chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 29.0
Sex: F
Vaccine: COVID19
Symptoms: Allergy to surgical sutures, C-reactive protein increased, Dermatitis allergic, Drug hypersensitivity, Eosinophil count increased
Clinical narrative: 2 weeks after covid 19 vaccine, had severe multiple allergic reactions never experienced.; Suture reaction to surgical site; allergic flare up of previously healed and closed nerve block locations; slight increase in eosinophils, CRP; slight increase in eosinophils, CRP; increase in platelets; This is a spontaneous report from a contactable nurse (patient). A 29-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) (lot number Ek5t30), intramuscularly on 20Dec2020 12:00 at single dose for covid-19 immunization. Vaccine location was right arm and it was the first dose. Patient is not pregnant. The facility type vaccine was workplace clinic. Medical history included hypothyroidism from an unknown date. Patient was not diagnosed with COVID-19 prior to vaccination nor tested for COVID-19 since the vaccination. The patient didn't receive any other vaccines within 4 weeks prior to the COVID vaccine. 2 weeks after COVID-19 vaccine on 01Jan2021 21:00, patient had severe multiple allergic reactions never experienced. Suture reaction to surgical site, allergic flare up of previously healed and closed nerve block locations, then later apparent full body reaction to Bactrim. At least 3 allergic reactions never experienced before with slight increase in eosinophils, CRP, and increase in platelets. Severe Suture rejection to extremely common sutures. The adverse events resulted in Doctor or other healthcare professional office/clinic visit, Emergency room/department or urgent care, Hospitalization one day. Patient received IV methylprednisone, Benadryl, famotidine as treatment for the adverse events. The outcome of events was recovered in Jan2021. Known allergies included apparent Bactrim allergy, in spite of allergic symptoms starting 4 days prior to taking Bactrim.; Sender's Comments: Based on the information currently provided, the vaccination might trigger the onset of multiple allergic reactions accompanying with lab abnormalities, considering the plausible temporal relationship.  Severe allergic reaction is the known risk for the 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
Symptoms: Multiple allergies, Platelet count increased
Clinical narrative: 2 weeks after covid 19 vaccine, had severe multiple allergic reactions never experienced.; Suture reaction to surgical site; allergic flare up of previously healed and closed nerve block locations; slight increase in eosinophils, CRP; slight increase in eosinophils, CRP; increase in platelets; This is a spontaneous report from a contactable nurse (patient). A 29-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) (lot number Ek5t30), intramuscularly on 20Dec2020 12:00 at single dose for covid-19 immunization. Vaccine location was right arm and it was the first dose. Patient is not pregnant. The facility type vaccine was workplace clinic. Medical history included hypothyroidism from an unknown date. Patient was not diagnosed with COVID-19 prior to vaccination nor tested for COVID-19 since the vaccination. The patient didn't receive any other vaccines within 4 weeks prior to the COVID vaccine. 2 weeks after COVID-19 vaccine on 01Jan2021 21:00, patient had severe multiple allergic reactions never experienced. Suture reaction to surgical site, allergic flare up of previously healed and closed nerve block locations, then later apparent full body reaction to Bactrim. At least 3 allergic reactions never experienced before with slight increase in eosinophils, CRP, and increase in platelets. Severe Suture rejection to extremely common sutures. The adverse events resulted in Doctor or other healthcare professional office/clinic visit, Emergency room/department or urgent care, Hospitalization one day. Patient received IV methylprednisone, Benadryl, famotidine as treatment for the adverse events. The outcome of events was recovered in Jan2021. Known allergies included apparent Bactrim allergy, in spite of allergic symptoms starting 4 days prior to taking Bactrim.; Sender's Comments: Based on the information currently provided, the vaccination might trigger the onset of multiple allergic reactions accompanying with lab abnormalities, considering the plausible temporal relationship.  Severe allergic reaction is the known risk for the 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
Symptoms: Rash vesicular, Vaccination site rash
Clinical narrative: rash on the arm where the vaccine was administered into; she said, "it looks blistery".; rash on the arm where the vaccine was administered into; she said, "it looks blistery".; This is a spontaneous report from a non-contactable other health professional. A female patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), batch/lot number and expiry date not provided, via an unspecified route of administration on an unspecified date at a SINGLE DOSE for covid-19 immunization. The patient's medical history and concomitant medications were not reported. The patient experienced rash on the arm where the vaccine was administered into; she said, "it looks blistery". The outcome of events was unknown.  No follow up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Abdominal discomfort, Chills, Fatigue, Headache, Malaise
