chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 38.0
Sex: F
Vaccine: COVID19
Symptoms: Pain, Pain in extremity, Vaccination site pain
Clinical narrative: "pain radiating from where it was administered" on the left arm "all the way down with to her fingers"; "pain radiating from where it was administered" on the left arm "all the way down with to her fingers"; "pain radiating from where it was administered" on the left arm "all the way down with to her fingers"; This is a spontaneous report from a contactable 38-year-old female consumer reported for herself via Medical Information Team. A 38-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot number: Unknown), via an unspecified route of administration in left arm on 15Jun2021 (at the age of 38 years old) as single for covid-19 immunisation. The patient medical history and concomitant medications were not reported. She reported that within minutes, she experienced "pain radiating from where it was administered" on the left arm "all the way down with to her fingers" on 15Jun2021. She said that she has already spoken to her doctors, but asked if there was any other information or has it been previously reported? No information found on "pain from the injection site radiating to the fingers" and referred to Health Care Professional for further guidance. Reporter considered events as non-serious. The events resulted in Physician Office Visit. The outcome of events was unknown.  The lot number for BNT162b2 was not provided and will be requested during follow up.
Sex: F
Vaccine: COVID19
Symptoms: Lymphadenopathy, Mass
Clinical narrative: she experienced a lump just above her collar bone on the same side she received the injection; Caller states she originally thought it could be swollen lymph nodes; This is a spontaneous report from a contactable consumer (patient). A female patient of an unspecified age received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Batch/Lot number was not reported), via an unspecified route of administration on 08Sep2021 as DOSE 2, SINGLE for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. On 10Sep2021, the patient experienced she experienced a lump just above her collar bone on the same side she received the injection, caller states she originally thought it could be swollen lymph nodes. Caller states the lump has remained about the same since Friday. Caller states she saw her primary care doctor, but the doctor did not know what it was and "had never seen this before." Caller states she went to the hospital today and the providers at the hospital also told her they had never seen this before. Caller states she originally thought it could be swollen lymph nodes. The outcomes of events were not recovered.   The Lot number for BNT162b2 was not provided and will be requested during follow up.
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Back pain, Chest pain, Dyskinesia, Pain in extremity
Clinical narrative: pain in his right arm down to his wrist across his chest and across his back; pain in his right arm down to his wrist across his chest and across his back; pain in his right arm down to his wrist across his chest and across his back; pain in his right arm down to his wrist across his chest and across his back; can't even pick up his tool bag; he cannot sleep on his right side; This is a spontaneous report from a contactable 61-year-old male consumer reported for himself via Medical Information Team. A 61-year-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot number: Unknown), via an unspecified route of administration on 21May2021 as single for covid-19 immunisation. The patient medical history and concomitant medications were not reported. He has been experiencing pain in his right arm down to his wrist across his chest and across his back. This was the same arm he received the vaccine in. He reported that he was a heating and air worker and he can't even pick up his tool bag because of the pain. He also reports that he cannot sleep on his right side. He also reports he was worried about his heart. Reporter considered events as non-serious. The outcome of events was unknown.  The lot number for BNT162b2 was not provided and will be requested during follow up.
Sex: M
Vaccine: COVID19
Symptoms: Sleep disorder
Clinical narrative: pain in his right arm down to his wrist across his chest and across his back; pain in his right arm down to his wrist across his chest and across his back; pain in his right arm down to his wrist across his chest and across his back; pain in his right arm down to his wrist across his chest and across his back; can't even pick up his tool bag; he cannot sleep on his right side; This is a spontaneous report from a contactable 61-year-old male consumer reported for himself via Medical Information Team. A 61-year-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot number: Unknown), via an unspecified route of administration on 21May2021 as single for covid-19 immunisation. The patient medical history and concomitant medications were not reported. He has been experiencing pain in his right arm down to his wrist across his chest and across his back. This was the same arm he received the vaccine in. He reported that he was a heating and air worker and he can't even pick up his tool bag because of the pain. He also reports that he cannot sleep on his right side. He also reports he was worried about his heart. Reporter considered events as non-serious. The outcome of events was unknown.  The lot number for BNT162b2 was not provided and will be requested during follow up.
Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: Anxiety, Blood test, Magnetic resonance imaging, Nervousness, Paraesthesia
Clinical narrative: Tremors, shaking, internal vibrations, severe anxiety, tingling
Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: Tremor
Clinical narrative: Tremors, shaking, internal vibrations, severe anxiety, tingling
Age: 31.0
Sex: F
Vaccine: COVID19
Symptoms: Pruritus, Pyrexia, Swelling face
Clinical narrative: The same day of vaccination, high fever 39 and the next day reaction on the face (swelling and intense itching) 10 days two days of fever 39, 3 and greater reaction on the face.
