chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 56.0
Sex: M
Vaccine: COVID19
Symptoms: Rash, SARS-CoV-1 test
Clinical narrative: mild rash on abdomen and back (bilateral), sides of torso and armpit (bilateral), left lower arm, inside of both thighs; This is a spontaneous report from a contactable consumer (patient). A 56-years-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot Number: EM9809 and Expiry date was not reported), via an unspecified route of administration administered in Arm Left on 05Feb2021 11:00 (at the age of 56-years-old) as dose 1, single for COVID-19 immunization. Patient had no known allergies. Medical history included mycotic allergy, seasonal allergy and food allergy from an unknown date and unknown if ongoing Various environmental and food allergies: Mold, tree pollens, tomato, variety of beans. Concomitant medication(s) included fluvoxamine maleate (FLUVOXAMINE MALEATE) and trazodone (TRAZODONE), both taken for an unspecified indication, start and stop date were not reported.Patient did not receive any other vaccine in four weeks. The patient was not diagnosed with COVID-19 prior to vaccination. Post vaccination the patient tested negative for COVID 19. It was reported that on 13Feb2021 20:00, adverse event mild rash on abdomen and back(bilateral), sides of torso and armpit (bilateral), left lower arm, inside of both thighs.Patient did not received any treatment for the event. The patient underwent lab tests and procedures which included sars-cov-1 test with nasal swab was negative on 18Feb2021. The outcome of rash was recovered.   Follow-up attempts are completed. No further information is expected.
Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Pain in extremity
Clinical narrative: headache; arm was a little sore; This is a spontaneous report from a contactable consumer (patient) reported for herself. A 72-years-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number: EZ9204, Expiration date: unknown) via an unspecified route of administration, administered in left arm (left shoulder) on 02Feb2021 a little after 12:00 pm (age at vaccination was 72 years) as dose 1, single for COVID-19 immunization. The patient's medical history included ongoing blood pressure, ongoing sinus, ongoing acid reflux and ongoing stress from an unknown date. Concomitant medications included famotidine taken for acid reflux, amlodipine taken for blood pressure (her blood pressure was about normal but since she was on a low dose they told her to stay on it), montelukast sodium (SINGULAIR) taken for sinus pill, oxymetazoline hydrochloride (CLARITIN ALLERGIC) taken for sinus pill and vitamins. She also takes a medication as needed for stress, but she has not taken it recently. She couldn't remember the name of the medication. No additional vaccines were administered on same date of the Pfizer suspect. On an unspecified date, the patient had a headache after the first dose for 3 to 4 days and her arm was a little sore and it went away on the second day. She didn't have fever, chills, cough, or sore throat with the first dose. The adverse events did not require a visit to Emergency Room and Physician Office. The patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number: EN6198, Expiration date: unknown) via an unspecified route of administration, administered in left arm (left shoulder) on 23Feb2021 a little after 12:00 pm (age at vaccination was 72 years) as dose 2, single for COVID-19 immunization. There was a Product Complaint. The outcome of the events was resolved on an unspecified date in 2021.  No follow up attempts are possible. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Pruritus, Rash papular
Clinical narrative: small red bumps that developed on her neck, chest; skin was itching for 2 days, starting on her hands and arms, and progressing to her abdomen, back and one leg; This is a spontaneous report from a non-contactable consumer or other non hcp. A female patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection), dose 1 via an unspecified route of administration on 18Feb2021 (Batch/Lot number was not reported) as single dose for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. It was reported that on Thursday, 18Feb2021 the patient received the first Covid-19 vaccine and on 23Feb2021 her skin was itching for 2 days, starting on her hands and arms, and progressing to her abdomen, back and one leg, she took Benadryl for the itching 2 nights in a row. This morning she sent me a photo of small red bumps that developed on her neck, chest and back, she reported that she does not have any itching today. She has not yet seen a healthcare provider. Therapeutic measures were taken as a result of itching. The outcome of the events was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Eye pruritus
Clinical narrative: Bulls eye itch; it is still itchy; This is a spontaneous report from a contactable consumer (patient). A 64-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot Number: EL9264) via an unspecified route of administration on an unspecified date (at the age of 64 years old) as dose 1, single for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. The patient experienced bulls eye itch; it is still itchy on an unspecified date. Reported as, patient have bulls eye itch from the first shot 10 days after and it was still itchy, like a week already. Outcome of the event was not recovered.  No follow-up attempts are possible. No further information is expected.
Sex: U
Vaccine: COVID19
Symptoms: Biopsy, Rash
Clinical narrative: Developed a rash on my body from kind of like head to toe; This is a spontaneous report from a contactable consumer (patient). A patient of unspecified age and gender received bnt162b2 (BNT162B2, solution for injection), dose 1 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's medical history and concomitant medications was not reported. After Pfizer Covid vaccine shot, patient developed a rash on body from kind of like head to toe and patient went to dermatologist, she does not think, because they did two biopsy, both of which showed that patient had an allergic reaction to something but she did not feel like it was related to the vaccine and has encouraged me to get the second shot and patient just thought to call her to get a little more information about this side effect that might be a rash. Outcome of the event was unknown.  Information about lot/batch was requested. Follow-up attempts are completed. No further information is expected.
