chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 53.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Urticaria
Clinical narrative: anaphylactic signs in throat; wheezing; This is a spontaneous report from a contactable consumer. This 53-year-old female consumer reported that she received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot #EP7534) via an unspecified route of administration in right arm on 23Mar2021 01:30PM (at the age of 53-year-old) at single dose for COVID-19 immunisation. Relevant medical history included high blood pressure, seasonal asthma and allergies, depression, stomach ulcers and allergies to nuts and seafood. Concomitant medications included losartan, omeprazole (OMEPRAZOL), venlafaxine hydrochloride (EFFEXOR), ascorbic acid (VIT C), trazodone hydrochloride (TRAZODON) and cetirizine hydrochloride (ZYRTEC). On the evening of 23Mar2021 the patient had wheezing. On 24Mar2021 09:30AM she woke with rash on right side of face, followed by hives, then itchy head and neck, then in throat. When she got to rash stage, symptoms developed quickly, leading up to anaphylactic signs in throat. She called the doctor immediately (after taking Benadryl). The event resulted in doctor or other HCP office/clinic visit. Treatments included prednisone, Benadryl, famotidine, Zyrtec - 8 days. The patient did not have COVID prior vaccination and was not tested for COVID post vaccination.  Information on the lot/batch number has been requested.
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal pain upper, Blood pressure measurement, Body temperature, Chills, Computerised tomogram
Clinical narrative: Got violent shakes and chills; Got violent shakes and chills; Stomach pain; temperature suddenly got to 103.5; Blood Pressure was very high; flu like; 1st dose :20Mar2021; 2nd dose: 04Apr2021; 1st dose :20Mar2021; 2nd dose: 04Apr2021; This is a spontaneous report from a contactable consumer (patient). A 59-year-old female patient not pregnant received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, administered in Arm Left on 04Apr2021 11:00 (Lot Number: EW0150) as single dose (at the age of 59-years-old) for covid-19 immunisation. Medical history included breast cancer, anxiety, depression, irritable bowel syndrome (IBS), Low Thyroid, arthritis. Patient had no known allergies. It was reported that patient received concomitant medications in two weeks prior to the vaccination, no details reported. Patient did not receive other vaccine in four weeks prior to the COVID vaccine. The patient had previously received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, via an unspecified route of administration, administered in Arm Left (Lot number: ER2613) on 20Mar2021 12:00 PM (at the age of 59-years-old) for COVID-19 immunization. It was reported that patient received first dose on 20Mar2021 and second dose on 04Apr2021 (Inappropriate schedule). Patient stated that she had her second (2 nd) shot on 04Apr2021 (Sunday), was fine until 07Apr2021 (Wednesday). On 07Apr2021 at 15:00 she got violent shakes and chills, stomach pain, temperature suddenly got to 103.5. Patient went to Emergency room. Blood Pressure was very high. She was released and better on Friday but still flu like. They could find no reason for this and three doctors (Dr's) thought it was a reaction to the vaccine. Events resulted in Doctor or other healthcare professional office/clinic visit, Emergency room/department or urgent care, Hospitalization. The patient was hospitalized for 3 days. She was treated with intravenous (IV's), Antibiotics, cat scan and X-ray, results unknown. The patient was not diagnosed with COVID-19 prior to vaccination and had been tested for COVID-19 post vaccination. The patient underwent laboratory tests and procedures which included sars-cov-2 test (Nasal Swab) negative on 07Apr2021. She was recovering from the events, at the time of the report.
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Hypertension, Inappropriate schedule of product administration, Influenza like illness, Off label use, Pyrexia
Clinical narrative: Got violent shakes and chills; Got violent shakes and chills; Stomach pain; temperature suddenly got to 103.5; Blood Pressure was very high; flu like; 1st dose :20Mar2021; 2nd dose: 04Apr2021; 1st dose :20Mar2021; 2nd dose: 04Apr2021; This is a spontaneous report from a contactable consumer (patient). A 59-year-old female patient not pregnant received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, administered in Arm Left on 04Apr2021 11:00 (Lot Number: EW0150) as single dose (at the age of 59-years-old) for covid-19 immunisation. Medical history included breast cancer, anxiety, depression, irritable bowel syndrome (IBS), Low Thyroid, arthritis. Patient had no known allergies. It was reported that patient received concomitant medications in two weeks prior to the vaccination, no details reported. Patient did not receive other vaccine in four weeks prior to the COVID vaccine. The patient had previously received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, via an unspecified route of administration, administered in Arm Left (Lot number: ER2613) on 20Mar2021 12:00 PM (at the age of 59-years-old) for COVID-19 immunization. It was reported that patient received first dose on 20Mar2021 and second dose on 04Apr2021 (Inappropriate schedule). Patient stated that she had her second (2 nd) shot on 04Apr2021 (Sunday), was fine until 07Apr2021 (Wednesday). On 07Apr2021 at 15:00 she got violent shakes and chills, stomach pain, temperature suddenly got to 103.5. Patient went to Emergency room. Blood Pressure was very high. She was released and better on Friday but still flu like. They could find no reason for this and three doctors (Dr's) thought it was a reaction to the vaccine. Events resulted in Doctor or other healthcare professional office/clinic visit, Emergency room/department or urgent care, Hospitalization. The patient was hospitalized for 3 days. She was treated with intravenous (IV's), Antibiotics, cat scan and X-ray, results unknown. The patient was not diagnosed with COVID-19 prior to vaccination and had been tested for COVID-19 post vaccination. The patient underwent laboratory tests and procedures which included sars-cov-2 test (Nasal Swab) negative on 07Apr2021. She was recovering from the events, at the time of the report.
