chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: COVID19
Symptoms: Orthopaedic examination, Physical examination, Rheumatoid factor, Vitamin B1, Vitamin B12
Clinical narrative: Acute Immune-mediated Demyelinating Polyneuropathy; This is a literature report for the following literature source(s).  A 36-year-old female patient received BNT162b2 (BNT162B2), as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "progressive bilateral paresthesia" (unspecified if ongoing). The patient's concomitant medications were not reported. Vaccination history included: Covid-19-vaccine (DOSE 1, MANUFACTURER UNKNOWN), for COVID-19 immunisation. The following information was reported: DEMYELINATING POLYNEUROPATHY (medically significant), 1 week after the suspect product(s) administration, outcome "recovering", described as "Acute Immune-mediated Demyelinating Polyneuropathy". The patient underwent the following laboratory tests and procedures: Antibody test: unremarkable; unremarkable; unremarkable; unremarkable; negative, notes: for serum and CSF; Antineutrophil cytoplasmic antibody: unremarkable; Antinuclear antibody: unremarkable; positive; Bacterial test: which included hepatitis, notes: serologies,Campylobacter jejuni serology, Lyme atb, CMV atb, EBV atb were all negative; Blood folate: Normal; Cytomegalovirus test: negative, notes: for serum and CSF; Double stranded DNA antibody: unremarkable; Electromyogram: showed evidence of acute diffuse sensorimotor, notes: neuropathy with mixed axonal and demyelinating features; Epstein-Barr virus antibody: negative, notes: For serum and CSF; Helicobacter test: negative, notes: in serum and CSF; Hepatitis viral test: negative, notes: in serum and CSF; clinical features: not suggestive of Sjogren's Syndrome.; unremarkable; which included hepatitis, notes: serologies,Campylobacter jejuni serology, Lyme atb, CMV atb, EBV atb were all negative; not suggestive of Sjogren's Syndrome.; Magnetic resonance imaging head: showed small scattered foci of increased FLAIR, notes: signal in the white matter, suggesting an underlying inflammatory process; Neurological examination: normal; Orthopaedic examination: normal; Physical exam: was notable for decreased distal sensation to, notes: touch and pain in all 4 limbs, otherwise, the rest of her neurological and musculoskeletal evaluation was normal; Rheumatoid factor: unremarkable; Vitamin B1: Normal; Vitamin B12: normal. Therapeutic measures were taken as a result of demyelinating polyneuropathy.; Sender's Comments: As there is limited information in the case provided, the causal association between the reported events DEMYELINATING POLYNEUROPATHY and the suspect drug cannot be excluded. The case will be reassessed once new information is available.
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: woke up today with soreness at the injection site; This is a spontaneous report received from a contactable reporter (Consumer or other non HCP).  A 51-year-old female patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 07Sep2022 as dose number unknown (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 (Primary Immunization series complete; unknown manufacturer), for Covid-19 Immunization. The following information was reported: VACCINATION SITE PAIN (non-serious) with onset 08Sep2022, outcome "unknown", described as "woke up today with soreness at the injection site".  The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5 has been requested and will be submitted if and when received.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202201147439 same reporter/drug /event, different patient;
Age: 44.0
Sex: F
Vaccine: COVID19
Symptoms: Blood glucose, HIV test, Hepatitis viral test, Lichen planus, Pruritus
