chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Loss of consciousness, Nausea, Vomiting
Clinical narrative: Passed out; Sweats; Lightheaded; Fatigue; Chills; Nausea; Vomit; Headache; A spontaneous report was received from a consumer concerning herself, a 68 year old female patient who experienced passed out/loss of consciousness, sweats/hyperhidrosis, lightheadedness/dizziness, fatigue/fatigue, chills/chills, nauseas/nausea, vomit/vomiting, headache/headache.  The patient's medical history was not provided. Concomitant product use was not provided.  The patient received her first of two planned doses of mRNA-1273 on unknown date for prophylaxis of Covid-19 infection.  On 01-Mar-2021, prior to the onset of events, the patient received the second of two planned doses of mRNA-1273 (Batch number 014M20A) intramuscularly into her left arm for prophylaxis of Covid-19 infection.  On 02-Mar-2021, the patient stated she "passed out", she also experienced sweats, lightheadedness, fatigue chills, nauseas, vomit, and headache.    No other treatment information was provided.  The patient received both scheduled doses of mRNA-1273 prior to the events; therefore, action taken with the drug in response to the events is not applicable.  The events, passed out/loss of consciousness, sweats/hyperhidrosis, lightheadedness/dizziness, fatigue/fatigue, chills/chills, nauseas/nausea, vomit/vomiting, headache/headache.was considered unknown.; Reporter's Comments: Based on the information provided, a strong temporal association and the established safety profile of mRNA-1273 vaccine, a causal association between the reported events and the product use cannot be excluded. Fatigue, chills vomiting, headache and nausea are consistent with the known safety profile of the vaccine
Sex: F
Vaccine: COVID19
Symptoms: Feeling hot, Pain, Vomiting
Clinical narrative: Hurting all over; Body felt like a ball on fire; Could not drink water because it kept coming back up; A spontaneous report was received from a consumer concerning a 80 year old, female patient who experienced hurting all over her body (pain), body felt like a ball on fire (feeling hot), and vomiting.    The patient's medical history was not provided.  Products known to have been used by the patient, within two weeks prior to the event, included Vitamin C, Vitamin D, Echinacea, Losartan, lovastatin, baby aspirin (81 mg), metoprolol and pantoprazole.     The patient received the first of two planned doses of mRNA-1273 (Batch number: 011A4N) on 27 Feb 2021.   On 28 Feb 2021, the was hospitalized due to her symptoms like she was hurting all over her body like a ball on fire and vomiting. Treatment for the event included anti-inflammatory shot and acetaminophen.  Action taken with mRNA-1273 in response to the events was not provided.   The outcome of the events was not reported.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Age: 86.0
Sex: M
Vaccine: COVID19
Symptoms: Dysstasia, Mobility decreased
Clinical narrative: he could not move his hands easily, felt like paralyzed; he could not stand up; A spontaneous report was received from a consumer concerning a 86-year-old, male patient, who received Moderna's COVID-19 vaccine (mRNA-1273) and he could not stand up, he could not move his hands easily and felt like paralyzed.  The patient's medical history was not provided by the reporter. Concomitant medications reported included lisinopril and brimonidine tartrate/timolol maleate.  On 02 Mar 2021, prior to the onset of the events, the patient received their second of two planned doses of mRNA-1273 (Lot number: 039K20A) intramuscularly in the upper left arm for prophylaxis of COVID-19 infection.   On 03 Mar 2021, he could not stand up, he could not move his hands easily and felt like paralyzed.  Treatment for the events was not provided.  Action taken with mRNA-1273 in response to the events was unknown/not reported.   The outcome of the events, could not stand up, could not move his hands easily and felt like paralyzed, was considered recovering/resolving.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Blood magnesium, Chills, Headache, Seizure
Clinical narrative: A single seizure; Headache; Chills; A spontaneous report was received from a consumer who is a 71 year old, female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced headaches, chills, and seizure.  The patient's medical history was not reported.  Concomitant medicine reported included metoprolol. The patient received the first of two planned doses of mRNA-1273 (Lot number: unknown) intramuscularly for prophylaxis of COVID-19 infection on unknown date.   On 27 Feb 2021, prior to the onset of the events, the patient received the second of two planned doses of mRNA-1273 (Batch number: 014M20A] intramuscularly in the right dominant arm for prophylaxis of COVID-19 infection.   On 27 Feb 2021, the patient experienced headache and chills. On the morning of 01 March 2021, patient experienced a single seizure and transported to hospital. Emergency department discharged the patient stated that her magnesium levels were low and was given magnesium supplements and advised to follow up with PCP. Later the patient followed up with her PCP and they concluded her magnesium levels were normal then. Treatment for the event included Magnesium Supplements.   The patient received both scheduled doses of mRNA-1273 therefore, action taken with the drug in response to the events is not applicable.  The outcome of events, headaches, chills, and seizure were resolved on 28 Feb 2021.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Rheumatoid arthritis
Clinical narrative: Relapse of her rheumatoid arthritis; A spontaneous report was received from a consumer who was also a 65-year-old, female patient who received Moderna's COVID-19 Vaccine (mRNA-1273) and who experienced relapse of her rheumatoid arthritis.  The patient's medical history was not provided. Concomitant product use was not provided by the reporter.   On an unspecified date, prior to the onset of the symptoms, the patient received the first of two planned doses of mRNA-1273 (Batch number not provided) via an unknown route for prophylaxis of COVID-19 infection. On 02 Mar 2021, the patient received the second of two planned doses of mRNA-1273 (lot#062I70A).  On an unknown date patient had relapse of patient's rheumatoid arthritis. Treatment for the event included Tylenol every 4 hours.  The patient received both scheduled doses of mRNA-1273 prior to the report; therefore, action taken with the drug in response to the event is not applicable.  The outcome of the events was not reported.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.
