chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 35.0
Sex: F
Vaccine: COVID19
Symptoms: Cough, Flushing, Hypoxia, Pruritus, Rash
Clinical narrative: hypoxia; Flushing; itching; rash; coughing; wheezing; This is a spontaneous report from a contactable physician (patient). A 35-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot Number: Ew0169), via an unspecified route of administration, administered in left arm on 05Aug2021 09:30 (at the age of 35-year-old) as dose 1, single for COVID-19 immunization. Facility where the most recent COVID-19 vaccine was administered was hospital. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Medical history included asthma and hypothyroid. Prior to vaccination, the patient was diagnosed with COVID-19. The patient had known allergies: Penicillin, latex, nickel, avacados, bananas and erythromycin. Concomitant medication included cyproterone acetate, ethinylestradiol (XYLIA). The patient experienced flushing, itching, rash, coughing, wheezing and hypoxia on 05Aug2021 09:45. The events resulted in doctor or other healthcare professional office/clinic visit. The events were considered as non-serious by the patient. Since the vaccination, the patient had not been tested for COVID-19. Therapeutic measures were taken as a result of the events which included albuterol inhaler, BENADRYL and TYLENOL. The outcome of the events was unknown.; Sender's Comments: Based on the available information and the strong drug event temporal association, a possible contributory role of suspect product BNT162B2 to development of event hypoxia cannot be excluded.
Age: 35.0
Sex: F
Vaccine: COVID19
Symptoms: Wheezing
Clinical narrative: hypoxia; Flushing; itching; rash; coughing; wheezing; This is a spontaneous report from a contactable physician (patient). A 35-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot Number: Ew0169), via an unspecified route of administration, administered in left arm on 05Aug2021 09:30 (at the age of 35-year-old) as dose 1, single for COVID-19 immunization. Facility where the most recent COVID-19 vaccine was administered was hospital. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Medical history included asthma and hypothyroid. Prior to vaccination, the patient was diagnosed with COVID-19. The patient had known allergies: Penicillin, latex, nickel, avacados, bananas and erythromycin. Concomitant medication included cyproterone acetate, ethinylestradiol (XYLIA). The patient experienced flushing, itching, rash, coughing, wheezing and hypoxia on 05Aug2021 09:45. The events resulted in doctor or other healthcare professional office/clinic visit. The events were considered as non-serious by the patient. Since the vaccination, the patient had not been tested for COVID-19. Therapeutic measures were taken as a result of the events which included albuterol inhaler, BENADRYL and TYLENOL. The outcome of the events was unknown.; Sender's Comments: Based on the available information and the strong drug event temporal association, a possible contributory role of suspect product BNT162B2 to development of event hypoxia cannot be excluded.
Age: 40.0
Sex: M
Vaccine: COVID19
Symptoms: Pain in extremity, Vaccination site pain
Clinical narrative: Only sore arm for a few days; minor at injection site for additional day or two; This is a spontaneous report from a non-contactable consumer, the patient. A 40-year-old male patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 04Aug2021 (at the age of 40-year-old) as a single dose for COVID-19 immunisation. The patient had no medical history. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other medications within two weeks of vaccination. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient previously took BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on an unspecified date  as a single dose for COVID-19 immunisation. On 04Aug2021 at 15:00 the patient experienced sore arm only for a few days, minor at injection site for additional day or two. No therapeutic measures were taken as a result of the events. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events sore arm for few days, minor at injection site for additional day or two were resolving at the time of the report.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: U
Vaccine: COVID19
Symptoms: Arthralgia, Pain, Pain in extremity
Clinical narrative: Full body excruciating pain/Paralyzing pain in the evenings from chin down; Get so bad in evenings cannot walk, legs lock up, hips killing him, knees, fingers, and toes hurt.; Get so bad in evenings cannot walk, legs lock up, hips killing him, knees, fingers, and toes hurt.; This is a spontaneous report from a contactable consumer or other non hcp. A patient of unspecified age and gender received bnt162b2 (BNT162B2), via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as dose number unknown, single for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient experienced full body excruciating pain, paralyzing pain in the evenings from chin down, get so bad in evenings cannot walk, legs lock up, hips killing, knees, fingers, and toes hurt on an unspecified date with outcome of not recovered.  The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.; Sender's Comments: Linked Report(s) :PFIZER INC-202101008979 same product/event, different patient
Sex: F
Vaccine: COVID19, UNK
Symptoms: Off label use, Therapeutic product ineffective
