chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Hot flush, Myalgia, Vaccination site pain, Vaccination site swelling
Clinical narrative: Pain at the injection site; swelling at the injection site; muscle pain; hot flash after the injection; tiredness; Fatigue; This is a spontaneous report from a Non-contactable consumer. This 57-year-old Female consumer (Patient) reported.  A 57-year-old (non-pregnant) female patient received a dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot Number: 18, Expiration date: unknown), via unspecified route, administered on an unspecified date (at the age of 57-year-old) as dose number unknown, single for COVID-19 immunization. The patient medical history includes Fibromyalgia and Diabetes mellitus both from an unspecified date to unknown ongoing, and concomitant medications includes Diphenhydramine Hydrochloride, Paracetamol (TYLENOL EXTRA S.P) and Metformin. Past drug event include PERAZONE [CEFOPERAZONE SODIUM] induced Drug hypersensitivity on an unspecified date. On 18-FEB-2021 13:45, after the vaccination, the patient experienced Pain at the injection site, swelling at the injection site, muscle pain, hot flash after the injection, tiredness, fatigue. Patient took no other vaccine in four weeks; patient was not diagnosed with covid prior vaccination. Patient was not tested with covid post vaccination. The outcome of the events was recovering at the time of this report.  No follow-up attempts possible. No further information expected.
Sex: U
Vaccine: COVID19
Symptoms: Fatigue, Headache
Clinical narrative: Fatigue; headache; This is a spontaneous report from a contactable other hcp via a sales representative. A patient of unspecified age and gender received bnt162b2 (COMIRNATY, Solution for injection, Batch/Lot number was not reported), via an unspecified route of administration on an unspecified date as dose 1, single for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. Reporter stated that after the first dose, the patient felt fatigue and headache immediately following the dose, but it resolved in about 1/2 day. Outcome of the events was recovered.  Information about lot/batch number has been requested.  Follow-up (13May2021): Follow-up attempts completed. No further information expected.
Sex: U
Vaccine: COVID19
Symptoms: Dizziness
Clinical narrative: I couldn't get out of bed because I was too dizzy for about 4 hours; I had that dizziness reaction; This is a spontaneous report from a contactable consumer (patient). A patient of an unspecified age and gender received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot number: EN5318), via an unspecified route of administration on an unspecified date as dose 1, single for COVID-19 immunization. Medical history and concomitant medications were not reported. On an unspecified date, the patient experienced that patient couldn't get out of bed because patient was too dizzy for about 4 hours; patient had that dizziness reaction. It was reported that the patient was fine the day the patient took the first shot in the morning and was fine that day and during the night but the next morning when the patient got up, the patient couldn't get out of bed because the patient was too dizzy for about 4 hours and a medical person tell patient that they did not think that patient should take the second shot because the patient had that dizziness reaction the next day. The outcome of the event was unknown.   No follow-up attempts are possible. No further information is expected.
Age: 77.0
Sex: F
Vaccine: COVID19
Symptoms: Alopecia, Injection site pain, Pain in extremity
Clinical narrative: Pain at injection site; Arm hurt; Hair loss; This is a spontaneous report from a contactable consumer. This consumer reported for a 77-year-old female patient (wife) that:   A 77-year-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection, Batch/Lot Number: EL9261), via an unspecified route of administration, administered in Arm Left on 20Jan2021 (at the age of 77-year-old) as single dose for covid-19 immunisation. Medical history included reversible shoulder surgery from 03Dec2020 to an unknown date and ongoing blood cholesterol from an unknown date. Concomitant medication only prescription medication she takes is a stating drug to control cholesterol she has been on it for 2 to 3 years. He doesn't know the dose. Patient previously took flu shot and a pneumonia shot he thinks it might have been the end of Oct2020. Additional vaccines administered on same date of the Pfizer Suspect reported as none. Consumer reported side effect from the first dose was pain at the injection site along with for a day or two her arm hurt. But as far as fever and chills none. They received the first dose of the Pfizer vaccine on 20Jan2021 at the (facility name) in (place). The reason he called before around the eighth was because 10 days to two weeks after the vaccine his wife started a lot of hair loss, she continues to have a lot of hair loss she doesn't have much hair left. He is calling because he is curious to know. He talked to family doctor too. Received the first dose of COVID19 Vaccine on 20Jan2021. Ten to fourteen days after the vaccine his wife developed hair loss. It was around the first week of February. It is worsening and her hair is currently coming out. They were also told that she should have the second dose initially they were supposed to receive Moderna, but when it came their turn, they had run out of Moderna and had 20 vials of Pfizer left, so they got Pfizer. Because of the hair loss they had called the family doctor and asked if it would be a good idea to get the second dose since she is having a lot of hair loss. The doctor's response was yes, he would recommend the second dose. the doctor told them it would be better off to have no hair. Patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection, Batch/Lot Number: EL9269), via an unspecified route of administration, administered on 11Feb2021 as single dose for covid-19 immunisation. The outcome of the event hair loss was reported as not recovered and Pain at injection site, Arm hurt was unknown.   Follow-up attempts are completed. No further information is expected.
