chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 36.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: Its been 2 months since my second dose and multiple times a week the area on my arm where I had the injection hurts sometimes. It comes and goes, its the same pain every time. Its sort of a throb.; This is a spontaneous report from a contactable consumer (patient). A 36-year-old non-pregnant female patient received bnt162b2 (Pfizer-BioNTech COVID-19 Vaccine, solution for injection, Batch/Lot number was not reported) via an unspecified route of administration in left arm on 15May2021 at 13:30 (age at vaccination 36-year-old) as dose 2, single for covid-19 immunization. The patients medical history was not reported. The patients concomitant medications were none. The patient previously received the first dose of bnt162b2 (Pfizer-BioNTech COVID-19 Vaccine, solution for injection, Batch/Lot number was not reported) via an unspecified route of administration in arm left on 24Apr2021 at 13:30 at single for covid-19 immunization at doctors office/urgent care. Patient did not receive any other vaccines within 4 weeks prior to covid vaccine. Prior to the vaccination, the patient was not diagnosed with Covid-19. Since the vaccination, the patient had not been tested for Covid-19. On unspecified date, there was reported that it has been 2 months since patient second dose and multiple times a week the area on her arm where patient had the injection hurts sometimes. It comes and goes, it was the same pain every time. It was sort of a throb. Patient did not receive any treatment for adverse event. The outcome of event was unknown.  Follow-up attempts are completed. no further information is expected.; Sender's Comments: Linked Report(s) : -PFIZER INC-202100950840 same reporter/drug/event, different patient
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: sore arm; This is a spontaneous report from a contactable consumer. This contactable consumer (patient's mother) reported for a female patient of an unspecified age that she received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot Number, Expiry Date: not reported), via an unspecified route of administration on 06Jul2021 as dose 1, single for covid-19 immunisation. The patient medical history and concomitant medications were not reported. She had the first shot she just had a sore arm on an unspecified date that wasn't anything. The outcome of event was unknown.   The lot number for the vaccine, [bnt162b2], was not provided and will be requested during follow up.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202100985837 similar report from same reporter
Sex: U
Vaccine: COVID19
Symptoms: Injury
Clinical narrative: I got an injury; This is a spontaneous report received from a non-contactable consumer or other non hcp.A patient of unspecified age and gender received bnt162b2 (COMIRNATY,Batch/Lot number was not reported), via an unspecified route of administration on 2021 as Dose number unknown,single for covid-19 immunization.The patient medical history and concomitant medications were not reported.The patient experienced an injury on 2021.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Feeling abnormal
Clinical narrative: This is a spontaneous report from a contactable consumer. A male patient, of an unspecified age, received the 1st dose of BNT162B2 (Comirnaty, batch/lot# not reported), via an unspecified route of administration, on Aug 18, 2021, single dose, for COVID-19 immunisation. The patient's medical history and concomitant medications not reported. Their mom and dad felt haziness in their brain on 2021. Outcome of the event: unknown.
Age: 84.0
Sex: M
Vaccine: COVID19
Symptoms: Diarrhoea, Fatigue, Nausea
Clinical narrative: Nausia, diarreah, Fatighe; Nausia, diarreah, Fatighe; Nausia, diarreah, Fatighe; This is a spontaneous report from a contactable consumer (patient). A 84-year-old male patient received bnt162b2 (PFIZER BIONTECH COVID-19 MRNA VACCINE Solution for injection Lot Number: EN6206) via an unspecified route of administration in arm left on 19Mar2021 11:45 as dose 1, single (age at vaccination: 84 years) for COVID-19 immunisation. Medical history included heart disease from an unknown date and unknown if ongoing. Concomitant medications were not reported. No COVID prior vaccination and did not tested COVID post vaccination. No known Allergies. No other vaccine in four weeks. Numerous medications in two weeks but not specified. On 21Mar2021, the patient experienced nausia, diarreah, fatighe. The adverse event resulted in doctor or other healthcare professional office/clinic visit. Treatment was received and it was unknown and not reported. The clinical outcome of the event on an unspecified date 2021 was resolved.  Follow-up attempts are completed. No further information is expected.
Age: 34.0
Sex: F
Vaccine: COVID19
Symptoms: Alopecia areata, Hypoaesthesia, Limb injury, Muscle twitching, Peripheral swelling
Clinical narrative: Patient arm was twitching as if she had something under her skin on the vaccine section; arm was red on the vaccine site, also it was extremely itchy; arm was red on the vaccine site, also it was extremely itchy; Left had feels like it gets numb at times; left hand feels swollen; Patient middle finger hurts on her left hand; Alopecia areata; This is a spontaneous report from a contactable other health care professional (reported for herself). A 34-years-old female non-pregnant patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection, Lot Number: EWO164/Batch number was not reported), dose 1 via an unspecified route of administration, administered in arm left on 13Aug2021 at 08:00 (at the age of 34-years-old) as dose 1, single for covid-19 immunisation at Hospital. The patient medical history and concomitant medications were not reported. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient did not receive any other medications within 2 weeks of vaccination. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient been tested for COVID-19. The patient has no reported allergies. On 13Aug2021 at 08:30, it was reported that, Alopecia areata. Patient got her vaccine on the left arm and 20 min after her arm was twitching as if she had something under her skin on the vaccine section. The next day her arm was red on the vaccine site, also it was extremely itchy. Left had feels like it gets numb at times and also, she noticed her left hand feels swollen, her middle finger hurts on her left hand and her wedding ring fits snug and it happen after vaccination. No treatment was given for the events. The patient underwent lab tests and procedures which included sars-cov-2 test: negative on 22Aug2021. The outcome of the events was not resolved and alopecia areata was unknown.  Follow-up attempts are completed. No further information is expected.
