chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 57.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Lymphadenopathy, Pain, Swelling
Clinical narrative: Underarm lymph node swelling; pain; knot on the shot arm only; This is a spontaneous report from a contactable consumer (patient). 57-year-old non- pregnant female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot number: EN5318), at 57 years of age, via an unspecified route of administration on 10Feb2021; 09:30 at single dose for covid-19 immunization. The patient medical history included Obesity, high blood pressure, asthma and unknown if ongoing. No known allergies. Concomitant medication included Amlodipine Besylate, Atorvastatin and Escitalopram. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 11Feb2021;06:00 patient experienced Underarm lymph node swelling, pain, knot on the shot arm only. The events were considered as non-serious. No treatment was given for the events. Patient did not diagnosed with COVID-19 prior to vaccination. Since the vaccination, the patient had not been tested for COVID-19. The outcome of events was unknown.
Age: 57.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Lymphadenopathy, Pain, Peripheral swelling
Clinical narrative: Underarm lymph node swelling; pain; knot on the shot arm only; This is a spontaneous report from a contactable consumer (patient). 57-year-old non- pregnant female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot number: EN5318), at 57 years of age, via an unspecified route of administration on 10Feb2021; 09:30 at single dose for covid-19 immunization. The patient medical history included Obesity, high blood pressure, asthma and unknown if ongoing. No known allergies. Concomitant medication included Amlodipine Besylate, Atorvastatin and Escitalopram. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 11Feb2021;06:00 patient experienced Underarm lymph node swelling, pain, knot on the shot arm only. The events were considered as non-serious. No treatment was given for the events. Patient did not diagnosed with COVID-19 prior to vaccination. Since the vaccination, the patient had not been tested for COVID-19. The outcome of events was unknown.
Age: 26.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Feeling abnormal, Headache, Injection site pain, Migraine, Palpitations
Clinical narrative: Migraine; headache; visual impairments; pain at injection site; This is a spontaneous report from a contactable Other HCP (Patient). A 26-yearfemale patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot Number: EM9809) dose 1 administered in Arm Right on 04Feb2021 17:30 as single dose for covid-19 immunisation. Patient medical history contains allergies to Oats, sulfa containing antibiotics. Concomitant medications were not reported. It was reported that on 05Feb2021 12:30 PM patient experienced migraine and headache for 7 days (still ongoing) visual impairments and pain at injection site. The patient had taken migraine medication. On 08Feb2021 Patient undergone PCR test Covid test post vaccination through Nasal Swab shown a Negative Covid test result negative. On 11Feb2021 Patient undergone PCR test Covid test type post vaccination nasal Swab shown a negative Covid test result. The outcome of the event pain at injection site resolved in 1 day remaining events with outcome of not recovered.   The initial safety information received was reporting only non-serious adverse drug reaction(s), Upon receipt of follow-up information on [24Mar2021], this case now contains serious adverse reaction(s). Information processed together.
Age: 26.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Photophobia, Vision blurred
Clinical narrative: Migraine; headache; visual impairments; pain at injection site; This is a spontaneous report from a contactable Other HCP (Patient). A 26-yearfemale patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot Number: EM9809) dose 1 administered in Arm Right on 04Feb2021 17:30 as single dose for covid-19 immunisation. Patient medical history contains allergies to Oats, sulfa containing antibiotics. Concomitant medications were not reported. It was reported that on 05Feb2021 12:30 PM patient experienced migraine and headache for 7 days (still ongoing) visual impairments and pain at injection site. The patient had taken migraine medication. On 08Feb2021 Patient undergone PCR test Covid test post vaccination through Nasal Swab shown a Negative Covid test result negative. On 11Feb2021 Patient undergone PCR test Covid test type post vaccination nasal Swab shown a negative Covid test result. The outcome of the event pain at injection site resolved in 1 day remaining events with outcome of not recovered.   The initial safety information received was reporting only non-serious adverse drug reaction(s), Upon receipt of follow-up information on [24Mar2021], this case now contains serious adverse reaction(s). Information processed together.
Age: 26.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Antibody test negative, Ear discomfort, Magnetic resonance imaging normal, Migraine, Pain in jaw
Clinical narrative: Migraine; headache; visual impairments; pain at injection site; This is a spontaneous report from a contactable Other HCP (Patient). A 26-yearfemale patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot Number: EM9809) dose 1 administered in Arm Right on 04Feb2021 17:30 as single dose for covid-19 immunisation. Patient medical history contains allergies to Oats, sulfa containing antibiotics. Concomitant medications were not reported. It was reported that on 05Feb2021 12:30 PM patient experienced migraine and headache for 7 days (still ongoing) visual impairments and pain at injection site. The patient had taken migraine medication. On 08Feb2021 Patient undergone PCR test Covid test post vaccination through Nasal Swab shown a Negative Covid test result negative. On 11Feb2021 Patient undergone PCR test Covid test type post vaccination nasal Swab shown a negative Covid test result. The outcome of the event pain at injection site resolved in 1 day remaining events with outcome of not recovered.   The initial safety information received was reporting only non-serious adverse drug reaction(s), Upon receipt of follow-up information on [24Mar2021], this case now contains serious adverse reaction(s). Information processed together.
