chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: Back pain, Body temperature, Eating disorder, Feeling abnormal, Herpes zoster
Clinical narrative: Shingles; bad back pain; felt like something was not right; checked my temperature and it was 102.1/fever broke; but I had body aches; My ear my neck my nose my mouth and underneath my chin the lymph node was swollen; Then I had these lesions / sores starting to appear on my face, my nose , my lips and in my mouth all on the left side; my mouth was horrible much difficulty eating and pain was pretty intense; my mouth was horrible much difficulty eating and pain was pretty intense; This is a spontaneous report from a contactable consumer.  This patient  reported for 2 patients.  A 55-years-old female patient received bnt162b2 (BNT162B2), dose 1 via an unspecified route of administration, administered in Arm Left on 03Mar2021 at  10:30 at the age of 55 years-old(Batch/Lot Number: EN6203) as SINGLE DOSE for covid-19 immunisation. Medical history included High Blood Pressure , Vertigo, Meniere"s Disease, Gallbladder removed, Cluster of Calcifications and Nodules removed in left breast (benign) , Plaque Psoriasis ( had it very bad on hands and feet) Methotrexate (7 tablets I take on Saturdays)Methotrexate ( 7 tablets i take on Saturdays), also lots of enviromental allergies I was tested few years ago, possibly Augmentin and Clindamycin   The patient's concomitant medications were not reported. The patient reported that on 13Mar2021, I was awoken up with bad back pain and I felt like something was not right . I checked my temperature and it was 102.1 . The fever broke but I had body aches etc And the left side of my face wasn't feeling right . My ear my neck my nose my mouth and underneath my chin the lymph node was swollen. Then I had these lesions / sores starting to appear on my face,  my nose , my lips and in my mouth all on the left side, my mouth was horrible much difficulty eating and pain was pretty intense. Immediately scheduled appointments with my medical doctor and my dermatologist.  The dermatologist biopsy and came back as Shingles . He immediately put me anti viral drug and my medical doctor put me on amoxicillin, Acyclovir, Gabapentin. I was out of work for 4 weeks cause I work in a Supermarket ( Deli). The patient did not have COVID prior to vaccination nor tested positive after vaccination. The outcome of the events was recovered with sequelae.    No follow-up attempts are needed. No further information is expected.
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: Lymphadenopathy, Oral pain, Pain, Pyrexia, Skin lesion
Clinical narrative: Shingles; bad back pain; felt like something was not right; checked my temperature and it was 102.1/fever broke; but I had body aches; My ear my neck my nose my mouth and underneath my chin the lymph node was swollen; Then I had these lesions / sores starting to appear on my face, my nose , my lips and in my mouth all on the left side; my mouth was horrible much difficulty eating and pain was pretty intense; my mouth was horrible much difficulty eating and pain was pretty intense; This is a spontaneous report from a contactable consumer.  This patient  reported for 2 patients.  A 55-years-old female patient received bnt162b2 (BNT162B2), dose 1 via an unspecified route of administration, administered in Arm Left on 03Mar2021 at  10:30 at the age of 55 years-old(Batch/Lot Number: EN6203) as SINGLE DOSE for covid-19 immunisation. Medical history included High Blood Pressure , Vertigo, Meniere"s Disease, Gallbladder removed, Cluster of Calcifications and Nodules removed in left breast (benign) , Plaque Psoriasis ( had it very bad on hands and feet) Methotrexate (7 tablets I take on Saturdays)Methotrexate ( 7 tablets i take on Saturdays), also lots of enviromental allergies I was tested few years ago, possibly Augmentin and Clindamycin   The patient's concomitant medications were not reported. The patient reported that on 13Mar2021, I was awoken up with bad back pain and I felt like something was not right . I checked my temperature and it was 102.1 . The fever broke but I had body aches etc And the left side of my face wasn't feeling right . My ear my neck my nose my mouth and underneath my chin the lymph node was swollen. Then I had these lesions / sores starting to appear on my face,  my nose , my lips and in my mouth all on the left side, my mouth was horrible much difficulty eating and pain was pretty intense. Immediately scheduled appointments with my medical doctor and my dermatologist.  The dermatologist biopsy and came back as Shingles . He immediately put me anti viral drug and my medical doctor put me on amoxicillin, Acyclovir, Gabapentin. I was out of work for 4 weeks cause I work in a Supermarket ( Deli). The patient did not have COVID prior to vaccination nor tested positive after vaccination. The outcome of the events was recovered with sequelae.    No follow-up attempts are needed. No further information is expected.
