chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 33.0
Sex: F
Vaccine: COVID19
Symptoms: Burning sensation, Rash vesicular
Clinical narrative: burn-like lesion on top of right foot/started as a welt/looks like a blistered burn; sensation of low-grade current flowing through hands and sporadically throughout limbs; This is a spontaneous report from a contactable consumer reporting for herself. A 33-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE) (lot number EL1283/expiration date: not provided), via an unspecified route of administration, on 21Jan2021 at 14:45 (at the age of 33 years old) as a single dose in the right arm for COVID-19 IMMUNIZATION. Relevant medical history included latex allergy and allergy to some white cheeses. Concomitant medication was not provided. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient was not pregnant at the time of vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 21Jan2021, the patient experienced sensation of low-grade current flowing through hands and sporadically throughout limbs, mostly for 2hrs following the shot, then occasionally afterward. On 21Jan2021 at 22:45 the patient experienced a burn like lesion on top of right foot, which started as a welt approximately 8 hours after the shot. By morning of second day after shot (23Jan2021), it looks like a blistered burn the size of a dime. The patient did not receive any treatment for these events. The outcome of the events sensation of low-grade current flowing and burn-like lesion on top of right foot/started as a welt/looks like a blistered burn was not recovered. Since the vaccination, the patient had not been tested for COVID-19.
Age: 42.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Feeling abnormal, Headache, Joint range of motion decreased, Musculoskeletal stiffness
Clinical narrative: Temp between 99.5 to 100.5 degrees Fahrenheit; Achy; Headache; Injection site pain; Difficulty lifting arm; stiff neck; Feeling of having the flu; This is a spontaneous report from a contactable healthcare professional reporting for herself. A 42-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE) (lot number EL8982/expiration date: not provided), via intramuscular route of administration, on 13Jan2021 at 09:15 AM (at the age of 42 years old) as a single dose in the left arm for COVID-19 IMMUNIZATION. Relevant medical history included gastritis, and COVID-19. The patient had known allergies to Bactrim. Prior to the vaccination, the patient was diagnosed with COVID-19. Concomitant medication included omeprazole 20mg daily, cetirizine hydrochloride (ZYRTEC) 10mg daily, vitamin D3 200 IU daily, and bifidobacterium bifidum, bifidobacterium lactis, lactobacillus acidophilus, lactobacillus brevis, lactobacillus bulgaricus, lactobacillus casei, lactobacillus paracasei, lactobacillus plantarum, lactobacillus rhamnosus, lactobacillus salivarius (PROBIOTIC 10) 20 billion live probiotic cultures. The patient was not pregnant at the time of vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 13Jan2021 at 10:30 PM, the patient experienced temperature between 99.5 to 100.5 degrees Fahrenheit, achy, headache, injection site pain and difficulty lifting arm, stiff neck and feeling of having the flu. All symptoms lasting 48 hours. The events were reported as non-serious. The patient did not receive any treatment for these events. The outcome of the events temperature between 99.5 to 100.5 degrees Fahrenheit, achy, headache, injection site pain and difficulty lifting arm, stiff neck and feeling of having the flu was recovered on an unspecified date in Jan2021. Since the vaccination, the patient had been tested for COVID-19 which included a blood test on 21Jan2021 which was negative.
Age: 42.0
Sex: F
Vaccine: COVID19
Symptoms: Pain, Pyrexia, SARS-CoV-2 antibody test, Vaccination site pain
Clinical narrative: Temp between 99.5 to 100.5 degrees Fahrenheit; Achy; Headache; Injection site pain; Difficulty lifting arm; stiff neck; Feeling of having the flu; This is a spontaneous report from a contactable healthcare professional reporting for herself. A 42-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE) (lot number EL8982/expiration date: not provided), via intramuscular route of administration, on 13Jan2021 at 09:15 AM (at the age of 42 years old) as a single dose in the left arm for COVID-19 IMMUNIZATION. Relevant medical history included gastritis, and COVID-19. The patient had known allergies to Bactrim. Prior to the vaccination, the patient was diagnosed with COVID-19. Concomitant medication included omeprazole 20mg daily, cetirizine hydrochloride (ZYRTEC) 10mg daily, vitamin D3 200 IU daily, and bifidobacterium bifidum, bifidobacterium lactis, lactobacillus acidophilus, lactobacillus brevis, lactobacillus bulgaricus, lactobacillus casei, lactobacillus paracasei, lactobacillus plantarum, lactobacillus rhamnosus, lactobacillus salivarius (PROBIOTIC 10) 20 billion live probiotic cultures. The patient was not pregnant at the time of vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 13Jan2021 at 10:30 PM, the patient experienced temperature between 99.5 to 100.5 degrees Fahrenheit, achy, headache, injection site pain and difficulty lifting arm, stiff neck and feeling of having the flu. All symptoms lasting 48 hours. The events were reported as non-serious. The patient did not receive any treatment for these events. The outcome of the events temperature between 99.5 to 100.5 degrees Fahrenheit, achy, headache, injection site pain and difficulty lifting arm, stiff neck and feeling of having the flu was recovered on an unspecified date in Jan2021. Since the vaccination, the patient had been tested for COVID-19 which included a blood test on 21Jan2021 which was negative.
