chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 52.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Nasal discomfort, Nausea, Paraesthesia, Peripheral coldness, Respiratory tract congestion
Clinical narrative: April 5th 10-15 minutes after dose:  tight throat and chest, congested, feeling out of it within 10-15 minutes after dose  Later that day:  tachycardia, burning sensation throughout body, tingling in nasal passage, arms and legs, lower back pain, lightheaded, joint pain, chills  April 6th additional symptoms to above and ongoing at various degrees: migrating shock sensation, cold extremities, swollen lymph nodes, shaking, ear ringing, fatigue, muscle cramping and stiffness, unsteady while sitting and standing, back weakness, periodic cough, nausea
Age: 52.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Tachycardia, Throat tightness, Tinnitus, Tremor
Clinical narrative: April 5th 10-15 minutes after dose:  tight throat and chest, congested, feeling out of it within 10-15 minutes after dose  Later that day:  tachycardia, burning sensation throughout body, tingling in nasal passage, arms and legs, lower back pain, lightheaded, joint pain, chills  April 6th additional symptoms to above and ongoing at various degrees: migrating shock sensation, cold extremities, swollen lymph nodes, shaking, ear ringing, fatigue, muscle cramping and stiffness, unsteady while sitting and standing, back weakness, periodic cough, nausea
Age: 31.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Electrocardiogram, Headache, Magnetic resonance imaging, Tinnitus, Vision blurred
Clinical narrative: pressure headache; tinnitus; hyperacusis; grainy and double vision; photophobia; facial twitching; Pain in back, shoulders and arms; Pain in back, shoulders and arms; Pain in back, shoulders and arms; Burning sensations in back and arms; Muscle weakness in legs and arms; Large rash at injection site; Swollen lymph nodes in both arms; This is a spontaneous report received from a contactable consumer (patient). A 31-years-old male patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: solution for injection, Lot number: ER8736, Expiration date: not reported) via an unspecified route of administration in left arm on 23Apr2021 at 10:00 AM (at the age of 31 years) as 2ND DOSE, SINGLE for covid-19 immunisation. The patient medical history included diabetes (controlled) and concomitant medications were not reported. The patient had a history of allergies to Demerol. Historical vaccine included first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: EP6955, Expiration date: not reported) via an unspecified route of administration in left arm on 31Mar2021 at 12:00 PM as 1ST DOSE, SINGLE for covid-19 immunisation. The patient didn't receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient received other medications within 2 weeks of vaccination was reported as Vitamin C, D3. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. On 26Apr2021 at 07:45 AM, the patient stated that he woke up with pressure headache, tinnitus, hyperacusis, grainy and double vision, photophobia, facial twitching, pain in back, shoulders and arms, burning sensations in back and arms, muscle weakness in legs and arms, large rash at injection site, swollen lymph nodes in both arms. The adverse events resulted in the doctor or other healthcare professional office/clinic visit, Emergency room/department or urgent care. Treatment was received for the adverse events which includes Prednisone. The events were reported as non serious. Outcome of the events were reported as Not recovered.
Age: 31.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Visual snow syndrome
Clinical narrative: pressure headache; tinnitus; hyperacusis; grainy and double vision; photophobia; facial twitching; Pain in back, shoulders and arms; Pain in back, shoulders and arms; Pain in back, shoulders and arms; Burning sensations in back and arms; Muscle weakness in legs and arms; Large rash at injection site; Swollen lymph nodes in both arms; This is a spontaneous report received from a contactable consumer (patient). A 31-years-old male patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: solution for injection, Lot number: ER8736, Expiration date: not reported) via an unspecified route of administration in left arm on 23Apr2021 at 10:00 AM (at the age of 31 years) as 2ND DOSE, SINGLE for covid-19 immunisation. The patient medical history included diabetes (controlled) and concomitant medications were not reported. The patient had a history of allergies to Demerol. Historical vaccine included first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: EP6955, Expiration date: not reported) via an unspecified route of administration in left arm on 31Mar2021 at 12:00 PM as 1ST DOSE, SINGLE for covid-19 immunisation. The patient didn't receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient received other medications within 2 weeks of vaccination was reported as Vitamin C, D3. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. On 26Apr2021 at 07:45 AM, the patient stated that he woke up with pressure headache, tinnitus, hyperacusis, grainy and double vision, photophobia, facial twitching, pain in back, shoulders and arms, burning sensations in back and arms, muscle weakness in legs and arms, large rash at injection site, swollen lymph nodes in both arms. The adverse events resulted in the doctor or other healthcare professional office/clinic visit, Emergency room/department or urgent care. Treatment was received for the adverse events which includes Prednisone. The events were reported as non serious. Outcome of the events were reported as Not recovered.