Age: 77.0
Sex: F
Vaccine: COVID19
Symptoms: Anaphylactic reaction
Clinical narrative: Anaphylaxis reaction; A spontaneous report was received from a consumer concerning a 77 year old, female patient who developed Anaphylaxis reaction.    The patient's medical history included allergies. Concomitant product use was not provided by the reporter.     Vaccination details are not provided by the reporter. After she received vaccine developed Anaphylaxis reaction.  Treatment for the event included steroid shot. Now her doctor says the shot is ineffective and she can't get the second shot. She wants to know whether that information true and she is willing to take second shot despite her doctors advice.  Action taken with mRNA-1273 in response to the events was not provided.   The outcome of the event Anaphylaxis reaction was unknown.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.
Sex: M
Vaccine: COVID19
Symptoms: Headache, Pain, Seizure, Tremor
Clinical narrative: seizure; shaking; aches and pains; headache; A spontaneous report was received from a consumer concerning a 67-year-old, male patient, who experienced Seizure, aches and pain, headache, and shakes.   The patient's medical history, was not provided by the reporter. No Concomitant medications were reported.  On 29 Jan 2021, prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 (Lot number: 007MZ0A) in the left arm for prophylaxis of COVID-19 infection.  On 26 Feb 2021, prior to the onset of the events, the patient received their second  of two planned doses of mRNA-1273 (Lot number: 006MZ0A) in the left arm for prophylaxis of COVID-19 infection.   That night patient had aches/pains and a headache. The next day, on  27 Feb 2021,  patient had a seizure. The patient shook so hard he came off the chair, the shaking was unbelievable.He was taken by rescue squad to the local hospital but was transferred immediately to another hospital. Patient was discharged from hospital Wednesday, 3 March 2021.Treatment for the events were not reported.  Action taken with mRNA-1273 in response to the events was not applicable as patient received both the doses.   The outcome of the events, were Unknown.; Reporter's Comments: The events were consistent with increased risk of complications associated with elderly age of patient. Company assessed the events to be unlikely related to company product.
Age: 75.0
Sex: M
Vaccine: COVID19
Symptoms: Cellulitis, Rash
Clinical narrative: Diagnosed with cellulitis; both lower legs broke out with a rash; A spontaneous report was received from a  Consumer concerning himself,75 years-old male patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced both lower legs broke out with a rash(rash) and diagnosed with cellulitis(cellulitis).  The patient's medical history was not provided. No relevant concomitant medications were reported.   On 01 Mar 2021,approximately six hours prior to the onset of the events, the patient received the second of two planned doses of mRNA-1273 (batch: 010M20A) in the right non-dominant arm for prophylaxis of COVID-19 infection.  On 01 Mar 2021,the patient experienced both lower legs broke out with a rash. On 03 Mar 2021, Patient saw a physician and was diagnosed with cellulitis. The event cellulitis was medically significant.  Treatment for the event included beta methasone 0.1% topical cream.  The patient received both scheduled doses of mRNA-1273 prior to the events, therefore action taken with the drug in response to the events was not applicable.  The outcome of the events, both lower legs broke out with a rash and diagnosed with cellulitis were unknown.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Age: 76.0
Sex: M
Vaccine: COVID19
Symptoms: Parkinson's disease psychosis, Product dose omission issue
Clinical narrative: Parkinson's psychosis; Not received second dose; A spontaneous report was received from a consumer concerning a 76-years old, male patient who experienced the events Parkinson's disease psychosis and missed dose due hospitalization.   The patient's medical history was not provided.  Concomitant product was not reported.  On 05 Feb 2021, prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 (lot/batch: unknown) intramuscularly in the anatomical for prophylaxis of COVID-19 infection.    On 26 Feb 2021, the patient experienced the event Parkinson's psychosis and was hospitalized.  The patient's second dose was scheduled on 03 Mar 2021, but he did not receive the second dose due to hospitalization.  Action taken with mRNA-1273 in response to the events was not provided.  The outcome of the event Parkinson's disease psychosis and missed dose were unknown.; Reporter's Comments: The events were consistent with increased risk of complications associated with elderly age of patient. Company assessed the events to be unlikely related to company product.