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Headache, Lymphadenopathy, Myalgia, Pain
Clinical narrative: Swollen glands; severe headache; muscle pain; extremely tired; body hurts; This is a spontaneous report from a contactable consumer (patient). This 60-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE) (lot number El3248/expiration date: unknown), via unknown route of administration, on 09Jan2021 12:30 PM (at the age of 60 years old) as a single dose on left arm for COVID-19 immunisation for COVID-19 immunisation at a Public Health Clinic/Veterans Administration facility. Relevant medical history included breast cancer last year. The patient had no allergies to medications, food or other products. Relevant concomitant medications were not provided. 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. It was reported that the patient experienced swollen glands, severe headache, muscle pain, extremely tired, body hurts on 14Jan2021. The outcome of the events swollen glands, severe headache, muscle pain, extremely tired, body hurts was not recovered. No treatment was received for the events. Since the vaccination, the patient has not been tested for COVID-19.
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pruritus
Clinical narrative: Itch at site; This is a spontaneous report from a contactable consumer (patient). A 68-year-old female patient (not pregnant) received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot EL3247) via an unspecified route of administration in the right arm on 20Jan2021 10:45 AM at a single dose as COVID-19 vaccine. Medical history included allergies to maybe penicillin. Concomitant medications (received within 2 weeks of vaccination) included trazodone, fluticasone propionate (FLONASE), and cetirizine hydrochloride (ZYRTEC). The patient did not receive any other vaccines within 4 weeks prior to the COVID-19 vaccine. The patient experienced itch at site on 22Jan2021 12:00 PM. Treatment was not received for the event. The event was non-serious in which did not result in death, not life threatening, did not cause/prolonged hospitalization, not disabling/incapacitating, did not cause congenital anomaly/birth defect. It was unknown if the patient was diagnosed with COVID-19 prior to vaccination. She has not been tested for COVID-19 since the vaccination. The outcome of the event was not recovered.
Age: 96.0
Sex: M
Vaccine: COVID19
Symptoms: Pain in extremity, Paraesthesia, Swollen tongue
Clinical narrative: tongue began to swell; had a tingling feeling in chest and abdomen; Slightly sore arm; This is a spontaneous report from a contactable consumer.  A 96-year-old male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE solution for injection, lot/batch number: EL898), via an unspecified route of administration on the right arm on 16Jan2021 12:30 at SINGLE DOSE for COVID-19 immunization at the pharmacy or drug store. Medical history included hypertension, glaucoma, benign prostatic hyperplasia (BPH), skin cancer, gout, and malaria (three times experienced). The patient had also allergies with wasp stings which later manifested of anaphylactic. Patient had unspecified concomitant medications. The patient received vaccine on 16Jan2021 at approximately 12:30 pm. Within 5 minutes (12:35), the tongue began to swell, and patient had a tingling feeling in chest and abdomen. The patient also had slightly sore arm. The patient drove towards emergency room (ER) but within 20 minutes the symptoms had subsided enough to not go to ER and head home. The patient was not diagnosed with COVID-19 prior and since vaccination. No treatment was received for the events. Symptoms disappeared on unknown date in Jan2021 and never recurred.
Age: 89.0
Sex: F
Vaccine: COVID19
Symptoms: Vertigo
Clinical narrative: Vertigo (strong) about 2 hours after receiving shot; This is a spontaneous report from a contactable consumer (patient).   An 89-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection) 0n 21Jan2021 at 16:15 at single dose via an unspecified route of administration on left arm for COVID-19 immunization. Relevant medical history and concomitant medications were not reported. On 21Jan2021 about 2 hours after receiving shot the patient experienced vertigo (strong).    Information about Lot/Batch number has been requested.
