chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Chills, Dizziness, Fatigue, Headache
Clinical narrative: feeling unwell; dizziness; second vaccine: tiredness; second vaccine: elbow/joint pain; second vaccine: muscle pain; second vaccine: chills; second vaccine: fever; second vaccine: headache in her eyes; second vaccine: injection site pain, bubble entered in arm; This is a spontaneous report from a contactable consumer (patient) or other non-healthcare professional.  A 67-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number: EN6201), via an unspecified route of administration on 02Mar2021 14:15 (at the age of 67-year-old), as dose 2, single for COVID-19 immunization. Medical history included ongoing food allergy Verbatim: shellfish allergy. Concomitant medications included epinephrine (EPIPEN) taken for food allergy, start and stop date were not reported. Historical vaccine of patient included BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number: EN5318), via an unspecified route of administration on 09Feb2021 (at the age of 67-year-old), in Arm right (shoulder) as dose 1, single for COVID-19 immunization and experienced events after first dose of vaccination were injection site pain, weakness, body aches. Patient got the injection at 14:15 and felt injection site pain immediately. within 15 minutes, pretty quick around 14:30, the patient experienced headache in her eyes. The patient stated that it was a weird injection, like a bubble entered in her arm. Patient could feel the injection going into the body and stated she drove home with a headache, but didn't report it, because it wasn't a symptom that required medical attention. A headache was unusual for her. The patient felt unwell by noon (12:00) on 03Mar2021. 12 hours after the vaccine, it hit her intensely, had tiredness, dizziness, muscle pain, chills, fever and probably resolved 48 hours after the injection. The patient reported that these resolved on 04Mar2021. The patient stated that at first it was like the injection site pain, but more in her elbow/right arm from the injection. Patient's elbow hurt and joint pain, (specifically) and reported that it was ongoing, elbow still hurts, not any worse or any better. It was consistent, but did not subside, but comes back. Patient reported elbow/joint pain probably started at (noon) 12:00 on the 04Mar2021. Patient had a scheduled appointment with PCP when went on the 12Mar2021 and patient reported them all and the doctor said to call Pfizer. Patient was anxious to talk to him and didn't know if should take a booster. The clinical outcome of the event second vaccine: elbow/joint pain was not recovered while remaining events was recovered on 04mar2021.   No follow-up attempts are possible. No further information is expected
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site pain, Malaise, Myalgia, Pyrexia
Clinical narrative: feeling unwell; dizziness; second vaccine: tiredness; second vaccine: elbow/joint pain; second vaccine: muscle pain; second vaccine: chills; second vaccine: fever; second vaccine: headache in her eyes; second vaccine: injection site pain, bubble entered in arm; This is a spontaneous report from a contactable consumer (patient) or other non-healthcare professional.  A 67-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number: EN6201), via an unspecified route of administration on 02Mar2021 14:15 (at the age of 67-year-old), as dose 2, single for COVID-19 immunization. Medical history included ongoing food allergy Verbatim: shellfish allergy. Concomitant medications included epinephrine (EPIPEN) taken for food allergy, start and stop date were not reported. Historical vaccine of patient included BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number: EN5318), via an unspecified route of administration on 09Feb2021 (at the age of 67-year-old), in Arm right (shoulder) as dose 1, single for COVID-19 immunization and experienced events after first dose of vaccination were injection site pain, weakness, body aches. Patient got the injection at 14:15 and felt injection site pain immediately. within 15 minutes, pretty quick around 14:30, the patient experienced headache in her eyes. The patient stated that it was a weird injection, like a bubble entered in her arm. Patient could feel the injection going into the body and stated she drove home with a headache, but didn't report it, because it wasn't a symptom that required medical attention. A headache was unusual for her. The patient felt unwell by noon (12:00) on 03Mar2021. 12 hours after the vaccine, it hit her intensely, had tiredness, dizziness, muscle pain, chills, fever and probably resolved 48 hours after the injection. The patient reported that these resolved on 04Mar2021. The patient stated that at first it was like the injection site pain, but more in her elbow/right arm from the injection. Patient's elbow hurt and joint pain, (specifically) and reported that it was ongoing, elbow still hurts, not any worse or any better. It was consistent, but did not subside, but comes back. Patient reported elbow/joint pain probably started at (noon) 12:00 on the 04Mar2021. Patient had a scheduled appointment with PCP when went on the 12Mar2021 and patient reported them all and the doctor said to call Pfizer. Patient was anxious to talk to him and didn't know if should take a booster. The clinical outcome of the event second vaccine: elbow/joint pain was not recovered while remaining events was recovered on 04mar2021.   No follow-up attempts are possible. No further information is expected
