chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: COVID19
Symptoms: Arthritis
Clinical narrative: I have arthritis and I take the shot; it seems to be getting louder; This is a spontaneous report from a non-contactable consumer or other non hcp.  A patient of unspecified age and gender received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number: EL3247, Expiration date: unknown), via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as SINGLE DOSE for covid-19 immunisation. Medical history included arthritis.The patient's concomitant medications were not reported. The patient experienced i have arthritis and i take the shot; it seems to be getting louder (arthritis) on an unspecified date with outcome of unknown.    No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Age: 74.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, COVID-19, Influenza like illness, Myalgia, Pain
Clinical narrative: Took patient down for about a week./aching all over, joints and muscles too like the flu; flu-like symptoms; Took patient down for about a week./aching all over, joints and muscles too like the flu; Took patient down for about a week./aching all over, joints and muscles too like the flu; achiness; This is a spontaneous report from a contactable consumer or other non hcp. A 74-year-old male patient received first dose bnt162b2 BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; solution for injection, (Batch/Lot Number: EN6200; Expiration Date: Jun2021)), via an unspecified route of administration, administered in Arm Left on 26Feb2021(at the age of 74-year-old) as, Single for COVID-19 immunization. Medical history included arthritis from 2017 to 2018 arthritis is in his right foot only and his big toe. The patient's concomitant medications were not reported. He received the 1st dose on 26Feb2021 and the 2nd dose on 19Mar2021. She mentioned that both of them experienced achiness after the 1st dose and flu-like symptoms after both doses. Her husband however, had muscle weakness on his legs after the 2nd dose. On 13Apr2021, about 3 weeks and 4 days after the 2nd dose, her husband received a steroid shot on his right foot. They noticed that the weakness on his legs became extreme, to which he had trouble standing up and has to hold on to something to stand up as he cannot support himself. He also had a rash on his trunk, back, and down his arms. She mentioned that the rash was not itchy but was speckled like measles. They are wondering if this has been reported and if it is possibly an interaction between the vaccine and steroid. The patient experienced took patient down for about a week/aching all over, joints and muscles too like the flu on 26Feb2021 and achiness, flu-like symptoms. The patient underwent lab tests and procedures which included covid-19 was Negative on 19Apr2021. The outcome of the events pain and Influenza like illness was recovered on 03Mr2021 and unknown for other events.  No follow-up attempts are needed. No further information is expected
Age: 63.0
Sex: M
Vaccine: COVID19
Symptoms: Abdominal pain upper, Body temperature, Dehydration, Fatigue, Hypoaesthesia
Clinical narrative: Stomach pain; Dehydrated, after first vaccine; Fever, after first vaccine; Tired, after first vaccine; Numbness in legs, from knee all the way down to the feet, after the first vaccine; Nausea, after first vaccine; This is a spontaneous report from a contactable consumer or other non-HCP (patient). A 63-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, formulation: Solution for injection, Lot number: ER8730, Expiry date: Unknown via an unspecified route of administration on 23Mar2021 10:30 (at the age of 63-year-old) as dose 1, single for COVID-19 immunization. Medical history included chronic kidney failure ongoing from an unknown date, patient stated at least 8 years ago. Reported 5 stages of kidney failure, with the most severe stage as 5, and he reported he was in Stage 4 and Covid virus in Dec2020 unknown if ongoing and had some type of infusion, clarified as a monoclonal infusion while he had Covid, because if not, he would not have had a good outcome. Patient stated he was told that he had to wait 90 days, before getting the first vaccine, in Mar2021, and he hated it. Concomitant medications were not reported. It was reported that on 23Mar2021 15:00 patient experienced Dehydrated after first vaccine, on 23Mar2021 Nausea, after first vaccine, Numbness in legs, from knee all the way down to the feet, after the first vaccine ,23Mar2021 12:00 Fever after first vaccine and Tired after first vaccine and on 23Mar2021 21:00 Stomach pain. Patient visited emergency room for the event because of concerns of his history of kidney failure. Patient stated he was glad he went, to the emergency room, and he was assured that any symptoms or side effects were normal with the covid vaccine. Patient stated the doctor in the emergency room, reclarified, that his symptoms were in keeping with the side effects of the vaccine, however, that because he has chronic kidney failure, that was the reason why he was dehydrated. Patient stated he had called his Internist, and he did not want to take the second vaccine. Lab test and procedures included on 21Apr2021 Fever100degree, MRI brain-Normal. Therapeutic measures were taken as a result of the events included saline solution, anti-nausea medication and two Tylenol on 24th.Outcome of the event Nausea, after first vaccine resolved on 24Mar2021, Fever, after first vaccine: resolved on 25Mar2021, Tired, after first vaccine resolved: 26Mar2021, Numbness in legs, from knee all the way down to the feet, after the first vaccine, Stomach pain resolved on an unspecified date in 2021. Outcome of other event was unknown.  No follow up attempts are needed. No further information is expected.
