chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 67.0
Sex: M
Vaccine: COVID19
Symptoms: SARS-CoV-2 test
Clinical narrative: headache; Sore arm; muscle aches; weakness; congestion; This is a spontaneous report from a contactable consumer. A 67-years-old male patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, Solution for injection), via an unspecified route of administration, administered in Arm Left on 19Feb2021 at 11:45 (Batch/Lot Number: EN6200) as 2nd dose, single for covid-19 immunization. Medical history included High blood pressure, high blood cholesterol and ascending aortic aneurysm. The patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, Solution for injection), via an unspecified route of administration, administered in Arm Left on 27Jan2021 at 4:30 (Batch/Lot Number: EL982) as 1st dose, single for covid-19 immunization.Concomitant medications within 2 weeks included rosuvastatin calcium (CRESTOR), ezetimibe (ZETIA), omeprazole (PRILOSEC [OMEPRAZOLE]) and low dose acetylsalicylic acid (ASPIRIN ). Patient did not take other vaccines in four weeks. Patient did not had Allergies. The patient had Covid prior vaccination.The patient tested Covid post vaccination on 19May2020 which was negative. On 20Feb2021 at 09:00 the patient experienced headache, sore arm, muscle aches, weakness, congestion for about 36hours. No treatment was administered for the events. The patient was recovered from the events in 2021.  No follow up attempts are possible. No further information is expected.
Age: 77.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Blood pressure measurement, Headache, Pain
Clinical narrative: headache; low energy; body aches; This is a spontaneous report from a contactable consumer (patient) reported for herself. A 77-years-old female patient (patient was not pregnant at the time of vaccination) received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot Number: EN6203, Expiration Date: unknown) via an unspecified route of administration, administered in left arm on 26Feb2021 at 11:00 am (age at vaccination was 77 years) as 2ND DOSE, SINGLE DOSE for COVID-19 immunization. The patient's medical history included atrial fibrillation and high blood pressure. The patient did not have any allergies. Concomitant medication patient received within 2 weeks of vaccination included rivaroxaban (XARELTO), nebivolol hydrochloride (BYSTOLIC), atorvastatin and amlodipine besilate, olmesartan medoxomil (OLMESARTAN E AMLODIPINA EG). The patient previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot Number: EI9265, Expiration Date: unknown) via an unspecified route of administration, administered in left arm on 05Feb2021 at 11:00 am (age at vaccination was 77 years) as 1ST DOSE, SINGLE DOSE for COVID-19 immunization. On 27Feb2021 at 19:00 pm, the patient experienced headache, low energy and body aches. Today on 01Mar2021, 3 days after second dose patient was still experiencing headache, low energy, and body aches. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. The patient underwent lab tests and procedures which included blood pressure measurement: high on an unknown date. The patient received treatment with Tylenol Extra Strength. The outcome of events was not resolved.  No follow-up attempts are needed. No further information is expected.
Age: 63.0
Sex: M
Vaccine: COVID19
Symptoms: Cough, Headache, Heart rate increased, Pain, Rhinorrhoea
Clinical narrative: headache; dry hacking cough; running nose; repeated sneezing; Rapid heartbeat; body ache's; This is a spontaneous report from a contactable consumer (patient, self-reported). A 63-year-old male patient received first 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, in Arm Left, on 25Feb2021 at 07:15 AM, as a single dose for COVID-19 immunization. The patient did not receive any other vaccine in four weeks. The patient's medical history included HIV+, chronic bronchitis, asthma, and arrhythmia. It was unknown if the patient had known allergies. The patient received unspecified medications in two weeks. The patient was not diagnosed with COVID prior vaccination. The patient was not tested for COVID post vaccination. The patient reported that on 26Feb2021 at 02:30 PM, approx 20 hrs later, she started with a headache and a dry hacking cough, developed a running nose then repeated sneezing. She also had rapid heartbeat and body ache's at about 24 hrs. Symptoms continued through Saturday and Sunday. She felt better today (Monday 01Mar2021) but body aches were returning around 3:30 pm still had a headache and it had never gone away. The patient did not receive any treatment for the events. Outcome of the events was recovering.  No follow-up attempts are possible. Information about lot/batch number cannot be obtained. No further information is expected.