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Pruritus, Urticaria
Clinical narrative: Itching and appearance of hives around neck, on stomach.  During next couple of weeks would appear on legs and arms.; Itching and appearance of hives around neck, on stomach.  During next couple of weeks would appear on legs and arms.; This is a spontaneous report from a non-contactable consumer or other non-Health Care Professional.A 70-years-old non-pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number: EN5318 and Expiry date: Unknown), dose 1 via an unspecified route of administration, administered in Arm Left on 03Feb2021 10:45 at the age of 70-years-oldas DOSE 1, SINGLE for covid-19 immunization. The patient medical history was not reported. The patient did not receive any other vaccines within 4 weeks prior to the Covid vaccine. The patient received other medications of vaccination. The patient was not diagnosed with Covid 19 and has not been tested for Covid-19 Since the vaccination. The patient's concomitant medications were not reported.On 03Feb2021 16:30  the patient experienced itching and appearance of hives around neck, on stomach. during next couple of weeks would appear on legs and arms. The outcome of events was recovering. No follow-up attempts are possible. Information about lot/batch number could not be requested. No further information is expected.
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Dyspnoea exertional, Lymphadenopathy, Oedema
Clinical narrative: Left under arm lymph node swelling; dyspnea on exertion; lower body edema; This is a spontaneous report from a contactable other healthcare professional (patient, nurse). A 50-year-old non pregnant female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Batch/Lot Number: EL0142, expiration date: not reported), via an unspecified route of administration in left arm on 12Jan2021 (at age of 50-year-old) as dose 2, single for covid-19 immunization. Medical history included asthma, drug hypersensitivity (Known allergies: Sulfa). Concomitant medication(s) included bupropion hydrochloride (WELLBUTRIN) taken for an unspecified indication, start and stop date were not reported; budesonide, formoterol fumarate (SYMBICORT) taken for an unspecified indication, start and stop date were not reported; rosuvastatin calcium (CRESTOR) taken for an unspecified indication, start and stop date were not reported. 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. The patient previously took first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Batch/Lot Number: EJ1685, expiration date: not reported), via an unspecified route of administration in left arm on 23Dec2020 (at age of 50-year-old) as dose 1, single for covid-19 immunization. On 17Jan2021, the patient experienced left under arm lymph node swelling, dyspnea on exertion, lower body edema. The adverse events resulted in doctor's clinic visit. No therapeutic measures were taken as a result of the events. The outcome of events were recovered with sequel.  No follow-up attempts are possible. No further information is expected.
Age: 31.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Fatigue, Headache, Pain, Thirst
Clinical narrative: Soreness in arm; severe headache; body aches; tiredness; thirst; This is a spontaneous report from a non-contactable consumer or other non-health care professional (patient). A 31-years-old non-pregnant female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot number: EL3247), via an unspecified route of administration (at the age of 31-years administered in arm left on 16Feb2021 at 13:30 as dose 2, single for COVID-19 immunization. The patient medical history was not reported. Concomitant medications included ibuprofen (ADVIL [IBUPROFEN]) taken for an unspecified indication, start and stop date were not reported. The patient historical vaccine included first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot number: EL3247), via an unspecified route of administration, on 26Jan2021 at 11:30 as dose 2, single for COVID-19 immunization and experienced soreness in arm. The patient did not received any other vaccine in four weeks. Patient does not have covid prior vaccination and has not been tested for covid post vaccination. On 17Feb2021, the patient experienced soreness in arm of injection for both shots, after second shot: severe headache, body aches, tiredness, thirst. The treatment was not received for all the events. The clinical outcome for the events was reported as recovered on an unspecified date in 2021.  No follow-up attempts are possible. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021353701 Same reporter, patient, product/ different dose
Sex: M
Vaccine: COVID19
Symptoms: Rash
Clinical narrative: he developed rashes after.; This is a spontaneous report from a contactable consumer (patient) received from a Pfizer-sponsored program. A male patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Batch/Lot number was not reported), via an unspecified route of administration on an unspecified date as dose 1, single and second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Batch/Lot number was not reported), via an unspecified route of administration on an unspecified date as dose 2, single for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient received the first dose of Covid 19 vaccine, and he developed rashes after on an unspecified date. Got the second dose and still had rashes after receiving the dose. He asked on what to do on this. The outcome of event was not recovered.  No follow-up attempts are possible; information about lot/batch number cannot been obtained.