Clinical narrative: Botox cosmetic not working; maybe using botox off label; This is a spontaneous report from a contactable consumer or other non-HCP. A 41-years-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number was not reported), via an unspecified route of administration on an unspecified date as dose 1, single and received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number was not reported), via an unspecified route of administration on an unspecified date as dose 2, single for COVID-19 immunization; botulinum toxin type a (BOTOX), via an unspecified route of administration from an unspecified date (Batch/Lot number was not reported) and ongoing, at unspecified dose for an unspecified indication. The patient's medical history and concomitant medications were not reported. On an unspecified date, the patient experienced Botox not working for her. Patient stated that she is the injector, and she has been doing it on herself for 13 years. Two recent administrations in a row resulted in Botox not working for her; dates of administration not reported. She said that the second injection that resulted in Botox not working was 6 weeks after the first. She said she may be using the Botox off-label because she has a "tall, strong" forehead, so she injected 22 units into her forehead. She injected a total of 100 units from her forehead to her collarbone to her platysma. She clarified that muscles she injected included her forehead, her glabella, her eyes, her DAO's (depressor), her chin, and her platysma. She said in 6 weeks after the injection she had full movement. She stated she injected herself today again (22Jul2021). Results of the 22Jul2021 injection were not reported. She states she heard that if you inject Botox for a long time, that eventually it stops working, and she was worried that was what was happening. She has been injecting Botox long enough and she has not noticed that happening. She is wondering if this is a "lot number thing". She also asked if it's "a thing" for Botox to stop working. Patient stated she has not had a positive COVID diagnosis in the past and she confirmed she has had the COVID vaccine, both doses, Pfizer. The outcome of events was unknown.  Follow-up attempts are completed. No further information is expected.
Age: 28.0
Sex: M
Vaccine: COVID19
Symptoms: Dizziness, Loss of personal independence in daily activities, SARS-CoV-2 test
Clinical narrative: Dizziness; Interfered with daily activities/work; This is a spontaneous report from a contactable pharmacist (patient). A 28-year-old male patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; solution for injection; Lot Number: EW0198) intramuscularly on 15Jul2021 at 15:00 (at the age of 28-years-old) as a single dose in the left arm for COVID-19 immunization. Medical history was reported as none. The patient had no known allergies. It was unknown if the patient was diagnosed with COVID-19 prior to vaccination. Concomitant medications were reported as none (no other medications received within 2 weeks of vaccination). The patient did not receive any other vaccines within 4 weeks prior to the COVID-19 vaccine. The patient previously received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; solution for injection; Lot Number: EW0217) intramuscularly on 21Jun2021 at 15:00 (at the age of 28-years-old) as a single dose in the left arm for COVID-19 immunization. On 17Jul2021 at 15:00 the patient experienced dizziness and interfered with daily activities/work. The reporter assessed the events as non-serious. It was reported that a mild case of dizziness occurred 2 days after the first vaccination date and it resolved after about one day (AER: 202101007616). A second case of dizziness started 2 days after the second dose and had not resolved yet. The dizziness was constant and was moderate to severe and interfered with daily activities/work. The events resulted in emergency room/department or urgent care visit. Treatment was not received for the adverse events. The patient underwent lab tests that included: BinaxNOW COVID-19 test (nasal swab) on 26Jul2021 which was negative and a rapid test for COVID-19 which was negative on 28Jul2021. The clinical outcomes of the events dizziness and interfered with daily activities/work were both not recovered/ not resolved. Since the vaccination, the patient had been tested for COVID-19.   Follow-up attempts are completed. No further information is expected.; Sender's Comments: Based on the plausible temporal relation, the association between the event of dizziness and the suspect product of BNT162B2 cannot be completely ruled out.  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.
Sex: F
Vaccine: COVID19
Symptoms: Blindness unilateral, Ocular vascular disorder, SARS-CoV-2 test
Clinical narrative: blood clot in left eye which left her blinded; blood clot in left eye which left her blinded; This is a spontaneous report from a contactable consumer (patient). A non-pregnant 73-year-old female received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration in right arm on 27Mar2021 at 10:45 am (Lot Number: EN6203, unknown expiration) as dose 1, single for COVID-19 immunization.  Medical history included diabetes, AFib, and known allergies. Concomitant medication included rivaroxaban (XARELTO). No other vaccine in four weeks. The patient experienced a blood clot in left eye which left her blinded in Mar2021 (pending clarification). The events resulted in emergency room/department or urgent care visit. The patient underwent many tests and received treatment for the events. No COVID prior vaccination and was tested for COVID via nasal swab post vaccination on 18May2021 with negative result. The patient had not yet recovered from the events. The events were assessed as serious (hospitalization for 4 days and disability or permanent damage).  No follow-up attempts are possible; information about batch number was already obtained.
