chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 36.0
Sex: F
Vaccine: FLU4
Symptoms: Computerised tomogram normal, Electrocardiogram normal, Gait disturbance, Hemiparesis, Influenza like illness
Clinical narrative: I received a flu shot Friday, Dec 1st, and got sick with "flu-like" symptoms for the following two days with a very sore left arm. That Monday, I woke up with bilateral tingling in my feet and hands. These symptoms progressed, as well as chest and neck pain. I went to urgent care on Dec 18th. The urgent care Dr wanted to rule out MS and set up an MRI and PCP consult. Around Dec 20th, I developed a limp and weakness on my left side, as well as brain fog and aphasia. Dec 27th, I left work to go to the ED due to crushing chest pain and worsening tingling moving up both arms and up to my buttock. The ED Doctor ordered MRI, CT, ECG, and blood work to rule out MS, meningitis, and mineral deficiencies. These tests all came back negative for those issues. The ED doctor, my PCP, and my neurologist all believed these symptoms could be related to the flu vaccine.
Age: 36.0
Sex: F
Vaccine: FLU4
Symptoms: Magnetic resonance imaging normal, Neck pain, Neurological examination, Pain in extremity, Paraesthesia
Clinical narrative: I received a flu shot Friday, Dec 1st, and got sick with "flu-like" symptoms for the following two days with a very sore left arm. That Monday, I woke up with bilateral tingling in my feet and hands. These symptoms progressed, as well as chest and neck pain. I went to urgent care on Dec 18th. The urgent care Dr wanted to rule out MS and set up an MRI and PCP consult. Around Dec 20th, I developed a limp and weakness on my left side, as well as brain fog and aphasia. Dec 27th, I left work to go to the ED due to crushing chest pain and worsening tingling moving up both arms and up to my buttock. The ED Doctor ordered MRI, CT, ECG, and blood work to rule out MS, meningitis, and mineral deficiencies. These tests all came back negative for those issues. The ED doctor, my PCP, and my neurologist all believed these symptoms could be related to the flu vaccine.
Age: 36.0
Sex: F
Vaccine: FLU4
Symptoms: Scan with contrast normal
Clinical narrative: I received a flu shot Friday, Dec 1st, and got sick with "flu-like" symptoms for the following two days with a very sore left arm. That Monday, I woke up with bilateral tingling in my feet and hands. These symptoms progressed, as well as chest and neck pain. I went to urgent care on Dec 18th. The urgent care Dr wanted to rule out MS and set up an MRI and PCP consult. Around Dec 20th, I developed a limp and weakness on my left side, as well as brain fog and aphasia. Dec 27th, I left work to go to the ED due to crushing chest pain and worsening tingling moving up both arms and up to my buttock. The ED Doctor ordered MRI, CT, ECG, and blood work to rule out MS, meningitis, and mineral deficiencies. These tests all came back negative for those issues. The ED doctor, my PCP, and my neurologist all believed these symptoms could be related to the flu vaccine.
Age: 76.0
Sex: M
Vaccine: VARZOS
Symptoms: Extra dose administered
Clinical narrative: Patient got 2 doses of shingrix (instead of shingrix 1st dose and prevnar20) at the same time.
