chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: COVID19
Symptoms: Drug ineffective, SARS-CoV-2 test, Suspected COVID-19
Clinical narrative: Drug ineffective; 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-163-4536227-00.  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; adalimumab (HUMIRA), at (citrate free), subcutaneous for rheumatoid arthritis. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: SUSPECTED COVID-19 (medically significant) with onset 30Aug2022, outcome "unknown", described as "COVID-19"; DRUG INEFFECTIVE (medically significant) with onset 30Aug2022, outcome "unknown". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Unknown Results. The action taken for adalimumab was unknown.  Clinical course: 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) COVID-19 was not provided. Causality for BNT162b2: The reporter considered "drug ineffective" and "covid-19" related to BNT162b2.   The lot number for [BNT162b2], was not provided and will be requested during follow up.; Sender's Comments: Drug ineffective depends on many factors including pharmacokinetics, severity of disease and patient general health condition. However on conservative basis, the possible causality cannot be excluded.
Age: 51.0
Sex: F
Vaccine: COVID19, UNK
Symptoms: COVID-19, Plantar fasciitis, Vaccination failure
Clinical narrative: COVID-19; COVID-19; Plantar fasciitis; 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-163-4535813-00ff.  A 52-year-old female patient received BNT162b2 (BNT162B2), on 12Mar2021 as dose 1, single (Batch/Lot number: unknown) and on 12Apr2021 as dose 2, single (Batch/Lot number: unknown) at the age of 51 years, all intramuscular for covid-19 immunisation; adalimumab (HUMIRA), (ongoing) (Batch/Lot number: unknown) at citrate free, subcutaneous for rheumatoid arthritis, ankylosing spondylitis. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: PLANTAR FASCIITIS (non-serious) with onset 2022, outcome "recovering"; VACCINATION FAILURE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID-19". The action taken for adalimumab was dosage not changed.  Clinical course: Duration was 4 weeks. On an unknown date, the patient experienced covid virus. In 2022, the patient experienced plantar fasciitis. Pfizer biontech covid-19 vaccine (tozinameran) Was also considered suspect. It was unknown if patient was enrolled in a covid-19 vaccine trial. Action(s) taken with BNT162b2 was Unknown.  The reporter's assessment of the causal relationship of "covid-19" with the suspect product(s) BNT162b2 was probable and "plantar fasciitis" 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.  The reporter's assessment of the causal relationship of "covid-19" and "plantar fasciitis" with the suspect product(s) HUMIRA (adalimumab) was not provided at the time of this report.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.; Sender's Comments: As there is limited information in the case provided, the causal association between the Reported events Vaccination failure, Covid-19 and Plantar fasciitis cannot be excluded for the suspect drug. The case will be reassessed once new information is available.
Sex: M
Vaccine: PNC20
Symptoms: Vaccination site erythema, Vaccination site pain, Vaccination site swelling
Clinical narrative: Excessive pain, redness and swelling at injection site; Excessive pain, redness and swelling at injection site; Excessive pain, redness and swelling at injection site; This is a spontaneous report received from contactable reporter(s) (Nurse) from a Pfizer sales representative.  A male patient (age reported as 50+, unit not reported) received pneumococcal 20-val conj vac (dipht CRM197 protein) (PREVNAR 20), as dose number unknown, single (Batch/Lot number: unknown). The patient's relevant medical history and concomitant medications were not reported. The following information was reported: VACCINATION SITE PAIN (non-serious), VACCINATION SITE ERYTHEMA (non-serious), VACCINATION SITE SWELLING (non-serious), outcome "unknown" and all described as "Excessive pain, redness and swelling at injection site".  Follow-up attempts are completed. No further information is expected.