Clinical narrative: I noticed some rash on my abdomen and arms; Itching; Lichen Planus autoimmune disease; This is a spontaneous report received from a contactable reporter(s) (Other HCP). The reporter is the patient.  A 44-year-old female patient (not pregnant) received  (BNT162B2), on 17Mar2021 at 15:00 as dose 1, single (Lot number: EP7534) at the age of 44 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "High blood pressure after Covid" (unspecified if ongoing), notes: Other medical history: High blood pressure after COVID; "COVID-19" (unspecified if ongoing), notes: Prior to vaccination, was the patient diagnosed with COVID-19: Yes. There were no concomitant medications.  The following information was reported: RASH (non-serious) with onset 18Mar2021 at 08:00, outcome "not recovered", described as "I noticed some rash on my abdomen and arms"; PRURITUS (non-serious) with onset 18Mar2021 at 08:00, outcome "not recovered", described as "Itching"; LICHEN PLANUS (non-serious) with onset 18Mar2021 at 08:00, outcome "not recovered", described as "Lichen Planus autoimmune disease". The events "i noticed some rash on my abdomen and arms", "itching" and "lichen planus autoimmune disease" required physician office visit. Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were taken as a result of rash, pruritus, lichen planus.  Additional information: On 18Mar2021 the patient noticed some rash on abdomen and arms. Thought it was mosquito bites and within 5 days it got worse. Went to physician for consult and then dermatologist and infectious disease doctor. The patient submitted to of blood work to file out diseases like syphilis, DM, hepatitis and HIV. All test results were back normal. Took doses and doses of cortisone to help with itching and recently got diagnosed with Lichen Planus autoimmune disease.  Doctor believe it is a reaction of Covid vaccine and now I have no hope. The patient was a healthy women and never had skin issues until she got vaccinated. Her body is all covered with scars and few treatments options including light therapy which is not cover by my insurance. The patient had all test results including biopsy and pictures. Treatment received for the adverse event included Cortisone pills and steroids cream. The patient had past drug history included unspecified drug Reaction: Allergy.
Age: 44.0
Sex: F
Vaccine: COVID19
Symptoms: Rash, Treponema test
Clinical narrative: I noticed some rash on my abdomen and arms; Itching; Lichen Planus autoimmune disease; This is a spontaneous report received from a contactable reporter(s) (Other HCP). The reporter is the patient.  A 44-year-old female patient (not pregnant) received  (BNT162B2), on 17Mar2021 at 15:00 as dose 1, single (Lot number: EP7534) at the age of 44 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "High blood pressure after Covid" (unspecified if ongoing), notes: Other medical history: High blood pressure after COVID; "COVID-19" (unspecified if ongoing), notes: Prior to vaccination, was the patient diagnosed with COVID-19: Yes. There were no concomitant medications.  The following information was reported: RASH (non-serious) with onset 18Mar2021 at 08:00, outcome "not recovered", described as "I noticed some rash on my abdomen and arms"; PRURITUS (non-serious) with onset 18Mar2021 at 08:00, outcome "not recovered", described as "Itching"; LICHEN PLANUS (non-serious) with onset 18Mar2021 at 08:00, outcome "not recovered", described as "Lichen Planus autoimmune disease". The events "i noticed some rash on my abdomen and arms", "itching" and "lichen planus autoimmune disease" required physician office visit. Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were taken as a result of rash, pruritus, lichen planus.  Additional information: On 18Mar2021 the patient noticed some rash on abdomen and arms. Thought it was mosquito bites and within 5 days it got worse. Went to physician for consult and then dermatologist and infectious disease doctor. The patient submitted to of blood work to file out diseases like syphilis, DM, hepatitis and HIV. All test results were back normal. Took doses and doses of cortisone to help with itching and recently got diagnosed with Lichen Planus autoimmune disease.  Doctor believe it is a reaction of Covid vaccine and now I have no hope. The patient was a healthy women and never had skin issues until she got vaccinated. Her body is all covered with scars and few treatments options including light therapy which is not cover by my insurance. The patient had all test results including biopsy and pictures. Treatment received for the adverse event included Cortisone pills and steroids cream. The patient had past drug history included unspecified drug Reaction: Allergy.
