chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 37.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Burning sensation, Herpes zoster, Paraesthesia, Rash vesicular
Clinical narrative: Shingles; This is a spontaneous report from a contactable consumer (patient) and other HCP. A 37-year-old male patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection, lot number: FF2589), via an unspecified route of administration, administered in arm left on 07Sep2021 at 11:00 (at the age of 37-year-old) as dose 1, single for COVID-19 immunization. The patient's medical history included asthma and allergic contact dermatitis. The patient's concomitant medications included fluticasone propionate, salmeterol xinafoate (ADVAIR) taken daily; fluticasone propionate (FLONASE) taken 1x daily; fexofenadine hydrochloride (ALLEGRA) taken 1x daily all three received within 2 weeks of vaccination. The patient previously took propylene glycol, methylisothiazolinone, formaldehyde and experienced allergies. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient was not diagnosed with COVID-19 prior to vaccination. Since the vaccination, the patient had not been tested for COVID-19. On 12Sep2021 at 17:00 (5 days after receiving the 1st dose), the patient developed a case of shingles. First symptoms were a tingly and numb right leg from his hip to his knee. A rash appeared on his lower back and right hip a few days later then became inflamed and blistered. The patient was first diagnosed about shingles from emergency room/department or urgent care, then he got a second opinion from the dermatologist. Valacyclovir was taken as a therapeutic measure as a result of the events. Outcome of event at the time of last observation was recovering.  Follow-up attempts are completed. No further information is expected.
Age: 37.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Herpes zoster
Clinical narrative: Shingles; This is a spontaneous report from a contactable consumer (patient) and other HCP. A 37-year-old male patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection, lot number: FF2589), via an unspecified route of administration, administered in arm left on 07Sep2021 at 11:00 (at the age of 37-year-old) as dose 1, single for COVID-19 immunization. The patient's medical history included asthma and allergic contact dermatitis. The patient's concomitant medications included fluticasone propionate, salmeterol xinafoate (ADVAIR) taken daily; fluticasone propionate (FLONASE) taken 1x daily; fexofenadine hydrochloride (ALLEGRA) taken 1x daily all three received within 2 weeks of vaccination. The patient previously took propylene glycol, methylisothiazolinone, formaldehyde and experienced allergies. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient was not diagnosed with COVID-19 prior to vaccination. Since the vaccination, the patient had not been tested for COVID-19. On 12Sep2021 at 17:00 (5 days after receiving the 1st dose), the patient developed a case of shingles. First symptoms were a tingly and numb right leg from his hip to his knee. A rash appeared on his lower back and right hip a few days later then became inflamed and blistered. The patient was first diagnosed about shingles from emergency room/department or urgent care, then he got a second opinion from the dermatologist. Valacyclovir was taken as a therapeutic measure as a result of the events. Outcome of event at the time of last observation was recovering.  Follow-up attempts are completed. No further information is expected.
Age: 14.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Blood test, Hypoaesthesia, Lumbar puncture, Magnetic resonance imaging, Paraesthesia
Clinical narrative: Numbness and tingling throughout body; Numbness and tingling throughout body; dizziness in standing; cold feet and body sporadically; cold feet and body sporadically; administration date=03Sep2021, dose number=2, administration date=18May2021,dose number=1; This is a spontaneous report from a contactable consumer (patient).  A 14-year-old male patient received BNT162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 2 via an unspecified route of administration administered in the left arm on 03Sep2021 at 16:30 (Batch/Lot Number: PC3181) (age at vaccination: 14 years old) as single dose for COVID-19 immunisation. The patient medical history was not reported. Prior to vaccination, the patient had not been diagnosed with COVID-19. Concomitant medication(s) included cefotaxime sodium (OMNICEF) taken for an unspecified indication, start and stop date were not reported. The patient had previously received the first dose of BNT162b2 on 18May2021 (Batch/lot number : EW0178) for COVID-19 immunization. The patient didn't receive any other vaccines within 4 weeks prior to the COVID vaccine.  The patient experienced numbness and tingling throughout body, dizziness in standing, and cold feet and body sporadically. Onset date was 09Sep2021 07:00. The events resulted in doctor or other healthcare professional office/clinic visit and emergency room/department or urgent care. The events were serious as caused hospitalization. The patient was hospitalized for 2 days. No treatment was received for the adverse events. SARS-COV-2 test (Nasal Swab) was negative on 23Sep2021. The adverse events were not resolved.
