chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: COVID19
Symptoms: Balance disorder, Cerebrovascular accident, Hypersomnia, Illness, Nausea
Clinical narrative: I went to bed for 12 hours before I could even get up and function, its kind of stroke'; nauseous; lack of balance; I went to bed for 12 hours before I could even get up and function; I am speeding up a clear substance looks like white blood cell or something ''flams'' it comes up all the times; ill; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A patient (no qualifiers provided) received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose number unknown  (booster), single for covid-19 immunisation. Relevant medical history included: "Enlarged prostate" (unspecified if ongoing). Concomitant medication(s) included: TAMSULOSIN HYDROCHLORIDE taken for prostatomegaly. Vaccination history included: Covid-19 vaccine (Dose 1, Single, Lot number and vaccination date unknown), administration date: 06Mar2021, for Covid-19 immunisation, reaction(s): "No adverse effect". The following information was reported: CEREBROVASCULAR ACCIDENT (medically significant), outcome "unknown", described as "I went to bed for 12 hours before I could even get up and function, its kind of stroke'"; NAUSEA (non-serious), outcome "unknown", described as "nauseous"; BALANCE DISORDER (non-serious), outcome "unknown", described as "lack of balance"; HYPERSOMNIA (non-serious), outcome "unknown", described as "I went to bed for 12 hours before I could even get up and function"; WHITE BLOOD CELL DISORDER (non-serious), outcome "unknown", described as "I am speeding up a clear substance looks like white blood cell or something ''flams'' it comes up all the times"; ILLNESS (non-serious), outcome "unknown", described as "ill". Therapeutic measures were taken as a result of hypersomnia.  Clinical course: Patient want to report an adverse effect from Pfizer booster shot and that Pfizer number 2, that he got definitely ill on both of the shot, terribly ill. The booster shot which he had in last month got terrible adverse effect from it and he had the same reaction to Pfizer 2 shot, he had nauseous, lack of balance, essentially, he went to bed for 12 hours before he can even get up and function, it's kind of stroke and he had speeding up a clear substance looks like white blood cell or something 'flams' it comes up all the times. The Concomitant medication include Flomax, it is used for enlarged prostate and there is a technical name for it he can read it off here, Tamsulosin HCL.  Patient said that he didn't take any treatment for any adverse event except sleep.  The lot number for bnt162b2 was not provided and will be requested during follow up.
Sex: U
Vaccine: COVID19
Symptoms: White blood cell disorder
Clinical narrative: I went to bed for 12 hours before I could even get up and function, its kind of stroke'; nauseous; lack of balance; I went to bed for 12 hours before I could even get up and function; I am speeding up a clear substance looks like white blood cell or something ''flams'' it comes up all the times; ill; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A patient (no qualifiers provided) received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose number unknown  (booster), single for covid-19 immunisation. Relevant medical history included: "Enlarged prostate" (unspecified if ongoing). Concomitant medication(s) included: TAMSULOSIN HYDROCHLORIDE taken for prostatomegaly. Vaccination history included: Covid-19 vaccine (Dose 1, Single, Lot number and vaccination date unknown), administration date: 06Mar2021, for Covid-19 immunisation, reaction(s): "No adverse effect". The following information was reported: CEREBROVASCULAR ACCIDENT (medically significant), outcome "unknown", described as "I went to bed for 12 hours before I could even get up and function, its kind of stroke'"; NAUSEA (non-serious), outcome "unknown", described as "nauseous"; BALANCE DISORDER (non-serious), outcome "unknown", described as "lack of balance"; HYPERSOMNIA (non-serious), outcome "unknown", described as "I went to bed for 12 hours before I could even get up and function"; WHITE BLOOD CELL DISORDER (non-serious), outcome "unknown", described as "I am speeding up a clear substance looks like white blood cell or something ''flams'' it comes up all the times"; ILLNESS (non-serious), outcome "unknown", described as "ill". Therapeutic measures were taken as a result of hypersomnia.  Clinical course: Patient want to report an adverse effect from Pfizer booster shot and that Pfizer number 2, that he got definitely ill on both of the shot, terribly ill. The booster shot which he had in last month got terrible adverse effect from it and he had the same reaction to Pfizer 2 shot, he had nauseous, lack of balance, essentially, he went to bed for 12 hours before he can even get up and function, it's kind of stroke and he had speeding up a clear substance looks like white blood cell or something 'flams' it comes up all the times. The Concomitant medication include Flomax, it is used for enlarged prostate and there is a technical name for it he can read it off here, Tamsulosin HCL.  Patient said that he didn't take any treatment for any adverse event except sleep.  The lot number for bnt162b2 was not provided and will be requested during follow up.
