chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 51.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Balance disorder, Canalith repositioning procedure, Dizziness, Gait disturbance, Injection site swelling
Clinical narrative: inability maintain balance; Vomiting for two days following 2nd dose; injection site swelling for 2 weeks following 2nd dose; extreme dizziness; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 51 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 29Nov2021 13:00 (Lot number: FH8020) at the age of 51 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "Epilepsy since childhood" (unspecified if ongoing); "Known allergies Penicillin" (unspecified if ongoing). Concomitant medication(s) included: DEPAKOTE; PROPRANOLOL; DILANTIN [PHENYTOIN]; LEVOTHYROXINE. Vaccination history included: Bnt162b2 (Dose Number: 1, Batch/Lot No: FH8020, Location of injection: Arm Right, Vaccine Administration Time: 01:00 PM), administration date: 08Nov2021, for Covid-19 immunization. The following information was reported: BALANCE DISORDER (disability) with onset 01Dec2021 08:00, outcome "not recovered", described as "inability maintain balance"; VOMITING (disability) with onset 01Dec2021 08:00, outcome "not recovered", described as "Vomiting for two days following 2nd dose"; VACCINATION SITE SWELLING (disability) with onset 01Dec2021 08:00, outcome "not recovered", described as "injection site swelling for 2 weeks following 2nd dose"; DIZZINESS (disability) with onset 01Dec2021 08:00, outcome "not recovered", described as "extreme dizziness". Vomiting for two days following 2nd dose injection site swelling for 2 weeks following 2nd dose extreme dizziness and inability maintain balance started 2 days after 2nd dose and continues to this day. The events "inability maintain balance", "vomiting for two days following 2nd dose", "injection site swelling for 2 weeks following 2nd dose" and "extreme dizziness" were evaluated at the physician office visit. Therapeutic measures were not taken as a result of balance disorder, vomiting, vaccination site swelling, dizziness. No other vaccine in four weeks. It was unknown if patient had COVID prior vaccination and was not tested post vaccination.  No follow-up attempts are needed. No further information is expected.
Age: 51.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Surgical procedure repeated, Vomiting, Walking aid user
Clinical narrative: inability maintain balance; Vomiting for two days following 2nd dose; injection site swelling for 2 weeks following 2nd dose; extreme dizziness; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 51 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 29Nov2021 13:00 (Lot number: FH8020) at the age of 51 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "Epilepsy since childhood" (unspecified if ongoing); "Known allergies Penicillin" (unspecified if ongoing). Concomitant medication(s) included: DEPAKOTE; PROPRANOLOL; DILANTIN [PHENYTOIN]; LEVOTHYROXINE. Vaccination history included: Bnt162b2 (Dose Number: 1, Batch/Lot No: FH8020, Location of injection: Arm Right, Vaccine Administration Time: 01:00 PM), administration date: 08Nov2021, for Covid-19 immunization. The following information was reported: BALANCE DISORDER (disability) with onset 01Dec2021 08:00, outcome "not recovered", described as "inability maintain balance"; VOMITING (disability) with onset 01Dec2021 08:00, outcome "not recovered", described as "Vomiting for two days following 2nd dose"; VACCINATION SITE SWELLING (disability) with onset 01Dec2021 08:00, outcome "not recovered", described as "injection site swelling for 2 weeks following 2nd dose"; DIZZINESS (disability) with onset 01Dec2021 08:00, outcome "not recovered", described as "extreme dizziness". Vomiting for two days following 2nd dose injection site swelling for 2 weeks following 2nd dose extreme dizziness and inability maintain balance started 2 days after 2nd dose and continues to this day. The events "inability maintain balance", "vomiting for two days following 2nd dose", "injection site swelling for 2 weeks following 2nd dose" and "extreme dizziness" were evaluated at the physician office visit. Therapeutic measures were not taken as a result of balance disorder, vomiting, vaccination site swelling, dizziness. No other vaccine in four weeks. It was unknown if patient had COVID prior vaccination and was not tested post vaccination.  No follow-up attempts are needed. No further information is expected.