Age: 14.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Peripheral coldness
Clinical narrative: Numbness and tingling throughout body; Numbness and tingling throughout body; dizziness in standing; cold feet and body sporadically; cold feet and body sporadically; administration date=03Sep2021, dose number=2, administration date=18May2021,dose number=1; This is a spontaneous report from a contactable consumer (patient).  A 14-year-old male patient received BNT162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 2 via an unspecified route of administration administered in the left arm on 03Sep2021 at 16:30 (Batch/Lot Number: PC3181) (age at vaccination: 14 years old) as single dose for COVID-19 immunisation. The patient medical history was not reported. Prior to vaccination, the patient had not been diagnosed with COVID-19. Concomitant medication(s) included cefotaxime sodium (OMNICEF) taken for an unspecified indication, start and stop date were not reported. The patient had previously received the first dose of BNT162b2 on 18May2021 (Batch/lot number : EW0178) for COVID-19 immunization. The patient didn't receive any other vaccines within 4 weeks prior to the COVID vaccine.  The patient experienced numbness and tingling throughout body, dizziness in standing, and cold feet and body sporadically. Onset date was 09Sep2021 07:00. The events resulted in doctor or other healthcare professional office/clinic visit and emergency room/department or urgent care. The events were serious as caused hospitalization. The patient was hospitalized for 2 days. No treatment was received for the adverse events. SARS-COV-2 test (Nasal Swab) was negative on 23Sep2021. The adverse events were not resolved.
Age: 14.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Dizziness postural, Feeling cold, Hypoaesthesia, Inappropriate schedule of product administration, Paraesthesia
Clinical narrative: Numbness and tingling throughout body; Numbness and tingling throughout body; dizziness in standing; cold feet and body sporadically; cold feet and body sporadically; administration date=03Sep2021, dose number=2, administration date=18May2021,dose number=1; This is a spontaneous report from a contactable consumer (patient).  A 14-year-old male patient received BNT162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 2 via an unspecified route of administration administered in the left arm on 03Sep2021 at 16:30 (Batch/Lot Number: PC3181) (age at vaccination: 14 years old) as single dose for COVID-19 immunisation. The patient medical history was not reported. Prior to vaccination, the patient had not been diagnosed with COVID-19. Concomitant medication(s) included cefotaxime sodium (OMNICEF) taken for an unspecified indication, start and stop date were not reported. The patient had previously received the first dose of BNT162b2 on 18May2021 (Batch/lot number : EW0178) for COVID-19 immunization. The patient didn't receive any other vaccines within 4 weeks prior to the COVID vaccine.  The patient experienced numbness and tingling throughout body, dizziness in standing, and cold feet and body sporadically. Onset date was 09Sep2021 07:00. The events resulted in doctor or other healthcare professional office/clinic visit and emergency room/department or urgent care. The events were serious as caused hospitalization. The patient was hospitalized for 2 days. No treatment was received for the adverse events. SARS-COV-2 test (Nasal Swab) was negative on 23Sep2021. The adverse events were not resolved.
Age: 14.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Peripheral coldness, SARS-CoV-2 test
Clinical narrative: Numbness and tingling throughout body; Numbness and tingling throughout body; dizziness in standing; cold feet and body sporadically; cold feet and body sporadically; administration date=03Sep2021, dose number=2, administration date=18May2021,dose number=1; This is a spontaneous report from a contactable consumer (patient).  A 14-year-old male patient received BNT162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 2 via an unspecified route of administration administered in the left arm on 03Sep2021 at 16:30 (Batch/Lot Number: PC3181) (age at vaccination: 14 years old) as single dose for COVID-19 immunisation. The patient medical history was not reported. Prior to vaccination, the patient had not been diagnosed with COVID-19. Concomitant medication(s) included cefotaxime sodium (OMNICEF) taken for an unspecified indication, start and stop date were not reported. The patient had previously received the first dose of BNT162b2 on 18May2021 (Batch/lot number : EW0178) for COVID-19 immunization. The patient didn't receive any other vaccines within 4 weeks prior to the COVID vaccine.  The patient experienced numbness and tingling throughout body, dizziness in standing, and cold feet and body sporadically. Onset date was 09Sep2021 07:00. The events resulted in doctor or other healthcare professional office/clinic visit and emergency room/department or urgent care. The events were serious as caused hospitalization. The patient was hospitalized for 2 days. No treatment was received for the adverse events. SARS-COV-2 test (Nasal Swab) was negative on 23Sep2021. The adverse events were not resolved.
