chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 34.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Pain of skin, Paraesthesia, Pruritus, Pyrexia, Sensitive skin
Clinical narrative: This is a spontaneous report from a contactable consumer (patient). A 34-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: EW0162), via an unspecified route of administration, administered in the right arm on 17Apr2021 14:45 (at the age of 34 years old) as dose 2, single for COVID-19 immunization. Medical history included seasonal allergies, known allergies: dairy, egg, known allergies: cat and known allergies: penicillin, all from an unknown date and unknown if ongoing. The patient is not pregnant. Concomitant medications included hydroxyzine hcl and ibuprofen, both taken for unspecified indications, start and stop dates were not reported. The patient previously took neosporin, azithromycin, reglan [metoclopramide] and zofran [ondansetron] and experienced allergy for all. The patient previously received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: ER8730), via an unspecified route of administration, administered in the right arm on 27Mar2021 15:00 (at the age of 34 years old) as dose 1, single for COVID-19 immunization. The patient experienced server joint pain (especially in hips & rt shoulder ongoing), painful skin sensitivity (especially on face & scalp, now spread to limbs; ongoing), headache, nausea, fever, chills, shaking, pins & needles, allergic reaction type rash on arms, back & neck muscle pain and swollen lymph nodes in both sides of neck on 17Apr2021 15:00. The reporter assessed all events as serious (resulted in disability or permanent damage). Treatment received for the adverse events included pain 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 has not been tested for COVID-19. Device date was reported as 10Aug2021. The outcome of all events was not recovered. No follow-up attempts are needed. No further information is expected.
Age: 34.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Sleep disorder, Swelling, Throat tightness, Tremor
Clinical narrative: This is a spontaneous report from a contactable consumer (patient). A 34-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: EW0162), via an unspecified route of administration, administered in the right arm on 17Apr2021 14:45 (at the age of 34 years old) as dose 2, single for COVID-19 immunization. Medical history included seasonal allergies, known allergies: dairy, egg, known allergies: cat and known allergies: penicillin, all from an unknown date and unknown if ongoing. The patient is not pregnant. Concomitant medications included hydroxyzine hcl and ibuprofen, both taken for unspecified indications, start and stop dates were not reported. The patient previously took neosporin, azithromycin, reglan [metoclopramide] and zofran [ondansetron] and experienced allergy for all. The patient previously received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: ER8730), via an unspecified route of administration, administered in the right arm on 27Mar2021 15:00 (at the age of 34 years old) as dose 1, single for COVID-19 immunization. The patient experienced server joint pain (especially in hips & rt shoulder ongoing), painful skin sensitivity (especially on face & scalp, now spread to limbs; ongoing), headache, nausea, fever, chills, shaking, pins & needles, allergic reaction type rash on arms, back & neck muscle pain and swollen lymph nodes in both sides of neck on 17Apr2021 15:00. The reporter assessed all events as serious (resulted in disability or permanent damage). Treatment received for the adverse events included pain 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 has not been tested for COVID-19. Device date was reported as 10Aug2021. The outcome of all events was not recovered. No follow-up attempts are needed. No further information is expected.
Age: 34.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Arthralgia, Chills, Dermatitis allergic, Headache, Hyperaesthesia
Clinical narrative: This is a spontaneous report from a contactable consumer (patient). A 34-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: EW0162), via an unspecified route of administration, administered in the right arm on 17Apr2021 14:45 (at the age of 34 years old) as dose 2, single for COVID-19 immunization. Medical history included seasonal allergies, known allergies: dairy, egg, known allergies: cat and known allergies: penicillin, all from an unknown date and unknown if ongoing. The patient is not pregnant. Concomitant medications included hydroxyzine hcl and ibuprofen, both taken for unspecified indications, start and stop dates were not reported. The patient previously took neosporin, azithromycin, reglan [metoclopramide] and zofran [ondansetron] and experienced allergy for all. The patient previously received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: ER8730), via an unspecified route of administration, administered in the right arm on 27Mar2021 15:00 (at the age of 34 years old) as dose 1, single for COVID-19 immunization. The patient experienced server joint pain (especially in hips & rt shoulder ongoing), painful skin sensitivity (especially on face & scalp, now spread to limbs; ongoing), headache, nausea, fever, chills, shaking, pins & needles, allergic reaction type rash on arms, back & neck muscle pain and swollen lymph nodes in both sides of neck on 17Apr2021 15:00. The reporter assessed all events as serious (resulted in disability or permanent damage). Treatment received for the adverse events included pain 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 has not been tested for COVID-19. Device date was reported as 10Aug2021. The outcome of all events was not recovered. No follow-up attempts are needed. No further information is expected.
