chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: COVID19
Symptoms: Hypersensitivity, Rash macular, Vaccination site erythema, Vaccination site mass, Vaccination site pain
Clinical narrative: Red spot; Non-severe allergic reactions to the vaccine; Little bit bump; Little itchy; Pain, a little bit red on the injection site; little bit red on the injection site; She had a little bit pain; This is a spontaneous report received from a contactable consumer (patient). A 48-years-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection, lot number: EW0168) via an unspecified route of administration, on 26Jul2021 as DOSE 1, SINGLE for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. Caller stated, she had her 1st dose of the vaccine on Monday (26Jul2021) and yesterday she experienced some side effects which were not severe. According to caller, there was a little itchy, little bump, pain, a little bit red on the injection site, but today it was not much itchy, she wants to know if she should get the 2nd dose of the vaccine which was scheduled on 16Aug2021. States the 1st day she had a little bit pain on Jul2021, non-severe allergic reactions to the vaccine and red spot on unknown date. Caller was asking why it needed to get the 2nd dose of the vaccine, was the 1st dose of the Pfizer Covid19 vaccine not enough for her to be protected. Caller stated she has a question, she was a little concerned. States she got the 1st dose of the Pfizer 2 days before and the same day she did not had any problems. Caller stated that yesterday she was a little itchy, a had little bit bump and a little ride up. States in this situation can she still had the 2nd dose that was scheduled on 16Aug2021. States she wanted to make sure she can had the 2nd dose or see if she needs to go back to the place she took the shot and show them to see if she was ok for the 2nd dose. Caller declines to make a report. States this was not a severe problem. Caller relays that her son took the same shot and she did not see anything and he was a little itchy but like a bump up now the 2nd day he was a little itchy. Caller states she has lighter skin and he has darker skin. States she was not so much itchy and at night time she took off her clothes and was a little bit red, did not feel itchy and did not feel pain. States the 2nd day she had pain and itchy and the bump and today it was getting better, she has no pain, no itching and the red spot was still there. Caller states it was not a severe problem she just concerned about the 2nd dose, it was a little bit reaction on her arm at the spot and she was not sure for the 2nd shot or if she needs to go back to where she got it and show them. Caller states she does not had any information about the name of the shot, that she did not ask any questions. The outcome of the events itchy, vaccination site pain, vaccination site erythema, was reported as recovered in Jul2021 and pain, allergic reaction was unknown and event red spotty rash was not recovered and vaccination site mass was recovering.  Follow-up attempts are completed. No further information was expected.
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pruritus
Clinical narrative: Red spot; Non-severe allergic reactions to the vaccine; Little bit bump; Little itchy; Pain, a little bit red on the injection site; little bit red on the injection site; She had a little bit pain; This is a spontaneous report received from a contactable consumer (patient). A 48-years-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection, lot number: EW0168) via an unspecified route of administration, on 26Jul2021 as DOSE 1, SINGLE for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. Caller stated, she had her 1st dose of the vaccine on Monday (26Jul2021) and yesterday she experienced some side effects which were not severe. According to caller, there was a little itchy, little bump, pain, a little bit red on the injection site, but today it was not much itchy, she wants to know if she should get the 2nd dose of the vaccine which was scheduled on 16Aug2021. States the 1st day she had a little bit pain on Jul2021, non-severe allergic reactions to the vaccine and red spot on unknown date. Caller was asking why it needed to get the 2nd dose of the vaccine, was the 1st dose of the Pfizer Covid19 vaccine not enough for her to be protected. Caller stated she has a question, she was a little concerned. States she got the 1st dose of the Pfizer 2 days before and the same day she did not had any problems. Caller stated that yesterday she was a little itchy, a had little bit bump and a little ride up. States in this situation can she still had the 2nd dose that was scheduled on 16Aug2021. States she wanted to make sure she can had the 2nd dose or see if she needs to go back to the place she took the shot and show them to see if she was ok for the 2nd dose. Caller declines to make a report. States this was not a severe problem. Caller relays that her son took the same shot and she did not see anything and he was a little itchy but like a bump up now the 2nd day he was a little itchy. Caller states she has lighter skin and he has darker skin. States she was not so much itchy and at night time she took off her clothes and was a little bit red, did not feel itchy and did not feel pain. States the 2nd day she had pain and itchy and the bump and today it was getting better, she has no pain, no itching and the red spot was still there. Caller states it was not a severe problem she just concerned about the 2nd dose, it was a little bit reaction on her arm at the spot and she was not sure for the 2nd shot or if she needs to go back to where she got it and show them. Caller states she does not had any information about the name of the shot, that she did not ask any questions. The outcome of the events itchy, vaccination site pain, vaccination site erythema, was reported as recovered in Jul2021 and pain, allergic reaction was unknown and event red spotty rash was not recovered and vaccination site mass was recovering.  Follow-up attempts are completed. No further information was expected.
