chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 67.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Disorientation, Fatigue, Laboratory test, Muscle spasms
Clinical narrative: Disorientation; Severe cramps; Muscle ache; Fatigue extreme; Muscle chills; Nausea; This is a spontaneous report from a contactable consumer, the patient.  A 67-years-old male patient received first dose of bnt162b2 (PFIZER BIONTECH COVID 19 VACCINE, formulation: solution for injection, lot number was not reported), via an unspecified route of administration on 05Feb2021 as dose 1, single (age at vaccination 67 years) for covid-19 immunisation. Medical history included grover's disease. Concomitant medication(s) included vitamin c; ergocalciferol (VIT D); vitamin b complex since an unknown date, about 5000 each. The patient reported that the side effects did not start 24 hours after the injection. They lasted for initially 3 and a half days where he had severe cramps and muscle aches, extreme fatigue, disorientation, nausea and muscle chills on an unknown date in 2021. And nausea went away on day 4 but the fatigue and the chills lasted 12 days. The patient had lab work done, last Thursday, on 18Feb2021, he went to the hospital so they did a lot of lab work there can tell you because he thought he was having a heart attack. The patient did not receive any treatment for reported events. The outcome of the events was recovered on an unknown date in 2021 for fatigue, muscle chills and nausea and unknown for the rest.  Follow-up attempts completed. No further information expected.
Age: 67.0
Sex: M
Vaccine: COVID19
Symptoms: Myalgia, Nausea
Clinical narrative: Disorientation; Severe cramps; Muscle ache; Fatigue extreme; Muscle chills; Nausea; This is a spontaneous report from a contactable consumer, the patient.  A 67-years-old male patient received first dose of bnt162b2 (PFIZER BIONTECH COVID 19 VACCINE, formulation: solution for injection, lot number was not reported), via an unspecified route of administration on 05Feb2021 as dose 1, single (age at vaccination 67 years) for covid-19 immunisation. Medical history included grover's disease. Concomitant medication(s) included vitamin c; ergocalciferol (VIT D); vitamin b complex since an unknown date, about 5000 each. The patient reported that the side effects did not start 24 hours after the injection. They lasted for initially 3 and a half days where he had severe cramps and muscle aches, extreme fatigue, disorientation, nausea and muscle chills on an unknown date in 2021. And nausea went away on day 4 but the fatigue and the chills lasted 12 days. The patient had lab work done, last Thursday, on 18Feb2021, he went to the hospital so they did a lot of lab work there can tell you because he thought he was having a heart attack. The patient did not receive any treatment for reported events. The outcome of the events was recovered on an unknown date in 2021 for fatigue, muscle chills and nausea and unknown for the rest.  Follow-up attempts completed. No further information expected.
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Grip strength decreased, Pain in extremity, Tenderness
Clinical narrative: my left thumb & wrist feel tender; I have a hard time grasping with my left hand without my hand feeling painful.; I have a hard time grasping with my left hand without my hand feeling painful; This is a spontaneous report from a non-contactable consumer. A 59-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection and batch no: not reported/lot number: EL3247), dose 2 via an unspecified route of administration, administered in Arm Left on 12Feb2021 15:00 (at the age of 59-years-old) as dose 2, single for covid-19 immunization. The patient medical history was not reported. The patient's concomitant medications were not reported. The patient previously took codeine and had allergic to it. Historical vaccine included as patient received her first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection and batch no: not reported/lot number: EL3247) via an unspecified route of administration, in left arm on 22Jan2021 15:00 (at the age of 59-years-old) as dose 1, single for covid-19 immunization and experienced the muscle under her left thumb started to hurt. Prior to vaccination, the patient was not diagnosed with covid-19 and since the vaccination, the patient has not been tested for covid-19. It was reported that, after the second shot, her left thumb & wrist feel very tender, and she had a hard time grasping with her left hand without her hand feeling painful. No treatment received for event. Outcome of the events was not recovered.  No follow-up attempts are possible. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Dizziness
Clinical narrative: Dizzy; This is a spontaneous report from a contactable consumer (daughter). A male patient of an unspecified age received bnt162b2 (BNT162B2), dose 2 via an unspecified route of administration on an unspecified date (Lot number was not reported) as dose 2, single for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient previously received the first dose of bnt162b2 on unspecified date as single dose for COVID-19 immunization. After he got his second vaccine shot of Pfizer the patient started getting dizzy on an unspecified date and has been dizzy for a while now. The outcome of the event was unknown.    The lot number for BNT162B2 was not provided and will be requested during follow up.