Sex: F
Vaccine: COVID19
Symptoms: Malaise, Pyrexia, Vomiting
Clinical narrative: not feeling well; fever; threwup; Case reference number MOD-2021-036768 is a spondaneous report which refers to a Female patient.    The patients relevant medical history included Covid-19. There were no concomitant medications provided.  On unknown date, the patient first of two planned doses of mRNA-1273 (Batch # unknown) unknown location, for prophylaxis of COVID-19 infection.  .  On an unknown date, the patient experienced not feeling well, fever, and threw up. The patient went to the hospital for not feeling well and was admitted for two days. There was no treatment information provided.   The action taken for Moderna COVID-19 Vaccine was not provided.  The outcome for the reported events was unknown.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.
Sex: F
Vaccine: COVID19
Symptoms: Abdominal discomfort, Dizziness, Dyspnoea, Fatigue, Feeling cold
Clinical narrative: passed out; could not breath; twitching of foot; extremely cold; became warm; upset stomach; room began to spin; unusually tired; A Spontaneous report was received from a health care professional concerning an female patient who received Moderna's COVID-19 Vaccine (mRNA-1273) and experienced unusually tired, extremely cold, became warm, upset stomach, room began to spin, could not breath, pass out, twitching foot.  The patient's medical history, included cancer, prior radiation and chemotherapy and surgery. Concomitant product use included unspecified inhaler.   On 03 Mar 2021, the patient received their first of two planned doses of mRNA-1273 (lot number 011az1a) intramuscularly for prophylaxis of COVID-19 infection.  On 03 Mar 2021, the same day of vaccination the patient was unusually tired and slept ten hours. Next day, the patient felt extreme cold and decided to take warm bath. Then within ten minutes after the bath, patient became warm, had an upset stomach, and noted the room began to spin. The patient subsequently could not breath and passed out.  The patient's husband noted the patient's foot twitching, and felt that she was still alive.  Per the patient's spouse, the patient was unresponsive for one minute.  Once awakened, the patient took her inhaler and Benadryl.  Within 30 minutes all the symptoms were gone and have not returned.  The patient noted having this same type of experience during her Sep 2020 first round of chemotherapy.  The patient has been cancer free for five months.  Treatment information included inhaler and Benadryl.  There was no change planned to the dosing schedule of mRNA-1273 in response to the events. Patient's physician stated it was okay to take the second dose.  The events unusually tired, extremely cold, became warm, upset stomach, room began to spin, could not breath, passed out, and twitching foot were considered resolved on 04 Mar 2021.; Reporter's Comments: Very limited information regarding this event/s has been provided at this time.  Further information has been requested
Sex: F
Vaccine: COVID19
Symptoms: Feeling hot, Loss of consciousness, Muscle twitching
Clinical narrative: passed out; could not breath; twitching of foot; extremely cold; became warm; upset stomach; room began to spin; unusually tired; A Spontaneous report was received from a health care professional concerning an female patient who received Moderna's COVID-19 Vaccine (mRNA-1273) and experienced unusually tired, extremely cold, became warm, upset stomach, room began to spin, could not breath, pass out, twitching foot.  The patient's medical history, included cancer, prior radiation and chemotherapy and surgery. Concomitant product use included unspecified inhaler.   On 03 Mar 2021, the patient received their first of two planned doses of mRNA-1273 (lot number 011az1a) intramuscularly for prophylaxis of COVID-19 infection.  On 03 Mar 2021, the same day of vaccination the patient was unusually tired and slept ten hours. Next day, the patient felt extreme cold and decided to take warm bath. Then within ten minutes after the bath, patient became warm, had an upset stomach, and noted the room began to spin. The patient subsequently could not breath and passed out.  The patient's husband noted the patient's foot twitching, and felt that she was still alive.  Per the patient's spouse, the patient was unresponsive for one minute.  Once awakened, the patient took her inhaler and Benadryl.  Within 30 minutes all the symptoms were gone and have not returned.  The patient noted having this same type of experience during her Sep 2020 first round of chemotherapy.  The patient has been cancer free for five months.  Treatment information included inhaler and Benadryl.  There was no change planned to the dosing schedule of mRNA-1273 in response to the events. Patient's physician stated it was okay to take the second dose.  The events unusually tired, extremely cold, became warm, upset stomach, room began to spin, could not breath, passed out, and twitching foot were considered resolved on 04 Mar 2021.; Reporter's Comments: Very limited information regarding this event/s has been provided at this time.  Further information has been requested
Sex: M
Vaccine: COVID19
Symptoms: Chest pain, Product dose omission issue
Clinical narrative: Chest pains; missed dose; A spontaneous report was received from a consumer concerning a male patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced hospitalization with chest pain and missed dose.   The patient's medical history was not provided. No concomitant was provided.  On 09 Feb 2021, prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 (Lot number: 027L20A) intramuscularly on his left arm for prophylaxis of COVID-19 infection.   On 04/Mar/20201 patient reported that he was admitted in hospital with chest pain. Patient reports that he had no symptoms after the Moderna COVID-19, but will be unable to make his second vaccine appointment.   Action taken with mRNA-1273 in response to the events was not reported.   The outcome of the event:, chest pain,  was considered unknown/not reported  The outcome of the event, missed dose, was considered recovered/resolved on an unknown date.; Reporter's Comments: Very limited information regarding the events has been provided at this time. Company assessed the events to be unlikely related to company product.
