chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 45.0
Sex: F
Vaccine: COVID19
Symptoms: Menstruation irregular, Pemphigoid, SARS-CoV-2 test, Visual impairment
Clinical narrative: This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. A 45-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 13Dec2021 as dose 3 (booster), single (Lot number: FD7218) at the age of 45 years, in left arm for Covid-19 immunisation. The patient's relevant medical history was not reported. There were no concomitant medications. Vaccination history included: BNT162b2 (Dose Number: 2, Batch/Lot No: EW0173, Location of injection: Arm Left), administration date: 30Apr2021, when the patient was 44-year-old, for Covid-19 Immunization; Pfizer (Dose Number: 1, Batch/Lot No: FW0158, Location of injection: Arm Left), administration date: 09Apr2021, when the patient was 44-year-old, for Covid-19 Immunization. The following information was reported: PEMPHIGOID (medically significant) with onset 01Jan2022, outcome "not recovered", described as "Bullous pemphigoid"; MENSTRUATION IRREGULAR (non-serious) with onset 01Jan2022, outcome "not recovered", described as "Very first month after 3shot - my period changed"; VISUAL IMPAIRMENT (non-serious) with onset 01Jan2022, outcome "not recovered", described as "eye sight changed". The events "bullous pemphigoid", "very first month after 3shot - my period changed" and "eye sight changed" required physician office visit. The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Unknown results. Therapeutic measures were taken as a result of pemphigoid, menstruation irregular, visual impairment. Additional information: The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient did not receive any other medications within 2 weeks of vaccination. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has been tested for COVID-19. Reported Event: Very first month after 3shot - my period changed and eye sight changed. Now my doctor diagnosed Bullous pemphigoid. No follow-up attempts are possible. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Burning sensation, Erythema, Feeling abnormal, Feeling hot, Inflammation
Clinical narrative: red area that got larger and larger; felt inflamed; peeling; being very itchy; burning; icky; area that was red at the beginning of the symptoms is now dark and warm; area that was red at the beginning of the symptoms is now dark and warm; the dark part as if someone had hit punched her; This is a spontaneous report received from a contactable reporter(s) (Nurse) from medical information team. The reporter is the patient.  A 74-year-old female patient received BNT162b2 (BNT162B2), on 05Apr2022 as dose number unknown (booster), single (Lot number: FM0698) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Primary Immunization series complete; unknown manufacturer, Caller on the line got the 2nd booster of the Pfizer COVID-19 Vaccine.), for Covid-19 immunization; Covid-19 vaccine (First Booster, Manufacturer unknown, Caller on the line got the 2nd booster of the Pfizer COVID-19 Vaccine.), for Covid-19 immunization. The following information was reported: SKIN DISCOLOURATION (non-serious), FEELING HOT (non-serious) all with onset 06Apr2022, outcome "unknown" and all described as "area that was red at the beginning of the symptoms is now dark and warm"; PRURITUS (non-serious) with onset 06Apr2022, outcome "unknown", described as "being very itchy"; BURNING SENSATION (non-serious) with onset 06Apr2022, outcome "unknown", described as "burning"; INFLAMMATION (non-serious) with onset 06Apr2022, outcome "unknown", described as "felt inflamed"; MALAISE (non-serious) with onset 06Apr2022, outcome "unknown", described as "icky"; SKIN EXFOLIATION (non-serious) with onset 06Apr2022, outcome "unknown", described as "peeling"; ERYTHEMA (non-serious) with onset 06Apr2022, outcome "unknown", described as "red area that got larger and larger"; FEELING ABNORMAL (non-serious) with onset 06Apr2022, outcome "unknown", described as "the dark part as if someone had hit punched her".  Additional information: Caller on the line got the 2nd booster of the Pfizer COVID-19 Vaccine on 05Apr2022 from lot number FM0698. On 06Apr2022 she had a red area that got larger and larger and felt inflamed. She stated it started peeling and being very itchy. Besides the peeling and itchy, caller also described as if it had been burning, icky. She said that she could tolerate the other symptoms but that it was really itchy. The area that was red at the beginning of the symptoms is now dark and warm. Caller later described the dark part as if someone had hit punched her. Caller's inquiry was if this side effects have been reported. Caller also stated she would consult with his physician whether or not to get her next dose if a 3rd dose is ever required.  No follow-up attempts are possible. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Malaise, Pruritus, Skin discolouration, Skin exfoliation
