chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 73.0
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; Dose Number: 5: Moderna /Dose Number: 4 :Pfizer/Dose Number: 3 :Pfizer/Dose Number: 2 :Pfizer/Dose Number: 1 :Pfizer; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 74-year-old male patient received BNT162b2 (BNT162B2), in Feb2021 as dose 1, single (Batch/Lot number: unknown), in Mar2021 as dose 2, single (Batch/Lot number: unknown), in Sep2021 as dose 3 (booster), single (Batch/Lot number: unknown) and in Apr2022 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 73 years, in left arm for covid-19 immunisation; elasomeran (MODERNA COVID-19 VACCINE), on 11Sep2022 at 09:00 as dose 5 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: INTERCHANGE OF VACCINE PRODUCTS (medically significant) with onset 11Sep2022 at 09:00, outcome "unknown", described as "Dose Number: 5: Moderna /Dose Number: 4 :Pfizer/Dose Number: 3 :Pfizer/Dose Number: 2 :Pfizer/Dose Number: 1 :Pfizer"; 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: Rebound symptoms of COVID-19, with a positive antigen test; Positive, notes: COVID 19 Treatment. Therapeutic measures were taken as a result of drug ineffective, covid-19. anti viral details treatment start date 22Sep2022 and stop date 27Sep2022.  Clinical information: Patient took other medication in 2 weeks   The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 68.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Interchange of vaccine products, SARS-CoV-2 test
Clinical narrative: Dose Number: 5: Pfizer/Dose Number: 4 :Moderna; Paxlovid as COVID 19 Treatment which started on 23Sep2022; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 68-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 20Sep2022 as dose 5 (booster), single (Batch/Lot number: unknown) at the age of 68 years, in left arm for covid-19 immunisation; elasomeran (MODERNA COVID-19 VACCINE), on 27May2022 as dose 4 (booster), single (Lot number: 038A22A), 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: Dairy" (unspecified if ongoing); "known allergies: avoid corticosteroids" (unspecified if ongoing). There were no concomitant medications. The following information was reported: COVID-19 (non-serious) with onset Sep2022, outcome "not recovered", described as "Paxlovid as COVID 19 Treatment which started on 23Sep2022"; INTERCHANGE OF VACCINE PRODUCTS (non-serious) with onset 20Sep2022, outcome "unknown", described as "Dose Number: 5: Pfizer/Dose Number: 4 :Moderna". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were taken as a result of covid-19 including Paxlovid given on 23Sep2022 to 28Sep2022.  The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5 has been requested and will be submitted if and when received.
Age: 71.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from product quality group. The reporter is the patient.  A 71-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 18Apr2022 as dose 4 (booster), single (Lot number: FK9893) at the age of 71 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: "Migraine" (unspecified if ongoing), notes: other medical history: Migraine. The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (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: Positive; Positive; Negative; Positive. Therapeutic measures were taken as a result of drug ineffective, covid-19. Positive Covid antigen home test with reoccurrence of runny nose, sneezing, nasal congestion after 1 wk of discontinuing treatment and positive Covid test after 5 days of negative test   No follow-up attempts are possible. No further information is expected.
Age: 71.0
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 contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 72-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 07Mar2021 at 14:30 as dose 1, single (Lot number: EN6205), in left arm, on 31Mar2021 at 14:30 as dose 2, single (Lot number: ER 8732), in left arm and on 07Dec2021 at 10:15 as dose 3 (booster), single (Lot number: FJ8762) at the age of 71 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Diabetes" (unspecified if ongoing). Concomitant medication(s) included: METFORMIN; SIMVASTATIN; VITAMIN C [ASCORBIC ACID]; VITAMIN D NOS; GLUCOSAMINE. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (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: COVID 19 Treatment; (30Sep2022) Positive, notes: Recurrence of Covid symptoms. Therapeutic measures were taken as a result of vaccination failure, covid-19.  Clinical course: Paxlovid used for treatment Of COVID-19. Known allergies reported as no.