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: PS I also had Covid back in January; PS I also had Covid back in January; This is a spontaneous report from a contactable female consumer (Patient). A female patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection, Lot number: unknown; Expiration date: unknown) via an unspecified route of administration on an unspecified date as dose 1, single for Covid-19 immunization. The patient medical history and concomitant medications were not reported. On an unspecified date in Jan2021, patient had Covid back in January. The outcome of events was unknown.  The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: They all had Pfizer Covid vaccines in Feb.  Many have had the breakthrough Covid virus.; They all had Pfizer Covid vaccines in Feb.  Many have had the breakthrough Covid virus.; This is a spontaneous report from a non-contactable consumer reported for a patient. A potential AE has been reported to the Pfizer regulatory authority. A female patient of an unspecified age received an unknown dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number: unknown, Expiration date: unknown) via an unspecified route of administration, administered at an unspecified anatomical location on an unspecified date in Feb2021 (age at vaccination was unknown) as dose number unknown, single for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The caller was in a senior assisted living facility of 500 residents. They all had Pfizer COVID vaccines in Feb. Many have had the breakthrough COVID virus on an unspecified date in 2021. She wanted to speak to someone about doing a booster trial there, because they would be good candidates. The patient underwent lab test which included COVID test: positive (COVID-19) on an unspecified date. The outcome of the event was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 51.0
Sex: M
Vaccine: COVID19
Symptoms: Lymphadenopathy
Clinical narrative: Swollen painful glands in the neck.; This is a spontaneous report from a non-contactable consumer, the patient. A 51-year-old male patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0198) via an unspecified route of administration in the right arm on 15Jul2021 at 16:00 (at the age of 51-year-old) as a single dose for COVID-19 immunisation. Medical history included allergy to latex (skin) and shellfish. Concomitant medications were not reported. The patient did not receive any other vaccines within four weeks prior to the vaccination. Prior to the vaccination, the patient was not diagnosed with COVID-19. On 16Jul2021 at 00:00, the patient experienced swollen painful glands in the neck. The event resulted in doctor or other healthcare professional office/clinic visit. Therapeutic measures were not taken as a result of the events.  Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the event swollen painful glands in the neck was recovering at the time of report.   No follow-up attempts are possible. No further information is expected.
Age: 43.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity, Vaccination site pain
Clinical narrative: Arm sore near injection site; Arm sore near injection site; This is a spontaneous report from a contactable consumer, the patient. A 43-year-old non-pregnant female patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 04Aug2021 at 09:45 (at the age of 43-years-old) as a single dose for COVID-19 immunisation. Medical history and concomitant medications were not reported. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccine within four weeks prior to the COVID vaccine. On an unknown date in Aug2021, the patient experienced arm sore near injection site. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of event arm sore near injection site was unknown at the time of this report.  The batch/lot numbers for, BNT162b2, were not provided and will be requested during follow up
Sex: M
Vaccine: COVID19
Symptoms: Chills, Drug ineffective, Illness
Clinical narrative: Tested positive for Covid 19; Tested positive for Covid 19; Bad chills, and all this stuff; Got a lot sicker than she did; This is a spontaneous report from a contactable consumer. A contactable consumer reported different event for 2 patients. This is 2 of 2 reports. This contactable consumer reported for a male patient (reporter's friend) of an unspecified age received bnt162b2 (BNT162B2, Pfizer-BioNTech Covid-19 mRNA Vaccine, Solution for injection, Batch/Lot number was not reported), dose 1 via an unspecified route of administration on Jan2021 as DOSE 1, SINGLE and received bnt162b2 (BNT162B2, Pfizer-BioNTech Covid-19 mRNA Vaccine, Solution for injection, Batch/Lot number was not reported) dose 2 via an unspecified route of administration on Feb2021 (Batch/Lot number was not reported) as DOSE 2, SINGLE for covid-19 immunisation. The patient medical history and concomitant medications were not reported. On an unspecified date in 2021 patient experienced tested positive for covid 19, bad chills, and all this stuff got a lot sicker than she did. The patient underwent lab tests which included sars-cov-2 test: positive on 2021. The outcome for all events was unknown.   The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.