Age: 49.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Epistaxis, Headache, Insomnia, Syncope
Clinical narrative: Nose bleeds; Fainted; Insomnia; headache; Chills; This is a spontaneous report from a contactable consumer (patient). A 49-year-old female patient (non-pregnant) received first dose of BNT162B2 (Pfizer-BioNTech COVID-19 mRNA vaccine; lot number: ER8737), via an unspecified route of administration, administered in left arm on 05Apr2021 18:45 (at the age of 49-years) as single dose for COVID-19 immunization. Medical history included migraine and known allergies to sunflower oil, chamomile, mold, and dogs. The patient is not pregnant at the time of the vaccination. Concomitant medications included atenolol and rizatriptan benzoate (MAXALT). The patient has no other vaccine in four weeks. The patient previously had allergies to hydroxyethyl methacrylate, sodium pentothal, and erythromycin. The patient was not tested for covid post vaccination. The patient experienced insomnia and headache for three days, and chills on and off for over a week on 05Apr2021 at 21:00. The patient also experienced fainted on 06Apr2021 and nose bleeds lasting 15-45 minutes on 07Apr2021, 14Apr2021, 20Apr2021, and 23Apr2021 (patient never get nose bleeds previously). The patient received pain and antibiotics medications as treatments. The outcome of the events was unknown.  No follow-up attempts are possible. No further information is expected.
Age: 40.0
Sex: M
Vaccine: COVID19
Symptoms: Abdominal pain, Appendicitis
Clinical narrative: worried it's appendicitis; have abdominal pain on the right side; This is a spontaneous report from a contactable consumer reporting for himself. A 40-year-old male patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE) (lot number/expiration date: not provided), via an unspecified route of administration, on 05Apr2021 (at the age of 40 years old) as a single dose for COVID-19 IMMUNIZATION. The patient previously received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE) (lot number/expiration date: not provided), via an unspecified route of administration, on an unspecified date as a single dose for COVID-19 IMMUNIZATION. Relevant medical history and concomitant medication were not provided. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On an unspecified date in Apr2021, the patient started to have abdominal pain on the right side, 1 week after his second dose. The patient was worried it's appendicitis. The events resulted in a physician's office visit. The patient did not receive any treatment for these events. The outcome of the events abdominal pain and suspected appendicitis was not recovered. Since the vaccination, the patient had not been tested for COVID-19.   Information about Batch/Lot number has been requested.
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: Tested positive for COVID-19 after being fully vaccinated; Tested positive for COVID-19 after being fully vaccinated; This is a spontaneous report from a Pfizer-sponsored program from a contactable nurse. A male patient of an unspecified age received 1st and 2nd doses of bnt162b2 (BNT162B2, Manufacturer Pfizer-BioNTech), both on unspecified route of administration, on unspecified date, as single dose, for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient tested positive for COVID-19 after being fully vaccinated on unspecified date with outcome of unknown. The patient underwent lab tests and procedures which included COVID-19 virus test: positive on unknown date.  The information on the lot/batch number has been requested.; Sender's Comments: The association between the event lack of effect (COVID-19) with BNT162b2 can not be fully excluded.
Age: 42.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal pain, Anaphylactic reaction, Body temperature, Chest discomfort, Chills
Clinical narrative: flu-like symptoms; given an injection of steroids/difficulty breathing; difficulty breathing; fever 100F; chills; body aches; chest tightness; abdominal pain; This is a spontaneous report from a contactable other HCP (patient). This 42-year-old female other HCP reported for herself received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), via an unspecified route of administration, administered in Arm Left on 12Mar2021 10:00 (Batch/Lot Number: EN6206) as 1ST DOSE, 0.3 ML SINGLE for covid-19 immunisation.  Medical history included asthma (well controlled prior to vaccine) migraines, chronic UTI, bronchitis, pneumonia, all from an unknown date and unknown if ongoing.  The patient did not have COVID prior to vaccination. The patient's concomitant medications were not reported.  The patient experienced anaphylactic reaction ("given an injection of steroids/difficulty breathing") on 13Mar2021 with outcome of not recovered , difficulty breathing on 13Mar2021 with outcome of not recovered , fever 100F on 13Mar2021 with outcome of not recovered , chills on 13Mar2021 with outcome of not recovered , body aches on 13Mar2021 with outcome of not recovered , chest tightness on 13Mar2021 with outcome of not recovered , abdominal pain on 13Mar2021 with outcome of not recovered , flu-like symptoms on 15Mar2021 with outcome of not recovered.  The patient underwent lab tests and procedures which included body temperature: 100F on 13Mar2021 , oxygen saturation ("O2 stats"): between 88-93 for 3 weeks, sars-cov-2 "antibody" test: positive  on 16Apr2021 (blood test) , CXR with unknown  result on 17Mar2021.  Therapeutic measures were taken as a result of the reported events included injection of steroids and antibiotics.; Sender's Comments: Based on available information, a possible contributory role of the subject product,  BNT162B2 vaccine, cannot be excluded for the anaphylactic reaction and other reported events.   There is limited information provided in this report.  This case will be reassessed once additional information is available. 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: 42.0
