chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test
Clinical narrative: Caller received the first dose of the Pfizer Covid-19 vaccine on 15Aug2021 and on 17AUG2021 was diagnosed with Covid-19; This is a spontaneous report from a contactable consumer. This female consumer (patient) reported for herself that:  A female patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot number: unknown), dose 1 via an unspecified route of administration on 15Aug2021 as dose 1,single for covid-19 immunisation. The patient medical history and concomitant medications were not reported. On 15aug2021, the patient experienced caller received the first dose of the pfizer covid-19 vaccine and on 17aug2021, patient was diagnosed with covid-19. The patient underwent lab tests and procedures which included sars-cov-2 test: positive on 17Aug2021. Patient had scheduled second dose after 21 days. She tested positive for Covid on 17Aug2021. Asked if she can get the second dose or should she wait longer.The outcome of the event was unknown.  (01Sep2021) This is a Follow-up spontaneous report from a Pfizer Sponsored Program. A contactable female consumer (patient) reported for herself that:  The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.
Age: 78.0
Sex: M
Vaccine: COVID19
Symptoms: Asthenia, Diarrhoea, Fatigue, Illness, Malaise
Clinical narrative: he was not feeling well; he was so sick; fatigue; diarrhea; weakness; This is a spontaneous report from a contactable consumer(patient). A 57-year-old non pregnant female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, (Batch/Lot Number: EW0180)), via an unspecified route of administration, administered in the left arm on 04Aug2021 18:15 (age at the time of vaccination was 57-year-old) as single dose for COVID-19 immunisation. The patient's medical history included other medical his heart murmur, controlled BP, Allergic reactions to many drugs/environmental, take sublingual drops, diverticulum disease, testing for hyperparathyroidism. The patient had Known allergies to Azor, Biaxin, Cardizem, Crestor, Cipro, Exforge, Ibuprofen, Lipitor, Sulfa, Tetracycline, Topamax,Ventol, Lisi. The patient concomitant medications include spironolactone (ALDACTONE ), ezetimibe (ZETIA), doxazosin mesilate (CARDURA), hydralazine(HYDRALAZINE), cetirizine hydrochloride (ZYRTEC) ) taken for an unspecified indication, start and stop date were not reported. Patient did not receive any other vaccines within four weeks prior to the COVID vaccine. Prior to vaccination, patient was diagnosed with COVID-19 was unknown. The patient had not tested covid post vaccination. On 04Aug2021, at 10:00 PM, the patient experienced Chills/severe shakes, joint pain, vomiting 2 days/Nausea 4 days, diarrhea, congestion, Extreme headache 2 days/mild for up to a week with fuzzy head feeling, little dizzy, would get a wheeze and then feel mildly out of breath for a couple minutes, twice felt mild chest pain briefly, hands tingling, extremely tired for 10 days. The patient not received treatment foe AE. The outcome of the events was recovering.  Follow-up attempts are completed. No further information is expected.  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: Antibody test, Extra dose administered, Illness, Off label use
Clinical narrative: Dose #1 received on 04JAN2021 - Lot # EJ1685 - , Dose #2 received on 25JAN2021 - Lot # EL3302 and Dose #3 received on 18AUG2021 - Lot # FC3182; Dose #1 received on 04JAN2021 - Lot # EJ1685 - , Dose #2 received on 25JAN2021 - Lot # EL3302 and Dose #3 received on 18AUG2021 - Lot # FC3182; sick; This is a spontaneous report from a contactable other healthcare professional (patient). A 41-year-old female patient received third dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection), via an unspecified route of administration, administered in Arm Left on 18Aug2021 09:00 (at the age of 41-year-old) (Lot Number: FC3182) as single dose for COVID-19 immunization. The patient medical history included currently at the hospital with mom who was in ICU with Covid (exposure to covid-19). The patient's concomitant medications were not reported. The patient previously received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection), dose 1 on 04Jan2021 (Lot Number: EJ1685), dose 2 on 25Jan2021 (Lot Number: EL3302), both via an unspecified route of administration, administered in Arm Left at the age of 41-year-old as 3ml single dose for COVID-19 immunization. No other vaccines given the same days and none 4 weeks prior the booster dose. No problems with vaccines in past and states the last time she got vaccines was when she went on a mission trip and opted to get vaccines back in 2018. It was reported that the patient received the booster dose given on 18 August at 9am. States the booster dose made her sick. She got sick around 5pm that day. The patient underwent lab test which included antibody test after her first two doses of the Pfizer COVID-19 vaccine and she was positive for antibodies. Outcome of the event sick was unknown.
