chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal pain, Asthenia, Chills, Dizziness, Feeling abnormal
Clinical narrative: Dizzy; Abdominal pain; headache; Extreme chills; Fever; Weakness; Feels awful; she could not sleep for 24 hours; Body ache; This is a spontaneous report received from a contactable consumer (patient).   A 71-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH m-RNA COVID-19 VACCINE, formulation: Solution for injection, Lot number: EW0175 and expiry date: not reported), via an unspecified route of administration from 27Apr2021 as dose 2, single (Age at vaccination: 71-year-old) COVID-19 immunisation. Medical history was not reported. Concomitant medications included: ongoing fluoxetine hydrochloride (PROZAC) at 40 mg daily as an antidepressant. The patient previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE) via an unspecified route of administration on an unspecified date as dose 1, single (Age at vaccination: 71-year-old) for Covid-19 immunization. The patient hand second dose of vaccine on 27Apr2021 (Tuesday) within 9 hours, the patient had fever, extreme chills. The patient was shaking so badly that she could not even lay still in the bed. The patient had abdominal pain, headache and she could not sleep for 24 hours. The patient was in such pain like she had the worst flu that she had ever in her life. She could not sleep for 24 hours and even now she can't sleep for now couple of hours at a time and she was still having a headache on Friday. The patient was dizzy and weak. 9 hours after the vaccination, the patient had a fever, a high fever, chills so bad, abdominal pain. The patient couldn't sleep like every bone in her body ache, and it took her full 24 hours to sleep. The patient can only sleep, for couple of hours at a time and on Friday, this Friday, She still has headache and weakness and was feeling awful. The patient was having a headache, weakness and dizziness, 3 days after having the second vaccination. The patient does not have fever anymore but couldn't sleep. The patient did not undergo any laboratory tests. The patient took something for the pain the over the counter, Aleve. The patient stated that she was fine after taking first dose of vaccination but does not feel well after second dose. Outcome of events (Dizziness, weakness, headache, feeling awful, could not sleep) was not recovered. Fever got recovered on an unspecified date in Apr2021 and outcome of other events was unknown.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Insomnia, Pain, Pyrexia
Clinical narrative: Dizzy; Abdominal pain; headache; Extreme chills; Fever; Weakness; Feels awful; she could not sleep for 24 hours; Body ache; This is a spontaneous report received from a contactable consumer (patient).   A 71-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH m-RNA COVID-19 VACCINE, formulation: Solution for injection, Lot number: EW0175 and expiry date: not reported), via an unspecified route of administration from 27Apr2021 as dose 2, single (Age at vaccination: 71-year-old) COVID-19 immunisation. Medical history was not reported. Concomitant medications included: ongoing fluoxetine hydrochloride (PROZAC) at 40 mg daily as an antidepressant. The patient previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE) via an unspecified route of administration on an unspecified date as dose 1, single (Age at vaccination: 71-year-old) for Covid-19 immunization. The patient hand second dose of vaccine on 27Apr2021 (Tuesday) within 9 hours, the patient had fever, extreme chills. The patient was shaking so badly that she could not even lay still in the bed. The patient had abdominal pain, headache and she could not sleep for 24 hours. The patient was in such pain like she had the worst flu that she had ever in her life. She could not sleep for 24 hours and even now she can't sleep for now couple of hours at a time and she was still having a headache on Friday. The patient was dizzy and weak. 9 hours after the vaccination, the patient had a fever, a high fever, chills so bad, abdominal pain. The patient couldn't sleep like every bone in her body ache, and it took her full 24 hours to sleep. The patient can only sleep, for couple of hours at a time and on Friday, this Friday, She still has headache and weakness and was feeling awful. The patient was having a headache, weakness and dizziness, 3 days after having the second vaccination. The patient does not have fever anymore but couldn't sleep. The patient did not undergo any laboratory tests. The patient took something for the pain the over the counter, Aleve. The patient stated that she was fine after taking first dose of vaccination but does not feel well after second dose. Outcome of events (Dizziness, weakness, headache, feeling awful, could not sleep) was not recovered. Fever got recovered on an unspecified date in Apr2021 and outcome of other events was unknown.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Ear pain, Insomnia, Rash, Tinnitus