Age: 77.0
Sex: F
Vaccine: COVID19
Symptoms: Alpha 1 globulin, Beta 2 globulin, Blood test, C-reactive protein, Immunoglobulins
Clinical narrative: Kidney issue; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP), Program ID. The reporter is the patient.  A 79-year-old female patient received BNT162b2 (BNT162B2), on 11Feb2021 as dose 1, single (Batch/Lot number: unknown) at the age of 77 years for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: RENAL DISORDER (non-serious), outcome "unknown", described as "Kidney issue". Relevant laboratory tests and procedures are available in the appropriate section.  Additional information: Patient originally contacted Pfizer due to a kidney issue following patient second booster & starting with patient 1st COVID-19 Vaccine shot. Patient provided all that information to you. The latest results of testing from May to Sep show information.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 77.0
Sex: F
Vaccine: COVID19
Symptoms: Renal disorder, Urine analysis
Clinical narrative: Kidney issue; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP), Program ID. The reporter is the patient.  A 79-year-old female patient received BNT162b2 (BNT162B2), on 11Feb2021 as dose 1, single (Batch/Lot number: unknown) at the age of 77 years for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: RENAL DISORDER (non-serious), outcome "unknown", described as "Kidney issue". Relevant laboratory tests and procedures are available in the appropriate section.  Additional information: Patient originally contacted Pfizer due to a kidney issue following patient second booster & starting with patient 1st COVID-19 Vaccine shot. Patient provided all that information to you. The latest results of testing from May to Sep show information.  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: Diarrhoea
Clinical narrative: Diarrhea; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 50-year-old female patient 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. The patient had no relevant medical history. The patient's concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Primary immunization series complete, MANUFACTURER UNKNOWN), for COVID-19 immunization; Covid-19 vaccine (1st booster dose, Unknown manufacturer), for COVID-19 immunization. The following information was reported: DIARRHOEA (non-serious), outcome "recovered", described as "Diarrhea".  Additional Information: It was reported that her second booster dose, AE occurred 3 days after the vaccination. No underlying conditions. AE was mild to moderate, it lasted for 1 day. Event 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.
Sex: U
Vaccine: COVID19
Symptoms: Stem cell transplant
Clinical narrative: Stem cell transplant; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. Other Case identifier(s): (MODERNA), (MODERNA).  A patient (no qualifiers provided) received BNT162b2 (BNT162B2), as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation; elasomeran (MODERNA COVID-19 VACCINE), on 23Feb2022 as dose 4 (booster), single (Lot number: 045J21A) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose: 1), for COVID-19 Immunization; Bnt162b2 (Dose: 2), for COVID-19 Immunization. The following information was reported: STEM CELL TRANSPLANT (non-serious) with onset 17Jun2022, outcome "unknown".  Additional information: Call received from patient who completed primary series and 1 booster dose with Pfizer. had second booster on 23Feb2022, as was Immunocompromised and was diagnosed with Multiple Myeloma Sep2021. However, had to have a stem cell transplant on 17Jun2022, and doctor said had to have 3 months. doctor states that will need to restart COVID vaccinations, so can the Bivalent vaccines be used as primary series, since they provide better protection.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Conjunctivitis
Clinical narrative: after 1st vaccine had adverse event of pink eye; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A 52-year-old female patient received BNT162b2 (BNT162B2), as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Cancer" (ongoing); "Bone Health" (ongoing); "Antidepressant" (ongoing). Concomitant medication(s) included: ARIMIDEX oral taken for neoplasm malignant, start date: 2018 (ongoing); CALTRATE PLUS D oral taken for bone disorder, start date: 2020 (ongoing); LEXAPRO oral taken for antidepressant therapy, start date: 2017 (ongoing). The following information was reported: CONJUNCTIVITIS (non-serious) with onset Jan2021, outcome "recovered", described as "after 1st vaccine had adverse event of pink eye". The event "after 1st vaccine had adverse event of pink eye" required emergency room visit. Therapeutic measures were taken as a result of conjunctivitis.  Additional information: The patient received eye drop for pink eye.   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, Fatigue, Myalgia, Weight
Clinical narrative: myalgias; chills; fatigue; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 49-year-old female patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 12Sep2022 at 18:00 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 but unknown manufacturer), for COVID-19 Immunization. The following information was reported: CHILLS (non-serious) with onset 13Sep2022 at 04:30, outcome "unknown"; FATIGUE (non-serious) with onset 13Sep2022 at 04:30, outcome "unknown"; MYALGIA (non-serious) with onset 13Sep2022 at 04:30, outcome "unknown", described as "myalgias". Relevant laboratory tests and procedures are available in the appropriate section.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: M
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-000003254.  An 82-year-old male patient received BNT162b2 (BNT162B2), on 28Apr2022 as dose 2, single (Lot number: FK9894) for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), 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: 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, notes: Vaccine breakthrough infection.  Clinical Course: On 29Aug2022, it was reported that a patient started treatment on 28Apr2022 with Pfizer at Dose 2 for unknown indication. It was reported the patient had COVID-19, Inappropriate schedule of product administration, SARS-CoV-2 test positive and Vaccine breakthrough infection. No further follow-up is anticipated.