Age: 42.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal pain, Diarrhoea, Dyspepsia, Headache, Nausea
Clinical narrative: Pain in my left arm, pain on the back of neck Diarrhea and burning sensation in my stomach  Very nauseous and cramping in my abdomen  Woke up in the morning again with the burning sensation and diarrhea? Having headaches
Age: 42.0
Sex: F
Vaccine: COVID19
Symptoms: Neck pain, Pain in extremity
Clinical narrative: Pain in my left arm, pain on the back of neck Diarrhea and burning sensation in my stomach  Very nauseous and cramping in my abdomen  Woke up in the morning again with the burning sensation and diarrhea? Having headaches
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Atrial tachycardia, Electrocardiogram ambulatory abnormal, Myocarditis, Supraventricular extrasystoles, Supraventricular tachycardia
Clinical narrative: Superventricular Tacacardia Wore Holter monitor for 15 days 85 events in total 3 significant with heart rate over 200  Myocarditis Perscibed Metatropol to lower heart rate  Sudden onset no prior heart issies
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Ventricular extrasystoles, Ventricular tachycardia
Clinical narrative: Superventricular Tacacardia Wore Holter monitor for 15 days 85 events in total 3 significant with heart rate over 200  Myocarditis Perscibed Metatropol to lower heart rate  Sudden onset no prior heart issies
Age: 46.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity, Paraesthesia, Peripheral swelling
Clinical narrative: Lingering soreness (or swelling)  in left arm. I still feel tingling throughout the arm even after a month later.  While my arm feels somewhat  better now, it is still not at 100 percent prior to the shot.
Age: 30.0
Sex: F
Vaccine: COVID19
Symptoms: Dyshidrotic eczema, Rash
Clinical narrative: Dyshidrotic eczema On left arm started on ring finger and progressively got worse and still have it. I?ve never had eczema and neither has my family.
Age: 24.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Headache, Pain, Pain in extremity
Clinical narrative: Headaches; Body aches; Teeth chattering/Chills; Arm sore; This is a spontaneous report from a contactable consumer, the patient. A 24-year-old non-pregnant female patient received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration on 30Aug2021 at 15:15 (at the age of 24-years-old) as a single dose for COVID-19 immunisation. Medical history included hypertension, pre-diabetic, sleep apnea, polycystic ovarian syndrome (PCOS), allergies to milk and shrimp. Prior to the vaccination, the patient was diagnosed with COVID-19. On 24Aug2021, the patient underwent nasal swab test and the result was negative. The patient did not receive any other vaccines within four weeks prior to the vaccination. Concomitant medications were not reported. On 31Aug2021, the patient experienced headaches, body aches, chills, arm sore and teeth chattering. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events headaches, body aches, chills, teeth chattering and arm sore was recovered on an unknown date in 2021.  The lot number for BNT162b2 was not provided and will be requested during follow up.
Age: 13.0
Sex: M
Vaccine: COVID19
Symptoms: Malaise
Clinical narrative: Systemic: Child does not feel well-Mild, Additional Details: Mother only described that the child is not feeling well today. Additional details not available.
Age: 33.0
Sex: F
Vaccine: COVID19
Symptoms: Burning sensation, Pain, Pruritus, Urticaria
Clinical narrative: Mid-May, welts began to appear all over my body, filled with water and it looks like acne but it is not. They are painful and itchy. They burn me when it's hot day. They are on the head, face, neck, arms, thighs and legs.