Age: 6.0
Sex: M
Vaccine: COVID19-2, FLU4
Symptoms: No adverse event, Wrong product administered
Clinical narrative: wrong vaccine given, no symptoms
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Vaccination failure
Clinical narrative: COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a Consumer or other non HCP.  A 60-year-old female patient (not pregnant) received BNT162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 11Nov2023 at 15:00 as dose 1, single (Lot number: IOHHG4G675) at the age of 59 years, in left arm for covid-19 immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) included: METFORMIN HCL, start date: 01Jan2023, stop date: 25Feb2024; MONTELUCAST, start date: 01Jan2023, stop date: 25Feb2024; PROGESTERONE, start date: 01Jan2023, stop date: 25Feb2024; OMEPRAZOLE, start date: 01Jan2023, stop date: 25Feb2024; SIMVASTATIN, start date: 01Jan2023, stop date: 14Feb2024; E2, start date: 01Jan2023, stop date: 25Feb2024; DHEA, start date: 01Jan2023, stop date: 25Feb2024; TESTOSTERONE, start date: 01Jan2023, stop date: 25Feb2024; OZEMPIC, start date: 26Apr2023, stop date: 07Feb2024. Past drug history included: Dyflucane, reaction(s): "Known allergies: Dyflucane". Vaccination history included: BNT162b2 (DOSE 1, SINGLE, at 03:00 PM, Batch/lot number: ER8727 , Anatomical location: Left arm), administration date: 26Mar2021, when the patient was 57-year-old, for COVID-19 immunization; BNT162b2 (DOSE 2, SINGLE, at 03:00 PM, Batch/lot number: EW0164 , Anatomical location: Left arm), administration date: 16Apr2021, when the patient was 57-year-old, for COVID-19 immunization; BNT162b2 (DOSE 3 (BOOSTER), SINGLE, at 03:00 PM, Batch/lot number: FE3590 , Anatomical location: Left arm), administration date: 27Oct2021, when the patient was 57-year-old, for COVID-19 immunization; BNT162b2 (DOSE 4 (BOOSTER), SINGLE, at 03:00 PM, Batch/lot number: FJ4991, Anatomical location: Left arm), administration date: 29Jul2022, when the patient was 58-year-old, for COVID-19 immunization; BNT162b2;BNT162b2 omi ba.4-5 (DOSE 5 (BOOSTER), SINGLE, at 03:00 PM, Batch/lot number: GJ3277, Anatomical location: Left arm), administration date: 21Oct2022, when the patient was 58-year-old, for COVID-19 immunization. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset Feb2024, outcome "unknown" and all described as "COVID 19 Treatment". Therapeutic measures were taken as a result of vaccination failure, covid-19 with paxlovid from 15Feb2024 to 20Feb2024.
Age: 78.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Vaccination failure
Clinical narrative: COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a Consumer or other non HCP.  A 79-year-old female patient (not pregnant) received BNT162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 01Nov2023 as dose 1, single (Batch/Lot number: unknown) at the age of 78 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Known allergies: Avalox antibiotic" (unspecified if ongoing). There were no concomitant medications. Vaccination history included: moderna (DOSE NUMBER UNKNOWN, SINGLE, Anatomical Location: Left arm), administration date: 21Aug2023, when the patient was 78-year-old, for COVID-19 immunisation. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset Feb2024, outcome "unknown" and all described as "COVID 19 Treatment". Therapeutic measures were taken as a result of vaccination failure, covid-19 which included Paxlovid from 14Feb2024 to 19Feb2024.  No follow-up attempts are possible. Batch/lot number is not provided, and it cannot be obtained.
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a Consumer or other non HCP.  A 66-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), in Jul2023 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 patient's had no known allergies. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 15Feb2024, outcome "recovered" (19Feb2024) and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (15Feb2024) Positive; (19Feb2024) Negative. Therapeutic measures were taken as a result of drug ineffective, covid-19 included Paxlovid from 15Feb2024 to 19Feb2024. Clinical course: Patient first tested positive for covid on 15Feb2024 and started Paxlovid on 15Feb2024. Patient felt much better by 18Feb2024 and tested negative to Covid on 19Feb2024.  The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5 will be requested and submitted if and when received.
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, COVID-19, Heart rate, SARS-CoV-2 test, Vaccination failure
Clinical narrative: Treatment of COVID 19; Treatment of COVID 19; This is a spontaneous report received from a Consumer or other non HCP.  A 60-year-old female patient (not pregnant) received BNT162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 26Dec2023 as dose 1, single (Batch/Lot number: unknown) at the age of 60 years, in right arm for covid-19 immunisation. The patient's relevant medical history included: "Breast Cancer" (unspecified if ongoing), notes: Breast Cancer, 15 yrs ago; "Allergies: Dust" (unspecified if ongoing); "Allergies: mites" (unspecified if ongoing). The patient's concomitant medications were not reported. Past drug history included: Chemo med taxotere, reaction(s): "Allergies: Taxotere". The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset Feb2024, outcome "not recovered" and all described as "Treatment of COVID 19". The patient underwent the following laboratory tests and procedures: Body temperature: (unspecified date) 100.4; Heart rate: (unspecified date) 115; SARS-CoV-2 test: (21Feb2024) Negative; (25Feb2024) Positive. Therapeutic measures were taken as a result of vaccination failure, covid-19.  The information on the batch/lot number for BNT162b2 omi xbb.1.5 will be requested and submitted if and when received.