Age: 34.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Lymphadenopathy, Myalgia, Nausea, Pain of skin, Paraesthesia
Clinical narrative: This is a spontaneous report from a contactable consumer (patient). A 34-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: EW0162), via an unspecified route of administration, administered in the right arm on 17Apr2021 14:45 (at the age of 34 years old) as dose 2, single for COVID-19 immunization. Medical history included seasonal allergies, known allergies: dairy, egg, known allergies: cat and known allergies: penicillin, all from an unknown date and unknown if ongoing. The patient is not pregnant. Concomitant medications included hydroxyzine hcl and ibuprofen, both taken for unspecified indications, start and stop dates were not reported. The patient previously took neosporin, azithromycin, reglan [metoclopramide] and zofran [ondansetron] and experienced allergy for all. The patient previously received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: ER8730), via an unspecified route of administration, administered in the right arm on 27Mar2021 15:00 (at the age of 34 years old) as dose 1, single for COVID-19 immunization. The patient experienced server joint pain (especially in hips & rt shoulder ongoing), painful skin sensitivity (especially on face & scalp, now spread to limbs; ongoing), headache, nausea, fever, chills, shaking, pins & needles, allergic reaction type rash on arms, back & neck muscle pain and swollen lymph nodes in both sides of neck on 17Apr2021 15:00. The reporter assessed all events as serious (resulted in disability or permanent damage). Treatment received for the adverse events included pain 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 has not been tested for COVID-19. Device date was reported as 10Aug2021. The outcome of all events was not recovered. No follow-up attempts are needed. No further information is expected.
Age: 34.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Pyrexia, Tremor
Clinical narrative: This is a spontaneous report from a contactable consumer (patient). A 34-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: EW0162), via an unspecified route of administration, administered in the right arm on 17Apr2021 14:45 (at the age of 34 years old) as dose 2, single for COVID-19 immunization. Medical history included seasonal allergies, known allergies: dairy, egg, known allergies: cat and known allergies: penicillin, all from an unknown date and unknown if ongoing. The patient is not pregnant. Concomitant medications included hydroxyzine hcl and ibuprofen, both taken for unspecified indications, start and stop dates were not reported. The patient previously took neosporin, azithromycin, reglan [metoclopramide] and zofran [ondansetron] and experienced allergy for all. The patient previously received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: ER8730), via an unspecified route of administration, administered in the right arm on 27Mar2021 15:00 (at the age of 34 years old) as dose 1, single for COVID-19 immunization. The patient experienced server joint pain (especially in hips & rt shoulder ongoing), painful skin sensitivity (especially on face & scalp, now spread to limbs; ongoing), headache, nausea, fever, chills, shaking, pins & needles, allergic reaction type rash on arms, back & neck muscle pain and swollen lymph nodes in both sides of neck on 17Apr2021 15:00. The reporter assessed all events as serious (resulted in disability or permanent damage). Treatment received for the adverse events included pain 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 has not been tested for COVID-19. Device date was reported as 10Aug2021. The outcome of all events was not recovered. No follow-up attempts are needed. No further information is expected.
Age: 90.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Abdominal pain upper, Computerised tomogram, Depressed level of consciousness, Dizziness, Investigation
Clinical narrative: dizziness; nausea; blurred vision; The initial case was missing the following minimum criteria: unspecified product. Upon receipt of follow-up information on 09Jul2021, this case now contains all required information to be considered valid. This is a spontaneous report from a contactable consumer (patient).   A 90-year-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: EN6198), via intramuscular route of administration, administered on 27Feb2021 09:00 (at the age of 90-years-old) as DOSE 1, SINGLE for covid-19 immunisation. Medical history included ongoing blood pressure abnormal (Blood pressure) and ongoing glaucoma. Concomitant medications included clonidine HCL (Clonidine HCL) taken for blood pressure abnormal from 15 unknown month of 2021 and ongoing; Meclozine (Meclizine Hydrochloride) taken for blood pressure abnormal from 2021 and ongoing; Amlodipine (Amlodipine) taken for blood pressure abnormal from an unspecified start date and ongoing; Ondansetron ODT (Ondansetron hydrochloride) taken for blood pressure abnormal from an unspecified start date and ongoing; Dorzolamide HCL (Dorzolamide HCL) taken for glaucoma from an unspecified start date and ongoing. The patient has no previous vaccinations within 4 weeks. The patient experienced dizziness, nausea on 27Feb2021 09:00 AM, blurred vision on 27Feb2021 09:00. Caller says that she is calling because there is a 90-year-old lady who got her first dose of the Pfizer COVID-19 vaccine Saturday and is having a reaction, and she is trying to make sure she is ok. The patient underwent lab tests and procedures which included computerised tomogram: negative on 18May2021 (not pertaining to previous medical condition), ophthalmological examination: negative on 25May2021 (not pertaining to glaucoma). The outcome of event was unknown.  Follow-up (16Aug2021): Follow-up attempts are completed. No further information is expected.
