chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 33.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Immunisation, SARS-CoV-2 test, Vaccination failure
Clinical narrative: got covid; got covid; Booster; This is a spontaneous report received from a non-contactable reporter(s) (Other HCP) from product quality group.  A 33 year-old male patient received bnt162b2 (BNT162B2), administration date 18Dec2021 (Lot number: EL3247) at the age of 33 years as dose 3(booster), single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (lot number=EL3247, dose number=2), administration date: 18Feb2021, when the patient was 33 years old, for Covid-19 immunization; Bnt162b2 (lot number=EL3247, dose number=1), administration date: 28Jan2021, when the patient was 33 years old, for Covid-19 immunization. The following information was reported: IMMUNISATION (medically significant) with onset 18Dec2021, outcome "unknown", described as "Booster"; DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 02Jan2022, outcome "recovering" and all described as "got covid"; COUGH (non-serious) with onset 02Jan2022, outcome "recovering", described as "cough"; UPPER RESPIRATORY TRACT INFECTION (non-serious) with onset 02Jan2022, outcome "recovering", described as "mild URI symptoms". The patient underwent the following laboratory tests and procedures: sars-cov-2 test: (02Jan2022) positive, notes: Nasal Swab. It was unknown if therapeutic measures were taken as a result of drug ineffective, covid-19, cough, upper respiratory tract infection.   No follow-up attempts are possible. No further information is expected.; Sender's Comments: (Based on plausible dose -event relationship post vaccination and no other alternate explanation the causal role of BNT162B2 cannot be excluded for the reported LOE events and Immunization
Age: 43.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Immunisation, SARS-CoV-2 test, Vaccination failure
Clinical narrative: Breakthrough COVID case; Breakthrough COVID case; Dose number=3; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from product quality group. The reporter is the patient.  A 44 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), intramuscular, administered in arm left, administration date 27Oct2021 (Lot number: FF8841) at the age of 43 years as dose 3 (booster), single for covid-19 immunisation. The patient had no relevant medical history. The patient's concomitant medications were not reported. Patient had not received vaccine in four weeks. Patient had not received covid prior vaccination. Patient had covid tested post vaccination. Patient had not known allergies. Patient had not received Other medical History. Vaccination history included: Bnt162b2 (previous dose product=COVID 19, previous dose brand=Pfizer-BioNtech,, previous dose lot number=EN6199, previous dose administrator route=Intramuscular,, previous dose administration date=01Apr2021 , previous dose dose number=2, previous dose vaccine location=Right arm), administration date: 01Apr2021, when the patient was 43 years old, for COVID-19 immunization; Bnt162b2 (previous dose product=COVID 19, previous dose brand=Pfizer-BioNtech, previous dose brand unknown=False, previous dose lot number= EL3248, previous dose administrator route=Intramuscular, previous dose administration date=11Mar2021, previous dose dose number=1, previous dose vaccine location=Left arm), administration date: 11Mar2021, when the patient was 43 years old, for COVID-19 immunization. The following information was reported: IMMUNISATION (medically significant) with onset 27Oct2021, outcome "unknown", described as "Dose number=3"; VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 02Jan2022, outcome "recovering" and all described as "Breakthrough COVID case". The patient underwent the following laboratory tests and procedures: sars-cov-2 test: (03Jan2022) positive, notes: Test name : FlowFlex. Therapeutic measures were not taken as a result of vaccination failure, covid-19.
Age: 32.0
Sex: F
Vaccine: COVID19
Symptoms: Bell's palsy, SARS-CoV-2 test
Clinical narrative: Sudden Bell's palsy to the right side of my face; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 32 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 08Oct2021 (Lot number: Ff2590) at the age of 32 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "Von willebrands disease" (unspecified if ongoing); "thyroid disease" (unspecified if ongoing). Concomitant medication(s) included: VYVANSE; TRILEPTAL; DOXEPIN; EUTHYROX; PAXIL [PIROXICAM]. Vaccination history included: Bnt162b2 (Dose Number: 1, Batch/Lot No: Fd8448, Location of injection: Arm Left), administration date: 11Sep2021, when the patient was 31 years old, for Covid-19 immunization. The following information was reported: BELL'S PALSY (disability, medically significant) with onset 29Dec2021, outcome "recovering", described as "Sudden Bell's palsy to the right side of my face". The event "sudden bell's palsy to the right side of my face" was evaluated at the emergency room visit. The patient underwent the following laboratory tests and procedures: sars-cov-2 test: (30Dec2021) negative, notes: Nasal Swab. Therapeutic measures were taken as a result of bell's palsy. Patient did not receive other vaccine in four-weeks. AE treatment medication included Antibiotics, steroids, medications. Patient did not have covid prior vaccination. No Known allergies.
