chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: M
Vaccine: COVID19
Symptoms: Urticaria
Clinical narrative: he had a flare up of urticaria; This is a spontaneous report from a contactable consumer (patient). A male patient of an unspecified age received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number was not reported) via an unspecified route of administration on 25Apr2021 as dose 1, single for COVID-19 immunization. The patient medical history included idiopathic chronic urticaria and takes cyclosporine for flare ups. The patient concomitant medications were not reported. After the first dose of the Pfizer Covid 19 vaccine on 25Apr2021 he had a flare up of urticaria. It happened about 4-5 days after the first dose of the vaccine. He had his second dose this past Friday, 21May2021. The patient was getting a little bit of urticaria back. The outcome of the event was unknown.  Follow-up attempts not completed; information about lot/batch number cannot be obtained. No further information expected.
Age: 14.0
Sex: F
Vaccine: COVID19
Symptoms: Diarrhoea, Fatigue, Headache, Rash
Clinical narrative: Rash on chest and Neck; Intermittent headache; Diarrhea; Tiredness; This is a spontaneous report from a contactable consumer (patient). A 14-years-old non pregnant female patient received bnt162b2 (Pfizer-BioNTech COVID-19 Vaccine, solution for injection, Batch/Lot Number: EW0168, expiry date: unknown), via an unspecified route of administration, administered in left arm on 21May2021 11:00 (at the age of 14-year-old) as dose 1, single for covid-19 immunisation. The patients medical history and concomitant medications were not reported. The patient previously took erythromycin (MANUFACTURER UNKNOWN) for unspecified indication from unknown date and experienced drug allergy. The patient was not tested positive for covid 19 prior to vaccination and had not been tested post vaccination. Patient did not receive any other vaccines within 4 weeks to the COVID vaccine. On 23May2021 12:00, the patient experienced rash on chest and neck, intermittent headache, diarrhea and tiredness. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. Therapeutic measures were not taken as a result of the events. Outcome of all the events was not recovered at the time of reporting.   Follow-up attempts are completed. No further information is expected.
Age: 54.0
Sex: M
Vaccine: COVID19
Symptoms: Rash
Clinical narrative: Rash on scalp, forehead, back and armpits; This is a spontaneous report from a contactable consumer (patient). A 54-years-old male patient received first dose of bnt162b2 (BNT162B2 PFIZER-BIONTECH COVID-19 VACCINE, Formulation: solution for injection Batch/Lot Number: Ex06130121) via an unspecified route of administration on 15Mar2021 at 12:00 (at the age of 54-years-old) in left arm as dose 1, single for covid-19 immunisation. Medical history included penicillin allergy from an unknown date and unknown if ongoing. The patient's concomitant medications were not reported. Prior to vaccination, he was not diagnosed with COVID-19. Since the vaccination, He had not been tested for COVID-19. He did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient did not receive any other medications within 2 weeks of vaccination. The patient experienced rash on scalp, forehead, back and armpits on 01Apr2021. The adverse event resulted in doctor or other healthcare professional office/clinic visit. He did not provided information regarding the reported adverse event with the use of the product. Therapeutic measures were taken, and the patient was treated with topical lotion. The patient received second dose of bnt162b2 (BNT162B2 PFIZER-BIONTECH COVID-19 VACCINE, Formulation: solution for injection Batch/Lot Number: EP7533) via unspecified route of administration in arm left on 05Apr2021 at 12:00pm as single for covid-19 immunisation. Device date was reported as 24May2021. The outcome of event was not resolved.  Follow-up attempts are completed. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Back pain, Nausea, Pain in extremity, Pyrexia
Clinical narrative: got a sore arm; feeling queasy; her back hurt; fever; This is a solicited report from a non-Pfizer sponsored program (marketing program name not available) from a contactable consumer, based on information received by Pfizer. This case was split from master case 2021163836 for BNT162B2 experienced sore arm, fever, feeling queasy and her back hurt. This is a spontaneous report from a contactable consumer or other non hcp.   