Age: 51.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Balance disorder, Dizziness, Vaccination site swelling, Vomiting
Clinical narrative: inability maintain balance; Vomiting for two days following 2nd dose; injection site swelling for 2 weeks following 2nd dose; extreme dizziness; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 51 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 29Nov2021 13:00 (Lot number: FH8020) at the age of 51 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "Epilepsy since childhood" (unspecified if ongoing); "Known allergies Penicillin" (unspecified if ongoing). Concomitant medication(s) included: DEPAKOTE; PROPRANOLOL; DILANTIN [PHENYTOIN]; LEVOTHYROXINE. Vaccination history included: Bnt162b2 (Dose Number: 1, Batch/Lot No: FH8020, Location of injection: Arm Right, Vaccine Administration Time: 01:00 PM), administration date: 08Nov2021, for Covid-19 immunization. The following information was reported: BALANCE DISORDER (disability) with onset 01Dec2021 08:00, outcome "not recovered", described as "inability maintain balance"; VOMITING (disability) with onset 01Dec2021 08:00, outcome "not recovered", described as "Vomiting for two days following 2nd dose"; VACCINATION SITE SWELLING (disability) with onset 01Dec2021 08:00, outcome "not recovered", described as "injection site swelling for 2 weeks following 2nd dose"; DIZZINESS (disability) with onset 01Dec2021 08:00, outcome "not recovered", described as "extreme dizziness". Vomiting for two days following 2nd dose injection site swelling for 2 weeks following 2nd dose extreme dizziness and inability maintain balance started 2 days after 2nd dose and continues to this day. The events "inability maintain balance", "vomiting for two days following 2nd dose", "injection site swelling for 2 weeks following 2nd dose" and "extreme dizziness" were evaluated at the physician office visit. Therapeutic measures were not taken as a result of balance disorder, vomiting, vaccination site swelling, dizziness. No other vaccine in four weeks. It was unknown if patient had COVID prior vaccination and was not tested post vaccination.  No follow-up attempts are needed. No further information is expected.
Age: 21.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Chest pain, Dyspnoea, Echocardiogram, Ejection fraction abnormal, Electrocardiogram normal
Clinical narrative: developed severe myocarditis; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 21 year-old male patient received bnt162b2 (BNT162B2), administered in arm left, administration date 30Dec2021 (Lot number: 33030BD) at the age of 21 years as dose 2, single for covid-19 immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) included: FLU taken for immunisation, administration date 09Dec2021. Vaccination history included: Bnt162b2 (Dose Number: 1, Batch/Lot No: 33030BD, Location of injection: Arm Left), administration date: 09Dec2021, when the patient was 21 years old, for COVID-19 immunization, reaction(s): "Product use for unapproved combination", "off label use". The following information was reported: MYOCARDITIS (hospitalization, medically significant, life threatening) with onset 02Jan2022, outcome "not recovered", described as "developed severe myocarditis". The patient was hospitalized for myocarditis (hospitalization duration: 3 day(s)). The event "developed severe myocarditis" was evaluated at the physician office visit and emergency room visit. Therapeutic measures were taken as a result of myocarditis  included medication. Clinical course: Patient developed severe myocarditis within 2 days, Had to be admitted to hospital. Patient did not have covid prior vaccination. Covid was not tested post vaccination. Known allergies was reported as no.
Age: 21.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Myocarditis, Troponin increased
Clinical narrative: developed severe myocarditis; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 21 year-old male patient received bnt162b2 (BNT162B2), administered in arm left, administration date 30Dec2021 (Lot number: 33030BD) at the age of 21 years as dose 2, single for covid-19 immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) included: FLU taken for immunisation, administration date 09Dec2021. Vaccination history included: Bnt162b2 (Dose Number: 1, Batch/Lot No: 33030BD, Location of injection: Arm Left), administration date: 09Dec2021, when the patient was 21 years old, for COVID-19 immunization, reaction(s): "Product use for unapproved combination", "off label use". The following information was reported: MYOCARDITIS (hospitalization, medically significant, life threatening) with onset 02Jan2022, outcome "not recovered", described as "developed severe myocarditis". The patient was hospitalized for myocarditis (hospitalization duration: 3 day(s)). The event "developed severe myocarditis" was evaluated at the physician office visit and emergency room visit. Therapeutic measures were taken as a result of myocarditis  included medication. Clinical course: Patient developed severe myocarditis within 2 days, Had to be admitted to hospital. Patient did not have covid prior vaccination. Covid was not tested post vaccination. Known allergies was reported as no.
Age: 21.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Myocarditis
Clinical narrative: developed severe myocarditis; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 21 year-old male patient received bnt162b2 (BNT162B2), administered in arm left, administration date 30Dec2021 (Lot number: 33030BD) at the age of 21 years as dose 2, single for covid-19 immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) included: FLU taken for immunisation, administration date 09Dec2021. Vaccination history included: Bnt162b2 (Dose Number: 1, Batch/Lot No: 33030BD, Location of injection: Arm Left), administration date: 09Dec2021, when the patient was 21 years old, for COVID-19 immunization, reaction(s): "Product use for unapproved combination", "off label use". The following information was reported: MYOCARDITIS (hospitalization, medically significant, life threatening) with onset 02Jan2022, outcome "not recovered", described as "developed severe myocarditis". The patient was hospitalized for myocarditis (hospitalization duration: 3 day(s)). The event "developed severe myocarditis" was evaluated at the physician office visit and emergency room visit. Therapeutic measures were taken as a result of myocarditis  included medication. Clinical course: Patient developed severe myocarditis within 2 days, Had to be admitted to hospital. Patient did not have covid prior vaccination. Covid was not tested post vaccination. Known allergies was reported as no.
