chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: M
Vaccine: COVID19
Symptoms: Peripheral swelling, Thrombosis, Ultrasound scan
Clinical narrative: He went to the hospital and was told he had a blood clot in his leg; his leg 'blew up and swelled up double the size'; This is a spontaneous report from a non-contactable consumer (patient).   A male patient of an unspecified age received bnt162b2 (COMIRNATY, solution for injection) via an unspecified route of administration on an unspecified date as dose 2, single for COVID-19 immunisation. Medical history and concomitant medications were not reported. The patient previously received BNT162B2 on an unspecified date as dose 1, single for COVID-19 immunization and experienced leg started to hurt. On an unspecified date, the patient went to the hospital and was told he had a blood clot in his leg and 'blew up and swelled up double the size'. The patient stated that he was being followed by doctor and was given blood thinners. The patient underwent lab tests and procedures which included ultrasound scan: blood clot in his leg (diagnosis via ultrasound) on an unspecified date. The outcome of the events was unknown, events led to a physician office visit and treatment (blood thinners) received.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 34.0
Sex: M
Vaccine: COVID19
Symptoms: Antinuclear antibody, Antinuclear antibody positive, Fatigue, Investigation, Tremor
Clinical narrative: a feeling in my body of tiredness/ fatigue; a tremor in right hand and body; positive for ANA titer; weight loss; This is a spontaneous report from a contactable consumer (patient). A 34-year-old male patient received bnt162b2 (Pfizer-BioNTech Covid-19 vaccine), dose 2 via an unspecified route of administration on 02Sep2021 (Batch/Lot Number: FE 3592) as DOSE 2, SINGLE, at age of 34-year-old of vaccination, for covid-19 immunisation. The patient previously received first dose of BNT162b2 on 12Aug2021 (lot number EW 0181) at 34-year-old of vaccination for Covid-19 immunization and experienced metallic taste in mouth. Medical history included attention deficit hyperactivity disorder (ADHD), obsessive-compulsive disorder (OCD), gastrooesophageal reflux disease (GERD). The patient had no known drug allergies. Concomitant medications included bupropion hydrochloride (WELLBUTRIN), amfetamine aspartate, amfetamine sulfate, dexamfetamine saccharate, dexamfetamine sulfate (ADDERALL), omeprazole, all taken for an unspecified indication, start and stop date were not reported. The patient experienced a feeling in my body of tiredness, a tremor in right hand and body, positive for ANA titer, weight loss, all on 23Sep2021 with outcome of not recovered. The events resulted in disability or permanent damage. Clinical course was as follows: after second injection, the patient had a feeling in her body of tiredness, fatigue and developed a tremor in right hand and body which still had not subsided, positive ANA titer, weight loss. She had seen two specialists and no new diagnosis had been made. The patient had multiple doctor visits and lab work, and received treatment for the events. The patient underwent lab tests and procedures which included antinuclear antibody: positive on 23Sep2021, investigation: unknown results on, weight: loss on 23Sep2021.  No follow-up attempts are possible. No further information is expected.
Age: 34.0
Sex: M
Vaccine: COVID19
Symptoms: Weight, Weight decreased
Clinical narrative: a feeling in my body of tiredness/ fatigue; a tremor in right hand and body; positive for ANA titer; weight loss; This is a spontaneous report from a contactable consumer (patient). A 34-year-old male patient received bnt162b2 (Pfizer-BioNTech Covid-19 vaccine), dose 2 via an unspecified route of administration on 02Sep2021 (Batch/Lot Number: FE 3592) as DOSE 2, SINGLE, at age of 34-year-old of vaccination, for covid-19 immunisation. The patient previously received first dose of BNT162b2 on 12Aug2021 (lot number EW 0181) at 34-year-old of vaccination for Covid-19 immunization and experienced metallic taste in mouth. Medical history included attention deficit hyperactivity disorder (ADHD), obsessive-compulsive disorder (OCD), gastrooesophageal reflux disease (GERD). The patient had no known drug allergies. Concomitant medications included bupropion hydrochloride (WELLBUTRIN), amfetamine aspartate, amfetamine sulfate, dexamfetamine saccharate, dexamfetamine sulfate (ADDERALL), omeprazole, all taken for an unspecified indication, start and stop date were not reported. The patient experienced a feeling in my body of tiredness, a tremor in right hand and body, positive for ANA titer, weight loss, all on 23Sep2021 with outcome of not recovered. The events resulted in disability or permanent damage. Clinical course was as follows: after second injection, the patient had a feeling in her body of tiredness, fatigue and developed a tremor in right hand and body which still had not subsided, positive ANA titer, weight loss. She had seen two specialists and no new diagnosis had been made. The patient had multiple doctor visits and lab work, and received treatment for the events. The patient underwent lab tests and procedures which included antinuclear antibody: positive on 23Sep2021, investigation: unknown results on, weight: loss on 23Sep2021.  No follow-up attempts are possible. No further information is expected.