Age: 13.0
Sex: F
Vaccine: COVID19
Symptoms: Hypoaesthesia, Injection site erythema, Injection site hypoaesthesia, Injection site pain, Injection site paraesthesia
Clinical narrative: Site: Pain at Injection Site-Medium, Site: Redness at Injection Site-Severe, Systemic: Allergic: Rash (specify: facial area, extremeties)-Severe, Systemic: Numbness (specify: facial area, extremities)-Severe, Systemic: Shakiness-Mild, Systemic: Tingling (specify: facial area, extemities)-Severe, Additional Details: tingling and numbness from site of injection to finger tips- mom bringing daughter to doctor asap
Age: 13.0
Sex: F
Vaccine: COVID19
Symptoms: Paraesthesia, Rash, Tremor
Clinical narrative: Site: Pain at Injection Site-Medium, Site: Redness at Injection Site-Severe, Systemic: Allergic: Rash (specify: facial area, extremeties)-Severe, Systemic: Numbness (specify: facial area, extremities)-Severe, Systemic: Shakiness-Mild, Systemic: Tingling (specify: facial area, extemities)-Severe, Additional Details: tingling and numbness from site of injection to finger tips- mom bringing daughter to doctor asap
Age: 25.0
Sex: M
Vaccine: COVID19
Symptoms: Product storage error
Clinical narrative: Error: Improper Storage (temperature)-
Age: 67.0
Sex: M
Vaccine: COVID19
Symptoms: Peyronie's disease
Clinical narrative: Peyronie?s disease Bent penis
Sex: U
Vaccine: COVID19
Symptoms: Death
Clinical narrative: I personally know 9 people who died from your vaccination; This is a spontaneous report from a non-contactable consumer reporting same event under the same suspect product for 9 patients. This is one of 9 reports. A patient of unspecified age and gender received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on unspecified date as single dose for COVID-19 immunization. Medical history and concomitant medications were not reported. Reporter stated, "I personally know 9 people who died from your vaccination. You reported 16,000 people have died in the US, even the people who work for the company speaking on this." It was unknown if autopsy was done. The outcome of the event was fatal.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202101145863 Same reporter/drug/event, different patient.; Reported Cause(s) of Death: died from your vaccination
Sex: U
Vaccine: COVID19
Symptoms: Death
Clinical narrative: I personally know 9 people who died from your vaccination; This is a spontaneous report from a non-contactable consumer reporting same event under the same suspect product for 9 patients. This is one of 9 reports. A patient of unspecified age and gender received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on unspecified date as single dose for COVID-19 immunization. Medical history and concomitant medications were not reported. Reporter stated, "I personally know 9 people who died from your vaccination. You reported 16,000 people have died, even the people who work for the company speaking on this." It was unknown if autopsy was done. The outcome of the event was fatal.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.No further information is expected.; Sender's Comments: Linked Report(s) : PFIZER INC-202101145863 Same reporter/drug/event, different patient.; Reported Cause(s) of Death: died from your vaccination
Sex: U
Vaccine: COVID19
Symptoms: Death
Clinical narrative: I personally know 9 people who died from your vaccination; This is a spontaneous report from a non-contactable consumer reporting same event under the same suspect product for 9 patients. This is one of 9 reports. A patient of unspecified age and gender received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on unspecified date as single dose for COVID-19 immunization. Medical history and concomitant medications were not reported. Reporter stated, "I personally know 9 people who died from your vaccination. You reported 16,000 people have died even the people who work for the company speaking on this." It was unknown if autopsy was done. The outcome of the event was fatal.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.No further information is expected.; Sender's Comments: Linked Report(s) : PFIZER INC-202101145863 Same reporter/drug/event, different patient.; Reported Cause(s) of Death: died from your vaccination
Sex: U
Vaccine: COVID19
Symptoms: Death
Clinical narrative: I personally know 9 people who died from your vaccination; This is a spontaneous report from a non-contactable consumer reporting same event under the same suspect product for 9 patients. This is one of 9 reports. A patient of unspecified age and gender received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on unspecified date as single dose for COVID-19 immunization. Medical history and concomitant medications were not reported. Reporter stated, "I personally know 9 people who died from your vaccination. You reported 16,000 people have died, even the people who work for the company speaking on this." It was unknown if autopsy was done. The outcome of the event was fatal.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202101145863 Same reporter/drug/event, different patient.; Reported Cause(s) of Death: died from your vaccination
Age: 40.0
Sex: F
Vaccine: COVID19
Symptoms: Heavy menstrual bleeding, Polymenorrhoea, SARS-CoV-2 test
Clinical narrative: Period has changed. It has been crazy heavy and it happening every 18-21 days.; Period has changed. It has been crazy heavy and it happening every 18-21 days.; This is a spontaneous report from a non-contactable consumer, the patient. A 40-year-old non-pregnant female patient received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration on an unknown date (at the age of 40-years-old) as a single dose for COVID-19 immunisation. Medical history was not reported. Prior to the vaccination, the patient was not diagnosed with COVID-19 The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient did not receive any concomitant medications. On an unknown date, the patient's period had changed, it had been crazy heavy and it was happening every 18-21 days. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Therapeutic measures were not taken as a result of the events. Since the vaccination, the patient had been tested for COVID-19. On an unknown date, the patient underwent COVID-19 test via nasal swab and the result was unknown. The clinical outcome of the events period had changed, it had been crazy heavy and it was happening every 18-21 days was unknown at the time of this report.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 31.0
Sex: F
Vaccine: COVID19
Symptoms: Axillary pain, Fatigue, Feeling cold, Headache
Clinical narrative: Intense head ache; Pain in armpit on the same side as dose; Extreme fatigue; Extremely cold; This is a spontaneous report from a non-contactable consumer, the patient. A 31-year-old female patient received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: FC3182) via an unspecified route of administration in the left arm on 14Sep2021 at 15:30 (at the age of 31-years-old) as a single dose for COVID-19 immunisation. The patient had no medical history and no known allergies. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccine within four weeks prior to the vaccination. Concomitant medication included bupropion (MANUFACTURER UNKNOWN) for an unknown indication from an unknown date and unknown if ongoing. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: FD8448) via an unspecified route of administration in the left arm on 23Aug2021 (at the age of 31-years-old) as a single dose for COVID-19 immunisation. On 14Sep2021, the patient experienced intense head ache, pain in armpit on the same side as dose, extreme fatigue, all lasting for several days (as reported) and on the day of (vaccination), the patient was extremely cold. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. It was unknown whether any therapeutic measures were taken as a result of the events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events intense head ache, pain in armpit, extreme fatigue and extremely cold was not resolved at the time of report.  No follow-up attempts are possible. No further information is expected.