Age: 21.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Cardiac disorder, Myocarditis
Clinical narrative: developed severe myocarditis; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 21 year-old male patient received bnt162b2 (BNT162B2), administered in arm left, administration date 30Dec2021 (Lot number: 33030BD) at the age of 21 years as dose 2, single for covid-19 immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) included: FLU taken for immunisation, administration date 09Dec2021. Vaccination history included: Bnt162b2 (Dose Number: 1, Batch/Lot No: 33030BD, Location of injection: Arm Left), administration date: 09Dec2021, when the patient was 21 years old, for COVID-19 immunization, reaction(s): "Product use for unapproved combination", "off label use". The following information was reported: MYOCARDITIS (hospitalization, medically significant, life threatening) with onset 02Jan2022, outcome "not recovered", described as "developed severe myocarditis". The patient was hospitalized for myocarditis (hospitalization duration: 3 day(s)). The event "developed severe myocarditis" was evaluated at the physician office visit and emergency room visit. Therapeutic measures were taken as a result of myocarditis  included medication. Clinical course: Patient developed severe myocarditis within 2 days, Had to be admitted to hospital. Patient did not have covid prior vaccination. Covid was not tested post vaccination. Known allergies was reported as no.
Age: 65.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Asthenia, Dizziness, Headache, Loss of consciousness, Pain
Clinical narrative: passing out for a few moments; light-headedness; vomiting; severe weakness; body aches; headache that lasted for about 9-10 hours; received the third dose of BNT162B2; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 65 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administration date 27Nov2021 (Lot number: FG3527) at the age of 65 years as dose 3 (booster dose), single for covid-19 immunisation. The patient had no relevant medical history. Concomitant medication(s) included: IBUPROFEN. Vaccination history included: Bnt162b2 (Dose Number: 2, Batch/Lot No: EW0151), administration date: 10Apr2021, when the patient was 64 years old, for COVID-19 Immunization, reaction(s): "tiredness"; Bnt162b2 (Dose Number: 1, Batch/Lot No: EP7534), administration date: 20Mar2021, when the patient was 64 years old, for COVID-19 immunization. The following information was reported: IMMUNISATION (medically significant) with onset 27Nov2021, outcome "recovered", described as "received the third dose of BNT162B2"; LOSS OF CONSCIOUSNESS (medically significant) with onset 28Nov2021 10:30, outcome "recovered", described as "passing out for a few moments"; DIZZINESS (non-serious) with onset 28Nov2021 10:30, outcome "recovered", described as "light-headedness"; VOMITING (non-serious) with onset 28Nov2021 10:30, outcome "recovered", described as "vomiting"; ASTHENIA (non-serious) with onset 28Nov2021 10:30, outcome "recovered", described as "severe weakness"; PAIN (non-serious) with onset 28Nov2021 10:30, outcome "recovered", described as "body aches"; HEADACHE (non-serious) with onset 28Nov2021 10:30, outcome "recovered", described as "headache that lasted for about 9-10 hours". Therapeutic measures were not taken as a result of immunisation, loss of consciousness, dizziness, vomiting, asthenia, pain, headache. Addition information: Other vaccine in four weeks was none. Covid prior vaccination was none. Covid tested post vaccination was none. Known allergies was none.
Age: 65.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Vomiting
Clinical narrative: passing out for a few moments; light-headedness; vomiting; severe weakness; body aches; headache that lasted for about 9-10 hours; received the third dose of BNT162B2; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 65 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administration date 27Nov2021 (Lot number: FG3527) at the age of 65 years as dose 3 (booster dose), single for covid-19 immunisation. The patient had no relevant medical history. Concomitant medication(s) included: IBUPROFEN. Vaccination history included: Bnt162b2 (Dose Number: 2, Batch/Lot No: EW0151), administration date: 10Apr2021, when the patient was 64 years old, for COVID-19 Immunization, reaction(s): "tiredness"; Bnt162b2 (Dose Number: 1, Batch/Lot No: EP7534), administration date: 20Mar2021, when the patient was 64 years old, for COVID-19 immunization. The following information was reported: IMMUNISATION (medically significant) with onset 27Nov2021, outcome "recovered", described as "received the third dose of BNT162B2"; LOSS OF CONSCIOUSNESS (medically significant) with onset 28Nov2021 10:30, outcome "recovered", described as "passing out for a few moments"; DIZZINESS (non-serious) with onset 28Nov2021 10:30, outcome "recovered", described as "light-headedness"; VOMITING (non-serious) with onset 28Nov2021 10:30, outcome "recovered", described as "vomiting"; ASTHENIA (non-serious) with onset 28Nov2021 10:30, outcome "recovered", described as "severe weakness"; PAIN (non-serious) with onset 28Nov2021 10:30, outcome "recovered", described as "body aches"; HEADACHE (non-serious) with onset 28Nov2021 10:30, outcome "recovered", described as "headache that lasted for about 9-10 hours". Therapeutic measures were not taken as a result of immunisation, loss of consciousness, dizziness, vomiting, asthenia, pain, headache. Addition information: Other vaccine in four weeks was none. Covid prior vaccination was none. Covid tested post vaccination was none. Known allergies was none.
