chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: Having covid. Also just received covid vaccine and ended up in hospital; Having covid. Also just received covid vaccine and ended up in hospital; This is a spontaneous report from a contactable female consumer (patient herself) via Pfizer sponsored program. A female patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection; Batch/Lot number: unknown), via an unspecified route of administration in 2021 as single dose for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. It was reported that hard to understand caller. Mentioned having covid. Also just received covid vaccine and ended up in hospital. Believes she had a reaction. Outcome of the events was unknown.  Information on the lot/batch number has been requested.
Sex: U
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: received 1st dose of covid vaccine and 7 - 10 days later tested positive for covid virus.; received 1st dose of covid vaccine and 7 - 10 days later tested positive for covid virus.; This spontaneous report from a Pfizer-sponsored program  from a contactable pharmacist.  patient of an unspecified age and gender received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot number and expiry dates were not provided), via unspecified route of administration, on unknown date, as a single dose for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. On an unknown date after the vaccination 7-10days later, the patient tested positive for COVID virus. The reporter wanted to know when the patient can receive 2nd dose of vaccination. The outcome of the events was unknown.  Information about lot/batch number has been requested.; Sender's Comments: Considering a plausible temporal relationship and known product safety profile, a possible contributory role of suspect product Comirnaty to the reported 'COVID 19' cannot be completely excluded
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: since he got the 1st dose he was tested positive; since he got the 1st dose he was tested positive; This is a spontaneous report from a Pfizer Sponsored Program by contactable consumer (patient). A male patient of unspecified age received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN), via an unspecified route of administration on 01Mar2021 as a single dose for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. On 17Mar2021, since he got the first dose, he was tested positive for virus. The patient wanted to know whether he could receive second dose on 23Mar2021 (More than 21 days). The outcome of the events was unknown.
Sex: M
Vaccine: COVID19
Symptoms: COVID-19
Clinical narrative: I got diagnosed with Covid; This is a spontaneous report from a Pfizer-sponsored program. A contactable consumer (patient) reported that a male patient of unspecified age received the first dose of bnt162b2 (BNT162B2), via an unspecified route of administration on 08Mar2021 (Batch/Lot number was not reported) as single dose for covid-19 immunisation. The patient medical history was not reported. The patient's concomitant medications were not reported.  The patient got diagnosed with covid on 19Mar2021. He stated, "Do I need to keep my appointment since I got diagnosed with Covid last Friday (19Mar2021)? I am due for my second dose 29Mar2021". Outcome of the event was unknown.   Information on the lot/Batch number has been requested.
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, Inappropriate schedule of product administration, Off label use
Clinical narrative: got her first dose of COVID-19 vaccine on 30Jan2021/had her second dose on 19Mar2021; got her first dose of COVID-19 vaccine on 30Jan2021/had her second dose on 19Mar2021; (15Feb2021) felt a little sick then (19Feb2021) were tested positive for Covid 19; (15Feb2021) felt a little sick then (19Feb2021) were tested positive for Covid 19; This is a spontaneous report from a contactable consumer (patient) via a female patient of an unspecified age received the first dose of BNT162B2 (Pfizer-BIONTECH COVID-19 Vaccine), via an unspecified route of administration on 30Jan2021 (Batch/Lot number was not reported) as a single dose; and the second dose via an unspecified route of administration on 19Mar2021 (Batch/Lot number was not reported) as a single dose, for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient got her first dose of COVID-19 vaccine on 30Jan2021 then on 15Feb2021, she felt a little sick. On 19Feb2021, she tested positive for COVID-19. She had her second dose on 19Mar2021. The patient underwent lab tests and procedures which included COVID-19: positive on 19Feb2021. Outcome of the events was unknown.  Information on the lot/batch number has been requested.
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test
Clinical narrative: tested positive to COVID-19 Virus; This is a spontaneous report from a contactable consumer (patient) via a Pfizer-sponsored program. A male patient of an unspecified age received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 14Mar2021 (Batch/Lot number was not reported) as a single dose for COVID-19 immunisation.  The patient's medical history and concomitant medications were not reported. The patient received the first dose on 14Mar2021. After the first dose, the patient was tested positive to COVID-19 virus on unspecified date in Mar2021. The patient was scheduled for second dose on 03Apr2021. The patient wanted to know if he could have the second dose after he tested positive to COVID-19 virus. Outcome of the event was unknown.   Information on the lot/batch number has been requested.