Age: 90.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Malaise, Nausea, Quality of life decreased, Vision blurred
Clinical narrative: dizziness; nausea; blurred vision; The initial case was missing the following minimum criteria: unspecified product. Upon receipt of follow-up information on 09Jul2021, this case now contains all required information to be considered valid. This is a spontaneous report from a contactable consumer (patient).   A 90-year-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: EN6198), via intramuscular route of administration, administered on 27Feb2021 09:00 (at the age of 90-years-old) as DOSE 1, SINGLE for covid-19 immunisation. Medical history included ongoing blood pressure abnormal (Blood pressure) and ongoing glaucoma. Concomitant medications included clonidine HCL (Clonidine HCL) taken for blood pressure abnormal from 15 unknown month of 2021 and ongoing; Meclozine (Meclizine Hydrochloride) taken for blood pressure abnormal from 2021 and ongoing; Amlodipine (Amlodipine) taken for blood pressure abnormal from an unspecified start date and ongoing; Ondansetron ODT (Ondansetron hydrochloride) taken for blood pressure abnormal from an unspecified start date and ongoing; Dorzolamide HCL (Dorzolamide HCL) taken for glaucoma from an unspecified start date and ongoing. The patient has no previous vaccinations within 4 weeks. The patient experienced dizziness, nausea on 27Feb2021 09:00 AM, blurred vision on 27Feb2021 09:00. Caller says that she is calling because there is a 90-year-old lady who got her first dose of the Pfizer COVID-19 vaccine Saturday and is having a reaction, and she is trying to make sure she is ok. The patient underwent lab tests and procedures which included computerised tomogram: negative on 18May2021 (not pertaining to previous medical condition), ophthalmological examination: negative on 25May2021 (not pertaining to glaucoma). The outcome of event was unknown.  Follow-up (16Aug2021): Follow-up attempts are completed. No further information is expected.
Age: 90.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Computerised tomogram, Dizziness, Nausea, Ophthalmological examination, Vision blurred
Clinical narrative: dizziness; nausea; blurred vision; The initial case was missing the following minimum criteria: unspecified product. Upon receipt of follow-up information on 09Jul2021, this case now contains all required information to be considered valid. This is a spontaneous report from a contactable consumer (patient).   A 90-year-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: EN6198), via intramuscular route of administration, administered on 27Feb2021 09:00 (at the age of 90-years-old) as DOSE 1, SINGLE for covid-19 immunisation. Medical history included ongoing blood pressure abnormal (Blood pressure) and ongoing glaucoma. Concomitant medications included clonidine HCL (Clonidine HCL) taken for blood pressure abnormal from 15 unknown month of 2021 and ongoing; Meclozine (Meclizine Hydrochloride) taken for blood pressure abnormal from 2021 and ongoing; Amlodipine (Amlodipine) taken for blood pressure abnormal from an unspecified start date and ongoing; Ondansetron ODT (Ondansetron hydrochloride) taken for blood pressure abnormal from an unspecified start date and ongoing; Dorzolamide HCL (Dorzolamide HCL) taken for glaucoma from an unspecified start date and ongoing. The patient has no previous vaccinations within 4 weeks. The patient experienced dizziness, nausea on 27Feb2021 09:00 AM, blurred vision on 27Feb2021 09:00. Caller says that she is calling because there is a 90-year-old lady who got her first dose of the Pfizer COVID-19 vaccine Saturday and is having a reaction, and she is trying to make sure she is ok. The patient underwent lab tests and procedures which included computerised tomogram: negative on 18May2021 (not pertaining to previous medical condition), ophthalmological examination: negative on 25May2021 (not pertaining to glaucoma). The outcome of event was unknown.  Follow-up (16Aug2021): Follow-up attempts are completed. No further information is expected.