Sex: U
Vaccine: COVID19
Symptoms: Balance disorder, Cerebrovascular accident, Nausea, Sleep disorder, Sputum abnormal
Clinical narrative: I went to bed for 12 hours before I could even get up and function, its kind of stroke'; Nauseous; Lack of balance; I went to bed for 12 hours before I could even get up and function; I am speeding up a clear substance looks like white blood cell or something ''flams'' it comes up all the times; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non-HCP).  A patient (no qualifiers provided) 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: CEREBROVASCULAR ACCIDENT (medically significant), outcome "unknown", described as "I went to bed for 12 hours before I could even get up and function, its kind of 'stroke'; NAUSEA (non-serious), outcome "unknown", described as "Nauseous"; BALANCE DISORDER (non-serious), outcome "unknown", described as "Lack of balance"; SLEEP DISORDER (non-serious), outcome "unknown", described as "I went to bed for 12 hours before I could even get up and function"; SPUTUM ABNORMAL (non-serious), outcome "unknown", described as "I am speeding up a clear substance looks like white blood cell or something ''flams'' it comes up all the times". The patient underwent the following laboratory tests and procedures: white blood cell counts abnormal: unknown result.  Additional information: Consumer was informed about the Pfizer Medical Information department and telephone# was shared as # option 3, 8 AM to 8 PM, Monday to Friday, as per time zone.  The lot number for bnt162b2 was not provided and will be requested during follow up.
Sex: U
Vaccine: COVID19
Symptoms: White blood cell count abnormal
Clinical narrative: I went to bed for 12 hours before I could even get up and function, its kind of stroke'; Nauseous; Lack of balance; I went to bed for 12 hours before I could even get up and function; I am speeding up a clear substance looks like white blood cell or something ''flams'' it comes up all the times; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non-HCP).  A patient (no qualifiers provided) 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: CEREBROVASCULAR ACCIDENT (medically significant), outcome "unknown", described as "I went to bed for 12 hours before I could even get up and function, its kind of 'stroke'; NAUSEA (non-serious), outcome "unknown", described as "Nauseous"; BALANCE DISORDER (non-serious), outcome "unknown", described as "Lack of balance"; SLEEP DISORDER (non-serious), outcome "unknown", described as "I went to bed for 12 hours before I could even get up and function"; SPUTUM ABNORMAL (non-serious), outcome "unknown", described as "I am speeding up a clear substance looks like white blood cell or something ''flams'' it comes up all the times". The patient underwent the following laboratory tests and procedures: white blood cell counts abnormal: unknown result.  Additional information: Consumer was informed about the Pfizer Medical Information department and telephone# was shared as # option 3, 8 AM to 8 PM, Monday to Friday, as per time zone.  The lot number for bnt162b2 was not provided and will be requested during follow up.
Sex: U
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: Diagnosed with COVID; Diagnosed with COVID; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program (005570). The reporter is the patient.  A patient (no qualifiers provided) received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), administration date Apr2021 (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 01Jan2022, outcome "unknown" and all described as "Diagnosed with COVID". Additional information: It was reported that the patient is a healthy person.  The lot number for bnt162b2 was not provided and will be requested during follow up.
Age: 41.0
Sex: F
Vaccine: COVID19
Symptoms: Dysmenorrhoea, Menstrual disorder, Menstruation delayed, SARS-CoV-2 test
Clinical narrative: awful cramps and bleeding; awful cramps and bleeding; period was delayed; This is a spontaneous report received from a contactable consumer. The reporter is the patient.  A 41 year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), administered in arm left, administration date 10Apr2021 (Lot number: EW0193) at the age of 41 years as dose 1, single for COVID-19 immunisation. Relevant medical history included: "Anxiety" (unspecified if ongoing); "Known allergy: Gadolinium contrast" (unspecified if ongoing). Concomitant medication(s) included: CLONAZEPAM; PAROXETINE; ROSUVASTATIN. The following information was reported: MENSTRUAL DISORDER (non-serious), DYSMENORRHOEA (non-serious) all with onset 01May2021, outcome "recovering" and all described as "awful cramps and bleeding"; MENSTRUATION DELAYED (non-serious) with onset 01May2021, outcome "recovering", described as "period was delayed". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of menstrual disorder, dysmenorrhea and menstruation delayed. Additional information: the patient had not received other vaccine in four weeks. The patient stated, "my period was delayed and had awful cramps and bleeding. I have had awful periods since". The patient had no COVID prior to vaccination.  No follow-up attempts are possible. No further information is expected.
Age: 24.0
Sex: M
Vaccine: COVID19
Symptoms: Upper limb fracture
Clinical narrative: broke his right arm; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A 24 year-old male patient received COVID-19 Vaccine - Manufacturer Unknown, (Batch/Lot number: unknown) at the age of 24 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: UPPER LIMB FRACTURE (medically significant), outcome "unknown", described as "broke his right arm". Clinical course: (Name withheld) broke his right arm just above the elbow and is now in a sling with arm wrapped. Do not know exact date took place but must have been recent (potentially in past couple days) - had images sent to me last night. Do not know circumstances that caused the break.  The lot number for COVID-19 Vaccine - Manufacturer Unknown was not provided and will be requested during follow up.
