chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 34.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Vomiting
Clinical narrative: Dizziness; Vomited within 60-90 mins; This is a spontaneous report from a contactable consumer, the patient. A 34-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0178) via an unspecified route of administration in the left arm on 28Aug2021 at 12:45 (at the age of 34-year-old) as a single dose for COVID-19 immunisation. The patient did not have any relevant medical history. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. Concomitant medications included gliclazide (CLARITIN), PRENATAL VITAMIN and vitamin D NOS (MANUFACTURER UNKNOWN); all started on an unknown date and for unknown indication. The patient had no known allergies to food, medication or other products. On 28Aug2021 at 13:45, the patient experienced dizziness and vomited within 60-90 mins. The events did not result in doctor or other healthcare professional office/clinic visit and emergency room/department or urgent care. The patient did not receive any treatment for the events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events dizziness and vomited within 60-90 mins was resolved on an unknown date in Aug2021.
Age: 43.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site scar
Clinical narrative: Bandaid scar where the shot was administered; This is a spontaneous report from a non-contactable consumer, the patient. A 43-year-old female patient received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: Unknown) via an unspecified route of administration in the left arm on an unknown date (at the age of 43-years-old) as a single dose for COVID-19 immunisation. Medical history included allergy to powdered latex. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medications were not reported. On an unknown date, the patient had a bandaid scar where the shot was administered and it was been there since she had taken the shot and the scar was still on her arm. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the event bandaid scar where the shot was administered was unknown at the time of report.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 13.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue
Clinical narrative: Exhaustion; This is a spontaneous report from a contactable consumer, the patient. A 13-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0217) via an unspecified route of administration in the left arm on 27Aug2021 at 11:15 (at the age of 13-years-old) as a single dose for COVID-19 immunisation. Medical history included known allergies to penicillin. The patient had known allergies to amoxicillin. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medications included sambucus nigra fruit (ELDERBERRY), loratadine (MANUFACTURER UNKNOWN) and smarty pants multivitamin (MANUFACTURER UNKNOWN); all from unknown dates for unknown indications and unknown if ongoing. The patient received human papillomavirus (HPV) vaccine (MANUFACTURER UNKNOWN) in the left arm on 29Jul2021, within four weeks prior to the vaccination. On 27Aug2021 at 13:15, the patient experienced exhaustion. The event 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 event. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the event exhaustion was recovering at the time of this report.
Age: 46.0
Sex: F
Vaccine: COVID19
Symptoms: Paraesthesia
Clinical narrative: Right hand and arm up to shoulder has tingling and feeling of pins poking, started to feel in left hand & arm; This is a spontaneous report from a contactable consumer, the patient. A 46-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: FC3182) via an unspecified route of administration in the right arm on 27Aug2021 at 18:00 (at the age of 46-year-old) as a single dose for COVID-19 immunisation. Medical history included methicillin-susceptible staphylococcus aureus sepsis (MSSA). The patient had known allergy to antihistamines. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medications included buspirone (MANUFACTURER UNKNOWN) and ALIVE WOMEN'S MULTI VITAMIN both for 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: FC3180), via an unspecified route of administration in the right arm on 09Aug2021 at 12:15 (at the age of 46-year-old), as a single dose for COVID-19 immunisation. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 29Aug2021 at 06:00 the patient experienced tingling in right hand and arm up to shoulder and feeling of pins poking which had started 2 days after injection. On 30Aug2021 patient started to feel in left hand & arm too and seemed to be getting worse. It was happening at least a dozen times day. 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 event tingling in right hand and arm up to shoulder, feeling of pins poking and started to feel in left hand & arm too was not recovered at the time of this report.
Age: 25.0
Sex: F
Vaccine: COVID19
Symptoms: Diarrhoea, Fatigue, Headache, Nausea
Clinical narrative: Bad diarrhea; Headache; Nausea; Fatigue; This is a spontaneous report from a contactable consumer, the patient. A 25-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0182) via an unspecified route of administration in the left arm on 27Aug2021 at 12:00 (at the age of 25-year-old) as a single dose for COVID-19 immunisation. The patient did not have any medical history. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. The patient did not receive any medication within two weeks of vaccination. The patient did not have any allergies to food, medications, or other products. On 28Aug2021 at 17:30, the patient experienced bad diarrhea, headache, nausea and fatigue. The events did not result in doctor or other healthcare professional office or clinic visit, and emergency room or department or urgent care. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events bad diarrhea, headache, nausea and fatigue was resolving at the time of this report.
