chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 72.0
Sex: M
Vaccine: COVID19
Symptoms: Nausea, Pyrexia, Tinnitus
Clinical narrative: Tinnitus/ringing in ears; Fever; Nausea; This is a spontaneous report from a contactable consumer (patient). A 72-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection; lot number: ENU202 and expiration date not reported), via intramuscular, administered in Arm Left, on 02Mar2021 15:00 (at the age of 72-year-old), as dose 2, single, for COVID-19 immunisation in clinic at a football stadium. Patient had no medical history of compromised immune status, respiratory illness, genetic /chromosomal abnormalities, endocrine abnormalities (including diabetes) and obesity: None. The patient was allergic to sulfa drugs. There were no concomitant medications. The patient previously took statins and lipitor [atorvastatin] and experienced allergy years ago. Patient had no family history. Historical vaccines included shingles vaccine (manufacturer, lot or expiration unknown) about a year ago and was very sick for 36 hours, fever, nausea and did not get second dose; Flu vaccine on Sep2020; and BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection; lot number: EL9269 and expiration date not reported), via intramuscular, administered in Arm Left, on 09Feb2021 (at the age of 72-year-old), as dose 1, single, for COVID-19 immunisation in clinic at a football stadium. No additional vaccines administered on same date of the Pfizer suspect. No prior vaccinations within 4 weeks. The patient experienced fever and nausea on 03Mar2021 11:00. On 20Mar2021 evening, the patient experienced tinnitus. He got a hissing noise, ringing in ears and thought it was something in the kitchen. It has been constant. He was able to sleep, but it was annoying. Patient had no relevant test. The outcome of fever and nausea was recovering while the outcome of tinnitus was not recovered.  No follow-up attempts are possible. No further information is expected.
Age: 73.0
Sex: M
Vaccine: COVID19
Symptoms: Pruritus
Clinical narrative: Itching on both ears, back of neck, left arm and behind both knees occurred after his first dose Pfizer Vaccine also.; This is a spontaneous report from a contactable nurse (patient's wife). A 73-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, administered in left arm on 26Feb2021 (at the age of 73-year-old) (Lot Number: EN6203) as dose 1, single for COVID-19 immunization. Medical history included COVID-19 (in October). The patient's concomitant medications were none. The patient did not receive any other vaccine within 4 weeks prior to COVID vaccine. The patient experienced itching on both ears, back of neck, left arm and behind both knees occurred on an unspecified date. The outcome of the events was unknown.  No follow-up attempts are possible. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Headache, Loss of personal independence in daily activities, Pyrexia
Clinical narrative: fever; headache; couldn't function; This is a spontaneous report from a contactable consumer reported for a patient (Fiance). A 60-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Formulation: Solution for injection, Lot number and Expiration Date was not reported) via an unspecified route of administration on an unspecified date as dose 1, single for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient experienced fever, headache and couldn't function on an unspecified date. It was reported that, his symptoms began at 3 pm on Wednesday as well with a fever, headache, couldn't function and felt like he hit a wall. Caller enquired if they should get 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.
Age: 49.0
Sex: M
Vaccine: COVID19
Symptoms: Contusion
Clinical narrative: bruising appear on my right hip; This is a spontaneous report from a non-contactable consumer (patient). A 49-years-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), via an unspecified route of administration, administered in left arm on 23Mar2021 11:00 (Lot Number: EN6200) (at the age of 49-years-old) as dose 2, single for covid-19 immunisation. Medical history included cholesterol, high blood pressure and elevated uric acid. The patient had no known allergies. The patient received other concomitant medications within two weeks of vaccination. The patient did not receive other vaccine within four weeks of vaccination. The patient did not have COVID prior vaccination and was not tested for COVID post vaccination. Historical vaccine included bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), administered in left arm on 18Feb2021 (Lot Number: EN6200) (at the age of 49-years-old) as dose 1, single for covid-19 immunisation and experienced grade two muscle tear in left pectoral muscle. On the day of reporting on 25Mar2021, 2 days after second vaccination, he had bruising appeared on his right hip without any related injury, pain or trauma. The patient received treatment for the event. The patient did not visit doctor for bruising till the time of reporting. The outcome of the event was not recovered.  No follow-up attempts are possible. No further information is expected.