Sex: M
Vaccine: COVID19
Symptoms: Ageusia, SARS-CoV-2 test
Clinical narrative: loss of taste; This is a spontaneous report from a Pfizer. A contactable male consumer reported. A male patient with unspecified age received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: Not reported) via an unspecified route of administration on 23Feb2021 as DOSE 1, SINGLE for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. On unspecified date the patient experienced loss of taste. The patient was tested for covid 6 or 8 weeks ago and came back negative. Clarified noticed loss of taste after vaccine. The patient underwent lab tests and procedures which included SARS-CoV-2 test and resulted negative on unspecified date. The outcome of the event was unknown.  Information of batch/lot number has been requested.  Follow-up attempts are completed. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Headache, Pyrexia, Rash
Clinical narrative: rashes on chest; fever; headache; This is a spontaneous report from contactable consumer via a Pfizer-sponsored program Support. A male patient of an unspecified age received bnt162b2 (PFIZER BIONTECH COVID-19 mRNA VACCINE Solution for injection Lot number was not reported) via an unspecified route of administration on 08Feb2021 as dose 1, single for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. On 16Feb2021, 8 days after the vaccination the patient experienced rashes on chest, fever and headache and he asked if these side effects are from the vaccine. The clinical outcome of the events was unknown.  Follow-up attempts are completed. No further information is expected.
Sex: U
Vaccine: COVID19
Symptoms: Body temperature, Headache, Nausea, Raynaud's phenomenon
Clinical narrative: Severe headache; Nauseous; Temperature was 96.9; Extremely cold feet and hands; This is a spontaneous report from a contactable consumer or other non-healthcare professional. A patient of unspecified age and gender received bnt162b2 (BNT162B2, PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection), dose 1 via an unspecified route of administration on 24Feb2021 (Batch/Lot Number: EN6198) as DOSE 1, SINGLE for covid-19 immunization. The patient medical history and concomitant medications were not reported. On 24Feb2021, the patient experienced severe headache, nauseous, temperature was 96.9 and extremely cold feet and hands. It was reported that the patient received the Covid19 vaccine yesterday morning and had side effects last night and called the 24-hour (insurance company name) Nurse with my (insurance company name) Provider and she told me to call this number to report side effects. The patient confirmed that it was the Covid19 vaccine of Pfizer. The intention of the call was to report side effects. The patient developed a severe headache immediately after and was kept under observation for 30 minutes, then released and came home. The headache continued most of the night. Also, the patient was very nauseous. My temperature was 96.9 and had extremely cold feet and hands. She just called on the advice of the 24-hour nurse associated with (insurance company name) Health Plan. Further probing could not be done as consumer hung up the call abruptly. Laboratory tests on 24Feb2021 included body temperature: 96.9. The clinical outcome of the events was unknown.  No follow-up attempts are possible. No further information is expected.
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Contusion
Clinical narrative: When she got the shot, it left a big bruise on her arm; It started to swell up; This is a spontaneous report from a contactable consumer (husband) or other non-healthcare professional reporting for female patient (wife). A 61-years-old female patient received bnt162b2 (BNT162B2, PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection), via an unspecified route of administration on an unspecified date (Batch/Lot number and Expiry date was not reported) (at the age of 61-years-old)as DOSE NUMBER UNKNOWN, SINGLE for covid-19 immunization.Medical history included rheumatoid arthritis. The patient's concomitant medications were not reported. On an unspecified date, the patient experienced when she got the shot, it left a big bruise on her arm, it started to swell up. The reporter was calling regarding my wife. She just had the Pfizer vaccine eight days ago and originally, first of all, when she got the shot, it left a big bruise on her arm, which the nurse who administered the shot said, that never happened before. Eight days later now, it started to swell up. She is going to call her doctor of course but I thought I should go ahead and give you a call just kind of like to see what this particular number is about, what you guys do. There was no treatment received. The clinical outcome of the event was unknown.  Follow-up attempts completed. No further information expected.
Sex: F
Vaccine: COVID19
Symptoms: Abdominal pain upper, Arthralgia, Diarrhoea, Headache, Hot flush
Clinical narrative: muscle and joint pain; muscle and joint pain; hot flashes; headaches; stomach pain; diarrhea; This is a spontaneous report from a Pfizer sponsored program COVAX US Support from a contactable consumer. A Patient of unspecified age and gender received Covid-19 Vaccine (BNT162B2) (Batch/Lot number: Unknown, Expiration date: Unknown, Solution for injection) via an unspecified route of administration on 18Feb2021 as Dose 1, single for covid-19 immunization. Medical history and concomitant medications were not reported. On an unknown date patient experienced side effects like muscle and joint pain, hot flashes, headaches, stomach pain and diarrhea. No therapeutic treatments were received. The outcome of the events were reported as unknown.  Information on lot/ batch number has been requested.
