was unknown if patient was enrolled in a COVID-19 Vaccine Trial. The patient had not recovered from bladder cancer while the outcome of the remaining event was unknown.  Reporter's Causality for HUMIRA 40MG/0.4ML (ADALIMUMAB) and Bladder cancer: The reporter's causality for the event of Bladder cancer with HUMIRA 40mg/0.4ml (ADALIMUMAB) was no reasonable possibility. The reporter's causality for the event(s) of HUMIRA was fail medication for patient was not provided. Reporter's Causality assessment for HUMIRA 40MG/0.4ML (ADALIMUMAB) and Lack drug effect: not reported.  Pfizer statement: The reporter's assessment of the causal relationship of the event with BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) was not provided at the time of this report. Since no determination has been received, the case is managed based on the company causality assessment. RA's opinion is that the event of Bladder cancer is not assessable.RA's opinion is that there is no reasonable possibility that the event of HUMIRA was fail medication for patient is related to HUMIRA 40mg/0.4ml (ADALIMUMAB).   No follow-up attempts are possible. Information about Lot/Batch number cannot be obtained. No further information is expected.; Sender's Comments: Based on the information in the case, a contributory effect of the vaccine BNT162B2 to the reported events cannot be established.
Sex: U
Vaccine: COVID19
Symptoms: Peripheral swelling
Clinical narrative: swelling under L/R arm; This is a spontaneous report from a contactable consumer (patient). A patient of unspecified age and gender received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), dose 2 intramuscular, administered in Arm Right on 20Jan2021 (Batch/Lot Number: EJ1686) as DOSE 2, SINGLE; dose 3 intramuscular, administered in Arm Right on 01Oct2021 (Batch/Lot Number: FC3182) as DOSE 3 (BOOSTER), SINGLE  for covid-19 immunisation. Medical history included ongoing seasonal allergy, ongoing osteoporosis. Concomitant medications included cetirizine hydrochloride (ZYRTEC) taken for seasonal allergy from an unspecified start date and ongoing; colecalciferol (VITAMIN D) taken for osteoporosis from an unspecified start date and ongoing. Historical vaccine included BNT162B2 on 29Dec2020 for COVID-19 immunization, 1st dose; Anatomical location: Left arm; Route of administration: Intramuscular; Batch/Lot number: EL1284. The patient experienced Swelling under L/R arm, more so on the right, since last 2 vaccinations were in right arm, some swelling remain under both arms on 25Jan2021 and 10OCt2021. No treatment given, outcome of the event was recovering. Seriousness Criteria: Important Medical Event as per reporter. AE required visit to Physician office.  Follow-up attempts are completed. No further information is expected.
Age: 27.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Joint warmth, Pain, Rheumatoid arthritis, Swelling
Clinical narrative: This is a Solicited report based on the information received by Pfizer (manufacturer control number: 21K-163-4122639-00) from a contactable female consumer reporting for herself.  A 27-year-old female subject received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), intramuscular on 10Sep2021 (Batch/Lot number was not reported) (at the age of 27-year-old) as single dose for COVID-19 immunisation and adalimumab (HUMIRA), subcutaneous from an unspecified date to an unspecified date (Batch/Lot number was not reported), at unspecified dose and frequency for moderate to severe rheumatoid arthritis.  The subject medical history included ongoing moderate to severe rheumatoid arthritis.  The subject's concomitant medications were not reported. The subject previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE) (at the age of 27-year-old) for COVID-19 immunization. The subject experienced increase in arthritis symptoms after COVID-19 vaccine in Sep2021 with outcome of not recovered, swelling on an unspecified date with outcome of recovered, joint warmth on an unspecified date with outcome of recovered, vaccination adverse reaction in Sep2021 with outcome of unknown, body aches on an unspecified date with outcome of unknown and chills on an unspecified date with outcome of unknown.  The action taken in response to the events for adalimumab was unknown. The reporter's causality for the event swelling, joint warmth, generalized aching, chills after Pfizer/BioNTech Covid Vaccine was not provided and for the events rheumatoid arthritis aggravated, vaccination adverse reaction was possible. Pfizer opinion for the events of swelling and joint warmth with adalimumab (HUMIRA) was no reasonable possibility and for the events of increase in rheumatoid arthritis symptoms after COVID-19 vaccine, body aches and chills was not provided.  The reporter's assessment of the causal relationship of the event with BNT162b2 was not provided at the time of this report. Since no determination has been received, the case is managed based on the company causality assessment.  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 a possible contributory role of suspect product BNT162B2 to the development of events rheumatoid arthritis aggravated, swelling, joint warmth, vaccination complication, pain and chills cannot be totally 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 RAs, Ethics Committees, and Investigators, as appropriate.