Sex: U
Vaccine: COVID19
Symptoms: Appendicitis
Clinical narrative: appendicitis; This is a spontaneous report from a contactable consumer. This consumer reported similar events for three patients. This is one of three reports. A patient of unspecified age and gender received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 04May2021 (lot number Rx261443606215) as single dose for COVID-19 immunization. Medical history and concomitant medications were not reported. Historical Vaccine included first dose of BNT162B2 on 04May2021 (lot number Rx259586906215) for COVID-19 immunization. The patient experienced appendicitis on 20May2021 which caused hospitalization. Surgical treatment received for the event included appendectomy. The outcome of the event was resolved on 20May2021.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202100963152 same product and event, different patient;US-PFIZER INC-2021599448 same product and event, different patient
Sex: U
Vaccine: COVID19
Symptoms: Appendicitis
Clinical narrative: appendicitis; This is a spontaneous report from a contactable consumer. A patient of unspecified age and gender received BNT162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), dose 2 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. The patient experienced appendicitis on an unspecified date. As reported, the reporter stated that 'I have never been to the hospital for medical issues. I had 2 friends call me to let me know of same experience of appendectomy within 2 weeks of 2nd vaccine'. Therapeutic measures were taken as a result of appendicitis. The outcome of the event was unknown.   The lot number for the vaccine, BNT162b2, was not provided and will be requested during follow up.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202100963151
Age: 40.0
Sex: F
Vaccine: COVID19
Symptoms: Cognitive disorder, Memory impairment, Mental impairment
Clinical narrative: Mental dullness; impaired cognitive function; usually has no trouble remembering things, now has to write them down or can't recall them; This is a spontaneous report from a non-contactable other healthcare professional (patient). A 40-year-old female patient received BNT162B2, via an unspecified route of administration, administered in arm left on 22Jun2021 (Batch/Lot Number: Ew0196) at the age of 40 years old as dose 1, single for COVID-19 immunisation. The patient was not pregnancy at time of vaccination. The patient's medical history and concomitant medications were not reported. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19 and since the vaccination, has not been tested for COVID-19. The patient experienced mental dullness and impaired cognitive function that started 2 days after the vaccine (on 24Jun2021) and lasted for 24 hours. To the point where patient was scared to drive her car. She still feels off frankly as she is a health professional and usually has no trouble remembering things and now has to write them down or can't recall them. No hospitalization prolonged and no treatment for adverse events. Outcome of events were recovered with sequelae.  No follow-up attempts are possible. No further information is expected.; Sender's Comments: Based on the information in the case report and a positive temporal relationship, a possible causal relationship between events mental impairment and suspect drug BNT162B2 cannot be excluded.  The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
Sex: U
Vaccine: COVID19
Symptoms: Dry eye, Dyschromatopsia, Eye inflammation, Night blindness, Visual impairment
Clinical narrative: eye inflammation; dry eyes; dim vision; the way I see colors is different; my vision at night is terrible; This is a spontaneous report from a contactable consumer received from marketing program Epsilon.    A  patient of an unspecified gender and age reported that received first dose of  BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot number unknown), on unknown date at single dose for COVID-19 immunization. Medical history and concomitant drugs were unknown.  The patient has developed eye problems one week after she took the first shot of Pfizer vaccine. The patient has had eye inflammation and dry eyes and now dim vision and the way the patient sees colors was different. The patient went to three different eye doctors and they don't know why she was having these issues. The patient's  vision at night is terrible and colors seem darker. The outcome of the events was unknown.  Information about lot/batch number has been requested.
