chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
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 60-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 08Mar2021 as dose 1, single (Batch/Lot number: unknown), in left arm and on 29Mar2021 as dose 2, single (Batch/Lot number: unknown) at the age of 58 years, in left arm for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Past drug history included: Asa, reaction(s): "known allergies: ASA", notes: known allergies: ASA. It was unknown that patient took any other medications in 2 weeks. The following information was reported: VACCINATION FAILURE (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: Treatment of COVID-19. Therapeutic measures were taken as a result of vaccination failure, covid-19.   The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Sex: M
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: diagnosed with COVID today; diagnosed with COVID today; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A 55-year-old male patient received BNT162b2 (BNT162B2), as dose 5 (booster), single (Batch/Lot number: unknown) 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 included: "Ehlers Dahloss" (unspecified if ongoing), notes: Ehlers Dahloss; "Stroke" (unspecified if ongoing). Concomitant medication(s) included: FLU [INFLUENZA VACCINE] taken for immunisation as dose number unknown, single. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 21Dec2022 at 11:00, outcome "not recovered" and all described as "diagnosed with COVID today". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (21Dec2022) Positive. Therapeutic measures were not taken as a result of drug ineffective, covid-19.  Clinical course: The patient had no known allergies. No covid prior vaccination and covid tested post vaccination was reported as yes. It was reported that, the patient became aware of the adverse events on 21Dec same day as the report was filed.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 39.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: COVID 19; COVID 19; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP) from product quality group. The reporter is the patient.  A 39-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 23Sep2022 as dose 4 (booster), single (Lot number: GJ2529) at the age of 39 years for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) included: ALLOPURINOL. Past drug history included: Ampicillin, reaction(s): "known allergies: Ampicillin". The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID 19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive, notes: COVID 19 Treatment. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical course: The patient received Paxlovid (start date: 07Dec2022, stop date: 11Dec2022) as treatment.  No follow-up attempts are possible. No further information is expected.
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Embolism, Full blood count, Platelet count, Platelet count decreased
Clinical narrative: thromboembolic events; She had the Pfizer mRNA Covid vaccine in Feb2021. In Mar2021 her platelets were at 135,000; This is a spontaneous report received from a contactable reporter(s) (Pharmacist). The reporter is the patient.  A 62-year-old female patient received BNT162b2 (BNT162B2), on 25Feb2021 as dose 2, single (Lot number: EN6201) at the age of 61 years intramuscular, in right arm for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. Vaccination history included: BNT162b2 (DOSE 1, SINGLE; Date and Time of Start of Drug: 04Feb2021, Batch/lot number: EZ9265, one time intramuscular injection right arm, Pharmaceutical form (Dosage form): Suspension), administration date: 04Feb2021, when the patient was 61-year-old, for COVID-19 immunization. The following information was reported: PLATELET COUNT DECREASED (caused and prolonged hospitalization, medically significant) with onset Mar2021, outcome "not recovered", described as "She had the Pfizer mRNA Covid vaccine in Feb2021. In Mar2021 her platelets were at 135,000"; EMBOLISM (caused and prolonged hospitalization, medically significant) with onset Mar2021, outcome "unknown", described as "thromboembolic events". The patient underwent the following laboratory tests and procedures: Full blood count: (unspecified date) decreased platelet, notes: had a CBC with differential and that is how they discovered the decreased platelet; Platelet count: (2020) 187,000, notes: In 2020 before any vaccine at her physical her platelets were 187,000; (Mar2021) 135,000, notes: decreased; (unspecified date) Unknown results.  