chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 39.0
Sex: F
Vaccine: COVID19
Symptoms: Paraesthesia oral
Clinical narrative: ache all over body; tiredness; arm pain; she is getting sick; her lips and tongue are a little numb and tingly; her lips and tongue are a little numb and tingly; her lips and tongue are a little numb and tingly; her lips and tongue are a little numb and tingly; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A 39-year-old female patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 12Sep2022 as dose 3 (booster), single (Lot number: GJ5342) at the age of 39 years, in right arm for covid-19 immunisation. The patient's relevant medical history included: "Blood pressure high" (unspecified if ongoing), notes: Comments: Blood pressure high; "Panic attacks" (unspecified if ongoing), notes: Comments: Panic attacks. The patient took concomitant medications. Vaccination history included: Moderna covid-19 vaccine (Primary immunization series completed), for Covid-19 immunization. The following information was reported: PAIN (non-serious) with onset 13Sep2022, outcome "unknown", described as "ache all over body"; PAIN IN EXTREMITY (non-serious) with onset 13Sep2022, outcome "unknown", described as "arm pain"; PARAESTHESIA ORAL (non-serious), HYPOAESTHESIA ORAL (non-serious), HYPOAESTHESIA ORAL (non-serious), PARAESTHESIA ORAL (non-serious) all with onset 13Sep2022, outcome "unknown" and all described as "her lips and tongue are a little numb and tingly"; ILLNESS (non-serious) with onset 13Sep2022, outcome "unknown", described as "she is getting sick"; FATIGUE (non-serious) with onset 13Sep2022, outcome "unknown", described as "tiredness". Therapeutic measures were taken as a result of pain, fatigue, pain in extremity, illness, paraesthesia oral, hypoaesthesia oral, hypoaesthesia oral, paraesthesia oral.  Additional information: She states she received the Pfizer Covid-19 Bivalent booster vaccine yesterday and she has had body ache, arm pain, overall achy feeling like she is getting sick, her lips and tongue are a little numb and tingly. She states that her son also got the vaccine yesterday and he came home and went to sleep and has a headache. So, she is calling today give her experiences and her son's experiences were normal with the vaccines. She did also state that she had recieved the primary Covid series with Moderna vaccine'. Treatment, consumer stated, He didn't took no medicine. I took some Advil today. Reporter stated, I do take high blood pressure pills and also for panic attack, that's it'.  No follow-up attempts are possible. No further information is expected.
Age: 76.0
Sex: F
Vaccine: COVID19-2, FLUX
Symptoms: Body temperature, Hyperhidrosis, Pyrexia
Clinical narrative: a high grade fever; sweating; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A 76-year-old female patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 10Sep2022 at 15:00 as dose 4 (booster), single (Lot number: GJ5342) at the age of 76 years, in left arm for covid-19 immunisation; influenza vaccine (FLU VACCINE VII), as dose number unknown, single (Batch/Lot number: unknown). The patient's relevant medical history included: "Rheumatoid arthritis" (ongoing), notes: She has rheumatoid arthritis (RA) and on she is on an immune suppression drug Orencia. She was diagnosed with RA before receiving COVID-19 vaccines and about 26 years ago; "Diabetic" (unspecified if ongoing), notes: Comments: Diabetic. Concomitant medication(s) included: ORENCIA taken for rheumatoid arthritis. Vaccination history included: BNT162b2 (Dose: 1, Date given: 30Jan2021, Manufacturer: Pfizer, Lot: EL9253, Expiration: Unknown, Dose given: Unknown, Time given: Unknown), administration date: 30Jan2021, when the patient was 74-year-old, for COVID-19 Immunization; BNT162b2 (Dose: 2, Date given: 21Feb2021, NDC: Unknown, Lot: GL9267, Expiration: Unknown, Dose given: Unknown, Time given: Unknown), administration date: 21Feb2021, when the patient was 74-year-old, for COVID-19 Immunization; Moderna (Dose: 3, Date: Dec2021, Manufacturer name: Moderna), administration date: Dec2021, when the patient was 75 years old, for COVID-19 Immunization. The following information was reported: PYREXIA (non-serious) with onset 11Sep2022 at 09:30, outcome "unknown", described as "a high grade fever"; HYPERHIDROSIS (non-serious) with onset 11Sep2022 at 09:30, outcome "unknown", described as "sweating". Relevant laboratory tests and procedures are available in the appropriate section.  No follow-up attempts are possible. No further information is expected.