Age: 46.0
Sex: F
Vaccine: COVID19, FLUX
Symptoms: Fatigue, Headache, Nausea, Pain, Product use issue
Clinical narrative: Hives; wheezing; fever; aches; fatigue; headache; nausea; Product use for unapproved combination; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 46-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 29Sep2022 at 13:45 as dose 4 (booster), single (Lot number: GJ6742) at the age of 46 years intramuscular, in right arm for covid-19 immunisation; influenza vaccine (FLU VACCINE VII), on 29Sep2022 as dose 1, single (Batch/Lot number: unknown), in left arm for immunisation. The patient's relevant medical history included: "Chronic Asthma" (unspecified if ongoing); "Allergies" (unspecified if ongoing); "Alopecia" (unspecified if ongoing); "High Blood Pressure" (unspecified if ongoing); "Known allergies: Penicillin" (unspecified if ongoing); "Known allergies: Sulfonamide Antibiotics" (unspecified if ongoing); "Known allergies: Tree nuts" (unspecified if ongoing). Concomitant medication(s) included: SYNTHROID; ATENOLOL; CALAN [VERAPAMIL HYDROCHLORIDE]. Vaccination history included: Covid-19 vaccine (DOSE 1,SINGLE, MANUFACTURER UNKNOWN), for COVID-19 immunization; Covid-19 vaccine (DOSE 2,SINGLE, MANUFACTURER UNKNOWN), for COVID-19 immunization; Covid-19 vaccine (DOSE 3,SINGLE, MANUFACTURER UNKNOWN), for COVID-19 immunization. The following information was reported: PRODUCT USE ISSUE (non-serious) with onset 29Sep2022, outcome "unknown", described as "Product use for unapproved combination"; URTICARIA (non-serious) with onset 29Sep2022 at 21:00, outcome "recovering", described as "Hives"; PAIN (non-serious) with onset 29Sep2022 at 21:00, outcome "recovering", described as "aches"; FATIGUE (non-serious) with onset 29Sep2022 at 21:00, outcome "recovering"; PYREXIA (non-serious) with onset 29Sep2022 at 21:00, outcome "recovering", described as "fever"; HEADACHE (non-serious) with onset 29Sep2022 at 21:00, outcome "recovering"; NAUSEA (non-serious) with onset 29Sep2022 at 21:00, outcome "recovering"; WHEEZING (non-serious) with onset 29Sep2022 at 21:00, outcome "recovering". Therapeutic measures were taken as a result of urticaria, wheezing, pyrexia, pain, fatigue, headache, nausea.  Additional information: The patient did not receive any other vaccine in four weeks. The patient did not have covid prior vaccination and patient had not tested for covid post vaccination. The patient received Benadryl, Albuterol Inhaler, Ice pack, Rest, Advil as treatment for the events.
Age: 46.0
Sex: F
Vaccine: COVID19, FLUX
Symptoms: Pyrexia, Urticaria, Wheezing
Clinical narrative: Hives; wheezing; fever; aches; fatigue; headache; nausea; Product use for unapproved combination; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 46-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 29Sep2022 at 13:45 as dose 4 (booster), single (Lot number: GJ6742) at the age of 46 years intramuscular, in right arm for covid-19 immunisation; influenza vaccine (FLU VACCINE VII), on 29Sep2022 as dose 1, single (Batch/Lot number: unknown), in left arm for immunisation. The patient's relevant medical history included: "Chronic Asthma" (unspecified if ongoing); "Allergies" (unspecified if ongoing); "Alopecia" (unspecified if ongoing); "High Blood Pressure" (unspecified if ongoing); "Known allergies: Penicillin" (unspecified if ongoing); "Known allergies: Sulfonamide Antibiotics" (unspecified if ongoing); "Known allergies: Tree nuts" (unspecified if ongoing). Concomitant medication(s) included: SYNTHROID; ATENOLOL; CALAN [VERAPAMIL HYDROCHLORIDE]. Vaccination history included: Covid-19 vaccine (DOSE 1,SINGLE, MANUFACTURER UNKNOWN), for COVID-19 immunization; Covid-19 vaccine (DOSE 2,SINGLE, MANUFACTURER UNKNOWN), for COVID-19 immunization; Covid-19 vaccine (DOSE 3,SINGLE, MANUFACTURER UNKNOWN), for COVID-19 immunization. The following information was reported: PRODUCT USE ISSUE (non-serious) with onset 29Sep2022, outcome "unknown", described as "Product use for unapproved combination"; URTICARIA (non-serious) with onset 29Sep2022 at 21:00, outcome "recovering", described as "Hives"; PAIN (non-serious) with onset 29Sep2022 at 21:00, outcome "recovering", described as "aches"; FATIGUE (non-serious) with onset 29Sep2022 at 21:00, outcome "recovering"; PYREXIA (non-serious) with onset 29Sep2022 at 21:00, outcome "recovering", described as "fever"; HEADACHE (non-serious) with onset 29Sep2022 at 21:00, outcome "recovering"; NAUSEA (non-serious) with onset 29Sep2022 at 21:00, outcome "recovering"; WHEEZING (non-serious) with onset 29Sep2022 at 21:00, outcome "recovering". Therapeutic measures were taken as a result of urticaria, wheezing, pyrexia, pain, fatigue, headache, nausea.  Additional information: The patient did not receive any other vaccine in four weeks. The patient did not have covid prior vaccination and patient had not tested for covid post vaccination. The patient received Benadryl, Albuterol Inhaler, Ice pack, Rest, Advil as treatment for the events.
