chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: the patients got covid 2 weeks later; the patients got covid 2 weeks later; This is a spontaneous report received from a contactable reporter(s) (Physician) from medical information team,   A 7-year-old female patient received BNT162b2 (BNT162B2), on 11Nov2021 as dose 1 (orange cap), 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) all with onset Nov2021, outcome "unknown" and all described as "the patients got covid 2 weeks later".  Clinical information: Product: Comirnaty, Pfizer-BioNTech COVID-19 vaccine [monovalent] and/or bivalent. Dose/dosage form: orange cap, original (monovalent), 5 to 11 years- 10 mcg/dose, dilute before use. Caller was a pediatrician who reported that two patients received the first dose of Pfizer COVID-19 monovalent for ages 5-11 vaccine on 11Nov2021. Caller stated the patients got COVID 2 weeks later and did not come back in for the second dose. On 11Nov2022, another dose of Pfizer COVID-19 for ages 5 to 11 monovalent was given to both patients. Caller stated she saw the patients on 11Nov2022 and gave them Pfizer COVID 19 for ages 5-11 monovalent vaccine. Caller asked is this the second primary dose or should she repeat the dose. Patients were a boy 9 years and a girl 7 years.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.; Sender's Comments: Based on the available information in the case, the causal association between the events 'drug ineffective', 'COVID-19' and the suspect drug BNT162B2 cannot be excluded.,Linked Report(s) : US-PFIZER INC-202201300457 Same reporter/product/event, different patient;
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a contactable reporter(s) (Other HCP).  A 68-year-old male patient received BNT162b2 (BNT162B2), 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 included: "HTN" (unspecified if ongoing); "follicular lymphoma" (unspecified if ongoing); "Afib" (unspecified if ongoing). Concomitant medication(s) included: AMBIEN; DILTIAZEM; ELIQUIS; LEVOTHYROXINE; REVLIMID oral, start date: 01Oct2021, stop date: Nov2022. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive, notes: COVID 19 Treatment; Positive, notes: test positive for Covid via rapid test. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Paxlovid was taken as therapeutic measures for drug ineffective, covid-19 from 27Oct2022 to 01Nov2022.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.; Sender's Comments: As per the available information the causality of the events drug ineffective and covid-19 with suspect BNT162b2 can not be ruled out completely.
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 57-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 23Sep2022 at 12:00 as dose 1, single (Batch/Lot number: unknown) at the age of 57 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "asthmatic" (unspecified if ongoing); "Known allergies: penicillin" (unspecified if ongoing); "Known allergies: sulfa" (unspecified if ongoing). There were no concomitant medications. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 2022, outcome "not recovered" and all described as "COVID 19 Treatment". Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical course: Patient received covid-19 treatment (lot number: 2692134) on 05Nov2022 and was stopped on 10Nov2022.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 30.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a contactable reporter(s) (Physician). The reporter is the patient.  A 31-year-old female patient received BNT162b2 (BNT162B2), on 21Aug2021 as dose 3 (booster), single (Lot number: EW0185) at the age of 30 years for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), 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 included: "Anxiety" (unspecified if ongoing); "Known Allergies: Sulfa" (unspecified if ongoing). Concomitant medication(s) included: ESCITALOPRAM [ESCITALOPRAM OXALATE], start date: 10Oct2017. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 2022, outcome "unknown" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (unspecified date) Negative, notes: Negative antigen test; (14Nov2022) Positive, notes: Positive antigen test. Therapeutic measures were taken as a result of drug ineffective, covid-19 which included Paxlovid from 02Nov2022 to 06Nov2022.; Sender's Comments: Based on the known the information available the Causal relation between the events DRUG INEFFECTIVE, COVID-19 and suspect drug cannot be excluded completely
Age: 45.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 45-year-old male patient received BNT162b2 (BNT162B2), on 03Oct2022 as dose number unknown, single (Batch/Lot number: unknown) at the age of 45 years, in left arm for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Oct2022, outcome "unknown" and all described as "Treatment of COVID-19". Therapeutic measures were taken as a result of covid-19 which include Paxlovid from 31Oct2022 to 04Nov2022.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Gastrointestinal disorder, Neurological symptom
