chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 43.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: I tested positive for covid while being vaccinated; I tested positive for covid while being vaccinated; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 43 year-old male patient received bnt162b2 (COMIRNATY), administration date Oct2021 (Batch/Lot number: unknown) at the age of 43 years as dose 2, single and administration date Sep2021 (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. Relevant medical history included: "known allergies: Shell fish" (unspecified if ongoing). The patient's concomitant medications were not reported.  The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 01Feb2022, outcome "recovering" and all described as "I tested positive for covid while being vaccinated". The event "i tested positive for covid while being vaccinated" and "i tested positive for covid while being vaccinated" was evaluated at the physician office visit. The patient underwent the following laboratory tests and procedures: sars-cov-2 test: (01Feb2022) positive, notes: I tested positive for covid while being vaccinated. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Additional information: No other vaccine in four weeks and not available details about other medications in two weeks. No Covid prior vaccination and no Covid tested post vaccination.  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: Chest X-ray, Colonoscopy, Echocardiogram, Endoscopy, Pericardial effusion
Clinical narrative: pericarditis; pericardial effusions; This is a spontaneous report received from contactable reporter(s) (Other HCP). The reporter is the patient.  A 45 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 11Jun2021 (Lot number: EW0179) at the age of 45 years as dose 2, single for covid-19 immunisation. There was no other vaccine in the 4 weeks prior. Relevant medical history included: "Asthma" (unspecified if ongoing); "shellfish allergy" (unspecified if ongoing). She had not had COVID prior to vaccination. Concomitant medication(s) included: NASACORT and daily multivitamin. Vaccination history included: Bnt162b2 (Dose Number: 1, Batch/Lot No: EW0179, Location of injection: Arm Left), administration date: 21May2021, for Covid-19 Immunization. The following information was reported: PERICARDITIS (medically significant) with onset 27Jun2021 13:15, outcome "recovering", described as "pericarditis"; PERICARDIAL EFFUSION (medically significant) with onset 27Jun2021 13:15, outcome "recovering", described as "pericardial effusions". On 27Jun2021 experienced chest pain, radiated to neck and jaw. Then had persistent neck pressure afterwards. The events "pericarditis" and "pericardial effusions" were evaluated at the physician office visit; patient saw PCP (primary care physician), and was referred to GI and ENT, urgent care at one point. The patient underwent the following laboratory tests and procedures: chest x-ray: normal; colonoscopy: unknown result; echocardiogram: pericardial effusions; endoscopy: unknown result; thyroid function test: normal; x-ray (soft tissue neck): normal. Multiple meds to treat GERD. Finally has echo and had pericardial effusions. She saw cardiologist "last week" (as of 07Feb2022) who confirmed pericarditis. She was still having intermittent chest pain. She had not been Covid tested post-vaccination.; Sender's Comments: Considering the temporal association, a causal association between administration of bnt162b2 and the onset of "pericarditis" and "pericardial effusions"  cannot be excluded.  The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
Age: 45.0
Sex: F
Vaccine: COVID19
Symptoms: Pericarditis, Thyroid function test, X-ray
Clinical narrative: pericarditis; pericardial effusions; This is a spontaneous report received from contactable reporter(s) (Other HCP). The reporter is the patient.  