Sex: U
Vaccine: COVID19
Symptoms: Fatigue, Headache, Somnolence
Clinical narrative: headache; my body was drained like really tired; slept all day; This is a spontaneous report from a non-contactable consumer communicated to Pfizer. This consumer reported.  A patient with unspecified age and gender received a dose of BNT162B2 (BNT162B2, Formulation: Solution for injection, Lot Number: unknown, Expiration date: unknown), via unspecified route, administered on unspecified date as dose 2, single for COVID-19 immunization. Patient received a dose of BNT162B2 (BNT162B2, Formulation: Solution for injection, Lot Number: unknown, Expiration date: unknown), via unspecified route, administered on an unspecified date 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 headache and her body was drained like tired. she didn't go to work Wednesday. The patient slept all day. On Thursday she felt much better and rested and went to work. The outcome of the events was recovering at the time of this report.  No follow-up attempts possible. No further information expected.
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal pain upper, Fatigue, Headache, Pyrexia, Vomiting
Clinical narrative: Vomiting; Stomach ache; Fatigue extreme; Headache; Low grade fever; This is a spontaneous report from a contactable consumer (Patient). A 67-year-old female patient received first dose bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; formulation: Solution for injection Batch/Lot Number: EN6200), dose 1 via an unspecified route of administration on 23Feb2021 as dose 1, single for covid-19 immunisation. Medical history included immune thrombocytopenia from an unknown date and unknown if ongoing (Idiopathic thrombocytopenia). The patient's concomitant medications was not reported. On 24Feb2021 patient experienced extreme fatigue, headache, very low grade fever, vomiting, patient was feeling still fatigued but little headache just about it and patient question was though have Idiopathic thrombocytopenia and patient not known that should proceed with the second dose of vaccine or not. Patient received treatment with ibuprofen. The outcome of fatigue extreme and headache was not recovered and outcome of low grade fever, vomiting and stomach ache was unknown.  No follow up attempts are possible. No further information is available.
Sex: F
Vaccine: COVID19
Symptoms: Influenza
Clinical narrative: flu; This is a spontaneous report from a Pfizer-sponsored program Covax US support.  A Non contactable consumer reported for a female patient (reporter's sister).  A female patient of unspecified age received a dose of BNT162B2 (BNT162B2, Formulation: Solution for injection, Lot Number: unknown, Expiration date: unknown), via unspecified route, administered on an unspecified route as dose 2, single for COVID-19 immunization. The patient medical history and concomitant medications were not reported. On an unspecified date, after the vaccination, the patient got sick with the flu. The events assessed as non-serious. The outcome of the event was unknown.  No follow-up attempts possible. No further information expected.
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Pruritus, Rash
Clinical narrative: Rash is itching; rash trunk neck arm; This is a spontaneous report from a Contactable physician (Patient). A 56 year old female patient started to receive bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/Lot Number: EL9269) via an unspecified route of administration on 19Feb2021 at as DOSE 1, SINGLE for COVID-19 immunization (at the age of 56 Years). Medical history included Benign essential tremor and Concomitant medication(s) included was on 20mg Propranolol and was switched to 60mg extended release for Benign essential tremor, which she had been on for a while now. Was switched at least a year ago. On 21Feb2021 The patient experienced rash started all over her body, neck, head, and arms. Rash is ongoing. Rash is itching. It was reported that, thought it would start to clear by now. Wanted to know if this is a normal response and should she take her second shot. Her breathing has not changed. She is just constantly itching and can't stop. Had been taking Hydrocortisone cream, Benadryl and also taking Pepcid, and Zyrtec for the H2 antihistamine. Zyrtec 10mg every night around 7PM Lot: 1797699 Exp: Jun2023, Pepcid: 10mg every night around 7PM Lot: SLF055 Exp: Aug2023 7PM, Benadryl: 25mg tablet at night, around 10PM, to go to sleep and stop itching. Lot: 16L0001 Exp: Jun2020, Clarified Hydrocortisone cream Cortisone 10 for eczema, itchy, dry skin, Exp: Aug2012, and she is applied as many times as she can and also reported taking benadryl and hydrocortisone cream for the itching. It still itching non-stop. She noticed it is expired when looking for the expiry. Stated that is maybe why it is not working. Outcome of the event was unknown.  No follow-up attempts are needed. No further information is expected.