Clinical narrative: GI and neurologic symptoms; GI and neurologic symptoms; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). 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: GASTROINTESTINAL DISORDER (non-serious), NEUROLOGICAL SYMPTOM (non-serious), outcome "not recovered" and all described as "GI and neurologic symptoms". The events "gi and neurologic symptoms" required physician office visit. Additional information: The patient is currently followed by neurology, primary care, emergency medicine, Gl consultants, otolaryngology, audiology, and ophthalmology.   The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Vaccination failure
Clinical narrative: COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from product quality group. The reporter is the patient.  A 62-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 16Mar2021 as dose 1, single (Lot number: EN6207), in right arm, on 06Apr2021 as dose 2, single (Lot number: EP7533), in right arm and on 17Dec2021 as dose 3 (booster), single (Lot number: FE3594) at the age of 61 years, in right arm for covid-19 immunisation; cilgavimab, tixagevimab (EVUSHELD), on 05Sep2022 as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Other medical history: cancer" (unspecified if ongoing); "Known allergies: yes" (unspecified if ongoing). There were no concomitant medications. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset Nov2022, outcome "unknown" and all described as "COVID 19 Treatment". Therapeutic measures were taken as a result of vaccination failure, covid-19.  Clinical information: Patient received vaccine. The patient did not receive any other medications in 2 weeks. Patient received treatment with Paxlovid. Treatment start date: 13Nov2022.
Sex: F
Vaccine: COVID19
Symptoms: Peripheral swelling
Clinical narrative: Arm swelled up real bad; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A female patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 20Oct2022 as dose 4 (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 (Dose 1, Manufacturer Unknown), for COVID-19 Immunization; Covid-19 vaccine (Dose 2, Manufacturer Unknown), for COVID-19 Immunization; Covid-19 vaccine (Dose 3, Manufacturer Unknown), for COVID-19 Immunization. The following information was reported: PERIPHERAL SWELLING (non-serious) with onset 20Oct2022, outcome "not recovered", described as "Arm swelled up real bad".  Additional information: Consumer stated, when she got the injection, arm swelled up really bad and it has not gone away yet. It was still swollen and had it 20Oct2022. Paraphrased the concern: Reporter stated, she got it, but it was still swollen up and it still kind of hard so, it was probably since 20Sep, and it was swollen up hard. How do we, what can we do about that? Reporter stated, let me say something, Pfizer 30 mcg/0D 3 ml Inj Pfizer. It came through on the shot when she got it (not clarified further).  No follow-up attempts are possible. No further information is expected.
Sex: M
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, Interchange of vaccine products, SARS-CoV-2 test
Clinical narrative: Interchange of vaccine products; tested positive for COVID; tested positive for COVID; This is a spontaneous report received from non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 59-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), as dose 5 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation; elasomeran (MODERNA COVID-19 VACCINE), 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: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "tested positive for COVID"; INTERCHANGE OF VACCINE PRODUCTS (medically significant), outcome "unknown". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive, notes: tested positive for COVID.  Clinical course: This person had some throat clearing upon awakening from a nap today and his wife suggested that he test. He tested positive for COVID. Other than the throat clearing earlier today, he feels well and has not had any additional symptoms. He has discussed with his primary care provider. This is being reported as a positive COVID test in a person approximately 3-4 weeks s/p the Comirnaty bivalent booster vaccine.  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, Interchange of vaccine products, SARS-CoV-2 test
Clinical narrative: received the Moderna primary vaccine series and 2 Moderna boosters; She tested again an hour later and was positive; She tested again an hour later and was positive; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the parent.  A 27-year-old female patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), as dose 5 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation; elasomeran (COVID-19 VACCINE MODERNA), 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: INTERCHANGE OF VACCINE PRODUCTS (medically significant), outcome "unknown", described as "received the Moderna primary vaccine series and 2 Moderna boosters"; DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "She tested again an hour later and was positive". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Negative, notes: home rapid antigen test; Positive, notes: an hour later. Patient received the Pfizer bivalent booster vaccine around 1 month ago. Prior to that, she received the Moderna primary vaccine series and 2 Moderna boosters. The patient was with her parents a few days ago, and both parents tested positive for COVID-19 within the past 2 days. The patient felt fatigued earlier on 12Nov2022 and had sore throat. She initially tested negative for COVID 19 on a home rapid antigen test. She tested again an hour later and was positive. This is being reported as a breakthrough COVID infection approximately 1 month s/p the Pfizer bivalent booster vaccine.  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-PV202200102739 Same reporter/vaccine, similar event, different patient;US-PFIZER INC-202201296516 Same reporter/vaccine, similar event, different patient;
