chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 17.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Rash pruritic, Skin warm, Urticaria
Clinical narrative: Inflamed sore; Inflamed sore; Itchy rash around the neck; Hives; Heart palpitations; Lightheadedness; Feeling of hotness; Energy rush; Swollen lips; Slight feeling of a swollen tongue; This is a spontaneous report from a contactable consumer, the patient. A 17-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0158) via an unspecified route of administration in the right arm on 15Apr2021 at 11:30 (at the age of 17-year-old) as a single dose for COVID-19 immunisation. Medical history included chronic hives and typical seasonal 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 vaccine. Concomitant medications included multivitamin (MANUFACTURER UNKNOWN), colecalciferol (VITAMIN D3), potassium (MANUFACTURER UNKNOWN), ascorbic acid (VITAMIN C) and cyanocobalamin (VITAMIN B-12) all from unknown dates for unspecified indications and unknown if ongoing. On 15Apr2021 at 11:45, within minutes after the vaccine, the patient experienced hives, heart palpitations, lightheadedness, the feeling of hotness, and an energy rush. All resolved by the time the patient got home. On 20Apr2021, 5 days later, the patient experienced an inflamed sore and itchy rash around the neck ongoing for several days. On an unknown date in 2021, the patient experienced swollen lips and a slight feeling of a swollen tongue on one occasion. The events resulted in doctor or other healthcare professional office/clinic visit. Since the vaccination, the patient had not been tested for COVID-19. Therapeutic measures were not taken as a result of the events. The clinical outcome of the events hives, heart palpitations, lightheadedness, feeling of hotness, and energy rush were resolved on 15Apr2021. The clinical outcome of the events inflamed sore and itchy rash around the neck, swollen lips and slight feeling of a swollen tongue were not resolved at the time of this report.  No follow-up attempts are needed. No further information is expected.
Age: 17.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Dizziness, Energy increased, Feeling hot, Inflammation, Lip swelling
Clinical narrative: Inflamed sore; Inflamed sore; Itchy rash around the neck; Hives; Heart palpitations; Lightheadedness; Feeling of hotness; Energy rush; Swollen lips; Slight feeling of a swollen tongue; This is a spontaneous report from a contactable consumer, the patient. A 17-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0158) via an unspecified route of administration in the right arm on 15Apr2021 at 11:30 (at the age of 17-year-old) as a single dose for COVID-19 immunisation. Medical history included chronic hives and typical seasonal 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 vaccine. Concomitant medications included multivitamin (MANUFACTURER UNKNOWN), colecalciferol (VITAMIN D3), potassium (MANUFACTURER UNKNOWN), ascorbic acid (VITAMIN C) and cyanocobalamin (VITAMIN B-12) all from unknown dates for unspecified indications and unknown if ongoing. On 15Apr2021 at 11:45, within minutes after the vaccine, the patient experienced hives, heart palpitations, lightheadedness, the feeling of hotness, and an energy rush. All resolved by the time the patient got home. On 20Apr2021, 5 days later, the patient experienced an inflamed sore and itchy rash around the neck ongoing for several days. On an unknown date in 2021, the patient experienced swollen lips and a slight feeling of a swollen tongue on one occasion. The events resulted in doctor or other healthcare professional office/clinic visit. Since the vaccination, the patient had not been tested for COVID-19. Therapeutic measures were not taken as a result of the events. The clinical outcome of the events hives, heart palpitations, lightheadedness, feeling of hotness, and energy rush were resolved on 15Apr2021. The clinical outcome of the events inflamed sore and itchy rash around the neck, swollen lips and slight feeling of a swollen tongue were not resolved at the time of this report.  No follow-up attempts are needed. No further information is expected.