A female patient of an unspecified age received bnt162b2(PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number was not reported), via an unspecified route of administration on 04Feb2021 as DOSE 1, SINGLE for COVID-19 immunisation. The patient medical history was not reported. Concomitant medications included etanercept (ENBREL), denosumab (PROLIA), methotrexate (MTX [METHOTREXATE]) and hydroxychloroquine (HYDROXYCHLOROQUINE). The patient began Enbrel, Single Dose Prefilled Autoinjector, Prolia, Single Dose Prefilled Syringe on an unknown date. The patient began Enbrel on an unknown date. On an unknown date, the patient experienced cough or sniffles, she had gone without her Enbrel. When she was not taking her Enbrel she was in pain with her feet throbbing and her wrists hurting. The patient resumed Enbrel therapy. The patient's rheumatologist said she could not take Enbrel and MTX for two weeks after each COVID-19 injection. She usually takes her Enbrel on Sundays but had put it off. She never had good luck not taking her Enbrel and MTX over the nine years. She said afterwards, (after having covid-19 injection) on an unspecified date in 2021, she did have reactions including she got a sore arm, fever, feeling queasy and her back hurt. On an unspecified date she got a slight headache, slightly nauseous and her temperature went up two degrees or so and was achy. Symptoms lasted five to six hours. The patient feels fine on. Also, the patient reported after a couple of days without both medications usually Tuesday or Wednesday she would be so sore she would had to leave work to go home just to take her Enbrel injection. When patient went to clinic to get COVID-19 vaccine, it was advised she take her medication now, but after second vaccine dose she should hold off for two weeks. The patient was due for Prolia injection at the beginning of March and wanted to know if it was okay to take COVID-19 vaccine along with Prolia and Enbrel. No treatment information was received. The outcome of the events fever, pain, nausea and headache were reported as unknown.   No follow up attempts are possible. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Cough, Oropharyngeal discomfort
Clinical narrative: gets a tickle every once and a while; coughing; This is a spontaneous report from a contactable consumer. This female consumer reported for herself that:  A female 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 as dose number unknown, single on an unspecified date for covid-19 immunisation. The patient medical history and concomitant medications were not reported. Caller called to provide adverse event for her husband, and in doing so, caller said she started coughing, and said they both had Pfizer COVID shots, through Pfizer, and stated she just got a tickle everyone once and a while on unspecified date. At the time of this report, the outcome of events was unknown.  This follow-up is being submitted to notify that the lot/batch number is not available despite the follow-up attempts made. Follow-up attempts completed. No further information is expected.
Age: 12.0
Sex: F
Vaccine: COVID19
Symptoms: Epistaxis, Headache
Clinical narrative: Headache; Blood Nose; This is a spontaneous report from a contactable consumer (Patient) and a contactable physician. A 12-years-old non-pregnant female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Batch/Lot Number: EW0180, patient was not pregnant at the time of vaccination), via an unspecified route of administration, administered in Deltoid Left on 24May2021 at 12:00 PM (at the age of 12-year-old) as DOSE 1, SINGLE for covid-19 immunisation. Medical history and concomitant medications were reported as none. It was reported that patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Batch/Lot Number: EW0202, patient was not pregnant at the time of vaccination), via an unspecified route of administration, administered in Deltoid Left on 14Jun2021 (at the age of 12-year-old) as DOSE 2, SINGLE for covid-19 immunisation. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19; since the vaccination, the patient was not tested for COVID-19. On 24May2021 at 09:00 PM (Evening), the patient experienced blood nose, on 25May2021 (AM unspecified) patient experienced headache. It was reported that physician did not consider the Pfizer product had a causal effect to the adverse event. No seriousness criteria were reported. No treatment was received for events. The outcomes of events were recovered on an unspecified date in 2021.  Follow-up attempts are completed. No further information is expected.
Age: 41.0
Sex: F
Vaccine: COVID19
Symptoms: Feeling abnormal, Headache, Pain in extremity, Swelling, Tinnitus
Clinical narrative: Tinnitus; Headache; Foggy; Sore arm; Swelling; This is a spontaneous report from a contactable consumer, the patient. A 41-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0176) via an unspecified route of administration in the left arm on 26Apr2021 at 16:30 (at the age of 41-years-old) as a single dose for COVID-19 immunisation. Medical history included none. The patient had no known allergies. Concomitant medications included norethisterone acetate, ethinylestradiol (AUROVELA 1/20) from an unknown date for birth control, omeprazole (PRILOSEC), and vitamins nos (MULTIVITAMIN) both from an unknown date for an unspecified indication. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On an unknown date in 2021, the patient experienced headache/foggy, sore arm and some swelling for 3-4 days. On an unknown date in May2021, 1 week or so prior to the second shot, the patient experienced tinnitus, the patient have never had it before, and it has not resolved. The patient did not receive any treatment for the events. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The clinical outcome of the events headache/foggy, sore arm and some swelling recovered on an unspecified date in 2021. Whereas, that of tinnitus was not recovered.  Follow-Up (17Aug2021): Follow-up attempts are completed. No further information is expected.
