chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 32.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Heart rate increased, Urticaria
Clinical narrative: strong metallic taste; flushing; a warm sensation from her head to her toes; lightheaded; fast heartbeat; 2 hives appeared on her chest; This is a spontaneous report from a contactable consumer (patient). The 32-years-old female patient received bnt162b2 (BNT162B2), dose 1 via an unspecified route of administration on 06Apr2021 (Batch/Lot number was not reported) as SINGLE DOSE for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient experienced strong metallic taste, flushing, a warm sensation from her head to her toes, lightheaded, fast heartbeat, 2 hives appeared on her chest on 06Apr2021. Reported as: immediately after receiving the vaccine she experienced a strong metallic taste, flushing and a warm sensation from her head to her toes, she also felt lightheaded, and a fast heartbeat; after 5 minutes she felt better and these symptoms subsided. In the afternoon 2 hives appeared on her chest. She's not experiencing these symportoms currently. Patient states that she already talked to her HCP and she's most likely not gonna proceed with the second dose of the vaccine at this time, so she will not have increased immunity against Sars-CoV-2, she would like to know if this is true, and the efficacy after one dose of the vaccine. The outcome of the events was recovered.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Age: 40.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Anaphylactic reaction, Erythema, Lip swelling, Swelling face, Throat tightness
Clinical narrative: anaphylaxis; rash/hives on face; rash/hives on face; progressed to swollen lips, tongue; progressed to swollen lips, tongue; cough; throat irritation; wheezing; This is a spontaneous report from a contactable consumer (patient). The 40-year-old non pregnant female patient received first dose of BNT162B2 (Pfizer Covid-19 vaccine, lot number: EW0150 expiry date unknown) via an unspecified route of administration on Left arm as a single dose on 06Apr2021 09:30 AM. Medical history included asthma, known allergies: Biaxin, albuterol, xopenex, apples, pears, stone fruit (peaches, plums, apricot, etc), almond, hazel-nut. Concomitant medications included Zyrtec, Nasonex, Flovent, Singulair and Zoloft. On 06Apr2021 10:00 AM, started with rash/hives on face, then progressed to swollen lips, tongue, cough, throat irritation/swelling and wheezing. Initially treated in emergency room (ER) for anaphylaxis then released. Within 30 minutes, symptoms returned and was treated ER for anaphylaxis and was admitted for observation. She was discharged in the morning of 07Apr2021, but had to return to ER that evening, and was discharged in the morning of 09Apr2021. She was treated with Epinephrine, Benadryl, steroids and Pepcid. She did not receive any other vaccine in four weeks prior to the suspect. The patient was not suffering from covid prior vaccination. On 06Apr2021, she was tested through Nasal Swab for Covid and results were found to be negative. The outcome of events was recovering.  No further information was available.
Age: 40.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Urticaria
Clinical narrative: anaphylaxis; rash/hives on face; rash/hives on face; progressed to swollen lips, tongue; progressed to swollen lips, tongue; cough; throat irritation; wheezing; This is a spontaneous report from a contactable consumer (patient). The 40-year-old non pregnant female patient received first dose of BNT162B2 (Pfizer Covid-19 vaccine, lot number: EW0150 expiry date unknown) via an unspecified route of administration on Left arm as a single dose on 06Apr2021 09:30 AM. Medical history included asthma, known allergies: Biaxin, albuterol, xopenex, apples, pears, stone fruit (peaches, plums, apricot, etc), almond, hazel-nut. Concomitant medications included Zyrtec, Nasonex, Flovent, Singulair and Zoloft. On 06Apr2021 10:00 AM, started with rash/hives on face, then progressed to swollen lips, tongue, cough, throat irritation/swelling and wheezing. Initially treated in emergency room (ER) for anaphylaxis then released. Within 30 minutes, symptoms returned and was treated ER for anaphylaxis and was admitted for observation. She was discharged in the morning of 07Apr2021, but had to return to ER that evening, and was discharged in the morning of 09Apr2021. She was treated with Epinephrine, Benadryl, steroids and Pepcid. She did not receive any other vaccine in four weeks prior to the suspect. The patient was not suffering from covid prior vaccination. On 06Apr2021, she was tested through Nasal Swab for Covid and results were found to be negative. The outcome of events was recovering.  No further information was available.
Age: 40.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Cough, Dysphagia, Laboratory test normal, Lip swelling, Swelling face
Clinical narrative: anaphylaxis; rash/hives on face; rash/hives on face; progressed to swollen lips, tongue; progressed to swollen lips, tongue; cough; throat irritation; wheezing; This is a spontaneous report from a contactable consumer (patient). The 40-year-old non pregnant female patient received first dose of BNT162B2 (Pfizer Covid-19 vaccine, lot number: EW0150 expiry date unknown) via an unspecified route of administration on Left arm as a single dose on 06Apr2021 09:30 AM. Medical history included asthma, known allergies: Biaxin, albuterol, xopenex, apples, pears, stone fruit (peaches, plums, apricot, etc), almond, hazel-nut. Concomitant medications included Zyrtec, Nasonex, Flovent, Singulair and Zoloft. On 06Apr2021 10:00 AM, started with rash/hives on face, then progressed to swollen lips, tongue, cough, throat irritation/swelling and wheezing. Initially treated in emergency room (ER) for anaphylaxis then released. Within 30 minutes, symptoms returned and was treated ER for anaphylaxis and was admitted for observation. She was discharged in the morning of 07Apr2021, but had to return to ER that evening, and was discharged in the morning of 09Apr2021. She was treated with Epinephrine, Benadryl, steroids and Pepcid. She did not receive any other vaccine in four weeks prior to the suspect. The patient was not suffering from covid prior vaccination. On 06Apr2021, she was tested through Nasal Swab for Covid and results were found to be negative. The outcome of events was recovering.  No further information was available.