Sex: F
Vaccine: PNC20
Symptoms: Injection site erythema, Injection site swelling, Vaccination site erythema, Vaccination site mass
Clinical narrative: injection site had a raised bump the size of a half dollar coin and redness spread out beyond injection site.; injection site had a raised bump the size of a half dollar coin and redness spread out beyond injection site.; injection site had a raised bump the size of a coin and redness spread out beyond injection site.; This is a spontaneous report received from contactable reporter(s) (Nurse) from a sales representative.  A 51-year-old female patient received pneumococcal 20-val conj vac (dipht CRM197 protein) (PREVNAR 20), as dose number unknown, single (Lot number: FJ2606, Expiration Date: Jul2023) for immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: VACCINATION SITE MASS (non-serious), VACCINATION SITE ERYTHEMA (non-serious), ERYTHEMA (non-serious), outcome "unknown" and all described as "injection site had a raised bump the size of a coin and redness spread out beyond injection site.".  Follow-up attempts are completed. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: was diagnosed with covid 19; was diagnosed with covid 19; This is a spontaneous report received from contactable reporter(s) (Nurse).  A 74-year-old male patient received BNT162b2 (BNT162B2), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) included: CALCITRIOL; ALLOPURINOL; PREDNISONE. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "recovering" and all described as "was diagnosed with covid 19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive, notes: The patient stated that he was diagnosed with covid 19 and was positive for 3 weeks but is recovering now. It was not known that reporter consider event caused by suspect product or not with COVID 19.   The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.; Sender's Comments: As there is limited information in the case provided, the causal association between the events and the suspect drug cannot be excluded. The case will be reassessed once new information is available.
Sex: U
Vaccine: COVID19
Symptoms: Bradycardia
Clinical narrative: bradycardia was not attributable to these shots; 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 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: 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: BRADYCARDIA (medically significant), outcome "unknown", described as "bradycardia was not attributable to these shots". Clinical information: There is and has almost always been concerns about the safety and effectiveness of Covid 19 vaccinations. Just for my own peace of mind, can I assume that all covid vaccinations have been thoroughly tested peer reviewed subjected to clinical trials and found safe and effective. I have had four shots now and waiting for a fifth and wanted to make sure bradycardia was not attributable to these shots.   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: Pain in extremity
Clinical narrative: Sore arm; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team, Program ID: (005570). The reporter is the patient.  A patient (no qualifiers provided) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 12Sep2022 as dose number unknown (booster), single (Lot number: GH9694) 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 but unknown manufacturer), for COVID-19 immunization. The following information was reported: PAIN IN EXTREMITY (non-serious) with onset Sep2022, outcome "unknown", described as "Sore arm".  Additional information: On 12Sep2022, the patient hoped to receive bivalent vaccine. The sticker on the card did not mention as bivalent. It was stated that Pfizer COVID-19 Vaccine with Lot: GH9694. The patient asked whether it could be a bivalent vaccine. After receiving vaccine the patient had no side effects except a sore arm.