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Dry mouth, Dyspnoea, Electric shock sensation, Fear, Feeling abnormal
Clinical narrative: for several hours during the night I kept feeling like electrical shocks in my body in my different body parts; had no cold symptoms but today and during the night I woke up and my mouth was really dry; I was breathing through my mouth and when I closed my mouth it's like like oh, I can't breathe from my nose and it was very strange.; tried like pulling my nose I didn't feel like I didn't feel congested. I didn't feel pressuring my nose; but it was weird and it was scaring her; but it was weird and it was scaring her; fever; headache; This is a spontaneous report from a contactable consumer (Patient). A 64-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Lot Number: EW0187, Expiry Date: Unknown), via an unspecified route of administration, administered in left arm on 22May2021 as dose 2, single for COVID-19 immunisation (Age at Vaccination was 64 years). The patient medical history included blood pressure high. Patient previously received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Lot Number: EW0176, Expiry Date: Unknown), via an unspecified route of administration, administered in left arm on 01May2021 as dose 1, single for COVID-19 immunization (Age at Vaccination was 64 years). It was reported that, the other treatment medications included for high blood pressure she was taking medications. On an unspecified date, the patient experienced for several hours during the night she kept feeling like electrical shocks in her body in her different body parts (That was very strange, it happened In her ankle, in her abdomen and then at the base of her spine and then it felt like it radiated up towards her neck and her spine), It happened like you know off and on over a period of like four hours but she does not had that sensation since but it was weird and it was scaring her, had no cold symptoms but today and during the night she woke up and her mouth was really dry, she was breathing through her mouth and when she closed her mouth it was like oh, she cannot breathe from her nose and it was very strange, tried like pulling her nose she did not feel like she did not feel congested. She did not feel pressuring her nose, fever, and headache. It was reported that, no, after four hours Saturday night she has not experienced anything else other than fever and headache. The outcome of the events fever and headache was unknown and for the remaining events was recovered on an unspecified date.  Follow-up attempts are completed. No further information is expected.
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Nasal discomfort, Pyrexia
Clinical narrative: for several hours during the night I kept feeling like electrical shocks in my body in my different body parts; had no cold symptoms but today and during the night I woke up and my mouth was really dry; I was breathing through my mouth and when I closed my mouth it's like like oh, I can't breathe from my nose and it was very strange.; tried like pulling my nose I didn't feel like I didn't feel congested. I didn't feel pressuring my nose; but it was weird and it was scaring her; but it was weird and it was scaring her; fever; headache; This is a spontaneous report from a contactable consumer (Patient). A 64-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Lot Number: EW0187, Expiry Date: Unknown), via an unspecified route of administration, administered in left arm on 22May2021 as dose 2, single for COVID-19 immunisation (Age at Vaccination was 64 years). The patient medical history included blood pressure high. Patient previously received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Lot Number: EW0176, Expiry Date: Unknown), via an unspecified route of administration, administered in left arm on 01May2021 as dose 1, single for COVID-19 immunization (Age at Vaccination was 64 years). It was reported that, the other treatment medications included for high blood pressure she was taking medications. On an unspecified date, the patient experienced for several hours during the night she kept feeling like electrical shocks in her body in her different body parts (That was very strange, it happened In her ankle, in her abdomen and then at the base of her spine and then it felt like it radiated up towards her neck and her spine), It happened like you know off and on over a period of like four hours but she does not had that sensation since but it was weird and it was scaring her, had no cold symptoms but today and during the night she woke up and her mouth was really dry, she was breathing through her mouth and when she closed her mouth it was like oh, she cannot breathe from her nose and it was very strange, tried like pulling her nose she did not feel like she did not feel congested. She did not feel pressuring her nose, fever, and headache. It was reported that, no, after four hours Saturday night she has not experienced anything else other than fever and headache. The outcome of the events fever and headache was unknown and for the remaining events was recovered on an unspecified date.  Follow-up attempts are completed. No further information is expected.
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Asthma, Chills, Dysphonia, Headache
Clinical narrative: Congested; voice is different; severe headache; weak; Asthma; Chills; This is the spontaneous report from a contactable consumer (patient). A 64-year-old female patient received second dose of bnt162b2 formulation: solution for injection, Lot Number: EW0177; Expiration Date: 31Aug2021) via an unspecified route of administration in arm left on 21May2021 (age at the time of the vaccination 64 year) as dose 2, single for COVID-19 immunization. Medical history included Severe allergies (diagnosed many years ago), asthma (diagnosed in her 20's), blood pressure high (diagnosed 15 years ago), high cholesterol (diagnosed many years ago), PTSD with depression (diagnosed 16 years ago) and PTSD with depression. The patient taking Pfizer BioNTech COVID vaccine to get protection from the corona virus. Concomitant medications included loratadine (CLARITIN [LORATADINE]) for allergy and montelukast sodium (SINGULAIR) for allergy. The patient historical vaccine included received first dose of bnt162b2 formulation: solution for injection, Lot Number: EW0167; Expiration Date: 31Aug2021) via an unspecified route of administration on 30Apr2021 (age at the time of the vaccination 64 year) as dose 1, single for COVID-19 immunization. The caller was concerned about her severe allergic reaction that she was having from the vaccine. On 21May2021, the patient experienced severe headache, weak, asthma and chills. On 23May2021, the patient voice was different. On an unspecified date, the patient was very congested maybe, she was unsure how to explain it. The patient used her inhaler she felt better. The outcome of the events severe headache, weak, voice was different and chills was not recovered. The outcome of the event asthma was recovering while outcome of the event congested was unknown.  Follow-up attempts are completed. No further information is expected.
