chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 41.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: Arm Soreness; This is a spontaneous report from a contactable consumer (patient herself). A 41-years-old non-pregnant female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number: EL3247) via an unspecified route of administration, administered in arm left on 08Apr2021 at 12:30 (at the age of 41-year-old) as single dose for COVID-19 immunization.  Medical history included chronic autoimmune hives. No allergies to medications, food, or other products. Concomitant medications included within 2 weeks of vaccination, Azo Cranberry, MVI Vitamins Nos, Menopur, Follistim and Ganirelix. On 08Apr2021 at 18:30, the patient experienced arm soreness. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Patient was not diagnosed with COVID-19 prior to vaccination. Patient not received treatment for the adverse event. since the vaccination, patient not been tested for COVID-19. The outcome of the event was recovered on an unspecified date.  No follow-up attempts are needed. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Herpes zoster
Clinical narrative: Shingles; This is a spontaneous report from Pfizer-sponsored program, COVAX Support. A contactable consumer (patient) reported that a female patient of an unspecified age received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), via an unspecified route of administration on 19Mar2021 (Batch/Lot number was not reported) as single dose for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient had been diagnosed with Shingles on 06Apr2021 and her second dose schedule is this coming Friday. She also confirmed that she has not taken any medication. Second dose appointment is on 09Apr2021 and she received her first dose on 19Mar2021. The outcome of the event was unknown.  No follow-up attempts are needed. Information about lot/batch number cannot be obtained.
Age: 59.0
Sex: M
Vaccine: COVID19
Symptoms: Herpes zoster
Clinical narrative: shingles outbreak; This is a spontaneous report from a non-contactable consumer. A 59-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), dose 1 via an unspecified route of administration on 22Mar2021 (Batch/Lot number was not reported) as SINGLE DOSE for COVID-19 immunisation. Medical history included lung issues and rheumatoid arthritis with rheumatoid factor of multiple sites from an unknown date and unknown if ongoing. Concomitant medications included tocilizumab (ACTEMRA) taken for an unspecified indication, start and stop date were not reported. On the week after vaccination, it was reported that patient experienced shingles outbreak. The outcome of the event was unknown.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Sex: M
Vaccine: COVID19
Symptoms: Toothache
Clinical narrative: tooth ache; This is a spontaneous report from a contactable consumer (the patient) from a Pfizer-sponsored program t. A male patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, lot number not provided), via an unspecified route of administration on an unspecified date (age at vaccination unknown) as a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient had a tooth ache and wanted to take antibiotics. He asked if he can do so after getting the COVID vaccine. The outcome of tooth ache was not recovered.   No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Sex: F
Vaccine: COVID19
Symptoms: Malaise
Clinical narrative: not feeling well; This is a spontaneous report from a contactable consumer (daughter of the patient) received via Medical information Team and via Pfizer Sponsored Program. A female patient of an unspecified age received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number and expiration date were not reported), via an unspecified route of administration on 09Mar2021 at single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient experienced not feeling well on 30Mar2021. The patient was due to get the second dose on 30Mar2021 but she was not feeling well that day and was not able to get the second dose. The consumer was asking if someone can come to their home to administer the vaccine to the patient. Outcome of the event was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Sex: F
Vaccine: COVID19
Symptoms: Herpes zoster
Clinical narrative: shingles; This is a spontaneous report from a contactable consumer (patient) via a Pfizer-sponsored program, . A female patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as single dose for Covid-19 immunization. The patient's medical history and concomitant medications were not reported. The patient wanted to know if she can receive her 2nd dose of vaccine as she was diagnosed with shingles on an unspecified date after receiving her first dose of the vaccine. The outcome of event was unknown.  No follow-up attempts are needed; Information about lot/batch number cannot be obtained.
Sex: F
Vaccine: COVID19
Symptoms: Hypoacusis, Malaise
Clinical narrative: she is hard of hearing; not so well today; This is a spontaneous report from a contactable consumer (patient).   A 72-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) at age of 72 years old at single dose for covid-19 immunisation.  The patient medical history was not reportable and concomitant medications included pregabalin (LYRICA). The patient stated she is hard of hearing and not so well today(09Apr2021). Patient she was back and forth on getting vaccine not easy decision due to she is 72yrs old. Outcome for events was unknown.   No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Sex: F
Vaccine: COVID19, UNK
Symptoms: Chills, Malaise, Nasopharyngitis, Pyrexia
Clinical narrative: she got deathly sick with the first COVID vaccine; fever; cold; cold chills; This is a spontaneous report from Pfizer Program from a contactable consumer (patient). A 69-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration on an unspecified date (Lot number was not reported) as single dose for covid-19 immunisation; pregabalin (LYRICA) via an unspecified route of administration from an unspecified date at an unknown dose for an unspecified indication. The patient medical history and concomitant medications were not reported. The patient stated that she got deathly sick with the first COVID vaccine. She had a fever cold chill. She said she was going to get her second shot today (on 09Apr2021). Events outcome was unknown.  Information on the lot/batch number has been requested.