Age: 65.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Asthenia, Dizziness, Headache, Immunisation, Loss of consciousness
Clinical narrative: passing out for a few moments; light-headedness; vomiting; severe weakness; body aches; headache that lasted for about 9-10 hours; received the third dose of BNT162B2; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 65 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administration date 27Nov2021 (Lot number: FG3527) at the age of 65 years as dose 3 (booster dose), single for covid-19 immunisation. The patient had no relevant medical history. Concomitant medication(s) included: IBUPROFEN. Vaccination history included: Bnt162b2 (Dose Number: 2, Batch/Lot No: EW0151), administration date: 10Apr2021, when the patient was 64 years old, for COVID-19 Immunization, reaction(s): "tiredness"; Bnt162b2 (Dose Number: 1, Batch/Lot No: EP7534), administration date: 20Mar2021, when the patient was 64 years old, for COVID-19 immunization. The following information was reported: IMMUNISATION (medically significant) with onset 27Nov2021, outcome "recovered", described as "received the third dose of BNT162B2"; LOSS OF CONSCIOUSNESS (medically significant) with onset 28Nov2021 10:30, outcome "recovered", described as "passing out for a few moments"; DIZZINESS (non-serious) with onset 28Nov2021 10:30, outcome "recovered", described as "light-headedness"; VOMITING (non-serious) with onset 28Nov2021 10:30, outcome "recovered", described as "vomiting"; ASTHENIA (non-serious) with onset 28Nov2021 10:30, outcome "recovered", described as "severe weakness"; PAIN (non-serious) with onset 28Nov2021 10:30, outcome "recovered", described as "body aches"; HEADACHE (non-serious) with onset 28Nov2021 10:30, outcome "recovered", described as "headache that lasted for about 9-10 hours". Therapeutic measures were not taken as a result of immunisation, loss of consciousness, dizziness, vomiting, asthenia, pain, headache. Addition information: Other vaccine in four weeks was none. Covid prior vaccination was none. Covid tested post vaccination was none. Known allergies was none.
Age: 65.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Pain, Vomiting
Clinical narrative: passing out for a few moments; light-headedness; vomiting; severe weakness; body aches; headache that lasted for about 9-10 hours; received the third dose of BNT162B2; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 65 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administration date 27Nov2021 (Lot number: FG3527) at the age of 65 years as dose 3 (booster dose), single for covid-19 immunisation. The patient had no relevant medical history. Concomitant medication(s) included: IBUPROFEN. Vaccination history included: Bnt162b2 (Dose Number: 2, Batch/Lot No: EW0151), administration date: 10Apr2021, when the patient was 64 years old, for COVID-19 Immunization, reaction(s): "tiredness"; Bnt162b2 (Dose Number: 1, Batch/Lot No: EP7534), administration date: 20Mar2021, when the patient was 64 years old, for COVID-19 immunization. The following information was reported: IMMUNISATION (medically significant) with onset 27Nov2021, outcome "recovered", described as "received the third dose of BNT162B2"; LOSS OF CONSCIOUSNESS (medically significant) with onset 28Nov2021 10:30, outcome "recovered", described as "passing out for a few moments"; DIZZINESS (non-serious) with onset 28Nov2021 10:30, outcome "recovered", described as "light-headedness"; VOMITING (non-serious) with onset 28Nov2021 10:30, outcome "recovered", described as "vomiting"; ASTHENIA (non-serious) with onset 28Nov2021 10:30, outcome "recovered", described as "severe weakness"; PAIN (non-serious) with onset 28Nov2021 10:30, outcome "recovered", described as "body aches"; HEADACHE (non-serious) with onset 28Nov2021 10:30, outcome "recovered", described as "headache that lasted for about 9-10 hours". Therapeutic measures were not taken as a result of immunisation, loss of consciousness, dizziness, vomiting, asthenia, pain, headache. Addition information: Other vaccine in four weeks was none. Covid prior vaccination was none. Covid tested post vaccination was none. Known allergies was none.
Age: 65.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Blood test, Diarrhoea, Feeling abnormal, Interchange of vaccine products, Retching
Clinical narrative: Violently threw up for several hours.  Had to go to the ER.  Kidneys shut down.