Sex: F
Vaccine: COVID19
Symptoms: Anaphylactic reaction, Vaccination site erythema, Vaccination site pain, Vaccination site rash, Vaccination site swelling
Clinical narrative: Rash; Redness; dizziness, headache, burning in her throat and chest, tingling in her chest, her arm felt light weight,; Hand was sore; Swelling; A report was received from a consumer concerning a 65-year-old, female patient of unknown race. Developed anaphylactic reaction and vaccine site reactions.  The patient's medical history included head injury and symptoms of passing out.  Concomitant medication included antibiotic (unknown name)  On 26 Feb 2021, the patient received their first of two planned doses of mRNA-1273 injection (Lot number- 030L20A) via unknown route in right arm for prophylaxis of COVID-19 infection.     On same day, immediately after receiving vaccination, the patient experienced dizziness, headache, burning in her throat and chest, tingling in her chest, her arm felt light weight, not responding to verbal stimuli, hard time breathing, low blood pressure. she also had her hand sore, swelling and redness. She  received Epi pen couple shots (number unknown) and was taken to Emergency room, where she stayed for 4 hours and was discharged with a diagnosis of sever allergy reaction. The treatment details in ER was reported.    Health care provider assessed the events  as related to the combination of vaccine plus antibiotic.  Action taken with mRNA-1273 in response to the events was not reported.    The outcome of the anaphylactic events were resolved.  The causality assessment of the reported events was unknown.; Reporter's Comments: Very limited information regarding this event/s has been provided at this time.  Further information has been requested.
Age: 46.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Migraine, Myalgia, Systemic lupus erythematosus
Clinical narrative: her LUPUS flare up/burning LUPUS; tremendous body pain; dizzy; migraine; A spontaneous report  was received from a consumer concerning a 46-year-old, female patient, who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced tremendous body pain, a burning LUPUS, dizzy, LUPUS flare up, and migraine.  The patient's medical history was not provided.  Concomitant medications reported included Prednisone two weeks Synthroid, hydroxychloroquine every day, Pantoprazole, Famotidine, Xyzal, Byden, Tramadol.  On 3 Feb 2021, prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 (Lot number: 012M20A) intramuscularly in the left arm for prophylaxis of COVID-19 infection.   On 21 Feb 2021, her LUPUS flare up. On an unknown date patient experienced events as tremendous body pain, dizzy, headache and migraine.  She has been under steroids treatment for a week and a half.  Action taken with mRNA-1273 in response to the events was not reported.   The outcome of the events experienced tremendous body pain, a burning LUPUS, dizzy, LUPUS flare up, migraine was unknown.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Age: 78.0
Sex: M
Vaccine: COVID19
Symptoms: Cerebrovascular accident, Seizure
Clinical narrative: seizures; small stroke; A spontaneous report was received from a consumer (wife of patient) concerning a 78- year-old, male patient who  developed seizure and a small stroke.    The patient's medical history included seizure 4 years ago, stroke long time ago. Products known to have been used by the patient, within two weeks prior to the event, Cholesterol medicines, Blood pressure medicines and Aspirin.  On 18 Feb 2021, prior to the onset of the event, the patient received their first of two planned doses of mRNA-1273 (Lot 031M20A) intramuscularly in the Right arm for prophylaxis of COVID-19 infection.   On 18 Feb 2021, the patient developed seizure, small stroke .  Treatment for the event was not reported. Doctors are not sure about the causality, but want to report it. They spoke to his doctor  about not getting the second vaccine.    Action taken with mRNA-1273 in response to the event was unknown.  The outcome of the event's, seizure, stroke was considered unknown.; Reporter's Comments: The events were consistent with increased risk of complications associated with history of seizure confounded by elderly age of patient. Company assessed the events to be unlikely related to company product.