Sex: F
Vaccine: COVID19
Symptoms: Dyspnoea, Influenza like illness, Oxygen saturation, Pain, Pyrexia
Clinical narrative: flu-like symptoms; given an injection of steroids/difficulty breathing; difficulty breathing; fever 100F; chills; body aches; chest tightness; abdominal pain; This is a spontaneous report from a contactable other HCP (patient). This 42-year-old female other HCP reported for herself received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), via an unspecified route of administration, administered in Arm Left on 12Mar2021 10:00 (Batch/Lot Number: EN6206) as 1ST DOSE, 0.3 ML SINGLE for covid-19 immunisation.  Medical history included asthma (well controlled prior to vaccine) migraines, chronic UTI, bronchitis, pneumonia, all from an unknown date and unknown if ongoing.  The patient did not have COVID prior to vaccination. The patient's concomitant medications were not reported.  The patient experienced anaphylactic reaction ("given an injection of steroids/difficulty breathing") on 13Mar2021 with outcome of not recovered , difficulty breathing on 13Mar2021 with outcome of not recovered , fever 100F on 13Mar2021 with outcome of not recovered , chills on 13Mar2021 with outcome of not recovered , body aches on 13Mar2021 with outcome of not recovered , chest tightness on 13Mar2021 with outcome of not recovered , abdominal pain on 13Mar2021 with outcome of not recovered , flu-like symptoms on 15Mar2021 with outcome of not recovered.  The patient underwent lab tests and procedures which included body temperature: 100F on 13Mar2021 , oxygen saturation ("O2 stats"): between 88-93 for 3 weeks, sars-cov-2 "antibody" test: positive  on 16Apr2021 (blood test) , CXR with unknown  result on 17Mar2021.  Therapeutic measures were taken as a result of the reported events included injection of steroids and antibiotics.; Sender's Comments: Based on available information, a possible contributory role of the subject product,  BNT162B2 vaccine, cannot be excluded for the anaphylactic reaction and other reported events.   There is limited information provided in this report.  This case will be reassessed once additional information is available. 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: 42.0
Sex: F
Vaccine: COVID19
Symptoms: SARS-CoV-2 antibody test, X-ray
Clinical narrative: flu-like symptoms; given an injection of steroids/difficulty breathing; difficulty breathing; fever 100F; chills; body aches; chest tightness; abdominal pain; This is a spontaneous report from a contactable other HCP (patient). This 42-year-old female other HCP reported for herself received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), via an unspecified route of administration, administered in Arm Left on 12Mar2021 10:00 (Batch/Lot Number: EN6206) as 1ST DOSE, 0.3 ML SINGLE for covid-19 immunisation.  Medical history included asthma (well controlled prior to vaccine) migraines, chronic UTI, bronchitis, pneumonia, all from an unknown date and unknown if ongoing.  The patient did not have COVID prior to vaccination. The patient's concomitant medications were not reported.  The patient experienced anaphylactic reaction ("given an injection of steroids/difficulty breathing") on 13Mar2021 with outcome of not recovered , difficulty breathing on 13Mar2021 with outcome of not recovered , fever 100F on 13Mar2021 with outcome of not recovered , chills on 13Mar2021 with outcome of not recovered , body aches on 13Mar2021 with outcome of not recovered , chest tightness on 13Mar2021 with outcome of not recovered , abdominal pain on 13Mar2021 with outcome of not recovered , flu-like symptoms on 15Mar2021 with outcome of not recovered.  The patient underwent lab tests and procedures which included body temperature: 100F on 13Mar2021 , oxygen saturation ("O2 stats"): between 88-93 for 3 weeks, sars-cov-2 "antibody" test: positive  on 16Apr2021 (blood test) , CXR with unknown  result on 17Mar2021.  Therapeutic measures were taken as a result of the reported events included injection of steroids and antibiotics.; Sender's Comments: Based on available information, a possible contributory role of the subject product,  BNT162B2 vaccine, cannot be excluded for the anaphylactic reaction and other reported events.   There is limited information provided in this report.  This case will be reassessed once additional information is available. 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: F
Vaccine: COVID19
Symptoms: Cough, Dizziness, Dyspnoea, Hypersensitivity, Hypertension
Clinical narrative: urticaria; allergic process urticaria; swelling of the face; cough; shortness of breath; high blood pressure; dizziness; This is a spontaneous report from a contactable Other HCP, the patient. A 41-years-old non-pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), dose 1 via an unspecified route of administration, administered in left arm on 09Apr2021 at 10:00 (Lot Number: Ew0150) as a single dose (at the age of 41-years-old) for COVID-19 immunisation.  Medical history included allergy to animal from an unknown date and unknown if ongoing and COVID prior to the vaccination on an unknown date. The patient did not receive any other vaccine within 4 weeks prior to the vaccine.  Concomitant medication included anti contraception (unspecified product).  