Clinical course: Reported that in 2020 before any vaccine at her physical her platelets were 187,000. She had the Pfizer mRNA Covid vaccine in Feb2021 had two doses three weeks apart. In Mar2021 her platelets were at 135,000. In Dec2021 she had the first booster. Any other vaccinations within four weeks prior to the first administration date of the suspect vaccine(s) was none reported. There was investigation assessment. For thromboembolic events with thrombocytopenia: Yes had a CBC with differential and that was how they discovered the decreased platelet. It was first noticed at her physical. Initially, they were not specifically looking for it. They also did titrated platelet level. Antibody test to platelet factor IV was none reported.; Sender's Comments: Based on known drug safety profile, there is reasonable possibility of causal association between the reported event of platelet count decreased and embolism and BNT162B2. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
Age: 55.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, Interchange of vaccine products, SARS-CoV-2 test
Clinical narrative: Moderna Dose Number: 2; Pfizer / BioNTech Dose Number: 3; 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 55-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 08Nov2022 as dose 5 (booster), single (Batch/Lot number: unknown) at the age of 55 years, in left arm for covid-19 immunisation; BNT162b2 (BNT162B2), on 30Nov2021 as dose 3 (booster), single (Batch/Lot number: unknown), in left arm and on 23Apr2022 as dose 4 (booster), single (Batch/Lot number: unknown), in left arm for covid-19 immunisation; elasomeran (MODERNA COVID-19 VACCINE), on 28Mar2021 as dose 1, single (Batch/Lot number: unknown), in left arm and on 23Apr2021 as dose 2, single (Batch/Lot number: unknown), in left arm for covid-19 immunisation. The patient's relevant medical history included: "broken arm" (unspecified if ongoing), notes: Currently recovering from broken arm. The patient had no known allergies. Concomitant medication(s) included: OXYCODONE, start date: 15Nov2022, stop date: 21Dec2022. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Dec2022, outcome "unknown" and all described as "Treatment of COVID-19"; INTERCHANGE OF VACCINE PRODUCTS (medically significant), outcome "unknown", described as "Moderna Dose Number: 2; Pfizer / BioNTech Dose Number: 3". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (Dec2022) Positive. Therapeutic measures were taken as a result of drug ineffective, covid-19 for which included PF-07321332, ritonavir (PAXLOVID) from 06Dec2022 to 11Dec2022.  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.
Age: 61.0
Sex: F
Vaccine: COVID19, FLUC3
Symptoms: Asthenia, Fatigue, Lymph node pain, Lymphadenopathy, Off label use
Clinical narrative: Both flu and covid vaccine in left arm/ administration date = 19Dec2022; Both flu and covid vaccine in left arm/ administration date = 19Dec2022; Body aches; weak; tired; arm soreness; swollen lymph nodes; Painful lymph nodes; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 61-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 19Dec2022 at 16:45 as dose 1, single (Lot number: FR2587) at the age of 61 years, in left arm for covid-19 immunisation; influenza vaccine inact sag 3v (FLUCELVAX), on 19Dec2022 as dose 1, single (Batch/Lot number: unknown), in left arm for immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: PAIN (non-serious) with onset 19Dec2022, outcome "recovering", described as "Body aches"; PRODUCT USE ISSUE (non-serious), OFF LABEL USE (non-serious) all with onset 19Dec2022, outcome "unknown" and all described as "Both flu and covid vaccine in left arm/ administration date = 19Dec2022"; LYMPH NODE PAIN (non-serious) with onset 19Dec2022, outcome "recovering", described as "Painful lymph nodes"; PAIN IN EXTREMITY (non-serious) with onset 19Dec2022, outcome "recovering", described as "arm soreness"; LYMPHADENOPATHY (non-serious) with onset 19Dec2022, outcome "recovering", described as "swollen lymph nodes"; FATIGUE (non-serious) with onset 19Dec2022, outcome "recovering", described as "tired"; ASTHENIA (non-serious) with onset 19Dec2022, outcome "recovering", described as "weak". Therapeutic measures were taken as a result of pain, asthenia, fatigue, pain in extremity, lymphadenopathy, lymph node pain.  Additional information: it was reported that no other vaccine in four weeks. Took 1000 mg. Tylenol 16 hours after injection, switched to Alleve 24 hours after injections. Tylenol 1,000 mg 38 hours after injections. It was reported that no treatment received for AE (not updated in tab). No covid prior vaccination and no covid tested post vaccination.
