chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 42.0
Sex: M
Vaccine: COVID19
Symptoms: Headache, Myalgia, Pyrexia, Restlessness, Thirst
Clinical narrative: pain at injection site 24 hours later; Fever; chills/shakes; joint pain; muscle pain; fatique; restlessness; difficulty concentrating; gas; extreme thirst; headache; shakes; This is a spontaneous report from a non-contactable other hcp (health care professional). A 42-year-old male patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot Number: EL9262) via intramuscular route of administration, administered in left arm on 02Feb2021 at 09:00 (at the age of 42-year-old), at a single dose for covid-19 immunization in doctor's office/urgent care. The patient had no allergies and medical history. Concomitant medications were not reported. The patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot Number: EL3246) via intramuscular route of administration, administered in left arm on 11Jan2021 at 11:45, at a single dose for covid-19 immunization and received Influenza vaccine (within 4 weeks of vaccine) on an unknown date for immunization. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On 02Feb2021 at 19:00, after receiving the second dose of vaccine the patient experienced fever, chills, joint pain, muscle pain, fatigue, restlessness, difficulty concentrating, gas, extreme thirst, headache, shakes and on 03Feb2021 (24 hours later), the patient experienced pain at injection site. The patient did not receive any treatment for the events. The outcome of the events was recovering.  No follow-up attempts are possible. Information about lot/batch number could not be requested. No further information is expected.
Age: 42.0
Sex: M
Vaccine: COVID19
Symptoms: Tremor, Vaccination site pain
Clinical narrative: pain at injection site 24 hours later; Fever; chills/shakes; joint pain; muscle pain; fatique; restlessness; difficulty concentrating; gas; extreme thirst; headache; shakes; This is a spontaneous report from a non-contactable other hcp (health care professional). A 42-year-old male patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot Number: EL9262) via intramuscular route of administration, administered in left arm on 02Feb2021 at 09:00 (at the age of 42-year-old), at a single dose for covid-19 immunization in doctor's office/urgent care. The patient had no allergies and medical history. Concomitant medications were not reported. The patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot Number: EL3246) via intramuscular route of administration, administered in left arm on 11Jan2021 at 11:45, at a single dose for covid-19 immunization and received Influenza vaccine (within 4 weeks of vaccine) on an unknown date for immunization. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On 02Feb2021 at 19:00, after receiving the second dose of vaccine the patient experienced fever, chills, joint pain, muscle pain, fatigue, restlessness, difficulty concentrating, gas, extreme thirst, headache, shakes and on 03Feb2021 (24 hours later), the patient experienced pain at injection site. The patient did not receive any treatment for the events. The outcome of the events was recovering.  No follow-up attempts are possible. Information about lot/batch number could not be requested. No further information is expected.
Sex: U
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: Running fever; infectious because I have low grade fever; This is a spontaneous report from a contactable consumer (patient). A patient of unspecified age and gender received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection; Lot number: unknown) via an unspecified route of administration on 02Feb2021 at 03:45, as 1st single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported.  On 03Feb2021 the patient experienced running fever, infectious because patient had low grade fever. The outcome of event was unknown.  Information on about lot/Batch number has been requested.  Follow-up attempts were completed. No further information was expected.
Sex: M
Vaccine: COVID19
Symptoms: Headache
Clinical narrative: Headache; This is a spontaneous report from a contactable pharmacist, the patient. A 65-year-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), via an unspecified route of administration on an unspecified date at 15:00 (at the age of 65-year-old) as single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. On an unknown date, 8 hours after the vaccination at 11 PM, the patient experienced headache and was treated with Excedrin. Event continued till Sunday. The reporter assessed the event as non-serious.   Information about lot/batch number has been requested. Follow-up attempts are completed. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Urticaria
Clinical narrative: breaking out in welts on her bottom the size of his thumb; This is a spontaneous report from a contactable consumer (husband). A female patient of an unspecified age received bnt162b2 (BNT162B2, PFIZER-BIONTECH COVID-19 mRNA VACCINE; Formulation: Solution for injection, Lot number: unknown; Expiration Date: unknown), via an unspecified route of administration on an unspecified date as single dose for covid-19 immunization. The patient medical history was not reported. The patient's concomitant medications were not reported. On an unspecified date after vaccination, the patient experienced breaking out in welts on her bottom the size of his thumb. He stated his wife has already seen a dermatologist who prescribed a cream but that didn't appear to be helping. Event was assessed as non serious. The clinical outcome of the events was unknown.    Information on the lot/batch number has been requested.  Follow-up attempts are completed. No further information is expected.