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: SARS-CoV-2 test, Tremor, X-ray
Clinical narrative: Got violent shakes and chills; Got violent shakes and chills; Stomach pain; temperature suddenly got to 103.5; Blood Pressure was very high; flu like; 1st dose :20Mar2021; 2nd dose: 04Apr2021; 1st dose :20Mar2021; 2nd dose: 04Apr2021; This is a spontaneous report from a contactable consumer (patient). A 59-year-old female patient not pregnant received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, administered in Arm Left on 04Apr2021 11:00 (Lot Number: EW0150) as single dose (at the age of 59-years-old) for covid-19 immunisation. Medical history included breast cancer, anxiety, depression, irritable bowel syndrome (IBS), Low Thyroid, arthritis. Patient had no known allergies. It was reported that patient received concomitant medications in two weeks prior to the vaccination, no details reported. Patient did not receive other vaccine in four weeks prior to the COVID vaccine. The patient had previously received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, via an unspecified route of administration, administered in Arm Left (Lot number: ER2613) on 20Mar2021 12:00 PM (at the age of 59-years-old) for COVID-19 immunization. It was reported that patient received first dose on 20Mar2021 and second dose on 04Apr2021 (Inappropriate schedule). Patient stated that she had her second (2 nd) shot on 04Apr2021 (Sunday), was fine until 07Apr2021 (Wednesday). On 07Apr2021 at 15:00 she got violent shakes and chills, stomach pain, temperature suddenly got to 103.5. Patient went to Emergency room. Blood Pressure was very high. She was released and better on Friday but still flu like. They could find no reason for this and three doctors (Dr's) thought it was a reaction to the vaccine. Events resulted in Doctor or other healthcare professional office/clinic visit, Emergency room/department or urgent care, Hospitalization. The patient was hospitalized for 3 days. She was treated with intravenous (IV's), Antibiotics, cat scan and X-ray, results unknown. The patient was not diagnosed with COVID-19 prior to vaccination and had been tested for COVID-19 post vaccination. The patient underwent laboratory tests and procedures which included sars-cov-2 test (Nasal Swab) negative on 07Apr2021. She was recovering from the events, at the time of the report.
Sex: F
Vaccine: COVID19
Symptoms: Bell's palsy
Clinical narrative: Bell's Palsy; This is a spontaneous report from a contactable consumer (patient) via a Pfizer-sponsored program COVAX US Support. A female patient of an unspecified age received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection; Batch/Lot number was not reported), via an unspecified route of administration on an unspecified date as single dose for COVID-19 immunization.  The patient's medical history and concomitant medications were not reported. On an unspecified date, the patient experienced Bell's Palsy within two days following first dose of vaccine. The patient stated that she was hospitalized, and a neurologist told her to get it (as reported). The outcome of the event was unknown.   Information on the lot/batch number has been requested.
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Hypersensitivity, Myalgia, Nasal congestion, Rheumatoid arthritis
Clinical narrative: Allergic reaction/Reaction or allergies; Stuffy head; nose began to run and began to sneeze; sneeze; Nasal stuffiness; Seasonal allergies; Rheumatoid arthritis; Joint and muscle pain that are worse; Joint and muscle pain that are worse; This is a spontaneous report from a non-contactable consumer (patient). A 66-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number was not reported), via an unspecified route of administration on 29Mar2021 as single dose for COVID-19 immunization; and treprostinil sodium (TYVASO), via resp inhalation from Feb2021 to an unspecified date, at 18-54mug (3-9 breaths), 4x/day for secondary pulmonary arterial hypertension. Medical history included ongoing secondary pulmonary arterial hypertension, ongoing arthralgia, ongoing myalgia, seasonal allergy, and hypertension from an unknown date. Concomitant medications included sildenafil citrate taken for an unspecified indication; and amlodipine besilate taken for hypertension. The patient previously took meloxicam for joint pain. On an unspecified date in 2021, the patient experienced joint and muscle pain that are worse, rheumatoid arthritis and seasonal allergies. The patient had joint and muscle pain for a while, but was worse since starting treprostinil sodium. The event of rheumatoid arthritis was considered as medically significant. The patient had joint and muscle issues (arthralgia, myalgia, and rheumatoid arthritis) that could be debilitating, reported that they were getting better with the Nabumetone. On 29Mar2021, the patient had nasal stuffiness that started when she went on an outing. She felt like she was doing better this week than last week (at time of report). On 31Mar2021, the patient reported that she was having a reaction or allergies. She received her first COVID vaccine on 29Mar2021 and felt fine but woke up on Tuesday (30Mar2021) with stuffy head, nose began to run, and began to sneeze. The action taken in response to the events for treprostinil sodium was unknown. The outcome of the events arthralgia and myalgia was recovering, for rheumatoid arthritis was not recovered, and for other events was unknown.  The reporter's causality for the event of myalgia and arthralgia with IH Tyvaso was considered to be possibly related. The reporter did not provide causality for the events of rheumatoid arthritis and seasonal allergy.  Case Comment/Senders Comment: The company has assessed the serious adverse event of drug hypersensitivity and rheumatoid arthritis as not related to IH treprostinil and TD-300/A device. Drug hypersensitivity was likely due to administration of COVID vaccine. Rheumatoid arthritis was likely an underlying medical condition in this 66-year-old patient based on an implausible time to onset for the reported event.  Information on the lot/batch number has been requested.
