chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 13.0
Sex: M
Vaccine: COVID19
Symptoms: Pain, Pustule, Varicella
Clinical narrative: Broke out with multiple pustules that looked like chicken pox. They were on his arms, under arms, torso, back and hairline.; Broke out with multiple pustules that looked like chicken pox. They were on his arms, under arms, torso, back and hairline.; A few were painful when pressed on or if they rubbed against clothing.; This is a spontaneous report from a contactable consumer or other non hcp (parent). A 13-years-old male patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; formulation: Solution for injection, Batch/Lot Number: EW0168), via an unspecified route of administration, administered in Arm Left on an unspecified date in May2021 (at the age of: 13-years-old) as dose 1, single for covid-19 immunisation at hospital. Medical history included seasonal allergy from an un-known date and unknown if ongoing. Concomitant medications within 2 weeks included loratadine (CLARITINE) Claritin 24hr; pseudoephedrine hydrochloride (SUDAFED 12 HOUR); fluticasone propio-nate (FLONASE [FLUTICASONE PROPIONATE]) and ketotifen fumarate (KETOTIFEN FUMARATE) Alaway eye all were taken for an unspecified indication, start and stop date were not reported. The patient previously received VARICELLA VACCINE (Lot Number: UNKNOWN), via unspecified route of administration on an unspecified date for Chickenpox. The patient did not receive any other vaccine within 4 weeks prior to covid vaccination. Prior to the vaccination, the patient was not diagnosed with COVID-19. On 23May2021, it was reported that 4 days after his 1st vaccine dose, the patient broke out with multiple pustules that looked like chicken pox. They were on his arms, under arms, torso, back and hairline. Patient continued to get more for 48 hours or more. They looked exactly like chicken pox even though he has had his varicella vaccines. They started drying up after 3 to 4 days. Some had a crust on them as they dried similar to chicken pox. Patient said they did not had itch, but a few were painful when pressed on or if they rubbed against clothing. They are now all gone. The patient did not received treatment for the events. Patient required Doctor or other healthcare professional office/clinic visit for the event. Since the vaccination, the patient had not been tested for COVID-19. Device timestamp was reported as 01Jun2021. Outcome of the events was recovered on an unspecified date in 2021.  Follow-Up (30Jun2021): Follow-up attempts are completed. No further information is expected.
Age: 44.0
Sex: M
Vaccine: COVID19
Symptoms: Back pain, Headache, Lymphadenopathy, Neck pain, Pain
Clinical narrative: rash on arms, chest, &stomach; 2nd day slight headache, neck ache; Left underarm(lymph)swollen; whole body aching, upper body, lower back, bad headache; whole body aching, upper body, lower back, bad headache; pain at injection site; Bad headache&got worse&worse; Still red where band aid was over injection site/ redness shape of band aid; itchiness between fingers lft hand, face lft, neck arms; red spot on nose (looks like Rosacea); This is a spontaneous report from a contactable consumer (patient). A 44-years-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Batch/Lot number: ew0170, Expiry date: not reported), via an unspecified route of administration in left arm on 04May2021 (at age of 44-years-old) as dose 2, single for covid-19 immunization. The patient medical history was not reported. The patient's concomitant medications were not reported. The patient previously took first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Batch/Lot number: Not reported, Expiration Date: Not reported), via an unspecified route of administration in left arm 13Apr2021 19:00 (at age of 44-years-old) as dose 1, single for covid-19 immunization and experienced had trouble breathing, chest pain, felt like lungs were hurting in back, weak, tired, passed out. The patient had not received any other vaccine within 4 weeks. Prior to vaccination, the patient was not diagnosed with COVID-19 and since the vaccination, the patient was not tested for COVID-19. Second shot on 04May2021, felt pain at injection site (that was expected), that night started to get a bad headache & got worse & worse. Next morning (05May2021), whole body aching, upper body, lower back, bad headache, Left underarm(lymph)swollen. Second day (06May2021) slight headache, neck ache, lft underarm swollen. That night rash on arms, chest, &stomach. 3rd day (07May2021), nighttime rash arms, chest, stomach. Still red where band aid was over injection site (on an unspecified date in May2021). Over a week later still have redness shape of band aid, Seems patient had sensitive skin since the second covid shot. 10 days after second shot the patient still had redness the shape of the Band Aid on his left arm. Got a red spot on nose (looks like Rosacea). 4 weeks later, still have a red spot on nose. The patient had itchiness between fingers lft hand, face lft, neck arms on an unspecified date in May2021. The reporter assessed the events as non-serious. No therapeutic measures were taken in response to the events. The outcome of the events was not recovered.  Follow-up attempts are completed. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021635813 Same reporter/patient/product; different doses/events.
