chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Fatigue, Malaise, Nausea, Pain
Clinical narrative: Got a ball like a golf ball as diameter at injection site/ I have got ball in my arm I have got a ball about the size of a tennis ball; Rash near elbow but not injection site; Fever; Feeling down kind of not feeling well; Fatigue, tiredness; Dizziness; Nausea; Aching for few days all over the body; Very achy; arm is sore; Aching for few days all over the body but still feeling it at the injection site; This is a spontaneous report from a contactable consumer (patient) received from a Pfizer- sponsored program. A 64-year-old female 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 10Apr2021 as dose 2, single for COVID-19 immunization. Historical vaccine included 1st dose of BNT162B2 (Lot number and expiration date was not reported) via an unspecified route of administration on 20Mar2021 for COVID-19 immunization. Medical history included diabetes mellitus and obesity from an unknown date and unknown if ongoing. The patient's concomitant medications were not reported. The patient experienced got a ball like a golf ball as diameter at injection site/ i have got ball in my arm i have got a ball about the size of a tennis ball, rash near elbow but not injection site, fever, feeling down kind of not feeling well, fatigue, tiredness, dizziness, nausea, aching for few days all over the body, very achy, arm is sore, aching for few days all over the body but still feeling it at the injection site on an unspecified date. It was reported that, after received the 2nd dose she experienced injection site swelling about the size of a tennis ball, nausea, fatigue, fever and pain on the arm. Patient took it on Saturday and had got ball in her arm, got a ball like a golf ball as diameter at injection site and rash near elbow but not injection site. She was feeling still tired. After 4 days she had got a ball about the size of a tennis ball. It has not gone down. It was hot. Her arm was sore and she was still very achy and very fatigue. She asked if that was normal for this shot and could she have this reaction for this long. Also had fever for 1 day then it was ok also was feeling down kind of not feeling well. Added symptoms as fatigue, tiredness, dizziness, nausea, aching for few days all over the body but still felt it at the injection site. She enquired if rash, the ball on her injection site, the fatigue and not feeling well was normal. The 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: Pain in extremity, Pyrexia, Rash, Vaccination site mass, Vaccination site pain
Clinical narrative: Got a ball like a golf ball as diameter at injection site/ I have got ball in my arm I have got a ball about the size of a tennis ball; Rash near elbow but not injection site; Fever; Feeling down kind of not feeling well; Fatigue, tiredness; Dizziness; Nausea; Aching for few days all over the body; Very achy; arm is sore; Aching for few days all over the body but still feeling it at the injection site; This is a spontaneous report from a contactable consumer (patient) received from a Pfizer- sponsored program. A 64-year-old female 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 10Apr2021 as dose 2, single for COVID-19 immunization. Historical vaccine included 1st dose of BNT162B2 (Lot number and expiration date was not reported) via an unspecified route of administration on 20Mar2021 for COVID-19 immunization. Medical history included diabetes mellitus and obesity from an unknown date and unknown if ongoing. The patient's concomitant medications were not reported. The patient experienced got a ball like a golf ball as diameter at injection site/ i have got ball in my arm i have got a ball about the size of a tennis ball, rash near elbow but not injection site, fever, feeling down kind of not feeling well, fatigue, tiredness, dizziness, nausea, aching for few days all over the body, very achy, arm is sore, aching for few days all over the body but still feeling it at the injection site on an unspecified date. It was reported that, after received the 2nd dose she experienced injection site swelling about the size of a tennis ball, nausea, fatigue, fever and pain on the arm. Patient took it on Saturday and had got ball in her arm, got a ball like a golf ball as diameter at injection site and rash near elbow but not injection site. She was feeling still tired. After 4 days she had got a ball about the size of a tennis ball. It has not gone down. It was hot. Her arm was sore and she was still very achy and very fatigue. She asked if that was normal for this shot and could she have this reaction for this long. Also had fever for 1 day then it was ok also was feeling down kind of not feeling well. Added symptoms as fatigue, tiredness, dizziness, nausea, aching for few days all over the body but still felt it at the injection site. She enquired if rash, the ball on her injection site, the fatigue and not feeling well was normal. The outcome of the events was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Fatigue, Muscle spasms, Pain, Pyrexia
Clinical narrative: body aches, joints/shooting pain; body aches, joints/joint, neck and shoulder pain after the first dose; fatigue; dozing on and off cause he's had no sleep; spasms; fever; This is a spontaneous report from a contactable consumer (patient). A 56-year-old male patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number and Expiration date: unknown), via an unspecified route of administration, administered at an unspecified anatomical location on 14Apr2021 08:00 as dose 1, single for COVID-19 immunization. The patient medical history included two surgeries in his spine. Concomitant medications were not reported. On an unspecified date in Apr2021, the patient experienced body aches, joints, fatigue, neck and shoulder pain. Patient states that he dozing on and off cause he's had no sleep because it started getting to him at 02:00-03:00. He had spasms and shooting pain from his fusion, and his bad bones, the patient had got a lot of broken bones (inaudible side effects). Patient later mentioned fever, back of his skull, the fusion in his spine was standard but it's kicking more. Patient was wondering if he can take aspirin or tramadol. The outcome of all events was unknown.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Sex: M