Age: 34.0
Sex: F
Vaccine: COVID19
Symptoms: SARS-CoV-2 test, Vaccination site erythema, Vaccination site pruritus
Clinical narrative: Patient arm was twitching as if she had something under her skin on the vaccine section; arm was red on the vaccine site, also it was extremely itchy; arm was red on the vaccine site, also it was extremely itchy; Left had feels like it gets numb at times; left hand feels swollen; Patient middle finger hurts on her left hand; Alopecia areata; This is a spontaneous report from a contactable other health care professional (reported for herself). A 34-years-old female non-pregnant patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection, Lot Number: EWO164/Batch number was not reported), dose 1 via an unspecified route of administration, administered in arm left on 13Aug2021 at 08:00 (at the age of 34-years-old) as dose 1, single for covid-19 immunisation at Hospital. The patient medical history and concomitant medications were not reported. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient did not receive any other medications within 2 weeks of vaccination. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient been tested for COVID-19. The patient has no reported allergies. On 13Aug2021 at 08:30, it was reported that, Alopecia areata. Patient got her vaccine on the left arm and 20 min after her arm was twitching as if she had something under her skin on the vaccine section. The next day her arm was red on the vaccine site, also it was extremely itchy. Left had feels like it gets numb at times and also, she noticed her left hand feels swollen, her middle finger hurts on her left hand and her wedding ring fits snug and it happen after vaccination. No treatment was given for the events. The patient underwent lab tests and procedures which included sars-cov-2 test: negative on 22Aug2021. The outcome of the events was not resolved and alopecia areata was unknown.  Follow-up attempts are completed. No further information is expected.
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Psoriasis
Clinical narrative: psoriasis lesions that would disappear after 1 application of clobetesol foam/I had a flare-up which spread to every part of my body; This is a spontaneous report from a contactable consumer (patient). A 70-years-old non pregnant female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot number: EL9267), via an unspecified route of administration in arm left on 18Feb2021 at 09:15 (at the age of 70-years-old) as single dose for COVID-19 immunisation. Medical history included blood cholesterol increased and psoriasis. Concomitant medication included atorvastatin calcium, loperamide hydrochloride, psyllium husk [plantago ovata husk]. The patient previously took macrodantin and experienced drug hypersensitivity, the patient previously received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot number: not reported), via an unspecified route of administration on an unknown date as single dose for COVID-19 immunisation. The patient was not pregnant at time of vaccination. The patient was not received any other vaccines within 4 weeks prior to the COVID vaccine. The patient was not having COVID prior vaccination and has not been COVIDtested post vaccination. For 40 years patient have had very occasional (less than 3 times a year) single location (less than 2 inches square) psoriasis lesions that would disappear after 1 application of clobetesol foam. 2 weeks after the 2nd jab on 01Mar2021 patient had a psoriasis flare-up which spread to every part of her body. Adverse event resulted in doctor or other healthcare professional office/clinic visit. patient received phototherapy as treatment for event. The outcome of the event was recovering.  Follow-Up (02Sep2021): Follow-up attempts are completed. No further information is expected.
Age: 86.0
Sex: F
Vaccine: COVID19
Symptoms: Alopecia, Amnesia, Cough, Fatigue, Feeling abnormal
Clinical narrative: felt lousy; brain fog; sweaty feet; head pain; shooting pain going across her head, from the base of her neck up to the middle of her and also around the top of head; Dry cough; Runny nose; Hair loss; Memory loss; they had fatigue, fatigue in arm,; strange sensation in the nerves; inappropriate schedule of vaccine administered; This is a spontaneous report from a contactable consumer (patient's daughter). A 86-years-old female patient received second dose of bnt162b2 (Solution injection; Batch/Lot Number: EL9266), via an unspecified route of administration, administered in Arm Left on 23Feb2021 (at the age of 86-years-old) as single dose for covid-19 immunisation. Medical history included lung cancer. She has been on chemo for about 5 years now. The patient's concomitant medications included osimertinib mesilate (TAGRISSO), amlodipine besilate for blood pressure and some vitamins. Patient previously received first dose of bnt162b2 (Solution injection; Batch/Lot Number: EL3302), via an unspecified route of administration, administered in Arm Left on 06Feb2021 as 225mcg/0.45mL single dose for covid-19 immunisation. The patient experienced brain fog, sweaty feet, dry cough, runny nose, hair loss, memory loss. Caller reported that the patient felt lousy and had all these strange happenings. She had head pain; shooting pain going across her head, from the base of her neck up to the middle of her and also around the top of head. It was like this strange sensation in the nerves. It was like a tension headache that where a part of it didn't materialize. Caller stated that they had fatigue, fatigue in arm. Caller questioned if the patient should get an antibody test to see if she still has some antibodies. The outcome of all the events was recovered.  Follow-Up (01Sep2021): Follow-up attempts are completed. No further information is expected.