Sex: M
Vaccine: COVID19
Symptoms: Headache, Myalgia, Pain in extremity, Pyrexia
Clinical narrative: Experienced arm pain; Fever; headache; muscle pain; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from a sales representative. The reporter is the patient.  An adult 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) 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 completed, Unknown Manufacturer), for COVID-19 immunization. The following information was reported: PAIN IN EXTREMITY (non-serious), outcome "recovered", described as "Experienced arm pain"; PYREXIA (non-serious), outcome "recovered", described as "Fever"; HEADACHE (non-serious), outcome "not recovered"; MYALGIA (non-serious), outcome "recovered", described as "muscle pain". Additional Information: Male, late 40's, DOB not available, received the Pfizer bivalent vaccine and flu vaccine at the same time. Event took place after use of product.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: PNC20
Symptoms: Chronic kidney disease, Diabetes mellitus, Hypertension, Myocardial infarction
Clinical narrative: heart attack; stage 3 kidney failure; diabetes; hypertension; This is a spontaneous report received from a contactable reporter (consumer or other non HCP), Program ID. The reporter is the patient.  A female patient received pneumococcal 20-val conj vac (dipht CRM197 protein) (PREVNAR 20), as dose number unknown, single (batch/lot number: unknown) for immunization. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: MYOCARDIAL INFARCTION (medically significant), outcome "unknown", described as "heart attack"; RENAL FAILURE (medically significant), outcome "unknown", described as "stage 3 kidney failure"; DIABETES MELLITUS (medically significant), outcome "unknown", described as "diabetes"; HYPERTENSION (non-serious), outcome "unknown". Clinical course: The patient called in seeking assistance with the medication Prevnar 20. During the call caller stated. "I'm a recent a heart attack patient, and I'm stage 3 kidney failure, diabetes, hypertension."  The information on the batch/lot number for Prevnar 20 has been requested and will be submitted if and when received.  Follow-up (15Sep2022): Follow-up attempts completed. No further information expected.
Sex: U
Vaccine: COVID19-2
Symptoms: Body temperature, Influenza like illness, Pain, Pyrexia
Clinical narrative: Flu like symptoms next day; Sore; 102 fever; This is a spontaneous report received from contactable reporter(s) (Physician) from a sales representative. 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. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Primary immunization series completed; unknown manufacturer), for COVID-19 immunization. The following information was reported: INFLUENZA LIKE ILLNESS (non-serious), outcome "unknown", described as "Flu like symptoms next day"; PAIN (non-serious), outcome "unknown", described as "Sore"; PYREXIA (non-serious), outcome "unknown", described as "102 fever". Relevant laboratory tests and procedures are available in the appropriate section.  Additional information: Description of Event: Flu like symptoms next day, Sore, 102 fever. Name of Product: Pfizer BioNTech Covid bivalent. Awareness Date: 14Sep2022. Country of Occurrence: Event took place after use of product.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Hypersensitivity, Loss of personal independence in daily activities
Clinical narrative: developed an allergy or sensitivity to glycols since receiving the covid vaccine; This has resulted in not being able to color my hair, take meds, wear makeup, eat most foods.; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP), Program ID:  The reporter is the patient.  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: HYPERSENSITIVITY (non-serious), outcome "unknown", described as "developed an allergy or sensitivity to glycols since receiving the covid vaccine"; LOSS OF PERSONAL INDEPENDENCE IN DAILY ACTIVITIES (non-serious), outcome "unknown", described as "This has resulted in not being able to color my hair, take meds, wear makeup, eat most foods.".  Additional Information: It was reported that; it appears that patient had developed an allergy or sensitivity to glycols since receiving the covid vaccine. This has resulted in not being able to color patient hair, take meds, wear makeup, eat most foods. Further, it was asked Pfizer developing a drug to reverse the effects of what peg did to a number of people who got the 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
Symptoms: Chills, Fatigue, Nausea, Pain
Clinical narrative: chills; aches; nausea; fatigue; This is a spontaneous report received from non-contactable reporter(s) (Consumer or other non HCP) from a sales representative. The reporter is the patient.  A 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. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Primary Immunization series complete;  manufacturer unknown), for COVID-19 immunization. The following information was reported: CHILLS (non-serious), 24 hrs after the suspect product(s) administration, outcome "unknown"; PAIN (non-serious), 24 hrs after the suspect product(s) administration, outcome "unknown", described as "aches"; NAUSEA (non-serious), 24 hrs after the suspect product(s) administration, outcome "unknown"; FATIGUE (non-serious), 24 hrs after the suspect product(s) administration, outcome "unknown".  Additional information: Patient received bivalent COVID vaccine. 24 hours later reports of chills, aches, nausea and fatigue. Event took place after use of product.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: U