Age: 26.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Photophobia, Tension headache
Clinical narrative: Migraine; headache; visual impairments; pain at injection site; This is a spontaneous report from a contactable Other HCP (Patient). A 26-yearfemale patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot Number: EM9809) dose 1 administered in Arm Right on 04Feb2021 17:30 as single dose for covid-19 immunisation. Patient medical history contains allergies to Oats, sulfa containing antibiotics. Concomitant medications were not reported. It was reported that on 05Feb2021 12:30 PM patient experienced migraine and headache for 7 days (still ongoing) visual impairments and pain at injection site. The patient had taken migraine medication. On 08Feb2021 Patient undergone PCR test Covid test post vaccination through Nasal Swab shown a Negative Covid test result negative. On 11Feb2021 Patient undergone PCR test Covid test type post vaccination nasal Swab shown a negative Covid test result. The outcome of the event pain at injection site resolved in 1 day remaining events with outcome of not recovered.   The initial safety information received was reporting only non-serious adverse drug reaction(s), Upon receipt of follow-up information on [24Mar2021], this case now contains serious adverse reaction(s). Information processed together.
Age: 26.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Headache, Migraine, SARS-CoV-2 test, Vaccination site pain, Visual impairment
Clinical narrative: Migraine; headache; visual impairments; pain at injection site; This is a spontaneous report from a contactable Other HCP (Patient). A 26-yearfemale patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot Number: EM9809) dose 1 administered in Arm Right on 04Feb2021 17:30 as single dose for covid-19 immunisation. Patient medical history contains allergies to Oats, sulfa containing antibiotics. Concomitant medications were not reported. It was reported that on 05Feb2021 12:30 PM patient experienced migraine and headache for 7 days (still ongoing) visual impairments and pain at injection site. The patient had taken migraine medication. On 08Feb2021 Patient undergone PCR test Covid test post vaccination through Nasal Swab shown a Negative Covid test result negative. On 11Feb2021 Patient undergone PCR test Covid test type post vaccination nasal Swab shown a negative Covid test result. The outcome of the event pain at injection site resolved in 1 day remaining events with outcome of not recovered.   The initial safety information received was reporting only non-serious adverse drug reaction(s), Upon receipt of follow-up information on [24Mar2021], this case now contains serious adverse reaction(s). Information processed together.
Age: 40.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Injection site reaction, Injection site swelling
Clinical narrative: Redness at the injection site 9 days after dose 1; This is a spontaneous report from a contactable other health care professional (patient herself). A 40-year-old non-pregnant female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot number: Ek4176), via an unspecified route of administration in right arm at the age of 40-years (non-pregnant at the time of vaccination), on 03Feb2021 at 02:30 PM at a single dose for COVID-19 immunization. The patient's medical history was reported as none. The patient had no known allergies. Concomitant medications included desogestrel, ethinylestradiol (VELIVET), loratadine, pseudoephedrine sulfate (CLARITIN-D), and cyanocobalamin (VITAMIN B 12 [CYANOCOBALAMIN]). The patient received other vaccine in four weeks was reported as no. Prior to the vaccination, the patient was not diagnosed with COVID. On 13Feb2021 at 08:45 AM (9 days after dose 1), the patient experienced redness at the injection site. The patient did not receive any treatment for the event. The outcome of the event was not recovered. It was also reported that post vaccination, the patient had not been tested for COVID.
Age: 40.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Vaccination site erythema
Clinical narrative: Redness at the injection site 9 days after dose 1; This is a spontaneous report from a contactable other health care professional (patient herself). A 40-year-old non-pregnant female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot number: Ek4176), via an unspecified route of administration in right arm at the age of 40-years (non-pregnant at the time of vaccination), on 03Feb2021 at 02:30 PM at a single dose for COVID-19 immunization. The patient's medical history was reported as none. The patient had no known allergies. Concomitant medications included desogestrel, ethinylestradiol (VELIVET), loratadine, pseudoephedrine sulfate (CLARITIN-D), and cyanocobalamin (VITAMIN B 12 [CYANOCOBALAMIN]). The patient received other vaccine in four weeks was reported as no. Prior to the vaccination, the patient was not diagnosed with COVID. On 13Feb2021 at 08:45 AM (9 days after dose 1), the patient experienced redness at the injection site. The patient did not receive any treatment for the event. The outcome of the event was not recovered. It was also reported that post vaccination, the patient had not been tested for COVID.