Age: 86.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Hyperhidrosis, Inappropriate schedule of product administration, Malaise, Nerve injury
Clinical narrative: felt lousy; brain fog; sweaty feet; head pain; shooting pain going across her head, from the base of her neck up to the middle of her and also around the top of head; Dry cough; Runny nose; Hair loss; Memory loss; they had fatigue, fatigue in arm,; strange sensation in the nerves; inappropriate schedule of vaccine administered; This is a spontaneous report from a contactable consumer (patient's daughter). A 86-years-old female patient received second dose of bnt162b2 (Solution injection; Batch/Lot Number: EL9266), via an unspecified route of administration, administered in Arm Left on 23Feb2021 (at the age of 86-years-old) as single dose for covid-19 immunisation. Medical history included lung cancer. She has been on chemo for about 5 years now. The patient's concomitant medications included osimertinib mesilate (TAGRISSO), amlodipine besilate for blood pressure and some vitamins. Patient previously received first dose of bnt162b2 (Solution injection; Batch/Lot Number: EL3302), via an unspecified route of administration, administered in Arm Left on 06Feb2021 as 225mcg/0.45mL single dose for covid-19 immunisation. The patient experienced brain fog, sweaty feet, dry cough, runny nose, hair loss, memory loss. Caller reported that the patient felt lousy and had all these strange happenings. She had head pain; shooting pain going across her head, from the base of her neck up to the middle of her and also around the top of head. It was like this strange sensation in the nerves. It was like a tension headache that where a part of it didn't materialize. Caller stated that they had fatigue, fatigue in arm. Caller questioned if the patient should get an antibody test to see if she still has some antibodies. The outcome of all the events was recovered.  Follow-Up (01Sep2021): Follow-up attempts are completed. No further information is expected.
Age: 86.0
Sex: F
Vaccine: COVID19
Symptoms: Rhinorrhoea
Clinical narrative: felt lousy; brain fog; sweaty feet; head pain; shooting pain going across her head, from the base of her neck up to the middle of her and also around the top of head; Dry cough; Runny nose; Hair loss; Memory loss; they had fatigue, fatigue in arm,; strange sensation in the nerves; inappropriate schedule of vaccine administered; This is a spontaneous report from a contactable consumer (patient's daughter). A 86-years-old female patient received second dose of bnt162b2 (Solution injection; Batch/Lot Number: EL9266), via an unspecified route of administration, administered in Arm Left on 23Feb2021 (at the age of 86-years-old) as single dose for covid-19 immunisation. Medical history included lung cancer. She has been on chemo for about 5 years now. The patient's concomitant medications included osimertinib mesilate (TAGRISSO), amlodipine besilate for blood pressure and some vitamins. Patient previously received first dose of bnt162b2 (Solution injection; Batch/Lot Number: EL3302), via an unspecified route of administration, administered in Arm Left on 06Feb2021 as 225mcg/0.45mL single dose for covid-19 immunisation. The patient experienced brain fog, sweaty feet, dry cough, runny nose, hair loss, memory loss. Caller reported that the patient felt lousy and had all these strange happenings. She had head pain; shooting pain going across her head, from the base of her neck up to the middle of her and also around the top of head. It was like this strange sensation in the nerves. It was like a tension headache that where a part of it didn't materialize. Caller stated that they had fatigue, fatigue in arm. Caller questioned if the patient should get an antibody test to see if she still has some antibodies. The outcome of all the events was recovered.  Follow-Up (01Sep2021): Follow-up attempts are completed. No further information is expected.
Age: 13.0
Sex: M
Vaccine: COVID19
Symptoms: Agitation, Crying
Clinical narrative: became distraught and inconsolably crying; became distraught and inconsolably crying; This is a spontaneous report from a contactable consumer (patient). A 13-years-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot Number: FA3180), via an unspecified route of administration, administered in Arm Left on 23Aug2021 17:30 (at the age of 13-years-old) as dose 2, single for covid-19 immunization. Medical history was none. Concomitant medication included dextromethorphan hydrobromide/ guaifenesin (MUCINEX DM), received within 2 weeks of vaccination, 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: FA7485), via an unspecified route of administration, administered in Arm Left on 02Aug2021 13:30 (at the age of 13-years-old) as dose 1, single for covid-19 immunization. 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. On 24Aug2021 08:30, the patient became distraught and inconsolably crying. He spent time at school in the bathroom and could not understand or verbalize why he was crying. He was like this for two days unless he was sleeping. The third day was much better, and on the 4th day he was back to his normal, talkative, happy-go-lucky self. The only change in his life was the vaccine. The patient received treatment for the adverse evens which included Child psycologist assistance. The patient was visited to Doctor or other healthcare professional office/clinic visit for the events. No seriousness was provided. The outcome of the events was recovered on 28Aug2021 08:30.  Follow-up attempts are completed. No further information is expected.