Age: 59.0
Sex: M
Vaccine: COVID19
Symptoms: Blood test, Bone pain, Chills, Fatigue, Pain
Clinical narrative: shaking; chills; fever between 100-102F; bone aches; fatigue; body aches; This is a spontaneous report from a contactable consumer (patient) received via medical information team. A 59-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot Number: EN6206), via an unspecified route of administration in left arm on 11Mar2021 17:45 (at the age of 59-years-old) as dose 1, single for COVID-19 immunization. Medical history included ongoing HIV undetectable for 23 years, Hepatitis C and ongoing immunodeficiency (immune system is not in tip top shape). Concomitant medication included bictegravir sodium, emtricitabine, tenofovir alafenamide fumarate (BIKTARVY) taken for HIV and ongoing. No additional vaccines administered on same date of the BNT162B2. Prior to vaccination, the patient did not receive any vaccines within four weeks. His mother's side has, heart attack and high coronary disease, stroke blood pressure. The patient experienced fatigue and body aches on an unspecified date in Mar2021, fever between 100-102F and bone aches on 16Mar2021, shaking and chills on 19Mar2021 09:00. In the afternoon of vaccination, he started spiking fevers and bone aches. On 17Mar2021, he reported a fever of 101, reported that he tried to keep it under 100 so he was not shaking so much. One day before this report, nothing until last night early in evening on 18Mar2021, temperature was 100.6 F, Patient stated he took Tylenol 500 mg (Lot: P121400; Expiry date: Aug2023) and brought it back down, went to bed and woke up this morning shaking so hard couldn't hold the phone or put a thermometer in his mouth. When he finally got the thermometer in his mouth, his temperature was 103.4 on 19Mar2021. Stated that he is in bed with 4 quilts on him. His doctor is the infection disease specialist and he said that there should be no problem with any of the medications he's on, and he should go ahead and get any of the vaccines. Took 2 Tylenol (1000 mg) at 10:30 a.m. and not shivering as much and feels like fever is actually a fever and not that he is freezing shaking cold. Outcome of events was not resolved.  No follow-up attempts are possible. No further information is expected.
Age: 59.0
Sex: M
Vaccine: COVID19
Symptoms: Pyrexia, Tremor
Clinical narrative: shaking; chills; fever between 100-102F; bone aches; fatigue; body aches; This is a spontaneous report from a contactable consumer (patient) received via medical information team. A 59-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot Number: EN6206), via an unspecified route of administration in left arm on 11Mar2021 17:45 (at the age of 59-years-old) as dose 1, single for COVID-19 immunization. Medical history included ongoing HIV undetectable for 23 years, Hepatitis C and ongoing immunodeficiency (immune system is not in tip top shape). Concomitant medication included bictegravir sodium, emtricitabine, tenofovir alafenamide fumarate (BIKTARVY) taken for HIV and ongoing. No additional vaccines administered on same date of the BNT162B2. Prior to vaccination, the patient did not receive any vaccines within four weeks. His mother's side has, heart attack and high coronary disease, stroke blood pressure. The patient experienced fatigue and body aches on an unspecified date in Mar2021, fever between 100-102F and bone aches on 16Mar2021, shaking and chills on 19Mar2021 09:00. In the afternoon of vaccination, he started spiking fevers and bone aches. On 17Mar2021, he reported a fever of 101, reported that he tried to keep it under 100 so he was not shaking so much. One day before this report, nothing until last night early in evening on 18Mar2021, temperature was 100.6 F, Patient stated he took Tylenol 500 mg (Lot: P121400; Expiry date: Aug2023) and brought it back down, went to bed and woke up this morning shaking so hard couldn't hold the phone or put a thermometer in his mouth. When he finally got the thermometer in his mouth, his temperature was 103.4 on 19Mar2021. Stated that he is in bed with 4 quilts on him. His doctor is the infection disease specialist and he said that there should be no problem with any of the medications he's on, and he should go ahead and get any of the vaccines. Took 2 Tylenol (1000 mg) at 10:30 a.m. and not shivering as much and feels like fever is actually a fever and not that he is freezing shaking cold. Outcome of events was not resolved.  No follow-up attempts are possible. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Body temperature, Body temperature increased, Bone pain, Condition aggravated
