chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Burning sensation
Clinical narrative: Burning sensation inside entire body; This is a spontaneous report from a contactable consumer, the patient. A 64-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: FC3180) via an unspecified route of administration in the right arm on 10Aug2021 at 08:45 (at the age of 64-year-old) as a single dose for COVID-19 immunisation. Medical history included hashimotos disease, melanoma and allergy to sulfa. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medications included levothyroxine sodium (SYNTHROID) from an unknown date for an unknown indication and unknown if ongoing. The patient previously took clindamycin (MANUFACTURER UNKNOWN) on an unknown date for an unknown indication and experienced drug allergy. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 10Aug2021 at 23:00, the patient experienced burning sensation inside entire body. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The patient did not receive any treatment for the reported event. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the event burning sensation inside entire body was not recovered at the time of this report.
Age: 45.0
Sex: M
Vaccine: COVID19
Symptoms: Blood test, Weight decreased
Clinical narrative: Lost 50 pounds between mid January and March with no explanation; This is a spontaneous report from a contactable healthcare professional, the patient. A 45-year-old male patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EL0142) via an unspecified route of administration in the right arm on 10Jan2021 at 12:00 (at the age of 45-year-old) as a single dose for COVID-19 immunisation. The patient had no medical history. The patient had no known allergies. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient did not take any concomitant medications. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EK5730) via an unspecified route of administration in the right arm on 18Dec2020 at 12:00 (at the age of 45-year-old) as a single dose for COVID-19 immunisation. On 15Jan2021 at 12:00, the patient lost 50 pounds between mid Jan2021 and Mar2021 with no explanation. The patient went to the doctor and they did blood work and told him everything was normal. The patient had always been healthy and had never lost weight like that until he got the vaccine series. The event resulted in doctor or other healthcare professional office/clinic visit. On an unknown date, the patient underwent blood test and the result was normal. Since the vaccination, the patient had not been tested for COVID-19.  Therapeutic measures were not taken as a result of the event. The clinical outcome of the event lost 50 pounds between mid Jan2021 and Mar2021 with no explanation was not resolved at the time of the report.
Sex: M
Vaccine: COVID19
Symptoms: Malaise
Clinical narrative: Not doing well with mild symptoms and severe symptoms; This is a spontaneous report from a Pfizer-sponsored program  Support. A contactable nurse reported for a male patient that: A male patient of an unspecified age received bnt162b2 (BNT162B2, Formulation: Solution for injection, Lot number was not reported, Expiry date: Unknown) via an unspecified route of administration on an unknown date as dose number unknown, single for COVID-19 immunization. The patient medical history and concomitant medications were not reported. On an unspecified date, the patient was not doing well with mild symptoms and severe symptoms. The outcome of the event was unknown.  The lot number for BNT162b2 was not provided and will be requested during follow up.   (PRD/SRD01Sep2021): Follow-up activities closed. Batch/lot number not available.
Sex: M
Vaccine: COVID19
Symptoms: Sweat discolouration
Clinical narrative: I had a blood color sweat. It was a rust color.; This is a spontaneous report from a contactable consumer or other non hcp (patient). A male patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection, lot number and expiration date was not reported), via an unspecified route of administration on an unspecified date as dose 1, single for covid-19 immunization. The patient medical history was not reported. The patient's concomitant medications were not reported. The patient experienced had a blood color sweat, it was a rust color. Patient never experienced anything like that his life. Patient mentioned he spoke to a department that took down all his medical and physician information. Patient wants to know if this is a side effect of the Pfizer covid 19 vaccine. Treatment for the event was not reported. The outcome of event was unknown.  The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.