Age: 48.0
Sex: M
Vaccine: COVID19
Symptoms: Dysuria, Erectile dysfunction, Neuropathy peripheral, Urinary incontinence
Clinical narrative: Erectile dysfunction within a week of 2nd dose which cleared up after 3-4 weeks; lateral neuropathy in right big toe and upper left thigh within 2 months; dribbling after urination; trouble urinating; This is a spontaneous report from a contactable consumer or other non hcp (patient). A 48-year-old male patient received bnt162b2 (BNT162B2), dose 2 via an unspecified route of administration, administered in Arm Left on 24May2021 08:45 (Batch/Lot Number: ER8731) as single dose for covid-19 immunisation at the age of 48-year-old.  Medical history included allergy to mango skin, cashews, poison ivy. The patient previously received bnt162b2 dose 1 administered in Arm Left on 03May2021 10:30 (Batch/Lot Number: EW0158) as single dose for covid-19 immunisation at the age of 48-year-old. Concomitant medications included atorvastatin calcium; aspirin [acetylsalicylic acid]; vitamin D3. On 30May2021 14:00, the patient experienced erectile dysfunction which cleared up after 3-4 weeks, dribbling after urination, lateral neuropathy in right big toe and upper left thigh, trouble urinating. Outcome of erectile dysfunction was recovered in 2021, outcome of other events as not recovered. The events resulted Doctor or other healthcare professional office/clinic visit. Treatment received for erectile dysfunction included Sildenafil. The patient didn't receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19, and since the vaccination the patient hasn't been tested for COVID-19.  Follow-up attempts are completed. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: infect with SARS-COV-2 following full vaccination with Pfizer COVID vaccine.; infect with SARS-COV-2 following full vaccination with Pfizer COVID vaccine.; This is a spontaneous report from a contactable consumer or other non hcp. A male patient of an unspecified age received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Formulation: Solution for injection; Lot Number and Expiration date was not reported), via an unspecified route of administration on an unspecified date as dose 2, single and received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Formulation: Solution for injection; Lot Number and Expiration date was not reported), via an unspecified route of administration on an unspecified date as dose 1, single for covid-19 immunization. The patient medical history was not reported. The patient concomitant medications were not reported. Prior to the vaccination, the patient diagnosed with covid-19 was reported as unknown. Since the vaccination, the patient had been tested for covid -19. On 03Jul2021 the patient experienced infect with sars-cov-2 following full vaccination with Pfizer covid vaccine. The patient underwent lab tests and procedures which included sars-cov-2 test: unknown on Unknown date. The patient did not receive treatment for the resulted events. The clinical outcome of event covid-19, drug ineffective was unknown.  The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.
Sex: M
Vaccine: COVID19
Symptoms: Body temperature, Illness, Pyrexia
Clinical narrative: sick with temperature over 100 degrees for four days; sick with temperature over 100 degrees for four days; This is a spontaneous report from a contactable consumer (patient). A 68-year-old male patient received unknown dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot number was not reported), via an unspecified route of administration on an unspecified date as dose number unknown, single for COVID-19 immunization. Medical history and concomitant medications were not reported. On an unspecified date, 2 weeks after vaccination, the patient was sick with temperature over 100 degrees for four days. The patient underwent lab test which included body temperature over 100 degrees for four days on an unspecified date. The outcome of the events was unknown.  No follow-up attempts are possible; Information about lot/batch number cannot be obtained. No further information is expected.
Age: 56.0
Sex: F
Vaccine: COVID19, UNK
Symptoms: Haematoma
Clinical narrative: Ptinr levels increased from 2.3 to 4.7; Developed Hemetoma on top of hand from levels being so high and blood too thin; This is a spontaneous report from a contactable consumer or other non hcp (patient). A 56-year-old non-pregnant female patient received bnt162b2 (BNT162B2), dose 1 via an unspecified route of administration, administered in Arm Right on 27Jul2021 09:15 (Batch/Lot Number: EW0181) as single dose for covid-19 immunisation at the age of 56-year-old; warfarin sodium (COUMADIN) for Factor V Leiden Mutation Blood Disorder. Medical history included high cholesterol, bipolar disorder, COVID-19. Concomitant medications included aripiprazole (ABILIFY); lamotrigine (LAMICTAL); atorvastatin. On 04Aug2021 19:00, the patient experienced PT-INR levels increased from 2.3 to 4.7, danger of bleeding, developed hemetoma on top of hand from levels being so high and blood too thin. The patient underwent lab tests and procedures which included PT-INR on 04Aug2021: PT-INR levels increased from 2.3 to 4.7 in 10 days. No treatment received for the event. the event resulted in Doctor or other healthcare professional office/clinic visit. Prior to vaccination, the patient was diagnosed with COVID-19, Since the vaccination, the patient hasn't been tested for COVID-19. The action taken in response to the event(s) for warfarin sodium was unknown. The outcome of the event was unknown. The case was reported as non-serious. The patient didn't receive any other vaccines within 4 weeks prior to the COVID vaccine.
