chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 44.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Pruritus, Urticaria
Clinical narrative: Diffuse itching; Hives; This is a spontaneous report from a contactable physician. A 44-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8736) via an unspecified route of administration in the arm left on 04May2021 at 14:00 (at the age of 44-year-old) as a single dose for COVID-19 immunisation. Medical history included sars and allergy-induced asthma. Concomitant medications included fluticasone propionate (FLONASE), gabapentin (MANUFACTURER UNKNOWN, levothyroxine sodium (SYNTHROID), salbutamol (ALBUTEROL) and fexofenadine hydrochloride (ALLEGRA) all for unknown indications from an unknown date. The patient previously took codeine, clindamycin, indomethacin, macrobid, shellfish and  carrots. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, it was unknown whether the patient had been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 04May2021 at 14:00 the patient experienced diffuse itching and hives. The adverse event resulted in emergency room/department or urgent care. Therapeutic measures were taken as a result of diffuse itching and hives and included treatment with BENADRYL 50mg PO once .The clinical outcome of the event diffuse itching and hives was unknown at the time of report.  No follow-up attempts are needed. No further information is expected.
Age: 49.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Migraine, Nausea, Pain
Clinical narrative: Body aches; Severe headache; Nausea; This is a spontaneous report from a contactable consumer, the patient. A 49-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 02May2021 at 16:00 (at the age of 49-years-old) as a single dose for COVID-19 immunisation. Medical history included sleep apnea. Concomitant medication included acetylsalicylic acid, caffeine, paracetamol (GOODY'S POWDER), taken from an unknown date for an unknown indication. The patient previously took penicillin (PCN). The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration on an unknown date as a single dose for COVID-19 immunisation. On 15Sep2020, the patient underwent COVID-19 test (nasal swab) and the result was negative. Prior to vaccination, the patient was not diagnosed with COVID -19. Since the vaccination, the patient had been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 03May2021 at 06:00, the patient experienced severe headache, body aches and nausea. The clinical outcome of the events severe headache, body aches and nausea were resolving at the time of this report.  No follow up attempts are needed; information about lot/batch number cannot be obtained.
Age: 49.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Headache, Nausea, Pain, SARS-CoV-2 test
Clinical narrative: Body aches; Severe headache; Nausea; This is a spontaneous report from a contactable consumer, the patient. A 49-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 02May2021 at 16:00 (at the age of 49-years-old) as a single dose for COVID-19 immunisation. Medical history included sleep apnea. Concomitant medication included acetylsalicylic acid, caffeine, paracetamol (GOODY'S POWDER), taken from an unknown date for an unknown indication. The patient previously took penicillin (PCN). The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration on an unknown date as a single dose for COVID-19 immunisation. On 15Sep2020, the patient underwent COVID-19 test (nasal swab) and the result was negative. Prior to vaccination, the patient was not diagnosed with COVID -19. Since the vaccination, the patient had been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 03May2021 at 06:00, the patient experienced severe headache, body aches and nausea. The clinical outcome of the events severe headache, body aches and nausea were resolving at the time of this report.  No follow up attempts are needed; information about lot/batch number cannot be obtained.
Age: 22.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Incorrect dose administered
Clinical narrative: Administered 0.5 mL vaccine instead of 0.3 mL; This is a spontaneous report from a contactable healthcare professional. A 22-year-old female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE;Lot Number: EW0162) via intramuscular route of administration in the arm left on 08Apr2021 (at the age of 22-years-old) as a single dose for COVID-19 immunisation. Medical history and concomitant medications were not reported. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 08Apr2021 the patient was administered 0.5 millilitre vaccine instead of 0.3 millilitre. The clinical outcome of the event administered 0.5 millilitre vaccine instead of 0.3 millilitre was unknown at the time of this report.  No follow-up attempts are needed. No further information is expected.
Age: 49.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Overdose
Clinical narrative: Administered 0.5 mL of vaccine, not 0.3 mL; Administered 0.5 mL of vaccine, not 0.3 mL; This is a spontaneous report from a contactable health care professional. A 49-year-old male patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot Number: EW0162) via intramuscular route of administration in the left arm on 08Apr2021 (at the age of 49-years-old) as a single dose for COVID-19 immunisation. Medical history and concomitant medications were not reported. On 08Apr2021, the patient was administered with 0.5 mL of vaccine, not 0.3 mL. The clinical outcome of the event administered 0.5 mL of vaccine, not 0.3 mL was unknown at the time of this report.   No follow-up attempts are needed. No further information is expected.