A 45 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 11Jun2021 (Lot number: EW0179) at the age of 45 years as dose 2, single for covid-19 immunisation. There was no other vaccine in the 4 weeks prior. Relevant medical history included: "Asthma" (unspecified if ongoing); "shellfish allergy" (unspecified if ongoing). She had not had COVID prior to vaccination. Concomitant medication(s) included: NASACORT and daily multivitamin. Vaccination history included: Bnt162b2 (Dose Number: 1, Batch/Lot No: EW0179, Location of injection: Arm Left), administration date: 21May2021, for Covid-19 Immunization. The following information was reported: PERICARDITIS (medically significant) with onset 27Jun2021 13:15, outcome "recovering", described as "pericarditis"; PERICARDIAL EFFUSION (medically significant) with onset 27Jun2021 13:15, outcome "recovering", described as "pericardial effusions". On 27Jun2021 experienced chest pain, radiated to neck and jaw. Then had persistent neck pressure afterwards. The events "pericarditis" and "pericardial effusions" were evaluated at the physician office visit; patient saw PCP (primary care physician), and was referred to GI and ENT, urgent care at one point. The patient underwent the following laboratory tests and procedures: chest x-ray: normal; colonoscopy: unknown result; echocardiogram: pericardial effusions; endoscopy: unknown result; thyroid function test: normal; x-ray (soft tissue neck): normal. Multiple meds to treat GERD. Finally has echo and had pericardial effusions. She saw cardiologist "last week" (as of 07Feb2022) who confirmed pericarditis. She was still having intermittent chest pain. She had not been Covid tested post-vaccination.; Sender's Comments: Considering the temporal association, a causal association between administration of bnt162b2 and the onset of "pericarditis" and "pericardial effusions"  cannot be excluded.  The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Adnexa uteri pain, Alopecia, Breast pain, COVID-19, Fatigue
Clinical narrative: Covid test date=14Jan2022, Covid test result=Positive; Covid test date=14Jan2022, Covid test result=Positive; am extremely fatigued all the time; I'm losing a lot of hair; gaining weight; I have intermittent severe breast pain; I am having pain from my left ovary just like when I normally ovulate on that side.; I have not had my menses since Nov2021; This is a spontaneous report received from a contactable reporter(s) (Other HCP). The reporter is the patient.  A 50 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 18Aug2021 06:45 (Lot number: EW0171) at the age of 50 years as dose 3 (booster), single, administered in arm left, administration date 18Jan2021 17:00 (Lot number: EL3248) as dose 2, single and administered in arm left, administration date 18Dec2020 17:45 (Lot number: EK5730) as dose 1, single for covid-19 immunisation. Relevant medical history included: "Rheumatoid Arthritis" (unspecified if ongoing); "Fibromyalgia" (unspecified if ongoing); "Sjogren's syndrome" (unspecified if ongoing); "Raynaud's Vasculitis" (unspecified if ongoing); "Hashimoto's" (unspecified if ongoing); "Latex" (unspecified if ongoing). Concomitant medication(s) included: IBUPROFEN; TYLENOL; ASPIRIN [ACETYLSALICYLIC ACID]; METFORMIN. Past drug history included: Wellbutrin, reaction(s): "known allergies: Welbutrin", notes: known allergies: Welbutrin, latex. The following information was reported: COVID-19 (medically significant), DRUG INEFFECTIVE (medically significant) all with onset 14Jan2022, outcome "unknown" and all described as "Covid test date=14Jan2022, Covid test result=Positive"; MENSTRUATION DELAYED (non-serious) with onset Nov2021, outcome "not recovered", described as "I have not had my menses since Nov2021"; FATIGUE (non-serious) with onset 21Dec2021, outcome "not recovered", described as "am extremely fatigued all the time"; ALOPECIA (non-serious) with onset 21Dec2021, outcome "not recovered", described as "I'm losing a lot of hair"; WEIGHT INCREASED (non-serious) with onset 21Dec2021, outcome "not recovered", described as "gaining weight"; BREAST PAIN (non-serious) with onset 21Dec2021, outcome "not recovered", described as "I have intermittent severe breast pain"; PAIN (non-serious) with onset 21Dec2021, outcome "not recovered", described as "I am having pain from my left ovary just like when I normally ovulate on that side.". The patient underwent the following laboratory tests and procedures: sars-cov-2 test: (14Jan2022) positive, notes: Nasal Swab. Therapeutic measures were not taken as a result of menstruation delayed, fatigue, alopecia, weight increased, breast pain, pain.  Clinical Course: Patient did not have COVID prior vaccination and tested COVID positive post vaccination. Patient did not take other vaccine in four weeks. Facility type vaccine: Hospital.; Sender's Comments: Based on known drug safety profile, there is reasonable possibility of causal association between the events VACCINATION FAILURE and covid-19 and BNT162B2.