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Rhinorrhoea, Seasonal allergy, Sneezing, Upper respiratory tract congestion
Clinical narrative: Allergic reaction/Reaction or allergies; Stuffy head; nose began to run and began to sneeze; sneeze; Nasal stuffiness; Seasonal allergies; Rheumatoid arthritis; Joint and muscle pain that are worse; Joint and muscle pain that are worse; This is a spontaneous report from a non-contactable consumer (patient). A 66-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number was not reported), via an unspecified route of administration on 29Mar2021 as single dose for COVID-19 immunization; and treprostinil sodium (TYVASO), via resp inhalation from Feb2021 to an unspecified date, at 18-54mug (3-9 breaths), 4x/day for secondary pulmonary arterial hypertension. Medical history included ongoing secondary pulmonary arterial hypertension, ongoing arthralgia, ongoing myalgia, seasonal allergy, and hypertension from an unknown date. Concomitant medications included sildenafil citrate taken for an unspecified indication; and amlodipine besilate taken for hypertension. The patient previously took meloxicam for joint pain. On an unspecified date in 2021, the patient experienced joint and muscle pain that are worse, rheumatoid arthritis and seasonal allergies. The patient had joint and muscle pain for a while, but was worse since starting treprostinil sodium. The event of rheumatoid arthritis was considered as medically significant. The patient had joint and muscle issues (arthralgia, myalgia, and rheumatoid arthritis) that could be debilitating, reported that they were getting better with the Nabumetone. On 29Mar2021, the patient had nasal stuffiness that started when she went on an outing. She felt like she was doing better this week than last week (at time of report). On 31Mar2021, the patient reported that she was having a reaction or allergies. She received her first COVID vaccine on 29Mar2021 and felt fine but woke up on Tuesday (30Mar2021) with stuffy head, nose began to run, and began to sneeze. The action taken in response to the events for treprostinil sodium was unknown. The outcome of the events arthralgia and myalgia was recovering, for rheumatoid arthritis was not recovered, and for other events was unknown.  The reporter's causality for the event of myalgia and arthralgia with IH Tyvaso was considered to be possibly related. The reporter did not provide causality for the events of rheumatoid arthritis and seasonal allergy.  Case Comment/Senders Comment: The company has assessed the serious adverse event of drug hypersensitivity and rheumatoid arthritis as not related to IH treprostinil and TD-300/A device. Drug hypersensitivity was likely due to administration of COVID vaccine. Rheumatoid arthritis was likely an underlying medical condition in this 66-year-old patient based on an implausible time to onset for the reported event.  Information on the lot/batch number has been requested.
Age: 39.0
Sex: F
Vaccine: COVID19
Symptoms: Back pain, Chest discomfort, Chest pain, Chills, Dyspnoea
Clinical narrative: I tested Positive for Covid after my 1st vaccine; chills; nausea; vomiting; extreme fatigue; difficulty breathing; muscle aches; tight and sore back and chest; tight and sore back and chest; tight and sore back and chest; tight and sore back and chest; This is a spontaneous report from a contactable consumer. A 39-years-old black, not hispanic or latino female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, Solution for injection, Lot number: 59267-1000-2; Age at vaccination 39 Year), dose 1 via an unspecified route of administration, administered in Arm Left on 18Mar2021 14:30 as single dose for covid-19 immunisation. Medical history included diabetes, high blood pressure, depression, anxiety, rheumatoid arthritis, chonic neck and back pain, allergy sulfur. The patient's concomitant therapy was not reported. It was reported that, i tested positive for covid after my 1st vaccine, chills, nausea, vomiting, extreme fatigue, difficulty breathing, muscle aches, tight and sore back and chest on 01Apr2021. Therapeutic measures were not taken. The outcome of event was recovered/resolved with sequelae on Apr2021.