Age: 61.0
Sex: F
Vaccine: COVID19, FLUC3
Symptoms: Pain, Pain in extremity, Product use issue
Clinical narrative: Both flu and covid vaccine in left arm/ administration date = 19Dec2022; Both flu and covid vaccine in left arm/ administration date = 19Dec2022; Body aches; weak; tired; arm soreness; swollen lymph nodes; Painful lymph nodes; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 61-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 19Dec2022 at 16:45 as dose 1, single (Lot number: FR2587) at the age of 61 years, in left arm for covid-19 immunisation; influenza vaccine inact sag 3v (FLUCELVAX), on 19Dec2022 as dose 1, single (Batch/Lot number: unknown), in left arm for immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: PAIN (non-serious) with onset 19Dec2022, outcome "recovering", described as "Body aches"; PRODUCT USE ISSUE (non-serious), OFF LABEL USE (non-serious) all with onset 19Dec2022, outcome "unknown" and all described as "Both flu and covid vaccine in left arm/ administration date = 19Dec2022"; LYMPH NODE PAIN (non-serious) with onset 19Dec2022, outcome "recovering", described as "Painful lymph nodes"; PAIN IN EXTREMITY (non-serious) with onset 19Dec2022, outcome "recovering", described as "arm soreness"; LYMPHADENOPATHY (non-serious) with onset 19Dec2022, outcome "recovering", described as "swollen lymph nodes"; FATIGUE (non-serious) with onset 19Dec2022, outcome "recovering", described as "tired"; ASTHENIA (non-serious) with onset 19Dec2022, outcome "recovering", described as "weak". Therapeutic measures were taken as a result of pain, asthenia, fatigue, pain in extremity, lymphadenopathy, lymph node pain.  Additional information: it was reported that no other vaccine in four weeks. Took 1000 mg. Tylenol 16 hours after injection, switched to Alleve 24 hours after injections. Tylenol 1,000 mg 38 hours after injections. It was reported that no treatment received for AE (not updated in tab). No covid prior vaccination and no covid tested post vaccination.
Age: 60.0
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) from product quality group. The reporter is the patient.  A 60-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 17Oct2022 at 18:00 as dose 5 (booster), single (Lot number: GH9693) at the age of 60 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 included: "Hypothyroidism" (unspecified if ongoing); "Obesity" (unspecified if ongoing); "known allergies: Penicillin" (unspecified if ongoing). Concomitant medication(s) included: LEVOTHYROXINE. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (unspecified date) Positive, notes: COVID 19 Treatment; (21Dec2022) Positive, notes: Tested positive again on 21Dec2022. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical course: Product: COVID 19 Treatment, Paxlovid, Treatment start date: 08Dec2022, Treatment stop date: 13Dec2022. Rebound case of Covid. Tested positive again on 21Dec2022.
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Illness
Clinical narrative: The second shot made me very sick as well-Down for 6 days; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 67-year-old female patient received BNT162b2 (BNT162B2), on 24Mar2021 as dose 2, single (Lot number: EP7534) at the age of 66 years intramuscular, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Hashimoto" (ongoing). Concomitant medication(s) included: NP THYROID taken for autoimmune thyroiditis (ongoing). Vaccination history included: BNT162b2 (DOSE 1, SINGLE; Administration time: 10:00 AM, Route of administration: Intramuscular, Anatomical location: Right arm, Lot number: EN6198), administration date: 03Mar2021, when the patient was 66-year-old, for COVID-19 immunization. The following information was reported: ILLNESS (non-serious), outcome "recovered", described as "The second shot made me very sick as well-Down for 6 days". The event "the second shot made me very sick as well-down for 6 days" required emergency room visit.  Additional information: The patient did not received any other vaccine within the 4 weeks prior to vaccination. The reporter notified that there are too many tests to list for lab data. The patient is a very healthy Individual very active and did not get COVID. Still work, had business 38 years, care for 3 workers, eat organic. Have many witnesses who can testify to the fact that was basically paralysed within days of the booster. The second shot made the patient very sick as well-Down for 6 days. The patient had 2 emergency room visits and no one could figure out why the patient was in such state. The patient was under the care of 2 osteopaths, 2 Neurologists, 1 Rheumatologist and now 1 Cardiologist.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202201346544 same patient/drug/event, different dose;US-PFIZER INC-PV202200116558 same reporter/drug, different events/patient;
