chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 67.0
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).  A 68-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 22Apr2022 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 67 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: "HLD" (unspecified if ongoing); "fibromyalgia" (unspecified if ongoing); "inflamm arthritis" (unspecified if ongoing); "MDD" (unspecified if ongoing); "osteopenia" (unspecified if ongoing). The patient's concomitant medications were not reported. Past drug history included: Dulcolax, reaction(s): "known allergies: dulcolax", notes: known allergies: dulcolax, ceclor, dilaudid, novacaine; Ceclor, reaction(s): "known allergies: ceclor"; Dilaudid, reaction(s): "known allergies:dilaudid"; Novacaine, reaction(s): "known allergies: novacaine". The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 13Nov2022, outcome "not recovered" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (unspecified date) Negative, notes: tested negative shortly after (21Nov, and 22Nov); (unspecified date) Positive, notes: rested positive for covid this am (all home tests); (13Nov2022) Positive, notes: pt tested positive on 13Nov started paxlovid. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical course: The patient tested positive on 13Nov treated with Paxlovid, treatment start date=13Nov2022, treatment stop date=17Nov2022, finished course; no complications; tested negative shortly after (21Nov, and 22Nov); then symptoms restarted on 22Nov pm and rested positive for covid this am (all home tests).  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.; Sender's Comments: The efficacy of a drug varies from patient to patient and can be affected by different factors, however a contributory role of the suspect drug to the reported events Drug ineffective and COVID-19 cannot be ruled out.
Sex: F
Vaccine: COVID19
Symptoms: Abortion spontaneous, Maternal exposure timing unspecified
Clinical narrative: My wife lost her kid, a miscarriage; my unborn child who has died because of the COVID-19 Vaccine; My wife lost her kid, a miscarriage; my unborn child who has died because of the COVID-19 Vaccine; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP).  A female patient (pregnant) 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: ABORTION SPONTANEOUS (medically significant), MATERNAL EXPOSURE TIMING UNSPECIFIED (medically significant), outcome "unknown" and all described as "My wife lost her kid, a miscarriage; my unborn child who has died because of the COVID-19 Vaccine". Clinical Course: The reporter stated that, his wife lost her kid, a miscarriage; the unborn child died because of the COVID-19 Vaccine.     No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 82.0
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 contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  An 83-year-old male patient received BNT162b2 (BNT162B2), in Dec2021 as dose number unknown, single (Batch/Lot number: unknown) at the age of 82 years for covid-19 immunisation. The patient's relevant medical history included: "Mitral valve prolapse repair" (unspecified if ongoing); "LAD bypass" (unspecified if ongoing); "right coronary stent" (unspecified if ongoing); "dual chamber pacemaker" (unspecified if ongoing); "cardiomyopathy" (unspecified if ongoing); "Afib" (unspecified if ongoing). Concomitant medication(s) included: SOTALOL; ELIQUIS; COZAAR; COREG; ASPIRIN [ACETYLSALICYLIC ACID]; LIPITOR, stop date: 21Nov2022 (other medication in 2weeks). Past drug history included: Ranexa, reaction(s): "Known allergies: Ranexa"; Lisinopril, reaction(s): "Known allergies: Lisinopril". Vaccination history included: Tb shot, reaction(s): "Known allergies: TB shot". The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Nov2022, outcome "unknown" and all described as "Treatment of COVID-19". Therapeutic measures were taken as a result of drug ineffective, covid-19 and treatment included Paxlovid from 21Nov2022.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Sex: M
Vaccine: COVID19
Symptoms: Muscular weakness