Age: 67.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: (name) who received his 1st dose of our COVID-19 vaccine last 26Feb and tested COVID-19 positive in between doses.; (name) who received his 1st dose of our COVID-19 vaccine last 26Feb and tested COVID-19 positive in between doses.; This is a spontaneous report from a Pfizer-sponsored program COVAX US Support. A contactable pharmacist (patient's daughter) reported that 67-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), dose 1 via an unspecified route of administration on 26Feb2021 (Batch/Lot number not reported) as single dose for COVID-19 immunization. The patient medical history concomitant medications were not reported. On an unspecified date in 2021, pharmacist called on-behalf of a male patient who received his 1st dose of our COVID-19 vaccine last 26Feb2021 and tested COVID-19 positive in between doses. The patient was scheduled to receive his 2nd dose on 26Mar2021. The reporter was asking if the patient can still take the 2nd dose and clarified that the COVID-19 diagnosis came a week after receiving the vaccine. The reporter also mentioned that she does not know why she needed to call back because she already received information for her query regarding the spacing of the 2nd dose and 1st dose of the Pfizer Covid19 vaccine because she and her father received the 1st dose but tested positive for COVID before receiving the 2nd dose. They were referred to their HCP. She mentioned that she will be receiving the 2nd dose by next Monday. The outcome of the events was unknown.  Information on the lot/batch number has been requested.; Sender's Comments: Based on known drug safety profile, there is reasonable possibility of causal association between the event COVID-19 and the suspect vaccine BNT162B2.
Age: 25.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test
Clinical narrative: I tested positive for covid 9 days later from the day I got the vaccine; This is a spontaneous report from a contactable consumer reporting the same events under the same suspect product for 3 patients. This is one of the 3 reports (patient herself).  A 25-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration, administered in Arm Right on 16Mar2021 17:30 (Batch/Lot Number: EN6208) as SINGLE DOSE for covid-19 immunisation, at 25 years old. Medical history reported as none. No other vaccines in four weeks. No known allergies. The patient has unspecified concomitant medications in two weeks. The reporting consumer tested positive for COVID (Qualitative PCR) on 25Mar2021 12:00 (also reported as 9 days later from the day patient got the vaccine). Symptom started 7 days. Other 2 people who got the vaccine the same day as the patient, tested positive too. The event resulted in doctor or other healthcare professional office/clinic visit. Treatment included COVID treatment. Outcome of the event was not recovered.  Follow-up attempts are completed. No further information is expected. Lot number has been obtained.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021332606 Same reporter/drug/event for different patients;US-PFIZER INC-2021332607 Same reporter/drug/event for different patients
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Blood test, COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: took it on 05Mar on 15Mar I feel coughing a lot and fever on 19Mar I went to take Covid-19 test, and it come positive/ still have coughing/ doesn't feel good; took it on 05Mar on 15Mar I feel coughing a lot and fever on 19Mar I went to take Covid-19 test, and it come positive/ still have coughing/ doesn't feel good; This is a spontaneous report from a contactable consumer (patient). A 59-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE lot/batch number and expiration date not reported) via an unspecified route of administration, administered on the left arm on 05Mar2021 at a single dose for COVID-19 immunisation. Medical history included asthma and high cholesterol. Concomitant medications included salbutamol (ALBUTEROL HFA), rosuvastatin calcium (CRESTOR) taken for high cholesterol and montelukast sodium (SINGULAIR). The patient stated, "This is I took it on 05Mar on 15Mar I feel coughing a lot and fever on 19Mar I went to take Covid-19 test, and it come positive and I still have coughing since 19 but my question I have to took the second dose on 26 which is Friday I don't know if I should take it or I cannot take it or how I can do." The scheduled date for the second dose of Covid-19 vaccine is 26Mar2021. Patient was still coughing, took pills for coughing and took inhaler. Nothing improved. The patient just doesn't feel good. Patient mentioned that blood test (not specified) was done. The facility where the vaccine was administered was in a hospital. Outcome of the event was not recovered.   Information on the lot/batch number has been requested.
