chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 39.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Anosmia, Aphonia, Oropharyngeal pain, SARS-CoV-2 test positive
Clinical narrative: result back w positive covid; positive COVID-19 test with symptoms; This is a spontaneous report from a contactable nurse reporting for herself.  A 39-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), via an unspecified route of administration on 19Dec2020 11:00 (at age 39 years old) as a single dose (Dose 1) in the left arm for COVID-19 vaccination. The patient was not pregnant at the time of vaccination. The patient was not administered any other vaccine in the 4 weeks prior to COVID-19 vaccination.  Medical history was none. There were no allergies to medication, food, or other products. The patient's concomitant medications were not reported; however the patient had not received any other medications in the last 2 weeks. The patient experienced a sore throat, voice loss on day 4, loss of smell on day 5, went to test, and the result came back with positive COVID. The events resulted in a Doctor's office visit. The patient was tested post vaccination on 22Dec2020 via NAAT-PCR (nasal swab), with a positive result. The patient had not been diagnosed with COVID-19 prior to vaccination. There was no treatment received for the event(s). The clinical outcome of the event positive COVID was unknown The event was reported as non-serious.  The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow up.; Sender's Comments: The association between the event drug ineffective (COVID-19 infection) with BNT162b2 can not be fully excluded.
Age: 39.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Cough, SARS-CoV-2 test positive
Clinical narrative: result back w positive covid; positive COVID-19 test with symptoms; This is a spontaneous report from a contactable nurse reporting for herself.  A 39-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), via an unspecified route of administration on 19Dec2020 11:00 (at age 39 years old) as a single dose (Dose 1) in the left arm for COVID-19 vaccination. The patient was not pregnant at the time of vaccination. The patient was not administered any other vaccine in the 4 weeks prior to COVID-19 vaccination.  Medical history was none. There were no allergies to medication, food, or other products. The patient's concomitant medications were not reported; however the patient had not received any other medications in the last 2 weeks. The patient experienced a sore throat, voice loss on day 4, loss of smell on day 5, went to test, and the result came back with positive COVID. The events resulted in a Doctor's office visit. The patient was tested post vaccination on 22Dec2020 via NAAT-PCR (nasal swab), with a positive result. The patient had not been diagnosed with COVID-19 prior to vaccination. There was no treatment received for the event(s). The clinical outcome of the event positive COVID was unknown The event was reported as non-serious.  The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow up.; Sender's Comments: The association between the event drug ineffective (COVID-19 infection) with BNT162b2 can not be fully excluded.
Age: 42.0
Sex: F
Vaccine: COVID19
Symptoms: Pain, Vaccination site erythema, Vaccination site induration, Vaccination site pruritus, Vaccination site swelling
Clinical narrative: I had soreness; started with itching, redness and swelling at site of immunization.; started with itching, redness and swelling at site of immunization./5.0 cm area of redness and induration; 5.0 cm area of redness and induration at site; started with itching, redness and swelling at site of immunization.; This is a spontaneous report from a contactable physician (patient herself). A 42-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: ek5730, expiry date not reported), via an unspecified route of administration on the left arm on 17Dec2020 10:15 at single dose for COVID-19 immunisation. Medical history included food allergy, oral allergy, no anaphylaxis. Concomitant medications were not reported. On 26Dec2020 18:00, the patient started with itching, redness and swelling at site of immunization. Patient also had a 5.0 cm area of redness and induration at site. Patient also had soreness on an unspecified date but no other reaction. No therapeutic measure was taken as a result of the events. Clinical outcome of pain was unknown while for the other events was not recovered.  Follow-up attempts are not possible. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Chills, Dizziness, Nausea, Vaccination site pain
Clinical narrative: Pain on the injection site; chill; nausea; lightheaded; This is a spontaneous report from a contactable physician via a Pfizer colleague. The Pfizer colleague received from a friend a video where the physician (also the patient) was interviewed on 25Dec2020 after getting the Pfizer/BioNtech vaccination and he reported the symptoms described below.  An adult male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: unkown, expiry date not reported), via an unspecified route of administration on the left arm on 24Dec2020 at a single dose for COVID-19 immunisation. Medical history was unknown. It was unknown if the patient was allergic to medication, food or other products and it was not known if the patient was diagnosed with COVID-19 before vaccination or if the patient had been tested for COVID-10 since the vaccination. It was unknown if the patient received any other vaccines within 4 weeks prior to the COVID vaccine. Concomitant medications were not reported. On 24Dec2020, the patient experienced pain on the injection site (was still ongoing on 25Dec2020); also chill, nausea and lightheadedness which all disappeared 30 minutes after the injection. Clinical outcome of pain on the injection site was unknown, while for the other events was recovered on 24Dec2020.  The batch/lot number was unknown as it was not available or not provided by the reporter at the time of report completion. Follow-up attempts are not possible. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Dyspnoea, Malaise, SARS-CoV-2 test positive
Clinical narrative: tested positive for covid19/diagnosed with Covid; tested positive for covid19/diagnosed with Covid; she had SOB the day of her first vaccination; I am very sick; I feel bad; This is a spontaneous report from a contactable consumer (patient). A female patient of an unspecified age received 1st dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EH9899), via an unspecified route of administration on 21Dec2020 at a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient got the first dose of COVID-19 vaccine on Monday, 21Dec2020 and then was diagnosed with COVID-19 on 23Dec2020. Added that she was very sick and wondering if he'll get her second dose or not. The patient feel bad and is due for her second dose on 11Jan2021. The patient also reported that she had shortness of breath (SOB) the day of her first vaccination on 21Dec2020 and then tested positive for COVID-19 later. She posits she may have received the vaccine when she had an active COVID-19 infection. She is wondering if she can still get her second vaccination. Outcome of the events was unknown.