Clinical narrative: lost power to his arms and legs; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (DOSE: 1, SINGLE), for COVID-19 immunisation; Covid-19 vaccine (DOSE: 2, SINGLE), for COVID-19 immunisation. The following information was reported: MUSCULAR WEAKNESS (hospitalization), outcome "unknown", described as "lost power to his arms and legs". Additional information: Consumer stated that he got the Pfizer booster shot, he took it a couple times, then 24 hours after he lost power to his arms and legs and wound up in the hospital, so he stopped using boosters. He does not want to document his experience with a safety report, and he has been in the hospital a couple times. He did not see anything written up online like his experience, though he knows of people who had heart attacks after getting the shot. No further details provided about people having heart attacks. His happened 24 hours after, but there was nothing online about that particular thing. When asked if he is a doctor, nurse, or pharmacist, caller says he is a victim. He says it happened a few times so he knows what caused it, and he would be hospitalized a few days then go to rehab until he gets stronger. He had two shots in the beginning, two vaccines, he did not have a problem with them, it is only the new booster that seemed to trigger off the problems. He clarifies that it is the Pfizer COVID-19 vaccine booster.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 76.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 76-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 01Oct2022 as dose 5 (booster), single (Batch/Lot number: unknown) at the age of 76 years, in left arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown), 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 was not reported. Concomitant medication(s) included: DORZOLAMIDE TIMOLOL. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive, notes: tested positive on the tenth day after my initial positive test; Positive, notes: tested positive on the tenth day after my initial positive test. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical information: I was feeling well about two days after starting medication with Paxlovid but a week after that I began to feel sick again and tested positive on the tenth day after my initial positive test. patient had no Known allergies.  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: Monoplegia
Clinical narrative: lost power on arms and legs and ended up in hospital; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A male patient received BNT162b2 (BNT162B2), in Apr2022 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, In Mar2021, got the Pfizer CN6206.), administration date: Mar2021, for COVID-19 immunization; Bnt162b2 (A couple of weeks later, got the second vaccine and had no problems what so ever, no reactions, DOSE 2, SINGLE), for COVID-19 immunization; Bnt162b2 (DOSE 3 (BOOSTER), SINGLE), administration date: Sep2021, for COVID-19 immunization, reaction(s): "lost power on arms and legs and ended up in hospital". The following information was reported: MONOPLEGIA (hospitalization, medically significant), outcome "unknown", described as "lost power on arms and legs and ended up in hospital".  Clinical course: The reporter wanted to know if there were any preventive medicines for interactions caused by the Pfizer COVID-19 Vaccine. After caller was transferred, he mentioned he received the first two COVID-19 Vaccine doses on Mar2021and was everything was fine, he had no problem. Then, on Sep2021 he received the booster and 24 hours later he lost power on arms and legs and ended up in hospital after 911 call and then he had to take some therapy. On Apr2022 he got another booster and again got the same reaction 24 hours later. On Sep2022 he took another booster and the same thing happened. Caller wanted to know if this had been reported since he didn't find any information on the internet.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202201325029 similar report from same reporter;
Sex: U
Vaccine: COVID19
Symptoms: Myocardial infarction
Clinical narrative: heard of 4 or 5 people with heart attacks after the COVID-19 Vaccine; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP) from medical information team.  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: MYOCARDIAL INFARCTION (medically significant), outcome "unknown", described as "heard of 4 or 5 people with heart attacks after the COVID-19 Vaccine".  Clinical course: Caller wanted to know if this had been reported since he didn't find any information on the internet. Caller then mentioned about how he heard of 4 or 5 people with heart attacks after the COVID-19 Vaccine. He added that he's obviously not going to take another booster. When caller was referred to his HCP, he mentioned that in one of the visits, he was told the booster reacts with immunological system and that his doctor said things that didn't made sense, and that he was actually medical misdiagnosed, which is common to happen to him. Knows people who have heart attacks from the shot. Has heard several people with recent immunization, who got the shot, had heart attacks.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Myocardial infarction
