chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 19.0
Sex: F
Vaccine: COVID19
Symptoms: Confusional state, Dizziness, Dysarthria, Fatigue, Feeling abnormal
Clinical narrative: Dizziness; Hungry; Tingling lips; Shakiness/ trembling; Fast heartbeat; Easily irritated; Confusion; Slurred speech; Muscle weakness; Memory issues; Foggy brain; Exhaustion; This is a spontaneous report received from a contactable consumer, the patient. A 19-year-old non-pregnant female patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EN6206) via unspecified route of administration in left arm on 20Mar2021 at 12:00 as a single dose for COVID-19 immunisation. The patients medical history included type 1 diabetes, celiac disease, asthma, vasovagal syncope, chiari malformation and major depressive disorder. The patient was allergic with naproxen, nonsteroidal anti-inflammatory drugs (NSAIDs), avocado and almonds. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within 4 weeks prior vaccination. Concomitant medications included Humalog, Cymbalta and Remeron. On 21Mar2021 at 18:00, the patient experienced dizziness, hungry, tingling lips, shakiness, trembling, fast heartbeat, easily irritated, foggy brain, confusion, slurred speech, muscle weakness, memory issues and exhaustion. After vaccination on 21Mar2021, the patient underwent lab test for COVID-19 (nasal swab test; RT-PCR for SARS-CoV-2) and the result was pending. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The patient did not receive any treatment for these events. The clinical outcome of the events dizziness, hungry, tingling lips, shakiness, trembling, fast heartbeat, easily irritated, foggy brain, confusion, slurred speech, muscle weakness, memory issues and exhaustion was not recovered at the time of this report.   No follow-up attempts are needed. No further information is expected.
Age: 19.0
Sex: F
Vaccine: COVID19
Symptoms: Heart rate increased, Hunger, Irritability, Memory impairment, Muscular weakness
Clinical narrative: Dizziness; Hungry; Tingling lips; Shakiness/ trembling; Fast heartbeat; Easily irritated; Confusion; Slurred speech; Muscle weakness; Memory issues; Foggy brain; Exhaustion; This is a spontaneous report received from a contactable consumer, the patient. A 19-year-old non-pregnant female patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EN6206) via unspecified route of administration in left arm on 20Mar2021 at 12:00 as a single dose for COVID-19 immunisation. The patients medical history included type 1 diabetes, celiac disease, asthma, vasovagal syncope, chiari malformation and major depressive disorder. The patient was allergic with naproxen, nonsteroidal anti-inflammatory drugs (NSAIDs), avocado and almonds. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within 4 weeks prior vaccination. Concomitant medications included Humalog, Cymbalta and Remeron. On 21Mar2021 at 18:00, the patient experienced dizziness, hungry, tingling lips, shakiness, trembling, fast heartbeat, easily irritated, foggy brain, confusion, slurred speech, muscle weakness, memory issues and exhaustion. After vaccination on 21Mar2021, the patient underwent lab test for COVID-19 (nasal swab test; RT-PCR for SARS-CoV-2) and the result was pending. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The patient did not receive any treatment for these events. The clinical outcome of the events dizziness, hungry, tingling lips, shakiness, trembling, fast heartbeat, easily irritated, foggy brain, confusion, slurred speech, muscle weakness, memory issues and exhaustion was not recovered at the time of this report.   No follow-up attempts are needed. No further information is expected.
Age: 19.0
Sex: F
Vaccine: COVID19
Symptoms: Paraesthesia oral, SARS-CoV-2 test, Tremor
Clinical narrative: Dizziness; Hungry; Tingling lips; Shakiness/ trembling; Fast heartbeat; Easily irritated; Confusion; Slurred speech; Muscle weakness; Memory issues; Foggy brain; Exhaustion; This is a spontaneous report received from a contactable consumer, the patient. A 19-year-old non-pregnant female patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EN6206) via unspecified route of administration in left arm on 20Mar2021 at 12:00 as a single dose for COVID-19 immunisation. The patients medical history included type 1 diabetes, celiac disease, asthma, vasovagal syncope, chiari malformation and major depressive disorder. The patient was allergic with naproxen, nonsteroidal anti-inflammatory drugs (NSAIDs), avocado and almonds. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within 4 weeks prior vaccination. Concomitant medications included Humalog, Cymbalta and Remeron. On 21Mar2021 at 18:00, the patient experienced dizziness, hungry, tingling lips, shakiness, trembling, fast heartbeat, easily irritated, foggy brain, confusion, slurred speech, muscle weakness, memory issues and exhaustion. After vaccination on 21Mar2021, the patient underwent lab test for COVID-19 (nasal swab test; RT-PCR for SARS-CoV-2) and the result was pending. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The patient did not receive any treatment for these events. The clinical outcome of the events dizziness, hungry, tingling lips, shakiness, trembling, fast heartbeat, easily irritated, foggy brain, confusion, slurred speech, muscle weakness, memory issues and exhaustion was not recovered at the time of this report.   No follow-up attempts are needed. No further information is expected.