Age: 39.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Musculoskeletal stiffness, Myalgia, Nausea, SARS-CoV-2 test
Clinical narrative: I tested Positive for Covid after my 1st vaccine; chills; nausea; vomiting; extreme fatigue; difficulty breathing; muscle aches; tight and sore back and chest; tight and sore back and chest; tight and sore back and chest; tight and sore back and chest; This is a spontaneous report from a contactable consumer. A 39-years-old black, not hispanic or latino female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, Solution for injection, Lot number: 59267-1000-2; Age at vaccination 39 Year), dose 1 via an unspecified route of administration, administered in Arm Left on 18Mar2021 14:30 as single dose for covid-19 immunisation. Medical history included diabetes, high blood pressure, depression, anxiety, rheumatoid arthritis, chonic neck and back pain, allergy sulfur. The patient's concomitant therapy was not reported. It was reported that, i tested positive for covid after my 1st vaccine, chills, nausea, vomiting, extreme fatigue, difficulty breathing, muscle aches, tight and sore back and chest on 01Apr2021. Therapeutic measures were not taken. The outcome of event was recovered/resolved with sequelae on Apr2021.
Age: 39.0
Sex: F
Vaccine: COVID19
Symptoms: SARS-CoV-2 test positive, Vomiting
Clinical narrative: I tested Positive for Covid after my 1st vaccine; chills; nausea; vomiting; extreme fatigue; difficulty breathing; muscle aches; tight and sore back and chest; tight and sore back and chest; tight and sore back and chest; tight and sore back and chest; This is a spontaneous report from a contactable consumer. A 39-years-old black, not hispanic or latino female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, Solution for injection, Lot number: 59267-1000-2; Age at vaccination 39 Year), dose 1 via an unspecified route of administration, administered in Arm Left on 18Mar2021 14:30 as single dose for covid-19 immunisation. Medical history included diabetes, high blood pressure, depression, anxiety, rheumatoid arthritis, chonic neck and back pain, allergy sulfur. The patient's concomitant therapy was not reported. It was reported that, i tested positive for covid after my 1st vaccine, chills, nausea, vomiting, extreme fatigue, difficulty breathing, muscle aches, tight and sore back and chest on 01Apr2021. Therapeutic measures were not taken. The outcome of event was recovered/resolved with sequelae on Apr2021.
Age: 42.0
Sex: F
Vaccine: COVID19
Symptoms: Anaphylactic reaction, Chest discomfort, Chest pain, Dizziness, Dyspnoea
Clinical narrative: Anaphylactic reaction to vaccine; Felt like an elephant was sitting on my chest; Could not take a deep breath; dizzy lightheaded; Had tingling in my feet; headache; chest pains; This is a spontaneous report from a contactable consumer (patient). A 42-years-old non pregnant female patient received bnt162b2 (BNT162B2), dose 2 via an unspecified route of administration, administered in Arm Left on 10Apr2021 10:00 (at the age of 42-year-old) (Batch/Lot Number: Ew0158) as SINGLE DOSE for covid-19 immunisation. Medical history included Asthma, anaphylactic reactions to shellfish, PCN, codeine. Known allergies included: PCN, codeine, nuts, shellfish, potatoes, green beans, apples, tomatoes. Concomitant medication(s) included loratadine (CLARITIN [LORATADINE]) taken for an unspecified indication, start and stop date were not reported; polycarbophil calcium (FIBER) taken for an unspecified indication, start and stop date were not reported; vitamin b complex (B COMPLEX [VITAMIN B COMPLEX]) taken for an unspecified indication, start and stop date were not reported; magnesium (MAGNESIUM) taken for an unspecified indication, start and stop date were not reported; iron (IRON) taken for an unspecified indication, start and stop date were not reported. The patient took Clartin, fiber, b complex, magnesium, iron, probot in two weeks. The patient previously took first dose of bnt162b2 in left arm on 20Mar2021 at 14:15 (lot number=Er2613) for covid-19 immunisation. No other vaccine in four weeks. No covid prior vaccination. No covid tested post vaccination. On 11Apr2021 02:00 AM, the patient experienced Anaphylactic reaction to vaccine. Felt like an elephant was sitting on her chest. Could not take a deep breath. She was also dizzy lightheaded. Had tingling in her feet, headache and chest pains. Most of her symptoms went away after she was given a high dose of Benadryl and prednisone. She also has asthma and a history of delayed anaphylactic reactions. It will be a 4-5 days before her lungs completely recover from this. AE Resulted in Emergency room/department or urgent care. Outcome of the events was recovering.