Age: 54.0
Sex: M
Vaccine: COVID19
Symptoms: Chronic spontaneous urticaria, Urticaria
Clinical narrative: Chronic Spontaneous Urticaria (hives); hive outbreaks; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 55 year-old male patient received bnt162b2 (BNT162B2), administered in arm left, administration date 01Apr2021 15:00 (Lot number: EP7533) at the age of 54 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "Asthma" (unspecified if ongoing); "known allergies : Sulfa ACE inhibitors" (unspecified if ongoing), notes: known allergies : Sulfa ACE inhibitors. Concomitant medication(s) included: SIMVASTATIN; HYDROCHLOROTHIAZIDE; AMLODIPINE. Vaccination history included: Bnt162b2 (Dose Number: 1, Batch/Lot No: EN6207, Location of injection: Arm Left, Vaccine Administration Time: 10:00 AM), administration date: 11Mar2021, when the patient was 54 years old, for COVID-19 immunization. The following information was reported: CHRONIC SPONTANEOUS URTICARIA (non-serious) with onset 15May2021, outcome "not recovered", described as "Chronic Spontaneous Urticaria (hives)"; URTICARIA (non-serious) with onset 15May2021, outcome "not recovered", described as "hive outbreaks". The events "chronic spontaneous urticaria (hives)" and "hive outbreaks" were evaluated at the physician office visit. Therapeutic measures were taken as a result of chronic spontaneous urticaria, urticaria.  Additional information: Most received facility of Covid-19 vaccine administration was reported as Public Health Clinic/Veterans. Patient was neither diagnosed with COVID-19 prior to vaccination and nor tested since the vaccination. The patient had not received any other vaccine within 4 weeks. The patient mentioned that he never had hives before the covid vaccine and had been having hive outbreaks ever since the covid vaccine. The treatment received for the adverse event includes Cortisone Shots (3 rounds) Pepcid and 4x antihistamines daily. Device Date: 03Jan2022.
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: 2nd dose should be on 28Dec but they missed the dose since the son got tested positive with the Covid virus; he tested positive without symptoms; 2nd dose should be on 28Dec but they missed the dose since the son got tested positive with the Covid virus; he tested positive without symptoms; This is a spontaneous report received from a contactable reporter consumer or other non Health professional for a Pfizer sponsored program. The reporter is the parent.  A 5 year-old male patient received bnt162b2 (COMIRNATY, PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: solution for injection, Lot Number: FK5618; Expiration Date: Unknown) via an unspecified route of administration on 07Dec2021, as dose 1, single for COVID-19 immunization. The patient's relevant medical history and concomitant medications were not reported. On an unknown date in Dec2021, the patient experienced 2nd dose should be on 28Dec but they missed the dose since the son got tested positive with the COVID virus; he tested positive without symptoms (DRUG INEFFECTIVE and COVID-19). It was reported that, a mother of of 5 years old son, called because 1st dose was given to the son on Dec 07Dec2021, 2nd dose should be on 28Dec but they missed the dose since the son got tested positive with the Covid virus and they called to ask when it's going to be time, he could get the 2nd dose after the positive testing and the reporter mentioned that this is the without symptoms, he tested positive without symptoms. On an unknown date in Dec2021 the patient underwent the laboratory tests and procedures included sars-cov-2 test result was positive. The clinical outcome of the events was unknown at the time of this report.  No follow-up attempts are possible. No further information expected.
Age: 10.0
Sex: F
Vaccine: COVID19
Symptoms: Rash
Clinical narrative: Had a lot of rash all over the body; This is a spontaneous report received from a contactable reporter(s) (Other HCP). The reporter is the parent.  A 10 year-old female patient received bnt162b2 (BNT162B2), administered in deltoid right, administration date 28Dec2021 (Lot number: SK5127) at the age of 10 years as dose 1 (tris), single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: RASH (non-serious) with onset 30Dec2021, outcome "not recovered", described as "Had a lot of rash all over the body". Therapeutic measures were taken as a result of rash.  Additional information: Stated that her daughter had the shot on Tuesday and yesterday she had a lot of rash all over the body and they went to the pharmacy. Treatment: Stated she gave her Benadryl.