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Condition aggravated, Injection site erythema, Pruritus, Rash, Urticaria
Clinical narrative: rash/welt is a bit worse; welts and rash around the site; welts and rash around the site; redness, warm to touch at the site; redness, warm to touch at the site; itching; Rash; This is a spontaneous report from a contactable consumer (husband) reported for her wife. A 69-year-old female patient who received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), Solution for injection, Batch/lot number EN5318, Expiration date unknown), via an unspecified route of administration in left arm on 11Feb2021 at 10:30, at a single dose for covid-19 immunization. Patient's medical history included Mitral valve replacement in 2000. Patient has not had any other recent vaccinations or started any new medications. Patient had no medications prior to the event being reported. Neither the patient received any recent vaccines for any other conditions prior to the event being reported nor received any recent vaccines for SARs-CoV2 other than Pfizer-BioNtech Covid-19 Vaccine. Patient did not receive any other vaccines around the time of Pfizer-BioNtech Covid-19 Vaccine Vaccination. On 12Feb2021, the patient experienced welts and rash around the injection site and had itching. The reporter said that the welt is hot to the touch on injection site. She put a bit of ice there and used Benadryl, which subsided the itching, and she tries not to scratch it, she was on Warfarin. He clarifies that the Benadryl cream was Calahist, a calamine lotion, that she only used once a little bit she was wanting to consult with her doctor to use whatever they recommend. Calahist UPC #, LOT: Unknown, EXP: Unknown, he does not see the LOT/EXP on the tube of the cream. Her rash/welt was a bit worse, it was spreading towards the bottom, but it was not hurting, it was itching and was warm to the touch. The patient was taking warfarin at the dose of 3mg one day, then for the rest of the week she takes 1.5 mg, by mouth. On 23Feb2021, Upon response to the query regarding clarification of the name of patient, screenshot was attached. On 25Mar2021, Other HCP reported in response to HCP letter regarding the patient that no anaphylactic reaction reported, No medical intervention required, neither the patient was seen in the Emergency Department nor was hospitalized and patient was not admitted to an Intensive Care Unit. No information on organ involvement. The outcome of welts and rash around the site was not recovered, and rest was unknown.  Lot/batch number is not available despite the follow up attempts made. Follow-up attempts are completed. No further information is expected.
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site rash, Vaccination site warmth
Clinical narrative: rash/welt is a bit worse; welts and rash around the site; welts and rash around the site; redness, warm to touch at the site; redness, warm to touch at the site; itching; Rash; This is a spontaneous report from a contactable consumer (husband) reported for her wife. A 69-year-old female patient who received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), Solution for injection, Batch/lot number EN5318, Expiration date unknown), via an unspecified route of administration in left arm on 11Feb2021 at 10:30, at a single dose for covid-19 immunization. Patient's medical history included Mitral valve replacement in 2000. Patient has not had any other recent vaccinations or started any new medications. Patient had no medications prior to the event being reported. Neither the patient received any recent vaccines for any other conditions prior to the event being reported nor received any recent vaccines for SARs-CoV2 other than Pfizer-BioNtech Covid-19 Vaccine. Patient did not receive any other vaccines around the time of Pfizer-BioNtech Covid-19 Vaccine Vaccination. On 12Feb2021, the patient experienced welts and rash around the injection site and had itching. The reporter said that the welt is hot to the touch on injection site. She put a bit of ice there and used Benadryl, which subsided the itching, and she tries not to scratch it, she was on Warfarin. He clarifies that the Benadryl cream was Calahist, a calamine lotion, that she only used once a little bit she was wanting to consult with her doctor to use whatever they recommend. Calahist UPC #, LOT: Unknown, EXP: Unknown, he does not see the LOT/EXP on the tube of the cream. Her rash/welt was a bit worse, it was spreading towards the bottom, but it was not hurting, it was itching and was warm to the touch. The patient was taking warfarin at the dose of 3mg one day, then for the rest of the week she takes 1.5 mg, by mouth. On 23Feb2021, Upon response to the query regarding clarification of the name of patient, screenshot was attached. On 25Mar2021, Other HCP reported in response to HCP letter regarding the patient that no anaphylactic reaction reported, No medical intervention required, neither the patient was seen in the Emergency Department nor was hospitalized and patient was not admitted to an Intensive Care Unit. No information on organ involvement. The outcome of welts and rash around the site was not recovered, and rest was unknown.  Lot/batch number is not available despite the follow up attempts made. Follow-up attempts are completed. No further information is expected.