Age: 29.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Exercise tolerance decreased, Fatigue, Lymphadenopathy, Myalgia
Clinical narrative: injection site pain; arm soreness; muscle aches; pains in forearms,shoulders, abdomen, quadriceps, and calves.; minor joint pain; swollen lymph nodes under both arms.; fatigue; exercise intolerance; This is a spontaneous report from a contactable physician. A 29-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Formulation: Solution for injection, Lot number: EL9264, Expiration Date: not reported) via intramuscular, administered in left arm on an unspecified date as dose 2, single for COVID-19 immunization at the age of 29-year-old. Patient previously took BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Formulation: Solution for injection, Lot number: EN5318, Expiration Date: not reported) via intramuscular, administered in left arm on 29Jan2021 as dose 1, single for COVID-19 immunization. Medical history included known allergies to tree nuts, shell fish, penicillin. Patient had covid-19 prior vaccination. The patient's concomitant medications were not reported. Patient did not receive other vaccine in four weeks. The patient experienced some injection site pain and arm soreness, patient had no side effects for the first day. Two days after vaccinated, started debilitating muscle aches and pains in forearms, shoulders, abdomen, quadriceps, and calves. Also had some minor joint pain and swollen lymph nodes under both arms, patient noted fatigue and exercise intolerance since injection on an unspecified date. Resulted in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. The patient was covid tested post vaccination. The patient underwent lab tests and procedures which included sars-cov-1 test (Nasal Swab) unknown on 26Feb2021, result was pending. Patient did not receive treatment for the events. The outcome of the events was recovering.  No follow-up attempts are possible. No further information is expected.
Age: 29.0
Sex: M
Vaccine: COVID19
Symptoms: Pain in extremity, SARS-CoV-1 test, Vaccination site pain
Clinical narrative: injection site pain; arm soreness; muscle aches; pains in forearms,shoulders, abdomen, quadriceps, and calves.; minor joint pain; swollen lymph nodes under both arms.; fatigue; exercise intolerance; This is a spontaneous report from a contactable physician. A 29-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Formulation: Solution for injection, Lot number: EL9264, Expiration Date: not reported) via intramuscular, administered in left arm on an unspecified date as dose 2, single for COVID-19 immunization at the age of 29-year-old. Patient previously took BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Formulation: Solution for injection, Lot number: EN5318, Expiration Date: not reported) via intramuscular, administered in left arm on 29Jan2021 as dose 1, single for COVID-19 immunization. Medical history included known allergies to tree nuts, shell fish, penicillin. Patient had covid-19 prior vaccination. The patient's concomitant medications were not reported. Patient did not receive other vaccine in four weeks. The patient experienced some injection site pain and arm soreness, patient had no side effects for the first day. Two days after vaccinated, started debilitating muscle aches and pains in forearms, shoulders, abdomen, quadriceps, and calves. Also had some minor joint pain and swollen lymph nodes under both arms, patient noted fatigue and exercise intolerance since injection on an unspecified date. Resulted in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. The patient was covid tested post vaccination. The patient underwent lab tests and procedures which included sars-cov-1 test (Nasal Swab) unknown on 26Feb2021, result was pending. Patient did not receive treatment for the events. The outcome of the events was recovering.  No follow-up attempts are possible. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Heart rate increased, Hypersensitivity, Nervousness, Presyncope
Clinical narrative: almost fainted; dizzy; was also very shaky; her heart beating really fast; having other symptoms that she don't know if they may be an allergic reaction; This is a spontaneous report from a contactable consumer (Patient herself). A 42 (unspecified unit) old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection) via an unspecified route of administration on 25Feb2021 (Batch/Lot number was not reported) as DOSE 2, SINGLE for covid-19 immunisation. The patient's medical history was not reported. The patient's concomitant medications were not reported. Patient stated that she received her second COVID-19 vaccine and experienced some other side effects. she does have some medication allergies and allergic to one of the vaccines. After 1 hour of taking the vaccine she was dizzy and almost fainted twice; again after one and half hour later of taking the vaccine she got really dizzy. It happened 2 times right after the vaccine. She said she was also very shaky and her heart beating really fast, now as well. Patient wanted to know if they were allergic reactions. Reporter said she got the second dose of the vaccine yesterday. Outcome of the events was unknown.   No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Body temperature, Chills, Headache, Influenza like illness
Clinical narrative: chills; didn't sleep good last night; sore shoulder; Achy; flu like symptoms; muscle aches; fever; little bit of a headache; This is a spontaneous report from a contactable consumer or other non-hcp (Patient). A 69-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: solution for injection; Lot Number: EN8202; Expiration Date: 30Jun2021) via an unspecified route of administration (age at vaccination 69-year) in arm left on 23Feb2021 as dose 1, 0.3 ml single for COVID-19 immunization. Medical history reported none. There were no concomitant medications. On 26Feb2021 the patient experienced flu like symptoms, muscle aches, fever, little bit of a headache, didn't sleep good last night, achy; on an unspecified date the patient experienced sore shoulder, chills, and didn't sleep good last night. The patient underwent lab tests and procedures which included body temperature: 99.9 on an unspecified date. As reported "the symptoms started this morning when the patient woke up, she didn't sleep good last night, she has a sore shoulder. When the patient got up, she had these other symptoms. The patient has taken some Tylenol, but the Tylenol hasn't had time to kick in. Question asked by the patient if she could get her second dose of the vaccine given that she had these side effects post vaccination. She was scheduled to receive the second dose of the vaccine 3 weeks after dose 1. If she wants to change her appointment date how far she could extend it." Therapeutic measures were taken as a result of sore shoulder, the patient was treated with Tylenol. The clinical outcome of the event flu like symptoms, muscle aches, fever, achy, was not resolved; outcome of little bit of a headache was resolving; while the outcome of other events was unknown.  No follow-up attempts are possible. No further information is expected.