Sex: M
Vaccine: COVID19
Symptoms: Exercise tolerance decreased, Illness
Clinical narrative: my kid has been violently ill and cannot even exercise vigorously anymore after he got this shot; my kid has been violently ill and cannot even exercise vigorously anymore after he got this shot; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP), Program ID. The reporter is the parent.  A male patient received BNT162b2 (BNT162B2), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: ILLNESS (non-serious), EXERCISE TOLERANCE DECREASED (non-serious), outcome "unknown" and all described as "my kid has been violently ill and cannot even exercise vigorously anymore after he got this shot".  Additional information: The associated LRN and the product mentioned is Pfizer-BioNTech COVID-19 vaccine. Please let us know if there are any questions. Open-ended question: While you were rating the ad, we noticed that your interest changed during different portions. Please press PLAY below to view a portion where your interest. Then please take a moment to tell us in the box below why your interest. Open-ended question: Your classic typical fear mongering acting as if the virus will come and take your kids out unless you mask them to death and shoot them up with a bunch of vaccines and it falsely States the fact that it is less harmful than the actual covid itself. I can tell you for the fact that my kid has been violently ill and cannot even exercise vigorously anymore after he got this shot.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Drug ineffective, Suspected COVID-19
Clinical narrative: My thoughts were my daughter has gotten the Covid vaccine and ended up catching Covid the first day of school.; My thoughts were my daughter has gotten the Covid vaccine and ended up catching Covid the first day of school.; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP), Program ID. The reporter is the parent.  A female patient received BNT162b2 (BNT162B2), as dose number unknown, single (Batch/Lot number: unknown) 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 "My thoughts were my daughter has gotten the Covid vaccine and ended up catching Covid the first day of school.".  Clinical course: My thoughts were my daughter has gotten the Covid vaccine and ended up catching Covid the first day of school. So I'm kinda in the middle of the road about it.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: U
Vaccine: COVID19
Symptoms: Contusion, Musculoskeletal chest pain
Clinical narrative: Bruising and pain along rib cage; Bruising and pain along rib cage; 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 patient (no qualifiers provided) received BNT162b2 (BNT162B2), as dose number unknown, single (Batch/Lot number: unknown), in arm for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: CONTUSION (non-serious), MUSCULOSKELETAL CHEST PAIN (non-serious), outcome "unknown" and all described as "Bruising and pain along rib cage". Clinical course: the patient experienced bruising and pain along rib cage on same side of body as the arm where vaccine was received.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Sex: M
Vaccine: COVID19
Symptoms: Psoriatic arthropathy
Clinical narrative: Psoriatic arthritis flare up; This is a solicited report received from contactable reporter(s) (Consumer or other non HCP). Other Case identifier(s): 22K-163-4532174-00.  A 58-year-old male patient received BNT162b2 (BNT162B2), as dose number unknown (booster), single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and as dose 1, single (Batch/Lot number: unknown), all intramuscular for covid-19 immunisation; adalimumab (HUMIRA), (Batch/Lot number: unknown), subcutaneous for psoriatic arthropathy. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: PSORIATIC ARTHROPATHY (medically significant), outcome "recovered", described as "Psoriatic arthritis flare up". The action taken for adalimumab was unknown.  The reporter's assessment of the causal relationship of "psoriatic arthritis flare up" 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.  Additional information: On an unknown date, the patient experienced Psoriatic arthritis flare up. On an unknown date, Psoriatic arthritis flare up resolved. Pfizer Biontech Covid-19 vaccine (Tozinameran) was also considered suspect.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Based on available information and temporal association  the causal role of suspect BNT162B2 cannot be excluded for reported events. Case will be reviewed on receipt of FU information.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: Chills, Dehydration, Dry mouth
Clinical narrative: Chills; dehydration; dryness; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: CHILLS (non-serious), outcome "unknown"; DEHYDRATION (non-serious), outcome "unknown"; DRY MOUTH (non-serious), outcome "unknown", described as "dryness".  The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5 has been requested and will be submitted if and when received.
