chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 21.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Chills, Headache, Nausea, Oropharyngeal pain
Clinical narrative: itchy rash; A mild rash has also now formed along my ribcage; fever; chills; headache; body aches; sore throat; nausea; This is a spontaneous report was received from a contactable Other-HCP (patient). A 21-year-old non pregnant female patient received 2nd dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/lot number EL3247) via an unspecified route of administration, administered in left arm on 16Feb2021 10:15 AM (at age of 21-year-old) as single dose for covid-19 immunisation. Not pregnant at the time of vaccination. The patient medical history not provided. Known allergies: blueberries. Concomitant medications included valacyclovir, JUNEL FE taken for birth control. The patient had received 1st dose of BNT162B2 Batch/lot number: EL3247 on 26Jan2021 at 10:15AM at left arm. On 16Feb2021, Fever that started at 3:00pm bouncing between 100.8 and 101.8, chills and headache started at 12:30pm, body aches, sore throat, nausea. On 17Feb2021, the patient had a mild itchy rash started on the middle of the front of my arms, in the elbow crease. Seemed to go away quickly with cortisone cream but had been popping up again on and off every day. Today the patient woke up to a very itchy rash in the same area that now extends all the way down the arm and up to the shoulder. A mild rash had also now formed along her ribcage. The patient did not take other vaccine in four weeks and prior to vaccination, the patient was not diagnosed with COVID-19 and since the vaccination, has the patient has not been tested for COVID-19. The patient received treatment as cortisone cream for event itchy rash and rash, for rest all no treatment. The patient did not have covid prior vaccination and was tested post vaccination. Upon follow up#1, the first dose received date, medical history, event, and concomitant medications were updated. the patient was not recovered from the events.  Follow-up (17Feb2021): This is a follow-up spontaneous report from a contactable Other-HCP. This Other-HCP reported that the first dose received date, medical history, event, and concomitant medications were updated.  Follow-up (01Mar2021): This is a follow-up spontaneous mail trail received in response to the query sent regarding the confirmation of PRD. This report included that: awareness date was 17Feb2021  Follow-up (24Feb2021): This is a follow-up spontaneous mail trail received in response to the query sent regarding the confirmation of Onset date of AE. This report included that the onset date of AE was 16Feb2021, but the reporter did not have the ability to submit a report until 17Feb2021.  Follow-up (14May2021): Follow-up attempts completed. No further information expected.
Age: 21.0
Sex: F
Vaccine: COVID19
Symptoms: Pain, Pyrexia, Rash, Rash pruritic
Clinical narrative: itchy rash; A mild rash has also now formed along my ribcage; fever; chills; headache; body aches; sore throat; nausea; This is a spontaneous report was received from a contactable Other-HCP (patient). A 21-year-old non pregnant female patient received 2nd dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/lot number EL3247) via an unspecified route of administration, administered in left arm on 16Feb2021 10:15 AM (at age of 21-year-old) as single dose for covid-19 immunisation. Not pregnant at the time of vaccination. The patient medical history not provided. Known allergies: blueberries. Concomitant medications included valacyclovir, JUNEL FE taken for birth control. The patient had received 1st dose of BNT162B2 Batch/lot number: EL3247 on 26Jan2021 at 10:15AM at left arm. On 16Feb2021, Fever that started at 3:00pm bouncing between 100.8 and 101.8, chills and headache started at 12:30pm, body aches, sore throat, nausea. On 17Feb2021, the patient had a mild itchy rash started on the middle of the front of my arms, in the elbow crease. Seemed to go away quickly with cortisone cream but had been popping up again on and off every day. Today the patient woke up to a very itchy rash in the same area that now extends all the way down the arm and up to the shoulder. A mild rash had also now formed along her ribcage. The patient did not take other vaccine in four weeks and prior to vaccination, the patient was not diagnosed with COVID-19 and since the vaccination, has the patient has not been tested for COVID-19. The patient received treatment as cortisone cream for event itchy rash and rash, for rest all no treatment. The patient did not have covid prior vaccination and was tested post vaccination. Upon follow up#1, the first dose received date, medical history, event, and concomitant medications were updated. the patient was not recovered from the events.  Follow-up (17Feb2021): This is a follow-up spontaneous report from a contactable Other-HCP. This Other-HCP reported that the first dose received date, medical history, event, and concomitant medications were updated.  Follow-up (01Mar2021): This is a follow-up spontaneous mail trail received in response to the query sent regarding the confirmation of PRD. This report included that: awareness date was 17Feb2021  Follow-up (24Feb2021): This is a follow-up spontaneous mail trail received in response to the query sent regarding the confirmation of Onset date of AE. This report included that the onset date of AE was 16Feb2021, but the reporter did not have the ability to submit a report until 17Feb2021.  Follow-up (14May2021): Follow-up attempts completed. No further information expected.