Age: 48.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Contusion, Joint dislocation, Joint swelling, Ligament sprain
Clinical narrative: sprained ankle in sleep; dislocated finger when barely caught on grocery cart, patellar and shoulder subluxation; been having loose ligaments since the shots; This is a spontaneous report from a contactable healthcare professional, the patient. A 48-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, lot unknown, second dose) solution for injection intramuscular in the right arm on 12Jan2021 at 15:30 (at the age of 48-years-old) as a single dose for COVID-19 vaccination. The patient was not pregnant at the time of vaccination. Medical and past drug history included known allergies: pine nuts and levofloxacin (LEVAQUIN). Concomitant medications included cetirizine hydrochloride (ZYRTEC) and esomeprazole sodium (NEXIUM). Historical vaccine included BNT162B2 (first dose) for COVID-19 vaccination on 22Dec2020 with no adverse effect reported. The patient did not receive any other vaccine within 4 weeks prior to the vaccine. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient stated, "I have been having loose ligaments since the shots (23Feb2021). Began 6 weeks after second shot but I didn't realize I had problem. Since then I have sprained ankle in sleep (02Mar2021 at 02:00), and dislocated finger when barely caught on grocery cart, patellar and shoulder subluxation (23Feb2021). Just would like to know if others are reporting this. I'm a medical provider so I'm just wondering.  I did not see doctor as I know how to treat these symptoms. Just seems like so many coincidences." No treatment was provided for the events. The outcome of the events was not recovered. The patient has not been tested for COVID post vaccination.  The lot number for the vaccine (BNT162B2) was not provided and will be requested during follow up.; Sender's Comments: Based on the information currently available,The casual association between the reported events and suspected vaccine BNT162B2 cannot be completely excluded.  The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
Age: 48.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Joint dislocation, Ligament injury, Ligament sprain
Clinical narrative: sprained ankle in sleep; dislocated finger when barely caught on grocery cart, patellar and shoulder subluxation; been having loose ligaments since the shots; This is a spontaneous report from a contactable healthcare professional, the patient. A 48-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, lot unknown, second dose) solution for injection intramuscular in the right arm on 12Jan2021 at 15:30 (at the age of 48-years-old) as a single dose for COVID-19 vaccination. The patient was not pregnant at the time of vaccination. Medical and past drug history included known allergies: pine nuts and levofloxacin (LEVAQUIN). Concomitant medications included cetirizine hydrochloride (ZYRTEC) and esomeprazole sodium (NEXIUM). Historical vaccine included BNT162B2 (first dose) for COVID-19 vaccination on 22Dec2020 with no adverse effect reported. The patient did not receive any other vaccine within 4 weeks prior to the vaccine. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient stated, "I have been having loose ligaments since the shots (23Feb2021). Began 6 weeks after second shot but I didn't realize I had problem. Since then I have sprained ankle in sleep (02Mar2021 at 02:00), and dislocated finger when barely caught on grocery cart, patellar and shoulder subluxation (23Feb2021). Just would like to know if others are reporting this. I'm a medical provider so I'm just wondering.  I did not see doctor as I know how to treat these symptoms. Just seems like so many coincidences." No treatment was provided for the events. The outcome of the events was not recovered. The patient has not been tested for COVID post vaccination.  The lot number for the vaccine (BNT162B2) was not provided and will be requested during follow up.; Sender's Comments: Based on the information currently available,The casual association between the reported events and suspected vaccine BNT162B2 cannot be completely excluded.  The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
Age: 44.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Chest discomfort, Dyspnoea, Palpitations
Clinical narrative: fluttering heart; panic attack; Pressure in the chest; hard to breath; This is a spontaneous report from a contactable consumer (patient). This non-pregnant 44-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration, administered in Arm Left on 19Jul2021 10:00 (Lot Number: EW0186) at age of 44-years-old as dose 1, single for COVID-19 immunisation.  Medical history included covid-19 from Dec2020. The patient's concomitant medications were not reported. No other vaccine in four weeks. On 21Jul2021 09:00 AM, the patient experienced pressure in the chest, made her feel like it was hard to breath, fluttering heart. Made her feel like she was going to pass out, king of like a panic attack. They came and went. Worried about taking 2nd shot. Had covid back in December. Treatment included ibuprofen. No covid tested post vaccination. The outcome of the events was recovering.   No follow-up attempts are possible. No further information is expected.