Age: 42.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: COVID 19; COVID 19; This is a spontaneous report received from a Consumer or other non HCP.  A 42-year-old female patient received BNT162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 28Oct2023 at 11:00 as dose 1, single (Batch/Lot number: unknown) at the age of 42 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "reactive airway dysfunction" (unspecified if ongoing). The patient took Women's Probiotics (GARDEN OF LIFE) as concomitant medication. 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 (BOOSTER); MANUFACTURER UNKNOWN), for COVID-19 immunization; Covid-19 vaccine (DOSE 4 (BOOSTER); MANUFACTURER UNKNOWN), for COVID-19 immunization. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset Feb2024, outcome "recovered" (Feb2024) and all described as "COVID 19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (Feb2024) negative; (Feb2024) negative; (Feb2024) negative; (Feb2024) negative; (Feb2024) negative; (Feb2024) negative; (Feb2024) negative; (Feb2024) negative; (Feb2024) negative. Therapeutic measures were taken as a result of vaccination failure, covid-19. The patient was given nirmatrelvir, ritonavir (PAXLOVID) as treatment of COVID-19 starting on 08Feb2024 until 13Feb2024.  The information on the batch/lot number for BNT162b2 omi xbb.1.5 will be requested and submitted if and when received.
Age: 74.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, Interchange of vaccine products, SARS-CoV-2 test
Clinical narrative: COVID-19; COVID-19; Moderna 11Apr2022 / Pfizer / BioNTech 20Sep2022; This is a spontaneous report received from a Consumer or other non HCP.  A 76-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 (Lot number: GH9703) at the age of 74 years, in left arm for covid-19 immunisation; BNT162b2 (BNT162B2), on 21Jan2021 as dose 1, single (Lot number: EL3302), in left arm, on 15Feb2021 as dose 2, single (Lot number: EN6201), in right arm and on 23Sep2021 as dose 3 (booster), single (Lot number: EW0198), in left arm for covid-19 immunisation; elasomeran (MODERNA COVID-19 VACCINE), on 11Apr2022 as dose 4 (booster), single (Lot number: 001M21A), in right arm, on 26Mar2023 as dose 6 (booster), single (Lot number: AS7171B), in right arm and on 03Oct2023 as dose 7 (booster), single), in left arm for covid-19 immunisation. The patient's relevant medical history included: "known allergies: Gluten" (unspecified if ongoing); "High blood pressure" (unspecified if ongoing). Concomitant medication(s) included: VITAMINS NOS, stop date: 13Feb2024; AMLODIPINE, stop date: 13Feb2024. Past drug history included: Phenergan, reaction(s): "allergies". The following information was reported: INTERCHANGE OF VACCINE PRODUCTS (medically significant) with onset 20Sep2022, outcome "unknown", described as "Moderna 11Apr2022 / Pfizer / BioNTech 20Sep2022"; DRUG INEFFECTIVE (medically significant)), COVID-19 (medically significant) all with onset Feb2024, outcome "unknown" and all described as "COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (Feb2024) COVID 19. Therapeutic measures were taken as a result of drug ineffective, covid-19. The patient received PAXLOVID as COVID-19 treatment from 13Feb2024 to 18Feb2024.  No follow-up attempts are possible. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202400049279 Same patient, different drug and event;
Age: 59.0
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 Nurse.  A 59-year-old female patient (not pregnant) received BNT162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 17Oct2023 as dose 1, single (Batch/Lot number: unknown) at the age of 59 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Cancer-breast" (unspecified if ongoing). There were no concomitant medications. Past drug history included: Vancomycin, reaction(s): "Drug allergies". Vaccination history included: Covid-19 vaccine (DOSE 3 (BOOSTER), SINGLE, MANUFACTURER: UNKNOWN), for COVID-19 Immunization; Covid-19 vaccine (DOSE 2, SINGLE, MANUFACTURER: UNKNOWN), for COVID-19 Immunization; Covid-19 vaccine (DOSE 1, SINGLE, MANUFACTURER: UNKNOWN), for COVID-19 Immunization. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset Feb2024, outcome "not recovered" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (24Feb2024) Positive. Therapeutic measures were taken as a result of vaccination failure, covid-19. The patient had no other medication in 2 weeks. The patient mentioned that she took Paxlovid as COVID 19 Treatment from 13Feb2024 to 17Feb2024. Patient got rebound Covid. She took the Paxlovid on the 13Feb2024 and finished entire meds. Then on 24Feb2024, patient was positive and symptoms were back. Patient felt terrific after taking Paxlovid, no problems.  The information on the batch/lot number for BNT162b2 omi xbb.1.5 will be requested and submitted if and when received.; Sender's Comments: The efficacy of a vaccine varies from one patient to another and can be affected by different factors; however, a contributory role of the suspect vaccine product to the reported events Vaccination failure and COVID-19 cannot be ruled out.
Age: 33.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from an Other HCP.  A 34-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 01Sep2023 as dose 5 (booster), single (Batch/Lot number: unknown) at the age of 33 years, in left arm for covid-19 immunisation; COVID-19 vaccine (COVID-19 VACCINE), as dose 1, single), as dose 2, single), as dose 3 (booster), single) and as dose 4 (booster), single) for covid-19 immunisation. The patient's relevant medical history included: "Heart palpitations" (unspecified if ongoing); "anxiety" (unspecified if ongoing); "IBS/acid reflux" (unspecified if ongoing); "IBS/acid reflux" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Feb2024, outcome "not recovered" and all described as "COVID 19 Treatment". Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical course: The patient received anti viral COVID 19 treatment of Paxlovid from 13Feb2024 to 17Feb2024. known allergies: None.  The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5 will be requested and submitted if and when received.; Sender's Comments: Based on the known safety profile of the drug and temporal association, a causal relationship between suspect drug and the events covid 19 and drug ineffective cannot be excluded.
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, Interchange of vaccine products
Clinical narrative: COVID 19 Treatment; COVID 19 Treatment; Interchange of vaccine products; This is a spontaneous report received from a Consumer or other non HCP from product quality group.  A 58-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 17Mar2021 at 15:00 as dose 1, single (Lot number: EN6206), in left arm, on 07Apr2021 at 09:00 as dose 2, single (Lot number: EN6205), in left arm and on 19Nov2021 as dose 3 (booster), single (Lot number: FG3527) at the age of 56 years, in left arm for covid-19 immunisation; elasomeran (SPIKEVAX), on 05Oct2023 at 10:00 as dose 5 (booster), single (Lot number: 3031283), in left arm for covid-19 immunisation; elasomeran (MODERNA COVID-19 VACCINE), on 22Apr2022 as dose 4 (booster), single (Lot number: 005M21A), in left arm for covid-19 immunisation. The patient's relevant medical history included: "Osteoarthritis" (unspecified if ongoing); "NSAIDS" (unspecified if ongoing), notes: Sensitivities to some NSAIDS. The patient's concomitant medications were not reported. Past drug history included: Codeine, reaction(s): "Allergy: Codeine", notes: Allergy: Codeine; Morphine derivatives, reaction(s): "Allergy: morphine derivatives", notes: Allergy: morphine derivatives.  The following information was reported: INTERCHANGE OF VACCINE PRODUCTS (medically significant) with onset 22Apr2022, outcome "unknown"; DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Feb2024, outcome "unknown" and all described as "COVID 19 Treatment". Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical course: The anti viral COVID 19 Treatment of Paxlovid started 24Feb2024, Lot number: HM2449.