Age: 63.0
Sex: M
Vaccine: COVID19
Symptoms: Magnetic resonance imaging head, Nausea, Pyrexia
Clinical narrative: Stomach pain; Dehydrated, after first vaccine; Fever, after first vaccine; Tired, after first vaccine; Numbness in legs, from knee all the way down to the feet, after the first vaccine; Nausea, after first vaccine; This is a spontaneous report from a contactable consumer or other non-HCP (patient). A 63-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, formulation: Solution for injection, Lot number: ER8730, Expiry date: Unknown via an unspecified route of administration on 23Mar2021 10:30 (at the age of 63-year-old) as dose 1, single for COVID-19 immunization. Medical history included chronic kidney failure ongoing from an unknown date, patient stated at least 8 years ago. Reported 5 stages of kidney failure, with the most severe stage as 5, and he reported he was in Stage 4 and Covid virus in Dec2020 unknown if ongoing and had some type of infusion, clarified as a monoclonal infusion while he had Covid, because if not, he would not have had a good outcome. Patient stated he was told that he had to wait 90 days, before getting the first vaccine, in Mar2021, and he hated it. Concomitant medications were not reported. It was reported that on 23Mar2021 15:00 patient experienced Dehydrated after first vaccine, on 23Mar2021 Nausea, after first vaccine, Numbness in legs, from knee all the way down to the feet, after the first vaccine ,23Mar2021 12:00 Fever after first vaccine and Tired after first vaccine and on 23Mar2021 21:00 Stomach pain. Patient visited emergency room for the event because of concerns of his history of kidney failure. Patient stated he was glad he went, to the emergency room, and he was assured that any symptoms or side effects were normal with the covid vaccine. Patient stated the doctor in the emergency room, reclarified, that his symptoms were in keeping with the side effects of the vaccine, however, that because he has chronic kidney failure, that was the reason why he was dehydrated. Patient stated he had called his Internist, and he did not want to take the second vaccine. Lab test and procedures included on 21Apr2021 Fever100degree, MRI brain-Normal. Therapeutic measures were taken as a result of the events included saline solution, anti-nausea medication and two Tylenol on 24th.Outcome of the event Nausea, after first vaccine resolved on 24Mar2021, Fever, after first vaccine: resolved on 25Mar2021, Tired, after first vaccine resolved: 26Mar2021, Numbness in legs, from knee all the way down to the feet, after the first vaccine, Stomach pain resolved on an unspecified date in 2021. Outcome of other event was unknown.  No follow up attempts are needed. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Asthenia, Chills, Dizziness, Fatigue
Clinical narrative: really debilitated; extreme dizziness; arm pain; couldn't lift her head off the pillow; debilitating nausea; shaking chills; extreme muscle and joint pain throughout the body; extreme muscle and joint pain throughout the body; exhaustion so significant; weakness she could not get out of the bed; This is a spontaneous report from a contactable consumer. A female patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for Injection, Batch/Lot number: EW0161) via an unspecified route of administration on 15Apr2021 as DOSE 2, SINGLE for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient received first dose of bnt162b2 on 18Mar2021, lot No. EN6207 for covid-19 immunisation. The second dose of the vaccine was so horrendous, and the reporter was considering to never get vaccines ever again. The reporter thought that this reaction correlates with premenopausal women. Upon injection of the second dose of the vaccine the patient had flushing and nausea instantaneously. The patient received the second dose on 15Apr2021 and then 12-14 hours later the patient had debilitating nausea, shaking chills, extreme muscle and joint pain throughout the body, and exhaustion so significant and weakness patient could not get out of the bed, patient couldn't unscrew the lid off her mug of tea. The patient was really debilitated and was so scared. The patient started reading that these effects were usually in women and testosterone bluttens the effects in men. The patient thinks that these reactions need to be studied in women. The nausea was debilitating. The patient didn't feel well and was able to go to a dentist appointment after the first dose of the vaccine, but after the second dose patient couldn't lift her head off the pillow. The patient has no medical conditions, was healthy and triathlete. The arm pain was much less with the second dose of the vaccine, the first time it was much worse, patient did not care about arm pain patient was just so scared because patient was so sick. The patient also had extreme dizziness, she felt like she was drunk. The outcome of the events was unknown.  No follow-up attempts are needed. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Head discomfort, Myalgia, Nausea, Pain in extremity
Clinical narrative: really debilitated; extreme dizziness; arm pain; couldn't lift her head off the pillow; debilitating nausea; shaking chills; extreme muscle and joint pain throughout the body; extreme muscle and joint pain throughout the body; exhaustion so significant; weakness she could not get out of the bed; This is a spontaneous report from a contactable consumer. A female patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for Injection, Batch/Lot number: EW0161) via an unspecified route of administration on 15Apr2021 as DOSE 2, SINGLE for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient received first dose of bnt162b2 on 18Mar2021, lot No. EN6207 for covid-19 immunisation. The second dose of the vaccine was so horrendous, and the reporter was considering to never get vaccines ever again. The reporter thought that this reaction correlates with premenopausal women. Upon injection of the second dose of the vaccine the patient had flushing and nausea instantaneously. The patient received the second dose on 15Apr2021 and then 12-14 hours later the patient had debilitating nausea, shaking chills, extreme muscle and joint pain throughout the body, and exhaustion so significant and weakness patient could not get out of the bed, patient couldn't unscrew the lid off her mug of tea. The patient was really debilitated and was so scared. The patient started reading that these effects were usually in women and testosterone bluttens the effects in men. The patient thinks that these reactions need to be studied in women. The nausea was debilitating. The patient didn't feel well and was able to go to a dentist appointment after the first dose of the vaccine, but after the second dose patient couldn't lift her head off the pillow. The patient has no medical conditions, was healthy and triathlete. The arm pain was much less with the second dose of the vaccine, the first time it was much worse, patient did not care about arm pain patient was just so scared because patient was so sick. The patient also had extreme dizziness, she felt like she was drunk. The outcome of the events was unknown.  No follow-up attempts are needed. No further information is expected.