Clinical narrative: Fatigue/Tiredness/I was tired that I could hardly get out the bed the next day; Nausea; Headache; Muscle paining; Chills; Feeling unwell; upset stomach; This is a spontaneous report from a contactable consumer (patient). A female patient of an unspecified age received first and second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number and expiry date: unknown), both intramuscular on an unspecified date (three weeks apart) at single dose (0.3 mL) for COVID-19 immunization. The patient medical history and concomitant medications were not reported. Patient wanted to know if the reaction to the vaccine after the second dose is expected to be the same than as for the first dose. She also wanted to know if the second dose of the vaccine is stronger or the same as the first dose of the Pfizer BioNtech Covid 19 vaccine. She also wanted to know if your immune system is compromised because of a heart transplant should you receive the Pfizer-BioNtech Covid-19 vaccine or follow your HCP recommendations if they know this information. The patient experienced fatigue and nausea after her first dose of the COVID Vaccine. It was further reported that "It was the Pfizer vaccine for virus (further not clarified hence, captured as Unspecified vaccine" (pending clarification). The patient reacted but not seriously, she had most of the symptoms like upset stomach, tiredness. She didn't have the injection site pain, she was tired that she could hardly get out the bed the next day and then headache, muscle paining, some chills and no fever and some nausea. Just kind of feeling unwell. And she was just wondering a little bit about the second dose that they get. She was asking if she reacted to this that way will she react even worse to the next one or do they know that. Unknown if treatment was given. Limited information was available over the call. The outcome of the events was unknown.  No follow-up attempts are possible. Information about lot/batch number could not be requested. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Myalgia, Nausea
Clinical narrative: Fatigue/Tiredness/I was tired that I could hardly get out the bed the next day; Nausea; Headache; Muscle paining; Chills; Feeling unwell; upset stomach; This is a spontaneous report from a contactable consumer (patient). A female patient of an unspecified age received first and second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number and expiry date: unknown), both intramuscular on an unspecified date (three weeks apart) at single dose (0.3 mL) for COVID-19 immunization. The patient medical history and concomitant medications were not reported. Patient wanted to know if the reaction to the vaccine after the second dose is expected to be the same than as for the first dose. She also wanted to know if the second dose of the vaccine is stronger or the same as the first dose of the Pfizer BioNtech Covid 19 vaccine. She also wanted to know if your immune system is compromised because of a heart transplant should you receive the Pfizer-BioNtech Covid-19 vaccine or follow your HCP recommendations if they know this information. The patient experienced fatigue and nausea after her first dose of the COVID Vaccine. It was further reported that "It was the Pfizer vaccine for virus (further not clarified hence, captured as Unspecified vaccine" (pending clarification). The patient reacted but not seriously, she had most of the symptoms like upset stomach, tiredness. She didn't have the injection site pain, she was tired that she could hardly get out the bed the next day and then headache, muscle paining, some chills and no fever and some nausea. Just kind of feeling unwell. And she was just wondering a little bit about the second dose that they get. She was asking if she reacted to this that way will she react even worse to the next one or do they know that. Unknown if treatment was given. Limited information was available over the call. The outcome of the events was unknown.  No follow-up attempts are possible. Information about lot/batch number could not be requested. No further information is expected.
Age: 38.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Headache, Myalgia, SARS-CoV-2 test, Vaccination site pain
Clinical narrative: headache; Right arm pain; fatigue; myalgia; This is a spontaneous report from a contactable healthcare professional (patient). A 38-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: EK9231), via an unspecified route of administration on right arm on 12Jan2021 08:30 (dose number 2) at a single dose for COVID-19 immunization. Medical history included allergic rhinitis. The patient was not pregnant at the time of vaccination. No other vaccine in four weeks and no other medication in two weeks. There were no concomitant medications. The patient previously took dexilant and had known allergies to the medication. The patient experienced right arm pain, fatigue, myalgia and headache on 12Jan2021 15:00. Treatment for the events included Advil 200 mg. The patient was tested for COVID (Nasal Swab) on 19Nov2020 which showed negative result. The outcome of the events was not recovered.