Age: 27.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination complication
Clinical narrative: This is a Solicited report based on the information received by Pfizer (manufacturer control number: 21K-163-4122639-00) from a contactable female consumer reporting for herself.  A 27-year-old female subject received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), intramuscular on 10Sep2021 (Batch/Lot number was not reported) (at the age of 27-year-old) as single dose for COVID-19 immunisation and adalimumab (HUMIRA), subcutaneous from an unspecified date to an unspecified date (Batch/Lot number was not reported), at unspecified dose and frequency for moderate to severe rheumatoid arthritis.  The subject medical history included ongoing moderate to severe rheumatoid arthritis.  The subject's concomitant medications were not reported. The subject previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE) (at the age of 27-year-old) for COVID-19 immunization. The subject experienced increase in arthritis symptoms after COVID-19 vaccine in Sep2021 with outcome of not recovered, swelling on an unspecified date with outcome of recovered, joint warmth on an unspecified date with outcome of recovered, vaccination adverse reaction in Sep2021 with outcome of unknown, body aches on an unspecified date with outcome of unknown and chills on an unspecified date with outcome of unknown.  The action taken in response to the events for adalimumab was unknown. The reporter's causality for the event swelling, joint warmth, generalized aching, chills after Pfizer/BioNTech Covid Vaccine was not provided and for the events rheumatoid arthritis aggravated, vaccination adverse reaction was possible. Pfizer opinion for the events of swelling and joint warmth with adalimumab (HUMIRA) was no reasonable possibility and for the events of increase in rheumatoid arthritis symptoms after COVID-19 vaccine, body aches and chills was not provided.  The reporter's assessment of the causal relationship of the event with BNT162b2 was not provided at the time of this report. Since no determination has been received, the case is managed based on the company causality assessment.  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 a possible contributory role of suspect product BNT162B2 to the development of events rheumatoid arthritis aggravated, swelling, joint warmth, vaccination complication, pain and chills cannot be totally 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 RAs, Ethics Committees, and Investigators, as appropriate.
Age: 21.0
Sex: F
Vaccine: COVID19, UNK
Symptoms: COVID-19, Drug ineffective, Pain
Clinical narrative: non-serious COVID-19; non-serious COVID-19; Aches/ Pain; FACILITATED COLLECT  This is a Solicited report based on the information received by Pfizer. (manufacturer control number: 21K-163-4126510-00) from a contactable female consumer reporting for herself.  An adult female subject received two doses of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), dose 2 on 01May2021 and dose 1 on 01Apr2021, both intramuscular (Batch/Lot number was not reported) (at the age of 21-year-old) as single dose for COVID-19 immunisation and adalimumab (HUMIRA), via an unspecified route of administration from an unspecified date to an unspecified date (Batch/Lot number was not reported), at unspecified dose and frequency for an unspecified indication.  The subject medical history included corrective surgery in 2018. Concomitant medications were not reported.  The subject experienced non-serious COVID-19 in 2021 with outcome of unknown, aches/pain in 2021 with outcome of unknown.  The subject underwent lab tests and procedures which included COVID-19 test: positive in 2021.  The action taken in response to the events for adalimumab was unknown. The reporter's causality for the event non-serious COVID-19, aches/pain after Pfizer/BioNTech Covid Vaccine was not provided. Company's opinion for the events non-serious COVID-19, aches/pain with adalimumab (HUMIRA) was no reasonable possibility.  The reporter's assessment of the causal relationship of the event with BNT162b2 was not provided at the time of this report. Since no determination has been received, the case is managed based on the company causality assessment.  The lot number for the vaccine, BNT162b2, was not provided and will be requested during follow up.; Sender's Comments: Based on plausible dose -event relationship post vaccination and no other alternate explanation the causal role of BNT162B2 cannot be excluded for the reported LOE events and pain.