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Costochondritis, Disturbance in attention, Dizziness, Dyspnoea
Clinical narrative: pain in the sternum; Vertigo; Dizziness; headache; pressure in sinuses & ears; pressure in sinuses & ears; tinnitus worse; blurry vision; body aches; joint aches; fatigue (especially hard getting out of bed in the morning); brain fog; problem concentrating; tingling in my foot on injection side; nausea; calves occasionally feel like popcorn popping; legs go weak; shortness of breath when walking; This is a spontaneous report from a contactable consumer or other non hcp (herself).   A 56-years-old non pregnant female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection, lot number was EW0196 and expiration date was not reported), via an unspecified route of administration, administered in right arm on 16Jul2021 (Age at vaccination was 56 years) as single dose for COVID-19 immunisation. The patient's medical history was not reported. The patient did not have covid prior to vaccination. The patient's concomitant medication(s) included clonazepam (CLONOPIN), buspirone hydrochloride (BUSPAR), loratadine, pseudoephedrine sulfate (CLARITIN-D), sertraline hydrochloride (ZOLOFT) all taken for an unspecified indication, start and stop date were not reported. The patient previously took cephalexine and experienced drug hypersensitivity. The patient did not take any vaccine in four weeks. On 28Jul2021 the patient experienced pain in the sternum, vertigo, dizziness, headache, pressure in sinuses & ears, tinnitus worse, blurry vision, body aches, joint aches, fatigue especially hard getting out of bed in the morning, brain fog, problem concentrating, tingling in my foot on injection side, nausea, calves occasionally feel like popcorn popping, legs go weak, shortness of breath when walking. The patient also stated that while some of these effects were getting better/less severe, there are many still effecting my daily life. The patient have not driven since this started. Doctors did not think it was anything to worry about. The patient extremely worried that I will not get back to normal and am very afraid to get the second shot. The patient was sensitive to medication and have often wondered if a lesser dosage would have been a better option for people like me. The patient underwent lab tests and procedures which included polymerase chain reaction with nasal swab having result negative on 01Aug2021 and on 08Aug2021. The patient did not receive the treatment. The outcome of event was not recovered.  No follow up attempts are needed . No further information is expected
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Ear discomfort, Fatigue, Feeling abnormal, Headache, Muscular weakness
Clinical narrative: pain in the sternum; Vertigo; Dizziness; headache; pressure in sinuses & ears; pressure in sinuses & ears; tinnitus worse; blurry vision; body aches; joint aches; fatigue (especially hard getting out of bed in the morning); brain fog; problem concentrating; tingling in my foot on injection side; nausea; calves occasionally feel like popcorn popping; legs go weak; shortness of breath when walking; This is a spontaneous report from a contactable consumer or other non hcp (herself).   A 56-years-old non pregnant female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection, lot number was EW0196 and expiration date was not reported), via an unspecified route of administration, administered in right arm on 16Jul2021 (Age at vaccination was 56 years) as single dose for COVID-19 immunisation. The patient's medical history was not reported. The patient did not have covid prior to vaccination. The patient's concomitant medication(s) included clonazepam (CLONOPIN), buspirone hydrochloride (BUSPAR), loratadine, pseudoephedrine sulfate (CLARITIN-D), sertraline hydrochloride (ZOLOFT) all taken for an unspecified indication, start and stop date were not reported. The patient previously took cephalexine and experienced drug hypersensitivity. The patient did not take any vaccine in four weeks. On 28Jul2021 the patient experienced pain in the sternum, vertigo, dizziness, headache, pressure in sinuses & ears, tinnitus worse, blurry vision, body aches, joint aches, fatigue especially hard getting out of bed in the morning, brain fog, problem concentrating, tingling in my foot on injection side, nausea, calves occasionally feel like popcorn popping, legs go weak, shortness of breath when walking. The patient also stated that while some of these effects were getting better/less severe, there are many still effecting my daily life. The patient have not driven since this started. Doctors did not think it was anything to worry about. The patient extremely worried that I will not get back to normal and am very afraid to get the second shot. The patient was sensitive to medication and have often wondered if a lesser dosage would have been a better option for people like me. The patient underwent lab tests and procedures which included polymerase chain reaction with nasal swab having result negative on 01Aug2021 and on 08Aug2021. The patient did not receive the treatment. The outcome of event was not recovered.  No follow up attempts are needed . No further information is expected
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Nausea, Pain, Paraesthesia, Polymerase chain reaction, Sinus disorder