Sex: F
Vaccine: COVID19
Symptoms: Headache, Illness, Inflammation, Nausea
Clinical narrative: Stated the buildup of inflammation of not taking the Celebrex made her very sick, nausea, headache.; very sick; nausea; headache; This is a spontaneous report from a Pfizer sponsored program from a contactable consumer (patient). A female patient of unspecified age received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration on an unspecified date (Lot number was not reported) as single dose for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient previously took CELEBREX. It was reported that the patient took Celebrex and was advised to abstain from taking that for 72 hours before, the day of and 72 hours after receiving 1st Pfizer vaccine. She stated the buildup of inflammation of not taking the Celebrex made her very sick, nausea, headache. She would receive the 2nd shot on 19Apr2021. Events outcome was unknown.  Information on the lot/batch number has been requested.
Age: 78.0
Sex: F
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration, Off label use, Rash erythematous
Clinical narrative: First dose of BNT162B2 on 22Jan2021 13:00 and Second dose of BNT162B2 on 08Mar2021 15:00; First dose of BNT162B2 on 22Jan2021 13:00 and Second dose of BNT162B2 on 08Mar2021 15:00; red rash all over her body; This is a spontaneous report from two contactable consumers (patient and patient's husband). A 78-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), intramuscular on 08Mar2021 15:00 (lot number: EN6205) as single dose for COVID-19 immunisation. The patient's medical history was not reported. There were no concomitant medications. Historical vaccine included first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), intramuscular, administered in left arm on 22Jan2021 13:00 (lot number: EL9261) at single dose for COVID-19 immunization, and experienced red rash all over her body on 25Jan2021 09:00, had required visit to physician office, treatment with prednisone given, and was recovering. The patient experienced red rash all over her body on 08Mar2021 (reported at "09:00"), which required physician office visit, treatment received with Triamcinolone acetonide ointment. Red rash developed after 1st shot (also reported after 2 days) and after 2nd shot (also reported after 3 days) after vaccination. Doctors had her tab Prednisone. The rash had cleaned up, but 2nd shot caused reoccurrence. She is applying cream now. The outcome of the event red rash all over her body was recovering.  No follow-up attempts are possible. No further information expected.
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Diarrhoea, Headache, Nausea, Pruritus
Clinical narrative: Fever; Headache; Injection site pain; Nausea; Diarrhea; Some itching for a little bit; Chills; This is a spontaneous report received from a contactable consumer (patient). A 68-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot Number: EW0150), dose 1 via intramuscular route in right upper arm on 06Apr2021 (at 68-years age) as single dose for covid-19 immunisation. Medical history included osteoporosis, asthma, chronic pain, IVP, GERD. Concomitant medication(s) included paracetamol (TYLENOL); colecalciferol (VITAMIN D [COLECALCIFEROL]); calcium (CALCIUM); magnesium (MAGNESIUM); omeprazole (PROTONIX); ergocalciferol, retinol palmitate (VITAMINS). On 06Apr2021 patient experienced fever, headache, injection site pain, nausea, diarrhea, some itching for a little bit, chills. The itching started half hour after the injection and then the rest of it started about 23 hours after the next dose on 06Apr2021. Patient was scheduled for second dose on 27Apr2021. Patient had not decided if she was going to get it. The outcome of the events was unknown.  No follow-up attempts are needed. No further information is expected.