Clinical narrative: ear pain; less of an abdominal rash; a gradual worsening of tinnitus to the point where I am unable to sleep it is so loud; a gradual worsening of tinnitus to the point where I am unable to sleep it is so loud; This is a spontaneous report from a contactable consumer (patient). A 56-year-old non-pregnant female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, solution for injection, Lot Number: ED6955, Expiry date: not reported) via an unspecified route of administration, administered in Arm Left on 01Apr2021 05:00 (at the age of 56 years old) as dose 2, single for COVID-19 immunization. Medical history was no, and concomitant medications were not reported. Historical vaccine included: the patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, solution for injection, Batch/Lot Number: EN6206, Expiry date: not reported) via an unspecified route of administration, administered in Arm Left on 09Mar2021 05:15 (at the age of 56 years old) as dose 1 single for COVID-19 immunization. The patient was non-pregnant at the time of vaccination. The facility where the most recent COVID-19 vaccine was administered was in pharmacy or drug Store. The patient had not received any other vaccine within 4 weeks. list of any other medications the patient received within 2 weeks of vaccination was no. The patient was not diagnosed with COVID-19 prior to vaccination. The patient was not tested for COVID post vaccination. The patients hospitalization prolonged was no. On 02Apr2021 (after the second vaccine), the patient experienced less of an abdominal rash but have had a gradual worsening of tinnitus to the point where she was unable to sleep it was so loud. It began in her left ear and has increased along with ear pain. In the last few days, it has moved to her right ear as well, also an extremely loud high-pitched noise. It is constant, has not lessened or stopped for the last 3-4 weeks. It is intolerable and she need to understand how to treat this. The patient was on a waiting list to see a doctor but have not gotten in yet. The patient did not receive any therapeutic measures for the events. The outcome of the events was not recovered.  No follow-up attempts are needed. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Cough, Malaise, Nasopharyngitis
Clinical narrative: cough; colds; sick; This is a spontaneous report from a Regulatory Authority via a contactable consumer (patient).  A female patient of unknown age received first dose of BNT162B2 (PFIZER-BIONTECH m-RNA COVID-19 VACCINE, formulation: Solution for injection, Lot number and expiry date: Not reported), via an unspecified route of administration on 14Apr2021 as dose 1, single for COVID-19 immunization. Medical history and concomitant medications were not reported. On an unspecified date in 2021, the patient got sick with Cough and colds and was wondering if she could still go and get the 2nd dose of the vaccine upcoming on 05May2021. Outcome of events was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected
Sex: U
Vaccine: COVID19
Symptoms: Vaccination site bruising
Clinical narrative: experienced bruising of approx 4 to 6 inches in diameter at the injection site.; This is a spontaneous report from a contactable consumer or other non-health care professional (patient). A patient of unspecified age and gender received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, formulation : solution for injection, Batch/Lot number and expiry date was not reported), via an unspecified route of administration on an unspecified date as DOSE 1, SINGLE for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. On an unspecified date, the patient experienced bruising of approximately 4 to 6 inches in diameter at the injection site. The outcome of the event was unknown.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 31.0
Sex: M
Vaccine: COVID19
Symptoms: Blood test, Erythema, Headache, Illness, Investigation
Clinical narrative: severe edema in lower legs; horrible pain in his lower legs; swelling comes and goes in his feet; redness in his feet; feet are super sensitive to the touch; extreme pain in his lower extremities; he was sick as a dog; woke up in so much pain he was afraid to put his feet on the ground; couldn't push down on the gas pedal in his car; softball sized swelling in his feet; severe nausea; headaches; felt like someone hit him with a 100 mile per hour fast ball the next day, clarified he had pain at his injection site; This is a spontaneous report from a contactable other health professional via the regulatory authority. Regulatory authority report number is 543654.   A 31-years-old male patient received bnt162b2 (BNT162B2, PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot number: EW0164), via an unspecified route of administration, administered in left arm on 19Apr2021 09:45 (At the age of 31 years) as DOSE 1, SINGLE for covid-19 immunisation. Medical history included ongoing migraine. Concomitant medications included Aimovig taken for migraine, start and stop date were not reported. The patient was taken to emergency room due to swelling and pain in lower legs. No prior vaccination was taken within 4 weeks. The patient experienced severe nausea and headaches on 21Apr2021, severe edema in lower legs, horrible pain in his lower legs, swelling comes and goes in his feet, redness in his feet, feet are super sensitive to the touch, felt like someone hit him with a 100 mile per hour fast ball the next day, clarified he had pain at his injection site on 20Apr2021, softball sized swelling in his feet on 29Apr2021 with outcome of unknown, woke up in so much pain he was afraid to put his feet on the ground, couldn't push down on the gas pedal in his car on 30Apr2021, extreme pain in his lower extremities and he was sick as a dog on an unspecified date. The patient underwent lab tests and procedures which included blood test: unknown on 28Apr2021, investigation: no blood clots on unspecified date. At the time of reporting the outcome of the events severe nausea, felt like someone hit him with a 100 mile per hour fast ball the next day, clarified he had pain at his injection site, softball sized swelling in his feet, woke up in so much pain he was afraid to put his feet on the ground and couldn't push down on the gas pedal in his car was unknown. For events severe edema in lower legs, horrible pain in his lower legs and extreme pain in his lower extremities was recovering. And for the event headache was recovered. For the events swelling comes and goes in his feet, redness in his feet and feet are super sensitive to touch was not recovered.    No follow-up attempts are possible. No further information is expected.