Age: 49.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Incorrect dose administered, Overdose
Clinical narrative: Administered 0.5 mL of vaccine, not 0.3 mL; Administered 0.5 mL of vaccine, not 0.3 mL; This is a spontaneous report from a contactable health care professional. A 49-year-old male patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot Number: EW0162) via intramuscular route of administration in the left arm on 08Apr2021 (at the age of 49-years-old) as a single dose for COVID-19 immunisation. Medical history and concomitant medications were not reported. On 08Apr2021, the patient was administered with 0.5 mL of vaccine, not 0.3 mL. The clinical outcome of the event administered 0.5 mL of vaccine, not 0.3 mL was unknown at the time of this report.   No follow-up attempts are needed. No further information is expected.
Age: 30.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Incorrect dose administered
Clinical narrative: Administered 0.5 mL of vaccine, not 0.3 mL; This is a spontaneous report from a contactable other healthcare professional. A 30-year-old male patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0162) via an unspecified route of administration in the left arm on 08Apr2021(at the age of 30-year-old) as a single dose for COVID-19 immunisation. Medical history and concomitant medications were not reported. On 08Apr2021, the patient was administered 0.5 mL of vaccine and not 0.3 mL. The clinical outcome of the event administered 0.5 mL of vaccine and not 0.3 mL was recovered on 08Apr2021.   No follow-up attempts are needed. No further information is expected.
Age: 17.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Incorrect dose administered
Clinical narrative: Administered 0.5 mL of vaccine, not 0.3 mL; This is a spontaneous report from a contactable healthcare professional. A 17-year-old male patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE: Lot Number: EW0162) via an unspecified route of administration in the left arm on 08Apr2021 at dose 0.5 mL (at the age of 17-years-old) as a single dose for COVID-19 immunisation. Medical history and concomitant medications were not reported. On 08Apr2021, the patient was administered 0.5 mL of vaccine, not 0.3 mL (incorrect dose administered). The clinical outcome of the event incorrect dose administered was resolved on an unknown date in Apr2021.  No follow-up attempts are needed. No further information is expected.
Age: 56.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Arthralgia, Blood test, Chest X-ray, Chest pain, Electrocardiogram
Clinical narrative: On 3/12/21 I developed severe pain in the area underneath my left shoulder-blade. This lasted about 18 hours. On 3/14/21 at 1am I was awaken with severe pain under my sternum (heart pain). It felt like what I imagine a heart attack would feel like.  ice pack and I was able to get back to sleep. Woke up later that night with rapid breathing, thought I was having a bad dream. Pain went away in about six hours. On 4-1-21 (three days after second dose from same pharmacy - Phizer EP6955) at around 11pm I developed pain above my right eye at top of cheek-bone. A vein was buldging about 8mm long and 2mm wide. Vision in that eye went extreemly blurry with tunnel vission. lasted 45 minutes then sewlling left and vision came bac
Age: 56.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Eye pain, Ophthalmological examination, Periorbital swelling, Physical examination, Tunnel vision
Clinical narrative: On 3/12/21 I developed severe pain in the area underneath my left shoulder-blade. This lasted about 18 hours. On 3/14/21 at 1am I was awaken with severe pain under my sternum (heart pain). It felt like what I imagine a heart attack would feel like.  ice pack and I was able to get back to sleep. Woke up later that night with rapid breathing, thought I was having a bad dream. Pain went away in about six hours. On 4-1-21 (three days after second dose from same pharmacy - Phizer EP6955) at around 11pm I developed pain above my right eye at top of cheek-bone. A vein was buldging about 8mm long and 2mm wide. Vision in that eye went extreemly blurry with tunnel vission. lasted 45 minutes then sewlling left and vision came bac
Age: 56.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Ultrasound Doppler, Vein disorder, Vision blurred, Visual impairment
Clinical narrative: On 3/12/21 I developed severe pain in the area underneath my left shoulder-blade. This lasted about 18 hours. On 3/14/21 at 1am I was awaken with severe pain under my sternum (heart pain). It felt like what I imagine a heart attack would feel like.  ice pack and I was able to get back to sleep. Woke up later that night with rapid breathing, thought I was having a bad dream. Pain went away in about six hours. On 4-1-21 (three days after second dose from same pharmacy - Phizer EP6955) at around 11pm I developed pain above my right eye at top of cheek-bone. A vein was buldging about 8mm long and 2mm wide. Vision in that eye went extreemly blurry with tunnel vission. lasted 45 minutes then sewlling left and vision came bac
Age: 56.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Abdominal distension, Angina pectoris, Arthralgia, Blood test normal, Chest X-ray normal