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Menstruation delayed, SARS-CoV-2 test, Vaccination failure, Weight increased
Clinical narrative: Covid test date=14Jan2022, Covid test result=Positive; Covid test date=14Jan2022, Covid test result=Positive; am extremely fatigued all the time; I'm losing a lot of hair; gaining weight; I have intermittent severe breast pain; I am having pain from my left ovary just like when I normally ovulate on that side.; I have not had my menses since Nov2021; This is a spontaneous report received from a contactable reporter(s) (Other HCP). The reporter is the patient.  A 50 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 18Aug2021 06:45 (Lot number: EW0171) at the age of 50 years as dose 3 (booster), single, administered in arm left, administration date 18Jan2021 17:00 (Lot number: EL3248) as dose 2, single and administered in arm left, administration date 18Dec2020 17:45 (Lot number: EK5730) as dose 1, single for covid-19 immunisation. Relevant medical history included: "Rheumatoid Arthritis" (unspecified if ongoing); "Fibromyalgia" (unspecified if ongoing); "Sjogren's syndrome" (unspecified if ongoing); "Raynaud's Vasculitis" (unspecified if ongoing); "Hashimoto's" (unspecified if ongoing); "Latex" (unspecified if ongoing). Concomitant medication(s) included: IBUPROFEN; TYLENOL; ASPIRIN [ACETYLSALICYLIC ACID]; METFORMIN. Past drug history included: Wellbutrin, reaction(s): "known allergies: Welbutrin", notes: known allergies: Welbutrin, latex. The following information was reported: COVID-19 (medically significant), DRUG INEFFECTIVE (medically significant) all with onset 14Jan2022, outcome "unknown" and all described as "Covid test date=14Jan2022, Covid test result=Positive"; MENSTRUATION DELAYED (non-serious) with onset Nov2021, outcome "not recovered", described as "I have not had my menses since Nov2021"; FATIGUE (non-serious) with onset 21Dec2021, outcome "not recovered", described as "am extremely fatigued all the time"; ALOPECIA (non-serious) with onset 21Dec2021, outcome "not recovered", described as "I'm losing a lot of hair"; WEIGHT INCREASED (non-serious) with onset 21Dec2021, outcome "not recovered", described as "gaining weight"; BREAST PAIN (non-serious) with onset 21Dec2021, outcome "not recovered", described as "I have intermittent severe breast pain"; PAIN (non-serious) with onset 21Dec2021, outcome "not recovered", described as "I am having pain from my left ovary just like when I normally ovulate on that side.". The patient underwent the following laboratory tests and procedures: sars-cov-2 test: (14Jan2022) positive, notes: Nasal Swab. Therapeutic measures were not taken as a result of menstruation delayed, fatigue, alopecia, weight increased, breast pain, pain.  Clinical Course: Patient did not have COVID prior vaccination and tested COVID positive post vaccination. Patient did not take other vaccine in four weeks. Facility type vaccine: Hospital.; Sender's Comments: Based on known drug safety profile, there is reasonable possibility of causal association between the events VACCINATION FAILURE and covid-19 and BNT162B2.
Age: 38.0
Sex: M
Vaccine: COVID19
Symptoms: Biopsy, Lichen planus, Oral lichen planus, SARS-CoV-2 test
Clinical narrative: oral Lichen Planus; I have Lichen Planus (LP), an autoimmune disorder.; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 38 year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), administered in arm left, administration date 26Mar2021 (Batch/Lot number: unknown) at the age of 38 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "Hypothyroid" (unspecified if ongoing). Concomitant medication(s) included: LEVOTHYROXINE. Vaccination history included: Bnt162b2 (dose 1, Left arm), administration date: 04Mar2021, when the patient was 38 years old, for Covid-19 Immunization, reaction(s): "muscle pains", "muscle tinglings in the left arm bicep and both feet area". No other vaccine in four weeks. No covid prior vaccination. The following information was reported: LICHEN PLANUS (disability) with onset May2021, outcome "not recovered", described as "I have Lichen Planus (LP), an autoimmune disorder."; ORAL LICHEN PLANUS (disability) with onset Oct2021, outcome "not recovered", described as "oral Lichen Planus". The events "i have lichen planus (lp), an autoimmune disorder." and "oral lichen planus" were evaluated at the physician office visit. The patient underwent the following laboratory tests and procedures: biopsy: (May2021) lichen planus (lp); (Oct2021) oral lichen planus; sars-cov-2 test: (22Jan2022) negative. Therapeutic measures (Oral treatment) were taken as a result of lichen planus, oral lichen planus. Clinical course: The patient started observing several changes in his body. Around the end of May2021, the patient started observing some black spots on his face under the beard. He went to dermatologist for biopsy and found that he had Lichen Planus (LP), an autoimmune disorder. Around early October, the patient started feeling some burning sensations in his mouth. Later symptoms started getting worse and he was unable to eat even very very mild spicy food. Analysis of biopsy sample showed that he had oral Lichen Planus. The lot number for bnt162b2 was not provided and will be requested during follow up.
Age: 6.0
Sex: M
Vaccine: COVID19
Symptoms: Aggression, Autism spectrum disorder, Delusional disorder, unspecified type, Eating disorder symptom
Clinical narrative: Severe autism symptoms; Very aggressive behaviors - Hitting friends and teachers; Not eating well; Delusional like behaviors; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A 6 year-old male patient received bnt162b2 (BNT162B2), administered in arm left, administration date 17Nov2021 15:30 (Batch/Lot number: unknown) at the age of 6 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "delayed speech" (unspecified if ongoing); "known allergies: some nuts" (unspecified if ongoing); "known allergies: dairy" (unspecified if ongoing); "Covid" (unspecified if ongoing), notes: If covid prior vaccination: Yes. There were no concomitant medications. The following information was reported: AUTISM SPECTRUM DISORDER (medically significant) with onset 22Nov2021, outcome "not recovered", described as "Severe autism symptoms"; AGGRESSION (non-serious) with onset 22Nov2021, outcome "not recovered", described as "Very aggressive behaviors - Hitting friends and teachers"; EATING DISORDER SYMPTOM (non-serious) with onset 22Nov2021, outcome "not recovered", described as "Not eating well"; DELUSIONAL DISORDER, UNSPECIFIED TYPE (non-serious) with onset 22Nov2021, outcome "not recovered", described as "Delusional like behaviors". The events "severe autism symptoms", "very aggressive behaviors - hitting friends and teachers", "not eating well" and "delusional like behaviors" were evaluated at the physician office visit. Therapeutic measures were taken as a result of autism spectrum disorder, aggression, eating disorder symptom, delusional disorder, unspecified type included: Speech and occupational therapy. Clinical course: No other vaccine in four weeks. No other medications in two weeks: No. No covid tested post vaccination: No.  The lot number for bnt162b2 was not provided and will be requested during follow up.