Vaccine: COVID19
Symptoms: Somnolence
Clinical narrative: body aches, joints/shooting pain; body aches, joints/joint, neck and shoulder pain after the first dose; fatigue; dozing on and off cause he's had no sleep; spasms; fever; This is a spontaneous report from a contactable consumer (patient). A 56-year-old male patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number and Expiration date: unknown), via an unspecified route of administration, administered at an unspecified anatomical location on 14Apr2021 08:00 as dose 1, single for COVID-19 immunization. The patient medical history included two surgeries in his spine. Concomitant medications were not reported. On an unspecified date in Apr2021, the patient experienced body aches, joints, fatigue, neck and shoulder pain. Patient states that he dozing on and off cause he's had no sleep because it started getting to him at 02:00-03:00. He had spasms and shooting pain from his fusion, and his bad bones, the patient had got a lot of broken bones (inaudible side effects). Patient later mentioned fever, back of his skull, the fusion in his spine was standard but it's kicking more. Patient was wondering if he can take aspirin or tramadol. The outcome of all events was unknown.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Age: 48.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Contusion, Odynophagia
Clinical narrative: A bruise on the left side of her mouth; Pain when swallowing and drinking water; Joint pain; This is a spontaneous report from a contactable consumer (patient). A 48-years-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection, Batch/Lot Number: not reported), dose 1 via an unspecified route of administration on 23Mar2021 (at the age of 48-years-old) as a DOSE 1, SINGLE for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient experienced joint pain on 24Mar2021 with outcome of recovered, on an unspecified date he had a bruise on the left side of her mouth and pain when swallowing and drinking water. Reporter mentioned that he got the first dose of the Pfizer covid vaccine on 23Mar2021. The next two days he suffered from joint pain that went away on the third day. But one week after getting the vaccine, while he was eating, he felt that something under her tongue burst up and after a while that he checked this up, he said a bruise on the left side of her mouth. This got him pain when swallowing and drinking water. This has disappeared also. He mentioned that he should have received the second dose but when he went to the vaccination post and described his experienced, they changed his appointment and sent him to his doctor. He just wanted to know if he should get the second dose or not. He reported that, he read that there might be swelling on the lymph nodes after the vaccine, and he thinks that this is what happened to him. Case was reported as non-serious. PQC was not present. Outcome of the joint pain was resolved on 26Mar2021 whereas, rest of the events were resolved on an unspecified date.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Sex: F
Vaccine: COVID19
Symptoms: Face oedema, Tongue disorder
Clinical narrative: face was swollen; tongue felt fat; This is a spontaneous report from a contactable consumer. A female patient with unknown age received bnt162b2 (COMIRNATY PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Strength: unknown, Batch/Lot Number: unknown) through an unspecified route on an unspecified date as Dose 1 SINGLE for covid-19 immunization. The patient medical history included she had shellfish allergy. Concomitant medications were not reported. Reporter stated that she went last Saturday to get her first dose of the Covid vaccine at 4:15 in the afternoon and at 3 am her face was swollen, and tongue felt fat, She was afraid to go to the walk-in because she did not want to come in contact with someone who has Covid. She took Benadryl but that did not work. The patient was asked to take prednisone. The outcome of the event was unknown.  No follow up attempts are possible. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Eye swelling, Headache, Hypersensitivity, Nausea, Pain
Clinical narrative: allergic reaction; swelling of her eyes and face; swelling of her eyes and face; headaches; nausea; fever; body aches; This is a spontaneous report received from a contactable consumer (patient).  A 24-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/Lot number-unknown, Expiry date-unknown) via an unspecified route of administration, on unspecified date of Apr2021 as Dose 1, Single for covid-19 immunisation. The patient's medical history and concomitant medication were not reported. Patient experienced headaches, nausea, fever, bodyaches after first dose of the vaccine. On 14Apr2021 patient experienced allergic reaction that was manifested in swelling of her eyes and face. The patient received treatment with taken Tylenol, Ibuprofen and Aspirin it was reported that the medication had helped with 60% of the symptoms but have not eliminated them completely. The outcome of all events were recovering.  No follow-up attempts are needed. Information about lot/batch number cannot be obtained.