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) (Consumer or other non HCP). The reporter is the patient.  A 63-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), as dose 4 (booster), single (Batch/Lot number: unknown), 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 had no relevant medical history. Concomitant medication(s) included: METOPROLOL, start date: 01Nov2019. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive, notes: COVID 19 Treatment. Therapeutic measures were taken as a result of drug ineffective, covid-19. Clinical course: The patient had no known allergies. She received anti-viral treatment (COVID 19 Treatment) as Paxlovid from 08Sep2022 to 13Sep2022.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 58.0
Sex: M
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 contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 59-year-old male patient received BNT162b2 (BNT162B2), on 18Apr2022 as dose 4 (booster), single (Lot number: FH9894) at the age of 58 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: CRESTOR, start date: 02Sep2022. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 2022, outcome "recovering" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (2022) Positive, notes: COVID 19 Treatment. Therapeutic measures were taken as a result of drug ineffective, covid-19. Clinical course: Anti viral details: product=COVID 19 Treatment, brand=Paxlovid, Treatment start date=02Sep2022, Treatment stop date=06Sep2022, Indication=Treatment of COVID-19.
Sex: F
Vaccine: COVID19
Symptoms: Illness, Investigation, Musculoskeletal stiffness
Clinical narrative: On the second vaccine I got stiff hands; when I got really sick; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 29-year-old female patient received BNT162b2 (BNT162B2), as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. Vaccination history included: Covid-19 vaccine (Dose 1, Unknown Manufacturer), for COVID-19 Immunization. The following information was reported: MUSCULOSKELETAL STIFFNESS (non-serious), outcome "unknown", described as "On the second vaccine I got stiff hands"; ILLNESS (non-serious), outcome "unknown", described as "when I got really sick". Relevant laboratory tests and procedures are available in the appropriate section.  Additional information: There were no prior vaccinations within 4 weeks.   The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 45.0
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 a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 45-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 22May2022 as dose 3 (booster), single (Lot number: FK9894) at the age of 45 years, in left arm 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: "lupus" (unspecified if ongoing); "Known allergies: penicillin" (unspecified if ongoing). Concomitant medication(s) included: HYDROXYCHLOROQUINE, start date: Sep2011; VITAMIN D NOS; GLUCOSAMINE AND CHONDROITIN.  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: Indication=Treatment of COVID-19. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical course: Anti-viral details: Product: COVID 19 Treatment, Brand: Paxlovid, Treatment start date: 13Sep2022, Lot number: GE1671, Indication: Treatment of COVID-19. The patient previously receive a COVID-19 Vaccine. The patient taken other medications/products within 2 weeks of starting COVID-19 treatment. Device Date : 14Sep2022.  No follow-up attempts are possible. No further information is expected.
Age: 45.0
Sex: F
Vaccine: 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) (Other HCP). The reporter is the patient.  A 46-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 04Mar2021 as dose 2, single (Lot number: EN6201), in left arm and on 13Oct2021 as dose 3 (booster), single (Lot number: FE3590) at the age of 45 years, in left arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), on 11Feb2021 as dose 1, single (Lot number: EM9809), in left arm for covid-19 immunisation. The patient's relevant medical history included: "Morbid obesity" (unspecified if ongoing); "renal insufficiency" (unspecified if ongoing). There were no concomitant medications. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 2022, outcome "unknown" and all described as "COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive. Therapeutic measures were taken as a result of drug ineffective, covid-19. Clinical information: The patient did not receive any other medication in 2 weeks. The patient received Paxlovid from 31Aug2022 to 04Sep2022 for the treatment of Covid-19. The patient had no known allergies.  No follow-up attempts are needed. No further information is expected.; Sender's Comments: As there is limited information in the case provided, the causal association between the Reported events DRUG INEFFECTIVE, COVID-19, INTERCHANGE OF VACCINE PRODUCTS and the suspect drug cannot be excluded. The case will be reassessed once new information is available.,Linked Report(s) : US-PFIZER INC-202201162723 Same patient, different product and event;
Age: 67.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from product quality group. The reporter is the patient.  A 68-year-old male patient received BNT162b2 (BNT162B2), on 25Oct2021 as dose 3 (booster), single (Lot number: FH8020) at the age of 67 years, in left arm for covid-19 immunisation; elasomeran (MODERNA COVID-19 VACCINE), on 15Mar2021 as dose 1, single (Lot number: 044A21A), in right arm and on 12Apr2021 as dose 2, single (Lot number: 030B21A), in right arm for covid-19 immunisation. The patient had no relevant medical history. The patient had no known allergies. There were no concomitant medications. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 2022, outcome "recovered" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: positive, notes: Retested positive; negative, notes: testing negative; positive, notes: Treatment of COVID-19. Therapeutic measures were taken as a result of drug ineffective, covid-19, patient was treated with anti-viral Paxlovid from 04Sep2022 to 09Sep2022. The patient retested positive after testing negative following 7 days of a first Covid 19 infection.