Sex: F
Vaccine: COVID19
Symptoms: Dyschezia
Clinical narrative: has had a hard time going to the bathroom.  (Asked what that meant: urination or defecation and he said defecation/the lady he spoke to referred him to Pfizer and said she had the same problem, too; This is a spontaneous report from a contactable consumer. An unspecified age of female patient received bnt162b2(PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number was not reported), via an unspecified route of administration on an unspecified date as a single dose for COVID-19 immunization. The patient medical history and concomitant medications were not reported. On an unknown date, the patient had a hard time going to the bathroom.  (Asked what that meant: urination or defecation and he said defecation) He has only gone twice in the last 5 days. The outcome of the event was unknown.  The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.  Follow-up activities closed. Batch/lot number not available for [vaccine BNT162B2], F/UP closure to be managed as significant.
Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: Blood glucose, Blood glucose increased, Pain in extremity
Clinical narrative: Elevated blood glucose level of 178mg/dL after receiving the second dose of BNT162B2/ Blood sugar was extremely high; Pain in the arm; This is a spontaneous report from a contactable consumer (Patient) via medical information team.  A 72-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), via an unspecified route of administration, administered in Arm Left on 30Aug2021; 11:30 (at the age of 72 years) (Lot Number: FC3180) as dose 2, single for covid-19 immunization.  Medical history included, type 2 diabetes mellitus diagnosed about 15 years ago, sciatica diagnosed about 5 years ago, for which the patient goes to the chiropractor for treatment, back pain and headache. Historical vaccine included, received BNT162B2 via unspecified route of administration on 09Aug2021 (at the age of 72 years) as dose 1, single for covid-19 immunization and experienced sore arm. Concomitant medications included ZINC supplements, dabigatran etexilate mesilate (PRADAXA), lisinopril, duloxetine, carvedilol, digoxin, tramadol taken for back pain, paracetamol (TYLENOL) taken for headache and dulaglutide (TRULICITY 1.5 mini pen). It was reported, the patient had second dose on 30Aug2021 and then had pain in the arm, like she was punched in the arm, like she did with the first one. The patient had type 2 diabetes and she got her blood test every Wednesday and took her dulaglutide shot after it and blood glucose was always between 122 and 133 (she also reported her blood glucose is usually 122 and never over 125). The patient blood glucose on 01Sep2021 morning was 178mg/dL, she asked if this could be caused by the vaccine. The sore arms lasted for about a day. Treatment for the events was not reported. The outcome for the event Pain in the arm was recovering/resolving and "Elevated blood glucose level of 178mg/dL noticed on 01Sep2021 morning during the routine blood sugar checks/ Blood sugar was extremely high" was not reported.   No follow-up attempts are needed. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Drug ineffective, Illness, Suspected COVID-19
Clinical narrative: He was sick with COVID  like symptoms for approx. 2-3 days; He was sick with COVID  like symptoms for approx. 2-3 days; He was sick; This is a spontaneous report from a contactable consumer. The consumer reported events for both doses of vaccine. This is the first of two reports.  A male patient of unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), dose 1 via an unspecified route of administration on Apr2021 (Batch/Lot number was not reported) as single dose for covid-19 immunisation. The patient medical history and the patient's concomitant medications were not reported. The patient experienced who he was sick with covid like symptoms for approximately 2-3 days on Apr2021 with outcome of unknown.  The lot number for the vaccine, BNT162B2, was not provided and will be re-quested during follow up. Sender's Comments: Linked Report(s): US-PFIZER INC-202101138967 Same patient/ drug and different events separated by dose.