Age: 32.0
Sex: F
Vaccine: COVID19
Symptoms: Chalazion
Clinical narrative: Developed chalazion in right eye 4 days after 2nd dose given then in left eye developed chalazion after 1 week 2nd dose given; This is a spontaneous report from a contactable nurse (the patient). A 32-years-old non-pregnant female patient received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot no: Unknown) via unspecified route of administration in the right arm on 16Mar2021 at 15:30 (at the age of 32-years-old) as a single dose for COVID-19 immunisation. Medical history was not reported. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot no: Unknown) via unspecified route of administration in the left arm on 16Feb2021 at 15:30 (at the age of 32-years-old) as a single dose for COVID-19 immunisation. Concomitant medications were not reported. The patient had not received any other vaccines within 4 weeks prior to the vaccine. Since the vaccination, the patient had not been tested for COVID-19. On 20Mar2021, four days after receiving the second dose the patient developed chalazion in right eye; then in the left eye a week after receiving the second dose. The patient had no recent history of chalazion. No therapeutic measures were taken for the event. The clinical outcome of the event chalazion was recovering at the time of this report. No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Age: 27.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site erythema, Vaccination site mass
Clinical narrative: knot in arm where shot was injected; Red spot on arm; This is a spontaneous report received from a contactable consumer, the patient. A 27-year-old non-pregnant female patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EN6204) via an unspecified route of administration in left arm on 20Mar2021 at 08:15 (at the age of 27-year-old), as a single dose, for COVID-19 immunisation. Concomitant medications included vitamin D (MANUFACTURER UNKNOWN), ZOLOFT, XANAX, biotin (MANUFACTURER UNKNOWN), buspiron (MANUFACTURER UNKNOWN) and AIMOVIG. The patient had history of drug allergy to Zofran. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient was not tested for COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the COVID -19 vaccine. On 20Mar2021 at 21:00, the patient experienced red spot-on arm (vaccination site erythema) and a knot in arm where shot was injected (vaccination site mass). No therapeutic measures were taken as a result of adverse event. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The clinical outcome of events vaccination site mass and vaccination site erythema was not resolved at the time of this report.   No follow-up attempts are needed. No further information is expected.
Age: 36.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Chills, Lymph node pain, Lymphadenopathy, Pyrexia
Clinical narrative: Lymph nodes under the left arm were swollen and tender, painful to touch; Lymph nodes under the left arm were swollen and tender, painful to touch.; chills; Painful injection site; Fever of 102.2 F; This is spontaneous report from contactable healthcare professional, the patient. A 36-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: ER2613), via an unspecified route of administration in the left arm on 19Mar2021 at 09:45 (at the age of 36-years-old) as a single dose for COVID-19 immunisation. Medical history included macroprolactinemia. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EN6198), via an unspecified route of administration in the left arm on 25Feb2021 at 16:30, (at the age of 36-years-old) as a single dose for COVID-19 immunisation. Concomitant medications were not reported. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On 19Mar2021 at 20:30 (during the day of vaccination), the patient experienced painful injection site and chills. In the evening, the patient had fever of 102.2 Fahrenheit (F), at this point the patient took unspecified medication and fever dropped to 101.3 F. On 20Mar2021, the entire day temperature hovered around 101 to 102 F and the patient slept the whole day. On 21Mar2021, the lymph nodes under the left arm were swollen, tender and painful to touch. Adverse events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The clinical outcome of painful injection site, fever of 102.2 F, chills and lymph nodes under the left arm were swollen and tender, painful to touch were recovering at the time of report.   No follow-up attempts are needed. No further information is expected.