On 12Apr2021 at 01:00 the patient experienced allergic process urticaria on the body and swelling of the face, cough, shortness of breath, high blood pressure and dizziness. The events all required visit to emergency department. The clinical course is as follows:  on 12Apr2021 the patient started with a allergic process urticaria on the body and swelling of the face and this condition was getting worse with cough shortness of breath and high blood pressure and dizziness when on 14Apr2021, the patient couldn't stand it and went to the hospital. The patient was medicated with antiallergics and corticosteroids, but the patient still didn't feel well, her pressure keeps going up she still feel dizzy. Therapeutic measures taken as a result of urticaria, swelling, cough, shortness of breath, high blood pressure, and dizziness included unspecified antiallergics and corticosteroids. The patient was tested for COVID post vaccination on 14Apr2021 with molecular test (Swab sample) with negative result. The clinical outcome of the events allergic process urticaria on the body and swelling of the face, cough, shortness of breath, high blood pressure and dizziness was not recovered.; Sender's Comments: Based on available information, a possible contributory role of the subject product,  BNT162B2 vaccine, cannot be excluded for the reported events of urticaria, allergic reaction, swelling, cough, shortness of breath, high blood pressure  and dizziness.   There is limited information provided in this report.  This case will be reassessed once additional information is available. 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.,Linked Report(s) : PFIZER INC-2021477200 mother/baby
Age: 41.0
Sex: F
Vaccine: COVID19
Symptoms: SARS-CoV-2 test, Swelling face, Urticaria
Clinical narrative: urticaria; allergic process urticaria; swelling of the face; cough; shortness of breath; high blood pressure; dizziness; This is a spontaneous report from a contactable Other HCP, the patient. A 41-years-old non-pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), dose 1 via an unspecified route of administration, administered in left arm on 09Apr2021 at 10:00 (Lot Number: Ew0150) as a single dose (at the age of 41-years-old) for COVID-19 immunisation.  Medical history included allergy to animal from an unknown date and unknown if ongoing and COVID prior to the vaccination on an unknown date. The patient did not receive any other vaccine within 4 weeks prior to the vaccine.  Concomitant medication included anti contraception (unspecified product).  On 12Apr2021 at 01:00 the patient experienced allergic process urticaria on the body and swelling of the face, cough, shortness of breath, high blood pressure and dizziness. The events all required visit to emergency department. The clinical course is as follows:  on 12Apr2021 the patient started with a allergic process urticaria on the body and swelling of the face and this condition was getting worse with cough shortness of breath and high blood pressure and dizziness when on 14Apr2021, the patient couldn't stand it and went to the hospital. The patient was medicated with antiallergics and corticosteroids, but the patient still didn't feel well, her pressure keeps going up she still feel dizzy. Therapeutic measures taken as a result of urticaria, swelling, cough, shortness of breath, high blood pressure, and dizziness included unspecified antiallergics and corticosteroids. The patient was tested for COVID post vaccination on 14Apr2021 with molecular test (Swab sample) with negative result. The clinical outcome of the events allergic process urticaria on the body and swelling of the face, cough, shortness of breath, high blood pressure and dizziness was not recovered.; Sender's Comments: Based on available information, a possible contributory role of the subject product,  BNT162B2 vaccine, cannot be excluded for the reported events of urticaria, allergic reaction, swelling, cough, shortness of breath, high blood pressure  and dizziness.   There is limited information provided in this report.  This case will be reassessed once additional information is available. 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.,Linked Report(s) : PFIZER INC-2021477200 mother/baby
Age: 39.0
Sex: F
Vaccine: COVID19
Symptoms: Abortion spontaneous, Dysmenorrhoea, Haemorrhage
Clinical narrative: I miscarried; bleeding really bad the 3 day.; Starting cramping the night if my second vaccine.; This is a spontaneous report from a contactable other HCP (the patient). A 39-year-old female patient received the second dose of  BNT162B2  (PFIZER-BIONTECH COVID-19 MRNA VACCINE, Lot number unknown), via an unspecified route of administration, on 10Apr2021 at 15:30 (at the age of 39-years-old)  as a single dose in the left arm for COVID-19 immunization. The patient's medical history was not reported.  The patient did not have COVID-19 prior to the vaccination. The patient had not received any other vaccines within four weeks prior to the vaccination. Historical vaccinations included the first dose of  bnt162b2  (PFIZER-BIONTECH COVID-19 MRNA VACCINE, Lot number unknown) on 20Mar2021 at 15:45 (at the age of 39 years old) as a single dose in the right arm. The patient previously took celecoxib (CELEXA) and experienced drug hypersensitivity and morphine and experienced drug hypersensitivity. The patient's last menstrual period was 16Feb2021. She reported that she became pregnant while taking bnt162b2.  The patient was due to deliver on 23Nov2021.  She stated that she was 8 weeks pregnant at the onset of the following reported events: The patient experienced "started  cramping" the night of her second vaccine on 10 Apr2021 and the cramping lasted for two days with outcome of recovering,  she started bleeding really bad the third day on 13Apr2021 with outcome of recovering and she reports that she miscarried  on 13Apr2021 with outcome of recovering. The patient commented further that she mscarried right after her doctor confirmed her pregnancy was healthy and her  baby had heartbeat the day before her second vaccine. The patient has not been tested for COVID-19 since vaccination.   Information on the lot/batch number has been requested.; Sender's Comments: Based on chronological connection to the vaccine a causal relationship between reported events and BNT162B2  (PFIZER-BIONTECH COVID-19 MRNA VACCINE) cannot be completely excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