Clinical narrative: pain in the sternum; Vertigo; Dizziness; headache; pressure in sinuses & ears; pressure in sinuses & ears; tinnitus worse; blurry vision; body aches; joint aches; fatigue (especially hard getting out of bed in the morning); brain fog; problem concentrating; tingling in my foot on injection side; nausea; calves occasionally feel like popcorn popping; legs go weak; shortness of breath when walking; This is a spontaneous report from a contactable consumer or other non hcp (herself).   A 56-years-old non pregnant female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection, lot number was EW0196 and expiration date was not reported), via an unspecified route of administration, administered in right arm on 16Jul2021 (Age at vaccination was 56 years) as single dose for COVID-19 immunisation. The patient's medical history was not reported. The patient did not have covid prior to vaccination. The patient's concomitant medication(s) included clonazepam (CLONOPIN), buspirone hydrochloride (BUSPAR), loratadine, pseudoephedrine sulfate (CLARITIN-D), sertraline hydrochloride (ZOLOFT) all taken for an unspecified indication, start and stop date were not reported. The patient previously took cephalexine and experienced drug hypersensitivity. The patient did not take any vaccine in four weeks. On 28Jul2021 the patient experienced pain in the sternum, vertigo, dizziness, headache, pressure in sinuses & ears, tinnitus worse, blurry vision, body aches, joint aches, fatigue especially hard getting out of bed in the morning, brain fog, problem concentrating, tingling in my foot on injection side, nausea, calves occasionally feel like popcorn popping, legs go weak, shortness of breath when walking. The patient also stated that while some of these effects were getting better/less severe, there are many still effecting my daily life. The patient have not driven since this started. Doctors did not think it was anything to worry about. The patient extremely worried that I will not get back to normal and am very afraid to get the second shot. The patient was sensitive to medication and have often wondered if a lesser dosage would have been a better option for people like me. The patient underwent lab tests and procedures which included polymerase chain reaction with nasal swab having result negative on 01Aug2021 and on 08Aug2021. The patient did not receive the treatment. The outcome of event was not recovered.  No follow up attempts are needed . No further information is expected
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Tendon discomfort, Tinnitus, Vertigo, Vision blurred
Clinical narrative: pain in the sternum; Vertigo; Dizziness; headache; pressure in sinuses & ears; pressure in sinuses & ears; tinnitus worse; blurry vision; body aches; joint aches; fatigue (especially hard getting out of bed in the morning); brain fog; problem concentrating; tingling in my foot on injection side; nausea; calves occasionally feel like popcorn popping; legs go weak; shortness of breath when walking; This is a spontaneous report from a contactable consumer or other non hcp (herself).   A 56-years-old non pregnant female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection, lot number was EW0196 and expiration date was not reported), via an unspecified route of administration, administered in right arm on 16Jul2021 (Age at vaccination was 56 years) as single dose for COVID-19 immunisation. The patient's medical history was not reported. The patient did not have covid prior to vaccination. The patient's concomitant medication(s) included clonazepam (CLONOPIN), buspirone hydrochloride (BUSPAR), loratadine, pseudoephedrine sulfate (CLARITIN-D), sertraline hydrochloride (ZOLOFT) all taken for an unspecified indication, start and stop date were not reported. The patient previously took cephalexine and experienced drug hypersensitivity. The patient did not take any vaccine in four weeks. On 28Jul2021 the patient experienced pain in the sternum, vertigo, dizziness, headache, pressure in sinuses & ears, tinnitus worse, blurry vision, body aches, joint aches, fatigue especially hard getting out of bed in the morning, brain fog, problem concentrating, tingling in my foot on injection side, nausea, calves occasionally feel like popcorn popping, legs go weak, shortness of breath when walking. The patient also stated that while some of these effects were getting better/less severe, there are many still effecting my daily life. The patient have not driven since this started. Doctors did not think it was anything to worry about. The patient extremely worried that I will not get back to normal and am very afraid to get the second shot. The patient was sensitive to medication and have often wondered if a lesser dosage would have been a better option for people like me. The patient underwent lab tests and procedures which included polymerase chain reaction with nasal swab having result negative on 01Aug2021 and on 08Aug2021. The patient did not receive the treatment. The outcome of event was not recovered.  No follow up attempts are needed . No further information is expected
Sex: M
Vaccine: COVID19
Symptoms: Nausea
Clinical narrative: Nausea; This is a spontaneous report from a contactable consumer. This consumer reported for a male patient that an unspecified age received first dose of bnt162b2 (formulation: Solution for injection), via an unspecified route of administration on Jun2021 (Batch/Lot number was not reported) as SINGLE for covid-19 immunization. The patient medical history was and concomitant medications were not reported. He took the Pfizer BioNTech Covid-19 Vaccine in Jun2021, with first dose he experienced nausea for 12 to 14 hours. The outcome of event was recovered in Jun2021.  The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.