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Myalgia, Pain, Pyrexia, Sleep disorder
Clinical narrative: chills; didn't sleep good last night; sore shoulder; Achy; flu like symptoms; muscle aches; fever; little bit of a headache; This is a spontaneous report from a contactable consumer or other non-hcp (Patient). A 69-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: solution for injection; Lot Number: EN8202; Expiration Date: 30Jun2021) via an unspecified route of administration (age at vaccination 69-year) in arm left on 23Feb2021 as dose 1, 0.3 ml single for COVID-19 immunization. Medical history reported none. There were no concomitant medications. On 26Feb2021 the patient experienced flu like symptoms, muscle aches, fever, little bit of a headache, didn't sleep good last night, achy; on an unspecified date the patient experienced sore shoulder, chills, and didn't sleep good last night. The patient underwent lab tests and procedures which included body temperature: 99.9 on an unspecified date. As reported "the symptoms started this morning when the patient woke up, she didn't sleep good last night, she has a sore shoulder. When the patient got up, she had these other symptoms. The patient has taken some Tylenol, but the Tylenol hasn't had time to kick in. Question asked by the patient if she could get her second dose of the vaccine given that she had these side effects post vaccination. She was scheduled to receive the second dose of the vaccine 3 weeks after dose 1. If she wants to change her appointment date how far she could extend it." Therapeutic measures were taken as a result of sore shoulder, the patient was treated with Tylenol. The clinical outcome of the event flu like symptoms, muscle aches, fever, achy, was not resolved; outcome of little bit of a headache was resolving; while the outcome of other events was unknown.  No follow-up attempts are possible. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Pruritus
Clinical narrative: arm is slightly itchy and scratching; there's a pinkish area approximately an inch in diameter; This is a spontaneous report from a contactable consumer or other non hcp. This (Age:90; unit: Unknown) female consumer reported that the patient received the  bnt162b2 ((PFIZER-BIONTECH COVID -19 VACCINE, Injection for injection, dose 1 at an unspecified date (Batch/Lot number was not reported, expiry date: unknown) as SINGLE DOSE for covid-19 immunization on Wednesday (age at vaccination: 90 (unit not specified)). The patient medical history was not reported. The patient's concomitant medications were not reported. The patient experienced arm is slightly itchy and scratching (pruritus) on an unspecified date, there's a pinkish area approximately an inch in diameter (erythema) on an unspecified date. The outcome of all events was reported as unknown.  Follow-up attempts completed. No further information expected.
Sex: F
Vaccine: COVID19
Symptoms: Formication, Joint stiffness, Myalgia, Rash pruritic
Clinical narrative: skin crawling feeling; joint stiffness; itchy rash on leg and skin crawling and itchiness for the next 24 hours; myaelgia; This is a spontaneous report from a contactable consumer (patient). A female patient of an unspecified age received first dose of bnt162b2 (BNT162B2, PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection, batch/lot number: EL9265, expiration date: not reported) via an unspecified route of administration on 03Feb2021 as DOSE 1, SINGLE for COVID-19 immunisation. Consumer stated, "I needed to talk to a medical professional at Pfizer. I am of age 60 (not clarified), I have had the first Covid vaccine. I do have rheumatoid arthritis and long history of allergies to many things. So, I do have like immune problems to begin with. The patient's concomitant medications were not reported. But, not immediately, not within the first 30 minutes, but I had it in first hour or hour and a half, after my first shot, I got a small rash on my leg probably like four inches in diameter, it itched. So, I put some prescription strength Cortisone cream on it and it went away. But then for the next 24 hours, I did not have any like I would say rash but I had severe skin itching like skin crawling feeling. So, what I need to know was, I am looking at the CDC guidelines for what you guys classify an allergic reaction and there was a start of a grey area. It was reported that the patient experienced skin crawling feeling, itchy rash on leg and skin crawling and itchiness for the next 24 hours, myalgia, joint stiffness on an unspecified date. The outcome of the events was unknown.   No follow-up attempts are possible. No further information was expected.