Age: 31.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Arthralgia, Back pain, Burning sensation, Diplopia, Headache
Clinical narrative: pressure headache; tinnitus; hyperacusis; grainy and double vision; photophobia; facial twitching; Pain in back, shoulders and arms; Pain in back, shoulders and arms; Pain in back, shoulders and arms; Burning sensations in back and arms; Muscle weakness in legs and arms; Large rash at injection site; Swollen lymph nodes in both arms; This is a spontaneous report received from a contactable consumer (patient). A 31-years-old male patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: solution for injection, Lot number: ER8736, Expiration date: not reported) via an unspecified route of administration in left arm on 23Apr2021 at 10:00 AM (at the age of 31 years) as 2ND DOSE, SINGLE for covid-19 immunisation. The patient medical history included diabetes (controlled) and concomitant medications were not reported. The patient had a history of allergies to Demerol. Historical vaccine included first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: EP6955, Expiration date: not reported) via an unspecified route of administration in left arm on 31Mar2021 at 12:00 PM as 1ST DOSE, SINGLE for covid-19 immunisation. The patient didn't receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient received other medications within 2 weeks of vaccination was reported as Vitamin C, D3. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. On 26Apr2021 at 07:45 AM, the patient stated that he woke up with pressure headache, tinnitus, hyperacusis, grainy and double vision, photophobia, facial twitching, pain in back, shoulders and arms, burning sensations in back and arms, muscle weakness in legs and arms, large rash at injection site, swollen lymph nodes in both arms. The adverse events resulted in the doctor or other healthcare professional office/clinic visit, Emergency room/department or urgent care. Treatment was received for the adverse events which includes Prednisone. The events were reported as non serious. Outcome of the events were reported as Not recovered.
Age: 31.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Hyperacusis, Lymphadenopathy, Muscle twitching, Muscular weakness, Pain in extremity
Clinical narrative: pressure headache; tinnitus; hyperacusis; grainy and double vision; photophobia; facial twitching; Pain in back, shoulders and arms; Pain in back, shoulders and arms; Pain in back, shoulders and arms; Burning sensations in back and arms; Muscle weakness in legs and arms; Large rash at injection site; Swollen lymph nodes in both arms; This is a spontaneous report received from a contactable consumer (patient). A 31-years-old male patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: solution for injection, Lot number: ER8736, Expiration date: not reported) via an unspecified route of administration in left arm on 23Apr2021 at 10:00 AM (at the age of 31 years) as 2ND DOSE, SINGLE for covid-19 immunisation. The patient medical history included diabetes (controlled) and concomitant medications were not reported. The patient had a history of allergies to Demerol. Historical vaccine included first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: EP6955, Expiration date: not reported) via an unspecified route of administration in left arm on 31Mar2021 at 12:00 PM as 1ST DOSE, SINGLE for covid-19 immunisation. The patient didn't receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient received other medications within 2 weeks of vaccination was reported as Vitamin C, D3. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. On 26Apr2021 at 07:45 AM, the patient stated that he woke up with pressure headache, tinnitus, hyperacusis, grainy and double vision, photophobia, facial twitching, pain in back, shoulders and arms, burning sensations in back and arms, muscle weakness in legs and arms, large rash at injection site, swollen lymph nodes in both arms. The adverse events resulted in the doctor or other healthcare professional office/clinic visit, Emergency room/department or urgent care. Treatment was received for the adverse events which includes Prednisone. The events were reported as non serious. Outcome of the events were reported as Not recovered.
Age: 31.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Photophobia, Tinnitus, Vaccination site rash
Clinical narrative: pressure headache; tinnitus; hyperacusis; grainy and double vision; photophobia; facial twitching; Pain in back, shoulders and arms; Pain in back, shoulders and arms; Pain in back, shoulders and arms; Burning sensations in back and arms; Muscle weakness in legs and arms; Large rash at injection site; Swollen lymph nodes in both arms; This is a spontaneous report received from a contactable consumer (patient). A 31-years-old male patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: solution for injection, Lot number: ER8736, Expiration date: not reported) via an unspecified route of administration in left arm on 23Apr2021 at 10:00 AM (at the age of 31 years) as 2ND DOSE, SINGLE for covid-19 immunisation. The patient medical history included diabetes (controlled) and concomitant medications were not reported. The patient had a history of allergies to Demerol. Historical vaccine included first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: EP6955, Expiration date: not reported) via an unspecified route of administration in left arm on 31Mar2021 at 12:00 PM as 1ST DOSE, SINGLE for covid-19 immunisation. The patient didn't receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient received other medications within 2 weeks of vaccination was reported as Vitamin C, D3. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. On 26Apr2021 at 07:45 AM, the patient stated that he woke up with pressure headache, tinnitus, hyperacusis, grainy and double vision, photophobia, facial twitching, pain in back, shoulders and arms, burning sensations in back and arms, muscle weakness in legs and arms, large rash at injection site, swollen lymph nodes in both arms. The adverse events resulted in the doctor or other healthcare professional office/clinic visit, Emergency room/department or urgent care. Treatment was received for the adverse events which includes Prednisone. The events were reported as non serious. Outcome of the events were reported as Not recovered.
