chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Chills, Headache, Pain, Pyrexia
Clinical narrative: body aches; fever; headache; chills; This is a spontaneous report from a contactable consumer, who is also the patient. This male patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration on 23Dec2020 at single dose for COVID-19 immunisation. Relevant medical history and concomitant medications were not reported. In Dec2020, the patient experienced body aches, fever, headache and chills; the patient specified that he received the vaccine on 23Dec2020 and for 13 days he had been experiencing body aches, fever, headache and chills. The patient was taking ibuprofen (ADVIL) and he responded well to that, but when it wears off the symptoms return. At the time of the report, the outcome of the events was unknown.  The information on the lot/batch number has been requested.
Sex: F
Vaccine: COVID19
Symptoms: SARS-CoV-2 test positive
Clinical narrative: tested positive for Covid-19; tested positive for Covid-19; This is a spontaneous report from a contactable healthcare professional (reporting for herself). A female patient of an unspecified age received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number and expiry date not reported) via an unspecified route of administration, on 24Dec2020, single dose for COVID-19 immunization. Relevant medical history and concomitant medications were not reported. The patient tested negative for Covid-19 on 22Dec2020, received her first vaccine dose on 24Dec2020 and then tested positive for Covid-19 on 26Dec2020. Outcome of the events was unknown.   Information on the lot/batch number has been requested.; Sender's Comments: The efficacy of a drug varies from patient to patient and can be affected by different factors; however, a contributory role of the suspect product bnt162b2 to the reported drug ineffective and SARS-CoV-2 test positive cannot be ruled out.
Sex: F
Vaccine: COVID19
Symptoms: Blood electrolytes normal, Electrocardiogram normal, Palpitations, Rash, Troponin normal
Clinical narrative: full body rash; heart palpitations; reaction to drug excipient; This is a spontaneous report from a contactable nurse, the patient. 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 26Dec2020 as a single dose for COVID-19 immunization. Medical history included several outdoor allergies, but no known food allergies. The patient's concomitant medications were not reported.  On 28Dec2020, the patient experienced full body rash and heart palpitations. The clinical course was as follows: the patient developed a full body rash and heart palpitations on 28Dec2020 and went to the emergency room. The patient had a full work-up which included electrocardiogram, troponin levels, and electrolytes, and all were normal. She was instructed to take diphenhydramine hydrochloride (BENADRYL). She thought it may have been due to the polyethylene glycol; however, she did mention that she previously took macrogol 3350 (MIRALAX)  on unknown dates for an unknown indication and was fine. The clinical outcomes of the full body rash, heart palpitations, and reaction to polyethylene glycol, were unknown.     The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow up.; Sender's Comments: The Company cannot completely exclude the possible causality between the reported full body rash and the administration of the suspect, BNT162B2, based on the reasonable temporal association. While the possibility of allergic to polyethylene glycol (drug excipient) might have provided alternative explanations.   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 RA, IEC, as appropriate.
Age: 47.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Chest discomfort, Electrocardiogram, SARS-CoV-2 test positive, Swelling of eyelid
Clinical narrative: Throat very hot Swollen Eye lids, Chest Tighten  Tested positive for covid 12/31/2020
Age: 47.0
Sex: F
Vaccine: COVID19
Symptoms: Throat irritation
Clinical narrative: Throat very hot Swollen Eye lids, Chest Tighten  Tested positive for covid 12/31/2020
Age: 31.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Chest discomfort, Hypertension, Tachycardia
Clinical narrative: diarrhea; headache; lower back pain; Fatigue; arrhythmia; Tachycardia; High Blood pressure; Redness on chest; Chest tightness; Lightheaded; possible tongue swelling; possible tongue swelling (felt heavy after vaccine); dry mouth; sore throat; This is a spontaneous report from a contactable nurse (patient) who reported for herself that a 31-year-old female patient received her first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EH9899) via an unspecified route of administration, on 20Dec2020 14:15 at left arm/arm right (pending clarification), single dose for COVID-19 immunization. Medical history included factor II, history of melanoma. She has no known allergies. She was not pregnant at the time of the vaccination. Concomitant medications included bupropion hydrochloride (WELLBUTRIN), ibuprofen (MOTRIN), multivitamin. Nurse reported administering COVID-19 vaccine at hospital,  experiencing tachycardia, high blood pressure, redness on chest, chest tightness, lightheaded, possible tongue swelling (felt heavy after vaccine), arrhythmia, dry mouth, sore throat (after leaving emergency department) at 14:30 on 20Dec2020; After one day, she experienced diarrhea, headache, lower back pain and