Clinical narrative: I felt flu like symptoms that after another 6 hours worsened; I felt flu like symptoms that after another 6 hours worsened; bone/skull pain and aches; felt weakened; felt only like lying down; I had a temp that started that morning and at the highest was 102.4; I also have a spot of hives on my left temple; I feel a little off but not bad; This is a spontaneous report from a contactable consumer (patient).   A 64-year-old non pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot number was not reported), via an unspecified route of administration, administered in Arm Left on 15Mar2021 as dose 1, single for covid-19 immunisation from pharmacy or drug store. Medical history included cancer 16 years ago (None currently) and covid 19 for around 10 days, quite mild symptoms, last fall, Nov2020. The patient's concomitant medications were not reported. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient was not diagnosed with covid prior to vaccination and patient was not tested for COVID-19 post vaccination. After 12 hours from vaccine,  patient felt flu like symptoms that after another 6 hours worsened and she had bone/skull pain and aches, felt weakened, felt only like lying down and went to bed after another 6 hours and slept off and on, but not well. she had temp that started that morning and at the highest was 102.4. By the next morning though it was down and by noon it was very close to normal. she felt quite a lot better that day and even better the next. Then today, the fourth day, she feels a little off but not bad. Patient also have a spot of hives on my left temple. At least she believes they are never had them before.  The patient did not receive any treatment in response to the events. The outcome of the event s was recovered with sequelae.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected
Sex: F
Vaccine: COVID19
Symptoms: Feeling abnormal, Influenza like illness, Malaise, Urticaria
Clinical narrative: I felt flu like symptoms that after another 6 hours worsened; I felt flu like symptoms that after another 6 hours worsened; bone/skull pain and aches; felt weakened; felt only like lying down; I had a temp that started that morning and at the highest was 102.4; I also have a spot of hives on my left temple; I feel a little off but not bad; This is a spontaneous report from a contactable consumer (patient).   A 64-year-old non pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot number was not reported), via an unspecified route of administration, administered in Arm Left on 15Mar2021 as dose 1, single for covid-19 immunisation from pharmacy or drug store. Medical history included cancer 16 years ago (None currently) and covid 19 for around 10 days, quite mild symptoms, last fall, Nov2020. The patient's concomitant medications were not reported. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient was not diagnosed with covid prior to vaccination and patient was not tested for COVID-19 post vaccination. After 12 hours from vaccine,  patient felt flu like symptoms that after another 6 hours worsened and she had bone/skull pain and aches, felt weakened, felt only like lying down and went to bed after another 6 hours and slept off and on, but not well. she had temp that started that morning and at the highest was 102.4. By the next morning though it was down and by noon it was very close to normal. she felt quite a lot better that day and even better the next. Then today, the fourth day, she feels a little off but not bad. Patient also have a spot of hives on my left temple. At least she believes they are never had them before.  The patient did not receive any treatment in response to the events. The outcome of the event s was recovered with sequelae.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected
Sex: U
Vaccine: COVID19
Symptoms: Cough
Clinical narrative: Dry cough; This is a spontaneous report from a contactable consumer (Patient's friend) via Pfizer-sponsored program. A patient of an unspecified age and gender received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/Lot number was not reported), via an unspecified route of administration on an unspecified date as dose number unknown, single for COVID-19 immunization. Medical history and concomitant medications were not reported. The reporter reported that the patient (friend) talked about having a dry cough after having the vaccine on an unspecified date. The outcome of event was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal pain upper, Chills, Condition aggravated, Dizziness, Headache
Clinical narrative: Chills again; Headache again; Stomach Hurt really bad, worse than the first time; Fever; Very achy all over; Headache; Almost Passed Out/Lightheaded; Nauseous; Stomach Pain; Chills; This is a spontaneous report from a contactable consumer (patient).   A 65-years-old female patient received First dose of bnt162b2 (BNT162B2) (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/Lot Number: EN6202) administered in right arm via an unknown route of administration on 04Mar2021 as dose 1, single for covid-19 immunisation. The Patients Medical history and concomitant medications were not reported. On 05Mar2021, the patient got sick, Headache, lightheaded, almost passed out, nauseous, really bad stomach pain, and chills for 24 hours. On 06Mar2021, the patient didn't feel great, but states felt better and the patient states that she started feeling a little better but her stomach pains lingered, she wasn't nauseous. On 14Mar2021, the patient started getting sick, started with chills, woke up with headache, stomach hurt really bad; worse than it did on 05 Mar 2021.  Nauseous, fever, very achy all over and her joints hurt. The patient states she was sick all day on 15Mar2021 and started to feel better on 16Mar2021. On 17Mar2021, the patient states that all other symptoms are gone but that her stomach is still not right.  States she has been eating a little, has a little bit of pain; but that it is not back to normal yet. There were no Relevant tests was done. The outcome of all the events was reported as unknown. No follow-up attempts are possible. No further information is expected.