Age: 26.0
Sex: M
Vaccine: COVID19
Symptoms: Headache, Heart rate, Heart rate increased, Influenza like illness, Myalgia
Clinical narrative: Flu like symptoms; Headache; muscle aches; nausea; elevated heart rate; This is a spontaneous report from a contactable consumer (Patient himself). A 26-years-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, formulation: solution for injection), dose 2 via an unspecified route of administration, administered in Arm Right on 16Feb2021 11:30 (Batch/Lot Number: EL3247) as 2nd dose, single for covid-19 immunisation. The patient previously received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), dose 1, administered in Arm right (Batch/Lot number: EL3247) on 26Jan2021 12:30 PM as 1st dose, single for covid-19 immunisation. Medical history included none. There were no concomitant medications. The patient had no known allergies. The patient did not receive any other vaccines within four weeks prior to the vaccination and did not receive other medications in two weeks. 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 16Feb2021 23:30 the patient experienced flu like symptoms, headache, muscle aches, nausea, elevated heart rate. No treatment was taken for the event caused. The patient underwent lab tests and procedures which included heart rate results elevated on 16Feb2021. The outcome of the events were recovering.  Follow-up (24Feb2021): This is a follow-up spontaneous report received in response for the first awareness date of the adverse events caused by Pfizer COVID-19 vaccine and the response included with event onset date. (16Feb2021).
Age: 26.0
Sex: M
Vaccine: COVID19
Symptoms: Nausea
Clinical narrative: Flu like symptoms; Headache; muscle aches; nausea; elevated heart rate; This is a spontaneous report from a contactable consumer (Patient himself). A 26-years-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, formulation: solution for injection), dose 2 via an unspecified route of administration, administered in Arm Right on 16Feb2021 11:30 (Batch/Lot Number: EL3247) as 2nd dose, single for covid-19 immunisation. The patient previously received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), dose 1, administered in Arm right (Batch/Lot number: EL3247) on 26Jan2021 12:30 PM as 1st dose, single for covid-19 immunisation. Medical history included none. There were no concomitant medications. The patient had no known allergies. The patient did not receive any other vaccines within four weeks prior to the vaccination and did not receive other medications in two weeks. 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 16Feb2021 23:30 the patient experienced flu like symptoms, headache, muscle aches, nausea, elevated heart rate. No treatment was taken for the event caused. The patient underwent lab tests and procedures which included heart rate results elevated on 16Feb2021. The outcome of the events were recovering.  Follow-up (24Feb2021): This is a follow-up spontaneous report received in response for the first awareness date of the adverse events caused by Pfizer COVID-19 vaccine and the response included with event onset date. (16Feb2021).
Age: 43.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Diarrhoea, Headache, Injection site pain, Nausea
Clinical narrative: Nauseated; Vomited; Diarrhea; Headache; Body aches; Injection site pain; Fever of 102; This is a spontaneous report from a contactable consumer (patient). A 43-years-old female patient (not pregnant at the time of vaccination) received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), dose 2 via an unspecified route of administration, administered in Arm Right on 16Feb2021 11:45 (Batch/Lot Number: EL3247) as single dose for covid-19 immunisation. Medical history included eczema, asthma and seasonal allergy from an unknown date and patient had no known allergies. The past vaccination history included BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE) dose 1 via an unspecified route of administration, administered in Arm Left on 26Jan2021 12:45 (Batch/Lot Number: EL3247) as single dose for covid-19 immunisation. There were no concomitant medications. The patient had not received any other vaccine and other medications with in four weeks and two weeks of vaccination. Patient had no COVID-19 prior to vaccination and was not tested for the same post vaccination. On 17Feb2021 patient woke up at 4:45 AM and experienced headache, body aches, injection site pain, nauseated, vomited, diarrhea, and a fever of 102 (usually 96, not 98). No treatment was provided as result of events and the outcome of the events was reported as not recovered.  Follow-up (25Feb-021): This is a follow-up spontaneous report received in response to the mail trail sent regarding confirmation of onset date of adverse events. A query response was received with respect to the event.
Age: 43.0
Sex: F
Vaccine: COVID19
Symptoms: Pain, Pyrexia, Vomiting
Clinical narrative: Nauseated; Vomited; Diarrhea; Headache; Body aches; Injection site pain; Fever of 102; This is a spontaneous report from a contactable consumer (patient). A 43-years-old female patient (not pregnant at the time of vaccination) received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), dose 2 via an unspecified route of administration, administered in Arm Right on 16Feb2021 11:45 (Batch/Lot Number: EL3247) as single dose for covid-19 immunisation. Medical history included eczema, asthma and seasonal allergy from an unknown date and patient had no known allergies. The past vaccination history included BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE) dose 1 via an unspecified route of administration, administered in Arm Left on 26Jan2021 12:45 (Batch/Lot Number: EL3247) as single dose for covid-19 immunisation. There were no concomitant medications. The patient had not received any other vaccine and other medications with in four weeks and two weeks of vaccination. Patient had no COVID-19 prior to vaccination and was not tested for the same post vaccination. On 17Feb2021 patient woke up at 4:45 AM and experienced headache, body aches, injection site pain, nauseated, vomited, diarrhea, and a fever of 102 (usually 96, not 98). No treatment was provided as result of events and the outcome of the events was reported as not recovered.  Follow-up (25Feb-021): This is a follow-up spontaneous report received in response to the mail trail sent regarding confirmation of onset date of adverse events. A query response was received with respect to the event.