Sex: M
Vaccine: COVID19
Symptoms: Aortic valve disease
Clinical narrative: Had an aortic valve procedure; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  An elderly male patient received bnt162b2 (BNT162B2), administration date Apr2021 (Batch/Lot number: unknown) as dose 2, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose:1), administration date: Mar2021, for COVID-19 Immunization. The following information was reported: AORTIC VALVE DISEASE (medically significant) with onset 2021, outcome "unknown", described as "Had an aortic valve procedure". Therapeutic measures were taken as a result of aortic valve disease. The patient got the first dose of the Pfizer BioNtech covid-19 Vaccine on Mar2021 and the second dose on Apr2021 and had an aortic valve procedure 2 months ago and was currently on a blood thinner (Plavix 75mg 1 pill/day). The patient mentioned that during his first and second dose, he was not on a blood thinner.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 31.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Immunisation, SARS-CoV-2 test, Vaccination failure
Clinical narrative: confirmed COVID positive; confirmed COVID positive/ cough/congestion/fatigue; Dose number=3; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 31 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administration date 15Dec2021 13:00 (Lot number: FE3594) at the age of 31 years as dose 3 (booster), single, administration date 26Mar2021 (Lot number: EP6955) as dose 2, single and administration date 05Mar2021 (Lot number: EL3248) as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Known allergies: no. If covid prior vaccination: no. The following information was reported: IMMUNISATION (medically significant) with onset 15Dec2021, outcome "unknown", described as "Dose number=3"; VACCINATION FAILURE (medically significant) with onset 29Dec2021, outcome "recovered", described as "confirmed COVID positive"; COVID-19 (medically significant) with onset 29Dec2021, outcome "recovered", described as "confirmed COVID positive/ cough/congestion/fatigue". As reported: had symptoms of cough, congestion, brain fog, and general exhaustion for a period of about 7 - 10 days. The patient underwent the following laboratory tests and procedures: sars-cov-2 test: (29Dec2021) positive. Therapeutic measures were not taken as a result of vaccination failure, covid-19.
Age: 31.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Cough, Fatigue, Feeling abnormal, Immunisation, Nasal congestion
Clinical narrative: confirmed COVID positive; confirmed COVID positive/ cough/congestion/fatigue; Dose number=3; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 31 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administration date 15Dec2021 13:00 (Lot number: FE3594) at the age of 31 years as dose 3 (booster), single, administration date 26Mar2021 (Lot number: EP6955) as dose 2, single and administration date 05Mar2021 (Lot number: EL3248) as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Known allergies: no. If covid prior vaccination: no. The following information was reported: IMMUNISATION (medically significant) with onset 15Dec2021, outcome "unknown", described as "Dose number=3"; VACCINATION FAILURE (medically significant) with onset 29Dec2021, outcome "recovered", described as "confirmed COVID positive"; COVID-19 (medically significant) with onset 29Dec2021, outcome "recovered", described as "confirmed COVID positive/ cough/congestion/fatigue". As reported: had symptoms of cough, congestion, brain fog, and general exhaustion for a period of about 7 - 10 days. The patient underwent the following laboratory tests and procedures: sars-cov-2 test: (29Dec2021) positive. Therapeutic measures were not taken as a result of vaccination failure, covid-19.
Age: 31.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: SARS-CoV-2 test
Clinical narrative: confirmed COVID positive; confirmed COVID positive/ cough/congestion/fatigue; Dose number=3; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 31 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administration date 15Dec2021 13:00 (Lot number: FE3594) at the age of 31 years as dose 3 (booster), single, administration date 26Mar2021 (Lot number: EP6955) as dose 2, single and administration date 05Mar2021 (Lot number: EL3248) as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Known allergies: no. If covid prior vaccination: no. The following information was reported: IMMUNISATION (medically significant) with onset 15Dec2021, outcome "unknown", described as "Dose number=3"; VACCINATION FAILURE (medically significant) with onset 29Dec2021, outcome "recovered", described as "confirmed COVID positive"; COVID-19 (medically significant) with onset 29Dec2021, outcome "recovered", described as "confirmed COVID positive/ cough/congestion/fatigue". As reported: had symptoms of cough, congestion, brain fog, and general exhaustion for a period of about 7 - 10 days. The patient underwent the following laboratory tests and procedures: sars-cov-2 test: (29Dec2021) positive. Therapeutic measures were not taken as a result of vaccination failure, covid-19.