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Dyspnoea, Rash
Clinical narrative: hard time breathing; Rash all over body; This is a spontaneous report from a contactable pharmacist.  A 57-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: El3249), intramuscular at arm left on 24Jan2021 at 13:30 at single dose for COVID-19 immunization.  The patient medical history and concomitant medications were not reported. On 24Jan2021 at 13:30, the patient experienced rash all over body and hard time breathing. The events resulted in doctor or other healthcare professional office/clinic visit. Therapeutic measures were taken as a result of the events and included treatment with BENADRYL and EPIPEN. The patient outcome of the events was recovering.; Sender's Comments: Based on temporal association, the causal relationship between BNT162B2 and the events dyspnea and rash cannot be excluded. The information available in this report is limited and does not allow a medically meaningful assessment. This case will be reassessed once additional information becomes 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: 76.0
Sex: F
Vaccine: COVID19
Symptoms: Parosmia, SARS-CoV-2 test
Clinical narrative: Caller wanted to know if the vaccine would cause a strange odor in her nose/I have an odd odor that I continue to smell in my nose; This is a spontaneous report from a contactable consumer (patient). This 76-years-old female patient received the first dose of BNT162B2 (the covid 19 vaccine Batch/lot number: EL3249) on 18Jan2021 at single dose for covid-19 immunization. Medical history was Diabetic, High Blood pressure, Pain, Heart burn. On 04Jan2020, patient stated became quite ill and that was before COVID was made public. So I thought I had flu but I was sick about for two and a half weeks that I did not get out of bed, could barely move. I couldn't eat, I lose a lot of weight, I lost my sense of smell and taste. I think now I may have COVID. I am getting a smell that is very unusual and it's hard to describe, it's kind of a pungent kind of a smell. I can't really describe it, correct and is there any remedy for it After that I took a COVID test in March and in March it was negative. Then I took another one in August and it was negative. Concomitant drug included Metformin for Diabetic, Lisinopril for High Blood pressure, Tramadol for pain. Patient had a strange odor in her nose from 19Jan2021/20Jan2021, continue to smell in her nose. Outcome of the event was not recovered.  Follow-up attempts are completed. No further information is expected.
Age: 42.0
Sex: F
Vaccine: COVID19
Symptoms: Ageusia
Clinical narrative: Loss of taste; This is a spontaneous report from a contactable health professional, the patient. A 42-year-old non-pregnant female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), intramuscular in the right arm on 22Jan2021 at 15:45 (at the age of 42-years-old) as a single dose for COVID-19 immunization. Medical history and concomitant medications were not reported; however, it was reported that the patient received other unspecified medications within 2 weeks of vaccination. The patient did not receive any other vaccines within 4 weeks prior to the vaccination. Prior to vaccination, the patient was not diagnosed with COVID-19. On 23Jan2021 at 09:00, the patient experienced loss of taste. The patient was not treated for the event. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of loss of taste was resolving.   Information on the lot/batch number has been requested.
Age: 27.0
Sex: F
Vaccine: COVID19
Symptoms: Rash
Clinical narrative: Rash on inside of elbow on same arm as injection; This is a spontaneous report from a non-contactable consumer report for self. This 27-year-old not pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL8982), via an unspecified route of administration at arm on 20Jan2021 16:00 at single dose for COVID-19 immunization. The patient's medical history and patient's concomitant medications were not reported. The patient experienced rash on inside of elbow on same arm as injection on 22Jan2021. Event recovered on 24Jan2021.  No follow-up attempts are possible. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: Soreness at site of injection the following morning; This is a spontaneous report from a non-contactable consumer. An adult male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on an unspecified date at single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient experienced soreness at site of injection the following morning on an unspecified date. The event was reported as non-serious. The outcome of event was unknown.   No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Age: 78.0
Sex: M
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: I had some pain around the shot area; This is a spontaneous report from a contactable consumer (patient). A 78-year-old male consumer received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on 19Jan2021 at 14:30 at single dose in left arm for COVID-19 immunisation at the age of 78-year-old. Lot number was EL3302. The medical history and the concomitant medications were not reported. The patient had some pain around the shot area on 19Jan2021 at 17:30 and he took TYLENOL, 2 tablets 500 mg each within 4 hours of receiving the shot. Prior to vaccination, the patient was not diagnosed with COVID-19; since the vaccination, the patient has not been tested for COVID-19. The patient recovered from the event.
Age: 47.0
Sex: M
Vaccine: COVID19
Symptoms: Erectile dysfunction
Clinical narrative: Erectile Dysfunction; This is a spontaneous report from a contactable Other HCP.  A 47-year-old male Other HCP reported that he received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number unknown), intramuscular at single dose into the right arm on 05Jan2021 09:30 AM for COVID-19 immunization. Medical history included kidney stones. Concomitant drugs were unknown. The patient reported that on 20Jan2021 he experienced erectile dysfunction. No treatment was received. The outcome of the event was unknown.  Information on the lot/batch number has been requested.; Sender's Comments: As an individual case report there is not enough evidence to establish a causal relationship with the suspect vaccine. Currently there is no clear biological plausibility between the vaccine use and the even onset.  More information such as complete medical history and concomitant medications are needed for fully medical assessment. 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, COVID19
Symptoms: COVID-19, SARS-CoV-2 test positive
Clinical narrative: First vaccine 31Dec, tested positive for covid 01Jan; First vaccine 31Dec, tested positive for covid 01Jan; This is a spontaneous report from a contactable Other HCP. This Other HCP reported for self that the 21-year-old female patient received first dose of bnt162b2 (BNT162B2, COVID 19, Pfizer), via an unspecified route of administration on 31Dec2020 02:30 PM on Right arm at single dose for covid-19 immunisation. Medical history included known allergies: Cefdinir, asthma, anxiety, and depression. Concomitant medications included Duloxetine, lamotrigine, buspirone hydrochloride (BUSPAR), etonogestrel (NEXPLANON), ethinylestradiol/ norethisterone acetate (JUNEL). First vaccine 31Dec2020, tested positive for covid 01Jan2021, had second dose 21Jan2021. The outcome of the events was unknown.   Information on the Lot/Batch number has been requested.; Sender's Comments: A causal association between BNT162B2 and the reported events cannot be excluded based on a compatible temporal relation. However, full immunity is only expected 2 weeks after the second dose.