Age: 66.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Abdominal pain upper, Dizziness, Fatigue, Malaise, Nausea
Clinical narrative: body aches; stomach pains; tiredness; feeling unwell; nausea; Body tingling; dizziness; This is a spontaneous report from a contactable consumer or other non hcp (patient). A 66-years-old female patient received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA) vaccine (Formulation: Solution for injection, Lot Number: EL8982, Expiry date: Unknown) via an unspecified route of administration in left arm on 10Feb2021 09:00 as single dose for covid-19 immunisation. Medical history included chronic depression, high cholesterol and first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA) vaccine (Formulation: Solution for injection, Lot Number: EL3248, Expiry date: Unknown) via an unspecified route of administration in left arm on 21Jan2021 17:15 as single dose for covid-19 immunisation. There was no special history of allergies. Concomitant medications included citalopram 20 mg, aripiprazole 2 mg and rosuvastatin for an unspecified indication. The patient was not pregnant at the time of vaccination. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient had not received any other vaccine within 4 weeks prior to the vaccine. On 10Feb2021 09:00, the patient experienced body tingling and dizziness. 3 days after injection on 14Feb2021, the patient experienced body aches, stomach, tiredness, feeling unwell and nausea. The patient hasn't been tested PCR for COVID-19 since the vaccination. Therapeutic measures were not taken as a result of adverse events. The outcome of the events were reported as recovering.
Age: 66.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Pain, Paraesthesia
Clinical narrative: body aches; stomach pains; tiredness; feeling unwell; nausea; Body tingling; dizziness; This is a spontaneous report from a contactable consumer or other non hcp (patient). A 66-years-old female patient received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA) vaccine (Formulation: Solution for injection, Lot Number: EL8982, Expiry date: Unknown) via an unspecified route of administration in left arm on 10Feb2021 09:00 as single dose for covid-19 immunisation. Medical history included chronic depression, high cholesterol and first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA) vaccine (Formulation: Solution for injection, Lot Number: EL3248, Expiry date: Unknown) via an unspecified route of administration in left arm on 21Jan2021 17:15 as single dose for covid-19 immunisation. There was no special history of allergies. Concomitant medications included citalopram 20 mg, aripiprazole 2 mg and rosuvastatin for an unspecified indication. The patient was not pregnant at the time of vaccination. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient had not received any other vaccine within 4 weeks prior to the vaccine. On 10Feb2021 09:00, the patient experienced body tingling and dizziness. 3 days after injection on 14Feb2021, the patient experienced body aches, stomach, tiredness, feeling unwell and nausea. The patient hasn't been tested PCR for COVID-19 since the vaccination. Therapeutic measures were not taken as a result of adverse events. The outcome of the events were reported as recovering.
Age: 66.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Abdominal pain upper, Dizziness, Fatigue, Malaise, Myalgia
Clinical narrative: body aches; stomach pains; tiredness; feeling unwell; nausea; Body tingling; dizziness; This is a spontaneous report from a contactable consumer or other non hcp (patient). A 66-years-old female patient received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA) vaccine (Formulation: Solution for injection, Lot Number: EL8982, Expiry date: Unknown) via an unspecified route of administration in left arm on 10Feb2021 09:00 as single dose for covid-19 immunisation. Medical history included chronic depression, high cholesterol and first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA) vaccine (Formulation: Solution for injection, Lot Number: EL3248, Expiry date: Unknown) via an unspecified route of administration in left arm on 21Jan2021 17:15 as single dose for covid-19 immunisation. There was no special history of allergies. Concomitant medications included citalopram 20 mg, aripiprazole 2 mg and rosuvastatin for an unspecified indication. The patient was not pregnant at the time of vaccination. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient had not received any other vaccine within 4 weeks prior to the vaccine. On 10Feb2021 09:00, the patient experienced body tingling and dizziness. 3 days after injection on 14Feb2021, the patient experienced body aches, stomach, tiredness, feeling unwell and nausea. The patient hasn't been tested PCR for COVID-19 since the vaccination. Therapeutic measures were not taken as a result of adverse events. The outcome of the events were reported as recovering.