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test
Clinical narrative: COVID 19; This is a spontaneous report received from a Consumer or other non HCP.  A 55-year-old female patient (not pregnant) received BNT162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 07Feb2024 as dose 1, single (Batch/Lot number: unknown) at the age of 55 years, in right arm for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. The following information was reported: COVID-19 (non-serious) with onset Feb2024, outcome "not recovered", described as "COVID 19". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were taken as a result of covid-19.  Additional information: This event was treated with Paxlovid from 10Feb2024 to 14Feb2024. No Known allergies.   The information on the batch/lot number for BNT162b2 omi xbb.1.5 will be requested and submitted if and when received.
Age: 73.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Vaccination failure
Clinical narrative: COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a Consumer or other non HCP.  A 74-year-old male patient received BNT162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 28Oct2023 at 14:30 as dose 1, single (Batch/Lot number: unknown) at the age of 73 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Allergies: Penicillin" (unspecified if ongoing); "Myocardial Infarction", start date: 06Jul2022 (unspecified if ongoing), notes: Myocardial Infarction 06Jul2022 has Taxus Express stents; "Taxus Express stents" (unspecified if ongoing), notes: Myocardial Infarction 06Jul2022 has Taxus Express stents. Concomitant medication(s) included: ROSUVASTATIN CALCIUM, start date: 10Jul2009, stop date: 14Feb2024; METOPROLOL SUCCINATE, start date: 10Jul2009; TAMSULOSIN HCL, start date: 17Aug2022, stop date: 14Feb2024; LOSARTAN POTASSIUM, start date: 17Sep2021. Vaccination history included: BNT162b2 (Dose 1, single, lot number: not reporter, in the left arm), administration date: 24Feb2021, when the patient was 71-year-old, for COVID-19 Immunization; BNT162b2 (Dose 2, single, lot number: not reporter, in the left arm), administration date: 19Mar2021, when the patient was 71-year-old, for COVID-19 Immunization; BNT162b2 (Dose 3 (booster), single, lot number: FF8841, in the right arm), administration date: 07Oct2021, when the patient was 71-year-old, for COVID-19 Immunization; BNT162b2 (Does 4 (booster), single, lot number: FK9893, in the right arm), administration date: 11Apr2022, when the patient was 72-year-old, for COVID-19 Immunization; BNT162b2;BNT162b2 omi ba.4-5 (Dose 5 (booster), single, lot number: GJ3275, in the right arm), administration date: 29Oct2022, when the patient was 72-year-old, for COVID-19 Immunization. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "COVID 19 Treatment". Therapeutic measures were taken as a result of vaccination failure, covid-19 which included Paxlovid (start date: 15Feb2024, stop date: 20Feb2024).  No follow-up attempts are possible. Batch/lot number is not provided, and it cannot be obtained.
Sex: F
Vaccine: COVID19
Symptoms: Vertigo
Clinical narrative: vertigo; This is a spontaneous report received from a Consumer or other non HCP from medical information team, Program ID: 005570.  A female patient received BNT162b2 (COMIRNATY), in Sep2023 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. The following information was reported: VERTIGO (non-serious), outcome "unknown". Additional information: The patient received the Comirnaty booster vaccine in Sept 2023.  About 4-5 days after receipt of this last booster vaccine she started having vertigo and it's not going away and is still going on.  The vertigo will go away for a week or two sometimes and then it comes right back.  It's really getting bad.  She had all of Pfizer's booster shots and never had any trouble until this last one in September.   She says she looked it up online by asking her phone and it said that up to 60% of patients have experienced vertigo after this last Pfizer booster vaccine, so it must be some effect from this last shot.  It's really getting bad.  She can stand up out of bed she just about falls. And when she bends over, it's just really concerning. She is afraid to drive.   The information on the batch/lot number for BNT162b2 will be requested and submitted if and when received.