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia, Vaccination site pain
Clinical narrative: Fever; Headache; Injection site pain; Nausea; Diarrhea; Some itching for a little bit; Chills; This is a spontaneous report received from a contactable consumer (patient). A 68-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot Number: EW0150), dose 1 via intramuscular route in right upper arm on 06Apr2021 (at 68-years age) as single dose for covid-19 immunisation. Medical history included osteoporosis, asthma, chronic pain, IVP, GERD. Concomitant medication(s) included paracetamol (TYLENOL); colecalciferol (VITAMIN D [COLECALCIFEROL]); calcium (CALCIUM); magnesium (MAGNESIUM); omeprazole (PROTONIX); ergocalciferol, retinol palmitate (VITAMINS). On 06Apr2021 patient experienced fever, headache, injection site pain, nausea, diarrhea, some itching for a little bit, chills. The itching started half hour after the injection and then the rest of it started about 23 hours after the next dose on 06Apr2021. Patient was scheduled for second dose on 27Apr2021. Patient had not decided if she was going to get it. The outcome of the events was unknown.  No follow-up attempts are needed. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Herpes zoster
Clinical narrative: Shingles; This is a spontaneous report from a contactable consumer (patient). A 42-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number and expiry date: unknown), dose 1 via an unspecified route of administration on 02Mar2021 as single dose, dose 2 via an unspecified route of administration on 26Mar2021 as single dose for COVID-19 immunization. The patient medical history and concomitant medications were not reported. It was reported that the patient got the first dose and she was diagnosed with shingles on 22Mar2021. She got her second dose and she was better with the shingles but now she had shingles again and stated that she was 42 and she never had shingles in her entire life. She just thought she wanna call and let them know. The patient was under doctor's care at that time. The outcome of the events was unknown.   No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: Caller took the Pfizer vaccine and then contracted Covid; Caller took the Pfizer vaccine and then contracted Covid; This is a spontaneous report from a non-contactable consumer (patient) received from the Pfizer-sponsored program. A female patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), 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 experienced "took the pfizer vaccine and then contracted covid" on an unspecified date. The outcome of the events was unknown.  No follow-up attempts are possible; information about lot/batch number cannot been obtained
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Blood pressure decreased, Blood pressure measurement, Chills, Headache
Clinical narrative: faint; I start to see blurry; I start to sweat; nauseous; blood pressure was dropping; headache; fever; chills; joint pain; This is a spontaneous report from a contactable other healthcare professional. A 56-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 2 via an unspecified route of administration, administered in Arm Left on 20Apr2021 (Batch/Lot number was not reported) as a single dose (at the age of 56 years) for covid-19 immunization. The patient's medical history was not reported. Concomitant medications included curcuma longa (TURMERIC [CURCUMA LONGA]); fish oil (OMEGA 3 [FISH OIL]); zinc (ZINC); vitamin d [vitamin d nos] (VITAMIN D [VITAMIN D NOS]). The patient received the first dose of COMIRNATY on 30Mar2021, 11:00 in the left arm at the age of 56-years for covid-19 immunization. On 21Apr2021 at 19:00, when the patient stood up for 10 minutes she started to see blurry,  start to sweat, felt nauseous and felt like going to faint, she had to sit or lie down immediately so she don't fall. Patient sweat cold as if her blood pressure was dropping, this was happening to her on the second day after the second dose, also headache, a little fever, chills and a little nausea, on the third day (at the time of the report) she got up and stood up for 10 minutes again the same thing happened to me, although I no longer have fever or joint pain only a slight headache. The outcome of the events was not recovered.   Information on the lot/batch number has been requested.; Sender's Comments: Based on data given and temporal association, the event syncope is assessed as possibly related to BNT162B2.  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.
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Hyperhidrosis, Nausea, Pyrexia, Syncope, Vision blurred
Clinical narrative: faint; I start to see blurry; I start to sweat; nauseous; blood pressure was dropping; headache; fever; chills; joint pain; This is a spontaneous report from a contactable other healthcare professional. A 56-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 2 via an unspecified route of administration, administered in Arm Left on 20Apr2021 (Batch/Lot number was not reported) as a single dose (at the age of 56 years) for covid-19 immunization. The patient's medical history was not reported. Concomitant medications included curcuma longa (TURMERIC [CURCUMA LONGA]); fish oil (OMEGA 3 [FISH OIL]); zinc (ZINC); vitamin d [vitamin d nos] (VITAMIN D [VITAMIN D NOS]). The patient received the first dose of COMIRNATY on 30Mar2021, 11:00 in the left arm at the age of 56-years for covid-19 immunization. On 21Apr2021 at 19:00, when the patient stood up for 10 minutes she started to see blurry,  start to sweat, felt nauseous and felt like going to faint, she had to sit or lie down immediately so she don't fall. Patient sweat cold as if her blood pressure was dropping, this was happening to her on the second day after the second dose, also headache, a little fever, chills and a little nausea, on the third day (at the time of the report) she got up and stood up for 10 minutes again the same thing happened to me, although I no longer have fever or joint pain only a slight headache. The outcome of the events was not recovered.   Information on the lot/batch number has been requested.; Sender's Comments: Based on data given and temporal association, the event syncope is assessed as possibly related to BNT162B2.  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.