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Axillary mass, Breast mass, Immunisation, Menstruation delayed, Menstruation irregular
Clinical narrative: Softball size lump in armpit that moved to Brest area and later into throat and subsided after 7 days.; Softball size lump in armpit that moved to Brest area and later into throat and subsided after 7 days. Softball size lump in armpit that moved to Brest area and later into throat and subsided after 7 days.; I also have not had a return to my menstrual cycle; I also have not had a return to my menstrual cycle. I have had my monthly cycle consistently until the booster vaccine.; Dose received: 3; This is a spontaneous report from a contactable reporter (consumer or other non HCP). The reporter is the patient.  A 50-year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in left arm, administration date 23Dec2021 at 17:30 (Lot number: FD7218) at the age of 50 years as dose 3 (booster), single for COVID-19 immunisation. The patient's relevant medical history was not reported. There were no concomitant medications. Vaccination history included: Bnt162b2 (DOSE 1, SINGLE, Lot Number: EN6208, Anatomical location: Left arm, Administration time: 08:30), administration date: 18Mar2021, when the patient was 49 years old, for COVID-19 immunisation and Bnt162b2 (DOSE 2, SINGLE, Lot Number: EP7534, Anatomical location: Left arm, Administration time: 08:30), administration date: 06Apr2021, when the patient was 49 years old, for COVID-19 immunisation. The following information was reported: IMMUNISATION (non-serious) with onset 23Dec2021 at 17:30, outcome "unknown", described as "Dose received: 3"; AXILLARY MASS (non-serious), BREAST MASS (non-serious), PHARYNGEAL MASS (non-serious) all with onset 24Dec2021 at 04:30, outcome "recovered" (31Dec2021 at 04:30), and all described as "Softball size lump in armpit that moved to Brest area and later into throat and subsided after 7 days"; MENSTRUATION DELAYED (non-serious) with onset 24Dec2021 at 04:30, outcome "not recovered", described as "I also have not had a return to my menstrual cycle"; MENSTRUATION IRREGULAR (non-serious) with onset 24Dec2021 at 04:30, outcome "not recovered", described as "I also have not had a return to my menstrual cycle. I have had my monthly cycle consistently until the booster vaccine.". The events "Softball size lump in armpit that moved to Brest area and later into throat and subsided after 7 days.", "I also have not had a return to my menstrual cycle" and "I also have not had a return to my menstrual cycle. I have had my monthly cycle consistently until the booster vaccine." were evaluated at the physician office visit. Therapeutic measures were not taken as a result of axillary mass, breast mass, pharyngeal mass, menstruation delayed and menstruation irregular.  Additional information: The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19.
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Pharyngeal mass
Clinical narrative: Softball size lump in armpit that moved to Brest area and later into throat and subsided after 7 days.; Softball size lump in armpit that moved to Brest area and later into throat and subsided after 7 days. Softball size lump in armpit that moved to Brest area and later into throat and subsided after 7 days.; I also have not had a return to my menstrual cycle; I also have not had a return to my menstrual cycle. I have had my monthly cycle consistently until the booster vaccine.; Dose received: 3; This is a spontaneous report from a contactable reporter (consumer or other non HCP). The reporter is the patient.  A 50-year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in left arm, administration date 23Dec2021 at 17:30 (Lot number: FD7218) at the age of 50 years as dose 3 (booster), single for COVID-19 immunisation. The patient's relevant medical history was not reported. There were no concomitant medications. Vaccination history included: Bnt162b2 (DOSE 1, SINGLE, Lot Number: EN6208, Anatomical location: Left arm, Administration time: 08:30), administration date: 18Mar2021, when the patient was 49 years old, for COVID-19 immunisation and Bnt162b2 (DOSE 2, SINGLE, Lot Number: EP7534, Anatomical location: Left arm, Administration time: 08:30), administration date: 06Apr2021, when the patient was 49 years old, for COVID-19 immunisation. The following information was reported: IMMUNISATION (non-serious) with onset 23Dec2021 at 17:30, outcome "unknown", described as "Dose received: 3"; AXILLARY MASS (non-serious), BREAST MASS (non-serious), PHARYNGEAL MASS (non-serious) all with onset 24Dec2021 at 04:30, outcome "recovered" (31Dec2021 at 04:30), and all described as "Softball size lump in armpit that moved to Brest area and later into throat and subsided after 7 days"; MENSTRUATION DELAYED (non-serious) with onset 24Dec2021 at 04:30, outcome "not recovered", described as "I also have not had a return to my menstrual cycle"; MENSTRUATION IRREGULAR (non-serious) with onset 24Dec2021 at 04:30, outcome "not recovered", described as "I also have not had a return to my menstrual cycle. I have had my monthly cycle consistently until the booster vaccine.". The events "Softball size lump in armpit that moved to Brest area and later into throat and subsided after 7 days.", "I also have not had a return to my menstrual cycle" and "I also have not had a return to my menstrual cycle. I have had my monthly cycle consistently until the booster vaccine." were evaluated at the physician office visit. Therapeutic measures were not taken as a result of axillary mass, breast mass, pharyngeal mass, menstruation delayed and menstruation irregular.  Additional information: The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19.