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Vaccination failure
Clinical narrative: Tested positive for covid yesterday; Tested positive for covid yesterday; This is a spontaneous report received from a Consumer or other non HCP.  A 68-year-old female patient received BNT162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 19Dec2023 as dose 1, single (Batch/Lot number: unknown) at the age of 68 years for covid-19 immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) included: AREXVY taken for immunisation, on 19Dec2023 as dose number unkown, single. The patient also took other concomitant therapy, the only prescription she took was a low statin. Vaccination history included: Bnt162b2 (DOSE NUMBER UNKNOWN, SINGLE), for Covid-19 Immunization. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset Feb2024, outcome "not recovered" and all described as "Tested positive for covid yesterday". Therapeutic measures were taken as a result of vaccination failure, covid-19, patient took Paxlovid from 21Feb2024 for 5 days. The information on the batch/lot number for BNT162b2 omi xbb.1.5 will be requested and submitted if and when received.
Age: 38.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, Interchange of vaccine products, SARS-CoV-2 test
Clinical narrative: COVID 19 Treatment; COVID 19 Treatment; Dose 01: Janssen Covid-19 vaccine, Dose 02: Pfizer; This is a spontaneous report received from a Consumer or other non HCP from product quality group.  A 40-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 25Oct2021 as dose 2 (booster), single (Lot number: FF2593) at the age of 38 years, in left arm for covid-19 immunisation; COVID-19 vaccine nrvv ad26 (jnj 78436735) (JANSSEN COVID-19 VACCINE), on 01Apr2021 as dose 1, single (Lot number: 842A21A), in left arm for covid-19 immunisation. The patient's relevant medical history included: "current non-smoker with history of smoking" (unspecified if ongoing); "Known allergies: Penicillins" (unspecified if ongoing); "medical history includes blood transfusion and appendectomy" (not ongoing); "chronic stress" (unspecified if ongoing); "medical history includes blood transfusion and appendectomy" (not ongoing); "POTS" (unspecified if ongoing); "SVT" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: INTERCHANGE OF VACCINE PRODUCTS (medically significant) with onset 25Oct2021, outcome "recovered", described as "Dose 01: Janssen Covid-19 vaccine, Dose 02: Pfizer"; DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 13Feb2024, outcome "recovered" (16Feb2024) and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (13Feb2024) Positive; (16Feb2024) negative. Therapeutic measures were taken as a result of drug ineffective, covid-19 with paxlovid from 13Feb2024 to 18Feb2024. Clinical course: it was reported that she Was sick for approximately 36 hours after testing positive on 13Feb and starting Paxlovid. Primarily GI symptoms and severe exhaustion, no respiratory symptoms. Tested negative and felt fully recovered on third day after beginning Paxlovid (16Feb). Remained negative through 9 days after initial negative test.  No follow-up attempts are possible.
Age: 48.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Vaccination failure
Clinical narrative: Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a Consumer or other non HCP.  A 48-year-old male patient received BNT162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), in Nov2023 as dose 1, single (Batch/Lot number: unknown) at the age of 48 years, in left arm for covid-19 immunisation. The patient had no relevant medical history and no known allergies. The patient's concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (DOSE 1; MANUFACTURER UNKNOWN), for COVID-19 immunisation; Covid-19 vaccine (DOSE 2; MANUFACTURER UNKNOWN), for COVID-19 immunisation; Covid-19 vaccine (DOSE 3 (BOOSTER); MANUFACTURER UNKNOWN), for COVID-19 immunisation. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset Feb2024, outcome "unknown" and all described as "Treatment of COVID-19". Therapeutic measures were taken as a result of vaccination failure, covid-19 include Paxlovid from 15Feb2024 to 19Feb2024.  No follow-up attempts are possible. Batch/lot number is not provided, and it cannot be obtained.
Sex: F
Vaccine: COVID19
Symptoms: Rash
Clinical narrative: Rash on her body; This is a spontaneous report received from a Consumer or other non HCP from medical information team.  A 73-year-old female patient received BNT162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 13Oct2023 as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: RASH (non-serious), outcome "unknown", described as "Rash on her body". Additional information: Caller mentioned that she wanted to talk to someone regarding the covid vaccine ingredients because she got a rash. She got the vaccine last October 13. Caller said her doctor has seen it but has no insight or understanding of what is in the vaccine could have triggered it. Caller is a 73 year old patient who got an unspecified long term Rash on her body after getting the Covid Comirnaty vaccine. Caller wants to know if Rash is a common adverse reaction for Comirnaty.  Batch/lot number is not provided, and it cannot be obtained.