Age: 44.0
Sex: F
Vaccine: COVID19
Symptoms: Electromyogram abnormal, Magnetic resonance imaging abnormal, Mononeuropathy
Clinical narrative: I had acute onset Mononeuropathy of the R posterior interosseous nerve; This is a spontaneous report from a contactable physician (patient herself). A 44-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: EK9231; expiry date: unknown) intramuscular on 07Jan2021 at 16:30, at a single dose, for COVID-19 immunization. The patient has no relevant medical history, has no known allergies, and has no concomitant medications. The patient is not pregnant at the time of vaccination. The patient was not diagnosed with COVID prior vaccination. The patient did not receive other vaccines within four weeks prior to COVID vaccination. The patient previously received first dose of (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: EK5730; expiry date: unknown) on 17Dec2020 at 12:00, for COVID-19 immunization. The patient stated that 48 hours after administration, on 09Jan2021 at 15:00, she had an acute onset mononeuropathy of the right (R) posterior interosseous nerve. Patient stated this may be unrelated and she wanted to know if this is a trend. She was seen by neuro, she had electromyogram (EMG) and magnetic resonance imaging (MRI) and it was definitely an isolated nerve. The event was treated with prednisone. Outcome of the event was recovering. The patient has not been tested for COVID-19 since vaccination.; Sender's Comments: Based on the information currently provided, the vaccination with BNT162B2 might play a contributory role in triggering the onset of mononeuropathy.  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: 51.0
Sex: F
Vaccine: COVID19
Symptoms: Dysgeusia
Clinical narrative: Chemical taste in mouth; This is a spontaneous report from a non-contactable other hcp (patient). A 51-year-old female patient received their first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number: Ek9231, expiry date not reported), via an unspecified route of administration on 13Jan2021 13:30 at single dose for COVID-19 immunization. The patient medical history was not reported. Concomitant medication included fluoxetine hydrochloride (PROZAC). The patient experienced chemical taste in mouth on 13Jan2021 14:00. The patient did not have COVID prior to vaccination and has not tested positive post vaccination. The patient was recovering from the event.   No follow up attempts are possible. No further information is expected.
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Fatigue, Headache, Heart rate, Heart rate increased
Clinical narrative: Soreness in neck; headache; nausea; joint ache; jaws hurting; rapid heartbeat; fatigue; This is a spontaneous report from a contactable other healthcare professional (patient). A 55-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot number: EL3248), via an unspecified route of administration on 08Jan2021 14:30 (reported as 02:30 PM) at single dose on the left arm for COVID-19 immunization. Patient is not pregnant. Medical history included Attack cardia, reflux and arthritis. Concomitant medications (other medications in two weeks) included amoxicillin, verapamil, omeprazole, estradiol (ESTROGEN) and cetirizine hydrochloride (ZYRTEC [CETIRIZINE HYDROCHLORIDE]). No other vaccine in four weeks. The patient previously took morphine, Remeron, azithromycin and digoxin and experienced allergies. No COVID prior vaccination. The patient experienced soreness in neck, headache, nausea, joint ache, jaws hurting, rapid heartbeat and fatigue on 09Jan2021 8:00 AM. No treatment received for the events. Outcome of the events was recovering. Patient was not tested for COVID post vaccination.
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: Nausea, Neck pain, Pain in jaw
Clinical narrative: Soreness in neck; headache; nausea; joint ache; jaws hurting; rapid heartbeat; fatigue; This is a spontaneous report from a contactable other healthcare professional (patient). A 55-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot number: EL3248), via an unspecified route of administration on 08Jan2021 14:30 (reported as 02:30 PM) at single dose on the left arm for COVID-19 immunization. Patient is not pregnant. Medical history included Attack cardia, reflux and arthritis. Concomitant medications (other medications in two weeks) included amoxicillin, verapamil, omeprazole, estradiol (ESTROGEN) and cetirizine hydrochloride (ZYRTEC [CETIRIZINE HYDROCHLORIDE]). No other vaccine in four weeks. The patient previously took morphine, Remeron, azithromycin and digoxin and experienced allergies. No COVID prior vaccination. The patient experienced soreness in neck, headache, nausea, joint ache, jaws hurting, rapid heartbeat and fatigue on 09Jan2021 8:00 AM. No treatment received for the events. Outcome of the events was recovering. Patient was not tested for COVID post vaccination.