Age: 42.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Paraesthesia
Clinical narrative: Anaphylactic reaction to vaccine; Felt like an elephant was sitting on my chest; Could not take a deep breath; dizzy lightheaded; Had tingling in my feet; headache; chest pains; This is a spontaneous report from a contactable consumer (patient). A 42-years-old non pregnant female patient received bnt162b2 (BNT162B2), dose 2 via an unspecified route of administration, administered in Arm Left on 10Apr2021 10:00 (at the age of 42-year-old) (Batch/Lot Number: Ew0158) as SINGLE DOSE for covid-19 immunisation. Medical history included Asthma, anaphylactic reactions to shellfish, PCN, codeine. Known allergies included: PCN, codeine, nuts, shellfish, potatoes, green beans, apples, tomatoes. Concomitant medication(s) included loratadine (CLARITIN [LORATADINE]) taken for an unspecified indication, start and stop date were not reported; polycarbophil calcium (FIBER) taken for an unspecified indication, start and stop date were not reported; vitamin b complex (B COMPLEX [VITAMIN B COMPLEX]) taken for an unspecified indication, start and stop date were not reported; magnesium (MAGNESIUM) taken for an unspecified indication, start and stop date were not reported; iron (IRON) taken for an unspecified indication, start and stop date were not reported. The patient took Clartin, fiber, b complex, magnesium, iron, probot in two weeks. The patient previously took first dose of bnt162b2 in left arm on 20Mar2021 at 14:15 (lot number=Er2613) for covid-19 immunisation. No other vaccine in four weeks. No covid prior vaccination. No covid tested post vaccination. On 11Apr2021 02:00 AM, the patient experienced Anaphylactic reaction to vaccine. Felt like an elephant was sitting on her chest. Could not take a deep breath. She was also dizzy lightheaded. Had tingling in her feet, headache and chest pains. Most of her symptoms went away after she was given a high dose of Benadryl and prednisone. She also has asthma and a history of delayed anaphylactic reactions. It will be a 4-5 days before her lungs completely recover from this. AE Resulted in Emergency room/department or urgent care. Outcome of the events was recovering.
Sex: F
Vaccine: COVID19
Symptoms: Influenza like illness
Clinical narrative: had the 2nd dose on March 23rd and has been experiencing flu-like symptoms without fever since yesterday; This is a spontaneous report from a Pfizer-sponsored  via a contactable female consumer (patient). A female patient of an unspecified age received bnt162b2 (Pfizer Covid-19 Vaccine), dose 2 via an unspecified route of administration on 23Mar2021 (Batch/Lot number was not reported) as single dose for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. The patient historical vaccine included first dose of bnt162b2 on 28Feb2021 for COVID-19 immunisation and experienced headache. The patient had the 2nd dose on 23Mar2021 and has been experiencing flu-like symptoms without fever since yesterday on 06Apr2021. The patient took Tylenol. The outcome of the event was unknown.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Age: 53.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Dry mouth, Headache, Pain, Palpitations
Clinical narrative: Severe headaches; swelling; heavy dizziness; Heart palpitations; heavy body aches and pain; dry mouth; This is a spontaneous report from a contactable consumer (Patient herself). A 53-year-old female patient received first dose of BNT162B2 (Pfizer COVID-19 Vaccine, Formulation: Solution for injection, Lot number: Unknown, Expiry date: Unknown), via an unspecified route of administration in left arm on 10Apr2021 at 14:15 as single dose for COVID-19 immunisation. The patient was not pregnant at the time of vaccination. Medical history included diabetes, high cholesterol. There were no known allergies. Concomitant medication included metformin 100 mg, atorvastatin 20 mg and lisinopril for unknown indication. The patient not had COVID prior vaccination. The patient had not taken any other vaccines four weeks prior vaccination.  On 10Apr2021 at 14:30 (15-minutes after vaccination), patient experienced severe headaches, swelling, heavy dizziness, heart palpitations, heavy body aches and pain, dry mouth. The patient visited emergency room/ department or urgent care and was hospitalized for the events for one day on unspecified date. The patient was not tested for COVID post vaccination. Therapeutic measures taken as a result of events included intravenous drip, Prednisone. The outcome of all the events was recovering.  Information about Lot/Batch number is requested.
Age: 53.0
Sex: F
Vaccine: COVID19
Symptoms: Swelling
Clinical narrative: Severe headaches; swelling; heavy dizziness; Heart palpitations; heavy body aches and pain; dry mouth; This is a spontaneous report from a contactable consumer (Patient herself). A 53-year-old female patient received first dose of BNT162B2 (Pfizer COVID-19 Vaccine, Formulation: Solution for injection, Lot number: Unknown, Expiry date: Unknown), via an unspecified route of administration in left arm on 10Apr2021 at 14:15 as single dose for COVID-19 immunisation. The patient was not pregnant at the time of vaccination. Medical history included diabetes, high cholesterol. There were no known allergies. Concomitant medication included metformin 100 mg, atorvastatin 20 mg and lisinopril for unknown indication. The patient not had COVID prior vaccination. The patient had not taken any other vaccines four weeks prior vaccination.  On 10Apr2021 at 14:30 (15-minutes after vaccination), patient experienced severe headaches, swelling, heavy dizziness, heart palpitations, heavy body aches and pain, dry mouth. The patient visited emergency room/ department or urgent care and was hospitalized for the events for one day on unspecified date. The patient was not tested for COVID post vaccination. Therapeutic measures taken as a result of events included intravenous drip, Prednisone. The outcome of all the events was recovering.  Information about Lot/Batch number is requested.