Age: 36.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: Lymph nodes under the left arm were swollen and tender, painful to touch; Lymph nodes under the left arm were swollen and tender, painful to touch.; chills; Painful injection site; Fever of 102.2 F; This is spontaneous report from contactable healthcare professional, the patient. A 36-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: ER2613), via an unspecified route of administration in the left arm on 19Mar2021 at 09:45 (at the age of 36-years-old) as a single dose for COVID-19 immunisation. Medical history included macroprolactinemia. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EN6198), via an unspecified route of administration in the left arm on 25Feb2021 at 16:30, (at the age of 36-years-old) as a single dose for COVID-19 immunisation. Concomitant medications were not reported. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On 19Mar2021 at 20:30 (during the day of vaccination), the patient experienced painful injection site and chills. In the evening, the patient had fever of 102.2 Fahrenheit (F), at this point the patient took unspecified medication and fever dropped to 101.3 F. On 20Mar2021, the entire day temperature hovered around 101 to 102 F and the patient slept the whole day. On 21Mar2021, the lymph nodes under the left arm were swollen, tender and painful to touch. Adverse events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The clinical outcome of painful injection site, fever of 102.2 F, chills and lymph nodes under the left arm were swollen and tender, painful to touch were recovering at the time of report.   No follow-up attempts are needed. No further information is expected.
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Asthenia, Dehydration, Dizziness postural, Fatigue
Clinical narrative: Joint pain; extreme fatigue; Migraine; Dizziness when standing; overall weakness; Severe dehydration; his is a spontaneous report received from a contactable consumer, the patient. A 55-year-old non-pregnant female patient received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: UNKNOWN) via an unspecified route in the left arm on 17Mar2021 at 10:00 (at the age of 55-years-old) as a single dose for COVID-19 immunisation. Medical history included diabetes, status post (s/p) lung cancer, obesity, double knee replacement due to car accident, disabled since 2004. The patient was allergic to penicillin. Concomitant medications included regular unspecified medications for pain, cholesterol and diabetes. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: UNKNOWN) via unspecified route in the left arm on 18Feb2021(at the age of 55-years-old) as a single dose for COVID-19 immunisation. The patient did not receive any other vaccination within four weeks prior to the COVID-19 vaccination. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not tested positive for COVID-19. The patient experienced joint pain, extreme fatigue, migraine, dizziness when standing, overall weakness and severe dehydration on 17Mar2021 at 13:00. Therapeutic measures were taken as a result of joint pain, extreme fatigue, migraine, dizziness when standing, overall weakness, severe dehydration and included treatment with ALEVE, rest and hourly hydration. The events did not resulted in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The clinical outcome of the events joint pain, extreme fatigue, migraine, dizziness when standing, overall weakness and severe dehydration was recovering at the time of report.   Information about lot/batch number cannot be obtained. No further information is expected.
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: Migraine
Clinical narrative: Joint pain; extreme fatigue; Migraine; Dizziness when standing; overall weakness; Severe dehydration; his is a spontaneous report received from a contactable consumer, the patient. A 55-year-old non-pregnant female patient received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: UNKNOWN) via an unspecified route in the left arm on 17Mar2021 at 10:00 (at the age of 55-years-old) as a single dose for COVID-19 immunisation. Medical history included diabetes, status post (s/p) lung cancer, obesity, double knee replacement due to car accident, disabled since 2004. The patient was allergic to penicillin. Concomitant medications included regular unspecified medications for pain, cholesterol and diabetes. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: UNKNOWN) via unspecified route in the left arm on 18Feb2021(at the age of 55-years-old) as a single dose for COVID-19 immunisation. The patient did not receive any other vaccination within four weeks prior to the COVID-19 vaccination. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not tested positive for COVID-19. The patient experienced joint pain, extreme fatigue, migraine, dizziness when standing, overall weakness and severe dehydration on 17Mar2021 at 13:00. Therapeutic measures were taken as a result of joint pain, extreme fatigue, migraine, dizziness when standing, overall weakness, severe dehydration and included treatment with ALEVE, rest and hourly hydration. The events did not resulted in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The clinical outcome of the events joint pain, extreme fatigue, migraine, dizziness when standing, overall weakness and severe dehydration was recovering at the time of report.   Information about lot/batch number cannot be obtained. No further information is expected.
Age: 61.0
Sex: M
Vaccine: COVID19
Symptoms: Headache, Nervousness, SARS-CoV-2 test
Clinical narrative: Headache; Internal shaking when lie down.; This is a spontaneous report received from a contactable consumer, the patient. A 61-year-old male patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; lot number: ENG206) in the right arm via an unspecified route on 06Mar2021 at 14:45 as a single dose (at the age of 61-year-old) for COVID-19 immunisation. The patients past drug history included allergy to sulfur. The patient did not receive any vaccine within four weeks prior to the COVID-19 vaccine. Concomitant medications included multi vitamins (MANUFACTURER UNKNOWN), fish oil (MANUFACTURER UNKNOWN), crestor (MANUFACTURER UNKNOWN), RAPFLO all for unknown indications from an unknown date. Prior to the vaccination, the patient was not diagnosed with COVID-19. On 15Mar2021, the patient had SARS CoV-2 test via rapid nasal swab and resulted negative. On 11Mar2021 at 07:00 am (5 days after vaccination), the patient had headache started with internal shaking when patient lied down. Therapeutic measures were taken as resulted events and included treatment with muscle relaxer. The events resulted in doctor or other healthcare professional office/clinic visit. The clinical outcome of events headache and internal shaking was not resolved at the time of this report.   No follow-up attempts are needed. No further information is expected.
