chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 69.0
Sex: M
Vaccine: COVID19
Symptoms: Respiratory distress
Clinical narrative: Respiratory distress on exertion; Chills; Joint pain; first dose of BNT162B2 administered in left leg; first dose and second dose received on same day (08Mar2021); first dose and second dose received on same day (08Mar2021); This is a spontaneous report received from a contactable Other Health Professional (patient). A 69-year-old male patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection, Lot Number: EN6204) via an unspecified route of administration in the left leg and second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection, Lot Number: 8732) via an unspecified route of administration in the right arm on 08Mar2021 (at the age of 69-year-old) at 11:00 as a single dose for Covid-19 immunization in hospital. The patient had no allergies and medical history. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Concomitant medication included an unspecified blood pressure medication (within 2 weeks of vaccination). Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On 01Apr2021, the patient experienced respiratory distress on exertion, chills and Joint pain. Patient did not receive any treatment for the events. The outcome of the events was recovering.  Information on Lot/Batch number was available. Additional information has been requested.; Sender's Comments: Based on the information currently available,The casual association between the reported events and suspected vaccine BNT162B2 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 Committees, and Investigators, as appropriate.
Age: 26.0
Sex: M
Vaccine: COVID19
Symptoms: Loss of consciousness
Clinical narrative: passed out/unconscious; This is a spontaneous report from a contactable consumer (patient). A 26-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), dose 1 via an unspecified route of administration, administered in Arm Right on 30Mar2021 06:00 (Lot Number: ER8732) as SINGLE DOSE and dose 2 via an unspecified route of administration, administered in Arm Right on 22Apr2021 06:00 (Lot Number: ER8736) as SINGLE DOSE for COVID-19 immunization. Medical history included penicillin, amoxicillin and sulfa drugs allergy from an unknown date and unknown if ongoing. The patient's concomitant medications were not reported. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. It was reported that after both doses of the vaccine, the patient had a regular evening and a full night's sleep. On 31Mar2021 07:00, the patient stated, "When I woke up and walked to the bathroom, I passed out both times. I was unconscious for a minute and was helped up, but passed out again and woke up a minute later. Emergency medical services were contacted both times". The events resulted in visit in emergency room/department or urgent care. The outcome of the event was recovered on unspecified date.  No follow-up attempts are needed. No further information is expected.
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Diplopia, Headache, Pain
Clinical narrative: This is a spontaneous report from a contactable consumer (patient). A 65-years-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), via an unspecified route of administration at arm left on 11Feb2021 07:30 (Batch/Lot Number: Unknown as unable to locate or read the details; expiration: not reported) as single dose for COVID-19 immunization (at the age of 65 years and the patient was not pregnant). Medical history included known allergies: penicillin. The patient concomitant medications were not reported. No other medications the patient received within 2 weeks of vaccination. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On 18Feb2021 at 07:00, exactly one week after shot, the patient experienced body aches, then severe 3-day headache during which sudden onset diplopia began and had persisted to this day, almost 10 weeks later. No other cause of the diplopia has been determined after numerous scans, MRIs, blood texts, etc. The patient went to doctor or other healthcare professional office/clinic visit. The outcome for all the events was not recovered.   Follow up needed. Information on the lot/batch number has been requested.
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, Inappropriate schedule of product administration, Off label use, SARS-CoV-2 test
Clinical narrative: tested positive for Covid-19; tested positive for Covid-19; She was advised by a physician that they will administer the second dose after 90 days; She was advised by a physician that they will administer the second dose after 90 days; This is a spontaneous report from a contactable consumer (patient) from the Pfizer-sponsored program. A female patient of unspecified age received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), via an unspecified route of administration on 19Mar2021 (Batch/Lot number: not reported) as a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient said that, after her first dose, she started getting sick and tested positive for COVID-19 on 08Apr2021. She was advised by a physician that they will administer the second dose after 90 days. The patient underwent lab tests and procedures which included SARS-CoV-2 test: positive on 08Apr2021. The outcome of the events was unknown.   Information on the batch/lot number has been requested.
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, Illness, SARS-CoV-2 test positive
Clinical narrative: tested positive for Covid-19; tested positive for Covid-19; She was advised by a physician that they will administer the second dose after 90 days; She was advised by a physician that they will administer the second dose after 90 days; This is a spontaneous report from a contactable consumer (patient) from the Pfizer-sponsored program. A female patient of unspecified age received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), via an unspecified route of administration on 19Mar2021 (Batch/Lot number: not reported) as a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient said that, after her first dose, she started getting sick and tested positive for COVID-19 on 08Apr2021. She was advised by a physician that they will administer the second dose after 90 days. The patient underwent lab tests and procedures which included SARS-CoV-2 test: positive on 08Apr2021. The outcome of the events was unknown.   Information on the batch/lot number has been requested.