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Angioedema, Chest discomfort, Chest pain, Chills, Diarrhoea
Clinical narrative: angio edema flair; chills; sweats; severe headache; body aches; nausea; diarrhea; I also developed a discomfort/ ache in my left chest; I also developed a discomfort/ ache in my left chest; swelling to face; swelling to face, hands and feet; fatigue; This is a spontaneous report from a contactable nurse (patient). A 58-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) (Lot Number: Fc3184) via unspecified route in left arm single dose for COVID-19 immunisation on 27Aug2021, 10:45 AM, at 58-year-old. Medical history included angio edema, COVID-19 from Dec2020.  Concomitant medications included hydroxyzine pamoate 50 mg; famotidine 10mg daily. No other vaccine in four weeks. 3 days after first vaccine (30Aug2021, 04:30 AM), the patient had an angio edema flair (I have not had one since last March when the patient started taking hydroxyzine and famotidine daily), the patient did also have COVID like symptoms including chills, sweats, severe headache, body aches, nausea and diarrhea but most resolved by day 4 (31Aug2021) except the severe headache. The patient also developed a discomfort/ ache in left chest? The patient was now past day 5 and the angio edema, which also included swelling to face, hands and feet, severe headache, chest discomfort and fatigue continue. Events resulted in doctor or other healthcare professional office/clinic visit. Treatment included: prednisone, hydroxyzine, Pepcid. COVID tested post vaccination (Nasal Swab) on 24Aug2021 (as reported, pending clarification) resulted in negative. Outcome of the events chills, sweats, body aches, nausea and diarrhea was resolved; outcome of the other events was not recovered.  The lot number for BNT162B2, was not provided and will be requested during follow up.; Sender's Comments: Based on the information currently available, a possible contributory role of the suspect vaccine BNT162B2 or comirnarty in triggering the onset of angioedema flair 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: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Headache, Hyperhidrosis, Nausea, Pain
Clinical narrative: angio edema flair; chills; sweats; severe headache; body aches; nausea; diarrhea; I also developed a discomfort/ ache in my left chest; I also developed a discomfort/ ache in my left chest; swelling to face; swelling to face, hands and feet; fatigue; This is a spontaneous report from a contactable nurse (patient). A 58-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) (Lot Number: Fc3184) via unspecified route in left arm single dose for COVID-19 immunisation on 27Aug2021, 10:45 AM, at 58-year-old. Medical history included angio edema, COVID-19 from Dec2020.  Concomitant medications included hydroxyzine pamoate 50 mg; famotidine 10mg daily. No other vaccine in four weeks. 3 days after first vaccine (30Aug2021, 04:30 AM), the patient had an angio edema flair (I have not had one since last March when the patient started taking hydroxyzine and famotidine daily), the patient did also have COVID like symptoms including chills, sweats, severe headache, body aches, nausea and diarrhea but most resolved by day 4 (31Aug2021) except the severe headache. The patient also developed a discomfort/ ache in left chest? The patient was now past day 5 and the angio edema, which also included swelling to face, hands and feet, severe headache, chest discomfort and fatigue continue. Events resulted in doctor or other healthcare professional office/clinic visit. Treatment included: prednisone, hydroxyzine, Pepcid. COVID tested post vaccination (Nasal Swab) on 24Aug2021 (as reported, pending clarification) resulted in negative. Outcome of the events chills, sweats, body aches, nausea and diarrhea was resolved; outcome of the other events was not recovered.  The lot number for BNT162B2, was not provided and will be requested during follow up.; Sender's Comments: Based on the information currently available, a possible contributory role of the suspect vaccine BNT162B2 or comirnarty in triggering the onset of angioedema flair 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: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Peripheral swelling, SARS-CoV-2 test, Swelling face
Clinical narrative: angio edema flair; chills; sweats; severe headache; body aches; nausea; diarrhea; I also developed a discomfort/ ache in my left chest; I also developed a discomfort/ ache in my left chest; swelling to face; swelling to face, hands and feet; fatigue; This is a spontaneous report from a contactable nurse (patient). A 58-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) (Lot Number: Fc3184) via unspecified route in left arm single dose for COVID-19 immunisation on 27Aug2021, 10:45 AM, at 58-year-old. Medical history included angio edema, COVID-19 from Dec2020.  Concomitant medications included hydroxyzine pamoate 50 mg; famotidine 10mg daily. No other vaccine in four weeks. 3 days after first vaccine (30Aug2021, 04:30 AM), the patient had an angio edema flair (I have not had one since last March when the patient started taking hydroxyzine and famotidine daily), the patient did also have COVID like symptoms including chills, sweats, severe headache, body aches, nausea and diarrhea but most resolved by day 4 (31Aug2021) except the severe headache. The patient also developed a discomfort/ ache in left chest? The patient was now past day 5 and the angio edema, which also included swelling to face, hands and feet, severe headache, chest discomfort and fatigue continue. Events resulted in doctor or other healthcare professional office/clinic visit. Treatment included: prednisone, hydroxyzine, Pepcid. COVID tested post vaccination (Nasal Swab) on 24Aug2021 (as reported, pending clarification) resulted in negative. Outcome of the events chills, sweats, body aches, nausea and diarrhea was resolved; outcome of the other events was not recovered.  The lot number for BNT162B2, was not provided and will be requested during follow up.; Sender's Comments: Based on the information currently available, a possible contributory role of the suspect vaccine BNT162B2 or comirnarty in triggering the onset of angioedema flair 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: 78.