Age: 31.0
Sex: M
Vaccine: COVID19
Symptoms: Loss of personal independence in daily activities, Nausea, Oedema, Pain, Pain in extremity
Clinical narrative: severe edema in lower legs; horrible pain in his lower legs; swelling comes and goes in his feet; redness in his feet; feet are super sensitive to the touch; extreme pain in his lower extremities; he was sick as a dog; woke up in so much pain he was afraid to put his feet on the ground; couldn't push down on the gas pedal in his car; softball sized swelling in his feet; severe nausea; headaches; felt like someone hit him with a 100 mile per hour fast ball the next day, clarified he had pain at his injection site; This is a spontaneous report from a contactable other health professional via the regulatory authority. Regulatory authority report number is 543654.   A 31-years-old male patient received bnt162b2 (BNT162B2, PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot number: EW0164), via an unspecified route of administration, administered in left arm on 19Apr2021 09:45 (At the age of 31 years) as DOSE 1, SINGLE for covid-19 immunisation. Medical history included ongoing migraine. Concomitant medications included Aimovig taken for migraine, start and stop date were not reported. The patient was taken to emergency room due to swelling and pain in lower legs. No prior vaccination was taken within 4 weeks. The patient experienced severe nausea and headaches on 21Apr2021, severe edema in lower legs, horrible pain in his lower legs, swelling comes and goes in his feet, redness in his feet, feet are super sensitive to the touch, felt like someone hit him with a 100 mile per hour fast ball the next day, clarified he had pain at his injection site on 20Apr2021, softball sized swelling in his feet on 29Apr2021 with outcome of unknown, woke up in so much pain he was afraid to put his feet on the ground, couldn't push down on the gas pedal in his car on 30Apr2021, extreme pain in his lower extremities and he was sick as a dog on an unspecified date. The patient underwent lab tests and procedures which included blood test: unknown on 28Apr2021, investigation: no blood clots on unspecified date. At the time of reporting the outcome of the events severe nausea, felt like someone hit him with a 100 mile per hour fast ball the next day, clarified he had pain at his injection site, softball sized swelling in his feet, woke up in so much pain he was afraid to put his feet on the ground and couldn't push down on the gas pedal in his car was unknown. For events severe edema in lower legs, horrible pain in his lower legs and extreme pain in his lower extremities was recovering. And for the event headache was recovered. For the events swelling comes and goes in his feet, redness in his feet and feet are super sensitive to touch was not recovered.    No follow-up attempts are possible. No further information is expected.
Age: 31.0
Sex: M
Vaccine: COVID19
Symptoms: Peripheral swelling, Sensitive skin, Swelling, Vaccination site pain
Clinical narrative: severe edema in lower legs; horrible pain in his lower legs; swelling comes and goes in his feet; redness in his feet; feet are super sensitive to the touch; extreme pain in his lower extremities; he was sick as a dog; woke up in so much pain he was afraid to put his feet on the ground; couldn't push down on the gas pedal in his car; softball sized swelling in his feet; severe nausea; headaches; felt like someone hit him with a 100 mile per hour fast ball the next day, clarified he had pain at his injection site; This is a spontaneous report from a contactable other health professional via the regulatory authority. Regulatory authority report number is 543654.   A 31-years-old male patient received bnt162b2 (BNT162B2, PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot number: EW0164), via an unspecified route of administration, administered in left arm on 19Apr2021 09:45 (At the age of 31 years) as DOSE 1, SINGLE for covid-19 immunisation. Medical history included ongoing migraine. Concomitant medications included Aimovig taken for migraine, start and stop date were not reported. The patient was taken to emergency room due to swelling and pain in lower legs. No prior vaccination was taken within 4 weeks. The patient experienced severe nausea and headaches on 21Apr2021, severe edema in lower legs, horrible pain in his lower legs, swelling comes and goes in his feet, redness in his feet, feet are super sensitive to the touch, felt like someone hit him with a 100 mile per hour fast ball the next day, clarified he had pain at his injection site on 20Apr2021, softball sized swelling in his feet on 29Apr2021 with outcome of unknown, woke up in so much pain he was afraid to put his feet on the ground, couldn't push down on the gas pedal in his car on 30Apr2021, extreme pain in his lower extremities and he was sick as a dog on an unspecified date. The patient underwent lab tests and procedures which included blood test: unknown on 28Apr2021, investigation: no blood clots on unspecified date. At the time of reporting the outcome of the events severe nausea, felt like someone hit him with a 100 mile per hour fast ball the next day, clarified he had pain at his injection site, softball sized swelling in his feet, woke up in so much pain he was afraid to put his feet on the ground and couldn't push down on the gas pedal in his car was unknown. For events severe edema in lower legs, horrible pain in his lower legs and extreme pain in his lower extremities was recovering. And for the event headache was recovered. For the events swelling comes and goes in his feet, redness in his feet and feet are super sensitive to touch was not recovered.    No follow-up attempts are possible. No further information is expected.