Age: 44.0
Sex: M
Vaccine: COVID19
Symptoms: Pruritus, Rash, Rosacea, Vaccination site erythema, Vaccination site pain
Clinical narrative: rash on arms, chest, &stomach; 2nd day slight headache, neck ache; Left underarm(lymph)swollen; whole body aching, upper body, lower back, bad headache; whole body aching, upper body, lower back, bad headache; pain at injection site; Bad headache&got worse&worse; Still red where band aid was over injection site/ redness shape of band aid; itchiness between fingers lft hand, face lft, neck arms; red spot on nose (looks like Rosacea); This is a spontaneous report from a contactable consumer (patient). A 44-years-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Batch/Lot number: ew0170, Expiry date: not reported), via an unspecified route of administration in left arm on 04May2021 (at age of 44-years-old) as dose 2, single for covid-19 immunization. The patient medical history was not reported. The patient's concomitant medications were not reported. The patient previously took first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Batch/Lot number: Not reported, Expiration Date: Not reported), via an unspecified route of administration in left arm 13Apr2021 19:00 (at age of 44-years-old) as dose 1, single for covid-19 immunization and experienced had trouble breathing, chest pain, felt like lungs were hurting in back, weak, tired, passed out. The patient had not received any other vaccine within 4 weeks. Prior to vaccination, the patient was not diagnosed with COVID-19 and since the vaccination, the patient was not tested for COVID-19. Second shot on 04May2021, felt pain at injection site (that was expected), that night started to get a bad headache & got worse & worse. Next morning (05May2021), whole body aching, upper body, lower back, bad headache, Left underarm(lymph)swollen. Second day (06May2021) slight headache, neck ache, lft underarm swollen. That night rash on arms, chest, &stomach. 3rd day (07May2021), nighttime rash arms, chest, stomach. Still red where band aid was over injection site (on an unspecified date in May2021). Over a week later still have redness shape of band aid, Seems patient had sensitive skin since the second covid shot. 10 days after second shot the patient still had redness the shape of the Band Aid on his left arm. Got a red spot on nose (looks like Rosacea). 4 weeks later, still have a red spot on nose. The patient had itchiness between fingers lft hand, face lft, neck arms on an unspecified date in May2021. The reporter assessed the events as non-serious. No therapeutic measures were taken in response to the events. The outcome of the events was not recovered.  Follow-up attempts are completed. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021635813 Same reporter/patient/product; different doses/events.
Age: 44.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Headache, Illness, Pyrexia, SARS-CoV-2 test
Clinical narrative: Extreme fatigue; I was sick in bed for 3 days; headache; slight fever; This is a spontaneous report received from a contactable consumer(patient). A 44-Year-old non-pregnant female (Patient) reported herself. A 44-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; solution for injection, Lot Number: EW0183), dose 2 via an unspecified route of administration, administered in Arm Left on 13May2021 15:00 (at the age of 44-years-old) as a single dose for covid-19 immunization. The patient medical history was not reported. The patient's concomitant medications were not reported. The patient previously took erythromycin and experienced drug hypersensitivity. Patient previously received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; solution for injection, Lot Number: EW0150), via an unspecified route of administration, administered in Arm Left on 02Apr2021 16:00 (at the age of 44-years-old) as a single dose for covid-19 immunization and experienced lymphadenopathy. The patient had no other vaccine within four weeks. On 14May2021 03:00, the patient was sick in bed for 3 days and have been sick with headache, slight fever, extreme fatigue. She went to urgent care. Tested for Covid, mono, UTI, etc. The adverse event resulted in emergency room department or urgent care visit. The patient received treatment with antibiotics. No hospitalization prolonged. Prior to the vaccination, the patient was diagnosed with COVID-19. Since the vaccination, the patient had been tested for COVID-19. The patient underwent lab tests and procedures which included sars-cov-2 test: negative- nasal swab on 26May2021, sars-cov-2 test: negative on 28May2021. The seriousness of the event was considered as non-serious. Outcome of the event was not recovered, at the time of this report. Device Date was 01Jun2021 Follow-up attempts are completed. No further information is expected.
Age: 49.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Body temperature increased, Dizziness, Epistaxis, Fatigue
Clinical narrative: mild headache; arm pain was minimal; but I did feel a little lightheaded immediately.; slight temperature elevation; fatigue; 24 hours later I had a nosebleed (not common for me); This is a spontaneous report from a contactable consumer. A 49-year-old non-pregnant female consumer (patient) reported that she received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection; Lot number: EW0179 and expiry date Aug2021) via an unspecified route of administration on 30May2021 at 10:00 AM on left arm (at 49-year-old), as dose 2, single for COVID-19 immunization. The patient's medical history, concomitant medications, prior vaccinations and relevant tests were reported as none. Patient had no history of allergies, and no other vaccine was received in four weeks. The patient did not have covid prior to vaccination and was not tested for covid tested post vaccination.The patient previously received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection; Lot number: EW0169) intramuscular route of administration on 09May2021 at 06:00 PM on left arm (at 49-year-old), as dose 1, single for COVID-19 immunization and experienced arm pain. On 31May2021 at 11: 00 am after the second shot, arm pain was minimal, but patient did feel a little lightheaded immediately, slight temperature elevation, fatigue and a mild headache. On the same date (31May2021) at 01:00 PM she had an unexplained nosebleed. Patient does not get nose bleeds. There was no injury or banging to nose or face. The blood just began dripping as patient was sitting on a chair relaxing in the backyard. No treatment was received for events. On an unknown date in 2021 nosebleed recovered. The outcome of rest of the events was unknown.  Follow-up attempts were completed. No further information was expected.