Clinical narrative: On 3/12/21 I developed severe pain in the area underneath my left shoulder-blade. This lasted about 18 hours. On 3/14/21 at 1am I was awaken with severe pain under my sternum (heart pain). It felt like what I imagine a heart attack would feel like.  ice pack and I was able to get back to sleep. Woke up later that night with rapid breathing, thought I was having a bad dream. Pain went away in about six hours. On 4-1-21 (three days after second dose from same pharmacy - Phizer EP6955) at around 11pm I developed pain above my right eye at top of cheek-bone. A vein was buldging about 8mm long and 2mm wide. Vision in that eye went extreemly blurry with tunnel vission. lasted 45 minutes then sewlling left and vision came bac
Age: 56.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Dyspnoea, Eye pain, Eye swelling, Facial pain, Sleep disorder
Clinical narrative: On 3/12/21 I developed severe pain in the area underneath my left shoulder-blade. This lasted about 18 hours. On 3/14/21 at 1am I was awaken with severe pain under my sternum (heart pain). It felt like what I imagine a heart attack would feel like.  ice pack and I was able to get back to sleep. Woke up later that night with rapid breathing, thought I was having a bad dream. Pain went away in about six hours. On 4-1-21 (three days after second dose from same pharmacy - Phizer EP6955) at around 11pm I developed pain above my right eye at top of cheek-bone. A vein was buldging about 8mm long and 2mm wide. Vision in that eye went extreemly blurry with tunnel vission. lasted 45 minutes then sewlling left and vision came bac
Age: 56.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Tunnel vision, Ultrasound Doppler, Vision blurred
Clinical narrative: On 3/12/21 I developed severe pain in the area underneath my left shoulder-blade. This lasted about 18 hours. On 3/14/21 at 1am I was awaken with severe pain under my sternum (heart pain). It felt like what I imagine a heart attack would feel like.  ice pack and I was able to get back to sleep. Woke up later that night with rapid breathing, thought I was having a bad dream. Pain went away in about six hours. On 4-1-21 (three days after second dose from same pharmacy - Phizer EP6955) at around 11pm I developed pain above my right eye at top of cheek-bone. A vein was buldging about 8mm long and 2mm wide. Vision in that eye went extreemly blurry with tunnel vission. lasted 45 minutes then sewlling left and vision came bac
Age: 58.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Acoustic stimulation tests abnormal, Deafness unilateral, Tinnitus
Clinical narrative: Tinnitus became much more pronounced, it is much louder, especially at night; This is a spontaneous report from a contactable consumer, the patient. A 58-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EP734) via an unspecified route of administration in the left arm on 24Mar2021 at 12:15 (at the age of 58-years-old) as a single dose for COVID-19 immunisation. Medical history included slight tinnitus which the patient usually did not notice. Concomitant medications included rosuvastatin calcium (CRESTOR) taken for an unspecified indication from an unknown date, estradiol (ESTRADIOL) patch taken for an unspecified indication from an unknown date and progesterone (PROGESTERONE) taken for an unspecified indication from an unknown date. The patient previously received codeine and experienced an allergy. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the COVID-19 vaccine. On 31Mar2021, the patient experienced tinnitus which became much more pronounced a few days to one week after the vaccine. The patient reported that he had a slight case of tinnitus before the vaccine, but usually did not notice it at all. After the vaccine, it was much louder, especially at night. The event did not result in a doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. Therapeutic measures were not taken as a result of the event. The clinical outcome of the event pronounced tinnitus was not resolved at the time of this report.   No follow-up attempts are needed. No further information is expected.
Age: 58.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Tinnitus
Clinical narrative: Tinnitus became much more pronounced, it is much louder, especially at night; This is a spontaneous report from a contactable consumer, the patient. A 58-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EP734) via an unspecified route of administration in the left arm on 24Mar2021 at 12:15 (at the age of 58-years-old) as a single dose for COVID-19 immunisation. Medical history included slight tinnitus which the patient usually did not notice. Concomitant medications included rosuvastatin calcium (CRESTOR) taken for an unspecified indication from an unknown date, estradiol (ESTRADIOL) patch taken for an unspecified indication from an unknown date and progesterone (PROGESTERONE) taken for an unspecified indication from an unknown date. The patient previously received codeine and experienced an allergy. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the COVID-19 vaccine. On 31Mar2021, the patient experienced tinnitus which became much more pronounced a few days to one week after the vaccine. The patient reported that he had a slight case of tinnitus before the vaccine, but usually did not notice it at all. After the vaccine, it was much louder, especially at night. The event did not result in a doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. Therapeutic measures were not taken as a result of the event. The clinical outcome of the event pronounced tinnitus was not resolved at the time of this report.   No follow-up attempts are needed. No further information is expected.