Age: 47.0
Sex: M
Vaccine: COVID19
Symptoms: Vomiting
Clinical narrative: Pancreas level is 600 to 700; More half asleep than he was awake; Booster; Throwing up; This is a spontaneous report from a contactable consumer (patient). A 47-year-old male patient received BNT162B2 (COMIRNATY; Lot Number: FF8839), intramuscular in left arm, on 30Oct2021 at 12:00 PM (at the age of 47 years), as dose 3 (booster), single, for COVID-19 immunization. The patient's medical history included chronic obstructive pulmonary disease (COPD; diagnosed 4 to 5 years ago), asthma (11 to 12 years ago), bronchitis, and HIV positive from 24Jan2001. The patient's family history included diabetic. The patient's concomitant medications included unspecified daily medications. The patient previously received the first dose of BNT162B2 (COMIRNATY; Lot Number: ER8727), intramuscular in left arm, on 31Mar2021 at 13:00 (at the age of 46 years), for COVID-19 immunization, and experienced aches and pains, got sick, felt kind of like he had a cold, metal taste in mouth, bronchitis and asthma were really bad, and left arm hurt at injection site; and the second dose of BNT162B2 (COMIRNATY; Lot Number: EW0169), intramuscular in left arm, on 21Apr2021 at 13:15 (at the age of 47 years), for COVID-19 immunization. The patient was considered high risk for COVID-19. The patient has received 3 doses of Pfizer COVID-19 vaccine. The patient received his third or booster dose last 30Oct2021 12 noon and was throwing up ever since. The patient was advised to wait for 72 hours before seeing the doctor, but he was only able to visit the emergency room yesterday (10Nov2021). On 10Nov2021, the patient's pancreas level is 600 to700 and he will only be admitted in the hospital once it reached 1000. The patient wanted to know if this has been reported as an adverse event. The patient went to the hospital and has been throwing up. The doctor said the booster might have messed with his pancreas, because his numbers were off the chart. The patient wanted to know if there have been any reports of others who have had this. He later confirmed he was not admitted to the hospital, but rather went to the emergency room, where he was treated and released. The throwing up started on 30Oct2021. The patient does not have a primary care provider, he lost his job and does not have insurance. The patient did not remember the name of the emergency room doctor that was there yesterday when he went. The doctor told him to follow up with his primary care. The patient was treated and released. The doctor did not keep him because his pancreas level was 600 to 700 and she said they only admit when it is over 1000. Yesterday (10Nov2021), the throwing up got better because they gave him some intravenous (IV) and medicine and it is better since then. The patient did not know the name of the medication, but it was something to stop him from throwing up. The patient was more half asleep than he was awake (10Nov2021). The patient was treated and released for the events. The patient was recovering from "Throwing up". The outcome of the other events was unknown.  Follow-up attempts are completed. No further information is expected.
Age: 14.0
Sex: F
Vaccine: COVID19
Symptoms: Dyspnoea, Endoscopy, Endoscopy upper gastrointestinal tract, Haemorrhage, Headache
Clinical narrative: Headache; body aches; Trouble breathing; Had bleeding from her bottom; This is a spontaneous report from a contactable consumer (patient's parent). A 14-year-old female non-pregnant patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/Lot number was not reported), via an unspecified route of administration, administered in left arm on 13Jul2021 10:00 (14-year-old at time of vaccination) as single dose for COVID-19 immunisation. Medical history included asthma, JRA, migraines, blood pressure, and allergy to corn, beef, coconut, egg, coffee. The patient had no COVID-19 prior vaccination. Concomitant medication (other medications in two weeks) included vitamins nos (VITAMINS NOS) and unspecified medications for asthma, blood pressure, and migraine. The patient previously took amoxicillin and experienced allergy. There was no other vaccine in four weeks. Adverse event: The patient had headaches and body aches for 3 months. Trouble breathing, she has had ongoing medical issues since getting the vaccine. All her tests have came back normal so there is no reason for all the new medical issues. Only common factor is the Pfizer vaccine. She has been sick non stop since 13Jul2021. Including being hospitalized on 8/2- 8/5. She has not caught a break she is constantly sick and new medical issues popping up every other week. She had bleeding from her bottom while hospitalized. Adverse events started from 13Jul2021 10:30. Adverse events resulted in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care, and hospitalization (from 02Aug2021 to 05Aug2021, while number of days hospitalization was reported as 5). The patient had to get an upper and lower endoscopy. COVID-19 was tested post vaccination: Nasal Swab on 02Aug2021 with result negative. Therapeutic measures were taken as a result of the events. The outcome of the events was not recovered.  Information on the lot/batch number has been requested.