Age: 26.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity, Vaccination site mass, Vaccination site pain, Vaccination site warmth
Clinical narrative: Severe swelling and lump at injection sight/ the lumpwas extremely tight feeling; Severe swelling and lump at injection sight, hot to the touch; The lump was extremely painful to touch; Soreness of arm went all the way down to elbow; This is a spontaneous report from a contactable consumer, the patient. A 26-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: FC3184) via an unspecified route of administration in right arm on 25Aug2021 (at the age of 26-years-old) as a single dose for COVID-19 immunisation. The patient's medical history included COVID-19, idiopathic intracranial hypertension (reported as idiopathic intercranial hypertension), common variable immunodeficiency and allergy to sulfa antibiotics. Prior to the vaccination, the patient was diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the COVID-19 vaccine. Concomitant medications included desvenlafaxine succinate monohydrate (PRISTIQ), clonazepam (KLONOPIN) and topiramate (TOPAMAX); all for unknown indications from unknown dates and unknown if ongoing. On 26Aug2021, the patient developed severe swelling and lump at injection site which was hot to the touch. Lump was about the size of a golf ball. The patient felt the lump to be extremely tight and extremely painful to touch. The events lasted for almost two weeks. It was reported that soreness of arm went all the way down to the elbow. No therapeutic measures were taken as a result of the events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events severe swelling and lump at injection site, hot to the touch and the lump was extremely tight feeling and extremely painful to touch was resolved on an unknown date in Sep2021. The clinical outcome of the event soreness of arm went all the way down to elbow was resolved on an unknown date in 2021.
Age: 31.0
Sex: M
Vaccine: COVID19
Symptoms: Heart rate, Heart rate decreased
Clinical narrative: Low resting heart rate 58bpm; This is a spontaneous report from a contactable consumer, the patient. A 31-year-old male 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 13Sep2021 at 18:00 (at the age of 31-years-old) as a single dose for COVID-19 immunisation. Medical history included sleep apnea and penicillin allergy. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccine within four weeks prior to the COVID-19 vaccine. The patient did not receive any concomitant medications. On 14Sep2021 at 16:00, the patient had low resting heart rate 58bpm. It was reported that normal for the patient was middle 80s. The event did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Since the vaccination, the patient had not been tested for COVID-19. Therapeutic measures were not taken as a result of the reported event. The clinical outcome of the event low resting heart rate 58bpm was not recovered at the time of this report.   The batch/lot numbers for, BNT162b2, were not provided and will be requested during follow up.