Sex: U
Vaccine: COVID19
Symptoms: Chills, Feeling cold, Pain
Clinical narrative: I felt achy like when we get the flu; I was cold but it rest the next day too; night I got up with the worst chill; This is a spontaneous report from a contactable consumer or other non hcp (Patient).  A patient of unspecified age and gender received bnt162b2 (BNT162B2, PFIZER-BIOTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number was not reported), via an unspecified route of administration on 09Aug2021 as dose number unknown, single for covid-19 immunization. No medical history and no concomitant medications were not reported. It was reported that patient just calling to tell what side effects were, patient did not have adverse side effects, just had side effects but it was on 9th. Consumer stated had the Vaccine on Monday, 09Aug. That night everything was well but that night patient got got up with the worst chill, no fever but had chill and had cold but it rest the next day too, patient was cold and felt achy like when we get the flu. The outcome for the events was reported as unknown at the time of this report.  Information on Lot/Batch number has been requested.  Follow-up (31Aug2021): This follow-up is being submitted to notify that the lot/batch number is not available despite the follow-up attempts made. Follow-up attempts have been completed and no further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Asthenia, Body temperature, Headache, Pain
Clinical narrative: He is experiencing general body pain specifically on shoulder, feeling like he has a fever - headache, no energy at all/His wife also experienced similar symptoms; He is experiencing general body pain specifically on shoulder, feeling like he has a fever - headache, no energy at all/His wife also experienced similar symptoms; He is experiencing general body pain specifically on shoulder, feeling like he has a fever - headache, no energy at all/His wife also experienced similar symptoms; He is experiencing general body pain specifically on shoulder, feeling like he has a fever - headache, no energy at all/His wife also experienced similar symptoms; He is experiencing general body pain specifically on shoulder, feeling like he has a fever - headache, no energy at all/His wife also experienced similar symptoms; This is a spontaneous report from a Pfizer-sponsored program COVAX US Support. A contactable consumer reported similar events for himself and wife. This report is for wife. A female patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Batch/Lot Number: unknown) via an unspecified route of administration on 19Mar2021 as dose 1, single and dose 2 bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Batch/Lot Number: unknown) via an unspecified route of administration on 10Apr2021 as dose 2, single for covid-19 immunisation. The patient medical history and concomitant medications were not reported. It was reported that reporter and his wife received both doses of the Pfizer COVID 19 vaccine 1st dose 19Mar2021 and 2nd dose was 10Apr2021, not exactly sure of the schedule as he did not have his card with him. Reporter was experiencing general body pain specifically on shoulder, feeling like he has a fever-headache, he had no energy at all, asking for recommendations on what to do with the symptoms and if they need to consult their doctor, his wife (patient) also experienced similar symptoms. The patient underwent lab tests and procedures which included body temperature: feeling like he has a fever on an unspecified date. The outcome of the events was unknown.  Information on the lot/batch number has been requested.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202101046973 same reporter, events, diff pt
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: He is experiencing general body pain specifically on shoulder, feeling like he has a fever - headache, no energy at all/His wife also experienced similar symptoms; He is experiencing general body pain specifically on shoulder, feeling like he has a fever - headache, no energy at all/His wife also experienced similar symptoms; He is experiencing general body pain specifically on shoulder, feeling like he has a fever - headache, no energy at all/His wife also experienced similar symptoms; He is experiencing general body pain specifically on shoulder, feeling like he has a fever - headache, no energy at all/His wife also experienced similar symptoms; He is experiencing general body pain specifically on shoulder, feeling like he has a fever - headache, no energy at all/His wife also experienced similar symptoms; This is a spontaneous report from a Pfizer-sponsored program COVAX US Support. A contactable consumer reported similar events for himself and wife. This report is for wife. A female patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Batch/Lot Number: unknown) via an unspecified route of administration on 19Mar2021 as dose 1, single and dose 2 bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Batch/Lot Number: unknown) via an unspecified route of administration on 10Apr2021 as dose 2, single for covid-19 immunisation. The patient medical history and concomitant medications were not reported. It was reported that reporter and his wife received both doses of the Pfizer COVID 19 vaccine 1st dose 19Mar2021 and 2nd dose was 10Apr2021, not exactly sure of the schedule as he did not have his card with him. Reporter was experiencing general body pain specifically on shoulder, feeling like he has a fever-headache, he had no energy at all, asking for recommendations on what to do with the symptoms and if they need to consult their doctor, his wife (patient) also experienced similar symptoms. The patient underwent lab tests and procedures which included body temperature: feeling like he has a fever on an unspecified date. The outcome of the events was unknown.  Information on the lot/batch number has been requested.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202101046973 same reporter, events, diff pt
Age: 49.0
Sex: F
Vaccine: COVID19
Symptoms: Tinnitus
Clinical narrative: My tinnitus loudness has tripled. It was barely noticeable before the shot, now it is very noticeable; This is a spontaneous report from a contactable consumer or other non hcp. A 49-years-old non-pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot Number: FL3180), dose 1 via an unspecified route of administration, administered in Arm Left on 09Aug2021 at 12:00 (at the age of 49-years-old) as dose 1, single for covid-19 immunisation. Medical history included Prone to panic attacks, anxiety, tinnitus. Tinnitus loudness has tripled. It was barely noticeable before the shot.  The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Concomitant medication included clonazepam.  The patient experienced "my tinnitus loudness has tripled. it was barely noticeable before the shot, now it is very noticeable" in Aug2021.  Facility where the most recent COVID-19 vaccine was administered pharmacy or drug Store. The case was non serious as it did not meet any of the seriousness criteria. No treatment was given for the event. The event did not cause hospitalization Prolongation. Prior to vaccination, the patient was not diagnosed with COVID. Since the vaccination, the patient has not been tested for COVID-19. Outcome of the event was not recovered.  Follow-up attempts are completed. No further information is expected.