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Cough, Dysphonia, Headache, SARS-CoV-2 test positive
Clinical narrative: tested positive for COVID-19; headache; cough; voice being hoarse; Drug ineffective; This is a spontaneous report from a Pfizer Sponsored Program Pfizer First Connect from a Contactable nurse reporting for herself.  A 58-years-old female patient received bnt162b2 (BNT162B2; Lot # EK5730) vaccine , via an unspecified route of administration on 18Dec2020 10:30 at single dose for covid-19 immunisation .  Medical history included hypertension from an unknown date and blood cholesterol increased.  Concomitant medication included losartan (LOSARTAN), hctz (HCTZ), ezetimibe (ZETIA), famotidine (PEPCID).  The patient  started having a headache and cough on 25Dec2020 and these symptoms worsened on 26Dec2020 in addition to her voice being hoarse. On 26Dec2020 she went to get tested at an urgent center and tested positive for Covid-19. The outcome of the event was not recovered.; Sender's Comments: The association between the event "tested positive for COVID-19, headache, cough, and dysphonia" with BNT162b2 can not be fully 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: 51.0
Sex: F
Vaccine: COVID19
Symptoms: Rash papular
Clinical narrative: Approximately 15 small pencil point red bumps on arms and legs. Itchy. Not raised. Did not increase in size. Kept appearing within 5 days after the shot.; This is a spontaneous report from a contactable nurse (patient).  A 51-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), Lot number: EK5730 intramuscular in the left deltoid, from 22Dec2020 15:00 at a, single dose, for COVID-19 immunization. Patient received another Pfizer vaccine on the same date. Medical history included hypertension (HTN), guillain-barre syndrome from 2008. Patient's allergies included penicillin and ASA. Concomitant medication included paroxetine and amlodipine. On 23Dec2020 08:00, approximately 15 small pencil point res bumps on arms and legs. Itchy. Not raised. Did not increase in size. Kept appearing within 5 days after the shot. The outcome of events was recovered. no treatment or hospitalization was required.  Follow-up attempts are completed. Information on the batch/lot number has been obtained.
Age: 48.0
Sex: F
Vaccine: COVID19
Symptoms: Chest discomfort, Dyspnoea, SARS-CoV-2 test, Throat irritation, Throat tightness
Clinical narrative: chest got tight; Shortness of breath; throat was itchy, and felt like it closed; throat was itchy, and felt like it closed; This is a spontaneous report from a contactable other health care professional (HCP) (also reported as respiratory therapist) from a Pfizer Sponsored Program.  A 48-year-old female patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; Lot Number: EK5730), via an unspecified route of administration on 21Dec2020 at 48-years-old at a single dose for COVID-19 immunization. Medical history included asthma from 2000 and ongoing (diagnosed 20 year ago).  There were no concomitant medications. On 21Dec2020, the patient experienced: chest got tight (non-serious), shortness of breath (non-serious), throat was itchy, and felt like it closed.  The clinical course was reported as follows: The caller was a respiratory therapist (also reported as health care professional (HCP)). The patient's first dose of the vaccine was on 21Dec2020 at the hospital where she works. Five hours after getting the vaccine, her chest got tight, she has shortness of breath, her throat was itchy, and she felt like it closed. The patient had asthma (diagnosed 20 years ago) and felt this reaction. It took 48 hours after the initial symptoms that she felt better.  For treatment, the patient took her salbutamol (ALBUTEROL) inhaler and diphenhydramine hydrochloride (BENADRYL). The patient was scared to have the second dose; and she was going to talk to her primary care physician (PCP) about the second dose (but she did not think she would have much knowledge on what to do). The patient had a COVID PCR test the day she received the vaccine, and it was negative. The patient underwent lab tests and procedures which included COVID-19 PCR test: negative on 21Dec2020.  The clinical outcome of the events was recovered on an unspecified date.