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Paraesthesia, Rash erythematous, Skin warm, Swollen tongue
Clinical narrative: Tingling on face; Dizziness; tongue began to itch and then swell; tongue began to itch and then swell; a hot dark red rash on face to spread to neck and chest; a hot dark red rash on face to spread to neck and chest; This is a spontaneous report from a contactable consumer, the patient. A 62-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN5318) via an unspecified route of administration in the right arm on 27Jan2021 at 15:30 (at the age of 62-years-old) as a single dose for COVID-19 immunisation. Medical history included hypothyroidism, asthma and type-2 diabetes. The patient was allergic to most antibiotics, latex and adhesive. Concomitant medications included levothyroxine sodium (SYNTHROID) and metformin (MANUFACTURER UNKNOWN), both taken for unspecified indications from unknown dates. 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 vaccination. On 27Jan2021 at 15:45, the patient experienced tingling on face and dizziness. The patient was told to go home and take Benadryl. On the way home, her tongue began to itch and then swell. She took Benadryl but it did not help and then she had hot dark red rash on her face and it began to spread to the neck and chest. All the while the tongue was still swollen. She took a second Benadryl and by that time the effect of the symptoms started to ease a bit. It was very frightening for the patient. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. Therapeutic measures were taken as a result of the events and included treatment with two Benadryl tablets. The clinical outcome of the events tingling on face, dizziness, tongue itch and swelling and hot dark red rash on face, neck and chest were resolved on an unknown date in 2021.
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Tongue pruritus
Clinical narrative: Tingling on face; Dizziness; tongue began to itch and then swell; tongue began to itch and then swell; a hot dark red rash on face to spread to neck and chest; a hot dark red rash on face to spread to neck and chest; This is a spontaneous report from a contactable consumer, the patient. A 62-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN5318) via an unspecified route of administration in the right arm on 27Jan2021 at 15:30 (at the age of 62-years-old) as a single dose for COVID-19 immunisation. Medical history included hypothyroidism, asthma and type-2 diabetes. The patient was allergic to most antibiotics, latex and adhesive. Concomitant medications included levothyroxine sodium (SYNTHROID) and metformin (MANUFACTURER UNKNOWN), both taken for unspecified indications from unknown dates. 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 vaccination. On 27Jan2021 at 15:45, the patient experienced tingling on face and dizziness. The patient was told to go home and take Benadryl. On the way home, her tongue began to itch and then swell. She took Benadryl but it did not help and then she had hot dark red rash on her face and it began to spread to the neck and chest. All the while the tongue was still swollen. She took a second Benadryl and by that time the effect of the symptoms started to ease a bit. It was very frightening for the patient. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. Therapeutic measures were taken as a result of the events and included treatment with two Benadryl tablets. The clinical outcome of the events tingling on face, dizziness, tongue itch and swelling and hot dark red rash on face, neck and chest were resolved on an unknown date in 2021.
Age: 37.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: My husband tested positive for Covid 30Aug2021; My husband tested positive for Covid 30Aug2021; This is a spontaneous report from a non-contactable consumer. This consumer reported for a patient. A 37-years-old male patient received an unknown dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number: EP6955, Expiration date: unknown) intramuscular, administered in left arm on 22Mar2021 (age at vaccination was 37 years) as dose number unknown, single for COVID-19 immunization. The patient's medical history was not reported. Concomitant medication the patient received within 2 weeks of vaccination included pantoprazole taken for an unspecified indication. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. On 30Aug2021, the patient tested positive for COVID-19 (drug ineffective). The patient was not hospitalized for the event. The patient underwent lab test which included COVID test (Sars-cov-2 test), positive on 30Aug2021. No treatment was received for the adverse event. The case was reported as non-serious. The outcome of the event was resolving.  No follow-up attempts are possible. No further information is expected.
Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Fatigue, Headache, Lymphadenopathy
Clinical narrative: Swollen glands; Extreme tiredness; Joint pain; Severe head pain; This is a spontaneous report from a contactable healthcare professional, the patient. A 51-year-old non-pregnant female patient received the third dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 22Aug2021 at 16:30 (at the age of 51-years-old) as a single dose for COVID-19 immunisation. Medical history included psoriasis/psoriatic arthritis. The patient had no known allergies to medications, food, or other products. The patient did not receive any concomitant medication within two weeks of vaccination. 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 vaccination. On 23Aug2021, the patient experienced swollen glands, extreme tiredness, joint pain and severe head pain. Therapeutic measures were not taken as a result of the events. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. The clinical outcome of the events swollen glands, extreme tiredness, joint pain and severe head pain was resolving at the time of this report.   The lot number for BNT162b2 was not provided and will be requested during follow up.
Age: 42.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Lymphadenopathy, Pain, Pyrexia
Clinical narrative: Swollen lymph nodes (2 inch); Fever; Chills; Body aches; This is a spontaneous report from a contactable healthcare professional, the patient. A 42-year-old non-pregnant female patient received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an intramuscular route of administration in the left arm on 28Aug2021 at 11:30 (at the age of 42-years-old) as a single dose for COVID-19 immunisation. Medical history included hypertension. Prior to the vaccination, the patient was not diagnosed with COVID-19. It was unknown whether the patient received any other vaccines within four weeks prior to the COVID vaccine. Concomitant medications were not reported. The patient previously received codeine (MANUFACTURER UNKNOWN) and experienced drug allergy. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an intramuscular route of administration in the left arm on 07Aug2021 at 11:00 (at the age of 42-years-old) as a single dose for COVID-19 immunisation. On 29Aug2021 at 10:00, the patient had swollen lymph nodes (2 inch), fever, chills, body aches for 2 days. The events resulted in doctor or other healthcare professional office/clinic visit. Since the vaccination, the patient had not been tested for COVID-19. Therapeutic measures were taken as a result of the event which included treatment with unspecified medications (reported as prescription given). The clinical outcome of the events swollen lymph nodes (2 inch), fever and chills were resolving; while that of body aches was resolved on 31Aug2021.  The batch/lot numbers for, BNT162b2, were not provided and will be requested during follow up.
Age: 28.0
Sex: F
Vaccine: COVID19
Symptoms: Aphasia, Euphoric mood, Feeling abnormal, Memory impairment
Clinical narrative: Brain fog; Could not remember simple things such as house address; Felt like had a marijuana high and looked very high; Hard time forming words and sentences and answering questions; This is a spontaneous report from a contactable consumer, the patient. A 28-year-old, non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, lot number: FC3180) via an unspecified route of administration in the left arm on an unknown date in Aug2021 at 15:00 (at the age of 28-year-old) as a single dose for COVID-19 immunisation. Medical history included bell's palsy, allergy to bee stings and latex. Prior to vaccination, it was unknown whether the patient was diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient received unspecified birth control pills (MANUFACTURER UNKNOWN) within two weeks of vaccination. On an unknown date in Aug2021 at 17:30, the patient had brain fog, could not remember simple things such as her house address and felt like had a marijuana high. The patient had a hard time forming words and sentences. When her husband asked her questions she had a hard time answering him. Her husband also commented that she looked very high. The adverse events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. No therapeutic measures were taken as a result of the reported events.. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events brain fog, could not remember simple things such as house address, felt like had a marijuana high, had a hard time forming words and sentences and answering questions were recovered on an unknown date in Aug2021.