Age: 29.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Back pain, Feeling abnormal, Headache, Myalgia
Clinical narrative: Felt a huge pain on left calf; Swollen and extremely painful injection site; Swollen and extremely painful injection site; Muscle pains all over the back and legs; Muscle pains all over the back and legs; Headaches; Joint pain; Swollen fingers; Brain fog; Pain started on the right leg and thigh; This is a spontaneous report from a contactable consumer, the patient. A 29-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 31Aug2021 (at the age of 29-years-old) as a single dose for COVID-19 immunisation. Medical history included asthma and polycystic ovarian syndrome (PCOS). Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. Concomitant medications included ibuprofen (MANUFACTURER UNKNOWN) and salbutamol (ALBUTEROL); both from unknown dates for unknown indications and unknown if ongoing. On 01Sep2021, the patient experienced swollen and extremely painful injection site for about 4 days. The patient had muscle pains all over the back and legs that had not gone away even after 2 weeks and it was getting worse. The patient had headaches, joint pain/ swollen fingers, and also experienced brain fog. On 02Sep2021 (Day 2), the patient felt a huge pain on the left calf that got better after 2 weeks. Then, on an unknown date in Sep2021, the pain started on the right leg and thigh. It was reported that the events were all after the first dose only. The events did not result in doctor or other healthcare professional office/clinic visit and emergency room/department or urgent care. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events swollen and extremely painful injection site was resolved on 05Sep2021, after the duration of 4 days. The clinical outcome of the event felt a huge pain on left calf was resolving. The clinical outcome of the events pain started on the right leg and thigh, muscle pains all over the back and legs, headaches, joint pain, swollen fingers and brain fog were not resolved at the time of this report.  The lot number for BNT162b2 was not provided and will be requested during follow up.
Age: 29.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity, Peripheral swelling, Vaccination site pain, Vaccination site swelling
Clinical narrative: Felt a huge pain on left calf; Swollen and extremely painful injection site; Swollen and extremely painful injection site; Muscle pains all over the back and legs; Muscle pains all over the back and legs; Headaches; Joint pain; Swollen fingers; Brain fog; Pain started on the right leg and thigh; This is a spontaneous report from a contactable consumer, the patient. A 29-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 31Aug2021 (at the age of 29-years-old) as a single dose for COVID-19 immunisation. Medical history included asthma and polycystic ovarian syndrome (PCOS). Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. Concomitant medications included ibuprofen (MANUFACTURER UNKNOWN) and salbutamol (ALBUTEROL); both from unknown dates for unknown indications and unknown if ongoing. On 01Sep2021, the patient experienced swollen and extremely painful injection site for about 4 days. The patient had muscle pains all over the back and legs that had not gone away even after 2 weeks and it was getting worse. The patient had headaches, joint pain/ swollen fingers, and also experienced brain fog. On 02Sep2021 (Day 2), the patient felt a huge pain on the left calf that got better after 2 weeks. Then, on an unknown date in Sep2021, the pain started on the right leg and thigh. It was reported that the events were all after the first dose only. The events did not result in doctor or other healthcare professional office/clinic visit and emergency room/department or urgent care. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events swollen and extremely painful injection site was resolved on 05Sep2021, after the duration of 4 days. The clinical outcome of the event felt a huge pain on left calf was resolving. The clinical outcome of the events pain started on the right leg and thigh, muscle pains all over the back and legs, headaches, joint pain, swollen fingers and brain fog were not resolved at the time of this report.  The lot number for BNT162b2 was not provided and will be requested during follow up.
Age: 34.0
Sex: F
Vaccine: COVID19
Symptoms: Heavy menstrual bleeding, Limb discomfort, Menstrual disorder, Pain in extremity
Clinical narrative: Period change; Spotting continues after regular 7 day period, spotting has been continuing for longer than 7 to 10 days; Having strange pain/heaviness in right arm occasionally; Having strange pain/heaviness in right arm occasionally; This is a spontaneous report from a non-contactable consumer, the patient. A 34-year-old non-pregnant female patient received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration on 17Jul2021 (at the age of 34-years-old) as a single dose for COVID-19 immunisation. The patient had no medical history. The patient had no known allergies. 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. The patient did not receive any concomitant medications. On 01Aug2021, the patient had period change. The spotting continued after regular 7 day period and spotting had been continuing for longer than 7 to 10 days. The patient had strange pain/ heaviness in right arm occasionally. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Therapeutic measures were not taken as a result of the events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events period change, spotting continues after regular 7 day period, spotting has been continuing for longer than 7 to 10 days and having strange pain/heaviness in right arm occasionally were unknown at the time of this report.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Cerebrovascular accident
Clinical narrative: He got both doses of the vaccine already. He mentioned that he had a stroke; The initial case was missing the following minimum criteria: no adverse event or at-risk situation. Upon receipt of follow-up information on (01Sep2021), this case now contains all required information to be considered valid.  This is a spontaneous report from a contactable consumer  from a Pfizer-sponsored program.     A 86-years-old male patient received bnt162b2 (BNT162B2), dose 2 via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as single dose, for covid-19 immunisation. The patient medical history was not reported.     There were no concomitant medications.  On  08Jan2021 the patient received the first dose of BNT162B2 vaccine (Batch/Lot Number: EL3246; Expiration Date: Apr2021).  The patient got both doses of the vaccine already. he mentioned that he had a stroke  (medically significant) on an unspecified date with outcome of unknown.