Age: 31.0
Sex: F
Vaccine: COVID19
Symptoms: Herpes zoster
Clinical narrative: shingles about 2 months after getting the vaccine; This is a spontaneous report from a non-contactable consumer, the patient. A 31-year-old non-pregnant female patient received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EW0175) via an unspecified route of administration on an unknown date in May2021 (at the age of 31-years-old) as a single dose for COVID-19 immunisation. Medical history and concomitant medications were not reported. Prior to vaccination, the patient was not diagnosed with COVID -19. The patient did not receive any other vaccine within four weeks prior to the vaccination. On 05Jul2021, about two months after getting the vaccine, the patient developed shingles. The event resulted in doctor or other healthcare professional office/clinic visit. Therapeutic measures were taken as a result of shingles and included treatment with an unspecified anti viral. Since the vaccination, the patient had been tested for COVID-19. The clinical outcome of the event shingles was recovered on an unknown date in 2021.  No follow-up attempts are possible. No further information is expected.
Age: 29.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Chills, Headache, Pain, Pruritus
Clinical narrative: Fever of 101.5; Chills; Body aches; Headache; Injection site pain; redness; hot; Swelling; Right arm itching that radiated to back and part of left shoulder; This is a spontaneous report from a contactable nurse, the patient. A 29-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: FA7485) via an unspecified route of administration in the right arm on 31Jul2021 at 09:45 (at the age of 29-year-old) as a single dose for COVID-19 immunisation. Medical history was not reported. The patient previously took naproxen(MANUFACTURER UNKNOWN) for an unknown indication on an unknown date and experienced drug allergy. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: FA6780) via an unspecified route of administration in the right arm on 10Jul2021 at 10:30 (at the age of 29-year-old) as a single dose for COVID-19 immunisation. On 01Aug2021 at 08:00 the patient experienced fever of 101.5 the next day and chills/body aches. Headache for 24 hours the following day. Injection site pain, redness, hot and swelling. Right arm itching that radiated to back and part of left shoulder for 5 days following injection. The events did not result in doctor or other healthcare professional office/clinic, emergency room/department or urgent care.No therapeutic measures were taken as a result of the events.  On an unknown date the patient underwent nasal swab SARS CoV-2 virus test and the result was negative. On 01Aug2021 at 08:00, the patient checked body temperature and the result was fever of 101.5(unspecified units).  Since the vaccination, the patient had been tested for COVID-19. The clinical outcome of the events fever of 101.5, chills, body aches, headache for 24hours, vaccination site pain, redness, hot, swelling and right arm itching that radiated to back and part of left shoulder were resolving at the time of this report.
Age: 29.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia, SARS-CoV-2 test, Vaccination site erythema, Vaccination site pain, Vaccination site swelling
Clinical narrative: Fever of 101.5; Chills; Body aches; Headache; Injection site pain; redness; hot; Swelling; Right arm itching that radiated to back and part of left shoulder; This is a spontaneous report from a contactable nurse, the patient. A 29-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: FA7485) via an unspecified route of administration in the right arm on 31Jul2021 at 09:45 (at the age of 29-year-old) as a single dose for COVID-19 immunisation. Medical history was not reported. The patient previously took naproxen(MANUFACTURER UNKNOWN) for an unknown indication on an unknown date and experienced drug allergy. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: FA6780) via an unspecified route of administration in the right arm on 10Jul2021 at 10:30 (at the age of 29-year-old) as a single dose for COVID-19 immunisation. On 01Aug2021 at 08:00 the patient experienced fever of 101.5 the next day and chills/body aches. Headache for 24 hours the following day. Injection site pain, redness, hot and swelling. Right arm itching that radiated to back and part of left shoulder for 5 days following injection. The events did not result in doctor or other healthcare professional office/clinic, emergency room/department or urgent care.No therapeutic measures were taken as a result of the events.  On an unknown date the patient underwent nasal swab SARS CoV-2 virus test and the result was negative. On 01Aug2021 at 08:00, the patient checked body temperature and the result was fever of 101.5(unspecified units).  Since the vaccination, the patient had been tested for COVID-19. The clinical outcome of the events fever of 101.5, chills, body aches, headache for 24hours, vaccination site pain, redness, hot, swelling and right arm itching that radiated to back and part of left shoulder were resolving at the time of this report.