Age: 77.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Pain in extremity
Clinical narrative: he got the Pfizer vaccine last Thursday and on his right arm his Joint, and the Elbow the upper arm a little bit, he is having pain; he got the Pfizer vaccine last Thursday and on his right arm his Joint, and the Elbow the upper arm a little bit, he is having pain; This is a spontaneous report from consumer (patient's wife) reported for a patient (patient's husband). A 77-years-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number: EW0169, Expiration Date: 31Aug2021) via an unspecified route of administration, administered at an unspecified anatomical location on 15Apr2021 (age at vaccination was 77 years) as dose 1, single for COVID-19 immunization. The patient's medical history included pain. Concomitant medications included paracetamol (TYLENOL) taken for pain (he takes some 2 tablet 3 times a day) and warfarin taken for an unspecified indication. On 16Apr2021, the day after the shot, the patient experienced little bit pain in joint elbow upper arm. The patient had a side effect, he got the Pfizer vaccine last Thursday and on 16Apr2021, the patient's right arm his Joint and the elbow the upper arm a little bit, he was having pain. He was just on his regular medication, but he had been taking Tylenol. He hasn't had any medical test late or right now or lab work. He was prominent he was on Warfarin blood thinner. The outcome of the events was unknown.  No follow-up attempts are needed. No further information is expected.
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Breast pain, Chills, Insomnia, Pain
Clinical narrative: Arm was very sore; pain on my arm was very bad where on my whole arm and my whole side, back side of that arm; very strong pain on my arm, all back side, under my arm; very strong pain around my breast, all that side; Body ache; Chills; Fever; temperature; Last night I wasn't able to sleep because of the pain; This is a spontaneous report from a contactable consumer (patient) or other non-health care professional. A 60-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot number was not reported) via an unspecified route of administration, administered in left arm on 17Apr2021 (at the age of 60-year-old) as dose 2, single for covid-19 immunization. Medical history included blood pressure high from an unknown date and unknown if ongoing. Concomitant medications included metoprolol (METOPROLOL) taken as 50 mg once a day for hypertension, start and stop date were not reported. Patient previously received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot Number: ER8730) via an unspecified route, administered on 27Mar2021 as dose 1 single for COVID-19 immunization. The patient underwent lab test and procedure include fever result was unknown on an unspecified date in 2021. On an unspecified date in 2021, from Saturday morning and for the rest of the day the patient experienced arm was very sore, pain on her arm was very bad where on her whole arm and whole side, back side of that arm; very strong pain on her arm, all back side, under arm, very strong pain around her breast, all that side, all that side, body ache, chills, fever; temperature, last night she wasn't able to sleep because of the pain. Treatment received with 2 Tylenol 500 mg each. Consumer stated, no doctor, patient just went to get the vaccination where they were giving the vaccination. She just went herself. It was not facility but they were giving facility in big event for many people. Outcome of the event arm was very sore; pain on her arm was very bad where on her whole arm and whole side, back side of that arm; very strong pain on her arm, all back side, under her arm was not resolved, outcome of the event very strong pain around her breast, all that side, fever; temperature, last night she wasn't able to sleep because of the pain were unknown, outcome of the events body ache, chills were resolving.  No follow-up attempts are needed; information about lot/batch number cannot be obtained
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity, Pyrexia
Clinical narrative: Arm was very sore; pain on my arm was very bad where on my whole arm and my whole side, back side of that arm; very strong pain on my arm, all back side, under my arm; very strong pain around my breast, all that side; Body ache; Chills; Fever; temperature; Last night I wasn't able to sleep because of the pain; This is a spontaneous report from a contactable consumer (patient) or other non-health care professional. A 60-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot number was not reported) via an unspecified route of administration, administered in left arm on 17Apr2021 (at the age of 60-year-old) as dose 2, single for covid-19 immunization. Medical history included blood pressure high from an unknown date and unknown if ongoing. Concomitant medications included metoprolol (METOPROLOL) taken as 50 mg once a day for hypertension, start and stop date were not reported. Patient previously received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot Number: ER8730) via an unspecified