Sex: U
Vaccine: COVID19
Symptoms: Pruritus
Clinical narrative: Itching really bad; This is a spontaneous report from a contactable consumer (patient). A patient of unspecified age and gender received unknown dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot Number and Expiration Date were not reported), via unspecified route of administration, on an unspecified date, as dose number unknown, single dose for COVID-19 immunization. The patient medical history and concomitant medications were not reported. The patient stated had Pfizer vaccine on Wednesday and didn't know it was not approved. But anyways are all the vaccines not approved you know for the COVID-19. The patient confirmed the name of the vaccine as Pfizer COVID Vaccine. The patient had on Wednesday but had concern that the patient was itching, itching really bad, whether there was anything that have to do about that. The patient was calling for, to see if there was anything could do it been 2 days now. The patient stated that don't know what the patient can do to stop the itching. Outcome of the event was unknown.  No follow-up attempts are possible; information about lot/batch number cannot been obtained.
Age: 47.0
Sex: M
Vaccine: COVID19
Symptoms: Eye swelling, Headache
Clinical narrative: Headache; Left eye swelling; I didn't feel well for my eye; This is a spontaneous report from a contactable consumer (patient). A 47-year-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, formulation: solution for injection, Batch/Lot Number: EW0175, expiry date: unknown), via an unspecified route of administration on 28Apr2021 (at the age of 47-year-old) as DOSE 1, SINGLE for covid-19 immunisation. The patient's medical history and concomitant medication reported as none. The patient has not been for any lab test and have not been to the Hospital. On an unspecified date, the patient experienced headache and left eye swelling; I didn't feel well for my eye. Patient reported, he received that dose on April 28th and the details he provided that he experienced the headache, he did take Tylenol (treatment) for the headache. The reason for his call is he noticed yesterday that his left eye started to have swelling and he called us for medical advice on what to do. I am just doing it because I mean before the vaccine. I just doing it I didn't feel well for my eye comes again swelling up, I never had it. I got the vaccine and first person (Medical Information Department) told me that it was the part of the possible symptoms. I want to know whether I can go and buy over the counter medication for my eye, that's the reason I was calling, I was not calling for any other reason. I want to know if it was ok for me to go and get an eye medication, but she was telling me that maybe I can go to walk in clinic but then you know walk in clinic wants insurance, they to cost lot of money, so that's the reason I am not going to a clinic. Therapeutic measures were taken as a result of headache (Tylenol). The outcome of the event was unknown.   No follow-up attempts are possible. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Paraesthesia, Vaccination site bruising
Clinical narrative: She said last night her arm felt like it had fallen asleep. She said her arm had a tingling feeling in it, clarifying it was her arm that she received her COVID-19 Vaccine in on Saturday.; She also had a light bruise at the COVID-19 Vaccine injection site; This is a spontaneous report from a contactable consumer (reported for herself). A female patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, formulation: solution for injection, Batch/Lot number and expiry date not reported), via an unspecified route of administration on 01May2021 as dose number unknown, single for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. On 01May2021, the patient felt her arm felt like it had fallen asleep, she said her arm had a tingling feeling in it, clarifying it was her arm that she received her vaccine. On an unspecified date in May2021 she also had a light, very faint bruise at the injection site. The outcome of the event tingling sensation was not recovered, and the outcome of the event bruising was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 25.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Hyperhidrosis, Pyrexia
Clinical narrative: Headache; fever; Sweaty; This is a spontaneous report from a contactable consumer (Mother). A 25 years old female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: solution for injection, Lot Number was not reported, Expiry date: Unknown) via an unspecified route of administration on an unspecified date (at the age of 25 years old) as dose 2, single for COVID-19 immunization. The patient medical history and concomitant medications were not reported. Patient previously took first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE) for COVID-19 Immunisation on an unspecified date. Consumer states after her second dose her daughter had a headache and she took tylenol. The next morning, she woke up sweaty so caller states she probably had a fever. Mentions her daughter was on vacation. Consumer was not sure if she had a fever since she took Tylenol. She didn't have anything special. Patient received treatment for the events fever and headache. Outcome of the events was unknown. No Follow-up attempts are needed. Information about lot/batch number cannot be Obtained.