Age: 30.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Decreased appetite, Delirium, Dysgeusia, Nausea
Clinical narrative: delirious; left side of body feeling swollen; whole body sensitive; do not want to eat anything; have a metallic taste in my mouth; nausea/I still feel nausea; I woke up at 4am on Thursday feeling chills; This is a spontaneous report from a contactable consumer.   A 30-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 2 via an unspecified route of administration, administered in Left Arm on 21Apr2021 13:30 (Batch/Lot Number: ER8729) as SINGLE DOSE (at the age of 30) for covid-19 immunisation.  Dose 1 of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) was given on 30Mar2021 16:45 lot number EW0150, in left arm for Covid-19 immunisation.  Medical history was none.   The patient did not have Covid-19 prior vaccination.  The patient had no known allergies.  The patient is not pregnant.  Concomitant medication included ethinylestradiol, levonorgestrel (SEASONIQUE) taken for an unspecified indication.  The patient took no other vaccine except BNT162B2 in four weeks.  The patient experienced delirious (medically significant) on 22Apr2021 04:00 with outcome of recovering, left side of body feeling swollen on 22Apr2021 04:00 with outcome of recovering, whole body sensitive on 22Apr2021 04:00 with outcome of recovering, do not want to eat anything on 22Apr2021 04:00 with outcome of recovering, have a metallic taste in my mouth on 22Apr2021 04:00 with outcome of recovering, nausea and still feel nausea on 22Apr2021 04:00 with outcome of recovering, woke up at 4am feeling chills on 22Apr2021 04:00 with outcome of recovering.  The patient was not Covid tested post vaccination.
Age: 30.0
Sex: F
Vaccine: COVID19
Symptoms: Sensitisation, Swelling
Clinical narrative: delirious; left side of body feeling swollen; whole body sensitive; do not want to eat anything; have a metallic taste in my mouth; nausea/I still feel nausea; I woke up at 4am on Thursday feeling chills; This is a spontaneous report from a contactable consumer.   A 30-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 2 via an unspecified route of administration, administered in Left Arm on 21Apr2021 13:30 (Batch/Lot Number: ER8729) as SINGLE DOSE (at the age of 30) for covid-19 immunisation.  Dose 1 of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) was given on 30Mar2021 16:45 lot number EW0150, in left arm for Covid-19 immunisation.  Medical history was none.   The patient did not have Covid-19 prior vaccination.  The patient had no known allergies.  The patient is not pregnant.  Concomitant medication included ethinylestradiol, levonorgestrel (SEASONIQUE) taken for an unspecified indication.  The patient took no other vaccine except BNT162B2 in four weeks.  The patient experienced delirious (medically significant) on 22Apr2021 04:00 with outcome of recovering, left side of body feeling swollen on 22Apr2021 04:00 with outcome of recovering, whole body sensitive on 22Apr2021 04:00 with outcome of recovering, do not want to eat anything on 22Apr2021 04:00 with outcome of recovering, have a metallic taste in my mouth on 22Apr2021 04:00 with outcome of recovering, nausea and still feel nausea on 22Apr2021 04:00 with outcome of recovering, woke up at 4am feeling chills on 22Apr2021 04:00 with outcome of recovering.  The patient was not Covid tested post vaccination.
Age: 30.0
Sex: F
Vaccine: COVID19
Symptoms: Angioedema, Arthralgia, Inflammation, Lethargy, Oedema
Clinical narrative: Angioedema of left arm at the inoculation site; Pruritus; Inflammation; Pain; edema; Lethargy; arthralgia/shoulder joint pain; This is a spontaneous report from a contactable consumer (patient). A 30-year-old non-pregnant female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; solution for injection; Lot Number: EW0170) via an unspecified route of administration on 20Apr2021 at 11:15 (at the age of 30-years-old) as a single dose in the left arm for COVID-19 immunisation. Medical history included penicillin allergy, HAE (hereditary angioedema), endometriosis, narcolepsy and depression, all from unspecified dates and unspecified if ongoing. The patient was not diagnosed with COVID-19 prior to vaccination. The patient previously received NSAIDs for an unspecified indication on an unspecified date and experienced allergy. The patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; solution for injection; Lot Number: EW0170) via an unspecified route of administration on 30Mar2021 at 16:15 (at the age of 30-years-old) as a single dose in the left arm for COVID-19 immunisation. Concomitant medications (other medications in two weeks) included bupropion, desvenlafaxine, oxybate sodium (XYREM) and icatibant, all taken for unspecified indications on unspecified dates. The patient did not receive another vaccine within 4 weeks prior to the COVID-19 vaccination. On 20Apr2021 at 13:15 the patient experienced angioedema of left arm at the inoculation site, pruritus, inflammation, pain, edema, lethargy and arthralgia/shoulder joint pain. The clinical course was reported as follows: "Angioedema of left arm at the inoculation site. Diameter of 70 mm. Pruritus subsided within 72 hours. Inflammation remains at present: Approx 96 hours after injection. Pain accompanies edema when pressure is applied. Lethargy and arthralgia for 72 hours. Shoulder joint pain. Note: patient's arm is thin; angioedema extended from anterior to posterior sides of the arm." The patient did not receive treatment for the events. The clinical outcomes of the events angioedema of left arm at the inoculation site, pruritus, inflammation, pain, edema, lethargy and arthralgia/shoulder joint pain were recovering/resolving. Since the vaccination, the patient had not been tested for COVID-19.