Age: 51.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Blood test normal, Discomfort, Palpitations, Tremor
Clinical narrative: Shaking; heart pounding; weak; like an adrenaline rush, comes in waves; This is a spontaneous report from a contactable consumer or other non hcp (patient). A 51-year-old (non-pregnant) female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number was not reported) via an unspecified route of administration on an unspecified date at dose 1, single and received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot Number: EW0179) via an unspecified route of administration, administered in arm left on 17May2021 15:00 (at the age of 51-year-old) at dose 2, single for covid-19 immunisation. Medical history was not reported. Patient has no known allergies. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. Concomitant medications included montelukast (MONTELUKAST); Albuterol inhaler (ALBUTEROL [SALBUTAMOL]) (list of any other medications the patient received within 2 weeks of vaccination). On an unspecified date the patient experienced shaking, heart, weak, like an adrenaline rush, comes in waves. Reported Event: Shaking, heart pounding, weak, like an adrenaline rush, comes in waves. Hard at first and scary. Both times, with the shot. First time it happened two days after the shot. Second time it happened in 2 minutes. First time I went to the ER, this time I did not. Lot EW0179. Adverse event start date: 17May2021. Patient did not receive treatment for the adverse events. Outcome of the events was resolving.  Information on the lot/batch number has been requested.  Follow-up (19Jul2021): This follow-up is being submitted to notify that the lot/batch number is not available despite the follow-up attempts made. Follow-up attempts completed. No further information is expected.
Age: 51.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Arthralgia, Asthenia, Dry mouth, Neck pain, Pain in extremity
Clinical narrative: Shaking; heart pounding; weak; like an adrenaline rush, comes in waves; This is a spontaneous report from a contactable consumer or other non hcp (patient). A 51-year-old (non-pregnant) female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number was not reported) via an unspecified route of administration on an unspecified date at dose 1, single and received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot Number: EW0179) via an unspecified route of administration, administered in arm left on 17May2021 15:00 (at the age of 51-year-old) at dose 2, single for covid-19 immunisation. Medical history was not reported. Patient has no known allergies. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. Concomitant medications included montelukast (MONTELUKAST); Albuterol inhaler (ALBUTEROL [SALBUTAMOL]) (list of any other medications the patient received within 2 weeks of vaccination). On an unspecified date the patient experienced shaking, heart, weak, like an adrenaline rush, comes in waves. Reported Event: Shaking, heart pounding, weak, like an adrenaline rush, comes in waves. Hard at first and scary. Both times, with the shot. First time it happened two days after the shot. Second time it happened in 2 minutes. First time I went to the ER, this time I did not. Lot EW0179. Adverse event start date: 17May2021. Patient did not receive treatment for the adverse events. Outcome of the events was resolving.  Information on the lot/batch number has been requested.  Follow-up (19Jul2021): This follow-up is being submitted to notify that the lot/batch number is not available despite the follow-up attempts made. Follow-up attempts completed. No further information is expected.
Age: 51.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Palpitations, Tremor
Clinical narrative: Shaking; heart pounding; weak; like an adrenaline rush, comes in waves; This is a spontaneous report from a contactable consumer or other non hcp (patient). A 51-year-old (non-pregnant) female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number was not reported) via an unspecified route of administration on an unspecified date at dose 1, single and received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot Number: EW0179) via an unspecified route of administration, administered in arm left on 17May2021 15:00 (at the age of 51-year-old) at dose 2, single for covid-19 immunisation. Medical history was not reported. Patient has no known allergies. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. Concomitant medications included montelukast (MONTELUKAST); Albuterol inhaler (ALBUTEROL [SALBUTAMOL]) (list of any other medications the patient received within 2 weeks of vaccination). On an unspecified date the patient experienced shaking, heart, weak, like an adrenaline rush, comes in waves. Reported Event: Shaking, heart pounding, weak, like an adrenaline rush, comes in waves. Hard at first and scary. Both times, with the shot. First time it happened two days after the shot. Second time it happened in 2 minutes. First time I went to the ER, this time I did not. Lot EW0179. Adverse event start date: 17May2021. Patient did not receive treatment for the adverse events. Outcome of the events was resolving.  Information on the lot/batch number has been requested.  Follow-up (19Jul2021): This follow-up is being submitted to notify that the lot/batch number is not available despite the follow-up attempts made. Follow-up attempts completed. No further information is expected.