Age: 63.0
Sex: M
Vaccine: COVID19
Symptoms: Sneezing
Clinical narrative: headache; dry hacking cough; running nose; repeated sneezing; Rapid heartbeat; body ache's; This is a spontaneous report from a contactable consumer (patient, self-reported). A 63-year-old male patient received first 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, in Arm Left, on 25Feb2021 at 07:15 AM, as a single dose for COVID-19 immunization. The patient did not receive any other vaccine in four weeks. The patient's medical history included HIV+, chronic bronchitis, asthma, and arrhythmia. It was unknown if the patient had known allergies. The patient received unspecified medications in two weeks. The patient was not diagnosed with COVID prior vaccination. The patient was not tested for COVID post vaccination. The patient reported that on 26Feb2021 at 02:30 PM, approx 20 hrs later, she started with a headache and a dry hacking cough, developed a running nose then repeated sneezing. She also had rapid heartbeat and body ache's at about 24 hrs. Symptoms continued through Saturday and Sunday. She felt better today (Monday 01Mar2021) but body aches were returning around 3:30 pm still had a headache and it had never gone away. The patient did not receive any treatment for the events. Outcome of the events was recovering.  No follow-up attempts are possible. Information about lot/batch number cannot be obtained. No further information is expected.
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Myalgia, Nausea
Clinical narrative: Headache; muscle ache; nausea; This is a spontaneous report from a contactable consumer or other non-hcp (Patient). A 71-year-old non-pregnant female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation solution for injection; Lot Number: EL9266) via an unspecified route of administration in Left Arm on 22Feb2021 02:30 PM as 1st dose single for COVID-19 immunization. Medical history included diabetes mellitus from an unknown date and unknown if ongoing. Concomitant medication included dulaglutide, metformin, atorvastatin and estrogens conjugated taken for an unspecified indication, start and stop date were not reported. The patient does not have allergies. It was reported that the patient has not taken any other vaccine in four weeks. On 23Feb2021 07:00 AM; the patient experienced headache, muscle ache and nausea. The seriousness of the events was reported as non-serious. The clinical outcome of the events was recovered.  No follow-up attempts are possible. No further information expected.
Age: 40.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Gait disturbance
Clinical narrative: I had general joint pain starting the day after the vaccine. After two days it all went away except my knees. I have never had any issues with my joints or knees before this.; By the end of the day it hurts a lot to walk up stairs.; This is a spontaneous report from a contactable other health care professional. A 40-years-old non pregnant female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot Number: EM9809), dose 1 via an unspecified route of administration, administered in left arm on 08Feb2021 at 10:00 AM as 1ST DOSE, SINGLE for covid-19 immunisation. Medical history included drug hypersensitivity, iodine allergy, autoimmune thyroiditis. Concomitant medication included levothyroxine sodium (SYNTHROID). No COVID prior vaccination. COVID tested post vaccination was no. On 09Feb2021 at 09:00 AM, the patient experienced general joint pain starting the day after the vaccine. After two days it all went away except my knees. I have never had any issues with my joints or knees before this. It started suddenly after the vaccine. Two weeks after the vaccine my knees are still sore. By the end of the day it hurts a lot to walk up stairs. Throughout the day they feel mildly sore and will sometimes click as I bend them. Treatment was not received for the events. The outcome of events were not recovered.  Follow-up attempts completed. No further information expected.
Sex: U
Vaccine: COVID19
Symptoms: Back pain
Clinical narrative: Pain at the back; This is a spontaneous report from a contactable consumer or other non hcp. A patient of unspecified age and gender received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), via an unspecified route of administration on 20Feb2021(Batch/Lot number was not reported) as 1ST DOSE, SINGLE  for covid-19 immunisation. The patient medical history and concomitant medications were not reported. In Feb 2021, The patient experienced pain at the back. The patient reported that patient had vaccine, last Saturday and everything seems to be fine except last night. Last night, patient experienced pain at the back, at lower back below the waistline. The patient enquired was that common. Patient had the first dose last saturday. The outcome of event was unknown.  Information on the lot/batch number has been requested.  Follow-up attempts are completed. No further information is expected.
Age: 30.0
Sex: F
Vaccine: COVID19
Symptoms: Feeling cold, Hypoaesthesia, Nail discolouration
Clinical narrative: Cold fingers and toes; discoloration; numbness; This is a spontaneous report from a contactable other HCP(Patient). This 30-year-old non-pregnant female received her second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot number: Em9810), via an unspecified route of administration in right arm on 19Feb2021 at 07:00 PM (at the age of 30-year-old) as a single dose for COVID-19 Immunization, at hospital. Patient's medical history included Covid-19. Concomitant medications included multivitamins [vitamins nos] and melatonin;theanine (medications in 2 weeks). The patient previously took first dose of BNT62b2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection, Lot number El9264) for on 29Jan2021 at 07:00 PM via an unspecified route of administration in right arm at single dose for COVID-19 Immunization. Prior to the vaccination the patient was diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. Patient did not receive other vaccines in four weeks of vaccination. Adverse event resulted in Doctor or other healthcare professional office/clinic visit. Patient experienced cold fingers and toes; podiatrist said it appeared to have smaller capillaries in his toes led to discoloration and numbness. No treatment was given for the event. The outcome of events was unknown.  Follow-up (11May2021): Follow-up attempts completed. No further information expected.