Age: 40.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Anaphylactic reaction, Cough, Lip swelling, Rash, SARS-CoV-2 test
Clinical narrative: anaphylaxis; rash/hives on face; rash/hives on face; progressed to swollen lips, tongue; progressed to swollen lips, tongue; cough; throat irritation; wheezing; This is a spontaneous report from a contactable consumer (patient). The 40-year-old non pregnant female patient received first dose of BNT162B2 (Pfizer Covid-19 vaccine, lot number: EW0150 expiry date unknown) via an unspecified route of administration on Left arm as a single dose on 06Apr2021 09:30 AM. Medical history included asthma, known allergies: Biaxin, albuterol, xopenex, apples, pears, stone fruit (peaches, plums, apricot, etc), almond, hazel-nut. Concomitant medications included Zyrtec, Nasonex, Flovent, Singulair and Zoloft. On 06Apr2021 10:00 AM, started with rash/hives on face, then progressed to swollen lips, tongue, cough, throat irritation/swelling and wheezing. Initially treated in emergency room (ER) for anaphylaxis then released. Within 30 minutes, symptoms returned and was treated ER for anaphylaxis and was admitted for observation. She was discharged in the morning of 07Apr2021, but had to return to ER that evening, and was discharged in the morning of 09Apr2021. She was treated with Epinephrine, Benadryl, steroids and Pepcid. She did not receive any other vaccine in four weeks prior to the suspect. The patient was not suffering from covid prior vaccination. On 06Apr2021, she was tested through Nasal Swab for Covid and results were found to be negative. The outcome of events was recovering.  No further information was available.
Age: 40.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Swollen tongue, Throat irritation, Urticaria, Wheezing
Clinical narrative: anaphylaxis; rash/hives on face; rash/hives on face; progressed to swollen lips, tongue; progressed to swollen lips, tongue; cough; throat irritation; wheezing; This is a spontaneous report from a contactable consumer (patient). The 40-year-old non pregnant female patient received first dose of BNT162B2 (Pfizer Covid-19 vaccine, lot number: EW0150 expiry date unknown) via an unspecified route of administration on Left arm as a single dose on 06Apr2021 09:30 AM. Medical history included asthma, known allergies: Biaxin, albuterol, xopenex, apples, pears, stone fruit (peaches, plums, apricot, etc), almond, hazel-nut. Concomitant medications included Zyrtec, Nasonex, Flovent, Singulair and Zoloft. On 06Apr2021 10:00 AM, started with rash/hives on face, then progressed to swollen lips, tongue, cough, throat irritation/swelling and wheezing. Initially treated in emergency room (ER) for anaphylaxis then released. Within 30 minutes, symptoms returned and was treated ER for anaphylaxis and was admitted for observation. She was discharged in the morning of 07Apr2021, but had to return to ER that evening, and was discharged in the morning of 09Apr2021. She was treated with Epinephrine, Benadryl, steroids and Pepcid. She did not receive any other vaccine in four weeks prior to the suspect. The patient was not suffering from covid prior vaccination. On 06Apr2021, she was tested through Nasal Swab for Covid and results were found to be negative. The outcome of events was recovering.  No further information was available.
Age: 64.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Extra dose administered
Clinical narrative: low grade fever; feel discomfort in the night; Right arm soreness after second dose.; Received two doses on same date; could not lift her elbow too high; This is a spontaneous report from a contactable consumer (patient). A 64-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), dose 2 intramuscularly administered in arm right on 06Apr2021 at 14:00 (Lot Number: ER8734) at age of 64 years old as single dose for covid-19 immunisation.  Medical history included arteriosclerosis diagnosed 4-5 years ago.  No family medical history. The patient's concomitant medications were not reported. She previously had first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot EP7534), intramuscularly in left arm on 16Mar2021 at 14:00 at age of 64 years old as single dose for covid-19 immunisation and experienced left arm soreness  (It took a number of hours before it started to get sore.  It was probably 18:00-19:00. It was not excessive where she could not use arm and was much improved by the morning). No additional vaccines administered on same date of the Pfizer vaccine.  She had first vaccine on 16Mar2021 and just went 06Apr2021 for second one. The doctor who gave the vaccine actually gave her two shots in the same arm. Received two doses of Pfizer COVID vaccine on same date -14:00 and 14:01. She said when that happened, she immediately went to the medical director who was in charge. She was going to assume it would be uncommon for someone to receive two shots within minutes of each other. She said she felt like she should reach out and ask what she should look for and monitor.  It was explained and answered by the doctors in the facility what happened. Yesterday (07Apr2021) the patient experienced low grade fever and sore on her arm. The third dose of the Pfizer COVID Vaccine Lot ER8734 was the same as the second dose and expiration was unknown. It was also injected in right arm in the muscle. It hurt. Her arm was sore with the normal things.  There was no prescriber for the vaccines. Her arm pain with the second and third ones were worse than the first.  She could not lift her elbow too high after the second and third ones. By the morning (08Apr2021), it was just sore to touch like the first one. Right arm soreness - It could have been 20:00 or so at night.  It clearly was more sore and she did not have problem with first one with lifting elbow up like this one.  It was hard and painful. She could feel discomfort in the night (06Apr2021) and improved by 11:00-12:00 the next day.  It was still sore, but it was improved.  It was still sore to touch and this was not true of the first one.  No emergency room or physician's office required. The outcome of event right arm soreness was recovering. The outcome of other events was unknown.  No follow-up attempts are needed. No further information is expected.