Age: 66.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Nausea, Paraesthesia
Clinical narrative: body aches; stomach pains; tiredness; feeling unwell; nausea; Body tingling; dizziness; This is a spontaneous report from a contactable consumer or other non hcp (patient). A 66-years-old female patient received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA) vaccine (Formulation: Solution for injection, Lot Number: EL8982, Expiry date: Unknown) via an unspecified route of administration in left arm on 10Feb2021 09:00 as single dose for covid-19 immunisation. Medical history included chronic depression, high cholesterol and first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA) vaccine (Formulation: Solution for injection, Lot Number: EL3248, Expiry date: Unknown) via an unspecified route of administration in left arm on 21Jan2021 17:15 as single dose for covid-19 immunisation. There was no special history of allergies. Concomitant medications included citalopram 20 mg, aripiprazole 2 mg and rosuvastatin for an unspecified indication. The patient was not pregnant at the time of vaccination. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient had not received any other vaccine within 4 weeks prior to the vaccine. On 10Feb2021 09:00, the patient experienced body tingling and dizziness. 3 days after injection on 14Feb2021, the patient experienced body aches, stomach, tiredness, feeling unwell and nausea. The patient hasn't been tested PCR for COVID-19 since the vaccination. Therapeutic measures were not taken as a result of adverse events. The outcome of the events were reported as recovering.
Age: 43.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Dysphagia, Lymphadenopathy, Pain, SARS-CoV-2 test negative, Stomatitis
Clinical narrative: swollen glands; Body aches; sores in mouth; Ear ache; pain swallowing; This is a spontaneous report from a contactable consumer (patient himself) of 43-year-old male patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation solution for injection) via unspecified roue of administration on 07Feb2021 at 11:30 AM (at the age of 43-years-old) in the right arm and first dose BNT162B2 (lot number: EM9809) via unspecified route of administration in the right arm on 21Jan2021 at 02:00 PM both as single dose of Covid-19 immunization. The patient's medical history and concomitant medications were not reported. Patient was not having known allergies. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient was tested for COVID-19 and Nasal swab and rapid antigen result was negative, On 13Feb2021. The patient's concomitant medications were not reported. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine and was not on any other medications within 2 weeks of vaccination. On 08Feb2021 at 02:00 AM, the patient experienced body aches, swollen glands, sores in mouth, earache, pain swallowing. No therapeutic measures were taken. The outcome of event was not recovered.    Information on the lot/batch number has been requested.
Age: 43.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Ear pain, Lymphadenopathy, Odynophagia, Oral pain, Pain
Clinical narrative: swollen glands; Body aches; sores in mouth; Ear ache; pain swallowing; This is a spontaneous report from a contactable consumer (patient himself) of 43-year-old male patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation solution for injection) via unspecified roue of administration on 07Feb2021 at 11:30 AM (at the age of 43-years-old) in the right arm and first dose BNT162B2 (lot number: EM9809) via unspecified route of administration in the right arm on 21Jan2021 at 02:00 PM both as single dose of Covid-19 immunization. The patient's medical history and concomitant medications were not reported. Patient was not having known allergies. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient was tested for COVID-19 and Nasal swab and rapid antigen result was negative, On 13Feb2021. The patient's concomitant medications were not reported. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine and was not on any other medications within 2 weeks of vaccination. On 08Feb2021 at 02:00 AM, the patient experienced body aches, swollen glands, sores in mouth, earache, pain swallowing. No therapeutic measures were taken. The outcome of event was not recovered.    Information on the lot/batch number has been requested.
Age: 43.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: SARS-CoV-2 test
Clinical narrative: swollen glands; Body aches; sores in mouth; Ear ache; pain swallowing; This is a spontaneous report from a contactable consumer (patient himself) of 43-year-old male patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation solution for injection) via unspecified roue of administration on 07Feb2021 at 11:30 AM (at the age of 43-years-old) in the right arm and first dose BNT162B2 (lot number: EM9809) via unspecified route of administration in the right arm on 21Jan2021 at 02:00 PM both as single dose of Covid-19 immunization. The patient's medical history and concomitant medications were not reported. Patient was not having known allergies. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient was tested for COVID-19 and Nasal swab and rapid antigen result was negative, On 13Feb2021. The patient's concomitant medications were not reported. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine and was not on any other medications within 2 weeks of vaccination. On 08Feb2021 at 02:00 AM, the patient experienced body aches, swollen glands, sores in mouth, earache, pain swallowing. No therapeutic measures were taken. The outcome of event was not recovered.    Information on the lot/batch number has been requested.
Age: 78.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: COVID-19, SARS-CoV-2 test
Clinical narrative: Fever; Nausea; headaches; This is a spontaneous report from a contactable consumer. A 78-year-old non-pregnant female patient received first dose of BNT162B2 (BNT162B2, Solution for injection, Lot number: unknown), via unspecified route of administration on Left arm on 28Jan2021 09:45 at single dose for covid-19 immunisation. The patient's medical history included High Blood pressure, Obesity. The patient's concomitant medications were not reported. It was reported that patient experienced Fever, Nausea, and headaches after vaccine on 24Jan2021 08:00 AM. Other medications the patient received within 2 weeks of vaccination are blood Pressure Medication The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19; Since the vaccination, the patient not been tested for COVID-19. The seriousness was reported as non-serious. The outcome of the events was "Not recovered". Ethnicity information is available. Information on the lot/batch number has been requested.