Age: 35.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Antibody test positive, Blood test, Diarrhoea, Hypoaesthesia, Injection site erythema
Clinical narrative: felt like she lost circulation; tingling in the arms/ tingling to the legs/ Pins and Needles; numbness in the arms/ numbness to the legs/ numbness in her hands and feet; rash at the injection site; rash at the injection site that was red, hot and similar to a raised skin bump; rash at the injection site that was red, hot and similar to a raised skin bump; rash at the injection site that was red, hot and similar to a raised skin bump; Diarrhoea; The initial safety information received was reporting only non-serious adverse drug reactions. Upon receipt of follow-up information on 04Oct2021, this case now contains serious adverse reactions. Information processed together.  This is a spontaneous report from a contactable consumer, the patient. A 35-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; Lot: FA7484) intramuscular in the left arm on 30Jul2021 at 07:30, also reported as at 12:00, (at the age of 35-years-old) as a single dose for COVID-19 immunisation. Medical history and concomitant medications were none. There were no prior vaccinations. On 02Aug2021 at 07:00, three days after vaccination, the patient woke up to pins and needles, tingling and numbness in all the arms all day. On 03Aug2021, that tingling and numbness moved from the arms to all of the legs. The patient had numbness in her hands and feet. The patient stated it felt like she lost circulation. The patient went to the doctor, who told her it was a reaction from the vaccine, and it was not common. The events, "tingling in the arms/ tingling to the legs/ Pins and Needles", "numbness in the arms/ numbness to the legs/ numbness in her hands and feet", "felt like she lost circulation" were reported as serious as an important medical event. The patient was not treated for these events. On an unspecified date in 2021, the patient also had other minor reactions including a rash at the injection site that was hot, red, and similar to a raised skin bump and diarrhea. The reactions mostly subsided within a week, however, the patient had occasional mild waves of tingling and numbness in the arms. The patient underwent the following laboratory tests and procedures on 09Sep2021: Antibody blood test with positive results (positive for antibodies). The clinical outcome of "tingling in the arms/ tingling to the legs/ Pins and Needles" and "numbness in the arms/ numbness to the legs/ numbness in her hands and feet" was not resolved, of the remaining events was resolved on an unspecified date in 2021.  Follow-up attempts are completed. No further information is expected.
Age: 35.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Injection site rash, Injection site swelling, Injection site warmth, Paraesthesia
Clinical narrative: felt like she lost circulation; tingling in the arms/ tingling to the legs/ Pins and Needles; numbness in the arms/ numbness to the legs/ numbness in her hands and feet; rash at the injection site; rash at the injection site that was red, hot and similar to a raised skin bump; rash at the injection site that was red, hot and similar to a raised skin bump; rash at the injection site that was red, hot and similar to a raised skin bump; Diarrhoea; The initial safety information received was reporting only non-serious adverse drug reactions. Upon receipt of follow-up information on 04Oct2021, this case now contains serious adverse reactions. Information processed together.  This is a spontaneous report from a contactable consumer, the patient. A 35-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; Lot: FA7484) intramuscular in the left arm on 30Jul2021 at 07:30, also reported as at 12:00, (at the age of 35-years-old) as a single dose for COVID-19 immunisation. Medical history and concomitant medications were none. There were no prior vaccinations. On 02Aug2021 at 07:00, three days after vaccination, the patient woke up to pins and needles, tingling and numbness in all the arms all day. On 03Aug2021, that tingling and numbness moved from the arms to all of the legs. The patient had numbness in her hands and feet. The patient stated it felt like she lost circulation. The patient went to the doctor, who told her it was a reaction from the vaccine, and it was not common. The events, "tingling in the arms/ tingling to the legs/ Pins and Needles", "numbness in the arms/ numbness to the legs/ numbness in her hands and feet", "felt like she lost circulation" were reported as serious as an important medical event. The patient was not treated for these events. On an unspecified date in 2021, the patient also had other minor reactions including a rash at the injection site that was hot, red, and similar to a raised skin bump and diarrhea. The reactions mostly subsided within a week, however, the patient had occasional mild waves of tingling and numbness in the arms. The patient underwent the following laboratory tests and procedures on 09Sep2021: Antibody blood test with positive results (positive for antibodies). The clinical outcome of "tingling in the arms/ tingling to the legs/ Pins and Needles" and "numbness in the arms/ numbness to the legs/ numbness in her hands and feet" was not resolved, of the remaining events was resolved on an unspecified date in 2021.  Follow-up attempts are completed. No further information is expected.
Age: 35.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Antibody test, Diarrhoea, Hypoaesthesia, Paraesthesia, Poor peripheral circulation
Clinical narrative: felt like she lost circulation; tingling in the arms/ tingling to the legs/ Pins and Needles; numbness in the arms/ numbness to the legs/ numbness in her hands and feet; rash at the injection site; rash at the injection site that was red, hot and similar to a raised skin bump; rash at the injection site that was red, hot and similar to a raised skin bump; rash at the injection site that was red, hot and similar to a raised skin bump; Diarrhoea; The initial safety information received was reporting only non-serious adverse drug reactions. Upon receipt of follow-up information on 04Oct2021, this case now contains serious adverse reactions. Information processed together.  This is a spontaneous report from a contactable consumer, the patient. A 35-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; Lot: FA7484) intramuscular in the left arm on 30Jul2021 at 07:30, also reported as at 12:00, (at the age of 35-years-old) as a single dose for COVID-19 immunisation. Medical history and concomitant medications were none. There were no prior vaccinations. On 02Aug2021 at 07:00, three days after vaccination, the patient woke up to pins and needles, tingling and numbness in all the arms all day. On 03Aug2021, that tingling and numbness moved from the arms to all of the legs. The patient had numbness in her hands and feet. The patient stated it felt like she lost circulation. The patient went to the doctor, who told her it was a reaction from the vaccine, and it was not common. The events, "tingling in the arms/ tingling to the legs/ Pins and Needles", "numbness in the arms/ numbness to the legs/ numbness in her hands and feet", "felt like she lost circulation" were reported as serious as an important medical event. The patient was not treated for these events. On an unspecified date in 2021, the patient also had other minor reactions including a rash at the injection site that was hot, red, and similar to a raised skin bump and diarrhea. The reactions mostly subsided within a week, however, the patient had occasional mild waves of tingling and numbness in the arms. The patient underwent the following laboratory tests and procedures on 09Sep2021: Antibody blood test with positive results (positive for antibodies). The clinical outcome of "tingling in the arms/ tingling to the legs/ Pins and Needles" and "numbness in the arms/ numbness to the legs/ numbness in her hands and feet" was not resolved, of the remaining events was resolved on an unspecified date in 2021.  Follow-up attempts are completed. No further information is expected.