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Nausea, Pain, Pyrexia
Clinical narrative: Chills again; Headache again; Stomach Hurt really bad, worse than the first time; Fever; Very achy all over; Headache; Almost Passed Out/Lightheaded; Nauseous; Stomach Pain; Chills; This is a spontaneous report from a contactable consumer (patient).   A 65-years-old female patient received First dose of bnt162b2 (BNT162B2) (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/Lot Number: EN6202) administered in right arm via an unknown route of administration on 04Mar2021 as dose 1, single for covid-19 immunisation. The Patients Medical history and concomitant medications were not reported. On 05Mar2021, the patient got sick, Headache, lightheaded, almost passed out, nauseous, really bad stomach pain, and chills for 24 hours. On 06Mar2021, the patient didn't feel great, but states felt better and the patient states that she started feeling a little better but her stomach pains lingered, she wasn't nauseous. On 14Mar2021, the patient started getting sick, started with chills, woke up with headache, stomach hurt really bad; worse than it did on 05 Mar 2021.  Nauseous, fever, very achy all over and her joints hurt. The patient states she was sick all day on 15Mar2021 and started to feel better on 16Mar2021. On 17Mar2021, the patient states that all other symptoms are gone but that her stomach is still not right.  States she has been eating a little, has a little bit of pain; but that it is not back to normal yet. There were no Relevant tests was done. The outcome of all the events was reported as unknown. No follow-up attempts are possible. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Hypoaesthesia oral, Swelling face
Clinical narrative: face was swollen; she had a feeling as if someone had given a bunch of shots of Novocain in her mouth; This is a spontaneous report from a contactable consumer (patient) received via medical information team. A 69-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number and expiration date were not reported), via an unspecified route of administration on 09Mar2021 as dose 1, single for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient experienced face was swollen, and she had a feeling as if someone had given a bunch of shots of Novocain in her mouth on 18Mar2021 02:00. Patient stated on 18Mar2021 at 2 am she woke up and her face was swollen. Patient stated she thought it might have been attributed what she had for dinner and the salt content that caused the swelling. Patient took 1 tablet of Benadryl and drank a bunch of water so that the medicine could circulate through her system and she went back to bed. Patient stated the swelling went down some. Patient had a feeling as if someone had given a bunch of shots of Novocain in her mouth. Her face felt puffy, but it wasn't the best that she could describe it. She took more Benadryl when woke up as well as it seemed to be helping. Patient would like to know if this was a normal reaction because it happened a week after her first dose was given. Patient would like to know what she should do about the swelling if it continues. Patient would also like to know if she should receive the second dose. Outcome of events was resolving.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Sex: F
Vaccine: COVID19
Symptoms: Eye swelling, Lip swelling, Pruritus, Swelling of eyelid, Urticaria
Clinical narrative: her right eye to eyelid start to swell down; her right eye to eyelid start to swell down; hives through her body; lips swell; hands itchy; This is a spontaneous report from a contactable consumer (patient) received via medical information team. A 65-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number and expiration date were not reported), via an unspecified route of administration on 10Mar2021 as dose 2, single for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient experienced hands itchy on 12Mar2021, hives through her body and lips swell on 13Mar2021, her right eye to eyelid start to swell down on 14Mar2021. It was reported that patient had her hands itchy, but she did not give too much importance. Then on 13Mar2021, she had hives through her body and her lips swell. On 14Mar2021 she went to the emergency room because her right eye to eyelid start to swell down. She was treated there with steroids and Benadryl. On the day of this report, she did not take the Benadryl and got hives again this morning. Outcome of hives through her body was not resolved; outcome of remaining events was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Sex: F
Vaccine: COVID19
Symptoms: Eyelid disorder, Fatigue, Feeling abnormal, Hypersensitivity, Pruritus
Clinical narrative: she got a non-severe allergic reaction; It started in her right eye lid in her tear (also she received the vaccine in her right side), it was not swollen but it was feeling weird; then she had this sensation on her cheek  next to her nose and her cheekbone, caller states that it was a little bit swollen; Also after receiving the vaccine she felt sleepy(1:00PM) she felt very tired and sleepy; Also after receiving the vaccine she felt sleepy(1:00PM) she felt very tired and sleepy; had itching on her back; It started in her right eye lid in her tear (also she received the vaccine in her right side), it was not swollen but it was feeling weird; This is a spontaneous report from a contactable consumer (patient).  