Age: 29.0
Sex: F
Vaccine: COVID19
Symptoms: Dyspnoea, Pulmonary embolism, SARS-CoV-2 test
Clinical narrative: Presented to hospital 14Apr2021 with dyspnea and found to have bilateral pulmonary Embolism.; Presented to hospital 14Apr2021 with dyspnea and found to have bilateral pulmonary Embolism.; This is a spontaneous report from a contactable physician.  A 29-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number and expiration date not provided), intramuscular first dose on 08Apr2021 at single dose for covid-19 immunisation.  The patient's medical history and concomitant medications were not reported.  The patient was not pregnant at time of vaccination. The patient was presented to hospital on 14Apr2021 (also reported on 04Jan2021) with dyspnea and found to have bilateral pulmonary Embolism. The event caused hospitalization on 14Apr2021. The patient was treated with Anticoagulation. The patient underwent lab tests and procedures which included Nasal Swab: negative on 14Apr2021. The outcome of the events was recovered.  Information on the lot/batch number has been requested.
Sex: F
Vaccine: COVID19
Symptoms: Drug ineffective, SARS-CoV-2 test, SARS-CoV-2 test positive
Clinical narrative: tested positive with Covid-19; tested positive with Covid-19; This is a spontaneous report from contactable consumer (patient) through a Pfizer-sponsored program. A female patient of an unspecified age received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN), via an unspecified route of administration on 04Apr2021 as single dose for COVID-19 immunization.  The patient's medical history and concomitant medications were not reported.  The patient received her 1st dose of Covid-19 vaccine on 04Apr2021. However, a few weeks later in Apr2021 she got tested positive with COVID-19. She was scheduled tomorrow (25Apr2021) for her 2nd dose. She wants to know if it is safe for her to take the 2nd dose of COVID-19 vaccine. The patient tested positive on SARS-COV-2 test on an unspecified date in Apr2021. The clinical outcome of the tested positive with COVID-19 was not reported.  The lot number for the vaccine, BNT162b2, was not provided and will be requested during follow-up.
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: he caught covid-19 virus after his 1st dose and was done with his 14days quarantine yesterday; he caught covid-19 virus after his 1st dose and was done with his 14days quarantine yesterday; This is a spontaneous report from a contactable consumer, the patient. This male patient of unspecified age received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot Number: UNKNOWN) via an unspecified route on 06Apr2021 as a single dose for COVID-19 immunization. Medical history and concomitant medications were not reported. The patient reported that he already got his 1st dose 3 weeks ago (06Apr2021) and was scheduled to have his 2nd dose on 27Apr2021. The patient caught COVID-19 virus after his 1st dose (Apr2021) and was done with his 14 days quarantine yesterday (23Apr2021). The clinical outcome of caught COVID-19 virus after his 1st dose was unknown.  The lot number for the vaccine, BNT162b2, was not provided and will be requested during follow up.
Age: 85.0
Sex: F
Vaccine: COVID19
Symptoms: Cystitis, Viral infection
Clinical narrative: Bladder infection; Viral infection; This is a spontaneous report from a contactable consumer (patient). This 85-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration, administered in arm left on 20Mar2021 (Batch/Lot Number: ER2613) as a single dose for COVID-19 immunization. Medical history included arthritis and chronic obstructive pulmonary disease (COPD). Concomitant medication included paracetamol (TYLENOL) for arthritis. Patient was alright for a few days after vaccination and then all of a sudden, patient started getting infections on 28Mar2021, 8 days after she had the first vaccine. She got a really bad bladder infection then she went to the doctor and got medication for that. She was with bladder infection then she came down with the viral infection and she was not even been going anywhere because of the virus, she was been staying home, just to the grocery store and clinic to the doctor. Patient got medicines for the bladder infection: antibiotics (sulfamethoxazole) and she was not quite over that and then she got a virus infection. She went back to the clinic but they did not gave her any medication for that. It was just a viral infection, it was not the COVID-19. Outcome of the events was unknown.  No follow-up attempts are needed. No further information is expected.