Sex: F
Vaccine: COVID19
Symptoms: Therapeutic response unexpected
Clinical narrative: Patients got her period 2 days after receiving her second COVID vaccine. She had not had her period since Feb2021; This is a spontaneous report from a contactable pharmacist. A female patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 2 via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient got her period 2 days after receiving her second vaccine. She has not had her period since Feb2021. Outcome of the event was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 49.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal pain, Dyspnoea, Swollen tongue
Clinical narrative: Shortness of breath; Tongue swelling; Abdominal pain; This is a spontaneous report from a contactable consumer (patient). A 49-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/Lot Number: EWO178), via an unspecified route of administration, administered in left arm on 01Jun2021 10:30 (at the age of 49 years old) as dose 1, single for COVID-19 immunisation. Medical history included asthma, crohn's disease (reported as "Conhns") and Psoriasis. The patient is not pregnant at the time of vaccination. Concomitant medications included cetirizine hydrochloride (ZYRTEC); fluticasone propionate, salmeterol xinafoate (ADVAIR); inositol; azelastine hydrochloride (ASTELIN); mometasone furoate (NASONEX) and salbutamol (ALBUTEROL). The patient did not take any other vaccine in four weeks. The patient has not had COVID prior to vaccination. The patient experienced shortness of breath, tongue swelling and abdominal pain on 01Jun2021 15:00. The events resulted in Doctor or other healthcare professional office/clinic visit and Emergency room/department or urgent care. Therapeutic measures were taken as a result of the events which included Benadryl, Epipen and prednisone. The patient was not tested for COVID post vaccination. The outcome of the events was unknown. The reporter assessed the events as non-serious.   No follow-up attempts are possible. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: X-ray
Clinical narrative: severe diarrhea; sharp pain in lower back; tired more than usual; very little arm pain/soreness in her arm; sleepiness; exhausted; This is a spontaneous report received from a contactable consumer, the patient.   A 62-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, formulation: Solution for injection, Batch/Lot number unknown), via an unspecified route of administration in Arm on an unspecified date in 2021 as DOSE 2, SINGLE for COVID-19 immunization. Medical history and concomitant medications were not reported. Patient previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, formulation: Solution for injection, Batch/Lot number unknown), via an unspecified route of administration in Arm on an unspecified date in 2021 as DOSE 1, SINGLE for COVID-19 immunization and flipped out after her first. It was reported that some had the typical side effects, but the severe side effects the patient had, the patient had some kind of sharp pain in her lower back. The back pain was strange, it was not ongoing, but came on suddenly, acutely. The patient was at the hospital from 5:30 to 6pm on about, it would have been 27Mar2021, the patient got the vaccine later in the day, it was more than 24 hours, but less than 48 hours. The patient went in and was there for 12 hours at least, more than that. The patient got out about 7am the next morning. The lower back pain was sharper and painful, they said it was related to inflammation in lower intestine, which the patient thought was bizarre, as the patient left the ER, another guy was wheeled in with side effects. No further details provided. The patient experienced severe diarrhea on 28Mar2021, it was not ongoing, the patient got out of the ER on Sunday 28Mar2021. The patient had very little arm pain on an unspecified date in 2021, started within 24 hours of the injection, it was minimal for the patient, that lasted for maybe three days at most. The patient experienced sleepiness, no headache within 16 or 17 hours of injection, the patient got it at 11 or 12 in the morning. The next morning at 0400 or 0500, the patient woke up, could not go back to sleep, later that day, the patient wanted to go back, was exhausted, but the patient got up at 0400. The patient was unsure why she woke up and could not sleep, might be other reasons. The patient had concerns about the vaccine. The patient stated that the hope was the vaccine would prevent the patient from getting sick, in short term. The patient also experienced very tired, tired more than normal on an unspecified date in 2021. The patient stated that she was healthy. Patient underwent X-ray which showed inflammation in her lower intestine on an unspecified date in 2021. Outcome of the events tired more than usual, sleepiness and exhausted was unknown. Outcome of the events sharp pain in lower back, severe diarrhea and very little arm pain/soreness in her arm was reported as recovered on an unspecified date in 2021.  The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Anxiety, SARS-CoV-2 test
Clinical narrative: I have had bad anxiety attacks since having the first covid shot; This is a spontaneous report from a contactable consumer. A 50-year-old female patient received bnt162b2 (BNT162B2), via an unspecified route of administration at the age of 50 years old, administered in right arm on 13Jul2021 15:00 (Batch/Lot number was not reported) as dose 1, single for covid-19 immunisation. Medical history included allergies. Concomitant medication included amlodipine. The patient had nasal swab on 16Jul2021 which showed negative result. The patient experienced bad anxiety attacks since having the first covid shot on 19Jul2021. No treatment received. The outcome of the event was not recovered.  Information about lot/batch number has been requested.