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Pruritus, Urticaria
Clinical narrative: hives/itchiness started to occur 11Feb2021 mainly at night.; hives/itchiness started to occur 11Feb2021 mainly at night.; This is a spontaneous report from a contactable consumer (patient). This 62-year-old non-pregnant female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot number: EL3248, expiry date not reported) via unspecified route of administration on 28Jan2021 18:45 (at age of 62-years) as single dose for covid-19 Immunisation. Patient medical history include allergic to cobalt dichloride, quaternium 15, nickel, potassium dichromate, neomycin,p-tert-Butylphenol formaldehyde resin, epoxy resin, carba mix, thimerosal, CI+ Me-Isothiazolinone. Patient had allergen patch test in Jun2011. Patient concomitant medications include Calcium, colecalciferol (D3), ascorbic acid(Vit C), Multi Vit,chondroitin sulfate sodium, glucosamine hydrochloride (Glucosamine Chondr) for unspecified indication from unspecified date. The patient did not receive any other vaccines within four weeks prior to the vaccination. Prior to the vaccination, the patient was not diagnosed with covid-19. Post vaccination, the patient was not tested for covid. On 11Feb2021(after 14days of vaccination) patient experienced Hives/itchiness started to occur mainly at night. Events resulted in clinic visit. Patient had video visit for physician on 15Feb2021 for events. Patient received treatment Zyrtec 1x per day; Benadryl if needed at night. Even though 2 weeks after 1st vaccine, physician prescribed .The clinical outcome of events was unknown.  Follow-up attempts are completed. No further information is expected.
Age: 48.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Blood cholesterol, Blood glucose abnormal, Blood pressure measurement, Chills
Clinical narrative: injection site soreness; Chills; Weakness; Headache; This is a spontaneous report from a contactable consumer (patient). A 48-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot Number: EL9264; Expiration Date: Sep2021), via an unspecified route of administration on 03Feb2021 at 12:05 (at the age of 48-year-old) as 2nd dose, single, in left arm for COVID-19 immunisation. The patient's medical history included type 2 diabetes mellitus which was diagnosed probably more than 10 years, hypertension for which she was taking high blood pressure medication for 5-6 years and sleep apnoea syndrome. Concomitant medications were not reported. The patient previously received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot Number: EL8982), via an unspecified route of administration on 13Jan2021, as single dose for COVID-19 immunization. On 03Feb2021, the patient experienced headache. On 04Feb2021 at 07:30, she experienced chills and weakness. Patient had a headache prior to getting her second dose of the vaccine, as she had issues with her sinuses, so she took medicine before getting the vaccine because she assumed it was sinuses. There was no further details provided about medication she took for her sinuses. After the vaccine she had injection site soreness, and had a headache, chills, and weakness, which she knew it was common symptom of vaccine. Patient took Tylenol prior to the shot, so the soreness to injection site was minimal. The patient underwent lab tests and procedures which included blood cholesterol: normal, blood glucose abnormal: normal, blood pressure measurement: normal. The clinical outcome of the events was unknown.  Follow-up attempts are completed. No further information is expected.
Age: 48.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Vaccination site pain
Clinical narrative: injection site soreness; Chills; Weakness; Headache; This is a spontaneous report from a contactable consumer (patient). A 48-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot Number: EL9264; Expiration Date: Sep2021), via an unspecified route of administration on 03Feb2021 at 12:05 (at the age of 48-year-old) as 2nd dose, single, in left arm for COVID-19 immunisation. The patient's medical history included type 2 diabetes mellitus which was diagnosed probably more than 10 years, hypertension for which she was taking high blood pressure medication for 5-6 years and sleep apnoea syndrome. Concomitant medications were not reported. The patient previously received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot Number: EL8982), via an unspecified route of administration on 13Jan2021, as single dose for COVID-19 immunization. On 03Feb2021, the patient experienced headache. On 04Feb2021 at 07:30, she experienced chills and weakness. Patient had a headache prior to getting her second dose of the vaccine, as she had issues with her sinuses, so she took medicine before getting the vaccine because she assumed it was sinuses. There was no further details provided about medication she took for her sinuses. After the vaccine she had injection site soreness, and had a headache, chills, and weakness, which she knew it was common symptom of vaccine. Patient took Tylenol prior to the shot, so the soreness to injection site was minimal. The patient underwent lab tests and procedures which included blood cholesterol: normal, blood glucose abnormal: normal, blood pressure measurement: normal. The clinical outcome of the events was unknown.  Follow-up attempts are completed. No further information is expected.
Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Chills, Pyrexia
Clinical narrative: Fever run between 101-102; Chill; This is a spontaneous report received from a contactable pharmacist (patient). A 53-year-old non-pregnant female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot/Batch number: EJ1686, Pfizer ), via an unspecified route of administration on 05Jan2021 and second dose of bnt162b2 via an unspecified route of administration on 28Jan2021 (Batch/Lot Number: EL4262) both as a single dose for covid-19 immunisation. Medical history included hypertension. Concomitant medications were not reported. Patient had no allergies. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. Patient did not receive any other medications in two weeks of vaccination. On 08Jan2021, the patient experienced fever run between 101-102 with medications along with chill. Fever still didn't subside after 1 week of the 2nd dose. The events assessed as non-serious. No treatment was received for the events. The outcome of the events was reported as not recovered.   Follow-up (07May2021): Follow-up attempts completed. No further information expected.