route, administered on 27Mar2021 as dose 1 single for COVID-19 immunization. The patient underwent lab test and procedure include fever result was unknown on an unspecified date in 2021. On an unspecified date in 2021, from Saturday morning and for the rest of the day the patient experienced arm was very sore, pain on her arm was very bad where on her whole arm and whole side, back side of that arm; very strong pain on her arm, all back side, under arm, very strong pain around her breast, all that side, all that side, body ache, chills, fever; temperature, last night she wasn't able to sleep because of the pain. Treatment received with 2 Tylenol 500 mg each. Consumer stated, no doctor, patient just went to get the vaccination where they were giving the vaccination. She just went herself. It was not facility but they were giving facility in big event for many people. Outcome of the event arm was very sore; pain on her arm was very bad where on her whole arm and whole side, back side of that arm; very strong pain on her arm, all back side, under her arm was not resolved, outcome of the event very strong pain around her breast, all that side, fever; temperature, last night she wasn't able to sleep because of the pain were unknown, outcome of the events body ache, chills were resolving.  No follow-up attempts are needed; information about lot/batch number cannot be obtained
Sex: U
Vaccine: COVID19
Symptoms: Arthralgia, Feeling abnormal, Headache, Lymphadenopathy, Myalgia
Clinical narrative: Joint pain; lymph node swollen; Fever; Headache; Muscular pain; where she got the second vaccine, it is swollen and red and it is still so sore; where she got the second vaccine, it is swollen and red and it is still so sore; where she got the second vaccine, it is swollen and red and it is still so sore; Not feeling good; This is a spontaneous report from a contactable consumer. This consumer reported for unknown patient. A patient of unspecified age and gender received BNT162B2 (PFIZER-BIONTECH COVID-19 VAC-CINE, Solution for injection. Batch/Lot Number: ER8732), dose 2 via an unspecified route of administration on 15Apr2021 as DOSE 2, SINGLE for COVID-19 immunization. The patient medical and concomitant medication history were reported. Historical vaccine included: first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection) as dose 1, single for COVID-19 immunization. Patient got the COVID vaccine the other day, the second shot and has several symptoms and they did not seem to be going way, lot of joint pain, lymph node swollen, fever, headache, muscular pain, redness, where got the second vaccine, it was swollen and red and it was still so sore, patient could not move it and in response to further probing, reporter stated, no, not eight to ten minutes, patient (my wife) was not feeling good for that many questions. Reporter wanted to know, recommend anything to do? Do we just have to go to a doctor to have them look at it? Further probing could not be initiated as reporter was unwilling to further answer the questions. Hence, other details were unknown and limited information was available over the call. The outcome of the events were unknown.   No follow-up attempts are Possible. No further information is expected.
Sex: U
Vaccine: COVID19
Symptoms: Pyrexia, Vaccination site erythema, Vaccination site pain, Vaccination site swelling
Clinical narrative: Joint pain; lymph node swollen; Fever; Headache; Muscular pain; where she got the second vaccine, it is swollen and red and it is still so sore; where she got the second vaccine, it is swollen and red and it is still so sore; where she got the second vaccine, it is swollen and red and it is still so sore; Not feeling good; This is a spontaneous report from a contactable consumer. This consumer reported for unknown patient. A patient of unspecified age and gender received BNT162B2 (PFIZER-BIONTECH COVID-19 VAC-CINE, Solution for injection. Batch/Lot Number: ER8732), dose 2 via an unspecified route of administration on 15Apr2021 as DOSE 2, SINGLE for COVID-19 immunization. The patient medical and concomitant medication history were reported. Historical vaccine included: first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection) as dose 1, single for COVID-19 immunization. Patient got the COVID vaccine the other day, the second shot and has several symptoms and they did not seem to be going way, lot of joint pain, lymph node swollen, fever, headache, muscular pain, redness, where got the second vaccine, it was swollen and red and it was still so sore, patient could not move it and in response to further probing, reporter stated, no, not eight to ten minutes, patient (my wife) was not feeling good for that many questions. Reporter wanted to know, recommend anything to do? Do we just have to go to a doctor to have them look at it? Further probing could not be initiated as reporter was unwilling to further answer the questions. Hence, other details were unknown and limited information was available over the call. The outcome of the events were unknown.   No follow-up attempts are Possible. No further information is expected.