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia, Swelling face
Clinical narrative: allergic reaction; swelling of her eyes and face; swelling of her eyes and face; headaches; nausea; fever; body aches; This is a spontaneous report received from a contactable consumer (patient).  A 24-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/Lot number-unknown, Expiry date-unknown) via an unspecified route of administration, on unspecified date of Apr2021 as Dose 1, Single for covid-19 immunisation. The patient's medical history and concomitant medication were not reported. Patient experienced headaches, nausea, fever, bodyaches after first dose of the vaccine. On 14Apr2021 patient experienced allergic reaction that was manifested in swelling of her eyes and face. The patient received treatment with taken Tylenol, Ibuprofen and Aspirin it was reported that the medication had helped with 60% of the symptoms but have not eliminated them completely. The outcome of all events were recovering.  No follow-up attempts are needed. Information about lot/batch number cannot be obtained.
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Body temperature, Chills, Dizziness, Fatigue
Clinical narrative: my arm started hurting where shot was, then whole arm started hurting, then I could not lift it; muscle pain; could not sleep at all last night; I have the chills; itch; I am in pain, ache all over; nausea; dizziness; weakness; tiredness; headache; feeling unwell; sore throat; 101.4 F temperature; This is a spontaneous report from a contactable consumer or other non hcp.   A 53-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Batch/Lot number EW0153), dose 1 via an unspecified route of administration on 14Apr2021 as DOSE 1 SINGLE for covid-19 immunisation.  The patient medical history was not reported. The patient's concomitant medications were not reported.  On 14Apr2021, the patient stated that I got the first dose of the Pfizer Covid 19 vaccine yesterday,. Later one in the day, my arm started hurting where shot was, then whole arm started hurting, then I could not lift it, could not sleep at all last night, very excruciating.  I have the chills, I itch, I am in pain, ache all over, nausea, dizziness, weakness, tiredness, headache, muscle pain, chills, fever, feeling unwell, and sore throat. No additional details provided.  She declined transfer to Safety but consented to further follow-up from Safety. The patient underwent lab tests and procedures which included 101.4 F temperature on an unknown date. The outcome of all events was an unknown
Sex: F
Vaccine: COVID19
Symptoms: Headache, Insomnia, Malaise, Myalgia, Nausea
Clinical narrative: my arm started hurting where shot was, then whole arm started hurting, then I could not lift it; muscle pain; could not sleep at all last night; I have the chills; itch; I am in pain, ache all over; nausea; dizziness; weakness; tiredness; headache; feeling unwell; sore throat; 101.4 F temperature; This is a spontaneous report from a contactable consumer or other non hcp.   A 53-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Batch/Lot number EW0153), dose 1 via an unspecified route of administration on 14Apr2021 as DOSE 1 SINGLE for covid-19 immunisation.  The patient medical history was not reported. The patient's concomitant medications were not reported.  On 14Apr2021, the patient stated that I got the first dose of the Pfizer Covid 19 vaccine yesterday,. Later one in the day, my arm started hurting where shot was, then whole arm started hurting, then I could not lift it, could not sleep at all last night, very excruciating.  I have the chills, I itch, I am in pain, ache all over, nausea, dizziness, weakness, tiredness, headache, muscle pain, chills, fever, feeling unwell, and sore throat. No additional details provided.  She declined transfer to Safety but consented to further follow-up from Safety. The patient underwent lab tests and procedures which included 101.4 F temperature on an unknown date. The outcome of all events was an unknown
Sex: F
Vaccine: COVID19
Symptoms: Oropharyngeal pain, Pain, Pain in extremity, Pruritus, Pyrexia
Clinical narrative: my arm started hurting where shot was, then whole arm started hurting, then I could not lift it; muscle pain; could not sleep at all last night; I have the chills; itch; I am in pain, ache all over; nausea; dizziness; weakness; tiredness; headache; feeling unwell; sore throat; 101.4 F temperature; This is a spontaneous report from a contactable consumer or other non hcp.   A 53-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Batch/Lot number EW0153), dose 1 via an unspecified route of administration on 14Apr2021 as DOSE 1 SINGLE for covid-19 immunisation.  The patient medical history was not reported. The patient's concomitant medications were not reported.  On 14Apr2021, the patient stated that I got the first dose of the Pfizer Covid 19 vaccine yesterday,. Later one in the day, my arm started hurting where shot was, then whole arm started hurting, then I could not lift it, could not sleep at all last night, very excruciating.  I have the chills, I itch, I am in pain, ache all over, nausea, dizziness, weakness, tiredness, headache, muscle pain, chills, fever, feeling unwell, and sore throat. No additional details provided.  She declined transfer to Safety but consented to further follow-up from Safety. The patient underwent lab tests and procedures which included 101.4 F temperature on an unknown date. The outcome of all events was an unknown
Sex: U
Vaccine: COVID19
Symptoms: Arthralgia, Depression, Eye irritation, Eye pain, Fatigue