fatigue since 21Dec2020. Fatigue lasting for several days. Adverse events resulted in emergency room/department or urgent care (pending clarification). Nurse received intravenous diphenhydramine hydrochloride (BENADRYL) and fluids as treatments. Nurse assessed the events as non-serious. Nurse also reported that, prior to vaccination, she was not diagnosed with COVID-19; since the vaccination, she has not been tested for COVID-19. She did not receive other vaccine in four weeks. Outcome of fatigue was not recovered, outcome of the rest of the events was recovered.; Sender's Comments: Based on available information, a possible contributory role of the subject product, BNT162B2 vaccine, cannot be excluded for the tachycardia, high blood pressure, arrhythmia and the other reported events due to temporal relationship.  There is limited information provided in this report.  Additional information is needed to better assess the case, including complete medical history, diagnostics including EKG at baseline and during subject drug therapy, echocardiogram, cardiac enzymes, electrolytes, chemistry panel and serum toxicology screen, counteractive treatment measures and concomitant medications.  This case will be reassessed once additional information is available.  The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
Age: 31.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Arrhythmia, Back pain, Chest discomfort, Diarrhoea, Dizziness
Clinical narrative: diarrhea; headache; lower back pain; Fatigue; arrhythmia; Tachycardia; High Blood pressure; Redness on chest; Chest tightness; Lightheaded; possible tongue swelling; possible tongue swelling (felt heavy after vaccine); dry mouth; sore throat; This is a spontaneous report from a contactable nurse (patient) who reported for herself that a 31-year-old female patient received her first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EH9899) via an unspecified route of administration, on 20Dec2020 14:15 at left arm/arm right (pending clarification), single dose for COVID-19 immunization. Medical history included factor II, history of melanoma. She has no known allergies. She was not pregnant at the time of the vaccination. Concomitant medications included bupropion hydrochloride (WELLBUTRIN), ibuprofen (MOTRIN), multivitamin. Nurse reported administering COVID-19 vaccine at hospital,  experiencing tachycardia, high blood pressure, redness on chest, chest tightness, lightheaded, possible tongue swelling (felt heavy after vaccine), arrhythmia, dry mouth, sore throat (after leaving emergency department) at 14:30 on 20Dec2020; After one day, she experienced diarrhea, headache, lower back pain and fatigue since 21Dec2020. Fatigue lasting for several days. Adverse events resulted in emergency room/department or urgent care (pending clarification). Nurse received intravenous diphenhydramine hydrochloride (BENADRYL) and fluids as treatments. Nurse assessed the events as non-serious. Nurse also reported that, prior to vaccination, she was not diagnosed with COVID-19; since the vaccination, she has not been tested for COVID-19. She did not receive other vaccine in four weeks. Outcome of fatigue was not recovered, outcome of the rest of the events was recovered.; Sender's Comments: Based on available information, a possible contributory role of the subject product, BNT162B2 vaccine, cannot be excluded for the tachycardia, high blood pressure, arrhythmia and the other reported events due to temporal relationship.  There is limited information provided in this report.  Additional information is needed to better assess the case, including complete medical history, diagnostics including EKG at baseline and during subject drug therapy, echocardiogram, cardiac enzymes, electrolytes, chemistry panel and serum toxicology screen, counteractive treatment measures and concomitant medications.  This case will be reassessed once additional information is available.  The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
Age: 31.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Dry mouth, Erythema, Fatigue, Headache, Hypertension
Clinical narrative: diarrhea; headache; lower back pain; Fatigue; arrhythmia; Tachycardia; High Blood pressure; Redness on chest; Chest tightness; Lightheaded; possible tongue swelling; possible tongue swelling (felt heavy after vaccine); dry mouth; sore throat; This is a spontaneous report from a contactable nurse (patient) who reported for herself that a 31-year-old female patient received her first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EH9899) via an unspecified route of administration, on 20Dec2020 14:15 at left arm/arm right (pending clarification), single dose for COVID-19 immunization. Medical history included factor II, history of melanoma. She has no known allergies. She was not pregnant at the time of the vaccination. Concomitant medications included bupropion hydrochloride (WELLBUTRIN), ibuprofen (MOTRIN), multivitamin. Nurse reported administering COVID-19 vaccine at hospital,  experiencing tachycardia, high blood pressure, redness on chest, chest tightness, lightheaded, possible tongue swelling (felt heavy after vaccine), arrhythmia, dry mouth, sore throat (after leaving emergency department) at 14:30 on 20Dec2020; After one day, she experienced diarrhea, headache, lower back pain and fatigue since 21Dec2020. Fatigue lasting for several days. Adverse events resulted in emergency room/department or urgent care (pending clarification). Nurse received intravenous diphenhydramine hydrochloride (BENADRYL) and fluids as treatments. Nurse assessed the events as non-serious. Nurse also reported that, prior to vaccination, she was not diagnosed with COVID-19; since the vaccination, she has not been tested for COVID-19. She did not receive other vaccine in four weeks. Outcome of fatigue was not recovered, outcome of the rest of the events was recovered.; Sender's Comments: Based on available information, a possible contributory role of the subject product, BNT162B2 vaccine, cannot be excluded for the tachycardia, high blood pressure, arrhythmia and the other reported events due to temporal relationship.  