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Feeling hot, Pain in extremity, Skin exfoliation, Vaccination site pain
Clinical narrative: broke out in a rash on her arm right where the injection was given; on her arm right where the injection was given, and had a 2 inch slough; The site also itched, it was sore sore and it hurt; The site also itched, it was sore sore and it hurt; Felt hot; Tired; little sore arm; This is a spontaneous report from a contactable Consumer or other non-health professional (patient).  A 65-year-old female patient bnt162b2 (PFIZER BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch number: not reported/ lot number: EN6208) via an unspecified route of administration in right arm on 10Mar2021 (at the age of 65-year-old) as dose, 1 single for COVID-19 immunization. Medical history included ongoing osteoporosis (diagnosed in 2018 or 2019) and thyroid from an unknown date and unknown if ongoing. Concomitant medications included levothyroxine sodium (SYNTHROID) taken for thyroid from 1977 and ongoing. Patient did not receive any prior vaccinations within 4 weeks of vaccination. No Family Medical History Relevant to AE. No Additional Administered Vaccines on same day. On 11Mar2021, After the first vaccine patient broke out in a rash on her arm right where the injection was given, and she had a 2-inch slough. The site also itched, it was sore, and it hurt. It lasted for about two weeks. She still had remnants of an itch and marks when she got the second injection. On an unspecified date in Mar2021, after the first vaccine she felt hot, tired, and had a little sore arm. She needs to get Temlos injections for her osteoporosis, she was supposed to start, but she refrained from doing so because she was afraid it might affect the covid vaccine or the covid vaccine will affect these injections. AEs did not require a visit to ER or physician office. Investigation Assessment was reported as No. No relevant Tests provided. Outcome of the site also itched, it was sore sore and it hurt was recovering and outcome of the other events was unknown.  No follow-up attempts are needed. No further information is expected.
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pruritus, Vaccination site rash
Clinical narrative: broke out in a rash on her arm right where the injection was given; on her arm right where the injection was given, and had a 2 inch slough; The site also itched, it was sore sore and it hurt; The site also itched, it was sore sore and it hurt; Felt hot; Tired; little sore arm; This is a spontaneous report from a contactable Consumer or other non-health professional (patient).  A 65-year-old female patient bnt162b2 (PFIZER BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch number: not reported/ lot number: EN6208) via an unspecified route of administration in right arm on 10Mar2021 (at the age of 65-year-old) as dose, 1 single for COVID-19 immunization. Medical history included ongoing osteoporosis (diagnosed in 2018 or 2019) and thyroid from an unknown date and unknown if ongoing. Concomitant medications included levothyroxine sodium (SYNTHROID) taken for thyroid from 1977 and ongoing. Patient did not receive any prior vaccinations within 4 weeks of vaccination. No Family Medical History Relevant to AE. No Additional Administered Vaccines on same day. On 11Mar2021, After the first vaccine patient broke out in a rash on her arm right where the injection was given, and she had a 2-inch slough. The site also itched, it was sore, and it hurt. It lasted for about two weeks. She still had remnants of an itch and marks when she got the second injection. On an unspecified date in Mar2021, after the first vaccine she felt hot, tired, and had a little sore arm. She needs to get Temlos injections for her osteoporosis, she was supposed to start, but she refrained from doing so because she was afraid it might affect the covid vaccine or the covid vaccine will affect these injections. AEs did not require a visit to ER or physician office. Investigation Assessment was reported as No. No relevant Tests provided. Outcome of the site also itched, it was sore sore and it hurt was recovering and outcome of the other events was unknown.  No follow-up attempts are needed. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Asthenia, Blood test, Fatigue, Pain
Clinical narrative: Very tired; Very Weak; Joints are achy; Achy; This is a spontaneous report from a contactable other hcp (nurse). A 83-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot Number: EW0153), dose 2 via an unspecified route of administration on an unspecified date in Apr2021 as dose 2, single for COVID-19 immunisation. Patient had no medical history. Concomitant medication(s) included fish oil tablets at a dose of 1000mg, oral 4 times a day taken for an unspecified indication, start and stop date were not reported. Historical vaccine included bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot Number: not reported), dose 1 via an unspecified route of administration on an unspecified date as single dose for COVID-19 immunisation. The patient stated, She had reaction, not a reaction, side effect to her pfizer 2nd dose, she was good for 4 days and then 5th, 6th, 7th and 8th day after very, very weak and tired, and achy, joints are achy on 15Apr2021. Patient stated, It's covid vaccine, everybody has to get it. The place where she got it was mall. For causality, consumer stated, yes. When questioned about concomitant medication, she stated, oh my gosh, she take, I have to get my list, this is going to take a while, I take fish oil tablet, she take 4 of those a day, 1000 mg, Oral 4 times a day. Lab test included blood work on an unspecified date in 2021, she said 2 months ago yes, just blood work done, she don't know. If she was still experiencing the events, patient stated, no, not today, seem to be okay. No therapeutic measures were taken for any of the events, patient stated, no, she just rested. The outcome of all the events was recovered on an unspecified date in Apr2021. Verbatim event relatedness: Covid 19 Vaccine: Very tired - Related Covid 19 Vaccine: Very Weak - Related Covid 19 Vaccine: Joints are achy - Related  No follow-up attempts are needed. No further information is expected.