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: Developed COVID-19; Developed COVID-19; This is a spontaneous report from a contactable consumer or other non-healthcare professional. A 78-year-old non-pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number not reported), via an unspecified route of administration on an unspecified date in Jan2021 (at the age of 78-years-old) as dose number unknown, single for COVID-19 immunisation. Medical history included allergies to dairy products. Concomitant medications were not reported. 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 had been tested positive for COVID-19. On 27Aug2021, the patient had developed COVID-19. The event resulted in doctor or other healthcare professional office/clinic visit and Emergency room/department or urgent care visit. The patient underwent lab tests which included SARS-CoV-2 test Developed COVID-19 on 27Aug2021. Therapeutic measures taken as a result of developed COVID-19 included monoclonal antibodies. The outcome of the event was recovering.   The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, Illness, SARS-CoV-2 test, Weight decreased
Clinical narrative: Again sick with COVID-19 like symptoms; Again sick with COVID-19 like symptoms; Again sick with COVID-19 like symptoms; weight loss; This is a spontaneous report from a non-contactable consumer via a Pfizer sales representative. A male patient of an unspecified age received the 2nd dose of bnt162b2 (BNT162B2, Manufacturer Pfizer-BioNTech), via an unspecified route of administration in Apr2021 (Batch/Lot number was not reported) as DOSE 2, SINGLE for COVID-19 immunisation. Medical history included COVID-19 from Nov2020 to an unknown date (for 13 days and experienced weight loss), weight decreased from 2020 to an unknown date. Previously the patient received the 1st dose of bnt162b2 (BNT162B2, Manufacturer Pfizer-BioNTech) for COVID-19 immunisation and experienced sick with COVID-19 like symptoms. Concomitant medications were not reported. The patient experienced again sick with COVID-19 like symptoms (medically significant) in Apr2021 with outcome of recovered in 2021 and weight loss in Apr2021 with outcome of unknown. The reporter stated that his friend received 1st and 2nd dose in Apr2021. In Nov2020 he was sick with a confirmed COVID-19 infection for 13 days and experienced weight loss. Following the first dose of vaccine in Apr2021 he was sick with COVID-19 like symptoms for approximatively 2-3 days. The symptoms were similar to when he had COVID-19 infection in Nov2020. Following the second dose he was again sick with COVID-19 like symptoms for approximatively 10 days and experienced weight loss.  The lot number for bnt162b2 was not provided and will be requested during follow-up.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202101138866 Same patient/drug, different dose/events
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: COVID; COVID; This is a spontaneous report from a contactable consumer. This consumer reported for a male patient. A male patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection. Batch/Lot number was not reported), via an unspecified route of administration on an unspecified date as DOSE 1, SINGLE for COVID-19 immunization. Reason for no lot number of Pfizer COVID shot, Caller unwilling to complete the report. The patient medical and concomitant medication history were reported. Other products, patient history and investigation assessment were not provided. Caller is calling because got the vaccine and contracted COVID-19 virus, 2 weeks later. Caller wanted to know if there was a guidance if he can still get the second shot, and when was the best time to get second dose. Caller stated that he will get second dose on 27Aug2021. In the Pharmacy they advised them to wait for 90 days, she said I hear some say 10 days. The outcome of the events was unknown.  The lot number was not provided. Information on lot number has been requested during follow up.
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: Positive Covid 19 virus test; Positive Covid 19 virus test; This is a spontaneous report from a contactable consumer (patient) from a program. A 58-year-old female patient received bnt162b2 (PFIZER BIONTECH COVID-19 VACCINE), via an unspecified route of administration, administered in left arm on 15Mar2021 (Batch/Lot Number: EN6208) as dose 2, single, and via an unspecified route of administration, administered in left arm on 22Feb2021 (Batch/Lot Number: EN6200) as dose 1, single for COVID-19 immunisation (age at vaccination: 58 years old). Medical history included heart transplant on 09Apr2020. The patient's concomitant medications were not reported. The patient tested positive for the COVID-19 virus on 22Apr2021. She was also admitted to the hospital in Apr2021 after testing positive for the COVID-19 virus. That test was the swab in the nose, and it was an awful test. The patient reported they did that test. She was admitted on 22Apr2021 and stayed in the hospital for about 6 days. During this hospitalization, she received the monoclonal antibody infusion. The patient underwent lab tests and procedures which included COVID-19 virus test positive on 22Apr2021. Outcome of the events was unknown.
Sex: M
Vaccine: COVID19
Symptoms: Death
Clinical narrative: a friend of hers that died on 16Apr21; This is a spontaneous report received from a contactable consumer and downloaded from the Regulatory Authority, regulatory authority number ES-AEMPS-972586. This consumer reported for a 90-year-old male patient (friend) who received bnt162b2 (Formulation:Solution for injection, Batch/Lot number was not reported, Expiry date: unknown), via an unspecified route of administration on an unspecified date as dose number unknown, single for covid-19 immunization. The patient medical history and concomitant medications were not reported. The consumer reported a friend of hers (patient) that died on 16Apr2021. He got his vaccine at the same time her husband did, but she is unsure if it was Pfizer. It was not reported if an autopsy was performed. The outcome of the event was fatal.  The lot number for the vaccine, (BNT162B2), was not provided and will be requested during follow up.; Reported Cause(s) of Death: She also mentioned a friend of hers that died on 16Apr2021.