Sex: F
Vaccine: COVID19
Symptoms: Headache
Clinical narrative: Headache; This is a spontaneous report from a contactable consumer or other non Health Professional. A female patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration on 03Feb2021 (Batch/Lot Number: EN5318) as 1ST DOSE, SINGLE for covid-19 immunization.The patient medical history was not reported.The patient's concomitant medications were not reported.This consumer reported she had her first dose of Pfizer-BioNTech COVID-19 Vaccine 03Feb2021. She has a headache and was wondering if it is ok to take Tylenol for the headache. While she was on hold she called the Health Department and they told her it was ok to take Tylenol for headache; but she wanted to verify if it was ok with Pfizer. The outcome of event was unknown.  Follow-up attempts are completed. No further information is expected.
Age: 53.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Pyrexia
Clinical narrative: Fever still didn't subside after 1 week of the 2nd dose; This is a spontaneous report from a contactable pharmacist.A 53-years-old non-pregnant female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, Solution for injection), via an unspecified route of administration on 28Jan2021 (Batch/Lot Number: EL4262) as 2nd dose, single for covid-19 immunization.Medical history included hypertension. The patient's concomitant medications were not reported. Patient had no known allergies.The patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, Solution for injection), via an unspecified route of administration on 05Jan2021 (Batch/Lot Number: EJ1686) as 1st dose, single for covid-19 immunization and experienced fever run between 101-102 with medications along with chill. No other vaccine in four weeks and medications in two weeks within vaccination. Patient had no Covid prior vaccination and did not tested for Covid post vaccination. On an unknown date, the patient experienced fever which still did not subside after 1 week of the 2nd dose. No treatment was received for events. The outcome of event was not recovered.  Follow-up attempts are completed. No further information is expected.
Age: 44.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Chills, Myalgia, Pyrexia
Clinical narrative: Fever; chills; muscle pain; joint pain in knees and elbows; This is a spontaneous report from a non-contactable consumer reported for a patient. A 44-years-old female patient (patient was not pregnant at the time of vaccination) received first dose of BNT162B2 (PFIZER BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number: unknown, Expiration date: unknown) via an unspecified route of administration, administered in left arm on 03Feb2021 at 09:45 am (age at vaccination was 44 years) as 1ST DOSE, SINGLE for COVID-19 immunisation. Medical history included COPD, former smoker, depression/mental health. The patient did not have any known allergies. Concomitant medications patient received within 2 weeks of vaccination included loratadine, pseudoephedrine sulfate (CLARITIN-D), spironolactone, multivitamin, colecalciferol (VITAMIN D [COLECALCIFEROL]). On 03Feb2021 at 13:30 pm, the patient experienced fever, chills, muscle pain and joint pain in knees and elbows. The facility where the most recent COVID-19 vaccine was administered was Workplace clinic. 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. Post the vaccination, the patient has not been tested for COVID-19. No treatment was received for the adverse event. The outcome of events was not recovered.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Sex: F
Vaccine: COVID19
Symptoms: Headache
Clinical narrative: Severe headache; This is a spontaneous report from a contactable consumer. This consumer reported for a female patient (reporter's sister-in-law).  A female patient of an unspecified age received first and second dose of BNT162B2 (PFIZER-BIONTEC COVID-19 mRNA VACCINE, Solution for injection, lot number and expiry date were not reported), via an unspecified route of administration, on an unknown date, as a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The reporter (67-year-old) reported that the reporter received the first dose of the Pfizer COVID vaccine on 28Jan2021 at 10:45 am. Yesterday at 3:15 pm the reporter practically passed out and couldn't stand up. The reporter was pretty healthy and didn't drink anymore. Things like that used to happen when the reporter drank but not now. The reporter hope it wasn't something neurologic going on with the reporter's body. The reporter also reported that the patient (reporter's sister-in-law) just got her second shot yesterday. On an unknown date, she had a severe headache 5 days after getting the first dose of the vaccine. The reporter asked was it possible to have a side effect from the vaccine that many days later. The reporter just wanted to thank Pfizer for coming up with this medication to help millions of people and was looking forward to getting second dose. Outcome of the event was unknown.  Information on lot/batch number has been requested.  Follow-up attempts are completed. No further information is expected.