Age: 29.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site warmth
Clinical narrative: Fever of 101.5; Chills; Body aches; Headache; Injection site pain; redness; hot; Swelling; Right arm itching that radiated to back and part of left shoulder; This is a spontaneous report from a contactable nurse, the patient. A 29-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: FA7485) via an unspecified route of administration in the right arm on 31Jul2021 at 09:45 (at the age of 29-year-old) as a single dose for COVID-19 immunisation. Medical history was not reported. The patient previously took naproxen(MANUFACTURER UNKNOWN) for an unknown indication on an unknown date and experienced drug allergy. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: FA6780) via an unspecified route of administration in the right arm on 10Jul2021 at 10:30 (at the age of 29-year-old) as a single dose for COVID-19 immunisation. On 01Aug2021 at 08:00 the patient experienced fever of 101.5 the next day and chills/body aches. Headache for 24 hours the following day. Injection site pain, redness, hot and swelling. Right arm itching that radiated to back and part of left shoulder for 5 days following injection. The events did not result in doctor or other healthcare professional office/clinic, emergency room/department or urgent care.No therapeutic measures were taken as a result of the events.  On an unknown date the patient underwent nasal swab SARS CoV-2 virus test and the result was negative. On 01Aug2021 at 08:00, the patient checked body temperature and the result was fever of 101.5(unspecified units).  Since the vaccination, the patient had been tested for COVID-19. The clinical outcome of the events fever of 101.5, chills, body aches, headache for 24hours, vaccination site pain, redness, hot, swelling and right arm itching that radiated to back and part of left shoulder were resolving at the time of this report.
Age: 71.0
Sex: M
Vaccine: COVID19
Symptoms: Primary progressive multiple sclerosis, SARS-CoV-2 antibody test
Clinical narrative: Primary Progressive Multiple Sclerosis; This is a spontaneous report from a non-contactable consumer. A 71-year-old male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 13Feb2021 (Batch/Lot number was not reported) (at the age of 71 years old) as single dose, and the second dose via an unspecified route of administration in Mar2021 (Batch/Lot number was not reported) (at the age of 71 years old) as single dose for covid-19 immunisation. Medical history included took LSD in the 1960's, mitral valve repair, prostate type operations due to urinating too frequently, high blood pressure, a lot of operations including shoulder operation, left knee injured playing basketball, fuzzy vision, multiple sclerosis affecting his memory, major multiple sclerosis attack that made him hot all the time, gastroesophageal reflux, and A-fib (atrial fibrillation). Concomitant medication included ocrelizumab taken for an unspecified indication, start and stop date were not reported. After the two doses of vaccine, the patient experienced primary progressive multiple sclerosis on an unknown date in 2021. The patient underwent lab tests which included SARS 19 lgG: no antibodies in Jul2021. Outcome of the event was unknown.    No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 53.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Cough, Drug ineffective, Fatigue, SARS-CoV-2 test
Clinical narrative: Cough; Fatigue; received the COVID vaccine on 2nd May, and she tested positive for COVID yesterday; received the COVID vaccine on 2nd May, and she tested positive for COVID yesterday; This is a spontaneous report from a contactable consumer ( Husband). A 53-year-old female patient received BNT162B2 (Solution for injection, Lot and expiry date: unknown), as dose number unknown, single, via an unspecified route of administration on an unspecified date in May2021 (at the age of 53-year old), for COVID-19 immunisation.  The patient's medical history and concomitant medications were not reported.  The patient received the COVID vaccine on 2nd may, vaccinated, and she tested positive for COVID on 04Aug2021 and also experienced cough and fatigue on an unspecified date.  The patient underwent lab tests and procedures which included on 04Aug2021, SARS-COV-2 test: positive. No treatment was given for the events. The outcome of the events was unknown.  The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Joint range of motion decreased, Lymphadenopathy, SARS-CoV-2 test
Clinical narrative: Swollen lymph nodes; Could not turn head; This is a spontaneous report from a contactable consumer, the patient. A 61-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0185) via an unspecified route of administration in the right arm on 20May2021 at 12:30 (at the age of 61-year-old) as a single dose and the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0180) via an unspecified route of administration in the left arm on 10Jun2021 at 12:30 (at the age of 61-year-old) as a single dose for COVID-19 immunisation. Medical history of the patient was not reported. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient previously received nitrofurantoin (MACROBID) on an unspecified date for an unknown indication and experienced drug allergy.  Concomitant medications included semaglutide (OZEMPIC), bupropion (MANUFACTURER UNKNOWN) and acetylsalicylic acid (BABY ASPIRIN) and MULTIVITAMIN; all taken for unknown indication from unknown start date and unknown if ongoing. The patient did not receive any other vaccines within four weeks prior to the vaccination. On an unknown date in 2021, after the first dose the patient experienced swollen lymph nodes on the same side of neck where shot was given and could not turn head to side because of swelling. And the events went away in two weeks after first shot. On 12Jun2021 at 08:00 the patient experienced an episode of swollen lymph nodes on the same side of neck where shot was given and could not turn head or lean head to side because of swelling after the second dose. Since the vaccination, the patient had been tested for COVID-19. The event resulted in doctor or other healthcare professional office/clinic visit. No therapeutic measures were taken as a result of the event. On 04Aug2021, the patient underwent PCR and the result was negative. The clinical outcome of the events swollen lymph nodes and could not turn head were not recovered at the time of reporting.