Sex: F
Vaccine: COVID19
Symptoms: Contusion, Vaccination site discolouration
Clinical narrative: big yellow circle mark at injection site; various bruising on arms/forearms following 2nd dose; 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 56 year-old female patient received bnt162b2 (BNT162B2), administration date Apr2021 (Batch/Lot number: unknown) as dose 2, single for covid-19 immunisation. Relevant medical history included: "Diabetes" (unspecified if ongoing), notes: Optional Information: Diabetes; "Hypothyroidism" (unspecified if ongoing), notes: Optional Information: Hypothyroidism on Synthroid. Concomitant medication(s) included: SYNTHROID taken for hypothyroidism. Vaccination history included: Covid-19 vaccine (Dose:1, Manufacturer Unknown), for COVID-19 immunization. The following information was reported: VACCINATION SITE DISCOLOURATION (non-serious), outcome "unknown", described as "big yellow circle mark at injection site"; CONTUSION (non-serious), outcome "unknown", described as "various bruising on arms/forearms following 2nd dose".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 27.0
Sex: F
Vaccine: COVID19
Symptoms: Stillbirth
Clinical narrative: Still birth on 13Aug2021; This is a spontaneous report received from a contactable reporter(s) (Other HCP). The reporter is the patient.  A 27 year-old female patient (pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 08Jun2021 (Lot number: EW0180) at the age of 27 years as dose 2, single and administration date 13May2021 (Lot number: FW0172) as dose 1, single for covid-19 immunisation. The patient's relevant medical history was not reported. No covid prior vaccination. No Known allergies. Date of last menstrual period: 25Mar2021. The patient was 10 weeks pregnant at the time of exposure to bnt162b2. The patient was 20 weeks pregnant at the event onset. The patient is expected to deliver a baby(s) on 30Dec2021. The patient took concomitant medications Prenatal pills. No other vaccine in four weeks. The following information was reported: STILLBIRTH (medically significant) with onset 13Aug2021, outcome "unknown", described as "Still birth on 13Aug2021". The pregnancy resulted in still birth (30Dec2021). The fetal outcome is intrauterine death. No covid tested post vaccination. Therapeutic measures were not taken as a result of stillbirth.; Sender's Comments: The information currently provided is too limited to make a meaningful medical assessment hence, the events are conservatively assessed as related to the suspect drug BNT162B2 until further 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 RAs, Ethics Committees, and Investigators, as appropriate.