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Cough, Dyspnoea, SARS-CoV-2 test
Clinical narrative: First vaccine 31Dec, tested positive for covid 01Jan; First vaccine 31Dec, tested positive for covid 01Jan; This is a spontaneous report from a contactable Other HCP. This Other HCP reported for self that the 21-year-old female patient received first dose of bnt162b2 (BNT162B2, COVID 19, Pfizer), via an unspecified route of administration on 31Dec2020 02:30 PM on Right arm at single dose for covid-19 immunisation. Medical history included known allergies: Cefdinir, asthma, anxiety, and depression. Concomitant medications included Duloxetine, lamotrigine, buspirone hydrochloride (BUSPAR), etonogestrel (NEXPLANON), ethinylestradiol/ norethisterone acetate (JUNEL). First vaccine 31Dec2020, tested positive for covid 01Jan2021, had second dose 21Jan2021. The outcome of the events was unknown.   Information on the Lot/Batch number has been requested.; Sender's Comments: A causal association between BNT162B2 and the reported events cannot be excluded based on a compatible temporal relation. However, full immunity is only expected 2 weeks after the second dose.
Age: 19.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness
Clinical narrative: Dizziness; This is a spontaneous report from a contactable other healthcare professional (HCP) (patient). A 19-year-old female patient (not pregnant) received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot EL1284) via an unspecified route of administration in the left arm on 20Jan2021 at a single dose as Covid vaccine. There were no medical history and no concomitant medications (no other vaccine in four weeks and no other medications in two weeks). The patient experienced dizziness on an unspecified date. The outcome of the event was unknown.
Age: 45.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Feeling abnormal, Pain, Paraesthesia, Pharyngeal swelling
Clinical narrative: swelling on the left side of her jaw and throat began to swell/swelling on left side of face and throat; Tingling; swelling on the left side of her jaw and throat began to swell/swelling on left side of face and throat/whelping up on the left side of jaw; felt a funny sensation in her throat and face/still not feeling herself; soreness; left arm was sore; throat still feels funny; feels scratchy; feeling fatigued; This is a spontaneous report from a contactable consumer reporting for herself. A 45-years-old female patient started to receive bnt162b2 (BNT162B2, Manufacturer Pfizer-BioNTech) (lot# EH9899, exp date 31Mar2021), via an unspecified route of administration in the left arm, on 15Jan2021 at 14:30, at single dose, for COVID-19 immunisation.  Medical history and concomitant medications were none. The patient experienced left arm was sore on 16Jan2021 with outcome of recovered, swelling on the left side of her jaw and throat began to swell/swelling on left side of face and throat on 18Jan2021 with outcome of recovering, tingling on 18Jan2021 with outcome of recovering, swelling on the left side of her jaw and throat began to swell/swelling on left side of face and throat/whelping up on the left side of jaw on 18Jan2021 with outcome of recovering, felt a funny sensation in her throat and face/still not feeling herself  on 18Jan2021 with outcome of not recovered, feeling fatigued in Jan2021 with outcome of not recovered, soreness on 16Jan2021 with outcome of recovering, throat still feels funny; feels scratchy on Jan2021 with outcome of not recovered. The patient visited the emergency room for left arm was sore, swelling on the left side of her jaw and throat began to swell/swelling on left side of face and throat, tingling, swelling on the left side of her jaw and throat began to swell/swelling on left side of face and throat/whelping up on the left side of jaw. The patient was treated in the emergency room with prednisone, Benadryl and acid medicine for her stomach.
Age: 45.0
Sex: F
Vaccine: COVID19
Symptoms: Swelling face, Throat irritation, Vaccination site pain
Clinical narrative: swelling on the left side of her jaw and throat began to swell/swelling on left side of face and throat; Tingling; swelling on the left side of her jaw and throat began to swell/swelling on left side of face and throat/whelping up on the left side of jaw; felt a funny sensation in her throat and face/still not feeling herself; soreness; left arm was sore; throat still feels funny; feels scratchy; feeling fatigued; This is a spontaneous report from a contactable consumer reporting for herself. A 45-years-old female patient started to receive bnt162b2 (BNT162B2, Manufacturer Pfizer-BioNTech) (lot# EH9899, exp date 31Mar2021), via an unspecified route of administration in the left arm, on 15Jan2021 at 14:30, at single dose, for COVID-19 immunisation.  Medical history and concomitant medications were none. The patient experienced left arm was sore on 16Jan2021 with outcome of recovered, swelling on the left side of her jaw and throat began to swell/swelling on left side of face and throat on 18Jan2021 with outcome of recovering, tingling on 18Jan2021 with outcome of recovering, swelling on the left side of her jaw and throat began to swell/swelling on left side of face and throat/whelping up on the left side of jaw on 18Jan2021 with outcome of recovering, felt a funny sensation in her throat and face/still not feeling herself  on 18Jan2021 with outcome of not recovered, feeling fatigued in Jan2021 with outcome of not recovered, soreness on 16Jan2021 with outcome of recovering, throat still feels funny; feels scratchy on Jan2021 with outcome of not recovered. The patient visited the emergency room for left arm was sore, swelling on the left side of her jaw and throat began to swell/swelling on left side of face and throat, tingling, swelling on the left side of her jaw and throat began to swell/swelling on left side of face and throat/whelping up on the left side of jaw. The patient was treated in the emergency room with prednisone, Benadryl and acid medicine for her stomach.