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Nasal congestion
Clinical narrative: Congested; voice is different; severe headache; weak; Asthma; Chills; This is the spontaneous report from a contactable consumer (patient). A 64-year-old female patient received second dose of bnt162b2 formulation: solution for injection, Lot Number: EW0177; Expiration Date: 31Aug2021) via an unspecified route of administration in arm left on 21May2021 (age at the time of the vaccination 64 year) as dose 2, single for COVID-19 immunization. Medical history included Severe allergies (diagnosed many years ago), asthma (diagnosed in her 20's), blood pressure high (diagnosed 15 years ago), high cholesterol (diagnosed many years ago), PTSD with depression (diagnosed 16 years ago) and PTSD with depression. The patient taking Pfizer BioNTech COVID vaccine to get protection from the corona virus. Concomitant medications included loratadine (CLARITIN [LORATADINE]) for allergy and montelukast sodium (SINGULAIR) for allergy. The patient historical vaccine included received first dose of bnt162b2 formulation: solution for injection, Lot Number: EW0167; Expiration Date: 31Aug2021) via an unspecified route of administration on 30Apr2021 (age at the time of the vaccination 64 year) as dose 1, single for COVID-19 immunization. The caller was concerned about her severe allergic reaction that she was having from the vaccine. On 21May2021, the patient experienced severe headache, weak, asthma and chills. On 23May2021, the patient voice was different. On an unspecified date, the patient was very congested maybe, she was unsure how to explain it. The patient used her inhaler she felt better. The outcome of the events severe headache, weak, voice was different and chills was not recovered. The outcome of the event asthma was recovering while outcome of the event congested was unknown.  Follow-up attempts are completed. No further information is expected.
Age: 37.0
Sex: F
Vaccine: COVID19
Symptoms: Blood test, Laboratory test, Rash, Rash pruritic, Urticaria
Clinical narrative: Small rash on back of arm where Covid-19 vaccine was injected that progressed to hives all over body; Small rash on back of arm where Covid-19 vaccine was injected that progressed to hives all over body; it is sometimes itchy; This is a spontaneous report from a contactable consumer (patient). A 37-years-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Batch/Lot Number: EN6198; Expiration Date: Jun2021), via an unspecified route of administration, administered in Arm Left on 22Feb2021 between 12:30 or 12:45 (at the age of 37-year-old) as DOSE 2, SINGLE for covid-19 immunisation (Work in education). Medical history and concomitant medications were reported as no. Historical vaccine included first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Batch/Lot Number: EN5318; Expiration Date: May2021), via an unspecified route of administration, administered in Arm Left on 01Feb2021 (at the age of 37-year-old) as DOSE 1, SINGLE for covid-19 immunisation and had no issues with it. No additional Vaccines Administered on Same Date of the Pfizer Suspect. No prior Vaccinations received within 4 weeks. No AE(s) following prior vaccinations. On an unspecified date in Feb2021 (24Feb2021 or 25Feb2021, 2-3 days after receiving her second dose), the patient experienced small rash on back of arm where covid-19 vaccine was injected that progressed to hives all over body, it is sometimes itchy. It was reported that patient had covered in hives for the last 2 months. Reported that the rash was a kind of migratory and sometimes itchy in her legs, then her back, then her stomach, and then her arms. Patient visit physician office for events. The patient underwent lab tests and procedures which included blood test resulted as negative for a fungal infection or contact dermatitis, laboratory test which result was pending to check for autoimmune conditions, an allergy to the RNA pattern of the Covid-19 vaccine, and if the caller's natural histamine blockers have been shut down. The outcomes of events were not recovered.  Follow-up (30Jun2021): Follow-up attempts completed. No further information expected.