Age: 12.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: Sore arm; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A 12-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 20Dec2022 as dose 4 (booster), single (Lot number: GJ6738) at the age of 12 years intramuscular, in left arm for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: BNT162b2 (Prev dose product=COVID 19, Prev dose brand=Pfizer, Prev dose brand unknown=False, Is bivalent=False, Prev dose lot number=FJ4985, Prev dose lot unknown=False, Prev dose administrator route=Intramuscular, Prev dose administration date=21May2022, Prev dose dose number=3), administration date: 21May2022, when the patient was 11-year-old, for COVID-19 immunization; BNT162b2 (Prev dose product=COVID 19, Prev dose brand=Pfizer, Prev dose brand unknown=False, Is bivalent=False, Prev dose lot number=FK5127, Prev dose lot unknown=False, Prev dose administrator route=Intramuscular,, Prev dose administration date=26Nov2021, Prev dose dose number=2), administration date: 26Nov2021, when the patient was 10-year-old, for COVID-19 immunization; BNT162b2 (Prev dose product=COVID 19, Prev dose brand=Pfizer, Prev dose brand unknown=False, Is bivalent=False, Prev dose lot number=FK5127, Prev dose lot unknown=False, Prev dose administrator route=Intramuscular, Prev dose administration date=05Nov2021, Prev dose dose number=1), administration date: 05Nov2021, when the patient was 10-year-old, for COVID-19 immunization. The following information was reported: PAIN IN EXTREMITY (non-serious) with onset 20Dec2022, outcome "recovering", described as "Sore arm". Therapeutic measures were not taken as a result of pain in extremity.
Age: 37.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: COVID-19; COVID-19; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 37-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 19Nov2022 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 37 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) and as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Mild asthma" (unspecified if ongoing); "known allergies: Adhesive tape" (unspecified if ongoing). Concomitant medication(s) included: WELLBUTRIN; ZOLOFT; FLONASE [FLUTICASONE PROPIONATE]. 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". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (2022) Positive, notes: Symptoms were gone and my positive test line was very faint; (2022) Positive, notes: Now my positive line is very dark. Therapeutic measures were taken as a result of drug ineffective, covid-19 which included Paxlovid from 12Dec2022 to 16Dec2022.   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, COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: Taking Paxlovid for COVID virus; Taking Paxlovid for COVID virus; This is a spontaneous report received from a contactable reporter (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), as dose number unknown (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: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "Taking Paxlovid for COVID virus". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Negative. Therapeutic measures were taken as a result of drug ineffective, COVID-19. Clinical course: The patient reported that she and her husband were on Paxlovid. She reported that all her shots were from Pfizer, her booster and everything. She did a home test on an unspecified date and it was negative.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: U
Vaccine: COVID19
Symptoms: Thrombosis
Clinical narrative: Linked to blood clotting; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  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: THROMBOSIS (medically significant), outcome "unknown", described as "Linked to blood clotting".  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: Bursitis, Chest pain, Headache, Joint swelling, Myocarditis
Clinical narrative: Like myocarditis she thinks; it hurts; had bursitis in her elbow/her elbow was the size of an orange.; elbow swollen; shoulder swollen; random pains in her heart; random pains in her chest; has random pains in her head like a headache; 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 20Dec2022 at 03:30 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: MYOCARDITIS (medically significant) with onset Dec2022, outcome "unknown", described as "Like myocarditis she thinks; it hurts"; JOINT SWELLING (non-serious) with onset Dec2022, outcome "unknown", described as "elbow swollen"; BURSITIS (non-serious) with onset Dec2022, outcome "unknown", described as "had bursitis in her elbow/her elbow was the size of an orange."; HEADACHE (non-serious) with onset Dec2022, outcome "unknown", described as "has random pains in her head like a headache"; CHEST PAIN (non-serious) with onset Dec2022, outcome "unknown", described as "random pains in her chest"; PAIN (non-serious) with onset Dec2022, outcome "unknown", described as "random pains in her heart"; JOINT SWELLING (non-serious) with onset Dec2022, outcome "unknown", described as "shoulder swollen".  Clinical course: It was reported that patient had the new COVID Bivalent booster yesterday at 3:30. Caller rambling on despite attempts to redirect; unable to clarify details. Needle went through the muscle and it had hit the bursa and by 4:45 her elbow was the size of an orange. Was an inflammatory response of the body it had to protect itself. Had bursitis in her elbow and shoulder and now she can barely move her shoulder. Her shoulder is swollen and elbow is the size of an orange. Her elbow was also swollen. It also hurts. Caller wants it know to tell people to make sure pinch muscle up and get only in the muscle and not go through the muscle and hit the bursa. Caller rambling on despite attempts to redirect; unable to clarify details. Random stabbing pains in her heart and chest. Like myocarditis she thinks; it hurts. Doctor will do echocardiogram can't do until 27th. Has random pains in head like a headache for like 5 minutes then it goes away, but comes back in half an hour later. Patient supposed to do if she had an adverse reaction like this.   The lot number for [BNT162b2, BNT162b2 omi ba.4-5], was not provided and will be requested during follow up.