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, Interchange of vaccine products, SARS-CoV-2 test
Clinical narrative: Vaccine brand other=Moderna; 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 42-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), as dose 1, single (Batch/Lot number: unknown), in left arm and as dose 3 (booster), single (Batch/Lot number: unknown), in left arm for covid-19 immunisation; elasomeran (MODERNA COVID-19 VACCINE), as dose 2, single (Batch/Lot number: unknown), in left arm for covid-19 immunisation. The patient's relevant medical history included: "high blood pressure" (unspecified if ongoing), notes: Treated for high blood pressure; "Post-traumatic stress disorder" (unspecified if ongoing). Concomitant medication(s) included: LOSARTIN; PAROXETINE. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Sep2022, outcome "not recovered" and all described as "COVID-19"; INTERCHANGE OF VACCINE PRODUCTS (medically significant), outcome "unknown", described as "Vaccine brand other=Moderna". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: negative, notes: 5 days after negative test. Therapeutic measures were taken as a result of drug ineffective, 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: Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a contactable reporter(s) (Physician). The reporter is the patient.  A 36-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), as dose 4 (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) and as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Asthma" (unspecified if ongoing). There were no concomitant medications. The following information was reported: 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: (2022) Positive, notes: COVID 19 Treatment; (2022) Positive, notes: Rebound positive test. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical course: It was reported that patient did not received other medication in 2 weeks. Anti viral details: Patient was taking Paxlovid product from 25Sep2022 to 29Sep2022 for Covid-19 treatment.  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: Based on plausible dose -event relationship post vaccination and no other alternate explanation the causal role of BNT162B2 cannot be excluded for the reported LOE events.
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Oropharyngeal pain, Pain, Pain in extremity, Pyrexia
Clinical narrative: fever; body aches; headache; sore throat; severe arm pain; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 59-year-old female patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 02Oct2022 at 15:00 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 59 years intramuscular, in left arm for covid-19 immunisation. The patient's relevant medical history included: "no" (unspecified if ongoing). Concomitant medication(s) included: BUPROPION; SYNTHROID; TOPIRAMATE. Past drug history included: No, reaction(s): "Allergy". Vaccination history included: Covid-19 vaccine (Primary immunization complete, unknown manufacturer), for COVID-19 Immunization; Covid-19 vaccine (Dose 3, unknown manufacturer), for COVID-19 Immunization. The following information was reported: PAIN (non-serious) with onset 03Oct2022 at 08:00, outcome "recovered", described as "body aches"; PYREXIA (non-serious) with onset 03Oct2022 at 08:00, outcome "recovered", described as "fever"; HEADACHE (non-serious) with onset 03Oct2022 at 08:00, outcome "recovered"; PAIN IN EXTREMITY (non-serious) with onset 03Oct2022 at 08:00, outcome "recovered", described as "severe arm pain"; OROPHARYNGEAL PAIN (non-serious) with onset 03Oct2022 at 08:00, outcome "recovered", described as "sore throat". Therapeutic measures were not taken as a result of pyrexia, pain, headache, oropharyngeal pain, pain in extremity.  Additional information: Covid prior vaccination: No. Covid tested post vaccination: No. Known allergies: No. Other medical history: No. No other vaccine in fourweeks.  The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5 has been requested and will be submitted if and when received.
Sex: M
Vaccine: COVID19
Symptoms: 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 66-year-old male patient received BNT162b2 (BNT162B2), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 2022, outcome "not recovered" and all described as "COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (unspecified date) Positive; (unspecified date) Negative, notes: days after tested negative for 2 days; (unspecified date) Negative, notes: days after tested negative for 2 days; (02Oct2022) Positive, notes: Then tested positive. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical course: No other medication in two weeks. Patient received Paxlovid as COVID 19 Treatment from 23Sep2022 to 28Sep2022. Completed Paxlovid and two days after tested negative for two days. Then tested positive and symptoms reappeared Sinus, Cough, Headache, Tiredness.  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, 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 43-year-old male patient received BNT162b2 (BNT162B2), on 26Oct2021 as dose 3 (booster), single (Lot number: EW0187) at the age of 42 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: "Allergy: Sulfa" (unspecified if ongoing). There were no concomitant medications. The following information was reported: DRUG INEFFECTIVE (medically significant) with onset 03Oct2022, outcome "unknown", COVID-19 (medically significant) with onset 03Oct2022, 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: COVID 19 Treatment; (02Oct2022) negative, notes: Tested negative 48 hours after my last dose of Paxlovid(Sunday); (03Oct2022) positive, notes: but positive the following morning (monday). Therapeutic measures were taken as a result of drug ineffective, covid-19. Clinical information: Tested negative 48 hours after my last dose of Paxlovid (sunday) but positive the following morning (monday). Possible rebound effect. No other medication in in 2 weeks.