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Antibody test, Glycosylated haemoglobin, Glycosylated haemoglobin increased, Illness
Clinical narrative: She feels sick; A1C was 7.1; This is a spontaneous report from a Pfizer sponsored program  support. A contactable 62-year-old female consumer (patient) reported for herself.   A 62-year-old female patient received bnt162b2 (Pfizer-BioNTech COVID-19 Vaccine, solution for injection), dose 2 via an unspecified route of administration, administered in left arm on 18May2021 (at the age of 62-years-old) (Lot Number: EW0177) as dose 2, single for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. Patient previously took first dose of BNT162B2 (at the age of 62-years-old) (lot number: EW0161, vaccine location: Right arm) on 25Apr2021 for covid-19 immunisation. The patient experienced she feels sick and A1C was 7.1 on an unspecified date in 2021. It was reported that the patient doesn't know why she didn't had immunity. She felt sick and according to the doctors, she did't had a serious disease. The only problem that she had was her blood sugar. She states she did't had severe diabetes, her A1C is below. She clarifies her A1C is 6.9, the callers states she did't had severe diabetes, or high blood pressure or high cholesterol. She did't had an autoimmune disease, so she did't understood why her results were what they were. The caller clarifies she received her A1C after the vaccine. Her A1C was not bad either when she had the COVID-19 vaccines. Her doctor is very careful with her. When probed to clarify if she was diagnosed with diabetes, the caller responds not really. She states her doctor gave her Metformin because he doesn't want her glucose to go higher. She clarifies around the time she had the COVID-19 vaccine, her A1C was 7.1.  The patient underwent lab tests and procedures which included antibody test: no immunity/no antibodies on 27Aug2021, glycosylated haemoglobin: 7.1 on 2021, glycosylated haemoglobin: 6.9 on 27Aug2021. The patient received treatment for the events. The outcome of all the events was unknown.  No follow-up attempts are possible. No further information is expected.
Age: 24.0
Sex: F
Vaccine: COVID19
Symptoms: Foaming at mouth, Loss of consciousness, Seizure
Clinical narrative: Passed out twice a few minutes after receiving the vaccine; started convulsing; foaming at the mouth; This is a spontaneous report from a contactable consumer (patient). A 24-year-old non-pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration in right arm on 31Aug2021 11:00 (Batch/Lot Number: EW0217) as dose 1, single for COVID-19 immunisation. The patient had no relevant medical history, no known. There were no concomitant medications; no other medications in two weeks and no other vaccine in four weeks. Patient had no COVID prior to vaccination. On 31Aug2021 11:15 AM,  the patient passed out twice a few minutes after receiving the vaccine, started convulsing, and foaming at the mouth. The events resulted in Doctor or other healthcare professional office/clinic visit. No treatment was received. Outcome of events was recovering. Patient was not COVID tested post vaccination. Events were reported as non-serious.  Follow-up attempts are completed. No further information is expected.
Age: 46.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Pain in extremity, Swelling face
Clinical narrative: Left shoulder, arm, trap have had a nagging pain that has escalated to severe.; Left shoulder, arm, trap have had a nagging pain that has escalated to severe.; Left side of face has been very swollen; This is a spontaneous report from a contactable consumer (patient). A 46-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, administered in Arm Left on 19Jul2021 13:00 at 46-years-old (Batch/Lot Number: ER8734) as DOSE 1, SINGLE for COVID-19 immunization. Medical history includedCRPS, RSD, CIRS, known allergies: Mold. Patient was not pregnant. Patient had no covid prior to vaccination. Patient was not covid tested post vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Facility where the most recent COVID-19 vaccine was administered: Pharmacy or Drug Store. Concomitant medications included fluoxetine; progesterone; curcuma longa rhizome, piper nigrum fruit (TURMERIC +); fish oil. The patient 's left shoulder, arm, trap have had a nagging pain that has escalated to severe (31Jul2021). MRI done yesterday to see what it could be. Left side of face has been very swollen (31Jul2021) where facial/dermal filler was placed 2 weeks prior to the vaccine. Swelling only on left side despite filler on right and left. The patient was given Antihistamines for face, injections in shoulder. Events resulted in Doctor or other healthcare professional office/clinic visit. The outcome of the events was not recovered.   No follow-up attempts are possible. No further information expected.