Age: 46.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal discomfort, Dizziness, Feeling hot, Throat irritation, Vertigo
Clinical narrative: her throat is itchy.; she was feeling the dizziness.; she had the stomach upset; She also threw up all day; hot rush over her body; vertigo; This is a spontaneous report received from a contactable consumer (patient) via medical information team. A 46-year-old female patient (weight: 160-170) received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, supplemental form, Batch/lot number and Expiration date not reported) via an unspecified route of administration, on 13Feb2021 (at the age of 46 years) as a single dose for covid-19 immunization. The patient medical history and concomitant medications were not reported. Historical vaccine included first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number: EL9263 and Expiration date not reported) via unspecified route of administration, in right arm, on 23Jan2021 1:30 in the morning as a single dose for COVID-19 immunization. Proprietary medicinal product name includes Birth control. There were no prior vaccinations within 4 weeks and no AEs following prior vaccinations. She got the second dose on Saturday 13Feb2021. She was fine all day. However, Sunday, when she got up in the morning, she had vertigo which she is still experiencing now. It is like the room spins around. She also threw up all day on Sunday. HCP Stated she does not really have a primary care provider. She only goes to the doctor once a year annually for a physical. The doctor always changes. Therefore, she declines to provide consent to contact primary HCP. Confirmed still has the vertigo but did not really feel it as much yesterday. Overnight on Sunday she felt it some into Monday morning. She feels it some again today this morning, but it is not as frequent as it was on Sunday. She stated she only threw up on Sunday and she has stopped doing that already. However, her throat is itchy. She threw it up all day on Sunday. She felt like she was going to throw up while she was feeling the dizziness. It was like her whole head was spinning around and she had the stomach upset. When she got dizzy she felt like a hot rush over her body and her head would spin. Today she was able to eat oatmeal, but before she could not hold in water. She questioned that is this normal to have vertigo and throwing up after getting the second dose of the vaccine. Outcome of the event vertigo was reported as recovering, threw up was reported as recovered, feeling hot, stomach upset, dizziness, itchy throat as unknown.  Follow-up (11May2021): Follow-up attempts completed. No further information expected.
Age: 46.0
Sex: F
Vaccine: COVID19
Symptoms: Vomiting
Clinical narrative: her throat is itchy.; she was feeling the dizziness.; she had the stomach upset; She also threw up all day; hot rush over her body; vertigo; This is a spontaneous report received from a contactable consumer (patient) via medical information team. A 46-year-old female patient (weight: 160-170) received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, supplemental form, Batch/lot number and Expiration date not reported) via an unspecified route of administration, on 13Feb2021 (at the age of 46 years) as a single dose for covid-19 immunization. The patient medical history and concomitant medications were not reported. Historical vaccine included first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number: EL9263 and Expiration date not reported) via unspecified route of administration, in right arm, on 23Jan2021 1:30 in the morning as a single dose for COVID-19 immunization. Proprietary medicinal product name includes Birth control. There were no prior vaccinations within 4 weeks and no AEs following prior vaccinations. She got the second dose on Saturday 13Feb2021. She was fine all day. However, Sunday, when she got up in the morning, she had vertigo which she is still experiencing now. It is like the room spins around. She also threw up all day on Sunday. HCP Stated she does not really have a primary care provider. She only goes to the doctor once a year annually for a physical. The doctor always changes. Therefore, she declines to provide consent to contact primary HCP. Confirmed still has the vertigo but did not really feel it as much yesterday. Overnight on Sunday she felt it some into Monday morning. She feels it some again today this morning, but it is not as frequent as it was on Sunday. She stated she only threw up on Sunday and she has stopped doing that already. However, her throat is itchy. She threw it up all day on Sunday. She felt like she was going to throw up while she was feeling the dizziness. It was like her whole head was spinning around and she had the stomach upset. When she got dizzy she felt like a hot rush over her body and her head would spin. Today she was able to eat oatmeal, but before she could not hold in water. She questioned that is this normal to have vertigo and throwing up after getting the second dose of the vaccine. Outcome of the event vertigo was reported as recovering, threw up was reported as recovered, feeling hot, stomach upset, dizziness, itchy throat as unknown.  Follow-up (11May2021): Follow-up attempts completed. No further information expected.