Sex: U
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: 2 weeks later they got Covid; 2 weeks later they got Covid; This is a spontaneous report received from a contactable reporter(s) (Physician).  A child patient received BNT162b2 (BNT162B2), on 11Nov2021 as dose 1 (orange cap), 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) all with onset Nov2021, outcome "unknown" and all described as "2 weeks later they got Covid". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (Nov2021) Positive.  Clinical course: Caller is a Pediatrician, asking regarding 3 patients ages 5-9 years of age, for the Pfizer Covid-19 vaccine Orange cap, 3 patients received the 1st Primary Dose on 11Nov2021, 2 weeks later they got Covid, and never got the 2nd primary series dose after that. On 11Nov2022, these 3 patients received a primary dose of the Pfizer Covid-19 vaccine Orange cap, caller was asking if it was considered as a 2nd dose or need to repeat the doses.   The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.; Sender's Comments: As per the available information the causality of the events drug ineffective and covid-19  with the suspect BNT162b2 can not be ruled out completely.,Linked Report(s) : US-PFIZER INC-PV202200103531 Same reporter/Drug/AE, different patient;
Sex: U
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: got Covid; got Covid; This is a spontaneous report received from a contactable reporter(s) (Physician).  A child patient received BNT162b2 (BNT162B2), on 11Nov2021 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) all with onset 25Nov2021, outcome "unknown" and all described as "got Covid". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (25Nov2021) Positive, notes: 3 patients received the 1st Primary Dose on 11Nov2021, 2 weeks later they got Covid.  Additional information: Caller is a Pediatrician, asking regarding 3 patients ages 5-9 years of age, for the Pfizer Covid-19 vaccine Orange cap, 3 patients received the 1st Primary Dose on 11Nov2021, 2 weeks later they got Covid, and never got the 2nd primary series dose after that. On 11Nov2022, these 3 patients received a primary dose of the Pfizer Covid-19 vaccine Orange cap, caller is asking if it is considered as a 2nd dose or need to repeat the doses.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.; Sender's Comments: The reported COVID-19 positive 14 days after first dose of BNT162b2 immunization is considered ineffective of BNT162B2, and the Company cannot completely exclude the possible causality between the reported events and BNT162B2 administration.,Linked Report(s) : US-PFIZER INC-PV202200103524 Same reporter/drug/AE, different patient.;US-PFIZER INC-PV202200103531 Same reporter/drug/AE, different patient.;
Sex: F
Vaccine: COVID19
Symptoms: Alopecia
Clinical narrative: hair loss; This is a spontaneous report received from non-contactable reporter(s) (Pharmacist) from a sales representative.  A 59-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's relevant medical history included: "ovarian cancer" (unspecified if ongoing), notes: Patient is a less than 5 year ovarian cancer survivor; "flu" (unspecified if ongoing), notes: Patient reported having the flu 2 weeks prior to the COVID-19 booster. The patient's 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: ALOPECIA (non-serious), 2 weeks after the suspect product(s) administration, outcome "unknown", described as "hair loss".  Additional information: Patient experienced "significant" hair loss 2 weeks after COVID-19 bivalent booster. Event took place after use of product. Concurrent medications were unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: U
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: got Covid; got Covid; This is a spontaneous report received from a contactable reporter(s) (Physician).  A child patient received BNT162b2 (BNT162B2), on 11Nov2021 as dose 1 (orange cap), 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) all with onset Nov2021, outcome "unknown" and all described as "got Covid". Clinical course: Caller is a Pediatrician, asking regarding 3 patients ages 5-9 years of age, for the Pfizer Covid-19 vaccine Orange cap, 3 patients received the 1st Primary Dose on 11Nov2021, 2 weeks later they got Covid, and never got the 2nd primary series dose after that. On 11Nov2022, these 3 patients received a primary dose of the Pfizer Covid-19 vaccine Orange cap, caller is asking if it is considered as a 2nd dose or need to repeat the doses.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.; Sender's Comments: The reported COVID-19 positive 2 weeks(14 days) after dose 1 BNT162b2 is considered ineffective of BNT162B2, and the Company cannot completely exclude the possible causality between the reported events and BNT162B2 administration.,Linked Report(s) : US-PFIZER INC-PV202200103524 Same reporter/Drug/AE, different patient;US-PFIZER INC-PV202200103528 Same reporter/drug/AE, different patient.;