Sex: U
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test
Clinical narrative: Tested positive for COVID 19; This is a spontaneous report from a contactable consumer reporting the same events under the same suspect product for 3 patients. This is one of the 3 reports. A patient of unspecified age and gender received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot number: EN6208), via an unspecified route of administration on 16Mar2021 as single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient was COVID tested post vaccination via nasal swab on an 22Mar2021 with positive result. The patient tested positive for COVID 19 on 22Mar2021. The event resulted in a doctor or healthcare professional office/clinic visit. The patient has not recovered from the event.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021332607 Same reporter/drug/event for different patients;US-PFIZER INC-2021330055 Same reporter/drug/event for different patients
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: came down with COVID,  tested positive for COVID-19 after getting the first dose; came down with COVID,  tested positive for COVID-19 after getting the first dose; This is a spontaneous report from a sponsored program.  A contactable consumer (patient) reported that a male patient of an unspecified age received the first dose of BNT162B2 (Pfizer-BioNTech COVID-19 vaccine, lot number and expiry date was unknown), via an unspecified route of administration on 07Mar2021 as single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient had his first shot on 07Mar2021 and on an unspecified date (reported as 'last Monday'), he came down with COVID. He was tested positive for COVID-19 after getting the first dose. He was pretty much over it now. The patient's next shot is due on 28Mar2021. The patient would like to know if he can still get his second shot or if he should wait. The outcome of the events was unknown.  Follow-up attempts are completed. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: Tested positive for COVID-19 test; Tested positive for COVID-19 test; This is a spontaneous report from a contactable consumer (patient). A female patient of an unspecified age received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number and expiration date were not reported) as a single dose, with therapy date and route of administration unspecified, for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. On an unspecified date, after the first dose of vaccination, the patient had tested positive for COVID-19 test. The outcome of the event was unknown. The patient was asking how long to wait to get the second dose of vaccination.  Information on the lot/batch number has been requested.
Sex: U
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: I was tested with Covid; I was tested positive; I was tested with Covid; I was tested positive; This is a spontaneous report from a contactable consumer (patient). A patient of unspecified age and gender received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration on Feb2021 as single dose for COVID-19 immunisation.  The patient's medical history and concomitant medications were not reported. It was reported that the patient was tested with COVID and that it tested positive on 23Mar2021. The patient underwent lab tests and procedures which included SARS-CoV-2 test: positive on 23Mar2021. Outcome of events was unknown.   No follow up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Atelectasis, Pericardial effusion, Pleural effusion
Clinical narrative: Patient also has Moderate to large pericardial effusion; Patient has moderate left pleural effusion with associated atelectasis at the left lung; Patient has moderate left pleural effusion with associated atelectasis at the left lung; This is a spontaneous report from a contactable physician. This report was received via a Pfizer sales representative. A 52-year-old male patient received bnt162b2, dose 1 via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as single dose for COVID-19 Immunization. The patient's medical history and concomitant medications were not reported. The patient has moderate to large pericardial effusion, moderate left pleural effusion with associated atelectasis at the left lung on an unspecified date. Event took place after use of product. Outcome of events was unknown.  Information on the lot/batch number has been requested.; Sender's Comments: A possible contributory effect of suspect BNT162B2 on reported events 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 Committees, and Investigators, as appropriate
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Circumstance or information capable of leading to medication error, Drug ineffective, SARS-CoV-2 test
Clinical narrative: positive COVID-19 test with symptoms; positive COVID-19 test with symptoms; needs to wait 90 days before getting the second dose; This is a spontaneous report from a sponsored program, A non-contactable consumer reported that a female patient of an unspecified age received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), via an unspecified route of administration on an unspecified date (Batch/Lot number and Expiration date were not reported) as a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. On an unspecified date, the patient experienced positive COVID-19 test with symptoms. It was further reported that the patient was sick after receiving her first dose and when at the hospital, she was tested for COVID-19 and it came back positive. The reporter asked about re-scheduling the second appointment for the patient and also stated that she spoke to the doctor and was advised that the individual needed to wait 90 days before getting the second dose. The outcome of the event "positive COVID-19 test with symptoms" was unknown.  No follow-up attempts are possible, information about batch/lot number cannot be obtained. No further information is expected.
Age: 79.0
Sex: F
Vaccine: COVID19
Symptoms: SARS-CoV-2 antibody test, SARS-CoV-2 antibody test negative
Clinical narrative: got an antibody test  and it came back negative; The initial safety information received was reporting only non-serious adverse drug reaction. Upon receipt of follow-up information on 19Apr2021, this case now contains serious adverse reaction. Information processed together.  This is a spontaneous report from a contactable nurse (patient). A 79-year-old female patient received second dose for injection, lot number: EM9810), intramuscular, administered in Arm Left on 25Feb2021 13:00 (at the age of 79 years old) at a single dose for covid-19 immunisation. The patient had a vaccine in a hospital. Medical history included restless leg syndrome, sleep apnea, congestive heart failure, diabetes diagnosed in 2015, incontinence, pulmonologist diagnosed mid-esophageal GERD on unspecified date in 2020 (9 months ago and prescribed breathing treatments when she has wheezing), and shingles (after unspecified shingles vaccine). Concomitant medication included albuterol [salbutamol] for wheezing, heart medicines and all kinds of mediations. The patient previously took hepatitis A and B vaccine for immunization and experienced negative antibodies so she was given a booster; and first dose of bnt162b2 (lot number: EL9265) on 02Feb2021 (at the age of 78 years old) injected in left arm in the muscle at a single dose for covid-19 immunisation. The patient had no additional vaccines administered on the same date of the  vaccine. The patient had no prior vaccination within four weeks. It was reported that the patient got an antibody test (SARS COVID 19 IGG test) on 18Mar2021 and it came back negative. She wanted to travel to India this fall and is concerned she has not developed antibodies and wonders if she should get a booster. The patient had no other problems. The patient mentioned it was medically significant because if she does not build any antibodies, she could get shingles again. That is her concern and she would love to go to India. She does not think it is related to the vaccine. She thinks it is her. She thinks she just does not build antibodies. Outcome of the event was unknown.   Relatedness of drug to reaction(s)/event(s) Reaction assessed: SARS COVID 19 IGG test came back negative   Source of assessment: Primary Source Reporter   Method of assessment: Global Introspection Drug result: Unknown; Sender's Comments: Based on available information a contributory role of bnt162b2 SARS-CoV-2 antibody test negative  cannot be excluded.  case will be reassessed if additional information is received.