Age: 75.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Decreased appetite, Diarrhoea, Fatigue, Headache
Clinical narrative: feels rotten/feeling so rotten; running a temperature; both arms are hurting; headache; so tired; diarrhea; loss of appetite; This is a spontaneous report from a contactable consumer (patient) reported for herself. A 75-Year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number: EN9581, Expiry date, NDC number: unknown) via an unspecified route of administration, administered in left arm on 25Feb2021 (age at vaccination was 75 years) as dose 2, single for COVID-19 immunisation. The patient medical history includes congestive heart failure on an unspecified date in Aug2018, unknown and unknown if ongoing and rheumatoid arthritis, diagnosed 10 years; both were from an unknown date and unknown if ongoing. Concomitant medications were not reported. Historical vaccine includes first dose of BNT162B2 (Lot Number: unknown) in left arm on 04Feb2021 (age at vaccination was 75 years) for COVID-19 immunisation. On 25Feb2021, the patient was feeling so rotten this morning and was running a temperature, wants to know could this be normal, states patient was miserable last night, that the injection was in the left arm and both arms was hurting, states patient couldn't sleep on either side and developed a headache, her temperature this morning around 9 AM 99.8 degrees F. Also feels so tired and experienced loss of appetite. Had some diarrhea last night before bed, not bothering her this morning. The patient treated her symptoms with Tylenol, that her temperature went from 99.8 degrees to 88.8 degrees F after the Tylenol. The patient was asking are these are common side effects. No investigation assessment. Outcome of the event diarrhea was resolving, events feels rotten/feeling so rotten and loss of appetite were unknown and remaining events were not resolved.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Age: 75.0
Sex: F
Vaccine: COVID19
Symptoms: Malaise, Pain in extremity, Pyrexia
Clinical narrative: feels rotten/feeling so rotten; running a temperature; both arms are hurting; headache; so tired; diarrhea; loss of appetite; This is a spontaneous report from a contactable consumer (patient) reported for herself. A 75-Year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number: EN9581, Expiry date, NDC number: unknown) via an unspecified route of administration, administered in left arm on 25Feb2021 (age at vaccination was 75 years) as dose 2, single for COVID-19 immunisation. The patient medical history includes congestive heart failure on an unspecified date in Aug2018, unknown and unknown if ongoing and rheumatoid arthritis, diagnosed 10 years; both were from an unknown date and unknown if ongoing. Concomitant medications were not reported. Historical vaccine includes first dose of BNT162B2 (Lot Number: unknown) in left arm on 04Feb2021 (age at vaccination was 75 years) for COVID-19 immunisation. On 25Feb2021, the patient was feeling so rotten this morning and was running a temperature, wants to know could this be normal, states patient was miserable last night, that the injection was in the left arm and both arms was hurting, states patient couldn't sleep on either side and developed a headache, her temperature this morning around 9 AM 99.8 degrees F. Also feels so tired and experienced loss of appetite. Had some diarrhea last night before bed, not bothering her this morning. The patient treated her symptoms with Tylenol, that her temperature went from 99.8 degrees to 88.8 degrees F after the Tylenol. The patient was asking are these are common side effects. No investigation assessment. Outcome of the event diarrhea was resolving, events feels rotten/feeling so rotten and loss of appetite were unknown and remaining events were not resolved.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Nausea, Pruritus, Pyrexia, Rash
Clinical narrative: Rash all over the body - chest, abdomen, breast, upper legs and arms, shoulders; Itching; Chills; Fever; Nausea; This is a spontaneous report from a contactable nurse (patient). A 73-years-old female patient received second dose of bnt162b2 (BNT162B2, solution for injection), via an unspecified route of administration, administered in arm left on 20Feb2021 16:00 (Batch/Lot number was not reported) (at the age of 73-years-old) as SINGLE for covid-19 immunization. Historical vaccine included received first dose of bnt162b2 (BNT162B2, solution for injection), via an unspecified route of administration, administered in arm left on 23Jan2021 on an unspecified time (Batch/Lot number: E79231) (at the age of 72-years-old) as SINGLE for covid-19 immunization. Patient Medical history included pituitary problems, she had a tumor twice and had radiation and surgery from an unknown date and unknown if ongoing. The patient mentioned a previous reaction to a tetanus vaccine, it had to have been a DPT, when she was a baby. The patient's doctor told her mother to never get her another one. The patient does not have the lot number or expiration for it. Patient denied for any concomitant medications. It was reported that patient had the second dose of the Pfizer Covid vaccine and on the 20th, on the Tuesday after that she started getting a rash over quite a bit of her body and is still there. The patient mentioned the paperwork said that a bad rash all over the body could mean a severe allergic reaction but she has had no difficulty breathing, no swelling of the face, tongue and throat, and no fast heartbeat. On 20Feb2021 4:00, The patient received the shot and by 4:00 in the morning of 21Feb2021 she started getting chills, fever, and nausea. All of those symptoms may have lasted 24 hours, but the patient is not having those symptoms anymore, it is just the rash that is bothering her. The patient knows that the rash was there on Tuesday but it could have been Monday when she had some itching, but she did not look at that time. The patient wanted to knew if she should worry about this and how long would the rash last. The outcome of events for chills, fever, and nausea was recovered on an unspecified date in Feb2021 whereas for Itching it was unknown and for rash all over the body chest, abdomen, breast, upper legs and arms, shoulders outcome of events was not recovered.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Asthenia, Chills, Flushing, Pain