Age: 34.0
Sex: F
Vaccine: COVID19
Symptoms: Back pain, Fatigue, Myalgia, Pain in extremity
Clinical narrative: Complaining of being severe fatigue/extremely tired; Muscle pain/Muscles aches in the back; Muscles like her legs hurt a little bit; She has pain in her lower back like muscle pain; back pain; This is a spontaneous report from a contactable consumer (parent). A 34-year-old female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number: FA7484), via an unspecified route of administration on 29Jul2021 (age at the vaccination 34-yer-old) as DOSE 2, SINGLE for covid-19 immunisation. The patient medical history and concomitant medications were not reported. Historical vaccine included first dose of BNT162B2 (Lot Number: FW0198) on o6Jul2021 for COVID-19 Immunization. Patient took the vaccine at night, for last few days she has been complaining of being extremely tired/Complaining of being severe fatigue. This was her second shot of the Pfizer vaccine for COVID. So now she is complaining of being, starting from like Tuesday or Wednesday severe fatigue and her muscles aches in the back in her back like her legs and her muscles in her back, her back pain and like and her muscles like her legs hurt a little bit and she travels for business and she is away right now. She has pain in her lower back like muscle pain, back pain and like her legs hurt a little bit on an unspecified date in 2021. Therapeutic measures were taken Tylenol as a result for all events. The outcome of the event back pain was not recovered and unknown for another events.
Sex: U
Vaccine: COVID19
Symptoms: Diarrhoea
Clinical narrative: Unknown if patient experienced intestinal or diarrhea things; This is a spontaneous report from a contactable consumer or other non hcp. A patient of unspecified age and gender received bnt162b2 (BNT162B2), via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as dose 2, single for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient previously received dose 1 of bnt162b2 (BNT162B2), via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as dose 1, single for covid-19 immunisation. The patient experienced unknown if patient experienced intestinal or diarrhea things on an unspecified date. Reporter wanted to know if any adverse effect lets say three months or something like that after receiving the second dose of Pfizer as far as any kind of intestinal information diarrhea things like that had any severe symptoms like that. The clinical outcome for the event was unknown.  The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.
Sex: F
Vaccine: COVID19
Symptoms: Exposure during pregnancy, Vaccination site pain
Clinical narrative: Pain at injection site after second dose.; Is pregnant yes; This is a spontaneous report from a contactable consumer. This consumer reported information for mother. This is a maternal report. An adult female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Lot number: not reported), via intramuscular in Apr2021 as dose 2, single for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. Historical vaccine included BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Lot number: not reported), via intramuscular in Apr2021 as dose 1, single for COVID-19 immunisation and was pregnant. Prior to vaccination patient was not diagnosed with COVID-19. Since the vaccination the patient had been tested for COVID-19 was unknown. On an unspecified date in Apr2021, the patient experienced pain at injection site after second dose. Patient was pregnant at the time of vaccine in Apr2021. The mother reported she became pregnant while taking bnt162b2. Delivery date reported as May2021. Seriousness criteria reported as no. The patient did not receive treatment for the events. Outcome of the events was recovered in 2021.   The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.
Sex: M
Vaccine: COVID19
Symptoms: Blister
Clinical narrative: This is a spontaneous report from a contactable consumer or other non hcp. A male patient of an unspecified age received BNT162B2 (Pfizer-Biontech Covid-19 Vaccine, Formulation: solution for injection, Batch/Lot Number unspecified, expiration date unspecified), via an unspecified route of administration on an unspecified date as DOSE 2, SINGLE for covid-19 immunization. Previously the patient received BNT162B2 (Pfizer-Biontech Covid-19 Vaccine, Formulation: solution for injection, Batch/Lot Number unspecified, expiration date unspecified), via an unspecified route of administration on an unspecified date as DOSE 1, SINGLE for covid-19 immunization. The patient medical history and concomitant medications were not reported. On an unknown date, the reporter reported that one of her patients had to go to emergency room because he was vaccinated from second one, he had white blister breakout on his right leg. The outcome of the event was reported as unknown.   No follow up attempts possible. No further information is expected. Lot/batch number was not provided and unable to obtain.
Sex: M
Vaccine: COVID19
Symptoms: Chills, Headache, Malaise, Pain, Pyrexia
Clinical narrative: Fever; Body ache; Headache; He just did not feel good; Chills; This is a spontaneous report from a contactable Consumer (Reporter's husband). A male patient of an unspecified age received unknown dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, solution for injection, Batch/Lot Number: was not reported), via an unspecified route of administration, on 11Aug2021, as a single dose for COVID-19 immunization. The patient's medical history included COVID-19 on Dec2020. The patient's concomitant medications were not reported. On an unspecified date Aug2021, the patient experienced Fever, Body ache, Headache, He just did not feel good, and Chills. On an unspecified date Dec2020, the patient underwent lab tests and procedures which included Covid-19 test: Positive. The outcome for all the events was unknown.  Information on the lot/batch number has been requested.