Age: 35.0
Sex: F
Vaccine: COVID19
Symptoms: Heavy menstrual bleeding, Intermenstrual bleeding, Menstrual disorder, Polymenorrhoea, SARS-CoV-2 test
Clinical narrative: Change in menstrual cycle; Heavier periods/ increase in clot sizes; More frequent periods; Breakthrough bleeding with every cycle since vaccine; This is a spontaneous report from a contactable consumer, the patient. A 35-year-old non-pregnant female patient received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EL9262) via an unspecified route of administration in the left arm on 08Feb2021 at 17:00 (at the age of 35-year-old) as a single dose for COVID-19 immunisation. Medical history included contrast media allergy. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the COVID-19 vaccine. Concomitant medications included phentermine (MANUFACTURER UNKNOWN) and multivitamins (MANUFACTURER UNKNOWN); all from unknown dates for an unknown indication and unknown if ongoing. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EL1284) via an unspecified route of administration in the left arm on 18Jan2021 at 18:00 (at the age of 35-year-old) as a single dose for COVID-19 immunisation. On 01Mar2021, the patient experienced change in menstrual cycle. Heavier, more frequent periods, increase in clot sizes, breakthrough bleeding with every cycle since vaccine. The events resulted in doctor or other healthcare professional office/clinic visit. Since the vaccination, the patient had been tested for COVID-19. On 30Mar2021, the patient underwent SARS-CoV-2 SEROLOGY (COVID 19) AB (IGG), IA (Nasal Swab) and the result was Negative. On 20Apr2021, the patient underwent Lumira Dx SARS-CoV-2 Ag Test (Nasal Swab) and the result was Negative. On 25Apr2021, the patient underwent COVID-19 RT-qPCR test (Other) and the result was Negative. On 11May2021, the patient underwent Lumira Dx SARS-CoV-2 Ag Test (Nasal Swab) and the result was Negative. On 03Jun2021, the patient underwent Lumira Dx SARS-CoV-2 Ag Test (Nasal Swab) and the result was Negative. Therapeutic measures were not taken as a result of the events. The clinical outcome of the events change in menstrual cycle. Heavier periods/ increase in clot sizes, more frequent periods and Breakthrough bleeding with every cycle since vaccine were not recovered at the time of this report.
Sex: M
Vaccine: COVID19
Symptoms: Urticaria
Clinical narrative: hives; This is a spontaneous report from a contactable Physician via a Pfizer sales representative.  A 41-years-old male patient received unspecified dose of BNT162B2(PFIZER COVID-19 VACCINE, Batch/Lot number was not reported) via an unspecified route of administration on an unspecified date as single dose for covid-19 immunization. The patient medical history and concomitant medications were not reported. The patient developed hives after receiving the vaccine. Patient still  have hives after 3 months but not as bad. The outcome of the event was recovered.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Pruritus, Rash
Clinical narrative: Severe itching; slight rash entire body; slight rash entire body, particularly on legs below knee and all over feet and particularly on arms below the elbow and the entire hands.; This is a spontaneous report from a non-contactable consumer, the patient. A 56-year-old non-pregnant female patient received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 29Aug2021 at 16:00(at the age of 56-year-old) as a single dose for COVID-19 immunisation. Medical history included diabetes and high blood pressure. The patient had no known allergies to medications, food or other products. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medications included  amoxicillin (MANUFACTURER UNKNOWN) from an unknown date and for unknown indication and unknown if ongoing. The patient received other vaccine within four weeks prior to the COVID vaccine included pertussis vaccine, tetanus vaccine toxoid, diphtheria vaccine toxoid (DPT) on 05Aug2021 for unspecified indication. On 29Aug2021 at 16:15 the patient experienced severe itching and slight rash on entire body, particularly on legs below the knee and all over feet and also particularly on arms below the elbow and the entire hands. The events did not result in doctor or other healthcare professional office/clinic, emergency room/department or urgent care. Therapeutic measures were taken as a result of events which included treatment with Benadryl. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events severe itching and slight rash entire body  particularly on legs below the knee and all over feet and also particularly on arms below the elbow and the entire hands were recovered on a unknown date in Aug2021.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: Tinnitus
Clinical narrative: Ringing in left ear; This is a spontaneous report from a contactable consumer, the patient. A 51-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8730) via an unspecified route of administration in the left arm on 11Jun2021 at 15:45 (at the age of 51-years-old), as a single dose for COVID-19 immunisation. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medications included gabapentin (MANUFACTURER UNKNOWN), amitriptyline (MANUFACTURER UNKNOWN) and ibuprofen (MANUFACTURER UNKNOWN); all for unspecified indication from unknown date and unknown if ongoing. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. The patient previously received morphine (MANUFACTURER UNKNOWN) for unspecified indication from unknown date and experienced drug allergy. On 12Jun2021 at 15:45, after 24 hours of vaccination, the patient experienced ringing in left ear which had not stopped. Since the vaccination, the patient had not been tested for COVID-19. 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 event. The clinical outcome of the event ringing in left ear was not recovered at the time of this report.