Age: 31.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Fatigue, Headache
Clinical narrative: Headache; Chills; Fatigue; This is a spontaneous report received from a contactable consumer (patient). Follow-up (25Feb2021) was received from same reporter and processed together with initial information.   A 31-year-old non-pregnant female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; solution for injection, Lot number: EL3247) via an unspecified route of administration on 16Feb2021 09:15 (at the age of 31-year-old) as 2nd dose, single in left arm for covid-19 immunization. The patient's medical history was not reported and had no known allergies. The patient did not receive any other vaccine within 4 weeks prior to the vaccine. The patient did not take any medications within two weeks of vaccination. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient was not pregnant at the time of vaccination. The patient received first dose of BNT162B2 (Lot number: EL3247) via an unspecified route of administration on 26Jan2021 at 14:30 (at the age of 31-year-old) as 1st dose, single in left arm for covid-19 immunization. On 16Feb2021 at 12:30, the patient experienced headache, chills, fatigue. The patient did not receive any treatment for the events. Since the vaccination, the patient was not tested for COVID-19. The outcome of the events was not resolved.  Upon follow up, the patient confirmed that she knew of the adverse events on 16Feb2021 but reported on 17Feb2021.  Follow-up attempts completed. No further information expected.
Age: 84.0
Sex: M
Vaccine: COVID19
Symptoms: Rash pruritic
Clinical narrative: Round itchy red patch; This is a spontaneous report from a contactable consumer. A 84-year-old male Patient received BNT162B2(PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot and expiry date was Unknown) via unspecified route of administration on27Jan2021, 03:00 PM (at the age of 84-year-old) as a single dose for COVID-19 immunization. The patient past medical history included diabetes mellitus. The concomitant medication was not reported. There was no known allergies. Patient did not have COVID-19 prior and post to the medication. On 04Feb2021, the patient experienced Round itchy red patch. The outcome for the event recovered on an unspecified date in 2021.  Information on the Lot/batch number has been requested.
Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: Amnesia, Electrocardiogram, Gait disturbance, Headache, Investigation
Clinical narrative: headache, back of the head pain; memory loss; blurred vision; pain down my neck; stumbling; This is a spontaneous report received from a contactable consumer or other non hcp (patient). A 51-years-old female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot Number: EN9581), via an unspecified route of administration on an unspecified date (At the age of 51-years old)as 2ND DOSE, SINGLE for Covid-19 immunisation. The patient medical history and concomitant medications were not reported. Historical vaccine included BNT162b2 (Comirnaty) (Batch/Lot Number: EL3247) on 20Jan2021 for Covid-19 immunisation. It was reported that after second vaccine dose and next day patient was feeling okay and day and a half later, it all started all over again, headache, back of the head pain, memory loss, blurred vision, all started again. The patient got an MRI this time and the other day, since having severe headache all day, every day, pain down my neck and still little bit stumbling. The patient went to neurologist and he said all of my symptoms are symptoms that someone would have with the concussion but patient never felt like, she don't have a concussion (hence, concussion not captured as event as consumer was not sure). So, neurologist wanted me to call this number as she said that she believes that memory cognitive issues are all from the vaccine and I guess it is needed to be reported. Consumer stated, "Yes, they actually took me to the emergency room and they did blood work, EKG, MRI results were unknown. The outcome of the events were unknown .  Follow-up (12MAY2021): Follow-up attempts completed. No further information expected.
Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: Magnetic resonance imaging, Neck pain, Vision blurred
Clinical narrative: headache, back of the head pain; memory loss; blurred vision; pain down my neck; stumbling; This is a spontaneous report received from a contactable consumer or other non hcp (patient). A 51-years-old female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot Number: EN9581), via an unspecified route of administration on an unspecified date (At the age of 51-years old)as 2ND DOSE, SINGLE for Covid-19 immunisation. The patient medical history and concomitant medications were not reported. Historical vaccine included BNT162b2 (Comirnaty) (Batch/Lot Number: EL3247) on 20Jan2021 for Covid-19 immunisation. It was reported that after second vaccine dose and next day patient was feeling okay and day and a half later, it all started all over again, headache, back of the head pain, memory loss, blurred vision, all started again. The patient got an MRI this time and the other day, since having severe headache all day, every day, pain down my neck and still little bit stumbling. The patient went to neurologist and he said all of my symptoms are symptoms that someone would have with the concussion but patient never felt like, she don't have a concussion (hence, concussion not captured as event as consumer was not sure). So, neurologist wanted me to call this number as she said that she believes that memory cognitive issues are all from the vaccine and I guess it is needed to be reported. Consumer stated, "Yes, they actually took me to the emergency room and they did blood work, EKG, MRI results were unknown. The outcome of the events were unknown .  Follow-up (12MAY2021): Follow-up attempts completed. No further information expected.
Age: 52.0
Sex: M
Vaccine: COVID19
Symptoms: Fatigue, Pain
Clinical narrative: This is a spontaneous report received from a contactable consumer. A 52-year-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot number : EM9810, expiry date: unknown) via unknown route of administration on 15Feb2021 as single dose for covid-19 immunisation. The patient's medical history included asthma, diabetes, anxiety and depression. Concomitant medications included metformin, glipizide, steglatro (: ertugliflozin pidolate), wixela Inhub (fluticasone propionate, salmeterol) (indication for use: Asthma), Effexor (venlafaxine hydrochloride). On 16Feb2021, the patient experienced body aches and fatigue. It was reported that patient know that in the fact sheet, said could take Tylenol or see the medicine for the body aches. The patient had taken Aleve (as patient don't have Tylenol) and was just wondering if patient could take Aleve instead of Tylenol." . The patient confirmed that he had not taken any medication yet after receiving the first dose. Outcome of events was unknown.  Follow-up (11May2021): Follow-up attempts completed. No further information expected.