Sex: F
Vaccine: COVID19
Symptoms: Autoimmune disorder
Clinical narrative: Has multiple auto immune diseases; This is a spontaneous report from a Pfizer sponsored program. A non-contactable female consumer reported for herself that she received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, formulation: solution for injection; Lot number and expiration date were not reported) via an unspecified route of administration, on 24Mar2021 as single dose for COVID-19 immunization. The patient had multiple auto immune diseases. Patient was wondering if they had any data on people with having auto immune diseases and getting vaccine. Also is there any testing they should do to make sure vaccine worked, like IDG or IGM testing. HCP wasn't sure advised to call them. Relayed PMI number and transferred. They would fax into DSU not clarifying if had auto immune disease before or after covid vaccine. The outcome of the event was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test
Clinical narrative: got the first dose of Covid 19 vaccine a week ago (22Mar2021) and tested positive; This is a spontaneous report from a Pfizer sponsored program. A contactable consumer (parent) reported for a male patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), first dose via an unspecified route of administration on 22Mar2021, single dose for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. Patient got the first dose of Covid 19 vaccine a week ago (22Mar2021) and tested positive (assessed as Mar2021). The outcome of the event was unknown.
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: Got the 2nd dose yesterday (26Mar2021) and Caller tested positive for Covid-19 today (27Mar2021); Got the 2nd dose yesterday (26Mar2021) and Caller tested positive for Covid-19 today (27Mar2021); This is a spontaneous report from a Pfizer-sponsored program.  This contactable consumer reporting the same events under the same suspect product for 2 patients. This is one of 2 reports.   This contactable female consumer (patient) of an unspecified age received the 2nd dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 26Mar2021 (Batch/Lot number was not reported) as SINGLE DOSE for COVID-19 immunization.  Medical history and concomitant medications were not reported. The patient received the first dose of PFIZER-BIONTECH COVID-19 VACCINE on unknown date (Batch/Lot number was not reported) as COVID-19 immunization. The patient got the 2nd dose yesterday (26Mar2021) and she tested positive for covid-19 today (27Mar2021). She mentioned that she had an exposure to her son who also tested positive after getting the vaccine. Outcome of the events were unknown.  Information on the lot/batch number has been requested.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021364392 Same reporter, product and event, and different patient
Sex: F
Vaccine: COVID19
Symptoms: Pruritus, Rash
Clinical narrative: itch on her legs; broke out in a rash on her arms, back, chest, and hands; This is a spontaneous report from a contactable consumer (patient herself). A female patient of an unspecified age received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), via an unspecified route of administration on an unspecified date in Feb2021 (Batch/Lot number and Expiration date were not reported) as a single dose for COVID-19 immunization and estradiol (IMVEXXY, strength: 10 µg), vaginal from an unspecified date in Feb2021 (Batch/Lot Number: 388209BC; Expiration Date: 10May2021) and ongoing, at 10 ug, twice a week for vaginal dryness (vulvovaginal dryness), which was an off label use. Relevant medical history included vulvovaginal dryness and thyroid disorder, for which the patient was taking an unspecified thyroid medication on an unspecified date in Feb2021; both from an unknown date and unknown if ongoing. Concomitant medication included an unspecified thyroid medication. It was reported that on an unspecified date in Feb2021 (reported as 4 weeks prior reporting, relative to 15Mar2021), the patient started treatment with samples of IMVEXXY. On an unspecified date in Feb2021 (reported as 3 weeks prior reporting, relative to 15Mar2021), the patient received a COVID vaccine. On an unspecified date in Mar2021 (reported as about a week and a half prior reporting, relative to 15Mar2021) after starting the products, the patient broke out in a rash on her arms, back, chest, and hands. On 14Mar2021 (reported as last night, relative to 15Mar2021), the patient noticed she had developed an itch on her legs. On an unspecified date in Mar2021, she treated her symptoms with diphenhydramine hydrochloride (BENADRYL). She was not sure if IMVEXXY was the cause of the rash or not. As of 15Mar2021, treatment with IMVEXXY was ongoing, and the status of further COVID vaccine administration was not reported. The rash was not resolved, and the status of the itch on her legs was not reported. The patient had an appointment for medical evaluation scheduled for 19Mar2021 (reported as Friday, relative to 15Mar2021). The action taken in response to the events for estradiol was dose not changed. The patient was not recovered from the event "broke out in a rash on her arms, back, chest, and hands," while the outcome of the event "itch on her legs" was unknown.  No follow-up attempts are needed, information about batch/lot number cannot be obtained. No further information is expected.