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Optic nerve injury
Clinical narrative: Optical nerve damage; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. Other Case identifier(s): LRN4552099.  A 68-year-old female patient received BNT162b2 (BNT162B2), on 20Jan2021 as dose 1, single (Batch/Lot number: unknown) at the age of 67 years and on 08Feb2021 as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Other giant cell arteritis" (ongoing), notes: Other giant cell arteritis; "Anxiety" (ongoing); "Depression" (ongoing). Concomitant medication(s) included: XANAX; MIRTAZAPINE; PREDNISONE. The following information was reported: OPTIC NERVE INJURY (medically significant), outcome "unknown", described as "Optical nerve damage".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: U
Vaccine: COVID19
Symptoms: Sudden hearing loss
Clinical narrative: sudden hearing loss from your COVID-19 vaccine; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP), Program ID. The reporter is the patient.  A patient (no qualifiers provided) received BNT162b2 (BNT162B2), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: SUDDEN HEARING LOSS (medically significant), outcome "unknown", described as "sudden hearing loss from your COVID-19 vaccine".  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Sex: U
Vaccine: COVID19-2
Symptoms: Headache, Vaccination site pain
Clinical narrative: Arm soreness at injection site; headache; 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 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), as dose number unknown (booster), single (Batch/Lot number: unknown) for covid-19 immunisation; influenza vaccine (FLU VACCINE VII), as dose number unknown, single (Batch/Lot number: unknown) for immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Primary Immunization series complete but unknown manufacturer.), for COVID-19 immunization. The following information was reported: VACCINATION SITE PAIN (non-serious), outcome "unknown", described as "Arm soreness at injection site"; HEADACHE (non-serious), outcome "unknown". Additional information: Arm soreness at injection site, headache after receiving Pfizer BioNTech bivalent original and omicron ba.4/ba.5 vaccine and flu shot. Events took place after use of product.  The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5 has been requested and will be submitted if and when received.
Age: 44.0
Sex: M
Vaccine: COVID19-2
Symptoms: Cold sweat, Disturbance in attention, Fatigue, Headache, Pain
Clinical narrative: Following the new bivalent Covid vaccine booster shot. Taken at same time as seasonal flu shot.; Headache; fatigue; achiness; trouble concentrating; claminess; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 44-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), as dose number unknown (booster), single (Batch/Lot number: unknown) at the age of 44 years for covid-19 immunisation; influenza vaccine (FLU VACCINE VII), as dose number unknown, single (Batch/Lot number: unknown) for immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) included: LORATADINE; FINASTERIDE; VITAMIN D3. Vaccination history included: Covid-19 vaccine (Primary Immunization series complete;  unknown manufacturer), for Covid-19 immunization. The following information was reported: PRODUCT USE ISSUE (non-serious), outcome "unknown", described as "Following the new bivalent Covid vaccine booster shot. Taken at same time as seasonal flu shot."; HEADACHE (non-serious), outcome "unknown"; FATIGUE (non-serious), outcome "unknown"; PAIN (non-serious), outcome "unknown", described as "achiness"; DISTURBANCE IN ATTENTION (non-serious), outcome "unknown", described as "trouble concentrating"; COLD SWEAT (non-serious), outcome "unknown", described as "claminess".  Additional  Information: Loratadine 10mg, finasteride 1mg, one a day multivitamin, D3 25mcg.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 44.0
Sex: M
Vaccine: COVID19-2
Symptoms: Product use issue
Clinical narrative: Following the new bivalent Covid vaccine booster shot. Taken at same time as seasonal flu shot.; Headache; fatigue; achiness; trouble concentrating; claminess; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 44-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), as dose number unknown (booster), single (Batch/Lot number: unknown) at the age of 44 years for covid-19 immunisation; influenza vaccine (FLU VACCINE VII), as dose number unknown, single (Batch/Lot number: unknown) for immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) included: LORATADINE; FINASTERIDE; VITAMIN D3. Vaccination history included: Covid-19 vaccine (Primary Immunization series complete;  unknown manufacturer), for Covid-19 immunization. The following information was reported: PRODUCT USE ISSUE (non-serious), outcome "unknown", described as "Following the new bivalent Covid vaccine booster shot. Taken at same time as seasonal flu shot."; HEADACHE (non-serious), outcome "unknown"; FATIGUE (non-serious), outcome "unknown"; PAIN (non-serious), outcome "unknown", described as "achiness"; DISTURBANCE IN ATTENTION (non-serious), outcome "unknown", described as "trouble concentrating"; COLD SWEAT (non-serious), outcome "unknown", described as "claminess".  Additional  Information: Loratadine 10mg, finasteride 1mg, one a day multivitamin, D3 25mcg.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Nail disorder, Skin discolouration