A 57-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot number was not reported), via an unspecified route of administration on 18Mar2021 as dose 1, single for covid-19 immunisation. Medical history included allergies for other medications and she also takes high blood pressure medication. The patient non-severe allergic reaction. It started in her right eye lid in her tear (also she received the vaccine in her right side), it was not swollen but it was feeling weird, then they let her go half hour later and 40 minutes after she started feeling something on her felt upper lip in the right side, it was feeling different in the corner, then she had this sensation on her cheek  next to her nose and her cheekbone, caller states that it was a little bit swollen but it wasn't obvious, she noticed this when she looked herself in the mirror she could feel it when she talked like if she was going to bite her cheek on the inside, she has the sensation like it was hard but not really hard, it stopped but then she felt it again. She called her doctor, and her doctor told her to take Benadryl if it was bothering her. She didn't take anything and waited, today she took Benadryl because she felt her cheek a little different it is still swollen in the inside and after taking it felt very sleepy. Also after receiving the vaccine she felt sleepy(1:00PM) she felt very tired and sleepy so she took a nap from 3:00 to 5:30, she also had itching on her back but she didn't have anything, she felt it again last night but she has no redness or bumps, just the itching. Patient wants to know. if she should receive the second dose of the vaccine. The outcome of the events was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected
Sex: F
Vaccine: COVID19
Symptoms: Somnolence, Swelling face
Clinical narrative: she got a non-severe allergic reaction; It started in her right eye lid in her tear (also she received the vaccine in her right side), it was not swollen but it was feeling weird; then she had this sensation on her cheek  next to her nose and her cheekbone, caller states that it was a little bit swollen; Also after receiving the vaccine she felt sleepy(1:00PM) she felt very tired and sleepy; Also after receiving the vaccine she felt sleepy(1:00PM) she felt very tired and sleepy; had itching on her back; It started in her right eye lid in her tear (also she received the vaccine in her right side), it was not swollen but it was feeling weird; This is a spontaneous report from a contactable consumer (patient).  A 57-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot number was not reported), via an unspecified route of administration on 18Mar2021 as dose 1, single for covid-19 immunisation. Medical history included allergies for other medications and she also takes high blood pressure medication. The patient non-severe allergic reaction. It started in her right eye lid in her tear (also she received the vaccine in her right side), it was not swollen but it was feeling weird, then they let her go half hour later and 40 minutes after she started feeling something on her felt upper lip in the right side, it was feeling different in the corner, then she had this sensation on her cheek  next to her nose and her cheekbone, caller states that it was a little bit swollen but it wasn't obvious, she noticed this when she looked herself in the mirror she could feel it when she talked like if she was going to bite her cheek on the inside, she has the sensation like it was hard but not really hard, it stopped but then she felt it again. She called her doctor, and her doctor told her to take Benadryl if it was bothering her. She didn't take anything and waited, today she took Benadryl because she felt her cheek a little different it is still swollen in the inside and after taking it felt very sleepy. Also after receiving the vaccine she felt sleepy(1:00PM) she felt very tired and sleepy so she took a nap from 3:00 to 5:30, she also had itching on her back but she didn't have anything, she felt it again last night but she has no redness or bumps, just the itching. Patient wants to know. if she should receive the second dose of the vaccine. The outcome of the events was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected
Sex: F
Vaccine: COVID19
Symptoms: Rash, Vaccination site urticaria
Clinical narrative: after his mother received her first Pfizer Covid vaccine she developed a rash; Hives were just on her arms and legs/hives started around the injection site; This is a spontaneous report from a contactable consumer (patient). A 73-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot Number: not reported), via an unspecified route of administration on Jan2021 as single dose for COVID-19 immunisation. Medical history included cancer. The patient's concomitant medications were not reported. On Feb2021, the patient experienced rash and hives on her arms/legs around the injection site. It was reported as per caller that about one week after his mother received her first Pfizer COVID vaccine, she developed a rash. Caller states that when his mother had the first shot, the hives were just on her arms and legs. The clinical outcome of the events was recovered, on unspecified date in Feb2021.   No follow up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Erythema, Flushing, Pain in extremity, Palpitations
Clinical narrative: get a little red; flushing of his face; Heart racing a little inside; sore arm; This is a spontaneous report from a contactable consumer (patient).   A 69-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot number was not reported), via an unspecified route of administration on 01Mar2021 as dose 1, single for covid-19 immunisation. Medical history included patient occasionally drinks a glass of wine and also has a sensitivity to Tylenol with the same heart-racing response. The patient's concomitant medications were not reported. O 19Mar2021, patient experienced flushing of his face- get a little red only after having a few sips wine, usually starting with his nose, and his heart "feels a little race-y, inside". The reaction is not tolerable, and he cannot finish a glass of wine, regardless of if its white or red. No allergic reaction to wine/alcohol before getting the vaccine. Heart racing a little inside- do not take any Tylenol or stuff like that. Patient also had sore arm. Patient second dose of vaccine was due on 21Mar2021. The outcome of the event was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected
Sex: F
Vaccine: COVID19
Symptoms: Infectious mononucleosis, Oropharyngeal pain, Pyrexia
Clinical narrative: After 1 week, she was diagnosed with "mono"; fever; sore throat; This is a spontaneous report from a contactable consumer (patient) via Pfizer-sponsored program  Support.   A female patient of an unspecified age received bnt162b2 (Pfizer-BioNTech COVID-19 Vaccine, solution for injection), dose 1 via an unspecified route of administration on 04Mar2021 (Batch/Lot number was not reported) as DOSE 1, SINGLE for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. After 1 week, the patient was diagnosed with mono on an unspecified date in Mar2021. Patient had fever and sore throat on an unspecified date in 2021. She took antibiotics, Tylenol and ibuprofen for the events. She had been taking Tylenol every day. The patient wanted to know if she could proceed with her second dose on 24Mar2021. Outcome of the events was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Sex: F
Vaccine: COVID19
Symptoms: Cough, Dysphonia
Clinical narrative: a little hoarse; a little cough; This is a spontaneous report from a contactable consumer (patient). A 60-year-old female patient bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot number was not), 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. The patient felt a little hoarse, a little cough since she had her vaccine. The outcome of the event was unknow.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected
Age: 48.0
Sex: F
Vaccine: COVID19
Symptoms: Blood urine present, Epistaxis, Menstruation irregular, Rhinorrhoea
Clinical narrative: Yesterday I got the first dose and today at wakeup I felt runny nose; blood on both nosetrils; Blood in my urine; My period came early by 10 days; This is a spontaneous report from a contactable consumer or other non-health care professional (patient). A 48-year-old non-pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection), dose 1 via an unspecified route of administration, administered in Arm Left on 18Mar2021 at 14:00 (Batch/Lot Number: EP6955) as dose 1, single (at the age of 48-year-old) for covid-19 immunization. The patient was not pregnant at the time of vaccination. Medical history included Graves' disease, hypertension and anxiety from an unknown date and unknown if ongoing. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient did not have allergies to medications, food, or other products. Concomitant medications (other medications received within 2 weeks of vaccination) included celecoxib (CELEXA), meloxicam and famotidine all taken for an unspecified indication, start and stop date were not reported. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient stated yesterday she got the first dose and today at wake up she felt runny nose, but it was blood on both nostrils and blood in her urine on 19Mar2021 at 02:00 AM and she went to the bathroom and noticed that her period came early by 10 days on 19Mar2021. Since the vaccination, the patient has not tested for COVID-19. No treatment received for the adverse events. The outcome of events was reported as not recovered.   No follow-up attempts are needed. No further information is expected.
Age: 68.0
Sex: M
Vaccine: COVID19
Symptoms: Chest discomfort, Dizziness, Feeling abnormal, Headache, Nausea
Clinical narrative: chest discomfort; headache/Terrible headache; nausea/Feeling kind of queasy again; dizziness; feeling pretty bad/ just not feeling his self again/ reverted back to feeling kind of crappy; This is a spontaneous report from a contactable consumer (patient). A 68-years-old male patient received bnt162b2 (BNT162B2, Solution for injection, Batch/Lot number was not reported) via an unspecified route of administration, administered in Arm Left on 15Mar2021 at 14:30 (at the age of 68-year-old) as dose 1, single for COVID-19 immunization. Medical history included bad heart, 8 stents, Quadruple bypass, Died on the table during a heart cath, COVID Infection, pneumonia, 3 widow makers (he survived). The patient's concomitant medications were not reported. On 16Mar2021 the patient experienced headache/terrible headache, nausea, dizziness, feeling pretty bad/ just not feeling his self again/ reverted back to feeling kind of crappy. On 28Mar2021, the patient experienced chest discomfort. It was reported that 16Mar2021 Onset in the morning of feeling pretty bad for about a half the day. He took Ibuprofen because he had terrible headache. After that about half of the day he felt good. Felt good 17Mar2021 and 18Mar2021, back to normal. On 19Mar2021 When he woke this morning he reverted back to feeling kind of crappy, had dizziness, headache and just feeling kind of queasy again. He took another Ibuprofen and the headache is finally starting to go away, events are getting better after about 4 hours or so. He is just not feeling his self again. It was reported that on 28Mar2021 he had chest discomfort because he is a heart patient. He would like to know if the Pfizer-BIoNtech Covid-19 vaccine can give heart problems to this type of patients. It was reported that he already reported this to Safety. It was reported that the patient scheduled to receive the second dose of the vaccine on 05APR2021. Patient received treatment for the events headache, nausea, dizziness, feeling abnormal with Ibuprofen. Outcome of the event chest discomfort was unknown and other events was recovering.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Age: 24.0
Sex: F
Vaccine: COVID19
Symptoms: Lymphadenopathy, Rash, Vaccination site rash