Age: 51.0
Sex: M
Vaccine: COVID19
Symptoms: Cough, Pain, Pyrexia, SARS-CoV-2 test positive
Clinical narrative: positive COVID-19 antigen test with symptoms (ache, cough, fever); positive COVID-19 antigen test with symptoms (ache, cough, fever); This is a spontaneous report from a contactable physician (patient). A 51-year-old male patient received the first dose bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number EH9899), via an unspecified route of administration on 17Dec2020 at 10:30 at single dose in left arm for covid-19 immunization. Medical history included borderline diabetes, ongoing hypertension, ongoing hyperlipidemia, ongoing rhinitis allergic, and currently ill. Concomitant medication included ongoing fexofenadine hydrochloride (ALLEGRA, strength: 180 mg) at 180mg once daily by mouth for Rhinitis allergic taking for years, ongoing lisinopril (strength: 40 mg) at 40 mg once daily by mouth for hypertension taking for two or three years, ongoing atorvastatin (strength: 40 mg) at 40 mg once daily by mouth for hyperlipidemia taking for a year. The patient experienced positive covid-19 antigen test with symptoms (ache, cough, fever) from 19Dec2020. Event details: The patient received the COVID 19 Vaccine on 17Dec2020 10:30AM in the left arm. Tested for COVID 19 with the antigen test, on 20Dec2020 and his result was positive, he experienced ache and cough on 19Dec2020. Clarified he started having symptoms in the evening (19Dec2020) and then tested in the morning (20Dec2020). He experienced the low grade fever on 20Dec2020. His maximum temperature was 100.4 fahrenheit. He had only been treated with over the counter products. No further information provided for the over the counter products. He was not hospitalized. He will take the second dose of the COVID 19 vaccine on 07Jan2021. The patient didn't have SARS-CoV2 antibodies at diagnosis. The patient was not admitted to an Intensive Care Unit. The patient didn't display clinical signs at rest indicative of severe systemic illness. The patient didn't require supplemental oxygen (including high flow or ECMO) or receive mechanical ventilation. The patient didn't have any pre-existing diseases worsened during the SARS-CoV2 infection. The patient was not treated with immunomodulating or immunosuppressing medications or received any other vaccines around the time of COVID-19 vaccination. The outcome of all his symptoms was resolving.; Sender's Comments: The reported events drug ineffective and COVID-19 are likely intercurrent and are unrelated to suspect drug BNT162B2 based on short temporal relation between vaccination and onset of events.
Sex: U
Vaccine: COVID19
Symptoms: Headache, Nasal congestion, SARS-CoV-2 test positive
Clinical narrative: positive COVID-19 rapid test with symptoms; positive COVID-19 rapid test with symptoms; headache; nasal congestion; This is a spontaneous report from a contactable physician. A patient of unspecified age and gender received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, on an unspecified date at a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient experienced positive COVID-19 rapid test with symptoms, headache and nasal congestion on an unspecified date. The patient developed headache and nasal congestion by the third day after the vaccination. The patient underwent lab tests and procedures which included COVID-19 rapid test: positive on an unspecified date. The clinical outcome of positive COVID-19 rapid test with symptoms, headache and nasal congestion was unknown.  The batch/lot number for the vaccine, BNT162B2, was not provided and has been requested during follow up.; Sender's Comments: The reported positive COVID-19 rapid test with symptoms after COVID-19 immunization is considered ineffective of BNT162B2, and the Company cannot completely exclude the possible causality between the reported event and BNT162B2 administration.
Age: 37.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test positive
Clinical narrative: positive COVID-19 test with symptoms; positive COVID-19 test with symptoms; This is a spontaneous report from a contactable nurse (patient). A 37-year-old female patient received their first dose of BNT162B2 (lot number: EL0140; expiry date unknown), intramuscular on 21Dec2020 at single dose for COVID-19 immunization. Medical history included congestion and dry cough (before vaccination), and not tasting anything from an unknown date. Concomitant medication included vitamins. The patient reported that they just have the concern about the vaccination last Monday that was 21Dec2020, on 25Dec2020, Christmas day they were diagnosed with Covid. They were thinking because the day before their vaccination they already had like some kind of congestion and also some kind of dry cough but they didn't really think that it was Covid but they were still able to get the vaccination on Monday. When they started to feel like they were not tasting anything, that's when they decided to get tested and it turns out to be positive. They were confirmed positive on the 25th but in their mind they were probably having Covid since the day before they got they vaccination. So their worry is, is there any effect where they got the vaccine where they already have the Covid in their body. So that is really their worry right now. The patient underwent lab tests and procedures which included SARS-CoV-2 test: positive on 25Dec2020. The outcome of the events was unknown.; Sender's Comments: The association between the event drug ineffective (COVID-19) with BNT162b2 can not be completely excluded.