Sex: F
Vaccine: COVID19
Symptoms: Pain
Clinical narrative: Like myocarditis she thinks; it hurts; had bursitis in her elbow/her elbow was the size of an orange.; elbow swollen; shoulder swollen; random pains in her heart; random pains in her chest; has random pains in her head like a headache; 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 20Dec2022 at 03:30 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: MYOCARDITIS (medically significant) with onset Dec2022, outcome "unknown", described as "Like myocarditis she thinks; it hurts"; JOINT SWELLING (non-serious) with onset Dec2022, outcome "unknown", described as "elbow swollen"; BURSITIS (non-serious) with onset Dec2022, outcome "unknown", described as "had bursitis in her elbow/her elbow was the size of an orange."; HEADACHE (non-serious) with onset Dec2022, outcome "unknown", described as "has random pains in her head like a headache"; CHEST PAIN (non-serious) with onset Dec2022, outcome "unknown", described as "random pains in her chest"; PAIN (non-serious) with onset Dec2022, outcome "unknown", described as "random pains in her heart"; JOINT SWELLING (non-serious) with onset Dec2022, outcome "unknown", described as "shoulder swollen".  Clinical course: It was reported that patient had the new COVID Bivalent booster yesterday at 3:30. Caller rambling on despite attempts to redirect; unable to clarify details. Needle went through the muscle and it had hit the bursa and by 4:45 her elbow was the size of an orange. Was an inflammatory response of the body it had to protect itself. Had bursitis in her elbow and shoulder and now she can barely move her shoulder. Her shoulder is swollen and elbow is the size of an orange. Her elbow was also swollen. It also hurts. Caller wants it know to tell people to make sure pinch muscle up and get only in the muscle and not go through the muscle and hit the bursa. Caller rambling on despite attempts to redirect; unable to clarify details. Random stabbing pains in her heart and chest. Like myocarditis she thinks; it hurts. Doctor will do echocardiogram can't do until 27th. Has random pains in head like a headache for like 5 minutes then it goes away, but comes back in half an hour later. Patient supposed to do if she had an adverse reaction like this.   The lot number for [BNT162b2, BNT162b2 omi ba.4-5], was not provided and will be requested during follow up.