Age: 36.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Decreased appetite, Dizziness, Fatigue, Headache
Clinical narrative: Felt ill; dizziness; Bodyache; Shaking; Muscle weekness; Loss of appetite; Vomiting; headache; Extremely swollen lymph nodes; fatigue that made it difficult to even talk; Chills; Nausea; This is a spontaneous report from a contactable consumer, the patient. A 36-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot number: EP7534), in the left arm on 16Mar2021 at 0815 (at the age of 36-years-old), as a single dose for COVID-19 immunisation. Medical history included PCOS (Polycystic ovary syndrome). The patient had no allergies to medications, food, or other products. Concomitant medication included saxenda (MANUFACTURER UNKNOWN), for an unknown indication from an unspecified date and unknown if ongoing. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot number: EN6203), in the left arm on 23Feb2021 at 08:00 (at the age of 36-years-old), as a single dose for COVID-19 immunisation. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not tested for COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 16Mar2021, at 20:00, the patient experienced, violent shaking chills which begun 12 hours post shot and lasted for 48 hours, intense long-lasting vomiting and extreme muscle weakness, headache, body aches, extremely, swollen lymph nodes, dizziness, fatigue that made it difficult to even talk, nausea, and loss of appetite. The patient felt ill until about 96 hours post injection. The patient did not receive any treatment for the adverse events. The clinical outcome of the events, chills, vomiting and muscle weakness, headache, body aches, swollen lymph nodes, dizziness, fatigue that made it difficult to even talk, nausea, loss of appetite and felt ill was recovered on an unknown date.   No follow-up attempts are needed. No further information is expected.
Age: 36.0
Sex: F
Vaccine: COVID19
Symptoms: Lymphadenopathy, Malaise, Muscular weakness, Nausea, Pain
Clinical narrative: Felt ill; dizziness; Bodyache; Shaking; Muscle weekness; Loss of appetite; Vomiting; headache; Extremely swollen lymph nodes; fatigue that made it difficult to even talk; Chills; Nausea; This is a spontaneous report from a contactable consumer, the patient. A 36-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot number: EP7534), in the left arm on 16Mar2021 at 0815 (at the age of 36-years-old), as a single dose for COVID-19 immunisation. Medical history included PCOS (Polycystic ovary syndrome). The patient had no allergies to medications, food, or other products. Concomitant medication included saxenda (MANUFACTURER UNKNOWN), for an unknown indication from an unspecified date and unknown if ongoing. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot number: EN6203), in the left arm on 23Feb2021 at 08:00 (at the age of 36-years-old), as a single dose for COVID-19 immunisation. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not tested for COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 16Mar2021, at 20:00, the patient experienced, violent shaking chills which begun 12 hours post shot and lasted for 48 hours, intense long-lasting vomiting and extreme muscle weakness, headache, body aches, extremely, swollen lymph nodes, dizziness, fatigue that made it difficult to even talk, nausea, and loss of appetite. The patient felt ill until about 96 hours post injection. The patient did not receive any treatment for the adverse events. The clinical outcome of the events, chills, vomiting and muscle weakness, headache, body aches, swollen lymph nodes, dizziness, fatigue that made it difficult to even talk, nausea, loss of appetite and felt ill was recovered on an unknown date.   No follow-up attempts are needed. No further information is expected.