There is limited information provided in this report.  Additional information is needed to better assess the case, including complete medical history, diagnostics including EKG at baseline and during subject drug therapy, echocardiogram, cardiac enzymes, electrolytes, chemistry panel and serum toxicology screen, counteractive treatment measures and concomitant medications.  This case will be reassessed once additional information is available.  The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
Age: 31.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Oropharyngeal pain, Paraesthesia oral, Tachycardia
Clinical narrative: diarrhea; headache; lower back pain; Fatigue; arrhythmia; Tachycardia; High Blood pressure; Redness on chest; Chest tightness; Lightheaded; possible tongue swelling; possible tongue swelling (felt heavy after vaccine); dry mouth; sore throat; This is a spontaneous report from a contactable nurse (patient) who reported for herself that a 31-year-old female patient received her first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EH9899) via an unspecified route of administration, on 20Dec2020 14:15 at left arm/arm right (pending clarification), single dose for COVID-19 immunization. Medical history included factor II, history of melanoma. She has no known allergies. She was not pregnant at the time of the vaccination. Concomitant medications included bupropion hydrochloride (WELLBUTRIN), ibuprofen (MOTRIN), multivitamin. Nurse reported administering COVID-19 vaccine at hospital,  experiencing tachycardia, high blood pressure, redness on chest, chest tightness, lightheaded, possible tongue swelling (felt heavy after vaccine), arrhythmia, dry mouth, sore throat (after leaving emergency department) at 14:30 on 20Dec2020; After one day, she experienced diarrhea, headache, lower back pain and fatigue since 21Dec2020. Fatigue lasting for several days. Adverse events resulted in emergency room/department or urgent care (pending clarification). Nurse received intravenous diphenhydramine hydrochloride (BENADRYL) and fluids as treatments. Nurse assessed the events as non-serious. Nurse also reported that, prior to vaccination, she was not diagnosed with COVID-19; since the vaccination, she has not been tested for COVID-19. She did not receive other vaccine in four weeks. Outcome of fatigue was not recovered, outcome of the rest of the events was recovered.; Sender's Comments: Based on available information, a possible contributory role of the subject product, BNT162B2 vaccine, cannot be excluded for the tachycardia, high blood pressure, arrhythmia and the other reported events due to temporal relationship.  There is limited information provided in this report.  Additional information is needed to better assess the case, including complete medical history, diagnostics including EKG at baseline and during subject drug therapy, echocardiogram, cardiac enzymes, electrolytes, chemistry panel and serum toxicology screen, counteractive treatment measures and concomitant medications.  This case will be reassessed once additional information is available.  The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
Age: 38.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Flushing
Clinical narrative: The patient present  some flushing after vaccine administration and he doctor give Benadryl 50 mg IM one dose.
Age: 38.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Flushing
Clinical narrative: Patient present some flushing after vaccine administration
Age: 42.0
Sex: M
Vaccine: COVID19
Symptoms: Chest pain, Chills, Dehydration, Electrocardiogram, Electrocardiogram ambulatory
Clinical narrative: Went to ED 6 days after vaccination.  "42yoM with a hx of covid-19 infection in 3/2020 with sequelae of chest pain, insomnia, SIBO, and distant hx of testicular malignancy who presents with chest pain and chest palpitations.  Pt received COVID vaccine on Monday, then started to have symptoms reminiscent of his original covid infection on Wednesday, including chills, myalgias, substernal chest pain, heart palpitations, and fatigue. Denies any fevers recorded at home. He feels like he has extra beats intermittently. Also reports some nausea, but denies vomiting or diarrhea. He has maintained good PO intake since symptoms started, but is worried he may be a bit dehydrated because he had a small AKI when he had covid back in March?.  Etiology of chest pains unclear, but given all of the above workup, unlikely to be due to an acute cardiac or pulmonary etiology."  He continued to have palpitations for the next week and had further EKG's don thru urgent care.