Clinical narrative: weak feeling; joints are also a little achy today.; a little achy as well; a little bit of a drippy nose; felt weird in her arm as she got the injection; face is flushed; sore arm; chills; This is a spontaneous report from a contactable consumer (patient) other non-healthcare professional. A 68-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number: EN6198; Expiry date: 30Jun2021) via an unspecified route of administration, on 25Feb2021, in left arm, as dose 1, single (at the age of 68 year) for covid-19 immunisation. Medical history included covid-19 from 12Feb2021 to an unknown date, headache from Feb2021 to an unknown date, she only had mild symptoms like a headache, Rhinorrhoea from 12Feb2021 to an unknown date, blood pressure and an allergy medicine. Concomitant medications were not reported. On 25Feb2021 the patient experienced sore arm, Chills, face is flushed and from an unspecified date patient had weak feeling, joints are also a little achy today, felt weird in her arm as she got the injection, little achy as well, a little bit of a drippy nose. On 15Feb2021 the patient underwent lab tests and procedures which included sars-cov-2 test: positive. Treatment was taken for face is flushed with Ibuprofen. Patient was asking that what's Pfizer statement regarding researchers saying Pfizer-BioNTech COVID-19 Vaccine's second dose can be delayed as first dose is highly effective. The clinical outcome of all events was unknown.  No follow-up attempts are possible. No further information is expected.
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity, Rhinorrhoea, SARS-CoV-2 test, Vaccination site discomfort
Clinical narrative: weak feeling; joints are also a little achy today.; a little achy as well; a little bit of a drippy nose; felt weird in her arm as she got the injection; face is flushed; sore arm; chills; This is a spontaneous report from a contactable consumer (patient) other non-healthcare professional. A 68-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number: EN6198; Expiry date: 30Jun2021) via an unspecified route of administration, on 25Feb2021, in left arm, as dose 1, single (at the age of 68 year) for covid-19 immunisation. Medical history included covid-19 from 12Feb2021 to an unknown date, headache from Feb2021 to an unknown date, she only had mild symptoms like a headache, Rhinorrhoea from 12Feb2021 to an unknown date, blood pressure and an allergy medicine. Concomitant medications were not reported. On 25Feb2021 the patient experienced sore arm, Chills, face is flushed and from an unspecified date patient had weak feeling, joints are also a little achy today, felt weird in her arm as she got the injection, little achy as well, a little bit of a drippy nose. On 15Feb2021 the patient underwent lab tests and procedures which included sars-cov-2 test: positive. Treatment was taken for face is flushed with Ibuprofen. Patient was asking that what's Pfizer statement regarding researchers saying Pfizer-BioNTech COVID-19 Vaccine's second dose can be delayed as first dose is highly effective. The clinical outcome of all events was unknown.  No follow-up attempts are possible. No further information is expected.
Age: 46.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Eye irritation, Headache, Nausea, Pain in extremity
Clinical narrative: burning eyes; fever; headache; lighthead; nausea; strong pain in the arm; This is a spontaneous report from a contactable consumer or other non-healthcare professional. A 46- year-old non-pregnant female patient (not pregnant at the time of vaccination) received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection, Batch/lot number was not reported) via an unspecified route of administration on 25Feb2021 at 04:30 PM (46-year-old at the time of vaccination) at a dose number unknown, single for covid-19 immunization. The patient medical history was not reported. The patient previously took Amoxicillin (AMOXICILLIN) and experienced allergies. The patient's concomitant medications were not reported. The patient had not received any vaccine within four weeks. The patient had no covid prior to vaccination. The patient was not tested since vaccination. On 25Feb2021 06:00 PM, the patient experienced fever, headache, light head, burning eyes, nausea and strong pain in the arm. No treatment received for the events. The outcome of the events were recovering.   Information about lot/batch number has been requested.   Follow-up: Follow-up attempts completed. No further information expected.
Age: 46.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: burning eyes; fever; headache; lighthead; nausea; strong pain in the arm; This is a spontaneous report from a contactable consumer or other non-healthcare professional. A 46- year-old non-pregnant female patient (not pregnant at the time of vaccination) received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection, Batch/lot number was not reported) via an unspecified route of administration on 25Feb2021 at 04:30 PM (46-year-old at the time of vaccination) at a dose number unknown, single for covid-19 immunization. The patient medical history was not reported. The patient previously took Amoxicillin (AMOXICILLIN) and experienced allergies. The patient's concomitant medications were not reported. The patient had not received any vaccine within four weeks. The patient had no covid prior to vaccination. The patient was not tested since vaccination. On 25Feb2021 06:00 PM, the patient experienced fever, headache, light head, burning eyes, nausea and strong pain in the arm. No treatment received for the events. The outcome of the events were recovering.   Information about lot/batch number has been requested.   Follow-up: Follow-up attempts completed. No further information expected.