Age: 36.0
Sex: F
Vaccine: COVID19
Symptoms: Tremor, Vomiting
Clinical narrative: Felt ill; dizziness; Bodyache; Shaking; Muscle weekness; Loss of appetite; Vomiting; headache; Extremely swollen lymph nodes; fatigue that made it difficult to even talk; Chills; Nausea; This is a spontaneous report from a contactable consumer, the patient. A 36-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot number: EP7534), in the left arm on 16Mar2021 at 0815 (at the age of 36-years-old), as a single dose for COVID-19 immunisation. Medical history included PCOS (Polycystic ovary syndrome). The patient had no allergies to medications, food, or other products. Concomitant medication included saxenda (MANUFACTURER UNKNOWN), for an unknown indication from an unspecified date and unknown if ongoing. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot number: EN6203), in the left arm on 23Feb2021 at 08:00 (at the age of 36-years-old), as a single dose for COVID-19 immunisation. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not tested for COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 16Mar2021, at 20:00, the patient experienced, violent shaking chills which begun 12 hours post shot and lasted for 48 hours, intense long-lasting vomiting and extreme muscle weakness, headache, body aches, extremely, swollen lymph nodes, dizziness, fatigue that made it difficult to even talk, nausea, and loss of appetite. The patient felt ill until about 96 hours post injection. The patient did not receive any treatment for the adverse events. The clinical outcome of the events, chills, vomiting and muscle weakness, headache, body aches, swollen lymph nodes, dizziness, fatigue that made it difficult to even talk, nausea, loss of appetite and felt ill was recovered on an unknown date.   No follow-up attempts are needed. No further information is expected.
Age: 65.0
Sex: M
Vaccine: COVID19
Symptoms: Bronchitis, Chills, Muscle spasms, Pain, Pyrexia
Clinical narrative: Aches; bronchitis; Chills; fever; a few acute muscle cramps; This is a spontaneous report received from a contactable consumer, the patient. A 65-years-old male patient received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EN6204) via an unspecified route of administration in the left arm on 15Mar2021 at 10 : 00AM (at the age of 65-years-old) as a single dose for COVID-19 immunisation. Medical history of the patient included hiatal hernia from an unknown date. Concomitant medication included nexium, synthroid and cymbalta on an unspecified date for an unspecified reason. The patient previously took the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EN6210) via an unspecified route of administration in the left arm on 22Feb2021 for COVID-19 immunisation. The patient did not have any allergies to food, medications, or other products 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. Since the vaccination, the patient was not tested positive for COVID-19. The patient experienced aches, bronchitis, acute muscle cramps, chills and fever on 15Mar2021. The patient did not receive any treatment for the reported events. The events didn't result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The clinical outcome of the events aches, bronchitis, acute muscle cramps, chills and fever was resolving at the time of this report. No follow-up attempts are needed. No further information is expected.
Age: 80.0
Sex: F
Vaccine: COVID19
Symptoms: Pruritus, Rash
Clinical narrative: rash appeared on upper back; very itchy; This is a spontaneous report from a contactable consumer, the patient. A 80-years-old non-pregnant female patient received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EN6202) via an unspecified route of administration in left arm on 25Feb2021 at 10:45 (at the age of 80-year-old) as single dose, for COVID-19 immunisation. Medical history included osteoarthritis. The patient has known allergies to tree fruits and some nuts. The patient neither underwent COVID-19 test nor had symptoms associated with COVID-19. Since the vaccination, the patient had not been tested positive for COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient received PRESERVISION; calcium (MANUFACTURER UNKNOWN) started on unknown date for unknown indication. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EL9261) via an unspecified route of administration in left arm on 04Feb2021, as single dose, for COVID-19 immunisation. On an unknown date in Feb2021, a day or two after 2nd shot, rash appeared on patient's upper back; very itchy; over the past month, rash has moved down her back; on her arms, upper hip, abdomen. Therapeutic measures were taken as results of events and included treatment with Claritin 5mg to reduce itch & putting on gold bond psoriasis relief cream. Event didn't result in doctor or other healthcare professional office/clinic visit and emergency room/department or urgent care. The clinical outcome for the events rash appeared on my upper back and itchy was recovering at the time of this report.   No follow-up attempts are possible. No further information is expected.
Age: 68.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Cough, Fatigue, Feeling jittery
Clinical narrative: Extreme jitters; fatigue; chills; cough due to phlegm buildup; This is a spontaneous report received from contactable consumer. A 68-years-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: Er2613) via an unspecified route of administration in the left arm on 19Mar2021 at 14:30 (at the age of 68-years-old), as single dose for COVID-19 immunisation. The patients medical history was reported as diabetes, high blood pressure, forrestiers disease since an unknown duration. Concomitant medications were Indemithecin (MANUFACTURER UNKNOWN), pantoprozole (MANUFACTURER UNKNOWN). The patient was allergic to Celebrex, lisinapril. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 20Mar2021, at 13:15 the patient experienced extreme jitters, fatigue, chills, congestion, cough due to phlegm build-up. The patient was not tested for COVID-19. Since the vaccination, the patient had not been tested for COVID-19.  The clinical outcome of extreme jitters, fatigue, chills, congestion, cough due to phlegm build-up were resolved at the time of report. No treatment was received for the adverse events.   No follow-up attempts are possible; No further information is expected.