Age: 45.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, Interchange of vaccine products, SARS-CoV-2 test
Clinical narrative: COVID 19 Treatment; COVID 19 Treatment; Dose Number: 4:Moderna /Dose Number: 3: Pfizer; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 46-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 12Nov2021 as dose 3 (booster), single (Lot number: FG3527) at the age of 45 years for covid-19 immunisation; elasomeran (MODERNA COVID-19 VACCINE), on 12Sep2022 as dose 4 (booster), single (Lot number: AS7147B), 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: "Temporal lobe epilepsy" (unspecified if ongoing), notes: Other medical history: Temporal lobe epilepsy,; "prediabetes" (unspecified if ongoing), notes: Other medical history: prediabetes. Concomitant medication(s) included: LEVETIRACETAM; ASHLYNA. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "COVID 19 Treatment"; INTERCHANGE OF VACCINE PRODUCTS (medically significant), outcome "unknown", described as "Dose Number: 4:Moderna /Dose Number: 3: Pfizer". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive, notes: Rebound of Covid symptoms and positive home test approx 6 days after completing the 5-day course of Paxlovid; Negative, notes: Had an intervening negative home test 1 day after completion of Paxlovid. Therapeutic measures were taken as a result of drug ineffective, covid-19. Clinical course: The patient received Levetiracetam ER, combined oral contraceptive pills and Ashlyna in 2weeks. Patient received Paxlovid for Treatment of COVID-19.   No follow-up attempts are possible. No further information is expected.
Age: 68.0
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 non-contactable reporter(s) (Consumer or other non HCP) from product quality group. The reporter is the patient.  A 69-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 06Feb2021 as dose 1, single (Lot number: EL9269), in left arm, on 27Feb2021 as dose 2, single (Lot number: EN6202), in left arm, on 09Sep2021 as dose 3 (booster), single (Lot number: FC3183) and on 30Mar2022 as dose 4 (booster), single (Lot number: FK9895) at the age of 68 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Type 2 diabetes" (unspecified if ongoing); "peripheral neuropathy" (unspecified if ongoing); "hypertension" (unspecified if ongoing); "squamous cell carcinoma of skin" (unspecified if ongoing). Concomitant medication(s) included: GABAPENTIN; METFORMIN; LISINOPRIL/HCTZ; ROPINIROLE; NEXIUM [ESOMEPRAZOLE SODIUM]; ASPIRIN [ACETYLSALICYLIC ACID]; ROSUVASTIN; FISH OIL. 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: Presented with increase coughing and muscle aches with Positive antigen test. Therapeutic measures were taken as a result of vaccination failure, covid-19.  Clinical course: Patient has no known allergies. Patient received Multivitamin medication in 2weeks.  No follow-up attempts are possible. No further information is expected.