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Blood test
Clinical narrative: had joint pain; This is a spontaneous report from a Pfizer sponsored Program from a contactable other hcp. A 70-years-old female patient received bnt162b2 (BNT162B2 , Formulation: Solution for injection, Batch/Lot number : Not reported), via an unspecified route of administration on an unspecified date (at the age of 70-year-old) as DOSE NUMBER UNKNOWN, SINGLE for Covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient had joint pain on an unspecified date. The Patient reported last blood work showed kidney filtration levels dropped. MD changed dose of methotrexate from 6 tablets weekly to 3 tablets weekly started 2 weeks ago. No change in joint pain reported. Patient held xeljanz (XELJANZ) 5mg, orally once daily dose from 21Sep2021 for 2 weeks after covid shot. MD aware patient to receive vaccine. had joint pain but it wasn't bad per patient report. patient concerned about blood work and increased water intake with some energy drink per md recommendation. The patient underwent lab tests and procedures which included blood test: kidney filtration levels dropped. Outcome of the event was unknown.  Follow-up (16Jul2021): This follow-up is being submitted to notify that the lot/batch number is not available despite the follow-up attempts made. Follow-up attempts completed. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Rhinorrhoea, Sneezing
Clinical narrative: currently sneezing and experiencing runny nose.; currently sneezing and experiencing runny nose.; This is a spontaneous report from a sponsored program  support. A contactable consumer (patient's mother) reported for her daughter via medical information team.  A female patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 Vaccine, solution for injection, Batch/Lot number was not reported), dose 2 via an unspecified route of administration on 22May2021 as dose 2, single for covid-19 immunisation.  Medical history included seasonal allergy from an unknown date and unknown if ongoing. The patient's concomitant medications were not reported.  Historical vaccine included the patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 Vaccine, solution for injection, Lot number: unknown) via an unspecified route of administration on an unspecified date as dose 1, single for covid-19 immunisation. On an unspecified date on May2021, the patient currently sneezing and experiencing runny nose. She got the 2nd dose today, 22May, and forgot to ask if her daughter can take allergy medications. Reporter clarified that her daughter has seasonal allergies and is currently sneezing and experiencing runny nose. The outcome of events were not recovered.  Follow up attempts are needed, Information on lot/batch number has been requested.  No follow-up attempts are completed; information about lot/batch number cannot be obtained.
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Rash, Rash pruritic
Clinical narrative: Her rash was on her shoulder, hand, belly, and back; She stopped being itchy and it is painful.; This is a spontaneous report from a contactable consumer (Patient) reported for herself:  A 60-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot number: unknown), dose 2 via an unspecified route of administration on 22May2021 (at the age of 60 years old) as dose 2, single for covid-19 immunization. The patient medical history and concomitant medications were not reported. The patient previously took historical vaccine bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot number: unknown), dose 1 via an unspecified route of administration on an unspecified date (at the age of 60-years-old) as dose 1, single for covid-19 immunization. On 23May2021, the patient experienced rash. Reporter was asking if Prednisone was the correct treatment for her rash. Patient started to develop a rash on Sunday 23May2021. She was on her second day of taking prednisone and it was still there. It was a little bit of a lighter color but it was still there. How long will she have this rash?She just wanted to only speak with them because she was a little panicked right now because this rash is killing her. She stopped being itchy and it was painful. She was prescribed prednisone for 7 days and went to her doctor on Monday. Her rash was on her shoulder, hand, belly and back. The outcome of the event rash was unknown and outcome of itchy rash was recovered on an unspecified date.  Information on the lot/batch number has been requested. Follow-up attempts not completed; information about lot/batch number cannot be obtained. No further information expected.
Sex: M
Vaccine: COVID19
Symptoms: Cough, Nasopharyngitis, Rhinorrhoea
Clinical narrative: Slight cough; Runny nose; Cold-like symptoms; This is a spontaneous report from a Pfizer-sponsored program. A contactable male consumer (patient) reported that:  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 unspecified date as DOSE 1, SINGLE for COVID-19 immunization. The patient medical history had included deaf. The concomitant were not reported. On an unspecified date the patient had experienced slight cough, runny nose and cold-like symptoms. The clinical course was reported as follows, caller stated he got his first vaccine and was fine until just a little bit. He developed a runny nose and slight cough and had cold like symptoms. His second dose was scheduled for today, it's like he has a cold and asked you know what I am saying. He did not think his first vaccine caused his sickness because it's so far apart, about 2-3 weeks, something like that. He just wants to know if he can get his second vaccine or not. Caller encouraged to reach out to his primary care doctor to discuss getting the second dose. Caller stated he just wanted to know if he could get his second dose if he was not feeling good, that's all.  The clinical outcome of the events was unknown.  Follow-up attempts completed. No further information expected.