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Fatigue, Somnolence, Vaccination site pain, Vaccination site warmth
Clinical narrative: Sore and hot muscles near injection; Sore and hot muscles and joint in shoulder area; Sore and hot muscles near injection; Sleepiness; Extreme tiredness; This is a spontaneous report from a contactable consumer, the patient. A 71-year-old non-pregnant female patient received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER2613) via an unspecified route of administration in the left arm on 18Mar2021 at 13:30 (at the age of 71-years-old), as a single dose for COVID-19 immunisation. Medical history included COVID-19. The patient had a history of allergy (unspecified). Prior to the vaccination, the patient was diagnosed with COVID-19. Since the vaccination, the patient had not been tested positive for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient received medications (unspecified) within two weeks of vaccination. On 20Mar2021, the patient had shot extreme tiredness and sleepiness. On 21Mar2021, the patient experienced very sore and hot muscles near injection and joints in shoulder area painful to raise, however moving helped. The patient did not receive any treatment for the adverse events. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The clinical outcome of the events sleepiness, extreme tiredness, sore and hot muscles near injection and joint in shoulder area were resolving at the time of this report. No follow-up attempts are needed. No further information is expected.
Age: 72.0
Sex: M
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration, Ophthalmic migraine
Clinical narrative: Ocular migraine, bright lights in one eye for various lengths of time; Inappropriate schedule of vaccine administered; This is a spontaneous report received from a non-contactable consumer, the patient. A 72-year-old male patient received his second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot number: EN6199), via an unspecified route administration in the right arm on 01Mar2021 (at the age of 72-years-old), as a single dose for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6201), via an unspecified route of administration in the right arm on 12Feb2021 as a single dose for COVID-19 immunisation. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient received the second dose on 01Mar2021 (day 17) after the first dose (characterised as inappropriate schedule of vaccine administered). On 02Mar2021 the patient experienced ocular migraine, bright lights in one eye for various lengths. The patient did not receive any treatment for ocular migraine. The event of ocular migraine resulted in doctor or other healthcare professional office/clinic visit. The clinical outcome of ocular migraine was not recovered.  No follow-up attempts are possible. No further information is expected.
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Oropharyngeal pain, Pruritus, Rash macular, Urticaria
Clinical narrative: red blotches on skin of both arms, hands (with palms) and neck; Scratchy throat; Itchy sensation on her shoulders and back; Hives; Injection site pain; headache; This is a spontaneous report received from a contactable consumer, the patient. A 58-year-old non-pregnant female patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot no: EP6955) via an unspecified route of administration in the arm left on 20Mar2021 at 10:00 (at the age of 58-years) as a single dose for COVID-19 immunisation. Medical history included GERD (gastroesophageal reflux disease), IBS (irritable bowel syndrome), high cholesterol, obesity and allergy to acyclovir. Concomitant medications included Pantoprazole (MANUFACTURER UNKNOWN) 40 mg daily, Multivitamins (MANUFACTURER UNKNOWN), THERA TEARS within two weeks of vaccination. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 20Mar2021 patient experienced injection site pain, headache within 30 minutes of vaccination. On 20Mar2021, at 18:00 the patient experienced red blotches on skin of both arms, hands (with palms) and neck, hives, scratchy throat and itchy sensation on her shoulders and back. Six hours after vaccine, the patient had red blotches on skin on both arms, hands (with palms) and neck, with a few hives that were itchy, and a scratchy throat. It subsided in about two hours. On second day, she had some itchy sensation on her shoulders and back with no blotches or hives. The patient did not receive any treatment for the events. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The clinical outcome of the events hives and scratchy throat was resolved on an unknown date in Mar2021 and injection site pain, headache, red blotches on skin of both arms, hands (with palms) and neck, and itchy sensation on her shoulders and back was resolving at the time of the report.   No follow-up attempts are needed. No further information is expected.