Age: 64.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Dysphagia, Pharyngeal swelling, Throat tightness
Clinical narrative: low grade fever; feel discomfort in the night; Right arm soreness after second dose.; Received two doses on same date; could not lift her elbow too high; This is a spontaneous report from a contactable consumer (patient). A 64-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), dose 2 intramuscularly administered in arm right on 06Apr2021 at 14:00 (Lot Number: ER8734) at age of 64 years old as single dose for covid-19 immunisation.  Medical history included arteriosclerosis diagnosed 4-5 years ago.  No family medical history. The patient's concomitant medications were not reported. She previously had first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot EP7534), intramuscularly in left arm on 16Mar2021 at 14:00 at age of 64 years old as single dose for covid-19 immunisation and experienced left arm soreness  (It took a number of hours before it started to get sore.  It was probably 18:00-19:00. It was not excessive where she could not use arm and was much improved by the morning). No additional vaccines administered on same date of the Pfizer vaccine.  She had first vaccine on 16Mar2021 and just went 06Apr2021 for second one. The doctor who gave the vaccine actually gave her two shots in the same arm. Received two doses of Pfizer COVID vaccine on same date -14:00 and 14:01. She said when that happened, she immediately went to the medical director who was in charge. She was going to assume it would be uncommon for someone to receive two shots within minutes of each other. She said she felt like she should reach out and ask what she should look for and monitor.  It was explained and answered by the doctors in the facility what happened. Yesterday (07Apr2021) the patient experienced low grade fever and sore on her arm. The third dose of the Pfizer COVID Vaccine Lot ER8734 was the same as the second dose and expiration was unknown. It was also injected in right arm in the muscle. It hurt. Her arm was sore with the normal things.  There was no prescriber for the vaccines. Her arm pain with the second and third ones were worse than the first.  She could not lift her elbow too high after the second and third ones. By the morning (08Apr2021), it was just sore to touch like the first one. Right arm soreness - It could have been 20:00 or so at night.  It clearly was more sore and she did not have problem with first one with lifting elbow up like this one.  It was hard and painful. She could feel discomfort in the night (06Apr2021) and improved by 11:00-12:00 the next day.  It was still sore, but it was improved.  It was still sore to touch and this was not true of the first one.  No emergency room or physician's office required. The outcome of event right arm soreness was recovering. The outcome of other events was unknown.  No follow-up attempts are needed. No further information is expected.
Age: 64.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Body temperature, Discomfort, Overdose, Pain in extremity, Pyrexia
Clinical narrative: low grade fever; feel discomfort in the night; Right arm soreness after second dose.; Received two doses on same date; could not lift her elbow too high; This is a spontaneous report from a contactable consumer (patient). A 64-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), dose 2 intramuscularly administered in arm right on 06Apr2021 at 14:00 (Lot Number: ER8734) at age of 64 years old as single dose for covid-19 immunisation.  Medical history included arteriosclerosis diagnosed 4-5 years ago.  No family medical history. The patient's concomitant medications were not reported. She previously had first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot EP7534), intramuscularly in left arm on 16Mar2021 at 14:00 at age of 64 years old as single dose for covid-19 immunisation and experienced left arm soreness  (It took a number of hours before it started to get sore.  It was probably 18:00-19:00. It was not excessive where she could not use arm and was much improved by the morning). No additional vaccines administered on same date of the Pfizer vaccine.  She had first vaccine on 16Mar2021 and just went 06Apr2021 for second one. The doctor who gave the vaccine actually gave her two shots in the same arm. Received two doses of Pfizer COVID vaccine on same date -14:00 and 14:01. She said when that happened, she immediately went to the medical director who was in charge. She was going to assume it would be uncommon for someone to receive two shots within minutes of each other. She said she felt like she should reach out and ask what she should look for and monitor.  It was explained and answered by the doctors in the facility what happened. Yesterday (07Apr2021) the patient experienced low grade fever and sore on her arm. The third dose of the Pfizer COVID Vaccine Lot ER8734 was the same as the second dose and expiration was unknown. It was also injected in right arm in the muscle. It hurt. Her arm was sore with the normal things.  There was no prescriber for the vaccines. Her arm pain with the second and third ones were worse than the first.  She could not lift her elbow too high after the second and third ones. By the morning (08Apr2021), it was just sore to touch like the first one. Right arm soreness - It could have been 20:00 or so at night.  It clearly was more sore and she did not have problem with first one with lifting elbow up like this one.  It was hard and painful. She could feel discomfort in the night (06Apr2021) and improved by 11:00-12:00 the next day.  It was still sore, but it was improved.  It was still sore to touch and this was not true of the first one.  No emergency room or physician's office required. The outcome of event right arm soreness was recovering. The outcome of other events was unknown.  No follow-up attempts are needed. No further information is expected.