Age: 17.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Pain, Palpitations, Rash pruritic, Swollen tongue, Urticaria
Clinical narrative: Inflamed sore; Inflamed sore; Itchy rash around the neck; Hives; Heart palpitations; Lightheadedness; Feeling of hotness; Energy rush; Swollen lips; Slight feeling of a swollen tongue; This is a spontaneous report from a contactable consumer, the patient. A 17-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0158) via an unspecified route of administration in the right arm on 15Apr2021 at 11:30 (at the age of 17-year-old) as a single dose for COVID-19 immunisation. Medical history included chronic hives and typical seasonal 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 vaccine. Concomitant medications included multivitamin (MANUFACTURER UNKNOWN), colecalciferol (VITAMIN D3), potassium (MANUFACTURER UNKNOWN), ascorbic acid (VITAMIN C) and cyanocobalamin (VITAMIN B-12) all from unknown dates for unspecified indications and unknown if ongoing. On 15Apr2021 at 11:45, within minutes after the vaccine, the patient experienced hives, heart palpitations, lightheadedness, the feeling of hotness, and an energy rush. All resolved by the time the patient got home. On 20Apr2021, 5 days later, the patient experienced an inflamed sore and itchy rash around the neck ongoing for several days. On an unknown date in 2021, the patient experienced swollen lips and a slight feeling of a swollen tongue on one occasion. The events resulted in doctor or other healthcare professional office/clinic visit. Since the vaccination, the patient had not been tested for COVID-19. Therapeutic measures were not taken as a result of the events. The clinical outcome of the events hives, heart palpitations, lightheadedness, feeling of hotness, and energy rush were resolved on 15Apr2021. The clinical outcome of the events inflamed sore and itchy rash around the neck, swollen lips and slight feeling of a swollen tongue were not resolved at the time of this report.  No follow-up attempts are needed. No further information is expected.
Age: 35.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Back pain, Headache, Hypoaesthesia, Neck pain, Pain in extremity
Clinical narrative: Left side of my face went thumb 3 hours after getting the shot. A day later and my left cheek and around my eye still have a numbness feeling.; Random pain in my left leg (thigh).; Have had a constant headache; sore left arm.; This is a spontaneous report from a contactable consumer, the patient. A 35-year-old male patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8735) via an unspecified route of administration in the left arm  on 30Apr2021 at 11:15 (at the age of 35-years-old) as a single dose for COVID-19 immunisation. The patient had no medical history and no known allergies to medications, food or other products. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any concomitant medications and did not receive any other vaccines within four weeks prior to the COVID vaccine. On 30Apr2021 at 14:15, left side of the patients face went numb 3 hours after getting the shot. A day later and his left cheek and around eye still had a numbness feeling. Random pain in left leg (thigh) and had a constant headache and sore left arm. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. No therapeutic measures were taken as a result of the reported events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events left side of face went numb, left cheek and around eye still had a numbness feeling, random pain in the left leg (thigh), constant headache and sore left arm was recovering at the time of this report.   No follow-up attempts are needed. No further information is expected.
Age: 35.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Headache, Hypoaesthesia, Pain in extremity
Clinical narrative: Left side of my face went thumb 3 hours after getting the shot. A day later and my left cheek and around my eye still have a numbness feeling.; Random pain in my left leg (thigh).; Have had a constant headache; sore left arm.; This is a spontaneous report from a contactable consumer, the patient. A 35-year-old male patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8735) via an unspecified route of administration in the left arm  on 30Apr2021 at 11:15 (at the age of 35-years-old) as a single dose for COVID-19 immunisation. The patient had no medical history and no known allergies to medications, food or other products. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any concomitant medications and did not receive any other vaccines within four weeks prior to the COVID vaccine. On 30Apr2021 at 14:15, left side of the patients face went numb 3 hours after getting the shot. A day later and his left cheek and around eye still had a numbness feeling. Random pain in left leg (thigh) and had a constant headache and sore left arm. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. No therapeutic measures were taken as a result of the reported events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events left side of face went numb, left cheek and around eye still had a numbness feeling, random pain in the left leg (thigh), constant headache and sore left arm was recovering at the time of this report.   No follow-up attempts are needed. No further information is expected.