Age: 66.0
Sex: U
Vaccine: COVID19, COVID19
Symptoms: Hypotonia, Illness, Sepsis
Clinical narrative: right foot got floppy; getting sick; Sepsis; This is a spontaneous report received from a Consumer or other non HCP, Program ID:.  A 66-year-old patient received BNT162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), as dose 1, single (Batch/Lot number: unknown) at the age of 66 years 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 Immunisation; Bnt162b2 (DOSE 2, SINGLE), for Covid-19 Immunisation; Bnt162b2 nos (DOSE NUMBER UNKNOWN (BOOSTER), SINGLE), for Covid-19 Immunisation. The following information was reported: SEPSIS (medically significant) with onset Jan2024, outcome "unknown"; HYPOTONIA (non-serious), outcome "unknown", described as "right foot got floppy"; ILLNESS (non-serious), outcome "unknown", described as "getting sick". Therapeutic measures were taken as a result of sepsis. Clinical course: It was reported that patient had Sepsis about 18Jan2024 then had to transfer to a rehab place, patient right foot got floppy. While there patient tested positive for Covid. Patient got home about 12Feb2024, still recovering. First year patient didn't get a Covid shot or flu shot. Have had like 4 or 5 Pfizer shots in the past. Patient didn't get Covid shot because they stopped doing them for seniors who didn't get out much. They would come to patient Apt. 1st time missing his shot, first time getting sick. Patient will be 67.  The information on the batch/lot number for BNT162b2 omi xbb.1.5 will be requested and submitted if and when received.; Sender's Comments: Linked Report(s) : US-PFIZER INC-PV202400026949 same patient/drug, different dose/events;
Age: 66.0
Sex: U
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: right foot got floppy; getting sick; Sepsis; This is a spontaneous report received from a Consumer or other non HCP, Program ID:.  A 66-year-old patient received BNT162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), as dose 1, single (Batch/Lot number: unknown) at the age of 66 years 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 Immunisation; Bnt162b2 (DOSE 2, SINGLE), for Covid-19 Immunisation; Bnt162b2 nos (DOSE NUMBER UNKNOWN (BOOSTER), SINGLE), for Covid-19 Immunisation. The following information was reported: SEPSIS (medically significant) with onset Jan2024, outcome "unknown"; HYPOTONIA (non-serious), outcome "unknown", described as "right foot got floppy"; ILLNESS (non-serious), outcome "unknown", described as "getting sick". Therapeutic measures were taken as a result of sepsis. Clinical course: It was reported that patient had Sepsis about 18Jan2024 then had to transfer to a rehab place, patient right foot got floppy. While there patient tested positive for Covid. Patient got home about 12Feb2024, still recovering. First year patient didn't get a Covid shot or flu shot. Have had like 4 or 5 Pfizer shots in the past. Patient didn't get Covid shot because they stopped doing them for seniors who didn't get out much. They would come to patient Apt. 1st time missing his shot, first time getting sick. Patient will be 67.  The information on the batch/lot number for BNT162b2 omi xbb.1.5 will be requested and submitted if and when received.; Sender's Comments: Linked Report(s) : US-PFIZER INC-PV202400026949 same patient/drug, different dose/events;
Age: 66.0
Sex: U
Vaccine: COVID19, COVID19
Symptoms: Hypotonia, Illness, Sepsis
Clinical narrative: tested positive for Covid; tested positive for Covid; This is a spontaneous report received from a Consumer or other non HCP, Program ID:.  A 66-year-old patient received BNT162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), as dose 1, single (Batch/Lot number: unknown) at the age of 66 years 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 nos (DOSE NUMBER UNKNOWN (BOOSTER), SINGLE), for Covid-19 immunization. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 2024, outcome "unknown" and all described as "tested positive for Covid". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (2024) positive.  The information on the batch/lot number for BNT162b2 omi xbb.1.5 will be requested and submitted if and when received.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202400051241 same reporter/patient different dose/event;
Age: 66.0
Sex: U