Age: 43.0
Sex: F
Vaccine: COVID19
Symptoms: Rash
Clinical narrative: developed rashes on the chest area, not spreading; This is a spontaneous report from a contactable nurse (patient).  A 43-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number EK5730), via an unspecified route of administration into the left deltoid on 18Dec2020 as the first single dose for covid-19 immunization.  Medical history was reported as none.  Concomitant medication included rosuvastatin calcium (CRESTOR).  The patient developed rashes on the chest area, not spreading on 22Dec2020.  The event as reported between not serious and medically significant by the reporter.  Details were as follows: and patient was a nurse  that had her vaccine through her workplace on 18Dec2020, so she was 10 days out, and noticed a rash on her chest on day 4, which was still present. It did not seem to be spreading, and she could not  think of any reason for the reaction. She was scheduled to receive the second dose in three weeks.  The outcome of developed rashes on the chest area, not spreading was not recovered. The relatedness of the event to the suspect drug was reported as unknown from the reporter.; Sender's Comments: Based on the information currently provided, the vaccination with BNT162B2 might play a contributory role in triggering the onset of rash. 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: 53.0
Sex: F
Vaccine: COVID19
Symptoms: Eyelid disorder, Ophthalmological examination abnormal, Vision blurred, Visual impairment
Clinical narrative: blurred vision; little spots on the inside of her eyelids; This is a spontaneous report from a contactable nurse (patient). A 53-year-old female patient received first dose of BNT162B2 (Pfizer-BioNTech COVID-19 mRNA vaccine; batch/lot number and expiry date were unknown), via an unspecified route of administration on 18Dec2020 at a single dose for COVID-19 immunization. Medical history included eyeglasses wearer (reported as with her glasses). The patient's concomitant medications were not reported. The patient is experiencing symptoms from the COVID-19 vaccine received on 18Dec2020. She began to have blurred vision that night, and it worsened over the following weekend. She saw the eye doctor on 22Dec2020, and they stated her vision had changed even with her glasses. Now she has little spots on the inside of her eyelids that were also noticed on the eye examination in Dec2020. She has already reported these symptoms to the V-safe program. She mentioned that she is not the only nurse in the workplace that has experienced blurry vision. She asked if she should receive the second dose on 08Jan2021. It was still blurry, but it was better than it was a week ago. It still affected her reading and seeing at a distance. It scared her to get the second one because she doesn't want to go blind. She went to the eye doctor for visit on Tuesday. The outcome of the event blurred vision was recovering, while for the other event was unknown. The reporter considered blurred vision as serious due to being medically significant.  Information about lot/batch number has been requested.; Sender's Comments: There is not a reasonable possibility that the reported event vision blurred and eyelid disorder related to the suspect product event most likely due to patient underlying contributory factors
Sex: U
Vaccine: COVID19
Symptoms: SARS-CoV-2 test positive
Clinical narrative: positive COVID-19 test; positive COVID-19 test; This is a spontaneous report from a contactable pharmacist. A patient of unspecified age and gender received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, on an unspecified date at a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient experienced positive COVID-19 test on an unspecified date. The patient underwent lab tests and procedures which included COVID-19 test: positive on an unspecified date. The clinical outcome of positive COVID-19 test was unknown.  The batch/lot number for the vaccine, BNT162B2, was not provided and has been requested during follow up.; Sender's Comments: The reported positive COVID-19 test after COVID-19 immunization is considered ineffective of BNT162B2, and the Company cannot completely exclude the possible causality between the reported event and BNT162B2 administration.
Age: 32.0
Sex: M
Vaccine: COVID19
Symptoms: Headache, Nasal congestion, Pain
Clinical narrative: body aches; headache; congestion; This is a spontaneous report from a contactable physician (patient).  A 32-years-old male patient received his first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 18Dec2020 at a single dose for Covid-19 immunization.  The patient medical history was not reported.  The patient's concomitant medications were not reported.  The doctor (HCP) received his 1st vaccination on 18Dec2020. He started having symptoms on 26Dec2020. These symptoms are "body aches, headache and congestion." Outcome of the events was unknown.    Information on the lot/batch number has been requested.
Age: 41.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Chills, Diarrhoea, Illness, Pyrexia
Clinical narrative: very sick; chills; fever; diarrhea; vomiting; This is a spontaneous report from a contactable other hcp. A 41-year-old female patient received bnt162b2 (lot number: EH9899), intramuscularly at arm left, first dose on 22Dec2020, at single dose, for COVID-19 immunization. The patient medical history and concomitant medications were not reported. It was reported that the patient got the vaccination yesterday (22Dec2020) and she has been very sick, chills, fever, diarrhea and vomiting. Didn't come to work today and she claims is getting worse. The event was unwitnessed by staff and the reported by client employer. Age at vaccination is 41 years old. Adverse event started on 23Dec2020. The event was reported as non-serious. The outcome of the events was unknown.
Age: 41.0
Sex: F
Vaccine: COVID19
Symptoms: Vomiting
Clinical narrative: very sick; chills; fever; diarrhea; vomiting; This is a spontaneous report from a contactable other hcp. A 41-year-old female patient received bnt162b2 (lot number: EH9899), intramuscularly at arm left, first dose on 22Dec2020, at single dose, for COVID-19 immunization. The patient medical history and concomitant medications were not reported. It was reported that the patient got the vaccination yesterday (22Dec2020) and she has been very sick, chills, fever, diarrhea and vomiting. Didn't come to work today and she claims is getting worse. The event was unwitnessed by staff and the reported by client employer. Age at vaccination is 41 years old. Adverse event started on 23Dec2020. The event was reported as non-serious. The outcome of the events was unknown.