Sex: M
Vaccine: COVID19
Symptoms: SARS-CoV-2 test
Clinical narrative: Fever; Body ache; Headache; He just did not feel good; Chills; This is a spontaneous report from a contactable Consumer (Reporter's husband). A male patient of an unspecified age received unknown dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, solution for injection, Batch/Lot Number: was not reported), via an unspecified route of administration, on 11Aug2021, as a single dose for COVID-19 immunization. The patient's medical history included COVID-19 on Dec2020. The patient's concomitant medications were not reported. On an unspecified date Aug2021, the patient experienced Fever, Body ache, Headache, He just did not feel good, and Chills. On an unspecified date Dec2020, the patient underwent lab tests and procedures which included Covid-19 test: Positive. The outcome for all the events was unknown.  Information on the lot/batch number has been requested.
Sex: M
Vaccine: COVID19
Symptoms: Chills, Headache, Malaise, Myalgia, Nausea
Clinical narrative: Headache; Nauseous; arm pain; he felt his whole body hurting; Muscle pain; Chills; Injection site swelling; not feeling well; he felt like he could vomit; This is a spontaneous report from a contactable consumer or other non-healthcare professional reported for male patient (reporter son). A male patient of an unspecified age received bnt162b2 (BNT162B2, PFIZER-BIONTECH COVID-19 VACCINE, Solution for Injection,), via an unspecified route of administration on 13Aug2021 (Batch/Lot Number: FC3181) as DOSE NUMBER UNKNOWN, SINGLE for covid-19 immunization.  The patient medical history and concomitant medications were not reported. On 13Aug2021, the patient experienced headache, nauseous, arm pain, he felt his whole body hurting, chills, muscle pain, injection site swelling, not feeling well and he felt like he could vomit. The reporter was calling to report side effect for son. It was reported that he got his Pfizer Covid-19 Vaccine shot yesterday morning and by evening he felt he had a worse headache he ever had, he felt nauseous, he felt his whole body hurting, he had headache, muscle pain, chills, chills were really bad. The reporter did not know about his fever and did not check his fever and injection site swelling and then he also had nausea, not feeling well and he felt like he could vomit but he did not and arm pain. The reporter gave him two Tylenol last night and gave him two more today. Reporter was unwilling to provide further information. Limited information was available over the call. The clinical outcome of the events was unknown.  No Follow-up attempts are possible. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Pain, Pain in extremity, Vaccination site swelling, Vomiting
Clinical narrative: Headache; Nauseous; arm pain; he felt his whole body hurting; Muscle pain; Chills; Injection site swelling; not feeling well; he felt like he could vomit; This is a spontaneous report from a contactable consumer or other non-healthcare professional reported for male patient (reporter son). A male patient of an unspecified age received bnt162b2 (BNT162B2, PFIZER-BIONTECH COVID-19 VACCINE, Solution for Injection,), via an unspecified route of administration on 13Aug2021 (Batch/Lot Number: FC3181) as DOSE NUMBER UNKNOWN, SINGLE for covid-19 immunization.  The patient medical history and concomitant medications were not reported. On 13Aug2021, the patient experienced headache, nauseous, arm pain, he felt his whole body hurting, chills, muscle pain, injection site swelling, not feeling well and he felt like he could vomit. The reporter was calling to report side effect for son. It was reported that he got his Pfizer Covid-19 Vaccine shot yesterday morning and by evening he felt he had a worse headache he ever had, he felt nauseous, he felt his whole body hurting, he had headache, muscle pain, chills, chills were really bad. The reporter did not know about his fever and did not check his fever and injection site swelling and then he also had nausea, not feeling well and he felt like he could vomit but he did not and arm pain. The reporter gave him two Tylenol last night and gave him two more today. Reporter was unwilling to provide further information. Limited information was available over the call. The clinical outcome of the events was unknown.  No Follow-up attempts are possible. No further information is expected.
Sex: U
Vaccine: COVID19
Symptoms: Dizziness, Palpitations, Swelling
Clinical narrative: Heart palpitation; Swelling; Dizziness; This is a spontaneous report from a contactable consumer (patient) via Pfizer sponsored program COVAX US Support. A patient of unspecified age and gender received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA 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 immunisation. The patient medical history and concomitant medications were not reported. The patient previously took BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA 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 immunisation. On an unspecified date the patient experienced heart palpitation, swelling, dizziness. The outcome of the events was unknown.   Information on the lot/batch number has been requested.