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site erythema, Vaccination site pruritus, Vaccination site swelling
Clinical narrative: injection site redness; injection site itching; injection site swelling; This is a spontaneous report from a contactable consumer (patient). A 71-years-old non pregnant female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot Number: EN6203), via an unspecified route of administration, administered in Arm Left on 20Feb2021 13:15 (at the age of 71 years old) as a single dose for COVID-19 immunization. The patient medical history and concomitant medications were not reported. Patient had no known allergies. The patient previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot Number: EN5318), via an unspecified route of administration, administered in Arm Left on 30Jan2021 13:00 (at the age of 70 years old) as a single dose for COVID-19 immunization. Patient had not been diagnosed with COVID-19 prior to vaccination and had not been tested since the vaccination. The patient did not receive any other vaccination in last in four weeks. The patient received other medication in last 2 weeks but not reported. On 21Feb2021 12:00 the patient experienced injection site redness, injection site itching, and injection site swelling. The patient did not receive any treatment for events. The outcome of the events was recovering.  Follow-up attempts are completed. No further information is expected.
Age: 67.0
Sex: M
Vaccine: COVID19
Symptoms: Headache, Nausea, Somnolence
Clinical narrative: Very sleepy, could not stay awake; Headache; Nauseous; This is a spontaneous report from a contactable consumer, the patient. A 67-year-old male patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6200) via an unspecified route of administration in the left arm on 24Feb2021 at 15:00 (at the age of 67-year-old) as a single dose for COVID-19 immunisation. Medical history included aneurysm aortic (enlarged aorta), Chronic lymphocytic leukemia (CLL), eosinophilic esophagitis (EOE) and reduced 50 % kidney function. The patient was allergic to dairy. Prior to the vaccination, it was unknown whether the patient was diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. Concomitant medications included metoprolol succinate (MANUFACTURER UNKNOWN) and pantoprazole (MANUFACTURER UNKNOWN). The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 03Feb2021 at 12:00 (at the age of 67-year-old) as a single dose for COVID-19 immunisation. On 25Feb2021 at 17:30, the patient experienced very sleepy and could not stay awake, headache and nauseous. The patient went to bed slept for 14 hours and awake feeling fine. The event did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care.  No therapeutic measures were taken as a result of the reported events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the event very sleepy and could not stay awake, headache and nauseous were resolved on an unknown date in Feb2021.  No follow-up attempts are needed. No further information is expected.
Sex: U
Vaccine: COVID19
Symptoms: Peripheral swelling
Clinical narrative: have swelling on the underside of, right near my elbow, on the side that would not hit the sun,underneath it's like a lumpy swelling; This is a spontaneous report from a contactable consumer. A 85-year-old male patient received of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Batch/Lot Number: Unknown, Expiry Date: Unknown) via unspecified route of administration on 21Feb2021 at 18:00 in arm right as dose number unknown, single for COVID-19 immunization. Medical history included little handicap (He was 85 years old and he was a little handicap). Concomitant medications were not reported. Patient had vaccine yesterday around 6 O'clock in the evening and read all risk of Pfizer vaccine and tells you all good things. On unspecified date patient had swelling but the swelling was on underside on right near elbow on that side that would not hit the sun, underneath it's a lumpy swelling and its not at injection site, it on left arm. The clinical outcome of the event was unknown.   Follow-up attempts are completed. No further information is expected.
Age: 35.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Headache, Vaccination site pain
Clinical narrative: excessive tiredness day following injection; Muscle pain in arm where vaccine was injected; headache on day of injection; This is a spontaneous report from a non-contactable consumer, the patient. A 35-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the right arm on 27Feb2021 at 12:30 (at the age of 35-years-old) as a single dose for COVID-19 immunisation. Medical history included blood pressure high, obesity, unspecified allergies, bronchitis, and pneumonia. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medications included unspecified medications for high blood pressure from an unknown date and unknown if ongoing. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 27Feb2021 at 14:00, the patient experienced muscle pain in arm where vaccine was injected and headache. On 28Feb2021, day following injection, the patient experienced excessive tiredness. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The patient did not receive any treatment for the reported event. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events muscle pain in arm where vaccine was injected, headache, and excessive tiredness was recovering at the time of this report.  No follow-up attempts are possible, information about lot/batch number cannot be obtained. No further information is expected.