Sex: F
Vaccine: COVID19
Symptoms: SARS-CoV-2 test positive
Clinical narrative: having symptoms/She tested positive to COVID-19; having symptoms/She tested positive to COVID-19; This is a spontaneous report from a contactable nurse (patient). A 30-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 16Dec2020 at a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient started having symptoms on Thursday. On Friday, her supervisor had her get tested for COVID. She tested positive to COVID-19 in Dec2020. Outcome of the events was unknown. The patient wanted to know if she is symptom free, should/can she still get the 2nd dose as planned.  Information on the lot/batch number has been requested.; Sender's Comments: Based on the information available, a possible contributory role of the suspect products cannot be excluded for the reported event of positive for corona virus infection for the lack of efficacy of the vaccine. However, based on the mechanism of action of the vaccine, it is unlikely the patient would have fully developed immunity for the vaccine to be effective, due to the single dose and short duration
Sex: F
Vaccine: COVID19
Symptoms: SARS-CoV-2 test positive
Clinical narrative: ended up testing positive for COVID virus after receiving the first dose of Pfizer-BioNTech COVID-19 Vaccine/ She had symptoms; ended up testing positive for COVID virus after receiving the first dose of Pfizer-BioNTech COVID-19 Vaccine/ She had symptoms; This is a spontaneous report from a contactable nurse. This nurse reported similar events for two patients. This is 1st of two reports.   A female patient of an unspecified age received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EH9899; expiry date unknown), via an unspecified route of administration, on an unspecified date, at 0.3 mL, single for COVID-19 vaccination. The patient's medical history and concomitant medications were not reported. The nurse reported on an unspecified date that the patient tested positive after the first dose. The reporter works in employee health at their hospital. The employee ended up testing positive for COVID virus after receiving the first dose of Pfizer-BioNTech COVID-19 Vaccine. She had symptoms the first 2-3 days after getting the vaccine and assumed it was a normal immune response, but after that she continued to have the symptoms. They went to see the provider and tested positive for COVID virus. They were asking how to handle their second doses. Outcome of the events was unknown.; Sender's Comments: Based on the information available, a possible contributory role of the suspect products cannot be excluded for the reported event of corona virus infection for the lack of efficacy of the vaccine. However, based on the mechanism of action of the vaccine, it is unlikely the patient would have fully developed immunity for the vaccine to be effective, due to the short duration of less than 5 days since the vaccine first dose is given.,Linked Report(s) : US-PFIZER INC-2020516628 same reporter, same drug, same event, different patient.
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal pain lower, Headache, Nausea
Clinical narrative: nausea/waves of nausea; lower abdominal pain; headache; This is a spontaneous report from a contactable consumer (patient). A 60-year-old female patient received bnt162b2 (BNT162B2; reported as COVID19 Vaccine; lot number: EJ1685; expiration date: Mar2021), via an unspecified route of administration right arm on 18Dec2020 15:00 at single dose for Covid-19 vaccination. Medical history included IBS (irritable bowel syndrome), hysterectomy at age 42 and she doesn't have periods (amenorrhea). The patient family medical history included her family are all dead and has been for a long time. The patient's concomitant medications were not reported. It was reported that vaccinations within 4 weeks included shingles vaccination 5 weeks before covid-19 vaccine wherein the patient first singles shot was fine. Her second shingles shot made her sick, body aches, and fever for about 24 hours. She received it from a pharmacy inside a store. The reporter mentioned that she took her first covid vaccine shot and was able to experience nausea, headache lower abdominal pain. She inquired if there was information on until when she will be experiencing this or how long the symptoms will last. She mentioned that she had headaches and waves of nausea, and before nausea, she had lower abdominal pain. She doesn't know if abdominal pain was coincidental. She had a hysterectomy, so she doesn't have periods. She lives with IBS, but this abdominal pain was different. Immediately after COVID-19 Vaccine within about 20 minutes after injection (18Dec2020 15:20), she had headaches and she still has been having headaches. She had strange lower abdominal pain that lasted a minute and a half then shortly after that started having waves of nausea. She added that the waves of nausea began 24 hours after the COVID-19 Vaccine (19Dec2020 15:00). The outcome of the event headache was not recovered, as for nausea was unknown while the outcome of the other event was recovered on Dec2020.
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity, SARS-CoV-2 test
Clinical narrative: Sore left arm 2-3 days after vaccinated; This is a spontaneous report from a contactable consumer. A 56-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), Lot: EK5730, via an unspecified route of administration, in the left arm, from 22Dec2020 09:15 at a single dose for COVID-19 immunization. Medical history included allergies to penicillin, gluten, chicken eggs (whites & yolks) and cow's milk. Patient was not pregnant. The patient's concomitant medications were not reported.  on 23Dec2020 09:00, after being vaccinated, the patient experienced sore left arm for 2-3 days. The patient underwent lab tests and procedure on unspecified date which included Nasal Swab test/COVID test, yielding negative result. The outcome of event was recovered on Dec2020.  Follow-up attempts are completed. Information on the batch/lot number has been obtained.