Clinical narrative: heard of 4 or 5 people with heart attacks after the COVID-19 Vaccine; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP) from medical information team.  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: MYOCARDIAL INFARCTION (medically significant), outcome "unknown", described as "heard of 4 or 5 people with heart attacks after the COVID-19 Vaccine".  Clinical information: Reporter mentioned about how he heard of 4 or 5 people with heart attacks after the COVID-19 Vaccine. Knows people who have heart attacks from the shot. Has heard several people with recent immunization, who got the shot, had heart attacks. Reporter did not have anything like that.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: U
Vaccine: COVID19
Symptoms: Myocardial infarction
Clinical narrative: heard of 4 or 5 people with heart attacks after the COVID-19 Vaccine; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP) from medical information team.  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: MYOCARDIAL INFARCTION (medically significant), outcome "unknown", described as "heard of 4 or 5 people with heart attacks after the COVID-19 Vaccine".  Clinical course: The caller had heard of 4 or 5 people with heart attacks after the COVID-19 vaccine. The caller knew people who had heart attacks from the shot. Had heard several people with recent immunization, who got the shot and had heart attacks.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: U
Vaccine: COVID19
Symptoms: Myocardial infarction
Clinical narrative: heard of 4 or 5 people with heart attacks after the COVID-19 Vaccine; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP) from medical information team.  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: MYOCARDIAL INFARCTION (medically significant), outcome "unknown", described as "heard of 4 or 5 people with heart attacks after the COVID-19 Vaccine".  Additional information: Caller mentioned that he heard of 4 or 5 people with heart attacks after the COVID-19 Vaccine.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Hand deformity, Juvenile idiopathic arthritis, Psoriatic arthropathy
Clinical narrative: Psoriatic Arthritis; Hand deformity; Polyarticular Juvenile Idiopathic Arthritis Flare-up; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. Other Case identifier(s): US-ABBVIE-4157318.  A female patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 02Sep2022 as dose 3 (booster), single (Batch/Lot number: unknown) intramuscular for covid-19 immunisation; adalimumab (HUMIRA), from 2016 (Batch/Lot number: unknown) to 2021, subcutaneous for juvenile idiopathic arthritis. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: BNT162b2 (Dose: 01, Route of Administration: Intramuscular), administration date: 01Mar2021, for COVID-19 Vaccination, reaction(s): "COVID-19"; BNT162b2 (Dose: 02, Route of Administration: Intramuscular), administration date: 01Apr2021, for COVID-19 Vaccination, reaction(s): "COVID-19". The following information was reported: JUVENILE IDIOPATHIC ARTHRITIS (medically significant) with onset 2022, outcome "not recovered", described as "Polyarticular Juvenile Idiopathic Arthritis Flare-up"; PSORIATIC ARTHROPATHY (medically significant), outcome "not recovered", described as "Psoriatic Arthritis"; HAND DEFORMITY (non-serious), outcome "not recovered". The action taken for adalimumab was dosage permanently withdrawn in 2021.  Additional information: It was unknown if patient was enrolled in COVID-19-Vaccine Trial. Solicited report by a consumer of a female with events of and non-serious Polyarticular Juvenile Idiopathic Arthritis Flare-up, Hand deformity, COVID-19, and Psoriatic Arthritis with Adalimumab Solution for Injection, Single Dose Pen. There was no reported medical history. Pfizer BioNTech COVID-19 vaccine was also considered suspect. Primary reporter did not have the lot number information, because the packaging was discarded.  The causality for the events with Adalimumab Solution for Injection was not provided. The causality for the events with Pfizer BioNTech COVID-19 vaccine was not provided.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Pruritus