Vaccine: COVID19, FLUX
Symptoms: Headache, Loss of personal independence in daily activities, Pain in extremity, Product use issue
Clinical narrative: sore arms; moderately restrict activity; mild headache; Received COVID bivalent booster and flu shot on 13Sep2022; This is a spontaneous report received from contactable reporter(s) (Pharmacist) from a sales representative.  A patient (no qualifiers provided) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 13Sep2022 as dose number unknown (booster), single (Batch/Lot number: unknown) for covid-19 immunisation; influenza vaccine (INFLUENZA VACCINE), on 13Sep2022 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, Manufacturer: Unknown), for COVID-19 immunization. The following information was reported: PRODUCT USE ISSUE (non-serious) with onset 13Sep2022, outcome "unknown", described as "Received COVID bivalent booster and flu shot on 13Sep2022"; HEADACHE (non-serious) with onset 14Sep2022, outcome "unknown", described as "mild headache"; LOSS OF PERSONAL INDEPENDENCE IN DAILY ACTIVITIES (non-serious) with onset 14Sep2022, outcome "unknown", described as "moderately restrict activity"; PAIN IN EXTREMITY (non-serious) with onset 14Sep2022, outcome "unknown", described as "sore arms".  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: 76.0
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): LRN4715822.  A 77-year-old female patient received BNT162b2 (BNT162B2), on 08Feb2021 as dose 2, single (Batch/Lot number: unknown) at the age of 76 years 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. Vaccination history included: BNT162b2 (DOSE 1, SINGLE), administration date: 20Jan2021, when the patient was 76-year-old, for COVID-19 immunization. The following information was reported: OPTIC NERVE INJURY (medically significant), outcome "unknown", described as "Optical nerve damage".  Clinical course: On 20Jan2021 and 08Feb2021, patient started therapy with BioNTech, Pfizer vaccine for Covid. On unknown date, it was reported that patient experienced: optical nerve damage.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 66.0
Sex: M
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: Injection site soreness; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 68-year-old male patient received BNT162b2 (BNT162B2), on 24Feb2021 at 10:00 as dose 1, single (Lot number: EN6198) at the age of 66 years intramuscular, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Skin cancer (basal squamous)", start date: 2017 (ongoing), notes: 2/3 previous outpatient surgeries 1 recent radiation treatment,finally 20th treatment on 25Aug2022; "Prostate cancer", start date: Nov2019, stop date: Jan2020, notes: Surgical removal Jan2020; "Cholesterol" (ongoing); "Acid reflux" (ongoing). Concomitant medication(s) included: ATORVASTATIN oral taken for blood cholesterol (ongoing); OMEPRAZOLE oral taken for gastrooesophageal reflux disease (ongoing). The following information was reported: VACCINATION SITE PAIN (non-serious), outcome "unknown", described as "Injection site soreness".  Additional Information: Prior Vaccinations (within 4 weeks) was reported as none.
Sex: U
Vaccine: COVID19
Symptoms: Therapeutic response unexpected
Clinical narrative: I think that your Covid vaccine works against herpes simplex. I usually had an outbreak every two months or so, and I have not had one since my second 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 2, 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. The following information was reported: THERAPEUTIC RESPONSE UNEXPECTED (non-serious), outcome "unknown", described as "I think that your Covid vaccine works against herpes simplex. I usually had an outbreak every two months or so, and I have not had one since my second vaccine".  Additional information: Patient thought that Covid vaccine works against herpes simplex. Patient usually had an outbreak every two months or so, and patient have not had one since second vaccine. Perhaps Pfizer would be interested in researching the possibility that an mRNA vaccine can work against herpes.  No follow-up attempts are needed. Information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Lymphadenopathy, Vaccination site pain
Clinical narrative: very slightly swollen and tender armpit; slightly sore arm at injection site (left arm); very mild tiredness; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 36-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 11Sep2022 as dose number unknown (booster), single (Lot number: GJ2524), in left arm for covid-19 immunisation; influenza vaccine (FLU VACCINE VII), on 11Sep2022 as dose number unknown, single (Batch/Lot number: unknown), in left arm for immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Dose 1, Primary immunization series complete unknown, Manufacturer), for COVID-19 immunization; Covid-19 vaccine (Dose 2, Primary immunization series complete unknown, Manufacturer), for COVID-19 immunization. The following information was reported: VACCINATION SITE PAIN (non-serious) with onset 2022, outcome "unknown", described as "slightly sore arm at injection site (left arm)"; FATIGUE (non-serious) with onset 2022, outcome "unknown", described as "very mild tiredness"; LYMPHADENOPATHY (non-serious) with onset 2022, outcome "unknown", described as "very slightly swollen and tender armpit".