Age: 72.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Chills, Headache, Influenza like illness
Clinical narrative: Feels like the flu; joint ache; chills; headache; This is a spontaneous report from a contactable consumer (patient). A 72-years-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; solution for injection, Lot Number: ER8727), dose 1 via an unspecified route of administration, administered in Arm Left on 26Mar2021 (at the age of 72-years-old) as a single dose for covid-19 immunization. Medical history included depression- Additional Information for Other Conditions: Diagnosed many years ago when he was young. The patient's concomitant medications were not reported. On 29Mar2021, the patient experienced joint ache, chills and headache after receiving the vaccine. Also feels like the flu on an unspecified date. The caller is wondering is it okay for him to take Ibuprofen. The caller is scheduled for 21April2021 for his second shot. Outcome of the event joint ache, chills and headache was not recovered and rest other event was unknown. No follow-up attempts are possible. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Back pain, Decreased appetite, Feeling abnormal, Pain
Clinical narrative: Back pain; Back and hip problem; she is in pain; Feeling wiped out; feeling bad in the morning; Loss of appetite during lunch and dinner; Achy feeling in the body and always wanted to go to bed and sleep; Achy feeling in the body and always wanted to go to bed and sleep; This is a spontaneous report from a Pfizer sponsored program received from a contactable consumer (patient). A female patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCCINE; Batch/Lot number was not reported), via an unspecified route of administration on 09Mar2021 as dose 1, single for COVID-19 immunisation. The patient's medical history and the concomitant medications were not reported. In Mar2021, the patient experienced back pain, back and hip problem; she was in pain was feeling wiped out; feeling bad in the morning and then loss of appetite during lunch and dinner and had achy feeling in the body and always wanted to go to bed and sleep. She was supposed to receive a medication and injection for her pain but her doctor advised her that after second vaccination only the doctor will give that medication because he was concerned whether that would have an effect of the vaccine to. The outcome was unknown for the reported events.  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
Clinical narrative: Back pain; Back and hip problem; she is in pain; Feeling wiped out; feeling bad in the morning; Loss of appetite during lunch and dinner; Achy feeling in the body and always wanted to go to bed and sleep; Achy feeling in the body and always wanted to go to bed and sleep; This is a spontaneous report from a Pfizer sponsored program received from a contactable consumer (patient). A female patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCCINE; Batch/Lot number was not reported), via an unspecified route of administration on 09Mar2021 as dose 1, single for COVID-19 immunisation. The patient's medical history and the concomitant medications were not reported. In Mar2021, the patient experienced back pain, back and hip problem; she was in pain was feeling wiped out; feeling bad in the morning and then loss of appetite during lunch and dinner and had achy feeling in the body and always wanted to go to bed and sleep. She was supposed to receive a medication and injection for her pain but her doctor advised her that after second vaccination only the doctor will give that medication because he was concerned whether that would have an effect of the vaccine to. The outcome was unknown for the reported events.  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: Body temperature, Chills, Fatigue, Headache, Pyrexia
Clinical narrative: Pain & swelling at the injection site; Pain & swelling at the injection site; low grade fever (100.3); chills; fatigue; headache; This is a spontaneous report from a contactable consumer. A 38-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot number was not reported), via an unspecified route of administration on 08Feb2021 at the age of 38-year-old as dose 2, single for covid-19 immunisation.  The patient medical history and concomitant medications none. The patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot number was not reported), via an unspecified route of administration on unspecified  date as dose 1, single for covid-19 immunisation. On 09Feb2021, patient experienced pain and swelling at the injection site, low grade fever (100.3), chills, fatigue and headache. her symptoms lasted about 2 days. she felt normal by the 3rd day. The outcome of the event was recovered on 11Feb2021.  No follow-up attempts are possible. No further information is expected.