Age: 36.0
Sex: M
Vaccine: COVID19
Symptoms: Blood urine present, Haemorrhage urinary tract, Penile haemorrhage
Clinical narrative: blood drops in my urine and possibly passed a blood clot.; blood drops in my urine; When I woke up to use the bathroom, I noticed some blood coming out of my penis.; This is a spontaneous report from a contactable consumer. A 36-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), dose 2 via an unspecified route of administration, administered in Arm Left on 21Apr2021 13:45 (at the age of 36-years-old) (Batch/Lot Number: ER8735) as SINGLE DOSE for covid-19 immunisation. The patient's medical history was not reported. The patient received first dose of BNT162B2 for COVID-19 immunization on 31Mar2021 (Product=COVID-19, Brand=Pfizer, Lot number=ER8734, Lot unknown=False, Vaccine location=Left arm, Administration date=31Mar2021, Administration time=14:00 PM, Dose number=1). Concomitant medications included ibuprofen (ADVIL [IBUPROFEN]); cetirizine hydrochloride (ZYRTECNO). On 22Apr2021 06:30, When the patient woke up to use the bathroom, he noticed some blood coming out of his penis. At 06:45, it was reported, The morning after his second dose, he had blood drops in his urine and possibly passed a blood clot. The outcome of the events was unknown. The event "blood drops in my urine and possibly passed a blood clot" and "When I woke up to use the bathroom, I noticed some blood coming out of my penis" was assessed as serious (medically significant).
Age: 41.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Abdominal mass, Biopsy, Contusion, Eczema, Morphoea
Clinical narrative: Morphea; A lump developed/ lump on his abdomen; Eczema; itch all over his body; large bruise on his abdomen; This is a spontaneous report from a contactable nurse (patient). A 41-year-old male patient received the first dose of BNT162B2 (Pfizer-BioNTech COVID-19 vaccine, lot number: EL3248), via an unspecified route of administration, administered in the right arm on 22Dec2020 at 16:15 as a single dose in the hospital for COVID-19 immunization.  Medical history included hypertension and hyperlipidemia both from an unknown date and unknown if ongoing. The patient had no known allergies. The patient did not have COVID prior to the vaccination. The patient did not receive other vaccines in four weeks prior to the vaccine and received other medications in two weeks prior to the vaccine. The patient was not tested for COVID post vaccination. On 22Dec2021, shortly after the first dose vaccine, the patient started to get eczema and started to itch all over his body. On an unknown date in Dec2020, about 4-5 days after the vaccine, he noticed a large bruise on his abdomen. The bruise went away, however a lump developed on 28Dec2020. He saw his primary care physician (PCP) and he did an ultrasound on an unknown date in Dec2020 that was inconclusive. It wasn't until he went to the dermatologist about the itching and eczema and mentioned the lump on his abdomen that they did a biopsy on 28Dec2020 and diagnosed the patient with with Morphea. The patient received steriods and UVA 1 treatments for the events. The events were reported to have resulted to a disability or permanent damage. The outcome of the event large bruise on his abdomen was recovered on Dec2020 with the outcome of the other events was not recovered. The patient received the second dose of bnt162b2 (lot number: EL0140) on 15Jan2021.; Sender's Comments: Based on the available information and known product profile, the causal relationship between the event Morphea and the symptoms reported with it together with the use of BNT162B2 cannot be fully excluded. The case will be assessed further upon receipt of additional information.  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.