Age: 75.0
Sex: M
Vaccine: COVID19
Symptoms: Decreased appetite, Feeling abnormal, Illness, Vomiting
Clinical narrative: throwing up; No appetite; he had just been miserable for about 3-4 days; he had been sick; This is a spontaneous report from a contactable consumer or other non-health care professional (Patient's wife).  A 75-year-old male patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; solution for injection; Lot number: EL9267, Expiry date: Unknown) via an unspecified route of administration, administered in right arm on 10Feb2021 (at the age of 75-year-old) as DOSE 2, SINGLE for COVID-19 immunization. Patient previously took first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection; lot number - EL9261, Expiry date: Unknown) administered in right arm on an unspecified date for COVID-19 immunization. The patient medical history and concomitant medications were not reported. On 17Feb2021 the patient experienced throwing up, no appetite and had just been miserable for about 3-4 days. On an unspecified date in 2021, he had been sick. The reporter stated that her husband had the second dose of the Pfizer Covid vaccine on Wednesday morning 10Feb2021. He was perfectly fine, had nothing, but this past week he had been sick with almost identical symptoms. He had been throwing up, has had no appetite and he had just been miserable for about 3-4 days. The patient was feeling better but threw up again after his medicine last night. The outcome of events was recovering.   Follow-up attempts completed. No further information expected.
Sex: M
Vaccine: COVID19
Symptoms: Asthenia, Bedridden, Gait disturbance, Lethargy
Clinical narrative: Lethargic; No energy; Cannot put one foot in front of the other; in bed for two weeks; This is a spontaneous report from a contactable consumer. A male patient of an unspecified age received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number: was not reported) via an unspecified route of administration, administered anatomical location not reported, on an unspecified date, as DOSE 2, SINGLE for COVID-19 immunization. The patient medical history and concomitant medications were not reported. On an unspecified date, the patient experienced lethargic, no energy, cannot put one foot in front of the other and in bed for two weeks. It was reported patient called to report on the COVID 19 shot clarified calling about the Pfizer BioNTech COVID 19 Vaccine.  While providing details about himself he mentioned he knows a young lady's whose father Pfizer COVID Shot. He got their second shot and have been lethargic, no energy, cannot put one foot in front of the other He has been in bed for two weeks. The outcome of the events was reported as unknown.  Information on the lot/batch number has been requested.  Follow-up (11May2021): Follow-up attempts completed. No further information expected.
Age: 92.0
Sex: M
Vaccine: COVID19
Symptoms: Asthenia, Chills, Fatigue, Hyperhidrosis, SARS-CoV-2 test
Clinical narrative: Chills; Sweats; Exhaustion; Weakness; This is a spontaneous report from a contactable consumer, the patient. A 92-year-old male patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6202) via an unspecified route of administration in the left arm on 22Feb2021 at 19:30 (at the age of 92-years-old) as a single dose for COVID-19 immunisation. Medical history included unable to urinate, urethra and kidney issue. The patient also reported that prior to vaccination he had bladder and kidney issues and on 25Feb2021 after the vaccination, he was hospitalized. The patient had no known allergies. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medications included metoprolol (MANUFACTURER UNKNOWN) and lisinopril (MANUFACTURER UNKNOWN) and statin (MANUFACTURER UNKNOWN); all were taken for an unknown indication from an unknown date and unknown if ongoing. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: el9263) via an unspecified route of administration on 27Jan2021 at 19:00 (at the age of 92-years-old) as a single dose for COVID-19 immunisation. On 22Feb2021 at 21:00, the patient experienced chills, sweats, exhaustion and weakness. Therapeutic measures were taken as a result of the events which included unknown treatment. On 28Feb2021, the patient underwent nasal swab and the result was unknown results. The clinical outcome of the events chills, sweats, exhaustion and weakness was unknown at the time of this report.   No follow-up attempts are needed. No further information is expected.
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Fatigue, Headache, Loss of personal independence in daily activities, Nausea
Clinical narrative: Headache; Nausea; very fatigued/feeling really tired; has low energy; It is hard to work; This is a spontaneous report from a contactable consumer (Patient) or other non hcp.   A 50-years-old female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number: EL3248, Expiration date: not reported) via an unspecified route of administration, administered in Arm Left on 17Feb2021 at 10:50 (at the age of 50-years-old) as dose 2, single for covid-19 immunization. The patient medical history was not reported. Concomitant medication(s) included fluoxetine taken 40 mg, 1x/day; topiramate and bupropion taken 300 mg, 1x/day, all taken for decreased appetite, start and stop date was unknown. patient previously received first dose of BNT162B2 (PFIZER-BIONTEC COVID-19 VACCINE; Lot Number: EL3248), via an unspecified route of administration on 30Jan2021 (at the age of 50-years-old) as a single dose for COVID-19 immunization. On 17Feb2021, patient experienced headache, nausea, very fatigued/feeling really tired, has low energy and It is hard to work. The nausea and headache went away. She has continued to be tired and has low energy. No additional vaccines were administered on Same Date of the Pfizer suspect. No AE(s) prior to vaccinations.The outcome of events very fatigued/feeling really tired was not recovered, outcome of event headache and nausea was recovered on an unspecified date, outcome of event has low energy and It is hard to work was unknown.  Follow-up attempts completed. No further information expected.