Age: 35.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Vaccination site erythema, Vaccination site nodule, Vaccination site rash, Vaccination site warmth
Clinical narrative: felt like she lost circulation; tingling in the arms/ tingling to the legs/ Pins and Needles; numbness in the arms/ numbness to the legs/ numbness in her hands and feet; rash at the injection site; rash at the injection site that was red, hot and similar to a raised skin bump; rash at the injection site that was red, hot and similar to a raised skin bump; rash at the injection site that was red, hot and similar to a raised skin bump; Diarrhoea; The initial safety information received was reporting only non-serious adverse drug reactions. Upon receipt of follow-up information on 04Oct2021, this case now contains serious adverse reactions. Information processed together.  This is a spontaneous report from a contactable consumer, the patient. A 35-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; Lot: FA7484) intramuscular in the left arm on 30Jul2021 at 07:30, also reported as at 12:00, (at the age of 35-years-old) as a single dose for COVID-19 immunisation. Medical history and concomitant medications were none. There were no prior vaccinations. On 02Aug2021 at 07:00, three days after vaccination, the patient woke up to pins and needles, tingling and numbness in all the arms all day. On 03Aug2021, that tingling and numbness moved from the arms to all of the legs. The patient had numbness in her hands and feet. The patient stated it felt like she lost circulation. The patient went to the doctor, who told her it was a reaction from the vaccine, and it was not common. The events, "tingling in the arms/ tingling to the legs/ Pins and Needles", "numbness in the arms/ numbness to the legs/ numbness in her hands and feet", "felt like she lost circulation" were reported as serious as an important medical event. The patient was not treated for these events. On an unspecified date in 2021, the patient also had other minor reactions including a rash at the injection site that was hot, red, and similar to a raised skin bump and diarrhea. The reactions mostly subsided within a week, however, the patient had occasional mild waves of tingling and numbness in the arms. The patient underwent the following laboratory tests and procedures on 09Sep2021: Antibody blood test with positive results (positive for antibodies). The clinical outcome of "tingling in the arms/ tingling to the legs/ Pins and Needles" and "numbness in the arms/ numbness to the legs/ numbness in her hands and feet" was not resolved, of the remaining events was resolved on an unspecified date in 2021.  Follow-up attempts are completed. No further information is expected.
Age: 57.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Acoustic stimulation tests, Ear pain, Ear swelling, Nerve injury, Tinnitus
Clinical narrative: he will kill himself. He just can't imagine living like that; Hearing problems and tinnitus in right ear; Hearing problems and tinnitus in right ear; he has nerve damage; This is a spontaneous report from agency. A contactable consumer (patient) reported that a 57-years-old male patient received first dose of bnt162b2 (Pfizer-BioNTech COVID-19 Vaccine, solution for injection, Batch/Lot number FD8448) via an unspecified route of administration, administered in Arm Left on 26Aug2021 06:00 (age at vaccination 57 years old) as dose 1, single for COVID-19 immunisation. The patient's medical history was not reported. Concomitant medication included BC powder for headache as needed. There was no vaccine Administered at Work Facility. There was no history of all previous immunization with the Pfizer vaccine considered as suspect (or patient age at first and subsequent immunizations if dates of birth or immunizations are not available). There was no vaccines administered on same date with the Pfizer vaccine considered as suspect. There was prior Vaccinations (within 4 weeks). No following prior vaccinations. Patient states that he got his 1st dose of the vaccine on 26Aug2021 due to a company mandate. On 13Sep2021, 17 days later he had problems with his right ear. Hearing problems and tinnitus in right ear. He went to an ENT and did 2 hours of testing, and the ENT said that his ear drum was fine, but he has nerve damage; he doesn't know the percentage yet. Stated that he had an MRI on 01Oct2021, but hasnot gotten the results yet. Stated that if he goes deaf he would sue his company; actually his brother was a lawyer and he was already building a case to file a lawsuit against his company for making the vaccine mandatory. Stated that if he loses his hearing completely it will be life threatening because he will kill himself. He just cant imagine living like that, without being able to hear (13Sep2021). Stated that he doesn't know how much hearing he has lost. He felt like he constantly has water in his ears. He also has a high pitched ringing in both ears, tinnitus. He does hear a little better out of his left ear than he does out of his right ear. The outcome of events was reported as not recovered.  No follow-up attempts are possible. No further information is expected
Age: 57.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Hypoacusis, Magnetic resonance imaging, Nerve injury, Suicidal ideation, Tinnitus