Age: 30.0
Sex: F
Vaccine: COVID19
Symptoms: Pain, Pruritus
Clinical narrative: Angioedema of left arm at the inoculation site; Pruritus; Inflammation; Pain; edema; Lethargy; arthralgia/shoulder joint pain; This is a spontaneous report from a contactable consumer (patient). A 30-year-old non-pregnant female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; solution for injection; Lot Number: EW0170) via an unspecified route of administration on 20Apr2021 at 11:15 (at the age of 30-years-old) as a single dose in the left arm for COVID-19 immunisation. Medical history included penicillin allergy, HAE (hereditary angioedema), endometriosis, narcolepsy and depression, all from unspecified dates and unspecified if ongoing. The patient was not diagnosed with COVID-19 prior to vaccination. The patient previously received NSAIDs for an unspecified indication on an unspecified date and experienced allergy. The patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; solution for injection; Lot Number: EW0170) via an unspecified route of administration on 30Mar2021 at 16:15 (at the age of 30-years-old) as a single dose in the left arm for COVID-19 immunisation. Concomitant medications (other medications in two weeks) included bupropion, desvenlafaxine, oxybate sodium (XYREM) and icatibant, all taken for unspecified indications on unspecified dates. The patient did not receive another vaccine within 4 weeks prior to the COVID-19 vaccination. On 20Apr2021 at 13:15 the patient experienced angioedema of left arm at the inoculation site, pruritus, inflammation, pain, edema, lethargy and arthralgia/shoulder joint pain. The clinical course was reported as follows: "Angioedema of left arm at the inoculation site. Diameter of 70 mm. Pruritus subsided within 72 hours. Inflammation remains at present: Approx 96 hours after injection. Pain accompanies edema when pressure is applied. Lethargy and arthralgia for 72 hours. Shoulder joint pain. Note: patient's arm is thin; angioedema extended from anterior to posterior sides of the arm." The patient did not receive treatment for the events. The clinical outcomes of the events angioedema of left arm at the inoculation site, pruritus, inflammation, pain, edema, lethargy and arthralgia/shoulder joint pain were recovering/resolving. Since the vaccination, the patient had not been tested for COVID-19.
Age: 30.0
Sex: M
Vaccine: COVID19
Symptoms: Dyspnoea, SARS-CoV-2 test
Clinical narrative: severe dyspnea; This is a spontaneous report from a contactable Physician (patient). This  30-years-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), dose 2 via an unspecified route of administration, administered in left arm on 12Jan2021 (Lot Number: EK9231) at the age of 30 years, as single dose for COVID-19 immunization. Medical history included COVID-19 in Mar2020. The patient had no known allergies. There were no concomitant medications. Historical vaccine included BNT162B2, dose 1 in right arm, on 20Dec2020, lot # EK5730. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 26Jan2021 the patient experienced severe dyspnea, seriousness criteria reported as disability.  The clinical course was reported as follows:  Patient with history of COVID-19 infection in Mar2020 developed severe dyspnea approximately 2 weeks after vaccination. Refractory to treatment with bronchodilators. Only responsive to high-dose steroids. Of note, patients symptoms from COVID-19 had completely resolved months prior to vaccination and patient had no other medical history. Therapeutic measures were taken as a result of severe dyspnea and included Breztri, albuterol, prednisone. The clinical outcome of the severe dyspnea event was not recovered. . It was also reported that since the vaccination, the patient had tested for COVID-19: Sars-cov-2 test: negative on 04Feb2021 with nasal swab.; Sender's Comments: Based on the current available information and the plausible drug-event temporal association, a possible contributory role of the suspect product BNT162B2 to the development of event Dyspnea cannot be excluded.  The case will be reassessed if additional information becomes available.  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.
