chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 68.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Pain in extremity, Pneumonia viral, Pyrexia, Speech disorder
Clinical narrative: On 02Apr2021, she flared up with asthma (10 days after the second dose); She had flu-like symptoms for 2-3 days and these symptoms and the headache were gone on 28Mar2021; She had flu-like symptoms for 2-3 days and these symptoms and the headache were gone on 28Mar2021; This is a spontaneous report from a contactable pharmacist (patient). A 68-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Lot Number: Unknown, and Expiration date: Unknown), via an unspecified route of administration on 24Mar2021 (at the age of 68-year-old) as dose 2, single for COVID-19 immunization. The patient medical history included Flu in Jan2021 (she had a bad episode of flu (maybe Covid)) and ongoing asthma (in Jan2021, flared up her asthma). Concomitant medication included fluticasone propionate, salmeterol xinafoate (ADVAIR) and salbutamol sulfate (PROAIR [SALBUTAMOL SULFATE]). The patient previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Lot Number: Unknown, and Expiration date: Unknown), via an unspecified route of administration on an unspecified date as dose 1, single for COVID-19 immunization. It was reported that, the patient received the second dose of the Pfizer-BioNtech Covid-19 vaccine on 24Mar2021. On an unspecified date in Mar2021, "she had flu-like symptoms for 2-3 days and these symptoms and the headache were gone on 28Mar2021". On 02Apr2021, she flared up with asthma (10 days after the second dose). The patient wanted to know if this had been seen during the clinical trials or reported (anything that affects the immune system). The patient stated she usually takes a low dose of Advair and Proair. Around 03Apr2021 she received Duoneb nebulizer solution as a treatment for flared up asthma. The case was reported as non-serious. The outcome of the events flu like symptoms and headache was reported as resolved on 28Mar2021. The outcome of event "On 02Apr2021, she flared up with asthma (10 days after the second dose)" was unknown.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Age: 68.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Asthma, Headache, Influenza like illness
Clinical narrative: On 02Apr2021, she flared up with asthma (10 days after the second dose); She had flu-like symptoms for 2-3 days and these symptoms and the headache were gone on 28Mar2021; She had flu-like symptoms for 2-3 days and these symptoms and the headache were gone on 28Mar2021; This is a spontaneous report from a contactable pharmacist (patient). A 68-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Lot Number: Unknown, and Expiration date: Unknown), via an unspecified route of administration on 24Mar2021 (at the age of 68-year-old) as dose 2, single for COVID-19 immunization. The patient medical history included Flu in Jan2021 (she had a bad episode of flu (maybe Covid)) and ongoing asthma (in Jan2021, flared up her asthma). Concomitant medication included fluticasone propionate, salmeterol xinafoate (ADVAIR) and salbutamol sulfate (PROAIR [SALBUTAMOL SULFATE]). The patient previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Lot Number: Unknown, and Expiration date: Unknown), via an unspecified route of administration on an unspecified date as dose 1, single for COVID-19 immunization. It was reported that, the patient received the second dose of the Pfizer-BioNtech Covid-19 vaccine on 24Mar2021. On an unspecified date in Mar2021, "she had flu-like symptoms for 2-3 days and these symptoms and the headache were gone on 28Mar2021". On 02Apr2021, she flared up with asthma (10 days after the second dose). The patient wanted to know if this had been seen during the clinical trials or reported (anything that affects the immune system). The patient stated she usually takes a low dose of Advair and Proair. Around 03Apr2021 she received Duoneb nebulizer solution as a treatment for flared up asthma. The case was reported as non-serious. The outcome of the events flu like symptoms and headache was reported as resolved on 28Mar2021. The outcome of event "On 02Apr2021, she flared up with asthma (10 days after the second dose)" was unknown.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Age: 62.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Asthenia, Chills, Fatigue, Headache, Lymphadenopathy
Clinical narrative: Chills; I had a temperature, my first temperature was a 100.5 and then later on it was 102; Next time it was 101; Swollen lymph nodes; Under my arm is a little, it is soft and it is sore to touch; Tired; Nauseous; Still have a slight headache; Started feeling real bad; This is a spontaneous report from a contactable consumer (patient herself). A 62-years-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot Number: ER8731; Expiration Date: unknown) via an unspecified route of administration on 07Apr2021 (at the age of 62-years-old) as DOSE 2, SINGLE for COVID-19 immunization. The patient medical history and concomitant medications were not reported. Historical vaccine included first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot Number: EN6207; Expiration Date: unknown) via an unspecified route of administration on 17Mar2021 as DOSE 1, SINGLE for COVID-19 immunization. It was reported that, patient called to report she did have side effects with the Pfizer. On an unspecified date she had chills, fever, swollen lymph nodes and under arm was a little, it was soft, sore to touch but it was not hard. She was tired and kept feeling nauseous and this was her second shot. After the shot patient went home and then she started feeling real bad. She had a temperature, her first temperature was a 100.5 and then later on it was 102 when her husband checked and then next time it was 101. She did took some generic Tylenol 500 mg (as treatment; it said not exceed more than 6 a day). She still had a slight headache. She did feel a little better but it was not like she was halfway, maybe only 25% better. The patient underwent lab tests and procedures on an unspecified dates which included body temperature: 100.5; first temperature was a 100.5, later on it was 102 when patient's husband checked then next time it was 101. The outcome of all events was unknown.  No follow-up attempts are possible. No further information is expected.