Age: 41.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Pruritus, Ultrasound scan
Clinical narrative: Morphea; A lump developed/ lump on his abdomen; Eczema; itch all over his body; large bruise on his abdomen; This is a spontaneous report from a contactable nurse (patient). A 41-year-old male patient received the first dose of BNT162B2 (Pfizer-BioNTech COVID-19 vaccine, lot number: EL3248), via an unspecified route of administration, administered in the right arm on 22Dec2020 at 16:15 as a single dose in the hospital for COVID-19 immunization.  Medical history included hypertension and hyperlipidemia both from an unknown date and unknown if ongoing. The patient had no known allergies. The patient did not have COVID prior to the vaccination. The patient did not receive other vaccines in four weeks prior to the vaccine and received other medications in two weeks prior to the vaccine. The patient was not tested for COVID post vaccination. On 22Dec2021, shortly after the first dose vaccine, the patient started to get eczema and started to itch all over his body. On an unknown date in Dec2020, about 4-5 days after the vaccine, he noticed a large bruise on his abdomen. The bruise went away, however a lump developed on 28Dec2020. He saw his primary care physician (PCP) and he did an ultrasound on an unknown date in Dec2020 that was inconclusive. It wasn't until he went to the dermatologist about the itching and eczema and mentioned the lump on his abdomen that they did a biopsy on 28Dec2020 and diagnosed the patient with with Morphea. The patient received steriods and UVA 1 treatments for the events. The events were reported to have resulted to a disability or permanent damage. The outcome of the event large bruise on his abdomen was recovered on Dec2020 with the outcome of the other events was not recovered. The patient received the second dose of bnt162b2 (lot number: EL0140) on 15Jan2021.; Sender's Comments: Based on the available information and known product profile, the causal relationship between the event Morphea and the symptoms reported with it together with the use of BNT162B2 cannot be fully excluded. The case will be assessed further upon receipt of additional information.  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.
Age: 41.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Abdominal mass, Biopsy abdominal wall abnormal, Contusion, Eczema, Morphoea
Clinical narrative: Morphea; A lump developed/ lump on his abdomen; Eczema; itch all over his body; large bruise on his abdomen; This is a spontaneous report from a contactable nurse (patient). A 41-year-old male patient received the first dose of BNT162B2 (Pfizer-BioNTech COVID-19 vaccine, lot number: EL3248), via an unspecified route of administration, administered in the right arm on 22Dec2020 at 16:15 as a single dose in the hospital for COVID-19 immunization.  Medical history included hypertension and hyperlipidemia both from an unknown date and unknown if ongoing. The patient had no known allergies. The patient did not have COVID prior to the vaccination. The patient did not receive other vaccines in four weeks prior to the vaccine and received other medications in two weeks prior to the vaccine. The patient was not tested for COVID post vaccination. On 22Dec2021, shortly after the first dose vaccine, the patient started to get eczema and started to itch all over his body. On an unknown date in Dec2020, about 4-5 days after the vaccine, he noticed a large bruise on his abdomen. The bruise went away, however a lump developed on 28Dec2020. He saw his primary care physician (PCP) and he did an ultrasound on an unknown date in Dec2020 that was inconclusive. It wasn't until he went to the dermatologist about the itching and eczema and mentioned the lump on his abdomen that they did a biopsy on 28Dec2020 and diagnosed the patient with with Morphea. The patient received steriods and UVA 1 treatments for the events. The events were reported to have resulted to a disability or permanent damage. The outcome of the event large bruise on his abdomen was recovered on Dec2020 with the outcome of the other events was not recovered. The patient received the second dose of bnt162b2 (lot number: EL0140) on 15Jan2021.; Sender's Comments: Based on the available information and known product profile, the causal relationship between the event Morphea and the symptoms reported with it together with the use of BNT162B2 cannot be fully excluded. The case will be assessed further upon receipt of additional information.  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.
Age: 41.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Pruritus
Clinical narrative: Morphea; A lump developed/ lump on his abdomen; Eczema; itch all over his body; large bruise on his abdomen; This is a spontaneous report from a contactable nurse (patient). A 41-year-old male patient received the first dose of BNT162B2 (Pfizer-BioNTech COVID-19 vaccine, lot number: EL3248), via an unspecified route of administration, administered in the right arm on 22Dec2020 at 16:15 as a single dose in the hospital for COVID-19 immunization.  Medical history included hypertension and hyperlipidemia both from an unknown date and unknown if ongoing. The patient had no known allergies. The patient did not have COVID prior to the vaccination. The patient did not receive other vaccines in four weeks prior to the vaccine and received other medications in two weeks prior to the vaccine. The patient was not tested for COVID post vaccination. On 22Dec2021, shortly after the first dose vaccine, the patient started to get eczema and started to itch all over his body. On an unknown date in Dec2020, about 4-5 days after the vaccine, he noticed a large bruise on his abdomen. The bruise went away, however a lump developed on 28Dec2020. He saw his primary care physician (PCP) and he did an ultrasound on an unknown date in Dec2020 that was inconclusive. It wasn't until he went to the dermatologist about the itching and eczema and mentioned the lump on his abdomen that they did a biopsy on 28Dec2020 and diagnosed the patient with with Morphea. The patient received steriods and UVA 1 treatments for the events. The events were reported to have resulted to a disability or permanent damage. The outcome of the event large bruise on his abdomen was recovered on Dec2020 with the outcome of the other events was not recovered. The patient received the second dose of bnt162b2 (lot number: EL0140) on 15Jan2021.; Sender's Comments: Based on the available information and known product profile, the causal relationship between the event Morphea and the symptoms reported with it together with the use of BNT162B2 cannot be fully excluded. The case will be assessed further upon receipt of additional information.  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.