Sex: U
Vaccine: COVID19, COVID19
Symptoms: Drug ineffective, Suspected COVID-19
Clinical narrative: Have received all 5 shots. Had COVID; Have received all 5 shots. Had COVID; 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 5 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation; BNT162b2 (BNT162B2), 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: DRUG INEFFECTIVE (medically significant), SUSPECTED COVID-19 (medically significant), outcome "unknown" and all described as "Have received all 5 shots. Had COVID". Patient had immediately affects from Pfizer shots. Have received all 5 shots. Had COVID in 11/20 (as reported).   The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5, BNT162b2 has been requested and will be submitted if and when received.
Sex: U
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: tested positive on rapid test for covid after bivalent booster; tested positive on rapid test for covid after bivalent booster; This is a spontaneous report received from 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; coviD-19 vaccine (COVID-19 VACCINE), 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), COVID-19 (medically significant), outcome "unknown" and all described as "tested positive on rapid test for covid after bivalent booster". Events took place after use of product. The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: U
Vaccine: COVID19
Symptoms: Pericarditis
Clinical narrative: battle with pericarditis as a result of getting the 2nd Covid vaccine; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A patient (no qualifiers provided) received BNT162b2 (BNT162B2), as dose 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, UNKNOWN MANUFACTURE), for COVID-19 immunization. The following information was reported: PERICARDITIS (medically significant, life threatening), outcome "unknown", described as "battle with pericarditis as a result of getting the 2nd Covid vaccine". Therapeutic measures were taken as a result of pericarditis. Clinical courses: The patient had open heart surgery and barely survived.  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: Rheumatoid arthritis
Clinical narrative: After receiving the Covid-19 untested vaccine in May2021 I developed Rheumatoid Arthritis within a week; 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 May2021 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: RHEUMATOID ARTHRITIS (medically significant) with onset 2021, outcome "unknown", described as "After receiving the Covid-19 untested vaccine in May2021 I developed Rheumatoid Arthritis within a week". Clinical courses is as follows: After receiving the Covid-19 untested vaccine in May2021 the patient developed Rheumatoid Arthritis within a week. Is there any compensation without going to Court for this situation. The patient would have appreciated the truth prior to taking the vaccine. The patient know there were a number of folks paid to keep quiet about the Vaccine and we were Guinee Pigs for this issue for Pfizer. The patient never had an issue until the Vaccine was touted as safe. Trust me, It cuts your life by at least 5 years w/ much pain. 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: Disease recurrence, Dyspnoea, Heart rate, Heart rate increased, Insomnia
Clinical narrative: myocarditis; myocarditis; rapid heart beating; shortness of breathing; tingling all over body; unable to sleep when lay down; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 38-year-old female patient received BNT162b2 (BNT162B2), as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "PCOS" (unspecified if ongoing); "abnormal hormones" (unspecified if ongoing); "myocarditis symptoms", start date: 2020 (unspecified if ongoing), notes: myocarditis symptoms back in 2020. The patient's concomitant medications were not reported. The following information was reported: MYOCARDITIS (medically significant), DISEASE RECURRENCE (medically significant), all with latency 3 weeks after the suspect product(s) administration, outcome "recovered" and all described as "myocarditis"; HEART RATE INCREASED (non-serious), 3 weeks after the suspect product(s) administration, outcome "recovered", described as "rapid heart beating"; DYSPNOEA (non-serious), 3 weeks after the suspect product(s) administration, outcome "recovering", described as "shortness of breathing"; PARAESTHESIA (non-serious), 3 weeks after the suspect product(s) administration, outcome "recovered", described as "tingling all over body"; INSOMNIA (non-serious), 3 weeks after the suspect product(s) administration, outcome "recovered", described as "unable to sleep when lay down".   Clinical course: Her myocarditis symptoms back in 2020. Patient was a female with PCOS and abnormal hormones. She had experienced symptoms of myocarditis 3 weeks after her first dose of Pfizer. She had rapid heart beating, shortness of breathing, tingling all over her body and unable to sleep when she lay down. After her symptoms which lasted about a month they stopped and she has random shortness of breaths and no other symptoms.   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: Myocarditis, Paraesthesia