Age: 78.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: COVID-19 pneumonia, SARS-CoV-2 test
Clinical narrative: Fever; Nausea; headaches; This is a spontaneous report from a contactable consumer. A 78-year-old non-pregnant female patient received first dose of BNT162B2 (BNT162B2, Solution for injection, Lot number: unknown), via unspecified route of administration on Left arm on 28Jan2021 09:45 at single dose for covid-19 immunisation. The patient's medical history included High Blood pressure, Obesity. The patient's concomitant medications were not reported. It was reported that patient experienced Fever, Nausea, and headaches after vaccine on 24Jan2021 08:00 AM. Other medications the patient received within 2 weeks of vaccination are blood Pressure Medication The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19; Since the vaccination, the patient not been tested for COVID-19. The seriousness was reported as non-serious. The outcome of the events was "Not recovered". Ethnicity information is available. Information on the lot/batch number has been requested.
Age: 78.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Headache, Nausea, Pyrexia
Clinical narrative: Fever; Nausea; headaches; This is a spontaneous report from a contactable consumer. A 78-year-old non-pregnant female patient received first dose of BNT162B2 (BNT162B2, Solution for injection, Lot number: unknown), via unspecified route of administration on Left arm on 28Jan2021 09:45 at single dose for covid-19 immunisation. The patient's medical history included High Blood pressure, Obesity. The patient's concomitant medications were not reported. It was reported that patient experienced Fever, Nausea, and headaches after vaccine on 24Jan2021 08:00 AM. Other medications the patient received within 2 weeks of vaccination are blood Pressure Medication The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19; Since the vaccination, the patient not been tested for COVID-19. The seriousness was reported as non-serious. The outcome of the events was "Not recovered". Ethnicity information is available. Information on the lot/batch number has been requested.
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Eye disorder, Headache, Ophthalmic migraine
Clinical narrative: Ocular migraine; vague headache on right side of face; This is a spontaneous report from a contactable consumer, the patient. A 71-year-old non-pregnant female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Formulation: Solution for injection Lot Number: EN5318), via an unspecified route of administration, in the left arm on 10Feb2021 09:15 AM as single dose for COVID-19 immunisation. Medical history included blood cholesterol increased, alopecia, arthritis, penicillin allergy and shellfish allergy. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. Concomitant medications included rosuvastatin (ROSUVASTATIN); hydroxychloroquine (HYDROXYCHLOROQUINE) and finasteride (FINASTERIDE). The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Formulation: Solution for injection Lot Number: EL1283), via an unspecified route of administration, in the left arm on 21Jan2021 at 04:15 PM as single dose for COVID-19 immunisation. The patient previously took codeine and experienced allergies. On 10Feb2021 at 03:00 PM the patient exepereniced ocular migraine followed by vague headache on right side of face. Ophthalmologist contacted. It was reported that she never experienced one of these in her lifetime. No treatment was received for the events. Outcome of the events were recovered on unspecified date in 2021.
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Headache, Ophthalmic migraine
Clinical narrative: Ocular migraine; vague headache on right side of face; This is a spontaneous report from a contactable consumer, the patient. A 71-year-old non-pregnant female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Formulation: Solution for injection Lot Number: EN5318), via an unspecified route of administration, in the left arm on 10Feb2021 09:15 AM as single dose for COVID-19 immunisation. Medical history included blood cholesterol increased, alopecia, arthritis, penicillin allergy and shellfish allergy. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. Concomitant medications included rosuvastatin (ROSUVASTATIN); hydroxychloroquine (HYDROXYCHLOROQUINE) and finasteride (FINASTERIDE). The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Formulation: Solution for injection Lot Number: EL1283), via an unspecified route of administration, in the left arm on 21Jan2021 at 04:15 PM as single dose for COVID-19 immunisation. The patient previously took codeine and experienced allergies. On 10Feb2021 at 03:00 PM the patient exepereniced ocular migraine followed by vague headache on right side of face. Ophthalmologist contacted. It was reported that she never experienced one of these in her lifetime. No treatment was received for the events. Outcome of the events were recovered on unspecified date in 2021.
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Chest discomfort, Condition aggravated, Dyspnoea, Rash
Clinical narrative: anaphylactic attacks; This is a spontaneous report from a contactable consumer (patient). A female patient of an unspecified age received the second dose of BNT162B2 (COMIRNATY; lot/batch number and expiration date not reported) via an unspecified route of administration on 22Feb2021 at a single dose for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient previously received first dose of BNT162B2 on an unknown date for COVID-19 immunisation. The patient had 3 anaphylactic attacks and had to spend the night in the hospital on an unspecified date. "I want to avoid anyone else from this horrible experience". Outcome of the event was unknown.