Age: 65.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Tremor, Vomiting
Clinical narrative: Violently threw up for several hours.  Had to go to the ER.  Kidneys shut down.
Age: 65.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Blood test, Renal impairment, Urine analysis, Vomiting
Clinical narrative: Violently threw up for several hours.  Had to go to the ER.  Kidneys shut down.
Age: 62.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Vasodilatation
Clinical narrative: The veins on "my" face became extremely pronounced. It looked like "I" had drawn on my face with a dark blue pen. From "my" forehead around the sides of "my" face down to the jaw line. It looked like something was terribly wrong with "my" face; This is a spontaneous report from a contactable reporter (consumer or other non-HCP). The reporter is the patient.  A 62 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 30Dec2021 at 18:30 (Lot number: unknown)at the age of 62 year(s) as dose 1, single for COVID-19 immunisation. Relevant medical history included: "Blood pressure high" (unspecified if ongoing), notes: High blood pressure. Concomitant medication(s) included: HYDROCHOROTHIAZIDE.  The following information was reported: VEIN DISORDER (non-serious) with onset 02Jan2022 at 08:00, outcome "recovered with sequelae" (an unknown date in Jan2022), described as "The veins on "my" face became extremely pronounced. It looked like "I" had drawn on my face with a dark blue pen. From "my" forehead around the sides of "my" face down to the jaw line. It looked like something was terribly wrong with "my" face". Therapeutic measures were not taken as a result of vein disorder.  Additional information: The patient had no known allergies. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the prior to the COVID-19 vaccine. Since the vaccination, the patient had not been tested for COVID-19. The events did not result in doctor or other healthcare professional office/clinic visit and emergency room/department or urgent care.  The lot number for BNT162b2 was not provided and will be requested during follow up.
Age: 62.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Vein disorder
Clinical narrative: The veins on "my" face became extremely pronounced. It looked like "I" had drawn on my face with a dark blue pen. From "my" forehead around the sides of "my" face down to the jaw line. It looked like something was terribly wrong with "my" face; This is a spontaneous report from a contactable reporter (consumer or other non-HCP). The reporter is the patient.  A 62 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 30Dec2021 at 18:30 (Lot number: unknown)at the age of 62 year(s) as dose 1, single for COVID-19 immunisation. Relevant medical history included: "Blood pressure high" (unspecified if ongoing), notes: High blood pressure. Concomitant medication(s) included: HYDROCHOROTHIAZIDE.  The following information was reported: VEIN DISORDER (non-serious) with onset 02Jan2022 at 08:00, outcome "recovered with sequelae" (an unknown date in Jan2022), described as "The veins on "my" face became extremely pronounced. It looked like "I" had drawn on my face with a dark blue pen. From "my" forehead around the sides of "my" face down to the jaw line. It looked like something was terribly wrong with "my" face". Therapeutic measures were not taken as a result of vein disorder.  Additional information: The patient had no known allergies. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the prior to the COVID-19 vaccine. Since the vaccination, the patient had not been tested for COVID-19. The events did not result in doctor or other healthcare professional office/clinic visit and emergency room/department or urgent care.  The lot number for BNT162b2 was not provided and will be requested during follow up.
Age: 29.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Rash
Clinical narrative: After vaccination I developed a painful rash that is bilateral, under my arms and on my flanks.; This is a spontaneous report from a contactable reporter (nurse). The reporter is the patient.   A 29-year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in left arm, administration date 04Jan2022 (Lot number: FE3594) at the age of 29 years as dose 1, single for COVID-19 immunisation. Relevant medical history included: "None". The patient did not receive any concomitant medications. The following information was reported: RASH (non-serious) with onset 04Jan2022 at 21:30, outcome "not recovered", described as "After vaccination I developed a painful rash that is bilateral, under my arms and on my flanks". Therapeutic measures were not taken as a result of rash. Additional information: The patient had no known allergies. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the COVID-19 vaccine. Since the vaccination, the patient had not been tested for COVID-19. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care.