Age: 75.0
Sex: M
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 contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 75-year-old male patient received BNT162b2 (BNT162B2), on 04Apr2022 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 75 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: "Known allergies: Penecillin" (unspecified if ongoing). Concomitant medication(s) included: SIMVASTATIN. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 2022, outcome "not recovered" and all described as "COVID-19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (2022) Positive. Therapeutic measures were taken as a result of drug ineffective, covid-19. Clinical course: Paxlovid was used for COVID 19 treatment. Treatment start date was 04Sep2022 and stop date was 08Sep2022.  The information on the batch/lot number for [BNT162B2] has been requested and will be submitted if and when received.
Age: 36.0
Sex: M
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) (Consumer or other non HCP) from product quality group. The reporter is the patient.  A 36-year-old male patient received BNT162b2 (BNT162B2), on 18Jan2022 at 13:00 as dose 3 (booster), single (Lot number: 33025BD) at the age of 36 years, in left arm 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 had no relevant medical history. There were no concomitant medications. The patient had not received any other medication within 2 weeks of vaccination. The following information was reported: COVID-19 (medically significant) with onset 24Aug2022, outcome "not recovered", DRUG INEFFECTIVE (medically significant), 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) Positive, notes: Treatment of COVID-19; (30Aug2022) Negative, notes: Tested Negative on Day 7. Therapeutic measures were taken as a result of drug ineffective, covid-19. The patient had received Paxlovid from 24Aug2022 to 29Aug2022.
Sex: M
Vaccine: COVID19
Symptoms: Lip swelling, Urticaria
Clinical narrative: I seem to have had a reaction to my first booster shot and it was identified when I asked my pharmacist if he had ever seen the booster cause hives; huge lip; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team, Program ID:. The reporter is the patient.  A male patient received BNT162b2 (BNT162B2), 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: URTICARIA (non-serious), outcome "not recovered", described as "I seem to have had a reaction to my first booster shot and it was identified when I asked my pharmacist if he had ever seen the booster cause hives"; LIP SWELLING (non-serious), outcome "not recovered", described as "huge lip". The events "i seem to have had a reaction to my first booster shot and it was identified when i asked my pharmacist if he had ever seen the booster cause hives" and "huge lip" required physician office visit. Therapeutic measures were taken as a result of urticaria, lip swelling. Additional information: Patient reported that he seem to have had a reaction to his first booster shot and it was identified when he asked his pharmacist if he had ever seen the booster cause hives. He looked it up and the first picture that popped up on his database from site was a guy with a huge lip! That was him exactly! He have been fighting this for almost a year with an allergist and just started Xolair shots. Have been controlling it with Prednisone and Benadryl. He asked "Do you have any solutions or suggestions".  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: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: tested positive for Covid after receiving his 1st dose of Pfizer Covid19 maroon cap vaccine; tested positive for Covid after receiving his 1st dose of Pfizer Covid19 maroon cap vaccine; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team.  A 13-month-old male patient received BNT162b2 (COMIRNATY), as dose 1 (maroon cap), 3 ug single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "tested positive for Covid after receiving his 1st dose of Pfizer Covid19 maroon cap vaccine". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive.  Clinical course:Caller states that her son's doctor's office scheduled him to have his 2nd dose of Pfizer Covid19 maroon cap vaccine 6 weeks after receiving his 1st dose. Caller is asking, "is there a problem if his son receives his 2nd dose later than the recommended vaccine schedule.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 42.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: COVID 19 Treatment; COVID 19 Treatment; 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 43-year-old male patient received BNT162b2 (BNT162B2), on 31Mar2021 at 18:15 as dose 1, single (Lot number: EN6206), in left arm, on 28Apr2021 at 18:00 as dose 2, single (Lot number: EW0171), in left arm and on 29Dec2021 at 10:30 as dose 3 (booster), single (Lot number: 33130BA) at the age of 42 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "anxiety" (unspecified if ongoing); "depression" (unspecified if ongoing); "ADHD" (unspecified if ongoing). Concomitant medication(s) included: BUSPIRONE HCL, start date: 12Jan2022; SERTRALINE HCL, start date: 11Dec2021. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 2022, outcome "not recovered" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive, notes: COVID 19 Treatment; Negative, notes: Tested negative at 7th day after initial symptoms; Positive, notes: Tested positive again 2 days later. Therapeutic measures were taken as a result of vaccination failure, covid-19 with Anti-viral Paxlovid for started with 05Sep2022 and stopped on 09Sep2022. No known allergies. Other medication in 2weeks included Hydroxyzine HCL LLC started on 17Jan2022 and Bromphen-PSE-DM 2-30-10 mg/5 ml syrup started on 05Sep2022, Adderall XR started on 25Mar2022, Dextroamp-Amphetamine started on 25Mar2022. Tested negative at 7th day after initial symptoms and positive test. Tested positive again 2 days later. No worsening or recurrence of symptoms yet.