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Interchange of vaccine products, Vaccination failure
Clinical narrative: COVID 19 Treatment; COVID 19 Treatment; Dose Number: 5:Moderna/Dose Number: 4: Moderna/Dose Number: 3: Pfizer /Dose Number: 2: Pfizer/Dose Number: 1: Pfizer; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 69-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 07Jan2021 at 12:00 as dose 1, single (Batch/Lot number: unknown), in left arm, on 28Jan2021 at 12:00 as dose 2, single (Batch/Lot number: unknown), in left arm and on 18Aug2021 at 17:00 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 68 years, in left arm for covid-19 immunisation; elasomeran (MODERNA COVID-19 VACCINE), on 07Apr2022 at 13:00 as dose 4 (booster), single (Batch/Lot number: unknown), in left arm and on 14Sep2022 at 14:00 as dose 5 (booster), single (Batch/Lot number: unknown), 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 "recovering" and all described as "COVID 19 Treatment"; INTERCHANGE OF VACCINE PRODUCTS (medically significant), outcome "unknown", described as "Dose Number: 5:Moderna/Dose Number: 4: Moderna/Dose Number: 3: Pfizer /Dose Number: 2: Pfizer/Dose Number: 1: Pfizer". Therapeutic measures were taken as a result of vaccination failure, covid-19. Paxlovid was given as COVID 19 Treatment from 21Sep2022 to 25Sep2022. The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 70.0
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) (Nurse). The reporter is the patient.  A 71-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 22Apr2022 at 12:00 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 70 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: "Hypertension" (unspecified if ongoing); "known allergies: Shellfish" (unspecified if ongoing); "known allergies: Iodine" (unspecified if ongoing); "known allergies: Latex" (unspecified if ongoing). The patient took unspecified concomitant medications. 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: Negative, notes: Tested positive 5 days after testing negative; Positive, notes: Tested positive 5 days after testing negative; Positive, notes: Treatment of COVID-19. Therapeutic measures were taken as a result of drug ineffective, covid-19 which included Paxlovid (treatment start date: 20Sep2022; treatment stop date: 25Sep2022).  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.; Sender's Comments: Based on the information available and close temporal association, a possible contributory role of the suspect BNT162B2 cannot be excluded for the reported event  of Anaphylactic reaction. The case will be reassessed once new information is available .
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Gait disturbance, Vertigo
Clinical narrative: Dizziness; Vertigo; Couldn't walk straight; 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 54-year-old female patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 03Oct2022 as dose 4 (booster), single (Lot number: GJ3277) at the age of 54 years, in left arm for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. Vaccination history included: BNT162b2 (DOSE 1, SINGLE, LOT: EW0161), administration date: 17Apr2021, when the patient was 52-year-old, for COVID-19 Immunization; BNT162b2 (DOSE 2, SINGLE, LOT: EW0167), administration date: 08May2021, when the patient was 52-year-old, for COVID-19 Immunization; BNT162b2 (DOSE 3 (BOOSTER), SINGLE, LOT: 33130BA), administration date: 22Dec2021, when the patient was 53-year-old, for COVID-19 Immunization. The following information was reported: GAIT DISTURBANCE (non-serious) with onset 03Oct2022, outcome "unknown", described as "Couldn't walk straight"; DIZZINESS (non-serious) with onset 03Oct2022, outcome "recovering"; VERTIGO (non-serious) with onset 03Oct2022, outcome "unknown". Therapeutic measures were not taken as a result of dizziness.  Additional information: A 54-year-old female patient and states that she got the Pfizer Bivalent booster vaccine 3 hours ago. Caller stated that she had been experiencing dizziness and vertigo since after 50 minutes of getting the vaccine. Consumer calling about side effects of the booster shot, the latest one for COVID-19. She later clarifies that today she got the Pfizer COVID-19 vaccine bivalent booster. She had dizziness that had been there for three hours, it started 50 minutes after she got the shot. She got home and got out of the car to go to the door and she couldn't walk straight, and now if she moves her head fast she gets dizziness. The dizziness had gotten better, she had done no treatment, she was just drinking water. She would like to know, was gonna go away. She got the booster three hours ago, today, 03Oct2022. Her vaccine card is handwritten, today's dose was Pfizer COVID-19 vaccine Bivalent, on 03Oct2022 with LOT: GJ3277 injected in her left arm. There are no NDC/EXP provided for vaccines on her vaccine card. Her first dose of Pfizer COVID-19 vaccine was 17Apr2021 of LOT: EW0161. Her second dose was Pfizer LOT: EW0167, on 08May2021. Her Pfizer booster was LOT: 33130BA, on 22Dec2021.
Sex: U
Vaccine: COVID19
Symptoms: Death
Clinical narrative: she has known two people to get the vaccine and 'drop dead'; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team, Program ID: (159558).  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: DEATH (death, medically significant), outcome "fatal", described as "she has known two people to get the vaccine and 'drop dead'". The date and cause of death for the patient were unknown.  Clinical information: Caller seeking where in her state of (State name), can she get the Comirnaty labeled vaccine. She stated she was being forced to get the vaccine or lose her job. She relays that she had known two people to get the vaccine and 'drop dead' she does not specify which Covid 19 vaccine these people have received.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received. Sender's Comments: Linked Report(s): PFIZER INC-202201202498 same reporter/drug/event, different patients; Reported Cause(s) of Death: she has known two people to get the vaccine and 'drop dead.'