Clinical narrative: burning and pain in my eyes; Burning and pain in my eyes; felt very bad; pain throughout my body; sensitivity; sweating at night; joint pain; muscle and joint pain; felt very bad, with a headache; very strong tiredness and exhaustion; depression; loss of sleep; This is a spontaneous report from a Pfizer sponsored program (stimulated report) via a contactable consumer (patient). A patient of unspecified age and gender received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number and expiration date was not reported), dose 1 via an unspecified route of administration on 27Mar2021 as DOSE 1, SINGLE for covid-19 immunisation. The patient medical history and concomitant medications were not reported. Reported were the effects of the covid 19 vaccine Pfizer, the patient took the vaccine on 27Mar2021 and on 30Mar2021 (after three days) the patient "felt very bad, with a headache, pain throughout my body, muscle and joint pain, very strong tiredness, and exhaustion, sweating at night, sensitivity, burning and pain in my eyes, this lasted me three weeks". The patient had had depression and loss of sleep on unspecified date in 2021. On 13Apr2021 (today) the patient still had the same symptoms. The patient already did the PCR test, and it came out negative on unspecified date, and reportedly the patient must take patient's second vaccine on 17Apr2021. The outcome of events felt very bad, with a headache, pain throughout my body, muscle and joint pain, very strong tiredness, and exhaustion, sweating at night, sensitivity, burning and pain in my eyes, all were recovered in 2021; and for depression and loss of sleep was not recovered.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Sex: U
Vaccine: COVID19
Symptoms: Feeling abnormal, Headache, Insomnia, Myalgia, Night sweats
Clinical narrative: burning and pain in my eyes; Burning and pain in my eyes; felt very bad; pain throughout my body; sensitivity; sweating at night; joint pain; muscle and joint pain; felt very bad, with a headache; very strong tiredness and exhaustion; depression; loss of sleep; This is a spontaneous report from a Pfizer sponsored program (stimulated report) via a contactable consumer (patient). A patient of unspecified age and gender received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number and expiration date was not reported), dose 1 via an unspecified route of administration on 27Mar2021 as DOSE 1, SINGLE for covid-19 immunisation. The patient medical history and concomitant medications were not reported. Reported were the effects of the covid 19 vaccine Pfizer, the patient took the vaccine on 27Mar2021 and on 30Mar2021 (after three days) the patient "felt very bad, with a headache, pain throughout my body, muscle and joint pain, very strong tiredness, and exhaustion, sweating at night, sensitivity, burning and pain in my eyes, this lasted me three weeks". The patient had had depression and loss of sleep on unspecified date in 2021. On 13Apr2021 (today) the patient still had the same symptoms. The patient already did the PCR test, and it came out negative on unspecified date, and reportedly the patient must take patient's second vaccine on 17Apr2021. The outcome of events felt very bad, with a headache, pain throughout my body, muscle and joint pain, very strong tiredness, and exhaustion, sweating at night, sensitivity, burning and pain in my eyes, all were recovered in 2021; and for depression and loss of sleep was not recovered.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Sex: U
Vaccine: COVID19
Symptoms: Pain, Polymerase chain reaction, Sensitive skin
Clinical narrative: burning and pain in my eyes; Burning and pain in my eyes; felt very bad; pain throughout my body; sensitivity; sweating at night; joint pain; muscle and joint pain; felt very bad, with a headache; very strong tiredness and exhaustion; depression; loss of sleep; This is a spontaneous report from a Pfizer sponsored program (stimulated report) via a contactable consumer (patient). A patient of unspecified age and gender received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number and expiration date was not reported), dose 1 via an unspecified route of administration on 27Mar2021 as DOSE 1, SINGLE for covid-19 immunisation. The patient medical history and concomitant medications were not reported. Reported were the effects of the covid 19 vaccine Pfizer, the patient took the vaccine on 27Mar2021 and on 30Mar2021 (after three days) the patient "felt very bad, with a headache, pain throughout my body, muscle and joint pain, very strong tiredness, and exhaustion, sweating at night, sensitivity, burning and pain in my eyes, this lasted me three weeks". The patient had had depression and loss of sleep on unspecified date in 2021. On 13Apr2021 (today) the patient still had the same symptoms. The patient already did the PCR test, and it came out negative on unspecified date, and reportedly the patient must take patient's second vaccine on 17Apr2021. The outcome of events felt very bad, with a headache, pain throughout my body, muscle and joint pain, very strong tiredness, and exhaustion, sweating at night, sensitivity, burning and pain in my eyes, all were recovered in 2021; and for depression and loss of sleep was not recovered.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site haemorrhage
Clinical narrative: when she peeled off the band-aid she had on the injection site, she noticed blood on it.; This is a spontaneous case received from a non-contactable (patient). A female patient of unspecified age received second dose of bnt162b2 (BNT162B2, PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection, Batch/Lot number was not reported) via an unspecified route of administration on an unknown date as DOSE 2, SINGLE for COVID-19 immunization. The patient medical history and concomitant medication was not reported. The patient stated that she received the second dose of the Pfizer COVID vaccine and hours later when she peeled off the band-aid she had on the injection site, she noticed blood on it. The seriousness was reported as non-serious. The outcome of the event was unknown.   No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Sex: F