Sex: M
Vaccine: COVID19
Symptoms: Injury
Clinical narrative: Also reported having a male colleague who has been injured post vaccination of the Pfizer vaccine; This is a spontaneous report from a non-contactable consumer reporting for a patient (reporter's colleague). A 40-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Batch/Lot number was not reported), via an unspecified route of administration on an unspecified date as dose number unknown, single for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. It was reported that on an unspecified date, a male colleague has been injured post vaccination of the Pfizer vaccine (did not specify details of AE). The reporter doesn't have any details particular to the event. The case was reported as non-serious. The outcome of event was unknown.  No Follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Back pain, Discomfort, Dizziness, Loss of personal independence in daily activities, Malaise
Clinical narrative: Its not just the pain where the shot is at, its the pain all over my arm including in my fingers and all the way to my back and neck/Leg pain; Its not just the pain where the shot is at, its the pain all over my arm including in my fingers and all the way to my back and neck; Its not just the pain where the shot is at, its the pain all over my arm including in my fingers and all the way to my back and neck; nerve damage/ veins in my arm are severely damaged; I have to have someone over here to help me do almost everything; uncomfortable; Migraine headache; I can't stand in any light or noise or anything; I can't stand in any light or noise or anything; I am not really well; light headed; This is a spontaneous report received from a contactable consumer or other non hcp. A female patient of an unspecified age received 2nd dose of bnt162b2 (Pfizer-Biontech Covid19 vaccine,Batch/Lot Number: EW0187), via an unspecified route of administration, administered in Arm Right on 21May2021 as DOSE 2,single for covid-19 immunization.Medical history included asthma from an unknown date and unknown if ongoing Verbatim:Asthma.Concomitant medication(s) included albuterol sulfate taken for asthma, start and stop date were not reported.The patient experienced its not just the pain where the shot is at, its the pain all over my arm including in my fingers and all the way to my back and neck/leg pain, nerve damage/ veins in my arm are severely damaged , i have to have someone over here to help me do almost everything, uncomfortable, migraine headache, i can't stand in any light or noise or anything, i can't stand in any light or noise or anything, i am not really well and light headed on 2021.Therapeutic measures were taken as a result of its not just the pain where the shot is at, its the pain all over my arm including in my fingers and all the way to my back and neck/leg pain,its not just the pain where the shot is at, its the pain all over my arm including in my fingers and all the way to my back and neck,its not just the pain where the shot is at, its the pain all over my arm including in my fingers and all the way to my back and neck.pain medication which are Tylenol #4 (treatment) and patient take the 1 every 8 hours. Tylenol #4 I take 1 tablet by mouth every 6 hours as needed for pain.The outcome of the events was unknown.The patient previously received her 1st dose of Pfizer covid vaccine on 29Apr2021,lot number EW0167.  Follow up(17Sep2021):The patient therapy for pain was updated and patient took 1 pill every 8 hours tyenol.Lot number of 2 doses vaccine was updated to be EW0167 and EW0187. Follow-Up (22Sep2021): Follow-up attempts are completed. No further information is expected.
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Migraine, Neck pain, Nerve injury, Oversensing, Pain in extremity
Clinical narrative: Its not just the pain where the shot is at, its the pain all over my arm including in my fingers and all the way to my back and neck/Leg pain; Its not just the pain where the shot is at, its the pain all over my arm including in my fingers and all the way to my back and neck; Its not just the pain where the shot is at, its the pain all over my arm including in my fingers and all the way to my back and neck; nerve damage/ veins in my arm are severely damaged; I have to have someone over here to help me do almost everything; uncomfortable; Migraine headache; I can't stand in any light or noise or anything; I can't stand in any light or noise or anything; I am not really well; light headed; This is a spontaneous report received from a contactable consumer or other non hcp. A female patient of an unspecified age received 2nd dose of bnt162b2 (Pfizer-Biontech Covid19 vaccine,Batch/Lot Number: EW0187), via an unspecified route of administration, administered in Arm Right on 21May2021 as DOSE 2,single for covid-19 immunization.Medical history included asthma from an unknown date and unknown if ongoing Verbatim:Asthma.Concomitant medication(s) included albuterol sulfate taken for asthma, start and stop date were not reported.The patient experienced its not just the pain where the shot is at, its the pain all over my arm including in my fingers and all the way to my back and neck/leg pain, nerve damage/ veins in my arm are severely damaged , i have to have someone over here to help me do almost everything, uncomfortable, migraine headache, i can't stand in any light or noise or anything, i can't stand in any light or noise or anything, i am not really well and light headed on 2021.Therapeutic measures were taken as a result of its not just the pain where the shot is at, its the pain all over my arm including in my fingers and all the way to my back and neck/leg pain,its not just the pain where the shot is at, its the pain all over my arm including in my fingers and all the way to my back and neck,its not just the pain where the shot is at, its the pain all over my arm including in my fingers and all the way to my back and neck.pain medication which are Tylenol #4 (treatment) and patient take the 1 every 8 hours. Tylenol #4 I take 1 tablet by mouth every 6 hours as needed for pain.The outcome of the events was unknown.The patient previously received her 1st dose of Pfizer covid vaccine on 29Apr2021,lot number EW0167.  Follow up(17Sep2021):The patient therapy for pain was updated and patient took 1 pill every 8 hours tyenol.Lot number of 2 doses vaccine was updated to be EW0167 and EW0187. Follow-Up (22Sep2021): Follow-up attempts are completed. No further information is expected.