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Cataract
Clinical narrative: cataracts, which was told by her doctor as very small and causing no problems prior, had progressed to the point she needed surgery; This is a spontaneous report from a non-contactable consumer (patient herself) via self-reporting portal. A 60-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), via an unspecified route of administration, administered in the left arm on 25Mar2021 at 10:00 at the age of 60 years old (Batch/Lot Number: ER8728, Expiration date: unknown) as dose 1, single for COVID-19 immunization. The facility where the most recent COVID-19 vaccine was administered was a public health clinic/administration facility. Relevant medical history included cataracts, which were very small and causing no problems from an unknown date. The patient's concomitant medications were not reported. The patient was not pregnant at the time of vaccination. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Approximately two weeks after the shot, on an unspecified date in Apr2021, the patient's vision became very blurry to the point that she made an appointment with her eye doctor. The cataracts, which was told by her doctor as very small and causing no problems prior, had progressed to the point she needed surgery. The adverse event did result in a doctor or other healthcare professional office/clinic visit. Therapeutic measures were taken as a result of the event, which included cataract surgery. The patient was recovering from the event.  No follow-up attempts are possible. No further information is expected.
Age: 14.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness
Clinical narrative: Severe dizziness; This is a spontaneous report from a contactable consumer. A 14-year-old female patient (Age at vaccination; 14 Year) received second dose of BNT162B2 (BNT162B2) via an unspecified route of administration, administered in Arm Left on 06Jul2021 at 20:00 (Batch/Lot number was not reported) as DOSE 2, SINGLE for covid-19 immunization. Medical history included Tourettes, depression, anxiety and chronic fatigue syndrome all from unknown dates and unknown if ongoing. Concomitant medications included  ibuprofen (IBUPROFEN), duloxetine (DULOXETINE), fluoxetine (FLUOXETINE) and colecalciferol (VIT D [COLECALCIFEROL]) all taken for unspecified indications, start and stop dates were not reported. The patient received first dose of BNT162B2 on 23Jun2021 to right arm at 12pm. The patient experienced severe dizziness on 07Jul2021 18:00 with outcome of not recovered. No treatment was received for the event. Outcome of the event was not recovered.  The lot number for the vaccine BNT162B2 was not provided and will be requested during follow up.
Age: 41.0
Sex: F
Vaccine: COVID19
Symptoms: Ear pain
Clinical narrative: I'm painful ear ache right ear lasting three days so far; This is a spontaneous report from a non-contactable consumer (patient). A 41-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot Number: not reported), via an unspecified route of administration on an unspecified date (at the age of 41-years-old) as dose number unknown, single for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. On 01Jul2021, patient experienced painful earache in right ear, lasting three days so far. The outcome of the event was not recovered.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Fatigue, Heart rate, Heart rate increased, Illness, Pain
Clinical narrative: feeling aches; sick; tired; heart palpitations; My normal heart rate is between 62-65, but noticed that it elevated to around 75 and palpitations; This is a spontaneous report from a non-contactable consumer, the patient via Pfizer sponsored program. A 66-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection; Batch/Lot Number: Unknown, Expiration date: Unknown) via an unspecified route of administration on 12Mar2021 as DOSE 2, SINGLE for COVID-19 immunization. Medical history and concomitant medications were not reported. Previously, patient received first dose of BNT162B2 on an unspecified date for COVID-19 immunization. After receiving the Pfizer COVID vaccine on 12Mar2021 and hung around for 15 minutes, patient started feeling aches, was tired and sick but not real sick around 10 hours after. Patient felt tired for the next month or 2, for some period of time. Patient had some heart palpitations. His normal heart rate was between 62-65 but noticed that it elevated to around 75 and had palpitations. Went to see cardiologist in April and he did not know if it was caused by the vaccine, the palpitations eventually went away. Patient did not feel that he had an allergic reaction. The clinical outcome of heart palpitations was recovered on an unspecified date, while the outcome of all other events was unknown.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Palpitations
Clinical narrative: feeling aches; sick; tired; heart palpitations; My normal heart rate is between 62-65, but noticed that it elevated to around 75 and palpitations; This is a spontaneous report from a non-contactable consumer, the patient via Pfizer sponsored program. A 66-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection; Batch/Lot Number: Unknown, Expiration date: Unknown) via an unspecified route of administration on 12Mar2021 as DOSE 2, SINGLE for COVID-19 immunization. Medical history and concomitant medications were not reported. Previously, patient received first dose of BNT162B2 on an unspecified date for COVID-19 immunization. After receiving the Pfizer COVID vaccine on 12Mar2021 and hung around for 15 minutes, patient started feeling aches, was tired and sick but not real sick around 10 hours after. Patient felt tired for the next month or 2, for some period of time. Patient had some heart palpitations. His normal heart rate was between 62-65 but noticed that it elevated to around 75 and had palpitations. Went to see cardiologist in April and he did not know if it was caused by the vaccine, the palpitations eventually went away. Patient did not feel that he had an allergic reaction. The clinical outcome of heart palpitations was recovered on an unspecified date, while the outcome of all other events was unknown.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Blood test, Hypoaesthesia