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Fatigue, Headache, Pyrexia, Tremor
Clinical narrative: Fever; Shaking; Headache; Weakness; Exhaustion; Pain at injection site; Itching at injection site; This is a spontaneous report from a contactable consumer (the patient). A 67-years-old non-pregnant female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Batch/Lot number: E13246), via an unspecified route of administration, administered in right arm on 02Feb2021 08:30 (at the age of 67-years-old) as a single dose for COVID-19 immunization. Medical history included, known allergies to Sulfa, Penicillin, Cephalosporins. The patient previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Batch/Lot number: EL9623), via an unspecified route of administration, administered in right arm on 12Jan2021 09:00 (at the age of 67-years-old) as a single dose for COVID-19 immunization. Concomitant medication included ascorbic acid, copper, tocopheryl acetate, xantofyl, zinc (OCUVIT [ASCORBIC ACID; COPPER; TOCOPHERYL ACETATE; XANTOFYL; ZINC), vitamin d3 (VITAMIN D3), estradiol (ESTRADIOL), magnesium (MAGNESIUM), saccharomyces boulardii (FLORASTOR [SACCHAROMYCES BOULARDII]), all taken for an unspecified indication, start and stop date were not reported. The patient did not receive any other vaccine in four weeks. The patient was not diagnosed with COVID-19 prior to vaccination. The patient was not tested COVID-19 post vaccination. On 03Feb2021 01:00, the patient experienced fever, shaking, headache, weakness, exhaustion, pain at injection site, itching at injection site. The patient was not treated for adverse events. The outcome of events was recovered on unspecified date in Feb2021. Follow-up attempts are completed. No further information is expected.
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pain, Vaccination site pruritus
Clinical narrative: Fever; Shaking; Headache; Weakness; Exhaustion; Pain at injection site; Itching at injection site; This is a spontaneous report from a contactable consumer (the patient). A 67-years-old non-pregnant female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Batch/Lot number: E13246), via an unspecified route of administration, administered in right arm on 02Feb2021 08:30 (at the age of 67-years-old) as a single dose for COVID-19 immunization. Medical history included, known allergies to Sulfa, Penicillin, Cephalosporins. The patient previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Batch/Lot number: EL9623), via an unspecified route of administration, administered in right arm on 12Jan2021 09:00 (at the age of 67-years-old) as a single dose for COVID-19 immunization. Concomitant medication included ascorbic acid, copper, tocopheryl acetate, xantofyl, zinc (OCUVIT [ASCORBIC ACID; COPPER; TOCOPHERYL ACETATE; XANTOFYL; ZINC), vitamin d3 (VITAMIN D3), estradiol (ESTRADIOL), magnesium (MAGNESIUM), saccharomyces boulardii (FLORASTOR [SACCHAROMYCES BOULARDII]), all taken for an unspecified indication, start and stop date were not reported. The patient did not receive any other vaccine in four weeks. The patient was not diagnosed with COVID-19 prior to vaccination. The patient was not tested COVID-19 post vaccination. On 03Feb2021 01:00, the patient experienced fever, shaking, headache, weakness, exhaustion, pain at injection site, itching at injection site. The patient was not treated for adverse events. The outcome of events was recovered on unspecified date in Feb2021. Follow-up attempts are completed. No further information is expected.
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Urticaria
Clinical narrative: Hives; This is a spontaneous report from a contactable nurse reporting for herself. A 57-years-old non-pregnant female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot Number: EL3302), dose 1 via intramuscular route, administered in Arm Right on 03Feb2021 11:00 as SINGLE DOSE for covid-19 immunization. The patient did not receive any other vaccine in four weeks, no COVID prior vaccination and No COVID tested post vaccination. The patient had allergic to smallpox vaccination. The patient concomitant medication(s) included folic acid (FOLATE), VITAMIN D3, ubidecarenone (COQ 10), clonazepam, zinc, and vitamin C (ASCORBIC ACID); start and stop date were not reported for all. On 03Feb2021 at 12:00, the patient developed hives within less than an hour after receiving the vaccine, these continued to develop through Saturday morning until she started taking Prednisone per Urgent Care Physician. The AE resulted in Emergency room/department or urgent care visit. AE Treatment included Prednisone for 5 days with Pepcid and Benadryl. The outcome of event was recovering.  Follow-up attempts completed. No further information expected.
Sex: M
Vaccine: COVID19
Symptoms: Body temperature, Pyrexia, Urticaria
Clinical narrative: Hives on his rear; Slight fever of 100.1; This is a spontaneous report from a contactable consumer (Patient's spouse). A 98-year-old male patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection), via an unspecified route of administration on an unknown date as a single dose for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. On an unknown date, the patient experienced a slight fever of 100.1, and patient received 2 Tylenol and it went away. It was also reported that he experienced hives on his rear end but they went away after receiving a Benadryl. The caller asked if the patient should receive the second vaccine dose given reaction to the first dose. The outcome of the events was recovered.  Information on the lot/batch number has been requested. Follow-up attempts are completed. No further information was expected.