Age: 16.0
Sex: M
Vaccine: COVID19
Symptoms: Body temperature, Myalgia, Nausea, Pain, Pyrexia
Clinical narrative: Starting 11 hours after administration started having body aches which continued for 17 hours.; Developed fever with highest being 101.4 at 26 hours after vaccination.; Nausea & vomiting occurred at 26 hours post vaccination & lasted 8 hours.; myalgia; Nausea & vomiting occurred at 26 hours post vaccination & lasted 8 hours.; This is a spontaneous report from a contactable Nurse (patient's parent). A 16-year-old male patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Lot Number: ER8736, and Expiration date: Unknown), intramuscular, administered in left deltoid on 18May2021 17:35 (at the age of 18-year-old) as dose 2, single for COVID-19 immunization, at other facility. The patient medical history included Fever on 22Jan2021 (Seriousness criteria: Not Serious, Outcome: Recovered, Treatment: No), seasonal allergy, and headache. Concomitant medications included loratadine (CLARITIN [LORATADINE]) taken for seasonal allergy, cetirizine hydrochloride (ZYRTEC [CETIRIZINE HYDROCHLORIDE]) taken for seasonal allergy and ongoing, and ibuprofen (MOTRIN [IBUPROFEN]) taken for headache from 13May2021 and ongoing. The patient previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Lot Number: EW0169, and Expiration date: Unknown), intramuscular, administered in left deltoid on 27Apr2021 16:40 (at the age of 18-year-old) as dose 1, single for COVID-19 immunization. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. No relevant testes were done. It was reported that, on 19May2021 04:00, the patient experienced "Starting 11 hours after administration started having body aches which continued for 17 hours". On 19May2021, developed fever with highest being 101.4 at 26 hours after vaccination. "Nausea & vomiting occurred at 26 hours post vaccination & lasted 8 hours" and additionally experienced myalgia on the same day. The patient underwent lab tests and procedures which included body temperature: which showed 101.4 on 19May2021 (Developed fever with highest being 101.4 at 26 hours after vaccination). No treatment was received for the events. The reporter considered that the Pfizer product had a causal effect to the adverse event. The device date was reported as 24May2021. It was reported that the autopsy information was not applicable for this report. The outcome of event myalgia was reported as resolved on an unspecified date in 2021. The outcome of other events reported as resolved on an unspecified date in May2021.  Follow-up attempts are completed. No further information is expected.
Age: 16.0
Sex: M
Vaccine: COVID19
Symptoms: Vomiting
Clinical narrative: Starting 11 hours after administration started having body aches which continued for 17 hours.; Developed fever with highest being 101.4 at 26 hours after vaccination.; Nausea & vomiting occurred at 26 hours post vaccination & lasted 8 hours.; myalgia; Nausea & vomiting occurred at 26 hours post vaccination & lasted 8 hours.; This is a spontaneous report from a contactable Nurse (patient's parent). A 16-year-old male patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Lot Number: ER8736, and Expiration date: Unknown), intramuscular, administered in left deltoid on 18May2021 17:35 (at the age of 18-year-old) as dose 2, single for COVID-19 immunization, at other facility. The patient medical history included Fever on 22Jan2021 (Seriousness criteria: Not Serious, Outcome: Recovered, Treatment: No), seasonal allergy, and headache. Concomitant medications included loratadine (CLARITIN [LORATADINE]) taken for seasonal allergy, cetirizine hydrochloride (ZYRTEC [CETIRIZINE HYDROCHLORIDE]) taken for seasonal allergy and ongoing, and ibuprofen (MOTRIN [IBUPROFEN]) taken for headache from 13May2021 and ongoing. The patient previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Lot Number: EW0169, and Expiration date: Unknown), intramuscular, administered in left deltoid on 27Apr2021 16:40 (at the age of 18-year-old) as dose 1, single for COVID-19 immunization. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. No relevant testes were done. It was reported that, on 19May2021 04:00, the patient experienced "Starting 11 hours after administration started having body aches which continued for 17 hours". On 19May2021, developed fever with highest being 101.4 at 26 hours after vaccination. "Nausea & vomiting occurred at 26 hours post vaccination & lasted 8 hours" and additionally experienced myalgia on the same day. The patient underwent lab tests and procedures which included body temperature: which showed 101.4 on 19May2021 (Developed fever with highest being 101.4 at 26 hours after vaccination). No treatment was received for the events. The reporter considered that the Pfizer product had a causal effect to the adverse event. The device date was reported as 24May2021. It was reported that the autopsy information was not applicable for this report. The outcome of event myalgia was reported as resolved on an unspecified date in 2021. The outcome of other events reported as resolved on an unspecified date in May2021.  Follow-up attempts are completed. No further information is expected.