Age: 42.0
Sex: M
Vaccine: COVID19
Symptoms: Fatigue, Myalgia, Nausea, Palpitations
Clinical narrative: Went to ED 6 days after vaccination.  "42yoM with a hx of covid-19 infection in 3/2020 with sequelae of chest pain, insomnia, SIBO, and distant hx of testicular malignancy who presents with chest pain and chest palpitations.  Pt received COVID vaccine on Monday, then started to have symptoms reminiscent of his original covid infection on Wednesday, including chills, myalgias, substernal chest pain, heart palpitations, and fatigue. Denies any fevers recorded at home. He feels like he has extra beats intermittently. Also reports some nausea, but denies vomiting or diarrhea. He has maintained good PO intake since symptoms started, but is worried he may be a bit dehydrated because he had a small AKI when he had covid back in March?.  Etiology of chest pains unclear, but given all of the above workup, unlikely to be due to an acute cardiac or pulmonary etiology."  He continued to have palpitations for the next week and had further EKG's don thru urgent care.
Age: 30.0
Sex: F
Vaccine: COVID19
Symptoms: Dry skin, Pallor, Rash, Rash erythematous, Rash papular
Clinical narrative: Pt received first dose of Pfizer COVID vaccine on 12/22/20 on L deltoid. On 12/25/20 Pt began developing a rash on her left elbow. Rash then spread to the bilateral arms and became more concentrated, and scantly on the bilateral lower extremities. She denies any other symptoms. No improvement with hydrocortisone cream. Pt presented to Urgent Care on 12/29/20 for workup. Per provider "On exam there is a concentrated erythematous papular rash that blanches with pressure on the bilateral upper extremities, right greater than left. It coalesces on the right arm as seen in picture below. It does feel rough in texture. No vesicular lesions, bulla, crusting. Few erythematous papular lesions that are scant on the bilateral lower extremities. Rash spares the palm and soles of feet. Exam otherwise unremarkable." Pt treated with 12 mg dexamethasone PO and given prednisone 20 mg BID X 5 days for outpatient prescription. Patient was discharged without further escalation of care.
Age: 45.0
Sex: M
Vaccine: COVID19
Symptoms: Facet joint syndrome, Paraesthesia, Paraesthesia oral, Polyneuropathy, SARS-CoV-2 test negative
Clinical narrative: polyneuropathy; facet joint diagnosis/new left forefoot paresthesia; This is a spontaneous report from a contactable physician (patient).  A 45-years-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) (lot EJ1685) at the first dose in left arm on 17Dec2020 12:45 at single dose for COVID-19 immunisation. Facility where the most recent COVID-19 vaccine was administered at Doctor's office/urgent care. Medical history included ongoing back pain (thinking it was due to running/physical therapy overuse injury).  No allergies to medications, food, or other products. There were no concomitant medications. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. No any other medications the patient received within 2 weeks of vaccination. It was reported that 20Dec2020 morning: new left forefoot paresthesia. no weakness. Patient thought this might be due to the back pain he had been watching for 3 months, thinking it was due to running/physical therapy overuse injury. On 21Dec2020 sports medicine physician evaluation. numbness was gone, facet joint diagnosis, MRI lumbar ordered (still pending). On 24Dec2020 9 pm, paresthesia both hands and feet, no weakness nor other symptoms those continued and were slightly worse on 27Dec2020 morning, including face/teeth. no other symptoms; 27Dec2020 afternoon: internal medicine physician evaluation, working diagnosis polyneuropathy. Neurologist appointment will be 07Jan2021, 2 hours before 2nd shot was scheduled. The patient had been tested for COVID-19 test type post vaccination: negative on 22Dec2020.  No treatment for event. Prior to vaccination, the patient was not diagnosed with COVID-19. Outcome of events was not resolved.; Sender's Comments: Based on available information, a possible contributory role of the subject product, BNT162B2 vaccine, cannot be excluded for the reported events of polyneuropathy and facet joint diagnosis/new left forefoot paresthesia due to temporal relationship. However, the reported events may possibly represent intercurrent medical conditions in this patient.  There is limited information provided in this report.  Additional information is needed to better assess the case, including complete medical history, diagnostics including nerve conduction tests, counteractive treatment measures and concomitant medications.  This case will be reassessed once additional information is available.  The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
Age: 29.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Anaphylactic reaction, Blood test, Burning sensation, Central venous catheterisation, Dysphonia