Vaccine: COVID19
Symptoms: Bronchospasm, Cough, Rhinorrhoea
Clinical narrative: "bronchospasm, had a bad cough, and a lot of mucus".; "bronchospasm, had a bad cough, and a lot of mucus".; "bronchospasm, had a bad cough, and a lot of mucus".; This is a spontaneous report received from a contactable Nurse. A 56-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection; Lot number: unknown), via an unspecified route of administration on 05Apr2021 as dose 1, single for COVID-19 immunization. The patient medical history included Auto immune disease. The patient Concomitant medications were not reported. On an unspecified date, the patient experienced "bronchospasm, had a bad cough, and a lot of mucus". It was reported that patient received the first dose of the Pfizer-BioNTech COVID-19 vaccine on 05Apr2021 and the second dose is scheduled for 26Apr2021. She mentioned she has an auto-immune disease and is on a "couple things", including Stelara. She explained the morning following the injection she experienced "bronchospasm, had a bad cough, and a lot of mucus". She tested for COVID-19 twice, once on the following Wednesday and the other on the Friday, because she "wasn't any better". She explained she was prescribed an inhaler and Z-pack. She added she improved over the weekend but wasn't better on Monday. She asked if there is data on auto-immune vaccine recipient or those on Stelara showing that prolonged symptoms to the vaccine could correlated with either. She has auto immune disease and is on immunosuppressant medication and after the vaccine she developed coup and is on antibiotics and inhalers now. The outcome of events was unknown.  No follow-up attempts are needed. Information about lot/batch number cannot be obtained.
Age: 21.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Cough, Feeling hot, Nausea
Clinical narrative: has also been checking her temperature and it has been between 96-98 and earlier she was feeling warm but she was in class and couldn't check; a slight cough/had a cough and it wasn't long just a couple of times, a little more than normal; nausea/feels the nausea in her throat; This is a spontaneous report from a contactable consumer (patient). A 21-year-old female patient received first dose of bnt162b2 (Pfizer-BioNTech COVID-19 Vaccine, solution for injection, Batch/Lot Number: EW0158, NDC number: not reported, Expiration Date: Jul2021) via an unspecified route of administration, administered in upper right arm on 08Apr2021 09:45 (age at vaccination 21-year-old) as dose 1, single for covid-19 immunisation. The patient's medical history included COVID-19 from an unspecified date in Dec2020 to an unknown date. Concomitant medication included ibuprofen (MANUFACTURER UNKNOWN) (200mg and took 2 for a total of 400mg) for unknown indication from an unknown date. Patient stated she took ibuprofen one time around the beginning of the 2 weeks before the vaccine. There were no additional vaccines administered on same date of the pfizer suspect. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 08Apr2021, patient stated she got the Pfizer vaccine last thursday and she feels fine, none of it was very drastic. Caller stated that her side effects started on 09Apr2021. Stated she was feeling some side effects where the 1st day she had a cough and it wasn't long just a couple of times, a little more than normal. Stated she was nauseous but was not throwing up and that has been off and it will come at random times throughout the day and on since then. Patient stated she was concerned if this was normal or if she should see a doctor. Patient stated she had also been checking her temperature and it had been between 96-98 and earlier she was feeling warm, but she was in class and couldn't check. Patient stated this was her 1st shot and she was skeptical and knows it can last a couple days but not this long. stated she only had slight nausea and she can feel it in her throat, that it's not like she was going to throw up, but she was cautious about what she eats. Stated the cough was for the first 2 days. Caller wanted to know if she was fine or was there something else, she should do. Caller was concerned because her side effects have lasted seven days. The events did not result in emergency room or physician office. The outcome of event was resolved for cough on 10Apr2021 and unknown for other events.  No follow-up attempts are needed. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Asthma, Chest discomfort, Decreased appetite, Dizziness, Feeling abnormal
Clinical narrative: tightness of chest; asthma; Today she felt weird/she does not feel right; she has a sore throat; she also doesn't feel appetite; she felt dizzy; weird taste in her mouth; headache; This is a spontaneous report received from a contactable consumer (patient, reported for self). A female patient of an unspecified age (40-units not mentioned) received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA vaccine, Solution for injection, Batch/Lot number was not reported), via an unspecified route of administration on 10Apr2021 as dose 1, single for COVID-19 immunisation. The patient medical history included, Rheumatoid arthritis, asthma from an unknown date and unknown if ongoing. The patient's concomitant medications were not reported. The patient previously took metotrexate for 15 years for rheumatoid arthritis. On 10Apr2021, the patient experienced, immediately after receiving the injection she felt dizzy, and weird taste in her mouth only the first day along with headache. On 15Apr2021, she started experiencing tightness of chest, she has asthma and used her inhalator but it did not help, she also experienced felt weird, sore throat, headache, does not feel appetite (she also doesn't feel appetite) and she did not feel right. She has been only working from home in her computer. She would like to know if this was a regular side-effect even if it happened 5 days after she received the vaccine. The patient stated she has taken Methotrexate for 15 years for rheumatoid arthritis, she did not take it 2 weeks before the shot and has not taken it this week because she was told that it is not recommended to receive immunosuppressants a week before or a week after the vaccine. The outcome of the events was unknown.   No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Sex: F