Sex: F
Vaccine: MNQ
Symptoms: Exposure during pregnancy, No adverse event
Clinical narrative: patient receiving the Menquadifi during pregnant with no reported adverse event.; Initial information received on 08-Sep-2022 regarding an unsolicited valid  non-serious case received from a consumer/non-hcp.  This case involves an adult female patient who was exposed to vaccine MENINGOCOCCAL A-C-Y-W135 (T CONJ) VACCINE [MENQUADFI] who was receiving the menquadifi during pregnant with no reported adverse event.. Data regarding this pregnancy were received prospectively, i.e. before pregnancy outcome was known. The reported patient receiving the Menquadifi during pregnant with no reported adverse event occurred at unknown gestation period.  The date of last menstrual period was not reported. The estimated due date was not reported. The patient's past medical treatment(s), vaccination(s) and family history were not provided. It was unknown if the patient had any medical history, concomitant disease or risk factor.  On an unknown date, the patient received an unknown dose of suspect MENINGOCOCCAL A-C-Y-W135 (T CONJ) VACCINE, Solution for injection (strength: unknown) lot number not reported via unknown route in unknown administration site as Prophylactic vaccination.  On an unknown date the patient receiving the menquadifi during pregnant with no reported adverse event (exposure during pregnancy) (unknown latency) following the administration of MENINGOCOCCAL A-C-Y-W135 (T CONJ) VACCINE.  It was unknown if there were lab data/results available. It was unknown if the company suspect product was inappropriately used as per local Marketing authorization.  Action taken was not applicable.  It was not reported if the patient received a corrective treatment for the event (patient receiving the Menquadifi during pregnant with no reported adverse event.).  At time of reporting, the outcome was Unknown for the event. Additionally, at time of reporting, the outcome of the pregnancy is unknown.
Sex: F
Vaccine: FLU4
Symptoms: Exposure during pregnancy, No adverse event
Clinical narrative: Taking vaccine during pregnancy, with no reported adverse event; Initial information received on 08-Sep-2022 regarding an unsolicited valid  non-serious case received from a other health professional.  This case involves a 31 years old female patient who was exposed to vaccine INFLUENZA QUADRIVAL A-B VACCINE [FLUZONE QIV] in context of taking vaccine during pregnancy, with no reported adverse event.  Data regarding this pregnancy were received prospectively, i.e. before pregnancy outcome was known. The reported Taking vaccine during pregnancy, with no reported adverse event occurred at 5 weeks of pregnancy and the patient was exposed to INFLUENZA QUADRIVAL A-B VACCINE at 5 weeks of pregnancy, during first pregnancy trimester for INFLUENZA QUADRIVAL A-B VACCINE.  The date of last menstrual period was reported as 16-Jun-2022. The estimated due date is 23-Mar-2023. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. The patient had unknown previous pregnancy/ies.   On 09-Jul-2022, the patient received an unknown dose of suspect INFLUENZA QUADRIVAL A-B VACCINE Suspension for injection (strength was unknown, lot UT7682KA and expiry date was unknown) via intramuscular route in the deltoid nos for Prophylactic vaccination.  On 09-Jul-2022 the patient developed a non-serious event of taking vaccine during pregnancy, with no reported adverse event (maternal exposure timing unspecified) (Latency: same day) following the administration of INFLUENZA QUADRIVAL A-B VACCINE.  Action taken :not applicable.  Outcome: Unknown  Additionally, at time of reporting, the pregnancy was still ongoing.