Sex: M
Vaccine: COVID19
Symptoms: Body temperature, Pyrexia
Clinical narrative: Fever has been on and off and today its 102.3; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the parent.  A 7 year-old male patient received bnt162b2 (BNT162B2), administration date 30Dec2021 (Batch/Lot number: unknown) as dose 2 (tris), single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Primary immunization series complete but unknown manufacturer), for COVID-19 Immunization. The following information was reported: PYREXIA (non-serious) with onset 31Dec2021, outcome "not recovered", described as "Fever has been on and off and today its 102.3". Relevant laboratory tests and procedures are available in the appropriate section.  Additional information: Reported events experienced after 2nd dose of Pfizer covid vaccine received.  The lot number for bnt162b2 was not provided and will be requested during follow up.
Age: 49.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Immunisation, SARS-CoV-2 test, Vaccination failure
Clinical narrative: Tested positive for COVID; Tested positive for COVID; dose received: 3; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 49 year-old male patient received bnt162b2 (BNT162B2), intramuscular, administered in arm left, administration date 22Dec2021 18:00 (Lot number: FL2197) at the age of 49 years as dose 3 (booster), single, intramuscular, administered in arm left, administration date 11Feb2021 (Lot number: EL3247) as dose 2, single and intramuscular, administered in arm left, administration date 21Jan2021 (Lot number: EL3247) as dose 1, single for covid-19 immunisation. Relevant medical history included: "athsma" (unspecified if ongoing); "high uric acid" (unspecified if ongoing); "hypertension" (unspecified if ongoing); "low cholesterol ratio" (unspecified if ongoing); "diverticulitis" (unspecified if ongoing). Concomitant medication(s) included: ATORVASTATIN; LISINOPRIL; ALLOPURINOL. If other vaccine in fourweeks: No. Known allergies: No The following information was reported: IMMUNISATION (medically significant) with onset 22Dec2021 18:00, outcome "unknown", described as "dose received: 3"; VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 29Dec2021 18:00, outcome "recovering" and all described as "Tested positive for COVID". The patient underwent the following laboratory tests and procedures: sars-cov-2 test: (29Dec2021) positive, notes: Tested positive for COVID after receiving the vaccine. Therapeutic measures were not taken as a result of vaccination failure, covid-19. If covid prior vaccination: No
Sex: M
Vaccine: COVID19
Symptoms: Cardiac disorder
Clinical narrative: He experienced heart issues as a reaction to the second dose; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the parent.  A 20 year-old male patient received bnt162b2 (BNT162B2), administration date 28Apr2021 (Batch/Lot number: unknown) as dose 2, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose 1), administration date: 07Apr2021, when the patient was 19 years old, for COVID-19 Immunization. The following information was reported: CARDIAC DISORDER (non-serious), outcome "recovered", described as "He experienced heart issues as a reaction to the second dose". The event "he experienced heart issues as a reaction to the second dose" was evaluated at the physician office visit.  Additional details: Patient received Pfizer COVID-19 vaccines at the age of 19 years on 07Apr2021 and 28Apr2021. Patient is now 20 years old and experienced heart issues as a reaction to the second dose. Patient did not go to the hospital as a result of the adverse event. It was reported that by the time patient visited his cardiologist, he was back to normal. Reporter enquired if there was any data on patients who experienced side effects of myocarditis with the primary series, getting a booster dose.  The lot number for bnt162b2 was not provided and will be requested during follow up.
Age: 68.0
Sex: U
Vaccine: COVID19
Symptoms: Burning sensation, Cold urticaria, Erythema, Immunisation, Pruritus
Clinical narrative: This is a spontaneous report from a contactable reporter (consumer or other non HCP). The reporter is the patient. A 68-year-old patient received bnt162b2 (BNT162B2), administered in left arm, administration date 04Oct2021 at 19:00 (Lot number: 30155BA) at the age of 68 years as dose 3 (booster), single for COVID-19 immunisation. Relevant medical history included: "Penicillin allergy" (unspecified if ongoing), notes: Known allergies: Penicillin and "Bee sting hypersensitivity" (unspecified if ongoing), notes: Known allergies: Bees. The patient had received concomitant medications. Vaccination history included: Bnt162b2 (DOSE 1, SINGLE, Lot Number: 6203, Anatomical Location: Left arm), administration date: 27Feb2021, when the patient was 67 years old, for COVID-19 immunisation and Bnt162b2 (DOSE 2, SINGLE, Lot Number: 7534, Anatomical Location: Left arm), administration date: 20Mar2021, when the patient was 67 years old, for COVID-19 immunisation. The following information was reported: IMMUNISATION (non-serious) with onset 04Oct2021 at 19:00, outcome "unknown", described as "Dose received: 3"; URTICARIA (non-serious) with onset 11Oct2021, outcome "not recovered", described as "Went swimming in a lake with cold water, immediately welted up with red hives all over my body up to the water line"; PRURITUS (non-serious) with onset 11Oct2021, outcome "not recovered", and all described as "After that, Ive had the same skin reaction to cold weather - my skin breaks out in hives, itches, burns and turns red"; BURNING SENSATION (non-serious) with onset 11Oct2021, outcome "not recovered", and all described as "After that, Ive had the same skin reaction to cold weather - my skin breaks out in hives, itches, burns and turns red"; ERYTHEMA (non-serious) with onset 11Oct2021, outcome "not recovered", and all described as "After that, Ive had the same skin reaction to cold weather - my skin breaks out in hives, itches, burns and turns red"; COLD URTICARIA (non-serious) with onset 11Oct2021, outcome "not recovered", described as "Doctors office felt it was cold induced urticaria in a phone consult.". The events "Went swimming in a lake with cold water, immediately welted up with red hives all over my body up to the water line.", "After that, Ive had the same skin reaction to cold weather - my skin breaks out in hives, itches, burns and turns red." and "Doctors office felt it was cold induced urticaria in a phone consult." were evaluated at the physician office visit. Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of urticaria, pruritus, burning sensation, erythema and cold urticaria. Additional information: The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had been tested for COVID-19.
