chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Condition aggravated, Inflammation, Limb discomfort, Loss of personal independence in daily activities
Clinical narrative: she can't lift her right arm; started to get pain; inflammation; damage to my shoulder; pain to her shoulder; frozen shoulder; can't lift her right arm; getting very bad; she can't work; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  An 55 year-old female patient received bnt162b2 (BNT162B2), administered in arm right, administration date 22Apr2021 (Lot number: EW0158) at the age of 54 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "Diverticulitis" (unspecified if ongoing), notes: she has had this many years. There were no concomitant medications. Vaccination history included: Covid-19 vaccine (1st dose of covid vaccine, Manufacturer unknown, LOT: ER8732, first dose injected in her right arm), administration date: 01Apr2021, when the patient was 54 years old, for COVID-19 immunization, reaction(s): "Caller says after her first dose she had a little pain and fever but that dose was fine. She says her first dose was fine, it hurt but got better in a few days", "Caller says after her first dose she had a little pain and fever but that dose was fine. She says her first dose was fine, it hurt but got better in a few days". The following information was reported: MUSCULOSKELETAL DISCOMFORT (non-serious) with onset 2021, outcome "not recovered", described as "damage to my shoulder"; ARTHRALGIA (non-serious) with onset 2021, outcome "unknown", described as "pain to her shoulder"; PERIARTHRITIS (non-serious) with onset 2021, outcome "unknown", described as "frozen shoulder"; LIMB DISCOMFORT (non-serious) with onset 2021, outcome "unknown", described as "can't lift her right arm"; CONDITION AGGRAVATED (non-serious) with onset 2021, outcome "not recovered", described as "getting very bad"; LOSS OF PERSONAL INDEPENDENCE IN DAILY ACTIVITIES (non-serious) with onset 2021, outcome "unknown", described as "she can't work"; LIMB DISCOMFORT (non-serious) with onset Apr2021, outcome "not recovered", described as "she can't lift her right arm"; PAIN (non-serious) with onset 2021, outcome "unknown", described as "started to get pain"; INFLAMMATION (non-serious) with onset 2021, outcome "unknown", described as "inflammation". The events "damage to my shoulder", "pain to her shoulder", "frozen shoulder", "can't lift her right arm" and "getting very bad" were evaluated at the physician office visit. Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were taken as a result of musculoskeletal discomfort, arthralgia, periarthritis, limb discomfort, condition aggravated, pain, inflammation.  No follow up attempts are possible. No further information is expected.
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: Magnetic resonance imaging, Musculoskeletal discomfort, Pain, Periarthritis
Clinical narrative: she can't lift her right arm; started to get pain; inflammation; damage to my shoulder; pain to her shoulder; frozen shoulder; can't lift her right arm; getting very bad; she can't work; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  An 55 year-old female patient received bnt162b2 (BNT162B2), administered in arm right, administration date 22Apr2021 (Lot number: EW0158) at the age of 54 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "Diverticulitis" (unspecified if ongoing), notes: she has had this many years. There were no concomitant medications. Vaccination history included: Covid-19 vaccine (1st dose of covid vaccine, Manufacturer unknown, LOT: ER8732, first dose injected in her right arm), administration date: 01Apr2021, when the patient was 54 years old, for COVID-19 immunization, reaction(s): "Caller says after her first dose she had a little pain and fever but that dose was fine. She says her first dose was fine, it hurt but got better in a few days", "Caller says after her first dose she had a little pain and fever but that dose was fine. She says her first dose was fine, it hurt but got better in a few days". The following information was reported: MUSCULOSKELETAL DISCOMFORT (non-serious) with onset 2021, outcome "not recovered", described as "damage to my shoulder"; ARTHRALGIA (non-serious) with onset 2021, outcome "unknown", described as "pain to her shoulder"; PERIARTHRITIS (non-serious) with onset 2021, outcome "unknown", described as "frozen shoulder"; LIMB DISCOMFORT (non-serious) with onset 2021, outcome "unknown", described as "can't lift her right arm"; CONDITION AGGRAVATED (non-serious) with onset 2021, outcome "not recovered", described as "getting very bad"; LOSS OF PERSONAL INDEPENDENCE IN DAILY ACTIVITIES (non-serious) with onset 2021, outcome "unknown", described as "she can't work"; LIMB DISCOMFORT (non-serious) with onset Apr2021, outcome "not recovered", described as "she can't lift her right arm"; PAIN (non-serious) with onset 2021, outcome "unknown", described as "started to get pain"; INFLAMMATION (non-serious) with onset 2021, outcome "unknown", described as "inflammation". The events "damage to my shoulder", "pain to her shoulder", "frozen shoulder", "can't lift her right arm" and "getting very bad" were evaluated at the physician office visit. Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were taken as a result of musculoskeletal discomfort, arthralgia, periarthritis, limb discomfort, condition aggravated, pain, inflammation.  No follow up attempts are possible. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: he till had COVID-19; he till had COVID-19; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non-HCP) from medical information team for a Pfizer sponsored program (159558).  A male patient received bnt162b2 (BNT162B2) (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: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "he still had COVID-19". The patient underwent the following laboratory tests and procedures: sars-cov-2 test positive, notes had both the vaccine and a booster shot but he still had COVID-19.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: I am just getting over Covid and I was vaccinated and I still got it.; I am just getting over Covid and I was vaccinated and I still got it.; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program (002591). The reporter is the patient.  A 65 year-old female patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose number unknown, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "I am just getting over Covid and I was vaccinated and I still got it.".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 45.0
Sex: F
Vaccine: COVID19
Symptoms: Blood iron, Electrocardiogram, Fibrin D dimer, Fibrin D dimer increased, Haemoglobin
Clinical narrative: bleeding like having her period, it was a very very irregular situation to her; D-dimer levels were too high; Blood clots in lungs; patient received first dose on 08May2021 and second dose on 11Jul2021; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 46 year-old female patient (not pregnant) received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), administration date 11Jul2021 (Lot number: FA9094) at the age of 45 years as dose 2, single for COVID-19 immunisation. Relevant medical history included: "period was approximately 7 years ago" (unspecified if ongoing); "ablation due to fibroids on uterus" (unspecified if ongoing). The patient took concomitant medications. Vaccination history included: BNT162B2 (Dose 1; Lot number: EW0193), administration date: 08May2021, when the patient was 45 years old, for COVID-19 immunization, reaction(s): "No adverse events". The following information was reported: PULMONARY THROMBOSIS (medically significant), outcome "unknown", described as "Blood clots in lungs"; MENSTRUAL DISORDER (hospitalization), outcome "recovered", described as "bleeding like having her period, it was a very very irregular situation to her"; FIBRIN D DIMER INCREASED (medically significant), outcome "unknown", described as "D-dimer levels were too high"; INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (non-serious) with onset 11Jul2021, outcome "unknown", described as "patient received first dose on 08May2021 and second dose on 11Jul2021". The events "blood clots in lungs" and "d-dimer levels were too high" were evaluated at the physician office visit. The clinical course was reported as follows: The patient stated she received first dose of Pfizer vaccine on 08May2021 and second dose of Pfizer on 11Jul2021. She explained her last period was approximately 7 years ago, because at that time she got an ablation due to fibroids on her uterus. With Pfizer first dose there was no symptoms. With second dose, she experienced bleeding like having her period, it was a very very irregular situation to her; she ended up in the hospital. Doctors told patient her D-dimer levels were too high, and she experienced blood clots in her lungs. It was reported that after the second dose, both lungs had blood clots but heart was fine. Treatment of rivaroxaban (XARELTO) was given (a blood thinner medicine). The patient underwent the following laboratory tests and procedures: blood iron: low, notes: since always; electrocardiogram: normal; fibrin d dimer: too high; haemoglobin: low, notes: since always. Therapeutic measures were taken as a result of pulmonary thrombosis.  No follow-up attempts are possible. No further information is expected.