Clinical narrative: nail changes; dyschromia; This is a spontaneous report received from contactable reporter(s) (Physician) from a sales representative.  A 65-year-old female patient received BNT162b2 (BNT162B2), as dose number unknown, single (Batch/Lot number: unknown) for COVID-19 immunisation. The patient's relevant medical history included: "Rheumatoid arthritis" (unspecified if ongoing). Concomitant medication(s) included: METHOTREXATE taken for rheumatoid arthritis; HYDROXYCHLOROQUINE taken for rheumatoid arthritis. The following information was reported: NAIL DISORDER (non-serious), 3 weeks after the suspect product(s) administration, outcome "unknown", described as "nail changes"; SKIN DISCOLOURATION (non-serious), 3 weeks after the suspect product(s) administration, outcome "unknown", described as "dyschromia".  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: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: get covid; get covid; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP), Program ID. The reporter is the patient.  A 63-year-old female patient received BNT162b2 (BNT162B2), as dose 1, single (Batch/Lot number: unknown) and as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation; elasomeran (MODERNA COVID-19 VACCINE), as dose 3 (booster), single (Batch/Lot number: unknown) 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 "get covid". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive, notes: have been fully vaccinated but did get covid.  Clinical course: Supplier/Reporter Information Accompanying a Product Safety Report. Branded Concepts. She thought of her family son and grandkids how she want to enjoy time with them too. She have been fully vaccinated but did get covid but it could have been much worse. The respondent indicated that her initial series was Pfizer, and that she has received a Moderna booster.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Illness
Clinical narrative: receiving the two-shot application of vaccine and both times. She took extremely ill; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non-HCP), Program ID.  A female patient received BNT162b2 (COMIRNATY), as dose 1, single (Batch/Lot number: unknown) and as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported.  The following information was reported: ILLNESS (hospitalization) with onset 08Sep2022, outcome "unknown", described as "receiving the two-shot application of vaccine and both times. She took extremely ill".  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Sex: M
Vaccine: COVID19
Symptoms: Drug ineffective, SARS-CoV-2 test, Suspected COVID-19
Clinical narrative: had infection in July presumably due to the Delta variant; had infection in July presumably due to the Delta variant; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 40-year-old male patient received BNT162b2 (COMIRNATY), in Mar2021 as dose 1, single (Batch/Lot number: unknown) and in Mar2021 as dose 2, single (Batch/Lot number: unknown) 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) all with onset Jul2021, outcome "recovering" and all described as "had infection in July presumably due to the Delta variant". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (Jul2021) Unknown results, notes: He had infection in July presumably due to the Delta variant. Therapeutic measures were taken as a result of drug ineffective, suspected covid-19. Clinical course: A 40 y/o music teacher who received 2 does of Comirnaty in Mar2021 with no appreciable adverse events. He had infection in July presumably due to the Delta variant and had sore throat, cough, headache, brain fog all resolving except for a chronic cough that responded to steroids after about a month. The pt received a booster dose in Feb2022.   The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Sex: U
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: Pain at injection site; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP), Program ID. The reporter is the patient.  A patient (no qualifiers provided) received BNT162b2 (COMIRNATY), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown), as dose 3 (booster), single (Batch/Lot number: unknown) and 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. The following information was reported: VACCINATION SITE PAIN (non-serious), outcome "unknown", described as "Pain at injection site". Additional information: Patient preferred pfizer because all 4 of patient's shots were pfizer and had no reaction other than soreness at injection site.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: U
Vaccine: COVID19
Symptoms: Arthralgia, Bone pain, Pain in extremity