Clinical narrative: I had numbness on my legs; This is a spontaneous report from a contactable consumer (patient). A 65-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection, Lot number: unknown; Expiration date: unknown) via an unspecified route of administration on 10Mar2021 as dose 2, single for covid-19 immunization. The patients medical history included multiple sclerosis (MS) from Nov2020 (diagnosed last November with primary progressive MS). The patients concomitant medications were not provided. The patient previously took first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection, Lot number: Unknown) via an unspecified route of administration on 17Feb2021 as single dose for Covid-19 immunization. On an unspecified date in Mar2021, patient had numbness on his legs after second shot and was just lasted for one day. He had blood test on 14Apr2021 doctor sent an email stated that patient did not develop antibodies to the COVID vaccine. The patient underwent lab tests and procedures which included blood test: antibodies not developed on 14Apr2021 to the COVID vaccine. The outcome of event was recovered on an unspecified date in Mar2021.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 63.0
Sex: M
Vaccine: COVID19
Symptoms: Pain in extremity, Somnolence
Clinical narrative: Sore arm; Sleepy and went to sleep around 7:00PM but then he was fine; This is a spontaneous report from a contactable consumer (reporter's sister) via medical information team. A contactable consumer reported similar events for 3 patients. This is 2 of 3 reports. A 63-years-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot Number: EN6201, Expiration date: Unknown), via an unspecified route of administration in right arm on 26Mar2021 (at the age of 63-years-old) as dose 1, single, and second dose via an unspecified route of administration on 14Apr2021 (at the age of 63-years-old) (Batch/Lot Number: ER8737) as dose 2, single for covid-19 immunisation. Additional vaccines administered on same date of the Pfizer suspect was none. No prior vaccinations were performed within 4 weeks. The weight of the patient was between 135 and 138 lbs. Medical history included ongoing disabled (He's disabled, and he was in the military. He's had to learn to walk again). The patient's concomitant medications were not reported. On an unspecified date of 2021, the patient experienced sore arm and sleepy and went to sleep around 7:00pm but then he was fine. The events did not result in emergency room or physician office. The reporter was asking how long it will be before the third dose or booster shot comes out? Response: As part of Pfizer's and BioNTech's continued efforts to stay ahead of the virus causing COVID-19 and circulating mutations, the companies provided an update on booster dosing on 09Jul2021. Please note that the use of a 3rd or booster dose was not recommended or authorized and Pfizer does not suggest the use of the vaccine in any manner other than as described in the (if US) authorized EUA Prescribing Information authorized product monograph. Initial data from the ongoing study of booster doses demonstrated a consistent tolerability profile and high neutralization titers against the wild-type virus (the naturally occurring non-mutated virus) and the Beta variant. It is thought that the effects seen against the Beta variant may also be seen in the Delta variant. We are doing studies to confirm this. We expect to publish the data soon in a peer-reviewed journal and submit to regulatory authorities like the FDA in the coming weeks. Note to frontline: This FAQ should only be used if an HCP or non-HCP specifically asks about the Pfizer statement on booster doses. The patient has the mind of a young person. She reported her brother would not get the flu vaccine. He won't get any vaccination, but he was watching TV and wanted to get the Covid 19 vaccination. The outcome of the events was recovered on an unspecified date of 2021.  Follow-up attempts are completed. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202100962856 same reporter/product/event, different patient
Age: 15.0
Sex: M
Vaccine: COVID19
Symptoms: Pruritus, Rash
Clinical narrative: Itching; rash; This is a spontaneous report from a contactable consumer. This consumer (patients mother) reported for a 15-year-old male patient (reporters son). The report is cross referenced to report ID: This is Report 2 of 2. A 15-years-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Formulation: Solution for injection; Lot Number and Expiration date was not reported), via an unspecified route of administration, in Left arm on 27Jul2021 15:00 (at the age of 15-year-old) as dose 1, single for covid-19 immunization. The patient medical history reported as none. The patients concomitant medications were not reported. History of all previous immunization with the Pfizer vaccine considered as suspect was reported as none. Additional Vaccines Administered on Same Date of the Pfizer Suspect was reported as none. The patient did not receive any other vaccines within four weeks prior to the vaccination. AE(s) following prior vaccinations, patients medical history (including any illness at time of vaccination) and relevant tests all of these were reported as none. Reporter explained her youngest son, got his shot on 27Jul2021 and was having itching on belly and arm where got shot. The itching on arm and belly started at that night about 8:00. The patient did not visit to the emergency room or physician office. The clinical outcome of events was not recovered.  The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.