Sex: U
Vaccine: COVID19
Symptoms: Dysgeusia, Investigation
Clinical narrative: I started to getting metallic taste in my mouth; This is a spontaneous report from a contactable consumer (Patient).     A patient of unspecified age and gender received bnt162b2 (BNT162B2), dose 1 via an unspecified route of administration on an unspecified date (Batch/Lot number: Unknown) as 1ST DOSE, SINGLE for covid-19 immunisation.  The patient medical history was not reported.   The patient's concomitant medications were not reported. On an unspecified date around 5 days after the vaccination, the patient had metallic taste in mouth. It was reported that the patient informed physician about this, blood work was performed and no further details were provided. Outcome of event was unknown.   Follow-up attempts are completed. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Chills, Fatigue, Headache, Pain in extremity
Clinical narrative: Sore arm; mild chills; fatigue; mild headache/medium headache; This is a spontaneous report from a non-contactable consumer. An adult (18-64) female patient started to received first dose of bnt162b2 (BNT162B2), via an unspecified route of administration on 22Feb2021 (Batch/Lot Number: EL3247) as single dose for covid-19 immunisation .The patient medical history and concomitant medications were not reported. On 22Feb2021 within 12 hours of injection the patient experienced sore arm, mild chills, fatigue and mild headache between 24-36 hours; medium headache between 36-48 hours (both resolved with oral Advil, 3x 200mg total). The outcome of the events was recovered on an unspecified date.  No follow-up attempts are possible. No further information is expected.
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Lymphadenopathy, Pruritus, Rash, Skin burning sensation
Clinical narrative: headache; severe rashes in my forehead; bumps puffy face; swollen lymphnodes on the right side; sensitive to touch itching, and burning; sensitive to touch itching, and burning; This is a spontaneous report from a contactable other hcp (patient). A 60-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection, Lot Number: EN6201), dose 1 intramuscular, administered in Arm Right on 11Feb2021 at 10:30 (at the age of 60 years old) as 1st dose, single for COVID-19 immunization. Medical history included hypothyroidism, mild hypertension, acid reflux from an unknown date and unknown if ongoing. 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 was allergic to aspirin, NSAID, shellfish and some other fish. Concomitant medications included atorvastatin calcium (ATORVASTATIN CALCIUM); metoprolol tartrate (METOPROLOL TARTRATE); omeprazole (OMEPRAZOLE); levothyroxine sodium (LEVOTHYROXINE SODIUM) taken for an unspecified indication, start and stop date were not reported. The patient did not receive any other vaccines within four weeks. On 25Feb2021, 15 days after the first dose she got a headache, severe rashes in my forehead, bumps puffy face, swollen lymph nodes on the right side only sensitive to touch itching, and burning. The symptoms are beginning to subside now but was scheduled to get her 2nd dose on March 4th. She would like some guidance. The patient was treated with antibiotics. The patient visited physician office due to events. The outcome of the events was recovering.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Swelling face
Clinical narrative: headache; severe rashes in my forehead; bumps puffy face; swollen lymphnodes on the right side; sensitive to touch itching, and burning; sensitive to touch itching, and burning; This is a spontaneous report from a contactable other hcp (patient). A 60-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection, Lot Number: EN6201), dose 1 intramuscular, administered in Arm Right on 11Feb2021 at 10:30 (at the age of 60 years old) as 1st dose, single for COVID-19 immunization. Medical history included hypothyroidism, mild hypertension, acid reflux from an unknown date and unknown if ongoing. 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 was allergic to aspirin, NSAID, shellfish and some other fish. Concomitant medications included atorvastatin calcium (ATORVASTATIN CALCIUM); metoprolol tartrate (METOPROLOL TARTRATE); omeprazole (OMEPRAZOLE); levothyroxine sodium (LEVOTHYROXINE SODIUM) taken for an unspecified indication, start and stop date were not reported. The patient did not receive any other vaccines within four weeks. On 25Feb2021, 15 days after the first dose she got a headache, severe rashes in my forehead, bumps puffy face, swollen lymph nodes on the right side only sensitive to touch itching, and burning. The symptoms are beginning to subside now but was scheduled to get her 2nd dose on March 4th. She would like some guidance. The patient was treated with antibiotics. The patient visited physician office due to events. The outcome of the events was recovering.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Age: 30.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Fatigue, Nausea, Night sweats, Pain in extremity
Clinical narrative: night sweat; Fatigue; Sore arm; Nausea; Chills; This is a spontaneous report from a contactable consumer (reporting for herself). A 30-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE,Batch/Lot Number: EL3247), dose 2 via an unspecified route of administration, administered in Arm Left on 23Feb2021 11:15 (at the age of 30-year-old) as 2ND DOSE, SINGLE for covid-19 immunisation. The patient medical history and concomitant medications were not reported. Historical vaccine included BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot# EL3247), dose 1, via an unspecified route of administration single dose arm left on 02Feb2021 23:15 for covid-19 immunisation. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19; Since the vaccination, the patient not been tested for COVID-19. On 23Feb2021 at 23:00, the patient experienced night sweat, fatigue, sore arm, nausea and chills. No treatment received. The outcome of the events was recovering.  Follow-up (14May2021): Follow-up attempts completed. No further information expected.