Age: 31.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Menstruation irregular, Pain in extremity
Clinical narrative: Arm sore.; Headache for 3 days; Two week mark start the period on birth control.; This is a spontaneous report from a contactable consumer, the patient. A 31-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot Number: UNKNOWN) via an unspecified route of administration in the arm left on 29Jul2021 at 12:00 (at the age of 31-year-old) as a single dose for COVID-19 immunisation. The patient's medical history were reported as no. The patient had no known allergies. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. The concomitant medications are not reported. On 02Aug2021 at 00:00,  the patient experienced arm sore, headache for 3 days and two week mark start the patient's period on birth control. The adverse events did not result in doctor or other healthcare professional office/clinic visit and emergency room/department or urgent care. Therapeutic measures were not taken as a result of the reported events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events arm sore, headache and two week mark start the period on birth control was recovering at the time of this report.   The lot number for BNT162b2 was not provided and will be requested during follow up.
Age: 45.0
Sex: F
Vaccine: COVID19
Symptoms: Chest discomfort, Dizziness, Headache, Hyperhidrosis, Nausea
Clinical narrative: chest tightness; nauseated; vomiting; profuse sweating; Throat tightness; palpitation; Dizziness; headache; This is a spontaneous report from a contactable Nurse (patient self).  A 45-year-old female patient (not pregnant) received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), intramuscular, administered in Arm Left on 05Aug2021 15:45 (Lot Number: EW0186) (at the age of 45-year-old, not pregnant) as dose 1, single for COVID-19 immunisation.  Medical history included Bells Palsy, partial thyroidectomy, hysterectomy, asthma, known allergies: shellfish and Bactrim. Concomitant medication included orlistat.  The most recent COVID-19 vaccine was administered in Hospital. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19.  Since the vaccination, the patient had not been tested for COVID-19.  On 05Aug2021 16:15, the patient was severely nauseated and vomiting, palpitation with chest tightness and throat tightness, dizziness and headache, profuse sweating. Rapid response called she was sent to ED.  The adverse event result in Emergency room/department or urgent care.  Treatment received including Benadryl, zofran, Tylenol.  Outcome of the events was not resolved.  The reporter assessed this report as non-serious.; Sender's Comments: Based on known drug safety profile, there is reasonable possibility of causal association between the events nauseated and vomiting, palpitation with chest tightness and throat tightness, dizziness and headache, profuse sweating and the suspect drug BNT162B2. 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: 45.0
Sex: F
Vaccine: COVID19
Symptoms: Palpitations, Throat tightness, Vomiting
Clinical narrative: chest tightness; nauseated; vomiting; profuse sweating; Throat tightness; palpitation; Dizziness; headache; This is a spontaneous report from a contactable Nurse (patient self).  A 45-year-old female patient (not pregnant) received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), intramuscular, administered in Arm Left on 05Aug2021 15:45 (Lot Number: EW0186) (at the age of 45-year-old, not pregnant) as dose 1, single for COVID-19 immunisation.  Medical history included Bells Palsy, partial thyroidectomy, hysterectomy, asthma, known allergies: shellfish and Bactrim. Concomitant medication included orlistat.  The most recent COVID-19 vaccine was administered in Hospital. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19.  Since the vaccination, the patient had not been tested for COVID-19.  On 05Aug2021 16:15, the patient was severely nauseated and vomiting, palpitation with chest tightness and throat tightness, dizziness and headache, profuse sweating. Rapid response called she was sent to ED.  The adverse event result in Emergency room/department or urgent care.  Treatment received including Benadryl, zofran, Tylenol.  Outcome of the events was not resolved.  The reporter assessed this report as non-serious.; Sender's Comments: Based on known drug safety profile, there is reasonable possibility of causal association between the events nauseated and vomiting, palpitation with chest tightness and throat tightness, dizziness and headache, profuse sweating and the suspect drug BNT162B2. 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.