Clinical narrative: red area that got larger and larger; felt inflamed; peeling; being very itchy; burning; icky; area that was red at the beginning of the symptoms is now dark and warm; area that was red at the beginning of the symptoms is now dark and warm; the dark part as if someone had hit punched her; This is a spontaneous report received from a contactable reporter(s) (Nurse) from medical information team. The reporter is the patient.  A 74-year-old female patient received BNT162b2 (BNT162B2), on 05Apr2022 as dose number unknown (booster), single (Lot number: FM0698) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Primary Immunization series complete; unknown manufacturer, Caller on the line got the 2nd booster of the Pfizer COVID-19 Vaccine.), for Covid-19 immunization; Covid-19 vaccine (First Booster, Manufacturer unknown, Caller on the line got the 2nd booster of the Pfizer COVID-19 Vaccine.), for Covid-19 immunization. The following information was reported: SKIN DISCOLOURATION (non-serious), FEELING HOT (non-serious) all with onset 06Apr2022, outcome "unknown" and all described as "area that was red at the beginning of the symptoms is now dark and warm"; PRURITUS (non-serious) with onset 06Apr2022, outcome "unknown", described as "being very itchy"; BURNING SENSATION (non-serious) with onset 06Apr2022, outcome "unknown", described as "burning"; INFLAMMATION (non-serious) with onset 06Apr2022, outcome "unknown", described as "felt inflamed"; MALAISE (non-serious) with onset 06Apr2022, outcome "unknown", described as "icky"; SKIN EXFOLIATION (non-serious) with onset 06Apr2022, outcome "unknown", described as "peeling"; ERYTHEMA (non-serious) with onset 06Apr2022, outcome "unknown", described as "red area that got larger and larger"; FEELING ABNORMAL (non-serious) with onset 06Apr2022, outcome "unknown", described as "the dark part as if someone had hit punched her".  Additional information: Caller on the line got the 2nd booster of the Pfizer COVID-19 Vaccine on 05Apr2022 from lot number FM0698. On 06Apr2022 she had a red area that got larger and larger and felt inflamed. She stated it started peeling and being very itchy. Besides the peeling and itchy, caller also described as if it had been burning, icky. She said that she could tolerate the other symptoms but that it was really itchy. The area that was red at the beginning of the symptoms is now dark and warm. Caller later described the dark part as if someone had hit punched her. Caller's inquiry was if this side effects have been reported. Caller also stated she would consult with his physician whether or not to get her next dose if a 3rd dose is ever required.  No follow-up attempts are possible. No further information is expected.
Age: 36.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, Liver function test, Renal function test, Weight
Clinical narrative: COVID-19; COVID-19; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 37-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 19Nov2021 as dose 3 (booster), single (Lot number: FT1620) at the age of 36 years, in right arm for covid-19 immunisation; coviD-19 vaccine mrna (mrna 1273) (MODERNA COVID-19 VACCINE), on 05Mar2021 as dose 1, single (Batch/Lot number: unknown), in right arm and on 02Apr2021 as dose 2, single (Lot number: 003B21A), in right arm for covid-19 immunisation. The patient's relevant medical history included: "Moderate to severe persistent asthma (viral induced)" (unspecified if ongoing), notes: Moderate to severe persistent asthma, (viral induced); "post-viral gastroparesis" (unspecified if ongoing), notes: post-viral gastroparesis; "psoriasis" (unspecified if ongoing); "eczema" (unspecified if ongoing); "longhaul COVID from 2020 with neurological dysfunction", start date: 2020 (unspecified if ongoing), notes: longhaul COVID from 2020 with neurological dysfunction; "longhaul COVID from 2020 with neurological dysfunction", start date: 2020 (unspecified if ongoing), notes: longhaul COVID from 2020 with, neurological dysfunction; "concussion with double vision" (unspecified if ongoing), notes: concussion with double vision and neck/back injury; "concussion with double vision" (unspecified if ongoing), notes: concussion with double vision and neck/back injury; "neck/back injury" (unspecified if ongoing), notes: neck/back injury; "neck/back injury" (unspecified if ongoing), notes: neck/back injury; "Sulfa drugs" (unspecified if ongoing), notes: known allergies Sulfa drugs, latex; "latex" (unspecified if ongoing), notes: known allergies Sulfa drugs, latex. Concomitant medication(s) included: DULERA, start date: Nov2020; SPIRIVA RESPIMAT, start date: Mar2021; ZYRTEC [CETIRIZINE HYDROCHLORIDE]; AZELASTINE; DUONEB, start date: 05Apr2022; ALBUTEROL [SALBUTAMOL]; ALEVE, start date: 05Apr2022; MELOXICAM, start date: 08Feb2022; BENADRYL, start date: 06Apr2022; SUPER B COMPLEX WITH VITAMIN C, start date: 05Apr2022. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID-19". The patient underwent the following laboratory tests and procedures: Liver function test: in normal range, notes: before Paxlovid; Renal function test: in normal range, notes: before Paxlovid; Weight: 6 lbs, notes: loss (5%). Therapeutic measures were taken as a result of drug ineffective, covid-19.  No follow-up attempts are possible. No further information is expected.