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Chest pain, Chills, Dyspnoea, Erythema, Fatigue
Clinical narrative: Throat tightness/numbness; Throat tightness/numbness; Shortness of breath w/min exertion; Dull chest pain; Right calf pain/cramping; Right calf pain/cramping; Fever; Chill; Body aches; Severe headache; Left arm swelling; left arm swelling, redness, knot; left arm swelling, redness, knot; Pain at injection site; Fatigue; This is a spontaneous report received from a contactable nurse (who is also the patient). A 59-year-old female patient received the second dose of BNT162B2 (BNT162B2 PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL1284, expiry date: unknown), intramuscular in the left arm, on 11Jan2021 07:30, at single dose, for COVID-19 immunization, in the hospital. Medical history included COVID-19 (COVID prior vaccination: Yes) and known allergies to penicillin and erythromycin. There were no concomitant medications. Historical vaccine included the first dose of BNT162B2 (BNT162B2 PFIZER-BIONTECH COVID-19 VACCINE, lot number: EH9899, expiry date: unknown), intramuscular in the left arm, on 23Dec2020 07:15, for COVID-19 immunization. The patient experienced shortness of breath w/min exertion, right calf pain/cramping, fever, chill, body aches, severe headache, left arm swelling, redness, knot and pain at injection site, dull chest pain, fatigue, throat tightness/numbness on 11Jan2021. The events resulted to emergency room/department or urgent care visit. The patient did not receive treatment for the events. The patient was not tested for COVID-19 post vaccination. The outcome of the events was not recovered.; Sender's Comments: The 59-year-old patient received the second dose of BNT162B2 (BNT162B2 PFIZER-BIONTECH COVID-19 VACCINE) on 11Jan2021, and experienced shortness of breath w/min exertion, dull chest pain, throat tightness/numbness and other symptoms on the same day.  Considering plausible temporal relationship, the events were probably related to the second dose of BNT162B2.  The case will be reassessed should additional information become 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: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Injection site nodule, Injection site pain, Muscle spasms, Pain
Clinical narrative: Throat tightness/numbness; Throat tightness/numbness; Shortness of breath w/min exertion; Dull chest pain; Right calf pain/cramping; Right calf pain/cramping; Fever; Chill; Body aches; Severe headache; Left arm swelling; left arm swelling, redness, knot; left arm swelling, redness, knot; Pain at injection site; Fatigue; This is a spontaneous report received from a contactable nurse (who is also the patient). A 59-year-old female patient received the second dose of BNT162B2 (BNT162B2 PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL1284, expiry date: unknown), intramuscular in the left arm, on 11Jan2021 07:30, at single dose, for COVID-19 immunization, in the hospital. Medical history included COVID-19 (COVID prior vaccination: Yes) and known allergies to penicillin and erythromycin. There were no concomitant medications. Historical vaccine included the first dose of BNT162B2 (BNT162B2 PFIZER-BIONTECH COVID-19 VACCINE, lot number: EH9899, expiry date: unknown), intramuscular in the left arm, on 23Dec2020 07:15, for COVID-19 immunization. The patient experienced shortness of breath w/min exertion, right calf pain/cramping, fever, chill, body aches, severe headache, left arm swelling, redness, knot and pain at injection site, dull chest pain, fatigue, throat tightness/numbness on 11Jan2021. The events resulted to emergency room/department or urgent care visit. The patient did not receive treatment for the events. The patient was not tested for COVID-19 post vaccination. The outcome of the events was not recovered.; Sender's Comments: The 59-year-old patient received the second dose of BNT162B2 (BNT162B2 PFIZER-BIONTECH COVID-19 VACCINE) on 11Jan2021, and experienced shortness of breath w/min exertion, dull chest pain, throat tightness/numbness and other symptoms on the same day.  Considering plausible temporal relationship, the events were probably related to the second dose of BNT162B2.  The case will be reassessed should additional information become 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: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity, Peripheral swelling, Pharyngeal hypoaesthesia, Pyrexia, Throat tightness
Clinical narrative: Throat tightness/numbness; Throat tightness/numbness; Shortness of breath w/min exertion; Dull chest pain; Right calf pain/cramping; Right calf pain/cramping; Fever; Chill; Body aches; Severe headache; Left arm swelling; left arm swelling, redness, knot; left arm swelling, redness, knot; Pain at injection site; Fatigue; This is a spontaneous report received from a contactable nurse (who is also the patient). A 59-year-old female patient received the second dose of BNT162B2 (BNT162B2 PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL1284, expiry date: unknown), intramuscular in the left arm, on 11Jan2021 07:30, at single dose, for COVID-19 immunization, in the hospital. Medical history included COVID-19 (COVID prior vaccination: Yes) and known allergies to penicillin and erythromycin. There were no concomitant medications. Historical vaccine included the first dose of BNT162B2 (BNT162B2 PFIZER-BIONTECH COVID-19 VACCINE, lot number: EH9899, expiry date: unknown), intramuscular in the left arm, on 23Dec2020 07:15, for COVID-19 immunization. The patient experienced shortness of breath w/min exertion, right calf pain/cramping, fever, chill, body aches, severe headache, left arm swelling, redness, knot and pain at injection site, dull chest pain, fatigue, throat tightness/numbness on 11Jan2021. The events resulted to emergency room/department or urgent care visit. The patient did not receive treatment for the events. The patient was not tested for COVID-19 post vaccination. The outcome of the events was not recovered.; Sender's Comments: The 59-year-old patient received the second dose of BNT162B2 (BNT162B2 PFIZER-BIONTECH COVID-19 VACCINE) on 11Jan2021, and experienced shortness of breath w/min exertion, dull chest pain, throat tightness/numbness and other symptoms on the same day.  Considering plausible temporal relationship, the events were probably related to the second dose of BNT162B2.  The case will be reassessed should additional information become 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: 27.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Dizziness, Dry throat, Headache, Lymphadenopathy