Age: 68.0
Sex: U
Vaccine: COVID19
Symptoms: SARS-CoV-2 test, Urticaria
Clinical narrative: This is a spontaneous report from a contactable reporter (consumer or other non HCP). The reporter is the patient. A 68-year-old patient received bnt162b2 (BNT162B2), administered in left arm, administration date 04Oct2021 at 19:00 (Lot number: 30155BA) at the age of 68 years as dose 3 (booster), single for COVID-19 immunisation. Relevant medical history included: "Penicillin allergy" (unspecified if ongoing), notes: Known allergies: Penicillin and "Bee sting hypersensitivity" (unspecified if ongoing), notes: Known allergies: Bees. The patient had received concomitant medications. Vaccination history included: Bnt162b2 (DOSE 1, SINGLE, Lot Number: 6203, Anatomical Location: Left arm), administration date: 27Feb2021, when the patient was 67 years old, for COVID-19 immunisation and Bnt162b2 (DOSE 2, SINGLE, Lot Number: 7534, Anatomical Location: Left arm), administration date: 20Mar2021, when the patient was 67 years old, for COVID-19 immunisation. The following information was reported: IMMUNISATION (non-serious) with onset 04Oct2021 at 19:00, outcome "unknown", described as "Dose received: 3"; URTICARIA (non-serious) with onset 11Oct2021, outcome "not recovered", described as "Went swimming in a lake with cold water, immediately welted up with red hives all over my body up to the water line"; PRURITUS (non-serious) with onset 11Oct2021, outcome "not recovered", and all described as "After that, Ive had the same skin reaction to cold weather - my skin breaks out in hives, itches, burns and turns red"; BURNING SENSATION (non-serious) with onset 11Oct2021, outcome "not recovered", and all described as "After that, Ive had the same skin reaction to cold weather - my skin breaks out in hives, itches, burns and turns red"; ERYTHEMA (non-serious) with onset 11Oct2021, outcome "not recovered", and all described as "After that, Ive had the same skin reaction to cold weather - my skin breaks out in hives, itches, burns and turns red"; COLD URTICARIA (non-serious) with onset 11Oct2021, outcome "not recovered", described as "Doctors office felt it was cold induced urticaria in a phone consult.". The events "Went swimming in a lake with cold water, immediately welted up with red hives all over my body up to the water line.", "After that, Ive had the same skin reaction to cold weather - my skin breaks out in hives, itches, burns and turns red." and "Doctors office felt it was cold induced urticaria in a phone consult." were evaluated at the physician office visit. Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of urticaria, pruritus, burning sensation, erythema and cold urticaria. Additional information: The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had been tested for COVID-19.