Age: 69.0
Sex: M
Vaccine: COVID19
Symptoms: Feeling abnormal
Clinical narrative: Felt yucky; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team.  A 69-year-old male patient received BNT162b2 (COMIRNATY), on 28Feb2021 as dose 1, single (Lot number: EN6200) at the age of 69 years for covid-19 immunisation. The patient's relevant medical history included: "Parkinson's" (unspecified if ongoing), notes: He has Parkinson's. The patient's concomitant medications were not reported.  The following information was reported: FEELING ABNORMAL (non-serious) with onset 2021, outcome "unknown", described as "Felt yucky".
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: COVID-19; COVID-19; This is a spontaneous report received from contactable reporter(s) (Physician). The reporter is the patient.  A 38-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), as dose 3 (booster), single (Batch/Lot number: unknown), in right arm for covid-19 immunisation. The patient's relevant medical history included: "Depression" (unspecified if ongoing), notes: Depression/anxiety; "Anxiety" (unspecified if ongoing). Known allergies: No. Concomitant medication(s) included: ZOLOFT, start date: 15Jan2009; LAMICTAL, start date: 15Feb2021. Vaccination history included: Covid-19 vaccine (DOSE: 1, MANUFACTURER: UNKNOWN), for COVID-19 immunization; Covid-19 vaccine (DOSE: 2, MANUFACTURER: UNKNOWN), for COVID-19 immunization. The following information was reported: DRUG IN-EFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive, notes: anti viral details: product: COVID 19 Treatment brand: Paxlovid treatment start date: 06Apr2022 treatment stop date: 11Apr2022 indication: Treatment of COVID-19. Therapeutic measures were taken as a result of covid-19. It was reported that, extremely bitter and metallic taste in mouth. The intensity was almost unbelievable. It made it difficult to eat, sleep, or drink liquids. Nothing made it better. It only went away about 10 hours after patient had taken a dose. Also patient had akathisia after the evening dose. Patient felt like just had to get up and walk around. Patient limbs were just ready to go- could not lay still. Adverse event start date: 06Apr2022 at 08:00 PM.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.; Sender's Comments: Based on plausible dose -event relationship post vaccination and no other alternate explanation the causal role of BNT162B2 cannot be excluded for the reported LOE events
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Drug ineffective, SARS-CoV-2 test, Suspected COVID-19
Clinical narrative: COVID-19; COVID-19; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A female patient (not pregnant) received BNT162b2 (BNT162B2), on 01Feb2022 as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown). The patient's relevant medical history included: "Fibromyalgia" (unspecified if ongoing); "known allergies: Penicillin" (unspecified if ongoing); "known allergies: Sulfur" (unspecified if ongoing). Concomitant medication(s) included: CYMBALTA. The following information was reported: DRUG INEFFECTIVE (medically significant), SUSPECTED COVID-19 (medically significant), outcome "unknown" and all described as "COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive, notes: anti viral details: product: COVID 19 Treatment brand: Paxlovid Indication: Treatment of COVID-19. Therapeutic measures were taken as a result of suspected covid-19.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 64.0
Sex: M
Vaccine: COVID19
Symptoms: Drug ineffective, Suspected COVID-19
Clinical narrative: Covid-19; Covid-19; This was a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter was the patient.  A 64-year-old male patient received BNT162b2 (BNT162B2), on 02Mar2022 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 64 years, in left arm for covid-19 immunisation; coviD-19 vaccine mrna (mrna 1273) (MODERNA COVID-19 VACCINE), on 08Mar2021 as dose 1, single (Batch/Lot number: unknown), on 05Apr2021 as dose 2, single (Batch/Lot number: unknown) and on 22Aug2021 as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "CLL" (unspecified if ongoing); "Asthma" (unspecified if ongoing); "BPH" (unspecified if ongoing); "high cholesterol" (unspecified if ongoing). Concomitant medication(s) included: BACTRIM DS; LOVASTATIN, stop date: 09Apr2022; DULERA; LEVOTHYROXINE. The following information was reported: DRUG INEFFECTIVE (medically significant), SUSPECTED COVID-19 (medically significant), outcome "unknown" and all described as "Covid-19". Therapeutic measures were taken as a result of suspected covid-19.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Sex: F
Vaccine: COVID19
Symptoms: Chills, Myalgia, Vaccination site pain
Clinical narrative: injection site soreness; chills; muscle pain; This is a spontaneous report received from contactable reporter(s) (Pharmacist).  A female patient received BNT162b2 (BNT162B2), as dose 4 (booster), single (Lot number: FK9893) for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. Vaccination history included: Covid vaccine (DOSE 1, MANUFACTURER UNKNOWN), for Covid-19 immunization; Covid vaccine (DOSE 2, MANUFACTURER UNKNOWN), for Covid-19 immunization; Covid vaccine (DOSE 3 (BOOSTER), MANUFACTURER UNKNOWN), for Covid-19 immunization. The following information was reported: VACCINATION SITE PAIN (non-serious), outcome "unknown", described as "injection site soreness"; CHILLS (non-serious), outcome "unknown"; MYALGIA (non-serious), outcome "unknown", described as "muscle pain".  Additional information: Female experienced events following second booster dose of COVID-19 vaccine. Event took place after use of product.  No follow-up attempts are possible. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Drug ineffective, Suspected COVID-19
Clinical narrative: This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. A 60-year-old male patient received BNT162b2 (BNT162B2), on 04Mar2021 as dose 1, single (Lot number: EL9267), in right arm, on 23Mar2021 as dose 2, single (Lot number: EN6207), in right arm and on 11Dec2021 as dose 3 (booster), single (Lot number: FJ8757) for Covid-19 immunisation. The patient's relevant medical history included: "AFib" (unspecified if ongoing); "sleep apnea" (unspecified if ongoing). Concomitant medication(s) included: PREGABALIN, start date: 25Mar2022. The following information was reported: DRUG INEFFECTIVE (medically significant), outcome "unknown"; SUSPECTED COVID-19 (medically significant), outcome "unknown", described as "COVID-19". The other medication in 2weeks: Yes. Other medication in 2 weeks were Pregabalin, (other medication in 2weeks brand= Cipla, other medication in 2 weeks start date:25Mar2022). No follow-up attempts are possible. No further information is expected.