Age: 44.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Nausea, Pain, Vaccination site pain
Clinical narrative: soreness at injection site; body aches; headache; nauseous; This is a spontaneous report from a contactable consumer (patient). A 44-years-old non-pregnant female patient received second dose of BNT162B2((PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection; Lot Number: EL3247), via an unspecified route of administration, administered in left arm on 15Feb2021 (at the age of 44 years) as 2nd dose, single for COVID-19 immunisation. The patient medical history was not reported. The patient known allergies included morphine, contrast dye, cooked lemons and limes. The patient concomitant medication included birth control, daily vitamins taken in two weeks.The patient had no other vaccine in four weeks. The patient previously received first dose of BNT162B2((PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection; Lot Number: EL3247), via an unspecified route of administration, administered in left arm on 25Jan2021 at 14:00 as 1st dose, single for COVID-19 immunisation and experienced soreness at injection site. The patient was not diagnosed with COVID prior to vaccination. The patient was not tested for COVID post vaccination. On 16Feb2021 at 06:00 the patient experienced soreness at injection site, body aches, headache, nauseous the following 3 days. The patient did not receive treatment for events. The outcome of the events was recovering.  Follow-up (25Feb2021): This is a follow-up spontaneous report received in response to the mail trail sent regarding the confirmation below mentioned query. The response included: the product start and event start date.  Follow-up (11May2021): Follow-up attempts completed. No further information expected.
Age: 36.0
Sex: M
Vaccine: COVID19
Symptoms: Body temperature, Chills, Decreased appetite, Myalgia, Pyrexia
Clinical narrative: Arm became sore at injection site 10 hours after vaccine administration; Started getting chills; Body aches; Loss of appetite; Had a temperature of 100.0 F, still had chills/aches.32-34 hours had temperature of 100.7, still had chills/aches; This is a spontaneous report from a contactable consumer (patient). This 36-year-old male consumer received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection Lot number: EN5318), via an unspecified route of administration on left arm on 16Feb2021 at 09:30 AM (at age of 36-year-old) as a second single dose for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient had no allergies. The patient previously received first dose BNT162B2 (BNT162B2, PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection Lot number: EN5318), via an unspecified route of administration on left arm on 27Jan2021 at 08:30 (at age of 36-year-old) as a first single dose for COVID-19 immunisation. The patient had not received any other medications 2 weeks prior to the COVID vaccine. The patient had not received any other vaccine 4 weeks prior to the COVID vaccine. On 16Feb2021, 10 hours after vaccination with second dose the patient's arm became sore at injection site, 12 hours after vaccination started getting chills and body aches, loss of appetite, 22 hours after vaccination, the patient had a temperature of 100.0 F, and still had chills/aches. After 32-34 hours had temperature of 100.7, still had chills/aches. After 48 hours after 2nd dose, temperature returned to normal, and chills/aches went away. Patient was not received treatment for adverse event. Patient was not prior vaccination covid. Patient did not covid tested post vaccination. The outcome of the events arm became sore at injection site, loss of appetite was recovering and the outcome for rest of the events was recovered on an unknown date in Feb2021.  Follow-up attempts completed. No further information expected.
Age: 36.0
Sex: M
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: Arm became sore at injection site 10 hours after vaccine administration; Started getting chills; Body aches; Loss of appetite; Had a temperature of 100.0 F, still had chills/aches.32-34 hours had temperature of 100.7, still had chills/aches; This is a spontaneous report from a contactable consumer (patient). This 36-year-old male consumer received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection Lot number: EN5318), via an unspecified route of administration on left arm on 16Feb2021 at 09:30 AM (at age of 36-year-old) as a second single dose for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient had no allergies. The patient previously received first dose BNT162B2 (BNT162B2, PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection Lot number: EN5318), via an unspecified route of administration on left arm on 27Jan2021 at 08:30 (at age of 36-year-old) as a first single dose for COVID-19 immunisation. The patient had not received any other medications 2 weeks prior to the COVID vaccine. The patient had not received any other vaccine 4 weeks prior to the COVID vaccine. On 16Feb2021, 10 hours after vaccination with second dose the patient's arm became sore at injection site, 12 hours after vaccination started getting chills and body aches, loss of appetite, 22 hours after vaccination, the patient had a temperature of 100.0 F, and still had chills/aches. After 32-34 hours had temperature of 100.7, still had chills/aches. After 48 hours after 2nd dose, temperature returned to normal, and chills/aches went away. Patient was not received treatment for adverse event. Patient was not prior vaccination covid. Patient did not covid tested post vaccination. The outcome of the events arm became sore at injection site, loss of appetite was recovering and the outcome for rest of the events was recovered on an unknown date in Feb2021.  Follow-up attempts completed. No further information expected.