Clinical narrative: pain in my shoulder & it goes down my arm; pain in my bone; pain in my shoulder & it goes down my arm; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. Other Case identifier(s): MOD22-022934.  A patient (no qualifiers provided) received BNT162b2 (BNT162B2), in Sep2021 as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history was not reported. There were no concomitant medications. The following information was reported: BONE PAIN (non-serious) with onset 09Sep2022, outcome "not recovered", described as "pain in my bone"; PAIN IN EXTREMITY (non-serious), ARTHRALGIA (non-serious) all with onset 09Sep2022, outcome "not recovered" and all described as "pain in my shoulder & it goes down my arm".  Additional information; It was reported that, the patient started having pain in the shoulder and it went down the patient's arm. It was like pain in the patient's bone. The patient was afraid it might go into the back. There was no product complaint associated with this case.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202201156816 Same reporter/patient/events, different dose;
Sex: F
Vaccine: COVID19, FLUX
Symptoms: Fatigue, Headache, Pain
Clinical narrative: fatigue; headache; body aches; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from a sales representative. The reporter is the patient.  A 48-year-old female patient received BNT162b2 (BNT162B2), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation; influenza vaccine (FLU VACCINE VII), (Batch/Lot number: unknown). The patient's relevant medical history and concomitant medications were not reported. The following information was reported: FATIGUE (non-serious), outcome "unknown"; HEADACHE (non-serious), outcome "unknown"; PAIN (non-serious), outcome "unknown", described as "body aches".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: U
Vaccine: COVID19, COVID19
Symptoms: Seizure
Clinical narrative: I began having seizures 2 weeks after my 1st shot; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP), Program ID. The reporter is the patient.  A patient (no qualifiers provided) received BNT162b2 (BNT162B2), in Feb2021 as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: SEIZURE (medically significant) with onset 2021, outcome "unknown", described as "I began having seizures 2 weeks after my 1st shot".  Clinical information: Patient reported thank You (sarcasm intended) for ruining patient's life forever. After receiving 1 Covid shot in Feb2021 Patient began having seizures 2 weeks after 1st shot. Patient never had a seizure before in life nor anyone in patient's family! Patient know the company don't care, but patient do because patient's life will never be the same and had not been the same since 14Mar2021 Patient will never receive any compensation for the damage caused as well as others. Thanks for the he will you have put through.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: Covid-19; Covid-19; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 55-year-old female patient received BNT162b2 (BNT162B2), on 03May2021 as dose 1, single (Batch/Lot number: unknown) and on 24May2021 as dose 2, single (Batch/Lot number: unknown) at the age of 54 years, all intramuscular for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset Jan2022, outcome "unknown" and all described as "Covid-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (Jan2022) Positive.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Sex: F
Vaccine: COVID19, 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) (Consumer or other non HCP) from product quality group. Other Case identifier(s): 2022NVX-US-000003241 (Novavax).  A female patient received BNT162b2 (BNT162B2), on 02May2022 as dose 4 (booster), single (Lot number: FM9992) for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), 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) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "Covid-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive.  PQC results: This is a notification generated from the system. As part of the LOE simplification process, the following Complaint Records were classified as Product Use Attributes // Lack of Effect and have been moved to Closed (No Investigation) state referencing a previously completed investigation for the same product and lot as per the 'One and Done' business process according to in PQS Q1215 and/or Q1252. Refer to the below table for details. For this lot Adverse Event Safety Request For Investigation and/or Lack Of Effect was previously investigated. All analytical results were checked and were within registered limits. The investigation of the referenced PR ID resulted in the following conclusion: Reference PR ID 7142695 (see File attachment in this investigation record) The complaint for "PFIZER-BIONTECH COVID-19 VACCINE" was investigated. The investigation included reviewing the involved batch records, deviation investigation, an analysis of the complaint history for the reported lot and product type. The final scope was determined to be the associated lot(s) of the reported lot FM9992. A complaint sample was not returned. No related quality issues were identified during the investigation. There is no impact on product quality, regulatory, validation and stability. The company concludes that the reported defect is not representative of the quality of the batch and the batch remains acceptable. The process determined that no regulatory notification was required. The reported defect could not be confirmed. No root cause or ADR were identified as the complaint was not confirmed. PR ID of Previously Completed Inv: 7142808, PR Link (Previously Investigated CR): 7142605.