Sex: F
Vaccine: COVID19
Symptoms: Fatigue
Clinical narrative: tired; This is a spontaneous report from a contactable health care professional and a consumer. A 78-year-old female patient of an unspecified age received first dose of bnt162b2 (Batch/Lot number was not reported), via an unspecified route of administration in 2021 as single dose for covid-19 immunization. Medical history included ongoing diabetes, ongoing arthritis (arthritis pain to shoulders, knees, spine, hands, left hip), ongoing wheelchair bound, ongoing limited mobility. The patient's concomitant medications were not reported. The patient experienced tired in Mar2021 with outcome of recovering. Patient said this past month she got the first covid vaccine and felt "tired" for a couple days after the vaccine but felt better at the time of this report.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Age: 42.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Chills, Decreased appetite, Fatigue, Feeling of body temperature change
Clinical narrative: Fever of 102; chills; temperature swings hot/cold; sweating; Exhaustion; no appetite; entire arm extremely sore; This is a spontaneous report from a contactable consumer (patient). A 42-Year-old female patient received received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot number: unknown), via an unspecified route of administration in left arm on 05Apr2021 at 13:30 at single dose for COVID-19 immunization. The patient previously took first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot number: unknown), via an unspecified route of administration in left arm on 15Mar2021at single dose for COVID-19 immunization. Medical history and concomitant medications were not reported. The patient was not pregnant at the time of vaccination. Prior to vaccination, patient was not diagnosed with COVID-19. COVID prior vaccination was none. Since the vaccination, patient had not been tested for COVID-19. COVID tested post vaccination was none. On 06Apr2021 at 11:30 AM, the patient experienced fever of 102, chills, temperature swings hot/cold, sweating, Exhaustion, no appetite, entire arm extremely sore. No treatment was received. The outcome of the events was recovered.  Information on the lot/batch number has been requested.
Age: 42.0
Sex: F
Vaccine: COVID19
Symptoms: Hyperhidrosis, Hyperpyrexia, Pain in extremity
Clinical narrative: Fever of 102; chills; temperature swings hot/cold; sweating; Exhaustion; no appetite; entire arm extremely sore; This is a spontaneous report from a contactable consumer (patient). A 42-Year-old female patient received received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot number: unknown), via an unspecified route of administration in left arm on 05Apr2021 at 13:30 at single dose for COVID-19 immunization. The patient previously took first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot number: unknown), via an unspecified route of administration in left arm on 15Mar2021at single dose for COVID-19 immunization. Medical history and concomitant medications were not reported. The patient was not pregnant at the time of vaccination. Prior to vaccination, patient was not diagnosed with COVID-19. COVID prior vaccination was none. Since the vaccination, patient had not been tested for COVID-19. COVID tested post vaccination was none. On 06Apr2021 at 11:30 AM, the patient experienced fever of 102, chills, temperature swings hot/cold, sweating, Exhaustion, no appetite, entire arm extremely sore. No treatment was received. The outcome of the events was recovered.  Information on the lot/batch number has been requested.
Age: 28.0
Sex: M
Vaccine: COVID19
Symptoms: Loss of consciousness, Syncope
Clinical narrative: fainted; unconscious for a few minutes; This is a spontaneous report received from a contactable consumer (reporting on himself). A 28-years-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: solution for injection, Lot Number and Expiration Date was not reported), via an un-specified route of administration in in Arm Left on 09Apr2021 10:45 as single dose for COVID-19 immunization. The patient medical history was not reported and known allergies included Codeine, Abilify. The patient's concomitant medications were not reported. Patient did not receive any other vaccine in four weeks. Patient did not have COVID prior vaccination. Not tested COVID post vaccination. It was reported that 09Apr2021 11:00 patient fainted about a hour after getting home. Then the next day at approximately 2:45 she fainted again both times hitting the floor and laying unconscious for a few minutes. Patient had to go Emergency room and hospitalization for a few hours. The outcome of the events was recovered on an unspecified date.   Information on the lot/ batch number has been requested.