Age: 38.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pain, Vaccination site swelling
Clinical narrative: Pain & swelling at the injection site; Pain & swelling at the injection site; low grade fever (100.3); chills; fatigue; headache; This is a spontaneous report from a contactable consumer. A 38-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot number was not reported), via an unspecified route of administration on 08Feb2021 at the age of 38-year-old as dose 2, single for covid-19 immunisation.  The patient medical history and concomitant medications none. The patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot number was not reported), via an unspecified route of administration on unspecified  date as dose 1, single for covid-19 immunisation. On 09Feb2021, patient experienced pain and swelling at the injection site, low grade fever (100.3), chills, fatigue and headache. her symptoms lasted about 2 days. she felt normal by the 3rd day. The outcome of the event was recovered on 11Feb2021.  No follow-up attempts are possible. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Dysphagia, Heart rate, Heart rate increased, Lip swelling, Swelling face
Clinical narrative: I felt my lips and my tongue my face swelled; I felt my lips and my tongue my face swelled; I felt my lips and my tongue my face swelled; It had like fast heart  beat it wasn't severe; I was already feeling like couldn't swallow normally; This is a spontaneous report from a contactable consumer (patient). A 59-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot Number: ER2613, Expiration date: Not reported), via an unspecified route of administration in left upper arm, on an unspecified date as dose 1, single for COVID-19 immunization. The patient's medical history was not reported. The patient's concomitant medications included high blood pressure medication and inflammatory muscle relaxer for her back but not in that morning. Fifteen to sixteen minutes after the vaccination, on an unspecified date, the patient had noticed symptoms but once the patient left the center, she felt that her lips, her tongue and her face were swollen. She also had fast heart beat, it wasn't severe but makes her a little bit concerned about it and felt that she should turn around and go back or driven to the hospital or something but by the time she left home, she already had the feeling like she couldn't swallow normally between 3 hours and it was fine. She also informed that she was definitely going to get the second dose which was scheduled on 13Apr2021. The patient was questioning whether these events happens about 20 minutes later. She actually stayed there for 16 minutes because of long car lines but it hits her like after leaving the facility about 20 minutes later, she started to feel these symptoms. She also questioned that what kind of precaution should she take before her second vaccination and whether she needs to inform the individual who were vaccinating her at that time to let her stay more than 15 mins until an hour. The patient also reported that she was more concerned about having a stronger reaction after the second vaccine. The patient received antihistamines as treatment for these events. The outcome of these events was recovered (reported as improved) on an unspecified date.    No follow-up attempts are possible. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Swollen tongue
Clinical narrative: I felt my lips and my tongue my face swelled; I felt my lips and my tongue my face swelled; I felt my lips and my tongue my face swelled; It had like fast heart  beat it wasn't severe; I was already feeling like couldn't swallow normally; This is a spontaneous report from a contactable consumer (patient). A 59-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot Number: ER2613, Expiration date: Not reported), via an unspecified route of administration in left upper arm, on an unspecified date as dose 1, single for COVID-19 immunization. The patient's medical history was not reported. The patient's concomitant medications included high blood pressure medication and inflammatory muscle relaxer for her back but not in that morning. Fifteen to sixteen minutes after the vaccination, on an unspecified date, the patient had noticed symptoms but once the patient left the center, she felt that her lips, her tongue and her face were swollen. She also had fast heart beat, it wasn't severe but makes her a little bit concerned about it and felt that she should turn around and go back or driven to the hospital or something but by the time she left home, she already had the feeling like she couldn't swallow normally between 3 hours and it was fine. She also informed that she was definitely going to get the second dose which was scheduled on 13Apr2021. The patient was questioning whether these events happens about 20 minutes later. She actually stayed there for 16 minutes because of long car lines but it hits her like after leaving the facility about 20 minutes later, she started to feel these symptoms. She also questioned that what kind of precaution should she take before her second vaccination and whether she needs to inform the individual who were vaccinating her at that time to let her stay more than 15 mins until an hour. The patient also reported that she was more concerned about having a stronger reaction after the second vaccine. The patient received antihistamines as treatment for these events. The outcome of these events was recovered (reported as improved) on an unspecified date.    No follow-up attempts are possible. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Erythema, Hyperhidrosis, Pain, Pain in extremity