Clinical narrative: Each time I was extremely itchy on my scalp and in all joint areas.itching last for several hours.; Each time I was extremely itchy on my scalp and in all joint areas.itching last for several hours.; peri-orbital redness; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 55-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 04May2022 at 18:00 as dose 4 (booster), single (Lot number: FJ4989) at the age of 54 years, in right arm for covid-19 immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) included: ESTROGEN. Past drug history included: Neomycin, reaction(s): "known allergies: Neomycin", notes: known allergies: Neomycin. Vaccination history included: BNT162b2 (Dose Number: 3, Batch/Lot No: FF2587, Location of injection: Arm Right, Vaccine Administration Time: 12:00 PM), administration date: 08Oct2021, when the patient was 53-year-old, for COVID-19 immunization, reaction(s): "Each time I was extremely itchy on my scalp and in all joint areas.itching last for several hours. Also had peri-orbital redness each time", "Each time I was extremely itchy on my scalp and in all joint areas.itching last for several hours. Also had peri-orbital redness each time", "peri-orbital redness"; Covid-19 vaccine (DOSE 1; MANUFACTURER UNKNOWN), for COVID-19 immunization, reaction(s): "Each time I was extremely itchy on my scalp and in all joint areas.itching last for several hours. Also had peri-orbital redness each time", "peri-orbital redness", "Each time I was extremely itchy on my scalp and in all joint areas.itching last for several hours. Also had peri-orbital redness each time"; Covid-19 vaccine (DOSE 2; MANUFACTURER UNKNOWN), for COVID-19 immunization, reaction(s): "Each time I was extremely itchy on my scalp and in all joint areas.itching last for several hours. Also had peri-orbital redness each time", "peri-orbital redness", "Each time I was extremely itchy on my scalp and in all joint areas.itching last for several hours. Also had peri-orbital redness each time". The following information was reported: PRURITUS (non-serious), PRURITUS (non-serious), outcome "recovered" and all described as "Each time I was extremely itchy on my scalp and in all joint areas.itching last for several hours."; ERYTHEMA (non-serious), outcome "recovered", described as "peri-orbital redness". Therapeutic measures were not taken as a result of pruritus, pruritus, erythema.  Additional information: Prior to vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Since the vaccination, the patient had been tested positive for COVID-19 reported unknown.  No follow-up attempts are possible. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202201325402 same reporter/patient/event, different vaccine dose;US-PFIZER INC-202201325409 same reporter/patient/event, different vaccine dose;
Age: 45.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, Interchange of vaccine products, SARS-CoV-2 test
Clinical narrative: Treatment of COVID-19; Treatment of COVID-19; Interchange of vaccine products; 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 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 24Oct2022 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 45 years, in left arm for covid-19 immunisation; elasomeran (MODERNA COVID-19 VACCINE), on 04Dec2021 as dose 3 (booster), single (Batch/Lot number: unknown), in left arm for covid-19 immunisation; BNT162b2 (COMIRNATY), on 23Apr2021 as dose 1, single (Batch/Lot number: unknown), in left arm and on 07May2021 as dose 2, single (Batch/Lot number: unknown), in left arm for covid-19 immunisation. The patient's relevant medical history included: "Asthma" (unspecified if ongoing). There were no concomitant medications. The following information was reported: INTERCHANGE OF VACCINE PRODUCTS (medically significant) with onset 04Dec2021, outcome "unknown"; DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), all with latency 10 days after the suspect product(s) administration, outcome "unknown" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Negative, notes: 4 days after testing negative; Positive, notes: Tested positive again; Positive, notes: indication=Treatment of COVID-19. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical course: Tested positive again for COVID on antigen home test 4 days after testing negative. 6 days after completing paxlovid. COVID 19 Treatment from 14Nov2022 to 18Nov2022  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, Interchange of vaccine products
Clinical narrative: COVID-19; COVID-19; Interchange of vaccine products; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 57-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 23Sep2022 as dose 5 (booster), single (Batch/Lot number: unknown) at the age of 57 years, in left arm for covid-19 immunisation; elasomeran (MODERNA COVID-19 VACCINE), on 16Jan2021 as dose 1, single (Batch/Lot number: unknown), in left arm, on 02Feb2021 as dose 2, single (Batch/Lot number: unknown), in left arm, on 18Aug2021 as dose 3 (booster), single (Batch/Lot number: unknown), in left arm and on 24Apr2022 as dose 4 (booster), single (Batch/Lot number: unknown), in left arm for covid-19 immunisation. The patient's relevant medical history included: "Psoriatic arthritis" (unspecified if ongoing); "depression" (unspecified if ongoing); "Known allergies: Sulfa drugs" (unspecified if ongoing). Concomitant medication(s) included: SERTRALINE, start date: Sep2000; FOLIC ACID, start date: Aug2022. The following information was reported: INTERCHANGE OF VACCINE PRODUCTS (medically significant) with onset 23Sep2022, outcome "unknown"; DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID-19". Therapeutic measures were taken as a result of drug ineffective, covid-19.  Additional information: The patient received treatment of Paxlovid from 13Nov2022 to 18Nov2022 (lot number: GE9774).  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: 57.0