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Blister, Dyspnoea, Musculoskeletal stiffness, Rash vesicular
Clinical narrative: started scratching and now the holes are open on areas to her chest; stated that the left side of her face is hard as a rock; Has rash on left side of face down to chest with blistery spots; could not breathe/cannot catch her breath every now and then; This is a spontaneous report from a contactable consumer (patient). A 60-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) at the age of 60-year-old, dose 1 via an unspecified route of administration, administered in right arm on 17Apr2021 (Lot Number: EW0171) as single dose for COVID-19 immunisation. Medical history included high blood pressure; and bad feet since 2004. The patient's concomitant medications were not reported. The patient had first vaccine on 17Apr2021. On 18Apr2021, she had a reaction, could not breathe. She cannot catch her breath every now and then and had to use the Epipen. Has been using nebulizer. Has more Epipens in case something else happened. Stated that she has a rash on the left side of her face down to her chest with blistery spots and that the left side of face was hard as a rock on 19Apr2021. Stated that the rash was worst on her chest. Has put some cream on the rash but it burns. Had a pain cream called Volten that she put on it because the rash was painful but that made it worst. Stated that she started scratching and now the holes are open on areas to her chest on 21Apr2021. Stated that she had to wear low shirts because her shirts were rubbing her chest. Stated that she was told by her doctor not to take the second shot that was scheduled for 17May2021. Stated that she has scheduled doctor's appointments that were fine. The patient wanted to know if she could get something in writing to submit with her passport stating the she could not have the second shot. The outcome of the event could not breathe/cannot catch her breath every now and then was recovered with sequel, and for the rest of the events was not recovered.
Age: 24.0
Sex: F
Vaccine: COVID19
Symptoms: Delirium, Dysarthria, Memory impairment, Tremor
Clinical narrative: Delirium; mumbling unintelligbly; shaking uncontrollably; not recognizing family members; This is a spontaneous report from a non-contactable healthcare professional, the patient. A 24-year-old non-pregnant female patient received BNT162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) (at the age of 24-years-old) as a single dose for COVID-19 immunisation. Medical history included COVID from an unknown date and unknown if ongoing. The patient's concomitant medications were not reported. The patient did not receive other vaccine in four weeks. The patient did have COVID prior vaccination and the patient did not test for COVID post vaccination. On an unspecified date, the patient experienced delirium at night of given dose in the morning. The patient was not feverish, but she was mumbling unintelligibly, shaking uncontrollably and not recognizing family members. The patient received ibuprofen and acetaminophen as the treatment for the events. the outcome of events, delirium, mumbling unintelligibly, shaking uncontrollably and not recognizing family members was recovering.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.; Sender's Comments: Based on chronological connection to the vaccine a causal relationship between event delirium and BNT162b2 (PFIZER-BIONTECH COVID-19 VACCINE) cannot be excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Blood test, Body temperature, Circumoral swelling, Cough
Clinical narrative: High fever of 107.5 degree Fahrenheit; Dizziness; Nausea; Headache; Fatigue; Joint and muscle pain; Joint and muscle pain; Blurred vision; Persistent cough; My glands started hurting; My ears hurt specially on the right where the shot was given everything is the worse; Sore throat; Jaw pain; my neck under my chin is swollen and painful; my neck under my chin is swollen and painful; Abscess in my gum and swelling and blisters in my mouth; Abscess in my gum and swelling and blisters in my mouth; Abscess in my gum and swelling and blisters in my mouth; This is a spontaneous report from a contactable consumer(patient). A 60-years-old female patient received first dose of bnt162b2 (BNT162B2, solution for injection, Lot Number: EW016) via an unspecified route of administration in right arm on 19Apr2021 at 17:15 as SINGLE DOSE for covid-19 immunization. Patient was 60 years old at the time of vaccination. Medical history included rheumatoid arthritis, COPD, chronic empyema, asthma, chronic bronchitis, gastritis, irritable bowel syndrome, blood pressure high and digestive disorder, all from an unknown date and unknown if ongoing. Concomitant medications included quetiapine fumarate (SEROQUEL), POTASSIUM CHLORIDE, albuterol sulfate (ALBUTEROL), budesonide, formoterol fumarate (SYMBICORT), FLUNISOLIDE, FLUOXETINE, HYDROCHLOROTHIAZIDE, IPRATROPIN, METOPROLOL, MONTELUKAST, PANTOPRAZOLE, FAMOTIDINE and LOSARTAN, all taken on unspecified date for unknown indication. In Apr20, the patient had high fever of 107.5 degree fahrenheit, dizziness, nausea, headache, fatigue, joint and muscle pain, blurred vision, persistent cough, my glands started hurting, my ears hurt specially on the right where the shot was given everything was the worse, sore throat, jaw pain and neck pain, my neck under my chin is swollen and painful, abscess in my gum and swelling and blisters in my mouth. On unspecified date, the patient underwent lab tests and procedures which included body temperature 107.5 degree F, blood test which she does every year and she had a follow up every 6 months. Outcome of the events was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Ear pain, Fatigue, Gingival abscess, Headache