Age: 47.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: Sore at injection site; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 47-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 13Sep2022 at 16:00 as dose 4 (booster), single (Lot number: GH9694) at the age of 47 years, in right arm for covid-19 immunisation. The patient's relevant medical history included: "if covid prior vaccination: Yes" (unspecified if ongoing), notes: if covid prior vaccination: Yes; "Other Medical History: Environmental allergies" (unspecified if ongoing), notes: Other Medical History: Environmental allergies; "Known allergies: Allergic to raw egg" (unspecified if ongoing), notes: Known allergies: Allergic to raw egg. The patient took concomitant medications. Vaccination history included: Covid-19 vaccine (Dose: 03, Booster dose), for Covid-19 immunization; Covid-19 vaccine (Primary Immunization series complete, unknown manufacturer., Dose 2), for Covid-19 immunization; Covid-19 vaccine (Primary Immunization series complete, unknown manufacturer., Dose 1), for Covid-19 immunization. The following information was reported: VACCINATION SITE PAIN (non-serious) with onset 13Sep2022 at 20:00, outcome "recovered", described as "Sore at injection site". Therapeutic measures were not taken as a result of vaccination site pain. Additional information: Covid tested post vaccination was not done for patient.
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 67-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 02Mar2021 as dose 1, single (Batch/Lot number: unknown), in left arm, on 23Mar2021 as dose 2, single (Batch/Lot number: unknown), in left arm, on 27Sep2021 as dose 3 (booster), single (Batch/Lot number: unknown), in left arm and on 14Mar2022 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 67 years, in left arm for covid-19 immunisation. The patient's relevant medical history was not reported. There were no concomitant medications. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive, notes: symptoms and positive test; Positive, notes: COVID 19 Treatment. Therapeutic measures were taken as a result of vaccination failure, covid-19.  Clinical information: Anti-viral details product: COVID 19 Treatment. brand: Paxlovid. treatment start date:22Aug2022. treatment stop date:28Aug2022. Other medication in 2weeks was No. Known allergies was No. Other medical history was Nothing.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 58.0
Sex: M
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: My arm is still sore; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A 58-year-old male patient received BNT162b2 (BNT162B2), on 28Jun2022 as dose 4 (booster), single (Lot number: FM0173) at the age of 58 years, in left arm for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. Vaccination history included: BNT162b2 (First Dose, Lot Number: EN6201), administration date: 11Feb2021, when the patient was 56-year-old, for COVID-19 immunization; BNT162b2 (Second Dose, Lot Number: EN6025), administration date: 06Mar2021, when the patient was 56-year-old, for COVID-19 immunization; BNT162b2 (Third Dose/Booster Dose, he can barely read it on his card, reports Lot Number as FF8841), administration date: 11Oct2021, when the patient was 57-year-old, for COVID-19 immunization. The following information was reported: PAIN IN EXTREMITY (non-serious) with onset 2022, outcome "not recovered", described as "My arm is still sore".  Additional information: Caller mentioned that he got the Pfizer Booster Vaccine on 28Jun2022 and his arm is still sore from that booster. The caller stated that it has been three months and he has questions regarding this side effect. Caller stated that right after the vaccine it was the usual soreness like the other vaccines. It was really sore for a day or two. Since then, especially when he goes to the gym or golfs, he notices that it is more prevalent. Caller stated that he can also feel it if he sleeps the wrong way on his left arm. Stated that he feels it and its not like a bruise, it feels like it is inside of his arm. Caller stated that it has been ongoing and persistent. States that lately in his workouts he has been trying not to use his left arm as much. Then today he did use it, and now he was really feeling it. Patient did not receive any vaccinations within four weeks prior to the first administration date of the suspect vaccine. Caller denies any other medication.