Clinical narrative: Anaphylactic reaction; hives in the first 10 minutes of the vaccine; This is a spontaneous report from a contactable Other Health Professional (Physician Assistant). A 29-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 29Dec2020 at a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The reporter stated that she is treating a patient in ICU that got the COVID-19 vaccine on 29Dec2020. The patient developed hives in the first 10 minutes of the vaccine and had an anaphylactic reaction 1 hour later. Seriousness of events was reported to be hospitalization. Outcome of the events was unknown. The reporter also mentioned that it was not a mild reaction and patient was still in the ICU, 48 hours later.  Information about lot/batch number has been requested.; Sender's Comments: A possible causal association between administration of BNT162B2 and the onset of anaphylactic reaction and hives cannot be excluded, considering the plausible temporal relationship and the known adverse event profile of the suspect product.  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: 29.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Intensive care, Pruritus, Rash, Rash macular, Throat tightness
Clinical narrative: Anaphylactic reaction; hives in the first 10 minutes of the vaccine; This is a spontaneous report from a contactable Other Health Professional (Physician Assistant). A 29-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 29Dec2020 at a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The reporter stated that she is treating a patient in ICU that got the COVID-19 vaccine on 29Dec2020. The patient developed hives in the first 10 minutes of the vaccine and had an anaphylactic reaction 1 hour later. Seriousness of events was reported to be hospitalization. Outcome of the events was unknown. The reporter also mentioned that it was not a mild reaction and patient was still in the ICU, 48 hours later.  Information about lot/batch number has been requested.; Sender's Comments: A possible causal association between administration of BNT162B2 and the onset of anaphylactic reaction and hives cannot be excluded, considering the plausible temporal relationship and the known adverse event profile of the suspect product.  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: 29.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Anaphylactic reaction, Intensive care, Urticaria
Clinical narrative: Anaphylactic reaction; hives in the first 10 minutes of the vaccine; This is a spontaneous report from a contactable Other Health Professional (Physician Assistant). A 29-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 29Dec2020 at a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The reporter stated that she is treating a patient in ICU that got the COVID-19 vaccine on 29Dec2020. The patient developed hives in the first 10 minutes of the vaccine and had an anaphylactic reaction 1 hour later. Seriousness of events was reported to be hospitalization. Outcome of the events was unknown. The reporter also mentioned that it was not a mild reaction and patient was still in the ICU, 48 hours later.  Information about lot/batch number has been requested.; Sender's Comments: A possible causal association between administration of BNT162B2 and the onset of anaphylactic reaction and hives cannot be excluded, considering the plausible temporal relationship and the known adverse event profile of the suspect product.  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: 24.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Chest pain, Cold sweat, Cough, Dyspnoea
Clinical narrative: Increased heart rate of 124; clammy hands; nausea; calf pain; extreme muscle and joint pain; extreme muscle and joint pain; shortness of breath; coughing; chest pain; This is a spontaneous report from a contactable Other Health Professional (patient). A 24-year-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE) lot number was unknown, via an unspecified route of administration in the left arm, on 30Dec2020 08:00 at a single dose for COVID-19 immunization. Medical history included asthma and drug hypersensitivity to sulfa. The patient was not pregnant. The patient had not received any other vaccines in four weeks prior to Covid vaccine. The patient's concomitant medications included birth control and multivitamin, both unspecified. The patient experienced increased heart rate of 124, clammy hands, nausea, calf pain, extreme muscle and joint pain, shortness of breath, coughing and chest pain, all on 02Jan2021 12:00 PM with outcome of recovering. The events are reported as non-serious with no treatment received. The patient had no covid prior vaccination. She was not tested for covid post vaccination.   Information on the lot/batch number has been requested.
Age: 24.0
Sex: F
Vaccine: COVID19
Symptoms: Heart rate, Heart rate increased, Myalgia, Nausea, Pain in extremity
Clinical narrative: Increased heart rate of 124; clammy hands; nausea; calf pain; extreme muscle and joint pain; extreme muscle and joint pain; shortness of breath; coughing; chest pain; This is a spontaneous report from a contactable Other Health Professional (patient). A 24-year-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE) lot number was unknown, via an unspecified route of administration in the left arm, on 30Dec2020 08:00 at a single dose for COVID-19 immunization. Medical history included asthma and drug hypersensitivity to sulfa. The patient was not pregnant. The patient had not received any other vaccines in four weeks prior to Covid vaccine. The patient's concomitant medications included birth control and multivitamin, both unspecified. The patient experienced increased heart rate of 124, clammy hands, nausea, calf pain, extreme muscle and joint pain, shortness of breath, coughing and chest pain, all on 02Jan2021 12:00 PM with outcome of recovering. The events are reported as non-serious with no treatment received. The patient had no covid prior vaccination. She was not tested for covid post vaccination.   Information on the lot/batch number has been requested.