Age: 45.0
Sex: F
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration, Menstrual disorder, Pulmonary thrombosis
Clinical narrative: bleeding like having her period, it was a very very irregular situation to her; D-dimer levels were too high; Blood clots in lungs; patient received first dose on 08May2021 and second dose on 11Jul2021; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 46 year-old female patient (not pregnant) received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), administration date 11Jul2021 (Lot number: FA9094) at the age of 45 years as dose 2, single for COVID-19 immunisation. Relevant medical history included: "period was approximately 7 years ago" (unspecified if ongoing); "ablation due to fibroids on uterus" (unspecified if ongoing). The patient took concomitant medications. Vaccination history included: BNT162B2 (Dose 1; Lot number: EW0193), administration date: 08May2021, when the patient was 45 years old, for COVID-19 immunization, reaction(s): "No adverse events". The following information was reported: PULMONARY THROMBOSIS (medically significant), outcome "unknown", described as "Blood clots in lungs"; MENSTRUAL DISORDER (hospitalization), outcome "recovered", described as "bleeding like having her period, it was a very very irregular situation to her"; FIBRIN D DIMER INCREASED (medically significant), outcome "unknown", described as "D-dimer levels were too high"; INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (non-serious) with onset 11Jul2021, outcome "unknown", described as "patient received first dose on 08May2021 and second dose on 11Jul2021". The events "blood clots in lungs" and "d-dimer levels were too high" were evaluated at the physician office visit. The clinical course was reported as follows: The patient stated she received first dose of Pfizer vaccine on 08May2021 and second dose of Pfizer on 11Jul2021. She explained her last period was approximately 7 years ago, because at that time she got an ablation due to fibroids on her uterus. With Pfizer first dose there was no symptoms. With second dose, she experienced bleeding like having her period, it was a very very irregular situation to her; she ended up in the hospital. Doctors told patient her D-dimer levels were too high, and she experienced blood clots in her lungs. It was reported that after the second dose, both lungs had blood clots but heart was fine. Treatment of rivaroxaban (XARELTO) was given (a blood thinner medicine). The patient underwent the following laboratory tests and procedures: blood iron: low, notes: since always; electrocardiogram: normal; fibrin d dimer: too high; haemoglobin: low, notes: since always. Therapeutic measures were taken as a result of pulmonary thrombosis.  No follow-up attempts are possible. No further information is expected.
Age: 43.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test positive, Vaccination failure
Clinical narrative: + Ag home test for covid on 24Jan positive; illness mild cough loss of smell and fatigue starting 1/23 and + Ag home test for Covid on 24Jan positive; This is a spontaneous report received from a non-contactable reporter(s) (Other HCP).  A 43 year-old male patient received bnt162b2 (BNT162B2), administration date 21Dec2021 (Lot number: FF2589) at the age of 43 years as dose 3 (booster), single, administration date 24Feb2021 (Lot number: EL3247) as dose 2, single and administration date 02Feb2021 (Lot number: EL3247) 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: VACCINATION FAILURE (medically significant) with onset 24Jan2022, outcome "recovering", described as "+ Ag home test for covid on 24Jan positive"; COVID-19 (medically significant) with onset 23Jan2022, outcome "recovering", described as "illness mild cough loss of smell and fatigue starting 1/23 and + Ag home test for Covid on 24Jan positive". The patient underwent the following laboratory tests and procedures: sars-cov-2 test positive: (24Jan2022) positive. It was unknown if therapeutic measures were taken as a result of vaccination failure, covid-19.  Additional information: Unknown if other vaccine was taken in four weeks. Unknown if covid-19 prior vaccination.   No follow-up attempts are possible. No further information is expected.; Sender's Comments: The vaccine efficacy varies from one patient to another and can be affected by different factors; however, a contributory role of the suspect vaccine BNT162B2 to vaccination failure cannot be ruled out.
Sex: M
Vaccine: COVID19
Symptoms: Blood test, Dyspnoea, Malaise
Clinical narrative: short of breath; wasn''t feeling well; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A 58 year-old male patient received bnt162b2 (BNT162B2) (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: DYSPNOEA (non-serious), outcome "unknown", described as "short of breath"; MALAISE (non-serious), outcome "unknown", described as "wasn''t feeling well". Relevant laboratory tests and procedures are available in the appropriate section.  Additional information: on an unknown date, the blood work was unknown results.  The lot number for bnt162b2 was not provided and will be requested during follow up.