Sex: F
Vaccine: COVID19
Symptoms: Myalgia
Clinical narrative: muscle and joint pain; muscle and joint pain; hot flashes; headaches; stomach pain; diarrhea; This is a spontaneous report from a Pfizer sponsored program COVAX US Support from a contactable consumer. A Patient of unspecified age and gender received Covid-19 Vaccine (BNT162B2) (Batch/Lot number: Unknown, Expiration date: Unknown, Solution for injection) via an unspecified route of administration on 18Feb2021 as Dose 1, single for covid-19 immunization. Medical history and concomitant medications were not reported. On an unknown date patient experienced side effects like muscle and joint pain, hot flashes, headaches, stomach pain and diarrhea. No therapeutic treatments were received. The outcome of the events were reported as unknown.  Information on lot/ batch number has been requested.
Sex: M
Vaccine: COVID19
Symptoms: Rash
Clinical narrative: patient experienced a rash since the first dose; This is a spontaneous report from a Pfizer sponsored program. A contactable consumer (patient) reported that a male patient of unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number: unknown), via an unspecified route of administration on an unspecified date as dose 1, single for COVID-19 immunisation. Medical history and concomitant medication were not reported. The patient experienced a rash on an unspecified date since the first dose. The patient has received both doses. Outcome of the event was unknown.  Follow-up attempts completed. No further information expected.
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal pain upper, Arthralgia, Depressed mood, Diarrhoea, Fatigue
Clinical narrative: severe loose runny stools/Diarrhea; flu like symptoms; joint pain; muscle pain; tiredness; rash at injectoin site; stomach pain; ugh; This is a spontaneous report from a contactable consumer (patient). A 54-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection), dose 2 via an unspecified route of administration, administered in left arm on 12Feb2021 (Batch/Lot number was not reported) (at the age of 54-year-old) as single dose 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), dose 1 via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as single dose for covid-19 immunisation and experienced runny, loose stool specified as diarrhea, weight loss, stomach pain, ugh. In Feb2021, the patient experienced severe loose runny stools, flu-like symptoms including joint/muscle pain, tiredness, a giant rash at the injection site. Diarrhea that has lasted for 4 days, ugh, stomach pain as well. Normally she does not have GI issues. The outcome of events was unknown.  No follow-up attempts are possible; information about lot/batch number cannot been obtained.
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: Influenza like illness, Myalgia, Vaccination site rash
Clinical narrative: severe loose runny stools/Diarrhea; flu like symptoms; joint pain; muscle pain; tiredness; rash at injectoin site; stomach pain; ugh; This is a spontaneous report from a contactable consumer (patient). A 54-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection), dose 2 via an unspecified route of administration, administered in left arm on 12Feb2021 (Batch/Lot number was not reported) (at the age of 54-year-old) as single dose 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), dose 1 via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as single dose for covid-19 immunisation and experienced runny, loose stool specified as diarrhea, weight loss, stomach pain, ugh. In Feb2021, the patient experienced severe loose runny stools, flu-like symptoms including joint/muscle pain, tiredness, a giant rash at the injection site. Diarrhea that has lasted for 4 days, ugh, stomach pain as well. Normally she does not have GI issues. The outcome of events was unknown.  No follow-up attempts are possible; information about lot/batch number cannot been obtained.
Age: 84.0
Sex: F
Vaccine: COVID19
Symptoms: Chest discomfort, Vaccination site pain
Clinical narrative: Bit of tightness in chest; Soreness in her arm at site; This is a spontaneous report received from a contactable consumer or other non hcp. A female patient of an unspecified age received 1st dose of bnt162b2 (COMIRNATY,Batch/Lot number was not reported), via an unspecified route of administration on 29Jan2021 as Dose 1,single for covid-19 immunization.treprostinil sodium (TYVASO), via an unspecified route of administration from 26Mar2020 (Batch/Lot number was not reported) to an unspecified date, at unspecified dose, via an unspecified route of administration from an unspecified date (Batch/Lot Number: 2101898; Expiration Date: 31Oct2021) and ongoing, at UNK ug, 4x/day (18-54 mcg (3-9 breaths) for pulmonary arterial hypertension.Medical history included ongoing pulmonary arterial hypertension. Concomitant medication(s) included sildenafil citrate and ambrisentan (LETAIRIS) taken for an unspecified indication, start and stop date were not reported.The patient experienced bit of tightness in chest and soreness in her arm at vaccination site on 2021.On 19Feb2021, the following updates were made in the case with Day zero, 11Feb2021: This correction is being submitted to structure COVID vaccine as a co-suspect Product and to update the action taken with COVID vaccine from not reported to not applicable. Information about lot/batch number has been requested. Follow-up (19May2021): Follow-up attempts completed. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Diarrhoea, Dyspnoea
Clinical narrative: Diarrhea for about 2-3 days after COVID vaccine, was not sure if related to vaccine or medications; Shortness of breath; still gets out of breath; This is a spontaneous report based on the information received by Pfizer from United Therapeutics (Manufacturer Report Number: UNT-2021-002485) via a contactable consumer (patient, self-reported). A 85-years-old male patient received a dose of BNT162B2 (PFIZER-BIONTEC COVID-19 mRNA VACCINE, Solution for injection, lot number and expiry date were not reported), via an unspecified route of administration, on an unspecified date, as a single dose for COVID-19 immunization, treprostinil sodium (TYVASO, Inhalation gas), via an unspecified route of administration on an unspecified date and on 24Nov2020, for secondary pulmonary arterial hypertension, TADALAFIL and macitentan (OPSUMIT) for drug use for unknown indication. The patient's medical history included secondary pulmonary arterial hypertension. Concomitant medications were not reported. On an unspecified date, the patient experienced diarrhea for about 2-3 days after COVID vaccine, was not sure if related to vaccine or medications and shortness of breath; still gets out of breath. Tadalafil and Opsumit was not reported for the events of diarrhoea and dyspnoea. The patient reported that he had a little improvement, but he still got out of breath (dyspnoea previously reported). The reporter did not provide causality for the events of diarrhoea and dyspnoea. At the time of reporting, the outcome of the event shortness of breath; still gets out of breath was not recovered and for another event, it was unknown.  Information about lot/batch number has been requested.  Follow-up attempts completed. No further information expected.