Age: 64.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Vaccination site joint movement impairment
Clinical narrative: low grade fever; feel discomfort in the night; Right arm soreness after second dose.; Received two doses on same date; could not lift her elbow too high; This is a spontaneous report from a contactable consumer (patient). A 64-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), dose 2 intramuscularly administered in arm right on 06Apr2021 at 14:00 (Lot Number: ER8734) at age of 64 years old as single dose for covid-19 immunisation.  Medical history included arteriosclerosis diagnosed 4-5 years ago.  No family medical history. The patient's concomitant medications were not reported. She previously had first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot EP7534), intramuscularly in left arm on 16Mar2021 at 14:00 at age of 64 years old as single dose for covid-19 immunisation and experienced left arm soreness  (It took a number of hours before it started to get sore.  It was probably 18:00-19:00. It was not excessive where she could not use arm and was much improved by the morning). No additional vaccines administered on same date of the Pfizer vaccine.  She had first vaccine on 16Mar2021 and just went 06Apr2021 for second one. The doctor who gave the vaccine actually gave her two shots in the same arm. Received two doses of Pfizer COVID vaccine on same date -14:00 and 14:01. She said when that happened, she immediately went to the medical director who was in charge. She was going to assume it would be uncommon for someone to receive two shots within minutes of each other. She said she felt like she should reach out and ask what she should look for and monitor.  It was explained and answered by the doctors in the facility what happened. Yesterday (07Apr2021) the patient experienced low grade fever and sore on her arm. The third dose of the Pfizer COVID Vaccine Lot ER8734 was the same as the second dose and expiration was unknown. It was also injected in right arm in the muscle. It hurt. Her arm was sore with the normal things.  There was no prescriber for the vaccines. Her arm pain with the second and third ones were worse than the first.  She could not lift her elbow too high after the second and third ones. By the morning (08Apr2021), it was just sore to touch like the first one. Right arm soreness - It could have been 20:00 or so at night.  It clearly was more sore and she did not have problem with first one with lifting elbow up like this one.  It was hard and painful. She could feel discomfort in the night (06Apr2021) and improved by 11:00-12:00 the next day.  It was still sore, but it was improved.  It was still sore to touch and this was not true of the first one.  No emergency room or physician's office required. The outcome of event right arm soreness was recovering. The outcome of other events was unknown.  No follow-up attempts are needed. No further information is expected.
Age: 68.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Abdominal pain, Appendicitis, Computerised tomogram abdomen abnormal, Neuralgia, Pain
Clinical narrative: appendicitis; sore; tired; with in 12 hours I started with nerve pain on the level of shingle pain except it didn't stay in one part of the body.; This is a spontaneous report from a contactable consumer (reported for herself). A 68-years-old non pregnant female patient received second dose of bnt162b2 (BNT162B2, solution for injection, Batch/Lot Number: EN6199), administered in right arm via an unknown route of administration on 22Mar2021 at 09:00 am as SINGLE DOSE for covid-19 immunization. The patient previously took first dose of bnt162b2 (BNT162B2, solution for injection, Batch/Lot Number: EN6200), administered in right arm via an unknown route of administration on 27Feb2021 at 08:00 am. The patient medical history included blood pressure measurement. Concomitant medications in two weeks included Olanzapine 2.5mg, Olmesartan 20mg and Zetia 10mg. The patient had drug allergies for Codeine and Demerol. On 22Mar2021 within 12 hours, the patient started with nerve pain on the level of shingle pain except it didn't stay in one part of the body. The whole body was affected. Next day on 23Mar2021, the patient was sore and tired. On 26Mar2021 at 3:30 pm, the patient had abdominal pain and went to hospital at 09:00pm because of pain and was diagnosed with an appendicitis. The treatment for the events included appendectomy surgery to remove the next morning. There was no other vaccine in four weeks. On 26Mar2021, the patient was tested for covid with nasal swab post vaccination which was negative.The patient was hospitalized for 2 days for all the events. The outcome of the events was recovering.