Age: 14.0
Sex: F
Vaccine: COVID19
Symptoms: Pain, SARS-CoV-2 test
Clinical narrative: Headache; body aches; Trouble breathing; Had bleeding from her bottom; This is a spontaneous report from a contactable consumer (patient's parent). A 14-year-old female non-pregnant patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/Lot number was not reported), via an unspecified route of administration, administered in left arm on 13Jul2021 10:00 (14-year-old at time of vaccination) as single dose for COVID-19 immunisation. Medical history included asthma, JRA, migraines, blood pressure, and allergy to corn, beef, coconut, egg, coffee. The patient had no COVID-19 prior vaccination. Concomitant medication (other medications in two weeks) included vitamins nos (VITAMINS NOS) and unspecified medications for asthma, blood pressure, and migraine. The patient previously took amoxicillin and experienced allergy. There was no other vaccine in four weeks. Adverse event: The patient had headaches and body aches for 3 months. Trouble breathing, she has had ongoing medical issues since getting the vaccine. All her tests have came back normal so there is no reason for all the new medical issues. Only common factor is the Pfizer vaccine. She has been sick non stop since 13Jul2021. Including being hospitalized on 8/2- 8/5. She has not caught a break she is constantly sick and new medical issues popping up every other week. She had bleeding from her bottom while hospitalized. Adverse events started from 13Jul2021 10:30. Adverse events resulted in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care, and hospitalization (from 02Aug2021 to 05Aug2021, while number of days hospitalization was reported as 5). The patient had to get an upper and lower endoscopy. COVID-19 was tested post vaccination: Nasal Swab on 02Aug2021 with result negative. Therapeutic measures were taken as a result of the events. The outcome of the events was not recovered.  Information on the lot/batch number has been requested.
Age: 42.0
Sex: M
Vaccine: COVID19
Symptoms: Cardiac flutter, Vaccination site pain, Ventricular extrasystoles
Clinical narrative: Fluttering of the heart; Premature ventricular contractions; Arm hurts at injection site/hurting again at the injection site; This is a spontaneous report from a contactable consumer (patient) via a Pfizer sponsored program COVAX US support. A 42-year-old male patient received bnt162b2 (BNT162B2), dose 1 via an unspecified route of administration, administered in Arm Left on 01Sep2021 (Batch/Lot number was not reported) as DOSE 1, SINGLE, and via an unspecified route of administration, administered in Arm Left on 23Sep2021 (Batch/Lot number was not reported) as DOSE 2, SINGLE for COVID-19 immunization at the age of 42-year-old . The patient's medical history was not reported. The patient was taking unspecified medication concomitantly. The patient experienced fluttering of the heart, premature ventricular contractions and arm hurts at injection site/hurting again at the injection site in Sep2021. The patient has had PVC'S which are premature ventricular contractions. The patient clarifies he has had fluttering of the heart, basically it's almost like he is running a marathon. He has been given high blood pressure medication and Diazepam and nothing is working. Name of blood pressure medication is unknown by the caller, it started with an M, but he doesn't know. He confirms he has no NDC, Lot or expiry date for the blood pressure medication or the Diazepam, he doesn't know where it is. He makes the statement later in the call, that it wasn't a bad batch of Diazepam or anything like that. The patient explains the PVC's began immediately after receiving the first one, he clarifies the small dosage on 01Sep2021. He clarifies it was not immediately, but within a day or so. He doesn't understand why Pfizer is not telling the people on the news about the complications of the vaccine to make people aware of it. The American people should know about this. He confirms the PVC's have not improved. He adds that his arm started hurting him again. It was hurting and then it stopped, but now its hurting again at the injection site. This started about 3 weeks ago. The events resulted in doctor's visit. The patient had seen a doctor beforehand who said he was good to go and ever since he had the Pfizer vaccine, he had to go back. It's like because of his heart, he is not getting rest since he has that other heartbeat in between. He's beating double. He has his regular heartbeat, then another one, then a regular heartbeat, and then another one. He states they thought it was from anxiety, but it's not anxiety. The outcome of events was not recovered.  The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.
Sex: F
Vaccine: COVID19
Symptoms: Insomnia, Neuropathy peripheral
Clinical narrative: I have that neuropathy in my hands and it hurts.; I can hardly sleep at night; This is a spontaneous report from a contactable consumer (patient). A 71-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as dose 1, single, and via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as dose 2, single for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient stated that she has neuropathy in her hands, and it hurts. She can hardly sleep at night. She took the Pfizer shots and will get the booster when she can. The outcome of the events was unknown.  The lot number for BNT162B2, was not provided and will be requested during follow up.