Age: 62.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Nausea, Pyrexia
Clinical narrative: Chills; I had a temperature, my first temperature was a 100.5 and then later on it was 102; Next time it was 101; Swollen lymph nodes; Under my arm is a little, it is soft and it is sore to touch; Tired; Nauseous; Still have a slight headache; Started feeling real bad; This is a spontaneous report from a contactable consumer (patient herself). A 62-years-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot Number: ER8731; Expiration Date: unknown) via an unspecified route of administration on 07Apr2021 (at the age of 62-years-old) as DOSE 2, SINGLE for COVID-19 immunization. The patient medical history and concomitant medications were not reported. Historical vaccine included first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot Number: EN6207; Expiration Date: unknown) via an unspecified route of administration on 17Mar2021 as DOSE 1, SINGLE for COVID-19 immunization. It was reported that, patient called to report she did have side effects with the Pfizer. On an unspecified date she had chills, fever, swollen lymph nodes and under arm was a little, it was soft, sore to touch but it was not hard. She was tired and kept feeling nauseous and this was her second shot. After the shot patient went home and then she started feeling real bad. She had a temperature, her first temperature was a 100.5 and then later on it was 102 when her husband checked and then next time it was 101. She did took some generic Tylenol 500 mg (as treatment; it said not exceed more than 6 a day). She still had a slight headache. She did feel a little better but it was not like she was halfway, maybe only 25% better. The patient underwent lab tests and procedures on an unspecified dates which included body temperature: 100.5; first temperature was a 100.5, later on it was 102 when patient's husband checked then next time it was 101. The outcome of all events was unknown.  No follow-up attempts are possible. No further information is expected.
Age: 62.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Arthralgia, Body temperature, Chills, Fatigue, Feeling abnormal
Clinical narrative: Chills; I had a temperature, my first temperature was a 100.5 and then later on it was 102; Next time it was 101; Swollen lymph nodes; Under my arm is a little, it is soft and it is sore to touch; Tired; Nauseous; Still have a slight headache; Started feeling real bad; This is a spontaneous report from a contactable consumer (patient herself). A 62-years-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot Number: ER8731; Expiration Date: unknown) via an unspecified route of administration on 07Apr2021 (at the age of 62-years-old) as DOSE 2, SINGLE for COVID-19 immunization. The patient medical history and concomitant medications were not reported. Historical vaccine included first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot Number: EN6207; Expiration Date: unknown) via an unspecified route of administration on 17Mar2021 as DOSE 1, SINGLE for COVID-19 immunization. It was reported that, patient called to report she did have side effects with the Pfizer. On an unspecified date she had chills, fever, swollen lymph nodes and under arm was a little, it was soft, sore to touch but it was not hard. She was tired and kept feeling nauseous and this was her second shot. After the shot patient went home and then she started feeling real bad. She had a temperature, her first temperature was a 100.5 and then later on it was 102 when her husband checked and then next time it was 101. She did took some generic Tylenol 500 mg (as treatment; it said not exceed more than 6 a day). She still had a slight headache. She did feel a little better but it was not like she was halfway, maybe only 25% better. The patient underwent lab tests and procedures on an unspecified dates which included body temperature: 100.5; first temperature was a 100.5, later on it was 102 when patient's husband checked then next time it was 101. The outcome of all events was unknown.  No follow-up attempts are possible. No further information is expected.