Age: 59.0
Sex: U
Vaccine: COVID19, COVID19
Symptoms: Pharyngeal swelling, Rash
Clinical narrative: allergies to something in the Pfyzer Covid 19 Vaccine, I started having problems breathing; allergies to something in the Pfyzer Covid 19 Vaccine, I started having problems breathing; This is a spontaneous report from a contactable consumer (patient). A 59-year-old patient of an unspecified gender received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) dose 1 via an unspecified route of administration on 20Apr2021 (Lot number EW0173) as single dose for COVID-19 immunization. The patient medical history and concomitant medications were not reported. The patient was advised by her Family physician not to get the 2nd Dose because of allergies to something in the vaccine. When the Paramedics got to her home they gave her shots of epinephrine and Benadryl. Plus stated an l.V. The patient was at the Hospital for 9 hours until it was safe for her to go home. It was a very scary situation especially when the patient started having problems breathing. The patient was still recovering from this emotionally and physically.
Age: 59.0
Sex: U
Vaccine: COVID19, COVID19
Symptoms: Allergy to vaccine, Dyspnoea
Clinical narrative: allergies to something in the Pfyzer Covid 19 Vaccine, I started having problems breathing; allergies to something in the Pfyzer Covid 19 Vaccine, I started having problems breathing; This is a spontaneous report from a contactable consumer (patient). A 59-year-old patient of an unspecified gender received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) dose 1 via an unspecified route of administration on 20Apr2021 (Lot number EW0173) as single dose for COVID-19 immunization. The patient medical history and concomitant medications were not reported. The patient was advised by her Family physician not to get the 2nd Dose because of allergies to something in the vaccine. When the Paramedics got to her home they gave her shots of epinephrine and Benadryl. Plus stated an l.V. The patient was at the Hospital for 9 hours until it was safe for her to go home. It was a very scary situation especially when the patient started having problems breathing. The patient was still recovering from this emotionally and physically.
Age: 17.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Computerised tomogram, Computerised tomogram head, Electrocardiogram, Hyperhidrosis, Nausea
Clinical narrative: BLE and BUE went into abnormal extension; facial tics; shaking of the BUE; Pt was pale, diaphoretic, and verbalized "I am OK" three times in a row without being asked; Pt was pale, diaphoretic, and verbalized "I am OK" three times in a row without being asked; Pt was pale, diaphoretic, and verbalized "I am OK" three times in a row without being asked; nausea; This is a spontaneous report from a contactable consumer (patient). A 17-years-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 intramuscular, administered in right arm on 05May2021 13:50 (Batch/Lot Number: EW0167) as single dose for covid-19 immunisation. Medical history were none. Prescriptions, over the counter medications taken were none. Allergies to medication, Food or other products were none. Other illness at the time of vaccination and up to one month prior were none. Chronic or long-standing health conditions were none. The patient's concomitant medications were not reported. 5 minutes following the vaccination, patients BLE and BUE went into abnormal extension immediately followed by facial tics and shaking of the BUE patient was pale, diaphoretic, and verbalized iam ok three times in a row without being asked. patient stated that he was unaware of what had just happened then verbalized feelings of nausea. Airway breathing, circulation intact. patient was placed on gurney, side rails upx2, and transported to ED. The patient never had an adverse event following any previous vaccine. Event start date was 05May2021. Medical tests and laboratory results related to the adverse events included: Vital signs, EKG, CT of the head. Emergency room/department or urgent care visit. Outcome was recovered.   Follow-up attempts are needed. further information is expected.
Age: 17.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Pallor, Posturing, Tic, Tremor
Clinical narrative: BLE and BUE went into abnormal extension; facial tics; shaking of the BUE; Pt was pale, diaphoretic, and verbalized "I am OK" three times in a row without being asked; Pt was pale, diaphoretic, and verbalized "I am OK" three times in a row without being asked; Pt was pale, diaphoretic, and verbalized "I am OK" three times in a row without being asked; nausea; This is a spontaneous report from a contactable consumer (patient). A 17-years-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 intramuscular, administered in right arm on 05May2021 13:50 (Batch/Lot Number: EW0167) as single dose for covid-19 immunisation. Medical history were none. Prescriptions, over the counter medications taken were none. Allergies to medication, Food or other products were none. Other illness at the time of vaccination and up to one month prior were none. Chronic or long-standing health conditions were none. The patient's concomitant medications were not reported. 5 minutes following the vaccination, patients BLE and BUE went into abnormal extension immediately followed by facial tics and shaking of the BUE patient was pale, diaphoretic, and verbalized iam ok three times in a row without being asked. patient stated that he was unaware of what had just happened then verbalized feelings of nausea. Airway breathing, circulation intact. patient was placed on gurney, side rails upx2, and transported to ED. The patient never had an adverse event following any previous vaccine. Event start date was 05May2021. Medical tests and laboratory results related to the adverse events included: Vital signs, EKG, CT of the head. Emergency room/department or urgent care visit. Outcome was recovered.   Follow-up attempts are needed. further information is expected.