Age: 51.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Agitation, Asthenia, Palpitations, Tremor
Clinical narrative: Shaking; heart pounding; weak; like an adrenaline rush, comes in waves; This is a spontaneous report from a contactable consumer or other non hcp (patient). A 51-year-old (non-pregnant) female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number was not reported) via an unspecified route of administration on an unspecified date at dose 1, single and received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot Number: EW0179) via an unspecified route of administration, administered in arm left on 17May2021 15:00 (at the age of 51-year-old) at dose 2, single for covid-19 immunisation. Medical history was not reported. Patient has no known allergies. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. Concomitant medications included montelukast (MONTELUKAST); Albuterol inhaler (ALBUTEROL [SALBUTAMOL]) (list of any other medications the patient received within 2 weeks of vaccination). On an unspecified date the patient experienced shaking, heart, weak, like an adrenaline rush, comes in waves. Reported Event: Shaking, heart pounding, weak, like an adrenaline rush, comes in waves. Hard at first and scary. Both times, with the shot. First time it happened two days after the shot. Second time it happened in 2 minutes. First time I went to the ER, this time I did not. Lot EW0179. Adverse event start date: 17May2021. Patient did not receive treatment for the adverse events. Outcome of the events was resolving.  Information on the lot/batch number has been requested.  Follow-up (19Jul2021): This follow-up is being submitted to notify that the lot/batch number is not available despite the follow-up attempts made. Follow-up attempts completed. No further information is expected.
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Hypertension, Seizure
Clinical narrative: seizure; This is a spontaneous report from a Pfizer-sponsored program. A non-Contactable consumer (patient) reported that a male patient of an unspecified age received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) (at the age of unknown) as dose 2, single for COVID-19 immunisation.  The patient medical history and concomitant medications were not reported.  The patient previously received BNT162b2 as dose 1 at an unknown age for COVID-19 immunisation and experienced flu like symptoms. After his second shot of the vaccine, he had a seizure and ending up in the hospital.  Outcome of the event was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Seizure
Clinical narrative: seizure; This is a spontaneous report from a Pfizer-sponsored program. A non-Contactable consumer (patient) reported that a male patient of an unspecified age received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) (at the age of unknown) as dose 2, single for COVID-19 immunisation.  The patient medical history and concomitant medications were not reported.  The patient previously received BNT162b2 as dose 1 at an unknown age for COVID-19 immunisation and experienced flu like symptoms. After his second shot of the vaccine, he had a seizure and ending up in the hospital.  Outcome of the event was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 36.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Cardiovascular symptom, Chest pain, Echocardiogram, Magnetic resonance imaging heart, Myocarditis
Clinical narrative: Presented to the ED on 6/28/21 with symptoms of chest pain, diaphoresis and asymptomatic, eposodic VTach.  Patient had EKG, Echo and heart Cath. ST elevation indicative of STEMI, no structural abnormalities or CAD found.  Impression was acute pericarditis. Patient was put on Toporol XL 25 mg and scheduled for follow up on 8/6/21.
Age: 36.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Acute myocardial infarction, Catheterisation cardiac, Chest pain, Echocardiogram, Electrocardiogram
Clinical narrative: Presented to the ED on 6/28/21 with symptoms of chest pain, diaphoresis and asymptomatic, eposodic VTach.  Patient had EKG, Echo and heart Cath. ST elevation indicative of STEMI, no structural abnormalities or CAD found.  Impression was acute pericarditis. Patient was put on Toporol XL 25 mg and scheduled for follow up on 8/6/21.
Age: 36.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Hyperhidrosis, Pericarditis, Ventricular tachycardia
Clinical narrative: Presented to the ED on 6/28/21 with symptoms of chest pain, diaphoresis and asymptomatic, eposodic VTach.  Patient had EKG, Echo and heart Cath. ST elevation indicative of STEMI, no structural abnormalities or CAD found.  Impression was acute pericarditis. Patient was put on Toporol XL 25 mg and scheduled for follow up on 8/6/21.
Age: 37.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Rash
Clinical narrative: Shingles; Rash continues to spread and burn when in contact with water or steam; Rash continues to spread and burn when in contact with water or steam; This is a spontaneous report from a contactable consumer or other non hcp. A 37-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE solution for injection), via an unspecified route of administration, administered in left arm on 09Jul2021 16:30 (Batch/Lot number was not reported) as dose 2, single for covid-19 immunization. The patient medical history was not reported. The patient previously took first dose of bnt162b2 via an unspecified route of administration, administered in right arm on 18Jun2021 05:00 PM (Batch/Lot number was not reported) as dose 1, single for covid-19 immunization. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient did not test COVID-19 positive prior to vaccination. The patient had not been tested for COVID-19 since the vaccination. The patient had no known allergies.  Concomitant medication included vitamin d3 (VITAMIN D3) taken for an unspecified indication, start and stop date were not reported. On 09Jul2021 18:00 the patient experienced shingles, rash continues to spread and burn when in contact with water or steam. The patient received treatment for shingles with prednisone shot and 30pill pack. The outcome of the events was not recovered.  Information about lot/batch number has been requested.