Age: 15.0
Sex: F
Vaccine: COVID19
Symptoms: Illness, Malaise, SARS-CoV-2 test, SARS-CoV-2 test positive, Weight decreased
Clinical narrative: My 15 year old daughter got her 1st Pfizer Shot, and then tested positive for COVID19, fell Ill, Lost weight, missed her finals, and is still sick, due to this shot!; fell Ill; Lost weight; missed her finals, and is still sick, due to this shot!; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the parent.  A 15 year-old female patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) at the age of 15 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: SARS-COV-2 TEST POSITIVE (non-serious), outcome "unknown", described as "My 15 year old daughter got her 1st Pfizer Shot, and then tested positive for COVID19, fell Ill, Lost weight, missed her finals, and is still sick, due to this shot!"; MALAISE (non-serious), outcome "unknown", described as "fell Ill"; WEIGHT DECREASED (non-serious), outcome "unknown", described as "Lost weight"; ILLNESS (non-serious), outcome "unknown", described as "missed her finals, and is still sick, due to this shot!". Relevant laboratory tests and procedures are available in the appropriate section.  The lot number for bnt162b2 was not provided and will be requested during follow up.
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: Covid; Covid; This is a spontaneous report received from a contactable reporter (other healthcare professional, HCP).  An adult female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) (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 "Covid".  The lot number for BNT162b2 was not provided and will be requested during follow up.; Sender's Comments: Based on the information currently available, a lack of efficacy with bnt162b2 in this patient cannot be completely excluded.
Age: 41.0
Sex: U
Vaccine: COVID19
Symptoms: Dysmenorrhoea, Inappropriate schedule of product administration, Menstruation delayed, SARS-CoV-2 test
Clinical narrative: and had awful cramps and bleeding.; period was delayed; dose 1 on 09Dec2021, dose 2 on 30Aug2021; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 41 year-old patient received bnt162b2 (BNT162B2), administered in arm left, administration date 30Aug2021 (Lot number: EW0171) at the age of 41 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "Anxiety" (unspecified if ongoing); "Gadolinium contrast allergy" (unspecified if ongoing). Concomitant medication(s) included: CLONAZEPAM; PAROXETINE; ROSUVASTATIN. Vaccination history included: Bnt162b2 (lot number: FJ8762, administration date: 09Dec2021, dose 1, vaccine location: Left arm), administration date: 09Dec2021, when the patient was 41 years old, for Covid-19 Immunization, reaction(s): "had awful cramps and bleeding", "Ever since the first 2 shots my period was delayed". It was reported that ever since the first 2 shots the patient's period was delayed and had awful cramps and bleeding. She have had awful periods since. The patient underwent the following laboratory tests and procedures: sars-cov-2 test: (11Nov2021) negative, notes: Nasal Swab. Outcome of the events was unknown.  No follow-up attempts are possible. No further information is expected.
Age: 41.0
Sex: F
Vaccine: COVID19
Symptoms: Dysmenorrhoea, Immunisation, Inappropriate schedule of product administration, SARS-CoV-2 test
Clinical narrative: I recently got my booster; Dose 2 30Aug2021/Dose 3 09Dec2021; my period to start in severe pain. I have never had such painful periods in my life; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 41 year-old female patient received bnt162b2 (BNT162B2), administered in arm left, administration date 09Dec2021 (Lot number: FJ8762) at the age of 41 years as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included: "Anxiety" (unspecified if ongoing); "Known allergies: Gadolinium contrast" (unspecified if ongoing), notes: Known allergies: Gadolinium contrast. Concomitant medication(s) included: CLONAZEPAM; PAROXETINE; ROSUVASTATIN. Vaccination history included: Bnt162b2 (lot: EW0193, vaccine location=Left arm), administration date: 10Apr2021, when the patient was 41 years old, for Covid-19 Immunization, reaction(s): "had awful cramps and bleeding"; Bnt162b2 (lot: EW0193, vaccine location=Left arm), administration date: 10Apr2021, when the patient was 41 years old, for Covid-19 immunization, reaction(s): "had awful cramps and bleeding", "Ever since the first 2 shots my period was delayed"; Bnt162b2 (lot: EW0171, vaccine location: Left arm), administration date: 30Aug2021, when the patient was 41 years old, for Covid-19 immunization, reaction(s): "had awful cramps and bleeding", "had awful cramps and bleeding", "inappropriate schedule of vaccine administered", "Ever since the first 2 shots my period was delayed". The following information was reported: IMMUNISATION (non-serious) with onset 09Dec2021, outcome "unknown", described as "I recently got my booster"; DYSMENORRHOEA (non-serious) with onset 2021, outcome "recovering", described as "my period to start in severe pain. I have never had such painful periods in my life"; INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (non-serious) with onset 09Dec2021, outcome "unknown", described as "Dose 2 30Aug2021/Dose 3 09Dec2021". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were taken as a result of dysmenorrhoea. Additional information: Patient recently got booster and was waiting for period to start in severe pain. She never had such painful periods in life. She took pills for the pain and nothing worked (as reported, also reported as recovering). So painful, she ended up googling if this was happening to others and it was. She was like she knew she wasn't the only one. She was done getting the shots and cannot go thru all the pain anymore. It can't be good for this to be happening.  No follow-up attempts are possible. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Immunisation, SARS-CoV-2 test, Vaccination failure