Age: 72.0
Sex: M
Vaccine: COVID19
Symptoms: Computerised tomogram, Hypersensitivity, Pruritus, Urticaria
Clinical narrative: allergic reaction; one small itchy hive on left forearm; one small itchy hive on left forearm; The initial case was missing the following minimum criteria: No adverse event. Upon receipt of follow-up information on 04Mar2021, this case now contains all required information to be considered valid.  This is a spontaneous report from a contactable consumer (patient). A 72-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection; lot number and expiry date not reported), via an unspecified route of administration, on 05Feb2021 (at the age of 72-year-old), as dose 1, single, for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. It was reported that, the patient was scheduled for CT Scan on the same date as COVID vaccine and scheduled to take the Prednisone 55 mg(x3) on the same day to counter allergic reaction due to contrast dye used in CT scan. Upon consultation with radiologist, CT scan was postponed for 5 days, to avoid taking Prednisone on the same day as covid-19 vaccine. The patient took CT scan on 10Feb2021 and took three 55 mg prednisone to counter allergic reaction due to contrast dye used in CT scan. It was reported that the patient had no side effects during CT scan except for one small itchy hive on left forearm on 10Feb2021. The outcome for the events was recovered.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Headache, Inappropriate schedule of product administration, Pyrexia, SARS-CoV-2 test
Clinical narrative: chills; fever; headache; Patient received first dose of vaccine on 12Jan2021 and received second dose of vaccine on 24Feb2021; The initial case was missing the following minimum criteria: [No specific adverse event reported on second dose of vaccine]. Upon receipt of follow-up information on [02Mar2021], this case now contains all required information to be considered valid.   This is a spontaneous report from a contactable consumer or other non hcp (patient). A 58-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation solution for injection) via intramuscular, administered in Arm Left on 24Feb2021 at 12:30 (Batch/Lot Number: EN5318; Expiration Date: May2021) as dose 2, single for covid-19 immunization (at the age of 58-years-old). Medical history included ongoing hypertension, ongoing Vitamin B12 deficiency, Vitamin D3 deficiency and herpes zoster from 31Jan2021 to 15Feb2021. Concomitant medication(s) included metoprolol and hydrochlorothiazide both were taken for hypertension from 2018 and ongoing and cyanocobalamin (B12 [CYANOCOBALAMIN]) taken for Vitamin B12 deficiency and colecalciferol (D3) taken for Vitamin D3 deficiency both from an unspecified start date and ongoing. The patient previously received first dose bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation solution for injection) via intramuscular, administered in Arm Left on 12Jan2021 at 13:30 (Batch/Lot Number: EL0140) as single dose for covid-19 immunization (at the age of 58-years-old) and experienced shingles and soreness at site. It was reported that the patient received first dose of vaccine on 12jan2021 and received second dose of vaccine on 24feb2021 and experienced headache on 24Feb2021 and chills and fever on 25Feb2021. The patient had not received any treatment for the events. The patient underwent lab tests and procedures which included sars-cov-2 test which was negative on an unspecified date (bi-weekly at Nurshing home always negative). The patient was recovering from the event headache and was recovered from the events of chills and fever in Feb2021.  No follow-up attempts are possible. No further information is expected.