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Blood pressure fluctuation, Blood pressure measurement, Blood test, Echocardiogram, Electrocardiogram
Clinical narrative: first dose, her blood pressure went sky high and it continued to be high; first dose, her heart rate was up; tired; Blood pressure continues to fluctuate daily; This is a spontaneous report from a contactable consumer (patient). A 70-year-old female patient (age at vaccination: 70-year-old) received the first dose of bnt162b2 (BNT162B2, lot EN6198), via an unspecified route of administration in left arm, on 25Feb2021 16:00 as SINGLE DOSE for Covid-19 immunisation. Medical history was none. There were no concomitant medications. On 27Feb2021, her blood pressure went sky high and it continued to be high (reported as medically significant, disability) ending up in urgent care. She doubled her blood pressure medication which she did, she took Carvedilol and she could only take 2 of the double dose at night because she took 2 in the morning. On 27Feb2021, her heart rate was up (135) and felt tired. Her blood pressure continued to fluctuate daily (Feb2021). The patient underwent laboratory tests and procedures which included blood pressure measurement: high, 178/109, 168/98 on 25Feb2021, blood pressure measurement: went down to 60 on unknown date, blood test: negative on heart attack and everything came back negative, blood test: ok on 26Feb2021, blood test: ok on 27Feb2021, echocardiogram: ok, electrocardiogram: ok on 26Feb2021, electrocardiogram: ok on 27Feb2021 (all urgent care to check for blood enzyme for heart attack), heart rate: was up (135) on 25Feb2021. The outcome of the events was unknown.  Information on the lot number was already obtained.
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Heart rate, Heart rate increased, Hypertension
Clinical narrative: first dose, her blood pressure went sky high and it continued to be high; first dose, her heart rate was up; tired; Blood pressure continues to fluctuate daily; This is a spontaneous report from a contactable consumer (patient). A 70-year-old female patient (age at vaccination: 70-year-old) received the first dose of bnt162b2 (BNT162B2, lot EN6198), via an unspecified route of administration in left arm, on 25Feb2021 16:00 as SINGLE DOSE for Covid-19 immunisation. Medical history was none. There were no concomitant medications. On 27Feb2021, her blood pressure went sky high and it continued to be high (reported as medically significant, disability) ending up in urgent care. She doubled her blood pressure medication which she did, she took Carvedilol and she could only take 2 of the double dose at night because she took 2 in the morning. On 27Feb2021, her heart rate was up (135) and felt tired. Her blood pressure continued to fluctuate daily (Feb2021). The patient underwent laboratory tests and procedures which included blood pressure measurement: high, 178/109, 168/98 on 25Feb2021, blood pressure measurement: went down to 60 on unknown date, blood test: negative on heart attack and everything came back negative, blood test: ok on 26Feb2021, blood test: ok on 27Feb2021, echocardiogram: ok, electrocardiogram: ok on 26Feb2021, electrocardiogram: ok on 27Feb2021 (all urgent care to check for blood enzyme for heart attack), heart rate: was up (135) on 25Feb2021. The outcome of the events was unknown.  Information on the lot number was already obtained.