Age: 37.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Burning sensation, Herpes zoster, Rash
Clinical narrative: Shingles; Rash continues to spread and burn when in contact with water or steam; Rash continues to spread and burn when in contact with water or steam; This is a spontaneous report from a contactable consumer or other non hcp. A 37-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE solution for injection), via an unspecified route of administration, administered in left arm on 09Jul2021 16:30 (Batch/Lot number was not reported) as dose 2, single for covid-19 immunization. The patient medical history was not reported. The patient previously took first dose of bnt162b2 via an unspecified route of administration, administered in right arm on 18Jun2021 05:00 PM (Batch/Lot number was not reported) as dose 1, single for covid-19 immunization. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient did not test COVID-19 positive prior to vaccination. The patient had not been tested for COVID-19 since the vaccination. The patient had no known allergies.  Concomitant medication included vitamin d3 (VITAMIN D3) taken for an unspecified indication, start and stop date were not reported. On 09Jul2021 18:00 the patient experienced shingles, rash continues to spread and burn when in contact with water or steam. The patient received treatment for shingles with prednisone shot and 30pill pack. The outcome of the events was not recovered.  Information about lot/batch number has been requested.
Age: 57.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Abdominal discomfort, Back pain, Dizziness, Electrocardiogram, Fatigue
Clinical narrative: Severe head pain; sudden high blood pressure, nausea, MSK pain
Age: 57.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Feeling abnormal, Headache, Nausea, Pain, Palpitations
Clinical narrative: Severe head pain; sudden high blood pressure, nausea, MSK pain
Age: 57.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Cardiac function test normal, Headache, Hypertension, Laboratory test normal, Musculoskeletal pain
Clinical narrative: Severe head pain; sudden high blood pressure, nausea, MSK pain
Age: 57.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Nausea
Clinical narrative: Severe head pain; sudden high blood pressure, nausea, MSK pain
Age: 40.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Condition aggravated, Injected limb mobility decreased, Injection site joint pain, Injection site pain, Palpitations
Clinical narrative: Patient noted increasing frequency and intensity of palpitations. Holter monitor demonstrated symptomatic premature ventricular contractions. Patient referred to cardiology for possible treatment.
Age: 40.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Electrocardiogram ambulatory abnormal, Palpitations, Supraventricular extrasystoles, Ventricular extrasystoles
Clinical narrative: Patient noted increasing frequency and intensity of palpitations. Holter monitor demonstrated symptomatic premature ventricular contractions. Patient referred to cardiology for possible treatment.
Age: 54.0
Sex: M
Vaccine: COVID19, COVID19, COVID19, COVID19
Symptoms: Abdominal pain, Aspiration pleural cavity, Autopsy, Biopsy bone marrow, Blood test abnormal
Clinical narrative: See Attachments
Age: 54.0
Sex: M
Vaccine: COVID19, COVID19, COVID19, COVID19
Symptoms: Catheterisation cardiac, Computerised tomogram, Death, Decreased appetite, Eosinophil count increased
Clinical narrative: See Attachments
Age: 54.0
Sex: M
Vaccine: COVID19, COVID19, COVID19, COVID19
Symptoms: Inflammation, Myocarditis, Nausea, Night sweats, Paraesthesia
Clinical narrative: See Attachments
Age: 54.0
Sex: M
Vaccine: COVID19, COVID19, COVID19, COVID19
Symptoms: Pericardial effusion, Pleural effusion, Pyrexia, White blood cell count increased, X-ray
Clinical narrative: See Attachments
Age: 54.0
Sex: M
Vaccine: COVID19, COVID19, COVID19, COVID19
Symptoms: Death
Clinical narrative: See Attachments
Age: 63.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Central nervous system lesion, Hypoaesthesia, Magnetic resonance imaging head abnormal, Migraine, Paraesthesia
Clinical narrative: On June 25, 2021, MRI of brain shows 7-9 lesions; I developed migraines; I developed tingling; I developed numbness in face, arms, legs, hands, feet on Jan 15, 2021.; overdose; inappropriate schedule vaccine administered; This is a spontaneous report from a contactable other hcp. A 63-years-old non- pregnant female patient received first dose bnt162b2 (BNT162B2, Solution for injection, Batch/Lot Number: EK9231) via an unspecified route of administration in Arm Left on 29Dec2020 17:00(age at vaccination:63 years old) as DOSE 1, SINGLE, second dose bnt162b2 (BNT162B2, Solution for injection, Batch/Lot Number: EL3302) via an unspecified route of administration in Arm Left on 29Dec2020(age at vaccination:63 years old) as DOSE 2, SINGLE for covid-19 immunisation(at hospital). Patient didn't had pregnancy at the time of vaccination. Patient didn't received other vaccines prior to vaccination. Medical history included hypothyroidism from an unknown date and unknown if ongoing Hypothyroidism, osteoporosis from an unknown date and unknown if ongoing Osteoporosis. Concomitant medications included liothyronine (LIOTHYRONINE) taken for an unspecified indication, start and stop date were not reported; levothyroxine (LEVOTHYROXINE) taken for an unspecified indication, start and stop date were not reported. The patient previously took Bactrim and experienced drug hypersensitivity. Patient was not diagnosed with COVID-19 prior to vaccination and patient was not tested for COVID-19 to post vaccination. The patient experienced migraines, tingling, numbness in face, arms, legs, hands, feet on Jan 15, 2021. On June 25, 2021, MRI of brain shows 7-9 lesions on 25Jun2021, overdose on 29Dec2020, inappropriate schedule vaccine administered on 29Dec2020. Patient had disability for the events on 15Jan2021 patient had emergency room and physician's office visit for the events. Patient didn't received any treatment for the events. The outcome of the event tingling, numbness in face, arms, legs, hands, feet, central nervous system lesion was not recovered, the outcome of the events migraine was recovered, the outcome of the events overdose, inappropriate schedule of product administration was unknown.