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Headache, Herpes zoster
Clinical narrative: Breakthrough infection; His pulse oxygen went from 92 to 98; This is a spontaneous report received from a contactable physician. A male patient of an unspecified age received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot Number: Unknown) via an unspecified route of administration on Apr2021 as dose 2, single for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. The patient previously took first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot number: Unknown) via an unknown route of administration on Apr2021 as dose 1, single for COVID-19 immunisation. Patient received both doses of the Pfizer vaccines in April, on unknown date 2021 had a breakthrough infection. He stated that his pulse oxygen went from 92 to 98 and although he still has some remaining effects, he feels better. The patient underwent lab tests and procedures which included oxygen saturation: 92, oxygen saturation: 98 in 2021 (pulse oxygen went from 92 to 98). The outcome of the events was reported as recovering.   The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Infection, Oxygen saturation, Oxygen saturation increased
Clinical narrative: Breakthrough infection; His pulse oxygen went from 92 to 98; This is a spontaneous report received from a contactable physician. A male patient of an unspecified age received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot Number: Unknown) via an unspecified route of administration on Apr2021 as dose 2, single for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. The patient previously took first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot number: Unknown) via an unknown route of administration on Apr2021 as dose 1, single for COVID-19 immunisation. Patient received both doses of the Pfizer vaccines in April, on unknown date 2021 had a breakthrough infection. He stated that his pulse oxygen went from 92 to 98 and although he still has some remaining effects, he feels better. The patient underwent lab tests and procedures which included oxygen saturation: 92, oxygen saturation: 98 in 2021 (pulse oxygen went from 92 to 98). The outcome of the events was reported as recovering.   The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.
Age: 41.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Contusion, Erythema, Feeling abnormal, Livedo reticularis, Pain in extremity
Clinical narrative: Swelling over knee cap of a pocket of fluid. My whole knee is not swollen- it just simply appeared that I had a golf ball sized pocket of fluid.; It burned; It burned and tingled; Had bruising on knee and down the top of shin with sensitivity to touch and continued fluid build up; Sensitivity to touch; Skin and just under is very sensitive; This is a spontaneous report from a contactable consumer, the patient. A 41-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN), via an unspecified route of administration in the left arm on 01May2021 at 11:15 (at the age of 41-years-old), as a single dose for COVID-19 immunisation. The patient had no medical history. The patient did not have any allergies to medications, food or other products. The patient did not receive any other medication within two weeks of vaccination. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN), via an unspecified route of administration on 10Apr2021 (at the age of 41-years-old), as a single dose for COVID-19 immunisation. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 01May2021 at 14:15, 3 hours post injection, the patient experienced a swelling over the knee cap of a pocket of fluid; the whole knee is not swollen, it just simply appeared that the patient had a golf ball sized pocket of fluid. It burned and tingled. On 01May2021, since then, the patient had bruising on the knee and down the top of the shin with sensitivity to touch and continued fluid build-up. It swelled to golf ball size once since then after the patient kneeled on it. The patient was able to walk and had full mobility but the skin and just under was very sensitive, this was on the left leg. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. Therapeutic measures were not taken as a result of the events. The clinical outcome of the events swelling over knee cap of a pocket of fluid, the whole knee is not swollen- it just simply appeared that the patient had a golf ball sized pocket of fluid, it burned and tingled, had bruising on knee and down the top of the shin with sensitivity to touch and continued fluid build-up, skin and just under is very sensitive were not resolved at the time of this report.   No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Age: 41.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Paraesthesia, Skin burning sensation, Skin induration, Skin swelling, Skin warm
Clinical narrative: Swelling over knee cap of a pocket of fluid. My whole knee is not swollen- it just simply appeared that I had a golf ball sized pocket of fluid.; It burned; It burned and tingled; Had bruising on knee and down the top of shin with sensitivity to touch and continued fluid build up; Sensitivity to touch; Skin and just under is very sensitive; This is a spontaneous report from a contactable consumer, the patient. A 41-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN), via an unspecified route of administration in the left arm on 01May2021 at 11:15 (at the age of 41-years-old), as a single dose for COVID-19 immunisation. The patient had no medical history. The patient did not have any allergies to medications, food or other products. The patient did not receive any other medication within two weeks of vaccination. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN), via an unspecified route of administration on 10Apr2021 (at the age of 41-years-old), as a single dose for COVID-19 immunisation. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 01May2021 at 14:15, 3 hours post injection, the patient experienced a swelling over the knee cap of a pocket of fluid; the whole knee is not swollen, it just simply appeared that the patient had a golf ball sized pocket of fluid. It burned and tingled. On 01May2021, since then, the patient had bruising on the knee and down the top of the shin with sensitivity to touch and continued fluid build-up. It swelled to golf ball size once since then after the patient kneeled on it. The patient was able to walk and had full mobility but the skin and just under was very sensitive, this was on the left leg. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. Therapeutic measures were not taken as a result of the events. The clinical outcome of the events swelling over knee cap of a pocket of fluid, the whole knee is not swollen- it just simply appeared that the patient had a golf ball sized pocket of fluid, it burned and tingled, had bruising on knee and down the top of the shin with sensitivity to touch and continued fluid build-up, skin and just under is very sensitive were not resolved at the time of this report.   No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Age: 41.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Burning sensation, Bursitis, Contusion, Hyperaesthesia, Paraesthesia