Sex: F
Vaccine: COVID19
Symptoms: Illness, Neoplasm malignant
Clinical narrative: dealt with cancer issues; sick; This is a spontaneous report received from a non-contactable consumer (patient) via Pfizer-sponsored program COVAX US Support. A female patient of an unspecified age received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as single dose for covid-19 immunisation. The patient medical history was not reported. There were no concomitant medications. Caller got first dose of the covid vaccine and got sick, dealt with cancer issues. The outcome of the events was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Sex: U
Vaccine: COVID19
Symptoms: Arthralgia, Movement disorder
Clinical narrative: severe pain in shoulders; could not raise hands above elbows; This is a spontaneous report from a contactable consumer (patient). A patient of unspecified age and gender received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), via an unspecified route of administration on Apr2021 (Batch/Lot number was not reported) as dose 1, single for covid-19 immunisation. Medical history included fibromyalgia and chronic lyme disease; both from an unknown date and unknown if ongoing. Patient's concomitant medications were not reported.  After the 1st dose in Apr2021, patient had severe pain in shoulders and could not raise hands above elbows. Outcome of the events was not recovered.   The lot number for the vaccine [BNT162B2] was not provided and will be requested during follow up.
Sex: U
Vaccine: COVID19
Symptoms: Joint swelling, Pain in extremity
Clinical narrative: pain in my arms; swelling in my joints; This is a spontaneous report from a contactable consumer (patient). A patient of unspecified age and gender received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration in May2021 (Batch/Lot number was not reported) as DOSE 2, SINGLE for COVID-19 immunisation.  Medical history included fibromyalgia and Lyme disease; from unknown dates and unknown if ongoing. The patient's concomitant medications were not reported. Historical vaccine included the first dose of BNT162B2 in Apr2021 (Batch/Lot number was not reported) as DOSE 1, SINGLE for COVID-19 immunization and patient experienced severe pain in shoulders and could not raise hands above elbows. On an unspecified dates in May2021, after the second dose, the patient experienced excruciating pain in arms and swelling in joints. It was also reported that patient still had the symptoms of the first dose. The patient reported it had been 3 and 1/2 months and was getting no relief, was getting desperate and needed help. The outcome of the events was not recovered.  The lot number for the vaccine BNT162B2 was not provided and will be requested during follow-up.
Age: 57.0
Sex: M
Vaccine: COVID19
Symptoms: Biopsy, Fatigue, Feeling abnormal, Pain, Pain of skin
Clinical narrative: He has like this red open wounds that bleed and crust over; He has like this red open wounds that bleed and crust over; He has like this red open wounds that bleed and crust over; Patient started with a different kind of rash about one week out from receiving the vaccine; Patient broke out with red angry weeping bloody sores that crust over; He itches like crazy, no pain.; it hurts, it itches and it burns; it hurts, it itches and it burns; At the end of the day we are just exhausted; Really upset; spots all over; This is a spontaneous report from a contactable consumer (patient's wife). A 58-year-old male patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 03May2021 (Batch/Lot number was not reported) (at the age of 57 years old) as single dose for Covid-19 immunisation. The patient medical history was not reported. The first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) was administered on 12Apr2021 (lot number: EW0158) (at the age of 57 years old) for Covid-19 immunization and the patient felt tired. The patient's concomitant medications were not reported.  After the second dose, the patient's wife reported that on an unknown date in 2021, her husband (patient) had like this red open wounds that bleed and crust over, it itches, and at night when he was trying to get to bed, it was so bad and he just wanted to scratch but he can't, that would tear the skin apart and he put these little bandage on that he makes out of toilet paper and tap because it doesn't hug it like a bandage, so it can't breath and it crust over and then if it was getting worse, it was getting more of a (as reported), the husband (patient) was really upset. Patient started with a different kind of rash about one week out from receiving the vaccine. Patient broke out with red angry weeping bloody sores that crust over. He itches like crazy, no pain. It hurts, it itches and it burns, he doesn't have shingles. He had spots all over. At the end of the day they were both just exhausted. The events resulted in physician office visit. The patient was prescribed medicine for the events. The patient had biopsy with unknown result on an unknown date. Outcome of the events was unknown.