Sex: M
Vaccine: COVID19
Symptoms: Small cell lung cancer
Clinical narrative: . I am however on chemotherapy for stage 4 non small cell carcinoma of the lungs; 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 71-year-old male 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; Bnt162b2 (DOSE 2, SINGLE), for COVID-19 Immunization; Bnt162b2 (DOSE 3 (BOOSTER), SINGLE), for COVID-19 Immunization. The following information was reported: SMALL CELL LUNG CANCER (medically significant), outcome "unknown", described as ". I am however on chemotherapy for stage 4 non small cell carcinoma of the lungs". Additional information: Patient took the 4 Pfizer covid vaccines. He was eligible for the 5th bivalent vaccine. He was however on chemotherapy for stage 4 non small cell carcinoma of the lungs, and was trying to find literature as to whether this 5th dose is recommended. Event seriousness was reported as non serious by the reporter.   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
Symptoms: Inappropriate schedule of product administration, Malaise
Clinical narrative: Dose 1 15Mar2021: Dose 2 17Apr2022; After the second shot he really didn't feel good, and neither did his son; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the parent.  A 36-year-old male patient received BNT162b2 (BNT162B2), on 17Apr2022 as dose 2, single (Batch/Lot number: unknown) at the age of 36 years for covid-19 immunisation. The patient's relevant medical history was not reported. There were no concomitant medications. Vaccination history included: BNT162b2 (DOSE 1, SINGLE, Lot Number: Unknown.), administration date: 15Mar2021, when the patient was 35-year-old, for COVID-19 Immunization, reaction(s): "Elevated heart rate", "Felt like he was having a heart attack", "Elevated heart enzyme", "he took the first shot and didn't feel good after". The following information was reported: INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (non-serious) with onset 17Apr2022, outcome "unknown", described as "Dose 1 15Mar2021: Dose 2 17Apr2022"; MALAISE (non-serious) with onset 2022, outcome "unknown", described as "After the second shot he really didn't feel good, and neither did his son". Therapeutic measures were not taken as a result of malaise.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202201197909 same reporter/drug, different patient/event;
Age: 59.0
Sex: F
Vaccine: COVID19, FLUX
Symptoms: Body temperature, COVID-19, Hyperaesthesia, Immunisation, Malaise
Clinical narrative: Experienced fever (99.6 degrees F); malaise; skin sensitivity; Dose number=5; Dose number=5; This is a spontaneous report received from non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 59-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 30Sep2022 as dose 5 (booster), single (Lot number: GJ2524) at the age of 59 years intramuscular, in left arm for covid-19 immunisation; influenza vaccine (INFLUENZA VACCINE), on 30Sep2022 as dose 1, single (Batch/Lot number: unknown), in right arm. The patient's relevant medical history included: "hypothyroid" (unspecified if ongoing), notes: Other medical history: Hypothyroid and hypercholesterolemia, both controlled on medication; "hypercholesterolemia" (unspecified if ongoing), notes: Other medical history: Hypothyroid and hypercholesterolemia, both controlled on medication; "Known allergies: Penicillin" (unspecified if ongoing); "Known allergies: Sulfa drugs" (unspecified if ongoing); "COVID-19" (unspecified if ongoing), notes: Prior to vaccination, was the patient diagnosed with COVID-19: Yes. Concomitant medication(s) included: ATORVASTATIN; LEVOTHYROXINE; CALCIUM; VITAMIN D [COLECALCIFEROL]; COSAMIN. Past drug history included: Known allergies: aspirin, reaction(s): "Allergy". Vaccination history included: Covid-19 vaccine (Dose number: 4 (Booster), unknown manufacturer), for COVID-19 Immunization; Covid-19 vaccine (Dose number: 3 (Booster), unknown manufacturer), for COVID-19 Immunization; Covid-19 vaccine (Dose number: 2, unknown manufacturer), for COVID-19 Immunization; Covid-19 vaccine (Dose number: 1, unknown manufacturer), for COVID-19 Immunization. The following information was reported: OFF LABEL USE (non-serious), IMMUNISATION (non-serious) all with onset 30Sep2022, outcome "unknown" and all described as "Dose number=5"; PYREXIA (non-serious) with onset 01Oct2022, outcome "recovered" (Oct2022), described as "Experienced fever (99.6 degrees F)"; MALAISE (non-serious) with onset 01Oct2022, outcome "recovered" (Oct2022); HYPERAESTHESIA (non-serious) with onset 01Oct2022, outcome "recovered" (Oct2022), described as "skin sensitivity". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of pyrexia, malaise, hyperaesthesia.  Additional information: The reporter was reported case as non-serious. No other vaccine in four weeks. No treatment received for AE. Covid tested prior vaccination. No Covid tested post vaccination. Device stamp date was 01Oct2022.