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: red blotches on skin of both arms, hands (with palms) and neck; Scratchy throat; Itchy sensation on her shoulders and back; Hives; Injection site pain; headache; This is a spontaneous report received from a contactable consumer, the patient. A 58-year-old non-pregnant female patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot no: EP6955) via an unspecified route of administration in the arm left on 20Mar2021 at 10:00 (at the age of 58-years) as a single dose for COVID-19 immunisation. Medical history included GERD (gastroesophageal reflux disease), IBS (irritable bowel syndrome), high cholesterol, obesity and allergy to acyclovir. Concomitant medications included Pantoprazole (MANUFACTURER UNKNOWN) 40 mg daily, Multivitamins (MANUFACTURER UNKNOWN), THERA TEARS within two weeks of vaccination. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 20Mar2021 patient experienced injection site pain, headache within 30 minutes of vaccination. On 20Mar2021, at 18:00 the patient experienced red blotches on skin of both arms, hands (with palms) and neck, hives, scratchy throat and itchy sensation on her shoulders and back. Six hours after vaccine, the patient had red blotches on skin on both arms, hands (with palms) and neck, with a few hives that were itchy, and a scratchy throat. It subsided in about two hours. On second day, she had some itchy sensation on her shoulders and back with no blotches or hives. The patient did not receive any treatment for the events. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The clinical outcome of the events hives and scratchy throat was resolved on an unknown date in Mar2021 and injection site pain, headache, red blotches on skin of both arms, hands (with palms) and neck, and itchy sensation on her shoulders and back was resolving at the time of the report.   No follow-up attempts are needed. No further information is expected.
Age: 48.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Chills, Myalgia, Pyrexia, Vomiting
Clinical narrative: Chills; Fever throughout the first night/Fever reaching 102.7; Vomited; Muscle aches; This is a spontaneous report received from a contactable consumer, the patient. A 48-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EN6208), via an unspecified route of administration in the left arm on 19Mar2021 at 16:15 (at the age of 48-years-old), as a single dose for COVID-19 immunisation. Medical history included congenital ventricular septal defect. The patient had no allergies to medications, food or other products. Concomitant medication included chlorthalidone (MANUFACTURER UNKNOWN) and potassium citrate (MANUFACTURER UNKNOWN); all for an unknown indication from unknown date. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EN6203), via an unspecified route of administration in the left arm on 26Feb2021 at 16:00 (at the age of 48-years-old), as a single dose for COVID-19 immunisation. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 20Mar2021 at 00:00, the patient experienced chills and fever throughout the first night. She also vomited and had muscle aches and fever persisted until evening on 20Mar2021 (30 hours after vaccine). Fever was reaching up to 102.7 (units unspecified). The patient did not receive any treatment for the reported events. The adverse events did not result in a visit to the doctors or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The clinical outcome of the events chills, fever, vomiting and muscle ache were recovered on an unspecified date in Mar2021.   No follow-up attempts are needed. No further information is expected.
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Fatigue, Feeling cold, Headache, Nausea
Clinical narrative: 2 weeks of severe fatigue; Thirst; Nausea; Coldness; pain in left arm continues; Fever; Chills; Headache; This is a spontaneous report received from a contactable consumer, the patient. A 66-year-old non-pregnant female patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: Unknown) via an unspecified route of administration in the left arm on 04Mar2021 at 14:00 (at the age of 66-year-old) as a single dose for COVID-19 immunisation. The patient medical history included thyroid disease, menieres disease, neuropathy, psoriasis, lymphedema, survivor of breast cancer- had an adverse reaction to 1st chemo injection and brain seizure,3 days of a coma, temporary paralysis of left side of body, low tolerance to medications and hearing loss in left ear. The patient had previously taken Neulasta which resulted in a brain seizure. The patient had allergies to sulphate, pen vee k, monosodium glutamate (MSG). The concomitant medications included azithromycin (MANUFACTURER UNKNOWN), rosuvastatin (MANUFACTURER UNKNOWN), Khov-con, vitamin D (MANUFACTURER UNKNOWN) and vitamin B (MANUFACTURER UNKNOWN) all for unknown indication and from unknown dates. Prior to the vaccination the patient was diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 05Mar2021, at 14:15, the patient experienced 2 weeks of severe fatigue, thirst, nausea, coldness, headaches, pain in left arm that continued and 6 hours of severe coldness -nothing kept her warm one week later than vaccine injection 25 hours after receiving injection, fever, chills, headache and nausea. The patient did not receive any treatment for the events. The clinical outcomes of the events, 2 weeks of severe fatigue, chills, coldness, fever, headache, nausea, pain in left arm continues and thirst were recovered with lasting effects on an unspecified date.   No follow-up attempts are possible; information about lot number cannot be obtained.