Age: 57.0
Sex: M
Vaccine: COVID19
Symptoms: Pruritus, Rash, Rash macular, Scab, Thermal burn
Clinical narrative: He has like this red open wounds that bleed and crust over; He has like this red open wounds that bleed and crust over; He has like this red open wounds that bleed and crust over; Patient started with a different kind of rash about one week out from receiving the vaccine; Patient broke out with red angry weeping bloody sores that crust over; He itches like crazy, no pain.; it hurts, it itches and it burns; it hurts, it itches and it burns; At the end of the day we are just exhausted; Really upset; spots all over; This is a spontaneous report from a contactable consumer (patient's wife). A 58-year-old male patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 03May2021 (Batch/Lot number was not reported) (at the age of 57 years old) as single dose for Covid-19 immunisation. The patient medical history was not reported. The first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) was administered on 12Apr2021 (lot number: EW0158) (at the age of 57 years old) for Covid-19 immunization and the patient felt tired. The patient's concomitant medications were not reported.  After the second dose, the patient's wife reported that on an unknown date in 2021, her husband (patient) had like this red open wounds that bleed and crust over, it itches, and at night when he was trying to get to bed, it was so bad and he just wanted to scratch but he can't, that would tear the skin apart and he put these little bandage on that he makes out of toilet paper and tap because it doesn't hug it like a bandage, so it can't breath and it crust over and then if it was getting worse, it was getting more of a (as reported), the husband (patient) was really upset. Patient started with a different kind of rash about one week out from receiving the vaccine. Patient broke out with red angry weeping bloody sores that crust over. He itches like crazy, no pain. It hurts, it itches and it burns, he doesn't have shingles. He had spots all over. At the end of the day they were both just exhausted. The events resulted in physician office visit. The patient was prescribed medicine for the events. The patient had biopsy with unknown result on an unknown date. Outcome of the events was unknown.
Age: 57.0
Sex: M
Vaccine: COVID19
Symptoms: Wound, Wound haemorrhage
Clinical narrative: He has like this red open wounds that bleed and crust over; He has like this red open wounds that bleed and crust over; He has like this red open wounds that bleed and crust over; Patient started with a different kind of rash about one week out from receiving the vaccine; Patient broke out with red angry weeping bloody sores that crust over; He itches like crazy, no pain.; it hurts, it itches and it burns; it hurts, it itches and it burns; At the end of the day we are just exhausted; Really upset; spots all over; This is a spontaneous report from a contactable consumer (patient's wife). A 58-year-old male patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 03May2021 (Batch/Lot number was not reported) (at the age of 57 years old) as single dose for Covid-19 immunisation. The patient medical history was not reported. The first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) was administered on 12Apr2021 (lot number: EW0158) (at the age of 57 years old) for Covid-19 immunization and the patient felt tired. The patient's concomitant medications were not reported.  After the second dose, the patient's wife reported that on an unknown date in 2021, her husband (patient) had like this red open wounds that bleed and crust over, it itches, and at night when he was trying to get to bed, it was so bad and he just wanted to scratch but he can't, that would tear the skin apart and he put these little bandage on that he makes out of toilet paper and tap because it doesn't hug it like a bandage, so it can't breath and it crust over and then if it was getting worse, it was getting more of a (as reported), the husband (patient) was really upset. Patient started with a different kind of rash about one week out from receiving the vaccine. Patient broke out with red angry weeping bloody sores that crust over. He itches like crazy, no pain. It hurts, it itches and it burns, he doesn't have shingles. He had spots all over. At the end of the day they were both just exhausted. The events resulted in physician office visit. The patient was prescribed medicine for the events. The patient had biopsy with unknown result on an unknown date. Outcome of the events was unknown.
Sex: M
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: sore arm; This is a spontaneous report received from contactable reporter. This reporter reported for a male patient (reporter's son). A male patient of an unspecified age 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 on an unspecified date as dose 1, single for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. On an unspecified date, the patient experienced sore arm after receiving the Pfizer Covid 19 Vaccine. It was reported that consumer and her son got the vaccine and they both had a sore arm, but it has gone away now, only lasted a half of day. They said that was to be expected. The outcome of event was recovered on an unspecified date.
Sex: M
Vaccine: COVID19
Symptoms: Rhinorrhoea, Somnolence
Clinical narrative: runny nose; had to take 2 naps in one day; This is a spontaneous report from a contactable consumer (patient wife) reported for male Patient (reporter husband) via Medical Information Team.   A male patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection, Batch/Lot number and Expiration date was not reported), via an unspecified route of administration on an unspecified date as dose number unknown, single for covid-19 immunisation. The patient medical history and concomitant medications were not reported. On an unspecified date in 2021, the patient experienced runny nose and had to take 2 naps in one day. The outcome of the events was unknown.  Communication: Report 2 of 2. Caller was warm transferred to (name)  Medical inquiry was addressed in Report 1.  The lot number for the vaccine (BNT162B2), was not provided and will be requested during follow up.