Clinical narrative: he will kill himself. He just can't imagine living like that; Hearing problems and tinnitus in right ear; Hearing problems and tinnitus in right ear; he has nerve damage; This is a spontaneous report from agency. A contactable consumer (patient) reported that a 57-years-old male patient received first dose of bnt162b2 (Pfizer-BioNTech COVID-19 Vaccine, solution for injection, Batch/Lot number FD8448) via an unspecified route of administration, administered in Arm Left on 26Aug2021 06:00 (age at vaccination 57 years old) as dose 1, single for COVID-19 immunisation. The patient's medical history was not reported. Concomitant medication included BC powder for headache as needed. There was no vaccine Administered at Work Facility. There was no history of all previous immunization with the Pfizer vaccine considered as suspect (or patient age at first and subsequent immunizations if dates of birth or immunizations are not available). There was no vaccines administered on same date with the Pfizer vaccine considered as suspect. There was prior Vaccinations (within 4 weeks). No following prior vaccinations. Patient states that he got his 1st dose of the vaccine on 26Aug2021 due to a company mandate. On 13Sep2021, 17 days later he had problems with his right ear. Hearing problems and tinnitus in right ear. He went to an ENT and did 2 hours of testing, and the ENT said that his ear drum was fine, but he has nerve damage; he doesn't know the percentage yet. Stated that he had an MRI on 01Oct2021, but hasnot gotten the results yet. Stated that if he goes deaf he would sue his company; actually his brother was a lawyer and he was already building a case to file a lawsuit against his company for making the vaccine mandatory. Stated that if he loses his hearing completely it will be life threatening because he will kill himself. He just cant imagine living like that, without being able to hear (13Sep2021). Stated that he doesn't know how much hearing he has lost. He felt like he constantly has water in his ears. He also has a high pitched ringing in both ears, tinnitus. He does hear a little better out of his left ear than he does out of his right ear. The outcome of events was reported as not recovered.  No follow-up attempts are possible. No further information is expected
Age: 38.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Depression, Head discomfort, Headache, Hypoaesthesia, Hypoaesthesia oral
Clinical narrative: extreme depression; Numbness on right side of face and right arm; headache; panic attacks; received first dose on 20Apr2021; recevied second dose on 21Sep2021; This is a spontaneous report from a contactable consumer (patient). A 38-year-old non-pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Batch/Lot Number: FE3592), via an unspecified route of administration, administered in right arm on 21Sep2021 15:00 (at the age of 38-year-old) as dose 2, single for COVID-19 immunization at pharmacy or drug store. Medical history included COVID-19 prior to vaccination. The patient had no other medical history. The patient had no known allergies. There were no concomitant medications. The patient did not receive any other vaccine within four weeks of BNT162B2. The patient previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Batch/Lot Number: ER8792), via an unspecified route of administration, administered in right arm on 20Apr2021 at 12:00 (at the age of 37-year-old) as single dose for COVID-19 immunization. The patient experienced extreme depression, numbness on right side of face and right arm, headache, panic attacks on 23Sep2021 03:00. The events resulted in Doctor or other healthcare professional office/clinic visit. No treatment was received as a result of the events. The patient had not been tested for COVID after vaccination. The outcome of the events was not recovered.
Age: 38.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Panic attack
Clinical narrative: extreme depression; Numbness on right side of face and right arm; headache; panic attacks; received first dose on 20Apr2021; recevied second dose on 21Sep2021; This is a spontaneous report from a contactable consumer (patient). A 38-year-old non-pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Batch/Lot Number: FE3592), via an unspecified route of administration, administered in right arm on 21Sep2021 15:00 (at the age of 38-year-old) as dose 2, single for COVID-19 immunization at pharmacy or drug store. Medical history included COVID-19 prior to vaccination. The patient had no other medical history. The patient had no known allergies. There were no concomitant medications. The patient did not receive any other vaccine within four weeks of BNT162B2. The patient previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Batch/Lot Number: ER8792), via an unspecified route of administration, administered in right arm on 20Apr2021 at 12:00 (at the age of 37-year-old) as single dose for COVID-19 immunization. The patient experienced extreme depression, numbness on right side of face and right arm, headache, panic attacks on 23Sep2021 03:00. The events resulted in Doctor or other healthcare professional office/clinic visit. No treatment was received as a result of the events. The patient had not been tested for COVID after vaccination. The outcome of the events was not recovered.