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Interchange of vaccine products, SARS-CoV-2 test, Vaccination failure
Clinical narrative: COVID-19; COVID-19; Interchange of vaccine products; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 63-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 02Mar2021 as dose 1, single (Lot number: EN6203), in left arm, on 24Mar2021 as dose 2, single (Batch/Lot number: unknown), in left arm and on 07Oct2021 as dose 3 (booster), single (Lot number: FF8841) at the age of 61 years, in right arm for covid-19 immunisation; elasomeran (MODERNA COVID-19 VACCINE), on 10Apr2022 at 13:00 as dose 4 (booster), single (Lot number: 048L21A), in right arm and on 23Sep2022 as dose 5 (booster), single (Lot number: AS7148B), in left arm for covid-19 immunisation. The patient's relevant medical history included: "Diabetic" (unspecified if ongoing); "cholesterol" (unspecified if ongoing); "high blood pressure" (unspecified if ongoing). Concomitant medication(s) included: INSULIN; TRESIBA. The following information was reported: INTERCHANGE OF VACCINE PRODUCTS (medically significant) with onset 23Sep2022, outcome "unknown"; VACCINATION FAILURE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: positive, notes: Retesting positive for Covid after 2 days of testing negative; negative, notes: Retesting positive for Covid after 2 days of testing negative. Therapeutic measures were taken as a result of vaccination failure, covid-19.  Clinical course: Known allergies: Yes. Patient received COVID-19 treatment.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 44.0
Sex: F
Vaccine: COVID19
Symptoms: Epistaxis, Wrong product administered
Clinical narrative: Bloody nose for a hour. about 6 hours after shot haven't had a bloody nose in years; is bivalent True/dose number: 1; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 44-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 21Dec2022 at 12:15 as dose 1 (bivalent), single (Batch/Lot number: unknown) at the age of 44 years, in right arm for covid-19 immunisation. The patient didn't receive BNT162b2 (BNT162B2). The patient's relevant medical history included: "High BP" (unspecified if ongoing), notes: High BP; "Known allergies: Penicillin" (unspecified if ongoing), notes: Known allergies: Penicillin. There were no concomitant medications. The following information was reported: WRONG PRODUCT ADMINISTERED (non-serious) with onset 21Dec2022 at 12:15, outcome "unknown", described as "is bivalent True/dose number: 1"; EPISTAXIS (non-serious) with onset 21Dec2022 at 18:00, outcome "unknown", described as "Bloody nose for a hour. about 6 hours after shot haven't had a bloody nose in years". It was unknown if therapeutic measures were taken as a result of epistaxis. Additional information: the patient didn't receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient wasn't diagnosed with COVID-19. Since the vaccination, the patient hasn't been tested for COVID-19. 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: F
Vaccine: COVID19
Symptoms: Arthralgia
Clinical narrative: sore shoulder for a day or two; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP), Program ID. The reporter is the patient.  A female patient 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: Bnt162b2 (DOSE 1, SINGLE, sore shoulder for a day or two, ), for COVID-19 immunization, reaction(s): "sore shoulder for a day or two". The following information was reported: ARTHRALGIA (non-serious), outcome "recovered", described as "sore shoulder for a day or two".  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-PV202200129597 same patient/vaccine/event, different dose;
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia
Clinical narrative: I have had all my Pizer vaccinations and boosters except the one for the Omicron booster which was Moderna. I have never had a reaction to any of them except a sore shoulder for a day or two; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP), Program ID. The reporter is the patient.  A female patient received BNT162b2 (BNT162B2), 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: Bnt162b2 (DOSE 1, SINGLE), for COVID-19 immunization, reaction(s): "I have had all my Pizer vaccinations and boosters except the one for the Omicron booster which was Moderna. I have never had a reaction to any of them except a sore shoulder for a day or two"; Bnt162b2 (DOSE 2, SINGLE), for COVID-19 immunization, reaction(s): "I have had all my Pizer vaccinations and boosters except the one for the Omicron booster which was Moderna. I have never had a reaction to any of them except a sore shoulder for a day or two". The following information was reported: ARTHRALGIA (non-serious), outcome "recovered", described as "I have had all my Pizer vaccinations and boosters except the one for the Omicron booster which was Moderna. I have never had a reaction to any of them except a sore shoulder for a day or two".  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-PV202200129597 same patient/vaccine/event, different dose;
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia
Clinical narrative: Sore shoulder; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP), Program ID. The reporter is the patient.  A female patient received BNT162b2 (BNT162B2), as dose 4 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (DOSE 1, SINGLE), for COVID-19 immunization, reaction(s): "sore shoulder for a day or two"; Bnt162b2 (DOSE 2, SINGLE), for COVID-19 immunization, reaction(s): "sore shoulder for a day or two"; Bnt162b2 (DOSE 3 (BOOSTER), SINGLE), for COVID-19 immunization, reaction(s): "sore shoulder for a day or two". The following information was reported: ARTHRALGIA (non-serious), outcome "recovered", described as "Sore shoulder".  Additional information: The patient had all Pizer vaccinations and boosters except the one for the Omicron booster which was Moderna. The patient had never had a reaction to any of them except a sore shoulder for a day or two.  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-PV202200129597 same patient/vaccine/event, different dose;
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Deafness, Tinnitus
Clinical narrative: Noticed ringing in my ears; Have lost half of my hearing ability; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 63-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), in 2020 as dose 2, single (Lot number: ER8729), in left arm for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. Vaccination history included: Bnt162b2 (Dose Number: 1, Batch/Lot No: Unknown, Location of injection: Arm Left), administration date: 2020, for COVID-19 immunization. The following information was reported: DEAFNESS (medically significant) with onset 2020, outcome "not recovered", described as "Have lost half of my hearing ability"; TINNITUS (non-serious) with onset 2022, outcome "not recovered", described as "Noticed ringing in my ears". The events "have lost half of my hearing ability" and "noticed ringing in my ears" required physician office visit. Therapeutic measures were taken as a result of deafness, tinnitus.  Clinical course: the patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient did not receive any other medications within 2 weeks of vaccination. Prior to vaccination, the patient was not diagnosed with COVID-19. Patient was noticed ringing in ears. Over the course of many months-have lost half of hearing ability. Now have to use hearing aids. The adverse event resulted in doctor or other healthcare professional office/clinic visit.