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Photophobia
Clinical narrative: Its not just the pain where the shot is at, its the pain all over my arm including in my fingers and all the way to my back and neck/Leg pain; Its not just the pain where the shot is at, its the pain all over my arm including in my fingers and all the way to my back and neck; Its not just the pain where the shot is at, its the pain all over my arm including in my fingers and all the way to my back and neck; nerve damage/ veins in my arm are severely damaged; I have to have someone over here to help me do almost everything; uncomfortable; Migraine headache; I can't stand in any light or noise or anything; I can't stand in any light or noise or anything; I am not really well; light headed; This is a spontaneous report received from a contactable consumer or other non hcp. A female patient of an unspecified age received 2nd dose of bnt162b2 (Pfizer-Biontech Covid19 vaccine,Batch/Lot Number: EW0187), via an unspecified route of administration, administered in Arm Right on 21May2021 as DOSE 2,single for covid-19 immunization.Medical history included asthma from an unknown date and unknown if ongoing Verbatim:Asthma.Concomitant medication(s) included albuterol sulfate taken for asthma, start and stop date were not reported.The patient experienced its not just the pain where the shot is at, its the pain all over my arm including in my fingers and all the way to my back and neck/leg pain, nerve damage/ veins in my arm are severely damaged , i have to have someone over here to help me do almost everything, uncomfortable, migraine headache, i can't stand in any light or noise or anything, i can't stand in any light or noise or anything, i am not really well and light headed on 2021.Therapeutic measures were taken as a result of its not just the pain where the shot is at, its the pain all over my arm including in my fingers and all the way to my back and neck/leg pain,its not just the pain where the shot is at, its the pain all over my arm including in my fingers and all the way to my back and neck,its not just the pain where the shot is at, its the pain all over my arm including in my fingers and all the way to my back and neck.pain medication which are Tylenol #4 (treatment) and patient take the 1 every 8 hours. Tylenol #4 I take 1 tablet by mouth every 6 hours as needed for pain.The outcome of the events was unknown.The patient previously received her 1st dose of Pfizer covid vaccine on 29Apr2021,lot number EW0167.  Follow up(17Sep2021):The patient therapy for pain was updated and patient took 1 pill every 8 hours tyenol.Lot number of 2 doses vaccine was updated to be EW0167 and EW0187. Follow-Up (22Sep2021): Follow-up attempts are completed. No further information is expected.
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Urticaria
Clinical narrative: Hives on both arms,  thighs,  abdomen; This is a spontaneous report from a contactable pharmacist (patient) via Covid-19 Adverse Event Self-Reporting Solution (COVAES).   A 69-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, administered in Arm Left on 24Sep2021 16:30 (lot number: FF8841; expiry date: unknown) at the age of 69-years-old, as dose number unknown, single, for Covid-19 immunization. Medical history included chronic rhinitis. The patient was not pregnant at the time of vaccination. The patient had no relevant past drug history. Concomitant medication included loratadine taken for an unspecified indication, start and stop date were not reported.  The patient previously received single dose of influenza vaccine inact split 3v (FLUZONE HIGH DOSE) on 20Sep2021 (Batch/lot number: LDF/LJX) in left arm, for immunisation. On 24Sep2021 at 19:00, the patient experienced hives on both arms, thighs, abdomen. The reporter assessed the event as non-serious. Therapeutic measures were taken as a result of hives on both arms, thighs, abdomen which included loratadine 10 mg and diphenhydramine 25 mg. The patient recovered from the event on unspecified date in Sep2021. Since vaccination, patient has not been tested for COVID-19.
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Extra dose administered, Headache, Immunisation, Joint swelling
Clinical narrative: Headache; Fever 100.5; body aches; staying focused on thoughts; swelling in Left leg/ankle; swelling in Left leg/ankle; Third dose administered on 23sep2021; Third dose administered on 23sep2021; Third dose administered on 23sep2021; This is a spontaneous report from a contactable consumer (patient).   A 65-Year-old non pregnant female patient received her third dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot Number: FE3592) administered in left arm via an unspecified route of administration on 23Sep2021 as DOSE 3, SINGLE for COVID-19 immunization (age at vaccination 65 years). The patients past medical history included Obesity, heart murmur and the patient took fluconazole on 12Mar2021, lot number: UJ733AC, vaccine location on Right arm. Concomitant medication was not reported. Since the vaccination, the patient had not been tested for COVID-19. The patient was not diagnosed with COVID-19 Prior to vaccination. The patient previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number: EN5204) administered in left arm via an unspecified route of administration on 12Mar2021 01:15 PM as DOSE 1, SINGLE for COVID-19 immunization and second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number: ER8734) administered in left arm via an unspecified route of administration on 02Apr2021 as DOSE 2, SINGLE for COVID-19 immunization. On 24Sep2021 at 06:00 AM, the patient experienced Headache, Fever 100.5, body aches, staying focused on thoughts, swelling in Left leg/ankle. Treatment received for the adverse events are home massage, rest, sleep. The patient underwent lab tests and procedures which included body temperature was 100.5 on 24Sep2021. The outcome of the events was recovering.  Follow-up attempts are completed. No further information is expected.