Age: 23.0
Sex: F
Vaccine: FLU4
Symptoms: Exposure during pregnancy, No adverse event
Clinical narrative: Fluzone QIV administered during pregnancy no adverse event; Initial information received on 08-Sep-2022 regarding an unsolicited valid  non-serious case received from a other health professional.  This case involves a 23 years old female patient who was exposed to vaccine INFLUENZA QUADRIVAL A-B VACCINE [FLUZONE QIV] in context of fluzone qiv administered during pregnancy no adverse event.   Data regarding this pregnancy were received prospectively, i.e. before pregnancy outcome was known. The reported Fluzone QIV administered during pregnancy no adverse event occurred at 13 weeks of pregnancy and the patient was exposed to INFLUENZA QUADRIVAL A-B VACCINE at 13 weeks of pregnancy, during first pregnancy trimester for INFLUENZA QUADRIVAL A-B VACCINE.  The date of last menstrual period was reported as 14-Jun-2022. The estimated due date is 21-Mar-2023. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On 07-Sep-2022, the patient received a  dose 1 of suspect INFLUENZA QUADRIVAL A-B VACCINE Suspension for injection  (lot UT7682KA)  via intramuscular route in the left deltoid for prophylactic vaccination.  On 07-SEP-2022 the patient developed a non-serious event fluzone qiv administered during pregnancy no adverse event (exposure during pregnancy) (latency same day)following the administration of INFLUENZA QUADRIVAL A-B VACCINE.  Action taken: not applicable.  It was not reported if the patient received a corrective treatment for the event (exposure during pregnancy).  At time of reporting, the outcome was Unknown for the event. Additionally, at time of reporting, the pregnancy is still ongoing.
Age: 26.0
Sex: F
Vaccine: FLU4
Symptoms: Exposure during pregnancy, No adverse event
Clinical narrative: Patient administered Fluzone QIV with no reported adverse event; Initial information received on 08-Sep-2022 regarding an unsolicited valid non-serious case received via health professional.  This case involves a 26-year-old female patient who was exposed to vaccine Influenza Quadrival A-B Vaccine [Fluzone Quadrivalent] in context of patient administered fluzone qiv with no reported adverse event. Data regarding this pregnancy were received prospectively, i.e. before pregnancy outcome was known at 22 weeks, during second pregnancy trimester.  The date of last menstrual period was reported as 12-Apr-2022. The estimated due date is 17-Jan-2023. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  On 07-Sep-2022, the regnant patient received suspect Fluzone Quadrivalent vaccine at unknown dose (lot UT7682KA) via intramuscular route in unknown administration site for prophylactic vaccination with no reported adverse event (exposure during pregnancy) same day latency.  Action taken: Not applicable.  At time of reporting, the outcome was Unknown for the event patient administered fluzone qiv with no reported adverse event. Additionally, at time of reporting, the pregnancy is still ongoing.
Age: 11.0
Sex: F
Vaccine: MENB, MNQ
Symptoms: Wrong product administered
Clinical narrative: patient was supposed to receive Menactra vaccine but instead was given Trumenba with no reported adverse event; Initial information received  on 09-Sep-2022 regarding an unsolicited valid Courtesy non-serious case received from partner Pfizer via other health professional.  This case involves a 11 years old female patient who was supposed to receive MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE [MENACTRA] vaccine but instead was given TRUMENBA with no reported adverse event.  The patient's past medical history, medical treatment(s), concomitant medication, vaccination(s) and family history were not provided.   On an unknown date the patient developed a non-serious event of patient was supposed to receive menactra vaccine but instead was given trumenba (strength, formulation, route, administration site, batch and expiry date was unknown for prophylactic vaccination) with no reported adverse event (wrong product administered) (latency: same day) following the administration of MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE and (latency: same day) following the administration of TRUMENBA.  Action taken : not applicable.  Outcome: Unknown  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Age: 30.0
Sex: F
Vaccine: FLU4
Symptoms: Maternal exposure during pregnancy, No adverse event