Sex: F
Vaccine: COVID19-2, FLUX
Symptoms: Dizziness, Off label use, Product use issue, Tinnitus
Clinical narrative: tinnitus; dizziness; influenza 14Sep2022; influenza 14Sep2022; The initial case was missing the following minimum criteria. Upon receipt of follow-up information on 22Nov2022, this case now contains all required information to be considered valid.  This is a spontaneous report received from a contactable reporter(s) (Nurse), Program ID: (005570). The reporter is the patient.  A 57-year-old female patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 14Sep2022 as dose 4 (booster), 0.3 ml single (Lot number: GJ25201) at the age of 57 years intramuscular for covid-19 immunisation; influenza vaccine inact split 4v (QUADRIVALENT INFLUENZA VACCINE), on 14Sep2022 as dose number unknown, single (Batch/Lot number: unknown) for immunisation. The patient had no relevant medical history. The patient's concomitant medications were not reported. Vaccination history included: coviD-19 vaccine (Dose 1; Manufacturer Unknown), administration date: 28Dec2020, when the patient was 55-year-old, for COVID-19 Immunization; Covid-19 vaccine (Dose 2; Manufacturer Unknown), for COVID-19 Immunization; Covid-19 vaccine (Dose 3 (Booster); Manufacturer Unknown), for COVID-19 Immunization. The following information was reported: PRODUCT USE ISSUE (non-serious), OFF LABEL USE (non-serious) all with onset 14Sep2022, outcome "unknown" and all described as "influenza 14Sep2022"; DIZZINESS (non-serious) with onset 14Sep2022 at 15:22, outcome "not recovered"; TINNITUS (non-serious) with onset 14Sep2022 at 15:22, outcome "not recovered". Therapeutic measures were not taken as a result of tinnitus, dizziness.  Additional Information:The tinnitus resulting after immunization was accompanied by dizziness. Both influenced with sleep and balance and balance for 3-5 days. Enough that patient felt responsible to report as a health professional. Drug or alcohol abuse: No, Drug allergies: No, Family history: No.  Tinnitus and Dizziness Causal Relationship: there a reasonable possibility that the event is related to suspect product/s.
Sex: U
Vaccine: COVID19
Symptoms: Computerised tomogram, Pulmonary mass
Clinical narrative: I currently have multiple lung nodules less that 5mm in size; 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), in Mar2020 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: PULMONARY MASS (non-serious), outcome "unknown", described as "I currently have multiple lung nodules less that 5mm in size". Relevant laboratory tests and procedures are available in the appropriate section.  Additional information: In Dec2019, prior to vaccines, the patient had CT scan of lungs. There was nothing to report. In Mar2020 the patient began series of Mrna vaccines and currently have multiple lung nodules less that 5mm in size which need to be checked every 6 months.   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: 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): US-ABBVIE-4157318.  A female patient received BNT162b2 (BNT162B2), on 01Mar2021 as dose 1, single (Batch/Lot number: unknown) and on 01Apr2021 as dose 2, single (Batch/Lot number: unknown), all intramuscular for covid-19 immunisation; adalimumab (HUMIRA), from 2016 (Batch/Lot number: unknown) to 2021, subcutaneous for juvenile idiopathic 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 23Dec2021, outcome "recovered" and all described as "COVID-19". The action taken for adalimumab was dosage permanently withdrawn in 2021. Additional information: Company's opinion was that the causality for the event(s) of COVID-19 with Pfizer BioNTech COVID-19 vaccine (Tozinameran) was Not Provided. The reporter's causality for the event(s) of COVID-19, with Adalimumab Solution for Injection was Not Provided  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: Based on the available information, close temporal association and known product profile, a possible causal relationship cannot be excluded between the suspect vaccine bnt162b2 and the reported events DRUG INEFFECTIVE and SUSPECTED COVID-19.