Age: 34.0
Sex: M
Vaccine: COVID19
Symptoms: Retinal artery occlusion, Retinal vein occlusion
Clinical narrative: Combined central retinal vein and artery occlusion; Combined central retinal vein and artery occlusion; This is a spontaneous report from a contactable physician. A 34-years-old male patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number: EN6198, expiration date- unknown), via intramuscular, administered in right arm on 22Mar2021 12:00 (at the age of 34-years-old) as a single dose for covid-19 immunisation. Patient historical vaccine received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number: EN6198), via intramuscular, administered in right arm on 01Mar2021 12:00 as a single dose for covid-19 immunization. The patient medical history and concomitant medications were not reported. The patient did not have any known allergies. 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 received other vaccine within 4 weeks prior to the vaccine and no other medications in two weeks. On 07Apr2021 12:00, the patient had combined central retinal vein and artery occlusion. The patient received treatment with Hyperbaric oxygen, aflibercept, steroid. The seriousness of the event was considered as disability and resulted in other healthcare professional office/clinic visit, Emergency room/department or urgent care. Outcome of the event was not recovered.  No follow-up attempts are needed. No further information is expected. ; Sender's Comments: Considering a plausible temporal relationship , a possible contributory role of suspect vaccine BNT162B2 to the reported event combined central retinal vein and artery occlusion cannot be completely excluded. The case will be reassessed once new information is available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
Age: 24.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Seizure, Syncope, Tachycardia
Clinical narrative: fainting; seizure; Tachycardia; dizziness; This is a spontaneous report from a contactable consumer. This 24-year-old non-pregnant female consumer (Patient) reported that she received the first dose of BNT162B2 (Pfizer-BioNTech COVID-19 Vaccine; Solution for injection; Lot number: unknown; Expiry date: Unknown) via an unspecified route of administration in the right arm on 07Apr2021 at 12:45 PM. The patients past medical history included Postural orthostatic tachycardia syndrome. The patient was allergic to Phenergan and Zofran. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since vaccination, patient had not tested for COVID-19. Concomitant medication was not reported. On 10Apr2021, at 12:00PM the patient developed Tachycardia, dizziness, fainting and seizure. The patient did not receive any treatment for the events. The outcome for the events was recovering.  Information about Lot/batch number is requested.
Age: 49.0
Sex: F
Vaccine: COVID19
Symptoms: Pruritus
Clinical narrative: Itching; This is a spontaneous report from a contactable consumer (patient). This 49-years-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) (Batch/Lot Number: ER8730), via an unspecified route of administration administered in left arm on 25Mar2021 11:10 at single dose for COVID-19 immunization. The patient medical history and concomitant medications were none. No additional administered vaccines. No prior vaccinations within 4 weeks. No AE following prior vaccinations. No Family Medical History Relevant to AE. Patient stated on 15Mar2021 she received the first dose and probably 3 to 4 hours after the vaccine (25Mar2021) she started itching on her hands, feet, back just really itchy and happened for a couple of hours. Patient stated she took diphenhydramine hydrochloride (BENADRYL) and it settled down but she was due for her second shot and wants to know if she should take it. AE did not require a visit to emergency room and physician office. Outcome of the event was recovered on 25Mar2021. No investigation assessment.
Sex: U
Vaccine: COVID19
Symptoms: Insomnia, Toothache
Clinical narrative: not sleeping at all; very severe dental issues/ had to take something for pain; This is a spontaneous report from a non-contactable consumer (patient) from a Pfizer-sponsored program Pfizer RxPathways. A patient of unspecified age and gender received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as single dose for covid-19 immunization. The patient's medical history and concomitant medications were not reported.  The patient stated, there was all this confusion on if you can take acetaminophen or ibuprofen with the vaccine which the patient got recently. The first one, the vaccine. The patient trying to figure out what pain killer the patient can take for very severe dental issues. The patient had to take something for pain. The patient was not sleeping at all. The outcome of the events was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: she has tested positive for Covid.; she has tested positive for Covid.; This is a spontaneous report received from a contactable consumer (patient) via a Pfizer-sponsored program and Follow-up (07Apr2021) was received from same reporter from a Pfizer-sponsored program processed together with initial information. A female patient of an unspecified age received first dose of BNT162B2 (Covid-19 Vaccine; solution for injection) via an unspecified route of administration as single dose for covid-19 immunisation. Second dose was scheduled on 15Apr2021. The patient medical history and concomitant medications were not reported. On unknown date the patient tested positive for Covid. The patient underwent lab tests and procedures which included Covid positive. The outcome of the events was unknown.  Information on the lot/batch number has been requested.
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Chills, Fatigue, Illness, Nausea
Clinical narrative: sick; Nausea; Body Chills and Pain; Body Chills and Pain; Fatigue; Weakness; Arm where shot was administered just hurt unbelievable, nothing like anything ever before; This is a spontaneous report received from a contactable consumer (patient herself). A female patient who received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot number: EW0153, Expiration date: Unknown) via an unspecified route of administration in left arm on 07Apr2021 at 10:00 at a single dose for COVID-19 immunization. Historical vaccine included first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number: EN6204), on 17Mar2021 at single dose for COVID-19 immunization and the patient had a vaccine, last one was 2 years ago, it was the Flu shot and she had no reaction. The patient's medical history and concomitant medications were not reported. No additional Vaccines was administered on same date of the Pfizer Suspect. On 07Apr2021, the patient experienced arm where shot was administered just hurt unbelievable, nothing like anything ever before, nausea, body chills and pain, fatigue, weakness and on an unspecified date experienced sick. Caller states she would like the report that she was as sick as a dog. States she had no co-morbidities or medications, or going to doctor all the time, so to her this was a big event. Caller states that can she ask, will they be calling if there was a problem and if there was anything she needs to know about her health going forward. She asked that have you typically heard of anything like this being reported. Caller asked if Medical Information would be able to give any ideas of something else that she could be doing other than just Tylenol. Call handler states that her doctor would be the best person to provide appropriate treatment options. Patient states that they specifically said, she shouldn't have anything after the 30 minutes, so she didn't go to the Emergency Room and she was told that she didn't have any reaction and to go home. States then everything started like deck of cards and just fell into place. States her physician was very busy and she has not felt like waiting to see a doctor. The outcome of the event arm where shot was administered just hurt unbelievable, nothing like anything ever before was recovering, ill was unknown and rest of the events was not recovered.   No follow-up attempts are needed. No further information is expected.