Clinical narrative: Swelling over knee cap of a pocket of fluid. My whole knee is not swollen- it just simply appeared that I had a golf ball sized pocket of fluid.; It burned; It burned and tingled; Had bruising on knee and down the top of shin with sensitivity to touch and continued fluid build up; Sensitivity to touch; Skin and just under is very sensitive; This is a spontaneous report from a contactable consumer, the patient. A 41-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN), via an unspecified route of administration in the left arm on 01May2021 at 11:15 (at the age of 41-years-old), as a single dose for COVID-19 immunisation. The patient had no medical history. The patient did not have any allergies to medications, food or other products. The patient did not receive any other medication within two weeks of vaccination. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN), via an unspecified route of administration on 10Apr2021 (at the age of 41-years-old), as a single dose for COVID-19 immunisation. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 01May2021 at 14:15, 3 hours post injection, the patient experienced a swelling over the knee cap of a pocket of fluid; the whole knee is not swollen, it just simply appeared that the patient had a golf ball sized pocket of fluid. It burned and tingled. On 01May2021, since then, the patient had bruising on the knee and down the top of the shin with sensitivity to touch and continued fluid build-up. It swelled to golf ball size once since then after the patient kneeled on it. The patient was able to walk and had full mobility but the skin and just under was very sensitive, this was on the left leg. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. Therapeutic measures were not taken as a result of the events. The clinical outcome of the events swelling over knee cap of a pocket of fluid, the whole knee is not swollen- it just simply appeared that the patient had a golf ball sized pocket of fluid, it burned and tingled, had bruising on knee and down the top of the shin with sensitivity to touch and continued fluid build-up, skin and just under is very sensitive were not resolved at the time of this report.   No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Age: 41.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Sensitive skin
Clinical narrative: Swelling over knee cap of a pocket of fluid. My whole knee is not swollen- it just simply appeared that I had a golf ball sized pocket of fluid.; It burned; It burned and tingled; Had bruising on knee and down the top of shin with sensitivity to touch and continued fluid build up; Sensitivity to touch; Skin and just under is very sensitive; This is a spontaneous report from a contactable consumer, the patient. A 41-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN), via an unspecified route of administration in the left arm on 01May2021 at 11:15 (at the age of 41-years-old), as a single dose for COVID-19 immunisation. The patient had no medical history. The patient did not have any allergies to medications, food or other products. The patient did not receive any other medication within two weeks of vaccination. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN), via an unspecified route of administration on 10Apr2021 (at the age of 41-years-old), as a single dose for COVID-19 immunisation. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 01May2021 at 14:15, 3 hours post injection, the patient experienced a swelling over the knee cap of a pocket of fluid; the whole knee is not swollen, it just simply appeared that the patient had a golf ball sized pocket of fluid. It burned and tingled. On 01May2021, since then, the patient had bruising on the knee and down the top of the shin with sensitivity to touch and continued fluid build-up. It swelled to golf ball size once since then after the patient kneeled on it. The patient was able to walk and had full mobility but the skin and just under was very sensitive, this was on the left leg. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. Therapeutic measures were not taken as a result of the events. The clinical outcome of the events swelling over knee cap of a pocket of fluid, the whole knee is not swollen- it just simply appeared that the patient had a golf ball sized pocket of fluid, it burned and tingled, had bruising on knee and down the top of the shin with sensitivity to touch and continued fluid build-up, skin and just under is very sensitive were not resolved at the time of this report.   No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Age: 43.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Arthralgia, Burning sensation, Chills, Erythema, Facial pain
Clinical narrative: Chills; Body aches; Nausea; Fatigue; Flushing of the face; Redness of the face; Painful burning of face; Painful burning of face; Skin extremely sensitive to heat; Skin extremely sensitive to chemicals; Skin extremely sensitive to hypoallergenic dog; This is a spontaneous report from a contactable consumer, the patient. A 43-year-old non-pregnant female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot Number: EW0158), via an unspecified route of administration in left arm on 24Apr2021 at 13:30 (at the age of 43-year-old) at single dose for COVID-19 immunisation. The patient's medical history and concomitant medications were none. Prior to the vaccination, the patient was not diagnosed with COVID-19. Patient had no known allergies. The patient did not receive any medications within two weeks of vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID-19 vaccine. On 25Apr2021 at 14:00 (also reported as 24 hours after first vaccine), the patient experienced common reactions: chills, body aches, nausea, fatigue (these mostly resolved within 24 hours, except for the fatigue); in addition to a rare reaction: flushing, redness and painful burning of the face. It was reported that the redness and painful burning of the face had not subsided and had since made her skin extremely sensitive to heat, chemicals and her hypoallergenic dog in 2021. The adverse events resulted in doctor or other healthcare professional office/clinic visit. Since the vaccination, the patient had not been tested for COVID-19. Therapeutic measures were not taken as a result of the events. The clinical outcome of the events chills, body aches and nausea was recovered on 26Apr2021, outcome of the other events was not recovered.  No follow-up attempts are needed. No further information is expected.  Amendment: This follow-up report is being submitted to amend previously reported information: event Pain in face added, events details added (no treatment received).