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Ankylosing spondylitis, Muscular weakness, Pain in jaw, Vaccination site pain
Clinical narrative: Ankylosing spondylitis flare up; Reaction with Vaccine causing sore arm; Jaw ache; leg weakness; This is a solicited report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. Other Case identifier(s): 22K-163-4362679-00 (Company).  A 63-year-old female patient received BNT162b2 (BNT162B2), on 21Jan2021 as dose 1, single (Batch/Lot number: unknown), on 20Feb2021 as dose 2, single (Batch/Lot number: unknown) and on 20Sep2021 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 63 years, all intramuscular for covid-19 immunisation; adalimumab (HUMIRA), (ongoing) (Batch/Lot number: unknown) at unk (citrate free), subcutaneous for ankylosing spondylitis. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: ANKYLOSING SPONDYLITIS (medically significant) with onset 2021, outcome "not recovered", described as "Ankylosing spondylitis flare up"; PAIN IN JAW (non-serious) with onset 2021, outcome "not recovered", described as "Jaw ache"; VACCINATION SITE PAIN (non-serious) with onset 2021, outcome "recovered" (2021), described as "Reaction with Vaccine causing sore arm"; MUSCULAR WEAKNESS (non-serious) with onset 2021, outcome "not recovered", described as "leg weakness". The action taken for adalimumab was dosage not changed. Clinical information :On unknown dates, the patient experienced ankylosing spondylitis flare up, jaw ache and leg weakness. In Jan2021, the patient experienced reaction with vaccine causing sore arm. In Sep2021, the patient experienced reaction with vaccine causing sore arm. In 2021, the reaction with vaccine causing sore arm resolved. Pfizer BioNtech COVID-19 vaccine (Tozinameran) was also considered suspect. It was unknown if patient was enrolled in a covid-19 vaccine trial.  The reporter's causality for the event(s) of reaction with vaccine causing sore arm with BNT162b2 was probable. The reporter's causality for the event(s) of ankylosing spondylitis flare up, jaw ache and leg weakness with Humira(adalimumab) was a not reported.  The reporter's causality for the event(s) of reaction with vaccine causing sore arm with Humira(adalimumab) was no reasonable possibility. The reporter's causality for the event(s) of ankylosing spondylitis flare up, jaw ache and leg weakness with Humira(adalimumab) was a reasonable possibility.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: As there is limited information in the case provided, the causal association between the event Ankylosing Spondylitis, Vaccination site pain, Pain in JAW AND Muscular Weakness  and the suspect drug cannot be excluded. The case will be reassessed once new information is available.
Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: Pneumonia, Vaccination site rash, Vaccination site ulcer
Clinical narrative: Pneumonia three times; Reaction to Pfizer shot/rash looked like shingles with sores from injection site up from arm to neck; Reaction to Pfizer shot/rash looked like shingles with sores from injection site up from arm to neck; This is a solicited report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. Other Case identifier(s): 22K-163-4360554-00 (Company).  A 72-year-old female patient received BNT162b2 (BNT162B2), on 07Jan2021 as dose 1, single (Batch/Lot number: unknown) at the age of 72 years intramuscular for covid-19 immunisation; adalimumab (HUMIRA), from 01Apr2013 (Batch/Lot number: unknown) to 2020, subcutaneous for ankylosing spondylitis. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: PNEUMONIA (medically significant), outcome "recovered", described as "Pneumonia three times"; VACCINATION SITE RASH (non-serious), VACCINATION SITE ULCER (non-serious), outcome "not recovered" and all described as "Reaction to Pfizer shot/rash looked like shingles with sores from injection site up from arm to neck". The action taken for adalimumab was dosage permanently withdrawn in 2020.  Clinical course:  The reporter's assessment of the causal relationship of Humira for the event Pneumonia recurrent  (Pneumonia) was reported as Reasonable possibility, Vaccination site rash was reported as no reasonable possibility and Vaccination site ulcer was not reported.  The reporter's assessment of the causal relationship of Pfizer BioNTech  COVID-19 vaccine (Tozinameran) for the event Pneumonia recurrent  was not reported, Vaccination site rash and Vaccination site ulcer was reported as possible.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Based on the information available, the causal relationship between the reported events and suspect drug BNT162B2 cannot be excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
Sex: U
Vaccine: COVID19
Symptoms: Suicidal ideation, Tinnitus
Clinical narrative: 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), as dose 4 (booster), single (Batch/Lot number: unknown) for Covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Dose 1, Manufacturer unknown), for Covid-19 immunization; Covid-19 vaccine (Dose 2, Manufacturer unknown), for Covid-19 immunization; Covid-19 vaccine (Dose 3, Manufacturer unknown), for Covid-19 immunization. The following information was reported: SUICIDAL IDEATION (medically significant) with onset 21Apr2021, outcome "unknown", described as "maybe I will kill myself."; TINNITUS (non-serious), outcome "unknown", described as "buzzing in my left ear". Additional information: When probed for consumer's name and telephone#, consumer stated, "You're breaking up, need to have a better connection". Concern, consumer stated, "I am here for the Booster shots, it is really hard to hear you with a bad connection I am talking too, I can't hear you can you transfer me to someone else. Yes I want to report the side effect from the second Booster shot". When probed to clarify the concern, consumer stated, "No, they shouldn't give that shot because tonight is, I don't know what I am going to do about the buzzing in my left ear (hence MI documented), maybe I will kill myself. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, Frustration tolerance decreased, Immunodeficiency, Pneumonia
Clinical narrative: Pneumonia; Weak immune system; feels frustrated; COVID-19; COVID-19; This is a solicited report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. Other Case identifier(s): 22K-163-4361347-00.  A 62-year-old female patient received BNT162b2 (BNT162B2), on 01Jun2021 as dose 1, single (Batch/Lot number: unknown) and on 01Sep2021 as dose 2, single (Batch/Lot number: unknown) at the age of 62 years, all intramuscular for covid-19 immunisation; adalimumab (HUMIRA), (Batch/Lot number: unknown) at citrate free, subcutaneous for rheumatoid arthritis. The patient's relevant medical history was not reported and concomitant medications were not reported. The following information was reported: COVID-19 (medically significant) with onset Dec2021, outcome "recovered" (Jan2022), DRUG INEFFECTIVE (medically significant) with onset Dec2021, outcome "unknown" and all described as "COVID-19"; PNEUMONIA (medically significant), outcome "recovering"; IMMUNODEFICIENCY (medically significant), outcome "recovering", described as "Weak immune system"; FRUSTRATION TOLERANCE DECREASED (non-serious), outcome "not recovered", described as "feels frustrated". The action taken for adalimumab was unknown.  The reporter's assessment of the causal relationship of "pneumonia", "weak immune system", "covid-19" and "feels frustrated" with the suspect product(s) BNT162b2 was not provided at the time of this report. Since no determination has been received, the case is managed based on the company causality assessment.  Causality for Humira (Adalimumab): The reporter's causality for the event(s) of fells frustrated with Humira (Adalimumab) was a reasonable possibility. The reporter's causality for Covid-19, Pneumonia and Weak immune system was not provided.  Causality for Pfizer BioNTech Covid-19 vaccine: The reporter's causality for the event covid-19 with Pfizer BioNTech Covid-19 vaccine was possible. The reporter's causality for Covid-19, Pneumonia, fells frustrated and Weak immune system was not provided.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.; Sender's Comments: Based on available information a contributory role of BNT162B2 to the reported events Covid-19 and 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: U
Vaccine: COVID19
Symptoms: Chronic graft versus host disease, Condition aggravated