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity, Pyrexia, Thirst
Clinical narrative: 2 weeks of severe fatigue; Thirst; Nausea; Coldness; pain in left arm continues; Fever; Chills; Headache; This is a spontaneous report received from a contactable consumer, the patient. A 66-year-old non-pregnant female patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: Unknown) via an unspecified route of administration in the left arm on 04Mar2021 at 14:00 (at the age of 66-year-old) as a single dose for COVID-19 immunisation. The patient medical history included thyroid disease, menieres disease, neuropathy, psoriasis, lymphedema, survivor of breast cancer- had an adverse reaction to 1st chemo injection and brain seizure,3 days of a coma, temporary paralysis of left side of body, low tolerance to medications and hearing loss in left ear. The patient had previously taken Neulasta which resulted in a brain seizure. The patient had allergies to sulphate, pen vee k, monosodium glutamate (MSG). The concomitant medications included azithromycin (MANUFACTURER UNKNOWN), rosuvastatin (MANUFACTURER UNKNOWN), Khov-con, vitamin D (MANUFACTURER UNKNOWN) and vitamin B (MANUFACTURER UNKNOWN) all for unknown indication and from unknown dates. Prior to the vaccination the patient was diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 05Mar2021, at 14:15, the patient experienced 2 weeks of severe fatigue, thirst, nausea, coldness, headaches, pain in left arm that continued and 6 hours of severe coldness -nothing kept her warm one week later than vaccine injection 25 hours after receiving injection, fever, chills, headache and nausea. The patient did not receive any treatment for the events. The clinical outcomes of the events, 2 weeks of severe fatigue, chills, coldness, fever, headache, nausea, pain in left arm continues and thirst were recovered with lasting effects on an unspecified date.   No follow-up attempts are possible; information about lot number cannot be obtained.
Age: 43.0
Sex: F
Vaccine: COVID19
Symptoms: Breast swelling, Peripheral swelling
Clinical narrative: Major swelling under the arm; Major swelling under the arm and sideof breast. (Same side as vaccine wasadministered); Very painful to touch ormove.; Very painful to touch or move. Also warm to the touch; Very painful to touch or move. Also warm to the touch and slightly red.; Major swelling under the arm and sideof breast. (Same side as vaccine wasadministered); This is a spontaneous report from a contactable consumer, the patient. A 43 years old non-pregnant female patient received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: unknown), via an unspecified route of administration in the left arm on 19Mar2021 at 08:30 (at the age of 43-years-old), as a single dose for COVID-19 immunisation. The patients medical history included anxiety, depression, and hypothyroidism. The patient did not have any allergies to medications, food or other products. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. Concomitant medications included bupropion (MANUFACTURER UNKNOWN), levothyroxine (MANUFACTURER UNKNOWN) and citalopram (MANUFACTURER UNKNOWN) for unknown indications from an unknown dates. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot number: unknown), via an unspecified route of administration in the left arm on 24Feb2021 at 09:00 as a single dose for COVID-19 immunisation. The patient did not receive any other vaccines within four weeks prior to the COVID-19 vaccine. On 20Mar2021 at 09:00, the patient experienced major swelling under the arm and side of breast (same side as the vaccination was administered), which was very painful to touch or move. Also, warm to touch and slightly red. The clinical outcome of the events swelling in underarm, the side of breast, painful to touch or move and warm to touch and slightly red were not recovered.   No follow-up attempts are possible; information about lot number cannot be obtained.
Sex: F
Vaccine: COVID19
Symptoms: Heavy menstrual bleeding, Menstruation irregular
Clinical narrative: Irregular menstrual bleeding; Bleeding was almost two weeks long; This is a spontaneous report from a contactable healthcare professional, the patient. A 39-year-old non pregnant female patient received the second dose of BNT162b2(PFIZER- BIONTECH COVID-19 mRNA Vaccine, Lot number: EL1283) via an unspecified route of administration in the right arm on 27Jan2021 at 1600 (at the age of 39-years-old), as a single dose for COVID-19 immunisation. Medical history included hypothyroidism. Concomitant medications included trazadone (MANUFACTURER UNKNOWN), levothyroxine (MANUFACTURER UNKNOWN), UNISOM and BENADRYL. The patient previously received the first dose of BNT162b2(PFIZER- BIONTECH COVID-19 mRNA Vaccine, Lot number: EH9899) via an unspecified route of administration in the right arm on 05Jan2021 at 1600, as a single dose for COVID-19 immunisation. The patient did not receive any other vaccines within 4 weeks prior to the COVID-19 vaccine. The patient was not diagnosed with COVID-19 prior to the vaccination. Since the vaccination, the patient had not tested positive for COVID-19. On 21Feb2021, the patient experienced irregular menstrual bleeding and prolonged periods, bleeding was almost two weeks long and was of low flow. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. No therapeutic measures were taken as a result of the adverse events. The clinical outcome of the events irregular menstrual bleeding and prolonged periods was unknown, at the time of this report.   No follow up attempts are needed. No further information is expected