Age: 17.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Computerised tomogram head, Electrocardiogram, Hyperhidrosis, Limb discomfort, Nausea
Clinical narrative: BLE and BUE went into abnormal extension; facial tics; shaking of the BUE; Pt was pale, diaphoretic, and verbalized "I am OK" three times in a row without being asked; Pt was pale, diaphoretic, and verbalized "I am OK" three times in a row without being asked; Pt was pale, diaphoretic, and verbalized "I am OK" three times in a row without being asked; nausea; This is a spontaneous report from a contactable consumer (patient). A 17-years-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 intramuscular, administered in right arm on 05May2021 13:50 (Batch/Lot Number: EW0167) as single dose for covid-19 immunisation. Medical history were none. Prescriptions, over the counter medications taken were none. Allergies to medication, Food or other products were none. Other illness at the time of vaccination and up to one month prior were none. Chronic or long-standing health conditions were none. The patient's concomitant medications were not reported. 5 minutes following the vaccination, patients BLE and BUE went into abnormal extension immediately followed by facial tics and shaking of the BUE patient was pale, diaphoretic, and verbalized iam ok three times in a row without being asked. patient stated that he was unaware of what had just happened then verbalized feelings of nausea. Airway breathing, circulation intact. patient was placed on gurney, side rails upx2, and transported to ED. The patient never had an adverse event following any previous vaccine. Event start date was 05May2021. Medical tests and laboratory results related to the adverse events included: Vital signs, EKG, CT of the head. Emergency room/department or urgent care visit. Outcome was recovered.   Follow-up attempts are needed. further information is expected.
Age: 17.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Pallor, Soliloquy, Tic, Tremor, Vital signs measurement
Clinical narrative: BLE and BUE went into abnormal extension; facial tics; shaking of the BUE; Pt was pale, diaphoretic, and verbalized "I am OK" three times in a row without being asked; Pt was pale, diaphoretic, and verbalized "I am OK" three times in a row without being asked; Pt was pale, diaphoretic, and verbalized "I am OK" three times in a row without being asked; nausea; This is a spontaneous report from a contactable consumer (patient). A 17-years-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 intramuscular, administered in right arm on 05May2021 13:50 (Batch/Lot Number: EW0167) as single dose for covid-19 immunisation. Medical history were none. Prescriptions, over the counter medications taken were none. Allergies to medication, Food or other products were none. Other illness at the time of vaccination and up to one month prior were none. Chronic or long-standing health conditions were none. The patient's concomitant medications were not reported. 5 minutes following the vaccination, patients BLE and BUE went into abnormal extension immediately followed by facial tics and shaking of the BUE patient was pale, diaphoretic, and verbalized iam ok three times in a row without being asked. patient stated that he was unaware of what had just happened then verbalized feelings of nausea. Airway breathing, circulation intact. patient was placed on gurney, side rails upx2, and transported to ED. The patient never had an adverse event following any previous vaccine. Event start date was 05May2021. Medical tests and laboratory results related to the adverse events included: Vital signs, EKG, CT of the head. Emergency room/department or urgent care visit. Outcome was recovered.   Follow-up attempts are needed. further information is expected.
Age: 68.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Dizziness, Erythema, Headache, Nausea, Rash
Clinical narrative: rings of redness around my wrist and beneath my arm; sick; tired; burning; Worse allergy; When the itching and hives around my writs, neck, forearms, eyes, palms front and back would disappear; When the itching and hives around my writs, neck, forearms, eyes, palms front and back would disappear; keeping me awake; I have an itchy rash around my wrists, underneath my breasts and on my forearms that is spreading further around these areas.; This is a spontaneous report from a contactable consumer. A 68-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), dose 1 via an unspecified route of administration, administered in Arm Left on 04May2021 04:00 (Batch/Lot Number: ENO273) as 1ST DOSE, SINGLE for covid-19 immunisation. Medical history included known allergies: Aspirin. Concomitant medications included vitamin c [ascorbic acid] (VITAMIN C [ASCORBIC ACID]). On 04May2021 04:00, I have an itchy rash around my wrists, underneath my breasts and on my forearms that is spreading further around these areas. On 04May2021 16:45, When the itching and hives around my writs, neck, forearms, eyes, palms front and back/ hives in the arms, neck would disappear> I tried all kind of ointments and antihistamines. This has being going on for 10 days. On an unspecified date, rings of redness around my wrist and beneath my arm, tired, burning, Worse allergy. Hives around both writs, on forearms, neck, eyes, inside palm of hands. It is awfully itchy, burning and unbearable, keeping me awake. Tried Benadryl, several steroid creams, the patient is still suffering after 10 days. Therapeutic measures were taken as a result of when the itching and hives around my writs, neck, forearms, eyes, palms front and back would disappear (urticaria), when the itching and hives around my writs, neck, forearms, eyes, palms front and back would disappear (pruritus), i have an itchy rash around my wrists, underneath my breasts and on my forearms that is spreading further around these areas. (rash pruritic), rings of redness around my wrist and beneath my arm (erythema), keeping me awake (insomnia): Benadryl, Loratidine, Trimcinolone Acetonid + Fluo, Benadryl Allergy Antihistamine 25 mg gels tablets. The outcome of the event sick, tired, burning, Worse allergy was unknown, while not recovered for the other events.   Follow-up attempts are completed. No further information is expected.