Sex: U
Vaccine: COVID19
Symptoms: Confusional state, Hypoacusis
Clinical narrative: Confused; Can hardly hear; This is a spontaneous report from a contactable consumer (patient). A patient of an unspecified age and gender received first dose of BNT162B2 (PFIZER-BIONTEC COVID-19 mRNA VACCINE, Solution for injection, batch/lot number and expiry date were not reported), via an unspecified route of administration as a Dose 1, Single for COVID-19 immunization. The patient's medical history and Concomitant medication(s) were not reported. Patient was confused. Patient got this card. They did not tell patient had to call to get an appointment. Patient could hardly hear you. The Outcome of the events was unknown.  Information about lot/batch number has been requested.  Follow-up (14May2021): Follow-up attempts completed. No further information expected.
Age: 72.0
Sex: M
Vaccine: COVID19
Symptoms: Myalgia, Pain in extremity
Clinical narrative: Having a lot muscle pain in the leg, in the hip, and it has not gone away; Having a lot muscle pain in the leg, in the hip, and it has not gone away; This is a spontaneous report from a contactable consumer (Patient's wife). A 72-years-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, formulation: solution for injection and batch no/lot number: not reported), dose 1 via an unspecified route of administration on an unspecified date (at the age of 72-years-old) as dose 1, single for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. It was stated that her husband has just got the Pfizer vaccine and it's been 3 and half weeks so he was good to go for the second one. He had been having a lot muscle pain in the leg, in the hip, and it has not gone away. Outcome of the event was not recovered.  Follow-up attempts completed. No further information expected. Information on the lot batch number has been requested.
Age: 82.0
Sex: F
Vaccine: COVID19
Symptoms: Conjunctivitis
Clinical narrative: pinkeye; This is a spontaneous report from a contactable consumer via a Pfizer-sponsored program. An 82-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE Solution for injection), via an unspecified route of administration, on 02Feb2021 (Lot number: EL9261, Expiry date: 12May2021), at 82 years old, as dose 1, single, for COVID-19 immunisation. Relevant medical history included pacemaker user from an unknown date and ongoing. Concomitant medications included amlodipine, pantoprazole, atorvastatin, "Dxazepan" (as provided by the reporter) and "Qap" (as provided by the reporter) all taken for unknown indications, start and stop dates not reported. On 22Feb2021, the patient had a pinkeye. The patient was scheduled to get the second dose on 23Feb2021. The reporter asked if it was okay to get the second dose and if there would by complications. Treatment for the event included an unspecified eyedrops. The outcome of the event was unknown.  No follow-up attempts are possible. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Malaise
Clinical narrative: Twelve hour period of uncomfortableness; This is a spontaneous report from a contactable other hcp. A female patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Batch/Lot number Unknown, Expiry Date: Unknown), via an unspecified route of administration on an unspecified date as DOSE 1, SINGLE for covid-19 immunisation. The patient medical history and concomitant medications were not reported. On an unspecified date the patient experienced twelve hour period of uncomfortableness. The outcome of event unknown.  Information on lot and batch number has been requested.  Follow-up (11May2021): Follow-up attempts completed. No further information expected.