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Off label use, Pain, Peripheral swelling, Pyrexia, Therapeutic response unexpected
Clinical narrative: Headache; Fever 100.5; body aches; staying focused on thoughts; swelling in Left leg/ankle; swelling in Left leg/ankle; Third dose administered on 23sep2021; Third dose administered on 23sep2021; Third dose administered on 23sep2021; This is a spontaneous report from a contactable consumer (patient).   A 65-Year-old non pregnant female patient received her third dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot Number: FE3592) administered in left arm via an unspecified route of administration on 23Sep2021 as DOSE 3, SINGLE for COVID-19 immunization (age at vaccination 65 years). The patients past medical history included Obesity, heart murmur and the patient took fluconazole on 12Mar2021, lot number: UJ733AC, vaccine location on Right arm. Concomitant medication was not reported. Since the vaccination, the patient had not been tested for COVID-19. The patient was not diagnosed with COVID-19 Prior to vaccination. The patient previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number: EN5204) administered in left arm via an unspecified route of administration on 12Mar2021 01:15 PM as DOSE 1, SINGLE for COVID-19 immunization and second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number: ER8734) administered in left arm via an unspecified route of administration on 02Apr2021 as DOSE 2, SINGLE for COVID-19 immunization. On 24Sep2021 at 06:00 AM, the patient experienced Headache, Fever 100.5, body aches, staying focused on thoughts, swelling in Left leg/ankle. Treatment received for the adverse events are home massage, rest, sleep. The patient underwent lab tests and procedures which included body temperature was 100.5 on 24Sep2021. The outcome of the events was recovering.  Follow-up attempts are completed. No further information is expected.
Age: 38.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal pain lower, Vaginal haemorrhage
Clinical narrative: I had horrible lower abdominal cramps; vaginal bleeding for approximately 30 minutes.; This is a spontaneous report from a contactable consumer (patient). A 38-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection, lot number Ff2589 and expiry date not reported), via an unspecified route of administration, administered in Arm Left on 22Sep2021 17:30 (at the age of 38-year-old), as dose 1, single, for COVID-19 immunisation in Pharmacy or Drug Store. Patient was not pregnant at the time of vaccination. Medical history included asthma, hypotension, and allergies. There were no concomitant medications. 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 had not been tested for COVID-19. On 24Sep2021 08:30, the patient experienced vaginal bleeding for approximately 30 minutes. After the bleeding ends, the patient experienced horrible lower abdominal cramps. The events resulted in doctor or other healthcare professional office/clinic visit. Treatment for the event was unknown. The patient recovered from vaginal bleeding on 24Sep2021 09:00 while the outcome for abdominal cramps was unknown.
Age: 42.0
Sex: F
Vaccine: COVID19
Symptoms: Alopecia areata, Heavy menstrual bleeding, Oligomenorrhoea
Clinical narrative: Extremely heavy and lengthy menstrual cycle after both doses of Pfizer covid vaccine.; Extremely heavy and lengthy menstrual cycle after both doses of Pfizer covid vaccine.; Alopecia Areata; This is a spontaneous report from a non-contactable consumer (Patient). A 42-years-old non-pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID -19 VACCINE, formulation: solution for injection, Lot number and expiry date: not reported) via an unspecified route of administration, administered in Left Arm on 26May2021 16:00PM as dose 1, single and received bnt162b2 (PFIZER-BIONTECH COVID -19 VACCINE, formulation: solution for injection, Lot number and expiry date: not reported) via an unspecified route of administration on an unspecified date in 2021 as dose 2, single for COVID-19 immunization (age at Vaccination: 42). Medical history and concomitant medications were not reported. The patient was not pregnant at time of vaccination. The patient had not received other vaccines within 4 weeks prior to the vaccination and had not received other medications within 2 weeks prior to the vaccination. The patient was not diagnosed with COVID-19 before, and not tested post vaccination. On 26May2021 16:00PM the patient experienced extremely heavy and lengthy menstrual cycle after both doses of pfizer covid vaccine, and alopecia areata. The patient had visited doctor or other healthcare professional office/clinic visit, and Emergency room/department or urgent care for the events. Events assessed as non-serious. Therapeutic measures were taken as a result of extremely heavy and lengthy menstrual cycle after both doses of pfizer covid vaccine, and alopecia areata includes Iron infusion and steroid treatment. The outcome of the events was reported as not resolved.  Follow-up activities closed: No follow-up attempts are possible.