Clinical narrative: Exacerbation of chronic graft versus host disease; Condition aggravated; This is a literature report.  A patient (no qualifiers provided) received BNT162b2 (COMIRNATY), as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "haematopoietic stem cell transplantation (HSCT)" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: CHRONIC GRAFT VERSUS HOST DISEASE (medically significant), outcome "unknown", described as "Exacerbation of chronic graft versus host disease"; CONDITION AGGRAVATED (medically significant), outcome "unknown".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: As there is limited information in the case provided, the causal association between the reported events with the suspect drug Comirnaty cannot be excluded. The case will be reassessed once new information is available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.,Linked Report(s) : US-PFIZER INC-202200613055 Same reporter/product/event, different patient;US-PFIZER INC-202200613056 Same reporter/product/event, different patient;US-PFIZER INC-202200613052 Same reporter/product/event, different patient;US-PFIZER INC-202200613051 Same reporter/product/event, different patient;US-PFIZER INC-202200613054 Same reporter/product/event, different patient;US-PFIZER INC-202200613050 Same reporter/product/event, different patient;US-PFIZER INC-202200613049 Same reporter/product/event, different patient;US-PFIZER INC-202200613053 Same reporter/product/event, different patient
Sex: F
Vaccine: COVID19, UNK
Symptoms: Drug ineffective, Rheumatoid arthritis, Suspected COVID-19
Clinical narrative: COVID-19; COVID-19; Rheumatoid arthritis flare up in hands; This is a solicited report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. Other Case identifier(s): 22K-163-4365181-00 (Agency).  A 66-year-old female patient received BNT162b2 (BNT162B2), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and as dose 3 (booster), single (Batch/Lot number: unknown), all intramuscular for covid-19 immunisation; upadacitinib (RINVOQ), (Lot number: 1154506), oral for rheumatoid arthritis. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), outcome "unknown", SUSPECTED COVID-19 (medically significant), outcome "recovering" and all described as "COVID-19"; RHEUMATOID ARTHRITIS (medically significant), outcome "recovered", described as "Rheumatoid arthritis flare up in hands". The action taken for upadacitinib was unknown. Clinical course: The patient stated she was having pains In her hands. It was unknown If patient was enrolled in a COVID-19 Vaccine Trial.  Causality for Rinvoq (Upadacitinib): The reporter's causality for the events of Covid-19 and Rheumatoid Arthritis Flare up in Hands with Rinvoq (Upadacitinib) was no reasonable possibility.  Causality for Pfizer-BioNTech Covid-19 Vaccine (Tozinameran): The reporter's causality for the events of Covid-19 and Rheumatoid Arthritis Flare up in Hands with was possible.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.; Sender's Comments: Based on the information available and temporal association, a possible contributory role of the suspect BNT162B2 cannot be excluded for the reported events . The case will be reassessed once new information is available   The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
Age: 21.0
Sex: F
Vaccine: COVID19
Symptoms: SARS-CoV-2 test, SARS-CoV-2 test positive, Vaccination failure
Clinical narrative: COVID-19 virus test positive; COVID-19 virus test positive; This is a solicited report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 22-year-old female patient received BNT162b2 (BNT162B2), on 17Apr2021 as dose 1, single (Batch/Lot number: unknown), on 05May2021 as dose 2, single (Batch/Lot number: unknown) and on 12Dec2021 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 21 years, all intramuscular for covid-19 immunization; adalimumab (HUMIRA), (Batch/Lot number: unknown), subcutaneous for colitis ulcerative. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: VACCINATION FAILURE (medically significant), SARS-COV-2 TEST POSITIVE (medically significant) all with onset Feb2022, outcome "unknown" and all described as "COVID-19 virus test positive". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (Feb2022) Positive. The action taken for adalimumab was unknown. It was unknown if patient was enrolled in a covid-19 vaccine trail.  Causality for BNT162b2: The reporter's assessment of the causal relationship of "covid-19 virus test positive" with the suspect product(s) BNT162b2 was not provided at the time of this report. Since no determination has been received, the case is managed based on the company causality assessment. Causality for adalimumab (HUMIRA): The reporter(s) causality for the event(s)of covid positive was not provided with adalimumab (HUMIRA) was a reasonable possibility.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.; Sender's Comments: Based on the information in the case report and a plausible temporal relationship, a possible causal association between the events and suspect drug BNT162B2 cannot be excluded.
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Urinary tract infection
Clinical narrative: every time eats lettuce, shows blood in stool; Pneumonia; reoccurring urinary tract infections; sick with allergies; bronchitis; sore arm; This is a solicited report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. Other Case identifier(s): 22K-163-4318495-00 (Agency).  A 65-year-old female patient received BNT162b2 (BNT162B2), on 06Mar2021 as dose 1, single (Batch/Lot number: unknown) at the age of 64 years and on 08Apr2021 as dose 2, single (Batch/Lot number: unknown), all intramuscular for covid-19 immunisation; adalimumab (HUMIRA), (Lot number: 1159438) at unk (citrate free), subcutaneous for colitis ulcerative, crohn's disease. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: PAIN IN EXTREMITY (non-serious) with onset 2021, outcome "recovered", described as "sore arm"; HAEMATOCHEZIA (medically significant), outcome "recovered", described as "every time eats lettuce, shows blood in stool"; PNEUMONIA (medically significant), outcome "recovering"; URINARY TRACT INFECTION (non-serious), outcome "unknown", described as "reoccurring urinary tract infections"; HYPERSENSITIVITY (non-serious), outcome "recovered with sequelae", described as "sick with allergies"; BRONCHITIS (non-serious), outcome "recovering". The action taken for adalimumab was unknown. Therapeutic measures were taken as a result of haematochezia, pneumonia, pain in extremity, urinary tract infection, hypersensitivity, bronchitis.  