Age: 70.0
Sex: M
Vaccine: COVID19
Symptoms: Dysgeusia
Clinical narrative: Change in taste. Metallic taste day after. Two days after Now everything tastes bad.; This is a spontaneous report from a contactable consumer reported himself that a 70-years-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, batch/lot number: unknown), via an unknown route of administration in left arm on 14Feb2021 at 13:45 (at the age of 70-years-old) as dose number unknown, single for COVID-19 immunization. Facility type vaccine was mentioned as other. The patient's medical history included cancer from an unknown date and unknown if ongoing. No known allergies. Concomitant medication was not reported. Other vaccine 4 weeks vaccine date was on 24Jan2021 (detail not provided). On an unknown date in Feb2021, the patient experienced change in taste. Metallic taste day after. Two days after Now everything tastes bad. No covid prior vaccination. No covid tested post vaccination. No treatment received. The outcome of the event was unknown.  Follow-up attempts are completed. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Abdominal discomfort
Clinical narrative: GI Problems; This is a spontaneous report from a contactable consumer. This 71-year-old female consumer reported that:  A 71-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot number was not reported), via an unspecified route of administration on 04Feb2021 as DOSE NUMBER UNKNOWN, SINGLE for covid-19 immunisation. The patient medical history and concomitant medications were not reported. On an unspecified date, the patient experienced gi problems, off-label dosing schedule. Would the 2nd dose be bigger. Patient asked about the timing of the second dose beyond the 3 weeks. It was scheduled to have and endoscopy with anesthesia on 24Feb2021 (a day before second shot). Patient mentioned that she read that the anesthesia may lower the immune response, so Caller wanted to know the vaccine on the 25Feb2021 and should even get anesthesia. At the time of report. the outcome of events were unknown.  Lot/batch number is not available despite the follow-up attempts made. Follow-up attempts have been completed and no further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Nasopharyngitis, Oropharyngeal pain, Respiration abnormal, Secretion discharge
Clinical narrative: Sore throat; sore throat, he was also having mucus; felt like a cold; Went to bed with breathing issues; This is a spontaneous report from a contactable consumer (patient). A male patient of unspecified age received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection; Lot number: unknown) via an unspecified route of administration on last Friday 12Feb2021 as single dose for COVID-19 immunization. Medical history included LVAD machine. Concomitant medications were not reported. Patient previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection; Lot number: unknown) via an unspecified route of administration on an unspecified date as single dose for COVID-19 immunization. On 16Feb2021, last night, patient went to bed with breathing issues. This morning (17Feb2021) at 3 am, he woke up still with breathing issues and developed sore throat, he was also having mucus. He mentioned that he was attached to an LVAD machine and does not know if his effects are from the vaccine, or if it's the common cold, or if it has something to do with his heart. It felt like a cold. He had the second one last Friday. Patient asked could this be a side effect from the vaccine or just a common cold. Because of the snow, he doesn't know if he would be able to make it. Outcome of the events breathing issues was not resolved and for other events were unknown.  Follow-up attempts are completed. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Nausea
Clinical narrative: This is a spontaneous report from a contactable consumer or other non-hcp (Patient). Report 1 of 2 is for the reporter as the patient. A 72-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: solution for injection; Batch/Lot Number: Unknown, Expiration date: Unknown) via an unspecified route of administration on an unspecified date as dose 1, single for COVID-19 immunization. The patient medical history and concomitant medications were not reported. On an unspecified date the patient experienced nausea and dizziness. Adverse events lead to Emergency Room Visit. Caller stated that she and her husband are scheduled to get the second dose of the COVID-19 vaccine on day of reporting, but caller was not feeling well so they were unable to get the second dose. Caller stated she went to the ER with nausea and dizziness and the ER told her these symptoms were related to medication changes. Caller confirmed that she went the ER and was admitted into the hospital. The clinical outcome of the events was unknown. Follow-up attempts completed. No further information expected.
Age: 53.0
Sex: M
Vaccine: COVID19
Symptoms: Abdominal pain, Diarrhoea, Faeces discoloured, Vaccination site pain
Clinical narrative: he experienced injection site pain; Mild abdominal pain; Some mild diarrhea; Caller reports the stool to be a darker, unusual color; This is a spontaneous report from a contactable consumer (patient). A 53-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot Number: EL9265, Expiration Date: unknown), dose 1 via an unspecified route of administration, administered in Arm Left on 09Feb2021 (at the age of 53-year-old) as dose 1, single for COVID-19 immunization. The patient medical history and concomitant medications was not reported. Patient received the first dose of the Covid vaccine on 09Feb. Patient reported for the first 2-3 days he experienced injection site pain (Feb2021) and on the 4th day, he started getting mild abdominal pain and diarrhea (Feb2021). Patient reported on the 5th day he was still experiencing those symptoms and stated that was not normal for him. Patient reported the stool to be a darker, unusual color (Feb2021). Patient again reported that in the last 4 days kind of mild abdominal pain, some mild diarrhea but mostly it's just the darker stool than normal. I was not sure if that was something that had been reported before. Therapeutic measures (Imodium and Pepto-Bismol) were taken as a result of mild abdominal pain, some mild diarrhea, caller reports the stool to be a darker, unusual color. There was no investigation assessment. The clinical outcome of events vaccination site pain, abdominal pain, diarrhea was not recovered and event stool discolored was unknown.  Follow-up attempts completed. No further information expected.