Clinical narrative: Dizziness, fever, sore/dry throat, severe headache, muscle aches, swollen lymph nodes, sore arm at injection site, chills. Dizziness and headache persisting from time to time; Dizziness, fever, sore/dry throat, severe headache, muscle aches, swollen lymph nodes, sore arm at injection site, chills. Dizziness and headache persisting from time to time; Dizziness, fever, sore/dry throat, severe headache, muscle aches, swollen lymph nodes, sore arm at injection site, chills. Dizziness and headache persisting from time to time; Dizziness, fever, sore/dry throat, severe headache, muscle aches, swollen lymph nodes, sore arm at injection site, chills. Dizziness and headache persisting from time to time; Dizziness, fever, sore/dry throat, severe headache, muscle aches, swollen lymph nodes, sore arm at injection site, chills. Dizziness and headache persisting from time to time; Dizziness, fever, sore/dry throat, severe headache, muscle aches, swollen lymph nodes, sore arm at injection site, chills. Dizziness and headache persisting from time to time; Dizziness, fever, sore/dry throat, severe headache, muscle aches, swollen lymph nodes, sore arm at injection site, chills. Dizziness and headache persisting from time to time; Dizziness, fever, sore/dry throat, severe headache, muscle aches, swollen lymph nodes, sore arm at injection site, chills. Dizziness and headache persisting from time to time; Dizziness, fever, sore/dry throat, severe headache, muscle aches, swollen lymph nodes, sore arm at injection site, chills. Dizziness and headache persisting from time to time; This is a spontaneous report from a contactable other hcp. A 27-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number:ek9x31 and expiry date unknown), intramuscular on the right arm on 05Jan2021 11:45 at a SINGLE DOSE for covid-19 immunisation. Medical history included pneumonia, bronchitis and sinusitis from an unknown date and unknown if ongoing. Concomitant medication included ethinylestradiol, norgestimate (TRI-SPRINTEC), fish oil (FISH OIL) and olly womans multivitamin. The patient experienced dizziness, fever, sore/dry throat, severe headache, muscle aches, swollen lymph nodes, sore arm at injection site and chills on 06Jan2021. The patient underwent lab tests and procedures which included sars-cov-2 test: negative on 01Jan2021.  Therapeutic measures were taken as a result of the events. The patient was advised to rest for 2 days and take Tylenol. The outcome of the events was recovered with sequelae.
Age: 27.0
Sex: F
Vaccine: COVID19
Symptoms: Myalgia, Oropharyngeal pain, Pyrexia, SARS-CoV-2 test, Vaccination site pain
Clinical narrative: Dizziness, fever, sore/dry throat, severe headache, muscle aches, swollen lymph nodes, sore arm at injection site, chills. Dizziness and headache persisting from time to time; Dizziness, fever, sore/dry throat, severe headache, muscle aches, swollen lymph nodes, sore arm at injection site, chills. Dizziness and headache persisting from time to time; Dizziness, fever, sore/dry throat, severe headache, muscle aches, swollen lymph nodes, sore arm at injection site, chills. Dizziness and headache persisting from time to time; Dizziness, fever, sore/dry throat, severe headache, muscle aches, swollen lymph nodes, sore arm at injection site, chills. Dizziness and headache persisting from time to time; Dizziness, fever, sore/dry throat, severe headache, muscle aches, swollen lymph nodes, sore arm at injection site, chills. Dizziness and headache persisting from time to time; Dizziness, fever, sore/dry throat, severe headache, muscle aches, swollen lymph nodes, sore arm at injection site, chills. Dizziness and headache persisting from time to time; Dizziness, fever, sore/dry throat, severe headache, muscle aches, swollen lymph nodes, sore arm at injection site, chills. Dizziness and headache persisting from time to time; Dizziness, fever, sore/dry throat, severe headache, muscle aches, swollen lymph nodes, sore arm at injection site, chills. Dizziness and headache persisting from time to time; Dizziness, fever, sore/dry throat, severe headache, muscle aches, swollen lymph nodes, sore arm at injection site, chills. Dizziness and headache persisting from time to time; This is a spontaneous report from a contactable other hcp. A 27-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number:ek9x31 and expiry date unknown), intramuscular on the right arm on 05Jan2021 11:45 at a SINGLE DOSE for covid-19 immunisation. Medical history included pneumonia, bronchitis and sinusitis from an unknown date and unknown if ongoing. Concomitant medication included ethinylestradiol, norgestimate (TRI-SPRINTEC), fish oil (FISH OIL) and olly womans multivitamin. The patient experienced dizziness, fever, sore/dry throat, severe headache, muscle aches, swollen lymph nodes, sore arm at injection site and chills on 06Jan2021. The patient underwent lab tests and procedures which included sars-cov-2 test: negative on 01Jan2021.  Therapeutic measures were taken as a result of the events. The patient was advised to rest for 2 days and take Tylenol. The outcome of the events was recovered with sequelae.