Age: 19.0
Sex: F
Vaccine: COVID19
Symptoms: Cardiomegaly, Joint injury, Loss of consciousness, Nausea, Oral pain
Clinical narrative: nausea; passed out; seizure; enlarged heart; hurt knee; sore mouth; This is a spontaneous report from a contactable other HCP (patient). A 19-year-old female non-pregnant patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EP7534) via an unspecified route of administration, in the left arm on 20Apr2021 at 11:00 (at the age of 19-years-old) as a single dose for COVID-19 immunisation. Medical history was none. The patient's concomitant medications were not reported. The patient has no history of COVID-19 prior to vaccination. The patient had received other vaccines within 4 weeks prior to the COVID-19 vaccine: 2nd dose of Human papilloma virus (HPV) vaccine on 06Apr2021 in the right arm. On 20Apr2021 22:30, the patient experienced passed out, seizure, hurt knee, sore mouth, enlarged heart, and nausea.  The patient reported, "I was fine all day until around 10:30 pm I went into my mothers room and she was asking me how my arm feels I told her it was fine and right after saying that she said I passed out in front of her and then I began to have a seizure for about 50 seconds and then I woke up. After waking up from the event I had a hurt knee and sore mouth as well as an enlarged heart. I have no history of seizures in the past so it was definitely scary." The patient underwent lab tests and procedures which included SARS-COV-2 test: negative on 20Apr2021. Therapeutic measures taken included anti seizure meds, fentanyl, and paracetamol (TYLENOL). The patient recovered with sequelae from the events, passed out, seizure, hurt knee, sore mouth, and enlarged heart. Outcome of nausea was unknown.; Sender's Comments: A contributory role of BNT162B2 to the reported events cannot be fully excluded based on close temporal relationship and lack of alternate explanation at this time. However, the information provided is very limited and does not allow for a complete medical assessment. Case will be reassessed if additional information is received. 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.
Age: 19.0
Sex: F
Vaccine: COVID19
Symptoms: SARS-CoV-2 test, Seizure
Clinical narrative: nausea; passed out; seizure; enlarged heart; hurt knee; sore mouth; This is a spontaneous report from a contactable other HCP (patient). A 19-year-old female non-pregnant patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EP7534) via an unspecified route of administration, in the left arm on 20Apr2021 at 11:00 (at the age of 19-years-old) as a single dose for COVID-19 immunisation. Medical history was none. The patient's concomitant medications were not reported. The patient has no history of COVID-19 prior to vaccination. The patient had received other vaccines within 4 weeks prior to the COVID-19 vaccine: 2nd dose of Human papilloma virus (HPV) vaccine on 06Apr2021 in the right arm. On 20Apr2021 22:30, the patient experienced passed out, seizure, hurt knee, sore mouth, enlarged heart, and nausea.  The patient reported, "I was fine all day until around 10:30 pm I went into my mothers room and she was asking me how my arm feels I told her it was fine and right after saying that she said I passed out in front of her and then I began to have a seizure for about 50 seconds and then I woke up. After waking up from the event I had a hurt knee and sore mouth as well as an enlarged heart. I have no history of seizures in the past so it was definitely scary." The patient underwent lab tests and procedures which included SARS-COV-2 test: negative on 20Apr2021. Therapeutic measures taken included anti seizure meds, fentanyl, and paracetamol (TYLENOL). The patient recovered with sequelae from the events, passed out, seizure, hurt knee, sore mouth, and enlarged heart. Outcome of nausea was unknown.; Sender's Comments: A contributory role of BNT162B2 to the reported events cannot be fully excluded based on close temporal relationship and lack of alternate explanation at this time. However, the information provided is very limited and does not allow for a complete medical assessment. Case will be reassessed if additional information is received. 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: F
Vaccine: COVID19
Symptoms: Pruritus, Swelling of eyelid, Urticaria
Clinical narrative: hives; itching; swelling around the eyes; This is a spontaneous report from a contactable other healthcare professional. A 53-year-old female patient received first dose of BNT162B2(PFIZER-BIONTECH COVID-19 VACCINE) via unknown route on 04Apr2021 as a single dose for COVID-19 immunization. Medical history and concomitant medications were not reported. On 06Apr2021, two days after receiving the first dose patient experienced hives, itching, and swelling around the eyes. Patient was given Zyrtec and went to emergency room where she was given intravenous Solumedrol and intravenous Pepcid as a corrective treatment for the reported events. Outcome of the events were unknown.    No follow-up attempts are possible; information about lot/batch number cannot be obtained.; Sender's Comments: Based on the available information, the known safety profile and the temporal association of BNT162B2 administration to the events, a possible contribution of the drug to the events 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 appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees, and Investigators, as appropriate and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees, and Investigators, as appropriate.