Sex: U
Vaccine: COVID19
Symptoms: Myocarditis
Clinical narrative: myocarditis; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP) from medical information team.  An 18-year-old 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: MYOCARDITIS (medically significant), outcome "unknown".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 74.0
Sex: F
Vaccine: COVID19
Symptoms: Suspected COVID-19, Vaccination failure
Clinical narrative: COVID; COVID; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 75-year-old female patient received BNT162b2 (BNT162B2), on 30Jan2021 as dose 1, single (Lot number: EL9253) and on 21Feb2021 as dose 2, single (Lot number: GL9267) at the age of 74 years for covid-19 immunisation; elasomeran (MODERNA COVID-19 VACCINE), in Dec2021 as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Diabetic" (unspecified if ongoing); "Rheumatoid arthritis" (ongoing), notes: She has rheumatoid arthritis (RA) and on she is on an immune suppression drug Orencia. Concomitant medication(s) included: ORENCIA taken for rheumatoid arthritis. The following information was reported: VACCINATION FAILURE (medically significant), SUSPECTED COVID-19 (medically significant) all with onset 16Mar2022, outcome "unknown" and all described as "COVID".  Clinical course: Caller confirmed she received 2 Pfizer vaccines in Jan and Feb of 2021 and received a Moderna booster and she does not have the date and was not given a card from Withheld and thinks received Moderna booster in Dec2021. COVID-19 third vaccine, Moderna: She has nothing on that vaccine. NDC, Lot, and expiration are unknown. She was over 65 when she received the vaccines. She said the next thing that happened she had COVID on 16Mar2022. She said is infectious and she can't control the world. he has rheumatoid arthritis (RA) and on she is on an immune suppression drug Orencia and said may have something to do with it. She was diagnosed with RA before receiving COVID-19 vaccines and about 26 years ago. Caller said she did not get the second booster. She had COVID after receiving COVID -19 vaccines. For COVID -19 third vaccine, Moderna: She has nothing on that vaccine. NDC, Lot, and expiration are unknown.  No follow-up attempts are possible. No further information is expected.
Age: 48.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Interchange of vaccine products, SARS-CoV-2 test, Vaccination failure
Clinical narrative: 1st and 2nd dose: Pfizer/ 3rd and 4th dose: Moderna; COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from contactable reporter(s) (Nurse). The reporter is the patient.  A 50-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 18Dec2020 at 10:00 as dose 1, single (Lot number: EK5730), in right arm and on 21Jan2021 at 12:00 as dose 2, single (Lot number: EJ1686) at the age of 48 years, in right arm for covid-19 immunisation; elasomeran (MODERNA COVID-19 VACCINE), on 05Oct2021 at 16:00 as dose 3 (booster), single (Lot number: 077C218), in right arm and on 26May2022 at 12:00 as dose 4 (booster), single (Lot number: 057M21A), in right arm for covid-19 immunisation. The patient's relevant medical history included: "Thyroid" (unspecified if ongoing), notes: Thyroid; "cystic fibrosis" (unspecified if ongoing); "obese" (unspecified if ongoing), notes: obese. Concomitant medication(s) included: SYNTHROID taken for thyroid disorder, start date: 14Mar2001; VITAMIN D [COLECALCIFEROL], start date: 25May2018; CYTOMEL, start date: 11Jun2020; VYVANSE, start date: 01Apr2022; METFORMIN, start date: 25Feb2022. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset Sep2022, outcome "recovered" (13Sep2022 at 17:00) and all described as "COVID 19 Treatment"; INTERCHANGE OF VACCINE PRODUCTS (medically significant), outcome "unknown", described as "1st and 2nd dose: Pfizer/ 3rd and 4th dose: Moderna". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (13Sep2022) Negative, notes: Home test confirmed negative on 13Sep2022 at 5 PM. Therapeutic measures were taken as a result of vaccination failure, covid-19 include Paxlovid from 06Sep2022 to 11Sep2022. Patient took Other medication in 2weeks. Finished Paxlovid PM hours 11Sep2022.  No follow-up attempts are possible. No further information is expected.; 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 BNT162B2 to the reported events Vaccination failure, COVID-19 and Interchange of vaccine products cannot be ruled out.