Age: 63.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Central nervous system lesion, Hypoaesthesia, Inappropriate schedule of product administration, Magnetic resonance imaging head, Migraine
Clinical narrative: On June 25, 2021, MRI of brain shows 7-9 lesions; I developed migraines; I developed tingling; I developed numbness in face, arms, legs, hands, feet on Jan 15, 2021.; overdose; inappropriate schedule vaccine administered; This is a spontaneous report from a contactable other hcp. A 63-years-old non- pregnant female patient received first dose bnt162b2 (BNT162B2, Solution for injection, Batch/Lot Number: EK9231) via an unspecified route of administration in Arm Left on 29Dec2020 17:00(age at vaccination:63 years old) as DOSE 1, SINGLE, second dose bnt162b2 (BNT162B2, Solution for injection, Batch/Lot Number: EL3302) via an unspecified route of administration in Arm Left on 29Dec2020(age at vaccination:63 years old) as DOSE 2, SINGLE for covid-19 immunisation(at hospital). Patient didn't had pregnancy at the time of vaccination. Patient didn't received other vaccines prior to vaccination. Medical history included hypothyroidism from an unknown date and unknown if ongoing Hypothyroidism, osteoporosis from an unknown date and unknown if ongoing Osteoporosis. Concomitant medications included liothyronine (LIOTHYRONINE) taken for an unspecified indication, start and stop date were not reported; levothyroxine (LEVOTHYROXINE) taken for an unspecified indication, start and stop date were not reported. The patient previously took Bactrim and experienced drug hypersensitivity. Patient was not diagnosed with COVID-19 prior to vaccination and patient was not tested for COVID-19 to post vaccination. The patient experienced migraines, tingling, numbness in face, arms, legs, hands, feet on Jan 15, 2021. On June 25, 2021, MRI of brain shows 7-9 lesions on 25Jun2021, overdose on 29Dec2020, inappropriate schedule vaccine administered on 29Dec2020. Patient had disability for the events on 15Jan2021 patient had emergency room and physician's office visit for the events. Patient didn't received any treatment for the events. The outcome of the event tingling, numbness in face, arms, legs, hands, feet, central nervous system lesion was not recovered, the outcome of the events migraine was recovered, the outcome of the events overdose, inappropriate schedule of product administration was unknown.
Age: 63.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Overdose, Paraesthesia
Clinical narrative: On June 25, 2021, MRI of brain shows 7-9 lesions; I developed migraines; I developed tingling; I developed numbness in face, arms, legs, hands, feet on Jan 15, 2021.; overdose; inappropriate schedule vaccine administered; This is a spontaneous report from a contactable other hcp. A 63-years-old non- pregnant female patient received first dose bnt162b2 (BNT162B2, Solution for injection, Batch/Lot Number: EK9231) via an unspecified route of administration in Arm Left on 29Dec2020 17:00(age at vaccination:63 years old) as DOSE 1, SINGLE, second dose bnt162b2 (BNT162B2, Solution for injection, Batch/Lot Number: EL3302) via an unspecified route of administration in Arm Left on 29Dec2020(age at vaccination:63 years old) as DOSE 2, SINGLE for covid-19 immunisation(at hospital). Patient didn't had pregnancy at the time of vaccination. Patient didn't received other vaccines prior to vaccination. Medical history included hypothyroidism from an unknown date and unknown if ongoing Hypothyroidism, osteoporosis from an unknown date and unknown if ongoing Osteoporosis. Concomitant medications included liothyronine (LIOTHYRONINE) taken for an unspecified indication, start and stop date were not reported; levothyroxine (LEVOTHYROXINE) taken for an unspecified indication, start and stop date were not reported. The patient previously took Bactrim and experienced drug hypersensitivity. Patient was not diagnosed with COVID-19 prior to vaccination and patient was not tested for COVID-19 to post vaccination. The patient experienced migraines, tingling, numbness in face, arms, legs, hands, feet on Jan 15, 2021. On June 25, 2021, MRI of brain shows 7-9 lesions on 25Jun2021, overdose on 29Dec2020, inappropriate schedule vaccine administered on 29Dec2020. Patient had disability for the events on 15Jan2021 patient had emergency room and physician's office visit for the events. Patient didn't received any treatment for the events. The outcome of the event tingling, numbness in face, arms, legs, hands, feet, central nervous system lesion was not recovered, the outcome of the events migraine was recovered, the outcome of the events overdose, inappropriate schedule of product administration was unknown.