Age: 5.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Injection site erythema, Injection site swelling, Myalgia
Clinical narrative: Redness and swelling at injection site and pain aa; Redness and swelling at injection site and pain ss; Redness and swelling at injection site and pain; This is a spontaneous report from a contactable reporter (consumer or other non-HCP).   A 5-year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in right arm, administration date 07Jan2022 at 16:30 (Lot number: FL0007) at the age of 5 years as dose 1, single for COVID-19 immunisation. Relevant medical history included: "None". Concomitant medications were not reported. The following information was reported: VACCINATION SITE ERYTHEMA (non-serious) with onset 08Jan2022, outcome "not recovered", described as "Redness and swelling at injection site and pain aa"; VACCINATION SITE SWELLING (non-serious) with onset 08Jan2022, outcome "not recovered", described as "Redness and swelling at injection site and pain ss"; VACCINATION SITE PAIN (non-serious) with onset 08Jan2022, outcome "not recovered", described as "Redness and swelling at injection site and pain". Therapeutic measures were taken as a result of vaccination site erythema, vaccination site swelling and vaccination site pain.  Additional information: The patient had no known allergies. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the COVID-19 vaccine. Since the vaccination, the patient had not been tested for COVID-19. The events did not result in doctor or other healthcare professional office/clinic visit and emergency room/department or urgent care. Therapeutic measures were taken as a result of vaccination site erythema, vaccination site swelling and vaccination site pain which included treatment with ibuprofen and cold compress.
Age: 5.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Vaccination site erythema, Vaccination site pain, Vaccination site swelling
Clinical narrative: Redness and swelling at injection site and pain aa; Redness and swelling at injection site and pain ss; Redness and swelling at injection site and pain; This is a spontaneous report from a contactable reporter (consumer or other non-HCP).   A 5-year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in right arm, administration date 07Jan2022 at 16:30 (Lot number: FL0007) at the age of 5 years as dose 1, single for COVID-19 immunisation. Relevant medical history included: "None". Concomitant medications were not reported. The following information was reported: VACCINATION SITE ERYTHEMA (non-serious) with onset 08Jan2022, outcome "not recovered", described as "Redness and swelling at injection site and pain aa"; VACCINATION SITE SWELLING (non-serious) with onset 08Jan2022, outcome "not recovered", described as "Redness and swelling at injection site and pain ss"; VACCINATION SITE PAIN (non-serious) with onset 08Jan2022, outcome "not recovered", described as "Redness and swelling at injection site and pain". Therapeutic measures were taken as a result of vaccination site erythema, vaccination site swelling and vaccination site pain.  Additional information: The patient had no known allergies. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the COVID-19 vaccine. Since the vaccination, the patient had not been tested for COVID-19. The events did not result in doctor or other healthcare professional office/clinic visit and emergency room/department or urgent care. Therapeutic measures were taken as a result of vaccination site erythema, vaccination site swelling and vaccination site pain which included treatment with ibuprofen and cold compress.
Age: 53.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Allergy test negative, Angioedema, Blood immunoglobulin A increased, Hypersensitivity, Lip swelling
Clinical narrative: I developed significant swelling of the parts of my body, including face cheeks; I developed significant swelling of the parts of my body, including face (lips, neck, cheeks, etc).; I developed significant swelling of the parts of my body, including lips; This is a spontaneous report received from contactable reporter(Consumer or other non HCP). The reporter is the patient.  A 53 year-old male patient received bnt162b2 (Pfizer-BioNTech COVID-19), administered in arm right, administration date 12Jun2021 (Lot number: ER8733) at the age of 53 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "COVID-19" (unspecified if ongoing), notes: if covid prior vaccination: Yes. There were no concomitant medications. Vaccination history included: Bnt162b2 (Dose Number: 1, Batch/Lot No: EW0183, Location of injection: Arm Left), administration date: 22May2021, when the patient was 53 years old, for COVID-19 immunization.patient has not received other vaccine in four weeks. The following information was reported: SWELLING FACE (medically significant, life threatening) with onset 13Jun2021, outcome "not recovered", described as "I developed significant swelling of the parts of my body, including face cheeks"; SWELLING (medically significant, life threatening) with onset 13Jun2021, outcome "not recovered", described as "I developed significant swelling of the parts of my body, including face (lips, neck, cheeks, etc)."; LIP SWELLING (medically significant, life threatening) with onset 13Jun2021, outcome "not recovered", described as "I developed significant swelling of the parts of my body, including lips". The events "i developed significant swelling of the parts of my body, including face cheeks", "i developed significant swelling of the parts of my body, including face (lips, neck, cheeks, etc)." and "i developed significant swelling of the parts of my body, including lips" were evaluated at the physician office visit and emergency room visit. The swelling appears randomly, oftentimes requiring steroid injections; then subsides 1-2 days later with oral prednisone and diphenhydramine in addition to dexamethasone injections. patient received treatment for the adverse events used Steroids tasb and injections, Benadryl. patient was not tested for COVID after the vaccination.