Clinical narrative: booster; Booster could have happened between both covid cases/Covid ongoing for the current December-January case; Booster could have happened between both covid cases/Covid ongoing for the current December-January case; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A 35 year-old female patient (not pregnant) received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included: "has had issues with weight, unsure otherwise, potentially some mental health struggles" (unspecified if ongoing); "potentially some mental health struggles" (unspecified if ongoing). The patient's concomitant medications were not reported. Vaccination history included: Covid19 vaccine (Dose Number: 2, Batch/Lot No: Unknown. Not available/provided to reporter at the time of report completion, Manufacturer: Unknown), administration date: 12Mar2021, when the patient was 34 years old, for COVID-19 immunization; Covid-19 vaccine (Dose Number: 1, Batch/Lot No: Unknown. Not available/provided to reporter at the time of report completion, Manufacturer: Unknown), administration date: 19Feb2021, when the patient was 34 years old, for Covid-19 immunization. The following information was reported: COVID-19 (medically significant), VACCINATION FAILURE (medically significant) all with onset Dec2021, outcome "unknown" and all described as "Booster could have happened between both covid cases/Covid ongoing for the current December-January case"; IMMUNISATION (non-serious), outcome "unknown", described as "booster". The patient underwent the following laboratory tests and procedures: sars-cov-2 test: (Sep2021) positive; (Dec2021) positive.  The lot number for bnt162b2 was not provided and will be requested during follow up.
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, Immunisation, SARS-CoV-2 test, Sleep apnoea syndrome
Clinical narrative: Had both Pfizer-BioNTech vaccines and the booster and tested positive with a home test today; Sleep apnea; Had both Pfizer-BioNTech vaccines and the booster and tested positive with a home test today; Had both Pfizer-BioNTech vaccines and the booster and tested positive with a home test today; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A 62 year-old 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: IMMUNISATION (medically significant), outcome "unknown", DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 31Dec2021, outcome "unknown" and all described as "Had both Pfizer-BioNTech vaccines and the booster and tested positive with a home test today"; SLEEP APNOEA SYNDROME (non-serious), outcome "unknown", described as "Sleep apnea". The patient underwent the following laboratory tests and procedures: sars-cov-2 test: (31Dec2021) positive, notes: tested positive with a home test today. Therapeutic measures were taken as a result of sleep apnoea syndrome, patient was using cpap for sleep apnea.  The lot number for bnt162b2 was not provided and will be requested during follow up.
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Cellulitis, Immunisation
Clinical narrative: one month after receiving the booster dose; he had cellullitis; suffered terrible joint pain; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from information team.  A 79 year-old male patient received bnt162b2 (BNT162B2) (Batch/Lot number: 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 (MANUFACTURER UNKNOWN), for COVID-19 Immunization. The following information was reported: CELLULITIS (medically significant), outcome "unknown", described as "he had cellullitis"; IMMUNISATION (non-serious), outcome "unknown", described as "one month after receiving the booster dose"; ARTHRALGIA (non-serious), outcome "unknown", described as "suffered terrible joint pain". Clinical Course: Reporter's husband also suffered terrible joint pain about one month after receiving the booster dose and found out the next morning that he had cellulitis. They both had the same lot number of the vaccine. It was reported that side effects are usually reported within 7 days of application of the vaccine and in the follow up of one month after the booster dose there were no reports of joint pain.   The lot number for bnt162b2 was not provided and will be requested during follow up.
Age: 35.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Immunisation, SARS-CoV-2 test, Vaccination failure
Clinical narrative: This is a spontaneous report received from a non-contactable reporter(s) (Other HCP) from product quality group. A 35 year-old female patient (unknown if pregnant) received bnt162b2 (BNT162B2), administration date 30Nov2021 (Lot number: FF2589) at the age of 35 years as dose 3 (booster) single, administration date 18Feb2021 (Lot number: EL3247) as dose 2, single and administration date 18Jan2021 (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: IMMUNISATION (medically significant) with onset 30Nov2021, outcome "unknown", described as "dose received: 3"; VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 27Dec2021, outcome "recovering" and all described as "This colleague was triple vaxed and had a breakthrough infection 27Dec after exposure to family/PCR positive 29Dec". The patient underwent the following laboratory tests and procedures: sars-cov-2 test: (29Dec2021) positive, notes: Nasal Swab. It was unknown if therapeutic measures were taken as a result of vaccination failure, covid-19. 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 the vaccination failure (LOE) cannot be ruled out.