Clinical narrative: little fever; some sweating; arm was itching and pinkish/ middle finger it has some redness,redness across the nail bed; real sore up there in the arm /fingers are sore/fingers are tender; arm is itching and pinkish; In the shot area, the area was real tender and real sore; little dizzy; little aching; In the shot area, the area was real tender and real sore,and then, it started itching.; This is a spontaneous report from a contactable consumer (patient). A female patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection; lot number and expiration date: not reported), via an unspecified route of administration, in Right Arm, on 12Mar2021, as DOSE 2, SINGLE for covid-19 immunization. The patient's medical history and concomitant medications were not reported. Historical vaccine included BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection; lot number and expiration date: not reported), via an unspecified route of administration, on 20Feb2021, as DOSE 1, SINGLE for covid-19 immunization and her arm just got sore. On Mar2021 the patient became just a little dizzy but that went on away. The patient had a problem with a little aching but she slept that off. On 12Mar2021 patient got real sore up there in the arm and she rubbed alcohol on it. The soreness went down her arm and it was itching and pinkish. The soreness went on down to about 2 or 3 of fingers, her fingers are sore. It's her middle finger- it has some redness, like a streak across there, redness was across the nail bed of both fingers. These fingers are tender. The patient further stated that she had a little fever too and she had taken Tylenol but that went away, and she drank plenty of water. The patient clarified she had the fever on 13Mar2021 (the next day after the vaccine) and she did some sweating when she was sleeping. After that, her fever went away. In the shot area, the area was real tender and real sore, and then, it started itching. The outcome of the events dizziness, Pain in extremity, Fever was recovered, while outcome of all other events was unknown at time of report.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Pruritus, Pyrexia, Vaccination site pain, Vaccination site pruritus
Clinical narrative: little fever; some sweating; arm was itching and pinkish/ middle finger it has some redness,redness across the nail bed; real sore up there in the arm /fingers are sore/fingers are tender; arm is itching and pinkish; In the shot area, the area was real tender and real sore; little dizzy; little aching; In the shot area, the area was real tender and real sore,and then, it started itching.; This is a spontaneous report from a contactable consumer (patient). A female patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection; lot number and expiration date: not reported), via an unspecified route of administration, in Right Arm, on 12Mar2021, as DOSE 2, SINGLE for covid-19 immunization. The patient's medical history and concomitant medications were not reported. Historical vaccine included BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection; lot number and expiration date: not reported), via an unspecified route of administration, on 20Feb2021, as DOSE 1, SINGLE for covid-19 immunization and her arm just got sore. On Mar2021 the patient became just a little dizzy but that went on away. The patient had a problem with a little aching but she slept that off. On 12Mar2021 patient got real sore up there in the arm and she rubbed alcohol on it. The soreness went down her arm and it was itching and pinkish. The soreness went on down to about 2 or 3 of fingers, her fingers are sore. It's her middle finger- it has some redness, like a streak across there, redness was across the nail bed of both fingers. These fingers are tender. The patient further stated that she had a little fever too and she had taken Tylenol but that went away, and she drank plenty of water. The patient clarified she had the fever on 13Mar2021 (the next day after the vaccine) and she did some sweating when she was sleeping. After that, her fever went away. In the shot area, the area was real tender and real sore, and then, it started itching. The outcome of the events dizziness, Pain in extremity, Fever was recovered, while outcome of all other events was unknown at time of report.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 29.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Headache, Nausea, Pyrexia
Clinical narrative: Headache; Fever; Nausea; Chills; This is a spontaneous report from a contactable consumer or other non hcp (patient). A 29-years-old male patient received bnt162b2 (BNT162B2, Solution for injection, Batch/lot number was not provided) via unspecified route of administration, administered in arm left on 25Mar2021 12:00 (Age at vaccination: 29 years old) as dose number unknown, single for COVID-19 immunization. The patient medical history and concomitant medications was not reported. Patient had no allergies to medications, food, or other products. The patient received other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient not diagnosed with COVID-19, since the vaccination, the patient had not tested for COVID-19. The patient did not receive, any other medications within 2 weeks of vaccination. On 28Mar2021, patient experienced fever, nausea, chills and headache. Patient had not received treatment for the adverse event. The outcome for the events was recovered on an unspecified date.  No follow-up attempts are needed; Information about lot/batch number cannot be obtained.
Sex: F
Vaccine: COVID19
Symptoms: Pruritus
Clinical narrative: itchy patch on her back; This is a spontaneous report from a contactable consumer (patient). A 73-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), dose 1 via an unspecified route of administration on an unspecified date (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. It was reported that the patient initially asked if the Pfizer's vaccine cover against the new variants, and she wanted to know how long after the second dose the vaccine is fully effective. The patient reportedly developed an itchy patch on her back two and a half weeks after her first dose of the Pfizer BioNTech Covid 19 vaccine. She still has this itchy patch and is going to a dermatologist. The patient asked if this was from the vaccine. The outcome of the event was not resolved. The event required a Physician Office Visit.   No follow-up attempts are possible; information about batch/lot number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Hypersensitivity, Illness, Middle ear effusion
Clinical narrative: had been sick with allergies; with allergies; fluid on the eardrum; This is a spontaneous report from a contactable consumer (patient) received from a Pfizer-sponsored program. A female patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/Lot number was not reported), via an unspecified route of administration on 02Mar2021 as dose 1, single for COVID-19 immunisation. The patient medical history and concomitant medications were not reported.  On an unspecified date, the patient had been sick with allergies, and there were fluid on the eardrum. The physician prescribed antibiotics and steroid shots. At the time of report, she started taking 2 pills on 23Mar2021 (last night) and 2 on 24Mar2021 (this morning), continuously up to 7 days as per advised and a shot of Steroid 23Mar2021, afternoon. Her second dose of the vaccine was scheduled on 23Mar2021, where she wanted to reschedule it on 01Apr2021. 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.