Sex: M
Vaccine: COVID19
Symptoms: Hypertensive crisis
Clinical narrative: hypertensive crisis; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). Other Case identifier(s): 2022NVX-US-000004148.  A male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), in 2022 as dose 5 (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; Bnt162b2 (DOSE 4 (BOOSTER), SINGLE), for Covid-19 immunization. The following information was reported: HYPERTENSIVE CRISIS (medically significant) with onset 2022, outcome "unknown". Therapeutic measures were taken as a result of hypertensive crisis.  Clinical course: On 07Nov2022, it was reported that a patient started treatment on an unspecified date with Pfizer BioNTech COVID-19 Vaccine at 5 doses for COVID-19 immunisation. It was reported the patient experienced hypertensive crisis and now the patient was on four high-blood pressure pills. No further follow-up is anticipated.  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: F
Vaccine: COVID19
Symptoms: Fatigue
Clinical narrative: Fatigue; This is a spontaneous report received from contactable reporter (Other HCP). Other Case identifier(s): LRN4778579.  A 47-year-old female patient received BNT162b2 (BNT162B2), on 05Mar2021 as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Multiple sclerosis" (ongoing). Concomitant medications included: OCREVUS taken for multiple sclerosis. The following information was reported: FATIGUE (non-serious) with onset 10Jul2021, outcome "recovered".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Chest discomfort, Nervousness, Overweight
Clinical narrative: chest issues; Nervous; overweight; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 16-year-old male patient received BNT162b2 (BNT162B2), on 31Jul2022 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: CHEST DISCOMFORT (non-serious), outcome "recovering", described as "chest issues"; NERVOUSNESS (non-serious), outcome "unknown", described as "Nervous"; OVERWEIGHT (non-serious), outcome "unknown".  Additional information: Patient was really scared that will get severely sick and die or go to hospital. Patient was scared gonna be hospitalized because was overweight and know being overweight is a big issue when having covid. What are my chances of being hospitalized? Very nervous also since I had a bad reaction to the vaccine will that make me more vulnerable with covid.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Asymptomatic COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: COVID a year ago Aug2021/caller was asymptomatic/didn't have symptoms; COVID a year ago Aug2021/caller was asymptomatic/didn't have symptoms; This is a spontaneous report received from contactable reporter (Consumer or other non HCP). The reporter is the patient. Other Case identifier(s): MOD22-029797 (Moderna).  A 43-year-old male patient received BNT162b2 (BNT162B2), on 08Jul2021 as dose 1, single (Lot number: EY0586) for covid-19 immunisation. The patient had no relevant medical history. The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), ASYMPTOMATIC COVID-19 (medically significant) all with onset Aug2021, outcome "unknown" and all described as "COVID a year ago Aug2021/caller was asymptomatic/didn't have symptoms". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (Aug2021) Positive. Therapeutic measures were not taken as a result of drug ineffective, asymptomatic covid-19. Clinical course: Medical History relating to the mentioned AE and both acute and chronic illnesses at the time of vaccination was reported as no complete information for each condition and no allergies (medications, food and other products). No history of Myocarditis/pericarditis. Flu vaccine was received by the patient at the end of 2021. No hospitalization due to COVID-19.