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, Nasal congestion, Weight increased
Clinical narrative: Weight gain; COVID; COVID; nose (forget exactly what, but potentially congestion related); This is a spontaneous report received from a contactable reporter(s) (Other HCP).  A 25 year-old female patient received COVID-19 Vaccine - Manufacturer Unknown, (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. Relevant medical history included: "Weight gain" (unspecified if ongoing), notes: on medication earlier this year for several months (maybe around 6) causing weight gain, now off medication. The patient's concomitant medications were not reported. The following information was reported: COVID-19 (medically significant), DRUG INEFFECTIVE (medically significant) all with onset Aug2021, outcome "unknown" and all described as "COVID"; NASAL CONGESTION (non-serious) with onset Aug2021, outcome "not recovered", described as "nose (forget exactly what, but potentially congestion related)"; WEIGHT INCREASED (non-serious), outcome "unknown", described as "Weight gain". Clinical course: The patient had Covid in Aug2021 and her nose (forget exactly what, but potentially congestion related) is still not all the way back to normal. She was on a medication for several months earlier this year (as reported, forgot exact number but potentially around 6 months) that was causing excessive weight gain. She is now off the medication but this could also have been during the vaccine window (either after vaccine receipt or during vaccine receipt). As of now, she has an extra 60 lbs to lose. Reporter is unsure about the dosage received, what vaccine was received, and when received.  The lot number for COVID-19 Vaccine - Manufacturer Unknown was not provided and will be requested during follow up.; Sender's Comments: Based on the available information a contributory role of BNT162B2 to the reported events COVID-19, Drug ineffective cannot be totally excluded as efficacy of a drug varies from individual to individual depending upon the immune status. As with any vaccine, vaccination with BNT162B2 may not protect all vaccine recipients, so the expectedness of covid-19 and drug ineffective is : expected. The case will be reassessed further upon receipt of additional information.
Sex: F
Vaccine: COVID19
Symptoms: Condition aggravated, Joint injury, Sciatica
Clinical narrative: Old sacroiliac hip injury and sciatica flared up immediately after each injection; Old sacroiliac hip injury and sciatica flared up immediately after each injection; Old sacroiliac hip injury and sciatica flared up immediately after each injection; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 68 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 05Mar2021 (Lot number: EN6205) as dose 1, single and administered in arm left, administration date 01Apr2021 (Lot number: ER8734) as dose 2, single for covid-19 immunisation. Relevant medical history included: "hypothyroid" (unspecified if ongoing); "sciatica for 11 yrs" (unspecified if ongoing); "sacroiliacitis for 3 yrs" (unspecified if ongoing); "old sacroiliac hip injury" (unspecified if ongoing); "known allergies: statins" (unspecified if ongoing). No Covid prior vaccination. There were no concomitant medications. No other vaccine in four weeks. No other mediation in two weeks. The following information was reported: JOINT INJURY (disability), SCIATICA (disability), CONDITION AGGRAVATED (disability) all with onset 2021, outcome "not recovered" and all described as "Old sacroiliac hip injury and sciatica flared up immediately after each injection". Therapeutic measures were not taken as a result of joint injury, sciatica, condition aggravated. Clinical course: The patient's old sacroiliac hip injury and sciatica flared up immediately after each injection-inflammation. This faded after first vaccine after a couple of days, after second vaccination in a week. Pain started day of each injection. Serious side effects. Exercises and diet that helped in the past do not work. Patient was not tested for Covid post vaccination. Patient took the third dose of BNT162B2 on 05Oct2021 (Lot number: FE3590) administered to left arm.  No follow-up attempts are possible. No further information is expected.
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: tested Ag positive for covid; tested Ag positive for covid; This is a spontaneous report received from a non-contactable reporter(s) (Other HCP).  A 58 year-old female patient (not pregnant) received bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), via unspecified route of administration, administration date 24Mar2021 (Lot number: EL3247) at the age of 57 years as dose 2, single and administration date 03Mar2021 (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), COVID-19 (medically significant) all with onset 30Dec2021, outcome "recovering" and all described as "tested Ag positive for covid". The event "tested ag positive for covid" was evaluated at the physician office visit. The patient underwent the following laboratory tests and procedures: Ag rapid (nasal swab): (31Dec2021) positive. It was unknown if therapeutic measures were taken as a result of vaccination failure, covid-19. It was reported that patient went to family gathering on 12Dec and had congestion 30Dec and tested Ag positive for covid after another family member tested positive. It was unknown if patient had other vaccine in four weeks. The patient received the covid-19 vaccine at workplace clinic.  No follow-up attempts are possible. No further information is expected.; Sender's Comments: The efficacy of a drug varies from patient to patient and can be affected by different factors; however, a contributory role of the suspect product bnt162b2 to the reported vaccination failure and COVID-19 cannot be ruled out.