Clinical narrative: myocarditis; myocarditis; rapid heart beating; shortness of breathing; tingling all over body; unable to sleep when lay down; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 38-year-old female patient received BNT162b2 (BNT162B2), as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "PCOS" (unspecified if ongoing); "abnormal hormones" (unspecified if ongoing); "myocarditis symptoms", start date: 2020 (unspecified if ongoing), notes: myocarditis symptoms back in 2020. The patient's concomitant medications were not reported. The following information was reported: MYOCARDITIS (medically significant), DISEASE RECURRENCE (medically significant), all with latency 3 weeks after the suspect product(s) administration, outcome "recovered" and all described as "myocarditis"; HEART RATE INCREASED (non-serious), 3 weeks after the suspect product(s) administration, outcome "recovered", described as "rapid heart beating"; DYSPNOEA (non-serious), 3 weeks after the suspect product(s) administration, outcome "recovering", described as "shortness of breathing"; PARAESTHESIA (non-serious), 3 weeks after the suspect product(s) administration, outcome "recovered", described as "tingling all over body"; INSOMNIA (non-serious), 3 weeks after the suspect product(s) administration, outcome "recovered", described as "unable to sleep when lay down".   Clinical course: Her myocarditis symptoms back in 2020. Patient was a female with PCOS and abnormal hormones. She had experienced symptoms of myocarditis 3 weeks after her first dose of Pfizer. She had rapid heart beating, shortness of breathing, tingling all over her body and unable to sleep when she lay down. After her symptoms which lasted about a month they stopped and she has random shortness of breaths and no other symptoms.   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: Hip arthroplasty
Clinical narrative: hip replacement; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP), Program ID: (Unknown). The reporter is the patient.  An 87-year-old patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), as dose 5 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation; estrogens conjugated, medroxyprogesterone acetate (PREMPRO). 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; Bnt162b2 (Dose 3 (Booster)), for Covid-19 Immunization; Bnt162b2 (Dose 4 (Booster)), for Covid-19 Immunization. The following information was reported: HIP ARTHROPLASTY (medically significant), outcome "unknown", described as "hip replacement". The action taken for estrogens conjugated, medroxyprogesterone acetate was unknown.  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, COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: Tested positive on rapid test for covid after bivalent booster; Tested positive on rapid test for covid after bivalent booster; This is a spontaneous report received from contactable reporter (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; covid-19 vaccine (COVID-19 VACCINE), 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), COVID-19 (medically significant), outcome "unknown" and all described as "Tested positive on rapid test for covid after bivalent booster". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: U
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: consistently feel extreme pain from injection site; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP), Program ID: (005570). 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: VACCINATION SITE PAIN (non-serious), outcome "unknown", described as "consistently feel extreme pain from injection site". Additional information: Patient wanted the vaccine removed from the body immediately. Having a severe manic episode when the pressures of society forced patient to get it. Consistently felt extreme pain from injection site. Patient was taking this matter very seriously.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 41.0
Sex: F
Vaccine: COVID19, UNK
Symptoms: Drug ineffective, Suspected COVID-19
Clinical narrative: COVID-19; COVID-19; This is a solicited report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. Other Case identifier(s): 22K-163-4387234-00.  A 41-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) at the age of 41 years, all intramuscular for covid-19 immunisation; adalimumab (HUMIRA), since Aug2021 (Batch/Lot number: unknown) at 40 mg single (40 mg), subcutaneous for rheumatoid arthritis. 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 04May2022, outcome "recovered" (May2022) and all described as "COVID-19". The action taken for adalimumab was unknown.  The reporter's assessment of the causal relationship of "covid-19" 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 information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.; Sender's Comments: As per the available information the events drug ineffective and suspected covid-19 are possibly related to the suspect BNT162b2.