Sex: U
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: First dose of the vaccine on 13Aug; few days after that I tested positive for the COVID; First dose of the vaccine on 13Aug; few days after that I tested positive for the COVID; This is a spontaneous report from a contactable consumer.   A patient of an unspecified age and gender received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for Injection, Batch/Lot number: EW0185) via an unspecified route of administration on 13Aug2021 as single dose for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. It was reported that, patient had first dose of the vaccine on 13Aug2021 and few days after the patient tested positive for the COVID on an unspecified date. The patient underwent lab tests and procedures which included sars-cov-2 test positive. The outcome of the events was unknown.
Sex: M
Vaccine: COVID19
Symptoms: Cerebrovascular accident, Hemiplegia, Speech disorder
Clinical narrative: massive stroke; paralyzed on the right side; having issues with speech; This is a spontaneous report from a contactable consumer, the patient.  A 41-years-old male patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Lot number and expiry was not reported), via an unspecified route of administration, administered in Right arm (on right shoulder) on an unspecified date as dose 2, single for COVID-19 immunization. The patient medical history was not reported, although he had a few underlying conditions which were not specified. Concomitant medications were not reported. The patient previously received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Lot number and expiry was not reported), via an unspecified route of administration on an unspecified date for COVID-19 immunization and did not feel great and for three days he was nauseous. The patient reported that, he got his second shot on his right shoulder, and then two days later, on an unknown date, he had a massive stroke and woke up paralyzed on the right side and he was having issues with speech and his left arm and shoulder on the other side. He told that he had to get the shot or he could not see his 99 year old grandmother. There had not been enough time to see what the side effects of the shot caused. He felt it was what pushed him over the edge to get the stroke. It had not even been a year, there was not enough to go on yet. He did not know if there was enough paperwork and data and statistics. He knew there were large amount of young stroke victims. He was trying to come in here and they could test him all they want so that this could not happen to someone else. The investigation assessment was not provided. The outcome for the events was unknown.  Information on the lot/batch number has been requested.
Sex: M
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, Extra dose administered, Off label use, SARS-CoV-2 test
Clinical narrative: This is a spontaneous report from a contactable consumer (patient). A male patient of unspecified age received third dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot Number: Unknown), via unspecified route of administration, on 19Aug2021, as dose 3, single for COVID-19 immunization. Medical history and concomitant medications were not reported. The patient previously received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot Number: Unknown), via unspecified route of administration, on an unspecified date, as dose 1 and dose 2 for COVID-19 immunization. The patient had taken third shot of Pfizer on 19Aug2021 and was tested positive for COVID on 24Aug2021. I am now past my ten days with no further symptoms from COVID, and also got the antibody treatment on 25Aug2021. My question was do I need another booster now or in 90 days. The outcome of the event (I tested positive for covid on 24Aug2021) was recovered on an unspecified date.   The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow up.
Sex: M
Vaccine: COVID19, COVID19
Symptoms: SARS-CoV-2 test positive
Clinical narrative: This is a spontaneous report from a contactable consumer (patient). A male patient of unspecified age received third dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot Number: Unknown), via unspecified route of administration, on 19Aug2021, as dose 3, single for COVID-19 immunization. Medical history and concomitant medications were not reported. The patient previously received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot Number: Unknown), via unspecified route of administration, on an unspecified date, as dose 1 and dose 2 for COVID-19 immunization. The patient had taken third shot of Pfizer on 19Aug2021 and was tested positive for COVID on 24Aug2021. I am now past my ten days with no further symptoms from COVID, and also got the antibody treatment on 25Aug2021. My question was do I need another booster now or in 90 days. The outcome of the event (I tested positive for covid on 24Aug2021) was recovered on an unspecified date.   The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow up.