Age: 41.0
Sex: F
Vaccine: COVID19
Symptoms: Anxiety, Electrocardiogram normal, Erythema, Feeling abnormal, Hypertension
Clinical narrative: Patient reports seconds after receiving the vaccine she felt a strange sensation in her chest which she has a difficulty characterizing but describes as "a strange sensation".  Vitals at that time demonstrated tachycardia and hypertension which she was referred to the ED for further evaluation.  She does admit that she has anxiety and felt this may be contributing to the symptoms.  She reports she is already starting to feel improved.  She is noted to have some redness over her left ear and feels it is a little warm but no other rash.  She denies any associated shortness of breath, dizziness or lightheadedness, arm or jaw pain, associated nausea, vomiting, back pain, lip or tongue swelling. No fevers, chills, or cough. Patient was given one dose of diphenhydramine 50 mg PO Once and monitored in the emergency room. Symptoms completely resolved and was hemodynamically stable. Patient discharged home from the emergency room.
Age: 41.0
Sex: F
Vaccine: COVID19
Symptoms: Immediate post-injection reaction, Sinus rhythm, Skin warm, Tachycardia
Clinical narrative: Patient reports seconds after receiving the vaccine she felt a strange sensation in her chest which she has a difficulty characterizing but describes as "a strange sensation".  Vitals at that time demonstrated tachycardia and hypertension which she was referred to the ED for further evaluation.  She does admit that she has anxiety and felt this may be contributing to the symptoms.  She reports she is already starting to feel improved.  She is noted to have some redness over her left ear and feels it is a little warm but no other rash.  She denies any associated shortness of breath, dizziness or lightheadedness, arm or jaw pain, associated nausea, vomiting, back pain, lip or tongue swelling. No fevers, chills, or cough. Patient was given one dose of diphenhydramine 50 mg PO Once and monitored in the emergency room. Symptoms completely resolved and was hemodynamically stable. Patient discharged home from the emergency room.
Age: 33.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Blood pressure increased, Chest discomfort, Dizziness, Fatigue
Clinical narrative: Within a 5-8 minutes of receiving the vaccine, I became very dizzy and lightheaded.  The nurse had me lay down and took my blood pressure.  It was up to 145/94, unusual for me. I am normally under 120/80.  I rested and had some water and orange juice.  I felt weak but did not lose consiousness. After 30 minutes, my blood pressure was down to 131/87 and she thought it was okay for me to go home. On my drive home, the left side of my face/cheek was tingling. I still felt very weak but the dizziness had subsided.  My fingers were also very cold. I laid down at home and around 6:45 PM, my cheek was still tingling, so I went back to the clinic. They sent me over to the ER. Everything came back normal, except my blood pressure was still elevated in the 140s/90s and the doctor stated I'd had a mild adverse reaction. When I got home, I went to bed. While I was in bed, I noticed my mouth area felt slightly numb.  I went to bed and felt tired, but normal, in the morning. On 12/31/2020 and 1/1/2020 I experienced very bad arm pain that kept me up at night. I experienced a heaviness and throbbing sensation. It was very hard for me to move from side to side while laying down at night. During the day, the pain felt moderate, but at night was very severe. Over-the-counter pain medication helped some. The pain subsided after 2-3 days. One week after the vaccine, on 1/6/2021, I noticed pain at the injection sight again. On the night of 1/6/2021, the pain was severe again. I couldn't rotate from side to side without extreme pain and heaviness, and also felt the heaviness in my chest plate (not heart, but the bone of my chest). It kept me up most of the night. In the morning, the pain subsided to a mild pain. I applied heat and took ibuprofen the night of 1/7/2021 and noticed an improvement of pain.
Age: 33.0
Sex: F
Vaccine: COVID19
Symptoms: Hypoaesthesia oral, Injection site pain, Limb discomfort, Pain, Pain in extremity
Clinical narrative: Within a 5-8 minutes of receiving the vaccine, I became very dizzy and lightheaded.  The nurse had me lay down and took my blood pressure.  It was up to 145/94, unusual for me. I am normally under 120/80.  I rested and had some water and orange juice.  I felt weak but did not lose consiousness. After 30 minutes, my blood pressure was down to 131/87 and she thought it was okay for me to go home. On my drive home, the left side of my face/cheek was tingling. I still felt very weak but the dizziness had subsided.  My fingers were also very cold. I laid down at home and around 6:45 PM, my cheek was still tingling, so I went back to the clinic. They sent me over to the ER. Everything came back normal, except my blood pressure was still elevated in the 140s/90s and the doctor stated I'd had a mild adverse reaction. When I got home, I went to bed. While I was in bed, I noticed my mouth area felt slightly numb.  I went to bed and felt tired, but normal, in the morning. On 12/31/2020 and 1/1/2020 I experienced very bad arm pain that kept me up at night. I experienced a heaviness and throbbing sensation. It was very hard for me to move from side to side while laying down at night. During the day, the pain felt moderate, but at night was very severe. Over-the-counter pain medication helped some. The pain subsided after 2-3 days. One week after the vaccine, on 1/6/2021, I noticed pain at the injection sight again. On the night of 1/6/2021, the pain was severe again. I couldn't rotate from side to side without extreme pain and heaviness, and also felt the heaviness in my chest plate (not heart, but the bone of my chest). It kept me up most of the night. In the morning, the pain subsided to a mild pain. I applied heat and took ibuprofen the night of 1/7/2021 and noticed an improvement of pain.