Age: 68.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Rash pruritic
Clinical narrative: rings of redness around my wrist and beneath my arm; sick; tired; burning; Worse allergy; When the itching and hives around my writs, neck, forearms, eyes, palms front and back would disappear; When the itching and hives around my writs, neck, forearms, eyes, palms front and back would disappear; keeping me awake; I have an itchy rash around my wrists, underneath my breasts and on my forearms that is spreading further around these areas.; This is a spontaneous report from a contactable consumer. A 68-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), dose 1 via an unspecified route of administration, administered in Arm Left on 04May2021 04:00 (Batch/Lot Number: ENO273) as 1ST DOSE, SINGLE for covid-19 immunisation. Medical history included known allergies: Aspirin. Concomitant medications included vitamin c [ascorbic acid] (VITAMIN C [ASCORBIC ACID]). On 04May2021 04:00, I have an itchy rash around my wrists, underneath my breasts and on my forearms that is spreading further around these areas. On 04May2021 16:45, When the itching and hives around my writs, neck, forearms, eyes, palms front and back/ hives in the arms, neck would disappear> I tried all kind of ointments and antihistamines. This has being going on for 10 days. On an unspecified date, rings of redness around my wrist and beneath my arm, tired, burning, Worse allergy. Hives around both writs, on forearms, neck, eyes, inside palm of hands. It is awfully itchy, burning and unbearable, keeping me awake. Tried Benadryl, several steroid creams, the patient is still suffering after 10 days. Therapeutic measures were taken as a result of when the itching and hives around my writs, neck, forearms, eyes, palms front and back would disappear (urticaria), when the itching and hives around my writs, neck, forearms, eyes, palms front and back would disappear (pruritus), i have an itchy rash around my wrists, underneath my breasts and on my forearms that is spreading further around these areas. (rash pruritic), rings of redness around my wrist and beneath my arm (erythema), keeping me awake (insomnia): Benadryl, Loratidine, Trimcinolone Acetonid + Fluo, Benadryl Allergy Antihistamine 25 mg gels tablets. The outcome of the event sick, tired, burning, Worse allergy was unknown, while not recovered for the other events.   Follow-up attempts are completed. No further information is expected.
Age: 68.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Burning sensation, Erythema, Fatigue, Hypersensitivity, Illness
Clinical narrative: rings of redness around my wrist and beneath my arm; sick; tired; burning; Worse allergy; When the itching and hives around my writs, neck, forearms, eyes, palms front and back would disappear; When the itching and hives around my writs, neck, forearms, eyes, palms front and back would disappear; keeping me awake; I have an itchy rash around my wrists, underneath my breasts and on my forearms that is spreading further around these areas.; This is a spontaneous report from a contactable consumer. A 68-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), dose 1 via an unspecified route of administration, administered in Arm Left on 04May2021 04:00 (Batch/Lot Number: ENO273) as 1ST DOSE, SINGLE for covid-19 immunisation. Medical history included known allergies: Aspirin. Concomitant medications included vitamin c [ascorbic acid] (VITAMIN C [ASCORBIC ACID]). On 04May2021 04:00, I have an itchy rash around my wrists, underneath my breasts and on my forearms that is spreading further around these areas. On 04May2021 16:45, When the itching and hives around my writs, neck, forearms, eyes, palms front and back/ hives in the arms, neck would disappear> I tried all kind of ointments and antihistamines. This has being going on for 10 days. On an unspecified date, rings of redness around my wrist and beneath my arm, tired, burning, Worse allergy. Hives around both writs, on forearms, neck, eyes, inside palm of hands. It is awfully itchy, burning and unbearable, keeping me awake. Tried Benadryl, several steroid creams, the patient is still suffering after 10 days. Therapeutic measures were taken as a result of when the itching and hives around my writs, neck, forearms, eyes, palms front and back would disappear (urticaria), when the itching and hives around my writs, neck, forearms, eyes, palms front and back would disappear (pruritus), i have an itchy rash around my wrists, underneath my breasts and on my forearms that is spreading further around these areas. (rash pruritic), rings of redness around my wrist and beneath my arm (erythema), keeping me awake (insomnia): Benadryl, Loratidine, Trimcinolone Acetonid + Fluo, Benadryl Allergy Antihistamine 25 mg gels tablets. The outcome of the event sick, tired, burning, Worse allergy was unknown, while not recovered for the other events.   Follow-up attempts are completed. No further information is expected.