Age: 59.0
Sex: F
Vaccine: COVID19, FLUX
Symptoms: Off label use, Pyrexia
Clinical narrative: Experienced fever (99.6 degrees F); malaise; skin sensitivity; Dose number=5; Dose number=5; This is a spontaneous report received from non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 59-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 30Sep2022 as dose 5 (booster), single (Lot number: GJ2524) at the age of 59 years intramuscular, in left arm for covid-19 immunisation; influenza vaccine (INFLUENZA VACCINE), on 30Sep2022 as dose 1, single (Batch/Lot number: unknown), in right arm. The patient's relevant medical history included: "hypothyroid" (unspecified if ongoing), notes: Other medical history: Hypothyroid and hypercholesterolemia, both controlled on medication; "hypercholesterolemia" (unspecified if ongoing), notes: Other medical history: Hypothyroid and hypercholesterolemia, both controlled on medication; "Known allergies: Penicillin" (unspecified if ongoing); "Known allergies: Sulfa drugs" (unspecified if ongoing); "COVID-19" (unspecified if ongoing), notes: Prior to vaccination, was the patient diagnosed with COVID-19: Yes. Concomitant medication(s) included: ATORVASTATIN; LEVOTHYROXINE; CALCIUM; VITAMIN D [COLECALCIFEROL]; COSAMIN. Past drug history included: Known allergies: aspirin, reaction(s): "Allergy". Vaccination history included: Covid-19 vaccine (Dose number: 4 (Booster), unknown manufacturer), for COVID-19 Immunization; Covid-19 vaccine (Dose number: 3 (Booster), unknown manufacturer), for COVID-19 Immunization; Covid-19 vaccine (Dose number: 2, unknown manufacturer), for COVID-19 Immunization; Covid-19 vaccine (Dose number: 1, unknown manufacturer), for COVID-19 Immunization. The following information was reported: OFF LABEL USE (non-serious), IMMUNISATION (non-serious) all with onset 30Sep2022, outcome "unknown" and all described as "Dose number=5"; PYREXIA (non-serious) with onset 01Oct2022, outcome "recovered" (Oct2022), described as "Experienced fever (99.6 degrees F)"; MALAISE (non-serious) with onset 01Oct2022, outcome "recovered" (Oct2022); HYPERAESTHESIA (non-serious) with onset 01Oct2022, outcome "recovered" (Oct2022), described as "skin sensitivity". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of pyrexia, malaise, hyperaesthesia.  Additional information: The reporter was reported case as non-serious. No other vaccine in four weeks. No treatment received for AE. Covid tested prior vaccination. No Covid tested post vaccination. Device stamp date was 01Oct2022.
Sex: U
Vaccine: COVID19-2, TTOX
Symptoms: Headache
Clinical narrative: Headache; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP).  A 30-year-old patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation; tetanus vaccine (TETANUS VACCINE), as dose number unknown, single (Batch/Lot number: unknown) for immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Dose 1, Unknown manufacturer), for COVID-19 immunization; Covid-19 vaccine (Dose 2, Unknown manufacturer), for COVID-19 immunization. The following information was reported: HEADACHE (non-serious), outcome "unknown".  Additional information: Report was related to a study or programme. Details: 159558; COVAX Support. Reason for no lot number of Tetanus Shot was reported as reporter unwilling to complete the report. Reporter on line who was 77-year-old and got the Bivalent COVID-19 Vaccine on Friday. She had another friend of hers who got 3 shots together, her friend got that shot and the tetanus and just got a headache. Her friend was like 30 years old.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 30.0
Sex: F
Vaccine: COVID19
Symptoms: Dairy intolerance, Lactose intolerance, Nausea, SARS-CoV-2 test, Vomiting
Clinical narrative: I've developed a lactose intolerance; I was puking anytime I had dairy; I was puking anytime I had dairy; getting nauseous; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 30-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 20Sep2021 as dose 2, single (Lot number: 301358A) at the age of 30 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Allergy to avocado" (unspecified if ongoing), notes: Allergy to avocado. The patient took concomitant medications. Past drug history included: Known allergies: zyrtec, reaction(s): "known allergies: Zyrtec"; Known allergies: took benedryl with first dose, reaction(s): "known allergies: Took benedryl with first dose". Vaccination history included: BNT162b2 (Dose Number: 1, Single,, Batch/Lot No: Unknown. Ew0167, Location of injection: Arm Left), administration date: 30Aug2021, when the patient was 30-year-old, for COVID-19 Immunization. The following information was reported: VOMITING (non-serious) with onset 20Sep2021, outcome "recovered", DAIRY INTOLERANCE (non-serious) with onset 20Sep2021, outcome "not recovered" and all described as "I was puking anytime I had dairy"; LACTOSE INTOLERANCE (non-serious) with onset 20Sep2021, outcome "recovered", described as "I've developed a lactose intolerance"; NAUSEA (non-serious) with onset 20Sep2021, outcome "not recovered", described as "getting nauseous". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of lactose intolerance, vomiting, dairy intolerance, nausea.  Clinical course: The patient did not received any other vaccines within 4 weeks prior to the covid vaccine. The other medications the patient received within 2 weeks of vaccination was Centrum multivitamin. Prior to vaccination the patient did not diagnosed with covid. Since the vaccination the patient had been tested for covid. Reported Event: Ever since the second dose, patient has developed a lactose intolerance. Immediately following the dose, she was puking anytime she had dairy. Lasted about 2 weeks. She then noticed if she had dairy she needed to find a bathroom asap. Everything she read said adverse effects were supposed to wear off after 6 months. It's been a year and she still can't have a milkshake without blowing up a bathroom or getting nauseous.