Clinical narrative: maternal exposure during pregnancy with no adverse event; Initial information received on 09-Sep-2022 regarding an unsolicited valid non-serious case received from other health professional.  This case involves a 30 years old female patient who was exposed to vaccine QUADRIVAL A-B VACCINE [FLUZONE QIV] in context of maternal exposure during pregnancy with no adverse event. Data regarding this pregnancy were received prospectively, i.e. before pregnancy outcome was known. The reported maternal exposure during pregnancy with no adverse event occurred at 22 weeks of pregnancy and the patient was exposed to QUADRIVAL A-B VACCINE at 22 weeks of pregnancy, during second pregnancy trimester for QUADRIVAL A-B VACCINE.  The date of last menstrual period was reported as 08-Apr-2022. The estimated due date is 22-Jan-2023. The patient's past medical history, medical treatment(s), vaccination(s), concomitant medication and family history were not provided. The patient previous pregnancy was not reported.    On 08-Sep-2022, the patient received a dose 1 of suspect QUADRIVAL A-B VACCINE suspension for injection at an unknown dose (lot UT7682KA, expiry date: not reported) via intramuscular route in unknown administration site for immunisation.  On 08-Sep-2022 the patient had maternal exposure during pregnancy with no adverse event (exposure during pregnancy) same day latency following the administration of QUADRIVAL A-B VACCINE.  Relevant prenatal testing after exposure was not reported.  Action taken: Not applicable.  Outcome: Unknown for the event maternal exposure during pregnancy with no adverse event. Additionally, at time of reporting, the pregnancy is still ongoing.
Sex: U
Vaccine: MNQ
Symptoms: Syncope
Clinical narrative: fainting incident after receiving a MENQUADFI vaccine; Initial information received on 19-Aug-2022 regarding an unsolicited valid serious case received from a consumer/non-hcp.  This case involves 2 patients of unknown demographics who experienced fainting incident after receiving a menquadfi vaccine, after receiving vaccine MENINGOCOCCAL A-C-Y-W135 (T CONJ) VACCINE [MENQUADFI].  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On an unknown date, the patient received a  dose of suspect MENINGOCOCCAL A-C-Y-W135 (T CONJ) VACCINE lot number not reported at an unknown dose via unknown route in unknown administration site for immunization.   On an unknown date, the patient experienced fainting incident after receiving a menquadfi vaccine (syncope) (unknown latency).  Action taken :not applicable.  It was not reported if the patient received a corrective treatment for the event (fainting incident after receiving a MENQUADFI vaccine).  Outcome: unknown   Seriousness criteria: medically significant for the event; Sender's Comments: Sanofi company comment date 25-Aug-2022:This case concerns 2 patients of unknown demographics who experienced fainting , after vaccination with Menquadfi. The time to onset is compatible with the role of the vaccine. Patient's the lack of information regarding past drugs, relevant medical history, concurrent conditions, psychiatric history, personal history, therapy details, latency and concomitant medications preclude a comprehensive assessment of this case. Based upon the reported information, the role of an individual vaccine cannot be assessed.
Sex: F
Vaccine: FLU4
Symptoms: Poor quality product administered, Product storage error
Clinical narrative: Fluzone HD was administered but vaccines had been in transit too long and were not suitable for use, administration post excursion with no reported adverse event; Fluzone HD was administered but vaccines had been in transit too long and were not suitable for use, administration post excursion with no reported adverse event; Initial information received on 29-Aug-2022 regarding an unsolicited valid  non-serious case received from a pharmacist.  This case involves a 65 years old female patient who was administered Fluzone HD but vaccines had been in transit too long and were not suitable for use, administration post excursion with no reported adverse event, after receiving vaccine INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE [FLUZONE HIGH-DOSE QUADRIVALENT].  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On 29-Aug-2022, the patient received a  dose of suspect INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE (lot UJ904AB and expiration date: 30-Jun-2023) at an unknown dose via unknown route in unknown administration site for immunization.  On 29-Aug-2022,the patient developed a non-serious  event of fluzone hd was administered but vaccines had been in transit too long and were not suitable for use, administration post excursion with no reported adverse event (poor quality product administered)(latency: same day) (product storage error).   Action taken :not applicable.  It was not reported if the patient received a corrective treatment for the events  Outcome: Unknown for both events     This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.