Age: 68.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Insomnia, Pruritus, Rash pruritic, Urticaria
Clinical narrative: rings of redness around my wrist and beneath my arm; sick; tired; burning; Worse allergy; When the itching and hives around my writs, neck, forearms, eyes, palms front and back would disappear; When the itching and hives around my writs, neck, forearms, eyes, palms front and back would disappear; keeping me awake; I have an itchy rash around my wrists, underneath my breasts and on my forearms that is spreading further around these areas.; This is a spontaneous report from a contactable consumer. A 68-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), dose 1 via an unspecified route of administration, administered in Arm Left on 04May2021 04:00 (Batch/Lot Number: ENO273) as 1ST DOSE, SINGLE for covid-19 immunisation. Medical history included known allergies: Aspirin. Concomitant medications included vitamin c [ascorbic acid] (VITAMIN C [ASCORBIC ACID]). On 04May2021 04:00, I have an itchy rash around my wrists, underneath my breasts and on my forearms that is spreading further around these areas. On 04May2021 16:45, When the itching and hives around my writs, neck, forearms, eyes, palms front and back/ hives in the arms, neck would disappear> I tried all kind of ointments and antihistamines. This has being going on for 10 days. On an unspecified date, rings of redness around my wrist and beneath my arm, tired, burning, Worse allergy. Hives around both writs, on forearms, neck, eyes, inside palm of hands. It is awfully itchy, burning and unbearable, keeping me awake. Tried Benadryl, several steroid creams, the patient is still suffering after 10 days. Therapeutic measures were taken as a result of when the itching and hives around my writs, neck, forearms, eyes, palms front and back would disappear (urticaria), when the itching and hives around my writs, neck, forearms, eyes, palms front and back would disappear (pruritus), i have an itchy rash around my wrists, underneath my breasts and on my forearms that is spreading further around these areas. (rash pruritic), rings of redness around my wrist and beneath my arm (erythema), keeping me awake (insomnia): Benadryl, Loratidine, Trimcinolone Acetonid + Fluo, Benadryl Allergy Antihistamine 25 mg gels tablets. The outcome of the event sick, tired, burning, Worse allergy was unknown, while not recovered for the other events.   Follow-up attempts are completed. No further information is expected.
Age: 74.0
Sex: M
Vaccine: COVID19, COVID19, COVID19, COVID19
Symptoms: COVID-19, COVID-19 pneumonia, Endotracheal intubation, Intensive care, Respiratory distress
Clinical narrative: COVID-19 INFECTION, DIED 5/8/2021
Age: 74.0
Sex: M
Vaccine: COVID19, COVID19, COVID19, COVID19
Symptoms: SARS-CoV-2 test positive
Clinical narrative: COVID-19 INFECTION, DIED 5/8/2021
Age: 74.0
Sex: M
Vaccine: COVID19, COVID19, COVID19, COVID19
Symptoms: COVID-19, Death, SARS-CoV-2 test, SARS-CoV-2 test positive
Clinical narrative: COVID-19 INFECTION, DIED 5/8/2021
Age: 61.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Burning sensation, Cough, Headache, Nasopharyngitis, Paranasal sinus hypersecretion
Clinical narrative: Bad cold; Coughing, from a dry cough at first to a very wet cough; Coughing, from a dry cough at first to a very wet cough; Very large thick solid segments of gelled mucous coming out of my sinuses; could not think as tightly as usual on 19Apr2021; Sinuses became burning; Bad headaches; Unusally tired; This is a spontaneous report from a contactable consumer (patient). A 61-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) dose 2 via an unspecified route of administration, administered in arm left on 16Apr2021 17:00 (Lot Number: Lot EW0151) as 2nd dose, single for covid-19 immunisation. Medical history included Mild seizure disorder and Hay fever. No known allergies. Concomitant medications received within 2 weeks of vaccination included carbamazepine; oxcarbazepine; diphenhydramine hydrochloride (BENADRYL). The patient Did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient previously received first dose of BNT162B2 in arm left on 20Mar2021 05:00 PM (Lot number: ER8727). Prior to vaccination, patient was not diagnosed with COVID-19. Since the vaccination, patient has not been tested for COVID-19. No other vaccine in four weeks. The patient felt fine following the 2nd shot, for 48 hours on 18Apr2021, but unusually tired so he knew it must had been the shot. The next day on 19Apr2021 his sinuses became burning and he assumed it was hay fever because he had experienced some symptoms of that for the previous two weeks. But the next day on 20Apr2021, Tuesday, it was worst, like a bad cold (which all of this "reaction" may had been), but then the next 3 days he could barely get out of bed and that's unusual because he run every day and nothing stops him, including a cold. he had bad headaches on 19Apr2021 for 5 days or so and symptoms included coughing, from a dry cough at first that Wednesday to a very wet cough and very large thick solid segments of gelled mucous coming out of his sinuses, something he had never seen before. After almost two weeks he felt better but was still coughing, and now three weeks later he was still really tired, could not think as tightly as usual on 19Apr2021. His doctor's office told him not to come in, just to take pain reliever and cough syrup, which he was doing anyway. Test was neg. The adverse event result in doctor or other healthcare professional office/clinic visit. No covid prior vaccination. The patient underwent lab tests included covid test (Nasal Swab): negative on 24Apr2021. The outcome of events could not think as tightly as usual on 19Apr2021, sinuses became burning, bad cold, bad headaches and very large thick solid segments of gelled mucous coming out of my sinuses was recovered and other events was not recovered.  No follow-up attempts are needed. No further information is expected.