Age: 49.0
Sex: M
Vaccine: COVID19
Symptoms: Product use issue
Clinical narrative: massive joint pain; severe pain in both calves; severe sickness mimicing the flu for >1 week; severe sickness mimicing the flu for >1 week; flare of arthritis; other vaccine same date product=Prevnar; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 49 year-old male patient received bnt162b2 (BNT162B2), administered in arm right, administration date 27Jan2022 (Lot number: FL3209) at the age of 49 years as dose 3 (booster), single for covid-19 immunisation; pneumococcal vaccine conj 7v (crm197) (PREVNAR), administered in arm left, administration date 27Jan2022 (Batch/Lot number: unknown) as dose 1, single for immunisation. Relevant medical history included: "Spondoloarthritis" (unspecified if ongoing); "Heart Disease" (unspecified if ongoing); "known allergies DAIRY" (unspecified if ongoing). Concomitant medication(s) included: PLAVIX; REPATHA; ASPIRIN [ACETYLSALICYLIC ACID]; HUMIRA; VIBERZI; SINGULAIR. Vaccination history included: Bnt162b2 (DOSE 2, SINGLE., Batch/Lot No: EN6199, Location of injection: Arm Left), administration date: 27Mar2021, when the patient was 48 years old, for COVID-19 Immunization, reaction(s): "administration date: 27Mar2021, prev dose dose number: 2; prev dose administration date: 27Jan2021, prev dose dose number: 1"; Bnt162b2 (DOSE 1, SINGLE., Batch/Lot No: EN6201, Location of injection: Arm Left), administration date: 27Jan2021, when the patient was 48 years old, for COVID-19 Immunization. The following information was reported: ARTHRALGIA (non-serious) with onset 28Jan2022, outcome "not recovered", described as "massive joint pain"; PAIN IN EXTREMITY (non-serious) with onset 28Jan2022, outcome "not recovered", described as "severe pain in both calves"; ILLNESS (non-serious), INFLUENZA LIKE ILLNESS (non-serious) all with onset 28Jan2022, outcome "not recovered" and all described as "severe sickness mimicing the flu for >1 week"; ARTHRITIS (non-serious) with onset 28Jan2022, outcome "not recovered", described as "flare of arthritis"; PRODUCT USE ISSUE (non-serious) with onset 27Jan2022, outcome "unknown", described as "other vaccine same date product=Prevnar". The events "massive joint pain", "severe pain in both calves", "severe sickness mimicing the flu for >1 week", "severe sickness mimicing the flu for >1 week" and "flare of arthritis" were evaluated at the physician office visit. It was unknown if therapeutic measures were taken as a result of arthralgia, pain in extremity, illness, influenza like illness, arthritis. Additional information:Reported events included trying to get into a Dr. for evaluation massive joint pain, forearm pain, severe pain in both calves, severe sickness mimicking the flu for >1 week; flare of arthritis. Events resulted in doctor or other healthcare professional office/clinic visit. Prior to vaccination, the patient was diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. Device date was reported as 07Feb2022.  No follow-up attempts are possible. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Guillain-Barre syndrome
Clinical narrative: guillain barre syndrome; This is a spontaneous report received from a non-contactable reporter (Consumer or other non HCP) from medical information team. A 18 year-old female patient received bnt162b2 (COMIRNATY) (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: GUILLAIN-BARRE SYNDROME (hospitalization, medically significant), outcome "unknown", described as "guillain barre syndrome". The patient was hospitalized for guillain-barre syndrome (hospitalization duration: 14 day(s)). Clinical course: the consumer's granddaughter developed guillain barre syndrome from the Pfizer COVID-19 vaccine. Her nerves has been affected and cannot walk and is in a wheelchair. It has also went to her face and has affected her eyesight. Her doctor has said that the Pfizer COVID-19 vaccine has contributed to it.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Joint effusion
Clinical narrative: fluid on both knees that needed to be drained; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from a sales representative. The reporter is the patient.  A 66 year-old female patient received bnt162b2 (COMIRNATY) (Batch/Lot number: unknown) as dose 2, single for covid-19 immunisation. The patient's relevant medical history was not reported. There were no concomitant medications. Vaccination history included: Covid-19 vaccine (Dose: 1, MANUFACTURER UNKNOWN), for Covid-19 immunization. The following information was reported: JOINT EFFUSION (medically significant), outcome "unknown", described as "fluid on both knees that needed to be drained". Clinical course: Patient was referred to an orthopedic specialist which is recommending partial knee replacements to the patient. Patient had no reported knee problems prior to receiving the vaccine.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: U
Vaccine: COVID19
Symptoms: Cerebrovascular accident
Clinical narrative: stroke; 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 (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 NUMBER UNKNOWN, MANUFACTURER UNKNOWN), for Covid-19 Immunization. The following information was reported: CEREBROVASCULAR ACCIDENT (medically significant), outcome "unknown", described as "stroke". A patient suffered stroke after booster. The reporting consumer did not know if it's related but she was more and more on the fact that it is related.  The lot number for bnt162b2 was not provided and will be requested during follow up.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202200223241 same drug/reporter, different patient, similar event.