Age: 44.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Cardiac flutter, Chest discomfort, Dyspnoea, Panic attack
Clinical narrative: fluttering heart; panic attack; Pressure in the chest; hard to breath; This is a spontaneous report from a contactable consumer (patient). This non-pregnant 44-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration, administered in Arm Left on 19Jul2021 10:00 (Lot Number: EW0186) at age of 44-years-old as dose 1, single for COVID-19 immunisation.  Medical history included covid-19 from Dec2020. The patient's concomitant medications were not reported. No other vaccine in four weeks. On 21Jul2021 09:00 AM, the patient experienced pressure in the chest, made her feel like it was hard to breath, fluttering heart. Made her feel like she was going to pass out, king of like a panic attack. They came and went. Worried about taking 2nd shot. Had covid back in December. Treatment included ibuprofen. No covid tested post vaccination. The outcome of the events was recovering.   No follow-up attempts are possible. No further information is expected.
Age: 44.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Dyspnoea, Palpitations
Clinical narrative: fluttering heart; panic attack; Pressure in the chest; hard to breath; This is a spontaneous report from a contactable consumer (patient). This non-pregnant 44-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration, administered in Arm Left on 19Jul2021 10:00 (Lot Number: EW0186) at age of 44-years-old as dose 1, single for COVID-19 immunisation.  Medical history included covid-19 from Dec2020. The patient's concomitant medications were not reported. No other vaccine in four weeks. On 21Jul2021 09:00 AM, the patient experienced pressure in the chest, made her feel like it was hard to breath, fluttering heart. Made her feel like she was going to pass out, king of like a panic attack. They came and went. Worried about taking 2nd shot. Had covid back in December. Treatment included ibuprofen. No covid tested post vaccination. The outcome of the events was recovering.   No follow-up attempts are possible. No further information is expected.
Age: 57.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Acoustic stimulation tests abnormal, Hypoacusis, Tinnitus
Clinical narrative: Sound sensitivity; Sound sensitivity evolved into ear ringing/ Eventual24/7 tinnitus; Painful jabbing sensations in right ear; This is a spontaneous report from a contactable consumer, the patient. A 57-year-old non-pregnant female patient received a second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6207) via an unspecified route of administration in right arm on 09Apr2021 (at the age of 57-years-old) as a single dose for COVID-19 immunisation. The patient's medical history included breast cancer survivor, 2018. The patient previously received ceftin and had experienced drug 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. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Concomitant medications included tamoxifen (MANUFACTURER UNKNOWN), vitamin d nos (MANUFACTURER UNKNOWN), cyanocobalamin (MANUFACTURER UNKNOWN) and fish oil (MANUFACTURER UNKNOWN) for unknown indications from an unknown duration. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6207) via an unspecified route of administration in left arm on 15Mar2021 (at the age of 57-years-old) as a single dose for COVID-19 immunisation. On 10Apr2021, after 2nd vaccine, the patient had experienced sound sensitivity evolved into ear ringing, painful jabbing sensations in right ear to eventual 24/7 tinnitus. The events had resulted in a visit to the doctors or other healthcare professional office/clinic visit. No therapeutic measures were taken as a result of adverse events. The clinical outcome of the events, sound sensitivity evolved into ear ringing, painful jabbing sensations in right ear to eventual 24/7 tinnitus was not recovered at the time of report.  No follow-up attempts are needed. No further information is expected
Age: 57.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Ear pain, Hyperacusis, Tinnitus
Clinical narrative: Sound sensitivity; Sound sensitivity evolved into ear ringing/ Eventual24/7 tinnitus; Painful jabbing sensations in right ear; This is a spontaneous report from a contactable consumer, the patient. A 57-year-old non-pregnant female patient received a second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6207) via an unspecified route of administration in right arm on 09Apr2021 (at the age of 57-years-old) as a single dose for COVID-19 immunisation. The patient's medical history included breast cancer survivor, 2018. The patient previously received ceftin and had experienced drug 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. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Concomitant medications included tamoxifen (MANUFACTURER UNKNOWN), vitamin d nos (MANUFACTURER UNKNOWN), cyanocobalamin (MANUFACTURER UNKNOWN) and fish oil (MANUFACTURER UNKNOWN) for unknown indications from an unknown duration. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6207) via an unspecified route of administration in left arm on 15Mar2021 (at the age of 57-years-old) as a single dose for COVID-19 immunisation. On 10Apr2021, after 2nd vaccine, the patient had experienced sound sensitivity evolved into ear ringing, painful jabbing sensations in right ear to eventual 24/7 tinnitus. The events had resulted in a visit to the doctors or other healthcare professional office/clinic visit. No therapeutic measures were taken as a result of adverse events. The clinical outcome of the events, sound sensitivity evolved into ear ringing, painful jabbing sensations in right ear to eventual 24/7 tinnitus was not recovered at the time of report.  No follow-up attempts are needed. No further information is expected