Age: 44.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Decreased appetite, Disturbance in attention, Dysphagia, Feeling hot
Clinical narrative: 1. SEVERE weakness (CAN'T WORK)2. Constantly hot without a fever (skin is hot to touch)3. Can't focus to even read most of the time.4. Sporadic trouble swallowing; food, drink, and pills get "stuck; 1. SEVERE weakness (CAN'T WORK)2. Constantly hot without a fever (skin is hot to touch)3. Can't focus to even read most of the time.4. Sporadic trouble swallowing; food, drink, and pills get "stuck; 1. SEVERE weakness (CAN'T WORK)2. Constantly hot without a fever (skin is hot to touch)3. Can't focus to even read most of the time.4. Sporadic trouble swallowing; food, drink, and pills get "stuck; 1. SEVERE weakness (CAN'T WORK)2. Constantly hot without a fever (skin is hot to touch)3. Can't focus to even read most of the time.4. Sporadic trouble swallowing; food, drink, and pills get "stuck; 1. SEVERE weakness (CAN'T WORK)2. Constantly hot without a fever (skin is hot to touch)3. Can't focus to even read most of the time.4. Sporadic trouble swallowing; food, drink, and pills get "stuck; Not hungry. Not sure if that's because I can't stand up long enough to cook or what.; This is a spontaneous report from a contactable consumer (patient). A 44-years-old female patient received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot Number: EN6204), via an unspecified route on 03May2021 at 15:00 (at the age of 44-years) as dose 2, single in the left arm for covid-19 immunisation. The patient medical history was not reported. Patient had no known allergies. The patient concomitant medications included gabapentin, hydrocodone bitartrate, paracetamol (VICODIN), and a multivitamin from an unknown date and unknown if ongoing. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot Number: EW0150), via an unspecified route on 12Apr2021 at 15:00 (at the age of 44-years) as dose 1, single in the left arm for covid-19 immunisation. The patient did not receive any other vaccines within four weeks prior to the vaccination. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had been tested for COVID-19. On 03May2021 at 17:00, the patient experienced severe weakness (can't work), constantly hot without a fever (skin is hot to touch), can't focus to even read most of the time, sporadic trouble swallowing food, drink, and pills get "stuck" in chest, not hungry, not sure if that's because she can't stand up long enough to cook or what. Patient received treatment for events. Patient visited to Doctor or other healthcare professional office/clinic visit, Emergency room/department or urgent care. The patient underwent lab tests and procedures which included nasal swab, covid test was negative on 20May2021. The outcome of the events was not recovered.  Follow-Up (26Aug2021): Follow-up attempts are completed. No further information is expected.
Age: 44.0
Sex: F
Vaccine: COVID19
Symptoms: SARS-CoV-2 test, Skin warm
Clinical narrative: 1. SEVERE weakness (CAN'T WORK)2. Constantly hot without a fever (skin is hot to touch)3. Can't focus to even read most of the time.4. Sporadic trouble swallowing; food, drink, and pills get "stuck; 1. SEVERE weakness (CAN'T WORK)2. Constantly hot without a fever (skin is hot to touch)3. Can't focus to even read most of the time.4. Sporadic trouble swallowing; food, drink, and pills get "stuck; 1. SEVERE weakness (CAN'T WORK)2. Constantly hot without a fever (skin is hot to touch)3. Can't focus to even read most of the time.4. Sporadic trouble swallowing; food, drink, and pills get "stuck; 1. SEVERE weakness (CAN'T WORK)2. Constantly hot without a fever (skin is hot to touch)3. Can't focus to even read most of the time.4. Sporadic trouble swallowing; food, drink, and pills get "stuck; 1. SEVERE weakness (CAN'T WORK)2. Constantly hot without a fever (skin is hot to touch)3. Can't focus to even read most of the time.4. Sporadic trouble swallowing; food, drink, and pills get "stuck; Not hungry. Not sure if that's because I can't stand up long enough to cook or what.; This is a spontaneous report from a contactable consumer (patient). A 44-years-old female patient received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot Number: EN6204), via an unspecified route on 03May2021 at 15:00 (at the age of 44-years) as dose 2, single in the left arm for covid-19 immunisation. The patient medical history was not reported. Patient had no known allergies. The patient concomitant medications included gabapentin, hydrocodone bitartrate, paracetamol (VICODIN), and a multivitamin from an unknown date and unknown if ongoing. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot Number: EW0150), via an unspecified route on 12Apr2021 at 15:00 (at the age of 44-years) as dose 1, single in the left arm for covid-19 immunisation. The patient did not receive any other vaccines within four weeks prior to the vaccination. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had been tested for COVID-19. On 03May2021 at 17:00, the patient experienced severe weakness (can't work), constantly hot without a fever (skin is hot to touch), can't focus to even read most of the time, sporadic trouble swallowing food, drink, and pills get "stuck" in chest, not hungry, not sure if that's because she can't stand up long enough to cook or what. Patient received treatment for events. Patient visited to Doctor or other healthcare professional office/clinic visit, Emergency room/department or urgent care. The patient underwent lab tests and procedures which included nasal swab, covid test was negative on 20May2021. The outcome of the events was not recovered.  Follow-Up (26Aug2021): Follow-up attempts are completed. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Diarrhoea, Discomfort, Illness
Clinical narrative: sick; diarrhea; finds it uncomfortable to leave his house; This is a spontaneous report from a contactable consumer or other non hcp(patient). A 61-years-old male patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection, Batch/Lot number was not reported), via an unspecified route of administration on Jul2021 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 sick, diarrhea, finds it uncomfortable to leave his house. Therapeutic measures were taken as a result of sick (illness). The outcome of the events was unknown.  This follow-up is being submitted to notify that the batch/lot number is not available despite the follow-up attempts made. Follow-up attempts have been completed and no further information is expected.