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, Off label use, Product use issue, SARS-CoV-2 test
Clinical narrative: Patient has breastfed infant since receipt of primary series, unknown if pregnant at time of receipt of first dose; Patient has breastfed infant since receipt of primary series, unknown if pregnant at time of receipt of first dose; Notified patient tested positive for COVID-19 on 25Jan2022; Notified patient tested positive for COVID-19 on 25Jan2022; This is a spontaneous report received from non-contactable reporter(s) (Consumer or other non HCP) from a sales representative. The reporter is the patient.  A 31 year-old female patient (unknown if pregnant) received bnt162b2 (BNT162B2), administration date Oct2021 (Batch/Lot number: unknown) as dose 3 (booster), single, administration date Mar2021 (Batch/Lot number: unknown) as dose 2, single and administration date Mar2021 (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: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 25Jan2022, outcome "unknown" and all described as "Notified patient tested positive for COVID-19 on 25Jan2022"; OFF LABEL USE (non-serious), PRODUCT USE ISSUE (non-serious), outcome "unknown" and all described as "Patient has breastfed infant since receipt of primary series, unknown if pregnant at time of receipt of first dose". The patient underwent the following laboratory tests and procedures: sars-cov-2 test: (25Jan2022) positive. Therapeutic measures were not taken as a result of drug ineffective, covid-19.  Clinical course: Patient did not test COVID prior vaccination and tested positive post vaccination.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202200145127 Baby case
Sex: U
Vaccine: COVID19
Symptoms: Ankylosing spondylitis, Condition aggravated
Clinical narrative: Ankylosing Spondylitis; Ankylosing Spondylitis; This is a spontaneous report received from a contactable reporter (Consumer or other non HCP). The reporter is the patient.  A patient (no qualifiers provided) received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 1, single and (Batch/Lot number: unknown) as dose 2, single for COVID-19 immunization. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: ANKYLOSING SPONDYLITIS (medically significant), CONDITION AGGRAVATED (medically significant), outcome "unknown" and all described as "Ankylosing Spondylitis". Clinical course:  The patient stated "I suffer from ankylosing spondylitis. I have never taken biologics. I have taken two shots and a booster of the Pfizer COVID vaccine. It seems to have an effect on my illness."  The lot number for bnt162b2 was not provided and will be requested during follow up. ; Sender's Comments: Linked Report(s) : US-PFIZER INC-202200145008 same patient/vaccine, different dose/event
Age: 47.0
Sex: U
Vaccine: COVID19
Symptoms: Rash, SARS-CoV-2 antibody test
Clinical narrative: Rash; This is a spontaneous report received from a contactable reporter(s) (Other HCP). The reporter is the patient.  A 47 year-old patient received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), intramuscular, administered in deltoid left, administration date 22Nov2021 (Lot number: FH8030) at the age of 47 years 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; Lot number: FF8841; at 17:00 intramuscularly in the left shoulder), administration date: 14Oct2021, when the patient was 47 years old, for COVID-19 immunization, reaction(s): "Splotchy, red, and itchy raised rash under both arms and along side of torso", "Splotchy, red, and itchy raised rash/ rash mainly on right inner thigh near groin, smaller rash on left of inner side groin", "Splotchy, red, and itchy raised rash", "extremely itchy and dry elbows", "extremely itchy and dry elbows/ itchy and red rash on both ankles and up and down both thighs/small itchy rash on back waist", "rash under arm", "rash thighs & calves". The following information was reported: RASH (medically significant), outcome "recovering", described as "Rash". The clinical course was reported as follows: Upon receiving the first dose of the Pfizer COVID-19 vaccination shot, the patient began feeling extremely dry areas on the elbow. The dryness began a few days after my first dose. The dry progressed to a rash. The rash was red with small red bumps. This rash progressed into Nov2021 to areas on flanks on the side of torso as well into my waistline. A few days later, the patient began noticing areas on the back of the ankles and further areas around waistline. The patient began using hydrocortisone uptime on the areas around 03Nov2021/04Nov2021. A few days later, the patient noticed a rash on the right side of the thighs which progressed to the left side down. The symptoms began to subside in late Nov2021/early Dec2021. The patient underwent the following laboratory tests and procedures: sars-cov-2 antibody test: (30Aug2021) positive, notes: 65.6 U/mL.; Sender's Comments: Based on the information currently available, a possible contributory role of the suspect drug in the reported event cannot be completely ruled out given the known suspect drug profile and/or implied temporal association. 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
Age: 31.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, Headache, Nasal congestion, SARS-CoV-2 test
Clinical narrative: Patient tested positive for COVID-19 on home rapid test on 25Jan2022; Patient tested positive for COVID-19 on home rapid test on 25Jan2022; Reports headache and congestion that she states is mild; Reports headache and congestion that she states is mild; This is a spontaneous report received from non-contactable reporters (Consumer or other non HCP) from a sales representative.  A 32-year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administration date Mar2021 (Batch/Lot number: unknown) at 31-years-old as dose 1, single, administration date Mar2021 (Batch/Lot number: unknown) at 31-years-old as dose 2, single and administration date Oct2021 (Batch/Lot number: unknown) at 32-years-old as dose 3 (booster), single for COVID-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant) with onset 25Jan2022, outcome "unknown", COVID-19 (medically significant) with onset 25Jan2022, outcome "recovering" and all described as "Patient tested positive for COVID-19 on home rapid test on 25Jan2022"; HEADACHE (medically significant), NASAL CONGESTION (medically significant) all with onset 25Jan2022, outcome "recovering" and all described as "Reports headache and congestion that she states is mild". The patient underwent the following laboratory tests and procedures: COVID test: (25Jan2022) positive, notes: Nasal Swab. Therapeutic measures were not taken as a result of drug ineffective, COVID-19, headache, nasal congestion.  Clinical course: It was unknown if the patient received any other vaccines within four weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient tested positive for COVID-19 on a home rapid test on 25Jan2022, following a primary series in Mar2021 and booster in Oct2021. The patient reported a headache and congestion that she stated was mild.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 39.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, Immunisation, Interchange of vaccine products, Off label use