Age: 86.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Pain in extremity
Clinical narrative: tired; sore arm; This is a spontaneous report from a contactable consumer. An 86-years-old female patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot Number: UNKNOWN, Expiration date: UNKNOWN), via an unspecified route of administration on 13Feb2021 as 1ST DOSE, SINGLE for covid-19 immunisation. The patient had no medical history and concomitant medications were reported. The patient did not take any other products. On unspecified date of Feb2021, the patient experienced tired and sore arm. Patient states he just has a question, states he works in health care, in administration. States he was vaccinated with the Pfizer vaccine and his mother received her first dose of the Pfizer Covid vaccine on Saturday, 13Feb2021. Patient states they gave her an appointment date for the follow up, her second dose is scheduled 18 days after the first dose as opposed to the recommended 21 days. Patient stated he had his second dose at 20 days after the first and the provider told him it was fine. Wants to make sure that it was okay if she gets her second dose at only 18 days after the first, cannot find any information about this. States she has had no serious issues after the first dose, states she was tired after first dose but unsure if that is related to the vaccine, did have somewhat of a sore arm. The outcome of the events was unknown.  Information on the lot/batch number has been requested.  Follow-up attempts completed. No further information was expected.
Sex: F
Vaccine: COVID19
Symptoms: Headache
Clinical narrative: headache; This is a spontaneous report from a contactable consumer (patient) via Pfizer-sponsored program COVAX US Support.   A female patient of an unspecified age received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot number was not reported), via an unspecified route of administration on 12Feb2021 at single dose for covid-19 immunisation. The patient medical history and concomitant medications were not reported. On an unspecified date in Feb2021 patient  experienced headache. Patient was checking on the fact sheet and it does not say anywhere if she could take Excedrin for her headache.The final outcome of the event was unknown. Information on the batch number has been requested
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Bone pain, Fatigue, Nausea
Clinical narrative: Nausea; aching bones; horrible fatigue; This is a spontaneous report from a contactable consumer (patient reported herself). A 69-year-old non-pregnant female patient received second dose of BNT162B2 (COVID 19, Pfizer, Solution for injection) via an unspecified route of administration to her left arm on 02Feb2021 10:45 AM (Lot number: EL9262) as single dose for Covid-19 immunization. The patient's medical history included heart failure, 3 strokes and diverticulitis. The patient had known allergies with CIPRIANI, doxycycline (DOXY), methotrexate, nitrofurantoin and morphine. Concomitant medications included clopidogrel bisulfate (PLAVIX), ranolazine (RANEXA), levothyroxine, atorvastatin calcium (ATORVASTIN) and duloxetine hydrochloride (CYMBALTA) (other medications in two weeks). The patient previously took first dose of BNT162B2 (COVID 19, Pfizer) via an unspecified route of administration to her left arm on 12Jan2021 10:45 AM (Lot number: G1284) as single dose for Covid-19 immunization. On 02Feb2021 09:15 PM, the patient experienced nausea along with aching bones and horrible fatigue. Covid was not tested prior or post vaccination. The patient took an opioid for nausea that made worse. Outcome of the events was not recovered.  No follow-up attempts are needed. No further information is expected.
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Ear pain, Erythema, Flushing, Head discomfort
Clinical narrative: Face was bright red and hot; Face was bright red and hot; felt pressure in my head; my ears hurt; This is a spontaneous report from a contactable consumer (Patient). A 70-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), dose 1 via an unspecified route of administration, administered in Arm Left on 19Feb2021 08:15 am (Batch/Lot Number: EL9266, Lot unknown: False) as 1st Dose, SINGLE for covid-19 immunisation. Medical history included Non-Hodgkin Lymphoma, high blood pressure, known allergies: Sulfa, known allergies: IV Contrast. The patient previously took rituxan and has Known allergies: Rituxan, amoxicillin sodium (AMOXILLIN) and known allergies: Amoxillin. Patient was not pregnant. If other vaccine in four weeks: No. Other medications in two weeks: yes. Known allergies: Rituxan, IV Contrast, Sulfa, Amoxicillin. If covid prior vaccination: No, If covid tested post vaccination: No. The patient experienced face was bright red and hot (non-serious) on 19Feb2021 09:15 am, felt pressure in my head (non-serious) on 19Feb2021 09:15 am, my ears hurt (non-serious) on 19Feb2021 09:15 am. If treatment AE: No. Adverse event: Face was bright red and hot, felt pressure in my head and my ears hurt. For all events, outcome was recovered on an unspecified date in 2021.