Age: 42.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site swelling, Vaccination site warmth
Clinical narrative: Severe swelling surrounding injection site; hot to touch surrounding injection site; This is a spontaneous report from a contactable 42-year-old female Health care professional who reported for herself that she received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: Fck9231) intramuscular at single dose for COVID-19 immunisation on 11Jan2021 at 12:00 pm. Relevant history included allergy with sulfa. Relevant concomitant drugs included lamotrigine (LAMICTAL), propranolol. The patient was not pregnant at the time of vaccination. The patient experienced severe swelling, hot to touch surrounding injection site since 11Jan2021 at 13:00. Symptoms remained for 11 days after administration. No treatment was received. The outcome of events was resolving.  The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient was not diagnosed with COVID-19. Since the vaccination, the patient had not test for COVID-19.
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Nausea
Clinical narrative: Nausea; This is a spontaneous report from a contactable consumer (patient). A 60-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number: En5318; Expiration date was not reported) on 22Jan2021 (10:45) at a single dose on the left arm, with route of administration unspecified, for COVID-19 immunization. Medical history included multiple (MS), blood clots and pulmonary embolism. Concomitant medications included rivaroxaban (XARELTO) and omeprazole. The patient previously took clarithromycin (BIAXIN), and had drug allergies. The patient was not pregnant at the time of vaccination. On 23Jan2021 (16:00), the patient had nausea. The patient did not receive any treatment for the event, nausea. The outcome of the event, nausea, was not recovered. The patient was not diagnosed with COVID-19 prior to vaccination, and was not tested post-vaccination.
Age: 88.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Fatigue
Clinical narrative: Extreme fatigue; Chills; This is a spontaneous report from a contactable consumer (patient). A 88-year-old female patient started received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE solution for injection, lot/batch number: EL3247), via an unspecified route of administration on the right arm on 19Jan2021 13:30 at SINGLE DOSE for COVID-19 immunization at the hospital. Medical history included haemolytic anaemia, diabetes, had spleen removed (splenectomy) on an unknown date, breast cancer. The patient had allergies with cats, lisinopril, and furosemide. The patient was not pregnant (including at the time of vaccination). Concomitant medications included metformin (METFORMIN), insulin glargine (LANTUS), atorvastatin (ATORVASTATIN), and warfarin (WARFARIN). It was reported that the patient had chills and extreme fatigue from time of vaccination on 19Jan2021 14:30, all the way through the next day of 20Jan2021. The patient just went take a nap from 4:00 to 5:30 PM on 20Jan21 then slept through the alarm until 7:45 PM. The patient was not diagnosed with COVID-19 prior and since vaccination. The patient recovered from the events in Jan2021.
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test positive
Clinical narrative: Diagnosed with Covid 19; Diagnosed with Covid 19; This is a spontaneous report from a contactable Nurse reported for herself.  A 51-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), on 09Jan2021 at single dose for COVID-19 immunization. Medical history and Concomitant medications were not reported.  She was diagnosed with Covid 19 on 18Jan2021. She was supposed to get second dose on 26Jan2021. The outcome of the events was unknown.  Information about batch number was not available and is going to be requested.; Sender's Comments: The efficacy of a drug varies from patient to patient and can be affected by different factors; however, a contributory role of the suspect product BNT162B2 to the reported drug ineffective and COVID-19 cannot be ruled out.
Age: 26.0
Sex: F
Vaccine: COVID19
Symptoms: Rash
Clinical narrative: rash going down her arms; This is a spontaneous report from a contactable consumer.  A 26-year-old female patient received bnt162b2 (BNT162B2), lot number not reported, via an unspecified route of administration from an unspecified date to an unspecified date at SINGLE DOSE for COVID-19 immunisation.  The patient's medical history and concomitant medications were not reported.  The patient experienced rash going down her arms on an unspecified date with outcome of unknown.   Information on the lot/batch number has been requested.
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: arm pain; This is a spontaneous report from a contactable Health Professional. A 61-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), via an unspecified route of administration on 13Jan2021 (at the age of 61-years) as a single dose for Covid-19 immunization. The patient's medical history and concomitant medications were not reported. The patient experienced arm pain from vaccination on an unspecified date. The clinical outcome of the event was unknown.
Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: Decreased appetite, Nausea, Vomiting
Clinical narrative: Nausea; throwing up bile; no appetite; This is a spontaneous report from a contactable consumer (patient). A 72-year-old female patient received BNT162B2, via an unspecified route of administration on 13Jan2021 at single dose for COVID-19 immunization. Medical history included hypertension. No COVID prior vaccination. Concomitant medications included azilsartan kamedoxomil (EDARBI), troxipide (PRESTONE), and torsemide (TORSEMIDE). The patient previously took erythromycin and experienced drug allergy. Patient experienced nausea and throwing up bile, no appetite on 21Jan2021. No treatment received for these events. No COVID tested post vaccination. Outcome of the events was not resolved.  Information on the lot/batch number has been requested.
Age: 88.0
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Flushing, Paraesthesia oral, Skin warm
Clinical narrative: flushed in the face/warm; red face; tingling sensation of lips but no swelling; mild allergic reaction; This is a spontaneous report from contactable consumers. An 88-year-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number and expiration date unspecified), via an unspecified route of administration on 20Jan2021 11:45 at single dose (left arm) for COVID-19 immunization. Medical history included lung cancer. The patient was not pregnant. Concomitant medications were not reported. It was reported that the patient had unspecified other medication in two weeks. The reporter's mother's experienced mild allergic reaction in Jan2021 and she wants to know whether or not she should be getting her second dose. She will be asking her doctor as well as they were advised by the nurse administering the vaccine and also the doctor's nurses who observed her mother afterwards, but she was also advised to contact Pfizer. On 20Jan2021, at 12:00, within 5 minutes, the patient experienced flushed in the face/warm, red face, tingling sensation of lips but no swelling, no increased blood pressure, no hives or rash, no tongue or throat swelling, no dizziness, no nausea. It was mild but concerning. The patient was treated with oral Benadryl and Pepcid IV (also reported as IV of peptids), and extended observation for 1 hour and 30 minutes. The events resulted in doctor or other healthcare professional office/clinic visit. The patient had no Covid prior vaccination and was not Covid tested post vaccination. The consumer would like to know if her mother was safe to receive the second dose of the Covid vaccine and if the reaction to the second dose of the Covid vaccine will be more severe with a history of an allergic reaction to the first dose. Outcome of event mild allergic reaction was unknown; outcome of the rest of events was recovered in Jan2021.  Information on the lot/batch number has been requested.
Sex: F
Vaccine: COVID19
Symptoms: Fatigue
Clinical narrative: tiredness; This is a spontaneous report from a contactable consumer (patient), based on the information received by Pfizer from  (manufacturer control number: EC-2020-084563), for BNT162B2. A female patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 19Jan2021 at single dose for covid, lenvatinib mesilate (LENVIMA), via an unspecified route of administration from 16Nov2020 to an unspecified date at 12 mg, daily for hepatocellular carcinoma (HCC) C22. The patient's medical history included headache. Concomitant medications were not reported. Patient reported headache and some tiredness since taking lenvatinib mesilate but also thought that her tiredness was attributed to her receiving COVID vaccine. The patient experienced tiredness on 19Jan2021 with outcome of unknown. Action taken for lenvatinib mesylate was unknown.   No follow-up attempts are possible, information about batch number cannot be obtained.
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: soreness at the injection site; This is a spontaneous report from a contactable consumer (patient is reporter's mother). A female patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on an unspecified date at SINGLE DOSE for covid-19 immunization. The patient medical history and concomitant medications were not reported. The patient experienced soreness at the injection site on an unspecified date with outcome of unknown. The reporter learned the evening of Jan21.  Information on the Lot/batch number has been requested.
Age: 88.0
Sex: M
Vaccine: COVID19, UNK
Symptoms: Blister, Blood creatinine, Blood glucose, Blood urea, Laboratory test
Clinical narrative: swelling of right arm, where he received the vaccine; Palpable purpura/Some of the purpura was on the left arm and he had a few spots on the upper chest; Blistering; This is a spontaneous report from a contactable physician. An 88-year-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) at right arm on 09Jan2021 at single dose for COVID-19 vaccination (reported as for "1-B vaccine group, age greater than 75, history of heart disease") in hospital. Co-suspect drug included apixaban (ELIQUIS) orally from 2020 (Has been on Eliquis for over the last year, 12 months) and ongoing at 5 mg, 2 times a day (5mg, 1 tablet by mouth twice daily) for heart failure and atrial fib. Medical history included heart failure, atrial fib. Concomitant medication was not reported. No other vaccines given the same day or 4 weeks prior. Mentions patient did have a flu shot back in Sep2020 (unable to provide NDC, Lot, or expiry), no problems with vaccines in past.  Patient received the first dose Saturday morning of 09Jan2021 with no ill effects. 3-4 days later (Jan2021) patient had swelling of right arm, where he received the vaccine, and then developed palpable purpura. Some of the purpura was on the left arm and he had a few spots on the upper chest. Had no fever, no malaise, just what the patient described as blistering and so they had a dermatologist look at it. All seems to be improving. They were curious as to what this is. The patient feels fine and is ambulatory and the purpura does not itch. Caller does not provide seriousness criteria when queried. Initially it was thought, because the patient was on Eliquis for heart failure and atrial fib, that the Eliquis was related to events, but when the Dermatologist looked at it and stated it maybe excavation they decided to call and find out what Pfizer wanted them to do. Caller states he can give a list of medications if needed. Says patient had a comprehensive biochemical profile done non fasting also on 18Jan2021. Patient was seen by him initially on 19Jan2021. Wants to know whether this is a safety concern or/and if the patient should have the second dose. event requires a visit to physician office. Lab test on 18Jan2021 included Comprehensive Biochemical Profile, Blood Sugar of 116, Creatinine of 1.91, BUN of 43. Action taken of apixaban was dose not changed. Patient was recovering from the events. Relatedness of drug to event swelling of right arm, Palpable purpura and Blistering, feels fine, ambulatory, no fever, no malaise, seen by dermatologist, purpura does not itch, on Eliquis.  Per Source of assessment (Primary Source Reporter) and Method of assessment (Global Introspection) for drug result (Covid-19 vaccine) was Related, of drug result (Eliquis) was unrelated.      Information on the lot/ batch number has been requested.