Age: 53.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Swelling, Swelling face
Clinical narrative: I developed significant swelling of the parts of my body, including face cheeks; I developed significant swelling of the parts of my body, including face (lips, neck, cheeks, etc).; I developed significant swelling of the parts of my body, including lips; This is a spontaneous report received from contactable reporter(Consumer or other non HCP). The reporter is the patient.  A 53 year-old male patient received bnt162b2 (Pfizer-BioNTech COVID-19), administered in arm right, administration date 12Jun2021 (Lot number: ER8733) at the age of 53 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "COVID-19" (unspecified if ongoing), notes: if covid prior vaccination: Yes. There were no concomitant medications. Vaccination history included: Bnt162b2 (Dose Number: 1, Batch/Lot No: EW0183, Location of injection: Arm Left), administration date: 22May2021, when the patient was 53 years old, for COVID-19 immunization.patient has not received other vaccine in four weeks. The following information was reported: SWELLING FACE (medically significant, life threatening) with onset 13Jun2021, outcome "not recovered", described as "I developed significant swelling of the parts of my body, including face cheeks"; SWELLING (medically significant, life threatening) with onset 13Jun2021, outcome "not recovered", described as "I developed significant swelling of the parts of my body, including face (lips, neck, cheeks, etc)."; LIP SWELLING (medically significant, life threatening) with onset 13Jun2021, outcome "not recovered", described as "I developed significant swelling of the parts of my body, including lips". The events "i developed significant swelling of the parts of my body, including face cheeks", "i developed significant swelling of the parts of my body, including face (lips, neck, cheeks, etc)." and "i developed significant swelling of the parts of my body, including lips" were evaluated at the physician office visit and emergency room visit. The swelling appears randomly, oftentimes requiring steroid injections; then subsides 1-2 days later with oral prednisone and diphenhydramine in addition to dexamethasone injections. patient received treatment for the adverse events used Steroids tasb and injections, Benadryl. patient was not tested for COVID after the vaccination.
Age: 53.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Lip swelling, Swelling, Swelling face
Clinical narrative: I developed significant swelling of the parts of my body, including face cheeks; I developed significant swelling of the parts of my body, including face (lips, neck, cheeks, etc).; I developed significant swelling of the parts of my body, including lips; This is a spontaneous report received from contactable reporter(Consumer or other non HCP). The reporter is the patient.  A 53 year-old male patient received bnt162b2 (Pfizer-BioNTech COVID-19), administered in arm right, administration date 12Jun2021 (Lot number: ER8733) at the age of 53 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "COVID-19" (unspecified if ongoing), notes: if covid prior vaccination: Yes. There were no concomitant medications. Vaccination history included: Bnt162b2 (Dose Number: 1, Batch/Lot No: EW0183, Location of injection: Arm Left), administration date: 22May2021, when the patient was 53 years old, for COVID-19 immunization.patient has not received other vaccine in four weeks. The following information was reported: SWELLING FACE (medically significant, life threatening) with onset 13Jun2021, outcome "not recovered", described as "I developed significant swelling of the parts of my body, including face cheeks"; SWELLING (medically significant, life threatening) with onset 13Jun2021, outcome "not recovered", described as "I developed significant swelling of the parts of my body, including face (lips, neck, cheeks, etc)."; LIP SWELLING (medically significant, life threatening) with onset 13Jun2021, outcome "not recovered", described as "I developed significant swelling of the parts of my body, including lips". The events "i developed significant swelling of the parts of my body, including face cheeks", "i developed significant swelling of the parts of my body, including face (lips, neck, cheeks, etc)." and "i developed significant swelling of the parts of my body, including lips" were evaluated at the physician office visit and emergency room visit. The swelling appears randomly, oftentimes requiring steroid injections; then subsides 1-2 days later with oral prednisone and diphenhydramine in addition to dexamethasone injections. patient received treatment for the adverse events used Steroids tasb and injections, Benadryl. patient was not tested for COVID after the vaccination.
Age: 36.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Alopecia, Blood test, Dermatologic examination
Clinical narrative: Lost all hair on head; This is a spontaneous report from a contactable reporter (consumer or other non hcp). The reporter is the patient.  A 36-year-old male patient received bnt162b2 (BNT162B2), administered in left arm, administration date 13Dec2021 at 17:30 (Lot number: FJ8762) at the age of 36 years as dose 1, single for COVID-19 immunisation. Relevant medical history included: "None". The patient did not take any concomitant medications. The following information was reported: ALOPECIA (non-serious) with onset an unknown date in Dec2021, outcome "not recovered", described as "Lost all hair on head". The event "Lost all hair on head" was evaluated at the physician office visit. Therapeutic measures were taken as a result of alopecia.  Additional information: The patient had no known allergies. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the COVID-19 vaccine. Since the vaccination, the patient had not been tested for COVID-19. It was reported that the patient had no prior history of hair loss. Treatment included visit to dermatologist for alopecia.