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: Noticed ringing in my ears; Have lost half of my hearing ability; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 63-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), in 2020 as dose 2, single (Lot number: ER8729), in left arm for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. Vaccination history included: Bnt162b2 (Dose Number: 1, Batch/Lot No: Unknown, Location of injection: Arm Left), administration date: 2020, for COVID-19 immunization. The following information was reported: DEAFNESS (medically significant) with onset 2020, outcome "not recovered", described as "Have lost half of my hearing ability"; TINNITUS (non-serious) with onset 2022, outcome "not recovered", described as "Noticed ringing in my ears". The events "have lost half of my hearing ability" and "noticed ringing in my ears" required physician office visit. Therapeutic measures were taken as a result of deafness, tinnitus.  Clinical course: the patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient did not receive any other medications within 2 weeks of vaccination. Prior to vaccination, the patient was not diagnosed with COVID-19. Patient was noticed ringing in ears. Over the course of many months-have lost half of hearing ability. Now have to use hearing aids. The adverse event resulted in doctor or other healthcare professional office/clinic visit.
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Deafness, Tinnitus
Clinical narrative: COVID test result Positive; COVID test result Positive; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 63-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), in 2020 as dose 1, single (Batch/Lot number: unknown), in left arm and in 2020 as dose 2, single (Lot number: ER8729), in left arm 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), COVID-19 (medically significant) all with onset 30Dec2021, latency 1 year 8 months 17 days after the suspect product(s) administration, outcome "unknown" and all described as "COVID test result Positive". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (30Dec2021) Positive.  Additional information: No other vaccines received by the patient within 4 weeks prior to the COVID vaccine. No other medications received by the patient within 2 weeks of vaccination. Patient was not diagnosed with COVID-19 prior to vaccination.
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: COVID test result Positive; COVID test result Positive; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 63-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), in 2020 as dose 1, single (Batch/Lot number: unknown), in left arm and in 2020 as dose 2, single (Lot number: ER8729), in left arm 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), COVID-19 (medically significant) all with onset 30Dec2021, latency 1 year 8 months 17 days after the suspect product(s) administration, outcome "unknown" and all described as "COVID test result Positive". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (30Dec2021) Positive.  Additional information: No other vaccines received by the patient within 4 weeks prior to the COVID vaccine. No other medications received by the patient within 2 weeks of vaccination. Patient was not diagnosed with COVID-19 prior to vaccination.