Age: 79.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Asthenia, Feeling abnormal, Gait disturbance, Malaise
Clinical narrative: Muscle aches all over; His hands aches; Joint pain, aches in joints; He just feels out of energy, he just feels down; He just feeling terrible; He felt lot worse and was not feeling great at all; Little ache in his arm where they gave him a shot; Little bit of worst feeling kind of achy here and there; Little off balance in walking; This is a spontaneous case from a contactable consumer or other non-health care professional reported for himself. A 79-year-old male patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, lot number: EL9266 and expiry date: do not know it has an expiration date and he did not see an expiration date), via an unspecified route of administration on 19Feb2021 (at the age of 79-year-old) as dose 2, single for COVID-19 immunization. The patient's medical history was not provided. Concomitant medications included Amlodipine 25mg (dose was not clarified) with unknown start date and unknown if ongoing, once in night, he thinks it lowers blood pressure. Historical vaccine included first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, lot number and expiry date were not reported), via an unspecified route of administration on 29Jan2021 (at the age of 79-year-old) as dose 1, single for COVID-19 immunization. The patient went for his second shot, when he got call from hospital and said that he should went up there earlier in a day, but he was last person up there for the shot. It was on late afternoon on Friday about 5:00. However, he got the shot and returned home. On 20Feb2021 (next day, on Saturday), he has little ache in his arm where they gave him a shot, little bit of worst feeling kind of achy here and there and little off balance in walking. On Saturday, when he received, the date he went there. He does not know what date Saturday was. On 21Feb2021 (on Sunday), he felt lot worse and was not feeling great at all and just stayed in bed lying down all day. On 22Feb2021 (on Monday), the late day he just feeling terrible, he can hardly do anything much and went to work in yard today, but he feels out of energy and muscle aches all over and joint pain, aches in joints and even his hands aches, no headache. His sense of taste was fine, he just feels down. Patient asked that if this was just common to have the aches and pains after the injection and how long will it last. Therapeutic measures were reported as no, stated that he has not done anything, just stayed in bed, and tried to eat little soup as he does not know what to do. The outcome of the events was reported as unknown.  Follow-up attempts completed. No further information expected.
Age: 79.0
Sex: M
Vaccine: COVID19
Symptoms: Myalgia, Pain, Pain in extremity, Vaccination site pain
Clinical narrative: Muscle aches all over; His hands aches; Joint pain, aches in joints; He just feels out of energy, he just feels down; He just feeling terrible; He felt lot worse and was not feeling great at all; Little ache in his arm where they gave him a shot; Little bit of worst feeling kind of achy here and there; Little off balance in walking; This is a spontaneous case from a contactable consumer or other non-health care professional reported for himself. A 79-year-old male patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, lot number: EL9266 and expiry date: do not know it has an expiration date and he did not see an expiration date), via an unspecified route of administration on 19Feb2021 (at the age of 79-year-old) as dose 2, single for COVID-19 immunization. The patient's medical history was not provided. Concomitant medications included Amlodipine 25mg (dose was not clarified) with unknown start date and unknown if ongoing, once in night, he thinks it lowers blood pressure. Historical vaccine included first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, lot number and expiry date were not reported), via an unspecified route of administration on 29Jan2021 (at the age of 79-year-old) as dose 1, single for COVID-19 immunization. The patient went for his second shot, when he got call from hospital and said that he should went up there earlier in a day, but he was last person up there for the shot. It was on late afternoon on Friday about 5:00. However, he got the shot and returned home. On 20Feb2021 (next day, on Saturday), he has little ache in his arm where they gave him a shot, little bit of worst feeling kind of achy here and there and little off balance in walking. On Saturday, when he received, the date he went there. He does not know what date Saturday was. On 21Feb2021 (on Sunday), he felt lot worse and was not feeling great at all and just stayed in bed lying down all day. On 22Feb2021 (on Monday), the late day he just feeling terrible, he can hardly do anything much and went to work in yard today, but he feels out of energy and muscle aches all over and joint pain, aches in joints and even his hands aches, no headache. His sense of taste was fine, he just feels down. Patient asked that if this was just common to have the aches and pains after the injection and how long will it last. Therapeutic measures were reported as no, stated that he has not done anything, just stayed in bed, and tried to eat little soup as he does not know what to do. The outcome of the events was reported as unknown.  Follow-up attempts completed. No further information expected.
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity, Scar
Clinical narrative: And I just witnessed our arm got sore.; I got scars; This is a spontaneous report from a contactable other hcp (Patient). A female patient of an unspecified age received second dose of bnt162b2 ((PFIZER-BIONTECH COVID-19 mRNA VACCINE; formulation: Solution for injection, Lot Number: UNKNOWN), via an unspecified route of administration on 21Feb2021 as dose 2, single for COVID-19 immunisation. Medical history included diabetes mellitus from an unknown date and unknown if ongoing. The patient's concomitant medications were not reported. The patient previously received first dose of bnt162b2 ((PFIZER-BIONTECH COVID-19 mRNA VACCINE; formulation: Solution for injection, Lot Number: UNKNOWN), via an unspecified route of administration on 13Jan2021 as dose 1, single for COVID-19 immunisation. It was reported that on 21Feb2021, the patient reported that we just kind of made it. The patient reported that they gave us the shot now and she did not get any reaction yet, usually about now she gets tingling. She did not get anything so far he was doing all right. She just witnessed our arm got sore. They need to look up and mine was all dried up. She was worried that if she took it too soon the immune system will flare it up again and she did not want any more scars all over my leg. She got scars. The outcome of events was unknown.  Follow-up attempts are completed. No further information is expected.