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Pain, Vaccination site pain
Clinical narrative: sick; Nausea; Body Chills and Pain; Body Chills and Pain; Fatigue; Weakness; Arm where shot was administered just hurt unbelievable, nothing like anything ever before; This is a spontaneous report received from a contactable consumer (patient herself). A female patient who received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot number: EW0153, Expiration date: Unknown) via an unspecified route of administration in left arm on 07Apr2021 at 10:00 at a single dose for COVID-19 immunization. Historical vaccine included first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number: EN6204), on 17Mar2021 at single dose for COVID-19 immunization and the patient had a vaccine, last one was 2 years ago, it was the Flu shot and she had no reaction. The patient's medical history and concomitant medications were not reported. No additional Vaccines was administered on same date of the Pfizer Suspect. On 07Apr2021, the patient experienced arm where shot was administered just hurt unbelievable, nothing like anything ever before, nausea, body chills and pain, fatigue, weakness and on an unspecified date experienced sick. Caller states she would like the report that she was as sick as a dog. States she had no co-morbidities or medications, or going to doctor all the time, so to her this was a big event. Caller states that can she ask, will they be calling if there was a problem and if there was anything she needs to know about her health going forward. She asked that have you typically heard of anything like this being reported. Caller asked if Medical Information would be able to give any ideas of something else that she could be doing other than just Tylenol. Call handler states that her doctor would be the best person to provide appropriate treatment options. Patient states that they specifically said, she shouldn't have anything after the 30 minutes, so she didn't go to the Emergency Room and she was told that she didn't have any reaction and to go home. States then everything started like deck of cards and just fell into place. States her physician was very busy and she has not felt like waiting to see a doctor. The outcome of the event arm where shot was administered just hurt unbelievable, nothing like anything ever before was recovering, ill was unknown and rest of the events was not recovered.   No follow-up attempts are needed. No further information is expected.
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Body temperature, Fatigue, Headache, Pain
Clinical narrative: sleeping for 3 days; weak; really thirsty; tired; Fever; real achy; terrible headache; left arm hot, red, and swollen at injection site; left arm hot, red, and swollen at injection site; left arm hot, red, and swollen at injection site; This is a spontaneous report from a contactable Nurse (patient).  A 67-years-old female patient received bnt162b2 (BNT162B2), dose 2 via an unspecified route of administration, administered in Arm Left on 06Apr2021 09:00 (Batch/Lot Number: ER8734) as SINGLE DOSE (at the age of 67 years) for covid-19 immunisation.   The patient had the first dose of BNT162B2 for COVID-19 immunisation in the left arm lot number EP7534 and the patient experienced peripheral swelling in left leg and blood clot.   Medical history included ongoing thalassaemia beta Caller stated she was diagnosed with this in her later 20s or early 30s.     The patient's concomitant medications were not reported.  The patient experienced fever (disability) on 06Apr2021 20:00 with outcome of recovered, real achy (disability) on 06Apr2021 with outcome of recovered, terrible headache (disability) on 06Apr2021 with outcome of recovered, weak (disability) on 07Apr2021 with outcome of recovering, really thirsty (medically significant) on 07Apr2021 with outcome of recovered, tired (disability) on 07Apr2021 with outcome of recovered, sleeping for 3 days on an unspecified date with outcome of unknown, left arm hot, red, and swollen at injection site on 06Apr2021 with outcome of not recovered.  The patient underwent lab tests and procedures which included body temperature: 102, body temperature: 101.9, body temperature: 106, body temperature: 101.6.  Therapeutic measures were taken as a result of fever, real achy, terrible headache, weak. Treatment: Advil. The patient is not in a study or programme. No Additional vaccines administered within last 4 weeks. Events were considered related for real achy, terrible headache, weak, really thirsty, tired, and left arm hot, red, and swollen at injection site.  Follow-up attempts completed: case closed.; Sender's Comments: Based on available information, a possible contributory role of the subject product,  BNT162B2 vaccine, cannot be excluded for fever and other reported events.   There is limited information provided in this report.  This case will be reassessed once additional information is available.  The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.