Age: 38.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Depression, Headache, Hypoaesthesia, Inappropriate schedule of product administration, Panic attack
Clinical narrative: extreme depression; Numbness on right side of face and right arm; headache; panic attacks; received first dose on 20Apr2021; recevied second dose on 21Sep2021; This is a spontaneous report from a contactable consumer (patient). A 38-year-old non-pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Batch/Lot Number: FE3592), via an unspecified route of administration, administered in right arm on 21Sep2021 15:00 (at the age of 38-year-old) as dose 2, single for COVID-19 immunization at pharmacy or drug store. Medical history included COVID-19 prior to vaccination. The patient had no other medical history. The patient had no known allergies. There were no concomitant medications. The patient did not receive any other vaccine within four weeks of BNT162B2. The patient previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Batch/Lot Number: ER8792), via an unspecified route of administration, administered in right arm on 20Apr2021 at 12:00 (at the age of 37-year-old) as single dose for COVID-19 immunization. The patient experienced extreme depression, numbness on right side of face and right arm, headache, panic attacks on 23Sep2021 03:00. The events resulted in Doctor or other healthcare professional office/clinic visit. No treatment was received as a result of the events. The patient had not been tested for COVID after vaccination. The outcome of the events was not recovered.
Age: 48.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Atrial fibrillation, Blood test, Computerised tomogram thorax, Loss of consciousness
Clinical narrative: Passed out; A-Fib - heart beating out of rhythm.; This is a spontaneous report from a contactable consumer (patient). A 49-year-old non-pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/Lot Number: FC3183), via an unspecified route of administration, administered in right arm on 08Sep2021 17:00 (at the age of 48-year-old) as dose 2, single for COVID-19 immunization at Pharmacy or Drug Store. Medical history included ulcerative colitis and allergy to Sulfa. The patient was not diagnosed with COVID prior to vaccination. Concomitant medication included escitalopram oxalate (LEXAPRO) . The patient did not received any other vaccines within four weeks of BNT162B2. The patient previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/Lot Number: FA7U8U), via an unspecified route of administration, administered in right arm on an unspecified date in Aug2021 at 17:00 (at the age of 48-year-old) as single dose for COVID-19 immunization. The patient experienced passed out - taken to ER where it was determined she was in A-Fib - heart beating out of rhythm on 21Sep2021. The events resulted in Emergency room/department or urgent care. The patient had not been tested for COVID after vaccination. Therapeutic measures were taken as a result of the events which included IV with fluids - put on beta blocker. The outcome of the events was recovering.
Age: 48.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Atrial fibrillation, Heart rate, Loss of consciousness
Clinical narrative: Passed out; A-Fib - heart beating out of rhythm.; This is a spontaneous report from a contactable consumer (patient). A 49-year-old non-pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/Lot Number: FC3183), via an unspecified route of administration, administered in right arm on 08Sep2021 17:00 (at the age of 48-year-old) as dose 2, single for COVID-19 immunization at Pharmacy or Drug Store. Medical history included ulcerative colitis and allergy to Sulfa. The patient was not diagnosed with COVID prior to vaccination. Concomitant medication included escitalopram oxalate (LEXAPRO) . The patient did not received any other vaccines within four weeks of BNT162B2. The patient previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/Lot Number: FA7U8U), via an unspecified route of administration, administered in right arm on an unspecified date in Aug2021 at 17:00 (at the age of 48-year-old) as single dose for COVID-19 immunization. The patient experienced passed out - taken to ER where it was determined she was in A-Fib - heart beating out of rhythm on 21Sep2021. The events resulted in Emergency room/department or urgent care. The patient had not been tested for COVID after vaccination. Therapeutic measures were taken as a result of the events which included IV with fluids - put on beta blocker. The outcome of the events was recovering.
Age: 43.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Paraesthesia, Seizure, Vomiting
Clinical narrative: went into four separate series of seizures.; woke up vomiting; This is a spontaneous report from a contactable consumer (patient). A 43-year-old male patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot Number: fc3182), via an unspecified route of administration, administered in left arm on 24Sep2021 08:00 (at the age of 43-years-old) as single dose for COVID-19 immunization. Medical history reported as none. There were no concomitant medications. The patient previously received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot Number: ff2588), via an unspecified route of administration, administered in left arm on 03Sep2021 12:00 PM for COVID-19 immunization. Vaccination facility type was Pharmacy or Drug Store. The patient had no other vaccine in four weeks and no other medications in two weeks. It was reported that last Friday (24Sep2021), the patient received his second vaccination. On Sunday morning (26Sep2021 04:00), the patient promptly woke up vomiting and went into four separate series of seizures. His wife contacted EMS and services were administered. The patient had no COVID prior vaccination and has not been tested for COVID post vaccination. The events resulted in emergency room/department or urgent care. Therapeutic measures were taken as a result of both events. The outcome of the events was unknown.