Clinical narrative: lymph nodes were swollen in her armpit and in the back of her neck; rash in her armpit; rash on the shoulder where she got vaccinated; This is a spontaneous case received contactable consumer or other non-health care professional (patient). A 24-years-old female received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number was not reported) via an unspecified route of administration on 16Mar2021 (age at the time of vaccination was 24 years old) as a dose 1, single for COVID-19 immunization. Medical history and concomitant medications were not reported. On an unspecified date in Mar2021, the patient experienced lymph nodes were swollen in her armpit and in the back of her neck, rash in her armpit and rash on the shoulder where she got vaccinated. Caller received the first dose of the Pfizer-BioNtech Covid-19 vaccine on Tuesday 16MAR2021, the following day her lymph nodes were swollen in her armpit and in the back of her neck the nodes in her arm pit are still la little bit and those in the back of her neck hurt when she touched them, the following day her lymph nodes were not swollen but she had a rash in her armpit. Today around 11 she had a rash on the shoulder where she got vaccinated, it was not too big, it was the size of her hand, this lasted for 3 hours and is gone now. She would like to know if it's safe for her to receive the second dose of the vaccine. She wants to know if she should be concerned. And if she should still get second dose. The clinical outcome of rash on the shoulder where she got vaccinated was recovered on an unspecified date in 2021, while clinical outcome of lymph nodes was swollen in her armpit and in the back of her neck and rash in her armpit was unknown.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Insomnia, Pruritus, Urticaria
Clinical narrative: hives; it itches too much that it prevents her from sleeping; it itches too much that it prevents her from sleeping; This is a spontaneous report from a contactable nurse. A 67-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, administered in Right arm on 19Jan2021 16:00 (Batch/Lot Number: EL3249) as dose 2, single for COVID-19 immunisation. The patient medical history included blood pressure and cholesterol. Concomitant medications included gliclazide (DIAZIDE) for blood pressure from 2014; vitamin D and calcium taking over 5 years, for bones; linum usitatissimum oil (FLAXSEED OIL) taking over for heart, cholesterol; biotin taking over 5 years for hair and skin. Patient had no history of previous immunisations and did not receive any other vaccines within four weeks. No family history reported. Historical vaccine included first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), lot number : EK9231, via an unspecified route of administration in right arm, on 29Dec2021 16:00, as single dose for COVID-19 immunization. On 20Jan2021, she first noticed hives on the left hand and she thought they were bites on her knuckles. But then the hives appeared on her back and then it went to her chin, face, arms, legs, toes. The patient added they were most noticeable at night; and they were very itchy hives. At first they thought it might be related to the mask she has to wear, but now she didn't think the hives related because even when she is home for five days with no masks or gloves or any exposure to the chemicals at work, she still had the hives. The patient added the second dose of the vaccine is the dose she is concerned about. She didn't have anything after the first dose. The patient added she started taking Zyrtec and then added Pepcid because it is a H1 blocker and still continued to have hives. At night she took Benadryl and sometimes famotidine, too. After two weeks, she tried two Medrol dose packs and they did nothing. The patient added nothing has changed in her routine at home of showering or of soaps, creams, shampoos since before the vaccination. She believes the second dose of the vaccine caused the hives. The patient added she thinks it is an immune response maybe to a preservative in the vaccine. The patient added at the night on 18Mar2021 about 12:30, she didn't take any medication and woke up with such intense itching that she had to take a Benadryl. It itched too much that it prevented her from sleeping. The patient mentioned she worked in surgery three 12 hour shifts and then two 8s and has not had time to go to a doctor. The patient added she did show the hives to the surgeons she works with. The patient added she was not allergic to anything.  She has an appointment with dermatologist on 27Apr2021. No relevant test was done. The outcome of the event insomnia was unknown and of other events was not recovered.  No follow-up attempts are needed. No further information is expected.
Age: 80.0
Sex: M
Vaccine: COVID19
Symptoms: Burning sensation, Feeling abnormal, Herpes zoster, Pain in extremity, Pruritus
Clinical narrative: he felt so bad, went back to bed, it burns, sore/terrible pain on the inside of his thigh; burning and itching inner upper right thigh, kind of like shingles; he felt so bad, went back to bed, it burns, sore/terrible pain on the inside of his thigh; maybe a little rash, she can't tell/may be a slight rash; burning and itching inner upper right thigh, kind of like shingles; burning and itching inner upper right thigh, kind of like shingles; This is a spontaneous report from a contactable consumer from medical information team via Pfizer Sponsored Program. This consumer reported information for three similar patients. This is the first of three reports. An 80-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE; solution for injection, lot number, expiration date was not reported) via an unspecified route of administration, on 17Mar2021 (at the 80-years-old), at dose 2, single for covid-19 immunization. Medical history included shingles before, on his chest, several years ago, had postherpetic neuralgia pain, had a stroke on 16Jan (as reported) and blood pressure problems. The patient's concomitant medications were not reported. Historical vaccine included bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE; solution for injection, lot number, expiration date was not reported) via an unspecified route of administration, on an unspecified date (at the 80-years-old), at dose 1, single for covid-19 immunization. The patient experienced little rash, she can't tell/may be a slight rash, burning and itching inner upper right thigh, kind of like shingles, he felt so bad; went back to bed, it burns on Mar2021, sore/terrible pain on the inside of his thigh on 19Mar2021.  The outcome of the events was unknown.    No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021312432 Same reporter/drug and different patient/events;US-PFIZER INC-2021312433 Same reporter/drug and different patient/events