Age: 60.0
Sex: M
Vaccine: COVID19
Symptoms: Bell's palsy, SARS-CoV-2 test
Clinical narrative: Bell's Palsey; This is a spontaneous report from a contactable consumer, the patient. A 60-year-old male patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; Lot: ER8734) in the left arm on 01Apr2021 at 13:00 (at the age of 60-years-old)  as a single dose for COVID-19 immunization. Medical history was none. The patient had no known allergies. The patient was not diagnosed with COVID-19 prior to vaccination. Concomitant medications included loratadine (CLARITIN) and fexofenadine hydrochloride (ALLEGRA). The patient previous received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; Lot number: EN6204) on 11Mar2021 at 14:00 (at the age of 60-years-old) in the left arm for COVID-19 immunization. There were no other vaccinations within 4 weeks of the vaccine. On 04Apr2021 at 12:00 (reported as 3 days after the second vaccination), the patient experienced Bell's Palsy and it was difficult to close the left eye and move the left side of his mouth. The patient visited a doctor or other healthcare professional because of this event. It was unknown if the patient received treatment for the event. Since the vaccination, the patient was tested for COVID-19 via a molecular nasal swab on 15Apr2021 with negative results. The clinical outcome of Bell's Palsy was not resolved.
Age: 57.0
Sex: M
Vaccine: COVID19
Symptoms: Blood pressure measurement, Cardiac imaging procedure, Echocardiogram, Heart rate, Heart rate increased
Clinical narrative: (2) episodes of racing heart beat 110 and 139 with High Blood Pressure; (2) episodes of racing heart beat 110 and 139 with High Blood Pressure; This is a spontaneous report from a contactable consumer. A 57-years-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), dose 1, via an unspecified route of administration, administered in right arm on 10Apr2021 12:00 (Lot Number: EW0161) as SINGLE DOSE  (at the age of 57 years old) for covid-19 immunisation.  Medical history included atrial fibrillation from an unknown date and unknown if ongoing. Prior to COVID Vaccine on 07Apr2021 he entered in AFib and needed to be Cardioverted. The patient did not have any known allergies. The patient's concomitant medications was none.  The patient did receive any other vaccine within 4 weeks prior to the vaccine. The patient received the BNT162B2 vaccine at Public Health Clinic. Prior to the vaccination, the patient was not diagnosed with COVID-19.  The patient called his primary care physician and asked should he take the shot scheduled for 10Apr2021 and she told him he was ok to take the shot. On 16Apr2021 22:00 and 18Apr2021 he had (2) episodes of racing heart beat 110 and 139 with high blood pressure. On unknown date, he was admitted to the hospital on the second and had a Cardiac CT Scan and Echocardiogram both came back negative for coronary heart disease or any heart issues. He was on a patch for 2 week electrical study. On beta blockers and antianxiety. He had no prior heart or anxiety issues ever in his life. The events resulted in Emergency room/department or urgent care, and Hospitalization. Number of days of hospitalization was 1. The patient underwent lab tests and procedures which included blood pressure: high on 16Apr2021, Cardiac CT Scan: negative on unknown date, echocardiogram: negative on unknown date, heart beat: 110 on 16Apr2021, heart beat: 139   on 18Apr2021 , Covid test: Negative on 01Feb2021. Outcome of the events was not recovered.
Age: 57.0
Sex: M
Vaccine: COVID19
Symptoms: Palpitations, SARS-CoV-2 test
Clinical narrative: (2) episodes of racing heart beat 110 and 139 with High Blood Pressure; (2) episodes of racing heart beat 110 and 139 with High Blood Pressure; This is a spontaneous report from a contactable consumer. A 57-years-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), dose 1, via an unspecified route of administration, administered in right arm on 10Apr2021 12:00 (Lot Number: EW0161) as SINGLE DOSE  (at the age of 57 years old) for covid-19 immunisation.  Medical history included atrial fibrillation from an unknown date and unknown if ongoing. Prior to COVID Vaccine on 07Apr2021 he entered in AFib and needed to be Cardioverted. The patient did not have any known allergies. The patient's concomitant medications was none.  The patient did receive any other vaccine within 4 weeks prior to the vaccine. The patient received the BNT162B2 vaccine at Public Health Clinic. Prior to the vaccination, the patient was not diagnosed with COVID-19.  The patient called his primary care physician and asked should he take the shot scheduled for 10Apr2021 and she told him he was ok to take the shot. On 16Apr2021 22:00 and 18Apr2021 he had (2) episodes of racing heart beat 110 and 139 with high blood pressure. On unknown date, he was admitted to the hospital on the second and had a Cardiac CT Scan and Echocardiogram both came back negative for coronary heart disease or any heart issues. He was on a patch for 2 week electrical study. On beta blockers and antianxiety. He had no prior heart or anxiety issues ever in his life. The events resulted in Emergency room/department or urgent care, and Hospitalization. Number of days of hospitalization was 1. The patient underwent lab tests and procedures which included blood pressure: high on 16Apr2021, Cardiac CT Scan: negative on unknown date, echocardiogram: negative on unknown date, heart beat: 110 on 16Apr2021, heart beat: 139   on 18Apr2021 , Covid test: Negative on 01Feb2021. Outcome of the events was not recovered.