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Anaphylactic reaction
Clinical narrative: anaphylactic attacks; This is a spontaneous report from a contactable consumer (patient). A female patient of an unspecified age received the second dose of BNT162B2 (COMIRNATY; lot/batch number and expiration date not reported) via an unspecified route of administration on 22Feb2021 at a single dose for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient previously received first dose of BNT162B2 on an unknown date for COVID-19 immunisation. The patient had 3 anaphylactic attacks and had to spend the night in the hospital on an unspecified date. "I want to avoid anyone else from this horrible experience". Outcome of the event was unknown.
Age: 35.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Bell's palsy
Clinical narrative: developed left sided facial paralysis; some findings of inflammation on the 8th nerve; developed unilateral left ear symptoms such as muffled hearing, mild pain, pressure, tinnitus; developed unilateral left ear symptoms such as muffled hearing, mild pain, pressure, tinnitus; developed unilateral left ear symptoms such as muffled hearing, mild pain, pressure, tinnitus; ear discomfort; ear discomfort that worsened; progressed to mild hearing loss; This is a spontaneous report from a contactable healthcare professional (patient). A 35-year-old non-pregnant female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number and expiration date: EN5318), via an unspecified route of administration, administered in the left arm on 11Feb2021 08:15 at a single dose (at the age of 35-years-old) for COVID-19 immunisation; vaccinated in a hospital. Medical history was not reported. No known allergies. Concomitant medication included escitalopram. The patient had no other vaccine in four weeks. The patient did not have COVID prior to vaccination. Six days after the vaccine (17Feb2021), the patient developed unilateral left ear symptoms such as muffled hearing, mild pain, pressure, tinnitus, which then progressed to mild hearing loss. After about 7 days of ear discomfort that worsened (2 weeks exactly after first dose of vaccine), the patient developed left sided facial paralysis. The patient was seen by ENT, had a full workup including hearing test and head MRI with contrast. Came back normal aside for some findings of inflammation on the 8th nerve. The patient was placed on acyclovir 500mg 3x a day for 7 days and 60 mg of prednisone for 7 days with a 9 day taper. The facial paralysis completely recovered after 2-3 full weeks. The ear was mostly recovered with some residual tinnitus. The patient was not COVID tested post vaccination. The patient required a visit to the doctor and emergency room for the events. The patient recovered from left sided facial paralysis in Mar2021. The patient was recovering from the remaining events.; Sender's Comments: Considering plausible temporal association and lack of alternative explanations, the events left ear hearing loss, inflammation on the 8th nerve, and left sided facial paralysis are possibly related to BNT162B2.   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 RAs, Ethics Committees, and Investigators, as appropriate.
Age: 35.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Acoustic stimulation tests, Condition aggravated, Deafness unilateral, Ear discomfort, Ear pain
Clinical narrative: developed left sided facial paralysis; some findings of inflammation on the 8th nerve; developed unilateral left ear symptoms such as muffled hearing, mild pain, pressure, tinnitus; developed unilateral left ear symptoms such as muffled hearing, mild pain, pressure, tinnitus; developed unilateral left ear symptoms such as muffled hearing, mild pain, pressure, tinnitus; ear discomfort; ear discomfort that worsened; progressed to mild hearing loss; This is a spontaneous report from a contactable healthcare professional (patient). A 35-year-old non-pregnant female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number and expiration date: EN5318), via an unspecified route of administration, administered in the left arm on 11Feb2021 08:15 at a single dose (at the age of 35-years-old) for COVID-19 immunisation; vaccinated in a hospital. Medical history was not reported. No known allergies. Concomitant medication included escitalopram. The patient had no other vaccine in four weeks. The patient did not have COVID prior to vaccination. Six days after the vaccine (17Feb2021), the patient developed unilateral left ear symptoms such as muffled hearing, mild pain, pressure, tinnitus, which then progressed to mild hearing loss. After about 7 days of ear discomfort that worsened (2 weeks exactly after first dose of vaccine), the patient developed left sided facial paralysis. The patient was seen by ENT, had a full workup including hearing test and head MRI with contrast. Came back normal aside for some findings of inflammation on the 8th nerve. The patient was placed on acyclovir 500mg 3x a day for 7 days and 60 mg of prednisone for 7 days with a 9 day taper. The facial paralysis completely recovered after 2-3 full weeks. The ear was mostly recovered with some residual tinnitus. The patient was not COVID tested post vaccination. The patient required a visit to the doctor and emergency room for the events. The patient recovered from left sided facial paralysis in Mar2021. The patient was recovering from the remaining events.; Sender's Comments: Considering plausible temporal association and lack of alternative explanations, the events left ear hearing loss, inflammation on the 8th nerve, and left sided facial paralysis are possibly related to BNT162B2.   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 RAs, Ethics Committees, and Investigators, as appropriate.