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Head discomfort, Malaise, Nausea, Neck pain
Clinical narrative: changes in vision; a little bit of arm pain; She finds it weird that her head feels heavy and neck is sore; She finds it weird that her head feels heavy and neck is sore; she is nauseated; She is not feeling good; Dizziness; This is a spontaneous report from a contactable other health care professional, the patient. A female patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, solution for injection, lot number: unknown), via an unspecified route of administration on 11Feb2021 as dose number unknown, single for covid-19 immunization. Medical history included mild vision problems such as wearing glasses, history of slow allergic reactions to high blood pressure medications which included angioedema and She had vertigo years ago and an ear thing, but she hardly gets that now. The patient concomitant medications were not reported. The patient experienced dizziness, changes in vision, a little bit of arm pain. On and off symptoms but more profound today. Patient found it weird that her head felt heavy and neck was sore. The patient had just mild symptoms but started yesterday she began to experience a profound dizziness. She thought it would go away. The patient had no sinus symptoms. She woke up worsened. She had no teeth pain and no headache. Might be it was weather related. Patient had profound dizziness and she was nauseated. She has No Fever. The doctor had no idea about what to do. Even when sitting she felt dizzy, like the chair was moving, when she changed position it makes it worsened. She was playing with her cat and she had to stop because it was making it worse. She wanted to make sure could it be from the vaccine even though these symptoms started yesterday. The events were assessed as non-serious by the reporter. The outcome of the events was unknown.  Information on the lot/batch number had been requested.  Follow-up attempts were completed. No further information was expected.
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity, Visual impairment
Clinical narrative: changes in vision; a little bit of arm pain; She finds it weird that her head feels heavy and neck is sore; She finds it weird that her head feels heavy and neck is sore; she is nauseated; She is not feeling good; Dizziness; This is a spontaneous report from a contactable other health care professional, the patient. A female patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, solution for injection, lot number: unknown), via an unspecified route of administration on 11Feb2021 as dose number unknown, single for covid-19 immunization. Medical history included mild vision problems such as wearing glasses, history of slow allergic reactions to high blood pressure medications which included angioedema and She had vertigo years ago and an ear thing, but she hardly gets that now. The patient concomitant medications were not reported. The patient experienced dizziness, changes in vision, a little bit of arm pain. On and off symptoms but more profound today. Patient found it weird that her head felt heavy and neck was sore. The patient had just mild symptoms but started yesterday she began to experience a profound dizziness. She thought it would go away. The patient had no sinus symptoms. She woke up worsened. She had no teeth pain and no headache. Might be it was weather related. Patient had profound dizziness and she was nauseated. She has No Fever. The doctor had no idea about what to do. Even when sitting she felt dizzy, like the chair was moving, when she changed position it makes it worsened. She was playing with her cat and she had to stop because it was making it worse. She wanted to make sure could it be from the vaccine even though these symptoms started yesterday. The events were assessed as non-serious by the reporter. The outcome of the events was unknown.  Information on the lot/batch number had been requested.  Follow-up attempts were completed. No further information was expected.
Sex: F
Vaccine: COVID19
Symptoms: Myalgia, Product administration error, Product leakage
Clinical narrative: She has not experienced any side effects other than muscle pain; administered punctured the needle at an angle which resulted to tearing the skin and having the vaccine leak out; vaccine leaking from the needle as well; This is a spontaneous report from a Pfizer-sponsored program (CEP/PSP: 159558). A contactable consumer (patient) reported that, an 89-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection, Batch/Lot Number: not reported), dose 2 via an unspecified route of administration on 12Feb2021 as a DOSE 2, SINGLE for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection, Batch/Lot Number: not reported), dose 2 via an unspecified route of administration on an unspecified date as a DOSE 1, SINGLE for covid-19 immunisation. After first dose, she was feeling exhausted for two days and her muscles were sore. On 12Feb2021, the patient administered punctured the needle at an angle which resulted to tearing the skin and having the vaccine leak out and vaccine was leaking from the needle as well. She had muscle pain on an unspecified date. Reporter wanted to ask if she should be revaccinated as the person who gave her the 2nd dose of the vaccine on 12Feb2021 at a parking lot administered punctured the needle at an angle which resulted to tearing the skin and having the vaccine leak out. Reporter mentioned that there was also vaccine leaking from the needle as well. She was concerned that an incomplete dose was given to her. She had not experienced any side effects other than muscle pain. She mentioned that her doctor has patients with similar problems and referred her to Pfizer. Reporter had received both vaccines now. 2nd dose on 12Feb. Needle was inserted at an angle and reported that it hurt badly. When needle removed, she tore skin and brown liquid leaked out. Had no side effects like she did after first dose which were feeling exhausted for two days and her muscles were sore. Reporter was wondering if she should get vaccinated a third time. Outcome of the event was unknown.  Information about lot/batch number has been requested.  Follow-up (14May2021): Follow-up attempts completed. No further information expected.