Age: 49.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Headache, Vaccination site pain
Clinical narrative: Headache; Dizzy; sharp shooting pain at injection site.; This is a spontaneous report from a contactable consumer (patient). A 49-years-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number was not reported) via an unspecified route of administration, administered in right arm on 28Jan2021(at the age of 28-year-old) as 1ST DOSE, SINGLE for COVID-19 immunization. Patient's medical history includes allergic reactions to ACE inhibitors.Patient's past drug was Tylenol. Patient's concomitant medications were not reported. On 28Jan2021 the patient experienced, Clinical course was reported as: Patient states that she was dizzy after the vaccine- almost immediately but it could have been anxiety, states she had a headache for about 24 hours, states the main thing she experienced probably about 8 hours after is that she would get sharp shooting pain at injection site. Stated that her doctor recommended her the vaccine for underlying conditions which she does not want to disclose on the report. She did stop taking any Tylenol beforehand just because she read something somewhere that she should. They monitored her longer than the 15 minutes because she has a history of serious allergic reactions to ACE inhibitors. The outcome of the dizzy and shooting pain was recovered on 28Jan2021 and headache was recovered on 29Jan2021.   Information on the lot/batch number has been requested.  Follow-up attempts are completed. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Peripheral swelling, SARS-CoV-2 test
Clinical narrative: Left wrist joint ached; Left thumb swolled; This is a spontaneous report from a Pfizer sponsored program via contactable male consumer (the patient).  A male patient of unspecified age received first dose of bnt162b2 (Pfizer covid-19 vaccine, Lot number EM9810 and Expiration date not reported), via intramuscular route at Arm Left on 05Feb2021 at 10:30 at SINGLE DOSE for covid-19 immunization. The patient medical history includes type 2nd diabetic years ago, high blood pressure years ago, two back surgeries (in unknown date 1993 and 2016) both were laminectomy, Knee surgery 15plus years ago (arthoscopic) and had shoulder surgery on 05Nov2020 which was repair of rotator cuffs. Prior to shoulder surgery on 05Aug2020 patient had COVID-19 test result was negative. The concomitant medications were not reported. The patient had no known allergies. On 05Feb2021 at 04:00, after 6-7 hours, the patient experienced left wrist joint ahead and, left thumb swelled. The patient received second dose bnt162b2 (Pfizer covid-19 vaccine, Lot number EN6198 and Expiration date not reported), via intramuscular route at Arm Left on 26Feb2021 at 10:30 at SINGLE DOSE for covid-19 immunization. The patient was treated with Tylenol. The outcome of the events was unknown.  No follow-up attempts are possible. No further information is expected.  Follow-up (17May2021): The initial case was missing the following minimum criteria: identifiable patient. Upon receipt of follow-up information on 10Feb2021, this case now contains all required information to be considered valid.  No follow-up attempts are needed. No further information is expected.
Age: 76.0
Sex: M
Vaccine: COVID19
Symptoms: Headache
Clinical narrative: This is a spontaneous report was received from a contactable consumer. A 76-year-old male patient of weight 77.11 kilograms and height 173 centimetres received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot number: Unknown) via an unspecified route of administration in arm left on 04Feb2021 09:00 AM as 1st dose, single for covid-19 immunisation. The patient's medical history included blood pressure high and history of headaches this was diagnosed 50 years ago, high cholesterol this was diagnosed 30-40 years ago, stomach problems. Concomitant medications were not reported. On 04Feb2021, the patient had headache. He had his first dose of the vaccine yesterday and wound up with a headache later in the day that lasted all night and gets all the time. He heard that Aspirin should not be taken before or after getting the vaccine. So, he would like to know can he take Excedrin to treat his headache since it was one day after the vaccine dose. He heard that it was a general rule that you should not take aspirin with the vaccines and would like to know if this was true. He said he was supposed to get his second dose of vaccine on February 25th and was thinking that the end date on it for the vaccine was March 13th. Vaccine injection was given at 09:00AM yesterday, then it was not until the evening when his headache started the whole day, and it may have nothing to do with the vaccine since he gets two to three headaches a week. Reason for no lot number was complainant does not have the product with them at the time of call. The outcome of the event was unknown.  Follow-up (19Apr2021): This follow-up is being submitted to notify that the lot/batch number is not available despite the follow-up attempts made. Follow-up attempts have been completed and no further information is expected
Age: 23.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Oropharyngeal pain
Clinical narrative: left side of throat became sore after 6 hours of administration, and lasted for 3 days; Headache started about 6 hours after administration; This is a spontaneous report from a contactable Other HCP (patient herself). The 23-year-old non-pregnant female patient received the first dose of bnt162b2 (COMIRNATY, solution for injection) (lot number: EL1283; Expiration date: not reported) via unspecified route of administration on an unknown date as FIRST DOSE, SINGLE DOSE for covid-19 immunisation. The patient had medical history of known allergies of Jackfruit. The concomitant medications were not reported. The patient did not have COVID prior vaccination. Patient was not tested for COVID post vaccination. The patient had headache started about 6 hours after administration. Vaccine was administered on left arm and left side of throat became sore after 6 hours of administration and lasted for 3 days. Right side of throat was not affected. The outcome of the event was recovered.  Follow-up attempts are completed. No further information is expected.