Age: 32.0
Sex: F
Vaccine: COVID19
Symptoms: Myalgia, Vaccination site pain
Clinical narrative: Injection site pain; Muscle ache; This is a spontaneous report from a non-contactable consumer, the patient. A 32-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EM9809) via an unspecified route of administration in the right arm on 21Feb2021 (at the age of 32-year-old) as a single dose for COVID-19 immunisation. Medical history was not reported. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medications included unspecified medications. The patient did not receive any other vaccines within four weeks prior to the vaccination. On an unknown date in Feb2021, the patient experienced injection site pain and muscle ache. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events injection site pain and muscle ache was unknown at the time of this report.  No follow-up attempts are possible. No further information is expected.
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Decreased appetite, Headache, Nausea
Clinical narrative: Chills; headache; Nausea/still felt her stomach was still queasy; still does not have much of an appetite; This is a spontaneous report from a contactable consumer (patient). A 70-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTEC COVID-19 mRNA VACCINE, Solution for injection, lot number: EL9267 and expiry date was not reported), via an unspecified route of administration at arm left, on 10Feb2021 (age at vaccination: 70 years), as single dose for COVID-19 immunization. The patient's medical history was not reported. The patient concomitant medication includes levothyroxine sodium (Synthroid) (Start: Unspecified Stop: Unspecified) for thyroid and the patient has been taking a long time, just recently increased dose, levocetirizine dihydrochloride (Xyzal) (Start: Unspecified Stop: Unspecified) for allergies taking a couple of years. It was reported that prior to the first administration date of the suspect vaccine the patient did not receive any other vaccine. The patient historical vaccine includes BNT162B2 (PFIZER-BIONTEC COVID-19 mRNA VACCINE, Solution for injection, lot number: EL9261 and expiry date was not reported), via an unspecified route of administration in left arm, on 21Jan2021(age at vaccination: 70 years) as a dose 1, single for COVID-19 immunization. On 11Feb2021 on Thursday at middle of night, she got chills and could not stop shaking and the patient got an ice pick headache, a form of migraine headache that feels like they are shoving an ice-pick in her head, patient stated that she was nauseous. It was reported that the headache lasted about 2-3 days and has completely recovered now, no exact date provided. That the nausea lasted 2 days after, still felt her stomach was still queasy and still does not have much of an appetite. Outcome for the event chills, headache and still does not have much of an appetite was recovered on an unknown date in 2021. Outcome for the event nausea recovering resolving.  Follow-up attempts are completed. No further information is expected.
Age: 47.0
Sex: M
Vaccine: COVID19
Symptoms: Fatigue, Influenza like illness, Nasal congestion, Pain
Clinical narrative: Flu like symptoms; aches; congestion; fatigue; This is a spontaneous report from a contactable consumer or other non-health care professional. A 47-years-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number was not reported) via an unspecified route of administration on 18Feb2021 08:00 AM ((at the age of 47-years-old) as dose 2, single for covid-19 immunization. The patient medical history included overweight, high blood pressure and bipolar depression. The patient's concomitant medications were not reported. The patient previously took augmentin and had allergy. The patient previously received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/Lot number was not reported) via an unspecified route of administration on an unspecified date as dose 1, single for covid-19 immunization. Patient had not been diagnosed with COVID-19 prior to vaccination and had not been tested since the vaccination. Patient had not received any other medications in four weeks. On 18Feb2021, the patient experienced flu like symptoms (aches, congestion, fatigue - no fever) for 24 hours after the shot. Then patient was perfectly fine. Patient had not received any treatment for the events. Outcome of the events was recovered on an unspecified date in Feb2021.  Follow-up attempts completed. No further information expected.
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Lethargy, Movement disorder
Clinical narrative: Lethargic; No energy; cannot put one foot in front of the other; This is a spontaneous report from a contactable consumer.   A female patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot Number: not reported), via an unspecified route of administration on an unspecified date as SINGLE DOSE for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient experienced lethargic, no energy and cannot put one foot in front of the other on an unspecified date. Caller reported that patient got her second shot and has been lethargic, no energy, cannot put one foot in front of the other. She has been in bed for two weeks. The clinical outcome of the events was unknown.  Follow-up (14MAY2021): Follow-up attempts completed. No further information expected.