Age: 43.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Seizure, Vomiting
Clinical narrative: went into four separate series of seizures.; woke up vomiting; This is a spontaneous report from a contactable consumer (patient). A 43-year-old male patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot Number: fc3182), via an unspecified route of administration, administered in left arm on 24Sep2021 08:00 (at the age of 43-years-old) as single dose for COVID-19 immunization. Medical history reported as none. There were no concomitant medications. The patient previously received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot Number: ff2588), via an unspecified route of administration, administered in left arm on 03Sep2021 12:00 PM for COVID-19 immunization. Vaccination facility type was Pharmacy or Drug Store. The patient had no other vaccine in four weeks and no other medications in two weeks. It was reported that last Friday (24Sep2021), the patient received his second vaccination. On Sunday morning (26Sep2021 04:00), the patient promptly woke up vomiting and went into four separate series of seizures. His wife contacted EMS and services were administered. The patient had no COVID prior vaccination and has not been tested for COVID post vaccination. The events resulted in emergency room/department or urgent care. Therapeutic measures were taken as a result of both events. The outcome of the events was unknown.
Age: 56.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Axillary pain, Chills, Headache, Hypoaesthesia, Lymphadenopathy
Clinical narrative: Severe alergic reaction; a large swollen welt on left arm near injection site; swollen lymph nodes in arm pit with significant pain; swollen lymph nodes in arm pit with significant pain; fever; Chills; Nausea; severe headache; tingling down left arm; numb left fingers; This is a spontaneous report from a contactable consumer (patient). A 56-year-old non-pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration, administered in left arm on 07Sep2021 11:15 AM (Batch/Lot Number: 30130BA) as DOSE 1, SINGLE for covid-19 immunisation at Pharmacy or drug store. The patient medical history was not reported. No other vaccine in four weeks. Concomitant medications included acetylsalicylic acid (BAYER ASPIRIN) taken for an unspecified indication, start and stop date were not reported; chondroitin sulfate sodium, glucosamine hydrochloride (GLUCOSAMINE/CHONDROITIN [CHONDROITIN SULFATE SODIUM;GLUCOSAMINE HYDROCHLORIDE]) taken for an unspecified indication, start and stop date were not reported. The patient previously took KEFLEX [cefalexin monohydrate] and experienced drug hypersensitivity. On 07Sep2021 23:45 PM, the patient experienced severe allergic reaction resulting in a large swollen welt on left arm near injection site; swollen lymph nodes in arm pit with significant pain; fever, chills, nausea, severe headache, tingling down left arm and numb left fingers. The patient did not receive treatment for the events. The patient did not test covid post vaccination. The outcome of events was recovered in 2021.
Age: 56.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Nausea, Paraesthesia, Pyrexia, Skin swelling, Tenderness
Clinical narrative: Severe alergic reaction; a large swollen welt on left arm near injection site; swollen lymph nodes in arm pit with significant pain; swollen lymph nodes in arm pit with significant pain; fever; Chills; Nausea; severe headache; tingling down left arm; numb left fingers; This is a spontaneous report from a contactable consumer (patient). A 56-year-old non-pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration, administered in left arm on 07Sep2021 11:15 AM (Batch/Lot Number: 30130BA) as DOSE 1, SINGLE for covid-19 immunisation at Pharmacy or drug store. The patient medical history was not reported. No other vaccine in four weeks. Concomitant medications included acetylsalicylic acid (BAYER ASPIRIN) taken for an unspecified indication, start and stop date were not reported; chondroitin sulfate sodium, glucosamine hydrochloride (GLUCOSAMINE/CHONDROITIN [CHONDROITIN SULFATE SODIUM;GLUCOSAMINE HYDROCHLORIDE]) taken for an unspecified indication, start and stop date were not reported. The patient previously took KEFLEX [cefalexin monohydrate] and experienced drug hypersensitivity. On 07Sep2021 23:45 PM, the patient experienced severe allergic reaction resulting in a large swollen welt on left arm near injection site; swollen lymph nodes in arm pit with significant pain; fever, chills, nausea, severe headache, tingling down left arm and numb left fingers. The patient did not receive treatment for the events. The patient did not test covid post vaccination. The outcome of events was recovered in 2021.
Age: 56.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Urticaria
Clinical narrative: Severe alergic reaction; a large swollen welt on left arm near injection site; swollen lymph nodes in arm pit with significant pain; swollen lymph nodes in arm pit with significant pain; fever; Chills; Nausea; severe headache; tingling down left arm; numb left fingers; This is a spontaneous report from a contactable consumer (patient). A 56-year-old non-pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration, administered in left arm on 07Sep2021 11:15 AM (Batch/Lot Number: 30130BA) as DOSE 1, SINGLE for covid-19 immunisation at Pharmacy or drug store. The patient medical history was not reported. No other vaccine in four weeks. Concomitant medications included acetylsalicylic acid (BAYER ASPIRIN) taken for an unspecified indication, start and stop date were not reported; chondroitin sulfate sodium, glucosamine hydrochloride (GLUCOSAMINE/CHONDROITIN [CHONDROITIN SULFATE SODIUM;GLUCOSAMINE HYDROCHLORIDE]) taken for an unspecified indication, start and stop date were not reported. The patient previously took KEFLEX [cefalexin monohydrate] and experienced drug hypersensitivity. On 07Sep2021 23:45 PM, the patient experienced severe allergic reaction resulting in a large swollen welt on left arm near injection site; swollen lymph nodes in arm pit with significant pain; fever, chills, nausea, severe headache, tingling down left arm and numb left fingers. The patient did not receive treatment for the events. The patient did not test covid post vaccination. The outcome of events was recovered in 2021.