Sex: M
Vaccine: COVID19
Symptoms: Condition aggravated, Familial tremor
Clinical narrative: inherited Autosomal Dominant Neurological Essential Tremors; having the same condition and when he got his COVID shot his tremors worsened; This is a spontaneous report from a contactable consumer or other non hcp. A 75-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Batch/Lot number was not reported), via an unspecified route of administration on an unspecified date as dose number unknown, single for COVID-19 immunisation. The patient's medical history included inherited Autosomal Dominant Neurological Essential Tremors (not Parkinson's). The patient's concomitant medications were not reported. On an unspecified date, the patient experienced inherited autosomal dominant neurological essential tremors, having the same condition and when he got his COVID shot his tremors worsened. Therapeutic measures were taken as a result of events. The seriousness of the events was serious and medically significant. The outcome of the events was unknown.  No follow-up attempts are needed. No further information expected.
Sex: F
Vaccine: COVID19
Symptoms: Extra dose administered, Gait inability, Off label use
Clinical narrative: I was unable to walk; Third dose: 01Sep2021; Third dose: 01Sep2021; This is a spontaneous report from a contactable consumer (patient).  A female patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 3 via an unspecified route of administration, administered in right arm on 01Sep2021 (Batch/Lot number was not reported) as dose 3, single for covid-19 immunisation. Medical history included multiple sclerosis. The patient was not pregnant. The patient had no known allergies. Concomitant medications were not reported. The patient had any other medications the patient received within 2 weeks of vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient received first and second dose of bnt162b2 for covid-19 immunisation on an unspecified date. On 01Sep2021, the patient experienced was unable to walk. The event was considered as disabling/incapacitating. The patient reported that today, 01Sep2021, she was unable to walk and she was walking everyday. The patient does have multiple sclerosis, but this was not a symptom for her, and she usually walk at least 1 mile/day. There was no treatment for the event. Prior to vaccination, the patient was not diagnosed with covid-19 and since the vaccination, the patient had not been tested for covid-19. Outcome of event was not recovered.   The lot number for the vaccine, bnt162b2, was not provided and will be requested during follow up.
Age: 42.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: Tested positive for Covid; Tested positive for Covid; This is a spontaneous report from a contactable consumer. A 42-year-old female patient received bnt162b2 (Formulation: Solution for injection; Batch/Lot Number: EW0181), dose 1 via an unspecified route of administration, administered in Arm Left on 14Jul2021 10:30 (age at the time of vaccination (42-year-old) as dose 1, single, dose 2 via an unspecified route of administration on 04Aug2021 (Batch/Lot number was not reported) as dose 2, single for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient had no known allergies. On 30Aug2021 patient experienced tested positive for covid. Received second dose on 04Aug. Tested positive for Covid on 30Aug. The adverse event resulted in doctor or other healthcare professional office/clinic visit. The patient received treatment with medicines. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient underwent lab tests and procedures which included sars-cov-2 test positive on 30Aug2021. The outcome of the events was not recovered.  The lot number for the vaccine, (BNT162B2), was not provided and will be requested during follow up.
Age: 31.0
Sex: F
Vaccine: COVID19
Symptoms: Uterine leiomyoma
Clinical narrative: Diagnosis with Subserosal Fibroids; This is a spontaneous report from a contactable consumer (patient). A 31-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 20Apr2021 at the age of 31 years old (Lot Number: EW0151) as DOSE NUMBER UNKNOWN, SINGLE for COVID-19 immunization in the hospital. The patient was not pregnant at time of vaccination. The patient's medical history was not reported. Concomitant medications included sertraline hydrochloride (ZOLOFT) and moxifloxacin hydrochloride (TOPOMOX); taken for an unspecified indication, start and stop date were not reported. 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. The patient experienced diagnosis with subserosal fibroids on 21Jun2021 with outcome of not recovered. No treatment given for the event. The event was reported as non serious as it did not result in death, or not life-threatening. No hospitalization and birth defect reported. The event resulted in doctor or other healthcare professional office/clinic visit.  Follow-up attempts are completed. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Cough, Drug ineffective, Nasal congestion, Pain