Sex: U
Vaccine: COVID19
Symptoms: Epistaxis, Headache
Clinical narrative: Says a relative had severe nose bleeds and headaches from the vaccine; Says a relative had severe nose bleeds and headaches from the vaccine; This is a spontaneous report received from a non-contactable consumer via Pfizer sponsored Program Support. A patient of unspecified age and gender received bnt162b2 (BNT162B2, PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot number: was not reported), via an unspecified route of administration on an unspecified date as DOSE NUMBER UNKNOWN, SINGLE for covid-19 immunisation. The patient medical history and concomitant medications were not reported. On an unspecified date, the patient had experienced severe nose bleeds and headaches from the vaccine. At the time of reporting 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: Chest discomfort, Heart rate, Heart rate increased
Clinical narrative: Having some discomfort in her chest; Heart is beating fast; This is a spontaneous report from a contactable consumer (parent). A 19-year-old female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number was not reported), dose 2 via an unspecified route of administration on 04May2021 as DOSE 2, SINGLE for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient previously received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number was not reported), dose 1 via an unspecified route of administration on an unspecified date as DOSE 1, SINGLE for covid-19 immunisation. The patient experienced having some discomfort in her chest, heart is beating fast on an unspecified date. Reporter stated, her 19-year-old daughter had her second Pfizer vaccination today and she was having some discomfort in her chest and her heart was beating fast and we just want to make sure you know if that was normal or that was something to be concerned about. The patient underwent lab tests and procedures which included heart rate: fast on May2021. The clinical 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: Swelling face
Clinical narrative: swollen face; This is a spontaneous report from a non-contactable female consumer via Pfizer-sponsored program  support. A 71-years-old female patient received first dose of bnt162b2 (BNT162B2, Formulation: Solution for injection, Batch/Lot number was not reported) via an unspecified route of administration on an unspecified date as dose 1, single for covid-19 immunization and second dose of bnt162b2 (BNT162B2, Formulation: Solution for injection, Batch/Lot 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. It was reported that, on an unspecified date the patient was extremely upset that they had not responded to her reports of adverse event from both doses; she was in bed for four days with swollen face that lasted weeks. She received letter from department of health stating not to receive second dose as second reaction could be worse (after both doses), and she was upset as she did not know to get second dose. The outcome of the event was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Deformity, Inflammation, Pain, SARS-CoV-2 test
Clinical narrative: Inflammation; Deformation; severe pain; This is a spontaneous report from a contactable consumer (patient).   A 39-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; ), dose 1 via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as DOSE 1, SINGLE and dose 2 via an unspecified route of administration, administered in left arm on an unspecified date (Batch/Lot number was not reported) as DOSE 2, SINGLE for COVID-19 immunization. Medical history included liver disorder (liver) and Known allergies (yes). There were no concomitant medications. Patient not administered other vaccine in four weeks. The patient experienced Inflammation, deformation, and severe pain for more than 2 months after vaccinations on an unspecified date. Patient went to emergency room and physician room for visit. Patient not had Covid prior vaccination. Patient was tested Covid post vaccination. The patient underwent lab tests and procedures which included sars-cov-2 test and result was unknown. The patient received Colchicine for the treatment of events. The outcome of the events was not resolved.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Sex: M
Vaccine: COVID19
Symptoms: Chills, Fatigue, Headache, Lymphadenopathy, Pyrexia
Clinical narrative: I have a swollen gland under my arm, on the side of the injection and its sore as well; fever; headache; tiredness; Chills; pain at injection site; slept all day; This is a spontaneous report from a contactable consumer (patient). A male patient of an unspecified age received second dose bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number was not reported), dose 2 via an unspecified route of administration on 08May2021 as Dose 2, single for COVID-19 immunization. Medical history and concomitant medications were not reported. Previously patient received first dose bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number was not reported), dose 1 via an unspecified route of administration as Dose 1, single for COVID-19 immunization. On 10May2021 the patient experienced a swollen gland under his arm, on the side of the injection and it was sore as well, added on 09May2021 he had chills, headache, fever and tiredness. He slept all day on 09May2021". Also had pain at injection site. 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: Somnolence, Vaccination site pain