Sex: F
Vaccine: COVID19
Symptoms: Deafness, Dyspnoea, Metal poisoning
Clinical narrative: mercury spots on her lungs; Losing hearing; breathing problems; This is a spontaneous report from a contactable consumer (patient). A female patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number and expiration date were not reported), via an unspecified route of administration on an unspecified date, dose 1, single for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. It was reported that two days after the patient received first COVID vaccine shot, she started losing hearing and having breathing problems. The patient had been to the emergency room and her doctor several times. The patient also had mercury spots on her lungs. The patient said she had never been around mercury. The patient states she has made 6 reports since 15Oct2021 and all she gets was go to her physician and physician keeps telling her to contact Pfizer. The patient was due for her second shot. The outcome of the events was unknown.  Information on the lot/batch number has been requested.
Sex: U
Vaccine: COVID19
Symptoms: Burning sensation, Fatigue, Paraesthesia
Clinical narrative: I have tingling and burning feet more than 10 weeks now; I have tingling and burning feet more than 10 weeks now; feet fatigue; This is a spontaneous report from a contactable consumer (patient). A patient of an unspecified age and gender 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, 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. On an unspecified date, the patient experienced tingling and burning feet more than 10 weeks now, after 2nd shot of pfizer Covid-19 vaccination and feet fatigue. Outcome of the events was unknown. The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow up.
Age: 41.0
Sex: F
Vaccine: COVID19
Symptoms: Bell's palsy, SARS-CoV-2 test, Speech disorder
Clinical narrative: Bell''s palsy; Her speech is still off; This is a spontaneous report from a contactable consumer (patient herself). A 42-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot number and Expiry date was not reported), via an unspecified route of administration, administered in Arm Right on 02Jun2021 (at the age of 41years) as dose 1, single for COVID-19 immunization. Medical history included none. There were no concomitant medications. The patient confirms she was not on any new medications, she states everything was the same. She had been on the same medication, the only thing that was different was this shot. The patient did not receive any vaccines on same date with the Pfizer vaccine considered as suspect. Prior Vaccinations within 4 weeks the patient did not receive any other vaccine. The patient did not have any adverse events following prior vaccinations. The patient experienced bells palsy, her speech is still off in 2021. She confirms the Bells Palsy developed some time in between the two shots The patient underwent lab tests and procedures which included sars-cov-2 test negative on unspecified date. Therapeutic measures were taken because of bells palsy. The patient visited Emergency Room, Physician Office, because she thought she was having a stroke, but it was diagnosed as bells palsy the patient was hospitalized. The patients state the dates of her hospitalization are unknown but confirms it was between her first and second dose. The outcome of events bells palsy was recovering. The outcome of event her speech is still off is unknown.  The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202101453391 Same reporter/durg, different patients.
Sex: U
Vaccine: COVID19
Symptoms: Bell's palsy
Clinical narrative: Bell''s palsy; This is a spontaneous report from a contactable consumer or other non health professional.   A patient of unspecified age and gender received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE,Solution for injection),via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as dose number unknown single for COVID-19 immunization.The patient medical history was not reported. concomitant medications:None.The patient experienced bell''s palsy on an unspecified date. Outcome of the event was unknown.   The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202101453228 Same reporter/durg, different patients.