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Dry throat, Erythema, Fatigue, Panic attack, Pruritus
Clinical narrative: panic attack; tiredness; thirsty; throat and tongue completely dry; Fever 100.4; throat and tongue completely dry; itchiness, not sure if that is brought by anxiety/itching on face and arms; turned red from top of the head to waist/redness /solid bright red; This is a spontaneous report from a contactable consumer (patient). A 61-years-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution injection; Batch/Lot Number: EN6206; Expiration Date: 21Jun2021), via an unspecified route of administration, administered in Arm Left on 09Mar2021 at 13:20 as single dose for covid-19 immunisation. Medical history included highly allergic to Iodine, type 2 diabetes mellitus and she had two aortic stents in place. She stopped smoking in 2016. Concomitant medication included levothyroxine sodium taken for thyroid disorder from 2017 and ongoing. The patient previously took iodine and experienced drug hypersensitivity. Patient did not receive any vaccinations within four weeks prior to the first administration date of the suspect vaccine. After vaccination, patient experienced a reaction. She was not sure if it was considered an allergic reaction. Caller stated she is highly allergic to Iodine and they asked that she stay 30 minutes instead of 15 minutes after the shot for monitoring. Caller stated she waited the 30 minutes and got up and felt fine. Caller stated she was very thirsty, her throat and tongue were completely dry. She got up and went to the pharmacy because it was the closest place for her to get a bottle of water. Caller stated that the thirst and dryness went away right after drinking some water. Caller within 30 minutes of leaving where she got the shot, she turned red from the top of her head to her waist, she turned bright red on her arms, chest and face. She had itching on her face and arms. She kept scratching her face. Caller stated she is not sure the itching is due to her anxiety about the situation or the Pfizer COVID-19 vaccine. Caller stated she had a fever of 100.4. She came home took Zyrtec and Tylenol and the fever came down immediately and the redness lasted approximately 45 more minutes and then it went away. The next day on 10Mar2021, she was just tired, and she went to bed in the middle of the day and slept for 6 hours. She had a little bit of scratching, but she thought it was more from the anxiety of the circumstance. She did not have welts, she was just solid bright red. Caller stated that she was scheduled to get her second shot today at 1320 and was almost into a panic attack about having another one. She was concerned since reactions get worse, not better. She can deal with the fatigue and fever, she just does not want to have problems breathing. The outcome all the events was recovered on 09Mar2021. The outcome of the event tiredness was recovered on 10Mar2021.  No follow-up attempts are possible. No further information is expected.
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia, Thirst, Tongue dry
Clinical narrative: panic attack; tiredness; thirsty; throat and tongue completely dry; Fever 100.4; throat and tongue completely dry; itchiness, not sure if that is brought by anxiety/itching on face and arms; turned red from top of the head to waist/redness /solid bright red; This is a spontaneous report from a contactable consumer (patient). A 61-years-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution injection; Batch/Lot Number: EN6206; Expiration Date: 21Jun2021), via an unspecified route of administration, administered in Arm Left on 09Mar2021 at 13:20 as single dose for covid-19 immunisation. Medical history included highly allergic to Iodine, type 2 diabetes mellitus and she had two aortic stents in place. She stopped smoking in 2016. Concomitant medication included levothyroxine sodium taken for thyroid disorder from 2017 and ongoing. The patient previously took iodine and experienced drug hypersensitivity. Patient did not receive any vaccinations within four weeks prior to the first administration date of the suspect vaccine. After vaccination, patient experienced a reaction. She was not sure if it was considered an allergic reaction. Caller stated she is highly allergic to Iodine and they asked that she stay 30 minutes instead of 15 minutes after the shot for monitoring. Caller stated she waited the 30 minutes and got up and felt fine. Caller stated she was very thirsty, her throat and tongue were completely dry. She got up and went to the pharmacy because it was the closest place for her to get a bottle of water. Caller stated that the thirst and dryness went away right after drinking some water. Caller within 30 minutes of leaving where she got the shot, she turned red from the top of her head to her waist, she turned bright red on her arms, chest and face. She had itching on her face and arms. She kept scratching her face. Caller stated she is not sure the itching is due to her anxiety about the situation or the Pfizer COVID-19 vaccine. Caller stated she had a fever of 100.4. She came home took Zyrtec and Tylenol and the fever came down immediately and the redness lasted approximately 45 more minutes and then it went away. The next day on 10Mar2021, she was just tired, and she went to bed in the middle of the day and slept for 6 hours. She had a little bit of scratching, but she thought it was more from the anxiety of the circumstance. She did not have welts, she was just solid bright red. Caller stated that she was scheduled to get her second shot today at 1320 and was almost into a panic attack about having another one. She was concerned since reactions get worse, not better. She can deal with the fatigue and fever, she just does not want to have problems breathing. The outcome all the events was recovered on 09Mar2021. The outcome of the event tiredness was recovered on 10Mar2021.  No follow-up attempts are possible. No further information is expected.
Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Illness, Pyrexia, SARS-CoV-2 test
Clinical narrative: fever; really tired; sick; This is a spontaneous report from a contactable consumer or other non hcp.   A 72-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection), dose 1 via an unspecified route of administration, administered in Arm Right on 08Mar2021 (Age at vaccination 72 years old) (Batch/Lot number was not reported) as DOSE 1, SINGLE, dose 2 via an unspecified route of administration on 30Mar2021 (Batch/Lot number was not reported) as DOSE 2, SINGLE for covid-19 immunisation. Medical history included arthralgia verbatim: Joint Pain, breast cancer verbatim: Breast cancer, hypertension verbatim: high blood pressure, pneumonia verbatim: pneumonia, sleep disorder verbatim: Sleep from an unknown date and unknown if ongoing. No Prior Vaccinations within 4 weeks. Concomitant medication(s) included zolpidem tartrate (AMBIEN) taken for sleep disorder, tramadol (TRAMADOL) taken for arthralgia, start and stop date were not reported. on 09Mar2021 01:00 The patient experienced fever, really tired, sick. Caller states that she received her second dose of the Pfizer BioNTech COVID-19 vaccine today and is wondering if she should have taken Tylenol beforehand. Caller also mentions that when she received her first dose of the vaccine, she experienced a fever the next morning. The patient underwent lab tests and procedures which included sars-cov-2 test negative on, sars-cov-2 test negative on, sars-cov-2 test negative on, sars-cov-2 test negative on 14Dec2020.  Therapeutic measures were taken as a result of fever (pyrexia), really tired (fatigue), sick (illness). Outcome of the events was recovered on unspecified date of 2021. PSCC Communication: The caller was provided the contact number, #, option 3, and hours of operation of 8AM-8PM Monday through Friday and 9AM to 3PM Saturday and Sunday, for COVID vaccine calls prior to attempted warm transfer to Medical Information.  Caller wishes to speak with a live agent. Due to high call volume caller elects to be placed in the hold queue to continue holding for an agent. Follow up attempts are completed. No further information is expected.
Age: 90.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal discomfort, Abnormal dreams, Back pain, Body temperature, Fatigue
Clinical narrative: Sick to her stomach, not sure if she has vomited, but is upset; Very bad headache/ terrible headache; Fever; She is achy and fatigued/ Extremely fatigue; Hasn't drank much liquid; Doesn't feel too good/Today and last night seems to be ill; Doesn't want to get out of bed/ she still feels awful.; Sore arm right arm injection site; Vivid dreams; Had a back ache; She is achy and fatigued; This is a spontaneous report from a contactable consumer (daughter of patient). A 90-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot Number: EN6203), via an unspecified route of administration, administered in Arm Right on 20Mar2021 (at the age of 90-year-old) as dose 2, single for covid-19 immunisation. Medical history included hypothyroidism, alzheimer's from an unknown date and unknown if ongoing. The concomitant medications include thyroid pill. The patient previously received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/Lot Number: EL9266), administered in Arm Right on 22Feb2021 (at the age of 90-year-old) as dose 1, single for covid-19 immunisation. Patient did not receive any vaccines within 4 weeks of getting first COVID19 vaccine. The caller reported that her mother had her second dose of the Pfizer covid vaccine 20Mar2021, today and last night (unspecified date) seemed to be ill. The caller stated that her mother had fever last night (29Mar2021) and vivid dreams. That kind of thing, vivid dreams, were usual when she has a fever. She was extremely fatigue and sick to her stomach and has a terrible headache. This morning (30Mar2021) it was at 98 degrees, sick to her stomach, not sure if she has vomited, but is upset, very bad headache, and she had a backache for a couple of days. Her mother only had the fever last night. It was 97 this (30Mar2021) morning, but she still felt awful. She has no arm pain; she was achy and fatigued. Initial reaction was headache and sore arm right arm injection site. She had not drunk much liquid since last night. She does not want to get out of bed. Does not feel too good. The caller was asking was it too late to be having a reaction to the vaccine. Seriousness of the events was reported as non-serious. The patient underwent lab tests and procedures which included body temperature: 98 on 30Mar2021, body temperature: 97 on 30Mar2021. The outcome of fever, vivid dreams, backache, pain, vaccination site pain was unknown, and fatigue, fluid intake reduced, malaise, feeling abnormal, Stomach upset, headache was not recovered.  No follow-up attempts are needed. No further information is expected.