Age: 43.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Fatigue, Nausea, Swelling face
Clinical narrative: Chills; Body aches; Nausea; Fatigue; Flushing of the face; Redness of the face; Painful burning of face; Painful burning of face; Skin extremely sensitive to heat; Skin extremely sensitive to chemicals; Skin extremely sensitive to hypoallergenic dog; This is a spontaneous report from a contactable consumer, the patient. A 43-year-old non-pregnant female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot Number: EW0158), via an unspecified route of administration in left arm on 24Apr2021 at 13:30 (at the age of 43-year-old) at single dose for COVID-19 immunisation. The patient's medical history and concomitant medications were none. Prior to the vaccination, the patient was not diagnosed with COVID-19. Patient had no known allergies. The patient did not receive any medications within two weeks of vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID-19 vaccine. On 25Apr2021 at 14:00 (also reported as 24 hours after first vaccine), the patient experienced common reactions: chills, body aches, nausea, fatigue (these mostly resolved within 24 hours, except for the fatigue); in addition to a rare reaction: flushing, redness and painful burning of the face. It was reported that the redness and painful burning of the face had not subsided and had since made her skin extremely sensitive to heat, chemicals and her hypoallergenic dog in 2021. The adverse events resulted in doctor or other healthcare professional office/clinic visit. Since the vaccination, the patient had not been tested for COVID-19. Therapeutic measures were not taken as a result of the events. The clinical outcome of the events chills, body aches and nausea was recovered on 26Apr2021, outcome of the other events was not recovered.  No follow-up attempts are needed. No further information is expected.  Amendment: This follow-up report is being submitted to amend previously reported information: event Pain in face added, events details added (no treatment received).
Age: 43.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Allergy to animal, Allergy to chemicals, Burning sensation, Chills, Erythema
Clinical narrative: Chills; Body aches; Nausea; Fatigue; Flushing of the face; Redness of the face; Painful burning of face; Painful burning of face; Skin extremely sensitive to heat; Skin extremely sensitive to chemicals; Skin extremely sensitive to hypoallergenic dog; This is a spontaneous report from a contactable consumer, the patient. A 43-year-old non-pregnant female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot Number: EW0158), via an unspecified route of administration in left arm on 24Apr2021 at 13:30 (at the age of 43-year-old) at single dose for COVID-19 immunisation. The patient's medical history and concomitant medications were none. Prior to the vaccination, the patient was not diagnosed with COVID-19. Patient had no known allergies. The patient did not receive any medications within two weeks of vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID-19 vaccine. On 25Apr2021 at 14:00 (also reported as 24 hours after first vaccine), the patient experienced common reactions: chills, body aches, nausea, fatigue (these mostly resolved within 24 hours, except for the fatigue); in addition to a rare reaction: flushing, redness and painful burning of the face. It was reported that the redness and painful burning of the face had not subsided and had since made her skin extremely sensitive to heat, chemicals and her hypoallergenic dog in 2021. The adverse events resulted in doctor or other healthcare professional office/clinic visit. Since the vaccination, the patient had not been tested for COVID-19. Therapeutic measures were not taken as a result of the events. The clinical outcome of the events chills, body aches and nausea was recovered on 26Apr2021, outcome of the other events was not recovered.  No follow-up attempts are needed. No further information is expected.  Amendment: This follow-up report is being submitted to amend previously reported information: event Pain in face added, events details added (no treatment received).