Age: 49.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Pain in extremity
Clinical narrative: mild headache; arm pain was minimal; but I did feel a little lightheaded immediately.; slight temperature elevation; fatigue; 24 hours later I had a nosebleed (not common for me); This is a spontaneous report from a contactable consumer. A 49-year-old non-pregnant female consumer (patient) reported that she received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection; Lot number: EW0179 and expiry date Aug2021) via an unspecified route of administration on 30May2021 at 10:00 AM on left arm (at 49-year-old), as dose 2, single for COVID-19 immunization. The patient's medical history, concomitant medications, prior vaccinations and relevant tests were reported as none. Patient had no history of allergies, and no other vaccine was received in four weeks. The patient did not have covid prior to vaccination and was not tested for covid tested post vaccination.The patient previously received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection; Lot number: EW0169) intramuscular route of administration on 09May2021 at 06:00 PM on left arm (at 49-year-old), as dose 1, single for COVID-19 immunization and experienced arm pain. On 31May2021 at 11: 00 am after the second shot, arm pain was minimal, but patient did feel a little lightheaded immediately, slight temperature elevation, fatigue and a mild headache. On the same date (31May2021) at 01:00 PM she had an unexplained nosebleed. Patient does not get nose bleeds. There was no injury or banging to nose or face. The blood just began dripping as patient was sitting on a chair relaxing in the backyard. No treatment was received for events. On an unknown date in 2021 nosebleed recovered. The outcome of rest of the events was unknown.  Follow-up attempts were completed. No further information was expected.
Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Migraine, Myalgia, Nausea, Pyrexia
Clinical narrative: Second Dose had severe debilitating migraine headache 12hrs after dose with severe nausea and vomiting through 72hrs following dose.; with severe nausea and vomiting; with severe nausea and vomiting; Experienced severe muscle pain during 12-30hrs post dose with temp 101; Experienced severe muscle pain during 12-30hrs post dose with temp 101; This is a spontaneous report from a contactable consumer (patient) or other non HCP.   A 52-years-old non-pregnant female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Batch/Lot number: EW0182, Expiry date: not reported), via an unspecified route of administration in left arm on 28May2021, at 13:00 (at age of 52-years-old) as dose 2, single for covid-19 immunization. Medical history Gilbert's syndrome, Rosacea, irritable bowel syndrome from unknown date unknown if ongoing. Concomitant medication(s) included omeprazole taken for an unspecified indication, start and stop date were not reported; multivitamins [vitamins nos] taken for an unspecified indication, start and stop date were not reported. The patient previously took sulfonamides for drug hypersensitivity, cephalexine for drug hypersensitivity. The patient previously received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Batch/Lot number: EW0170, Expiry date: not reported), via an unspecified route of administration in left arm on 07May2021, at 14:00 as dose 1, single for covid-19 immunization and experienced moderate migraine, nausea and vomiting. The patient had not received any other vaccine within 4 weeks. Prior to vaccination, the patient was not diagnosed with COVID-19 and post the vaccination, the patient was not tested for COVID-19. On 29May2021 at 07:00, patient experienced second dose had severe debilitating migraine headache 12hrs after dose with severe nausea and vomiting through 72hrs following dose, severe muscle pain during 12-30hrs post dose with temp 101, which eased off with only migraine and nausea remaining through 72hrs. The patient underwent lab tests and procedures which included body temperature: 101 on May2021. The patient received treatment headache and anti-nausea meds over the counter. Therapeutic measures were taken as a result for all the events. The events recovered on an unspecified date in 2021.  Follow-up attempts are completed. No further information is expected.
Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: Vomiting
Clinical narrative: Second Dose had severe debilitating migraine headache 12hrs after dose with severe nausea and vomiting through 72hrs following dose.; with severe nausea and vomiting; with severe nausea and vomiting; Experienced severe muscle pain during 12-30hrs post dose with temp 101; Experienced severe muscle pain during 12-30hrs post dose with temp 101; This is a spontaneous report from a contactable consumer (patient) or other non HCP.   A 52-years-old non-pregnant female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Batch/Lot number: EW0182, Expiry date: not reported), via an unspecified route of administration in left arm on 28May2021, at 13:00 (at age of 52-years-old) as dose 2, single for covid-19 immunization. Medical history Gilbert's syndrome, Rosacea, irritable bowel syndrome from unknown date unknown if ongoing. Concomitant medication(s) included omeprazole taken for an unspecified indication, start and stop date were not reported; multivitamins [vitamins nos] taken for an unspecified indication, start and stop date were not reported. The patient previously took sulfonamides for drug hypersensitivity, cephalexine for drug hypersensitivity. The patient previously received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Batch/Lot number: EW0170, Expiry date: not reported), via an unspecified route of administration in left arm on 07May2021, at 14:00 as dose 1, single for covid-19 immunization and experienced moderate migraine, nausea and vomiting. The patient had not received any other vaccine within 4 weeks. Prior to vaccination, the patient was not diagnosed with COVID-19 and post the vaccination, the patient was not tested for COVID-19. On 29May2021 at 07:00, patient experienced second dose had severe debilitating migraine headache 12hrs after dose with severe nausea and vomiting through 72hrs following dose, severe muscle pain during 12-30hrs post dose with temp 101, which eased off with only migraine and nausea remaining through 72hrs. The patient underwent lab tests and procedures which included body temperature: 101 on May2021. The patient received treatment headache and anti-nausea meds over the counter. Therapeutic measures were taken as a result for all the events. The events recovered on an unspecified date in 2021.  Follow-up attempts are completed. No further information is expected.
Age: 48.0
Sex: F
Vaccine: COVID19
Symptoms: Dry throat, Swollen tongue, Throat irritation, Tongue discomfort
Clinical narrative: I drank 16 ounces of water 1 hour prior to getting vaccinated. However, within 20 minutes of receiving the 1st. dose, my throat felt dry and there was a slight burning sensation at my throat. Also, th; I drank 16 ounces of water 1 hour prior to getting vaccinated. However, within 20 minutes of receiving the 1st. dose, my throat felt dry and there was a slight burning sensation at my throat. Also, th; the right side of my tongue and the back of my tongue near my throat became slightly swollen to where there's some discomfort; The right side of my tongue and the back of my tongue near my throat became slightly swollen to where there's some discomfort; This is a spontaneous report from a contactable consumer (Patient).   A 48-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH m-RNA COVID-19 VACCINE, formulation: Solution for injection, Lot number: EW0178 and expiry date was not reported), via an unspecified route of administration into left arm on 01Jun2021 at 14:00 (at the age of 48-year-old) on left arm as Dose 1, single for COVID-19 immunization. The patient was not pregnant at the time of vaccination. Medical history included: known allergies (Allergic to Aspirin through my teen years; mild gluten sensitivity), Asthma, and Allergies (Seasonal, Dust mites, Animal dander (horses, cats and some dogs)). The patient did not receive any other vaccines in four weeks of first dose. Concomitant medications within two weeks of first dose were Vitamins and OTC Pain medications. Facility where the most recent COVID-19 vaccine was administered was Pharmacy or Drug Store. The patient was neither tested positive for covid prior vaccination nor post vaccination. The patient stated that she drank 16 ounces of water 1 hour prior to getting vaccinated. However, within 20 minutes of receiving the 1st dose on 01Jun2021 at 14:00, her throat felt dry and there was a slight burning sensation at her throat. Also, the right side of her tongue and the back of her tongue near throat became slightly swollen to where there's some discomfort, but she was only monitoring these effects since she can still breathe and function normally. The patient did not receive any treatment for reported adverse events. Outcome of events was recovering.  Follow-up attempts are completed. No further information is expected.
Age: 29.0
Sex: F
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration, Rash, Rash erythematous, Rash pruritic
Clinical narrative: all over body rash that has been painful, red and itchy all over body every day. Still have not found a solution it has been 3 months and still on going; all over body rash that has been painful, red and itchy all over body every day. Still have not found a solution it has been 3 months and still on going; all over body rash that has been painful, red and itchy all over body every day. Still have not found a solution it has been 3 months and still on going; Patient received first and second dose on 03Mar2021; This is a spontaneous report from a contactable consumer (patient). A 29-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number: EN6202) via an unspecified route of administration, administered in Arm Left on 03Mar2021 as DOSE 1, SINGLE and second dose of BNT162B2 (BNT162B2, Solution for injection, PFIZER-BIONTECH COVID-19 VACCINE, Lot Number: ER8734) via an unspecified route of administration, administered in Right Arm on 03Mar2021 as DOSE 2, SINGLE (at the age of 29-year-old) for covid-19 immunisation (Pharmacy or Drug Store). Medical history included covid from an unknown date and unknown if ongoing. The patient's concomitant medications were not reported. Patient was not received any other vaccines within 4 weeks prior to the COVID vaccine and not taking any other medications within 2 weeks of vaccination and had no known allergies. On 15Mar2021, the patient experienced all over body rash that has been painful, red and itchy all over body every day. Still have not found a solution it has been 3 months and still on going all. Reporter seriousness was reported as non serious. Prior to vaccination, patient was diagnosed with COVID-19 and since the vaccination, has the patient had not been tested for COVID-19. Patient received first and second dose on 03Mar2021. The adverse events resulted in physician's office visit. Therapeutic measures were taken as a result of events included steroids but has not worked. The outcome of the events patient received first and second dose on 03Mar2021 was unknown while the other events were not recovered.  Follow-up attempts are completed. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Abdominal pain upper, Asthenia, Cough, Fatigue, Headache