Clinical narrative: My wife tested positive for COVID today (Tuesday, 25Jan2022). The only symptom present at the time of this report being submitted is a ''soar throat''.; My wife tested positive for COVID today (Tuesday, 25Jan2022). The only symptom present at the time of this report being submitted is a ''soar throat''.; first dose and second dose were Moderna. 3 dose was Pfizer; first dose and second dose were Moderna. 3 dose was Pfizer; booster; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP).  A 40-year-old female patient (not pregnant) received bnt162b2 (BNT162B2), intramuscular, administered in arm left, administration date 12Nov2021 (Lot number: FH8030) at the age of 39 years as dose 3 (booster), single for covid-19 immunization. The patient had no relevant medical history. The patient took concomitant medications. Past drug history included: Aspirin, reaction(s): "known allergies: Aspirin". Vaccination history included: Moderna (Dose Number: 2, Batch/Lot No: 039B12A, Location of injection: Arm Left, Route of Administration: Intramuscular), administration date: 24Apr2021, when the patient was 39 years old, for Covid-19 Immunization; Moderna (Dose Number: 1, Batch/Lot No: 031A21A, Location of injection: Arm Left, Route of Administration: Intramuscular), administration date: 27Mar2021, when the patient was 39 years old, for Covid-19 Immunization. The following information was reported: OFF LABEL USE (medically significant), INTERCHANGE OF VACCINE PRODUCTS (medically significant) all with onset 12Nov2021, outcome "unknown" and all described as "first dose and second dose were Moderna. 3 dose was Pfizer"; IMMUNISATION (medically significant) with onset 12Nov2021, outcome "unknown", described as "booster"; COVID-19 (medically significant) with onset 25Jan2022, outcome "recovering", DRUG INEFFECTIVE (medically significant) with onset 25Jan2022, outcome "unknown" and all described as "My wife tested positive for COVID today (Tuesday, 25Jan2022). The only symptom present at the time of this report being submitted is a ''soar throat''.". The patient underwent the following laboratory tests and procedures: sars-cov-2 test: (25Jan2022) positive, notes: Nasal Swab. Therapeutic measures were not taken as a result of covid-19. Clinical course: The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine and no other medications received within 2 weeks of vaccination. The patient tested positive for COVID on Tuesday, 25Jan2022. The only symptom present at the time of this report being submitted was a sore throat. Prior to vaccination, was the patient was not diagnosed with COVID-19. Since the vaccination, has the patient been tested for COVID-19.  No follow-up attempts are possible. No further information is expected.
Age: 39.0
Sex: F
Vaccine: COVID19
Symptoms: SARS-CoV-2 test
Clinical narrative: My wife tested positive for COVID today (Tuesday, 25Jan2022). The only symptom present at the time of this report being submitted is a ''soar throat''.; My wife tested positive for COVID today (Tuesday, 25Jan2022). The only symptom present at the time of this report being submitted is a ''soar throat''.; first dose and second dose were Moderna. 3 dose was Pfizer; first dose and second dose were Moderna. 3 dose was Pfizer; booster; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP).  A 40-year-old female patient (not pregnant) received bnt162b2 (BNT162B2), intramuscular, administered in arm left, administration date 12Nov2021 (Lot number: FH8030) at the age of 39 years as dose 3 (booster), single for covid-19 immunization. The patient had no relevant medical history. The patient took concomitant medications. Past drug history included: Aspirin, reaction(s): "known allergies: Aspirin". Vaccination history included: Moderna (Dose Number: 2, Batch/Lot No: 039B12A, Location of injection: Arm Left, Route of Administration: Intramuscular), administration date: 24Apr2021, when the patient was 39 years old, for Covid-19 Immunization; Moderna (Dose Number: 1, Batch/Lot No: 031A21A, Location of injection: Arm Left, Route of Administration: Intramuscular), administration date: 27Mar2021, when the patient was 39 years old, for Covid-19 Immunization. The following information was reported: OFF LABEL USE (medically significant), INTERCHANGE OF VACCINE PRODUCTS (medically significant) all with onset 12Nov2021, outcome "unknown" and all described as "first dose and second dose were Moderna. 3 dose was Pfizer"; IMMUNISATION (medically significant) with onset 12Nov2021, outcome "unknown", described as "booster"; COVID-19 (medically significant) with onset 25Jan2022, outcome "recovering", DRUG INEFFECTIVE (medically significant) with onset 25Jan2022, outcome "unknown" and all described as "My wife tested positive for COVID today (Tuesday, 25Jan2022). The only symptom present at the time of this report being submitted is a ''soar throat''.". The patient underwent the following laboratory tests and procedures: sars-cov-2 test: (25Jan2022) positive, notes: Nasal Swab. Therapeutic measures were not taken as a result of covid-19. Clinical course: The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine and no other medications received within 2 weeks of vaccination. The patient tested positive for COVID on Tuesday, 25Jan2022. The only symptom present at the time of this report being submitted was a sore throat. Prior to vaccination, was the patient was not diagnosed with COVID-19. Since the vaccination, has the patient been tested for COVID-19.  No follow-up attempts are possible. No further information is expected.