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Anxiety, Dizziness, Fatigue, Gastric disorder
Clinical narrative: gastric problems; anxiety; Tiredness; Dizziness; This is a spontaneous report from a Pfizer-sponsored program COVAX US Support. A two contactable consumers (patient's husband and patient) reported that a 71-years-old female patient received bnt162b2 (BNT162B2), dose 1 via an unspecified route of administration, administered in Arm Right on 05Feb2021 10:15 (Batch/Lot Number: EL9269) as 1ST DOSE, SINGLE for covid-19 immunisation. Medical history was reported as none. There were no concomitant medications. The patient did not received any other vaccine within 4 weeks prior to the vaccine. It was reported that the customer was calling on behalf of his wife and was asking if it was okay for her to take Tylenol for the pain and take TUMS for acid. His wife had the first shot of the vaccine and wants to take Tylenol for anticipated pain. The agent confirmed the wife had the first shot already. Upon transfer, the caller clarifies the TUMS is for tummy pain, ya know like acidic pain. The patient had gastric problems. He clarified its not COVID related or any pains with that. He was just trying to determine the safety of her taking the usual stuff. The patient explained her gastric problems has nothing to do with the COVID-19 vaccine. She mentions she was shrinking because she was getting older. Caller explained her and her husband got their first COVID-19 Vaccine on Friday, 05Feb2021. She had a little tiredness (05Feb2021) right after 3 or 4 hours and a little dizziness (05Feb2021) afterwards, nothing serious. She confirmed she recovered completely. She was a very anxious person and she gets nervous and worried, so she contributed the symptoms to her anxiety to get the shot and all the anticipation. She stated it could have been the vaccine though, she doesnot know. The patient did not visited emergency room or physician office. The outcome of the events tiredness, dizziness were recovered on 05Feb2021 and unknown for other events.
Age: 38.0
Sex: F
Vaccine: COVID19
Symptoms: Lymphadenopathy
Clinical narrative: Swollen lymph node in the neck on the left side; This is a spontaneous report from a contactable Consumer. This 38-year-old Female Consumer (patient) reported that:  This is a spontaneous report from a contactable consumer or other non hcp. A 38-year-old female patient received bnt162b2 (BNT162B2, solution for injection, Lot Number: EL9264), dose 1 via an unspecified route of administration, administered in Arm Left on 18Feb2021 10:00 as SINGLE DOSE for covid-19 immunisation. Medical history included asthma, milk allergy known allergies Milk, doxycycline. The patient's concomitant medications were not reported. The patient previously took doxycycline and experienced drug hypersensitivity. The patient experienced swollen lymph node in the neck on the left side on 21Feb2021. The action taken in response to the event for bnt162b2 was not applicable. The outcome of the event was not recovered.
Age: 61.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Arthralgia, Fatigue, Pain
Clinical narrative: Extreme fatigue; body aches; joint pain; This is a spontaneous report from a contactable   A 46-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19. VACCINE, solution for injection, lot no: EN6203), dose2 at Right arm on 20 Feb 2021 at 03:45 PM as single dose for COVID-19 immunisation. Medical history included IBS, Szogrines syndrome and fibromyalgia. Concomitant medication included Omeprazole, bupropion, duloxetine, anastrozole. Historic vaccine included BNT162B2 (PFIZER-BIONTECH COVID-19. VACCINE, solution for injection, lot no: EL9264), dose1 intramuscular at Right arm on 30Jan2021 at 03:45 PM for COVID-19 immunisation. The patient did not receive covid prior vaccination and was not tested covid post vaccination. There were no known allergies. On 22 Feb 2021 at 12:00 AM, patient experienced Extreme fatigue, body aches joint pain. The outcome of events was reported as not recovered.  No follow-up attempts are needed. No further information is expected.
Age: 61.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Abdominal discomfort, Arthralgia, Fatigue, Myalgia
Clinical narrative: Extreme fatigue; body aches; joint pain; This is a spontaneous report from a contactable   A 46-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19. VACCINE, solution for injection, lot no: EN6203), dose2 at Right arm on 20 Feb 2021 at 03:45 PM as single dose for COVID-19 immunisation. Medical history included IBS, Szogrines syndrome and fibromyalgia. Concomitant medication included Omeprazole, bupropion, duloxetine, anastrozole. Historic vaccine included BNT162B2 (PFIZER-BIONTECH COVID-19. VACCINE, solution for injection, lot no: EL9264), dose1 intramuscular at Right arm on 30Jan2021 at 03:45 PM for COVID-19 immunisation. The patient did not receive covid prior vaccination and was not tested covid post vaccination. There were no known allergies. On 22 Feb 2021 at 12:00 AM, patient experienced Extreme fatigue, body aches joint pain. The outcome of events was reported as not recovered.  No follow-up attempts are needed. No further information is expected.
Age: 77.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Nausea, Somnolence
Clinical narrative: Extremely sleepy; nausea; headaches; This is a spontaneous report from a contactable consumer. This 77-year-old female consumer reported for herself that she received bnt162b2 (BNT162B2), dose 1 via an unspecified route of administration, administered in Arm Left on 08Feb2021 10:15 (Batch/Lot Number: EN6201) as SINGLE D0SE for covid-19 immunisation. Medical history included diabetes mellitus, rheumatoid arthritis, pulmonary hypertension, fibromyalgia, dermatitis contact, drug hypersensitivity from an unknown date and unknown if ongoing. Concomitant medications included chlorthalidone (CHLORTHALIDONE) taken for an unspecified indication; lansoprazole (LANSOPRAZOLE) taken for an unspecified indication; macitentan (MACITENTAN) taken for an unspecified indication; rosuvastatin calcium (ROSUVAS) taken for an unspecified indication, start and stop date were not reported. The patient previously took betadine [povidone-iodine] and experienced drug hypersensitivity, spironolactone and experienced drug hypersensitivity. On 08Feb2021 15:00 the patient experienced extremely sleepy, nausea, headaches. Extremely sleepy into the 3rd week now. Sleep night and day naps. Used 5 night hours, no day naps. 3rd week. The action taken in response to the events for bnt162b2 was not applicable. The outcome of the events was not recovered.