Vaccine: COVID19
Symptoms: Headache, Oropharyngeal pain, Taste disorder
Clinical narrative: tightness of chest; asthma; Today she felt weird/she does not feel right; she has a sore throat; she also doesn't feel appetite; she felt dizzy; weird taste in her mouth; headache; This is a spontaneous report received from a contactable consumer (patient, reported for self). A female patient of an unspecified age (40-units not mentioned) received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA vaccine, Solution for injection, Batch/Lot number was not reported), via an unspecified route of administration on 10Apr2021 as dose 1, single for COVID-19 immunisation. The patient medical history included, Rheumatoid arthritis, asthma from an unknown date and unknown if ongoing. The patient's concomitant medications were not reported. The patient previously took metotrexate for 15 years for rheumatoid arthritis. On 10Apr2021, the patient experienced, immediately after receiving the injection she felt dizzy, and weird taste in her mouth only the first day along with headache. On 15Apr2021, she started experiencing tightness of chest, she has asthma and used her inhalator but it did not help, she also experienced felt weird, sore throat, headache, does not feel appetite (she also doesn't feel appetite) and she did not feel right. She has been only working from home in her computer. She would like to know if this was a regular side-effect even if it happened 5 days after she received the vaccine. The patient stated she has taken Methotrexate for 15 years for rheumatoid arthritis, she did not take it 2 weeks before the shot and has not taken it this week because she was told that it is not recommended to receive immunosuppressants a week before or a week after the vaccine. The outcome of the events was unknown.   No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Age: 49.0
Sex: F
Vaccine: COVID19
Symptoms: Anal pruritus, Pruritus, Rash, Swelling of eyelid, Urticaria
Clinical narrative: Eyelids were swollen; Mild itching near anus; Full body rash and hives; Full body rash and hives; Itching began in armpits; This is a spontaneous report from a contactable consumer or other non-HCP. A 49-years-old female patient received BNT162B2 (PFIZER BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot Number: EW0151) via an unspecified route of administration in right arm on 05Apr2021 10:45 as dose 2, single (at the age of 49 years-old) for COVID-19 immunization. Patient medical history included blood cholesterol diagnosis, lumpectomy for a non-cancerous papiloma 2014, spinal fusion surgery 2011 and sulfa drugs allergy (drug hypersensitivity). The concomitant medications included montelukast sodium taken as 10mg 1 QD, loratadine taken as 10mg 1 QD, fluticasone propionate taken as 1 spray per nostril QD, atorvastatin taken as 10mg 1 QD all for an unspecified indication, start and stop date were not reported. The patient was not a pregnant at the time of vaccination. Historical vaccine included BNT162b2 (PFIZER BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot number- EN6208) via an unspecified route of administration in right arm on 14Mar2021 02:45 PM as dose 1, single for COVID-19 immunization. Vaccination facility type reported as Public Health Clinic. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the was not patient diagnosed with COVID-19. Since the vaccination, patient had not been tested for COVID-19. The patient experienced on 14Apr2021 morning itching began in armpits, full body rash and hives, the evening mild itching near anus that lasted a few days, and eyelids were swollen on 15Apr2021. Patient took three 12.5 mg Benadryl dose tablets and by morning of April 15 rash had spread to neck and eyelids were swollen. Took 2 more 12.5 mg Benadryl. Then patient went to Urgent Care facility to seek more medical attention. Therapeutic measures were taken as prescription issued for 6-day treatment course of 4mg methyl prednisone dose pack a result of eyelids was swollen (swelling of eyelid), mild itching near anus (anal pruritus), full body rash and hives (rash), full body rash and hives (urticaria), itching began in armpits (pruritus). The outcome of all events was recovering.  No follow-up attempts are needed. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site erythema, Vaccination site swelling
Clinical narrative: she reports a lot of swelling and redness of her arm; she reports a lot of swelling and redness of her arm; This is a spontaneous report from contactable consumer (patient) via medical information team. A 55-year-old female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, lot/batch number was not reported) via an unspecified route of administration on an unspecified date as dose 2, single for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient received the second dose of the Pfizer Covid 19 vaccine a week and one day ago. After it was administered, she said the provider massaged her arm. A day and a half later she reported a lot of swelling and redness of her arm that lasted for a day. The outcome of events was recovered on unspecified date.  Follow-up attempts were completed. No further information was expected.