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Osteoarthritis, Rheumatoid arthritis
Clinical narrative: got vaccinated for covid and rheumatoid arthritis came back hundred percent; pain on hips; bone on bone; 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-163-4533445-00 (Company).  A 41-year-old female patient received BNT162b2 (BNT162B2), as dose number unknown, single (Batch/Lot number: unknown) intramuscular for covid-19 immunisation; adalimumab (HUMIRA), (Batch/Lot number: unknown), subcutaneous for rheumatoid arthritis. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: RHEUMATOID ARTHRITIS (medically significant), outcome "unknown", described as "got vaccinated for covid and rheumatoid arthritis came back hundred percent"; ARTHRALGIA (non-serious), outcome "not recovered", described as "pain on hips"; OSTEOARTHRITIS (non-serious), outcome "unknown", described as "bone on bone". The action taken for adalimumab was unknown. Clinical course: Consumer of an adult female with events of non-serious bone on bone, got vaccinated for Covid and rheumatoid arthritis came back hundred percent and pain on hips with Humira (Adalimumab). There was no reported medical history. Pfizer Biontech covid-19 vaccine (Tozinameran) was also considered suspect. It was unknown if patient was enrolled in a covid-19 vaccine trial.  Causality for HUMIRA(ADALIMUMAB): The reporter's causality for the event(s) of bone on bone, got vaccinated for Covid and Rheumatoid arthritis came back hundred percent and pain on hips was not reported.  The reporter's assessment of the causal relationship of "got vaccinated for covid and rheumatoid arthritis came back hundred percent", "pain on hips" and "bone on bone" 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.  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: "Rheumatoid arthritis", "Arthralgia", "Osteoarthritis" and the suspect drug BNT162B2 cannot be completely 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: F
Vaccine: COVID19-2
Symptoms: Injected limb mobility decreased, Vaccination site erythema, Vaccination site pain
Clinical narrative: is experiencing significant pain limiting arm movement and redness at the site of injection; is experiencing significant pain limiting arm movement and redness at the site of injection; is experiencing significant pain limiting arm movement and redness at the site of injection; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the parent.  An 18-year-old female patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 10Sep2022 as dose 4 (booster), single (Batch/Lot number: unknown), in arm for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (DOSE 1, SINGLE), for COVID-19 Immunization; Bnt162b2 (DOSE 2, SINGLE), for COVID-19 Immunization; Bnt162b2 (DOSE 3, (BOOSTER) SINGLE), for COVID-19 Immunization.  The following information was reported: VACCINATION SITE PAIN (non-serious), INJECTED LIMB MOBILITY DECREASED (non-serious), VACCINATION SITE ERYTHEMA (non-serious) all with onset Sep2022, outcome "unknown" and all described as "is experiencing significant pain limiting arm movement and redness at the site of injection". Therapeutic measures were taken as a result of vaccination site pain, injected limb mobility decreased, vaccination site erythema.  The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5 has been requested and will be submitted if and when received.
Sex: U
Vaccine: COVID19
Symptoms: Bundle branch block right
Clinical narrative: I had/have a heart right bundle branch block. My EKG claimed from 420 to almost 500 and anything over 500 I can die of sudden death; I had/have a heart right bundle branch block. My EKG climed from 420 to almost 500 and anything over 500 I can die of sudden death; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. Other Case identifier(s): 02239709.  A patient (no qualifiers provided) received BNT162b2 (BNT162B2), in 2021 as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: ELECTROCARDIOGRAM ABNORMAL (medically significant), BUNDLE BRANCH BLOCK RIGHT (medically significant) all with onset 2021, outcome "unknown" and all described as "I had/have a heart right bundle branch block. My EKG claimed from 420 to almost 500 and anything over 500 I can die of sudden death". The patient underwent the following laboratory tests and procedures: Electrocardiogram: (2021) 420 to almost 500 and anything over 500, notes: My EKG claimed from 420 to almost 500 and anything over 500 I can die of sudden death.  Clinical course: The 2021 Pfizer COVID 19 shot destroyed my heart. I'm basically a dead man walking. I a heart right bundle branch block. My EKG claimed from 420 to almost 500 and anything over 500 1 can die of sudden death. No additional information provided.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 59.0
Sex: M
Vaccine: COVID19