Sex: F
Vaccine: COVID19
Symptoms: SARS-CoV-2 test positive
Clinical narrative: She received 1st dose of Covid vaccine and then tested positive for Covid.; She received 1st dose of Covid vaccine and then tested positive for Covid.; This is a spontaneous report from a contactable other health professional from a Pfizer-sponsored program Pfizer First Connect.  A female elderly patient (Grandmother, 80 or older) received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on an unspecified date at single dose for covid-19 immunization. The patient's medical history and concomitant medications were not reported. The patient received 1st dose of covid vaccine and then tested positive for covid on 12Jan2021. The patient underwent lab tests and procedures which included Covid: positive on 12Jan2021. The reporter's grandmother (female, caller stated age is 80 or older) received the vaccine 3 weeks ago and was scheduled to get the vaccine tomorrow but tested positive for covid on 12Jan2021. The reporter was wondering whether she could get the 2nd dose in this case. She's asymptomatic, not sure when she came down with it.  She resided in a Senior care facility. They would have (Pharmacy name) coming tomorrow to get the vaccine. They stated she won't be getting it. The reporter was asked whether it would lose effectiveness if wait and whether the efficacy would go down If wait longer to get the 2nd dose. The outcome of events was unknown.  Information on the batch number and lot number has been requested.
Age: 40.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Chest discomfort, Chest pain, Chills, Fatigue, Headache
Clinical narrative: body aches; chills; severe headache/Extreme headache; chest discomfort/chest pain/heaviness/Feels like something is heavy on my chest; chest discomfort/chest pain/heaviness/Feels like something is heavy on my chest; extremely tired; not able to carry out daily activities; This is a spontaneous report from a contactable other health care professional. A 40-year-old female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), via an unspecified route of administration on 11Jan2021 07:45 at SINGLE DOSE at left arm for COVID-19 immunization.  Medical history reported as none. The patient has no known allergies. The patient received first dose of COVID19 vaccine BNT162B2 on 24Dec2020 11:45PM at left arm. There were no concomitant medications. The patient stated, On 11Jan2021 16:00, "I'm having body aches, chills, severe headache/extreme headache and chest discomfort/chest pain. I understand that the body is trying to build an immune response and I understand that body aches and chills are part of that but I don't get headaches, ever, and I have never had chest discomfort or heaviness like this so how is that an immune response. I want you to tell me why I feel this way." It was also reported that the patient was extremely tired, and not able to carry out daily activities. The patient did not receive treatment for the events. The outcome of the events was not recovered. AE resulted in: Doctor or other healthcare professional office/clinic visit, Emergency room/department or urgent care.  Information about batch/lot number has been requested.
Age: 40.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Loss of personal independence in daily activities, Pain
Clinical narrative: body aches; chills; severe headache/Extreme headache; chest discomfort/chest pain/heaviness/Feels like something is heavy on my chest; chest discomfort/chest pain/heaviness/Feels like something is heavy on my chest; extremely tired; not able to carry out daily activities; This is a spontaneous report from a contactable other health care professional. A 40-year-old female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), via an unspecified route of administration on 11Jan2021 07:45 at SINGLE DOSE at left arm for COVID-19 immunization.  Medical history reported as none. The patient has no known allergies. The patient received first dose of COVID19 vaccine BNT162B2 on 24Dec2020 11:45PM at left arm. There were no concomitant medications. The patient stated, On 11Jan2021 16:00, "I'm having body aches, chills, severe headache/extreme headache and chest discomfort/chest pain. I understand that the body is trying to build an immune response and I understand that body aches and chills are part of that but I don't get headaches, ever, and I have never had chest discomfort or heaviness like this so how is that an immune response. I want you to tell me why I feel this way." It was also reported that the patient was extremely tired, and not able to carry out daily activities. The patient did not receive treatment for the events. The outcome of the events was not recovered. AE resulted in: Doctor or other healthcare professional office/clinic visit, Emergency room/department or urgent care.  Information about batch/lot number has been requested.
Age: 40.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Bedridden, Chest discomfort, Chills, Fatigue, Feeling abnormal
Clinical narrative: body aches; chills; severe headache/Extreme headache; chest discomfort/chest pain/heaviness/Feels like something is heavy on my chest; chest discomfort/chest pain/heaviness/Feels like something is heavy on my chest; extremely tired; not able to carry out daily activities; This is a spontaneous report from a contactable other health care professional. A 40-year-old female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), via an unspecified route of administration on 11Jan2021 07:45 at SINGLE DOSE at left arm for COVID-19 immunization.  Medical history reported as none. The patient has no known allergies. The patient received first dose of COVID19 vaccine BNT162B2 on 24Dec2020 11:45PM at left arm. There were no concomitant medications. The patient stated, On 11Jan2021 16:00, "I'm having body aches, chills, severe headache/extreme headache and chest discomfort/chest pain. I understand that the body is trying to build an immune response and I understand that body aches and chills are part of that but I don't get headaches, ever, and I have never had chest discomfort or heaviness like this so how is that an immune response. I want you to tell me why I feel this way." It was also reported that the patient was extremely tired, and not able to carry out daily activities. The patient did not receive treatment for the events. The outcome of the events was not recovered. AE resulted in: Doctor or other healthcare professional office/clinic visit, Emergency room/department or urgent care.  Information about batch/lot number has been requested.