Sex: M
Vaccine: COVID19-2
Symptoms: Urticaria
Clinical narrative: He got hives all over his body; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation; BNT162b2 (BNT162B2), as dose 1, single (Batch/Lot number: unknown) and as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: URTICARIA (non-serious), outcome "unknown", described as "He got hives all over his body".  Additional information: On 08Nov2022, it was reported that a patient started treatment on an unspecified date with Pfizer BioNTech COVID-19 Vaccine at primary series (2 doses) and a booster for COVID-19 immunization. It was reported the patient had a reaction, and the reaction was that he got hives all over his body.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: U
Vaccine: COVID19-2
Symptoms: Hypersensitivity
Clinical narrative: Reporting an allergic reaction to the bivalent booster; 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 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; Unknown manufacturer), for COVID-19 immunization. The following information was reported: HYPERSENSITIVITY (non-serious), outcome "unknown", described as "Reporting an allergic reaction to the bivalent booster".  Additional information: Description of Event Outcome: Hello please provide information for reporting an allergic reaction to the bivalent booster. I want to report this for science.  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: F
Vaccine: COVID19
Symptoms: Pharyngitis streptococcal
Clinical narrative: currently taking antibiotics for her strep throat; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 70-year-old female patient received BNT162b2 (BNT162B2), as dose 1, single (Batch/Lot number: unknown) and as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: PHARYNGITIS STREPTOCOCCAL (medically significant), outcome "unknown", described as "currently taking antibiotics for her strep throat". Therapeutic measures were taken as a result of pharyngitis streptococcal.  Clinical information: Caller, 70 years of age, was getting ready for her third dose of the Pfizer COVID-19 vaccine, Caller was currently taking antibiotics for her strep throat. The caller wanted to know if she could take the booster or if she needed to complete her antibiotics by tomorrow. created manual form because the caller mentioned that she had a sore throat and getting ready for her third dose (adverse event in between doses).  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202201325135 same reporter, different dose and event;
Age: 5.0
Sex: M
Vaccine: FLU3
Symptoms: Expired product administered, Medication error, Pain in extremity, Product expiration date issue
Clinical narrative: Wrong expiration written on outside by employee-Wrote 10 weeks out, after short dated drug received; Arm Sore; Initial information received on 14-Nov-2022 regarding an unsolicited valid  non-serious case received from a consumer/non-hcp.  This case involves a 5 years old male patient who experienced arm sore and wrong expiration written on outside by employee-wrote 10 weeks out, after short dated drug received while receiving vaccine INFLUENZA USP TRIVAL A-B VACCINE - UNSPECIFIED [FLUZONE UNSP].  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  On 20-Oct-2022, the patient received a  dose of suspect INFLUENZA USP TRIVAL A-B VACCINE - UNSPECIFIED lot GT774YJA via intramuscular route in unknown administration site for immunization.  On 21-OCT-2022 the patient developed a non-serious arm sore (pain in extremity) 1 day following the administration of INFLUENZA USP TRIVAL A-B VACCINE - UNSPECIFIED. On an unknown date the patient developed a non-serious wrong expiration written on outside by employee-wrote 10 weeks out, after short dated drug received (expired product administered) (unknown latency) following the administration of INFLUENZA USP TRIVAL A-B VACCINE - UNSPECIFIED.  Action taken was not applicable.  It was not reported if the patient received a corrective treatment for the events.  At time of reporting, the outcome was Recovered / Resolved on an unknown date for the event arm sore and was Unknown for the event wrong expiration written on outside by employee-wrote 10 weeks out, after short dated drug received.     This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the Regulatory 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: I got one 15 years ago, then I got the flu, haven't had the shot or the flu since then; Initial information received on 17-Nov-2022 regarding an unsolicited valid Social Media non-serious case received from a consumer/non-HCP.  This case involves an unknown age and unknown gender patient who said that I got one 15 years ago, then I got the flu, haven't had the shot or the flu since then after receiving 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 by unknown manufacturer (strength, dose, formulation, frequency, lot number and expiry date: not reported) via unknown route in unknown administration site for Prophylactic vaccination (Immunisation).  On an unknown date the patient had a non-serious event, "I got one 15 years ago, then I got the flu, haven't had the shot or the flu since then (influenza)" (unknown latency) following the administration of INFLUENZA VACCINE.  It was reported, "Description: Not today flu shot, I got one 15 years ago, then I got the flu, haven't had the shot or the flu since then. Since this is a public post we are assuming the consumer is referring to the Sanofi flu vaccine."  No lab data was reported.  Action taken was not applicable.  It was not reported if the patient received a corrective treatment for the event.  At time of reporting, the outcome was Unknown.