Age: 44.0
Sex: M
Vaccine: COVID19
Symptoms: Dyspnoea, Pain in extremity
Clinical narrative: losing air and having breathing problems; pain in his left leg near his knee; This is a spontaneous report from a contactable consumer. A 44-years-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection. Batch/Lot Number: EW0198), dose 1 via an unspecified route of administration, administered in left arm on 26Jul2021 at 11:02 (at the age of 44-years-old) as DOSE 1,SINGLE for COVID-19 immunization. Vaccination facility type at pharmacy not at military facility. Medical history included (including any illness at time of vaccination) mental disorder (mental illness), asthma, Diabetes mellitus (Diabetic) and cardiac murmur (Heart murmur) from an unknown date and unknown if ongoing. Blood cholesterol increased (blood cholesterol) from 26Jul2021 to an unknown date. Hypersensitivity (Allergy) from an unknown date and unknown if ongoing. Family Medical History Relevant to AE(s): Mother asthma. Concomitant medication(s) included metformin (METFORMIN), aripiprazole (ABILIFY), benztropine [benzatropine] (BENZTROPINE [BENZATROPINE]) and atorvastatin (ATORVASTATIN) taken for an unspecified indication, start and stop date were not reported. It as mentioned that, Up until the 31st the patient was not taking medications every day. History of all previous immunization with the Pfizer vaccine considered as suspect and additional Vaccines Administered on Same Date of the Pfizer Suspect reported as none. No prior Vaccinations (within 4 weeks). No adverse events following prior vaccinations. On 26Jul2021, after vaccination patient did not report anything because patient thought it was part of the vaccine. When the caller was at CVS, when patient got the vaccine patient had pain, after a few seconds or a minute, in left leg near knee. Then the patient was drinking a lot of water and when patient got home, about 30-40 minutes to an hour after leaving CVS, patient started losing air and having breathing problems. The patient has asthma, a heart murmur, allergies, and a few other things. The patient was praying for breathing to get better and it did. After a while the patient started losing air again and drank more water. The patient drank over a gallon of water or a liter, patient could not remember, probably a liter. The second day patient did not have any problems. Today the patient was supposed to get the second dose and patient talked to the woman and she said, should report this to the CDC and talk to his doctor to see what they say about receiving the second dose. The patient was scared. Patient not visited to Emergency Room/Physician office. The outcome of the events were recovering.