Sex: M
Vaccine: COVID19
Symptoms: Constipation, Malaise, Mental disorder, Muscle spasms, Pain
Clinical narrative: suicidal thoughts; muscles were cramping; constipated; physical and emotional breakdown; physical and emotional breakdown; vomiting; excruciating pain specially on her left side, from left shoulder to her neck and up into the skull; This is a spontaneous report received from a contactable consumer (patient's mother). A male patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as dose number unknown, single for covid-19 immunisation. The patient medical history was not reported. The patient's concomitant medications were not reported. The patient experienced suicidal thoughts on an unspecified date, muscles were cramping on an unspecified date, constipated on an unspecified date, physical and emotional breakdown on an unspecified date, vomiting on an unspecified date, excruciating pain on an unspecified date. The consumer (patient's mother) had a violent reaction a week after the covid vaccine; all her muscles were cramping, and she ended up in a wheelchair. She was also constipated and had to take a laxative, she had a physical and emotional breakdown, vomiting, excruciating pain specially on her left side, from left shoulder to her neck and up into the skull, and suicidal thoughts. She went to ER with her husband. Son (patient) got the shot and had the same events as her. The outcome of the events was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Suicidal ideation, Vomiting
Clinical narrative: suicidal thoughts; muscles were cramping; constipated; physical and emotional breakdown; physical and emotional breakdown; vomiting; excruciating pain specially on her left side, from left shoulder to her neck and up into the skull; This is a spontaneous report received from a contactable consumer (patient's mother). A male patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as dose number unknown, single for covid-19 immunisation. The patient medical history was not reported. The patient's concomitant medications were not reported. The patient experienced suicidal thoughts on an unspecified date, muscles were cramping on an unspecified date, constipated on an unspecified date, physical and emotional breakdown on an unspecified date, vomiting on an unspecified date, excruciating pain on an unspecified date. The consumer (patient's mother) had a violent reaction a week after the covid vaccine; all her muscles were cramping, and she ended up in a wheelchair. She was also constipated and had to take a laxative, she had a physical and emotional breakdown, vomiting, excruciating pain specially on her left side, from left shoulder to her neck and up into the skull, and suicidal thoughts. She went to ER with her husband. Son (patient) got the shot and had the same events as her. The outcome of the events was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Chills, Cold sweat, Eye discharge, Fatigue, Immunisation
Clinical narrative: runny nose; runny eyes; clammy; chills; nausea; tiredness; sore throat; recieved the Pfizer Covid 19 Vaccine Booster; Her son got the Johnson and Johnson.He wanted to get Pfizer so, he got Pfizer; recieved the Pfizer Covid 19 Vaccine Booster; Her son has a current diagnosis of cancer; This is a spontaneous report from a contactable consumer (Patient's mother). A 49-year-old male patient received BNT162B2 (COMIRNATY) on unspecified date at dose 2 booster single dose for COVID-19 immunization. Medical history included active cancer. Concomitant medications were not reported. Historical vaccine included first dose of Johnson and Johnson COVID-19 vaccine on unspecified date for COVID-19 immunization and experienced Totally panic stricken (got the Johnson and Johnson and he won't go around anyone. He was totally panic stricken). Her son has a current diagnosis of cancer. Caller reporting also on this call that her son recieved the Pfizer Covid 19 Vaccine Booster. He has experienced runny nose, runny eyes, clammy, chills, nausea, tiredness, and sore throat. Caller was initially reporting symptoms her husband had after receiving the Pfizer Covid booster shot. She had mentioned that her son has been having other symptoms. Her son got the Johnson and Johnson and he won't go around anyone. He was totally panic stricken. He knew Johnson and Johnson was not such a hot product, that they had problems. He wanted to get Pfizer so, he got Pfizer. The outcome of the events was unknown. The outcome of the events was Serious was No.   The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.
Sex: M
Vaccine: COVID19
Symptoms: Interchange of vaccine products, Nausea, Neoplasm malignant, Off label use, Oropharyngeal pain
Clinical narrative: runny nose; runny eyes; clammy; chills; nausea; tiredness; sore throat; recieved the Pfizer Covid 19 Vaccine Booster; Her son got the Johnson and Johnson.He wanted to get Pfizer so, he got Pfizer; recieved the Pfizer Covid 19 Vaccine Booster; Her son has a current diagnosis of cancer; This is a spontaneous report from a contactable consumer (Patient's mother). A 49-year-old male patient received BNT162B2 (COMIRNATY) on unspecified date at dose 2 booster single dose for COVID-19 immunization. Medical history included active cancer. Concomitant medications were not reported. Historical vaccine included first dose of Johnson and Johnson COVID-19 vaccine on unspecified date for COVID-19 immunization and experienced Totally panic stricken (got the Johnson and Johnson and he won't go around anyone. He was totally panic stricken). Her son has a current diagnosis of cancer. Caller reporting also on this call that her son recieved the Pfizer Covid 19 Vaccine Booster. He has experienced runny nose, runny eyes, clammy, chills, nausea, tiredness, and sore throat. Caller was initially reporting symptoms her husband had after receiving the Pfizer Covid booster shot. She had mentioned that her son has been having other symptoms. Her son got the Johnson and Johnson and he won't go around anyone. He was totally panic stricken. He knew Johnson and Johnson was not such a hot product, that they had problems. He wanted to get Pfizer so, he got Pfizer. The outcome of the events was unknown. The outcome of the events was Serious was No.   The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.