Age: 61.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: SARS-CoV-2 test negative
Clinical narrative: Bad cold; Coughing, from a dry cough at first to a very wet cough; Coughing, from a dry cough at first to a very wet cough; Very large thick solid segments of gelled mucous coming out of my sinuses; could not think as tightly as usual on 19Apr2021; Sinuses became burning; Bad headaches; Unusally tired; This is a spontaneous report from a contactable consumer (patient). A 61-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) dose 2 via an unspecified route of administration, administered in arm left on 16Apr2021 17:00 (Lot Number: Lot EW0151) as 2nd dose, single for covid-19 immunisation. Medical history included Mild seizure disorder and Hay fever. No known allergies. Concomitant medications received within 2 weeks of vaccination included carbamazepine; oxcarbazepine; diphenhydramine hydrochloride (BENADRYL). The patient Did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient previously received first dose of BNT162B2 in arm left on 20Mar2021 05:00 PM (Lot number: ER8727). Prior to vaccination, patient was not diagnosed with COVID-19. Since the vaccination, patient has not been tested for COVID-19. No other vaccine in four weeks. The patient felt fine following the 2nd shot, for 48 hours on 18Apr2021, but unusually tired so he knew it must had been the shot. The next day on 19Apr2021 his sinuses became burning and he assumed it was hay fever because he had experienced some symptoms of that for the previous two weeks. But the next day on 20Apr2021, Tuesday, it was worst, like a bad cold (which all of this "reaction" may had been), but then the next 3 days he could barely get out of bed and that's unusual because he run every day and nothing stops him, including a cold. he had bad headaches on 19Apr2021 for 5 days or so and symptoms included coughing, from a dry cough at first that Wednesday to a very wet cough and very large thick solid segments of gelled mucous coming out of his sinuses, something he had never seen before. After almost two weeks he felt better but was still coughing, and now three weeks later he was still really tired, could not think as tightly as usual on 19Apr2021. His doctor's office told him not to come in, just to take pain reliever and cough syrup, which he was doing anyway. Test was neg. The adverse event result in doctor or other healthcare professional office/clinic visit. No covid prior vaccination. The patient underwent lab tests included covid test (Nasal Swab): negative on 24Apr2021. The outcome of events could not think as tightly as usual on 19Apr2021, sinuses became burning, bad cold, bad headaches and very large thick solid segments of gelled mucous coming out of my sinuses was recovered and other events was not recovered.  No follow-up attempts are needed. No further information is expected.
Age: 61.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Cough, Fatigue, Headache, Nasal discomfort, Nasopharyngitis
Clinical narrative: Bad cold; Coughing, from a dry cough at first to a very wet cough; Coughing, from a dry cough at first to a very wet cough; Very large thick solid segments of gelled mucous coming out of my sinuses; could not think as tightly as usual on 19Apr2021; Sinuses became burning; Bad headaches; Unusally tired; This is a spontaneous report from a contactable consumer (patient). A 61-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) dose 2 via an unspecified route of administration, administered in arm left on 16Apr2021 17:00 (Lot Number: Lot EW0151) as 2nd dose, single for covid-19 immunisation. Medical history included Mild seizure disorder and Hay fever. No known allergies. Concomitant medications received within 2 weeks of vaccination included carbamazepine; oxcarbazepine; diphenhydramine hydrochloride (BENADRYL). The patient Did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient previously received first dose of BNT162B2 in arm left on 20Mar2021 05:00 PM (Lot number: ER8727). Prior to vaccination, patient was not diagnosed with COVID-19. Since the vaccination, patient has not been tested for COVID-19. No other vaccine in four weeks. The patient felt fine following the 2nd shot, for 48 hours on 18Apr2021, but unusually tired so he knew it must had been the shot. The next day on 19Apr2021 his sinuses became burning and he assumed it was hay fever because he had experienced some symptoms of that for the previous two weeks. But the next day on 20Apr2021, Tuesday, it was worst, like a bad cold (which all of this "reaction" may had been), but then the next 3 days he could barely get out of bed and that's unusual because he run every day and nothing stops him, including a cold. he had bad headaches on 19Apr2021 for 5 days or so and symptoms included coughing, from a dry cough at first that Wednesday to a very wet cough and very large thick solid segments of gelled mucous coming out of his sinuses, something he had never seen before. After almost two weeks he felt better but was still coughing, and now three weeks later he was still really tired, could not think as tightly as usual on 19Apr2021. His doctor's office told him not to come in, just to take pain reliever and cough syrup, which he was doing anyway. Test was neg. The adverse event result in doctor or other healthcare professional office/clinic visit. No covid prior vaccination. The patient underwent lab tests included covid test (Nasal Swab): negative on 24Apr2021. The outcome of events could not think as tightly as usual on 19Apr2021, sinuses became burning, bad cold, bad headaches and very large thick solid segments of gelled mucous coming out of my sinuses was recovered and other events was not recovered.  No follow-up attempts are needed. No further information is expected.