Age: 32.0
Sex: M
Vaccine: COVID19
Symptoms: Fatigue, Hyperaemia, Oropharyngeal pain, Pyrexia
Clinical narrative: congestion; Sore throat; extreme tiredness, extreme fatigue; Low grade fever; This is a spontaneous report from a contactable consumer (Patient). A 32-years-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Batch/Lot Number: EW0158; Expiration Date: 31Jul2021, patient was 32-year-old at the time of vaccination), via an unspecified route of administration, administered in Arm Left on 06Apr2021 at 05:00 PM as DOSE 1, 0.3 ML SINGLE for covid-19 immunisation. Medical history included ongoing borderline high blood pressure. Concomitant medication(s) included ongoing hydrochlorothiazide (HYDROCHLOROTHIAZIDE) taken for to regulate his blood pressure from an unspecified start date, taking this for maybe 6 months; ongoing lepidium meyenii root (MACA 2H) taken for supplementation therapy from an unspecified start date, he started taking this 3 weeks ago. He said it was just a good supplement. No previous immunization with the Pfizer vaccine considered as suspect, no additional Vaccines Administered on Same Date of the Pfizer Suspect. No prior vaccinations within 4 weeks, no AE(s) following prior vaccinations. No illnesses at time of vaccinations. No family medical history relevant to AE(s). It was reported that patient had symptoms for the last 7 days now. He asked that if it was normal or should he go into urgent care. Not really sure what to do. On 07Apr2021, the patient experienced extreme tiredness, extreme fatigue, low grade fever, sore throat on 09Apr2021, congestion on 10Apr2021. Reported that low grade fever which was 70 to 80% improved at the time of report, a little every morning when he wakes up its sore. The outcomes of events were recovering.  No follow-up attempts are possible. No further information is expected.
Age: 56.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Aphonia, Body temperature, Chills, Feeling abnormal, Headache
Clinical narrative: breaks out in sweats.; arm is still sore today; fever, temperature 102; Cough; Sore throat; lost voice; cold chills and achy all over; cold chills and achy all over; Headache; This is a spontaneous report from a non-contactable consumer. A 56-years-old female patient received bnt162b2 (COMIRNATY PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Strength: unknown, Batch/Lot Number: EW0151), dose 1 intramuscular on 07Apr 2021 as Dose 1 SINGLE for covid-19 immunization (Age at vaccoination: 56-Year-old) The patient medical included she has asthma and has had it for most of her life. She has autoimmune deficiency and Rheumatoid Arthritis that was diagnosed in her mid-20s and she was diagnosed with diverticulosis in the last year. Concomitant medications were not reported. On 09Apr2021 the patient had lost voice, cold chills, achy all over, headache and sore throat. On 10Apr2021 the patient had fever (temperature 102) and cough. She was weird because she heard the 2nd shot is worse than the 1st.  She was fine the first day and the next day she had a few symptoms.  On Friday, she went into work and felt like a train hit her.  She lost her voice had cold chills and was achy all over. The next day, her temperature was 102degrees.  She had a cough with bright green phlegm.  She thought it was weird.  She had cold chills, headache, and was sore all over. She did not expect this. She had a fever the last 2 days, and it broke early this morning between 2 and 3am.  She knows this because she was soaked and now has no fever.  She took her temperature before she called, and it was right at normal.  She doesn't have one right now but is not sure if it will go up later or what. Her arm was still sore today, but she figured that it would be gone. The outcome of the event lost voice, cold chills and achy all over, headache, cough and sore throat was not recovered. The outcome of the event fever and temperature 102 was recovered on 13Apr2021. The outcome of the event break out in sweats and arm is still sore today was reported as unknown. No follow up attempts are possible. No further information is expected.