Causality for Humira (Adalimumab): The reporter's causality for the event(s) of every time eats lettuce, shows blood in stool, sore arm, reoccurring urinary tract infections and sick with allergies with Humira (Adalimumab) was no reasonable possibility. The reporter's causality for the event(s) of pneumonia and bronchitis was not provided.  Causality for Pfizer BioNTech COVID-19 vaccine (Tozinameran): The reporter's causality for the event(s) of every time eats lettuce, shows blood in stool, reoccurring urinary tract infections and sick with allergies, pneumonia and bronchitis was not provided. The reporter causality for the event "sore arm" was possible for Pfizer BioNTech COVID-19 vaccine (Tozinameran).  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Based on the information in the case report, a possible causal relationship between the reported events: "Blood in stool", "Pneumonia", "Pain in arm", "Recurrent urinary tract infection", "Allergy", "Bronchitis" and the suspect drug BNT162B2 cannot be completely excluded.  The impact of this report on the benefit/risk profile of the Pfizer drug 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: 56.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, Polymerase chain reaction, SARS-CoV-2 test
Clinical narrative: This is a spontaneous report received from a contactable reporter(s) (Other HCP). The reporter is the patient. A 56-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 08Nov2021 as dose 2 (booster), single (Lot number: 301458A) at the age of 56 years, in left arm for Covid-19 immunisation; Janssen Covid-19 vaccine (JANSSEN COVID-19 VACCINE), on 08Apr2021 as dose 1, single (Lot number: 42A21A), in right arm for Covid-19 immunisation. The patient's relevant medical history included: "borderline type II diabetes" (unspecified if ongoing); "genetic hyperlipidemia" (unspecified if ongoing). There were no concomitant medications. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 07Apr2022, outcome "unknown" and all described as "I was infected on 03Apr; tested positive by rapid test 07Apr". The patient underwent the following laboratory tests and procedures: Polymerase chain reaction: (Apr2022) Ct of 20.6; SARS-CoV-2 test: (07Apr2022) Positive. Therapeutic measures were taken as a result of Covid-19. Clinical course: The patient was not taking any other medications/products within 2 weeks of starting COVID-19 treatment. 1st dose of Paxlovid evening of 07Apr; last dose Paxlovid 11Apr. Clinical signs 05Apr-08Apr sore throat, fatigue, muscle aches, cough, no fever. Clinical signs improved 09Apr and by last day of treatment single, residual cough. Residual cough lingered thru/out week of 10Apr not other clinical signs. 18Apr saw return of ILI thought to be allergies. Symptoms progressed & at home test 18Apr confirmed COVID positive. Since patient was a virologist & program officer, contacted colleagues on 19Apr and arranged to have samples taken for analyses on 20Apr for Ab, T cell, virus titer, confirmation infection, & virus sequencing. PCR confirmatory test results has Ct of 20.6. The patient signs of disease include heavy, frequent, nonproductive coughing w/ some mucus; heavy rhinorrhea, headache. No fever with either infection event. CBC & clinical chem. normal. Taking OTC Dayquil during "relapse". No follow-up attempts are possible. No further information is expected. Sender's Comments: Based on the information provide and plausible temporal association, the causality between BNT162B2 and events cannot be completely excluded.
Age: 56.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Antibody test, Blood test, COVID-19, SARS-CoV-2 test, SARS-CoV-2 test positive
Clinical narrative: This is a spontaneous report received from a contactable reporter(s) (Other HCP). The reporter is the patient. A 56-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 08Nov2021 as dose 2 (booster), single (Lot number: 301458A) at the age of 56 years, in left arm for Covid-19 immunisation; Janssen Covid-19 vaccine (JANSSEN COVID-19 VACCINE), on 08Apr2021 as dose 1, single (Lot number: 42A21A), in right arm for Covid-19 immunisation. The patient's relevant medical history included: "borderline type II diabetes" (unspecified if ongoing); "genetic hyperlipidemia" (unspecified if ongoing). There were no concomitant medications. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 07Apr2022, outcome "unknown" and all described as "I was infected on 03Apr; tested positive by rapid test 07Apr". The patient underwent the following laboratory tests and procedures: Polymerase chain reaction: (Apr2022) Ct of 20.6; SARS-CoV-2 test: (07Apr2022) Positive. Therapeutic measures were taken as a result of Covid-19. Clinical course: The patient was not taking any other medications/products within 2 weeks of starting COVID-19 treatment. 1st dose of Paxlovid evening of 07Apr; last dose Paxlovid 11Apr. Clinical signs 05Apr-08Apr sore throat, fatigue, muscle aches, cough, no fever. Clinical signs improved 09Apr and by last day of treatment single, residual cough. Residual cough lingered thru/out week of 10Apr not other clinical signs. 18Apr saw return of ILI thought to be allergies. Symptoms progressed & at home test 18Apr confirmed COVID positive. Since patient was a virologist & program officer, contacted colleagues on 19Apr and arranged to have samples taken for analyses on 20Apr for Ab, T cell, virus titer, confirmation infection, & virus sequencing. PCR confirmatory test results has Ct of 20.6. The patient signs of disease include heavy, frequent, nonproductive coughing w/ some mucus; heavy rhinorrhea, headache. No fever with either infection event. CBC & clinical chem. normal. Taking OTC Dayquil during "relapse". No follow-up attempts are possible. No further information is expected. Sender's Comments: Based on the information provide and plausible temporal association, the causality between BNT162B2 and events cannot be completely excluded.