Age: 33.0
Sex: F
Vaccine: COVID19
Symptoms: Paraesthesia, Peripheral coldness, Sleep disorder, Vaccination complication
Clinical narrative: Within a 5-8 minutes of receiving the vaccine, I became very dizzy and lightheaded.  The nurse had me lay down and took my blood pressure.  It was up to 145/94, unusual for me. I am normally under 120/80.  I rested and had some water and orange juice.  I felt weak but did not lose consiousness. After 30 minutes, my blood pressure was down to 131/87 and she thought it was okay for me to go home. On my drive home, the left side of my face/cheek was tingling. I still felt very weak but the dizziness had subsided.  My fingers were also very cold. I laid down at home and around 6:45 PM, my cheek was still tingling, so I went back to the clinic. They sent me over to the ER. Everything came back normal, except my blood pressure was still elevated in the 140s/90s and the doctor stated I'd had a mild adverse reaction. When I got home, I went to bed. While I was in bed, I noticed my mouth area felt slightly numb.  I went to bed and felt tired, but normal, in the morning. On 12/31/2020 and 1/1/2020 I experienced very bad arm pain that kept me up at night. I experienced a heaviness and throbbing sensation. It was very hard for me to move from side to side while laying down at night. During the day, the pain felt moderate, but at night was very severe. Over-the-counter pain medication helped some. The pain subsided after 2-3 days. One week after the vaccine, on 1/6/2021, I noticed pain at the injection sight again. On the night of 1/6/2021, the pain was severe again. I couldn't rotate from side to side without extreme pain and heaviness, and also felt the heaviness in my chest plate (not heart, but the bone of my chest). It kept me up most of the night. In the morning, the pain subsided to a mild pain. I applied heat and took ibuprofen the night of 1/7/2021 and noticed an improvement of pain.
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Paraesthesia oral, Rash, Swollen tongue
Clinical narrative: Anaphylactic reaction; This is a spontaneous report from a contactable nurse. A female patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EH9899), via an unspecified route of administration on deltoid (unknown which) on 31Dec2020 at 0.3 mL, single for COVID-19 immunization. There were no medical history and concomitant medications. The patient experienced anaphylactic reaction on 31Dec2020. The event required emergency room visit for observation and treatment.; Sender's Comments: A possible causal association between administration of BNT162B2 and the onset of anaphylactic reaction cannot be excluded, considering the plausible temporal relationship and the known adverse event profile of the suspect product.  The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Anaphylactic reaction
Clinical narrative: Anaphylactic reaction; This is a spontaneous report from a contactable nurse. A female patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EH9899), via an unspecified route of administration on deltoid (unknown which) on 31Dec2020 at 0.3 mL, single for COVID-19 immunization. There were no medical history and concomitant medications. The patient experienced anaphylactic reaction on 31Dec2020. The event required emergency room visit for observation and treatment.; Sender's Comments: A possible causal association between administration of BNT162B2 and the onset of anaphylactic reaction cannot be excluded, considering the plausible temporal relationship and the known adverse event profile of the suspect product.  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: 47.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Flushing, Hypersensitivity, Swollen tongue, Tongue discomfort
Clinical narrative: Allergic reaction; Hives on back; Flushed; Chills; Swollen tongue; Burning tongue; This is a spontaneous report from a contactable consumer (patient). This 47-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 29Dec2020 07:00 at single dose on left arm for COVID-19 vaccination. There were no medical history and concomitant medications. The patient previously took flu shot. Vaccination Facility Type was hospital. Patient did not receive any other vaccines at time COVID-19 vaccine given and no vaccines given 4 weeks prior. Patient got the Pfizer COVID-19 vaccine on 29Dec2020 and had an allergic reaction to it. Had hives on her back, was flushed, had chills, and swollen tongue on 29Dec2020. There was swelling on either side of tongue not in the center. Swelling seemed to bounce around sides of tongue. Patient mentioned she also had burning sensation of tongue first on 29Dec2020 and then the swelling was after that. Adverse events hives, flushed, chills, burning sensation of tongue and swelling of tongue required a visit to emergency room. Patient was seen in the emergency room and given diphenhydramine hydrochloride (BENADRYL) and an Epi-pen to take home. This all happened after receiving the vaccine on 29Dec2020. Patient wasn't getting any better/feeling better and went back to the emergency room on 30Dec2020. Patient was treated with dexamethasone and told her to take diphenhydramine hydrochloride every 4 hours, her last dose was at 2pm 31Dec2020. Patient said all events still persisting, but there maybe a little more swelling of the tongue, but not much. Patient had had a flu shot before, but never had anything to happen like this. Outcome of allergic reaction, hives, flushed, chills and burning tongue was not recovered, outcome of swollen tongue was unknown.  Information on the lot/batch number has been requested.