Sex: M
Vaccine: COVID19
Symptoms: Illness
Clinical narrative: sick; This is a spontaneous report from a contactable consumer or other non-HCP (patient wife) via Pfizer-sponsored program. A male patient of an unspecified age received BNT162b2 (PFIZER BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot number- UNKNOWN) via an unspecified route of administration on 28Jan2021 as dose 1, single for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient experienced sick (reported as he has to go to the hospital) on an unspecified date. He got his 1st dose on 28Jan2021. She wants to know if he will now have to revaccinate since he was going to miss the 2nd dose. The outcome of the event was unknown.  Follow-up attempts are completed. No further information is expected.
Age: 80.0
Sex: M
Vaccine: COVID19
Symptoms: Asthenia, Decreased appetite, Malaise, Nausea, Rash
Clinical narrative: This is a spontaneous report from a contactable consumer (patient's spouse). An 80-year-old male patient (husband) received the first dose of BNT162B2 (PFIZER BIONTECH COVID-19 VACCINE) via an unspecified route of administration, administered in left arm on 19Feb2021 (batch/lot number: EN9581) at 80 years old, as SINGLE DOSE for COVID-19 immunization (also reported as "because of the age, he didn't want to get COVID"). The patient's medical history included ongoing blood pressure high diagnosed years ago; cholesterol (blood cholesterol abnormal) from an unknown date; and leg amputation on an unknown date in 2020, reported as "one year ago." Concomitant medications included atorvastatin (ATORVASTATIN) taken for blood cholesterol (blood cholesterol abnormal) from an unspecified start date and ongoing; acetylsalicylic acid (ASPIRIN) taken for a long time, carvedilol (CARVEDILOL), clopidogrel (CLOPIDOGREL), fenofibrate (FENOFIBRATE),isosorbide (ISOSORBIDE), lisinopril (LISINOPRIL), and spironolactone (SPIRONOLACTONE), all taken for an unspecified indication, from an unspecified start date and ongoing. It was reported that the patient took the Pfizer shot (clarified as Covid vaccine) on Friday, 19Feb2021 and then, that night, he broke out a little rash. The reporter gave the patient some Benadryl 25mg tablet and it cleared up and went away. On 20Feb2021, Saturday, patient felt okay. Then, Sunday (21Feb2021) this morning he woke up and was nauseous/ feeling nausea. He has been having nausea all day on Sunday. He had been throwing up on and off all day. The reporter gave the patient a nausea pill (unspecified medication), Ginger ale (also reported as "Gingerol"), and crackers but it kept coming, his stomach was not settled. The reporter asked, "what should I do?" He has stopped the throwing up, but the reporter wanted to know what else they can do to get him back up to speed. It was further reported that the patient was queasy and doesn't really have an appetite since an unspecified date in Feb2021. The reporter had been giving him fluids and they all stayed down, and he has not had an episode since Sunday. But he still feels weak after throwing up all day. So, the reporter asked, "was there anything special I need to do?" The patient stopped throwing up and nausea, but he still doesn't feel good. Then reporter stated that the patient still had nausea, but he was not throwing up, it stopped yesterday on 22Feb2021. Nausea is about the same. Rashes stopped. When he threw up all day Sunday, he has been drinking water and liquids. Therapeutic measures were taken as a result of the events rash, nauseous/ feeling nausea/ stomach was not settled/ queasy, and throwing up. The patient recovered from the event rash on an unspecified date in Feb2021 and recovered from the event throwing up on 22Feb2021; has not recovered from the event nauseous/ feeling nausea/ stomach was not settled/ queasy. Outcome of the other events was unknown. No follow-up attempts are possible. No further information is expected.