Age: 25.0
Sex: F
Vaccine: COVID19
Symptoms: Hypomenorrhoea
Clinical narrative: Period was legit a couple dots of blood that lasted a half of a day.; This is a spontaneous report from a contactable consumer or other non healthcare professional (Patient). A 25-years-old female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot Number: FF2593), via an unspecified route, administered in Arm Left on 16Oct2021 (Age at vaccination 25-years-old), as DOSE 2, SINGLE for covid-19 immunization. The patient medical history was not reported. Patient took birth control medications within 2 weeks of vaccination. 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-19. Since the vaccination the patient has not been tested for COVID-19. Patient did not have any known allergies. The patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot Number: EW0217), via an unspecified route, administered in Arm Left on 11Sep2021 (Age at vaccination 25-years-old), as DOSE 1, SINGLE for covid-19 immunization. The patient experienced period was legit a couple dots of blood that lasted a half of a day on 17Oct2021. Reporter seriousness for event reported as congenital anomaly. Therapeutic measures were not taken as a result of the event. The clinical outcome of the event was not recovered.
Age: 46.0
Sex: M
Vaccine: COVID19
Symptoms: Anxiety, Cough, Dyspnoea, Feeling abnormal, Otitis externa
Clinical narrative: Swimmers ear; Vertigo; brain fog; Shortness of breath trouble breathing; coughing; panic attacks; Anxiety; This a spontaneous report from a contactable consumer (patient). A 46-years-old male patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; solution for injection, Batch/Lot number: CUS 295) dose 1 via an unspecified route of administration, administered in left arm on 12Oct2021 at 12:00 hours as DOSE 1, SINGLE (at the age of 46-years-old) for COVID-19 immunization. The patient's medical history included bipolar disorder, hypertension, and cholesterol. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient's concomitant medications within 2 weeks of vaccination included Lamotrigine (LAMICTAL); Atorvastatin calcium (LIPITOR); and Amlodipine besilate (NORVASC). The patient had no known allergies. 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-19. Since the vaccination, the patient has not been tested for COVID-19. On 14Oct2021, the patient experienced swimmers' ear, vertigo, brain fog, shortness of breath trouble breathing, Anxiety, panic attacks, and coughing. The events were resulted in doctor/other health care professional office/clinic visit. Therapeutic measures were taken as a result of the events. Treatment received included ear drops and ibuprofen. The clinical outcome of the events was not recovered. Follow-up attempts are completed. No further information is expected.
Age: 46.0
Sex: M
Vaccine: COVID19
Symptoms: Panic attack, Vertigo
Clinical narrative: Swimmers ear; Vertigo; brain fog; Shortness of breath trouble breathing; coughing; panic attacks; Anxiety; This a spontaneous report from a contactable consumer (patient). A 46-years-old male patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; solution for injection, Batch/Lot number: CUS 295) dose 1 via an unspecified route of administration, administered in left arm on 12Oct2021 at 12:00 hours as DOSE 1, SINGLE (at the age of 46-years-old) for COVID-19 immunization. The patient's medical history included bipolar disorder, hypertension, and cholesterol. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient's concomitant medications within 2 weeks of vaccination included Lamotrigine (LAMICTAL); Atorvastatin calcium (LIPITOR); and Amlodipine besilate (NORVASC). The patient had no known allergies. 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-19. Since the vaccination, the patient has not been tested for COVID-19. On 14Oct2021, the patient experienced swimmers' ear, vertigo, brain fog, shortness of breath trouble breathing, Anxiety, panic attacks, and coughing. The events were resulted in doctor/other health care professional office/clinic visit. Therapeutic measures were taken as a result of the events. Treatment received included ear drops and ibuprofen. The clinical outcome of the events was not recovered. Follow-up attempts are completed. No further information is expected.