Clinical narrative: High fever of 107.5 degree Fahrenheit; Dizziness; Nausea; Headache; Fatigue; Joint and muscle pain; Joint and muscle pain; Blurred vision; Persistent cough; My glands started hurting; My ears hurt specially on the right where the shot was given everything is the worse; Sore throat; Jaw pain; my neck under my chin is swollen and painful; my neck under my chin is swollen and painful; Abscess in my gum and swelling and blisters in my mouth; Abscess in my gum and swelling and blisters in my mouth; Abscess in my gum and swelling and blisters in my mouth; This is a spontaneous report from a contactable consumer(patient). A 60-years-old female patient received first dose of bnt162b2 (BNT162B2, solution for injection, Lot Number: EW016) via an unspecified route of administration in right arm on 19Apr2021 at 17:15 as SINGLE DOSE for covid-19 immunization. Patient was 60 years old at the time of vaccination. Medical history included rheumatoid arthritis, COPD, chronic empyema, asthma, chronic bronchitis, gastritis, irritable bowel syndrome, blood pressure high and digestive disorder, all from an unknown date and unknown if ongoing. Concomitant medications included quetiapine fumarate (SEROQUEL), POTASSIUM CHLORIDE, albuterol sulfate (ALBUTEROL), budesonide, formoterol fumarate (SYMBICORT), FLUNISOLIDE, FLUOXETINE, HYDROCHLOROTHIAZIDE, IPRATROPIN, METOPROLOL, MONTELUKAST, PANTOPRAZOLE, FAMOTIDINE and LOSARTAN, all taken on unspecified date for unknown indication. In Apr20, the patient had high fever of 107.5 degree fahrenheit, dizziness, nausea, headache, fatigue, joint and muscle pain, blurred vision, persistent cough, my glands started hurting, my ears hurt specially on the right where the shot was given everything was the worse, sore throat, jaw pain and neck pain, my neck under my chin is swollen and painful, abscess in my gum and swelling and blisters in my mouth. On unspecified date, the patient underwent lab tests and procedures which included body temperature 107.5 degree F, blood test which she does every year and she had a follow up every 6 months. Outcome of the events was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Hyperpyrexia, Lymphadenopathy, Myalgia, Nausea, Neck pain
Clinical narrative: High fever of 107.5 degree Fahrenheit; Dizziness; Nausea; Headache; Fatigue; Joint and muscle pain; Joint and muscle pain; Blurred vision; Persistent cough; My glands started hurting; My ears hurt specially on the right where the shot was given everything is the worse; Sore throat; Jaw pain; my neck under my chin is swollen and painful; my neck under my chin is swollen and painful; Abscess in my gum and swelling and blisters in my mouth; Abscess in my gum and swelling and blisters in my mouth; Abscess in my gum and swelling and blisters in my mouth; This is a spontaneous report from a contactable consumer(patient). A 60-years-old female patient received first dose of bnt162b2 (BNT162B2, solution for injection, Lot Number: EW016) via an unspecified route of administration in right arm on 19Apr2021 at 17:15 as SINGLE DOSE for covid-19 immunization. Patient was 60 years old at the time of vaccination. Medical history included rheumatoid arthritis, COPD, chronic empyema, asthma, chronic bronchitis, gastritis, irritable bowel syndrome, blood pressure high and digestive disorder, all from an unknown date and unknown if ongoing. Concomitant medications included quetiapine fumarate (SEROQUEL), POTASSIUM CHLORIDE, albuterol sulfate (ALBUTEROL), budesonide, formoterol fumarate (SYMBICORT), FLUNISOLIDE, FLUOXETINE, HYDROCHLOROTHIAZIDE, IPRATROPIN, METOPROLOL, MONTELUKAST, PANTOPRAZOLE, FAMOTIDINE and LOSARTAN, all taken on unspecified date for unknown indication. In Apr20, the patient had high fever of 107.5 degree fahrenheit, dizziness, nausea, headache, fatigue, joint and muscle pain, blurred vision, persistent cough, my glands started hurting, my ears hurt specially on the right where the shot was given everything was the worse, sore throat, jaw pain and neck pain, my neck under my chin is swollen and painful, abscess in my gum and swelling and blisters in my mouth. On unspecified date, the patient underwent lab tests and procedures which included body temperature 107.5 degree F, blood test which she does every year and she had a follow up every 6 months. Outcome of the events was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Oral mucosal blistering, Oropharyngeal pain, Pain in jaw, Swelling, Vision blurred
Clinical narrative: High fever of 107.5 degree Fahrenheit; Dizziness; Nausea; Headache; Fatigue; Joint and muscle pain; Joint and muscle pain; Blurred vision; Persistent cough; My glands started hurting; My ears hurt specially on the right where the shot was given everything is the worse; Sore throat; Jaw pain; my neck under my chin is swollen and painful; my neck under my chin is swollen and painful; Abscess in my gum and swelling and blisters in my mouth; Abscess in my gum and swelling and blisters in my mouth; Abscess in my gum and swelling and blisters in my mouth; This is a spontaneous report from a contactable consumer(patient). A 60-years-old female patient received first dose of bnt162b2 (BNT162B2, solution for injection, Lot Number: EW016) via an unspecified route of administration in right arm on 19Apr2021 at 17:15 as SINGLE DOSE for covid-19 immunization. Patient was 60 years old at the time of vaccination. Medical history included rheumatoid