Age: 38.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Fatigue, Headache, Muscle fatigue, Nausea
Clinical narrative: Chills; Body aches; Headache; Fatigue/Full body fatigue like just ran a marathon 56 hours after.; Arm muscle fatigue; Nausea; Pain from injection site up side of neck to point of too painful to turn head; Pain from injection site up side of neck to point of too painful to turn head.; Pain from injection site up side of neck to point of too painful to turn head; 48 hours after still arm pain.; This is a spontaneous report from a non-contactable consumer, the patient. A 38-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 20Feb2021 at 12:00 (at the age of 38-years-old) as a single dose for COVID-19 immunisation. Medical history and concomitant therapy were not reported. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the COVID-19 vaccine. The patient previously took amoxicillin (MANUFACTURER UNKNOWN) for unknown indication on an unknown date and experienced drug allergy. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration on an unknown date as a single dose for COVID-19 immunisation. On 21Feb2021 at 15:00, 27 hours after second shot the patient experienced chills, body aches, headache, fatigue, arm muscle fatigue, nausea, pain from injection site up side of neck to point of too painful to turn head. It was reported that the worst pain was about 30 to 40 hours after second shot. After 48 hours still the patient experienced arm pain, arm fatigue and headache. Neck pain and body aches had not gone but bearable. It was reported that, 56 hours after vaccination full body fatigue like just ran a marathon. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Therapeutic measures were not taken as a result of the events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events chills, body aches, headache, fatigue, arm muscle fatigue, nausea, pain from injection site up side of neck to point of too painful to turn head and arm pain was recovering at the time of this report.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 38.0
Sex: F
Vaccine: COVID19
Symptoms: Neck pain, Pain, Pain in extremity, Vaccination site pain
Clinical narrative: Chills; Body aches; Headache; Fatigue/Full body fatigue like just ran a marathon 56 hours after.; Arm muscle fatigue; Nausea; Pain from injection site up side of neck to point of too painful to turn head; Pain from injection site up side of neck to point of too painful to turn head.; Pain from injection site up side of neck to point of too painful to turn head; 48 hours after still arm pain.; This is a spontaneous report from a non-contactable consumer, the patient. A 38-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 20Feb2021 at 12:00 (at the age of 38-years-old) as a single dose for COVID-19 immunisation. Medical history and concomitant therapy were not reported. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the COVID-19 vaccine. The patient previously took amoxicillin (MANUFACTURER UNKNOWN) for unknown indication on an unknown date and experienced drug allergy. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration on an unknown date as a single dose for COVID-19 immunisation. On 21Feb2021 at 15:00, 27 hours after second shot the patient experienced chills, body aches, headache, fatigue, arm muscle fatigue, nausea, pain from injection site up side of neck to point of too painful to turn head. It was reported that the worst pain was about 30 to 40 hours after second shot. After 48 hours still the patient experienced arm pain, arm fatigue and headache. Neck pain and body aches had not gone but bearable. It was reported that, 56 hours after vaccination full body fatigue like just ran a marathon. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Therapeutic measures were not taken as a result of the events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events chills, body aches, headache, fatigue, arm muscle fatigue, nausea, pain from injection site up side of neck to point of too painful to turn head and arm pain was recovering at the time of this report.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Hyperhidrosis, Vomiting
Clinical narrative: chills; 30 hours after receiving the vaccine, had chills, sweaty and eventually vomited.; 30 hours after receiving the vaccine, had chills, sweaty and eventually vomited.; This is a spontaneous report from a non-contactable consumer, the patient. A 73-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6198) via an unspecified route of administration in the left arm on 20Feb2021 at 16:00 (at the age of 73-years-old) as a single dose for COVID-19 immunisation. The patient had no medical history and had no known allergies to medications, food or other products. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. Concomitant medications included calcium, vitamin d nos (CALCIUM; VITAMIN D NOS) and lutein (MANUFACTURER UNKNOWN); both for unknown indication, from an unknown date and unknown if ongoing. On 21Feb2021 at 22:00, 30 hours after vaccination, the patient experienced chills, sweaty and eventually vomited only once. The patient had no adverse events in the first 30 hours. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Therapeutic measures were not taken as a result of the reported events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events chills, sweaty and eventually vomited was resolved on an unknown date in Feb2021.  No follow-up attempts are possible. No further information is expected.