Sex: F
Vaccine: COVID19
Symptoms: Loss of consciousness, Nausea
Clinical narrative: I then passed out and ended up on the floor; got sick in the stomach; This is a spontaneous report from a contactable consumer (patient). An 86-year-old non-pregnant female patient received bnt162b2 (Pfizer Covid vaccine), dose 1 on an unspecified date and dose 2 administered in left arm on 20Apr2021 00:15 (Lot Number: 101 #EP7534); both via an unspecified route of administration, as single dose for COVID-19 immunisation. Medical history included post phlebitic syndrome, macular degeneration and arthritis from an unknown date and unknown if ongoing. Concomitant medications included pravastatin taken for an unspecified indication, start and stop date were not reported; gabapentin taken for an unspecified indication, start and stop date were not reported; levothyroxine sodium (LEVOTHYROXIN) taken for an unspecified indication, start and stop date were not reported. The patient has not received other vaccine in four weeks. The patient had known allergies to Sulfer Plus (also reported as Sulfer). On 08Apr2021 10:00, the patient suddenly got sick in the stomach and thought was going to throw up. She then passed out and ended up on the floor. She was only out a second and woke up when she hit the floor. Outcome of the events was recovering. No treatment given for AEs. The patient was not diagnosed of Covid prior vaccination and has not been tested for Covid post vaccination.  Information on the lot/batch number of first dose has been requested.
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: Already received the first dose of the Pfizer COVID-19 vaccine and came up positive to COVID-19; Already received the first dose of the Pfizer COVID-19 vaccine and came up positive to COVID-19; This is a spontaneous report from a contactable consumer (patient). A male patient of an unspecified age received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot Number and Expiration Date were not reported), via an unspecified route of administration, on 03Apr2021, at a single dose, for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient already received the first dose of the Pfizer COVID-19 vaccine on 03Apr2021 and last week (Apr2021), he came up positive to COVID-19. The patient's appointment to get the second dose is tomorrow (23Apr2021) and he would like to know if he can go to the appointment and get the vaccine. The outcome of the events was unknown.  Information about lot number and expiration date for the suspect product will be requested in follow-up attempts.
Sex: U
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: administered dose 1 and then they got Covid; administered dose 1 and then they got Covid; This is a spontaneous report from a contactable Other HCP. A patient of unspecified age and gender received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN)  via an unspecified route of administration on an unspecified date as a single dose for COVID-19 immunisation. The patient medical history and concomitant medications were not reported.  A patient in a nursing home was administered dose 1 and then they got Covid and was admitted to the hospital. They were administered convalescent plasma and monoclonal antibodies. Outcome of the events, administered dose 1 and then they got Covid was unknown.   No follow-up attempts are possible; information about lot/batch number cannot be obtained.; Sender's Comments: Based on the information currently available, lack of efficacy of the vaccine BNT162B2 cannot be completely excluded. However, individuals may not be protected until at least 7 days after their second dose of the vaccine. It is unlikely that the patient would have fully developed immunity between the first vaccine dose and the event onset. The case will be reevaluated should additional information become available.
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Deafness, Fatigue, Illness, Nasopharyngitis
Clinical narrative: I can't hear out of one ear,; I feel like I have a really bad cold; I'm very tired; I feel really sick; and I'm concerned that I may have covid now; This is a spontaneous report from a contactable consumer(Patient). A 62-year-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number was not reported), via an unspecified route of administration on an unspecified date as SINGLE DOSE for covid-19 immunization. The patient's medical history and concomitant medications were not reported. She had her first dose of the Pfizer BioNTech covid vaccine and concerned that she may have covid now. Since getting the shot she feels like having a really bad cold, can't hear out of one ear, she is very tired and feel really sick. She is not sure if these are side effects of getting the vaccine or if she has covid. The outcome of all the events was unknown.   Information about lot/batch number has been requested.