Sex: M
Vaccine: COVID19
Symptoms: Rhinorrhoea
Clinical narrative: runny nose; runny eyes; clammy; chills; nausea; tiredness; sore throat; recieved the Pfizer Covid 19 Vaccine Booster; Her son got the Johnson and Johnson.He wanted to get Pfizer so, he got Pfizer; recieved the Pfizer Covid 19 Vaccine Booster; Her son has a current diagnosis of cancer; This is a spontaneous report from a contactable consumer (Patient's mother). A 49-year-old male patient received BNT162B2 (COMIRNATY) on unspecified date at dose 2 booster single dose for COVID-19 immunization. Medical history included active cancer. Concomitant medications were not reported. Historical vaccine included first dose of Johnson and Johnson COVID-19 vaccine on unspecified date for COVID-19 immunization and experienced Totally panic stricken (got the Johnson and Johnson and he won't go around anyone. He was totally panic stricken). Her son has a current diagnosis of cancer. Caller reporting also on this call that her son recieved the Pfizer Covid 19 Vaccine Booster. He has experienced runny nose, runny eyes, clammy, chills, nausea, tiredness, and sore throat. Caller was initially reporting symptoms her husband had after receiving the Pfizer Covid booster shot. She had mentioned that her son has been having other symptoms. Her son got the Johnson and Johnson and he won't go around anyone. He was totally panic stricken. He knew Johnson and Johnson was not such a hot product, that they had problems. He wanted to get Pfizer so, he got Pfizer. The outcome of the events was unknown. The outcome of the events was Serious was No.   The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.
Age: 48.0
Sex: M
Vaccine: COVID19, UNK
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: COVID-19; COVID-19; This is a solicited report received from a contactable consumer based on the information received by Pfizer from company (Mfr. Control No. 21K-163-4148142-00). A 48-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/Lot number was not reported) (age at vaccination: 48 years old), intramuscular on 01Apr2021 as dose 1, single, then intramuscular on 01May2021 as dose 2, single for COVID-19 immunization; and adalimumab (HUMIRA), subcutaneous from an unspecified date to an unspecified date, at unspecified dose for moderate to severe rheumatoid arthritis. Medical history and concomitant medications were not reported. The patient experienced COVID-19 in 2021. The patient underwent COVID-19 Test: positive in 2021. The action taken in response to the event for adalimumab was unknown. The outcome of the event was recovering.   The reporter's causality for the event(s) of COVID-19 with adalimumab was no reasonable possibility.    Information on the batch/lot number has been requested.; Sender's Comments: Based on the reported information ,a causal relationship between the events and suspected drug cannot be excluded.
Age: 36.0
Sex: M
Vaccine: COVID19
Symptoms: Deep vein thrombosis, Pulmonary embolism
Clinical narrative: 2 DVTs; PE; This is a spontaneous report from a contactable nurse (patient). A 37-year-old male patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number: Er2613), on 29Mar2021 (at the age of 36-years-old) at dose 2, single for COVID-19 immunisation. Medical history included COVID prior vaccination; diabetes mellitus (DM); hypertension (HTN); high cholesterol; known allergies to bananas and latex. Concomitant medications included losartan; metformin; amlodipine besilate (NORVASC); sitagliptin phosphate (JANUVIA); canagliflozin hemihydrate, metformin hydrochloride (INVOKANA DUO); all reported as other medications in two weeks. The patient received the first dose of BNT162b2 (lot number: EN6199) on 06Mar2021 (at the age of 36-years-old) for COVID-19 immunisation. No other vaccine in four weeks. The patient experienced 2 deep vein thrombosis (DVTs) and a pulmonary embolism (PE) on 27Sep2021. The events resulted in doctor or other healthcare professional office/clinic visit and in emergency room/department or urgent care. Treatment was administered for the events and included prolonged blood thinner treatment. No COVID tested post vaccination. The patient was recovering from the events.; Sender's Comments: As there is limited information in the case provided, the causal association between the events Deep vein thrombosis and Pulmonary embolism and the suspect drug BNT162b2 cannot be excluded. 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: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Illness, Influenza, Pneumonia