Sex: F
Vaccine: COVID19
Symptoms: Bronchitis, COVID-19, Drug ineffective, Ear infection, SARS-CoV-2 test
Clinical narrative: tested positive for COVID-19/She sends herself to do Covid test and the result was positive; tested positive for COVID-19/She sends herself to do Covid test and the result was positive; sinus and ear infection; sinus and ear infection; bronchitis; This is a spontaneous report from a contactable consumer (patient) from a Pfizer sponsored.   This 64-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 02Apr2021 (Lot number was not reported) as single dose for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. On an unspecified date in Apr2021, the patient experienced tested positive for COVID-19/she sends herself to do COVID test and the result was positive, sinus and ear infection, bronchitis. The outcome of the events was unknown.  The patient underwent lab tests and procedures which included SARS-CoV-2 test: positive in Apr2021.   The patient stated that she received the first dose of Pfizer COVID vaccine on 02Apr2021. She traveled to (state) and had sinus and ear infection while there and when she came back to see her doctor she tested positive for COVID-19 and bronchitis. Her symptoms started on 15Apr2021. Her physician told her that her quarantine period would end on 26Apr2021. She mentioned that she traveled and went back home last 20Apr2021. She sends herself to do Covid test and the result was positive. The 2nd dose schedule will be on 28Apr2021, which is more than 21 days.  She asked if it is okay to get the 2nd dose. She would like to know if she should get re-tested prior to receiving the second dose?  Information about lot/batch number has been requested.
Sex: F
Vaccine: COVID19
Symptoms: Sinusitis
Clinical narrative: tested positive for COVID-19/She sends herself to do Covid test and the result was positive; tested positive for COVID-19/She sends herself to do Covid test and the result was positive; sinus and ear infection; sinus and ear infection; bronchitis; This is a spontaneous report from a contactable consumer (patient) from a Pfizer sponsored.   This 64-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 02Apr2021 (Lot number was not reported) as single dose for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. On an unspecified date in Apr2021, the patient experienced tested positive for COVID-19/she sends herself to do COVID test and the result was positive, sinus and ear infection, bronchitis. The outcome of the events was unknown.  The patient underwent lab tests and procedures which included SARS-CoV-2 test: positive in Apr2021.   The patient stated that she received the first dose of Pfizer COVID vaccine on 02Apr2021. She traveled to (state) and had sinus and ear infection while there and when she came back to see her doctor she tested positive for COVID-19 and bronchitis. Her symptoms started on 15Apr2021. Her physician told her that her quarantine period would end on 26Apr2021. She mentioned that she traveled and went back home last 20Apr2021. She sends herself to do Covid test and the result was positive. The 2nd dose schedule will be on 28Apr2021, which is more than 21 days.  She asked if it is okay to get the 2nd dose. She would like to know if she should get re-tested prior to receiving the second dose?  Information about lot/batch number has been requested.
Age: 39.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: tested positive with COVID-19; Tested positive with COVID-19; This is a spontaneous report from a contactable consumer, reporting for himself. This is the 1st of 2 reports.  A male patient of an unspecified age received BNT162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), dose 2 via an unspecified route of administration, administered in the left arm on 18Feb2021 at 15:30 (Batch/Lot Number: EN6201) as 2ND DOSE, SINGLE, and dose 1 via an unspecified route of administration, administered in the left arm on 28Jan2021 at 15:30 (Batch/Lot Number: EL9262) as 1ST DOSE, SINGLE for covid-19 immunisation.  The patient's medical history was not reported. There were concomitant medications, but they were not specified. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient tested positive with covid-19 on 22Apr2021 with outcome of recovering.  It was reported that his daughter and her daycare provider are the people whom exposed him. The event required Doctor or other healthcare professional office/clinic visit. The patient underwent lab tests and procedures which included sars-cov-2 test nasal swab: positive on 22Apr2021. Treatment was not required for the events.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021460648 same reporter/drug/AE, different patients.
Age: 36.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: COVID-19 confirmed by positive COVID-19 test; COVID-19 confirmed by positive COVID-19 test; This is a spontaneous report from a contactable consumer (patient). This 36-year-old non-pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE) (Batch/Lot Number: EL9262), dose 1, via an unspecified route of administration in the left arm on 28Jan2021 at 15:30 (at the age of 36-years-old) as 1st DOSE, SINGLE; and BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE) (Batch/Lot Number: EN6201), dose 2, via an unspecified route of administration in the left arm on 18Feb2021 at 15:30 (at the age of 36-years-old) as 2nd DOSE, SINGLE for covid-19 immunisation. The patient's medical history and concomitant medication were not reported. The patient had no known allergies. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient received other unspecified medications within 2 weeks of vaccination. On 22Apr2021 (also reported as 17Apr2021 at 14:00), the patient tested positive for covid 19 after being fully vaccinated. The onset date of the event was reported as 17Apr2021 at 1400. The adverse events resulted in a doctor or other healthcare professional office/clinic visit. No therapeutic measures were taken as a result of the events. The patient underwent lab tests and procedures which included sars-cov-2 test (PCR) (22Apr2021): positive (Nasal Swab). Clinical outcome of the events tested positive for covid-19 after being fully vaccinated was resolving.