Age: 69.0
Sex: U
Vaccine: COVID19
Symptoms: Chills
Clinical narrative: Some periods of chills; This is a spontaneous report from a contactable consumer or other non hcp. A 69-years-old patient of an unspecified gender received bnt162b2 (PFIZER-BIONTECH COVID -19 VACCINE, formulation: solution for injection via an unspecified route of administration, administered in Left Arm on 10Feb2021 (Lot Number: EM9810, expiry date: unknown) as dose 1, single for covid-19 immunisation (age at vaccination: 69-years-old) from hospital. Medical history included glaucoma (atleast 15 - 20 years ago), raynaud's phenomenon. Concomitant medication(s) included latanoprost, netarsudil mesilate (ROCKLATAN) 1 drop, 1x/day (One drop right eye only once a day); dorzolamide hydrochloride, timolol maleate (COSOPT) 1 drop, 3x/day taken for glaucoma. On 17Feb2021 the patient experienced some periods of chills. States had a history of Raynaud's syndrome; it is a condition where, as temperature starts to get colder, the small blood vessels and extremities tends to close down which causes extremities like finger tips to turn red and then to white and this happens with everybody and it happens with Raynaud's people before it's almost like; it's over reaction to cold, it's not very serious its annoying more than it is serious but experienced may be not even full day but some periods of chills, and don't know if it had anything to do with Raynaud's or not this was about may be a week after the shot, know the chills can be among be the symptoms or side effects of the vaccine. Stated, "in this case anyone else might have similar reactions who has Raynaud's.". States " experienced it for 3 period of time; it is improved; not having the symptoms." The patient had not received treatment for the event. The outcome of the event is recovering.  Follow-up attempts completed. No further information expected.
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site movement impairment, Vaccination site pain, Vaccination site swelling
Clinical narrative: Arm was swollen so big and was in so much pain; Arm was swollen so big and was in so much pain; can't use the injection arm, can barely use it; This is a spontaneous report from a contactable consumer (patient) reporting for herself. A 70-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number: EM9809) dose 1, via an unspecified route of administration, administered in Arm on 10Feb2021 as dose 1 single (at the age of 70 years) for covid-19 immunisation. Patient received the vaccine to avoid getting the virus.The patient medical history and concomitant medications were not reported. The patient experienced arm was swollen so big and was in so much pain, can't use the injection arm, can barely use it all on 12Feb2021. Patient screamed with the pain, called the doctor shoulder specialist, stated Vaccine was given too high on the shoulder. COVID-19 Vaccine should not have been administered that high. She has been seeing this shoulder specialist for problems with her other shoulder. Therapeutic measures were taken as a result of event. Rubbed her arm with alcohol. Put ice and heat on it. The swelling has gone down, arm just hurts now. Went to physical therapy on Friday and will be going back sometime. Doctor put patient in physical therapy to treat for it, patient has problems with her other arm and is supposed to have surgery scheduled for it. She was supposed to take second dose on 03Mar2021. She Wants to take second COVID-19 Vaccine, but doctor  recommends reporter receives it in her hip. Asked what kinds of plans she can make for this. The outcome of the event Arm was swollen so big was recovering while the other events were not recovered.   Follow-up attempts are completed. No further information is expected.
Age: 67.0
Sex: M
Vaccine: COVID19
Symptoms: Condition aggravated, Erythema, Fatigue, Malaise, Pain in extremity
Clinical narrative: my arm was sore and red; a bit worse after the second vaccine; slight feeling of being unwell; mild fatigue; my arm was sore and red; This is a spontaneous report from a contactable consumer (Patient).  A 67-years-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot Number: EN9581,Expiry date was not reported), dose 2 via an unspecified route of administration, administered in Arm Right on 19Feb2021 at 11:15 (at the age of 67-years-old ) as dose 2,single for covid-19 immunisation. Medical history included cardiac disease, asthma, hypertension, penicillin allergy. Concomitant medication included metoprolol; rosuvastatin; tamsulosin, aspirin (ASPIRIN [ACETYLSALICYLIC ACID]). Historical vaccine included bnt162b2 (Lot number: EL3247) on 29Jan2021 at 11:30 in right arm as dose 1 for covid-19 immunisation and patient had experienced arm sore, red and headache. On 19Feb2021 at 21:30 the patient experienced "my arm was sore and red", a bit worse after the second vaccine, slight feeling of being unwell and mild fatigue. Event lasted within about an 24-36 hours. Both the events feeling of being unwell and mild fatigue resolved without treatment other than a Tylenol. The patient had not received any other vaccine within 4 weeks. Patient had not been diagnosed with COVID-19 prior to vaccination and had not been tested since the vaccination. The clinical outcome of the events was recovered on an unspecified day in 2021.  Follow-up attempts completed. No further information expected.