Clinical narrative: Pneumonia; Sickness; Flu; This is a solicited report from a non-Pfizer sponsored program (marketing program name not available) from a non-contactable consumer (patient), based on the information received by Pfizer from Company (manufacturer control number: 21K-163-4149382-00).   A 61-year-old female patient received the dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; lot number and expiration date not reported), via intramuscular on an unspecified date in 2021 (at the age of 61-years-old) at dose number unknown, single for COVID-19 immunisation; and ibrutinib (IMBRUVICA) tablet via oral from 07Apr2021 and ongoing at 420 mg, once daily for CLL (chronic lymphocytic leukaemia). Medical history includes ongoing CLL (chronic lymphocytic leukaemia). The patient has no known allergies. The patient's concomitant medications were not reported. On Oct2021, the patient experienced pneumonia. On an unspecified date in 2021, the patient experienced sickness and flu. The action taken in response to the events for ibrutinib was dose not changed. Outcome of the events was recovering. Causality for ibrutinib (IMBRUVICA): The reporter's causality for the events pneumonia and flu was not provided. The reporters causality for the event sickness with ibrutinib (IMBRUVICA) was no reasonable possibility.                                                                                                                                                                                                           The reporter's assessment of the causal relationship of the events with the suspect product BNT162B2 was not provided at the time of this report. Since no determination has been received, the case is managed based on the company causality assessment.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: As there is limited information in the case provided, the causal association between the events pneumonia, illness and influenza and the suspect drug BNT162B2 cannot be excluded. 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: 64.0
Sex: F
Vaccine: COVID19, UNK
Symptoms: Clavicle fracture, Fall
Clinical narrative: Broke clavicle bone; Fell; This is a solicited report based on the information received by Pfizer from company (manufacture control number: 21K-163-4152477-00). A contactable consumer (patient) reported that a 64-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) intramuscularly on 05Apr2021 (Batch/Lot number was not reported) as dose 1, single and intramuscularly on 30Apr2021 (Batch/Lot number was not reported) as dose 2, single for COVID-19 immunisation; Age at vaccination was at 64-year-old. Medical history included COVID-19 from Jan2021 to an unknown date, moderate to severe rheumatoid arthritis and psoriatic arthritis. The patient's concomitant medications were not reported. On 2021, the patient fell and broke her clavicle bone. She underwent surgery and bone graft. It was unknown if she was enrolled in a COVID-19 vaccine trial. The action taken in response to the events for adalimumab was unknown. Outcome of events was recovering. Causality for Humira(Adalimumab): The reporter's causality for the events of Broke Clavicle Bone, Fell and Covid 19 was not provided. Company's opinion is that there is no reasonable possibility that the events of Broke Clavicle Bone, Fell and Covid 19 are related to Humira(Adalimumab). Causality for Drug/vaccine per reporter and the events Clavicle fracture and Fall was possible while for COVID-19 was not reported.  No follow-up attempts are needed; information about lot/batch number of BNT162B2 cannot be obtained. No further information is expected.; Sender's Comments: Based on available information and the drug temporal relationship, the causality between the events - fall, clavicle fracture, and the suspect drug "BNT162B2" cannot be completely excluded.  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.
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, Immunisation, SARS-CoV-2 test
Clinical narrative: This is a spontaneous report from a contactable consumer. A female patient of an unspecified age received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), dose 1 via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as single dose; dose 2 via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as single dose; dose 3 (booster dose) via an unspecified route of administration on an unspecified date in 2021 (Batch/Lot number was not reported) as single dose for covid-19 immunisation. The patient's medical history and concomitant medications were not reported.  The patient had a breakthrough covid-19 infection, she received a Pfizer booster dose the Friday before (on an unknown date in 2021) and she tested positive for COVID in Nov2021. The patient's symptoms are mild but she does not feel well and has a fever. The outcome of the events was unknown.  The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.
Age: 8.0
Sex: M
Vaccine: COVID19
Symptoms: Myocarditis
Clinical narrative: Myocarditis; This is a spontaneous report from a non-contactable consumer.   An 8-year-old male patient received bnt162b2 (BNT162B2), via an unspecified route of administration on Nov2021, at the age of 8-years-old, (Batch/Lot number was not reported) as DOSE 1, SINGLE for covid-19 immunisation.  The patient's medical history and concomitant medications were not reported.  The patient received Pfizer vaccine and was in ICU with myocarditis within 2 days (unspecified day of Nov2021). He was "totally healthy and active" prior to vaccination. The outcome of the event was unknown. Treatment was received for the events.  The lot number for (BNT162B2), was not provided and will be requested during follow-up.