Age: 81.0
Sex: F
Vaccine: COVID19
Symptoms: Asthma, Body height, Condition aggravated, Erythema, Hypersensitivity
Clinical narrative: itching all over; bad time with allergies; couldn't sleep; asthma was worse; red on her arm; second shot a lot worse than the first; This is a spontaneous report received from a contactable consumer or other non hcp. A 81-years-old female patient received 2nd dose of bnt162b2 (COMIRNATY,Batch/Lot Number: EL9266; Expiration Date: 31May2021), via an unspecified route of administration on 21Feb2021 ,at the age of 81 years old,as Dose 2 single for covid-19 immunization. Medical history included diabetes mellitus, neoplasm malignant Verbatim: cancer twice, asthma, osteoporosis, cardiac disorder, dermatitis contact and blood cholesterol abnormal from an unknown date and unknown if ongoing. The patient experienced itching all over, bad time with allergies, couldn't sleep, asthma was worse, red on her arm, second shot a lot worse than the first. The patient underwent lab tests and procedures which included body height: she is 5 foot 4 or 5 foot 5, stating that she shrunk , investigation: she had some sort of virus for about 3 weeks on, weight: 150 lbs on .Caller stated that she was 150 pounds and gained to 170.The outcome of the event was unknown.The patient previously received her 1st dose of Pfizer covid19 vaccine on 30Jan2021,lot EL892, exp 31May2021.Caller stated that she was asked when she took her 1st shot and was having reaction she thought it was because heart doctor had put on different cholesterol medication and she thought that she was reacting to that a little bit but then it eased off in a couple days. Upon transfer to medical information hold queue caller asked will the shots be as effective if she has taken Benadryl.
Age: 81.0
Sex: F
Vaccine: COVID19
Symptoms: Insomnia, Investigation, Pruritus, Weight
Clinical narrative: itching all over; bad time with allergies; couldn't sleep; asthma was worse; red on her arm; second shot a lot worse than the first; This is a spontaneous report received from a contactable consumer or other non hcp. A 81-years-old female patient received 2nd dose of bnt162b2 (COMIRNATY,Batch/Lot Number: EL9266; Expiration Date: 31May2021), via an unspecified route of administration on 21Feb2021 ,at the age of 81 years old,as Dose 2 single for covid-19 immunization. Medical history included diabetes mellitus, neoplasm malignant Verbatim: cancer twice, asthma, osteoporosis, cardiac disorder, dermatitis contact and blood cholesterol abnormal from an unknown date and unknown if ongoing. The patient experienced itching all over, bad time with allergies, couldn't sleep, asthma was worse, red on her arm, second shot a lot worse than the first. The patient underwent lab tests and procedures which included body height: she is 5 foot 4 or 5 foot 5, stating that she shrunk , investigation: she had some sort of virus for about 3 weeks on, weight: 150 lbs on .Caller stated that she was 150 pounds and gained to 170.The outcome of the event was unknown.The patient previously received her 1st dose of Pfizer covid19 vaccine on 30Jan2021,lot EL892, exp 31May2021.Caller stated that she was asked when she took her 1st shot and was having reaction she thought it was because heart doctor had put on different cholesterol medication and she thought that she was reacting to that a little bit but then it eased off in a couple days. Upon transfer to medical information hold queue caller asked will the shots be as effective if she has taken Benadryl.