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: Extreme soreness of her right arm; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 70-year-old female patient received BNT162b2 (BNT162B2), on 03Apr2022 as dose 4 (booster), single (Lot number: FK9894) at the age of 70 years for covid-19 immunisation. The patient's relevant medical history included: "ductile carcinoma of the left breast in site 2", start date: 2021 (unspecified if ongoing); "She completed 6 weeks of radiation followed by a year later" (unspecified if ongoing). The patient's family history included: "metastasis of melanoma" (unspecified if ongoing), notes: mother passed away from metastasis of melanoma; "congestive heart failure" (unspecified if ongoing), notes: father passed away at 100 from congestive heart failure. The patient's concomitant medications were not reported. Past drug history included: Tamoxifen, notes: she started a 5 years regimen of tamoxifen. Vaccination history included: BNT162b2 (Dose 1, Single; Lot: EP7534; Expiry: unknown; NDC: unknown. She felt lethargic after the first 2 rounds of the vaccine but nothing earth shattering.), administration date: 15Mar2021, when the patient was 69-year-old, for COVID-19 immunization, reaction(s): "felt lethargic"; BNT162b2 (Dose 2, Single; Lot: EW0151; Expiry: unknown; NDC: unknown. she felt lethargic after the first 2 rounds of the vaccine but nothing earth shattering.), administration date: 05Apr2021, when the patient was 69-year-old, for COVID-19 immunization, reaction(s): "felt lethargic"; BNT162b2 (Dose 3, Single; Lot: FD0810; Expiry: unknown; NDC: unknown), administration date: 25Oct2021, when the patient was 69-year-old, for COVID-19 immunization; Shingles shots (She also had the singles shots a year ago affect her for 24 hours), for Immunization. The following information was reported: PAIN IN EXTREMITY (non-serious) with onset 2022, outcome "unknown", described as "Extreme soreness of her right arm".  Additional information: Caller reported that she had extreme soreness of her right arm after the 4th dose, the 2nd booster. The patient did not receive any other vaccines within four weeks prior to the vaccination. Additional vaccines administered on same date was reported as no. Reporter said that she has never had an allergic reaction before. No relevant lab tests.  Follow-up attempts are completed. No further information is expected.
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Lethargy
Clinical narrative: felt lethargic; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 70-year-old female patient received BNT162b2 (BNT162B2), on 15Mar2021 as dose 1, single (Lot number: EP7534) at the age of 69 years for covid-19 immunisation. The patient's relevant medical history included: "Ductile carcinoma", start date: 2021 (unspecified if ongoing), notes: 2021 diagnosed with ductile carcinoma of the left breast in site 2; "She completed 6 weeks of radiation followed by a year" (unspecified if ongoing), notes: She completed 6 weeks of radiation followed by a year. The patient's family history included: "metastasis of melanoma" (unspecified if ongoing), notes: Mother passed away from metastasis of melanoma; "congestive heart failure" (unspecified if ongoing), notes: Her father passed away at 100 from congestive heart failure, Relevant Tests: No. There were no concomitant medications. Past drug history included: Tamoxifen, notes: she started a 5 years regimen of tamoxifen. Vaccination history included: Shingles shots (She also had the shingles shots a year ago affect her for 24 hours), administration date: 2021, for immunization. The following information was reported: LETHARGY (non-serious) with onset 2021, outcome "unknown", described as "felt lethargic".  Additional Information: Was report related to a study or programme was reported as No. Investigations: No. Other Products: No
Age: 66.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, Interchange of vaccine products, SARS-CoV-2 test
Clinical narrative: COVID 19 Treatment; COVID 19 Treatment; interchange of vaccine products; This is a spontaneous report received from a contactable reporter(s) (Physician). The reporter is the patient.  A 66-year-old male patient received BNT162b2 (BNT162B2), on 18Jul2022 as dose 4 (booster), single (Lot number: FP7135) at the age of 66 years, in left arm for covid-19 immunisation; elasomeran (MODERNA COVID-19 VACCINE), on 08Feb2021 as dose 1, single (Lot number: 030M20A), on 08Mar2021 as dose 2, single (Lot number: 026A21A) and on 12Nov2021 as dose 3 (booster), single (Lot number: 067F21A) for covid-19 immunisation. The patient had no relevant medical history. Concomitant medication(s) included: CITALOPRAM, start date: Jan2000, stop date: 13Sep2022; OMEPRAZOLE, start date: 01May2022, stop date: 13Sep2022; ATORVASTATIN, start date: Jan2007, stop date: 31Aug2022; VIT D [COLECALCIFEROL], start date: Jan2007, stop date: 13Sep2022. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive, notes: Treatment of COVID-19. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical course: Paxlovid was received from 01Sep2022 to 05Sep2022 (lot number:00069-0345-30) for the treatment of COVID-19. And experienced Headache, sore throat, body aches and fever resolved during treatment but recurred on 09Sep2022 (day 9).; Sender's Comments: The reported COVID-19 positive after BNT162b2 COVID-19 immunization is considered ineffective of BNT162B2, and the Company cannot completely exclude the possible causality between the reported events and BNT162B2 administration.Based on the information, the causal association between the event interchange of vaccine products and the use of suspect product BNT162b2 cannot be fully excluded.
Age: 65.0
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 a contactable reporter(s) (Pharmacist).  A 65-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 22Apr2022 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 65 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 included: "Coronary Artery Disease" (unspecified if ongoing); "dyslipidemia" (unspecified if ongoing); "obesity" (unspecified if ongoing); "Attention deficit hyperactivity disorder" (unspecified if ongoing); "anxiety" (unspecified if ongoing); "depression" (unspecified if ongoing). The patient took concomitant medications. Past drug history included: Midazolam, reaction(s): "Known allergies : Midazolam". 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; (13Sep2022) Positive, notes: throat on 13Sep, re-tested and it was positive for Covid. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical Course: Patient started Paxlovid on 01Sep2022 and completed Paxlovid treatment on 05Sep2022, indication was Treatment of COVID-19, orally and felt well enough to go out again 08Sep. She then developed a bad sore throat on 13Sep, re-tested and it was positive for Covid. Symptoms are mild. She received other medication in 2weeks.  The information on the batch/lot number for BNT162b2 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 the drug ineffective (LOE)  and Covid 19 cannot be ruled out.
Age: 45.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Body temperature, Dizziness, Headache, Myalgia
Clinical narrative: nausea; dizziness; somnolence; left shoulder pain; Continued overnight with fever (38.2degree C); pain in major and minor joint; myalgia; headache; This is a spontaneous report received from a 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 13Sep2022 at 12:00 as dose 4 (booster), single (Lot number: 2524) at the age of 45 years intramuscular, in left arm for covid-19 immunisation; influenza vaccine inact sag 3v (FLUCELVAX), on 13Sep2022 as dose 1, single (Batch/Lot number: unknown), in left arm for immunisation. The patient's relevant medical history included: "seasonal allergies" (unspecified if ongoing); "GERD" (unspecified if ongoing). The patient's concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Dose: 1, MANUFACTURER UNKNOWN), for COVID-19 Immunization; Covid-19 vaccine (Dose: 2, MANUFACTURER UNKNOWN), for COVID-19 Immunization; Covid-19 vaccine (Dose: 3, MANUFACTURER UNKNOWN), for COVID-19 Immunization. The following information was reported: PYREXIA (non-serious) with onset 13Sep2022 at 18:00, outcome "not recovered", described as "Continued overnight with fever (38.2degree C)"; DIZZINESS (non-serious) with onset 13Sep2022 at 18:00, outcome "not recovered"; HEADACHE (non-serious) with onset 13Sep2022 at 18:00, outcome "not recovered"; ARTHRALGIA (non-serious) with onset 13Sep2022 at 18:00, outcome "not recovered", described as "left shoulder pain"; MYALGIA (non-serious) with onset 13Sep2022 at 18:00, outcome "not recovered"; NAUSEA (non-serious) with onset 13Sep2022 at 18:00, outcome "not recovered"; ARTHRALGIA (non-serious) with onset 13Sep2022 at 18:00, outcome "not recovered", described as "pain in major and minor joint"; SOMNOLENCE (non-serious) with onset 13Sep2022 at 18:00, outcome "not recovered". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were taken as a result of nausea, dizziness, somnolence, arthralgia, pyrexia, arthralgia, myalgia, headache.  Additional Information: Event initiated 6 hours post injection with nausea, dizziness, somnolence, and left shoulder pain. Continued overnight with fever (38.2degree C), pain in major and minor joints, myalgia, and headache. Symptoms improved after taking 2x Tylenol and hydration improved after taking 2x Tylenol and hydration.  No other vaccine in four weeks. No coid prior vaccination. No Covid test post vaccination. AE treatment acetaminophen PRN.