Age: 48.0
Sex: M
Vaccine: COVID19
Symptoms: Headache, Pain in extremity
Clinical narrative: Starting 04Feb2021 I began having a headache; And then my left arm had pain radiating from my shoulder blade to my pinky; This is a spontaneous report from a contactable Other HCP (patient). A 48-years-old male patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: solution for injection, Lot number: EL1284) via an unspecified route of administration in Right arm on 12Jan2021 (at the age of 48-years-old) as 2ND DOSE, SINGLE for COVID-19 immunization. The patient's medical history included Herpes, eczema and concomitant medications included Truvada, escitalopram. Historical vaccine included first dose of COVID 19 (lot number= EH9899) via an unspecified route of administration in Right arm on 21Dec2020 at 07:00 AM. Patient had known allergies to Gluten/Wheat. The patient did not received any other vaccines within 4 weeks. The patient had no covid prior vaccination. Post vaccination, the patient was not tested covid. On 04Feb2021 at 08:00 AM, the patient reported that I began having a headache and then my left arm had pain radiating from my shoulder blade to my pinky. It has persisted for two days now and has made it difficult to hold heavy objects (10 lbs+). Though, it felt slightly better on day 2 than day 1. Treatment was not received. The outcome of the events was recovering.   Follow-up attempts are completed. No further information is expected.
Age: 75.0
Sex: F
Vaccine: COVID19
Symptoms: Blood pressure abnormal, Cardiac stress test, Echocardiogram, Electrocardiogram, Headache
Clinical narrative: Having really bad headaches; I have had the headache all week; My blood pressure was high all day; This is a spontaneous report from a contactable consumer (patient) or other non hcp. A 75-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot number: EL9265; Expiration Date: unknown), dose 1 via an unspecified route of administration on 31Jan2021 as UNK, single for an COVID-19 immunization. Medical history included diabetes mellitus (from an unknown date). The patient's concomitant medications were not reported. On an unspecified date, the patient experienced having really bad headaches; have had the headache all week, blood pressure was high all day. patient took Lisinopril for blood pressure. The patient underwent lab tests and procedures which included blood pressure abnormal: high, cardiac stress test: it was fine, echocardiogram: it was fine, laboratory test: last lab work everything was great. Therapeutic measures were taken with Tylenol. The clinical outcome of the events was unknown.   Follow-up (07MAY2021): Follow-up attempts completed. No further information expected.
Age: 75.0
Sex: F
Vaccine: COVID19
Symptoms: Hypertension, Laboratory test
Clinical narrative: Having really bad headaches; I have had the headache all week; My blood pressure was high all day; This is a spontaneous report from a contactable consumer (patient) or other non hcp. A 75-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot number: EL9265; Expiration Date: unknown), dose 1 via an unspecified route of administration on 31Jan2021 as UNK, single for an COVID-19 immunization. Medical history included diabetes mellitus (from an unknown date). The patient's concomitant medications were not reported. On an unspecified date, the patient experienced having really bad headaches; have had the headache all week, blood pressure was high all day. patient took Lisinopril for blood pressure. The patient underwent lab tests and procedures which included blood pressure abnormal: high, cardiac stress test: it was fine, echocardiogram: it was fine, laboratory test: last lab work everything was great. Therapeutic measures were taken with Tylenol. The clinical outcome of the events was unknown.   Follow-up (07MAY2021): Follow-up attempts completed. No further information expected.
Age: 81.0
Sex: M
Vaccine: COVID19
Symptoms: Urticaria
Clinical narrative: hives; This is a spontaneous report from a contactable consumer or other non hcp (Patient himself). A 81-years-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, Solution for injection,Batch/Lot Number: EL9262), dose 1 via an unspecified route of administration, administered in Arm Left on 01Feb2021 16:00 (age at the time of vaccination was 81-year-old)  as 1ST DOSE, SINGLE for covid-19 immunization. The patient medical history, concomitant medications were not reported. Facility type vaccine: Doctor's office/urgent care. The patient has no other vaccine in 4 week. The patient has not tested covid prior vaccination and post vaccination.On 14Feb2021 The patient experienced hives. The outcome of event was unknown.