Age: 43.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Facial pain, Fatigue, Flushing, Nausea, Pain
Clinical narrative: Chills; Body aches; Nausea; Fatigue; Flushing of the face; Redness of the face; Painful burning of face; Painful burning of face; Skin extremely sensitive to heat; Skin extremely sensitive to chemicals; Skin extremely sensitive to hypoallergenic dog; This is a spontaneous report from a contactable consumer, the patient. A 43-year-old non-pregnant female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot Number: EW0158), via an unspecified route of administration in left arm on 24Apr2021 at 13:30 (at the age of 43-year-old) at single dose for COVID-19 immunisation. The patient's medical history and concomitant medications were none. Prior to the vaccination, the patient was not diagnosed with COVID-19. Patient had no known allergies. The patient did not receive any medications within two weeks of vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID-19 vaccine. On 25Apr2021 at 14:00 (also reported as 24 hours after first vaccine), the patient experienced common reactions: chills, body aches, nausea, fatigue (these mostly resolved within 24 hours, except for the fatigue); in addition to a rare reaction: flushing, redness and painful burning of the face. It was reported that the redness and painful burning of the face had not subsided and had since made her skin extremely sensitive to heat, chemicals and her hypoallergenic dog in 2021. The adverse events resulted in doctor or other healthcare professional office/clinic visit. Since the vaccination, the patient had not been tested for COVID-19. Therapeutic measures were not taken as a result of the events. The clinical outcome of the events chills, body aches and nausea was recovered on 26Apr2021, outcome of the other events was not recovered.  No follow-up attempts are needed. No further information is expected.  Amendment: This follow-up report is being submitted to amend previously reported information: event Pain in face added, events details added (no treatment received).
Age: 43.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Temperature intolerance
Clinical narrative: Chills; Body aches; Nausea; Fatigue; Flushing of the face; Redness of the face; Painful burning of face; Painful burning of face; Skin extremely sensitive to heat; Skin extremely sensitive to chemicals; Skin extremely sensitive to hypoallergenic dog; This is a spontaneous report from a contactable consumer, the patient. A 43-year-old non-pregnant female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot Number: EW0158), via an unspecified route of administration in left arm on 24Apr2021 at 13:30 (at the age of 43-year-old) at single dose for COVID-19 immunisation. The patient's medical history and concomitant medications were none. Prior to the vaccination, the patient was not diagnosed with COVID-19. Patient had no known allergies. The patient did not receive any medications within two weeks of vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID-19 vaccine. On 25Apr2021 at 14:00 (also reported as 24 hours after first vaccine), the patient experienced common reactions: chills, body aches, nausea, fatigue (these mostly resolved within 24 hours, except for the fatigue); in addition to a rare reaction: flushing, redness and painful burning of the face. It was reported that the redness and painful burning of the face had not subsided and had since made her skin extremely sensitive to heat, chemicals and her hypoallergenic dog in 2021. The adverse events resulted in doctor or other healthcare professional office/clinic visit. Since the vaccination, the patient had not been tested for COVID-19. Therapeutic measures were not taken as a result of the events. The clinical outcome of the events chills, body aches and nausea was recovered on 26Apr2021, outcome of the other events was not recovered.  No follow-up attempts are needed. No further information is expected.  Amendment: This follow-up report is being submitted to amend previously reported information: event Pain in face added, events details added (no treatment received).
Age: 62.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Tinnitus
Clinical narrative: This is a spontaneous report from a contactable consumer (patient). A 62-year-old female patient received the first dose of BNT162B2 (Pfizer-BioNTech COVID-19 mRNA vaccine; batch/lot# EW0150), at the age of 62, via an unspecified route of administration, left arm, on Apr 2, 2021, at 08:30, single dose, for COVID-19 immunisation. The patient has no reported medical history. The patient has no allergies to medications, food or other products. Prior to the vaccination, patient was not diagnosed with COVID-19. Since the vaccination, patient has not tested for COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Concomitant medications not reported. On Apr 2, 2021, at 23:45, patient experienced ringing in ears. The event did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. It was unknown whether any therapeutic measures were taken as a result of the event. The clinical outcome of ringing in ears not resolved at the time of report. No follow-up attempts needed. No further information expected.