Sex: M
Vaccine: COVID19
Symptoms: Blood potassium decreased, Myocardial infarction, Tachycardia
Clinical narrative: Experienced tachycardia; Heart attack; Lowered potassium; This is a spontaneous report from a contactable consumer (reporting for his friend). A 54-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), via an unspecified route of administration on an unspecified date in 2021 (Batch/Lot number was not reported) as dose 2, single for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient previously received the first dose of BNT162B2 on an unspecified date for COVID-19 immunization. The reporter stated that the patient received both doses of the vaccine. The patient received Pfizer-BioNTech COVID-19 vaccine on Monday (as reported; unspecified date in 2021), and the patient experienced tachycardia, heart attack, and lowered potassium which rendered him hospitalized on an unspecified date in 2021 (just this Wednesday (as reported)). The reporter stated that the patient was hospitalized on Wednesday (2021) because he had tremendous tachycardia, a mild heart attack and all his potassium levels went down to barely 0, all on an unspecified date in 2021. The outcome of the events was unknown.   Information on the batch/lot number has been requested.
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Deafness
Clinical narrative: Sudden hearing loss in left ear; This is a spontaneous report from a contactable consumer (patient) via Covid-19 Adverse Event Self-Reporting Solution (COVAES).   A 58-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration, administered in Arm Left on 05Aug2021 12:45 (lot number: FA7485; expiry date: unknown) at the age of 58-years-old, as dose 2, single for Covid-19 immunization. The patient had no relevant medical history. There were no concomitant medications. The patient previously took FLAGYL 250 and experienced allergies. Historical vaccine included BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration, in right arm on 15Jul2021 at 14:00 (lot number: EW0198; expiry date: unknown) at the age of 58-years-old, as dose 1, single, for Covid-19 immunisation. The patient was not pregnant at the time of vaccination. The patient was not diagnosed with COVID prior vaccination. The patient did not receive other vaccines within four weeks prior to COVID vaccination. The vaccine was administered in Pharmacy or Drug Store.  The patient has not been tested for COVID-19 since vaccination. The patient experienced sudden hearing loss in left ear on 06Aug2021. The patient did not receive treatment for the event. Outcome of the event was not recovered.  Follow-up attempts are completed. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: She got the vaccine but then she got covid.; She got the vaccine but then she got covid.; This is a spontaneous report from a contactable consumer or other non hcp. A 21-years-old female patient received bnt162b2 (BNT162B2, Pfizer-BioNTech Covid-19 mRNA Vaccine, Solution for injection, Batch/Lot number was not reported), dose 2 via an unspecified route of administration on May2021 as DOSE 2, SINGLE, dose 1 via an unspecified route of administration, administered in Arm on May2021 as DOSE 1, SINGLE for covid-19 immunisation. The patient medical history was none. There were no concomitant medications. On an unspecified date in 2021 patient experienced breakthrough infection, she got the vaccine but then she got covid and sick on 03Aug2021. The patient underwent lab tests and procedures which included sars-cov-2 test: covid-19 on 03Aug2021. The outcome for all events was unknown.  Information about lo/batch number has been requested.
Age: 48.0
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Pain, Swelling
Clinical narrative: Swelling; Pain; Redness; This is a spontaneous report from a contactable consumer. This consumer reported for female patient (reporter's wife). A 48 years old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Formulation: Solution for injection, Lot number: EL1283, Expiration Date: Apr2021), via an unspecified route of administration in right arm on 07Jan2021 (at the age of 48-year-old) as dose 2, single for COVID-19 immunization (hospital employee and required require). Historical vaccine included bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Formulation: Solution for injection, Lot number: EK5730, Expiration Date: did not put on vaccination card), via an unspecified route of administration in right arm on 17Dec2020 (at the age of 47-year-old) as dose 1, single for COVID-19 immunization. The patient medical history was not reported. There were no concomitant medications. Caller mentioned that, his wife had swelling, pain and redness after getting the vaccine on 08Jan2021. He confirmed his wife informed him details of this event. She works in a hospital as an Ultrasound technician. The swelling, redness, pain, started the second day which was on 08Jan2021. It lasted 2-3 weeks. The patient was fine now. The outcome of the events was recovered on an unspecified date in 2021.