Clinical narrative: I have a swollen gland under my arm, on the side of the injection and its sore as well; fever; headache; tiredness; Chills; pain at injection site; slept all day; This is a spontaneous report from a contactable consumer (patient). A male patient of an unspecified age received second dose bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number was not reported), dose 2 via an unspecified route of administration on 08May2021 as Dose 2, single for COVID-19 immunization. Medical history and concomitant medications were not reported. Previously patient received first dose bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number was not reported), dose 1 via an unspecified route of administration as Dose 1, single for COVID-19 immunization. On 10May2021 the patient experienced a swollen gland under his arm, on the side of the injection and it was sore as well, added on 09May2021 he had chills, headache, fever and tiredness. He slept all day on 09May2021". Also had pain at injection site. The outcome of the events was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Sex: U
Vaccine: COVID19
Symptoms: Flushing, Hypersensitivity, Peripheral swelling
Clinical narrative: Allergic reaction; I can't get my second shot because I am afraid to it; Swelling of legs; Flushing of face; This is a spontaneous report from a contactable consumer or other non-health care professional. A patient of unspecified age and gender received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot Number: EW0169; Expiration Date: Aug2021), via an unspecified route of administration, administered at unspecified anatomical location on an unspecified date (age at vaccination was unknown) as dose 1, single for COVID-19 immunization. The patient medical history and concomitant medications were not reported. On an unspecified date, the patient experienced allergic reaction; patient can't get my second shot because and afraid to it, swelling of legs, flushing of face. The patient wanted to know about the vaccine (Pfizer, Covid vaccine) had first vaccine done and had a slight allergic reaction towards to it swelling in the legs, flushing on face and all. So, just took Benadryl (treatment), so was fine but cannot get second shot because patient was afraid to it. Patients need to know if he should be taking second shot because of reaction and had before or if what patient need to do because consumer do not want to get this, even the Hospital does not want gave it. The outcome of the event was unknown.  No follow-up attempts are possible. No further information is expected.
Age: 84.0
Sex: F
Vaccine: COVID19
Symptoms: Blood test, Rash, Vaccination site erythema, Vaccination site swelling
Clinical narrative: Swollen Rash on her Side Arm; Well 27Apr2021, I got the injection and it just gradually got large red patch; One large, its about 3 or 4 inches round around the site of injection and its swollen; This is a spontaneous report from a Pfizer-sponsored program Support from a contactable consumer (patient).   A 84-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot Number: ER8735), via an unspecified route of administration, administered in Arm Left on 27Apr2021 (at the age of 84-years-old) as dose 2, single for COVID-19 immunization. Medical history included blood pressure, thyroid disorder and Blood clot in lungs. Concomitant medication(s) included rivaroxaban (XARELTO) Dosage text: 20mg, Capsule, Oral, Once a day for Blood clot in lungs from Mar2021. Consumer stated, "That's obvious it happens to be before I got the injection, had the blood clot; It was Mar2021."levothyroxine (LEVOTHYROXINE) Dosage text: 112mg, Oral, Tablet, One a day taken for Thyroid, start and stop date were not reported, Consumer stated, "Its been years also."Metoprolol (METOPROLOL) 100mg, Oral, Tablet, One a day taken for blood pressure, start and stop date were not reported. Consumer stated, "Not particularly, its been years." Consumer stated, "I take Thyroid medication and a Blood pressure medication. Also I forgot to tell you I had a Blood Clot in my lungs. So they put me on Blood thinner." (further clarification unknown). Historical vaccine patient also received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot Number: ER8732) via an unspecified route of administration, on 06Apr2021 as dose 1, single for COVID-19 immunization. On unspecified date the patient experienced swollen rash on her side arm, well on 27apr2021, I got the injection and it just gradually got large red patch, one large, it is about 3- or 4-inches round around the site of injection and its swollen. The patient took the first dose the 06Apr2021, then the second dose last 27Apr2021. Then up until now after the second dose, she is experiencing Swollen Rash on her Side Arm. Consumer stated, "Well its been a gradual process of getting larger spot." Its not even sore to touch but it to me its swollen." The patient did not receive treatment for the adverse events. The patient want to know if this was totally typical or normal and if there was anything she should do about it. The patient underwent lab tests which included blood test was everything was fine except the raised thyroid on 14Apr2021 it was little bit higher. Consumer stated, "Yes, I was just, It was general. I was getting it as a Physical. She had this just the Blood Test. Everything was fine except the raised thyroid it was little bit higher." The outcome of the events was not recovered.  No follow-up attempts are possible. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Abdominal pain upper, Chills, Decreased appetite, Diarrhoea, Ear pain