Age: 62.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Headache, Lymphadenopathy, Nausea, Pyrexia
Clinical narrative: Chills; I had a temperature, my first temperature was a 100.5 and then later on it was 102; Next time it was 101; Swollen lymph nodes; Under my arm is a little, it is soft and it is sore to touch; Tired; Nauseous; Still have a slight headache; Started feeling real bad; This is a spontaneous report from a contactable consumer (patient herself). A 62-years-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot Number: ER8731; Expiration Date: unknown) via an unspecified route of administration on 07Apr2021 (at the age of 62-years-old) as DOSE 2, SINGLE for COVID-19 immunization. The patient medical history and concomitant medications were not reported. Historical vaccine included first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot Number: EN6207; Expiration Date: unknown) via an unspecified route of administration on 17Mar2021 as DOSE 1, SINGLE for COVID-19 immunization. It was reported that, patient called to report she did have side effects with the Pfizer. On an unspecified date she had chills, fever, swollen lymph nodes and under arm was a little, it was soft, sore to touch but it was not hard. She was tired and kept feeling nauseous and this was her second shot. After the shot patient went home and then she started feeling real bad. She had a temperature, her first temperature was a 100.5 and then later on it was 102 when her husband checked and then next time it was 101. She did took some generic Tylenol 500 mg (as treatment; it said not exceed more than 6 a day). She still had a slight headache. She did feel a little better but it was not like she was halfway, maybe only 25% better. The patient underwent lab tests and procedures on an unspecified dates which included body temperature: 100.5; first temperature was a 100.5, later on it was 102 when patient's husband checked then next time it was 101. The outcome of all events was unknown.  No follow-up attempts are possible. No further information is expected.
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Blood test, Computerised tomogram head, Impaired work ability, Loss of personal independence in daily activities, Migraine
Clinical narrative: CARPAL TUNNEL SYNDROME; PAIN; This spontaneous report received from a patient concerned a female of unspecified age, race and ethnicity. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose was not reported, 1 total, administered on 26-APR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported.  On 27-APR-2021, the patient experienced pain. On 23-MAY-2021, the patient experienced extreme pain and cramping in her thumb, wrist area and left hand. On 24-MAY-2021 Monday, patient went to the doctor and diagnosed with carpal tunnel (Coded as carpal tunnel syndrome). Patient stated that, the tests were not conclusive. Patient reported that, the pain was continued and changed to burning and tingling in the wrist and hand. The same pain patient was experienced the day following the vaccination which was lasted for a one day. Patient stated that, this extreme pain was lasted for 6 months. On an unspecified date, patient had a surgery. Patient reported that, she was known that, she had no Guillain barre, but believed that the events were from vaccine. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from pain on 27-APR-2021, and had not recovered from carpal tunnel syndrome. This report was serious (Other Medically Important Condition).; Sender's Comments: V0- 20211049635-covid-19 vaccine ad26.cov2.s-carpal tunnel syndrome. This event(s) is considered unassessable. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s).
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Carpal tunnel syndrome, Pain
Clinical narrative: CARPAL TUNNEL SYNDROME; PAIN; This spontaneous report received from a patient concerned a female of unspecified age, race and ethnicity. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose was not reported, 1 total, administered on 26-APR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported.  On 27-APR-2021, the patient experienced pain. On 23-MAY-2021, the patient experienced extreme pain and cramping in her thumb, wrist area and left hand. On 24-MAY-2021 Monday, patient went to the doctor and diagnosed with carpal tunnel (Coded as carpal tunnel syndrome). Patient stated that, the tests were not conclusive. Patient reported that, the pain was continued and changed to burning and tingling in the wrist and hand. The same pain patient was experienced the day following the vaccination which was lasted for a one day. Patient stated that, this extreme pain was lasted for 6 months. On an unspecified date, patient had a surgery. Patient reported that, she was known that, she had no Guillain barre, but believed that the events were from vaccine. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from pain on 27-APR-2021, and had not recovered from carpal tunnel syndrome. This report was serious (Other Medically Important Condition).; Sender's Comments: V0- 20211049635-covid-19 vaccine ad26.cov2.s-carpal tunnel syndrome. This event(s) is considered unassessable. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s).