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: Biopsy skin, Pruritus, Rash, Rash erythematous
Clinical narrative: Rash developed into some really bad itching; Rash developed into some really bad itching; A little red rash on her left lower shin; This is a spontaneous report from a contactable consumer (patient). A 55-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot number: EP6955), via an unspecified route of administration, administered in left arm on 17Mar2021 14:30 as dose 1, single for COVID-19 immunization (at the age of 55-year-old). Medical history included reflux. Concomitant medication included pantoprazole taken for reflux from unspecified date in Dec2019. On an unspecified date, about a week after vaccination, the patient got a small rash on the lower left leg. It spread more into a rash but still didn't associate it with the vaccine. The rash developed into some really bad itching. She thought it might be a mosquito or spider bite, she didn't think anything about it. It did spread a little bit and she was putting Aloe Vera and Calamine lotion on it thinking it was a bug bite. The rash still spread to the whole body and the primary care doctor decided to refer her to a dermatologist. The urgent care doctor prescribed Prednisone and an antibiotic. The rash didn't get better. The rash turned into a full body rash and hives. She does not know the name of the antibiotic. Both bottles or containers of the Prednisone and antibiotic have been thrown away. On an unspecified date, the patient underwent lab tests and procedures which included skin biopsy: unknown. The patient was treated with steroid topical oil last Tuesday as a therapeutic measure of rash developed into some really bad itching and a little red rash on her left lower shin. The outcome of the events was unknown.  Information on Lot/Batch number was available. Additional information has been requested.  No Follow-up attempts completed. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Infusion site erythema, Infusion site induration, Infusion site pain, Infusion site swelling, Infusion site warmth
Clinical narrative: This is a spontaneous report based on the information received by Pfizer from Regulatory Authority (Manufacturer Report Number: UNT-2021-007169) from a contactable consumer (patient). A 71-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Lot Number: Unknown, and Expiration date: Unknown), via an unspecified route of administration on an unspecified date in 2021 as dose number unknown, single for COVID-19 immunization. The patient also received co-suspect treprostinil sodium (REMODULIN), subcutaneous from 31Oct2019 (Batch/Lot number was not reported) to an unspecified date, as unspecified dose, and continuous via subcutaneous route from an unspecified date (Lot Number: 2101734; Expiration Date: 30Nov2021) to Apr2021, at 0.025 ug/kg for secondary pulmonary arterial hypertension. The patient medical history included ongoing secondary pulmonary arterial hypertension. The concomitant medications included amlodipine (AMLODIPINE), apixaban (ELIQUIS), selexipag (UPTRAVI), and amlodipine besilate (AMLODIPINE BESILATE). On an unspecified date in Apr2021, after receiving the COVID vaccine, the patient experienced the pain, redness, swelling, hot to touch and hard to touch at old subcutaneous Remodulin site (infusion site pain, infusion site erythema, infusion site swelling, infusion site warmth and infusion site induration) for past 2 weeks from the time of reporting. Patient changed the site 3 days ago and had no problem with new site. However, the old site had not improved since removed in last 3 days. The patient's Remodulin SQ (subcutaneous) sites became very tender and painful even after moving sites three times. On an unspecified date in 2021, the patient experienced mood issues with the pain (mood altered and pain) and wanted to stop therapy. The patient had reported that he decided to stop Remodulin subcutaneous on his own on 16Apr2021. The patient reported that he discontinued the SQ (subcutaneous) Remodulin last week (On an unreported date in Apr2021) as per physician advise because of subcutaneous infusion site pain. Action taken with SQ Remodulin was withdrawn on an unreported date in Apr2021 due to infusion site pain. The reporter did not provide causality for the events of infusion site pain, infusion site erythema, infusion site swelling, infusion site warmth, infusion site induration, mood altered, and pain. The outcome of the events infusion site pain, infusion site erythema, infusion site swelling, infusion site warmth, and infusion site induration was reported as not resolved, and the outcome of the events mood issues with the pain was unknown, at the time of reporting.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Sex: M
Vaccine: COVID19
Symptoms: Mood altered, Pain