Age: 76.0
Sex: F
Vaccine: COVID19
Symptoms: Urticaria
Clinical narrative: hives go from face to chest both sides of body; This is a spontaneous report from a contactable consumer (patient). A 76-year-old non-pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot Number: EL9261 and Expiration date was not reported), via an unspecified route of administration, administered in Arm Left on 15Feb2021 12:00 AM, as single dose for COVID-19 immunization. Medical history included sjogren's syndrome, Afib regulated and PMR. No known allergies were reported. The patient did not take other medications in two weeks. The patient did not receive other vaccine in four weeks. The patient did not had covid prior vaccination and was not tested for covid post vaccination. On 28Feb2021, 12:00 AM, the patient experienced hives which went from face to chest both sides of body. It was reported that, sunday (28Feb2021) hives go from face to chest both sides of body, never had hives before. No change in medications, food, or product use. The patient received treatment with benadryl. The outcome of the event was reported as not recovered.  No follow-up attempts are possible. No further information is expected.
Age: 82.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Chills, Headache, Myalgia, Vaccination site erythema
Clinical narrative: headache; muscle pain; chills; Joint pain; injection site redness swelling & pain; injection site redness swelling & pain; injection site redness swelling & pain; This is a spontaneous report from a contactable consumer or other non-HCP (patient). This 82-yerar-old non-pregnant female received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection; lot number: EN6198; expiration date: unknown), via an unspecified route of administration in right arm on 24Feb2021 09:00am, as a unknown single dose for COVID-19 immunization. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient's medical history included hypertension, arthritis and patient had known allergy's adverse reaction to compazine. The patient's concomitant medications were metoprolol, spironolactone, HCTZ, Azelastine nasal. On 24Feb2021, the patient experienced headache, muscle pain, chills, joint pain, injection site redness, swelling & Pain. No treatment was received in response to the adverse events. The patient was not diagnosed with COVID-19 prior to vaccination. Since the vaccination, patient was not tested for COVID-19. The outcome of events was recovered on an unspecified date of 2021.  No follow-up attempts are possible. No further information is expected.
Age: 82.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pain, Vaccination site swelling
Clinical narrative: headache; muscle pain; chills; Joint pain; injection site redness swelling & pain; injection site redness swelling & pain; injection site redness swelling & pain; This is a spontaneous report from a contactable consumer or other non-HCP (patient). This 82-yerar-old non-pregnant female received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection; lot number: EN6198; expiration date: unknown), via an unspecified route of administration in right arm on 24Feb2021 09:00am, as a unknown single dose for COVID-19 immunization. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient's medical history included hypertension, arthritis and patient had known allergy's adverse reaction to compazine. The patient's concomitant medications were metoprolol, spironolactone, HCTZ, Azelastine nasal. On 24Feb2021, the patient experienced headache, muscle pain, chills, joint pain, injection site redness, swelling & Pain. No treatment was received in response to the adverse events. The patient was not diagnosed with COVID-19 prior to vaccination. Since the vaccination, patient was not tested for COVID-19. The outcome of events was recovered on an unspecified date of 2021.  No follow-up attempts are possible. No further information is expected.
Age: 80.0
Sex: F
Vaccine: COVID19
Symptoms: Balance disorder, Body temperature, COVID-19, Chills, Fatigue
Clinical narrative: When she woke she felt like she did when she had Covid/felt like she had Covid; Chills; headache; temperature of 99.6-100.1F/Fever; I still felt a little tired; my arm was killing me; felt weird; felt weird like she was unsteady on her feet; This is a spontaneous report from a contactable consumer (patient). An 80-year-old female patient (Weight: 53.52 kg, Height: 157 cm) received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration, administered in Arm Left on 26Feb2021 08:30 as 1ST DOSE, SINGLE for covid-19 immunisation. She is unable to clearly identify the Lot due to illegible handwriting on the vaccine card. She thinks it is EN6200 or EN06200. Vaccination Facility Type: Clinic sponsored by (Name). Vaccine not administered at Military Facility. Medical history included covid-19 from 2020. She was also told that she might not need to get the second dose because of having antibodies. When she had Covid it was mild. She did not have the traditional symptoms. It affected her gastrointestinal system more. It was weird. Prior Vaccinations (within 4 weeks) was None. There were no concomitant medications. On 26Feb2021, after she got the vaccine, her arm was killing her. It was awful. She took Tylenol for it. Around 3-4pm she was feeling a little bit weird/"felt a little funny" like she was unsteady on her feet. She was not dizzy. She woke up the next day, 27Feb2021, felt "rotten", "almost like I felt when I had covid/ felt like she had Covid. Same symptoms, milder form": slight headache for 3 hours, chills lasted a couple of hours, temperature of 99.6-100.1F for 3 hours. She was awful in the morning and better as the day went on. It remined her of when she had Covid. After symptoms went away, she still felt a little tired. Didn't feel as good as she did before the day she took the vaccine. Caller said the vaccination Nurse told her that she might have more reaction because she may still have antibodies. Caller asking did she need to get 2nd dose? Should she expect reactions from the second dose? She still plans on taking it. The outcome of arm was killing her was recovering. Her arm is better but if she lays on her arm she can still feel it. The outcome of felt a little tired was unknown. The patient was recovered from other events on 27Feb2021.   Information on the lot/batch number has been requested.