Sex: M
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Extra dose administered, Off label use, SARS-CoV-2 test
Clinical narrative: This is a spontaneous report from a contactable consumer (patient). A male patient of unspecified age received third dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot Number: Unknown), via unspecified route of administration, on 19Aug2021, as dose 3, single for COVID-19 immunization. Medical history and concomitant medications were not reported. The patient previously received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot Number: Unknown), via unspecified route of administration, on an unspecified date, as dose 1 and dose 2 for COVID-19 immunization. The patient had taken third shot of Pfizer on 19Aug2021 and was tested positive for COVID on 24Aug2021. I am now past my ten days with no further symptoms from COVID, and also got the antibody treatment on 25Aug2021. My question was do I need another booster now or in 90 days. The outcome of the event (I tested positive for covid on 24Aug2021) was recovered on an unspecified date.   The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow up.
Age: 53.0
Sex: M
Vaccine: COVID19
Symptoms: Head discomfort, Headache
Clinical narrative: Ongoing dull headaches, never had an issue with headaches in life; have a dull pressure on the back of the head; This is a spontaneous report from a contactable consumer, the patient. A 53-year-old male patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8735) via unspecified route of administration in the right arm on 02Apr2021 at 15:00 (at the age of 53-year-old) and the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8735) via unspecified route of administration in the right arm on 23Apr2021 at 13:00 (at the age of 53-year-old) as a single dose for COVID-19 immunisation. The patient had no medical history. The patient had no known allergies. Prior to the vaccination, it was unknown whether the patient was diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. Concomitant medications included alfuzosin (MANUFACTURER UNKNOWN) for an unknown indication from unknown date and unknown if ongoing. On an unknown date in Apr2021 at 12:00, the patient experienced ongoing dull headaches, patient never had an issue with headaches in his life, but now he had them pretty much all day and patient also had a dull pressure on the back of his head. The events did not result in doctor or other health care professional office/clinic visit, and 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 reported events. The clinical outcome of the event dull headaches and dull pressure on the back of the head was not recovered at the time of this report.
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Fatigue, Headache, Nausea
Clinical narrative: Dizzy; Nauseous; Headache; Tired; This is a spontaneous report from a contactable consumer, the patient. A 65-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 26Aug2021 at 11:00 (at the age of 65-year-old) as a single dose for COVID-19 immunisation. The patient medical history included COVID-19 respiratory infection from unknown date and allergy to sulfur drug. 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 vaccination. The Concomitant medication included lisinopril (MANUFACTURER UNKNOWN) for an unknown indication on an unknown date and unknown if ongoing. The patient previously received pethidine hydrochloride (DEMEROL) and experienced drug allergy. On 26Aug2021 at 11:00, the patient felt dizzy right after the vaccination and 6 days later still the patient felt nauseous, tired and experienced headache. The events did not result in doctor or other healthcare professional office/clinic visit/ emergency visit. Therapeutic measures were not taken as a result of adverse events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events dizzy, nauseous, tired and headache 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: 41.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity, Vaccination site erythema, Vaccination site pruritus
Clinical narrative: Itchy red patch on the injection site; Soreness in the arm; Itchy red patch on the injection site; This is a spontaneous report from a contactable consumer, the patient. A 41-year-old 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 arm left on 28Aug2021 at 14:45 (at the age of 41-year-old) as a single dose for COVID-19 immunisation. The patient's medical history was not reported. 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 concomitant medications included melatonin (MANUFACTURER UNKNOWN) from an unknown date for an unknown indication. The patient previously took first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot Number: UNKNOWN) via an unspecified route of administration in the arm left on 07Aug2021 at 14:45 (at the age of 41-year-old) as a single dose for COVID-19 immunisation. On 28Aug2021, the patient experienced itchy red patch on the injection site and soreness in the arm. The adverse events did not result in 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 reported events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events itchy red patch on the injection site and soreness in the arm was not recovered at the time of this report.    The lot number for BNT162b2 was not provided and will be requested during follow up.
Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: Neuralgia, Palpitations, Pruritus, Rash macular
Clinical narrative: Nerve ends feel like they are on fire; Heart racing in chest and throat.; Raised spots on legs, arms, stomach and back; Itching; This is a spontaneous report from a contactable other healthcare professional, the patient. A 52-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: FC3180) via an unspecified route of administration in the left arm on 26Aug2021 at 10:30 (at the age of 52-year-old) as a single dose for COVID-19 immunisation. The patient had known allergy to penicillin. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medications included alprazolam (XANAX), oxycodone (MANUFACTURER UNKNOWN), ezetimibe (ZETIA), levothyroxine (MANUFACTURER UNKNOWN) and BUTALB; all for an unknown indication from an unknown date and unknown if ongoing. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: Ew0187) via an unspecified route of administration in the left arm on 05Aug2021 at 13:15 (at the age of 52-year-old) as a single dose for COVID-19 immunisation. The patient did not receive any other vaccines within four weeks prior to the vaccination.  On 27Aug2021 at 12:00, the patient experienced itching, nerve ends felt like they were on fire, raised spots on legs, arms, stomach and back and heart racing in chest and throat. 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 itching, nerve ends felt like they were on fire, raised spots on legs, arms, stomach and back and heart racing in chest and throat were not resolved at the time of this report.
Sex: F
Vaccine: COVID19
Symptoms: Cerebrovascular accident, Feeling abnormal, Haemorrhage, Headache
Clinical narrative: Stroke; bleed in the head; headaches; acting like she was on drugs; This is a spontaneous report from a contactable consumer. A 62-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection; Batch/Lot number: ER8733) via unspecified route of administration on 06Apr2021 as single dose for COVID-19 immunization. Medical history and concomitant medication were not reported. Patient had previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection; Batch/Lot number: EN6208) via unspecified route of administration on 15Mar2021 as single dose for COVID-19 immunization. Patient did not receive other vaccine in four weeks of vaccination. No event following prior vaccinations. In Jun2021 (after 2 months of vaccination), patient had stroke. On an unspecified date in 2021, patient had bleed in the head, headaches and she was acting like she was on drugs. Events require a visit to emergency room. Stroke occurred in Jun2021 after the second dose. She went to the hospital and they could not find anything wrong with her. Other than she was acting like she was on drugs and she does not take drugs or drink. She does not take medications and was a go getter. Patient was not admitted in the hospital and was taken home and now dealing with headaches, which are ongoing and persisting. When she had stoke or whatever she had, could not remember where she was or anybody but could hear everybody. Reporter seriousness for had stroke, bleed in the head and headaches was unspecified. Outcome for stroke and headaches was not resolved and for other events was unknown.
Sex: F
Vaccine: COVID19
Symptoms: Myocarditis
Clinical narrative: she knew/heard someone past away (die) due to inflammation of the heart; This is a spontaneous report from a contactable consumer via Pfizer Sponsored Program. This consumer reported for two patients. This is the second of two reports. A female patient of an unspecified age received BNT162B2, via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as DOSE NUMBER UNKNOWN, SINGLE for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The reporter would like to know if inflammation of the heart was a commonly reported side effect post-vaccination of the COMIRNATY vaccine and if there had been a lot of reports about it. The reporter stated that she knew/heard someone past away (die) due to inflammation of the heart (onset date not reported) as an AE post-vaccination. The patient died on an unspecified date. It was not reported if an autopsy was performed.  The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.; Sender's Comments: Linked Report(s) :PFIZER INC-202101132810 Same reporter/drug, different patient/AE; Reported Cause(s) of Death: she knew/heard someone past away (die) due to inflammation of the heart
Age: 40.0
Sex: F
Vaccine: COVID19
Symptoms: Lymphadenopathy
Clinical narrative: Reactive lymph nodes in underarm; Reactive lymph nodes in underarm and breast; This is a spontaneous report from a contactable consumer, the patient. A 40-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: Unknown) via an unspecified route of administration in the right arm on 19Aug2021 at 10:00 (at the age of 40-years-old) as a single dose for COVID-19 immunisation. Medical history included sulfa (sulfonamide) allergy and allergy to nitrates. The patient did not receive any medication within two weeks of vaccination. 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. On 20Aug2021 at 06:00, the patient experienced reactive lymph nodes in underarm and breast. The events resulted in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Therapeutic measures were taken as a result of events and included treatment with pain medication (unspecified name). Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the event reactive lymph nodes in underarm and breast was not recovered at the time of this report.  The batch/lot number for BNT162b2, was not provided and will be requested during   follow up.