Age: 31.0
Sex: F
Vaccine: COVID19
Symptoms: Chest pain, Dyspnoea, Inappropriate schedule of product administration, Palpitations
Clinical narrative: shortness of breath; heart palpitations/my heart is pounding to my chest; chest pain; Inappropriate schedule of vaccine administered; This is a spontaneous report from a contactable consumer (patient) reported for herself. A 31-years-old non pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection) via an unspecified route of administration, administered in Arm Right (reported as Right upper arm) on 07Oct2021 (Batch/Lot Number: FF8841) as DOSE 2, SINGLE and received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection; Batch/Lot Number: FF8841) via an unspecified route of administration, administered in Arm Right on 07Oct2021 at 17:00 as DOSE 1, SINGLE both doses taken at age of 31-years-old for COVID-19 immunisation. The patient was not pregnant at time of vaccination.  Medical history included Right bundle branch block, allergy to Shellfish, adhesive, iodine. Past Drug included Iodine and Reglan and experienced allergy. Patient took no other medications within 2 weeks of vaccination. Facility where the most recent COVID-19 vaccine was administered was Pharmacy or Drug Store, 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-19, Since the vaccination, the patient has not been tested for COVID-19. On 09Oct2021, the patient reported that she had shortness of breath, heart palpitations/my heart is pounding to my chest, chest pain and Inappropriate schedule of vaccine administered. Patient had heart palpitations at night. During the day being weekend like her heart was pounding to her chest, she had chest pain, she had the same symptoms three days after she received the vaccine. The adverse events resulted in doctor or other healthcare professional office/clinic visit and Emergency room/department or urgent care. As a treatment she was prescribed prednisone it had not helped, had been taking her inhaler for three weeks straight and it has not helped. Other treatment included for adverse events which the patient took was with Steroid. Outcome of events was not recovered.   Follow-up attempts are completed. No further information is expected.; Sender's Comments: Based on the information in the case report, a possible causal association between the event dyspnea and suspect drug BNT162B2 cannot be 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: 42.0
Sex: M
Vaccine: COVID19
Symptoms: Blood cholesterol, Chest pain, Condition aggravated, Dyspnoea, Insomnia
Clinical narrative: Chest pain; Shortness of breath; he didn't want to lay down to go to sleep; After he got the second vaccine, it got really bad.; This is a spontaneous report from a contactable consumer (patient). A 42-year-old male patient first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot Number: EL9246) via an unspecified route of administration in left arm/shoulder on 26Mar2021 between 09:00-09:30 (age at vaccination 42years) as dose 1, single and second dose on BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot Number: EW0153) via an unspecified route of administration in left arm/shoulder on 23Apr2021 between 09:00-09:30 (age at vaccination 42years) as dose 2, single for COVID-19 immunization. Medical history was not reported. Family history includes heart issue (mother had a bypass and brother had to have a bypass two years ago. The patient's concomitant medications were not reported. Patient had not received any other vaccinations within 4 weeks prior to the first administration date of the suspect vaccine. Patient don't have AE prior vaccination. Patient had had 4-5 weeks between his two vaccines. On unspecified date in 2021 patient experienced chest pain and shortness of breath a week or two after the first shot, but it was really mild. Patient was stubborn and ignored it. Patient got second dose and it got really bad. Evening of second vaccine when patient really worried and he didn't want to lay down to go to sleep. Patient landed in ER with chest pain and shortness of breath. Patient kept quite for a long time. In ER they did scan of his heart and couldn't find anything wrong. Right after that, patient heard reports of inflammation of the heart muscle related to the COVID-19 Vaccine. Patient didn't know if this was his condition or if the local healthcare providers weren't aware to look for that. The reporter felt symptoms and the COVID-19 Vaccines are directly related. Patient was discharged from ER and was not admitted to hospital. The patient did not receive any treatment for the events. The patient underwent lab tests and procedures which included Blood cholesterol: good and heart scan: couldn't find anything wrong in 2021. The outcome of the events was recovered on unspecified date (A week after he left the ER, he recovered completely).  Follow-Up (01Nov2021): Follow-up attempts are completed. No further information is expected.