arthritis, COPD, chronic empyema, asthma, chronic bronchitis, gastritis, irritable bowel syndrome, blood pressure high and digestive disorder, all from an unknown date and unknown if ongoing. Concomitant medications included quetiapine fumarate (SEROQUEL), POTASSIUM CHLORIDE, albuterol sulfate (ALBUTEROL), budesonide, formoterol fumarate (SYMBICORT), FLUNISOLIDE, FLUOXETINE, HYDROCHLOROTHIAZIDE, IPRATROPIN, METOPROLOL, MONTELUKAST, PANTOPRAZOLE, FAMOTIDINE and LOSARTAN, all taken on unspecified date for unknown indication. In Apr20, the patient had high fever of 107.5 degree fahrenheit, dizziness, nausea, headache, fatigue, joint and muscle pain, blurred vision, persistent cough, my glands started hurting, my ears hurt specially on the right where the shot was given everything was the worse, sore throat, jaw pain and neck pain, my neck under my chin is swollen and painful, abscess in my gum and swelling and blisters in my mouth. On unspecified date, the patient underwent lab tests and procedures which included body temperature 107.5 degree F, blood test which she does every year and she had a follow up every 6 months. Outcome of the events was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Age: 63.0
Sex: M
Vaccine: COVID19
Symptoms: Blister, Burning sensation, Chills, Condition aggravated, Hyperaesthesia
Clinical narrative: Rash is getting worse; severe rash on lower right leg with blistering and swelling; burning sensation to the touch; burning sensation to the touch; severe rash on lower right leg with blistering and swelling; severe rash on lower right leg with blistering and swelling; extreme chills est 3hrs; body ache all over; nausea; This is a spontaneous report received a contactable consumer, the patient. A 63-year-old adult male received the second dose of BNT162b2 (solution for injection; Lot ER8731 and expiry information not provided) as a single dose via unspecified route in the left arm on 21Apr2021 at 10:15  (at 63-years-old) for COVID-19 immunisation. Relevant medical history included Diabetes and High Blood Pressure. Concomitant medications sans indications, posology and therapy dates included carvedilol; losartan potassium; and levothyroxine sodium. The patient previously received COVID-19 immunisation with the first dose of BNT162b2 (Lot ER8735) in the left arm on 30Mar2021 at 11:45 (at 63-years-old). The patient denied any known allergies or any COVID-19 prior to the vaccine. The patient denied receiving any other vaccine within four weeks prior to this vaccine. On 21Apr2021 at 23:30, reported as twelve hours after receiving the vaccine, the patient began to experience extreme chills est 3 hrs, body aches all over, and nausea. On 22Apr2021 at 10:15, reported as twenty-four hours after receiving the vaccine, the patient developed a severe rash on lower right leg with blistering and swelling. The patient described the rash as going from ankle to knee, and no itchiness just a burning sensation to the touch. The patient reported that he had not yet sought medical attention though planned to go to the emergency room (ER) for the rash as it was getting worse. The patient denied any COVID testing since receiving the vaccine. It was reported unknown if any treatment was received. The outcome of the events extreme chills est 3 hrs, body aches all over, nausea, severe rash on lower right leg with blistering, burning sensation to the touch, and getting worse, was not recovered.
Age: 63.0
Sex: M
Vaccine: COVID19
Symptoms: Nausea, Pain, Rash, Swelling
Clinical narrative: Rash is getting worse; severe rash on lower right leg with blistering and swelling; burning sensation to the touch; burning sensation to the touch; severe rash on lower right leg with blistering and swelling; severe rash on lower right leg with blistering and swelling; extreme chills est 3hrs; body ache all over; nausea; This is a spontaneous report received a contactable consumer, the patient. A 63-year-old adult male received the second dose of BNT162b2 (solution for injection; Lot ER8731 and expiry information not provided) as a single dose via unspecified route in the left arm on 21Apr2021 at 10:15  (at 63-years-old) for COVID-19 immunisation. Relevant medical history included Diabetes and High Blood Pressure. Concomitant medications sans indications, posology and therapy dates included carvedilol; losartan potassium; and levothyroxine sodium. The patient previously received COVID-19 immunisation with the first dose of BNT162b2 (Lot ER8735) in the left arm on 30Mar2021 at 11:45 (at 63-years-old). The patient denied any known allergies or any COVID-19 prior to the vaccine. The patient denied receiving any other vaccine within four weeks prior to this vaccine. On 21Apr2021 at 23:30, reported as twelve hours after receiving the vaccine, the patient began to experience extreme chills est 3 hrs, body aches all over, and nausea. On 22Apr2021 at 10:15, reported as twenty-four hours after receiving the vaccine, the patient developed a severe rash on lower right leg with blistering and swelling. The patient described the rash as going from ankle to knee, and no itchiness just a burning sensation to the touch. The patient reported that he had not yet sought medical attention though planned to go to the emergency room (ER) for the rash as it was getting worse. The patient denied any COVID testing since receiving the vaccine. It was reported unknown if any treatment was received. The outcome of the events extreme chills est 3 hrs, body aches all over, nausea, severe rash on lower right leg with blistering, burning sensation to the touch, and getting worse, was not recovered.