Age: 63.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Magnetic resonance imaging head abnormal, Migraine, Neuropathy peripheral, White matter lesion
Clinical narrative: On June 25, 2021, MRI of brain shows 7-9 lesions; I developed migraines; I developed tingling; I developed numbness in face, arms, legs, hands, feet on Jan 15, 2021.; overdose; inappropriate schedule vaccine administered; This is a spontaneous report from a contactable other hcp. A 63-years-old non- pregnant female patient received first dose bnt162b2 (BNT162B2, Solution for injection, Batch/Lot Number: EK9231) via an unspecified route of administration in Arm Left on 29Dec2020 17:00(age at vaccination:63 years old) as DOSE 1, SINGLE, second dose bnt162b2 (BNT162B2, Solution for injection, Batch/Lot Number: EL3302) via an unspecified route of administration in Arm Left on 29Dec2020(age at vaccination:63 years old) as DOSE 2, SINGLE for covid-19 immunisation(at hospital). Patient didn't had pregnancy at the time of vaccination. Patient didn't received other vaccines prior to vaccination. Medical history included hypothyroidism from an unknown date and unknown if ongoing Hypothyroidism, osteoporosis from an unknown date and unknown if ongoing Osteoporosis. Concomitant medications included liothyronine (LIOTHYRONINE) taken for an unspecified indication, start and stop date were not reported; levothyroxine (LEVOTHYROXINE) taken for an unspecified indication, start and stop date were not reported. The patient previously took Bactrim and experienced drug hypersensitivity. Patient was not diagnosed with COVID-19 prior to vaccination and patient was not tested for COVID-19 to post vaccination. The patient experienced migraines, tingling, numbness in face, arms, legs, hands, feet on Jan 15, 2021. On June 25, 2021, MRI of brain shows 7-9 lesions on 25Jun2021, overdose on 29Dec2020, inappropriate schedule vaccine administered on 29Dec2020. Patient had disability for the events on 15Jan2021 patient had emergency room and physician's office visit for the events. Patient didn't received any treatment for the events. The outcome of the event tingling, numbness in face, arms, legs, hands, feet, central nervous system lesion was not recovered, the outcome of the events migraine was recovered, the outcome of the events overdose, inappropriate schedule of product administration was unknown.
Age: 34.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Headache
Clinical narrative: headache; It feels like a blockage in my head most of the time; Headache increases in intensity when trying to concentrate and during physical exercise; This is a spontaneous report from a contactable consumer (patient). A 34-year-old non pregnant female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot Number: EW0169, Expiration date not reported), via an unspecified route of administration, administered in arm left on 24Apr2021 (at the age of 34-year-old) as single dose for COVID-19 immunisation. Medical history included ongoing chronic sinusitis, consumer stated but this isn't getting fixed by medication or any other means that she has tried, and she is trying to get a neurologist appointment, but they are all booked out for months. The patient had no known allergies. The patient's concomitant medications were not reported. The patient previously received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot number: ER8734, Expiration date not reported), via an unspecified route of administration in left arm on 31Mar2021 as single dose for COVID-19 immunization. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient did not receive any other medications in two weeks. Prior to vaccination the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. On 25Apr2021, the patient reported that she has been experiencing a constant headache since the day after the second dose of the vaccine. she thought it was a normal side effect at first, but it's not getting better. It feels like a blockage in head most of the time. Headache increases in intensity when trying to concentrate and during physical exercise. Adverse events resulted in doctor or other healthcare professional office/clinic visit, disability or permanent damage. The patient did not receive any treatment for events. The outcome of all events was not resolved.  Follow-Up (22Jul2021): Follow-up attempts are completed. No further information is expected.