Clinical narrative: not feeling well / feeling like still under the weather / really feeling ill; tired; chills; feeling week nausea; severe stomach pain; dry hives; sweat; achy all over; ear ache; could not sleep; fever; no apatite; leg cramps; neck pain; sore throat; diarrhea; itchy face; This is a spontaneous report from a non-contactable consumer (patient). A female patient of 7-decade received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot number was not reported), via an unspecified route of administration on 05May2021 as dose 2, single for COVID-19 immunization. The patient medical history include respiratory Infection in Oct2019. The patient concomitant medications were not reported. The patient previously received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection), via an unspecified route of administration on unspecified date (Batch/Lot number was not reported) as dose 1, single for COVID-19 immunization. The patient stated she received her second dose of the Pfizer covid vaccine on 05May2021 and she was still not feeling well, feeling like still under the weather, tired, chills, feeling week nausea, severe stomach pain, dry hives, sweat, chills, achy all over, really feeling ill, ear ache, could not sleep, fever, no appetite, did not feel well. She was not tested. Patient stated she also experienced leg cramps, neck pain, sore throat, diarrhea, Itchy face. She wanted to know about it and how long it takes to go away. The outcome of events was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Hyperhidrosis, Insomnia, Malaise, Muscle spasms
Clinical narrative: not feeling well / feeling like still under the weather / really feeling ill; tired; chills; feeling week nausea; severe stomach pain; dry hives; sweat; achy all over; ear ache; could not sleep; fever; no apatite; leg cramps; neck pain; sore throat; diarrhea; itchy face; This is a spontaneous report from a non-contactable consumer (patient). A female patient of 7-decade received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot number was not reported), via an unspecified route of administration on 05May2021 as dose 2, single for COVID-19 immunization. The patient medical history include respiratory Infection in Oct2019. The patient concomitant medications were not reported. The patient previously received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection), via an unspecified route of administration on unspecified date (Batch/Lot number was not reported) as dose 1, single for COVID-19 immunization. The patient stated she received her second dose of the Pfizer covid vaccine on 05May2021 and she was still not feeling well, feeling like still under the weather, tired, chills, feeling week nausea, severe stomach pain, dry hives, sweat, chills, achy all over, really feeling ill, ear ache, could not sleep, fever, no appetite, did not feel well. She was not tested. Patient stated she also experienced leg cramps, neck pain, sore throat, diarrhea, Itchy face. She wanted to know about it and how long it takes to go away. The outcome of events was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Sex: F
Vaccine: COVID19
Symptoms: Nausea, Neck pain, Oropharyngeal pain, Pain, Pruritus
Clinical narrative: not feeling well / feeling like still under the weather / really feeling ill; tired; chills; feeling week nausea; severe stomach pain; dry hives; sweat; achy all over; ear ache; could not sleep; fever; no apatite; leg cramps; neck pain; sore throat; diarrhea; itchy face; This is a spontaneous report from a non-contactable consumer (patient). A female patient of 7-decade received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot number was not reported), via an unspecified route of administration on 05May2021 as dose 2, single for COVID-19 immunization. The patient medical history include respiratory Infection in Oct2019. The patient concomitant medications were not reported. The patient previously received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection), via an unspecified route of administration on unspecified date (Batch/Lot number was not reported) as dose 1, single for COVID-19 immunization. The patient stated she received her second dose of the Pfizer covid vaccine on 05May2021 and she was still not feeling well, feeling like still under the weather, tired, chills, feeling week nausea, severe stomach pain, dry hives, sweat, chills, achy all over, really feeling ill, ear ache, could not sleep, fever, no appetite, did not feel well. She was not tested. Patient stated she also experienced leg cramps, neck pain, sore throat, diarrhea, Itchy face. She wanted to know about it and how long it takes to go away. The outcome of events was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia, Urticaria