Sex: U
Vaccine: COVID19
Symptoms: Cerebrovascular accident
Clinical narrative: had stroke after booster; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A patient (no qualifiers provided) received bnt162b2 (BNT162B2) (Lot number: FL3127) 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,MANUFACTUERER UNKNOWN), for COVID-19 Immunization. The following information was reported: CEREBROVASCULAR ACCIDENT (medically significant), outcome "unknown", described as "had stroke after booster".  Follow-Up (09Feb2022): Follow-up attempts are completed. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202200223241 same drug/reporter, different patient, similar event
Sex: U
Vaccine: COVID19
Symptoms: Cerebrovascular accident
Clinical narrative: suffered stroke after booster; This is a spontaneous report received from a contactable consumer. A patient (no qualifiers provided) 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 (Dose: Unknown, manufacturer unknown), for COVID-19 immunization. The following information was reported: cerebrovascular accident (medically significant), outcome "unknown", described as "suffered stroke after booster". The reporter stated that reporter's mother was the fourth person that reporter knew that has suffered stroke after booster. The reporter stated didn't know if its related but reporter was more and more on the fact that it is related.  The lot number for bnt162b2 was not provided and will be requested during follow up.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202200223241 same drug/reporter, different patient, similar event
Sex: F
Vaccine: COVID19
Symptoms: Axillary pain, Mammogram, Muscle rupture
Clinical narrative: It felt like a torn intercostal muscle tear at first; sore on under my left arm across my chest area for almost 8 weeks; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program. The reporter is the patient.  A female patient received bnt162b2 (BNT162B2), administered in arm left, administration date 15Nov2021 (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: MUSCLE RUPTURE (medically significant), outcome "recovered", described as "It felt like a torn intercostal muscle tear at first"; AXILLARY PAIN (non-serious), outcome "recovered", described as "sore on under my left arm across my chest area for almost 8 weeks". The patient underwent the following laboratory tests and procedures: mammogram: (15Nov2021) unknown results. The patient was sore on under left arm across chest area for almost 8 weeks. It felt like a torn intercostal muscle tear at first. The patient did let doctor know and they said to see if it gets better after 2 weeks. The discomfort did lessen, but it took about 8 weeks. The patient did also have a mammogram that same morning (15Nov2021) but she has never been sore after a mammogram.  The lot number for bnt162b2 was not provided and will be requested during follow-up.
Sex: F
Vaccine: COVID19
Symptoms: Myocardial infarction, SARS-CoV-2 test
Clinical narrative: heart attack after the shots; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program.  A 45 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: MYOCARDIAL INFARCTION (medically significant), outcome "unknown", described as "heart attack after the shots". The patient underwent the following laboratory tests and procedures: sars-cov-2 test: unknown results. The clinical course of events was as follows: How can you test detected on a covid test if you are vaccinated.. and also how my wife had a heart attack after the shots and can't work for now..when we documents she has a healthy heart for her 45 yrs.. and now... The lot number for bnt162b2 was not provided and will be requested during follow up.
Sex: M
Vaccine: COVID19
Symptoms: Drug ineffective, SARS-CoV-2 test, Suspected COVID-19
Clinical narrative: got COVID after his first shot of the vaccine; got COVID after his first shot of the vaccine; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). Other Case identifier(s): 02101783.  A 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: DRUG INEFFECTIVE (medically significant), SUSPECTED COVID-19 (medically significant), outcome "unknown" and all described as "got COVID after his first shot of the vaccine". The patient underwent the following laboratory tests Reporter was a consumer called on behalf of his dad who took the PFIZER vaccine for COVID 19. Reporter stated that his dad got COVID after his first shot of the vaccine, and before receiving the second shot.  The lot number for bnt162b2 was not provided and will be requested during follow up.
Age: 35.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Heart rate, Heart rate increased, Loss of consciousness, Neuralgia
Clinical narrative: collapsed; seizure; vomited; neurological pain; elevated resting heart rate (around 123); fatigue; This is a spontaneous report received from contactable reporter(s) (Other HCP) from a sales representative. The reporter is the patient.  A 35 year-old female patient received bnt162b2 (BNT162B2), administration date 13Oct2021 (Batch/Lot number: unknown) at the age of 35 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 (1st dose of the Pfizer BioNTech vaccine, Event verbatim: neurological pain shooting up her body.), administration date: 22Sep2021, when the patient was 35 years old, for Covid-19 Immunization, reaction(s): "neurological pain"; Bnt162b2 (1st dose of the Pfizer BioNTech vaccine, Event verbatim: pain both sitting or standing.), administration date: 22Sep2021, when the patient was 35 years old, for COVID-19 immunization, reaction(s): "pain both sitting or standing", "Fatigue". The following information was reported: LOSS OF CONSCIOUSNESS (medically significant), outcome "unknown", described as "collapsed"; SEIZURE (medically significant), outcome "unknown", described as "seizure"; VOMITING (non-serious), outcome "unknown", described as "vomited"; NEURALGIA (non-serious), outcome "unknown", described as "neurological pain"; HEART RATE INCREASED (non-serious), outcome "unknown", described as "elevated resting heart rate (around 123)"; FATIGUE (non-serious), outcome "unknown", described as "fatigue". The patient underwent the following laboratory tests and procedures: heart rate: (unspecified date) elevated, notes: elevated resting heart rate (around 123); sars-cov-2 antibody test: (16Aug2021) positive.  Clinical course: Event took place after use of product.  The lot number for bnt162b2 was not provided and will be requested during follow up.; Sender's Comments: Based on available information, a possible contributory role of BNT162B2 vaccine cannot be excluded for the reported events of Loss of consciousness, Seizure. 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: 35.0