Age: 68.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Surgery
Clinical narrative: appendicitis; sore; tired; with in 12 hours I started with nerve pain on the level of shingle pain except it didn't stay in one part of the body.; This is a spontaneous report from a contactable consumer (reported for herself). A 68-years-old non pregnant female patient received second dose of bnt162b2 (BNT162B2, solution for injection, Batch/Lot Number: EN6199), administered in right arm via an unknown route of administration on 22Mar2021 at 09:00 am as SINGLE DOSE for covid-19 immunization. The patient previously took first dose of bnt162b2 (BNT162B2, solution for injection, Batch/Lot Number: EN6200), administered in right arm via an unknown route of administration on 27Feb2021 at 08:00 am. The patient medical history included blood pressure measurement. Concomitant medications in two weeks included Olanzapine 2.5mg, Olmesartan 20mg and Zetia 10mg. The patient had drug allergies for Codeine and Demerol. On 22Mar2021 within 12 hours, the patient started with nerve pain on the level of shingle pain except it didn't stay in one part of the body. The whole body was affected. Next day on 23Mar2021, the patient was sore and tired. On 26Mar2021 at 3:30 pm, the patient had abdominal pain and went to hospital at 09:00pm because of pain and was diagnosed with an appendicitis. The treatment for the events included appendectomy surgery to remove the next morning. There was no other vaccine in four weeks. On 26Mar2021, the patient was tested for covid with nasal swab post vaccination which was negative.The patient was hospitalized for 2 days for all the events. The outcome of the events was recovering.
Age: 68.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Appendicitis, Fatigue, Neuralgia, Pain, SARS-CoV-2 test
Clinical narrative: appendicitis; sore; tired; with in 12 hours I started with nerve pain on the level of shingle pain except it didn't stay in one part of the body.; This is a spontaneous report from a contactable consumer (reported for herself). A 68-years-old non pregnant female patient received second dose of bnt162b2 (BNT162B2, solution for injection, Batch/Lot Number: EN6199), administered in right arm via an unknown route of administration on 22Mar2021 at 09:00 am as SINGLE DOSE for covid-19 immunization. The patient previously took first dose of bnt162b2 (BNT162B2, solution for injection, Batch/Lot Number: EN6200), administered in right arm via an unknown route of administration on 27Feb2021 at 08:00 am. The patient medical history included blood pressure measurement. Concomitant medications in two weeks included Olanzapine 2.5mg, Olmesartan 20mg and Zetia 10mg. The patient had drug allergies for Codeine and Demerol. On 22Mar2021 within 12 hours, the patient started with nerve pain on the level of shingle pain except it didn't stay in one part of the body. The whole body was affected. Next day on 23Mar2021, the patient was sore and tired. On 26Mar2021 at 3:30 pm, the patient had abdominal pain and went to hospital at 09:00pm because of pain and was diagnosed with an appendicitis. The treatment for the events included appendectomy surgery to remove the next morning. There was no other vaccine in four weeks. On 26Mar2021, the patient was tested for covid with nasal swab post vaccination which was negative.The patient was hospitalized for 2 days for all the events. The outcome of the events was recovering.
Age: 25.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Asthenia, Bell's palsy, Dyskinesia, Ear pain, Facial paralysis
Clinical narrative: Bell's Palsy recurrence; This is a spontaneous report from a contactable consumer (Patient). A 25-years-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot number: 59267-1000-01) via unspecified route administered on left arm on 29Mar2021 at 17:45 as single dose for COVID-19 immunization. Medical history included facial paralysis two times before once in 2013 and in 2015. Concomitant medications included Zoloft 200. On 06Apr2021 at 20:00 pm, the patient experienced bell's palsy recurrence. It was reported that the patient developed recurrent symptoms of bell's palsy a week & one day out from the vaccine. The treatment for the event included Prednisone. The patient had no other vaccine in four weeks. The patient was not tested for covid post vaccination. There were no known allergies. The outcome of the event was unknown.
Age: 25.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Fatigue, Feeling abnormal, Headache, Lacrimation increased, Loss of personal independence in daily activities
Clinical narrative: Bell's Palsy recurrence; This is a spontaneous report from a contactable consumer (Patient). A 25-years-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot number: 59267-1000-01) via unspecified route administered on left arm on 29Mar2021 at 17:45 as single dose for COVID-19 immunization. Medical history included facial paralysis two times before once in 2013 and in 2015. Concomitant medications included Zoloft 200. On 06Apr2021 at 20:00 pm, the patient experienced bell's palsy recurrence. It was reported that the patient developed recurrent symptoms of bell's palsy a week & one day out from the vaccine. The treatment for the event included Prednisone. The patient had no other vaccine in four weeks. The patient was not tested for covid post vaccination. There were no known allergies. The outcome of the event was unknown.
Age: 25.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Paraesthesia, Paraesthesia oral, Swelling face
Clinical narrative: Bell's Palsy recurrence; This is a spontaneous report from a contactable consumer (Patient). A 25-years-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot number: 59267-1000-01) via unspecified route administered on left arm on 29Mar2021 at 17:45 as single dose for COVID-19 immunization. Medical history included facial paralysis two times before once in 2013 and in 2015. Concomitant medications included Zoloft 200. On 06Apr2021 at 20:00 pm, the patient experienced bell's palsy recurrence. It was reported that the patient developed recurrent symptoms of bell's palsy a week & one day out from the vaccine. The treatment for the event included Prednisone. The patient had no other vaccine in four weeks. The patient was not tested for covid post vaccination. There were no known allergies. The outcome of the event was unknown.