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: was exposed to Covid, tested postive; was exposed to Covid, tested postive; This is a spontaneous report from a contactable consumer 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 a single dose for covid-19 immunization. The patient's medical history included exposed to covid-19 on an unknown date. The patient's concomitant medications were not reported. The patient was exposed to covid and was tested positive on an unknown date. It was further reported that patient received the first dose of Covid Vaccine and was due to receive second dose Tuesday. As she was exposed to Covid, tested positive wants to know if she should still get second dose. The outcome of the events was unknown.   Information about lot/batch number has been requested.
Age: 74.0
Sex: F
Vaccine: COVID19
Symptoms: Blister, Ophthalmic herpes zoster, Pain of skin, Tenderness
Clinical narrative: Shingles on face; I could get acne breakout with that/it is gonna around the eyes was only the eyelid and it was on region on my eyelid; it started down my forehead and blistered.; top of my scalp near the crown there is little tenderness still. It was really tender.; She touched my hair and I didn't jump out if my skin but it hurts.; This is a spontaneous report for herself.  A 74-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), dose 1 via an unspecified route of administration on 17Mar2021 (Batch/Lot Number: Unknown) as 1ST DOSE, SINGLE for covid-19 immunisation.  Medical history included pulmonary hypertension from an unknown date, arthritis from an unknown date, and rosacea from an unknown date. Concomitant medications included atenolol taken for an unspecified indication, start and stop date were not reported; enalapril maleate (LOTRIAL [ENALAPRIL MALEATE]) taken for an unspecified indication, start and stop date were not reported; guanidine taken for an unspecified indication, start and stop date were not reported; levothyroxine sodium (SYNTHROID) taken for hypothyroidism, start and stop date were not reported, and other vitamins over the counter start and stop date were not reported.  The patient experienced shingles on face; I could get acne breakout with that/it is gonna around the eyes was only the eyelid and it was on region on my eyelid on Mar2021 with outcome of unknown, it started down her forehead and blistered on Mar2021 with outcome of unknown, top of her scalp near the crown there is little tenderness still. it was really tender on Mar2021 with outcome of unknown, and she touched her hair and she didn't jump out if her skin but it hurts on Mar2021 with outcome of unknown. As treatment, the patient received valacyclovir, that is for 7 days, 1000mg Once a day.  The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow up.; Sender's Comments: Based on the available information the reported events more likely represent intercurrent medical conditions which were unlikely related to BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE). The case will be reevaluated should additional information become available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of 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 Investigators, as appropriate.
Sex: F
Vaccine: COVID19
Symptoms: Deafness, Tinnitus
Clinical narrative: some hearing loss; Severe Tinnitus after the second which has not gone away; This is a spontaneous report from a contactable consumer, patient. A 63-year-old non-pregnant female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: Ew0151) via an unspecified route of administration, in the left arm on 03Mar2021 as a single dose for COVID-19 immunisation. The patient medical history was not reported. Since the vaccination, the patient has not been tested for COVID-19. Concomitant drugs were not provided. The patient previously received the first dose of BNT162b2 in the left arm on 03Mar2021 at 15:00 (Lot Number: EN6199) for COVID-19 immunisation. The patient had not received any other vaccines within 4 weeks prior to the COVID-19 vaccine. On 10Apr2021 at 03:15, the patient experienced some hearing loss and severe tinnitus after the second which has not gone away. The patient reported, she noticed ringing in the ears (tinnitus) after the first one then went away. Severe tinnitus after the second which has not gone away. Doc sent me for hearing test. Which I've had some hearing loss. No treatment was provided for the events.  The patient had not recovered from the events, some hearing loss and severe tinnitus after the second which has not gone away.