Age: 80.0
Sex: F
Vaccine: COVID19
Symptoms: Feeling abnormal, Headache, Pain in extremity, Pyrexia
Clinical narrative: When she woke she felt like she did when she had Covid/felt like she had Covid; Chills; headache; temperature of 99.6-100.1F/Fever; I still felt a little tired; my arm was killing me; felt weird; felt weird like she was unsteady on her feet; This is a spontaneous report from a contactable consumer (patient). An 80-year-old female patient (Weight: 53.52 kg, Height: 157 cm) received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration, administered in Arm Left on 26Feb2021 08:30 as 1ST DOSE, SINGLE for covid-19 immunisation. She is unable to clearly identify the Lot due to illegible handwriting on the vaccine card. She thinks it is EN6200 or EN06200. Vaccination Facility Type: Clinic sponsored by (Name). Vaccine not administered at Military Facility. Medical history included covid-19 from 2020. She was also told that she might not need to get the second dose because of having antibodies. When she had Covid it was mild. She did not have the traditional symptoms. It affected her gastrointestinal system more. It was weird. Prior Vaccinations (within 4 weeks) was None. There were no concomitant medications. On 26Feb2021, after she got the vaccine, her arm was killing her. It was awful. She took Tylenol for it. Around 3-4pm she was feeling a little bit weird/"felt a little funny" like she was unsteady on her feet. She was not dizzy. She woke up the next day, 27Feb2021, felt "rotten", "almost like I felt when I had covid/ felt like she had Covid. Same symptoms, milder form": slight headache for 3 hours, chills lasted a couple of hours, temperature of 99.6-100.1F for 3 hours. She was awful in the morning and better as the day went on. It remined her of when she had Covid. After symptoms went away, she still felt a little tired. Didn't feel as good as she did before the day she took the vaccine. Caller said the vaccination Nurse told her that she might have more reaction because she may still have antibodies. Caller asking did she need to get 2nd dose? Should she expect reactions from the second dose? She still plans on taking it. The outcome of arm was killing her was recovering. Her arm is better but if she lays on her arm she can still feel it. The outcome of felt a little tired was unknown. The patient was recovered from other events on 27Feb2021.   Information on the lot/batch number has been requested.
Age: 34.0
Sex: F
Vaccine: COVID19
Symptoms: Abnormal dreams, Headache, Nightmare, Pain in extremity, Vaccination site pain
Clinical narrative: Headache; vivid/anxious dreams; muscle pain in both thighs; injection site pain; vivid/anxious dreams; This is a spontaneous report from a contactable consumer (patient). A 34-year-old female patient (non-pregnant) received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, solution for injection, Lot Number: EN6202) via an unspecified route of administration at Left arm on 01Mar2021 17:30 (at the age of 34-year-old) as 1st dose, single for COVID-19 immunisation. Medical history included Insulin resistance, endometriosis and patient previously took Ciprol and experienced Known allergies. Concomitant medication(s) included Colecalciferol VITAMIN D taken 50000 IU 1x week (other medications in two weeks). The patient did not receive any other vaccine in four weeks. Prior to vaccination, the patient was not diagnosed with COVID-19. Post vaccination, the patient had not been tested for COVID-19. On 01Mar2021, patient experienced, vivid/anxious dreams, muscle pain in both thighs, injection site pain. There was no treatment for the events. Treatment recommended for AE to take Claritin and antihistamine eye. The outcome of the events was not recovered.  No follow-up attempts are possible. No further information is expected.
Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Headache, Nausea
Clinical narrative: severe headache; Nausea; tired; This is a spontaneous report received from a contactable consumer (reporting on herself). A 72-years-old Non-pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection Lot Number and Expiration Date was not reported), via an unspecified route of administration in Arm Left on 25Feb2021 13:00, as 2nd dose, single dose for covid-19 immunisation. Patient previously received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection Lot Number and Expiration Date was not reported), via an unspecified route of administration in Arm Left on 04Feb2021 12:00, as 1st dose, single dose for covid-19 immunisation. Medical history included known allergies: Sulfa, Macrodantin, morphine. The patient received unspecified  medication in two weeks. Prior to vaccination, the patient was not diagnosed with COVID-19 and did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Since the vaccination, the patient has not been tested for COVID-19. On 02Mar2021, day 5 woke with severe headache and nausea very tired. Patient did not received any treatment for adverse events. The outcome of the events was recovering.   No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Fatigue, Headache
Clinical narrative: headache; Fatigue; Chills; This is a spontaneous report from contactable pharmacist (patient). A 59-year-old non-pregnant female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot number: EN6201), via an unspecified route of administration in left arm on 25Feb2021 at 13:45 as single dose for covid-19 immunisation. Historical vaccine included first dose of BNT162B2 on 06Feb2021 at 11:45 AM for covid-19 immunisation. Medical history included Rheumatoid arthritis, HTN, hypothyroidism and Shellfish allergy. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient hasn't been tested for COVID-19. Concomitant medication included Amlodipine/Valsartan 10/160, Synthroid 150mcg. On 25Feb2021 at 04:45 PM, about 3 hours post second dose developed a headache and fatigue. The following day fatigue persisted and was accompanied by chills that lasted for two days. On the third day post dose, symptoms resolved and felt normal. The patient did not received treatment due to the events. The outcome of all the events were recovered on an unspecified date in 2021.  No follow-up attempts are possible. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Headache, Pain in extremity, Tenderness
Clinical narrative: headache; soreness in my arm; My lymph nodes are tender; This is a spontaneous report. A contactable (age 54; Unit: Unknown) male consumer reported that:  A 54-years-old male patient received bnt162b2, (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot Number, expiration date: not reported), via an unspecified route of administration on 23Feb2021 as 1st dose, single for COVID-19 immunization. The patient medical history and concomitant medications were not reported. The patient had first dose last Tuesday and called a while ago about transmissibility. Patient reported that the patient lives with family members. The patient stated that he did not know if he had a Covid asymptomatic carrier. After a couple of weeks, we are supposed to wear a mask. Are you transmissible? The patient also stated If I was vaccinated, and I give it to someone else is it going to be a new variant. It was stated that patient never had a headache and a week later starting last night patient had headache that feels like a nail going through my head and I have soreness in my arm. My lymph nodes are tender. The outcome of events was unknown No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal discomfort, Chills, Fatigue, Headache, Malaise
Clinical narrative: Headache; tiredness; sore arm at injection site; generally feel unwell,; Chills; upset stomach; This is a spontaneous report from a contactable consumer (patient). A 59-year-old non-pregnant female patient received first dose of bnt162b2 (BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection Batch/Lot Number: EN 6198), via an unspecified route of administration, administered in Arm Left on 01Mar2021 16:30 () as 1ST DOSE, SINGLE DOSE for covid-19 immunisation. Medical history included coeliac disease, asthma, hypothyroidism, polycythaemia bradycardia from an unknown date and unknown if ongoing and Allergy to wheat, yeast, orange peel, high fructose corn syrup, material used in stress tests and wheat, yeast, orange peel, high fructose corn syrup, material used in stress tests from an unknown date and unknown if ongoing. Concomitant medication(s) included Breo, Albuterol, Synthroid, Omeprazole taken for an unspecified indication, start and stop date were not reported. On unspecified date the patient previously took morphine and experienced drug hypersensitivity. On 01Mar2021 the patient experienced headache, tiredness, sore arm at injection site, generally feel unwell, chills and upset stomach. The patient did not receive any vaccine prior four week of COVID-19 vaccination. Patient not diagnosed with COVID-19 before vaccination and since vaccination patient not tested for covid-19. Patient did not received treatment for the events. The outcome of the event was reported as recovering.   No follow-up attempts are possible. No further information is expected.