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Blood test, Limb discomfort, SARS-CoV-2 antibody test, Thyroid disorder, Vaccination site pain
Clinical narrative: elevated thyroid; she had sore arm for a week and a half and a blister at the site of injection; she had sore arm for a week and a half and a blister at the site of injection; my whole arm felt a little tight like a blood pressure cuff was on it for 4 or 5 days; This is a spontaneous report from a contactable consumer (patient). A 60-years-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/Lot number was not reported), via an unspecified route of administration, administered in arm on unspecified date 2021 (at the age of 60-year-old) as DOSE 1, SINGLE for covid-19 immunisation. Medical history included covid-19 from Jan2020 to an unknown date covid illness. Father had a history of Guillain-Barre syndrome. The patient's concomitant medications were not reported. On unspecified date 2021, it was reported that patient had bloodwork done which revealed elevated thyroid and that she had antibodies, after her first dose, she had a sore arm for a week and a half and a blister at the site of injection she also reports it ached by the injection site and my whole arm felt a little tight like a blood pressure cuff was on it for 4 or 5 days. The patient underwent lab tests and procedures which included blood work: elevated thyroid on unspecified date 2021, Blood work/antibodies (sars-cov-2 antibody test): she had antibodies on unspecified date 2021. Reporter assessed case as non-serious. The outcome of event was unknown for elevated thyroid and rest all recovered on unspecified date Aug2021.  The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site vesicles
Clinical narrative: elevated thyroid; she had sore arm for a week and a half and a blister at the site of injection; she had sore arm for a week and a half and a blister at the site of injection; my whole arm felt a little tight like a blood pressure cuff was on it for 4 or 5 days; This is a spontaneous report from a contactable consumer (patient). A 60-years-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/Lot number was not reported), via an unspecified route of administration, administered in arm on unspecified date 2021 (at the age of 60-year-old) as DOSE 1, SINGLE for covid-19 immunisation. Medical history included covid-19 from Jan2020 to an unknown date covid illness. Father had a history of Guillain-Barre syndrome. The patient's concomitant medications were not reported. On unspecified date 2021, it was reported that patient had bloodwork done which revealed elevated thyroid and that she had antibodies, after her first dose, she had a sore arm for a week and a half and a blister at the site of injection she also reports it ached by the injection site and my whole arm felt a little tight like a blood pressure cuff was on it for 4 or 5 days. The patient underwent lab tests and procedures which included blood work: elevated thyroid on unspecified date 2021, Blood work/antibodies (sars-cov-2 antibody test): she had antibodies on unspecified date 2021. Reporter assessed case as non-serious. The outcome of event was unknown for elevated thyroid and rest all recovered on unspecified date Aug2021.  The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.
Sex: M
Vaccine: COVID19
Symptoms: Antibody test, Chills, Fatigue, Myalgia
Clinical narrative: 15-20 days of chills; muscle aches; fatigue; This is a spontaneous report from a contactable consumer or other non hcp. A 40-year-old male patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, solution for injection, Batch/Lot number was not reported) via an unspecified route of administration on 21Jun2021 at dose 1, single for covid-19 immunisation. Medical history included covid-19 from 05Mar2021 to an unknown date (He also already has had Covid on 05Mar2021 and has had an antibody test that was positive). Concomitant medications were not reported. On an unspecified date in Jul2021 the patient experienced 15-20 days of chills, muscle aches, fatigue. Question: Wife calling on behalf of husband, aged 40, received first dose of the Pfizer BioNTech Covid 19 vaccine on 21Jun2021. He had side effects for 15-20 days of chills, muscle aches and fatigue. He also already has had Covid on 05Mar2021 and has had an antibody test that was positive. Is it okay if he only gets one vaccine. Isn't he fully protected if he's already had Covid and the first dose. The patient underwent lab tests and procedures which included antibody test: positive on an unspecified date. Outcome of the events was resolved on an unspecified date in 2021.  Information on the lot/ batch number has been requested.  Follow-up (31Aug2021): No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected
Age: 62.0
Sex: M
Vaccine: COVID19
Symptoms: Heart rate, Heart rate irregular
Clinical narrative: experienced irregular heartbeat; This is a spontaneous report from a Pfizer-sponsored program. This consumer reported different events for two patients. This is the second of two reports. A contactable consumer (patient's wife) reported for a 62-year-old male patient (reporter's husband) that a 62-years-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number and Expiry Date was not reported), via an unspecified route of administration on Apr2021 (at the age of 62-year-old) as dose 2, single for COVID-19 immunisation. Medical history included irregular heart beat for several months before. The patient's concomitant medications were not reported. The patient previously received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), on an unknown date in 2021 (at the age of 62-year-old) as dose 1, single for COVID-19 immunization. The patient experienced an irregular heartbeat and was diagnosed in Jul2021. This case was considered as non serious. Outcome of the event was unknown  The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.
Sex: F
Vaccine: COVID19
Symptoms: Headache, Influenza like illness, Myalgia
Clinical narrative: flu like symptoms; headache; some muscle ache; This is a spontaneous report received from contactable consumer (patient's husband). A 66-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection) via unknown route of administration on 16Aug2021 (lot number: FA7485) as dose number unknown, single for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. The patient experienced flu-like symptoms, some muscle ache and headache on an unknown date Aug2021. Consumer stated, "Now the symptoms are very mild just got some muscle ache and headache. The outcome of the events was unknown.  Information on the lot/ batch number has been requested.