Age: 35.0
Sex: M
Vaccine: COVID19
Symptoms: Computerised tomogram thorax, Pulmonary embolism
Clinical narrative: Bilateral unprovoked pulmonary embolisms; A spontaneous report was received from a consumer concerning a 35-years-old male patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced bilateral unprovoked pulmonary embolisms.  The patient's medical history was not reported. Concomitant product use was not reported.  On 14-Jan-2021, prior to the onset of the event, the patient received their first of two planned doses of mRNA-1273 (Lot number: not provided) intramuscularly for prophylaxis of COVID-19 infection.   On 31-Jan-2021, approximately 17 days after receiving vaccine, the patient was diagnosed with bilateral unprovoked pulmonary embolisms after a chest computerized tomogram (CT) was performed. Treatment included hospitalization and starting of anticoagulation therapy.  Action taken with mRNA-1273 in response to the event was not reported.   The outcome of the event was considered not resolved.  The reporter did not provide the causality assessment for the events.; Reporter's Comments: Very limited information regarding this event has been provided at this time.  Further information has been requested.
Age: 50.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Body temperature, Diarrhoea, Myalgia, SARS-CoV-2 test
Clinical narrative: Diarrhea with 99.6 F temp. on day five after injection of second dose; New onset of myalgia and arthralgia in upper and lower extremities, bilaterally, at day 10 after second dose.; New onset of myalgia and arthralgia in upper and lower extremities, bilaterally, at day 10 after second dose.; This is a spontaneous report from a contactable nurse. A 50-year-old male patient received the first dose (also reported as the second dose) bnt162b2 PFIZER-BIONTECH COVID-19 MRNA VACCINE; Lot Number: EL1284), via an unspecified route of administration in the left arm on 22Dec2020 at 12:00 at 50-years-old at a single dose for COVID-19 immunization; administered in a hospital. The patient did not receive any other vaccine within four weeks of the suspect vaccine. Medical history included hypothyroidism from an unknown date and unknown if ongoing; no known drug or food allergy. The patient did not have COVID prior to the vaccination. Concomitant medications included levothyroxine (MANUFACTURER UNKNOWN; 100 ug) taken for an unspecified indication from an unspecified date to an unspecified date; received within two weeks of the suspect vaccine.  On 16Jan2021, the patient experienced: diarrhea with 99.6 F temp. on day five after injection of second dose (non-serious); new onset of myalgia and arthralgia in upper and lower extremities, bilaterally, at day 10 after second dose. (non-serious); with no treatment received. The patient underwent lab tests and procedures which included Nasal Swab PCR: negative on 05Feb2021.  The clinical outcome of the event, diarrhoea, was recovered on an unspecified date. The clinical outcome of the events: myalgia and arthralgia were not recovered; symptoms persisted through present day of this submission (greater than 4 weeks).
Age: 21.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: I got my second dose on 15Jan and yesterday 09Feb I tested positive on two separate tests for covid-19; I got my second dose on 15Jan and yesterday 09Feb I tested positive on two separate tests for covid-19; This is a spontaneous report from a contactable other HCP (patient). A 21-year-old female non-pregnant patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: solution for injection, Lot number: EL3247) via intramuscular in left arm on 15Jan2021 at 13:00 (at the age of 21-years-old) as a single dose and first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: solution for injection, Lot number: unknown) via an unspecified route of administration on an unknown date, as a single dose, both the doses for COVID-19 immunisation. The patient medical history was not reported. Prior to the vaccination, the patient was not diagnosed with COVID-19. The concomitant medication included desogestrel, ethinylestradiol (APRI) for birth control. The patient did not't receive any other vaccine with four weeks of prior to the vaccine. Since the vaccination, the patient had been tested for COVID-19. The patient reported that "I got my second dose on 15Jan and yesterday 09Feb2021 I tested positive on two separate tests for covid-19 (as reported) ".  The patient underwent two separate nasal swab tests on 09Feb2021 which resulted in positive. The patient did not receive any treatment for the events. The outcome of the events was not recovered.; Sender's Comments: Based on available information, a possible contributory role of the subject product, BNT162B2 vaccine, cannot be excluded for the reported events of vaccination failure and other event  due to temporal relationship  Additional information is needed to better assess the case, including complete medical history, diagnostics, counteractive treatment measures and concomitant medications.  This case will be reassessed once additional information is available.  The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
Age: 33.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: injection site pain the day after vaccination; This is a spontaneous report from a contactable Other HCP (patient). A 33-year-old non-pregnant female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; solution for injection; Lot #: El2348) via an unspecified route of administration on 18Jan2021 at 15:00 (at the age of 33-years-old) as a single dose in the left arm for COVID-19 vaccination. Medical history included ADHD and pneumonia 4 years prior, unspecified if ongoing. The patient had no known allergies. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medications (other medications in two weeks) included lisdexamfetamine mesilate (VYVANSE), trazodone, and daily multivitamin, all taken for unspecified indications on unspecified dates. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 19Jan2021 the patient experienced injection site pain the day after vaccination. The clinical outcome of the event injection site pain the day after vaccination was unknown. It was also reported that since the vaccination, the patient had not been tested for COVID-19.