Age: 68.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Arthralgia, Fatigue, Injection site pain, Poor quality sleep
Clinical narrative: pain in my vaccinated arm; fatigue; joint pain/These pains are chiefly in all my upper body joints,particularly in my hands, and they occur daily; pain in my vaccinated arm; This is a spontaneous report from a contactable consumer or other non hcp. A 68-year-old male patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Batch/Lot Number: EW0175) via an unspecified route of administration, administered in left arm on 29Apr2021 11:00 (age at vaccination: 68-year-old) as DOSE 2, SINGLE for COVID-19 immunisation. Medical history included hypothyroidism from an unknown date and unknown if ongoing. Concomitant medication was not provided. Previously, the patient had received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Batch/Lot Number: ER8737) via an unspecified route of administration, administered in left arm on 08Apr2021 11:00 as DOSE 1, SINGLE for COVID-19 immunisation. Patient had no known allergies. On 30Apr2021 the patient experienced pain in my vaccinated arm, fatigue recovering, joint pain/these pains are chiefly in all my upper body joints, particularly in my hands, and they occur daily. The patient received vaccine in Health Clinic facility and the adverse events were reported. The patient had not received any other vaccine within 4 weeks. Patient received no treatment for the event. Ae resulted in Doctor or other healthcare professional office/clinic visit. The patient had not been diagnosed with COVID-19 prior to vaccination and had not been tested since the vaccination. The outcome of pain in my vaccinated arm and fatigue was recovering whereas Arthralgia is Not recovered.  Follow-up attempts are completed. No further information is expected.
Age: 68.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Arthralgia, Fatigue, Pain in extremity, Vaccination site pain
Clinical narrative: pain in my vaccinated arm; fatigue; joint pain/These pains are chiefly in all my upper body joints,particularly in my hands, and they occur daily; pain in my vaccinated arm; This is a spontaneous report from a contactable consumer or other non hcp. A 68-year-old male patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Batch/Lot Number: EW0175) via an unspecified route of administration, administered in left arm on 29Apr2021 11:00 (age at vaccination: 68-year-old) as DOSE 2, SINGLE for COVID-19 immunisation. Medical history included hypothyroidism from an unknown date and unknown if ongoing. Concomitant medication was not provided. Previously, the patient had received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Batch/Lot Number: ER8737) via an unspecified route of administration, administered in left arm on 08Apr2021 11:00 as DOSE 1, SINGLE for COVID-19 immunisation. Patient had no known allergies. On 30Apr2021 the patient experienced pain in my vaccinated arm, fatigue recovering, joint pain/these pains are chiefly in all my upper body joints, particularly in my hands, and they occur daily. The patient received vaccine in Health Clinic facility and the adverse events were reported. The patient had not received any other vaccine within 4 weeks. Patient received no treatment for the event. Ae resulted in Doctor or other healthcare professional office/clinic visit. The patient had not been diagnosed with COVID-19 prior to vaccination and had not been tested since the vaccination. The outcome of pain in my vaccinated arm and fatigue was recovering whereas Arthralgia is Not recovered.  Follow-up attempts are completed. No further information is expected.
Age: 61.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Injection site pain, Injection site reaction, Injection site swelling, Injection site warmth, Peripheral swelling
Clinical narrative: This is a spontaneous report from a contactable nurse. A 61-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8731) via an intramuscular route of administration in the right arm on 21Apr2021 at 11:00 (at the age of 61-years-old) as a single dose for COVID-19 immunisation. Medical history included rheumatoid arthritis (RA), osteoarthritis, fibromyalgia and known allergies to sulfa and invisible sutures. Prior to vaccination, the patient was not diagnosed with COVID-19. Concomitant medications included pravastatin (MANUFACTURER UNKNOWN) and celecoxib (CELEBREX), all from an unknown date for an unknown indication and unknown if ongoing. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. The patient previously took erythromycin (MANUFACTURER UNKNOWN) and terbinafine(LAMISIL) and experienced drug allergy. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8733) via an unspecified route of administration on 31Mar2021 (at the age of 61-years-old) as a single dose for COVID-19 immunisation. On 01May2021 at 01:00, the patient experienced a bump on her forearm that appeared on 01May2021 and then her shoulder was read and swollen with bumps and very painful. The event resulted in doctor or other healthcare professional office/clinic visit. Therapeutic measures were taken as a result of events and included treatment with gabapentin (MANUFACTURER UNKNOWN), ciprofloxacin (CIPRO) and prednisone (MANUFACTURER UNKNOWN). Since the vaccination, it was unknown whether the patient had been tested for COVID-19. The clinical outcome of the events bump on her forearm, shoulder was read and swollen with bumps and very painful was unknown at the time of this report.   No follow-up attempts are needed. No further information is expected.