Age: 56.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Chills, Headache, Hypersensitivity, Hypoaesthesia, Lymph node pain
Clinical narrative: Severe alergic reaction; a large swollen welt on left arm near injection site; swollen lymph nodes in arm pit with significant pain; swollen lymph nodes in arm pit with significant pain; fever; Chills; Nausea; severe headache; tingling down left arm; numb left fingers; This is a spontaneous report from a contactable consumer (patient). A 56-year-old non-pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration, administered in left arm on 07Sep2021 11:15 AM (Batch/Lot Number: 30130BA) as DOSE 1, SINGLE for covid-19 immunisation at Pharmacy or drug store. The patient medical history was not reported. No other vaccine in four weeks. Concomitant medications included acetylsalicylic acid (BAYER ASPIRIN) taken for an unspecified indication, start and stop date were not reported; chondroitin sulfate sodium, glucosamine hydrochloride (GLUCOSAMINE/CHONDROITIN [CHONDROITIN SULFATE SODIUM;GLUCOSAMINE HYDROCHLORIDE]) taken for an unspecified indication, start and stop date were not reported. The patient previously took KEFLEX [cefalexin monohydrate] and experienced drug hypersensitivity. On 07Sep2021 23:45 PM, the patient experienced severe allergic reaction resulting in a large swollen welt on left arm near injection site; swollen lymph nodes in arm pit with significant pain; fever, chills, nausea, severe headache, tingling down left arm and numb left fingers. The patient did not receive treatment for the events. The patient did not test covid post vaccination. The outcome of events was recovered in 2021.
Age: 56.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Lymphadenopathy, Nausea, Paraesthesia, Pyrexia, Urticaria
Clinical narrative: Severe alergic reaction; a large swollen welt on left arm near injection site; swollen lymph nodes in arm pit with significant pain; swollen lymph nodes in arm pit with significant pain; fever; Chills; Nausea; severe headache; tingling down left arm; numb left fingers; This is a spontaneous report from a contactable consumer (patient). A 56-year-old non-pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration, administered in left arm on 07Sep2021 11:15 AM (Batch/Lot Number: 30130BA) as DOSE 1, SINGLE for covid-19 immunisation at Pharmacy or drug store. The patient medical history was not reported. No other vaccine in four weeks. Concomitant medications included acetylsalicylic acid (BAYER ASPIRIN) taken for an unspecified indication, start and stop date were not reported; chondroitin sulfate sodium, glucosamine hydrochloride (GLUCOSAMINE/CHONDROITIN [CHONDROITIN SULFATE SODIUM;GLUCOSAMINE HYDROCHLORIDE]) taken for an unspecified indication, start and stop date were not reported. The patient previously took KEFLEX [cefalexin monohydrate] and experienced drug hypersensitivity. On 07Sep2021 23:45 PM, the patient experienced severe allergic reaction resulting in a large swollen welt on left arm near injection site; swollen lymph nodes in arm pit with significant pain; fever, chills, nausea, severe headache, tingling down left arm and numb left fingers. The patient did not receive treatment for the events. The patient did not test covid post vaccination. The outcome of events was recovered in 2021.
Age: 56.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Aphonia, Dysphonia, Dyspnoea, Laryngeal oedema
Clinical narrative: laryngeal edema; This was my 3rd dose booster dose; This was my 3rd dose booster dose; complete loss of voice, could only whisper; slightly lightheaded; This is a spontaneous report from a contactable physician (patient).    A 56-year-old female patient received third booster dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot Number: FF2587), via an unspecified route of administration in Arm Right on 27Sep2021 at 18:15 (at 56 years)as single dose for covid-19 immunisation . Concomitant medication included influenza vaccine (FLUBLOCK) on 23Sep2021 in left arm for immunization. Medical history included very mild seasonal allergies, no chronic cough. No covid tested post vaccination no known allergies.Patient had covid prior vaccination, on an unknown date. On 27Sep2021 at 19:15, laryngeal edema onset just over an hour after injection. Progressed over 30-60 minutes to complete loss of voice, could only whisper on 27Sep2021. No stridor or shortness of breath. It started to subside without any treatment after about 2 hours (as reported). Symptoms had begun to subside before treatment was given. No other symptoms. No rash, tachycardia, clamminess, nausea or vomiting. Slightly lightheaded at peak (on 27Sep2021) but then it subsided. Events resulted in Emergency room/department or urgent care and Decadron 12 mg and Benadryl 25 mg were given as treatment (as reported). Patient recovered from the events in Sep2021.; Sender's Comments: Based on the temporal relation, the association between the events of laryngeal oedema and aphonia and the suspect product of BNT162B2 cannot be completely ruled out. 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.