Clinical narrative: This is a spontaneous report based on the information received by Pfizer from Regulatory Authority (Manufacturer Report Number: UNT-2021-007169) from a contactable consumer (patient). A 71-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Lot Number: Unknown, and Expiration date: Unknown), via an unspecified route of administration on an unspecified date in 2021 as dose number unknown, single for COVID-19 immunization. The patient also received co-suspect treprostinil sodium (REMODULIN), subcutaneous from 31Oct2019 (Batch/Lot number was not reported) to an unspecified date, as unspecified dose, and continuous via subcutaneous route from an unspecified date (Lot Number: 2101734; Expiration Date: 30Nov2021) to Apr2021, at 0.025 ug/kg for secondary pulmonary arterial hypertension. The patient medical history included ongoing secondary pulmonary arterial hypertension. The concomitant medications included amlodipine (AMLODIPINE), apixaban (ELIQUIS), selexipag (UPTRAVI), and amlodipine besilate (AMLODIPINE BESILATE). On an unspecified date in Apr2021, after receiving the COVID vaccine, the patient experienced the pain, redness, swelling, hot to touch and hard to touch at old subcutaneous Remodulin site (infusion site pain, infusion site erythema, infusion site swelling, infusion site warmth and infusion site induration) for past 2 weeks from the time of reporting. Patient changed the site 3 days ago and had no problem with new site. However, the old site had not improved since removed in last 3 days. The patient's Remodulin SQ (subcutaneous) sites became very tender and painful even after moving sites three times. On an unspecified date in 2021, the patient experienced mood issues with the pain (mood altered and pain) and wanted to stop therapy. The patient had reported that he decided to stop Remodulin subcutaneous on his own on 16Apr2021. The patient reported that he discontinued the SQ (subcutaneous) Remodulin last week (On an unreported date in Apr2021) as per physician advise because of subcutaneous infusion site pain. Action taken with SQ Remodulin was withdrawn on an unreported date in Apr2021 due to infusion site pain. The reporter did not provide causality for the events of infusion site pain, infusion site erythema, infusion site swelling, infusion site warmth, infusion site induration, mood altered, and pain. The outcome of the events infusion site pain, infusion site erythema, infusion site swelling, infusion site warmth, and infusion site induration was reported as not resolved, and the outcome of the events mood issues with the pain was unknown, at the time of reporting.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Age: 41.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Contusion, Erythema, Pain in extremity
Clinical narrative: Chills; sore arm; bruise; redness on arm below vaccination site; This is a spontaneous report from a contactable consumer (patient). A 41-year-old non-pregnant female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot Number: EW0187), via an unspecified route of administration in left arm on 17May2021 at 14:30 (at the age of 41 years old, not pregnant at the time of vaccination) as dose 2, single for covid-19 immunisation. There was no medical history. The patient had no known allergies. Concomitant medications the patient received within 2 weeks of vaccinations included ethinylestradiol, norethisterone acetate (AUROVELA 1/20) for contraception; omeprazole magnesium (PRILOSEC [OMEPRAZOLE MAGNESIUM]) for contraception; ascorbic acid, ergocalciferol, folic acid, nicotinamide, panthenol, retinol, riboflavin, thiamine hydrochloride (MULTIVITAMINS [ASCORBIC ACID; ERGOCALCIFEROL;FOLIC ACID;NICOTINAMIDE;PANTHENOL;RETINOL;RIBOFLAVIN;THIAMINE HYDROCHLORIDE]) for contraception. Historical vaccine included first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot number: EW0176), via an unspecified route of administration in left arm on 26Apr2021 at 16:30 (at the age of 41 years old) for covid-19 immunisation and experienced - just headache/foggy, sore arm and some swelling for 3-4 days.Tinnitus was the reason she was reporting, however, this started after the first vaccine; she would say about 1 week or so prior to the second shot. she have never had it before, and it has not resolved. She will be contacting her doctor about it, to notify her. She wasn't sure what the cause was, until recently learning it was something happening to others who have been vaccinated, as well. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient hasn't been tested for COVID-19. On 18May2021, 2day after application patient experienced chills, sore arm, bruise, redness on arm below vaccination site. The patient did not received treatment due to the events. The outcome of events was not recovered.  Follow-up (19Aug2021): Follow-up attempts are completed. No further information is expected.
Age: 41.0
Sex: M
Vaccine: COVID19
Symptoms: Swelling face
Clinical narrative: Moderate Facial Swelling; This is a spontaneous report from a contactable other hcp. A 41-year-old male patient received second dose of bnt162b2 (Formulation: Solution for injection; Batch/Lot Number: EW0185), dose 2 via an un-specified route of administration, administered in Arm Left on 25May2021 09:45 (Batch/Lot Number: EW0185) as DOSE 2, SINGLE for covid-19 immunisation (at the age of 41-year-old). Medical history included cancer and BRCA from an unknown date and unknown if ongoing. Not known allergies. Concomitant medications included alprazolam (XANAX) taken for an unspecified indication, start and stop date were not reported. The patient previously received first dose of BNT162B2 (Lot number EW0176) in Left arm on 04May2021 12:00PM for Covid-19 Immunization. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient was not received any other medications within 2 weeks of vaccination. On 25May2021 09:45 PM patient experienced Moderate Facial Swelling. The event was not required the initiation of new medication/other treatment/Procedure. The outcome of the event was recovered.  Follow-up attempts are completed. No further information is expected.