Age: 85.0
Sex: F
Vaccine: COVID19-2
Symptoms: Headache
Clinical narrative: a slight headache; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP), Program ID: (159558). The reporter is the patient.  An 85-year-old female patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 14Nov2022 as dose number unknown (booster), single (Batch/Lot number: unknown) at the age of 85 years for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Dose number: 1st booster), for COVID-19 immunization; Covid-19 vaccine (Primary Immunization series complete, Manufacturer: Unknown), for COVID-19 immunization. The following information was reported: HEADACHE (non-serious) with onset 14Nov2022, outcome "unknown", described as "a slight headache".  Additional information: she took her Second booster dose today at noon and she got a slight headache.  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: M
Vaccine: COVID19
Symptoms: Asthenia, Exercise tolerance decreased
Clinical narrative: lost the energy; his exercise tolerance had dropped drastically; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). Other Case identifier(s):  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: ASTHENIA (non-serious), outcome "unknown", described as "lost the energy"; EXERCISE TOLERANCE DECREASED (non-serious), outcome "unknown", described as "his exercise tolerance had dropped drastically".  Additional information: On 01Nov2022, it was reported that a patient started treatment on an unspecified date with Pfizer BioNTech COVID-19 Vaccine at an unspecified dose for COVID-19 immunisation. It was reported that from the time he had the Pfizer shot, his exercise tolerance had dropped drastically. He lost the energy he had, and it was within a week of that shot.   The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 84.0
Sex: F
Vaccine: COVID19, UNK
Symptoms: Drug ineffective, Sciatica, Suspected COVID-19
Clinical narrative: Sciatica was getting worse; Covid; Covid/Covid vaccine made ill; This is a solicited report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. Other Case identifier(s): US-ABBVIE-4136583.  An 84-year-old female patient received BNT162b2 (BNT162B2), in Feb2021 as dose 1, single (Batch/Lot number: unknown), in Feb2021 as dose 2, single (Batch/Lot number: unknown) and in Sep2021 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 84 years, all intramuscular for covid-19 immunisation; adalimumab (HUMIRA), (Lot number: 1165533), subcutaneous for psoriasis. The patient's relevant medical history included: "sciatica", start date: 2010 (ongoing), notes: On 2010, the patient experienced Sciatica was getting worse. The patient's concomitant medications were not reported.  The following information was reported: DRUG INEFFECTIVE (medically significant) with onset Jul2022, outcome "recovered" (2022), described as "Covid"; SUSPECTED COVID-19 (medically significant) with onset Jul2022, outcome "recovered" (2022), described as "Covid/Covid vaccine made ill"; SCIATICA (non-serious), outcome "not recovered", described as "Sciatica was getting worse". The action taken for adalimumab was unknown.  Additional information: The reporter's causality for the event of Covid vaccine made ill and Sciatica was getting worse with Adalimumab Solution for Injection was No Reasonable Possibility. The reporter's causality for the event of Covid with Adalimumab Solution for Injection was Not Provided. The reporter's causality for the event of Covid vaccine made ill with Pfizer BioNTech COVID-19 vaccine (Tozinameran) was Reasonable Possibility. The reporter's causality for the event(s) of Covid and Sciatica was getting worse with Pfizer BioNTech COVID-19 vaccine (Tozinameran) was Not Provided. Opinion was that the causality for the event(s) of Covid, Covid vaccine made ill and Sciatica was getting worse with Adalimumab Solution for Injection was Not Provided. opinion was that the causality for the event(s) of Covid, Covid vaccine made ill and Sciatica was getting worse with Pfizer BioNTech COVID-19 vaccine (Tozinameran) was Not Provided. Assessment Results were Humira: Illness, Non-Health Care Professional, Introspection, Not Related. Humira: Sciatica aggravated, Non-Health Care Professional, Introspection, Not Related. Pfizer BioNTech COVID-19 vaccine: Illness, Non-Health Care Professional, Introspection, Probable.  The reporter's assessment of the causal relationship of "covid", "covid/covid vaccine made ill" and "sciatica was getting worse" 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 information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.; Sender's Comments: As per the available information the events drug ineffective,Suspected COVID-19 and sciatica are possibly related to the suspect BNT162b2.