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: Headache; tiredness; sore arm at injection site; generally feel unwell,; Chills; upset stomach; This is a spontaneous report from a contactable consumer (patient). A 59-year-old non-pregnant female patient received first dose of bnt162b2 (BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection Batch/Lot Number: EN 6198), via an unspecified route of administration, administered in Arm Left on 01Mar2021 16:30 () as 1ST DOSE, SINGLE DOSE for covid-19 immunisation. Medical history included coeliac disease, asthma, hypothyroidism, polycythaemia bradycardia from an unknown date and unknown if ongoing and Allergy to wheat, yeast, orange peel, high fructose corn syrup, material used in stress tests and wheat, yeast, orange peel, high fructose corn syrup, material used in stress tests from an unknown date and unknown if ongoing. Concomitant medication(s) included Breo, Albuterol, Synthroid, Omeprazole taken for an unspecified indication, start and stop date were not reported. On unspecified date the patient previously took morphine and experienced drug hypersensitivity. On 01Mar2021 the patient experienced headache, tiredness, sore arm at injection site, generally feel unwell, chills and upset stomach. The patient did not receive any vaccine prior four week of COVID-19 vaccination. Patient not diagnosed with COVID-19 before vaccination and since vaccination patient not tested for covid-19. Patient did not received treatment for the events. The outcome of the event was reported as recovering.   No follow-up attempts are possible. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Condition aggravated, Fatigue, Headache, Pain in extremity
Clinical narrative: Headache; Shoulder was achy; Feeling wiped out; Heart palpitations; arm was really sore and this soreness went down to her elbow; she had a little headache that worsened; This is a spontaneous report from a contactable consumer (patient). A female patient (age:69; unit: unknown) received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, (Batch/Lot number was not reported), via an unspecified route of administration on 24Feb2021 as 1st dose, single dose for COVID-19 immunization. The patient medical history was covid previously (Patient thought she had covid previously and wanted to know if having covid made the side effects to the vaccine worse). Patient concomitant medications were not reported. Patient stated she received the first dose of the Pfizer covid 19 vaccine on 24Feb2021. Patient did not have symptoms until 30 hours later. Patient stated she had a little headache that worsened and the second day her shoulder was achy. She reported feeling wiped out and having heart palpitations. She reported her arm was really sore and this soreness went down to her elbow. She stated she did not rest after the vaccine and wanted to know if this is what caused her to have these side effects and is it normal to have late onset of these side effects. She stated she heard the side effects to the second dose are more severe. Patient wanted to know how much she would be protected if she did not get the second dose. There was no PQC (Product quality complaint). The outcome of the events was reported as unknown.  No follow-up attempts are possible; information about lot/batch number cannot been obtained.
Sex: F
Vaccine: COVID19
Symptoms: Palpitations
Clinical narrative: Headache; Shoulder was achy; Feeling wiped out; Heart palpitations; arm was really sore and this soreness went down to her elbow; she had a little headache that worsened; This is a spontaneous report from a contactable consumer (patient). A female patient (age:69; unit: unknown) received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, (Batch/Lot number was not reported), via an unspecified route of administration on 24Feb2021 as 1st dose, single dose for COVID-19 immunization. The patient medical history was covid previously (Patient thought she had covid previously and wanted to know if having covid made the side effects to the vaccine worse). Patient concomitant medications were not reported. Patient stated she received the first dose of the Pfizer covid 19 vaccine on 24Feb2021. Patient did not have symptoms until 30 hours later. Patient stated she had a little headache that worsened and the second day her shoulder was achy. She reported feeling wiped out and having heart palpitations. She reported her arm was really sore and this soreness went down to her elbow. She stated she did not rest after the vaccine and wanted to know if this is what caused her to have these side effects and is it normal to have late onset of these side effects. She stated she heard the side effects to the second dose are more severe. Patient wanted to know how much she would be protected if she did not get the second dose. There was no PQC (Product quality complaint). The outcome of the events was reported as unknown.  No follow-up attempts are possible; information about lot/batch number cannot been obtained.
Sex: M
Vaccine: COVID19
Symptoms: Body temperature, Body temperature increased, Chills, Headache, Pain
Clinical narrative: Headache; Slight temperature of about 100.3 Fahrenheit; Body ache; Chills; If has side effects or needs to go tested for Covid; This is a spontaneous report from a contactable consumer (wife) reported for a male patient (Husband). A male patient of unknown age received second dose of BNT162B2 (Pfizer covid vaccine, Lot number: EN6201, Expiration date: Unknown), via an unspecified route of administration on 21Feb2021 (Sunday) afternoon 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 covid vaccine) as a single dose for covid-19 immunization. On an unspecified date, patient experienced yesterday he started showing and he had a headache and a slight temperature of about 100.3 (Fahrenheit), body ache and chills. We didnt know if side effects didnt show up for like that would have been the fourth day from the time, we had the shot and this morning his chills are down, his headache is light and no temperature. Caller would like to know if it is a side effects or needs to go tested for Covid or side effect can occur after 3 or 4 days of vaccination. It was unknown if the patient received any treatment for the event. The clinical outcome of the events was unknown.  No follow-up attempts are possible; information about batch/ lot number cannot be obtained.