Age: 17.0
Sex: M
Vaccine: COVID19
Symptoms: Off label use, Peripheral swelling, Product use issue, Rash
Clinical narrative: Swelling of fingers; Rash on knee and elbows; Patient received BNT162B2 and FLU VACCINE VII on 18Nov2022; Patient received BNT162B2 and FLU VACCINE VII on 18Nov2022; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the parent.  A 17-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 18Dec2022 at 10:30 as dose 3 (booster), single (Lot number: GJ6738) at the age of 17 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Peanut" (unspecified if ongoing), notes: Name of Drug as Reported: Peanut, tree nuts and shellfish , Reaction: Allergy; "Shellfish" (unspecified if ongoing), notes: Name of Drug as Reported: Peanut, tree nuts and shellfish , Reaction: Allergy; "Tree nuts" (unspecified if ongoing), notes: Name of Drug as Reported: Peanut, tree nuts and shellfish , Reaction: Allergy; "if covid prior vaccination: Yes" (unspecified if ongoing), notes: if covid prior vaccination: Yes. Concomitant medication(s) included: FLU VACCINE VII, on 18Nov2022 as dose 1, single; DOXYCYCLINE. Vaccination history included: comirnaty (DOSE 2, SINGLE; Lot number: FL3198), administration date: 27Dec2021, when the patient was 16-year-old, for COVID-19 immunization; comirnaty (DOSE 1, SINGLE; Lot number: EW0186), administration date: 09Jun2021, when the patient was 15-year-old, for COVID-19 immunization. The following information was reported: PRODUCT USE ISSUE (non-serious), OFF LABEL USE (non-serious) all with onset 18Dec2022 at 10:30, outcome "unknown" and all described as "Patient received BNT162B2 and FLU VACCINE VII on 18Nov2022"; RASH (non-serious) with onset 20Dec2022, outcome "not recovered", described as "Rash on knee and elbows"; PERIPHERAL SWELLING (non-serious) with onset 20Dec2022, outcome "not recovered", described as "Swelling of fingers". Therapeutic measures were taken as a result of peripheral swelling, rash.  Additional information: Prior to vaccination, patient was diagnosed with COVID-19. Since the vaccination, patient was not been tested for COVID-19.
Sex: M
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a contactable reporter(s) (Other HCP).  A 58-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; 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 included: "Htn" (unspecified if ongoing); "myasthenia gravis" (unspecified if ongoing); "hemochromatosis" (unspecified if ongoing). Concomitant medication(s) included: LISINOPRIL oral. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "Treatment of COVID-19". Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical course: Known allergies: None. The patient received COVID 19 treatment with Paxlovid orally from 09Dec2022 to 13Dec2022.   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: The vaccine efficacy varies from one patient to another and can be affected by different factors; however, a contributory role of the suspect vaccine BNT162B2 to its Lack of efficacy cannot be ruled out.
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Blood pressure measurement, Blood test, Body temperature, COVID-19, Drug ineffective
Clinical narrative: she also had 2 Pfizer COVID boosters; and still got COVID.; she also had 2 Pfizer COVID boosters; and still got COVID.; Caller states she has had 5 Covid Shots, the First 2 were Moderna, and then a mixture of Pfizer Booster doses; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A 73-year-old female patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 09Sep2022 as dose 5 (booster), single (Lot number: GH9694) at the age of 73 years for covid-19 immunisation; BNT162b2 (BNT162B2), on 30Mar2022 as dose 4 (booster), single (Lot number: FK9895) for covid-19 immunisation; elasomeran (MODERNA COVID-19 VACCINE), on 12Feb2021 as dose 1, single (Lot number: 006M2014), on 12Mar2021 as dose 2, single (Lot number: 0016219) and on 22Oct2021 as dose 3 (booster), single (Lot number: 047C2114) for covid-19 immunisation. The patient's relevant medical history included: "High Blood Pressure" (ongoing); "Premature atrial contraction" (ongoing); "Cholesterol" (ongoing). Concomitant medication(s) included: DILTIAZEM taken for supraventricular extrasystoles (ongoing); ROSUVASTATIN taken for blood cholesterol (ongoing); LOSARTAN (ongoing). The following information was reported: INTERCHANGE OF VACCINE PRODUCTS (medically significant) with onset 30Mar2022, outcome "unknown", described as "Caller states she has had 5 Covid Shots, the First 2 were Moderna, and then a mixture of Pfizer Booster doses"; DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 21Dec2022, outcome "unknown" and all described as "she also had 2 Pfizer COVID boosters; and still got COVID.". The patient underwent the following laboratory tests and procedures: Blood pressure measurement: 112/76; Blood test: States her blood work comes out okay; Body temperature: 100.1; Heart rate: 83; SARS-CoV-2 test: negative, notes: Covid test before that and it was negative; positive, notes: The rapid test was positive. Therapeutic measures, Paxlovid,  were taken as a result of drug ineffective, covid-19.