Age: 25.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Bell's palsy
Clinical narrative: Bell's Palsy recurrence; This is a spontaneous report from a contactable consumer (Patient). A 25-years-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot number: 59267-1000-01) via unspecified route administered on left arm on 29Mar2021 at 17:45 as single dose for COVID-19 immunization. Medical history included facial paralysis two times before once in 2013 and in 2015. Concomitant medications included Zoloft 200. On 06Apr2021 at 20:00 pm, the patient experienced bell's palsy recurrence. It was reported that the patient developed recurrent symptoms of bell's palsy a week & one day out from the vaccine. The treatment for the event included Prednisone. The patient had no other vaccine in four weeks. The patient was not tested for covid post vaccination. There were no known allergies. The outcome of the event was unknown.
Age: 65.0
Sex: U
Vaccine: COVID19, COVID19
Symptoms: Alopecia, Blister, Rash
Clinical narrative: Itching; Losted all my hair; Weight loss; I had rash that started on my chest/ The rash has gotten worst has taken over entire body; The initial safety information received was reporting only non-serious adverse drug reactions. Upon receipt of follow-up information on 07Apr2021, this case now contains serious adverse reaction. Information processed together.  This is a spontaneous report from contactable consumers (including the patient). A 65-year-old patient of an unspecified gender received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE lot number: EN6201) intramuscular on 11Feb2021 10:00 at a single dose for COVID-19 immunization. Medical history included ongoing blood pressure (high) from Jan2015 and stomach (discomfort). Family history of heart attack. Concomitant medications included ongoing metoprolol succinate taken for blood pressure (high) from Oct2020; ongoing hydrochlorothiazide taken for blood pressure (high) from 2020; esomeprazole magnesium taken for stomach from 2020. On 15Feb2021, patient had rash that started on the chest. Patient contacted the doctor and dermatologist. The rash has gotten worst has taken over entire body. Prescribed a cream but it was getting worst. Before the 1st short patient was fine, never took the second one. Advise doctor of the rash. Patient needed help. Suffering from an all over body rash. Still have rash, pimple like pumps all over body better but not gone. "After Covid shot, skin covered with rash, even in my hair. Losted all my hair, face and damaged too. Still not feeling good. Never had the Covid virus never been tested". It was further reported that on Monday 15Feb2021- rash started on chest. Made Dr. Appt 16Feb2021 Doctor was not sure what was causing rash gave the patient something for Itching- referred me to dermatologist. Saw Dermatologist on 19Feb2021 and she did not know what it was either. Prescribed the triamcinolone acetonide - virus still have new bumps still appearing. "Weight loss look a mess. Just said that I was healthy and now I am a mess". The event rash was considered serious, Life-threatening Persistent / Significant disability / Incapacity. The facility where the vaccine was administered was in a clinic. Outcome of the event rash was recovering, while unknown for the other events.
Age: 65.0
Sex: U
Vaccine: COVID19, COVID19
Symptoms: Alopecia, Pruritus, Rash, Weight, Weight decreased
Clinical narrative: Itching; Losted all my hair; Weight loss; I had rash that started on my chest/ The rash has gotten worst has taken over entire body; The initial safety information received was reporting only non-serious adverse drug reactions. Upon receipt of follow-up information on 07Apr2021, this case now contains serious adverse reaction. Information processed together.  This is a spontaneous report from contactable consumers (including the patient). A 65-year-old patient of an unspecified gender received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE lot number: EN6201) intramuscular on 11Feb2021 10:00 at a single dose for COVID-19 immunization. Medical history included ongoing blood pressure (high) from Jan2015 and stomach (discomfort). Family history of heart attack. Concomitant medications included ongoing metoprolol succinate taken for blood pressure (high) from Oct2020; ongoing hydrochlorothiazide taken for blood pressure (high) from 2020; esomeprazole magnesium taken for stomach from 2020. On 15Feb2021, patient had rash that started on the chest. Patient contacted the doctor and dermatologist. The rash has gotten worst has taken over entire body. Prescribed a cream but it was getting worst. Before the 1st short patient was fine, never took the second one. Advise doctor of the rash. Patient needed help. Suffering from an all over body rash. Still have rash, pimple like pumps all over body better but not gone. "After Covid shot, skin covered with rash, even in my hair. Losted all my hair, face and damaged too. Still not feeling good. Never had the Covid virus never been tested". It was further reported that on Monday 15Feb2021- rash started on chest. Made Dr. Appt 16Feb2021 Doctor was not sure what was causing rash gave the patient something for Itching- referred me to dermatologist. Saw Dermatologist on 19Feb2021 and she did not know what it was either. Prescribed the triamcinolone acetonide - virus still have new bumps still appearing. "Weight loss look a mess. Just said that I was healthy and now I am a mess". The event rash was considered serious, Life-threatening Persistent / Significant disability / Incapacity. The facility where the vaccine was administered was in a clinic. Outcome of the event rash was recovering, while unknown for the other events.