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Antibody test, COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: positive COVID-19 test with symptoms; positive COVID-19 test with symptoms; This is a spontaneous report from a contactable consumer (patient). A 74-year-old female patient received bnt162b2 (BNT162B2 reported as PFIZER-BIONTECH COVID-19 VACCINE), dose 1 at vaccination age of 73-year-old via an unspecified route of administration in the left arm on 31Mar2021 [reported as 1:00 or 1:30 pm] (Lot Number: EW0150; Expiration Date: Jul2021) as a single dose for covid-19 immunisation (didn't want to get COVID again or the variants; also due to age group). The patient reported that she had Covid illness back in Jan2021 and she tested positive for antibodies afterward (2021) after the COVID infection. The patient had no family medical history relevant to the adverse events. The patient's concomitant medications were not reported. The patient did not receive additional vaccines administered on same date of the Pfizer suspect or history of all previous immunization with the Pfizer vaccine considered as suspect. The patient did not receive other vaccine within 4 weeks prior to vaccination. She has started her vaccine series with the Pfizer-Biontech Covid19 vaccine and was due for her second dose 27Apr2021. She recently took a rapid Covid test that came back positive on 20Apr2021. She inquired if she can still go for her second dose as scheduled. She states that she had a scheduled nuclear stress test that she had to reschedule because of her testing positive. She stated that she called her PCP and he stated that with all the antibodies she has, she shouldn't have to quarantine, and she would be able to get the second vaccine, but also to check with Pfizer. Her doctor doesn't think she is contagious or anything since she has the antibodies, so she was just trying to get a second opinion. She also stated that her symptoms were just the same as the first time she had COVID which are fatigue and headache which started the afternoon of 20Apr2021. She confirms these symptoms are still persisting. She's been treating the headache with Tylenol. She mentioned that the events did not require emergency room visit or physician's office visit. She made the comment she believes she can take the vaccine from what she gathered. The outcome of the events was not recovered.
Sex: M
Vaccine: COVID19
Symptoms: Fatigue, Malaise, Mental impairment, Nasal congestion, Vaccination site erythema
Clinical narrative: feeling like it takes a while to comprehend things; fatigue; congestion; ongoing redness at the injection site; he felt healthy and normal before getting the shot and now he feels terrible; This is a spontaneous report from a contactable consumer, the patient. A male patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), dose 2 via an unspecified route of administration on 18Apr2021 (Batch/Lot number was not reported) as single dose for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient previously received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), dose 1 on 19Mar2021 and had no adverse event. On an unspecified date in Apr2021, since the second dose he reports that he has had fatigue, congestion, feeling like it takes a while to comprehend things and ongoing redness at the injection site. The patient reported frustration because he felt healthy and normal before getting the shot and now, he feels terrible and doesn't know when he will feel better. The patient reported that he didn't want to get the shot, but his daughter coerced him into getting it. The outcome of the events ongoing redness at the injection site and he felt healthy and normal before getting the shot and now he feels terrible was not recovered and other events was unknown.  No follow-up attempts are needed. Information about lot/batch number cannot be obtained.
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Atrial fibrillation, Inappropriate schedule of product administration, Off label use
Clinical narrative: Atrial Fibrillation for 4 1/2 hours; 1st dose was 31Mar2021, 2nd dose on 04Apr2021; 1st dose was 31Mar2021, 2nd dose on 04Apr2021; This is a spontaneous report from a contactable consumer (patient). A 65-year-old female patient received bnt162b2 (BNT162B2), dose 2 via an unspecified route of administration, administered in arm left on 04Apr2021 13:00 (Batch/Lot Number: EP6955) as single dose for covid-19 immunisation. The first dose was received on 31Mar2021 13:00 on the left arm. The patient medical history was not reported. Patient was not pregnant. Concomitant medications included flecainide, apixaban (ELIQUIS), atorvastatin and unspecified multivitamins. No other vaccines within four weeks. The patient experienced atrial fibrillation for 4 1/2 hours on 22Apr2021 07:30. Flecainide was given as treatment. Outcome of the event of atrial fibrillation was recovered on an unspecified date. Patient did not have covid prior to vaccination and had not been tested post-vaccination.