Age: 28.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Feeling abnormal, Headache, Insomnia, Lip blister
Clinical narrative: Lung pain; splitting headache; could not sleep; feels run down; developed bubbles filled with fluid all over her lips; feels bad; achy; arm hurt; swelling and tingling sensation around my lip; swelling and tingling sensation around my lip; This is a spontaneous report from a contactable consumer (patient). A 28-year-old female patient received dose 2 of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), intramuscular on 09Feb2021 at (at the age of 28-years-old) as a single dose in the deltoid (unspecified) for COVID-19 vaccination. Medical history included asthma, Meniere's disease, cold sores and she had COVID-19 with symptoms of splitting headache, all on an unknown date. Concomitant medications included formoterol fumarate, mometasone furoate (DULERA) for asthma from an unknown date and ongoing and supplements (unspecified) for Meniere's disease. The patient previously received the first dose of BNT162B2 on 15Jan2021 and experienced achy, arm hurts, weird lung pain and splitting headache. Within minutes of receiving the second dose on 09Feb2021 the patient experienced swelling and tingling sensation around the lip and arm hurt. On 10Feb2021 the patient experienced bubbles filled with fluid over her lips in the morning, she felt bad and is achy; from an unknown date the patient experienced feels run down, weird lung pain, a splitting headache and she could not sleep. Therapeutic measures were taken as a result of the headache which included Aleve and she drank a bunch of water with her daily vitamins. The clinical outcome of the events lip swelling, tingling lips, lung pain, insomnia, fatigue was unknown; lip blister, feels bad, achy and arm hurt was not recovered; and headache was recovered   The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow up.
Age: 28.0
Sex: F
Vaccine: COVID19
Symptoms: Lip swelling, Pain, Pain in extremity, Paraesthesia oral, Pulmonary pain
Clinical narrative: Lung pain; splitting headache; could not sleep; feels run down; developed bubbles filled with fluid all over her lips; feels bad; achy; arm hurt; swelling and tingling sensation around my lip; swelling and tingling sensation around my lip; This is a spontaneous report from a contactable consumer (patient). A 28-year-old female patient received dose 2 of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), intramuscular on 09Feb2021 at (at the age of 28-years-old) as a single dose in the deltoid (unspecified) for COVID-19 vaccination. Medical history included asthma, Meniere's disease, cold sores and she had COVID-19 with symptoms of splitting headache, all on an unknown date. Concomitant medications included formoterol fumarate, mometasone furoate (DULERA) for asthma from an unknown date and ongoing and supplements (unspecified) for Meniere's disease. The patient previously received the first dose of BNT162B2 on 15Jan2021 and experienced achy, arm hurts, weird lung pain and splitting headache. Within minutes of receiving the second dose on 09Feb2021 the patient experienced swelling and tingling sensation around the lip and arm hurt. On 10Feb2021 the patient experienced bubbles filled with fluid over her lips in the morning, she felt bad and is achy; from an unknown date the patient experienced feels run down, weird lung pain, a splitting headache and she could not sleep. Therapeutic measures were taken as a result of the headache which included Aleve and she drank a bunch of water with her daily vitamins. The clinical outcome of the events lip swelling, tingling lips, lung pain, insomnia, fatigue was unknown; lip blister, feels bad, achy and arm hurt was not recovered; and headache was recovered   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 antibody test, SARS-CoV-2 antibody test positive, SARS-CoV-2 test
Clinical narrative: positive COVID-19 test with symptoms; positive COVID-19 test with symptoms; went for another kind of test and had antibodies; This is a spontaneous report from a contactable consumer, the parent. A 50-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), via an unspecified route of administration on Jan2021 (almost a month ago) as a single dose for COVID-19 immunization. Medical history and concomitant medications were not reported. On an unspecified date in 2021 (10 days ago), the patient was not feeling well and had a positive COVID-19 rapid test. The patient was feeling better currently and went for "another kind of test", on an unspecified date in 2021, and had antibodies. The reporter queried when the patient should go for the second shot. The clinical outcome of "positive COVID-19 test with symptoms" and "went for another kind of test and had antibodies" was unknown.  Information on batch/lot number was requested.