Age: 58.0
Sex: F
Vaccine: FLU4
Symptoms: Poor quality product administered, Product storage error
Clinical narrative: Temperature excursion with no reported AE; influenza vaccine may not be effective with no reported AE; Initial information received on 09-Nov-2022 regarding an unsolicited valid non-serious case received from a other health professional.  This case involves a 58 years old female patient to whom event Influenza quadrival A-B vaccine [Fluzone quadrivalent] influenza vaccine may not be effective after temperature excursion with no reported adverse event (AE)  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided and had no concomitant disease or risk factor.   On 20-Oct-2021, the patient received a dose of suspect Influenza quadrival A-B vaccine, Solution for injection in pre-filled syringe lot UT7680NA via intramuscular route (unknown dose, strength and site) for prophylactic vaccination after temperature excursion with no reported AE (product storage error) and influenza vaccine may not be effective with no reported AE (poor quality product administered) (latency: same day)  There were no lab data/results available.   Action taken: not applicable.  At time of reporting, the outcome was Unknown for the 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.
Sex: U
Vaccine: FLUX
Symptoms: Influenza
Clinical narrative: first time i've ever had the flu; Initial information was received on 08-Nov-2022 regarding an unsolicited valid Social Media non-serious case received from a consumer/non healthcare professional.  This case involves a patient with unknown demographics who experienced first time ever had the flu after being vaccinated with Influenza Vaccine.  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 Influenza vaccine (produced by unknown manufacturer) (with unknown strength, dose, route, administration site, lot number and expiration date) for prophylactic vaccination.  On an unknown date the patient had a non serious event first time ever had the flu (influenza) (unknown latency) following the administration of Influenza vaccine.  It was reported that: First time I have ever had the flu and I have gotten my shot every year. It was not fun. It was worse than Omicron covid we had in April. Iam sure without vaccine it would have been worse.  Action taken: Not applicable.  Corrective treatment: Not reported.   Outcome: Unknown.
Age: 51.0
Sex: F
Vaccine: FLU4
Symptoms: Product storage error
Clinical narrative: Flu vaccine may be ineffective due to temperature excursion with no reported adverse event; Initial information was received on 09-Nov-2022 regarding an unsolicited valid non-serious case received from a other health professional.  This case involves a 51 years old female patient who stated flu vaccine may be ineffective due to temperature excursion with no reported adverse event while receiving influenza quadrival A-B vaccine [Fluzone quadrivalent].  The patient had no medical history, concomitant disease or risk factor. The patient's medical treatment(s) and family history were not provided.  On 17-Oct-2022, the patient received an unknown dose of suspect  influenza quadrival A-B vaccine (Suspension for injection) (lot: UT7680NA) (expiry date, strength, frequency was unknown) via intramuscular route in an unknown administration site for prophylactic vaccination.  On 17-Oct-2022 the patient had a non-serious event flu vaccine may be ineffective due to temperature excursion with no reported adverse event (product storage error) (latency: same day) following the administration of influenza quadrival A-B vaccine.   Action taken: not applicable.  There were no lab data/results available.  It was not reported if the patient received a corrective treatment for the event.  At time of reporting, the outcome was Unknown for the event.   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 guidelines. 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.
Sex: U
Vaccine: FLUX
Symptoms: Influenza
Clinical narrative: came down with the flu; Initial information received on 09-Nov-2022 regarding an unsolicited valid Social Media non-serious case received from a consumer/non-hcp.  This case involves Adult and unknown gender patient who experienced came down with the flu after receiving vaccine INFLUENZA VACCINE.  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 INFLUENZA VACCINE produced by unknown manufacturer (strength, dose, formulation, route,lot number not reported) in unknown administration site for immunization.  On an unknown date the patient developed a non-serious event came down with the flu (influenza) (unknown latency) following the administration of INFLUENZA VACCINE.  Action taken: not applicable.  It was not reported if the patient received a corrective treatment for the event (influenza).  At time of reporting, the outcome was Unknown for the event.