Age: 61.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Rash macular, X-ray
Clinical narrative: This is a spontaneous report from a contactable nurse. A 61-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8731) via an intramuscular route of administration in the right arm on 21Apr2021 at 11:00 (at the age of 61-years-old) as a single dose for COVID-19 immunisation. Medical history included rheumatoid arthritis (RA), osteoarthritis, fibromyalgia and known allergies to sulfa and invisible sutures. Prior to vaccination, the patient was not diagnosed with COVID-19. Concomitant medications included pravastatin (MANUFACTURER UNKNOWN) and celecoxib (CELEBREX), all from an unknown date for an unknown indication and unknown if ongoing. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. The patient previously took erythromycin (MANUFACTURER UNKNOWN) and terbinafine(LAMISIL) and experienced drug allergy. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8733) via an unspecified route of administration on 31Mar2021 (at the age of 61-years-old) as a single dose for COVID-19 immunisation. On 01May2021 at 01:00, the patient experienced a bump on her forearm that appeared on 01May2021 and then her shoulder was read and swollen with bumps and very painful. The event resulted in doctor or other healthcare professional office/clinic visit. Therapeutic measures were taken as a result of events and included treatment with gabapentin (MANUFACTURER UNKNOWN), ciprofloxacin (CIPRO) and prednisone (MANUFACTURER UNKNOWN). Since the vaccination, it was unknown whether the patient had been tested for COVID-19. The clinical outcome of the events bump on her forearm, shoulder was read and swollen with bumps and very painful was unknown at the time of this report.   No follow-up attempts are needed. No further information is expected.
Age: 61.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Arthralgia, Erythema, Joint swelling, Peripheral swelling
Clinical narrative: This is a spontaneous report from a contactable nurse. A 61-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8731) via an intramuscular route of administration in the right arm on 21Apr2021 at 11:00 (at the age of 61-years-old) as a single dose for COVID-19 immunisation. Medical history included rheumatoid arthritis (RA), osteoarthritis, fibromyalgia and known allergies to sulfa and invisible sutures. Prior to vaccination, the patient was not diagnosed with COVID-19. Concomitant medications included pravastatin (MANUFACTURER UNKNOWN) and celecoxib (CELEBREX), all from an unknown date for an unknown indication and unknown if ongoing. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. The patient previously took erythromycin (MANUFACTURER UNKNOWN) and terbinafine(LAMISIL) and experienced drug allergy. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8733) via an unspecified route of administration on 31Mar2021 (at the age of 61-years-old) as a single dose for COVID-19 immunisation. On 01May2021 at 01:00, the patient experienced a bump on her forearm that appeared on 01May2021 and then her shoulder was read and swollen with bumps and very painful. The event resulted in doctor or other healthcare professional office/clinic visit. Therapeutic measures were taken as a result of events and included treatment with gabapentin (MANUFACTURER UNKNOWN), ciprofloxacin (CIPRO) and prednisone (MANUFACTURER UNKNOWN). Since the vaccination, it was unknown whether the patient had been tested for COVID-19. The clinical outcome of the events bump on her forearm, shoulder was read and swollen with bumps and very painful was unknown at the time of this report.   No follow-up attempts are needed. No further information is expected.
Age: 45.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Eye irritation, Headache, Pain, Pruritus, Pustule
Clinical narrative: Within an hour and a half develop pruritic, hive-like lesions that then morphed into more of a pustule appearance; Eyes were burning; With in an hour got hives/ Hives on legs, arms, neck, thighs and trunk; Headache; Body aches/ severe body aches the night of the shot.; This is a spontaneous report from a contactable consumer, the patient. A 45-year-old non-pregnant female patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0171) via an unspecified route of administration in the arm left on 21Apr2021 at 14:15 (at the age of 45-year-old) as a single dose for COVID-19 immunisation. Medical history included penicillin allergy. 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 furosemide (MANUFACTURER UNKNOWN), potassium chloride (KLOR-CON) and loratadine (CLARITIN); all for an unknown indication from an unknown start date and unknown if ongoing. The patient previously received erythromycin (MANUFACTURER UNKNOWN) on an unknown date and experienced allergy. On 21Apr2021 at 15:15, within an hour of vaccination, the patient experienced hives, headache and eyes were burning and body aches. At 15:45, within an hour and a half, the patient developed pruritic, hive-like lesions that then morphed into more of a pustule appearance. It was on legs, arms, neck, thighs, and trunk. Also, the patient had severe body aches the night of the shot. The events resulted in doctor or other healthcare professional office/clinic visit. Therapeutic measure was taken as a result of events which included treatment with fluocinonide (MANUFACTURER UNKNOWN) 0.05 % cream 2 times a day from an unknown date. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events within an hour got hives/ hives on legs, arms, neck, thighs and trunk, headache, body aches, pruritic hive-like lesions that then morphed into more of a pustule appearance and eyes were burning was resolving at the time of this report.   No follow-up attempts are needed. No further information is expected.