Sex: F
Vaccine: COVID19
Symptoms: Discomfort, Mouth ulceration, Oral disorder
Clinical narrative: ulcerations in her mouth; She got lesions in her mouth; my wife is in a lot of discomfort; This is a spontaneous report from a contactable consumer. This consumer (patient's husband) reported for a female patient (reporter's wife).   A female patient received bnt162b2 (COMIRNATY, solution for injection Batch/Lot Number: FB-EW0191), via an unspecified route of administration on 16Aug2021, dose 1, single for covid-19 immunization. Patient medical history and patient concomitant medications were not reported. On 16Aug2021 (same day of the vaccination) 4 hours after they got home his wife had adverse reactions. She got lesions in her mouth and dentist called it ulcerations in her mouth. Patient is in a lot of discomfort. The outcome events was unknown.   No follow-up attempts are possible. No further information is expected.
Age: 19.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site haemorrhage, Vaccination site pain
Clinical narrative: bleeding on her shoulder where she received the shot/have bleeding at site of injection; His daughter said ouch, so it hurt; This is a spontaneous report from a contactable consumer (patient's father). A 19-years-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot Number: EW0198), via an unspecified route of administration, administered in left arm on 17Aug2021 at 02:43 (at the age of 19-years-old) as DOSE 2, SINGLE for covid-19 immunisation. The patient medical history allergic to mites and crabs. There were no concomitant medications. The patient had received MMRV when she was 3 months old and after that vaccine she developed high fever and crying because of the high fever. The patient had received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot Number: EW0196), via an unspecified route of administration, administered on 24Jul2021 (at the age of 19-years-old) as DOSE 1, SINGLE for covid-19 immunisation. The reporter stated that the patient went through bloodwork and analysis for one of the components in Pfizer and she showed fine and was not allergic to it. Patient had no vaccines 4 weeks prior to receiving COVID vaccines. The reporter reported that on 17Aug2021 at 02:43, patient had bleeding on her shoulder where she received the shot. She had not any adverse symptoms for the time being, but she did had bleeding at site of injection. When the Pharmacist injected the vaccine my daughter said 'Ouch, it hurts' and the Pharmacist took out the needle and caused bleeding in my daughter's left shoulder, I was shocked because the Pharmacist made a movement that was kind of strange and it caused the rupture of a cavity, she then proceeded to clean the bleeding, put pressure on it and put a band-aid on it (as treatment). Patient did not any AE(s) require a visit to emergency room and physician office. The outcome of the event was unknown.  No follow-up attempts are possible. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Pyrexia, Tenderness
Clinical narrative: Her arm was tender today; got second shot yesterday 16Aug2021 and was a little tired and felt feverish; got second shot yesterday 16Aug2021 and was a little tired and felt feverish; This is a spontaneous report from a contactable other Health Care Professional.A female patient of an unspecified age received bnt162b2 (BNT162B2), dose 2 via an unspecified route of administration on 16Aug2021 (Batch/Lot Number: FA7484; Expiration Date: 01Sep2021) as DOSE 2, SINGLE for covid-19 immunization.The patient medical history was not reported.The patient's concomitant medications were not reported.On 16Aug2021 the patient experienced got second shot yesterday 6aug2021 and was a little tired and felt feverish. The outcome of event was unknown.
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Chromaturia, Condition aggravated, Illness, Investigation, Malaise
Clinical narrative: not feeling well for a day or two and needing to rest.; urine was dark; got really sick; She is progressively ill.; This is a spontaneous report from a contactable Consumer or other non-HCP (patient). A 69-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection), dose 1 via an unspecified route of administration on 06Jun2021 (Lot Number: Unknown) (at the age of 69-year-old) as DOSE 1, SINGLE for covid-19 immunisation. The patient medical history was not reported. AE(s) following prior vaccinations was none. The Patient Medical History (including any illness at time of vaccination) was none. No Family Medical History Relevant to AE(s). The patient concomitant medications were not reported. Additional Vaccines Administered on Same Date of the Pfizer Suspect was none. Prior Vaccinations (within 4 weeks) was none. The patient experienced not feeling well for a day or two and needing to rest and urine was dark (in morning) on an unspecified date in Jun2021. She got really sick and was progressively ill on an unspecified date in 2021. The clinical details of the events as follows: About two weeks following her first injection, she had typical reactions. She was not feeling well for a day or two and needing to rest. Two weeks after that, she did not connect the two events. Her urine was dark and two weeks following the injection to It continued on until she got really sick. It was an ongoing, progressive state of getting worse. She has been diagnosed with a medical condition as a result of receiving the vaccine. She was progressively ill. The AE(s) did not require a visit to emergency Room. The patient visited Physician Office. On an unknown date, she received heart tests, lab tests, and ultrasound for all the result was unknown. Relevant Tests were none. She wanted to report a severe side effect. She feels like it needs to be brought to our attention. She was not sure her doctor was going to send it in. Her urine was no longer brown. The patient outcome of the event urine was dark was resolved on an unspecified date in 2021 and the outcome of the other events was unknown at the time of this report.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.