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: received the first dose on 22Jan2021, then "got COVID"; received the first dose on 22Jan2021, then "got COVID"; This is a spontaneous report from a contactable consumer (patient herself). A 43-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number and expiry date unknown), via an unspecified route of administration, on 22Jan2021, at single dose, for covid-19 immunization. The patient's medical history and concomitant medications were not reported. The patient stated she received the first dose on 22Jan2021, then "got COVID" on an unspecified date in 2021 and indicated that she did not think of it as an adverse event. The outcome of the events was unknown. Due to receiving the second dose today (time of the report), she asked for any information that may supersede the CDC guidelines.  Information about the lot/batch number has been requested.
Sex: M
Vaccine: COVID19
Symptoms: Body temperature, Chills, Pyrexia
Clinical narrative: Went to bed chills; Fever 101.7; This is a spontaneous report from a contactable consumer (patient's wife). A 76-year-old male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number and expiration date not reported), via an unspecified route of administration on 11Feb2021 as single dose for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient went to bed with chills, treated with paracetamol (TYLENOL) and also experienced fever 101.7; both on an unspecified date. The outcome of the events was unknown.  Information on the Batch/Lot number has been requested.
Sex: F
Vaccine: COVID19
Symptoms: Ageusia, Mouth injury, Nasal congestion
Clinical narrative: feeling that there was a cut in the roof of her mouth; not tasting her food; real stuffy; This is a spontaneous report from a non-contactable consumer (patient). A female patient of an unspecified age (reported as 70; no unit provided) received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number and expiration date not provided), via an unspecified route of administration on 08Feb2021 as SINGLE DOSE for covid-19 immunisation.  Patient's medical history and concomitant medications were not reported. Patient also reported that she hasn't taken the flu shot for 3 years because she had a "bad reaction" to it one year and her doctor told her not to get it again. Patient reported that prior to getting her COVID vaccine, she took diphenhydramine (BENADRYL) before going just in case. The patient reported that she received the first vaccine on Monday (08Feb2021) and reported that last night (11Feb2021) that she noted that she was not tasting her food and was 'real stuffy'. Patient also reported feeling that there was a cut in the roof of her mouth on an unspecified date. Patient asked if this is normal and also asked what she should do about it. Patient further reported that she tried calling to report her symptoms yesterday but was on hold for about 4 hours and "I gave up".  Patient reported her plan to go online to report her symptoms today. 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.
Sex: M
Vaccine: COVID19
Symptoms: Condition aggravated, Epistaxis, Extrasystoles
Clinical narrative: Caller stated that he had "2 nose bleeds"; heart skipped a beat and stuff/beat 2-3 times and then skip a beat, then continue to beat again; it does it all the time but seemed to get worse; heart skipped a beat and stuff/beat 2-3 times and then skip a beat, then continue to beat again; it does it all the time but seemed to get worse; This is a spontaneous report from a contactable consumer (patient). An 86-year-old male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; batch/lot number and expiration date unknown), via an unspecified route of administration on 22Jan2021 at a single dose for covid-19 immunisation. Medical history included "heart skipped a beat". The patient's concomitant medications were not reported. On the 13th day after the first dose (Feb2021), the patient experienced his "heart skipped a beat and stuff". The patient stated that he had 2 nose bleeds and his heart would "beat 2-3 times and then skip a beat, then continue to beat again; it does it all the time but seemed to get worse". The patient wanted to know if he can proceed to the second dose. The patient received the Pfizer-BioNTech COVID-19 Vaccine first dose last 22Jan2021 and is scheduled for second dose today, 12Feb2021 at 4:45. The outcome of the events was unknown.  Information on the batch/lot number has been requested.
Age: 40.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Heart rate, Heart rate increased, Hyperhidrosis, Ventricular extrasystoles
Clinical narrative: experienced a fast heartbeat/heart rate went up to the 160s; sweaty; dizzy; Heart threw a few PVCs; This is a spontaneous report from a contactable consumer (patient). A 40-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/Lot Number: EL3249; Expiration Date: 31May2021), via an unspecified route of administration, administered in deltoid left on 22Jan2021 as 0.3 mL, single for covid-19 immunisation. Medical history included sensitive to drugs from an unknown date and unknown if ongoing. There were no concomitant medications. The patient previously took celecoxib (CELEXA) and experienced ventricular extrasystoles, dicycloverine (BENTYL) and experienced ventricular extrasystoles and heart rate went up to 180 and blood pressure dropped. She has had this [premature ventricular contractions (PVCs)] occur a few times before, a history of it. Sometimes it occurs with medicines. Stated she is sensitive to drugs. Added, this occurred with Celexa, every 5-10 beats she would throw PVCs and it occurred until she was weaned off and stopped Celexa. The PVCs also occurred with Bentyl. When she took it her heart rate went up to 180 and her blood pressure dropped. She had to be taken by ambulance and was given fluids and she believes diphenhydramine (BENADRYL) and some other things, but she is not sure. The patient got her first COVID vaccine and experienced a fast heartbeat, felt sweaty and dizzy. She was wondering if what she experienced after the first shot a normal side effect and if it would be worse with the second dose. After the first COVID vaccine shot (after the ten-minute wait), her heart threw a few PVCs, her heart rate went up to the 160s, she was sweaty, and dizzy. She had to pull the car over. Stated she is worried about getting the second dose. Wondering if this reaction could be worse. Initially stated these events all resolved that same day, but then she followed up and clarified sometimes she still feels her heart throwing PVCs again. The patient stated she turned her car towards the Emergency Room (ER), but she ended up talking herself out of going. The patient underwent lab tests and procedures which included heart rate went up to the 160s on 22Jan2021 (fast heartbeat). The outcome of the event Premature ventricular contractions was not recovered while of the rest was recovered on an unspecified date.