Sex: F
Vaccine: COVID19
Symptoms: Anosmia, Nasopharyngitis
Clinical narrative: lost sense of smell; cold like symptoms; This is a spontaneous report from a contactable consumer. A female patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 23Dec2020 at a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient experienced cold like symptoms on 24Dec2020. Then on the 26th (26Dec2020), patient lost sense of smell. Outcome of events was unknown.  Follow-up attempts are completed. The following information on the batch number has been requested.
Sex: U
Vaccine: COVID19
Symptoms: SARS-CoV-2 test positive
Clinical narrative: a patient received Pfizer COVID-19 vaccine, couple of days later the patient tested positive for COVID-19; a patient received Pfizer COVID-19 vaccine, couple of days later the patient tested positive for COVID-19; This is a spontaneous report from a contactable pharmacist. A patient of unspecified age and gender received the first dose of BNT162B2 (Pfizer-Biontech Covid-19 Vaccine) via an unspecified route of administration on an unspecified date at a single dose as Pfizer COVID-19 vaccine. Medical history and concomitant medications were not reported. It was reported that on an unspecified date, a patient received Pfizer COVID-19 vaccine, couple of days later the patient tested positive for COVID-19, patient subsequently received monoclonal antibody treatment: a combination of Casirivimab and Imdevimab. It was inquired if the patient could receive the second dose of COVID-19 vaccine. The outcome of the events was unknown.   Information about Lot/batch number has been requested.; Sender's Comments: Based on available information, a possible contributory role of BNT162B2 vaccine cannot be excluded for the reported events of  LOE and  COVID 19. There is very limited information provided in this report.  This case will be reassessed upon receipt of follow-up information. Based on the information provided in the case, this individual report would not seem to modify the risk-benefit profile of the subject product.
Sex: U
Vaccine: COVID19
Symptoms: Ageusia, Anosmia, SARS-CoV-2 test positive
Clinical narrative: I took the vaccine and two days after I tested positive/had lost my sense of smell and taste; I took the vaccine and two days after I tested positive/had lost my sense of smell and taste; Lost my sense of smell and taste; Lost my sense of smell and taste; This is a spontaneous report from a non-contactable consumer (patient). A patient of unspecified age and gender received BNT162B2 (Pfizer-BioNTech COVID-19 mRNA vaccine; lot/batch number and expiry date were unknown), via an unspecified route of administration on 23Dec2020 at a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The consumer stated that he/she just got the vaccine on Wednesday (23Dec2020), and he/she started experiencing some symptoms on 24Dec2020 where he/she had lost his/her sense of smell and taste. On 25Dec2020, he/she went 'health' to get tested, and he/she tested positive. The consumer is asking whether this has been reported that one of the side effects of getting the vaccine. The consumer said he/she hasn't read anything about loss of taste and smell after taking the vaccine. He/she was wondering if this has been reported or this is one of those small side effects that the vaccine has. The consumer further stated that he/she took the vaccine and two days after, he/she tested positive. Now, his/her whole family is also positive but only his/herself had the vaccine, because he/she is the only one that works in healthcare (further clarification was unknown, hence reporter was captured as consumer). The outcome of the events was unknown.  No follow-up attempts are possible; Information about lot/batch number could not be obtained. No further information is expected.; Sender's Comments: The association between the event lack of effect (COVID19, lost of taste and smell) with BNT162b2 can not completely excluded.
Sex: U
Vaccine: COVID19
Symptoms: SARS-CoV-2 test positive
Clinical narrative: ended up testing positive for COVID virus after receiving the first dose of Pfizer-BioNTech COVID-19 Vaccine/had symptoms; ended up testing positive for COVID virus after receiving the first dose of Pfizer-BioNTech COVID-19 Vaccine/had symptoms; This is a spontaneous report from a contactable nurse. This nurse reported similar events for two patients. This is the 2nd of two reports.   A patient of an unspecified age and gender received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, strength: 0.3 mL, lot number: EH9899; expiry date was unknown), via an unspecified route of administration on an unspecified date at 0.3 mL, single for COVID-19 vaccination. The patient's medical history and concomitant medications were not reported. The patient ended up testing positive for COVID virus after receiving the first dose of Pfizer-BioNTech COVID-19 Vaccine. The patient had symptoms the first 2-3 days after getting the vaccine and assumed it was a normal immune response, but after that the patient continued to have the symptoms. The patient went to see the provider and tested positive for COVID virus. The patient was asking how to handle his/her second dose. The outcome of the event was unknown.; Sender's Comments: Based on the information currently provided, the company considers that a causal relationship between the COVID-19 and vaccination with BNT162B2 cannot be excluded.,Linked Report(s) : US-PFIZER INC-2020516297 same reporter, same event, different patient.