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: got the 2nd dose yesterday (26Mar2021) and tested positive for covid-19 today (27Mar2021); got the 2nd dose yesterday (26Mar2021) and tested positive for covid-19 today (27Mar2021); This is a spontaneous report from a Pfizer-sponsored program. This contactable consumer (parent) reporting the same events under the same suspect product for 2 patients. This is one of 2 reports.   A male patient of an unspecified age received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 26Mar2021 as single dose for COVID-19 immunization. The patient medical history and concomitant medications were not reported. The patient got the 2nd dose yesterday (26Mar2021) and tested positive for covid-19 today (27Mar2021). Outcome of the events was unknown.  Information on the lot/batch number has been requested.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021359549 Same reporter, product and event, and different patient
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Bell's palsy, Burning sensation, Dry eye, Ear pain, Facial discomfort
Clinical narrative: it sounded like a form of Bell's Palsy; left cheek tingle; my left forehead, cheek, side of lip and chin felt like I had razor burn.; My head itched; left eye felt dry; salivate more than usual from the left side of my mouth; left side of my face began to feel heavy, sometimes also my sinuses, but more often my lower jaw; left side of my face began to feel heavy, sometimes also my sinuses, but more often my lower jaw; left side of my face began to feel heavy, sometimes also my sinuses, but more often my lower jaw; feel pain in my left ear; My lymph nodes on the left side of my face became swollen; This is a spontaneous report from a contactable consumer. A 65-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration, administered in Arm Left on 26Feb2021 12:45 (Batch/Lot Number: EN6202), at the age of 65-years-old, as single dose for COVID-19 immunization. Medical history included allergy to Sulfa. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Concomitant medication included calcium; magnesium; colecalciferol, menadione (VITAMIN K+D); glutathione; all taken for an unspecified indication, start and stop date were not reported. Within 45 mins (also reported as 20-25 minutes) of receiving the shot, she began to feel her left cheek tingle. In the intervening days, her left forehead, cheek, side of lip and chin felt like she had razor burn. Her head itched. Her left eye felt dry, but that went away. She began to salivate more than usual from the left side of her mouth. The left side of her face began to feel heavy, sometimes also my sinuses, but more often my lower jaw. Sometimes, she would feel pain in her left ear. Her lymph nodes on the left side of my face became swollen. Her doctor on Zoom said it sounded like a form of Bell's Palsy (medically significant), though she does not have the drooping eye or mouth. She had an MRI of her left lymph node that did not reveal any issues. Her symptoms, while they have abated, are still present five weeks after the shot. The events started on 26Feb2021 13:30. No treatment was received for the events. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination the patient has not been tested for COVID-19. The outcome of the event left eye felt dry was recovered while other events was not recovered.
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Lymphadenopathy, Magnetic resonance imaging, Pain in jaw, Paraesthesia, Paranasal sinus discomfort
Clinical narrative: it sounded like a form of Bell's Palsy; left cheek tingle; my left forehead, cheek, side of lip and chin felt like I had razor burn.; My head itched; left eye felt dry; salivate more than usual from the left side of my mouth; left side of my face began to feel heavy, sometimes also my sinuses, but more often my lower jaw; left side of my face began to feel heavy, sometimes also my sinuses, but more often my lower jaw; left side of my face began to feel heavy, sometimes also my sinuses, but more often my lower jaw; feel pain in my left ear; My lymph nodes on the left side of my face became swollen; This is a spontaneous report from a contactable consumer. A 65-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration, administered in Arm Left on 26Feb2021 12:45 (Batch/Lot Number: EN6202), at the age of 65-years-old, as single dose for COVID-19 immunization. Medical history included allergy to Sulfa. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Concomitant medication included calcium; magnesium; colecalciferol, menadione (VITAMIN K+D); glutathione; all taken for an unspecified indication, start and stop date were not reported. Within 45 mins (also reported as 20-25 minutes) of receiving the shot, she began to feel her left cheek tingle. In the intervening days, her left forehead, cheek, side of lip and chin felt like she had razor burn. Her head itched. Her left eye felt dry, but that went away. She began to salivate more than usual from the left side of her mouth. The left side of her face began to feel heavy, sometimes also my sinuses, but more often my lower jaw. Sometimes, she would feel pain in her left ear. Her lymph nodes on the left side of my face became swollen. Her doctor on Zoom said it sounded like a form of Bell's Palsy (medically significant), though she does not have the drooping eye or mouth. She had an MRI of her left lymph node that did not reveal any issues. Her symptoms, while they have abated, are still present five weeks after the shot. The events started on 26Feb2021 13:30. No treatment was received for the events. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination the patient has not been tested for COVID-19. The outcome of the event left eye felt dry was recovered while other events was not recovered.