Age: 42.0
Sex: M
Vaccine: COVID19
Symptoms: Scan
Clinical narrative: Chest pain; Shortness of breath; he didn't want to lay down to go to sleep; After he got the second vaccine, it got really bad.; This is a spontaneous report from a contactable consumer (patient). A 42-year-old male patient first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot Number: EL9246) via an unspecified route of administration in left arm/shoulder on 26Mar2021 between 09:00-09:30 (age at vaccination 42years) as dose 1, single and second dose on BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot Number: EW0153) via an unspecified route of administration in left arm/shoulder on 23Apr2021 between 09:00-09:30 (age at vaccination 42years) as dose 2, single for COVID-19 immunization. Medical history was not reported. Family history includes heart issue (mother had a bypass and brother had to have a bypass two years ago. The patient's concomitant medications were not reported. Patient had not received any other vaccinations within 4 weeks prior to the first administration date of the suspect vaccine. Patient don't have AE prior vaccination. Patient had had 4-5 weeks between his two vaccines. On unspecified date in 2021 patient experienced chest pain and shortness of breath a week or two after the first shot, but it was really mild. Patient was stubborn and ignored it. Patient got second dose and it got really bad. Evening of second vaccine when patient really worried and he didn't want to lay down to go to sleep. Patient landed in ER with chest pain and shortness of breath. Patient kept quite for a long time. In ER they did scan of his heart and couldn't find anything wrong. Right after that, patient heard reports of inflammation of the heart muscle related to the COVID-19 Vaccine. Patient didn't know if this was his condition or if the local healthcare providers weren't aware to look for that. The reporter felt symptoms and the COVID-19 Vaccines are directly related. Patient was discharged from ER and was not admitted to hospital. The patient did not receive any treatment for the events. The patient underwent lab tests and procedures which included Blood cholesterol: good and heart scan: couldn't find anything wrong in 2021. The outcome of the events was recovered on unspecified date (A week after he left the ER, he recovered completely).  Follow-Up (01Nov2021): Follow-up attempts are completed. No further information is expected.
Age: 13.0
Sex: F
Vaccine: COVID19
Symptoms: Blood test, Culture urine, Electrocardiogram, Fall, Pyrexia
Clinical narrative: shaking vigorously; Fever; Her daughter fell one time and hit her head.; Passing out; Throwing up; This is a spontaneous report from a contactable consumer or other non hcp (Parent). A 13-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot number: FC3183) via an unspecified route of administration, administered in Arm Left on 23Aug2021 as dose 2, single for covid-19 immunisation. The patient medical history and concomitant medications were not reported. Patient previously received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot number: not reported) via an unspecified route of administration, as dose 1, single for covid-19 immunisation.The patient was not received any other vaccines within 4 weeks prior to the COVID vaccine. The patient was not received any other medications within 2 weeks prior to the COVID vaccine. Adverse events following prior vaccinations was none. Reporter confirms her daughter received her second shot on 23Aug2021.The reporter states the throwing up and passing out is getting worse it seems. She thought it was going to get better. The caller thought it was just side effects that would go away, work itself out, but it's not. Her daughter is missing a lot of school. Her daughter is in bed right now. The Reporter states that the first time her daughter's symptoms began, her daughter was shaking vigorously. Her daughter couldn't stop. The Reporter asked her daughter if she was cold, and her daughter responded that she wasn't, and that she didn't know what was happening and asked the reporter to help her. The reporter didn't know what was going on. The caller clarifies this happened at 02:30 in the morning, (early the next morning after receiving the shot). The Reporter states she was scared and then her daughter got a fever. The Reporter called the ER and explained something was wrong with her daughter (it was the same night, clarified as early the next morning after receiving the second shot). The reporter was by herself with her daughter and it was scary her daughter blacked out. When she called the ER, the ER told her to not come in, it was just side effects of the shot. She took her daughter to the doctor the next morning and they have been running test on her ever since. The doctors have done blood work, an EKG, some other things. They plan to do a brain MRI. The reporter doesn't know what happened, but it started right after the shot. Ever since then, it's happened 3 or 4 times a week. Her daughter fell one time and hit her head. One time it was in the tub. Other times its been in her room. The outcome of the events syncope and vomiting was not recovered and for all other events it was unknown.