Age: 81.0
Sex: F
Vaccine: COVID19
Symptoms: Lip swelling, Pruritus
Clinical narrative: itchy and red spots; lip swelled up and it felt numb; This is a spontaneous report from a contactable Consumer (patient). An 81-year-old female patient received second dose of bnt162b2 (BNT162B2, Solution for injection, Lot number: EM9809), via an unspecified route of administration on 17Feb2021 (age at the vaccination 81-year-old) as DOSE 2, SINGLE for covid-19 immunisation. The patient medical history and concomitant medication were not reported. Historical vaccine included first dose of BNT162B2 Lot number: EL1283 on 27Jan2021 as DOSE 1, SINGLE for covid-19 immunisation. Patient and her husband and their got first COVID 19 shot 27Jan2021. Then, three weeks later they got their 2nd vaccine on 17Feb2021, Then, the 22Feb2021, she developed a side effect. The first shots were fine. The second shot they thought was fine. Then, Sunday evening, 22Feb2021, she developed itching and red spots. It was not very comfortable. The small spots were here and there. They were not all over her body. Then patient top right lip swelled up and felt numb on 22Feb2021. It was not painful. It was like waiting for Novocain to go away. By the morning it was way down, and then by afternoon, it was all gone. It has not returned. It felt like she had been to the dentist. At first, she thought it was just hives or something. She put some cortisone cream on it, and she was able to sleep a lot better. Therapeutic measures were taken as a result of both events. The outcome of the event lip swelling was recovered on 22Feb2021 and Itchy was recovering.  Follow-up (14May2021): Follow-up attempts are completed. No further information is expected.
Age: 78.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Arthralgia, Body height, Breast pain
Clinical narrative: pain in her breast and shoulder; pain in her breast and shoulder; This is a spontaneous report from a contactable consumer. A 78-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot number was not reported), dose 1 via an unspecified route of administration, administered in Arm Right on 09Feb2021 (at the age of 78 year) as dose 1, single for COVID-19 immunisation. Medical history included ongoing hypothyroidism, breast cancer (breast cancer 18 months ago), breast conserving surgery, chemotherapy, surgery, radiotherapy, lymphadenopathy. Concomitant medication(s) included ongoing levothyroxine sodium (SYNTHROID) taken for hypothyroidism and ongoing anastrozole (ANASTROZOLE) taken for breast cancer from Nov2020. Consumer reported that his wife went through with the COVID vaccine. Consumer stated that his wife had breast cancer 18 months ago, and she had chemo, and surgery and radiation, she had a partial mastectomy. Consumer stated that on an unspecified date in Feb2021 she experienced pain in her breast and shoulder. Consumer stated that when his wife had a partial mastectomy, they also removed 9 lymph nodes. Caller states that the pain his wife was having, was in the areas where she had her surgery. Consumer stated that his wife was between 5'6.5" and 5'7". Consumer provided that the patient could not say that the pain was constant, although it was constant in her left arm, but it was not constant in her breast. The patient didn't get the shot in her left arm, because that was the side that she had lymph nodes removed. The patient reports that the pain was in her left shoulder and where the lymph nodes were taken out, she had 9 removed, and that pain started a few days after she got the shot. The patient asked the woman giving the shot if the shot would affect her breast or other arm, and the patient was told that it should not affect those, but the patient did have pain in both arms, but especially in the left breast, where she had the cancer. Caller stated that just yesterday evening, she started taking Tylenol for the pain. The outcome of events was unknown.  No follow-up attempts are needed. Information about lot/batch cannot be obtained.
Age: 78.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Arthralgia, Pain in extremity
Clinical narrative: pain in her breast and shoulder; pain in her breast and shoulder; This is a spontaneous report from a contactable consumer. A 78-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot number was not reported), dose 1 via an unspecified route of administration, administered in Arm Right on 09Feb2021 (at the age of 78 year) as dose 1, single for COVID-19 immunisation. Medical history included ongoing hypothyroidism, breast cancer (breast cancer 18 months ago), breast conserving surgery, chemotherapy, surgery, radiotherapy, lymphadenopathy. Concomitant medication(s) included ongoing levothyroxine sodium (SYNTHROID) taken for hypothyroidism and ongoing anastrozole (ANASTROZOLE) taken for breast cancer from Nov2020. Consumer reported that his wife went through with the COVID vaccine. Consumer stated that his wife had breast cancer 18 months ago, and she had chemo, and surgery and radiation, she had a partial mastectomy. Consumer stated that on an unspecified date in Feb2021 she experienced pain in her breast and shoulder. Consumer stated that when his wife had a partial mastectomy, they also removed 9 lymph nodes. Caller states that the pain his wife was having, was in the areas where she had her surgery. Consumer stated that his wife was between 5'6.5" and 5'7". Consumer provided that the patient could not say that the pain was constant, although it was constant in her left arm, but it was not constant in her breast. The patient didn't get the shot in her left arm, because that was the side that she had lymph nodes removed. The patient reports that the pain was in her left shoulder and where the lymph nodes were taken out, she had 9 removed, and that pain started a few days after she got the shot. The patient asked the woman giving the shot if the shot would affect her breast or other arm, and the patient was told that it should not affect those, but the patient did have pain in both arms, but especially in the left breast, where she had the cancer. Caller stated that just yesterday evening, she started taking Tylenol for the pain. The outcome of events was unknown.  No follow-up attempts are needed. Information about lot/batch cannot be obtained.