Age: 30.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Accident, Fall, Loss of consciousness, Pain, Spinal X-ray
Clinical narrative: fainted or got disoriented; fainted or got disoriented; I was in a car accident; This is a spontaneous report from a contactable consumer (patient). A 30-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: ER8737), via an unspecified route of administration in the left arm, on 01Apr2021 14:30, as single dose, for COVID-19 immunisation. There was no medical history, no known allergies. The patient was not pregnant at the time of vaccination. The patient did not have COVID-19 prior to vaccination and was not tested for COVID-19 post vaccination. Concomitant medication included "digestion herbs" (as reported). Historical vaccine included the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot umber: EN6199) received at age 30 years, via an unspecified route of administration in the left arm, on 04Mar2021 10:30, for COVID-19 immunisation. The patient did not receive other vaccines in four weeks. After the patient received the second dose on 01Apr2021, the patient waited the full 15 minutes in the waiting are before leaving. The patient did not notice any adverse effects while waiting. However, it was reported that about 100 feet from the exit, at 14:45, "I was in a car accident. I believe I fainted or got disoriented because I do not remember anything for a short period from the time I left the parking lot until the moment of impact with an oncoming truck." The events resulted to emergency room, physician's office, and acupuncture visits. Treatment for the events was reported as "emergency room visit, acupuncture visit". The patient was recovering from the events.
Age: 30.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Disorientation, Road traffic accident, Syncope
Clinical narrative: fainted or got disoriented; fainted or got disoriented; I was in a car accident; This is a spontaneous report from a contactable consumer (patient). A 30-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: ER8737), via an unspecified route of administration in the left arm, on 01Apr2021 14:30, as single dose, for COVID-19 immunisation. There was no medical history, no known allergies. The patient was not pregnant at the time of vaccination. The patient did not have COVID-19 prior to vaccination and was not tested for COVID-19 post vaccination. Concomitant medication included "digestion herbs" (as reported). Historical vaccine included the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot umber: EN6199) received at age 30 years, via an unspecified route of administration in the left arm, on 04Mar2021 10:30, for COVID-19 immunisation. The patient did not receive other vaccines in four weeks. After the patient received the second dose on 01Apr2021, the patient waited the full 15 minutes in the waiting are before leaving. The patient did not notice any adverse effects while waiting. However, it was reported that about 100 feet from the exit, at 14:45, "I was in a car accident. I believe I fainted or got disoriented because I do not remember anything for a short period from the time I left the parking lot until the moment of impact with an oncoming truck." The events resulted to emergency room, physician's office, and acupuncture visits. Treatment for the events was reported as "emergency room visit, acupuncture visit". The patient was recovering from the events.
Age: 60.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Bell's palsy, Feeling cold, Hypoaesthesia oral
Clinical narrative: Bell's Palsy; right side of mouth felt numb; freezing cold; This is a spontaneous report from a contactable consumer (patient). A 60-year-old female patient received the second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, lot number: EN6207), via an unspecified route of administration administered in right arm on 01Apr2021 15:15 (at the age of 60-year-old) as SINGLE DOSE for COVID-19 immunisation. The patient was not pregnant at the time of vaccination. The patient had no other vaccine in four weeks. The patient had no COVID prior vaccination and was not COVID tested post vaccination. Medical history included high blood pressure. The patient had known allergies with Allegra. Concomitant medications included pravastatin; ascorbic acid, betacarotene, cupric oxide, tocopheryl acetate, zinc oxide (PRESERVISION); cetirizine hydrochloride (ZYRTEC [CETIRIZINE HYDROCHLORIDE]); and bupropion. Historical vaccine includes first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, lot number: EN6199), administered in the left arm on 14Mar2021 at 04:00 PM for COVID-19 immunisation. On 02Apr2021 at 13:00, the patient got freezing cold. The patient was cold for several hours. On 03Apr2021, the patient woke up and right side of mouth felt numb. The patient went to urgent care and was diagnosed with Bell's Palsy on 03Apr2021. The events resulted in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Therapeutic measures were taken as a result of bell's palsy, freezing cold, and right side of mouth felt numb. The patient had not yet recovered from the events.
Age: 54.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Abdominal pain, Computerised tomogram, Dry mouth, Fatigue, Headache
Clinical narrative: fast HB; Severe head ache; abdominal cramps; extremely high BP; This is a spontaneous report from a contactable consumer(patient). This 54-year-old female patient (not pregnant) received 2nd doe of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot EN6204) at single dose via an unwon route in right arm on 26Mar2021 02:15PM for Covid-19 immunization. Medical history included hypothyroidism. Patient had no known allergies. Other medications in two weeks included levothyroxine and meloxicam. Patient did not have COVID prior vaccination. Historical vaccine included 1st dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot EN6198) on 26Feb2021 in right arm for Covid-19 immunization. Patient experienced severe headache, abdominal cramps, extremely high blood pressure (BP) and fast heartbeats (HB), which was ongoing for 3 weeks as of 06Apr2021. The events onset date was 30Mar2021 08:00AM.  The events resulted in Emergency room/department or urgent care. Treatment included IV fluids and BP medications. Lab data included CT scans and blood/ urine tests. The events were reported as serious with seriousness criteria of medially significant and life-threatening illness (immediate risk of death from the event).   Outcome of the event was not resolved. Patient did not test for COVID post vaccination.