Age: 13.0
Sex: F
Vaccine: COVID19
Symptoms: Syncope, Tremor, Vomiting
Clinical narrative: shaking vigorously; Fever; Her daughter fell one time and hit her head.; Passing out; Throwing up; This is a spontaneous report from a contactable consumer or other non hcp (Parent). A 13-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot number: FC3183) via an unspecified route of administration, administered in Arm Left on 23Aug2021 as dose 2, single for covid-19 immunisation. The patient medical history and concomitant medications were not reported. Patient previously received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot number: not reported) via an unspecified route of administration, as dose 1, single for covid-19 immunisation.The patient was not received any other vaccines within 4 weeks prior to the COVID vaccine. The patient was not received any other medications within 2 weeks prior to the COVID vaccine. Adverse events following prior vaccinations was none. Reporter confirms her daughter received her second shot on 23Aug2021.The reporter states the throwing up and passing out is getting worse it seems. She thought it was going to get better. The caller thought it was just side effects that would go away, work itself out, but it's not. Her daughter is missing a lot of school. Her daughter is in bed right now. The Reporter states that the first time her daughter's symptoms began, her daughter was shaking vigorously. Her daughter couldn't stop. The Reporter asked her daughter if she was cold, and her daughter responded that she wasn't, and that she didn't know what was happening and asked the reporter to help her. The reporter didn't know what was going on. The caller clarifies this happened at 02:30 in the morning, (early the next morning after receiving the shot). The Reporter states she was scared and then her daughter got a fever. The Reporter called the ER and explained something was wrong with her daughter (it was the same night, clarified as early the next morning after receiving the second shot). The reporter was by herself with her daughter and it was scary her daughter blacked out. When she called the ER, the ER told her to not come in, it was just side effects of the shot. She took her daughter to the doctor the next morning and they have been running test on her ever since. The doctors have done blood work, an EKG, some other things. They plan to do a brain MRI. The reporter doesn't know what happened, but it started right after the shot. Ever since then, it's happened 3 or 4 times a week. Her daughter fell one time and hit her head. One time it was in the tub. Other times its been in her room. The outcome of the events syncope and vomiting was not recovered and for all other events it was unknown.
Sex: U
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: Covid diagnosis; Covid diagnosis; This is a spontaneous report from a non-contactable Nurse. The nurse reported the same event for three patients. This is the 1st of three reports.    A patient of unspecified age and gender received bnt162b2 (COVID-19 VACCINE - MANUFACTURER UNKNOWN) via an unspecified route of administration on an unspecified date as single dose for COVID-19 immunisation. Medical history and concomitant medications were unknown. The patient had a Covid diagnosis and died. It was unknown if autopsy was performed. The reporter mentioned that she knew 3 people who were vaccinated that went into the hospital that came out with a Covid diagnosis; one of whom died. She did not say which vaccine they had gotten. Outcome of the event Covid diagnosis was fatal.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: As there is limited information in the case provided, the causal association between the event and the suspect drug 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.,Linked Report(s) : US-PFIZER INC-202101468108 Same Reporter/Drug/AE, Different Patient;US-PFIZER INC-202101468109 Same Reporter/Drug/AE, Different Patient; Reported Cause(s) of Death: Covid diagnosis; Covid diagnosis
Sex: U
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: Covid diagnosis; Covid diagnosis; This is a spontaneous report from a non-contactable Nurse. The nurse reported the same event for three patients. This is the 2nd of three reports.    A patient of unspecified age and gender received bnt162b2 (COVID-19 VACCINE - MANUFACTURER UNKNOWN) via an unspecified route of administration on an unspecified date as single dose for COVID-19 immunisation. Medical history and concomitant medications were unknown. The patient had a Covid diagnosis. The reporter mentioned that she knew 3 people who were vaccinated that went into the hospital that came out with a Covid diagnosis. She did not say which vaccine they had gotten. Outcome of the event Covid diagnosis was unknown.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: The efficacy of a drug varies from patient to patient and can be affected by different factors; however, a contributory role of the suspect product bnt162b2 to the reported drug ineffective and COVID-19 cannot be ruled out.,Linked Report(s) : US-PFIZER INC-202101466426 Same Reporter/Drug/AE, Different Patient;US-PFIZER INC-202101468109 Same Reporter/Drug/AE, Different Patient