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Pruritus, Salivary hypersecretion
Clinical narrative: it sounded like a form of Bell's Palsy; left cheek tingle; my left forehead, cheek, side of lip and chin felt like I had razor burn.; My head itched; left eye felt dry; salivate more than usual from the left side of my mouth; left side of my face began to feel heavy, sometimes also my sinuses, but more often my lower jaw; left side of my face began to feel heavy, sometimes also my sinuses, but more often my lower jaw; left side of my face began to feel heavy, sometimes also my sinuses, but more often my lower jaw; feel pain in my left ear; My lymph nodes on the left side of my face became swollen; This is a spontaneous report from a contactable consumer. A 65-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration, administered in Arm Left on 26Feb2021 12:45 (Batch/Lot Number: EN6202), at the age of 65-years-old, as single dose for COVID-19 immunization. Medical history included allergy to Sulfa. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Concomitant medication included calcium; magnesium; colecalciferol, menadione (VITAMIN K+D); glutathione; all taken for an unspecified indication, start and stop date were not reported. Within 45 mins (also reported as 20-25 minutes) of receiving the shot, she began to feel her left cheek tingle. In the intervening days, her left forehead, cheek, side of lip and chin felt like she had razor burn. Her head itched. Her left eye felt dry, but that went away. She began to salivate more than usual from the left side of her mouth. The left side of her face began to feel heavy, sometimes also my sinuses, but more often my lower jaw. Sometimes, she would feel pain in her left ear. Her lymph nodes on the left side of my face became swollen. Her doctor on Zoom said it sounded like a form of Bell's Palsy (medically significant), though she does not have the drooping eye or mouth. She had an MRI of her left lymph node that did not reveal any issues. Her symptoms, while they have abated, are still present five weeks after the shot. The events started on 26Feb2021 13:30. No treatment was received for the events. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination the patient has not been tested for COVID-19. The outcome of the event left eye felt dry was recovered while other events was not recovered.
Age: 29.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Fatigue, Headache, Insomnia, Palpitations
Clinical narrative: Fever beginning at 7 pm of 101-102 F, racing heart beat, headache, swollen temples, insomnia due to racing heart beat, chills, fatigue
Age: 29.0
Sex: M
Vaccine: COVID19
Symptoms: Pyrexia, Swelling face
Clinical narrative: Fever beginning at 7 pm of 101-102 F, racing heart beat, headache, swollen temples, insomnia due to racing heart beat, chills, fatigue
Age: 31.0
Sex: M
Vaccine: COVID19
Symptoms: Spontaneous penile erection
Clinical narrative: Repeated nocturnal priaprism  lasting unknown time. Patient states every time he woke up he had an erection so he stayed awake one time and it took 40 minutes to resolve. This was the night of the 2nd vaccination. Vaccination was around 1350 4/21/2021
Age: 24.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Malaise
Clinical narrative: Severe Headache, Malaise
Age: 35.0
Sex: M
Vaccine: COVID19
Symptoms: Interchange of vaccine products
Clinical narrative: Although precautions in place to help prevent error, consumer was given mixed dose series.  Pfizer was first dose.
Age: 63.0
Sex: M
Vaccine: COVID19, UNK
Symptoms: COVID-19, Drug ineffective
Clinical narrative: experienced CORONA VIRUS; experienced CORONA VIRUS; This is a solicited report from a non-Pfizer-sponsored program received from a non-contactable consumer (patient) based on information received by Pfizer from Abbvie (manufacturer control number: 21K-163-3828742-00).  A 64-year-old male patient received the first dose (dose 1) of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via intramuscular on 08Mar2021 (Batch/Lot number was not reported) (at the age of 63-year-old) as single dose for COVID-19 immunization; adalimumab (HUMIRA), via subcutaneous from an unspecified date to an unspecified date, at daily, Citrate free for Moderate to severe rheumatoid arthritis. The patient medical history was not reported. The patient concomitant medications were not reported. On 20Mar2021, the patient experienced Corona virus. COVID-19 vaccine was also considered suspect. It was unknown if patient was enrolled in a COVID-19 Vaccine Trial. On 08Mar2021, patient received 1st dose COVID-19 Vaccine manufactured by Pfizer. The action taken in response to the event for adalimumab was unknown. The outcome of the event was unknown.  The reporter's assessment of the causal relationship of the event 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.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.  Follow-up (20Apr2021): This follow-up is being submitted to notify that the batch number is not available despite the follow-up attempts made. Follow-up attempts have been completed and no further information is expected.; Sender's Comments: Based on the current available information and the consistency with the known safety profile of the suspect product BNT162B2, there is a reasonable possibility that events were related to suspect drug. The case will be reassessed if additional information becomes available.
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site erythema, Injection site swelling, Rash macular, Skin warm
Clinical narrative: Red, hot, itchy swelling directly under site of injection.  Blotchy redness down arm to below elbow.
Age: 33.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal pain, Heavy menstrual bleeding, Menstrual disorder
Clinical narrative: Early period, heavy bleeding and extreme pain in abdominal area.
Age: 16.0
Sex: F
Vaccine: COVID19
Symptoms: Nodule
Clinical narrative: Patient has some kind of nodule/growth just above the collar bone. It feels like a small pebble and is sensitive to touch.