Age: 45.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Skin lesion, Urticaria
Clinical narrative: Within an hour and a half develop pruritic, hive-like lesions that then morphed into more of a pustule appearance; Eyes were burning; With in an hour got hives/ Hives on legs, arms, neck, thighs and trunk; Headache; Body aches/ severe body aches the night of the shot.; This is a spontaneous report from a contactable consumer, the patient. A 45-year-old non-pregnant female patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0171) via an unspecified route of administration in the arm left on 21Apr2021 at 14:15 (at the age of 45-year-old) as a single dose for COVID-19 immunisation. Medical history included penicillin allergy. 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 furosemide (MANUFACTURER UNKNOWN), potassium chloride (KLOR-CON) and loratadine (CLARITIN); all for an unknown indication from an unknown start date and unknown if ongoing. The patient previously received erythromycin (MANUFACTURER UNKNOWN) on an unknown date and experienced allergy. On 21Apr2021 at 15:15, within an hour of vaccination, the patient experienced hives, headache and eyes were burning and body aches. At 15:45, within an hour and a half, the patient developed pruritic, hive-like lesions that then morphed into more of a pustule appearance. It was on legs, arms, neck, thighs, and trunk. Also, the patient had severe body aches the night of the shot. The events resulted in doctor or other healthcare professional office/clinic visit. Therapeutic measure was taken as a result of events which included treatment with fluocinonide (MANUFACTURER UNKNOWN) 0.05 % cream 2 times a day from an unknown date. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events within an hour got hives/ hives on legs, arms, neck, thighs and trunk, headache, body aches, pruritic hive-like lesions that then morphed into more of a pustule appearance and eyes were burning was resolving at the time of this report.   No follow-up attempts are needed. No further information is expected.
Age: 45.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Eye irritation, Headache, Pain, Pruritus, Urticaria
Clinical narrative: Within an hour and a half develop pruritic, hive-like lesions that then morphed into more of a pustule appearance; Eyes were burning; With in an hour got hives/ Hives on legs, arms, neck, thighs and trunk; Headache; Body aches/ severe body aches the night of the shot.; This is a spontaneous report from a contactable consumer, the patient. A 45-year-old non-pregnant female patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0171) via an unspecified route of administration in the arm left on 21Apr2021 at 14:15 (at the age of 45-year-old) as a single dose for COVID-19 immunisation. Medical history included penicillin allergy. 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 furosemide (MANUFACTURER UNKNOWN), potassium chloride (KLOR-CON) and loratadine (CLARITIN); all for an unknown indication from an unknown start date and unknown if ongoing. The patient previously received erythromycin (MANUFACTURER UNKNOWN) on an unknown date and experienced allergy. On 21Apr2021 at 15:15, within an hour of vaccination, the patient experienced hives, headache and eyes were burning and body aches. At 15:45, within an hour and a half, the patient developed pruritic, hive-like lesions that then morphed into more of a pustule appearance. It was on legs, arms, neck, thighs, and trunk. Also, the patient had severe body aches the night of the shot. The events resulted in doctor or other healthcare professional office/clinic visit. Therapeutic measure was taken as a result of events which included treatment with fluocinonide (MANUFACTURER UNKNOWN) 0.05 % cream 2 times a day from an unknown date. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events within an hour got hives/ hives on legs, arms, neck, thighs and trunk, headache, body aches, pruritic hive-like lesions that then morphed into more of a pustule appearance and eyes were burning was resolving at the time of this report.   No follow-up attempts are needed. No further information is expected.