Sex: M
Vaccine: COVID19
Symptoms: Myocardial infarction
Clinical narrative: Pt apparently had a heart attack  and died according to the news article.; This is a spontaneous report received from a contactable reporter (Consumer or other non HCP).  An adolescent male patient received bnt162b2 (Pfizer-BioNTech COVID-19) (Batch/Lot number: unknown) as dose 2, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (prev dose product=COVID 19, prev dose brand=Pfizer, prev dose dose number=1), for COVID-19 immunization. The following information was reported: MYOCARDIAL INFARCTION (death), outcome "fatal", described as "Pt apparently had a heart attack  and died according to the news article.". It was unknown if therapeutic measures were taken as a result of myocardial infarction. The patient date of death was unknown. The reported cause of death was myocardial infarction. It was not reported if an autopsy was performed.  The lot number for bnt162b2 was not provided and will be requested during follow up.; Reported Cause(s) of Death: Pt apparently had a heart attack  and died according to the news article
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, Immunisation
Clinical narrative: Booster dose; break through case of COVID.; break through case of COVID.; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from a sales representative. A male patient received bnt162b2 (COMIRNATY) (Batch/Lot number: unknown) as dose 3 (booster), single, (Batch/Lot number: unknown) as dose 2, single and (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: IMMUNISATION (medically significant), outcome "unknown", described as "Booster dose"; DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "break through case of COVID." No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: U
Vaccine: FLUX
Symptoms: Malaise
Clinical narrative: got sick; Initial information received on 29-Dec-2021 regarding an unsolicited valid Social Media non-serious case received from a consumer/non-healthcare professional.  This case involves an unknown age and unknown gender patient who got sick while receiving vaccine INFLUENZA VACCINE.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.    On an unknown date, the patient received a dose of suspect INFLUENZA VACCINE produced by unknown manufacturer (form, strength, dose, frequency, route, lot number, expiry date unknown) in unknown administration site as prophylactic vaccination (flu vaccine).  On an unknown date the patient developed a non-serious event "got sick" (illness) (unknown latency) following the administration of INFLUENZA VACCINE.  Action taken with INFLUENZA VACCINE (INFLUENZA VACCINE) was not applicable.  It was not reported if the patient received a corrective treatment for the event (got sick).  At time of reporting, the outcome was Unknown for the event got sick.
Sex: U
Vaccine: TDAP
Symptoms: Vaccination complication
Clinical narrative: This case involves a patient with unknown demographics who had received adacel and suffered side effects while receiving vaccine DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE [ADACEL]. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. On an unknown date, the patient received a  dose of suspect DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE lot number not reported via unknown route in unknown administration site. On an unknown date the patient developed a non-serious received adacel and suffered side effects (vaccination complication) (unknown latency) following the administration of DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE. Action taken was not applicable. It was not reported if the patient received a corrective treatment for the event (received Adacel and suffered side effects). At time of reporting, the outcome was Unknown for the event received adacel and suffered side effects.
Sex: U
Vaccine: FLUX
Symptoms: Bronchitis, Pneumonia
Clinical narrative: bronchitis; pneumonia; Initial information received on 30-Dec-2021 regarding an unsolicited valid Social Media serious case received from a consumer/non-hcp.  This case involves a patient with unknown demographics who had bronchitis and pneumonia while receiving vaccine INFLUENZA VACCINE.  The patient's past medical history, medical treatment(s), vaccination(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 not reported via unknown route in unknown administration site.  On an unknown date the patient developed a serious bronchitis and pneumonia (unknown latency) following the administration of INFLUENZA VACCINE. This event was assessed as medically significant.  Action taken with INFLUENZA VACCINE (INFLUENZA VACCINE) was not applicable.  It was not reported if the patient received a corrective treatment for the events (bronchitis, pneumonia).  At time of reporting, the outcome was Recovered / Resolved on an unknown date for the event bronchitis and was Recovered / Resolved on an unknown date for the event pneumonia.; Sender's Comments: Sanofi Company Comment dated 05-Jan-2022: This case involves a patient with unknown demographics who had bronchitis and pneumonia while receiving vaccine INFLUENZA VACCINE.Based upon the reported information, the role of a vaccine cannot be assessed.
Sex: U
Vaccine: FLUX
Symptoms: Immune thrombocytopenia, Unevaluable event
Clinical narrative: A flu shot 6 years ago gave me ITP and almost killed me; almost killed; Initial information received on 01-Jan-2022 regarding an unsolicited valid Social Media serious case received from a consumer/non-hcp.  This case involves an unknown age and unknown gender patient who experienced a flu shot 6 years ago gave me itp and almost killed me and almost killed while receiving vaccine Influenza Vaccine.  The patient's past medical history, medical treatment(s), vaccination(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 not reported via unknown route in unknown administration site.  On an unknown date the patient developed a serious event a flu shot 6 years ago gave me  and almost killed me (immune thrombocytopenia) (unknown latency) and non-serious event almost killed (unevaluable event) (unknown latency) following the administration of Influenza Vaccine.    Action taken : not applicable.  Corrective treatment: No corrective reported for the events.  Event outcome : Unknown for both the events.  Seriousness criteria : This event(immune thrombocytopenia) was assessed as medically significant.; Sender's Comments: Sanofi company comment dated 06-Jan-2022. This case involves an unknown gender patient who experienced a flu shot 6 years ago gave me and almost killed me while receiving vaccine Influenza Vaccine. Based on the limited information provided regarding this case, causal role of the company suspect product cannot be excluded. Case will be re-evaluated post further update on the patient's underlying disease conditions, past medical and drug history, concurrent illnesses, and concomitant medications.