Age: 44.0
Sex: F
Vaccine: COVID19
Symptoms: Dysmenorrhoea, Heavy menstrual bleeding, Menstrual disorder
Clinical narrative: My last menstrual cycle was 4/14.  It is a regular cycle. My next cycle came just 2 days after I received the Vaccine dose and was a heavier and more painful cycle than normal.
Age: 37.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Condition aggravated, Joint swelling
Clinical narrative: I received the second shot at 9:22 by 10:30 my ankle swelling wasn?t the normal swelling I have early in the day. The pain around my ankle was more severe than ever right after getting out of my car and walking to the office. I got the 24 hours body aches. It is almost 5 days later and my ankle hasn?t gotten any better after the shot. I know I have tendonitis and a fused ankle and I?ve always get the pain. But normally it?s after 3/4 hours of work. It just doesn?t feel like the casual pain I?ve been having since I fused my ankle. This one feels more severe. Am I the only one?
Age: 42.0
Sex: M
Vaccine: COVID19
Symptoms: Influenza like illness, Syncope
Clinical narrative: Flu like symptoms followed by 4 episodes of orthostatic syncope
Age: 24.0
Sex: F
Vaccine: COVID19
Symptoms: Influenza like illness, Urticaria
Clinical narrative: flu like symptoms followed by hives
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: Soreness at jab site; This is a spontaneous report from a contactable consumer reported that a 55-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection) via unspecified route of administration as single dose for COVID-19 immunization. Medical history and concomitant medications were not reported. It was reported that patient used the product and experienced soreness at jab site. Outcome of the event was unknown.  No follow-up attempts are needed. No further information is expected.
Sex: U
Vaccine: COVID19
Symptoms: Anxiety
Clinical narrative: Anxiety; This is a spontaneous report received from a contactable consumer (patient). This patient of unspecified age and gender received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; lot number unknown) via an unspecified route of administration on 03Apr2021 as a single dose for COVID-19 immunisation. Medical history included arthritis from an unknown date and unknown if ongoing. Concomitant medications included paracetamol (TYLENOL) from an unknown date for arthritis. The patient previously received the first dose of BNT162B2 (lot number unknown) on an unspecified date for COVID-19 immunisation. The patient reported they received their last shot yesterday, their second shot, and they had a neighbor that seemed to know that they had very bad anxiety and that the patient took paracetamol for arthritis which is 125 mg and they took two of those sometimes. The patient stated nobody had told them that they should not take it before or after; the patient stated about their neighbor that she read that patients were not supposed to take paracetamol before or after the shot. The patient inquired if this was going to be a problem with taking this; further stating they thought they could die on the medication. The clinical outcome of anxiety was unknown.  The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow up.
Sex: U
Vaccine: COVID19
Symptoms: Feeling hot, Pain in extremity
Clinical narrative: My arm is kind of warm, not red but it hurts; My arm is kind of warm, not red but it hurts; This is a spontaneous report received from a non-contactable consumer (patient). A patient of unspecified age and gender received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE) via an unspecified route of administration on 03Apr2021 as a single dose for COVID-19 immunization. Medical history and concomitant medications were not reported. On 03Apr2021 the patient experienced arm kind of warm, not red but it hurt. The outcome of arm kind of warm, not red but it hurt was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site vesicles
Clinical narrative: Blisters formed near injection site; This is a spontaneous report from a contactable physician. A 25-year-old female patient received a dose of COVID-19 vaccine (UNSPECIFIED TRADE NAME; lot number unknown) via an unspecified route of administration on an unknown date as a single dose for COVID-19 immunisation. The patient had no medical history. Concomitant medications were not reported. The patient experienced blisters that formed near the injection site of the COVID-19 vaccine; it was reported as possibly from the band-aid. The clinical outcomes of blisters formed near the injection site were unknown.   The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow up.
Sex: F
Vaccine: COVID19
Symptoms: Chills, Myalgia, Pain, Pyrexia
Clinical narrative: low fever; chills; severe body/muscle aches; severe body/muscle aches; This is a spontaneous report from a contactable healthcare professional. A 32-year-old female patient received dose 2 of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE) via an unspecified route of administration on an unspecified date as a single dose for COVID-19 immunization. Medical history included the patient does not get vaccines such as for influenza regularly. Concomitant medications were not reported. The patient previously received dose 1 of BNT162B2 on an unspecified date as a single dose for COVID-19 immunization. On an unspecified date 12 hours after receiving dose 2 of BNT162B2 the patient experienced low fever, chills, and severe body/muscle aches. The muscle aches were severe for approximately 3 days and then subsided to mild aches for the next few days. The outcomes of low fever, chills, and body/muscle aches were unknown.   No follow-up attempts are possible. Information on lot/batch number cannot be obtained.