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Arthralgia, C-reactive protein increased, Condition aggravated, Myalgia, Peripheral swelling
Clinical narrative: Very sick and it started 2 weeks after my first vaccine; Had joint pain and it has gotten worse; Could not walk; This is a spontaneous report from a contactable consumer, the patient. A 42-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number: EL9264), dose 1 via an unspecified route of administration on 09Feb2021 as dose 1, single for covid-19 immunisation. The patient medical history and concomitant medications were not reported. In Feb2021, patient had been very sick, and it started 2 weeks after her first vaccine on 09Feb2021. Patient immune system was freaking out. she states that she was living in hell right now since she got her COVID vaccine and 2 weeks after she had severe joint pain, could not walk and it has gotten worse. Its kind of like creeped on with the joint pain. She spoke with her doctor who said to get the second dose and then the joint pain was even worsen so she went to urgent care and she had been on 5 months of prednisone and done all kinds of lab tests and just has had so many prescriptions and doctor bills and she doesn't know what was going on but it was all right after the COVID vaccine. Patient was a normal healthy person before all this and was suffering. Reporter assessed the events as non-serious. The outcome of the event was not recovered.   Follow-up attempts are completed. No further information is expected.
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Arthralgia, Gait disturbance, Illness, Investigation
Clinical narrative: Very sick and it started 2 weeks after my first vaccine; Had joint pain and it has gotten worse; Could not walk; This is a spontaneous report from a contactable consumer, the patient. A 42-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number: EL9264), dose 1 via an unspecified route of administration on 09Feb2021 as dose 1, single for covid-19 immunisation. The patient medical history and concomitant medications were not reported. In Feb2021, patient had been very sick, and it started 2 weeks after her first vaccine on 09Feb2021. Patient immune system was freaking out. she states that she was living in hell right now since she got her COVID vaccine and 2 weeks after she had severe joint pain, could not walk and it has gotten worse. Its kind of like creeped on with the joint pain. She spoke with her doctor who said to get the second dose and then the joint pain was even worsen so she went to urgent care and she had been on 5 months of prednisone and done all kinds of lab tests and just has had so many prescriptions and doctor bills and she doesn't know what was going on but it was all right after the COVID vaccine. Patient was a normal healthy person before all this and was suffering. Reporter assessed the events as non-serious. The outcome of the event was not recovered.   Follow-up attempts are completed. No further information is expected.
Age: 39.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Pruritus, Rash erythematous, Rash papular, Skin warm
Clinical narrative: 2 weeks after 1st shot - I broke out in a bright red, raised rash along my arms and torso.; 2 weeks after 1st shot - I broke out in a bright red, raised rash along my arms and torso.; This is a spontaneous report from a contactable consumer, the patient. A 39-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0161) via an unspecified route of administration in the arm right on an unknown date in Apr2021 at 14:00 (at the age of 39-years-old) as a single dose for COVID-19 immunisation. Medical history included allergy. The patients past drug was reported as no. Concomitant medications taken within two weeks prior to the vaccination included cetirizine hydrochloride (ZYRTEC) from an unknown date for allergy and ethinylestradiol, norethisterone acetate (JUNEL) from an unknown date for birth control. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 18Apr2021 at 14:30, two weeks after first shot the patient experienced a break out in a bright red, raised rash along her arms and torso. The patient had been hiking on a sunny day - wondering if it was triggered by the heat/sun. The rash was still on-going 10 days later, although it was fading. Therapeutic measures were taken as a result of bright red, raised rash along arms and torso and included over the counter treatment with benedryl and cortisone cream from an unknown date to an unknown date. The clinical outcome of the event bright red, raised rash along arms and torso was resolving at the time of this report. The patient also received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EW0179), via an unspecified route of administration in right arm on 02May2021 at 14:15 (at the age of 39-years-old) as single dose for COVID-19 immunisation and the adverse events for the second dose were not reported  No follow-up attempts are needed. No further information is expected.