Age: 77.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Asthenia, Body temperature, Chills, Dizziness
Clinical narrative: Chills; Low grade fever; Dizziness; joint and muscle aches; joint and muscle aches; Weakness; This is a spontaneous report from a contactable consumer (reported for himself). A 77-years-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection, Lot Number: EL9264/Batch number was not reported; Expiration Date: on an unspecified date in May2021), dose 2 via an unspecified route of administration, administered in arm left on 19Feb2021 (at the age of 77-years-old) as dose 2, single for covid-19 immunisation. Medical history included glucose tolerance impaired from an unknown date and unknown if ongoing (diagnosed 10 years) and sleep apnoea syndrome from an unknown date and unknown if ongoing (diagnosed 10-12 years ago). The patient's concomitant medications were not reported. The patient previously received first dose bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection, Lot Number: EN5318/Batch number was not reported; Expiration Date: on an unspecified date in May2021), dose 2 via an unspecified route of administration, administered in arm left on 28Jan2021 (at the age of 77-years-old) as dose 2, single for covid-19 immunisation. On 20Feb2021, chills, low grade fever, dizziness, joint and muscle aches and weakness. The patient underwent lab tests and procedures which included body temperature: low on 20Feb2021. The outcome of the events chills, low grade fever was resolved on 20Feb2021, joint and muscle aches, weakness was resolved on 21Feb2021 and dizziness was resolving.  Follow-up attempts are completed. No further information is expected.
Age: 77.0
Sex: M
Vaccine: COVID19
Symptoms: Myalgia, Pyrexia
Clinical narrative: Chills; Low grade fever; Dizziness; joint and muscle aches; joint and muscle aches; Weakness; This is a spontaneous report from a contactable consumer (reported for himself). A 77-years-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection, Lot Number: EL9264/Batch number was not reported; Expiration Date: on an unspecified date in May2021), dose 2 via an unspecified route of administration, administered in arm left on 19Feb2021 (at the age of 77-years-old) as dose 2, single for covid-19 immunisation. Medical history included glucose tolerance impaired from an unknown date and unknown if ongoing (diagnosed 10 years) and sleep apnoea syndrome from an unknown date and unknown if ongoing (diagnosed 10-12 years ago). The patient's concomitant medications were not reported. The patient previously received first dose bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection, Lot Number: EN5318/Batch number was not reported; Expiration Date: on an unspecified date in May2021), dose 2 via an unspecified route of administration, administered in arm left on 28Jan2021 (at the age of 77-years-old) as dose 2, single for covid-19 immunisation. On 20Feb2021, chills, low grade fever, dizziness, joint and muscle aches and weakness. The patient underwent lab tests and procedures which included body temperature: low on 20Feb2021. The outcome of the events chills, low grade fever was resolved on 20Feb2021, joint and muscle aches, weakness was resolved on 21Feb2021 and dizziness was resolving.  Follow-up attempts are completed. No further information is expected.
Age: 30.0
Sex: F
Vaccine: COVID19
Symptoms: Ageusia, Anosmia, Dizziness, Fatigue, Hypersomnia
Clinical narrative: No taste in my mouth, no scent.; No taste in my mouth, no scent; Cold fever and I had aches and pain; Cold fever and I had aches and pain; Tired; Dizzy/feeling dizzy; Never slept this much in my life; This is a spontaneous report from a contactable consumer (patient). A 30-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot Number: EL9267, Expiration date: Unknown) via an unspecified route of administration on 21Feb2021 (30-year-old at vaccination) as a Dose 1, Single for COVID-19 immunization. The patient's medical history reported as none. The patient's concomitant medication(s) included ascorbic acid (VITAMINE C); tocopheryl acetate (VITAMINE E; vitamin b complex (VITAMIN B). She took the vaccine on Sunday (21Feb2021), right and since she took it, right today, it was like 4 days and she had no taste in her mouth, no scent. She was like constantly dizzy and when she took the at first night, she had the cold fever and she had aches and pain like until Monday and then Monday afternoon it went away but now it's like since Sunday till now, she had no taste no scent. She just feeling dizzy and like she was very tired all she wanted was to sleep. On an unknown date in 2021, it was like she never slept this much in her life. She was getting this dizzy like if she goes to drive like she was so dizzy. She was always dizzy. She never a like was person that complained about dizziness even and all if she was sick she never lost her taste and her scent. No investigation assessment was provided. She said that she was old healthcare aid. She cared for older people. The outcome of the events was not recovered.  Follow-up attempts completed. No further information expected.