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Cough, Dizziness, Feeling hot, Headache
Clinical narrative: I am coughing out a lot of mucus; Sneezing; mucus /I am coughing out a lot of mucus; Headache; My arm was hurting; My body felt hot but I didn't have temperature; Chills; Feeling lousy; Light-headed/dizzines; Ache; This is a spontaneous report from contactable consumer (patient). A 56-year-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot number: EWASL) via unknown route of administration at left arm on 15Apr2021 (age at vaccination 56-year-old) as single dose for COVID-19 immunisation. The patient medical history included hysterectomy on 08Mar2021 and concomitant medications were reported as none. On an unspecified date in Apr2021, the patient experienced headache, dizziness/light-headed, ache, feeling lousy, chills, my arm was hurting, my body felt hot but didn't have temperature and after fourth day on 17Apr2021, sneezing, the patient coughing out a lot of mucus. The patient received treatment included Tylenol and Motrin. The second dose was scheduled at 06May2021. The outcome of the event I am coughing out a lot of mucus, sneezing was not recovered and outcome of the other events was unknown.   No follow-up attempts are needed. No further information is expected.
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Malaise, Pain, Pain in extremity, Productive cough, Sneezing
Clinical narrative: I am coughing out a lot of mucus; Sneezing; mucus /I am coughing out a lot of mucus; Headache; My arm was hurting; My body felt hot but I didn't have temperature; Chills; Feeling lousy; Light-headed/dizzines; Ache; This is a spontaneous report from contactable consumer (patient). A 56-year-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot number: EWASL) via unknown route of administration at left arm on 15Apr2021 (age at vaccination 56-year-old) as single dose for COVID-19 immunisation. The patient medical history included hysterectomy on 08Mar2021 and concomitant medications were reported as none. On an unspecified date in Apr2021, the patient experienced headache, dizziness/light-headed, ache, feeling lousy, chills, my arm was hurting, my body felt hot but didn't have temperature and after fourth day on 17Apr2021, sneezing, the patient coughing out a lot of mucus. The patient received treatment included Tylenol and Motrin. The second dose was scheduled at 06May2021. The outcome of the event I am coughing out a lot of mucus, sneezing was not recovered and outcome of the other events was unknown.   No follow-up attempts are needed. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Myalgia, Vaccination site pain
Clinical narrative: quite a bit of muscular or joint pain in the area where he received the shot; quite a bit of muscular or joint pain in the area where he received the shot; quite a bit of muscular or joint pain in the area where he received the shot; This is a spontaneous report from a contactable consumer or other non-healthcare professional (Co-Worker). A 29-years-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection), dose 2 via an unspecified route of administration, administered in Arm Left on 14Apr2021, mid-afternoon, unsure of exact time (Batch/Lot number, Expiry Date and NDC number were not reported) as dose 2, single for covid-19 immunization. Medical history included Celiac and Irritable bowel syndrome (IBS) diagnosed about 10 years ago. The patient's dad had autoimmune stuff, Celiac and IBS as well. The patient previously received first dose of bnt162b2 via an unspecified route of administration, administered in Arm right on 29Mar2021 (Batch/Lot number was not reported) as single dose for covid-19 immunization. There were not any additional vaccines administered on same date of the pfizer suspect, no Prior vaccinations within 4 weeks. The patient's concomitant medications were not reported. In Apr2021 the patient experienced quite a bit of muscular or joint pain in the area where he received the shot, the patient has nothing other than soreness. The reporter stated that, his employee had the Pfizer shot and had quite a bit of muscular or joint pain in the area where he received the shot and its ongoing. The patient neither visited to Emergency Room nor to Physician Office. The reporter verified that they all received the Pfizer Covid Vaccine and they had it done around the same time and around the same dates. The patient received his second dose last week, he thinks the second one was last Wednesday. The patient thinks he received his second dose on 14Apr2021, and he had his first dose exactly 3 weeks to the day from the second so that would mean his first dose was around 29Mar2021. The outcome of the events was not recovered and ongoing at time of reporting.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Sex: F
Vaccine: COVID19
Symptoms: Chills, Headache, Ocular hyperaemia, Pyrexia
Clinical narrative: cold shivers/chills; fevers; headaches; eyes were red; This is a spontaneous report from a contactable consumer(patient herself). A female patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot number was not reported) via an unspecified route of administration on 05Apr2021 as DOSE NUMBER UNKNOWN, SINGLE for COVID-19 immunization. The patient medical history were not reported and concomitant medications included patient was using Rybelsus therapy. On an unspecified date the patient experienced cold shivers/chills, fevers, headaches, eyes were red. The patient had taken 1 Tylenol as treatment. 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: Arthralgia, Muscle tightness, Vaccination site pain