Age: 45.0
Sex: M
Vaccine: COVID19
Symptoms: Nausea, Pyrexia, Somnolence
Clinical narrative: nausea; dizziness; somnolence; left shoulder pain; Continued overnight with fever (38.2degree C); pain in major and minor joint; myalgia; headache; This is a spontaneous report received from a 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 13Sep2022 at 12:00 as dose 4 (booster), single (Lot number: 2524) at the age of 45 years intramuscular, in left arm for covid-19 immunisation; influenza vaccine inact sag 3v (FLUCELVAX), on 13Sep2022 as dose 1, single (Batch/Lot number: unknown), in left arm for immunisation. The patient's relevant medical history included: "seasonal allergies" (unspecified if ongoing); "GERD" (unspecified if ongoing). The patient's concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Dose: 1, MANUFACTURER UNKNOWN), for COVID-19 Immunization; Covid-19 vaccine (Dose: 2, MANUFACTURER UNKNOWN), for COVID-19 Immunization; Covid-19 vaccine (Dose: 3, MANUFACTURER UNKNOWN), for COVID-19 Immunization. The following information was reported: PYREXIA (non-serious) with onset 13Sep2022 at 18:00, outcome "not recovered", described as "Continued overnight with fever (38.2degree C)"; DIZZINESS (non-serious) with onset 13Sep2022 at 18:00, outcome "not recovered"; HEADACHE (non-serious) with onset 13Sep2022 at 18:00, outcome "not recovered"; ARTHRALGIA (non-serious) with onset 13Sep2022 at 18:00, outcome "not recovered", described as "left shoulder pain"; MYALGIA (non-serious) with onset 13Sep2022 at 18:00, outcome "not recovered"; NAUSEA (non-serious) with onset 13Sep2022 at 18:00, outcome "not recovered"; ARTHRALGIA (non-serious) with onset 13Sep2022 at 18:00, outcome "not recovered", described as "pain in major and minor joint"; SOMNOLENCE (non-serious) with onset 13Sep2022 at 18:00, outcome "not recovered". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were taken as a result of nausea, dizziness, somnolence, arthralgia, pyrexia, arthralgia, myalgia, headache.  Additional Information: Event initiated 6 hours post injection with nausea, dizziness, somnolence, and left shoulder pain. Continued overnight with fever (38.2degree C), pain in major and minor joints, myalgia, and headache. Symptoms improved after taking 2x Tylenol and hydration improved after taking 2x Tylenol and hydration.  No other vaccine in four weeks. No coid prior vaccination. No Covid test post vaccination. AE treatment acetaminophen PRN.
Sex: F
Vaccine: COVID19
Symptoms: Tinnitus
Clinical narrative: Tinnitus after 2nd Pfizer vaccine; This is a spontaneous report received from a contactable reporter(s) (Pharmacist).  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: Covid-19 vaccine (Dose Number: 2, Manufacturer unknown, Batch/Lot No: Unknown. Not available/provided to reporter at the time of report completion), for COVID-19 immunization; J&j vaccine (Dose Number: 1, Batch/Lot No: Unknown. Not available/provided to reporter at the time of report completion), for COVID-19 immunization. The following information was reported: TINNITUS (non-serious), outcome "unknown", described as "Tinnitus after 2nd Pfizer vaccine".  Additional Information: It was reported that batch/lot was Unknown as it was Not available/provided to reporter at the time of report completion. The Awareness was reported as 13Sep2022.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.