Sex: F
Vaccine: COVID19
Symptoms: SARS-CoV-2 antibody test, Seizure, Vomiting
Clinical narrative: collapsed; seizure; vomited; neurological pain; elevated resting heart rate (around 123); fatigue; This is a spontaneous report received from contactable reporter(s) (Other HCP) from a sales representative. The reporter is the patient.  A 35 year-old female patient received bnt162b2 (BNT162B2), administration date 13Oct2021 (Batch/Lot number: unknown) at the age of 35 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 (1st dose of the Pfizer BioNTech vaccine, Event verbatim: neurological pain shooting up her body.), administration date: 22Sep2021, when the patient was 35 years old, for Covid-19 Immunization, reaction(s): "neurological pain"; Bnt162b2 (1st dose of the Pfizer BioNTech vaccine, Event verbatim: pain both sitting or standing.), administration date: 22Sep2021, when the patient was 35 years old, for COVID-19 immunization, reaction(s): "pain both sitting or standing", "Fatigue". The following information was reported: LOSS OF CONSCIOUSNESS (medically significant), outcome "unknown", described as "collapsed"; SEIZURE (medically significant), outcome "unknown", described as "seizure"; VOMITING (non-serious), outcome "unknown", described as "vomited"; NEURALGIA (non-serious), outcome "unknown", described as "neurological pain"; HEART RATE INCREASED (non-serious), outcome "unknown", described as "elevated resting heart rate (around 123)"; FATIGUE (non-serious), outcome "unknown", described as "fatigue". The patient underwent the following laboratory tests and procedures: heart rate: (unspecified date) elevated, notes: elevated resting heart rate (around 123); sars-cov-2 antibody test: (16Aug2021) positive.  Clinical course: Event took place after use of product.  The lot number for bnt162b2 was not provided and will be requested during follow up.; Sender's Comments: Based on available information, a possible contributory role of BNT162B2 vaccine cannot be excluded for the reported events of Loss of consciousness, Seizure. 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: M
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: Patient states he got COVID while on Xeljanz. He received the first 2 COVID shots but not the booster.; Patient states he got COVID while on Xeljanz. He received the first 2 COVID shots but not the booster.; This is a spontaneous report received from contactable reporter(s) (Other HCP).  A 63 year-old male patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 1, single and (Batch/Lot number: unknown) as dose 2, 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 "Patient states he got COVID while on Xeljanz. He received the first 2 COVID shots but not the booster".  The lot number for bnt162b2 was not provided and will be requested during follow up.; Sender's Comments: As there is limited information in the case provided, the causal association between the reported events with the suspect drug BNT162B2 cannot be excluded. The case will be reassessed once new information is available.
Age: 41.0
Sex: F
Vaccine: COVID19
Symptoms: Pain
Clinical narrative: No hoarseness but did have body aches night of; This is a spontaneous report received from a contactable reporter(s) (Other HCP). The reporter is the patient.  A 41 year-old female patient received bnt162b2 (BNT162B2), administered in arm left, administration date 02Feb2021 (Batch/Lot number: unknown) at the age of 41 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 (first dose, Batch/Lot no: Eh9899, Route: intramuscular, Time: 10 AM, Anatomical Location: Right Arm), administration date: 12Jan2021, when the patient was 41 years old, for Covid-19 immunization, reaction(s): "Body aches night of vaccine", "had lost voice (very hoarse) for a week after". The following information was reported: PAIN (non-serious), outcome "recovered", described as "No hoarseness but did have body aches night of". Therapeutic measures were taken as a result of pain. Additional information: It was reported that the patient took Advil 800mg 16 hours after vaccination.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Arthralgia, Arthritis reactive, Inappropriate schedule of product administration, Rash
Clinical narrative: reactive arthritis; joint pain; I developed a rash that eventually covered most of my extremities; Pfizer-BioNTech COVID-19 vaccine on 11Jan2021 and the second dose on 28Jan2021; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team for a Pfizer sponsored program. The reporter is the patient.  A female patient received bnt162b2 (BNT162B2), administration date 28Jan2021 (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 (I received the Pfizer-BioNTech COVID-19 vaccine on 11Jan2021), administration date: 11Jan2021, for COVID-19 immunization.In May2021 patient developed joint pain and was eventually told by the physician that she probably had reactive arthritis. The following information was reported: ARTHRITIS REACTIVE (medically significant) with onset May2021, outcome "unknown", described as "reactive arthritis"; INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (non-serious) with onset 28Jan2021, outcome "unknown", described as "Pfizer-BioNTech COVID-19 vaccine on 11Jan2021 and the second dose on 28Jan2021"; ARTHRALGIA (non-serious) with onset May2021, outcome "recovered" (Nov2021), described as "joint pain"; RASH (non-serious) with onset Approximately two weeks after the second vaccine on unknown date in Feb2021, outcome "not recovered", described as "I developed a rash that eventually covered most of my extremities". The rash had subsided with the onset of the joint pain and in Nov2021 the joint pain subsided, but the rash resumed. The patient enquired if it was safe for her to get a COVID booster?  The lot number for bnt162b2 was not provided and will be requested during follow up.