Age: 71.0
Sex: M
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: he had his first dose on 19Jan2021, it went well, his arm was a little sore; This is a spontaneous report from a contactable consumer (patient) via the medical information team. A 71-year-old male patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot: EL3246), via an unspecified route of administration (to left shoulder) on 19Jan2021 (given later in afternoon) (at the age of 71years) as single dose for covid-19 immunisation. Medical history included arthritis (has some arthritis in his knee and also in left elbow (diagnosed in left elbow around Nov2020)), injury (had an injury a year or so ago). Concomitant medications included acetylsalicylic acid (BABY ASPIRIN) and acetylsalicylic acid (ASPIRIN (E.C.)) taken because of injury. The patient previously took epinephrine and experienced he couldn't take it, procaine hydrochloride (NOVOCAINE), epinephrine and experienced epinephrine in it, his heart races for 3 days, it felt like he was running a marathon and smallpox vaccine for immunity to small pox (when he was probably in grade school). The patient had no investigation assessment. The patient had his first dose on 19Jan2021, it went well, his arm was a little sore (in 2021), but he didn't have any reaction to that. The vaccine facility was in a hospital clinic and not in a military facility. The event did not require an ER visit nor of physician's office There were no prior vaccinations (within 4 weeks). The outcome of the event was unknown.
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Hyperhidrosis, Nasopharyngitis, Pharyngitis streptococcal, SARS-CoV-2 test
Clinical narrative: tested positive for Strep yesterday and is on a Z-pak (today is day two for the medicine)/tested positive for Strep throat; dizzy with sweats; dizzy with sweats; head cold; This is a spontaneous report from a contactable consumer. A 66-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot Number: EL3248; Expiration Date: 01Apr2021), via an unspecified route of administration on the right arm on 23Jan2021 at single dose for COVID-19 immunisation .  Medical history included patient required acid reducer. Concomitant medication included omeprazole taken as acid reducer.The patient stated that she tested positive for Strep yesterday and is on a Z-pak (today is day two for the medicine). She asked if it is okay if she still gets her vaccine tomorrow. She tested negative for Covid on Feb2021. States she is being treated with Azithromycin, a z-pack, 250mg two tablets to start then one a day. States she just felt like she had a head cold, got up yesterday and was dizzy with sweats and it went away in about 15 minutes on 11Feb2021. The outcome of head cold and dizzy with sweats was recovered on 11Feb2021 and other event was not recovered.
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Streptococcus test
Clinical narrative: tested positive for Strep yesterday and is on a Z-pak (today is day two for the medicine)/tested positive for Strep throat; dizzy with sweats; dizzy with sweats; head cold; This is a spontaneous report from a contactable consumer. A 66-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot Number: EL3248; Expiration Date: 01Apr2021), via an unspecified route of administration on the right arm on 23Jan2021 at single dose for COVID-19 immunisation .  Medical history included patient required acid reducer. Concomitant medication included omeprazole taken as acid reducer.The patient stated that she tested positive for Strep yesterday and is on a Z-pak (today is day two for the medicine). She asked if it is okay if she still gets her vaccine tomorrow. She tested negative for Covid on Feb2021. States she is being treated with Azithromycin, a z-pack, 250mg two tablets to start then one a day. States she just felt like she had a head cold, got up yesterday and was dizzy with sweats and it went away in about 15 minutes on 11Feb2021. The outcome of head cold and dizzy with sweats was recovered on 11Feb2021 and other event was not recovered.
Age: 72.0
Sex: M
Vaccine: COVID19
Symptoms: Dizziness, Nausea
Clinical narrative: dizziness; queasiness; This is a spontaneous report from a contactable consumer (patient). A 72-year-old male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number and expiry date ere not reported), via an unspecified route of administration, on 11Feb2021 at a single dose for COVID-19 immunization. Medical history and concomitant medications were not reported. The patient experienced dizziness and queasiness on an unspecified date. He wanted to know how long these side effects would last. Outcome of the events as unknown.   Information on lot/batch number has been requested.