Age: 35.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Facial paralysis, Hypoacusis, Magnetic resonance imaging head, Tinnitus, VIIIth nerve lesion
Clinical narrative: developed left sided facial paralysis; some findings of inflammation on the 8th nerve; developed unilateral left ear symptoms such as muffled hearing, mild pain, pressure, tinnitus; developed unilateral left ear symptoms such as muffled hearing, mild pain, pressure, tinnitus; developed unilateral left ear symptoms such as muffled hearing, mild pain, pressure, tinnitus; ear discomfort; ear discomfort that worsened; progressed to mild hearing loss; This is a spontaneous report from a contactable healthcare professional (patient). A 35-year-old non-pregnant female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number and expiration date: EN5318), via an unspecified route of administration, administered in the left arm on 11Feb2021 08:15 at a single dose (at the age of 35-years-old) for COVID-19 immunisation; vaccinated in a hospital. Medical history was not reported. No known allergies. Concomitant medication included escitalopram. The patient had no other vaccine in four weeks. The patient did not have COVID prior to vaccination. Six days after the vaccine (17Feb2021), the patient developed unilateral left ear symptoms such as muffled hearing, mild pain, pressure, tinnitus, which then progressed to mild hearing loss. After about 7 days of ear discomfort that worsened (2 weeks exactly after first dose of vaccine), the patient developed left sided facial paralysis. The patient was seen by ENT, had a full workup including hearing test and head MRI with contrast. Came back normal aside for some findings of inflammation on the 8th nerve. The patient was placed on acyclovir 500mg 3x a day for 7 days and 60 mg of prednisone for 7 days with a 9 day taper. The facial paralysis completely recovered after 2-3 full weeks. The ear was mostly recovered with some residual tinnitus. The patient was not COVID tested post vaccination. The patient required a visit to the doctor and emergency room for the events. The patient recovered from left sided facial paralysis in Mar2021. The patient was recovering from the remaining events.; Sender's Comments: Considering plausible temporal association and lack of alternative explanations, the events left ear hearing loss, inflammation on the 8th nerve, and left sided facial paralysis are possibly related to BNT162B2.   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 RAs, Ethics Committees, and Investigators, as appropriate.
Age: 77.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Anaphylactic reaction, Asthenia, Fatigue, Flushing, Headache
Clinical narrative: 72 hrs. after dose #1 had a severe anaphalaxis reaction.; red rash; pressure dropped to 102/65/75 pulse; Tired; light-headed; weak; This is a spontaneous report from a contactable consumer (patient) and another consumer (receptionist). A 77-years-old male patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, administered in Arm Left on 25Feb2021 15:00 (Lot Number: EM9810) as SINGLE DOSE for covid-19 immunisation.  Medical history was not reported. The patient did not have COVID prior vaccination. Concomitant medication(s) included simvastatin, losartan, finasteride and tamsulosin. The patient previously took codeine and experienced allergies. On 28Feb2021 15:00, 72 hrs. after dose #1, the patient had a severe anaphalaxis reaction. His whole body turned into a red rash, temp was 97.8, pressure dropped to 102/65/75 pulse. Tired, light-headed, weak. Immediately took Prednisone (20 mg)and benedryl. Was going to call 911, but symptoms subsided slowly. The patient did not test COVID post vaccination. The outcome was recovered.
Age: 77.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Rash
Clinical narrative: 72 hrs. after dose #1 had a severe anaphalaxis reaction.; red rash; pressure dropped to 102/65/75 pulse; Tired; light-headed; weak; This is a spontaneous report from a contactable consumer (patient) and another consumer (receptionist). A 77-years-old male patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, administered in Arm Left on 25Feb2021 15:00 (Lot Number: EM9810) as SINGLE DOSE for covid-19 immunisation.  Medical history was not reported. The patient did not have COVID prior vaccination. Concomitant medication(s) included simvastatin, losartan, finasteride and tamsulosin. The patient previously took codeine and experienced allergies. On 28Feb2021 15:00, 72 hrs. after dose #1, the patient had a severe anaphalaxis reaction. His whole body turned into a red rash, temp was 97.8, pressure dropped to 102/65/75 pulse. Tired, light-headed, weak. Immediately took Prednisone (20 mg)and benedryl. Was going to call 911, but symptoms subsided slowly. The patient did not test COVID post vaccination. The outcome was recovered.