Clinical narrative: not feeling well / feeling like still under the weather / really feeling ill; tired; chills; feeling week nausea; severe stomach pain; dry hives; sweat; achy all over; ear ache; could not sleep; fever; no apatite; leg cramps; neck pain; sore throat; diarrhea; itchy face; This is a spontaneous report from a non-contactable consumer (patient). A female patient of 7-decade received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot number was not reported), via an unspecified route of administration on 05May2021 as dose 2, single for COVID-19 immunization. The patient medical history include respiratory Infection in Oct2019. The patient concomitant medications were not reported. The patient previously received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection), via an unspecified route of administration on unspecified date (Batch/Lot number was not reported) as dose 1, single for COVID-19 immunization. The patient stated she received her second dose of the Pfizer covid vaccine on 05May2021 and she was still not feeling well, feeling like still under the weather, tired, chills, feeling week nausea, severe stomach pain, dry hives, sweat, chills, achy all over, really feeling ill, ear ache, could not sleep, fever, no appetite, did not feel well. She was not tested. Patient stated she also experienced leg cramps, neck pain, sore throat, diarrhea, Itchy face. She wanted to know about it and how long it takes to go away. The outcome of events was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Sex: U
Vaccine: COVID19
Symptoms: Dyspnoea
Clinical narrative: Trouble breathing; This is a spontaneous report from a contactable consumer (patient) or other non hcp. A patient of an unspecified age and gender received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number was not reported) via an unspecified route of administration on an unspecified date as dose 2, single for COVID-19 immunization. Medical history included headache (the patient had all these headaches prior to the first injection and prior to yesterday second injection) from an unknown date and unknown if ongoing. The patient's concomitant medication was not reported. Historical vaccine included tetanus vaccine and a shingles vaccine in Oct2020. The patient previously received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number was not reported) via an unspecified route of administration on an unspecified date as dose 1, single for COVID-19 immunization. On an unspecified date, the patient experienced trouble breathing. The outcome of the event was unknown.  No follow-up attempts were possible; information about lot/batch number cannot be obtained. No further information was expected.
Age: 53.0
Sex: M
Vaccine: COVID19
Symptoms: Body temperature, Chills, Feeling abnormal, Feeling cold, Gait disturbance
Clinical narrative: Caller's arms are weak; Caller's knees are swollen and caller can barely walk; Caller's knees are swollen and caller can barely walk; Second dose: Just started to get a rash; Caller states his rash is not a bumpy rash, it is a blotchy rash; Second dose: Was violently shivering and freezing to death; Second dose: Fevers; Second dose: Was violently shivering and freezing to death; Second dose: Overall miserable; Second dose: Went home early from work with body aches; This is a spontaneous report from a contactable consumer or other non hcp (patient).  A 53-years-old male patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number: EW0162, Expiration date: not reported) via an unspecified route of administration, administered in left arm on 04May2021 at 09:15 (at the age of 53-years-old) as dose 2, single for covid-19 immunization. Medical history included atrial fibrillation, Verbatim: Afib, Blood pressure, Probably 3 years or so caller states he had Afib and Anti-inflammatory. Concomitant medication(s) included metoprolol tartrate (METOPROLOL TARTRATE) taken for blood pressure measurement; diclofenac (DICLOFENAC) taken for Anti-inflammatory. On 09May2021, patient experienced second dose: just started to get a rash; caller states his rash is not a bumpy rash, it is a blotchy rash, on 04May2021, second dose: went home early from work with body aches, on 06May2021, second dose: was violently shivering and freezing to death, on 05May2021, second dose: overall miserable, on 06May2021, second dose: fevers, on an unspecified date, caller's arms are weak, caller's knees are swollen and caller can barely walk. On 06May2021, patient underwent lab tests and procedures which included body temperature: 97.7 fahrenheit, 97.7 , body temperature: 103 fahrenheit, 103 (after 15 minutes from previous temperature) , body temperature: 101 fahrenheit. Therapeutic measures were taken as a result of second dose: was violently shivering and freezing to death, second dose: was violently shivering and freezing to death. Patient took Tylenol for was violently shivering and freezing to death and fevers. Dis not received prior Vaccinations within 4 weeks. No AE(s) following prior vaccinations, patient received flu shot every year with no issue. The outcome of events second dose: just started to get a rash; caller states his rash is not a bumpy rash, it is a blotchy rash, Caller's arms are weak and Caller's knees are swollen and caller can barely walk were unknown, rest all events was not recovered.   No follow-up attempts are possible. No further information is expected.