Clinical narrative: Muscle pain; Area swollen in her left face; Body Pain; Coughing; My stomach is sore; I feel weak; Tired; Headache; Nauseous; Pain in arm; This is a spontaneous report from a contactable consumer from a Pfizer Sponsored Program. An 81-year-old female patient received first dose of bnt162b2 (BNT162B2, solution for injection, Lot Number: EW0172; Expiration Date: 31Aug2021,) via an unspecified route of administration, administered in the left arm on 27May2021 as dose 1, single for COVID-19 immunisation. Medical history included Blood pressure high and diabetes. Concomitant medication included metformin taken for diabetes mellitus. On an unspecified date the patient experienced headache, nauseous, muscle pain, area swollen in her left face, body pain, coughing, my stomach is sore, I feel weak, tired. On 28May2021 the patient experienced pain in arm. Therapeutic measures were taken as a result of headache, nauseous, muscle pain, pain in arm, area swollen in her left face, body pain, coughing, my stomach is sore, I feel weak, tired, and included treatment with Tylenol which doctor told patient. She stated that she got the first vaccine last 27May and she mentioned that she had a lot of reactions. It is like she had headache, she is nauseous, there is pain in arm, muscle pain and area swollen in her left face and there is body pain and she is still coughing until now, her stomach was sore and she just did not feel good. She felt weak like tired. She could not find the vaccination card and she was not able to inform me about the second dose appointment. Friday, reporter started pain come on in her arm. Thursday, patient had all day, after got it Thursday, got it 30 evening had it all the time coughing. The clinical outcome of all the events was not resolved. Follow-up attempts are completed. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Myalgia, Nausea, Pain, Pain in extremity, Swelling face
Clinical narrative: Muscle pain; Area swollen in her left face; Body Pain; Coughing; My stomach is sore; I feel weak; Tired; Headache; Nauseous; Pain in arm; This is a spontaneous report from a contactable consumer from a Pfizer Sponsored Program. An 81-year-old female patient received first dose of bnt162b2 (BNT162B2, solution for injection, Lot Number: EW0172; Expiration Date: 31Aug2021,) via an unspecified route of administration, administered in the left arm on 27May2021 as dose 1, single for COVID-19 immunisation. Medical history included Blood pressure high and diabetes. Concomitant medication included metformin taken for diabetes mellitus. On an unspecified date the patient experienced headache, nauseous, muscle pain, area swollen in her left face, body pain, coughing, my stomach is sore, I feel weak, tired. On 28May2021 the patient experienced pain in arm. Therapeutic measures were taken as a result of headache, nauseous, muscle pain, pain in arm, area swollen in her left face, body pain, coughing, my stomach is sore, I feel weak, tired, and included treatment with Tylenol which doctor told patient. She stated that she got the first vaccine last 27May and she mentioned that she had a lot of reactions. It is like she had headache, she is nauseous, there is pain in arm, muscle pain and area swollen in her left face and there is body pain and she is still coughing until now, her stomach was sore and she just did not feel good. She felt weak like tired. She could not find the vaccination card and she was not able to inform me about the second dose appointment. Friday, reporter started pain come on in her arm. Thursday, patient had all day, after got it Thursday, got it 30 evening had it all the time coughing. The clinical outcome of all the events was not resolved. Follow-up attempts are completed. No further information is expected.
Age: 46.0
Sex: F
Vaccine: COVID19
Symptoms: Rash, Urticaria
Clinical narrative: Hives (neck) and rash (arms, neck, ears, legs) occurring due to exercise, heat outdoors and showering; Hives (neck) and rash (arms, neck, ears, legs) occurring due to exercise, heat outdoors and showering; This is a spontaneous report from a contactable consumer (patient herself). A 46-years-old non-pregnant female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, lot number: EW0186; Expiration date: unknown) intramuscular, administered in Arm Left on 25May2021 11:00 (at the age of 46-years-old) as DOSE 2, SINGLE for COVID-19 immunization. Patient was not pregnant at the time of vaccination. Medical history included SARS-COV-2 antibody test negative; prior to vaccination, did not get COVID when 3 persons in immediate family were positive and no extra precautions taken within household from an unknown date and unknown if ongoing. Concomitant medication included magnesium l-threonate (MAGNESIUM L-THREONATE) taken for an unspecified indication. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Patient was not taking any medications prior to the event being reported. She did not receive any vaccines for any other conditions prior to the event reported and not had any recent vaccines for SARS-CoV2 other than Pfizer-BioNTech COVID-19 Vaccine prior to event being reported. She did not receive any other vaccines around the time of Pfizer-BioNTech COVID-19 Vaccine vaccination. Patient had previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, lot number: EW0175; Expiration date: unknown) intramuscular, administered in Arm Left on 29Apr2021 10:00 (at the age of 46-years-old) as DOSE 1, SINGLE for COVID-19 immunization. On 25May2021 15:00 the patient experienced hives (neck) and rash (arms, neck, ears, legs) occurring due to exercise, heat outdoors and showering. AEs resulted in physician office visit but patient was not seen in the emergency department, not hospitalized nor admitted to an intensive care unit. Therapeutic measures were taken as a result of AEs as patient had received topical antihistamine only and patient took a dose prednisone after second dose (two weeks after as rash was still present); Details: Prednisone 20mg was taken X1day. The outcome of both the events was resolving.  Follow-up attempts are completed. No further information is expected.