Sex: F
Vaccine: COVID19
Symptoms: SARS-CoV-2 test positive
Clinical narrative: tested positive after receiving Covid-19 vaccine; tested positive after receiving Covid-19 vaccine; This is a spontaneous report from a contactable nurse. A 38-years-old female patient started received her first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number and expiration date not reported), via an unspecified route of administration on 18Dec2020 at a single dose for prevention of Covid 19. The patient medical history and concomitant medications were not reported.  The nurse reported that a staff member received the first dose of Covid-19 vaccine on 18Dec2020. Approximately 9 days later, on 27Dec2020, the patient developed/experienced tested positive after receiving Covid-19 vaccine. The seriousness criteria for this event was none. The nurse asked if the patient will be able to receive the second dose and what is the advice for the patient. The outcome of the event was unknown. The reporter considered the relationship of the event to treatment with BNT162B2 as not applicable.  Information about lot/batch number was requested.; Sender's Comments: Based on the information available, a possible contributory role of the suspect BNT162B2 cannot be excluded for the reported event tested positive Covid-19 based on the known safety profile. However the short duration of 9 days since the vaccine first dose is given it is unlikely patient would have fully developed immunity.
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Flushing, Pruritus, Urge incontinence
Clinical narrative: Flush; Itching; felt like she was going to wet herself; This is a spontaneous report from a contactable consumer. A 58-year-old female patient received the bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; Lot Number: EK5730 and Expiration Date: unknown), intramuscularly in the upper left arm on 22Dec2020 at 08:48 at 58-years-old at a single dose for COVID-19 immunization; which was received at a hospital. The patient stated the hospital had a line for employees to drive up and receive the vaccine, she was in her car when the vaccine was administered. Medical history included ongoing allergy to sulfates from an unknown date (diagnosed at least 20 years ago). The patient had an allergy to sulfates. The patient had a bad reaction to sulfamethoxazole and trimethoprim (BACTRIM) many years ago. The patient did not have the Lot and NDC numbers, or expiration date to provide. The patient stated the reaction was so bad she had to receive multiple injections because her throat was closing off and she had big hives. This occurred years ago. There were no concomitant medications.  The patient previously took sulfamethoxazole and trimethoprim (BACTRIM) and experienced bad reaction, throat was closing off and big hives from an unknown date to an unknown date. On 22Dec2020, the patient experienced: flush, itching, and felt like she was going to wet herself; all assessed as non-serious. The patient called about the COVID-19 vaccine. The patient was wondering if there was any sulfa in the vaccine. The patient had the vaccine on 22Dec2020, and she was fine for the first hour and then she became flush and started itching an hour later. The patient stated " you know when you get a CT scan and the contrast makes you feel warm down there", states she got that same feeling where she felt flush and where she was warm down there and she felt like she was going to wet herself. The patient stated, "the bladder feeling came on so harsh and fast." The patient took diphenhydramine hydrochloride (BENADRYL) for two days and she felt better. The patient later clarified that she recovered completely as of 25Dec2020. Therapeutic measures were taken as a result of flush and itching. The clinical outcome of the events, flush and itching, was recovered on 22Dec2020. The clinical outcome of the event, felt like she was going to wet herself, was unknown. There was no history of previous immunization with the Pfizer vaccine considered as a suspect. There were no additional vaccines administered on the same date of the Pfizer suspect. The events did not require a visit to an emergency room or physician office.  The patient did not receive any prior vaccinations within 4 weeks of the suspect vaccine.  There were no adverse events (AEs) following prior vaccinations.  There were no relevant tests performed.
Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal discomfort, Diarrhoea, Nausea, Vomiting
Clinical narrative: Patient had GI distress (N/V/diarrhea) on 12/25
Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Dizziness, Heart rate, Heart rate increased, Hypoaesthesia
Clinical narrative: lightheaded; chills; tingling/buzzing/numbness/swelling in face and lips; tingling/buzzing/numbness/swelling in face and lips; tingling/buzzing/numbness/swelling in face and lips; tingling/buzzing/numbness/swelling in face and lips; swelling in face; swelling in face and lips; rapid heart rate; flushed neck, upper chest, and face-a red rash here; This is a spontaneous report from a contactable consumer (patient). This 51-year-old female patient received the 1st dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration at left arm on 28Dec2020 03:30 PM at single dose (lot number: EH9899) for COVID-19 immunization. Medical history included asthma and known allergies to medications, food, or other products. Concomitant medications include Estradiol received in two weeks. No other vaccine in four weeks. The patient was not pregnant. The patient experienced lightheaded; chills; tingling/buzzing/numbness/swelling in face and lips; rapid heart rate; flushed neck, upper chest, and face-a red rash here that resembled sunburn, but was not painful; on 28Dec2020 04:00 PM. The patient took antihistamine (Claritin) and rest as treatment. All events were reported as non-serious. The patient had no Covid prior vaccination, no Covid tested post vaccination. Outcome of all events was recovering.
Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: Hypoaesthesia oral, Lip swelling, Paraesthesia, Paraesthesia oral, Rash
Clinical narrative: lightheaded; chills; tingling/buzzing/numbness/swelling in face and lips; tingling/buzzing/numbness/swelling in face and lips; tingling/buzzing/numbness/swelling in face and lips; tingling/buzzing/numbness/swelling in face and lips; swelling in face; swelling in face and lips; rapid heart rate; flushed neck, upper chest, and face-a red rash here; This is a spontaneous report from a contactable consumer (patient). This 51-year-old female patient received the 1st dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration at left arm on 28Dec2020 03:30 PM at single dose (lot number: EH9899) for COVID-19 immunization. Medical history included asthma and known allergies to medications, food, or other products. Concomitant medications include Estradiol received in two weeks. No other vaccine in four weeks. The patient was not pregnant. The patient experienced lightheaded; chills; tingling/buzzing/numbness/swelling in face and lips; rapid heart rate; flushed neck, upper chest, and face-a red rash here that resembled sunburn, but was not painful; on 28Dec2020 04:00 PM. The patient took antihistamine (Claritin) and rest as treatment. All events were reported as non-serious. The patient had no Covid prior vaccination, no Covid tested post vaccination. Outcome of all events was recovering.
Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: Swelling face
Clinical narrative: lightheaded; chills; tingling/buzzing/numbness/swelling in face and lips; tingling/buzzing/numbness/swelling in face and lips; tingling/buzzing/numbness/swelling in face and lips; tingling/buzzing/numbness/swelling in face and lips; swelling in face; swelling in face and lips; rapid heart rate; flushed neck, upper chest, and face-a red rash here; This is a spontaneous report from a contactable consumer (patient). This 51-year-old female patient received the 1st dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration at left arm on 28Dec2020 03:30 PM at single dose (lot number: EH9899) for COVID-19 immunization. Medical history included asthma and known allergies to medications, food, or other products. Concomitant medications include Estradiol received in two weeks. No other vaccine in four weeks. The patient was not pregnant. The patient experienced lightheaded; chills; tingling/buzzing/numbness/swelling in face and lips; rapid heart rate; flushed neck, upper chest, and face-a red rash here that resembled sunburn, but was not painful; on 28Dec2020 04:00 PM. The patient took antihistamine (Claritin) and rest as treatment. All events were reported as non-serious. The patient had no Covid prior vaccination, no Covid tested post vaccination. Outcome of all events was recovering.
Age: 42.0
Sex: F
Vaccine: COVID19
Symptoms: Anosmia, SARS-CoV-2 test positive
Clinical narrative: had loss of sense of smell and tested positive for the virus; had loss of sense of smell and tested positive for the virus; This is a spontaneous report from a contactable healthcare professional (patient).  A 42-years-old female patient  received her first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number and expiration date not reported), intramuscular on 17Dec2020 at a single dose on the left arm, for Covid-19 immunization. The patient has no medical history and no concomitant medications (no other vaccines in four weeks and no other medications in two weeks prior to vaccination). The patient has no known allergies to medications, food, or other products. The patient had loss of sense of smell, no other symptoms on 25Dec2020 and tested positive for the virus yesterday, on 27Dec2020. The patient has no Covid-19 prior to vaccination. The patient underwent Covid test (Nasal Swab) and result was positive on 27Dec2020.  The patient did not receive any treatment for the event. Outcome of the event was unknown. The events were assessed as non-serious by the reporter.  No follow-up attempts are possible, information about lot/batch number cannot be obtained.; Sender's Comments: A possible contributory role of BNT162B2 vaccine cannot be excluded for event based on available information.
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal pain upper, Body temperature decreased, Dizziness, Dysphagia, Dyspnoea
Clinical narrative: PATIENT VACCINATED AROUND 9AM.  SHE REPORTS SHE FELT WARM/FLUSHING, FAINT AND STOMACH SPASMS WITHIN ABOUT 4-5 MINS.  SHE FELT BETTER AND GOT UP TO WALK ABOUT 30 MINS LATER. SYMPTOMS WORSENED AFTER WALKING ~9:45AM:  FAINT AGAIN, SEVERE RETCHING, BP196/140 TO 199/164, TROUBLE SWALLOWING, SOB, WHEEZING.  AT 9:58AM, EPI PEN 0.3MG ADMINISTERED AND EMS ACTIVATED.  SYMPTOMS REPORTED IMPROVED FOLLOWING EPI.  EMS ARRIVED 10:05AM.  PATIENT REPORTED RECEIVING 2 BAGS OF PEPCID, STEROIDS, AND ZOFRAN AT HOSPITAL.  WAS RELEASED BETWEEN 11:30AM-12PM ON 1/4/21, BP 140/90 AND ACUTE SYMPTOMS RESOLVED. FOLLOW UP WITH PATIENT 1/5/21: NO PRIOR HX OF HTN, BP 120/60, NO SOB/ BREATHING DIFFICULTY. C/O SEVERE HEADACHE, LOW TEMP, FATIGUE, MUSCLE ACHES, SORE THROAT.