Age: 40.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Headache, Inappropriate schedule of product administration, Mobility decreased, Pain, Pain in extremity
Clinical narrative: body aches; chills; severe headache/Extreme headache; chest discomfort/chest pain/heaviness/Feels like something is heavy on my chest; chest discomfort/chest pain/heaviness/Feels like something is heavy on my chest; extremely tired; not able to carry out daily activities; This is a spontaneous report from a contactable other health care professional. A 40-year-old female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), via an unspecified route of administration on 11Jan2021 07:45 at SINGLE DOSE at left arm for COVID-19 immunization.  Medical history reported as none. The patient has no known allergies. The patient received first dose of COVID19 vaccine BNT162B2 on 24Dec2020 11:45PM at left arm. There were no concomitant medications. The patient stated, On 11Jan2021 16:00, "I'm having body aches, chills, severe headache/extreme headache and chest discomfort/chest pain. I understand that the body is trying to build an immune response and I understand that body aches and chills are part of that but I don't get headaches, ever, and I have never had chest discomfort or heaviness like this so how is that an immune response. I want you to tell me why I feel this way." It was also reported that the patient was extremely tired, and not able to carry out daily activities. The patient did not receive treatment for the events. The outcome of the events was not recovered. AE resulted in: Doctor or other healthcare professional office/clinic visit, Emergency room/department or urgent care.  Information about batch/lot number has been requested.
Age: 38.0
Sex: U
Vaccine: COVID19
Symptoms: Fatigue, Headache, Pyrexia
Clinical narrative: fatigue; headache; fever; This is a spontaneous report from a contactable nurse (patient). A 38-year-old patient of an unspecified gender received 2nd dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number and expiration date unspecified), via an unspecified route of administration on 11Jan2021, 07:45, at single dose (right arm) for COVID-19 immunization.  Medical history included asthma, atrial septal aneurysm, anxiety and migraines. The patient had known allergies. Concomitant medications were not reported. Patient had other unspecified medications in 2 weeks. The patient previously took first dose of bnt162b2 on 21Dec2020, 07:45, right arm for COVID-19 immunization. On 11Jan2021 at 22:00, the patient experienced fatigue, headache and fever. The patient had no other vaccine in four weeks. The patient did not have Covid prior vaccination and was not Covid tested post vaccination. Outcome of events was recovering.  Information about lot/batch number has been requested.
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: Headache
Clinical narrative: severe incapacitating headache starting several hours after vaccine and lasting at least through today 13Jan2021. Steroids prescribed today; This is a spontaneous report from a contactable nurse (patient).  A 55-year-old female patient receive BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number EH9899 and expiration date not provided), via an unspecified route of administration (right arm) first dose on 09Jan2021 11:30 at single dose for covid-19 immunisation. The patient's medical history included Asthma and hypertension. The patient's concomitant medication includes unspecified medication. On 09Jan2021 23:00, the patient experienced severe incapacitating headache starting several hours after vaccine and lasting at least through today 13Jan2021. The patient event resulted in doctor or other healthcare professional office/clinic visit and Steroids prescribed today. Treatment includes prednisone.  The outcome of the event was unknown.; Sender's Comments: Based on the compatible time association and drug's safety profile, the event headache is possibly related to suspect BNT162B2 administration. 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: 54.0
Sex: M
Vaccine: COVID19
Symptoms: Abdominal discomfort, Chills, Decreased appetite, Fatigue, Hypertension
Clinical narrative: sig elevation in previously controlled HTN; chills without fever; extreme fatigue; upset stomach without true nausea and loss of appetite; upset stomach without true nausea and loss of appetite; This is a spontaneous report from a contactable physician (patient). A 54-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number: EL0142), via an unspecified route of administration on 11Jan2021 08:30 at a single dose for COVID-19 immunization. Medical history included hypertension, environmental allergies, and COVID-19. Concomitant medication included nebivolol hydrochloride (BYSTOLIC), cetirizine hydrochloride (ZYRTEC), and esomeprazole magnesium (NEXIUM [ESOMEPRAZOLE MAGNESIUM]). The patient experienced sig elevation in previously controlled HTN, chills without fever, extreme fatigue, upset stomach without true nausea and loss of appetite on 11Jan2021. No treatment received for adverse events. The outcome of the events was recovering. Facility type Vaccine was Hospital. No other vaccine in four weeks. The patient was not COVID tested post vaccination.