Age: 19.0
Sex: F
Vaccine: COVID19
Symptoms: Aphthous ulcer, Vulval ulceration
Clinical narrative: Vulvar aphthous ulcers; Vulvar aphthous ulcers; This is a spontaneous report received from a non-contactable reporter(s) (Other HCP). The reporter is the patient.  A 19-year-old female patient (not pregnant) received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) at the age of 19 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 (DOSE 2), for COVID-19 immunization; Bnt162b2 (DOSE 1), for COVID-19 immunization. The following information was reported: VULVAL ULCERATION (non-serious), APHTHOUS ULCER (non-serious), outcome "recovering" and all described as "Vulvar aphthous ulcers". The event "vulvar aphthous ulcers" and "vulvar aphthous ulcers" was evaluated at the emergency room visit. Therapeutic measures were taken as a result of vulval ulceration, aphthous ulcer.  Additional information: Patient received treatment using steroid cream. The patient was not tested since the vaccination. The patient was not diagnosed with COVID-19 prior to vaccination.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 14.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Immunisation, SARS-CoV-2 test, Vaccination failure
Clinical narrative: Tested positive for COVID-19; Tested positive for COVID-19; Received dose 3 on 09Jan2022; This is a spontaneous report received from a contactable consumer via regulatory authority. A 14 year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), administered in arm left, administration date 09Jan2022,at 16:30 (Batch/Lot number: unknown) at the age of 14 years as dose 3 (booster), single, administered in arm left, administration date 16Jun2021, at 09:00 (Batch/Lot number: unknown) as dose 2, single and administered in arm left, administration date 26May2021 08:45 (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. Relevant medical history included topical ezcema from an unknown date. There were no known allergies. Concomitant medications included:  dupilumab (DUPIXENT). Prior to vaccination, the patient was mot diagnosed with COVID-19. The patient received dose 3 on 09Jan2022. The patient tested positive for COVID-19 on 25Jan2022, at 21:30. The patient underwent the following laboratory tests and procedures, which included  a positive COVID-19 test on 25Jan2022. Therapeutic measures were not taken as a result of covid-19, vaccination failure. The clinical outcome of received dose 3 on 09Jan2022 was unknown. The outcome of tested positive for COVID-19 was not recovered.   The lot number for BNT162B2 was not provided and will be requested during follow up.