Age: 77.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Anaphylactic reaction, Asthenia, Blood pressure decreased, Blood pressure measurement, Body temperature
Clinical narrative: 72 hrs. after dose #1 had a severe anaphalaxis reaction.; red rash; pressure dropped to 102/65/75 pulse; Tired; light-headed; weak; This is a spontaneous report from a contactable consumer (patient) and another consumer (receptionist). A 77-years-old male patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, administered in Arm Left on 25Feb2021 15:00 (Lot Number: EM9810) as SINGLE DOSE for covid-19 immunisation.  Medical history was not reported. The patient did not have COVID prior vaccination. Concomitant medication(s) included simvastatin, losartan, finasteride and tamsulosin. The patient previously took codeine and experienced allergies. On 28Feb2021 15:00, 72 hrs. after dose #1, the patient had a severe anaphalaxis reaction. His whole body turned into a red rash, temp was 97.8, pressure dropped to 102/65/75 pulse. Tired, light-headed, weak. Immediately took Prednisone (20 mg)and benedryl. Was going to call 911, but symptoms subsided slowly. The patient did not test COVID post vaccination. The outcome was recovered.
Age: 77.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Dizziness, Fatigue, Heart rate, Rash erythematous
Clinical narrative: 72 hrs. after dose #1 had a severe anaphalaxis reaction.; red rash; pressure dropped to 102/65/75 pulse; Tired; light-headed; weak; This is a spontaneous report from a contactable consumer (patient) and another consumer (receptionist). A 77-years-old male patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, administered in Arm Left on 25Feb2021 15:00 (Lot Number: EM9810) as SINGLE DOSE for covid-19 immunisation.  Medical history was not reported. The patient did not have COVID prior vaccination. Concomitant medication(s) included simvastatin, losartan, finasteride and tamsulosin. The patient previously took codeine and experienced allergies. On 28Feb2021 15:00, 72 hrs. after dose #1, the patient had a severe anaphalaxis reaction. His whole body turned into a red rash, temp was 97.8, pressure dropped to 102/65/75 pulse. Tired, light-headed, weak. Immediately took Prednisone (20 mg)and benedryl. Was going to call 911, but symptoms subsided slowly. The patient did not test COVID post vaccination. The outcome was recovered.
Age: 77.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Anaphylactic reaction, Erythema, Feeling abnormal, Rash
Clinical narrative: 72 hrs. after dose #1 had a severe anaphalaxis reaction.; red rash; pressure dropped to 102/65/75 pulse; Tired; light-headed; weak; This is a spontaneous report from a contactable consumer (patient) and another consumer (receptionist). A 77-years-old male patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, administered in Arm Left on 25Feb2021 15:00 (Lot Number: EM9810) as SINGLE DOSE for covid-19 immunisation.  Medical history was not reported. The patient did not have COVID prior vaccination. Concomitant medication(s) included simvastatin, losartan, finasteride and tamsulosin. The patient previously took codeine and experienced allergies. On 28Feb2021 15:00, 72 hrs. after dose #1, the patient had a severe anaphalaxis reaction. His whole body turned into a red rash, temp was 97.8, pressure dropped to 102/65/75 pulse. Tired, light-headed, weak. Immediately took Prednisone (20 mg)and benedryl. Was going to call 911, but symptoms subsided slowly. The patient did not test COVID post vaccination. The outcome was recovered.
Age: 37.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Dizziness, Pain in extremity, Pyrexia
Clinical narrative: swelling, joint pain, high fever, fatigue, and dizziness
Age: 37.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Arthralgia, Dizziness, Fatigue, Pyrexia, Swelling
Clinical narrative: swelling, joint pain, high fever, fatigue, and dizziness
Age: 49.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Dyspnoea, Lacrimation increased, Oxygen saturation decreased, Pharyngeal swelling, Pruritus
Clinical narrative: Anaphylactic reaction: other; This is a spontaneous report received from a contactable consumer (patient). A 49-year-old female patient (not pregnant) received BNT162B2 (lot number: EN6205) second dose on 06Mar202111:00 on Right arm at single dose for COVID-19 immunization. Medical history included Asthma, allergies to Sulfa, CT dye, Reglan, Morphine, and Gastrointestinal issues. Concomitant medications within 2 weeks of vaccination included Omeprezole, metformin, fluticasone propionate, salmeterol xinafoate (ADVAIR), cetirizine hydrochloride (ZYRTEC), galcanezumab (EMGALITY). No other vaccines within 4 weeks prior to the COVID vaccine. The patient previously took BNT162B2 first dose on 13Feb2021 13:00 (age at vaccination was 49-year-old) on Right arm for COVID-19 immunization. Patient had Adverse events: Anaphylactic reaction: rash, itching, cough, throat swelling and closing, difficulty breathing, rapid heart rate, face swelling, eye problems, dizziness, nausea, headache on 06Mar2021 11:15. The events resulted in Doctor or other healthcare professional office/clinic visit and Emergency room/department or urgent care. Patient received treatment included Epinephrine, Benadryl injections, O2, Breathing Tx. Prior to vaccination,was the patient was not diagnosed with COVID-19, Since the vaccination, the patient had not been tested for COVID-19. The outcome of the events was Recovered with lasting effects.