Age: 88.0
Sex: M
Vaccine: COVID19, UNK
Symptoms: Palpable purpura, Vaccination site swelling
Clinical narrative: swelling of right arm, where he received the vaccine; Palpable purpura/Some of the purpura was on the left arm and he had a few spots on the upper chest; Blistering; This is a spontaneous report from a contactable physician. An 88-year-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) at right arm on 09Jan2021 at single dose for COVID-19 vaccination (reported as for "1-B vaccine group, age greater than 75, history of heart disease") in hospital. Co-suspect drug included apixaban (ELIQUIS) orally from 2020 (Has been on Eliquis for over the last year, 12 months) and ongoing at 5 mg, 2 times a day (5mg, 1 tablet by mouth twice daily) for heart failure and atrial fib. Medical history included heart failure, atrial fib. Concomitant medication was not reported. No other vaccines given the same day or 4 weeks prior. Mentions patient did have a flu shot back in Sep2020 (unable to provide NDC, Lot, or expiry), no problems with vaccines in past.  Patient received the first dose Saturday morning of 09Jan2021 with no ill effects. 3-4 days later (Jan2021) patient had swelling of right arm, where he received the vaccine, and then developed palpable purpura. Some of the purpura was on the left arm and he had a few spots on the upper chest. Had no fever, no malaise, just what the patient described as blistering and so they had a dermatologist look at it. All seems to be improving. They were curious as to what this is. The patient feels fine and is ambulatory and the purpura does not itch. Caller does not provide seriousness criteria when queried. Initially it was thought, because the patient was on Eliquis for heart failure and atrial fib, that the Eliquis was related to events, but when the Dermatologist looked at it and stated it maybe excavation they decided to call and find out what Pfizer wanted them to do. Caller states he can give a list of medications if needed. Says patient had a comprehensive biochemical profile done non fasting also on 18Jan2021. Patient was seen by him initially on 19Jan2021. Wants to know whether this is a safety concern or/and if the patient should have the second dose. event requires a visit to physician office. Lab test on 18Jan2021 included Comprehensive Biochemical Profile, Blood Sugar of 116, Creatinine of 1.91, BUN of 43. Action taken of apixaban was dose not changed. Patient was recovering from the events. Relatedness of drug to event swelling of right arm, Palpable purpura and Blistering, feels fine, ambulatory, no fever, no malaise, seen by dermatologist, purpura does not itch, on Eliquis.  Per Source of assessment (Primary Source Reporter) and Method of assessment (Global Introspection) for drug result (Covid-19 vaccine) was Related, of drug result (Eliquis) was unrelated.      Information on the lot/ batch number has been requested.
Age: 28.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Discomfort, Disorientation, Fall, Loss of consciousness
Clinical narrative: Passed out; fell; became disoriented and weak; became disoriented and weak; could not control her body, all muscles felt heavy and weak; could not control her body, all muscles felt heavy and weak; Felt tingles in feet and lower legs; This is a spontaneous report from a contactable consumer(patient). The 28-year-old female patient(not pregnant) received first dose BNT162B2(COVID 19, lot number: EL9262), via an unspecified route of administration at left arm on 22Jan2021 13:00 at single dose for COVID-19 immunization.  Medical history included none. She had no known allergies.  Concomitant medication included spironolactone, amfetamine aspartate/amfetamine sulfate/ dexamfetamine saccharate/ dexamfetamine sulfate (ADDERALL), vitamin b complex (VITAMIN B), ergocalciferol (VIT D), ZINC, omeg(omeprazole). There was no other vaccine in four weeks. About 11 hours after receiving(23Jan2021), she very quickly became disoriented and weak, could not control her body, all muscles felt heavy and weak. She fell once and then presumably passed out - she came to after falling again. She felt tingles in feet and lower legs. After sleeping about 9 hours, she felt better. There was no treatment received, no covid prior vaccination, covid tested post vaccination.  Events were assessed as non-serious. Outcome of events was recovering.