Sex: F
Vaccine: COVID19
Symptoms: Demyelination, Magnetic resonance imaging head, SARS-CoV-2 test, Seizure
Clinical narrative: MRI brain performed showing large area of tumefactive demyelination; two weeks of vaccination with new onset seizure; This is a spontaneous report received from a contactable reporter(s) (Physician).  A 5 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), intramuscular, administration date Dec2021 (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. lot unknown reason=Not available/provided to reporter at the time of report completion. Relevant medical history included: "Autism spectrum disorder" (unspecified if ongoing). The patient's concomitant medications were not reported. Known allergies were reported as none. Other vaccines in four weeks was reported as no. It was reported Covid prior vaccination: No and covid tested post vaccination: Yes.  The following information was reported: DEMYELINATION (hospitalization, medically significant) with onset 13Dec2021, outcome "recovering", described as "MRI brain performed showing large area of tumefactive demyelination"; SEIZURE (hospitalization, medically significant) with onset 13Dec2021, outcome "recovering", described as "two weeks of vaccination with new onset seizure". The patient was hospitalized for demyelination, seizure (hospitalization duration: 5 day(s)). The events "mri brain performed showing large area of tumefactive demyelination" and "two weeks of vaccination with new onset seizure" were evaluated at the physician office visit and emergency room visit. It was reported Patient presented to hospital within two weeks of vaccination with new onset seizure. MRI brain performed showing large area of tumefactive demyelination. The patient underwent the following laboratory tests and procedures: magnetic resonance imaging head: (Dec2021) showing large area of tumefactive demyelination; sars-cov-2 test: (14Dec2021) negative, notes: Nasal Swab. Therapeutic measures were taken as a result of demyelination, seizure which included IV steroids.  The lot number for bnt162b2 was not provided and will be requested during follow up.; Sender's Comments: Based on the current available information and the plausible drug-event temporal association, a possible contributory role of the suspect product BNT162B2 to the development of events Demyelination and Seizure cannot be excluded.  The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
Sex: U
Vaccine: COVID19
Symptoms: Immunisation, Vaccination site reaction
Clinical narrative: Booster; The Covid booster shot (probably in fat not muscle) left quite a dent in the fat mass on my arm; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program (005570). The reporter is the patient.  A patient (no qualifiers provided) received bnt162b2 (BNT162B2), administered in arm (Batch/Lot number: 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 (MANUFACTURER UNKNOWN), for COVID-19 immunization. The following information was reported: IMMUNISATION (medically significant), outcome "unknown", described as "Booster"; VACCINATION SITE REACTION (medically significant), outcome "recovered", described as "The Covid booster shot (probably in fat not muscle) left quite a dent in the fat mass on my arm".  Additional information:  You might have something in the vaccine that can destroy fat cells. Maybe very very low diluted doses with size 26 needles? And months later it still seems to be working and the dent has smoothed out and my upper arm looks great!  The lot number for bnt162b2 was not provided and will be requested during follow up.
Age: 45.0
Sex: F
Vaccine: COVID19
Symptoms: Drug ineffective, Immunisation, Suspected COVID-19
Clinical narrative: COVID infections; COVID infections; Booster; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A 45 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administration date 04Nov2021 (Lot number: 320308D) at the age of 45 years as dose 3 (booster), single, administration date 24Mar2021 (Lot number: EP6955) as dose 2, single and administration date 01Mar2021 (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: IMMUNISATION (medically significant) with onset 04Nov2021, outcome "unknown", described as "Booster"; DRUG INEFFECTIVE (medically significant), SUSPECTED COVID-19 (medically significant) all with onset 03Jan2022, outcome "recovering" and all described as "COVID infections". Therapeutic measures were not taken as a result of drug ineffective, suspected covid-19.  No follow-up attempts are possible. No further information is expected.