Age: 11.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Chest discomfort, Chest pain
Clinical narrative: heart was bugging; heart flutters; He has pressure in his chest; hard to breath; 11 years old; This is a spontaneous report from a contactable consumer (patient). An 11-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, lot number: Lot Number: EW0186), via an unspecified route of administration, administered in Arm Left on 20Jul2021 10:00 as dose 1, single for covid-19 immunization at a pharmacy. Medical history included COVID-19 from Dec2020 to an unknown date. The patient's concomitant medications were not reported. On 21Jul2021 09:00, patient reported that he has pressure in his chest and his heart flutters. At times it is hard to breath. He was at lacrosse practice last night a whole week after the shot and said his heart was bugging him on an unspecified date. He was told to take ibuprofen for the symptoms. Since the vaccination, the patient has not been tested for COVID-19. The outcome of the events was not recovered.   Follow-up attempts are completed. No further information is expected.
Age: 11.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Cardiac disorder, Cardiac flutter, Chest discomfort, Dyspnoea, Product administered to patient of inappropriate age
Clinical narrative: heart was bugging; heart flutters; He has pressure in his chest; hard to breath; 11 years old; This is a spontaneous report from a contactable consumer (patient). An 11-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, lot number: Lot Number: EW0186), via an unspecified route of administration, administered in Arm Left on 20Jul2021 10:00 as dose 1, single for covid-19 immunization at a pharmacy. Medical history included COVID-19 from Dec2020 to an unknown date. The patient's concomitant medications were not reported. On 21Jul2021 09:00, patient reported that he has pressure in his chest and his heart flutters. At times it is hard to breath. He was at lacrosse practice last night a whole week after the shot and said his heart was bugging him on an unspecified date. He was told to take ibuprofen for the symptoms. Since the vaccination, the patient has not been tested for COVID-19. The outcome of the events was not recovered.   Follow-up attempts are completed. No further information is expected.
Age: 11.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Dyspnoea, Palpitations
Clinical narrative: heart was bugging; heart flutters; He has pressure in his chest; hard to breath; 11 years old; This is a spontaneous report from a contactable consumer (patient). An 11-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, lot number: Lot Number: EW0186), via an unspecified route of administration, administered in Arm Left on 20Jul2021 10:00 as dose 1, single for covid-19 immunization at a pharmacy. Medical history included COVID-19 from Dec2020 to an unknown date. The patient's concomitant medications were not reported. On 21Jul2021 09:00, patient reported that he has pressure in his chest and his heart flutters. At times it is hard to breath. He was at lacrosse practice last night a whole week after the shot and said his heart was bugging him on an unspecified date. He was told to take ibuprofen for the symptoms. Since the vaccination, the patient has not been tested for COVID-19. The outcome of the events was not recovered.   Follow-up attempts are completed. No further information is expected.
Age: 62.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Hypoaesthesia, Lip swelling
Clinical narrative: Right side of face by jaw line startedfeeling numb; Lip swelling; This is a spontaneous report from a contactable consumer, the patient. A 62-year-old female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: FA7484) via an unspecified route of administration in the left arm on 28Jul2021 at 10:30 (at the age of 62-years-old) as a single dose for COVID-19 immunisation. The patient did not have any relevant medical history. The patient had no known allergies. Concomitant medications were not reported. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 28Jul2021 at 11:30, the patient experienced numbness on the right side of face by the jaw line and then bottom lip had started swelling. It happened an hour before the time of this report and the patient stated she would report if it started to swell more. The events resulted in a visit to the doctors or other healthcare professional office/clinic visit. It was unknown if any therapeutic measures were taken as a result of the events. The clinical outcome of the events numbness on right side of face by jaw line and lip swelling were not resolved at the time of this report.