Sex: F
Vaccine: FLUX
Symptoms: Menstrual disorder
Clinical narrative: those yearly shots mess her up PERIOD; Initial information received on 01-Jan-2022 regarding an unsolicited valid Social Media non-serious case received from a consumer/non-hcp (non health care professional).  This case involves an unknown age female patient who's those yearly shots mess her up period while receiving vaccine INFLUENZA VACCINE.  The patient's past medical history, medical treatment(s), vaccination(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 not reported via unknown route in unknown administration site for prophylactic vaccination.  On an unknown date the patient those yearly shots (full form not specified) her up period (ill-defined disorder) (unknown latency) following the administration of INFLUENZA VACCINE.  Action taken was not applicable.  It was not reported if the patient received a corrective treatment for the event (those yearly shots mess her up PERIOD).  At time of reporting, the outcome was Unknown for the event those yearly shots mess her up period.
Sex: U
Vaccine: DTAP, DTAPIPVHIB, IPV, TDAP
Symptoms: Product storage error
Clinical narrative: reporting DAPTACEL, ADACEL, PENTACEL , IPOL, and FLUZONE QUADRIVALENT PREFILLED SYRINGES at a low of 0C for 17 hours, with no reported adverse event; Initial information received on 04-Jan-2022 regarding an unsolicited valid  non-serious case received from a consumer/non-hcp.  This case involves an unknown age and unknown gender patient who reported daptacel, adacel, pentacel , ipol, and fluzone quadrivalent prefilled syringes at a low of 0c for 17 hours, with no reported adverse event while receiving vaccines IPV (VERO) [IPOL], DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE [PENTACEL], DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE [ADACEL] and DIPHTHERIA-15/TETANUS/5 AC PERTUSSIS VACCINE [DAPTACEL] and with the use of medical device FLUZONE QUADRIVALENT PRE-FILLED SYRINGE. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On an unknown date, the patient started using FLUZONE QUADRIVALENT PRE-FILLED SYRINGE Unknown dosage unknown (lot - U7093AA, 30-Jun-2022). On an unknown date, the patient received a  dose of suspect DIPHTHERIA-15/TETANUS/5 AC PERTUSSIS VACCINE lot C5743AA in unknown administration site. On an unknown date, the patient received a  dose of suspect DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE lot U7093AA via unknown route in unknown administration site. On an unknown date, the patient received a  dose of suspect DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE lot UJ582AAA via unknown route in unknown administration site. On an unknown date, the patient received a  dose of suspect IPV (VERO) lot T1E872M in unknown administration site.  On an unknown date the patient developed an event of a non-serious reporting daptacel, adacel, pentacel , ipol, and fluzone quadrivalent prefilled syringes at a low of 0c for 17 hours, with no reported adverse event (product storage error) (unknown latency) after starting use of FLUZONE QUADRIVALENT PRE-FILLED SYRINGE.  Action taken was not applicable.  It was not reported if the patient received a corrective treatment for the event (reporting DAPTACEL, ADACEL, PENTACEL , IPOL, and FLUZONE QUADRIVALENT PREFILLED SYRINGES at a low of 0C for 17 hours, with no reported adverse event).  At time of reporting, the outcome was Unknown for the event reporting daptacel, adacel, pentacel , ipol, and fluzone quadrivalent prefilled syringes at a low of 0c for 17 hours, with no reported adverse event.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Sex: F
Vaccine: TDAP
Symptoms: Arthralgia, Mobility decreased, Pain in extremity, Vaccination site erythema, Vaccination site pain
Clinical narrative: This case involves a 74 years old female patient who reported trouble lifting their arm, swelling, redness, pain and pain in their shoulder and then severe joint pain in their shoulder while receiving vaccine DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE [ADACEL]. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. On 06-May-2021, the patient received a dose of suspect DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE lot U6853AA via intramuscular route in the left deltoid for prophylactic vaccination. On an unknown date the patient developed a non-serious  event "trouble lifting their arm" (limb discomfort) (unknown latency) following the administration of DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE. On an unknown date the patient developed a non-serious  event "swelling" (vaccination site swelling) (unknown latency) following the administration of DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE. On an unknown date the patient developed a non-serious event "redness" (vaccination site erythema) (unknown latency) following the administration of DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE. On an unknown date the patient developed a non-serious event "pain" (vaccination site pain) (unknown latency) following the administration of DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE. On an unknown date the patient developed a non-serious event "pain in their shoulder and then severe joint pain in their shoulder" (arthralgia) (unknown latency) following the administration of DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE. On an unknown date the patient developed a non-serious event "severe joint pain in legs" (pain in extremity) (unknown latency) following the administration of DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE. It was reported "The patient reported having swelling, redness, and pain and then trouble lifting their arm and then it moved to joint pain in their shoulder and then severe joint pain in their shoulder and then it was in their legs for the next few weeks". Action taken with DIPHTHERIA, TETANUS AND ACELLULAR PERTUSSIS VACCINE (ADACEL) was not applicable. It was not reported if the patient received a corrective treatment for the events (swelling, redness, pain, pain in their shoulder and then severe joint pain in their shoulder, trouble lifting their arm, severe joint pain in legs). At time of reporting, the outcome was Unknown for the event swelling, was Unknown for the event redness, was Unknown for the event pain, was Unknown for the event pain in their shoulder and then severe joint pain in their shoulder and was Unknown for the event trouble lifting their arm.