Age: 90.0
Sex: F
Vaccine: COVID19
Symptoms: Feeling abnormal, Fluid intake reduced, Headache, Malaise, Pain
Clinical narrative: Sick to her stomach, not sure if she has vomited, but is upset; Very bad headache/ terrible headache; Fever; She is achy and fatigued/ Extremely fatigue; Hasn't drank much liquid; Doesn't feel too good/Today and last night seems to be ill; Doesn't want to get out of bed/ she still feels awful.; Sore arm right arm injection site; Vivid dreams; Had a back ache; She is achy and fatigued; This is a spontaneous report from a contactable consumer (daughter of patient). A 90-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot Number: EN6203), via an unspecified route of administration, administered in Arm Right on 20Mar2021 (at the age of 90-year-old) as dose 2, single for covid-19 immunisation. Medical history included hypothyroidism, alzheimer's from an unknown date and unknown if ongoing. The concomitant medications include thyroid pill. The patient previously received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/Lot Number: EL9266), administered in Arm Right on 22Feb2021 (at the age of 90-year-old) as dose 1, single for covid-19 immunisation. Patient did not receive any vaccines within 4 weeks of getting first COVID19 vaccine. The caller reported that her mother had her second dose of the Pfizer covid vaccine 20Mar2021, today and last night (unspecified date) seemed to be ill. The caller stated that her mother had fever last night (29Mar2021) and vivid dreams. That kind of thing, vivid dreams, were usual when she has a fever. She was extremely fatigue and sick to her stomach and has a terrible headache. This morning (30Mar2021) it was at 98 degrees, sick to her stomach, not sure if she has vomited, but is upset, very bad headache, and she had a backache for a couple of days. Her mother only had the fever last night. It was 97 this (30Mar2021) morning, but she still felt awful. She has no arm pain; she was achy and fatigued. Initial reaction was headache and sore arm right arm injection site. She had not drunk much liquid since last night. She does not want to get out of bed. Does not feel too good. The caller was asking was it too late to be having a reaction to the vaccine. Seriousness of the events was reported as non-serious. The patient underwent lab tests and procedures which included body temperature: 98 on 30Mar2021, body temperature: 97 on 30Mar2021. The outcome of fever, vivid dreams, backache, pain, vaccination site pain was unknown, and fatigue, fluid intake reduced, malaise, feeling abnormal, Stomach upset, headache was not recovered.  No follow-up attempts are needed. No further information is expected.
Age: 90.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia, Vaccination site pain
Clinical narrative: Sick to her stomach, not sure if she has vomited, but is upset; Very bad headache/ terrible headache; Fever; She is achy and fatigued/ Extremely fatigue; Hasn't drank much liquid; Doesn't feel too good/Today and last night seems to be ill; Doesn't want to get out of bed/ she still feels awful.; Sore arm right arm injection site; Vivid dreams; Had a back ache; She is achy and fatigued; This is a spontaneous report from a contactable consumer (daughter of patient). A 90-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot Number: EN6203), via an unspecified route of administration, administered in Arm Right on 20Mar2021 (at the age of 90-year-old) as dose 2, single for covid-19 immunisation. Medical history included hypothyroidism, alzheimer's from an unknown date and unknown if ongoing. The concomitant medications include thyroid pill. The patient previously received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/Lot Number: EL9266), administered in Arm Right on 22Feb2021 (at the age of 90-year-old) as dose 1, single for covid-19 immunisation. Patient did not receive any vaccines within 4 weeks of getting first COVID19 vaccine. The caller reported that her mother had her second dose of the Pfizer covid vaccine 20Mar2021, today and last night (unspecified date) seemed to be ill. The caller stated that her mother had fever last night (29Mar2021) and vivid dreams. That kind of thing, vivid dreams, were usual when she has a fever. She was extremely fatigue and sick to her stomach and has a terrible headache. This morning (30Mar2021) it was at 98 degrees, sick to her stomach, not sure if she has vomited, but is upset, very bad headache, and she had a backache for a couple of days. Her mother only had the fever last night. It was 97 this (30Mar2021) morning, but she still felt awful. She has no arm pain; she was achy and fatigued. Initial reaction was headache and sore arm right arm injection site. She had not drunk much liquid since last night. She does not want to get out of bed. Does not feel too good. The caller was asking was it too late to be having a reaction to the vaccine. Seriousness of the events was reported as non-serious. The patient underwent lab tests and procedures which included body temperature: 98 on 30Mar2021, body temperature: 97 on 30Mar2021. The outcome of fever, vivid dreams, backache, pain, vaccination site pain was unknown, and fatigue, fluid intake reduced, malaise, feeling abnormal, Stomach upset, headache was not recovered.  No follow-up attempts are needed. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Headache, Pyrexia, Vision blurred
Clinical narrative: This is a spontaneous report from a contactable consumer (patient). A female patient, of an unspecified age, received the 1st dose of BNT162B2 (Comirnaty, batch/lot# not reported), via an unspecified route of administration, on Mar 24, 2021, single dose, for COVID-19 immunisation. Medical history and concomitant medications not reported. Prior vaccination, patient was exposed to COVID. On Mar 24, 2021, patient experienced blurring of vision, fever and headache. Her second dose scheduled on Apr 14, 2021. The outcome of the events: unknown. No follow-up attempts possible. Information about lot/batch number cannot be obtained. No further information expected.