Age: 30.0
Sex: F
Vaccine: COVID19
Symptoms: Pain, Pyrexia
Clinical narrative: No taste in my mouth, no scent.; No taste in my mouth, no scent; Cold fever and I had aches and pain; Cold fever and I had aches and pain; Tired; Dizzy/feeling dizzy; Never slept this much in my life; This is a spontaneous report from a contactable consumer (patient). A 30-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot Number: EL9267, Expiration date: Unknown) via an unspecified route of administration on 21Feb2021 (30-year-old at vaccination) as a Dose 1, Single for COVID-19 immunization. The patient's medical history reported as none. The patient's concomitant medication(s) included ascorbic acid (VITAMINE C); tocopheryl acetate (VITAMINE E; vitamin b complex (VITAMIN B). She took the vaccine on Sunday (21Feb2021), right and since she took it, right today, it was like 4 days and she had no taste in her mouth, no scent. She was like constantly dizzy and when she took the at first night, she had the cold fever and she had aches and pain like until Monday and then Monday afternoon it went away but now it's like since Sunday till now, she had no taste no scent. She just feeling dizzy and like she was very tired all she wanted was to sleep. On an unknown date in 2021, it was like she never slept this much in her life. She was getting this dizzy like if she goes to drive like she was so dizzy. She was always dizzy. She never a like was person that complained about dizziness even and all if she was sick she never lost her taste and her scent. No investigation assessment was provided. She said that she was old healthcare aid. She cared for older people. The outcome of the events was not recovered.  Follow-up attempts completed. No further information expected.
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Erythema
Clinical narrative: red knot; This is a spontaneous report from a contactable consumer (patient). A 71-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot number: EN6202, Expiration date: unknown), via an unspecified route of administration in arm left on 23Feb2021 at 11:10 (at the age of 71-year-old) as a dose 2, single for COVID-19 immunization. The patient's medical history (including any illness at time of vaccination) included high cholesterol, high blood pressure, diabetic. The patient's concomitant medications included aspirin [acetylsalicylic acid] and colecalciferol (VITAMIN D 3). Historical vaccine included BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot number: EM9810, Expiration date: unknown), via an unspecified route of administration in arm left on 02Feb2021 (at the age of 71-year-old) as a dose 1, single for COVID-19 immunization. Additional vaccines administered on same date of the Pfizer suspect was reported as none. The AE(s) following prior vaccinations were reported as none. It was reported that, the patient had her second shot on Tuesday. Stated that, she did fine on Tuesday and yesterday. Stated that, this morning on 25Feb2021, she woke up around 07:30 AM and she has a big red knot where she got the shot. Stated that, it was warm touch. There was a red circle around it. Stated that, was that something she should get checked and was that a side effect. The caller clarified shot as COVID-19 Vaccine. Stated that, it was more red today. The circle Band-Aid was still on and she took it off. The circle was getting bigger around it and more red. Stated that, she was not sure whether that was something that might happen. Stated that, she has not put any ice on it. Stated that, on the vaccine card, it said BioNTech. The lot number was EM9810 for first dose. Second dose lot number was EN6202, Expiry for both first and second dose was unknown. Stated that, as she was over 70, doesn't want to get it. Also stated that, her grandkids won't let her see them until she gets it. Stated that, she takes 9 pills. She takes medication for high cholesterol, high blood pressure and diabetes. Stated that, she also takes aspirin and vitamin D. She takes three different pills for diabetes. The caller did not provide list of medication names when queried. Treatment was not received for the event. The outcome of the event was not recovered.  Follow-up attempts are completed. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Aphonia, Cough, Malaise
Clinical narrative: not feeling well; having a cough; voice feels gone; This is spontaneous report from a Pfizer sponsored program. A contactable male consumer reported.  A male patient with unspecified age received a dose of BNT162B2 (BNT162B2, Formulation: Solution for injection, Lot Number: unknown, Expiration date: unknown), via unspecified route, administered on 01Feb2021 as dose 1, single for COVID-19 immunization. The patient medical history and concomitant medications were not reported. On an unspecified date, after the vaccination, the patient experienced not feeling well, having a cough, and voice feels gone. This happened a week before second dose. The events assessed all as non-serious. The outcome of the events was unknown.  No follow-up attempts possible. No further information expected.  Follow-up (14May2021): 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: M
Vaccine: COVID19
Symptoms: Pruritus
Clinical narrative: itchy arms; This is a Spontaneous report from a contactable consumer. A male patient of unspecified age received BNT162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot Number: Unknown), via an unspecified route on unspecified date as dose number unknown, single for covid-19 immunisation. The patient medical history and concomitant medications were not reported. On unspecified date, the patient experienced itchy arms. The outcome of the event was unknown.  No Follow-up attempts are needed. Information about lot/batch cannot be obtained.