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, 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's husband). This is the 2nd of 2 reports. A female patient of unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; solution for injection) dose 1 (lot number: EL9262) on 28Jan2021 at 15:30 and dose 2 (lot number: EN6201) on 18Feb2021 at 15:30, both via an unspecified route of administration and both as a single dose for COVID-19 immunisation. Medical history was reported as none. The patient had no known allergies and was not diagnosed with COVID-19 prior to vaccination. Concomitant medications (other medications in two weeks) were reported as yes. The patient did not receive another vaccine within 4 weeks prior to the COVID-19 vaccination. The patient experienced COVID-19 confirmed by positive COVID-19 test on 17Apr2021 at 14:00 (as reported). The clinical course was reported as follows: "My wife and I have both been fully vaccinated since 18Feb2021 at 3:30 pm. We both have since tested positive with COVID-19 on 22Apr2021. Our 15month old daughter and her daycare provider are the people who exposed us." It was reported that the event required a physician office visit and no treatment was received for the event. The patient tested positive for COVID-19 via nasal swab, COVID test name: Innovative care, on 22Apr2021. The clinical outcome of the event COVID-19 confirmed by positive COVID-19 test was recovering/resolving.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021456777 same reporter/drug/AE, different patients.
Age: 43.0
Sex: M
Vaccine: COVID19
Symptoms: Palpitations, Ventricular arrhythmia
Clinical narrative: Ventricular arrhythmia; Heart palpitations - ventricular arritmia; This is a spontaneous report from a contactable consumer (patient). A 43-year-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot number: 92EL9267) via unspecified route of administration on left arm on 11Feb2021 at 12:00 (at the age of 43 years) as single dose for COVID-19 immunisation. The patient had no medical history and allergy. The concomitant medications the patient received within 2 weeks of vaccination included Vitamin C and D. The patient did not receive any other vaccine within 4 weeks prior to the COVID vaccine. Prior to vaccination, patient was not diagnosed with COVID-19. Patient was not tested for COVID-19 since the vaccination. On 14Feb2021 at 00:00, the patient experienced heart palpita-tions - ventricular arrhythmia. The adverse event resulted in doctor or other healthcare professional office/clinic visit. The patient received amioadoron as treatment. The outcome of the events was unknown.
Sex: M
Vaccine: COVID19
Symptoms: Abdominal discomfort, Asthenia, COVID-19, Chills, Drug ineffective
Clinical narrative: COVID tested and had COVID; COVID tested and had COVID; Didn't feel well; Upset stomach; Chills; The worst headache of his life; no energy; This is a spontaneous report from a contactable consumer (patient's spouse) under the same suspect products for 2 patients. This is one of the 2 reports.  A male patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration on 18Mar2021 (Batch/Lot number was not reported) as single dose for Covid-19 immunization. The patient's medical history and concomitant medications were not reported. It was reported that the patient got the shot on 18Mar2021 and didn't feel well from it over the weekend. The patient started to feel worse and worse. On an unspecified date, the patient got COVID tested and had COVID. Somewhere around the time the patient got his first shot he had been exposed to COVID. He had COVID for 2 weeks. He didn't have to be hospitalized and his oxygen levels were fine. He had all other symptoms except fever, diarrhea, and oxygen depletion. The vaccine was scheduled out far enough and he was past COVID so he could come and get second dose. With the first dose, it is hard to tell what a reaction to the shot was when it was actually coming down with COVID. He did have an upset stomach and chills and the worst headache of his life on an unspecified date. He also had no energy on an unspecified date. The outcome of events was unknown.  Information on the lot/batch number has been requested.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021461372 same reporter, drug , event; different patient
Sex: M
Vaccine: COVID19
Symptoms: Headache, Malaise, Oxygen saturation, SARS-CoV-2 test
Clinical narrative: COVID tested and had COVID; COVID tested and had COVID; Didn't feel well; Upset stomach; Chills; The worst headache of his life; no energy; This is a spontaneous report from a contactable consumer (patient's spouse) under the same suspect products for 2 patients. This is one of the 2 reports.  A male patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration on 18Mar2021 (Batch/Lot number was not reported) as single dose for Covid-19 immunization. The patient's medical history and concomitant medications were not reported. It was reported that the patient got the shot on 18Mar2021 and didn't feel well from it over the weekend. The patient started to feel worse and worse. On an unspecified date, the patient got COVID tested and had COVID. Somewhere around the time the patient got his first shot he had been exposed to COVID. He had COVID for 2 weeks. He didn't have to be hospitalized and his oxygen levels were fine. He had all other symptoms except fever, diarrhea, and oxygen depletion. The vaccine was scheduled out far enough and he was past COVID so he could come and get second dose. With the first dose, it is hard to tell what a reaction to the shot was when it was actually coming down with COVID. He did have an upset stomach and chills and the worst headache of his life on an unspecified date. He also had no energy on an unspecified date. The outcome of events was unknown.  Information on the lot/batch number has been requested.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021461372 same reporter, drug , event; different patient