Clinical narrative: tested for Covid and the result was I was positive; tested for Covid and the result was I was positive; coughing; sneezing; nose blowing; body aching; This is a spontaneous report from a contactable consumer or other non hcp. A male patient of an unspecified age received  bnt162b2 (BNT162B2, Solution for injection, Batch/Lot number was not reported) via an unspecified route of administration on an unspecified date as Dose 1, Single and also received second dose bnt162b2 (BNT162B2, Solution for injection, Batch/Lot number was not reported) via an unspecified route of administration on an unspecified date as, Single Dose for covid-19 immunisation. The patient medical history and concomitant medications were not reported. On an unspecified date in 2021 the patient experienced tested for covid and the result was he was positive and also had coughing, nose blowing, body aching. The patient underwent lab tests and procedures which included sars-cov-2 test: positive on an unspecified date in 2021. The outcome of the events drug ineffective, covid-19, cough, sneezing, nasal congestion, pain was unknown.  The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Sex: M
Vaccine: COVID19
Symptoms: SARS-CoV-2 test, Sneezing
Clinical narrative: tested for Covid and the result was I was positive; tested for Covid and the result was I was positive; coughing; sneezing; nose blowing; body aching; This is a spontaneous report from a contactable consumer or other non hcp. A male patient of an unspecified age received  bnt162b2 (BNT162B2, Solution for injection, Batch/Lot number was not reported) via an unspecified route of administration on an unspecified date as Dose 1, Single and also received second dose bnt162b2 (BNT162B2, Solution for injection, Batch/Lot number was not reported) via an unspecified route of administration on an unspecified date as, Single Dose for covid-19 immunisation. The patient medical history and concomitant medications were not reported. On an unspecified date in 2021 the patient experienced tested for covid and the result was he was positive and also had coughing, nose blowing, body aching. The patient underwent lab tests and procedures which included sars-cov-2 test: positive on an unspecified date in 2021. The outcome of the events drug ineffective, covid-19, cough, sneezing, nasal congestion, pain was unknown.  The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Sex: F
Vaccine: COVID19, UNK
Symptoms: COVID-19, Drug ineffective, Immune system disorder, SARS-CoV-2 test
Clinical narrative: Tested positive  for covid 19; Tested positive  for covid 19; It lowers the immune system; This is a non-interventional study report from the marketing program received from a contactable 44-year-old female consumer (patient) based on information received by Pfizer from Sanofi (manufacturer control number: 2021SA264459). This is a non-serious case received from a consumer. A 44-year-old female patient received bnt162b2 (Pfizer Biontech Covid-19 Vaccine, Batch/Lot number was not reported), via an unspecified route of administration in Dec2020 and Jan2021 respectively, as dose number unknown, single for COVID-19 immunization; teriflunomide (AUBAGIO, coated tablet), via oral from 17Mar2021 and ongoing, at 14 mg, once daily for multiple sclerosis (MS). The patient's medical history and concomitant medications were not reported. Teriflunomide may be the cause of it because it lowered the immune system following the first dose intake. The patient tested positive for Covid19 on 30Aug2021 since Monday this week while being treated with teriflunomide and bnt162b2. The patient received Pfizer Covid-19 vaccination on Dec2020 and Jan2021, nothing else changed, and asked if teriflunomide may be the cause of it because it lowers the immune system. No treatment reported. The action taken in response to the events for bnt162b2 was not applicable, for teriflunomide was dose not changed. It was not reported if the patient received a corrective treatment for events. SARS-COV-2 test on 15Jun2021: Positive. At time of reporting, the outcome of events was not recovered.  Aubagio may be the cause of it lowers the immune system is considered to be causality not reported to TERIFLUNOMIDE by the reporter and reportable by the company based on company causality assessment. Patient Tested positive for Covid19 Since Monday this Week is considered to be causality not reported to TERFLUNOMIDE by the reporter and reportable by the company based on company causality assessment.   The reporter's assessment of the causal relationship of the events with the suspect product 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 BNT162b2 was not provided and will be requested during follow up.; Sender's Comments: Based on the information in the case report, causal relationship between the event Drug ineffective, COVID-19, Immune system disorder (NOS) and suspect drug BNT162B2 can be excluded.