Age: 80.0
Sex: M
Vaccine: COVID19
Symptoms: Vomiting
Clinical narrative: This is a spontaneous report from a contactable consumer (patient's spouse). An 80-year-old male patient (husband) received the first dose of BNT162B2 (PFIZER BIONTECH COVID-19 VACCINE) via an unspecified route of administration, administered in left arm on 19Feb2021 (batch/lot number: EN9581) at 80 years old, as SINGLE DOSE for COVID-19 immunization (also reported as "because of the age, he didn't want to get COVID"). The patient's medical history included ongoing blood pressure high diagnosed years ago; cholesterol (blood cholesterol abnormal) from an unknown date; and leg amputation on an unknown date in 2020, reported as "one year ago." Concomitant medications included atorvastatin (ATORVASTATIN) taken for blood cholesterol (blood cholesterol abnormal) from an unspecified start date and ongoing; acetylsalicylic acid (ASPIRIN) taken for a long time, carvedilol (CARVEDILOL), clopidogrel (CLOPIDOGREL), fenofibrate (FENOFIBRATE),isosorbide (ISOSORBIDE), lisinopril (LISINOPRIL), and spironolactone (SPIRONOLACTONE), all taken for an unspecified indication, from an unspecified start date and ongoing. It was reported that the patient took the Pfizer shot (clarified as Covid vaccine) on Friday, 19Feb2021 and then, that night, he broke out a little rash. The reporter gave the patient some Benadryl 25mg tablet and it cleared up and went away. On 20Feb2021, Saturday, patient felt okay. Then, Sunday (21Feb2021) this morning he woke up and was nauseous/ feeling nausea. He has been having nausea all day on Sunday. He had been throwing up on and off all day. The reporter gave the patient a nausea pill (unspecified medication), Ginger ale (also reported as "Gingerol"), and crackers but it kept coming, his stomach was not settled. The reporter asked, "what should I do?" He has stopped the throwing up, but the reporter wanted to know what else they can do to get him back up to speed. It was further reported that the patient was queasy and doesn't really have an appetite since an unspecified date in Feb2021. The reporter had been giving him fluids and they all stayed down, and he has not had an episode since Sunday. But he still feels weak after throwing up all day. So, the reporter asked, "was there anything special I need to do?" The patient stopped throwing up and nausea, but he still doesn't feel good. Then reporter stated that the patient still had nausea, but he was not throwing up, it stopped yesterday on 22Feb2021. Nausea is about the same. Rashes stopped. When he threw up all day Sunday, he has been drinking water and liquids. Therapeutic measures were taken as a result of the events rash, nauseous/ feeling nausea/ stomach was not settled/ queasy, and throwing up. The patient recovered from the event rash on an unspecified date in Feb2021 and recovered from the event throwing up on 22Feb2021; has not recovered from the event nauseous/ feeling nausea/ stomach was not settled/ queasy. Outcome of the other events was unknown. No follow-up attempts are possible. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity, Skin exfoliation
Clinical narrative: Her sister reported that on the 5th day she got a tremendous pain in her arm where she got the Pfizer COVID-19 Vaccine shot; Is almost like the flesh is being sucked underneath the titanium plate, there is like no blood or anything but there is a hole; This is a spontaneous report from a contactable consumer. This is report 2 of 2. A female patient of an unspecified age received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number was not reported, Expiry date: unknown), via an unspecified route of administration on an unspecified date as single dose for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. Her sister reported that on the 5th day, the patient experienced a tremendous pain in her arm where she got the Pfizer covid-19 vaccine shot, was almost like the flesh was being sucked underneath the titanium plate, there was like no blood or anything but there was a hole on an unspecified date. The outcome of the events was unknown.  Follow-up attempts are completed. No further information is expected.
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Anosmia, Arthralgia, Body temperature, Feeling abnormal, Glycosylated haemoglobin
Clinical narrative: body aches; hips were hurting; lost the sense of smell; pressure behind her eyes; stuffy nose; Headache; sore arm; felt a little feverish/It was a little elevated; feel as bad as she did; This is a spontaneous report from a contactable consumer (patient) via Medical information team. A 57-year-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number: EN6200), via an unspecified route of administration, administered in Arm Left on 18Feb2021 16:00 (age at the vaccination 57-year-old) as DOSE 1, SINGLE for covid-19 immunisation. Medical history included type 2 diabetes mellitus from Jul2020 to an unknown date and high blood pressure. Concomitant medications included metformin and metoprolol for high blood pressure. Patient had the Pfizer shot on 18Feb2021 which was last Thursday. The next day, 19Feb2021, she had a sore arm. Since patient developed stuffy nose and headache on 21Feb2021, body aches on 25Feb2021, lost sense of smell on 24Feb2021, patient also had pressure behind the eyes on 23Feb2021, patient felt a little feverish, but it did not register as a fever on an unspecified date in Feb2021. It was a little elevated. on day seven she had body aches. Specifically, both hips were hurting on 25Feb2021 It was achy like she had stretched too much. Today she feels a little better. Patient still has stuffiness, body aches, and still cannot smell. She does not feel as bad as she did on an unspecified date in Feb2021. Therapeutic measures were taken as a result of all events. The patient underwent lab tests and procedures which included feverish: little elevated on Feb2021, glycosylated haemoglobin (A1C): in the fives (numbers have been pretty good. A1C is in the fives), weight: about 160 lbs on an unspecified date. The outcome of the events stuffy nose, lost the sense of smell, body aches were not recovered, hips were hurting and feel as bad as she did was recovering and unknown for another events.  No follow-up attempts are possible. No further information is expected.