Age: 18.0
Sex: F
Vaccine: COVID19
Symptoms: Blood test, Burning sensation, Chest discomfort, Dyspepsia, Gastrooesophageal reflux disease
Clinical narrative: Ever since she got the Vaccine acid reflux reported as side effects; she is been like very tight and just like a burning sensation burning, like heartburn; Ever since she got the Vaccine acid reflux reported as side effects; she is been like very tight and just like a burning sensation burning, like heartburn; Ever since she got the Vaccine acid reflux reported as side effects; she is been like very tight and just like a burning sensation burning, like heartburn; Ever since she got the Vaccine acid reflux reported as side effects; she is been like very tight and just like a burning sensation burning, like heartburn; This is a spontaneous report received from a contactable consumer. A 18-Year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0173, Expiry Date: 31Aug2021), via an unspecified route of administration, administered in right arm on 28May2021 (at the age of 18 years old) as a single dose for COVID-19 immunisation. The patient's medical history included Type 1 diabetes mellitus and Anxiety from an unknown date and unknown if ongoing. The patient's concomitant medication included Humalog (INSULIN LISPRO) taken for Type 1 diabetes mellitus and zoloft (SERTRALINE HYDROCHLORIDE) taken for anxiety, start date and stop date was not reported. The patient had not received any prior vaccinations within 4 weeks. On an unspecified date the patient experienced ever since she got the Vaccine acid reflux reported as side effects; she has been like very tight and just like a burning sensation burning, like heartburn. The patient reported the patient did not know this question or not patient's daughter and they got the first dose of Pfizer Vaccine this past Friday. The patient's daughter is 19 years old and the patient ever since got the Vaccine. The patient could not find anywhere was any suggestions acid reflux was that thing reported as side effects. The patient received antacid like a Pepcid as treatment for the events. The patient underwent lab tests and procedures which included blood test on 02Jan2021. The outcome of the events was unknown.  Follow-up attempts completed. No further information expected.
Age: 40.0
Sex: U
Vaccine: COVID19
Symptoms: Fatigue, Feeling of body temperature change, Malaise, Nasopharyngitis, Nausea
Clinical narrative: Nausea; never vomit but start Nausea; Fatigue; my arm is swell up and the fever and cold was just for one day; Fever; I started feeling sick Saturday; my arm is swell up and the fever and cold was just for one day; had cold the next minute was hot; This is a spontaneous report from a contactable consumer. This 40-year-old consumer (patient) reported for himself that : A 40-years-old patient of an unspecified gender received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot Number: EW0124) via intramuscular route of administration in arm left (upper arm) on 28May2021 time probably 9:30 (age at vaccination: 40-year-old) as dose 2, single for COVID-19 immunization. The patient medical history and concomitant medications were not reported. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Patient previously took bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection) via unspecified route of administration on 02May2021 as DOSE 1, SINGLE for COVID-19 immunisation. Patient had side effect from Pfizer shot which was received on 28May2021 Friday. Patient experienced nausea, fever, cold, fatigue and arm is swell up, fever and cold was just for one day. On Saturday patient started feeling sick then nausea, never vomit but start nausea then cold next minute (I was hot), fever during night so when patient woke up on Sunday felt better, it like come and go it never stay it was bad as it was at Saturday. Probably something make sure that is side effect from shot and really want to find out to make sure side effect from medicine is nothing to worried about it. The clinical outcome of the event was unknown.   No follow-up attempts are possible. No further information is expected
Age: 40.0
Sex: U
Vaccine: COVID19
Symptoms: Peripheral swelling, Pyrexia
Clinical narrative: Nausea; never vomit but start Nausea; Fatigue; my arm is swell up and the fever and cold was just for one day; Fever; I started feeling sick Saturday; my arm is swell up and the fever and cold was just for one day; had cold the next minute was hot; This is a spontaneous report from a contactable consumer. This 40-year-old consumer (patient) reported for himself that : A 40-years-old patient of an unspecified gender received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot Number: EW0124) via intramuscular route of administration in arm left (upper arm) on 28May2021 time probably 9:30 (age at vaccination: 40-year-old) as dose 2, single for COVID-19 immunization. The patient medical history and concomitant medications were not reported. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Patient previously took bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection) via unspecified route of administration on 02May2021 as DOSE 1, SINGLE for COVID-19 immunisation. Patient had side effect from Pfizer shot which was received on 28May2021 Friday. Patient experienced nausea, fever, cold, fatigue and arm is swell up, fever and cold was just for one day. On Saturday patient started feeling sick then nausea, never vomit but start nausea then cold next minute (I was hot), fever during night so when patient woke up on Sunday felt better, it like come and go it never stay it was bad as it was at Saturday. Probably something make sure that is side effect from shot and really want to find out to make sure side effect from medicine is nothing to worried about it. The clinical outcome of the event was unknown.   No follow-up attempts are possible. No further information is expected