Sex: U
Vaccine: FLUX
Symptoms: Influenza
Clinical narrative: The only time I get the flu is when I take that shot; Initial information received from on 18-Nov-2022 regarding an unsolicited valid Social Media non-serious case received from a consumer/non-hcp.  This case involves an Adult  patient  with unknown gender who experienced the only time i get the flu is when i take that shot while 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 (batch no and expiry date unknown), frequency, route, strength, dose was unknown) for Prophylactic vaccination   On an unknown date the patient developed a non-serious the only time i get the flu is when i take that shot (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.  At time of reporting, the outcome was Unknown for the event the only time i get the flu is when i take that shot.
Sex: U
Vaccine: FLUX
Symptoms: Influenza
Clinical narrative: I caught the flu; Initial information received on 18-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 caught the flu after receiving 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 caught the flu (influenza) after receiving an unknown dose of suspect Influenza vaccine produced by unknown manufacturer lot number not reported via unknown route in unknown administration site for Influenza immunization with unknown form, strength, frequency, expiry date.  Action taken: not applicable.  It was not reported if the patient received a corrective treatment for the event (I caught the flu ).  Outcome: Unknown.
Sex: U
Vaccine: FLUX
Symptoms: Malaise
Clinical narrative: sick; Initial information received on 18-Nov-2022 regarding an unsolicited valid Social Media non-serious case received from a consumer/non-hcp.  This case involves an unknown age and unknown gender patient who experienced sick after receiving influenza vaccine.  The patient's past medical history, medical treatment(s), vaccination(s), concomitant(s) and family history were not provided.   On an unknown date, the patient received a dose of suspect influenza vaccine produced by unknown manufacturer via unknown route in unknown administration site. with unknown formulation, strength, batch number & expiry date for prophylactic vaccination. Batch number was requested.  On an unknown date the patient developed sick (malaise) (unknown latency).  It is unknown if the patient experienced any additional symptoms/events.  No lab data was reported.  Action taken: not applicable.  It was not reported if the patient received a corrective treatment.  Outcome: Unknown.
Sex: U
Vaccine: FLUX
Symptoms: Illness, Malaise
Clinical narrative: sick for two weeks; Initial information received on 19-Nov-2022 regarding an unsolicited valid Social Media non-serious case received from a consumer/non-HCP.  This case involves an unknown age and unknown gender patient who became sick for two weeks after receiving 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 1 DF (Dosage form) of suspect influenza vaccine produced by unknown manufacturer (with an unknown strength, formulation, frequency, route, expiry date, batch number, administration site) for prophylactic vaccination.   On an unknown date the patient developed a non-serious event sick for two weeks (illness) (unknown latency) following the administration of influenza vaccine.  Action taken was not applicable.  It was not reported if the patient received a corrective treatment for the event   Outcome was Unknown for the event sick for two weeks.
Sex: U
Vaccine: FLUX
Symptoms: Illness, Malaise
Clinical narrative: got my flu shot and im sick is a dog; Initial information received on 19-Nov-2022 regarding an unsolicited valid Social Media non-serious case received from a consumer.  This case involves an unknown age and unknown gender patient who experienced "got his/ her flu shot and got sick is a dog" while 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 (lot number, Expiry date :not reported) via unknown route in unknown administration site (form, strength, dose, frequency: unknown) for flu prophylaxis. information regarding batch number has been requested.  On an unknown date the patient developed a non-serious event "got his/her flu shot and got sick is a dog" (illness) (unknown latency) following the administration of INFLUENZA VACCINE.  Action taken with INFLUENZA VACCINE was not applicable.  At time of reporting, the outcome was Unknown for the event.