Age: 47.0
Sex: F
Vaccine: COVID19
Symptoms: Urticaria
Clinical narrative: Allergic reaction; Hives on back; Flushed; Chills; Swollen tongue; Burning tongue; This is a spontaneous report from a contactable consumer (patient). This 47-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 29Dec2020 07:00 at single dose on left arm for COVID-19 vaccination. There were no medical history and concomitant medications. The patient previously took flu shot. Vaccination Facility Type was hospital. Patient did not receive any other vaccines at time COVID-19 vaccine given and no vaccines given 4 weeks prior. Patient got the Pfizer COVID-19 vaccine on 29Dec2020 and had an allergic reaction to it. Had hives on her back, was flushed, had chills, and swollen tongue on 29Dec2020. There was swelling on either side of tongue not in the center. Swelling seemed to bounce around sides of tongue. Patient mentioned she also had burning sensation of tongue first on 29Dec2020 and then the swelling was after that. Adverse events hives, flushed, chills, burning sensation of tongue and swelling of tongue required a visit to emergency room. Patient was seen in the emergency room and given diphenhydramine hydrochloride (BENADRYL) and an Epi-pen to take home. This all happened after receiving the vaccine on 29Dec2020. Patient wasn't getting any better/feeling better and went back to the emergency room on 30Dec2020. Patient was treated with dexamethasone and told her to take diphenhydramine hydrochloride every 4 hours, her last dose was at 2pm 31Dec2020. Patient said all events still persisting, but there maybe a little more swelling of the tongue, but not much. Patient had had a flu shot before, but never had anything to happen like this. Outcome of allergic reaction, hives, flushed, chills and burning tongue was not recovered, outcome of swollen tongue was unknown.  Information on the lot/batch number has been requested.
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Facial pain, Glossodynia, Head discomfort, Heart rate
Clinical narrative: sores and redness at the back of throat and tongue; sores and redness at the back of throat and tongue; sores and redness at the back of throat and tongue; sores and redness at the back of throat and tongue; numbness; tingling; burning sensation in throat and the back of tongue; burning sensation in throat and the back of tongue; mild nausea; allergic reaction; dizzy, light-headed; ashen pale; head felt heavy; Burning and itchiness on chin persists; Burning and itchiness on chin persists; This is a spontaneous report from a contactable nurse (patient). A 50-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EK5730), via an unspecified route of administration in left arm on 29Dec2020 12:00 at first single dose for COVID-19 immunization. Medical history reported as none. No known allergies. Concomitant medication the patient received within 2 weeks of vaccination included ergocalciferol (VIT D), linum usitatissimum seed oil (FLAX SEED OIL), cyanocobalamin (VITAMIN B12) and multi-vitamin. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. 2 min after shot the patient was dizzy, light-headed, ashen pale, and head felt heavy. After sitting and lying down about 45 min, the patient felt numbness, tingling, and a burning sensation in throat and the back of tongue. MD took O2 sat (99%) and heart rate (72). The patient felt mild nausea for 5 min. MD gave her Pepcid 20 mg as antihistamine. About 30 min later, the patient noticed sores and redness at the back of throat and tongue. The patient consulted MD and she advised the patient to go to employee health clinic. The clinic MD stated the patient was probably having some kind of allergic reaction to vaccine. The patient was given steroid shot and Benadryl 25 mg PO (per oral) and observed for 90 min. The patient left and was given Medrol Dose pack if symptoms persisted after 2 days. The patient was told to take Benadryl 25 mg PO (per oral) 4-6 hours and Pepcid 20 mg PO (per oral) BID (twice a day) for 1-2 days. Redness, sores at back of throat and tongue persist. Burning and itchiness on chin persists. The patient had no difficulty breathing at any time. Adverse event start date was reported as 29Dec2020 12:15 PM. Events were non-serious. The adverse event result in doctor or other healthcare professional office/clinic visit. Treatment received for the adverse event included: Benadryl 25 mg PO and a steroid shot IM. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. Outcome of the events sores and redness at the back of throat and tongue, burning and itchiness on chin persists not recovered, of other events was recovered with sequel.