Age: 27.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Hypoaesthesia, Limb discomfort, SARS-CoV-2 test
Clinical narrative: Some numbing and discomfort around just the upper left arm area after the 1st shot; Some numbing and discomfort around just the upper left arm area after the 1st shot; This is a spontaneous report from a contactable consumer or other non-hcp (Patient).   A 27-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation solution for injection; Lot Number: EN6199) via an unspecified route of administration (Age at vaccination 27-year) in Left Arm in Mar2021 at 06:00 PM as dose 1, single for COVID-19 immunization. Medical history included asthma from an unknown date and unknown if ongoing. The patient's concomitant medications were not reported. Facility type vaccine was Pharmacy or Drug Store. No COVID prior vaccination was reported. The patient tested COVID, post vaccination. The patient received no other vaccine in four weeks. On an unspecified date in Mar2021 the patient experienced some numbing and discomfort around just the upper left arm area after the 1st shot. No treatment was received by the patient for adverse events. The patient underwent lab tests and procedures which included SARS-COV-2 test: negative on 22Mar2021. The clinical outcome of the events was not recovered.  No follow up attempts are possible. No further information is expected.
Age: 27.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Discomfort, Hypoaesthesia, SARS-CoV-2 test
Clinical narrative: Some numbing and discomfort around just the upper left arm area after the 1st shot; Some numbing and discomfort around just the upper left arm area after the 1st shot; This is a spontaneous report from a contactable consumer or other non-hcp (Patient).   A 27-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation solution for injection; Lot Number: EN6199) via an unspecified route of administration (Age at vaccination 27-year) in Left Arm in Mar2021 at 06:00 PM as dose 1, single for COVID-19 immunization. Medical history included asthma from an unknown date and unknown if ongoing. The patient's concomitant medications were not reported. Facility type vaccine was Pharmacy or Drug Store. No COVID prior vaccination was reported. The patient tested COVID, post vaccination. The patient received no other vaccine in four weeks. On an unspecified date in Mar2021 the patient experienced some numbing and discomfort around just the upper left arm area after the 1st shot. No treatment was received by the patient for adverse events. The patient underwent lab tests and procedures which included SARS-COV-2 test: negative on 22Mar2021. The clinical outcome of the events was not recovered.  No follow up attempts are possible. No further information is expected.
Age: 59.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Acoustic stimulation tests, Computerised tomogram, Deafness, Magnetic resonance imaging, Nerve injury
Clinical narrative: Hearing loss; Tinnitus; This is a spontaneous report from a contactable nurse (patient). A 59 year-old-female received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE Solution for injection), via an unspecified route of administration, administered in the left arm, in Jan2021 13:00 (as reported) (Batch/lot number unknown), at age 59 years old, as dose 2, single, for COVID-19 immunisation, at a hospital. The patient was not pregnant at the time of vaccination. There were no medical history, concomitant medications and relevant past drug history. There were no known allergies. The patient was not diagnosed with COVID-19 prior to the vaccination. Historical vaccine included BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE Solution for injection) received via an unspecified route of administration, administered in the left arm, in Dec2020 13:30 (Batch/lot number unknown), at age 59 years old, as dose 1, single for COVID-19 immunisation. The patient did not receive any other vaccines in 4 weeks prior to BNT162B2. On 26Feb2021, the patient experienced tinnitus and hearing loss. The events resulted to a physician's office visit. Treatment for the events included oral and injected steroid in the ear drum. On 23Jun2021, the patient was tested for COVID-19 via nasal swab and the result was negative. The outcome of the events was not resolved. The reporter assessed the events as non-serious.  The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow up.; Sender's Comments: Based on available information, a possible contributory role of BNT162B2 vaccine can not be excluded for the reported events of tinnitus and hearing loss due to temporal relationship.  Case will be re-assessed upon the additional information provided. 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, COVID19
Symptoms: Tinnitus
Clinical narrative: Hearing loss; Tinnitus; This is a spontaneous report from a contactable nurse (patient). A 59 year-old-female received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE Solution for injection), via an unspecified route of administration, administered in the left arm, in Jan2021 13:00 (as reported) (Batch/lot number unknown), at age 59 years old, as dose 2, single, for COVID-19 immunisation, at a hospital. The patient was not pregnant at the time of vaccination. There were no medical history, concomitant medications and relevant past drug history. There were no known allergies. The patient was not diagnosed with COVID-19 prior to the vaccination. Historical vaccine included BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE Solution for injection) received via an unspecified route of administration, administered in the left arm, in Dec2020 13:30 (Batch/lot number unknown), at age 59 years old, as dose 1, single for COVID-19 immunisation. The patient did not receive any other vaccines in 4 weeks prior to BNT162B2. On 26Feb2021, the patient experienced tinnitus and hearing loss. The events resulted to a physician's office visit. Treatment for the events included oral and injected steroid in the ear drum. On 23Jun2021, the patient was tested for COVID-19 via nasal swab and the result was negative. The outcome of the events was not resolved. The reporter assessed the events as non-serious.  The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow up.; Sender's Comments: Based on available information, a possible contributory role of BNT162B2 vaccine can not be excluded for the reported events of tinnitus and hearing loss due to temporal relationship.  Case will be re-assessed upon the additional information provided. 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, COVID19