Sex: M
Vaccine: COVID19
Symptoms: Abdominal pain upper, Asthenia, Constipation, Fatigue, Feeling abnormal
Clinical narrative: I just felt bad; sluggish; no energy and some nausea; stomach ache; some constipation; fatigue; sleepy; no energy and some nausea; This is a spontaneous report from a contactable consumer. A 72-years-old male patient received bnt162b2 (BNT162B2), via an unspecified route of administration, administered in Arm Left on 21Feb2021 14:45 (Batch/Lot number was not reported) as unknown, single for covid-19 immunization. The patient's medical history included Parkinson, dementia,high cholesterol, depressionand percocet allergy. The patients concomitant medications were not reported..The patient experienced i just felt bad, sluggish, no energy and some nausea, stomach ache, some constipation, fatigue, sleepy on 23Feb2021 .The outcome of the events was recovered on unspecified date.  Information on Lot/Batch number has been requested.
Sex: M
Vaccine: COVID19
Symptoms: Nausea, Sluggishness, Somnolence
Clinical narrative: I just felt bad; sluggish; no energy and some nausea; stomach ache; some constipation; fatigue; sleepy; no energy and some nausea; This is a spontaneous report from a contactable consumer. A 72-years-old male patient received bnt162b2 (BNT162B2), via an unspecified route of administration, administered in Arm Left on 21Feb2021 14:45 (Batch/Lot number was not reported) as unknown, single for covid-19 immunization. The patient's medical history included Parkinson, dementia,high cholesterol, depressionand percocet allergy. The patients concomitant medications were not reported..The patient experienced i just felt bad, sluggish, no energy and some nausea, stomach ache, some constipation, fatigue, sleepy on 23Feb2021 .The outcome of the events was recovered on unspecified date.  Information on Lot/Batch number has been requested.
Age: 43.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Presyncope, Pyrexia, Vomiting
Clinical narrative: Approx 18 hours later had a vasovagal episode with vomiting; Approx 18 hours later had a vasovagal episode with vomiting; that was then proceeded with fever of 102 for the next 10 hours; This is a spontaneous report from a contactable nurse. This is a 43-year-old female Nurse (patient) reported for herself that she started to receive BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number; EL9265) on 11Feb2021 at 03:30 pm at 2nd dose, single at left arm for covid-19 immunisation. Patient was not pregnant at the time of vaccination. Patient's medical history was not reported (Known allergies; NKDA, NKA, Other medical history: None). Historical vaccine included first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number; EL3248 on 21Jan2021 at 03:30 PM at 1st dose, single on eft arm for covid-19 immunisation. Concomitant medications (other medications in two weeks) included sertraline hcl, colecalciferol (VITAMIN D), cyanocobalamin (VITANMIN B12) and OMEPRAZOLE (Prilosec) (therapy date sand indications unspecified). If other vaccine in four weeks; No. Patient approximately 18 hours later had a vasovagal episode with vomiting, that was then proceeded with   fever of 102 for the next 10 hours on 12Feb2021 at 09:00 am. Treatment for AE was not given. Patient did not have covid-19 prior vaccination. Patient was not tested for covid-19 post vaccination. The outcome of events was recovered on an unknown date.  No follow up attempts are possible. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Rash pruritic
Clinical narrative: Itching bumpy rash on the left side of my neck directly under my face.; This is a spontaneous report from a contactable consumer (patient). A 70-years-old female patient received bnt162b2 (BNT162B2), dose 2 via an unspecified route of administration, administered in Arm Left on 25Feb2021 11:00 (Batch/Lot Number: EN6200) as 2ND DOSE, SINGLE for covid-19 immunisation. Medical history included asthma, polymyalgia rheumatica, vertigo, Stress Incontinence from an unknown date and unknown if ongoing. Concomitant medication included fluticasone propionate, salmeterol (WIXELA INHUB), montelukast sodium (SINGULAIR), prednisone, aciclovir sodium (ACYCLOVIR ABBOTT VIAL) taken for an unspecified indication, start and stop date were not reported. The patient previously took sulfonamide and experienced drug hypersensitivity. The patient previously took bnt162b2 (BNT162B2), dose 2 via an unspecified route of administration, administered in Arm Left on 02Jan2021 10:15 (Batch/Lot Number: EL3248) as 1ST DOSE, SINGLE for covid-19 immunisation. The patient experienced itching bumpy rash on the left side of my neck directly under my face on 25Feb2021 16:00. The action taken in response to the event for bnt162b2 was not applicable. The outcome of event was not recovered.