Sex: U
Vaccine: COVID19
Symptoms: Bell's palsy, HIV test
Clinical narrative: Bell's palsy; This is a literature report.  A patient (no qualifiers provided) received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose number unknown, single for covid-19 immunisation. Relevant medical history included: "HIV" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: BELL'S PALSY (medically significant), outcome "unknown", described as "Bell's palsy ". The patient underwent the following laboratory tests and procedures: hiv test: +.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Based on the compatible temporal association and the product's known safety profile, the company (Pfizer) considers the event Bell's palsy  is possibly related to COVID-19 vaccine administration. 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: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Headache, Lymphadenopathy, Oral herpes, Pyrexia
Clinical narrative: Headache; Chills; swollen lymph nodes under left arm, swolllen neck lymph nodes; fever blisters; Fever; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 66 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 20Jan2022 13:15 (Batch/Lot number: unknown) at the age of 66 years as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included: "Atrial runs" (unspecified if ongoing); "trigeminal neuralgia" (unspecified if ongoing). Concomitant medication(s) included: DILTIAZEM; GABAPENTIN; OXCARBAZEPINE; BUPROPION. Past drug history included: Augmentin, reaction(s): "allergies: Augmentin"; Clindomycin, reaction(s): "allergies:clindomycin". Vaccination history included: Bnt162b2 (prev dose product=COVID 19,, prev dose brand=Phizer,, prev dose brand unknown=False,, prev dose lot unknown=True,, prev dose lot unknown reason=Not available/provided to reporter at the time of report completion,, prev dose administration date=25Feb2021, prev dose dose number=2,, prev dose vaccine location=Left arm), administration date: 25Feb2021, when the patient was 65 years old, for COVID-19 immunization; Bnt162b2 (prev dose product=COVID 19,, prev dose brand=Phizer,, prev dose brand unknown=False,, prev dose lot unknown=True, prev dose lot unknown reason=Not available/provided to reporter at the time of report completion,, prev dose administration date=24Feb2021, prev dose dose number=1,, prev dose vaccine location=Left arm), administration date: 24Feb2021, when the patient was 65 years old, for COVID-19 immunization. The following information was reported: HEADACHE (non-serious) with onset 21Jan2022, outcome "not recovered", described as "Headache"; CHILLS (non-serious) with onset 21Jan2022, outcome "not recovered", described as "Chills"; LYMPHADENOPATHY (non-serious) with onset 21Jan2022, outcome "not recovered", described as "swollen lymph nodes under left arm, swolllen neck lymph nodes"; ORAL HERPES (non-serious) with onset 21Jan2022, outcome "not recovered", described as "fever blisters"; PYREXIA (non-serious) with onset 21Jan2022, outcome "not recovered", described as "Fever". Therapeutic measures were not taken as a result of headache, chills, lymphadenopathy, oral herpes, pyrexia.  Additional information: The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Adverse event did not require a visit to Emergency Room/Physician Office. Prior to vaccination, the patient was not diagnosed with COVID-19; Since the vaccination, the patient has not been tested for COVID-19.   The lot number for bnt162b2 was not provided and will be requested during follow up. Sender's Comments: Linked Report(s) : US-PFIZER INC-202200148630 similar report from same reporter
Age: 53.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Dysgeusia, Lymphadenopathy, Nausea
Clinical narrative: lymph nodes swelled; dizziness/lightheaded; heavy metal taste in mouth; nausea; This is a spontaneous report received from a contactable reporter(s) (Other HCP). The reporter is the patient.  A 53 year-old female patient (not pregnant) received bnt162b2 (COMIRNATY), administered in arm left, administration date 24Nov2021 08:30 (Lot number: fg3527) at the age of 53 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "migraines" (unspecified if ongoing); "Allergy" (unspecified if ongoing), notes: other immunizations, and have been exempt from them until this mandate. The patient's concomitant medications were not reported. No other vaccine in four weeks, no other medications in two weeks.  The following information was reported: LYMPHADENOPATHY (medically significant) with onset 24Nov2021 08:30, outcome "recovered with sequelae", described as "lymph nodes swelled"; DIZZINESS (medically significant) with onset 24Nov2021 08:30, outcome "recovered with sequelae", described as "dizziness/lightheaded"; DYSGEUSIA (medically significant) with onset 24Nov2021 08:30, outcome "recovered with sequelae", described as "heavy metal taste in mouth"; NAUSEA (medically significant) with onset 24Nov2021 08:30, outcome "recovered with sequelae", described as "nausea". Clinical course: First dose her lymph nodes swelled immediately, dizziness, lightheaded, heavy metal taste in mouth, nausea. The events "lymph nodes swelled", "dizziness/lightheaded", "heavy metal taste in mouth" and "nausea" were evaluated at the emergency room visit. Therapeutic measures were taken as a result of lymphadenopathy, dizziness, dysgeusia, nausea,  treatment included benadryl, prednisone, pepcid. No covid prior vaccination. No covid tested post vaccination.; Sender's Comments: Based on the available information provided, the causal association between the reported events and the suspect drug, cannot be excluded. Case to be reassessed should a follow-up information becomes available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.,Linked Report(s) : US-PFIZER INC-202200148543 same patient/drug, different vaccine dose/event
Age: 42.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: If covid tested post vaccination: Yes; If covid tested post vaccination: Yes; This is a spontaneous report received from a contactable reporter (Consumer). The reporter is the patient.  A 42-year-old female patient (not pregnant) received bnt162b2, administered in arm left, administration date 15Dec2021 (Batch/Lot number: unknown) at the age of 42 years as dose 3 (booster), single, administered in arm left, administration date 21Apr2021 (Batch/Lot number: unknown) at the age of 41 years as dose 2, single and administered in arm left, administration date 31Mar2021 (Batch/Lot number: unknown) at the age of 41 years 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: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 17Dec2021, outcome "unknown" and all described as "If covid tested post vaccination: Yes". The patient underwent the following laboratory tests and procedures: sars-cov-2 test: (17Dec2021) positive, notes: Nasal Swab. Facility where the most recent COVID-19 vaccine was administered was pharmacy or drug store. The patient didn't receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient wasn't diagnosed with COVID-19. Since the vaccination, the patient has been tested for COVID-19.  The lot number for bnt162b2 was not provided and will be requested during follow up.