Age: 80.0
Sex: M
Vaccine: COVID19
Symptoms: Rash
Clinical narrative: he felt so bad, went back to bed, it burns, sore/terrible pain on the inside of his thigh; burning and itching inner upper right thigh, kind of like shingles; he felt so bad, went back to bed, it burns, sore/terrible pain on the inside of his thigh; maybe a little rash, she can't tell/may be a slight rash; burning and itching inner upper right thigh, kind of like shingles; burning and itching inner upper right thigh, kind of like shingles; This is a spontaneous report from a contactable consumer from medical information team via Pfizer Sponsored Program. This consumer reported information for three similar patients. This is the first of three reports. An 80-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE; solution for injection, lot number, expiration date was not reported) via an unspecified route of administration, on 17Mar2021 (at the 80-years-old), at dose 2, single for covid-19 immunization. Medical history included shingles before, on his chest, several years ago, had postherpetic neuralgia pain, had a stroke on 16Jan (as reported) and blood pressure problems. The patient's concomitant medications were not reported. Historical vaccine included bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE; solution for injection, lot number, expiration date was not reported) via an unspecified route of administration, on an unspecified date (at the 80-years-old), at dose 1, single for covid-19 immunization. The patient experienced little rash, she can't tell/may be a slight rash, burning and itching inner upper right thigh, kind of like shingles, he felt so bad; went back to bed, it burns on Mar2021, sore/terrible pain on the inside of his thigh on 19Mar2021.  The outcome of the events was unknown.    No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021312432 Same reporter/drug and different patient/events;US-PFIZER INC-2021312433 Same reporter/drug and different patient/events
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal pain, Arthralgia, Diarrhoea, Dizziness, Hypersomnia
Clinical narrative: Severe abdominal cramps; Diarrhea; Dizzy; Almost passed out; Slept most; Mild pain in elbow and wrist/right knee in lots if pain (not normal), and left elbow; This is a spontaneous report from a contactable consumer (patient). A 67-year-old female non pregnant patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE; solution for injection, lot number: Er2613, expiration date was not reported) via an unspecified route of administration, in left arm, on 18Mar2021 11:30 (at the age of 67-year-old), at dose 1, single for covid-19 immunization from doctor's office/urgent care. Medical history included CAD (coronary artery disease), PVC's (ventricular extrasystoles), Sjogrens high cholesterol, allergies to Percoset (OXYCODONE HYDROCHLORIDE; OXYCODONE TEREPHTHALATE; PARACETAMOL), pork, history of vasovagal when sick from pork allergies. Concomitant medications included atorvastatin; acetylsalicylic acid (ASPIRIN LOW). Prior to vaccination the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the covid-19 vaccine. The patient experienced severe abdominal cramps, diarrhea, dizzy, almost passed out, slept most, mild pain in elbow and wrist on 19Mar2021 03:00, right knee in lots if pain (not normal), and left elbow on 21Mar2021. No treatment was reported for the events. The outcome of the event right knee in lots if pain (not normal), and left elbow was not recovered, and severe abdominal cramps, diarrhea, dizzy, almost passed out, slept most, mild pain in elbow and wrist were recovered on Mar2021.    No follow-up attempts are needed. No further information is expected.
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Presyncope
Clinical narrative: Severe abdominal cramps; Diarrhea; Dizzy; Almost passed out; Slept most; Mild pain in elbow and wrist/right knee in lots if pain (not normal), and left elbow; This is a spontaneous report from a contactable consumer (patient). A 67-year-old female non pregnant patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE; solution for injection, lot number: Er2613, expiration date was not reported) via an unspecified route of administration, in left arm, on 18Mar2021 11:30 (at the age of 67-year-old), at dose 1, single for covid-19 immunization from doctor's office/urgent care. Medical history included CAD (coronary artery disease), PVC's (ventricular extrasystoles), Sjogrens high cholesterol, allergies to Percoset (OXYCODONE HYDROCHLORIDE; OXYCODONE TEREPHTHALATE; PARACETAMOL), pork, history of vasovagal when sick from pork allergies. Concomitant medications included atorvastatin; acetylsalicylic acid (ASPIRIN LOW). Prior to vaccination the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the covid-19 vaccine. The patient experienced severe abdominal cramps, diarrhea, dizzy, almost passed out, slept most, mild pain in elbow and wrist on 19Mar2021 03:00, right knee in lots if pain (not normal), and left elbow on 21Mar2021. No treatment was reported for the events. The outcome of the event right knee in lots if pain (not normal), and left elbow was not recovered, and severe abdominal cramps, diarrhea, dizzy, almost passed out, slept most, mild pain in elbow and wrist were recovered on Mar2021.    No follow-up attempts are needed. No further information is expected.