Age: 61.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Paranasal sinus hypersecretion, Productive cough, SARS-CoV-2 test, Thinking abnormal
Clinical narrative: Bad cold; Coughing, from a dry cough at first to a very wet cough; Coughing, from a dry cough at first to a very wet cough; Very large thick solid segments of gelled mucous coming out of my sinuses; could not think as tightly as usual on 19Apr2021; Sinuses became burning; Bad headaches; Unusally tired; This is a spontaneous report from a contactable consumer (patient). A 61-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) dose 2 via an unspecified route of administration, administered in arm left on 16Apr2021 17:00 (Lot Number: Lot EW0151) as 2nd dose, single for covid-19 immunisation. Medical history included Mild seizure disorder and Hay fever. No known allergies. Concomitant medications received within 2 weeks of vaccination included carbamazepine; oxcarbazepine; diphenhydramine hydrochloride (BENADRYL). The patient Did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient previously received first dose of BNT162B2 in arm left on 20Mar2021 05:00 PM (Lot number: ER8727). Prior to vaccination, patient was not diagnosed with COVID-19. Since the vaccination, patient has not been tested for COVID-19. No other vaccine in four weeks. The patient felt fine following the 2nd shot, for 48 hours on 18Apr2021, but unusually tired so he knew it must had been the shot. The next day on 19Apr2021 his sinuses became burning and he assumed it was hay fever because he had experienced some symptoms of that for the previous two weeks. But the next day on 20Apr2021, Tuesday, it was worst, like a bad cold (which all of this "reaction" may had been), but then the next 3 days he could barely get out of bed and that's unusual because he run every day and nothing stops him, including a cold. he had bad headaches on 19Apr2021 for 5 days or so and symptoms included coughing, from a dry cough at first that Wednesday to a very wet cough and very large thick solid segments of gelled mucous coming out of his sinuses, something he had never seen before. After almost two weeks he felt better but was still coughing, and now three weeks later he was still really tired, could not think as tightly as usual on 19Apr2021. His doctor's office told him not to come in, just to take pain reliever and cough syrup, which he was doing anyway. Test was neg. The adverse event result in doctor or other healthcare professional office/clinic visit. No covid prior vaccination. The patient underwent lab tests included covid test (Nasal Swab): negative on 24Apr2021. The outcome of events could not think as tightly as usual on 19Apr2021, sinuses became burning, bad cold, bad headaches and very large thick solid segments of gelled mucous coming out of my sinuses was recovered and other events was not recovered.  No follow-up attempts are needed. No further information is expected.
Age: 53.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Bell's palsy
Clinical narrative: Bell's palsy-like symptoms: left eye lid drooping, numbness in left check, lips; Bell's palsy-like symptoms: left eye lid drooping, numbness in left check, lips; Bell's palsy-like symptoms: left eye lid drooping, numbness in left check, lips/ Left shoulder, arm hand numbness and tingling/ Left leg numbness and tingling; Bell's palsy-like symptoms: left eye lid drooping, numbness in left check, lips; Left eye pain and dryness; Left eye pain and dryness; Headache behind eye; Left shoulder, arm hand numbness and tingling/ Left leg numbness and tingling; Elevated blood pressure; This is a spontaneous report from a contactable healthcare professional (patient). A 53-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number and expiration date were unknown) at the age of 53-years-old, intramuscular in left arm on 22Apr2021 at 14:00 at 2nd dose, single for COVID-19 immunization. Medical history was reported as none. The patient has no known allergies. It was unknown if the patient has COVID prior to vaccination. Concomitant medication included macrogol 3350 (MIRALAX). The patient previously received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number and expiration date were not provided) at the age of 53-years-old, via an unspecified route of administration on 26Mar2021 at 1st dose, single for COVID-19 immunization. The facility where the most recent COVID-19 vaccine was administered was at a pharmacy/ drug store. On 25Apr2021, the patient experienced Bell's palsy-like symptoms: left eye lid drooping and numbness in left check and lips. He also experienced left eye pain and dryness; headache behind the eye; left shoulder, arm, hand, and left leg numbness and tingling; and elevated blood pressure. The events resulted in doctor or other healthcare professional office/clinic visit. No treatment was given in response to the events. The patient underwent lab tests and procedures which included PCR nasal swab for COVID: negative on 15Apr2021 and blood pressure: elevated on 25Apr2021. The outcome of the events was not recovered.   Information on the lot/ batch number has been requested.; Sender's Comments: Based on temporal association a contributory role of BNT162B2 to the reported events cannot be totally excluded.  The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.