Age: 42.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Amenorrhoea, SARS-CoV-2 test
Clinical narrative: If covid tested post vaccination: Yes; If covid tested post vaccination: Yes; This is a spontaneous report received from a contactable reporter (Consumer). The reporter is the patient.  A 42-year-old female patient (not pregnant) received bnt162b2, administered in arm left, administration date 15Dec2021 (Batch/Lot number: unknown) at the age of 42 years as dose 3 (booster), single, administered in arm left, administration date 21Apr2021 (Batch/Lot number: unknown) at the age of 41 years as dose 2, single and administered in arm left, administration date 31Mar2021 (Batch/Lot number: unknown) at the age of 41 years 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: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 17Dec2021, outcome "unknown" and all described as "If covid tested post vaccination: Yes". The patient underwent the following laboratory tests and procedures: sars-cov-2 test: (17Dec2021) positive, notes: Nasal Swab. Facility where the most recent COVID-19 vaccine was administered was pharmacy or drug store. The patient didn't receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient wasn't diagnosed with COVID-19. Since the vaccination, the patient has been tested for COVID-19.  The lot number for bnt162b2 was not provided and will be requested during follow up.
Age: 42.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: Amenorrhea. No period for three months after second shot. And no period so far after 3rd shot. I am very regular and typically get a period every 3 weeks.; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 42 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 15Dec2021 (Batch/Lot number: unknown) at the age of 42 years as dose 3 (booster), single and administered in arm left, administration date 21Apr2021 (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; Vaccine Location=Left arm), administration date: 31Mar2021, when the patient was 41 years old, for Covid-19 Immunization. The following information was reported: AMENORRHOEA (non-serious) with onset Apr2021, outcome "not recovered", described as "Amenorrhea. No period for three months after second shot. And no period so far after 3rd shot. I am very regular and typically get a period every 3 weeks.". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of amenorrhoea.   Additional Information: The patient was not diagnosed with COVID-19 prior to vaccination. The patient did not receive any other vaccine in four weeks prior to the COVID-19 vaccine. The patient tested positive for COVID-19 post vaccination on 17Dec2021 (captured in linked case).   The lot number for bnt162b2 was not provided and will be requested during follow up.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202200148622 Same patient and drug, different event separated in time
Age: 42.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Amenorrhoea, SARS-CoV-2 test
Clinical narrative: Amenorrhea. No period for three months after second shot. And no period so far after 3rd shot. I am very regular and typically get a period every 3 weeks.; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 42 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 15Dec2021 (Batch/Lot number: unknown) at the age of 42 years as dose 3 (booster), single and administered in arm left, administration date 21Apr2021 (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; Vaccine Location=Left arm), administration date: 31Mar2021, when the patient was 41 years old, for Covid-19 Immunization. The following information was reported: AMENORRHOEA (non-serious) with onset Apr2021, outcome "not recovered", described as "Amenorrhea. No period for three months after second shot. And no period so far after 3rd shot. I am very regular and typically get a period every 3 weeks.". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of amenorrhoea.   Additional Information: The patient was not diagnosed with COVID-19 prior to vaccination. The patient did not receive any other vaccine in four weeks prior to the COVID-19 vaccine. The patient tested positive for COVID-19 post vaccination on 17Dec2021 (captured in linked case).   The lot number for bnt162b2 was not provided and will be requested during follow up.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202200148622 Same patient and drug, different event separated in time
Sex: M
Vaccine: COVID19
Symptoms: Thrombosis
Clinical narrative: a blood clot in his leg; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP) from medical information team.  A 30 year-old male patient received bnt162b2 (BNT162B2) (Batch/Lot number and expiration date unknown) as dose number unknown (booster), single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Dose unknown, manufacturer unknown), for Covid-19 Immunization. The following information was reported: THROMBOSIS (medically significant), outcome "unknown", described as "a blood clot in his leg".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.