Clinical narrative: quite a bit of muscular; joint pain in the area where she received the shot; feels like her muscle is going to tear; This is a spontaneous report from a contactable consumer or other non health care professional. A 35-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, formulation: solution for injection, lot number was not reported, expiration date was not reported), via an unspecified route of administration on an unspecified date as dose 1, single for covid-19 immunization at Clinic. The patient medical history and concomitant medications were not reported. The patient did not receive any other vaccinations within four weeks prior to the first ad-ministration date of the suspect vaccine. It was reported that reporter states he did want to say that he thinks is very relevant, his employee had the Pfizer shot and she has quite a bit of muscular or joint pain in the area where she received the shot and its ongoing, if she goes to reach for something, she feels like her muscle is going to tear. Patient verifies she received the Pfizer Covid vaccine. Patient unsure of LOT, , Expiry date. Patient unsure of which arm she received it in. Patient unsure of date received the vaccine. Patient states she received the shot because she works in a hair salon and mostly for the compliance aspect and to resolve COVID but also to think about the community and stuff too. Reporter verifies he is unsure of dosage and it was given by injection. The adverse events did not result in emergency room and physician office. The outcome of the events was unknown.  No follow-up attempts are needed. Information about lot/batch number cannot be obtained.
Age: 78.0
Sex: M
Vaccine: COVID19
Symptoms: Blood test, Condition aggravated, Erythema, Pruritus, Rash
Clinical narrative: itchy when they appear; Rash; little red spots; his symptoms are worsening; This is a spontaneous report from a contactable consumer (patient). A 78-year-old male patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, solution for injection, Batch/Lot Number: EL3247), via an unspecified route of administration in left arm on 10Feb2021 at 11:00 (at the age of 78-years) as dose 2, single for covid-19 immunization. The patient's medical history and concomitant medications were not reported. The patient had not received any other vaccine within 4 weeks. The patient did not experience any event prior vaccination. The patient had previously received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, solution for injection, Batch/Lot Number: EK4174), via an unspecified route of administration in left arm on 20Jan2021 (at the age of 78-years) as dose 1, single for covid-19 immunization. The patient had no additional vaccines administered on same date of the Pfizer suspect. Following second dose of vaccination, on 10Feb2021 the patient had rash; little red spots, itchy when they appear, all over body and worse on arms. The patient stated that his symptoms had worsened from 10Feb2021, spots were not that noticeable, but they looked like mosquito bites. They were mostly on his arms and looked almost like they were under the skin. Other locations on his body, like his shoulders, they looked like they were on top of the skin. Patient also stated that the bumps are not raised, just a red blotch on his skin which were maybe 1/16th of an inch or less in size. This resulted in physician office visit and the patient was advised to put lotion and hydrocortisone cream on it by this doctor. The patient underwent lab tests and procedures in between the first and second dose on an unspecified date in 2021 at his 6-month check-up and included blood test resulted normal. The outcome of the events was not recovered at the time of report.  No follow-up attempts are needed. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Myalgia
Clinical narrative: This is a spontaneous report from a contactable consumer (patient). A female patient of an unspecified age received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/Lot number was not reported) via an unspecified route of administration on an unspecified date in Mar2021 as dose 1, single for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient reported that she was reading the whole pamphlet on Pfizer and she took the Pfizer COVID vaccine on 01Mar2021 or 08Mar2021 she believes. The patient was having some symptoms but she did not know it was from that and it still could not be from that maybe. The patient was having muscle and joint aches on an unspecified date and she always used a remedy and it would go away but with this first shot it came but then it went and came back and went again and she did not think anything else about it. The outcome of the events was unknown.  No follow up attempts are needed; information about lot/batch number cannot be obtained.
Sex: M
Vaccine: COVID19
Symptoms: Pruritus, Pyrexia
Clinical narrative: Next day he got fever; started feeling itchy all over his body; This is a spontaneous report received from a contactable consumer or other non hcp. A male patient of an unspecified age received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Batch/lot number was not reported) via an unspecified route of administration on 20Apr2021 as single dose for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient experienced started feeling itchy all over his body on 20Apr2021, next day he got fever on 21Apr2021. Clinical course was reported as he got on Tuesday 20Apr2021 the first dose of the Pfizer covid vaccine and that night at approximately 8-9 pm he started feeling itchy all over his body. Next day he got fever, but the itchiness has not got away. The clinical outcome of the event fever was unknown and another event feeling itchy all over his body was not recovered.  No follow-up attempts are possible; Information about lot/batch number cannot be obtained.