Sex: M
Vaccine: COVID19
Symptoms: Frustration tolerance decreased, Loss of personal independence in daily activities, Malaise
Clinical narrative: He cannot work; He is frustrated; out of the sorts lately; This is a spontaneous report from a contactable consumer (patient). A male patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number: unknown), dose 1 via an unspecified route of administration, administered in left arm on 31May2021 single dose and dose 2 via an unspecified route of administration on 23Jun2021 (Batch/Lot number was not reported) as a single dose for covid-19 immunization. Medical history included Heart attack (He clarified the heart attack he suffered occurred before he got the COVID vaccine from unspecified date and unknown if ongoing. He clarified the heart attack was due to taking care of his wife). The patient concomitant medications were not reported. On an unspecified date, the patient experienced he cannot work, he is frustrated, out of the sorts lately. The outcome of all the events was unknown.  Communication: At end of call, clarified statement provided from caller in beginning of call. He clarified the heart attack he suffered occurred before he got the COVID vaccine. He clarified the heart attack was due to taking care of his wife. He mentioned he received both shots and had no ill effects. While caller was providing details during report, he commented he has been out of it. He has been out of the sorts lately.He also mentioned he was frustrated. No additional details provided.   The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.
Age: 36.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Axillary pain, Pain in extremity
Clinical narrative: Left shoulder painful; Whole upper left side painful, armpit shoulder and arm; Whole upper left side painful, armpit shoulder and arm; This is a spontaneous report from a contactable consumer (patient). A 36-year-old non-pregnant female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection; Lot number: FA7485), via an unspecified route of administration on arm left on 27Jul2021 (age at vaccination: 36 years) as dose 1, single for COVID-19 immunization. The patient medical history was not reported. The patient has not received any other vaccines within 4 weeks prior to the COVID vaccine. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. The patient concomitant medications within 2 weeks of vaccination included escitalopram oxalate (LEXAPRO) taken for unspecified indication from an unknown date, cetirizine hydrochloride (ZYRTEC) taken for unspecified indication from an unknown date. On 28Jul2021, the patient experienced Left shoulder painful. Whole upper left side painful, armpit shoulder and arm. No lymph nodes affected. The patient received any treatment for the events was reported as no. Hospitalization Prolonged was reported as no. The events was considered as non-serious. The outcome of the events was not recovered.
Sex: F
Vaccine: COVID19
Symptoms: Feeling abnormal
Clinical narrative: she got the vaccine herself a while ago and didn't feel like myself for a month after; This is a spontaneous report received from a contactable consumer (patient herself). A female patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot number and Expiration date was not reported) via an unspecified route of administration on an unspecified date as dose number unknown, single for COVID-19 immunization. The patient medical history and concomitant medications were not reported. On an unspecified date, the caller stated that, she got the vaccine herself a while ago and didn't feel like myself for a month after. The outcome of the event was unknown.
Age: 12.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Fatigue, Headache, Malaise, Nasal congestion
Clinical narrative: has not been feeling well since receiving the pfizer covid vaccine; has an ongoing, non stop headache/her head really hurts; stuffy and runny nose; stuffy and runny nose; very tired and not herself; dizzy; seems like sinus issues going on; This is a spontaneous report from a contactable consumer (patient's mother) via Pfizer Medical Information department.    A 12-years-old female patient received first dose of bnt162b2 (BNT162B2, PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot Number: FA6780) via an unspecified route of administration on 24Jul2021 as DOSE 1, SINGLE for covid-19 immunisation. The patient medical history and concomitant medications was not reported. On Jul2021 the patient experienced not been feeling well since receiving the pfizer covid vaccine, had an ongoing, non stop headache/her head really hurts, stuffy and runny nose, stuffy and runny nose, very tired and not herself, dizzy, seems like sinus issues going on. Therapeutic measures were taken as a result of has an ongoing, non stop headache/her head really hurts. The patient had an ongoing, non stop headache and was given Motrin. The patient also experienced stuffy and runny nose. The patient was very tired and not herself. The clinical outcome of the event seemed like sinus issues going on. Patient did not recover at the time of this report while other events outcome was Unknown.  QR Comment: Reporter type was not available over the call as the reporter denied answering further questions, hence reporter type captured as consumer or non-healthcare professional by default.   Follow-Up (05Aug2021): Follow-up attempts are completed. No further information is expected.