Sex: M
Vaccine: COVID19
Symptoms: Drug ineffective, Suspected COVID-19
Clinical narrative: Died shortly after receiving second dose and contracting covid; Died shortly after receiving second dose and contracting covid; This is a spontaneous report from a non-contactable consumer. An adult male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), dose 2 via an unspecified route of administration on an unspecified date in 2021, dose 1 via an unspecified route of administration on an unspecified date, both single for COVID-19 immunisation. The patient's medical history was not reported. It was unknown whether the patient received any other vaccines within 4 weeks prior to the COVID vaccine. It was unknown whether there was list of any other medications the patient received within 2 weeks of vaccination. Prior to vaccination, the patient was not diagnosed as COVID-19. On 17Nov2021, the patient died shortly after receiving second dose and contracting COVID on 17Nov2021. The outcome of event was fatal. It was unknown if the patient received treatment. Since the vaccination, it was unknown of the patient had been tested for COVID-19. It was not reported if an autopsy was performed.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Reported Cause(s) of Death: Died shortly after receiving second dose and contracting covid
Sex: M
Vaccine: COVID19
Symptoms: Thrombosis
Clinical narrative: Died of blood clots after being vaccinated; This is a spontaneous report from a non-contactable consumer. A 36-year-old male patient received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection), 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 previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Batch/Lot number was not reported) on an unspecified date for covid-19 immunization. The patient died of blood clots after being vaccinated on an unspecified date, reported as Serious with serious criteria death, medically significant. The patient died on an unspecified date.  It was not reported if an autopsy was performed. The outcome of the event Clot blood was fatal.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Reported Cause(s) of Death: Died of blood clots after being vaccinated
Sex: U
Vaccine: FLUX
Symptoms: Erythema, Pruritus, Urticaria
Clinical narrative: This case involves an unknown age and gender patient who experienced have red, itchy welts all over my body (urticaria, erythema and pruritus) while receiving INFLUENZA VACCINE. Past medical treatment(s), vaccination(s) concomitant medication and family history were not provided. It was unknown if the patient had any medical history, concomitant disease or risk factor. On an unknown date, the patient received a dose of suspect INFLUENZA VACCINE produced by unknown manufacturer (batch number and expiry date were not reported) via unknown route in unknown administration site for prophylactic vaccination. On an unknown date the patient developed a non-serious red, itchy welts all over my body (urticaria, erythema and pruritus) (unknown latency) following the administration of INFLUENZA VACCINE. It was unknown if patient physician provide consent to be contacted. There were no lab data/results available. It was not reported if the patient received a corrective treatment for the events. At time of reporting, the outcome was unknown for all events. There will be no information available on the batch number for this case.
Sex: U
Vaccine: FLUX
Symptoms: Influenza
Clinical narrative: This case involves adult and unknown gender patient who experienced flu (influenza) while receiving INFLUENZA VACCINE. Past medical treatment(s), vaccination(s) concomitant medication and family history were not provided. It was unknown if the patient had any medical history, concomitant disease or risk factor. On an unknown date, the patient received a dose of suspect INFLUENZA VACCINE produced by unknown manufacturer (batch number and expiry date were not reported) via unknown route in unknown administration site for prophylactic vaccination. On an unknown date the patient developed a non-serious flu (influenza) (unknown latency) following the administration of INFLUENZA VACCINE. It was unknown if the patient experienced any additional symptoms/events. It was reported "When I do not, I typically do not get the flu. Same as Covid. Get the shot and you might get covid, you might not, just about the same chance as the flu. Sorry, no". It was unknown if there were lab data/results available. It was not reported if the patient received a corrective treatment for the event. At time of reporting, the outcome was unknown for the event. There will be no information available on the batch number for this case.
Sex: U
Vaccine: FLUX
Symptoms: Periarthritis
Clinical narrative: developed frozen shoulder after the flu shot; Initial information was received on 12-Nov-2021 regarding an unsolicited valid Social Media non-serious case from a consumer/non-health care professional (under reference number: US-SA-SAC20211117000538).  This case involves an adult patient with an unknown gender who developed a frozen shoulder (periarthritis) after receiving INFLUENZA VACCINE.   The patient's medical history, past medical treatments, concomitant medications, vaccinations, and family history were not provided.   It was unknown if the patient had any concomitant disease or risk factor.   On an unknown date, the patient received a dose of suspect INFLUENZA VACCINE produced by unknown manufacturer (lot number and expiry date not reported) via unknown route in unknown administration site for prophylactic vaccination.  On an unknown date the patient developed a non-serious frozen shoulder after the flu shot (periarthritis) (unknown latency) following the administration of INFLUENZA VACCINE.  It was unknown if the patient experienced any additional symptoms/events.   It was unknown if there were lab data/results available.  It was not reported if the patient received a corrective treatment for the event.  At time of reporting, the outcome of event was reported as unknown.  There will be no information on lot number for this case.