Sex: F
Vaccine: COVID19
Symptoms: Chills, Headache, Hypersensitivity, Pain in extremity, Pyrexia
Clinical narrative: allergic reactions; Fever; chills; Headache; her left arm (vaccine arm) developed soreness and pain.; This is a spontaneous report from a contactable consumer (Patient). A 51-year-old female patient received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: not reported), via an unspecified route of administration, administered in left arm on 17Apr2021 as Dose 2, single for COVID-19 immunisation. The patient medical history was not reported. The concomitant medications were not reported. On an unspecified date the patient experienced allergic reaction, fever, chills, headache and pain in arm. The patient received treatment for the event her left arm (vaccine arm) developed soreness and pain with oinments and put some ice directly. The patient reported that she was advised by the pharmacist to "put some ice directly" to manage the bruise and consulted a day before with her doctor, and diagnosed the "pain in arm" as a burn- was given ointments. And added an ampule asked if it it a possible AE. The patient asked for her future health, she would like to know if she was allergic or if she should not have had the vaccine. Offered to transfer to Safety, but she declined due to work. Asked for Physician information, gave contact number but did not provide other information. E-transmitting AE for review (Response: Spoke from attached documents and as per the Pfizer-BioNTech COVID-19 EUA PI ,6 Overall Safety Summary and 6.1 Clinical Trials Experience, LAB-1457-7.0, Revised: 06 April 2021, explained to patient that Pfizer cannot assess causality, and referred to HCP for further guidance). The outcome of the events was unknown.  No follow-up attempts are possible. No further information is expected.
Age: 31.0
Sex: M
Vaccine: COVID19
Symptoms: Eye discharge, Ocular hyperaemia, Pyrexia
Clinical narrative: after his second dose of Pfizer's COVID vaccine his eye has been red since then; getting eye discharge; Fever; This is a spontaneous report from a contactable consumer. A 31-years-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot number EW0162 & Expiry date not reported) via an unspecified route of administration, administered in Left arm on 20Apr2021 at 10:45 (at age of 31-years-old) as dose 2, single for COVID-19 immunisation. The patient medical history was not reported. Concomitant medication(s) includes paracetamol (TYLENOL) taken for an unspecified indication, start and stop date were not reported.The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. Patient previously received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot number ER8734, Expiry date not reported) via an unspecified route of administration, administered in Left arm on 30Mar2021 at 10:30 (at age of 30-years-old) as single dose for COVID-19 Immunisation. Caller that he just reported this using the website for him having problems due to the COVID vaccine. Well, he can't be too sure that it is from the COVID vaccine. After his second dose of Pfizer's COVID vaccine, on 21Apr2021 at 23:45(1 day 13 hrs after vaccination) Patient experienced his eye has been red since the second night. He did have a little bit of a fever that started and then that night he had eye discharge and it was red. He mentioned all of that in the online report he wanted to be enquired in general should he go somewhere for medical advice or is this a common symptom and should he wait it out? Caller asking if this has this been reported previously? Or should he get medical advice from his provider. Patient did not receive any treatment for red eye and eye discharge. The Outcome of the event red eye, eye discharge was not recovered; event fever was unknown.   No follow up attempts are needed. No further information expected.
Age: 21.0
Sex: M
Vaccine: COVID19
Symptoms: Dizziness, Dyspnoea
Clinical narrative: Dizziness from laying down to sitting up; Shortness of Breath; This is a spontaneous report from a contactable consumer or other non-HCP (patient). This report was not related to a study or program. A 21-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Lot Number and Expiration date: Unknown), dose 1 via an unspecified route of administration, administered in Arm Right on 22Apr2021 at 09:30 (at the age of 21-year-old), as DOSE 1, SINGLE for covid-19 immunisation. Additional Vaccines Administered on Same Date of the Pfizer Suspect was none. The patient medical history and concomitant medications were not reported. Family Medical History Relevant to AE(s) was none. History of all previous immunization with the Pfizer vaccine considered as suspect was none. Prior Vaccinations (within 4 weeks) was none. AE(s) following prior vaccinations was none. On 23Apr2021 at 09:30, the patient experienced dizziness from laying down to sitting up and shortness of breath. The patient stated that the first dose of Pfizers COVID vaccine yesterday, 22Apr2021, at 9:30. Patient stated today 23Apr2021, he woke up with shortness of breath, stated he did not know if it was from laying a certain way or if it is a side effect of the vaccine. Stated he also wanted to know if he should be taking it more serious or not. The patient was wondering is this a side effect of the vaccine. Patient stated slight dizziness and it is when he goes form laying down to sitting up. The AE(s) did not require a visit to emergency Room and Physician Office. Treatment for the events was none. There was no investigation assessment reported. The patient outcome of the event Dizziness was not resolved, and the outcome of the other event was Unknown at the time of this report.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.