Sex: U
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: Covid diagnosis; Covid diagnosis; This is a spontaneous report from a non-contactable Nurse. The nurse reported the same event for three patients. This is the 3rd of three reports.    A patient of unspecified age and gender received bnt162b2 (COVID-19 VACCINE - MANUFACTURER UNKNOWN) via an unspecified route of administration on an unspecified date as single dose for COVID-19 immunisation. Medical history and concomitant medications were unknown. The patient had a Covid diagnosis. The reporter mentioned that she knew 3 people who were vaccinated that went into the hospital that came out with a Covid diagnosis. She did not say which vaccine they had gotten. Outcome of the event Covid diagnosis was unknown.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Based on the reported information ,a causal relationship between the events Drug ineffective and Covid-19 and suspected drug cannot be excluded.,Linked Report(s) : US-PFIZER INC-202101468108 Same Reporter/Drug/AE, Different Patient;US-PFIZER INC-202101466426 Same Reporter/Drug/AE, Different Patient
Age: 59.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, Sinusitis
Clinical narrative: took a rapid Covid test and it came back positive; took a rapid Covid test and it came back positive; sinus infection and it went a little down into his lungs; This is a spontaneous report from a contactable consumer (patient) or other non-healthcare professional. A 59-year-old male patient received BNT162B2 (COMIRNATY, Formulation: Solution for Injection, Batch/Lot number was not reported), dose 2 via an unspecified route of administration on an unspecified date (age at vaccination: 59 year) as dose 2, single, dose 1 via an unspecified route of administration on an unspecified date (age at vaccination: 59 year) as dose 1, single for covid-19 immunisation. The patient medical history and concomitant medications were not reported. Patient received Pfizer Covid-19 shots and experienced like he had a sinus infection and it went a little down into his lungs. Patient reported that he went on a bike ride and that usually makes his sinuses act up, he said he went and took a rapid Covid test and it came back positive. Patient reported that someone told him that you can test positive after receiving the Covid-19 vaccine. Patient asked is that true. Patient supposed to go camping then he got a sinus infection, in his nose, patient thought might should get tested. Patient went and got tested, one of the pharmacy tests, the rapid test, and it said he was positive for Covid. The patient underwent lab tests and procedures which included sars-cov-2 test: positive, on unspecified date, He went and got tested, one of the pharmacy tests, the rapid test, and it says he was positive for Covid. The clinical outcome of the events was unknown.  The lot number for the vaccine [BNT162B2], was not provided and will be requested during follow up. .
Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: Thrombosis
Clinical narrative: unprovoked blood clots; This is a spontaneous report from a contactable other HCP. A 73 year old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 2 via an unspecified route of administration, administered in Arm Left at age of 72 years old on 04Feb2021 09:00 (Batch/Lot number was not reported) as DOSE 2, SINGLE for covid-19 immunisation. Pregnancy at time of Vaccination: No. Medical history included hypertension (HBP), sleep apnoea, osteoporosis. No covid prior vaccination. Concomitant medication(s) included calcium (CALCIUM) taken for an unspecified indication, start and stop date were not reported; colecalciferol (VITAMIN D) taken for an unspecified indication, start and stop date were not reported; hydrochlorothiazide, losartan potassium (LOSARTAN HCT) taken for an unspecified indication, start and stop date were not reported.  The patient previously received first dose of bnt162b2 at age of 72 years old 14Jan2021 08:00 AM arm left for covid-19 immunisation, took dimerol and experienced drug allergy. The patient experienced unprovoked blood clots on 16Jun2021 02:30 AM for which patient was hospitalized for 3 days. Treatment included blood thinner. The patient underwent lab tests and procedures which included covid test type post vaccination=Blood test: negative on 16Jun2021. Outcome of event was recovered in 2021. Event was resulted in: [Emergency room/department or urgent care, Hospitalization, Life threatening illness (immediate risk of death from the event)].  The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.; Sender's Comments: Considering the temporal association, a causal association between administration of bnt162b2 and the onset of unprovoked blood clots cannot be excluded. The history of hypertension may provide an explanation.   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.