Age: 35.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Headache, Influenza like illness, Pain in extremity, Pyrexia
Clinical narrative: Extreme arm soreness; Chills; Fever; Headache; It felt like he got the flu; This is a spontaneous report from a non-contactable pharmacist (patient). A 35-year-old male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot Number: EJ1686), via an unspecified route of administration in left arm, on 12Jan2021 at 12:00, at a single dose, for COVID-19 immunization. The patient's medical history included COVID-19 (prior to vaccination). There were no concomitant medications. No other vaccine was administered in four weeks. The facility where the vaccine was administered was in a nursing home or senior living facility. On 12Jan2021 at 10 PM, the patient had extreme arm soreness that did not go away with ibuprofen or paracetamol (TYLENOL). The patient had chills and a fever the night he got the injection. The patient also had a headache for 2 days after the injection (Jan2021). It felt like he got the flu in Jan2021. Post vaccination on 12Jan2021, the patient underwent COVID-19 nasal swab and PCR tests that was negative. Therapeutic measures were taken as a result of "Extreme arm soreness" including ibuprofen and paracetamol; no treatment was administered for the other events. The patient was recovering from the events.  No follow-up attempts are possible. No further information is expected.
Age: 35.0
Sex: M
Vaccine: COVID19
Symptoms: SARS-CoV-2 test
Clinical narrative: Extreme arm soreness; Chills; Fever; Headache; It felt like he got the flu; This is a spontaneous report from a non-contactable pharmacist (patient). A 35-year-old male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot Number: EJ1686), via an unspecified route of administration in left arm, on 12Jan2021 at 12:00, at a single dose, for COVID-19 immunization. The patient's medical history included COVID-19 (prior to vaccination). There were no concomitant medications. No other vaccine was administered in four weeks. The facility where the vaccine was administered was in a nursing home or senior living facility. On 12Jan2021 at 10 PM, the patient had extreme arm soreness that did not go away with ibuprofen or paracetamol (TYLENOL). The patient had chills and a fever the night he got the injection. The patient also had a headache for 2 days after the injection (Jan2021). It felt like he got the flu in Jan2021. Post vaccination on 12Jan2021, the patient underwent COVID-19 nasal swab and PCR tests that was negative. Therapeutic measures were taken as a result of "Extreme arm soreness" including ibuprofen and paracetamol; no treatment was administered for the other events. The patient was recovering from the events.  No follow-up attempts are possible. No further information is expected.
Age: 53.0
Sex: F
Vaccine: COVID19
Symptoms: Blood pressure increased, Electrocardiogram, Headache, Hypoaesthesia, Laboratory test
Clinical narrative: elevated BP : 193/113; Tachycardia 134 BPM; bad headache; numbness and tingling in both hands; numbness and tingling in both hands; nausea; rash across the top of my chest; sore muscles in legs; This is a spontaneous report from a contactable nurse.  A 53-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), lot number: EL1283, via intramuscular route of administration in the left arm, on 12Jan2021 10:30 at SINGLE DOSE for covid-19 immunization. Medical history included asthma, sinusitis and migraine.  Concomitant medications included fluticasone propionate, salmeterol xinafoate (ADVAIR), albuterol, estradiol, norethisterone acetate (ESTRADIOL AND NORETHINDRONE), vitamin d3, zinc, paracetamol (TYLENOL) and diphenhydramine hydrochloride (BENADRYL). The patient previously took erythromycin, levaquin, biaxin and cefzil (on unspecified dates) and experienced allergy.  The patient started having reactions after 20 mins (12Jan2021, 10:45am): a bad headache, elevated BP: 193/113 (no history of hypertension), tachycardia 134 BPM, numbness and tingling in both hands, nausea, and a rash across the top of the chest. Since it was administered in a workplace drive-thru clinic, there was a 15-30 mins post vaccine monitoring. She was taken inside for further evaluation and monitoring with no changes after 30 mins. EMS was called for transport to the closet hospital that wasn't on diversion. Her allergist was consulted by the treating ER physician and was later discharged with prescriptions for the following: Epipen, prednisone for 5 days, and pepcid. Follow-up with allergist in 3-5 days and PCP. Patient was still recovering however headache was and sore muscles in legs were still present. The outcome of events headache was and sore muscles in legs was not recovered whereas patient was recovering from all other events. Therapeutic measures taken as result of the events included Benadryl, Pepcid, Zofran, Tylenol, 1L Saline bolus, EKG, lab work, monitoring on a pulse ox, frequent BP.  No follow-up attempts are possible. No further information is expected. Information on the lot/batch number has been obtained.; Sender's Comments: Based on the compatible time association, the reported events are possibly related to suspect BNT162B2 administration. 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.