Sex: U
Vaccine: TDAP
Symptoms: Cellulitis, Pain in extremity, Peripheral swelling
Clinical narrative: classic exaggerated cellulitis; painful arm; really swollen arm; Initial information was received on 12-Nov-2021 regarding an unsolicited valid serious case from an Other Health Professional via Agency (under reference 00855939).  This case is linked to cases 2021SA380564 and 2021SA386973 (Same reporter).  This case involves three patients (unknown age and gender) who had classic exaggerated cellulitis (Cellulitis) with symptoms, swollen (Peripheral swelling) and painful arm (Pain in extremity), after receiving DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE [ADACEL].  It was unknown if the patients had any medical history, concomitant disease or risk factor.   Medical treatment(s), vaccination(s), concomitant medication(s) and family history were not provided   On an unknown date in between 8-nov-2021 to 11-Nov-2021, the patients received 0.5 mL dose of suspect DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE [Total, lot C5882AA and expiration date: not provided] via intramuscular route in the arm for prophylactic vaccination.  On an unknown date in Nov-2021, the patients developed serious exaggerated cellulitis (cellulitis) with symptoms, swollen (peripheral swelling) and painful arm (pain in extremity), 24 hours following the administration of vaccine.   These events were assessed as medically significant.  It was unknown if the patients experienced any additional symptoms/ events.  It was unknown if there were laboratory data/results available.  It was not reported if the patients received any corrective treatment.    At time of reporting, the outcome was unknown for the reported event.  Based on information previously received, the classification and initial justification were removed and narrative has been updated.; Sender's Comments: This case involves three patients (unknown age and gender) who had Cellulitis, Peripheral swelling and Pain in extremity after vaccination with ADACEL. The time to onset is compatible. Further information regarding medical history, concomitant medications, concurrent condition during vaccination, previous vaccination and tolerance, laboratory investigations excluding alternative etiologies for the reported event are needed to fully assess this case. Based upon the reported information, the role of the suspect vaccine cannot be assessed.
Sex: U
Vaccine: FLUX
Symptoms: Influenza
Clinical narrative: This case involves a patient (unknown age and gender) who got the flu (influenza), after receiving INFLUENZA VACCINE. It was unknown if the patient had any medical history, concomitant disease or risk factor. Medical treatment(s), vaccination(s), concomitant medication(s) and family history were not provided. On an unknown date, the patient received a dose of suspect INFLUENZA VACCINE produced by unknown manufacturer (lot number and expiration date were not reported) via unknown route in an unknown administration site for prophylactic vaccination. On an unknown date, the patient got the flu (influenza, non-serious) (unknown latency) following the administration of INFLUENZA VACCINE. It was unknown if the patient experienced any additional symptoms/events. It was unknown if there were laboratory data/results available. It was not reported if the patient received a corrective treatment. At time of reporting, the outcome was unknown for the reported event. There will be no information available on the batch number for this case.
Sex: U
Vaccine: FLUX
Symptoms: Influenza
Clinical narrative: Got the Flu most the time; Initial information received on 16-Nov-2021 regarding an unsolicited valid non-serious case from a consumer/non-healthcare professional via social media.  This case involves a patient (unknown age and gender) who had got the flu most the time (influenza) after receiving INFLUENZA VACCINE.  The patient had no medical history, concomitant disease or risk factor.   The patient's past vaccination included Influenza vaccine (lot number and expiry date not reported) via an unknown route in unknown administration site for prophylactic vaccination and had flu.  The patient's past medical treatment(s), concomitant medication(s) and family history were not provided.  On an unknown date, the patient received a dose of suspect INFLUENZA VACCINE produced by unknown manufacturer (lot number and expiry date not reported) via an unknown route in unknown administration site for prophylactic vaccination.  On an unknown date, the patient developed a non-serious flu most the time (influenza) (unknown latency) following the administration of INFLUENZA VACCINE.  It was unknown if the patient experienced any additional symptoms/events.  It was reported "Why, when I got the flu shot I got the Flu most the time."   There were no laboratory data/results available.  It was not reported if the patient received a corrective treatment for the event.  At time of reporting, the outcome was unknown for the reported event.  There will be no information on the batch number for this case.
Sex: U
Vaccine: FLUX
Symptoms: Influenza
Clinical narrative: This case involves adult and unknown gender patient who experienced flu (influenza) while receiving INFLUENZA VACCINE. The patient had no medical history, concomitant disease, or risk factor. The patient medical treatment(s), vaccination(s), concomitant medication, and family history were not provided. On an unknown date, the patient received a dose of suspect INFLUENZA VACCINE produced by unknown manufacturer [lot number and expiry date not reported] via an unknown route in unknown administration site for prophylactic vaccination. On an unknown date, the patient developed a non-serious flu (influenza) (unknown latency) following the administration of INFLUENZA VACCINE. Details of laboratory data not reported. It was not reported if the patient received any corrective treatment for the event. At time of reporting, the outcome was unknown for the event flu. There will be no information available on the batch number for this case.