Symptoms: Deafness, SARS-CoV-2 test, Tinnitus
Clinical narrative: Hearing loss; Tinnitus; This is a spontaneous report from a contactable nurse (patient). A 59 year-old-female received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE Solution for injection), via an unspecified route of administration, administered in the left arm, in Jan2021 13:00 (as reported) (Batch/lot number unknown), at age 59 years old, as dose 2, single, for COVID-19 immunisation, at a hospital. The patient was not pregnant at the time of vaccination. There were no medical history, concomitant medications and relevant past drug history. There were no known allergies. The patient was not diagnosed with COVID-19 prior to the vaccination. Historical vaccine included BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE Solution for injection) received via an unspecified route of administration, administered in the left arm, in Dec2020 13:30 (Batch/lot number unknown), at age 59 years old, as dose 1, single for COVID-19 immunisation. The patient did not receive any other vaccines in 4 weeks prior to BNT162B2. On 26Feb2021, the patient experienced tinnitus and hearing loss. The events resulted to a physician's office visit. Treatment for the events included oral and injected steroid in the ear drum. On 23Jun2021, the patient was tested for COVID-19 via nasal swab and the result was negative. The outcome of the events was not resolved. The reporter assessed the events as non-serious.  The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow up.; Sender's Comments: Based on available information, a possible contributory role of BNT162B2 vaccine can not be excluded for the reported events of tinnitus and hearing loss due to temporal relationship.  Case will be re-assessed upon the additional information provided. 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: 41.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Eye movement disorder, Headache, Muscle tightness
Clinical narrative: consistent dull headache with bursts of sharpstabbing pain; bursts of sharp stabbing pain; tense up; eyes roll back, almost like a tic.; This is a spontaneous report from a contactable consumer, the patient. A 41-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8733) via an unspecified route of administration in the left arm on an unknown date in Apr2021 at 13:30 (at the age of 41-year-old) as a single dose for COVID-19 immunisation. The patient had no medical history and no known allergies. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any concomitant medications within two weeks of vaccination. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6199) via an unspecified route of administration in the left arm on an unknown date in Mar2021 at 13:30 as a single dose for COVID-19 immunisation. On 10Apr2021, after the second dose of vaccination, the patient experienced consistent headache which was a dull headache with bursts of sharp stabbing pain that caused the patient to tense up and the eyes rolled back, almost like a tic. The patient got the bursts 2-3 times daily since April 2021 and did not have medical coverage to get seen by a doctor. Therapeutic measures were not taken as a result of the events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events dull headache, bursts of sharp stabbing pain, tense up and eyes rolled back almost like a tic were not recovered at the time of the report.
Age: 41.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Eye movement disorder, Headache, Pain, Tension
Clinical narrative: consistent dull headache with bursts of sharpstabbing pain; bursts of sharp stabbing pain; tense up; eyes roll back, almost like a tic.; This is a spontaneous report from a contactable consumer, the patient. A 41-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8733) via an unspecified route of administration in the left arm on an unknown date in Apr2021 at 13:30 (at the age of 41-year-old) as a single dose for COVID-19 immunisation. The patient had no medical history and no known allergies. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any concomitant medications within two weeks of vaccination. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6199) via an unspecified route of administration in the left arm on an unknown date in Mar2021 at 13:30 as a single dose for COVID-19 immunisation. On 10Apr2021, after the second dose of vaccination, the patient experienced consistent headache which was a dull headache with bursts of sharp stabbing pain that caused the patient to tense up and the eyes rolled back, almost like a tic. The patient got the bursts 2-3 times daily since April 2021 and did not have medical coverage to get seen by a doctor. Therapeutic measures were not taken as a result of the events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events dull headache, bursts of sharp stabbing pain, tense up and eyes rolled back almost like a tic were not recovered at the time of the report.