Age: 52.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Arthralgia, Pain, Pain in extremity
Clinical narrative: Quick onset of severe joint pain affecting finger joints, wrists, elbows, shoulder, hips, knees, ankles.; Quick onset of nerve pain throughout my body that continues to be persist/Severe nerve pain/burning from heels of feet to back of calves, behind knees, up thigh to buttocks and flaring at base of spine.; Quick onset of severe joint pain and nerve pain throughout my body that continues to be persist affecting upper and lower back; Severe nerve pain/burning from heels of feet to back of calves, behind knees, up thigh to buttocks and flaring at base of spine.; Pain moves around quickly, and flares in joints and nerves seemingly out of nowhere.; This is a spontaneous report from a contactable consumer, the patient. A 52-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8737) via an unspecified route of administration in the left arm on 12Apr2021 at 11:00 (at the age of 52-years-old) as a single dose for COVID-19 immunisation. Patient had no relevant medical history. The patient had no known allergies. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medications included vitamin d nos (MANUFACTURER UNKNOWN), daily vitamin (MANUFACTURER UNKNOWN) and polycarbophil calcium (FIBER); all from an unknown date for an unknown indication and unknown if ongoing . The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6199) via an unspecified route of administration in the left arm on 11Mar2021 at 13:45 (at the age of 52-years-old) as a single dose for COVID-19 immunisation. On 15Apr2021, the patient experienced quick onset of severe joint pain and nerve pain throughout her body that continues to  persist, affecting the finger joints, wrists, elbows, shoulders, upper and lower back, hips, knees, ankles, severe nerve pain/burning from heels of feet to back of calves, behind knees, up thigh to buttocks and flaring at base of spine, pain moves around quickly, and flares in joints and nerves seemingly out of nowhere. The event resulted in doctor or other healthcare professional office/clinic visit. Therapeutic measures were not taken as a result of the events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events quick onset of severe joint pain and nerve pain throughout her body that continues to be persist, affecting finger joints, wrists, elbows, shoulders, upper and lower back, hips, knees, ankles, severe nerve pain/burning from heels of feet to back of calves, behind knees, up thigh to buttocks and flaring at base of spine, pain moves around quickly, and flares in joints and nerves seemingly out of nowhere were not resolved at the time of this report.   No follow-up attempts are needed. No further information is expected.
Age: 52.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Arthralgia, Back pain, Burning sensation, Neuralgia, Pain
Clinical narrative: Quick onset of severe joint pain affecting finger joints, wrists, elbows, shoulder, hips, knees, ankles.; Quick onset of nerve pain throughout my body that continues to be persist/Severe nerve pain/burning from heels of feet to back of calves, behind knees, up thigh to buttocks and flaring at base of spine.; Quick onset of severe joint pain and nerve pain throughout my body that continues to be persist affecting upper and lower back; Severe nerve pain/burning from heels of feet to back of calves, behind knees, up thigh to buttocks and flaring at base of spine.; Pain moves around quickly, and flares in joints and nerves seemingly out of nowhere.; This is a spontaneous report from a contactable consumer, the patient. A 52-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8737) via an unspecified route of administration in the left arm on 12Apr2021 at 11:00 (at the age of 52-years-old) as a single dose for COVID-19 immunisation. Patient had no relevant medical history. The patient had no known allergies. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medications included vitamin d nos (MANUFACTURER UNKNOWN), daily vitamin (MANUFACTURER UNKNOWN) and polycarbophil calcium (FIBER); all from an unknown date for an unknown indication and unknown if ongoing . The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6199) via an unspecified route of administration in the left arm on 11Mar2021 at 13:45 (at the age of 52-years-old) as a single dose for COVID-19 immunisation. On 15Apr2021, the patient experienced quick onset of severe joint pain and nerve pain throughout her body that continues to  persist, affecting the finger joints, wrists, elbows, shoulders, upper and lower back, hips, knees, ankles, severe nerve pain/burning from heels of feet to back of calves, behind knees, up thigh to buttocks and flaring at base of spine, pain moves around quickly, and flares in joints and nerves seemingly out of nowhere. The event resulted in doctor or other healthcare professional office/clinic visit. Therapeutic measures were not taken as a result of the events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events quick onset of severe joint pain and nerve pain throughout her body that continues to be persist, affecting finger joints, wrists, elbows, shoulders, upper and lower back, hips, knees, ankles, severe nerve pain/burning from heels of feet to back of calves, behind knees, up thigh to buttocks and flaring at base of spine, pain moves around quickly, and flares in joints and nerves seemingly out of nowhere were not resolved at the time of this report.   No follow-up attempts are needed. No further information is expected.
Age: 50.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Dizziness, Motion sickness, Vertigo
Clinical narrative: "I" woke up with dizziness/vertigo, and continued to feel it like motion sickness especially when going up/down stairs or bending over.; "I" woke up with dizziness/vertigo, and continued to feel it like motion sickness especially when going up/down stairs or bending over; "I" woke up with dizziness/vertigo, and continued to feel it like motion sickness especially when going up/down stairs or bending over; This is a spontaneous report from a contactable consumer, the patient. A 50-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 arm left on 09Apr2021 at 12:30 (at the age of 50-years-old) as a single dose for COVID-19 immunisation. The medical history included endometriosis when the patient was young, environmental allergies(pets, dust, pollen, etc.). 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. The concomitant medications included multivitamin(unspecified), iron (MANUFACTURER UNKNOWN), ascorbic acid (VITAMIN C), vitamin d nos (VITAMIN D) and zinc (MANUFACTURER UNKNOWN); all from unknown dates for unknown indications and unknown if ongoing.  On 21Apr2021 at 08:00, 12th day after 1st COVID shot, the patient woke up with dizziness/vertigo, and continued to feel it like motion sickness especially when went up/down stairs or bending over. The patient never experienced this before. That was day 2 of menstrual cycle at the time of report and the patient originally thought perhaps due to that, but not a heavy period. The patient reported that it was severe the first half day and had persisted several days, though gradually got a bit better. The patient treated it with BENADRYL, iron, vitamin C/D/zinc, rest, etc. The therapeutic measures were taken as a result of the reported events and included treatment with diphenhydramine hydrochloride (BENADRYL), iron(MANUFACUTURER UNKNOWN), vitamin C (MANUFACUTURER UNKNOWN), vitamin D(MANUFACUTURER UNKNOWN), zinc (MANUFACUTURER UNKNOWN) and rest. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events dizziness/vertigo, motion sickness was resolved on an unknown date in 2021.   No follow-up attempts are needed. No further information is expected.