Age: 54.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Hypertension, Limb discomfort, Loss of personal independence in daily activities, Pyrexia, Skin burning sensation
Clinical narrative: fast HB; Severe head ache; abdominal cramps; extremely high BP; This is a spontaneous report from a contactable consumer(patient). This 54-year-old female patient (not pregnant) received 2nd doe of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot EN6204) at single dose via an unwon route in right arm on 26Mar2021 02:15PM for Covid-19 immunization. Medical history included hypothyroidism. Patient had no known allergies. Other medications in two weeks included levothyroxine and meloxicam. Patient did not have COVID prior vaccination. Historical vaccine included 1st dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot EN6198) on 26Feb2021 in right arm for Covid-19 immunization. Patient experienced severe headache, abdominal cramps, extremely high blood pressure (BP) and fast heartbeats (HB), which was ongoing for 3 weeks as of 06Apr2021. The events onset date was 30Mar2021 08:00AM.  The events resulted in Emergency room/department or urgent care. Treatment included IV fluids and BP medications. Lab data included CT scans and blood/ urine tests. The events were reported as serious with seriousness criteria of medially significant and life-threatening illness (immediate risk of death from the event).   Outcome of the event was not resolved. Patient did not test for COVID post vaccination.
Age: 54.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Urine analysis
Clinical narrative: fast HB; Severe head ache; abdominal cramps; extremely high BP; This is a spontaneous report from a contactable consumer(patient). This 54-year-old female patient (not pregnant) received 2nd doe of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot EN6204) at single dose via an unwon route in right arm on 26Mar2021 02:15PM for Covid-19 immunization. Medical history included hypothyroidism. Patient had no known allergies. Other medications in two weeks included levothyroxine and meloxicam. Patient did not have COVID prior vaccination. Historical vaccine included 1st dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot EN6198) on 26Feb2021 in right arm for Covid-19 immunization. Patient experienced severe headache, abdominal cramps, extremely high blood pressure (BP) and fast heartbeats (HB), which was ongoing for 3 weeks as of 06Apr2021. The events onset date was 30Mar2021 08:00AM.  The events resulted in Emergency room/department or urgent care. Treatment included IV fluids and BP medications. Lab data included CT scans and blood/ urine tests. The events were reported as serious with seriousness criteria of medially significant and life-threatening illness (immediate risk of death from the event).   Outcome of the event was not resolved. Patient did not test for COVID post vaccination.
Age: 54.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Abdominal pain, Blood pressure measurement, Blood test, Computerised tomogram, Headache
Clinical narrative: fast HB; Severe head ache; abdominal cramps; extremely high BP; This is a spontaneous report from a contactable consumer(patient). This 54-year-old female patient (not pregnant) received 2nd doe of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot EN6204) at single dose via an unwon route in right arm on 26Mar2021 02:15PM for Covid-19 immunization. Medical history included hypothyroidism. Patient had no known allergies. Other medications in two weeks included levothyroxine and meloxicam. Patient did not have COVID prior vaccination. Historical vaccine included 1st dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot EN6198) on 26Feb2021 in right arm for Covid-19 immunization. Patient experienced severe headache, abdominal cramps, extremely high blood pressure (BP) and fast heartbeats (HB), which was ongoing for 3 weeks as of 06Apr2021. The events onset date was 30Mar2021 08:00AM.  The events resulted in Emergency room/department or urgent care. Treatment included IV fluids and BP medications. Lab data included CT scans and blood/ urine tests. The events were reported as serious with seriousness criteria of medially significant and life-threatening illness (immediate risk of death from the event).   Outcome of the event was not resolved. Patient did not test for COVID post vaccination.
Age: 54.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Heart rate, Heart rate increased, Hypertension, Urine analysis
Clinical narrative: fast HB; Severe head ache; abdominal cramps; extremely high BP; This is a spontaneous report from a contactable consumer(patient). This 54-year-old female patient (not pregnant) received 2nd doe of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot EN6204) at single dose via an unwon route in right arm on 26Mar2021 02:15PM for Covid-19 immunization. Medical history included hypothyroidism. Patient had no known allergies. Other medications in two weeks included levothyroxine and meloxicam. Patient did not have COVID prior vaccination. Historical vaccine included 1st dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot EN6198) on 26Feb2021 in right arm for Covid-19 immunization. Patient experienced severe headache, abdominal cramps, extremely high blood pressure (BP) and fast heartbeats (HB), which was ongoing for 3 weeks as of 06Apr2021. The events onset date was 30Mar2021 08:00AM.  The events resulted in Emergency room/department or urgent care. Treatment included IV fluids and BP medications. Lab data included CT scans and blood/ urine tests. The events were reported as serious with seriousness criteria of medially significant and life-threatening illness (immediate risk of death from the event).   Outcome of the event was not resolved. Patient did not test for COVID post vaccination.