Sex: F
Vaccine: TDAP
Symptoms: Vaccination site swelling
Clinical narrative: This case involves a 74 years old female patient who reported trouble lifting their arm, swelling, redness, pain and pain in their shoulder and then severe joint pain in their shoulder while receiving vaccine DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE [ADACEL]. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. On 06-May-2021, the patient received a dose of suspect DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE lot U6853AA via intramuscular route in the left deltoid for prophylactic vaccination. On an unknown date the patient developed a non-serious  event "trouble lifting their arm" (limb discomfort) (unknown latency) following the administration of DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE. On an unknown date the patient developed a non-serious  event "swelling" (vaccination site swelling) (unknown latency) following the administration of DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE. On an unknown date the patient developed a non-serious event "redness" (vaccination site erythema) (unknown latency) following the administration of DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE. On an unknown date the patient developed a non-serious event "pain" (vaccination site pain) (unknown latency) following the administration of DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE. On an unknown date the patient developed a non-serious event "pain in their shoulder and then severe joint pain in their shoulder" (arthralgia) (unknown latency) following the administration of DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE. On an unknown date the patient developed a non-serious event "severe joint pain in legs" (pain in extremity) (unknown latency) following the administration of DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE. It was reported "The patient reported having swelling, redness, and pain and then trouble lifting their arm and then it moved to joint pain in their shoulder and then severe joint pain in their shoulder and then it was in their legs for the next few weeks". Action taken with DIPHTHERIA, TETANUS AND ACELLULAR PERTUSSIS VACCINE (ADACEL) was not applicable. It was not reported if the patient received a corrective treatment for the events (swelling, redness, pain, pain in their shoulder and then severe joint pain in their shoulder, trouble lifting their arm, severe joint pain in legs). At time of reporting, the outcome was Unknown for the event swelling, was Unknown for the event redness, was Unknown for the event pain, was Unknown for the event pain in their shoulder and then severe joint pain in their shoulder and was Unknown for the event trouble lifting their arm.
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Condition aggravated, Tinnitus
Clinical narrative: My tinnitus went from mild to near maddening. It is consistent and I am afraid a second dose will drive me over the edge.
Age: 67.0
Sex: M
Vaccine: COVID19
Symptoms: Acute kidney injury, Arthralgia, COVID-19, COVID-19 pneumonia, Cough
Clinical narrative: Patient tested positive for COVID on 11/12/2021. Fully vaccinated. Admitting dx acute kidney injury.  COVID-19 pneumonia.  The patient was having difficulty breathing and associated with nonproductive cough. The patient was having severe diarrhea without any fever.  No chills.  The patient has been sick for at least 1 week until his condition got worse.  He came to the emergency room to be found in acute renal failure with COVID-19 pneumonia. 2-week history of lightheadedness, dizziness, loose stools, myalgias and arthralgias.  He also had some dyspnea.  Treatment:  oxygen,  Lovenox.   Discharged to home.
Age: 67.0
Sex: M
Vaccine: COVID19
Symptoms: Diarrhoea, Dizziness, Dyspnoea, Malaise, Myalgia
Clinical narrative: Patient tested positive for COVID on 11/12/2021. Fully vaccinated. Admitting dx acute kidney injury.  COVID-19 pneumonia.  The patient was having difficulty breathing and associated with nonproductive cough. The patient was having severe diarrhea without any fever.  No chills.  The patient has been sick for at least 1 week until his condition got worse.  He came to the emergency room to be found in acute renal failure with COVID-19 pneumonia. 2-week history of lightheadedness, dizziness, loose stools, myalgias and arthralgias.  He also had some dyspnea.  Treatment:  oxygen,  Lovenox.   Discharged to home.
Age: 67.0
Sex: M
Vaccine: COVID19
Symptoms: SARS-CoV-2 test positive
Clinical narrative: Patient tested positive for COVID on 11/12/2021. Fully vaccinated. Admitting dx acute kidney injury.  COVID-19 pneumonia.  The patient was having difficulty breathing and associated with nonproductive cough. The patient was having severe diarrhea without any fever.  No chills.  The patient has been sick for at least 1 week until his condition got worse.  He came to the emergency room to be found in acute renal failure with COVID-19 pneumonia. 2-week history of lightheadedness, dizziness, loose stools, myalgias and arthralgias.  He also had some dyspnea.  Treatment:  oxygen,  Lovenox.   Discharged to home.