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test positive, Vaccination failure
Clinical narrative: Tested positive with Covid 19 30Aug2021; Tested positive with Covid 19 30Aug2021; This is a spontaneous report from a contactable consumer or other non hcp. A 60-years-old non-pregnant female patient received bnt162b2 (BNT162B2, Formulation Solution for injection, Lot number: EP7533 Expiry date: Unknown, Age at vaccination: 60 Years) via intramuscularly on 31Mar2021 as dose 2, single for COVID-19 immunisation. The patient previously took bnt162b2 (BNT162B2, Lot number: EN6202, Expiry date: Unknown) via an unspecified route of administration on 10Mar2021 as dose 1 single, for COVID-19 immunisation. The patient medical history was none and concomitant medications were not reported. The patient had no known allergies. The patient was not positive for COVID-19 prior to vaccination and had been tested post vaccination. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 26Aug2021, the patient tested positive with covid 19. The patient underwent lab tests and procedures which included sars-cov-2 test, positive on 30Aug2021, Nasal Swab. The adverse events resulted in Emergency room/department or urgent care. It was unknown if patient received treatment for the events. The outcome of the events was recovering.  Follow-up attempts are completed. No further information is expected.
Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Asthenia, Body temperature, Chills, Fatigue
Clinical narrative: Sore arm; Fever of 101; Chills; Nausea; Aches; Joint pain; Weakness; Fatigue; This is a spontaneous report from a contactable consumer, the patient. A 51-year-old non-pregnant 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 30Aug2021 at 16:00 (at the age of 51-years-old) as a single dose for COVID-19 immunisation. Medical history included bee sting allergy-anaphylaxis. 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 received unspecified concomitant medications. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: FC3180) via an unspecified route of administration in the left arm on 09Aug2021 at 16:00 (at the age of 51-years-old) as a single dose for COVID-19 immunisation. On 30Aug2021 at 20:00, the patient experienced sore arm, fever of 101(Unspecified units), chills, nausea, aches, joint pain, weakness and fatigue. 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. Therapeutic measures were not taken as a result of the events. The clinical outcome of the events sore arm, fever of 101 (Unspecified units), chills, nausea, aches, joint pain, weakness and fatigue were resolving at the time of this report.  No follow-up attempts are possible. No further information is expected.
Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: Nausea, Pain, Pain in extremity, Pyrexia
Clinical narrative: Sore arm; Fever of 101; Chills; Nausea; Aches; Joint pain; Weakness; Fatigue; This is a spontaneous report from a contactable consumer, the patient. A 51-year-old non-pregnant 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 30Aug2021 at 16:00 (at the age of 51-years-old) as a single dose for COVID-19 immunisation. Medical history included bee sting allergy-anaphylaxis. 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 received unspecified concomitant medications. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: FC3180) via an unspecified route of administration in the left arm on 09Aug2021 at 16:00 (at the age of 51-years-old) as a single dose for COVID-19 immunisation. On 30Aug2021 at 20:00, the patient experienced sore arm, fever of 101(Unspecified units), chills, nausea, aches, joint pain, weakness and fatigue. 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. Therapeutic measures were not taken as a result of the events. The clinical outcome of the events sore arm, fever of 101 (Unspecified units), chills, nausea, aches, joint pain, weakness and fatigue were resolving at the time of this report.  No follow-up attempts are possible. No further information is expected.