Age: 30.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: Nasal Swab (Date:19Jan2022/ Result: Positive); Nasal Swab (Date:19Jan2022/ Result: Positive); This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 30-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 30Aug2021 as dose 1, single (Lot number: Ew0167), in left arm and on 20Sep2021 as dose 2, single (Lot number: 301358A) at the age of 30 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Allergy to avocado" (unspecified if ongoing), notes: Allergy to avocado. Concomitant medication(s) included: CENTRUM FOR WOMEN. Past drug history included: Took benedryl with first dose, reaction(s): "Took benedryl with first dose"; Zyrtec with second, reaction(s): "Zyrtec with second". The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 19Jan2022, outcome "unknown" and all described as "Nasal Swab (Date:19Jan2022/ Result: Positive)". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (19Jan2022) Positive, notes: COVID test type post vaccination=Nasal Swab.  Clinical course: Ever since the second dose, Patient had developed a lactose intolerance. Immediately following the dose, patient was puking anytime had dairy. Lasted about 2 weeks. Then noticed if patient had dairy, patient needed to find a bathroom asap. Everything patient read said adverse effects were supposed to wear off after 6 months. It's been a year and patient still can't have a milkshake without blowing up a bathroom or getting nauseous. No COVID prior vaccination. COVID tested post vaccination. No other vaccine in four weeks. Other medications in two weeks Centrum multivitamin.
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Postmenopausal haemorrhage, Wrong product administered
Clinical narrative: Postmenopausal bleeding; Pfizer Bivalent, Dose Number: 01; This is a spontaneous report received from a contactable reporter (other HCP). The reporter is the patient. A 57-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 30Sep2022 at 16:45 as dose 1, single (lot number unknown) at the age of 57 years intramuscular, in left arm for covid-19 immunisation. The patient didn't receive BNT162b2 (PFIZER BIONTECH COVID-19 VACCINE). The patient's relevant medical history included: "anxiety" (unspecified if ongoing); "depression" (unspecified if ongoing); "known allergies: penicillin" (unspecified if ongoing); "menopause" (unspecified if ongoing). Concomitant medications included: FLU VACCINE VII taken for immunisation, on 28Sep2022 as dose number unknown, single; BUPROPION; SERTRALINE; ALLEGRA [FEXOFENADINE HYDROCHLORIDE]; CLONAZEPAM; BUSPIRONE; LEVOTHYROXINE. Past drug history included: Ibuprofen, reaction: "known allergies: Ibuprofen"; aspirin, reaction: "known allergies: Aspirin". The following information was reported: WRONG PRODUCT ADMINISTERED (non-serious) with onset 30Sep2022 at 16:45, outcome "unknown", described as "Pfizer Bivalent, Dose Number: 01"; POSTMENOPAUSAL HAEMORRHAGE (medically significant) with onset 03Oct2022 at 14:15, outcome "not recovered", described as "postmenopausal bleeding". It was unknown if therapeutic measures were taken as a result of postmenopausal haemorrhage.  Additional Information: The patient did not have covid prior vaccination. The patient was not tested for covid post-vaccination.  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.; Sender's Comments: Based on the information available, the causal relationship between the reported events and suspect drug BNT162B2 cannot be excluded. 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