Age: 56.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Hyperhidrosis, Oropharyngeal pain, Pain, Pain in extremity, Productive cough
Clinical narrative: breaks out in sweats.; arm is still sore today; fever, temperature 102; Cough; Sore throat; lost voice; cold chills and achy all over; cold chills and achy all over; Headache; This is a spontaneous report from a non-contactable consumer. A 56-years-old female patient received bnt162b2 (COMIRNATY PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Strength: unknown, Batch/Lot Number: EW0151), dose 1 intramuscular on 07Apr 2021 as Dose 1 SINGLE for covid-19 immunization (Age at vaccoination: 56-Year-old) The patient medical included she has asthma and has had it for most of her life. She has autoimmune deficiency and Rheumatoid Arthritis that was diagnosed in her mid-20s and she was diagnosed with diverticulosis in the last year. Concomitant medications were not reported. On 09Apr2021 the patient had lost voice, cold chills, achy all over, headache and sore throat. On 10Apr2021 the patient had fever (temperature 102) and cough. She was weird because she heard the 2nd shot is worse than the 1st.  She was fine the first day and the next day she had a few symptoms.  On Friday, she went into work and felt like a train hit her.  She lost her voice had cold chills and was achy all over. The next day, her temperature was 102degrees.  She had a cough with bright green phlegm.  She thought it was weird.  She had cold chills, headache, and was sore all over. She did not expect this. She had a fever the last 2 days, and it broke early this morning between 2 and 3am.  She knows this because she was soaked and now has no fever.  She took her temperature before she called, and it was right at normal.  She doesn't have one right now but is not sure if it will go up later or what. Her arm was still sore today, but she figured that it would be gone. The outcome of the event lost voice, cold chills and achy all over, headache, cough and sore throat was not recovered. The outcome of the event fever and temperature 102 was recovered on 13Apr2021. The outcome of the event break out in sweats and arm is still sore today was reported as unknown. No follow up attempts are possible. No further information is expected.
Age: 56.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Pyrexia
Clinical narrative: breaks out in sweats.; arm is still sore today; fever, temperature 102; Cough; Sore throat; lost voice; cold chills and achy all over; cold chills and achy all over; Headache; This is a spontaneous report from a non-contactable consumer. A 56-years-old female patient received bnt162b2 (COMIRNATY PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Strength: unknown, Batch/Lot Number: EW0151), dose 1 intramuscular on 07Apr 2021 as Dose 1 SINGLE for covid-19 immunization (Age at vaccoination: 56-Year-old) The patient medical included she has asthma and has had it for most of her life. She has autoimmune deficiency and Rheumatoid Arthritis that was diagnosed in her mid-20s and she was diagnosed with diverticulosis in the last year. Concomitant medications were not reported. On 09Apr2021 the patient had lost voice, cold chills, achy all over, headache and sore throat. On 10Apr2021 the patient had fever (temperature 102) and cough. She was weird because she heard the 2nd shot is worse than the 1st.  She was fine the first day and the next day she had a few symptoms.  On Friday, she went into work and felt like a train hit her.  She lost her voice had cold chills and was achy all over. The next day, her temperature was 102degrees.  She had a cough with bright green phlegm.  She thought it was weird.  She had cold chills, headache, and was sore all over. She did not expect this. She had a fever the last 2 days, and it broke early this morning between 2 and 3am.  She knows this because she was soaked and now has no fever.  She took her temperature before she called, and it was right at normal.  She doesn't have one right now but is not sure if it will go up later or what. Her arm was still sore today, but she figured that it would be gone. The outcome of the event lost voice, cold chills and achy all over, headache, cough and sore throat was not recovered. The outcome of the event fever and temperature 102 was recovered on 13Apr2021. The outcome of the event break out in sweats and arm is still sore today was reported as unknown. No follow up attempts are possible. No further information is expected.
Age: 56.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Aphonia, Body temperature, Chills, Cough, Headache
Clinical narrative: breaks out in sweats.; arm is still sore today; fever, temperature 102; Cough; Sore throat; lost voice; cold chills and achy all over; cold chills and achy all over; Headache; This is a spontaneous report from a non-contactable consumer. A 56-years-old female patient received bnt162b2 (COMIRNATY PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Strength: unknown, Batch/Lot Number: EW0151), dose 1 intramuscular on 07Apr 2021 as Dose 1 SINGLE for covid-19 immunization (Age at vaccoination: 56-Year-old) The patient medical included she has asthma and has had it for most of her life. She has autoimmune deficiency and Rheumatoid Arthritis that was diagnosed in her mid-20s and she was diagnosed with diverticulosis in the last year. Concomitant medications were not reported. On 09Apr2021 the patient had lost voice, cold chills, achy all over, headache and sore throat. On 10Apr2021 the patient had fever (temperature 102) and cough. She was weird because she heard the 2nd shot is worse than the 1st.  She was fine the first day and the next day she had a few symptoms.  On Friday, she went into work and felt like a train hit her.  She lost her voice had cold chills and was achy all over. The next day, her temperature was 102degrees.  She had a cough with bright green phlegm.  She thought it was weird.  She had cold chills, headache, and was sore all over. She did not expect this. She had a fever the last 2 days, and it broke early this morning between 2 and 3am.  She knows this because she was soaked and now has no fever.  She took her temperature before she called, and it was right at normal.  She doesn't have one right now but is not sure if it will go up later or what. Her arm was still sore today, but she figured that it would be gone. The outcome of the event lost voice, cold chills and achy all over, headache, cough and sore throat was not recovered. The outcome of the event fever and temperature 102 was recovered on 13Apr2021. The outcome of the event break out in sweats and arm is still sore today was reported as unknown. No follow up attempts are possible. No further information is expected.