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Arthralgia, Inappropriate schedule of product administration, Rash, SARS-CoV-2 test
Clinical narrative: reactive arthritis; joint pain; I developed a rash that eventually covered most of my extremities; Pfizer-BioNTech COVID-19 vaccine on 11Jan2021 and the second dose on 28Jan2021; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team for a Pfizer sponsored program. The reporter is the patient.  A female patient received bnt162b2 (BNT162B2), administration date 28Jan2021 (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 (I received the Pfizer-BioNTech COVID-19 vaccine on 11Jan2021), administration date: 11Jan2021, for COVID-19 immunization.In May2021 patient developed joint pain and was eventually told by the physician that she probably had reactive arthritis. The following information was reported: ARTHRITIS REACTIVE (medically significant) with onset May2021, outcome "unknown", described as "reactive arthritis"; INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (non-serious) with onset 28Jan2021, outcome "unknown", described as "Pfizer-BioNTech COVID-19 vaccine on 11Jan2021 and the second dose on 28Jan2021"; ARTHRALGIA (non-serious) with onset May2021, outcome "recovered" (Nov2021), described as "joint pain"; RASH (non-serious) with onset Approximately two weeks after the second vaccine on unknown date in Feb2021, outcome "not recovered", described as "I developed a rash that eventually covered most of my extremities". The rash had subsided with the onset of the joint pain and in Nov2021 the joint pain subsided, but the rash resumed. The patient enquired if it was safe for her to get a COVID booster?  The lot number for bnt162b2 was not provided and will be requested during follow up.
Sex: F
Vaccine: COVID19
Symptoms: Burning sensation, Neuropathy peripheral, Pain in extremity, Paraesthesia
Clinical narrative: Neuropathy; Severe burning and prickling sensation and pain in her upper thighs; Severe burning and prickling sensation and pain in her upper thighs; burning and prickling sensation; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team for a Pfizer sponsored program. The reporter is the patient.  A 73 year-old female patient received bnt162b2 (COMIRNATY) (Batch/Lot number: unknown) 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:1), for Covid-19 Immunization; Bnt162b2 (Dose:2), for Covid-19 immunization. The following information was reported: NEUROPATHY PERIPHERAL (medically significant), outcome "recovering", described as "Neuropathy"; BURNING SENSATION (non-serious), PAIN (non-serious), outcome "unknown" and all described as "Severe burning and prickling sensation and pain in her upper thighs". The event "neuropathy" was evaluated at the physician office visit. Therapeutic measures were taken as a result of neuropathy peripheral. It was a little bit better but gets worse at night. She had started to have severe nerve pain in my legs after the Pfizer vaccine shot. Is this common to develop this pain, are there other reports of this. After the booster she woke up with a severe burning and prickling sensation and pain in her upper thighs bilaterally and it has continued for 4 months. She has been seeing her physician who states he's had a few other patients with the same thing. It was disconcerting and frustrating that no one can tell her if this was the cause of it. The neuropathy. No one can tell her anything and everything she has done to help it has not worked. She has tried several different medications and they did not work. It was a little bit better but gets worse at night. No one can tell her if it will get better or last the rest of her life. If they suggest another booster she would refuse. This was one of the worst things she had to deal with in her life.  The lot number for bnt162b2 was not provided and will be requested during follow up.
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, Influenza like illness
Clinical narrative: COVID-19 infection on 13Jan; COVID-19 infection on 13Jan; flu-like symptoms; This is a spontaneous report received from contactable reporter(s) (Other HCP) for a Pfizer sponsored program.  A 39 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) all with onset 13Jan2022, outcome "unknown" and all described as "COVID-19 infection on 13Jan"; INFLUENZA LIKE ILLNESS (non-serious), outcome "recovered", described as "flu-like symptoms".  clinical course: Symptoms include flu-like symptoms for 3 days, but patient states overall mild due to vaccination.  The lot number for bnt162b2 was not provided and will be requested during follow up.; Sender's Comments: Based on the available information and a possible contributory role of suspect product BNT162B2 to the development of events drug ineffective, covid19 cannot be totally excluded.