Age: 75.0
Sex: F
Vaccine: COVID19
Symptoms: Rash, Urticaria
Clinical narrative: Hives around neck, over shoulders, back, chest, waist; light rash on legs.; This is a spontaneous report from a non-contactable consumer or other non hcp (patient). A 75-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot Number: EN6201, Expiration date: not reported), dose 2 via an unspecified route of administration in an unspecified anatomical location on 15Feb2021 (at the age of 75-year-old), as SINGLE for COVID-19 immunisation. The patient medical history included breast cancer 2 x survivor and allergies. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient received concomitant medications within 2 weeks included atenolol (ATENOLOL), lorazepam (LORAZEPAM), amlodipine besylate (AMLODIPINE BESYLATE), trazodone (TRAZODONE) all taken for an unknown indication. The patient previously received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot Number and Expiration date was not reported), via an unspecified route of administration in an unspecified anatomical location on an unknown date, as SINGLE for COVID-19 immunisation. The patient received first dose of unspecified vaccine (lot number: EN5318) in left hip on 25Jan2021 within four weeks prior to the vaccination. The patient had experienced hives around neck, over shoulders, back, chest, waist, light rash on legs on 17Feb2021 at 16:00. The patient received Benadryl allergy liquigels as treatment for the events. The outcome of the events was reported as recovering.   No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Age: 25.0
Sex: F
Vaccine: COVID19
Symptoms: SARS-CoV-2 test, Urticaria
Clinical narrative: red, itchy hives all over my body; This is a spontaneous report from a contactable other health care professional.  A 25-year-old female (non-pregnant) patient received bnt162b2 (Pfizer-BIONTECH COVID-19 Vaccine, Solution for injection, Batch/lot number and expiry date: not reported) 2ND DOSE via an unspecified route of administration, administered in Arm Left on 19Feb2021 08:15 as 2ND SINGLE DOSE for covid-19 immunisation. The patient medical history was not reported. The patient Historical vaccine includes first dose of bnt162b2 (BNT162B2, Solution for injection, Batch/lot number and expiry date: not reported)  via an unspecified route of administration, administered in Arm Left on 29JAN2021 at 08:30AM  as SINGLE DOSE for covid-19 immunisation. Other vaccine administered in 4 weeks was reported as no. The patient was not tested for COVID prior to vaccination. Any known history of allergies was reported as no. Concomitant medications included cetirizine hydrochloride (ZYRTEC [CETIRIZINE HYDROCHLORIDE]), fish oil, colecalciferol (VITAMIN D [COLECALCIFEROL]), vitamin b complex (VITAMIN B), magnesium. On 06FEB2021 the patient underwent lab tests and procedures which included sars-cov-2 test: negative. Approximately three days after the vaccine, on 22FEB2021 at 06:00, the patient experienced red, itchy hives all over my body. The outcome of the event was reported as not recovered.  Information about lot/ batch number has been requested. No follow up attempts possible. No further information is expected.
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Condition aggravated, Constipation, Erythema, Tremor, Urticaria
Clinical narrative: Believes the Pfizer shot constipated her; She is shaking all of the time now; hives were not severe and she had worse; appears to be a red spot in the middle of the hives; experiencing hives on her left wrist and arm; This is a spontaneous report from a contactable consumer (Patient). A 68-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number was not reported), via an unspecified route of administration on 14Feb2021 (at the age of 68-years) as single dosefor COVID-19 immunisation. Medical history included gout (hasn't had an attack in 8 months and when she has a flare-up, she is crippled and out of commission), blood pressure high, blood uric acid abnormal, arthritis and tried face creams and gets hives. Concomitant medication included allopurinol taken for blood uric acid down; colchicine for gout but has not taken in 8 months. On 15Feb2021 (one day after vaccination), patient experienced hives on her left wrist and arm which was the injection, and other two hives on the outside of the hand. One hive was on the inside her wrist. Patient took Benadryl and the original hives went away. However yesterday (unspecified date), another batch of three hives appeared on the inside of the wrist on the injection arm. Patient stated that Benadryl constipates her if she takes too much. Can't stay on Benadryl for too long. Believes the Pfizer shot constipated her on unspecified date. Patient was making herself sick over this. Her nerves are shot between the new variants and not knowing a lot about the vaccine. She is shaking all of the time now. Patient had tried Voltaren and got severe hives and was using it on the left side of her body and saw hives on the left side of her face and throughout her head. Hives were 100 times worse than the hives she has at the time of report. Patient just took a Benadryl and the hives have calmed down. One hive was very puffy. There appears to be a red spot in the middle of the hives. Patient thought hives were from a cuff watch that she wears. However, she was looking at it and now doesn't think the hives are from her watch. Therapeutic measures were taken as a result of hives included Benadryl HC1-25mg tablets (UPC: 312547171366), two tablets a day and Voltaren. Patient stated that doctor recommended her to get the COVID-19 Vaccine. Patient wanted to know if she can take the second dose of the vaccine. The outcome of the event hives was not recovered, while for other events, it was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.