Age: 36.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Alopecia
Clinical narrative: Lost all hair on head; This is a spontaneous report from a contactable reporter (consumer or other non hcp). The reporter is the patient.  A 36-year-old male patient received bnt162b2 (BNT162B2), administered in left arm, administration date 13Dec2021 at 17:30 (Lot number: FJ8762) at the age of 36 years as dose 1, single for COVID-19 immunisation. Relevant medical history included: "None". The patient did not take any concomitant medications. The following information was reported: ALOPECIA (non-serious) with onset an unknown date in Dec2021, outcome "not recovered", described as "Lost all hair on head". The event "Lost all hair on head" was evaluated at the physician office visit. Therapeutic measures were taken as a result of alopecia.  Additional information: The patient had no known allergies. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the COVID-19 vaccine. Since the vaccination, the patient had not been tested for COVID-19. It was reported that the patient had no prior history of hair loss. Treatment included visit to dermatologist for alopecia.
Age: 74.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Bell's palsy, Computerised tomogram
Clinical narrative: "I had my booster on December 16, 2021 and 2 weeks later have Bell's Palsy. I believe the Palsy is a side effect".
Age: 74.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Bell's palsy
Clinical narrative: "I had my booster on December 16, 2021 and 2 weeks later have Bell's Palsy. I believe the Palsy is a side effect".
Age: 16.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Angioedema, Oedema peripheral, Pruritus, Rash
Clinical narrative: Patient's mother has written down and kept track to see what patient reacts to. This paperwork shows patient receiving the pfizer booster on 1/8/2022 with no reactions all day. On 1/9/2022 at 11:00 AM patient ended up having minor itching after eating pancakes with raspberry jam and sausage links. that same day patient ended up with moderate itching on his whole body, swelling of his feet and toes as well as the soles of both feet after having mike & Ike candy. Patient had taken 37.5mg of benadryl and the swelling went away. 1800 patient had chili for dinner and had minor itching. At 2300 patient had mint chocolate chip ice cream and ended up having whole body itching and swelling of his lip. The swelling went away within 30 minutes. 1/10/2022 at 1500 patient had a coffee, at 1520 his left hand started swelling, he had a rash / welts to his entire face. 1535 he took 37.5mg of benadryl and the rash to his face went away however the swelling to his left hand was still present. At 1800 patient had chili for dinner with no reaction. 1/11/2022 they called the doctor for suggestions. At 1050 after consuming 2 scoops of mint chocolate chip ice cream patient experienced slight lip tingling that only lasted a couple of minutes. At 1120 he developed a rash on his ankles.
Age: 16.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Lip swelling, Paraesthesia oral, Peripheral swelling, Pruritus, Rash
Clinical narrative: Patient's mother has written down and kept track to see what patient reacts to. This paperwork shows patient receiving the pfizer booster on 1/8/2022 with no reactions all day. On 1/9/2022 at 11:00 AM patient ended up having minor itching after eating pancakes with raspberry jam and sausage links. that same day patient ended up with moderate itching on his whole body, swelling of his feet and toes as well as the soles of both feet after having mike & Ike candy. Patient had taken 37.5mg of benadryl and the swelling went away. 1800 patient had chili for dinner and had minor itching. At 2300 patient had mint chocolate chip ice cream and ended up having whole body itching and swelling of his lip. The swelling went away within 30 minutes. 1/10/2022 at 1500 patient had a coffee, at 1520 his left hand started swelling, he had a rash / welts to his entire face. 1535 he took 37.5mg of benadryl and the rash to his face went away however the swelling to his left hand was still present. At 1800 patient had chili for dinner with no reaction. 1/11/2022 they called the doctor for suggestions. At 1050 after consuming 2 scoops of mint chocolate chip ice cream patient experienced slight lip tingling that only lasted a couple of minutes. At 1120 he developed a rash on his ankles.
Age: 16.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Urticaria
Clinical narrative: Patient's mother has written down and kept track to see what patient reacts to. This paperwork shows patient receiving the pfizer booster on 1/8/2022 with no reactions all day. On 1/9/2022 at 11:00 AM patient ended up having minor itching after eating pancakes with raspberry jam and sausage links. that same day patient ended up with moderate itching on his whole body, swelling of his feet and toes as well as the soles of both feet after having mike & Ike candy. Patient had taken 37.5mg of benadryl and the swelling went away. 1800 patient had chili for dinner and had minor itching. At 2300 patient had mint chocolate chip ice cream and ended up having whole body itching and swelling of his lip. The swelling went away within 30 minutes. 1/10/2022 at 1500 patient had a coffee, at 1520 his left hand started swelling, he had a rash / welts to his entire face. 1535 he took 37.5mg of benadryl and the rash to his face went away however the swelling to his left hand was still present. At 1800 patient had chili for dinner with no reaction. 1/11/2022 they called the doctor for suggestions. At 1050 after consuming 2 scoops of mint chocolate chip ice cream patient experienced slight lip tingling that only lasted a couple of minutes. At 1120 he developed a rash on his ankles.