Age: 14.0
Sex: M
Vaccine: COVID19
Symptoms: Epistaxis
Clinical narrative: Epistaxis; This is a spontaneous report from a contactable physician. This physician (Patients parent) reported for a 14-year-old male patient that:  A 14-year-old male patient received bnt162b2 (BNT162B2, PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot number: EW0173), via an unspecified route of administration on 22May2021 10:00Am (At the age of 14 years) as DOSE NUMBER UNKNOWN, SINGLE for covid-19 immunisation. No known allergies. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient medical history was not reported. Concomitant medications were not reported. The patient received other medications within 2 weeks of vaccination. On an unspecified date May2021 01:00 PM, the patient had experienced epistaxis. No treatment was received in response to the adverse events. The patient was not diagnosed with COVID-19 prior to vaccination. Since the vaccination, patient was not tested for COVID-19. On an unspecified date in May2021, the event was recovered.  Follow-up attempts are completed. No further information is expected.
Age: 55.0
Sex: M
Vaccine: COVID19
Symptoms: Cough
Clinical narrative: Coughing up his lungs two days after his second injection.  Hes still doing it today; This is a spontaneous report from a contactable consumer (patient). A 55-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, formulation: Solution for injection, lot number: Ew0176, Expiry date: unknown) (age at the time of vaccination was 55 years), administered in Arm Left on 11May2021 at 15:30 as dose 2, single for COVID-19 immunization. The patient's medical history included pulmonary embolism. The patient's concomitant medication was not reported. The patient did not take any other vaccine in four weeks prior COVID -19 vaccine. Patient previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; formulation: Solution for injection, Lot Number: Ew0151), via an unspecified route of administration, via unspecified route on 20Apr2021 at 15:30 as dose 1, single for COVID-19 immunization. On 13May2021 at 05:00, the patient started coughing up his lungs. The patient was still doing it today. No treatment received. The outcome of the event was not resolved.  Follow-Up (01Jul2021): Follow-up attempts were completed. No further information was expected.
Age: 16.0
Sex: M
Vaccine: COVID19
Symptoms: Cough, SARS-CoV-2 test
Clinical narrative: cough; This is a spontaneous report from a contactable physician. A 16-years-old male patient received bnt162b2 (PFIZER COVID-19 VACCINE, Solution for injection, Batch/Lot number: EW0172), dose 1 via an intramuscular route of administration, administered in Arm Right on 08May2021 12:00 as DOSE 1, SINGLE for covid-19 immunisation (at the age of 16 years). Medical history included seasonal allergy from an unknown date and unknown if ongoing. The patient's concomitant medications were not reported. The patient was not diagnosed with COVID prior to vaccination. The patient did not received any other vaccines within 4 weeks prior to the COVID vaccine. No other medications the patient received within 2 weeks of vaccination. The patient experienced cough on May2021. The patient underwent lab tests and procedures which included sars-cov-2 test: negative on 01Jun2021 (If COVID tested post vaccination: Yes). Therapeutic measures were taken as result of cough included scheduled non-steroidal anti-inflammatory drugs (NSAIDs). The clinical outcome of the event was recovering.    Follow-Up (26Aug2021): Follow-up attempts are completed. No further information is expected.
Age: 53.0
Sex: F
Vaccine: COVID19
Symptoms: Inflammation
Clinical narrative: some mild inflammation; This is a spontaneous report from a contactable consumer, the patient. A 53-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, solution for injection, lot number: EP6955), dose 1 via an unspecified route of administration, administered in arm left on Mar2021 as dose 1, single (at the age of 53-years-old) for covid-19 immunisation. The patient was non-pregnant at the time of vaccination. Medical history included mild osteo arthritis. Concomitant medications included estradiol and progesterone. The patient experienced some mild inflammation on an unspecified date. The patient received anti-inflammatory and flexorall as treatment for the event. The patient did not receive any other vaccines within 4 weeks prior to the covid vaccine. The patient had not diagnosed with covid-19 prior to vaccination and had not tested for covid-19 since the vaccination. The outcome of the event was not recovered.  Follow-up attempts were completed. No further information was expected.