Age: 31.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Abortion spontaneous, Immunisation
Clinical narrative: Miscarriage. Unknown if due to vaccine, but I received vaccine at 6 weeks 3 days and miscarried at 6 weeks 6 days.; 3rd dose booster; This is a spontaneous report received from a contactable reporter (Consumer). The reporter is the patient.  A 31 year-old female patient (pregnant) received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), administered in arm left, administration date 08Dec2021 (Batch/Lot number: unknown) at the age of 31 years as dose 3 (booster), single for covid-19 immunization at a workplace clinic. Relevant medical history included: "Hypothyroid" (unspecified if ongoing). Date of last menstrual period: 25Oct2021. The patient was 6 weeks and 3 days pregnant at the time of exposure to bnt162b2. The patient was 6 weeks and 6 days pregnant at the event onset. The patient is expected to deliver a baby(s) on 01Aug2022. Concomitant medication(s) included: LEVOTHYROXINE and unspecified prenatal medication. Vaccination history included: Bnt162b2 (Dose Number: 1, Batch/Lot No: Unknown), for COVID-19 immunization; Bnt162b2 (Dose Number: 2, Batch/Lot No: Unknown.), for COVID-19 immunization. The following information was reported: IMMUNISATION (medically significant) with onset 08Dec2021, outcome "unknown", described as "3rd dose booster"; ABORTION SPONTANEOUS (medically significant) with onset 11Dec2021, outcome "recovered with sequelae", described as "Miscarriage. Unknown if due to vaccine, but I received vaccine at 6 weeks 3 days and miscarried at 6 weeks 6 days.". The pregnancy resulted in spontaneous abortion. Therapeutic measures were taken as a result of abortion spontaneous which includes D&C. The patient had no COVID prior to vaccination and has not been tested post vaccination.  The lot number for bnt162b2 was not provided and will be requested during follow up.
Age: 31.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Congenital anomaly, Immunisation, Maternal exposure during pregnancy
Clinical narrative: Miscarriage. Unknown if due to vaccine, but I received vaccine at 6 weeks 3 days and miscarried at 6 weeks 6 days.; 3rd dose booster; This is a spontaneous report received from a contactable reporter (Consumer). The reporter is the patient.  A 31 year-old female patient (pregnant) received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), administered in arm left, administration date 08Dec2021 (Batch/Lot number: unknown) at the age of 31 years as dose 3 (booster), single for covid-19 immunization at a workplace clinic. Relevant medical history included: "Hypothyroid" (unspecified if ongoing). Date of last menstrual period: 25Oct2021. The patient was 6 weeks and 3 days pregnant at the time of exposure to bnt162b2. The patient was 6 weeks and 6 days pregnant at the event onset. The patient is expected to deliver a baby(s) on 01Aug2022. Concomitant medication(s) included: LEVOTHYROXINE and unspecified prenatal medication. Vaccination history included: Bnt162b2 (Dose Number: 1, Batch/Lot No: Unknown), for COVID-19 immunization; Bnt162b2 (Dose Number: 2, Batch/Lot No: Unknown.), for COVID-19 immunization. The following information was reported: IMMUNISATION (medically significant) with onset 08Dec2021, outcome "unknown", described as "3rd dose booster"; ABORTION SPONTANEOUS (medically significant) with onset 11Dec2021, outcome "recovered with sequelae", described as "Miscarriage. Unknown if due to vaccine, but I received vaccine at 6 weeks 3 days and miscarried at 6 weeks 6 days.". The pregnancy resulted in spontaneous abortion. Therapeutic measures were taken as a result of abortion spontaneous which includes D&C. The patient had no COVID prior to vaccination and has not been tested post vaccination.  The lot number for bnt162b2 was not provided and will be requested during follow up.
Sex: U
Vaccine: COVID19, COVID19
Symptoms: Abortion spontaneous, Immunisation
Clinical narrative: Miscarriage./seriousness criterion was reported as 'Congenital anomaly/birth defect'; Miscarriage./seriousness criterion was reported as 'Congenital anomaly/birth defect'; booster; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the parent.  A fetus patient was exposed to bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), transplacental, administration date 08Dec2021 (Batch/Lot number: unknown) as dose 3 (booster), single for covid-19 immunisation. The mother of the patient was 31 years old at the time of vaccination. The mother's relevant medical history included: "Hypothyroid" (unspecified if ongoing). Date of last menstrual period of the mother: 25Oct2021. The mother was 6 weeks pregnant at the event onset. The mother is expected to deliver a baby(s) on 01Aug2022. The mother's concomitant medications were not reported. The mother's vaccination history included: Bnt162b2 (Dose 1, Lot number unknown), for COVID-19 immunization; Bnt162b2 (Dose 2, Lot number unknown). The mother did not have COVID prior to vaccination. The mother was not Covid test post vaccination. The mother had no known allergies.  The following information was reported: IMMUNISATION (death, congenital anomaly) with onset 08Dec2021, outcome "fatal", described as "booster"; CONGENITAL ANOMALY (death, congenital anomaly), MATERNAL EXPOSURE DURING PREGNANCY (death, congenital anomaly) all with onset 11Dec2021, outcome "fatal" and all described as "Miscarriage./seriousness criterion was reported as 'Congenital anomaly/birth defect'". The pregnancy resulted in spontaneous abortion. The fetal outcome is congenital anomaly. The patient date of death was unknown. The reported cause of death was congenital anomaly. It was not reported if an autopsy was performed.  The lot number for bnt162b2 was not provided and will be requested during follow up.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202200007639 mother case; Reported Cause(s) of Death: Miscarriage./seriousness criterion was reported as 'Congenital anomaly/birth defect'