Age: 32.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Acoustic stimulation tests, Hyperacusis, Intraocular pressure test, Tinnitus
Clinical narrative: This is a spontaneous report from a contactable consumer, the patient. A 32-year-old male patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0153) via an unspecified route of administration in the left arm on an unknown date in Apr2021 at 12:00 (at the age of 32-years-old), as a single dose for COVID-19 immunisation. The patient had no medical history. Patient had no known allergies. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not take any concomitant medications within 2 weeks of vaccination. The patient did not receive any other vaccines within four weeks prior to the vaccination. On an unknown date in Apr2021 at 14:30, the patient experienced tinnitus and hyperacusis since the shot. The event resulted in doctor or other healthcare professional office/clinic visit. Therapeutic measures were not taken as a result of the events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events tinnitus and hyperacusis were not resolved at the time of this report.  No follow-up attempts are needed. No further information is expected.
Age: 32.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Hyperacusis, Tinnitus
Clinical narrative: This is a spontaneous report from a contactable consumer, the patient. A 32-year-old male patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0153) via an unspecified route of administration in the left arm on an unknown date in Apr2021 at 12:00 (at the age of 32-years-old), as a single dose for COVID-19 immunisation. The patient had no medical history. Patient had no known allergies. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not take any concomitant medications within 2 weeks of vaccination. The patient did not receive any other vaccines within four weeks prior to the vaccination. On an unknown date in Apr2021 at 14:30, the patient experienced tinnitus and hyperacusis since the shot. The event resulted in doctor or other healthcare professional office/clinic visit. Therapeutic measures were not taken as a result of the events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events tinnitus and hyperacusis were not resolved at the time of this report.  No follow-up attempts are needed. No further information is expected.
Age: 82.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Arthralgia, Body temperature increased, Diarrhoea, Dizziness, Fatigue
Clinical narrative: light headed, loss of memory, tired, diarrhea, body aches
Age: 82.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Feeling abnormal, Injection site pain, Nasopharyngitis
Clinical narrative: light headed, loss of memory, tired, diarrhea, body aches
Age: 82.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Amnesia, Diarrhoea, Dizziness, Fatigue, Pain
Clinical narrative: light headed, loss of memory, tired, diarrhea, body aches
Age: 82.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Arthralgia, Balance disorder, Chills, Condition aggravated, Diarrhoea
Clinical narrative: light headed, loss of memory, tired, diarrhea, body aches
Age: 82.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Dizziness, Fatigue, Feeling abnormal, Feeling cold, Memory impairment
Clinical narrative: light headed, loss of memory, tired, diarrhea, body aches
Age: 82.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Pain in extremity, Pyrexia, Vaccination site pain
Clinical narrative: light headed, loss of memory, tired, diarrhea, body aches
Age: 20.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Headache, Pain in extremity, Pyrexia
Clinical narrative: Sore arm; Headache; Fever; Stomach ache; This is a spontaneous report from a contactable consumer, the patient. A 20-year-old male patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8736) via an unspecified route of administration in the left arm on 06May2021 at 15:00 (at the age of 20-years-old) as a single dose for COVID-19 immunisation. Medical history included overweight, anxiety, esophageal reflux and depression. The patient had no known allergies. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. Concomitant medications included daily vitamin (MANUFACTURER UNKNOWN) and sertraline (MANUFACTURER UNKNOWN) for unknown indication from an unknown date and unknown if ongoing. On 06May2021 at 22:30, the patient experienced sore arm, headache, fever and stomach ache. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Therapeutic measures were not taken as a result of the events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events sore arm, headache, fever and stomach ache were unknown at the time of this report.   No follow-up attempts are needed. No further information is expected.