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Pain in extremity
Clinical narrative: sore arm; redness; This is a spontaneous report from a contactable consumer (patient). A female patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), dose 2 via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as dose 2, single for Covid-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient previously received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), dose 1 via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as dose 1, single for Covid-19 immunisation. The patient stated that she got her second dose of the vaccine the day prior and was asking if she can be around people who she is not sure if they are vaccinated. She also asked the days she is fully vaccinated and if she can be around people who have had Covid. The patient then added that she experienced sore arm and redness after getting her vaccine but stated that she is already okay. The patient was also asking if there is a possibility that she could get a fake vaccine or a saltwater vaccine injected in her, and if she can drink alcohol after getting the vaccine. The events resolved in 2021.   No follow-up attempts are possible; information about batch/lot number cannot be obtained. No further information is expected.
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Pyrexia
Clinical narrative: headache; little fever; This is a spontaneous report from a contactable consumer (patient).   A 68-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE; solution for injection, lot number: EN6200, expiration date was not reported) via an unspecified route of administration, on 27Feb2021 16:00 (at the age of 68-years-old), at dose 1, single for covid-19 immunization. Medical history included allergy to arthropod sting. The patient's concomitant medications were not reported. The patient had a normal very mild reaction to the vaccination and stated that it was like a headache/ little headache and a little fever on the first day after the first dose of vaccination (28Feb2021). The patient had the second dose vaccination on 20Mar2021 15:30 (lot number: EN6205) for covid-19 immunization. The outcome of the events was unknown.     Follow-up (30Mar2021): No follow-up attempts are possible. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Cough, Vomiting
Clinical narrative: coughing; vomiting; This is a spontaneous report from a non-contactable consumer (patient). A female patient of an unspecified age received BNT162B2 (Pfizer-BioNTech COVID-19 vaccine), via an unspecified route of administration on 23Mar2021 (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 reported that on an unspecified date in Mar2021, since she received the second dose of BNT162B2, she had been coughing and vomiting. The patient wanted to know if this reaction is still related to the vaccine. She also wanted to know how long the side effects would last. 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: U
Vaccine: COVID19
Symptoms: Upper respiratory tract congestion, Urticaria
Clinical narrative: I had a very congested head and pretty good reaction to it; I had hives; Hives in my mouth, my eyes and my fingers; This is a spontaneous report from a contactable consumer (patient). A patient of unspecified age and gender received 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 dose number unknown, single for covid-19 immunization. The patient medical history and concomitant medications were not reported. The patient experienced very congested head and pretty good reaction to it and hives in mouth, eyes, and fingers on an unspecified date. 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.
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Eye pain, Fatigue, Feeling abnormal, Flushing
Clinical narrative: Low grade fever; Chills; Muscle ache; Fatigue; Foggy feeling 15 minutes after getting the vaccine; Flushed; Jaw ache; Headache; Sore neck; Right eye pain; This is a spontaneous report from a contactable consumer (patient). A 61-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), intramuscular, administered in left arm on 23Mar2021 14:45 (at the age of 61-year-old) (Lot Number: EP6955; Expiration Date: 30Jun2021) as dose 2, single for COVID-19 immunization. Medical history included type 2 diabetes mellitus from 2018 and ongoing, blood pressure high, vitamin D low, prophylaxis,. Concomitant medication(s) included valsartan taken for hypertension from 2018 and ongoing; hydrochlorothiazide taken for hypertension from 2017 and ongoing; aspirin taken for prophylaxis from 2015 and ongoing; vitamin D nos taken for vitamin d decreased from 2016 and ongoing; calcium carbonate taken for an unspecified indication from 2019 and ongoing. Historical vaccine included BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), intramuscular, administered in left arm on 03Mar2021 (at the age of 61-year-old) (Lot Number: EL3248) as dose 1, single for COVID-19 immunization and experienced upper abdominal swelling, mottling on abdomen and abdomen was kind of lump. The patient did not receive any other vaccines. On 23Mar2021, the patient experienced foggy feeling 15 minutes after getting the vaccine, flushed, jaw ache, headache, sore neck, right eye pain, fatigue and on 24Mar2021, low grade fever, chills, muscle ache. The outcome of headache and fatigue was recovering and the outcome of other events was recovered.  No follow-up attempts are possible. No further information is expected.