Age: 39.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Rash erythematous, Rash papular
Clinical narrative: 2 weeks after 1st shot - I broke out in a bright red, raised rash along my arms and torso.; 2 weeks after 1st shot - I broke out in a bright red, raised rash along my arms and torso.; This is a spontaneous report from a contactable consumer, the patient. A 39-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0161) via an unspecified route of administration in the arm right on an unknown date in Apr2021 at 14:00 (at the age of 39-years-old) as a single dose for COVID-19 immunisation. Medical history included allergy. The patients past drug was reported as no. Concomitant medications taken within two weeks prior to the vaccination included cetirizine hydrochloride (ZYRTEC) from an unknown date for allergy and ethinylestradiol, norethisterone acetate (JUNEL) from an unknown date for birth control. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 18Apr2021 at 14:30, two weeks after first shot the patient experienced a break out in a bright red, raised rash along her arms and torso. The patient had been hiking on a sunny day - wondering if it was triggered by the heat/sun. The rash was still on-going 10 days later, although it was fading. Therapeutic measures were taken as a result of bright red, raised rash along arms and torso and included over the counter treatment with benedryl and cortisone cream from an unknown date to an unknown date. The clinical outcome of the event bright red, raised rash along arms and torso was resolving at the time of this report. The patient also received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EW0179), via an unspecified route of administration in right arm on 02May2021 at 14:15 (at the age of 39-years-old) as single dose for COVID-19 immunisation and the adverse events for the second dose were not reported  No follow-up attempts are needed. No further information is expected.
Age: 27.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Chills, Pyrexia, Vaccination site pain
Clinical narrative: fever; chills; Injection site soreness; This is a spontaneous report from a contactable consumer or other non-health care professional (patient). A 27-years-old female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot number: EL3247), via an intramuscular route of administration (at the age of 27-years), administered in arm left on 24Feb2021 at 15:30 as dose 2, single for COVID-19 immunization. Medical history included none from an unknown date and unknown if ongoing. The patient concomitant medications were not reported. The patient historical vaccine included first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot number: EL3247), via an unspecified route of administration, administered in arm left on 03Feb2021 at 15:30 as dose 1, single for COVID-19 immunization. On 24Feb2021 at 09:00, the patient stated that fever and chills began at the evening after 2nd covid vaccine dose. The dose was administered at 3:30 PM, symptoms began at 9:00 PM on the day of dosing. Injection site soreness also began around the same time. All symptoms were gone within 24 hours by the evening of the next day. The treatment was not received for all the events. The clinical outcome for all the events was reported as recovered on 25Feb2021.  No follow-up attempts possible. No further information expected. Batch/Lot numbers can be obtained.
Age: 49.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Acoustic stimulation tests, Blood test, Tinnitus
Clinical narrative: Very bad ringing/Tinnitus in right ear.; This is a spontaneous report from a contactable consumer, the patient. A 49-year-old male patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8737) via an unspecified route of administration in the left arm on 31Mar2021 at 16:30 (at the age of 49-year-old) as a single dose for COVID-19 immunisation. Medical history included none. Patient had no allergies to food, medications or other products. The patient did not receive any medications within two weeks of vaccination. 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 vaccination. On 06Apr2021 at 22:00, the patient experienced very bad ringing/tinnitus in right ear. Therapeutic measures were not taken as a result of the event. The event resulted in doctor or other healthcare professional office/clinic visit. Since the vaccination the patient not been tested for COVID-19. The clinical outcome of the event bad ringing/tinnitus in right ear was not recovered at the time of this report.   No follow-up attempts are needed. No further information is expected.
Age: 49.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Tinnitus
Clinical narrative: Very bad ringing/Tinnitus in right ear.; This is a spontaneous report from a contactable consumer, the patient. A 49-year-old male patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8737) via an unspecified route of administration in the left arm on 31Mar2021 at 16:30 (at the age of 49-year-old) as a single dose for COVID-19 immunisation. Medical history included none. Patient had no allergies to food, medications or other products. The patient did not receive any medications within two weeks of vaccination. 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 vaccination. On 06Apr2021 at 22:00, the patient experienced very bad ringing/tinnitus in right ear. Therapeutic measures were not taken as a result of the event. The event resulted in doctor or other healthcare professional office/clinic visit. Since the vaccination the patient not been tested for COVID-19. The clinical outcome of the event bad ringing/tinnitus in right ear was not recovered at the time of this report.   No follow-up attempts are needed. No further information is expected.