Age: 28.0
Sex: F
Vaccine: COVID19
Symptoms: Muscular weakness, Paraesthesia
Clinical narrative: Passed out; fell; became disoriented and weak; became disoriented and weak; could not control her body, all muscles felt heavy and weak; could not control her body, all muscles felt heavy and weak; Felt tingles in feet and lower legs; This is a spontaneous report from a contactable consumer(patient). The 28-year-old female patient(not pregnant) received first dose BNT162B2(COVID 19, lot number: EL9262), via an unspecified route of administration at left arm on 22Jan2021 13:00 at single dose for COVID-19 immunization.  Medical history included none. She had no known allergies.  Concomitant medication included spironolactone, amfetamine aspartate/amfetamine sulfate/ dexamfetamine saccharate/ dexamfetamine sulfate (ADDERALL), vitamin b complex (VITAMIN B), ergocalciferol (VIT D), ZINC, omeg(omeprazole). There was no other vaccine in four weeks. About 11 hours after receiving(23Jan2021), she very quickly became disoriented and weak, could not control her body, all muscles felt heavy and weak. She fell once and then presumably passed out - she came to after falling again. She felt tingles in feet and lower legs. After sleeping about 9 hours, she felt better. There was no treatment received, no covid prior vaccination, covid tested post vaccination.  Events were assessed as non-serious. Outcome of events was recovering.
Sex: M
Vaccine: COVID19
Symptoms: Atrial fibrillation, Condition aggravated
Clinical narrative: atrial fibrillation; disease recurrence; This is a spontaneous report from a contactable consumer. A 76-year-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number unknown), at single dose on 21Jan2021 for COVID-19 immunization. medical history included atrial fibrillation. Concomitant drugs were unknown. the reporting consumer received a message on 23Jan2021 stating that the  patient started having atrial fibrillation the night before. The outcome of the event was unknown.  Information on batch/lot number was requested.
Age: 46.0
Sex: M
Vaccine: COVID19
Symptoms: Dizziness, Fatigue, Heart rate, Malaise, Nausea
Clinical narrative: tired; not feeling well; nausea; dizziness/almost passed out; This is a spontaneous report from a contactable nurse and a consumer. A 46-year-old male patient received the first dose of BNT162B2 (lot number: EL3247, expiry date: 31May2021), via an unspecified route of administration in left deltoid on 15Jan2021 12:56 at single dose for COVID-19 immunization. Medical history included had allergies as a child and carried as an epi pen. Concomitant medications were not reported. Reported to the waiting area for 15 minutes observation and left then came back to facility at 14:05 was not feeling well, reported dizziness and nausea. RN assessed patient, vital signs 122/84, pulse was 78 and O2 97 on room air, respiratory rate was 20, alert and oriented, was monitored for 30 minutes, reassessed at 14:25 188/76, heart rate 76, respiratory rate 18, O2 sats 98% on room air, encouraged patient to follow up with PCP or ER. Patient walked out with companion and stated he was feeling better. On 18Jan2021, patient was called for follow p, only complained he was as still tired, all other side effects had resolved. Stated he almost passed out upon coming back to the observation unit on 15Jan2021. Reporter stated it was noted that when patient returned for 2nd dose, would monitor for 45 minutes. Outcome of the event tired was not resolved, of event not feeling well was unknown, and of other events was resolved.
Age: 46.0
Sex: M
Vaccine: COVID19
Symptoms: Oxygen saturation, Respiratory rate, Vital signs measurement
Clinical narrative: tired; not feeling well; nausea; dizziness/almost passed out; This is a spontaneous report from a contactable nurse and a consumer. A 46-year-old male patient received the first dose of BNT162B2 (lot number: EL3247, expiry date: 31May2021), via an unspecified route of administration in left deltoid on 15Jan2021 12:56 at single dose for COVID-19 immunization. Medical history included had allergies as a child and carried as an epi pen. Concomitant medications were not reported. Reported to the waiting area for 15 minutes observation and left then came back to facility at 14:05 was not feeling well, reported dizziness and nausea. RN assessed patient, vital signs 122/84, pulse was 78 and O2 97 on room air, respiratory rate was 20, alert and oriented, was monitored for 30 minutes, reassessed at 14:25 188/76, heart rate 76, respiratory rate 18, O2 sats 98% on room air, encouraged patient to follow up with PCP or ER. Patient walked out with companion and stated he was feeling better. On 18Jan2021, patient was called for follow p, only complained he was as still tired, all other side effects had resolved. Stated he almost passed out upon coming back to the observation unit on 15Jan2021. Reporter stated it was noted that when patient returned for 2nd dose, would monitor for 45 minutes. Outcome of the event tired was not resolved, of event not feeling well was unknown, and of other events was resolved.