Age: 53.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Inflammation, Insomnia, Neck pain, Pain in extremity
Clinical narrative: After the second shot, major inflammation; Extreme shoulder, arm and neck pain; Extreme shoulder, arm and neck pain; Extreme shoulder, arm and neck pain; Sleeping has also been very difficult; This is a spontaneous report from a contactable consumer or other non hcp (patient) and Other HCP. A 53-year-old non-pregnant female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot Number: ER8731) via an un-specified route of administration, administered in left arm on 15Apr2021 11:15 (at the age of 53-year-old) at dose 2, single for covid-19 immunisation. Medical history included mild osteo arthritis. Patient had no known allergies. 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. Concomitant medications included estradiol (ESTRADIOL); progesterone (PROGESTERONE), both taken for an unspecified indication, start and stop date were not reported, patient received them within 2 weeks of vaccination. Patient previously received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot Number: EP6955) via an unspecified route of administration, administered in left arm on an unspecified date in Mar2021 11:15 (at the age of 53-year-old) at dose 1, single for covid-19 immunisation and experienced mild inflammation. On 26Apr2021 the patient experienced after the second shot, major inflammation, extreme shoulder, arm and neck pain, sleeping has also been very difficult. Reported Event: After the first shot, some mild inflammation. After the second shot, major inflammation. Day 12 after 2nd dose, extreme shoulder, arm and neck pain. Saw Dr. on day 16. I have been in Physical Therapy since May 11th working on the pain. I have been unable to wear my wedding rings since the second dose. Sleeping has also been very difficult. Adverse events resulted in doctor or other healthcare professional office/clinic visit. Patient received treatment with anti-inflammatory, flexorall for the adverse events. Outcome of the events was not resolved.  Follow-Up (30Jun2021): Follow-up attempts are completed. No further information is expected.
Age: 53.0
Sex: F
Vaccine: COVID19
Symptoms: Rash erythematous, Red breast syndrome
Clinical narrative: Within 12 hours of my second Pfizer COVID19 vaccination, my right breast had a 6cm area that was very red.  8 hors after that, the area had grown to approximately 10cm and was a darker, "angry" lookin; Within 12 hours of my second Pfizer COVID19 vaccination, my right breast had a 6cm area that was very red.  8 hors after that, the area had grown to approximately 10cm and was a darker, "angry" lookin; This is a spontaneous report from a contactable consumer (patient) reported for herself that.  A 53-years-old female patient received BNT162B2 (BNT162B2 solution for injection), dose 2 via an unspecified route of administration, administered in Arm Left on 02Jun2021 15:15 (Batch/Lot Number: EW0168) as DOSE 2, SINGLE for covid-19 immunization (Age at vaccination 53 years). Facility where the most recent COVID-19 vaccine was administered: Pharmacy or Drug Store. The patient past medical history included breast cancer from an unknown date and unknown if ongoing (occult primary, 1 lymph node of right axilla, ER-, PR+, HER2+), photon radiation therapy to breast from 12Oct2020 to an unknown date 25th day of radiation treatment.The patient previously received BNT162B2 (BNT162B2 solution for injection), dose 1 via an unspecified route of administration, administered in Arm Left on 12May2021 15:30 (Batch/Lot Number: EW0167) as DOSE 1, SINGLE for covid-19 immunization.Concomitant medication(s) included bupropion hydrochloride (WELLBUTRIN XL) taken for an unspecified indication, start and stop date were not reported. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccine within 4 weeks prior to covid-19 vaccination. On 03Jun2021 at 02:30 am the patient reported Within 12 hours of her second Pfizer COVID19 vaccination, her right breast had a 6cm area that was very red.  8 hours after that, the area had grown to approximately 10cm and was a darker, angry looking red, with almost purple veining. (This is the same breast that received radiation for cancer. My 25th day of radiation treatment was on October 12, 2020.) she contacted her radiology oncologist and am waiting to hear from her. No treatment was received. The event outcome was not recovered.  Device Date: 03Jun2021  Follow up attempts needed. Further information is expected
Age: 12.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal pain upper, Depression, Fatigue, Insomnia, Pyrexia
Clinical narrative: Low grade fever; Stomach ache; Depressed; Fatigue; Insomnia; This is a spontaneous report received from a contactable consumer. This consumer reported for a 12-year-old female patient. A 12-years-old non-pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; solution for injection, Lot Number: UNKNOWN), dose 1 intramuscular, administered in Arm Left on 01Jun2021 15:30 (at the age of 58-years-old) as a single dose for covid-19 immunization. The patient's medical history and concomitant medications were not reported. The patient was not pregnant at the time of vaccination. The patient had no other vaccine within four weeks and no other medications received within 2 weeks of vaccination. 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 02Jun2021 15:30, the patient experienced low grade fever, stomach ache, depressed, fatigue, insomnia. The patient received treatment with tylenol. No hospitalization prolonged. Outcome of the event was recovering, at the time of this report. Information about batch/lot number has been requested. Follow-up attempts completed. No further information expected.