Age: 56.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Vaccination failure
Clinical narrative: This is a spontaneous report received from a contactable reporter(s) (Other HCP). The reporter is the patient. A 56-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 08Nov2021 as dose 2 (booster), single (Lot number: 301458A) at the age of 56 years, in left arm for Covid-19 immunisation; Janssen Covid-19 vaccine (JANSSEN COVID-19 VACCINE), on 08Apr2021 as dose 1, single (Lot number: 42A21A), in right arm for Covid-19 immunisation. The patient's relevant medical history included: "borderline type II diabetes" (unspecified if ongoing); "genetic hyperlipidemia" (unspecified if ongoing). There were no concomitant medications. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 07Apr2022, outcome "unknown" and all described as "I was infected on 03Apr; tested positive by rapid test 07Apr". The patient underwent the following laboratory tests and procedures: Polymerase chain reaction: (Apr2022) Ct of 20.6; SARS-CoV-2 test: (07Apr2022) Positive. Therapeutic measures were taken as a result of Covid-19. Clinical course: The patient was not taking any other medications/products within 2 weeks of starting COVID-19 treatment. 1st dose of Paxlovid evening of 07Apr; last dose Paxlovid 11Apr. Clinical signs 05Apr-08Apr sore throat, fatigue, muscle aches, cough, no fever. Clinical signs improved 09Apr and by last day of treatment single, residual cough. Residual cough lingered thru/out week of 10Apr not other clinical signs. 18Apr saw return of ILI thought to be allergies. Symptoms progressed & at home test 18Apr confirmed COVID positive. Since patient was a virologist & program officer, contacted colleagues on 19Apr and arranged to have samples taken for analyses on 20Apr for Ab, T cell, virus titer, confirmation infection, & virus sequencing. PCR confirmatory test results has Ct of 20.6. The patient signs of disease include heavy, frequent, nonproductive coughing w/ some mucus; heavy rhinorrhea, headache. No fever with either infection event. CBC & clinical chem. normal. Taking OTC Dayquil during "relapse". No follow-up attempts are possible. No further information is expected. Sender's Comments: Based on the information provide and plausible temporal association, the causality between BNT162B2 and events cannot be completely excluded.
Sex: F
Vaccine: COVID19, UNK
Symptoms: Ankylosing spondylitis, COVID-19, Drug ineffective, Hyperhidrosis, Pruritus
Clinical narrative: Spondylitis ankylosing aggravated; itchiness; Sweaty; COVID 19; COVID-19; This is a solicited report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. Other Case identifier(s): 22K-163-4362309-00 (Agency).  A 33-year-old female patient received BNT162b2 (BNT162B2), as dose number unknown (booster), single (Batch/Lot number: unknown) and as dose 1, single (Batch/Lot number: unknown), all intramuscular for covid-19 immunisation; adalimumab (HUMIRA), since Sep2020 (ongoing) (Batch/Lot number: unknown) at daily (unk , daily (citrate free)), subcutaneous for ankylosing spondylitis. The patient had no relevant medical history and no known allergies. There were no concomitant medications. The following information was reported: DRUG INEFFECTIVE (medically significant) with onset Dec2021, outcome "unknown", described as "COVID 19"; COVID-19 (medically significant) with onset Dec2021, outcome "unknown"; HYPERHIDROSIS (non-serious) with onset Apr2022, outcome "recovering", described as "Sweaty"; ANKYLOSING SPONDYLITIS (medically significant), outcome "unknown", described as "Spondylitis ankylosing aggravated"; PRURITUS (non-serious), outcome "unknown", described as "itchiness". The action taken for adalimumab was dosage not changed. It was unknown if patient was led in a COVID-19 Vaccine Trial. Primary reporter did not have the lot number information, because the packaging was discarded.  Causality for Humira (Adalimumab): The reporter's causality for the event(s) of sweaty attacks with Humira (Adalimumab). was a reasonable possibility. The reporter's causality for the event(s) of ankylosing spondylitis symptoms got worse, COVID and itchiness was not provided.  Causality for Pfizer BioNTech COVID-19 vaccine (Tozinameran): The reporter's causality for the event(s) of sweaty attacks, ankylosing spondylitis symptoms got worse, COVID and itchiness with Pfizer BioNTech COVID-19 vaccine (Tozinameran) was a possible.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.; Sender's Comments: Based on known drug safety profile, there is reasonable possibility of causal association between the events and BNT162B2. 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.