Symptoms: Abdominal adhesions, Small intestinal obstruction
Clinical narrative: Small bowel blockage due to scar tissue; Small bowel blockage due to scar tissue; 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-163-4534693-00 (Company).  A 60-year-old male patient received BNT162b2 (BNT162B2), on 01Oct2021 as dose 1, single (Batch/Lot number: unknown) and on 01Nov2021 as dose 2, single (Batch/Lot number: unknown) at the age of 59 years, all intramuscular for covid-19 immunisation; adalimumab (HUMIRA), (Batch/Lot number: unknown) at unk (citrate free), subcutaneous for crohn's disease. The patient's relevant medical history included: "Moderate to severe adult Crohn's Disease" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: SMALL INTESTINAL OBSTRUCTION (medically significant), ABDOMINAL ADHESIONS (medically significant), outcome "unknown" and all described as "Small bowel blockage due to scar tissue". The action taken for adalimumab was unknown. Clinical course: The patient had small bowel blockage due to scar tissue. It was unknown if patient was enrolled in a COVID-19 Vaccine Trial.    The reporter considered "small bowel blockage due to scar tissue" related to BNT162b2. The reporter's causality for the event(s) of small bowel blockage due to scar tissue (intestinal adhesions and small bowel obstruction) unknown onset was possible to BNT162b2.   Causality for HUMIRA(Adalimumab): The reporter's causality for the event(s) of small bowel blockage due to scar tissue (intestinal adhesions and small bowel obstruction) unknown onset was not provided. Company's opinion is that there is no reasonable possibility that the events of small bowel blockage due to scar tissue (intestinal adhesions and small bowel obstruction) unknown onset are related to HUMIRA (Adalimumab).  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 known safety profile of the vaccine BNT162b2, a causal relation between the reported event "small bowel blockage due to scar tissue" and the administration of the vaccine is unlikely
Sex: M
Vaccine: COVID19
Symptoms: Skin disorder
Clinical narrative: has a bad skin reaction; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP) from product quality group, Program ID:   A male 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) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: SKIN DISORDER (non-serious), outcome "unknown", described as "has a bad skin reaction".  Additional information: Caller's concern: A caller said she would like to talk with someone about the COVID-19 vaccine because her husband had a reaction to the vaccine. He has a bad skin reaction. She said he completed the 3 doses. While trying to transfer the caller disconnected from the call. This is a notification generated from the  system. New/updated information pertaining to an AE was reported.  You are receiving this notification because you have been identified as a Recipient for this record. A brief summary of this CITI / Complaint Contact is listed:  Pfizer Receipt Date (PRD): 13Sep2022. Responsible Person: (name withheld) (id withheld) . Triage Location / Country: AE Reference Number: Status: Processing Complaint Creation. Please use the following link to log into the system and view the full details of this CITI / Complaint Contact:  Reporter Information: Is Reporter Anonymous is No. Product Description: COMPOUND BNT162 COVID-19 VACCINE SUSPENSION FOR INTRAMUSCULAR 2ML MULTIPLE DOSE VIAL X 1   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Chronic fatigue syndrome, Immune system disorder, Malaise
Clinical narrative: Chronic fatigue syndrome; Their immune system overreacted; Felt sick; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. Other Case identifier(s): 2022NVX-US-000003221 (Novavax).  A female patient received BNT162b2 (BNT162B2), in Jan2021 as dose 1, single (Batch/Lot number: unknown) and in Feb2021 as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: CHRONIC FATIGUE SYNDROME (non-serious), outcome "recovered"; IMMUNE SYSTEM DISORDER (non-serious), outcome "recovered", described as "Their immune system overreacted"; MALAISE (non-serious), outcome "recovered", described as "Felt sick".  Additional information: The patient got what doctors called Chronic fatigue syndrome. It was reported that immune system overreacted, and the patient felt sick. All that went on for 2 months. The lot number was reported as EL1283.   The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Sex: M
Vaccine: COVID19
Symptoms: Injury
Clinical narrative: Injury/Traumatize; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A male patient received BNT162b2 (BNT162B2), on 04Dec2021 as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: INJURY (non-serious) with onset 04Dec2021, outcome "unknown", described as "Injury/Traumatize".  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.