Sex: M
Vaccine: COVID19
Symptoms: SARS-CoV-2 test, Suspected COVID-19
Clinical narrative: Headache; Slight temperature of about 100.3 Fahrenheit; Body ache; Chills; If has side effects or needs to go tested for Covid; This is a spontaneous report from a contactable consumer (wife) reported for a male patient (Husband). A male patient of unknown age received second dose of BNT162B2 (Pfizer covid vaccine, Lot number: EN6201, Expiration date: Unknown), via an unspecified route of administration on 21Feb2021 (Sunday) afternoon 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 covid vaccine) as a single dose for covid-19 immunization. On an unspecified date, patient experienced yesterday he started showing and he had a headache and a slight temperature of about 100.3 (Fahrenheit), body ache and chills. We didnt know if side effects didnt show up for like that would have been the fourth day from the time, we had the shot and this morning his chills are down, his headache is light and no temperature. Caller would like to know if it is a side effects or needs to go tested for Covid or side effect can occur after 3 or 4 days of vaccination. It was unknown if the patient received any treatment for the event. The clinical outcome of the events was unknown.  No follow-up attempts are possible; information about batch/ lot number cannot be obtained.
Age: 77.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Muscle twitching, Nausea
Clinical narrative: tiredness; nausea; whole body was twitching; This is a spontaneous report from a contactable consumer reporting for herself. A 77-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection, Batch/Lot number was not reported), dose 2 via an unspecified route of administration on an unspecified date as single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. On an unspecified date, the patient experienced tiredness, nausea and whole body was twitching. The outcome of the events was unknown.  This Follow-up is being submitted to notify that lot/batch number is not available despite the follow-up attempts made. Follow-up attempts have been completed. No further information is expected.
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Headache
Clinical narrative: Headache; fatigue; This is a spontaneous report received from a contactable consumer or other non hcp (patient).   A 61-years-old non-pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection) dose 1 via an unspecified route of administration in Arm Left on 02Mar2021 at 09:45 am (Batch/Lot Number: en6205) as First dose, single for covid-19 immunisation. Medical history included colitis ulcerative and took ampicillin for hypersensitivity experienced rash. Concomitant medications included mesalazine, and citalopram. The patient has not taken any vaccine in four weeks. The patient has taken lialda and citalopram in two weeks. The patient has not experienced covid prior to vaccination. The patient has not tested for covid post vaccination. The patient experienced headache, and fatigue on 02Mar2021 at 19:00 pm. The patient has not taken any treatment for the events. Outcome of the events was not recovered.  No follow-up attempts are possible; information about lot/batch number cannot been obtained.
Age: 86.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Nasal congestion
Clinical narrative: Headache; Stuffiness symptoms; This is a spontaneous report from a contactable consumer. A 86-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection; Lot Number: EN6202; expiration date and NDC number were not reported) via an unspecified route of administration on 24Feb2021 at 11:50 in left arm as a single dose for COVID-19 immunization. Medical history included ongoing hypertension and ongoing hip arthroplasty. There were no additional vaccines administered on same date of the Pfizer suspect. History of all previous immunizations with the Pfizer vaccine considered as suspect was not reported as this was the first dose. The patient did not receive any prior vaccinations within 4 weeks and there were no adverse events following prior vaccinations. Investigation assessment was not provided. Patient was on other concomitant medications, but caller did not have the list to provide. As per the description, the caller reported that his aunt got the COVID vaccine on Wednesday (24Feb2021) and had headache which started half an hour after getting the shot at 12:20, and stuffiness symptoms (coded to nasal congestion) started later that evening. There was no emergency room or physician office visit. They spoke with the patient's doctor and the doctor wanted them to let us know about the events. Caller also mentioned he was wondering if there was anything that can be done to help relieve that events. The doctor suggested the patient to go and get tested for COVID. However, caller indicated the patient had not been out of the house besides going to get the shot. Patient had been quarantining in house for almost a full year and had not been going anywhere. She was deathly afraid of getting the disease. Hoping that getting the vaccine would at least allow her to go out more but do so cautiously. Caller stated he was not sure what rabbit hole the doctor was trying to go through or what was meant by the doctor recommending patient get tested for COVID. Relevant tests were not reported. The action taken with drug was unknown. The outcome of all events was not recovered.   No follow-up attempts are possible; No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Muscle spasms
Clinical narrative: mild lower body muscle cramps; This is a spontaneous report was received from a non-contactable consumer or other non hcp (patient). A female patient of age greater than 65 years received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, lot number: Unknown), via an unspecified route of administration on an unspecified date as 1st dose, single for covid-19 immunisation. The patient 's medical history and concomitant medication were not reported. On an unspecified date, It was reported that approximately 12 hours after receiving the first dose of the Pfizer COVID vaccine, the patient woke from sleeping feeling very mild lower body muscle cramps. Muscle cramps were transient, did not last, and went away with movement. The outcome of the events was recovered on an unspecified date.  No follow up attempts are possible. Information about Lot/batch cannot be obtained. No further information is expected.