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Immune system disorder, Pruritus, Rash pruritic, Scratch
Clinical narrative: extremely itchy rashes; itching; scratching; immune reaction; This is a spontaneous report from a contactable consumer (patient). A 71-year-old (also reported as 72years) female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/Lot Number: EL9267), dose 2 via an unspecified route of administration, administered in Arm on 04Mar2021 16:15 (at the age of 71years) as dose 2, single for Covid-19 immunization. There were no medical history and concomitant medications. Historical vaccine included first dose of BNT162B2 (Lot Number: EL9261) on 11Feb2021 (at the age of 71years) for Covid-19 immunization. The patient reported she have broken out in extremely itchy rashes over her entire body in various places 2 weeks after her final shot. She has been to her primary physician about it in late March. She added that 1 week after the second shot she has had the worst rash all over. She stated it was still going on and she has an appointment with her dermatologist tomorrow. Patient stated that she has taken all kinds of over the counter medications like Benadryl. She got the second shot on 04Mar2021, the following week, around 11 or 12 Mar 2021 she started scratching like a cougar. She stated that she has used lots of over the counter things like Benadryl and Zyrtec. She stated that it doesn't bother her at any certain time of day, or on any certain place on the body. It was everywhere. Prior to the shot she did not have this issue. She went to her own doctor in the latter part of March and he said it could be from the shot, but he wasn't sure.  Stated it could be her body having an overabundance of immune reaction to the shot. The patient also mentioned that she woke up at 0300 the other day itching. She had run out of Benadryl and had to go to the gas station to get some more since it helps with the itching. She mentioned that she has scratched her skin off in places. The events extremely itchy rashes and itching required require Physician office visit. There were no other vaccinations within four weeks prior to the first administration date of the suspect vaccine. The outcome of event extremely itchy rashes was not recovered; outcome of other events was unknown.  Follow-up attempts are completed. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: soreness in the arms; This is a spontaneous report from a contactable other healthcare professional (HCP). A 43-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), 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. Medical history included polyarthritis. The patient's concomitant medications were not reported. The patient experienced soreness in the arms on an unknown date. The outcome of the event was unknown.   The lot number for the vaccine (BNT162B2) was not provided and will be requested during follow-up.
Sex: F
Vaccine: COVID19
Symptoms: Chills, Febrile convulsion
Clinical narrative: fever-like convulsion; chills; This is a spontaneous report from a contactable other healthcare professional (HCP). A 43-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), dose 2 via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as dose 2, single for Covid-19 immunisation. Medical history included polyarthritis. The patient's concomitant medications were not reported. The patient previously received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), 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 and experienced soreness in the arms. The patient experienced fever-like convulsion and chills on an unspecified date. The patient was advised to call the rheumatologist first before receiving the Covid 19 vaccine booster. She planned to sign-up for the Covid 19 booster shot (3rd dose) next month. The outcome of the events was unknown.   The lot number for the vaccine (BNT162B2) was not provided and will be requested during follow-up.
Age: 44.0
Sex: F
Vaccine: COVID19
Symptoms: Cough, Dyspnoea
Clinical narrative: Dry cough; Shortness of breath; This is a spontaneous report from a contactable Consumer or other non-HCP (patient). A 44-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Lot Number: EV0153), dose 2 via an unspecified route of administration, administered in Arm Right on 17May2021 at 12:00 PM (at the age of 44-year-old), as DOSE 2, SINGLE for covid-19 immunisation. Patient medical history (including any illness at time of vaccination) was none. There were no concomitant medications. The patient previously received her first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Lot Number: ER8735), via an unspecified route of administration, administered in Arm Right on 26Apr2021 at 17:15 (at the age of 44-year-old), as single for covid-19 immunisation and experienced Dry cough. Prior vaccinations (within 4 weeks) were none. On an unspecified date in 2021, the patient experienced dry cough and shortness of breath. It was reported that the patient had Persistent dry cough that required getting on Inhaler. Dry cough was still ongoing with shortness of breath. Relevant tests were none. The patient outcome of the events was Not resolved at the time of this report.  Follow-up attempts are completed. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Pulmonary thrombosis
Clinical narrative: blood clots in his lungs; This is a spontaneous report from a contactable consumer (reporter's daughter's father in law). A male patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 2 via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as dose 2, single for covid-19 immunisation. Medical history included blood clots. The patient's concomitant medications were not reported. The patient received first dose of bnt162b2 for covid-19 immunisation on an unspecified date. On an unspecified date, the patient experienced blood clots in his lungs after the second dose. The patient was hospitalized on an unspecified date due to the event. The reporter stated that she had people she knows personally who have had a blot clot after the vaccine. Her daughter's father in law who also has a history of blood clots, after his second vaccine ended up in the hospital with blood clots in his lungs. Reporter stated that she does not want to report on her daughter's father in law as he was in another state and she thought he reported for himself, she only would be willing to complete information for herself. Outcome of event was unknown.  The lot number for the vaccine, bnt162b2, was not provided and will be requested during follow up.
Sex: U
Vaccine: COVID19
Symptoms: Paralysis
Clinical narrative: got paralyzed; This is a spontaneous report from a non-contactable consumer. An unspecified age and gender patient received an unknown dose of BNT162B2 (PFIZER COVID19 VACCINE) via an unspecified route of administration on an unspecified date as single dose for COVID-19 immunization. Medical history and concomitant medication were not reported. On an unspecified date, the patient got paralyzed. The reporter stated that "he had a video from his place of employment and it says over there that Pfizer vaccine is killing people, he added that he had a student who got the Pfizer vaccine and got paralyzed after getting the shot, caller did not provide any information. He mentioned that Pfizer is killing the normal immune system of the people." The outcome of event was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.