Sex: U
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: This is a spontaneous report from a contactable pharmacist. This pharmacist reported same events for 2 patients. This is the second of two reports. A patient of unspecified age and gender received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number was not reported), via an unspecified route of administration on an unspecified date as a single dose for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. It was reported that two patients who have been testing positive for Covid-19 after they got their first dose of the vaccine. The outcome of the events was unknown.   Information about the lot/batch number has been requested.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021455895 same reporter/drug/event, different patient
Age: 18.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Gait disturbance, Hallucination, Headache, Hypoaesthesia
Clinical narrative: extreme hallucinations; not feeling well; chills; aches and pains; headaches; slight numbness in his extremities; difficulty walking; he did not get much sleep; fever; This is a spontaneous report from contactable consumer (parent). An 18-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), dose 2 via an unspecified route of administration, administered in left arm on 23Apr2021 at 12:45 (Lot Number: Ew0153) at the age of 18 years, as a single dose for COVID-19 immunization. Medical history included autism spectrum disorder, ADHD (Attention deficit hyperactivity disorder) combined, learning disabilities. The patient had no known allergies. Prior to the vaccination, the patient was not diagnosed with COVID-19.  Concomitant medication taken within two weeks of vaccination included alfetamine aspartate/alfetamine sulfate/dexamphetamine saccharate/dexamphetamine sulfate (ADDERALL) taken for an unspecified indication. Historical vaccine included BNT162B2, dose 1 in left arm, on 02Apr2021, lot # EK5730. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 23Apr2021 at 21:00 the patient experienced extreme hallucinations, not feeling well, chills, aches and pains, headaches, slight numbness in his extremities, difficulty walking, he did not get much sleep, fever. The clinical course of events was reported as follows: My son reported to me at bedtime last night, the night of his second Pfizer vaccine dose, that he was not feeling well. I told him to take some Advil and go to bed. He had a very bad night with chills and aches and pains but most distressing was his description of having had extreme hallucinations. He said that he was aware they were hallucinations and not real during and after the experience, but it was nonetheless concerning. It is also concerning that he didn't wake me for help. At any rate, he did not get much sleep and I have to assume his fever went pretty high before morning. He described to me the need to hydrate during the night. He also relayed to me this morning an experience of headaches and slight numbness in his extremities, difficulty walking, but he is now feeling much better. He is dressed, has eaten, and is playing games on the computer. I am keeping a close eye on him today and should we return to that level of concern, we will take him to urgent care.  The clinical outcome of the events was recovering. It was also reported that since the vaccination, the patient had not been tested for COVID-19.
Age: 18.0
Sex: M
Vaccine: COVID19
Symptoms: Malaise, Pain, Pyrexia, Sleep disorder
Clinical narrative: extreme hallucinations; not feeling well; chills; aches and pains; headaches; slight numbness in his extremities; difficulty walking; he did not get much sleep; fever; This is a spontaneous report from contactable consumer (parent). An 18-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), dose 2 via an unspecified route of administration, administered in left arm on 23Apr2021 at 12:45 (Lot Number: Ew0153) at the age of 18 years, as a single dose for COVID-19 immunization. Medical history included autism spectrum disorder, ADHD (Attention deficit hyperactivity disorder) combined, learning disabilities. The patient had no known allergies. Prior to the vaccination, the patient was not diagnosed with COVID-19.  Concomitant medication taken within two weeks of vaccination included alfetamine aspartate/alfetamine sulfate/dexamphetamine saccharate/dexamphetamine sulfate (ADDERALL) taken for an unspecified indication. Historical vaccine included BNT162B2, dose 1 in left arm, on 02Apr2021, lot # EK5730. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 23Apr2021 at 21:00 the patient experienced extreme hallucinations, not feeling well, chills, aches and pains, headaches, slight numbness in his extremities, difficulty walking, he did not get much sleep, fever. The clinical course of events was reported as follows: My son reported to me at bedtime last night, the night of his second Pfizer vaccine dose, that he was not feeling well. I told him to take some Advil and go to bed. He had a very bad night with chills and aches and pains but most distressing was his description of having had extreme hallucinations. He said that he was aware they were hallucinations and not real during and after the experience, but it was nonetheless concerning. It is also concerning that he didn't wake me for help. At any rate, he did not get much sleep and I have to assume his fever went pretty high before morning. He described to me the need to hydrate during the night. He also relayed to me this morning an experience of headaches and slight numbness in his extremities, difficulty walking, but he is now feeling much better. He is dressed, has eaten, and is playing games on the computer. I am keeping a close eye on him today and should we return to that level of concern, we will take him to urgent care.  The clinical outcome of the events was recovering. It was also reported that since the vaccination, the patient had not been tested for COVID-19.