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: tested positive for Covid; tested positive for Covid; This is a spontaneous report received from a Consumer or other non HCP, Program ID:.  A 66-year-old patient received BNT162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), as dose 1, single (Batch/Lot number: unknown) at the age of 66 years 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 nos (DOSE NUMBER UNKNOWN (BOOSTER), SINGLE), for Covid-19 immunization. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 2024, outcome "unknown" and all described as "tested positive for Covid". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (2024) positive.  The information on the batch/lot number for BNT162b2 omi xbb.1.5 will be requested and submitted if and when received.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202400051241 same reporter/patient different dose/event;
Age: 39.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: COVID-19; COVID-19; This is a spontaneous report received from a Consumer or other non HCP.  A 41-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 07Oct2022 as dose 4 (booster), single (Lot number: 6H9702) at the age of 39 years for covid-19 immunisation; COVID-19 vaccine (COVID-19 VACCINE), as dose 1, single), as dose 2, single) and as dose 3 (booster), single) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Feb2024, outcome "unknown" and all described as "COVID-19". Therapeutic measures were taken as a result of drug ineffective, covid-19 which included Paxlovid.
Age: 76.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, Interchange of vaccine products, SARS-CoV-2 test
Clinical narrative: Interchange of vaccine products; Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a Consumer or other non HCP.  A 77-year-old female patient (not pregnant) received BNT162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 25Oct2023 as dose 1, single (Batch/Lot number: unknown) at the age of 76 years for covid-19 immunisation. The patient's relevant medical history included: "Known allergies: adhesives" (unspecified if ongoing). Concomitant medication(s) included: AMLODIPINE, start date: Jan2021, stop date: 14Feb2024; GABAPENTIN, start date: Jan2019, stop date: Feb2024. Past drug history included: Chlorhexidine, reaction(s): "Known allergies: Chlorhexidine". Vaccination history included: moderna (Dose Number: 6, Batch/Lot No: Unknown. Not available/provided to reporter at the time of report completion), administration date: 06Jun2023, when the patient was 76-year-old, for COVID-19 immunization; moderna (Dose Number: 5, Batch/Lot No: AS7162B), administration date: 27Sep2022, when the patient was 75-year-old, for COVID-19 immunization; moderna (Dose Number: 4, Batch/Lot No: 065K21A), administration date: 14Apr2022, when the patient was 75-year-old, for COVID-19 immunization; moderna (Dose Number: 3, Batch/Lot No: 032F21A), administration date: 28Oct2021, when the patient was 74-year-old, for COVID-19 immunization; moderna (Dose Number: 2, Batch/Lot No: 025A21A), administration date: 06Mar2021, when the patient was 74-year-old, for COVID-19 immunization; moderna (Dose Number: 1, Batch/Lot No: 013M20A), administration date: 06Feb2021, when the patient was 74-year-old, for COVID-19 immunization. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Feb2024, outcome "unknown" and all described as "Treatment of COVID-19"; INTERCHANGE OF VACCINE PRODUCTS (non-serious), outcome "unknown". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (Feb2024) Negative, notes: positive test after 5 days of negative tests; (Feb2024) Positive, notes: positive test after 5 days of negative tests. Therapeutic measures were taken as a result of drug ineffective, covid-19.  The information on the batch/lot number for BNT162b2 omi xbb.1.5 will be requested and submitted if and when received.
Age: 40.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: COVID-19; COVID-19; This is a spontaneous report received from a Consumer or other non HCP.  A 42-year-old male patient received BNT162b2 (BNT162B2), on 16Apr2021 as dose 1, single (Lot number: ER8735), in left arm, on 07May2021 as dose 2, single (Lot number: ER8736), in left arm and on 23Mar2022 as dose 3 (booster), single (Lot number: FK9895) at the age of 40 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Autoimmune thyroid issues" (unspecified if ongoing). Concomitant medication(s) included: ESTRADIOL, start date: May2004; VITAMIN D [COLECALCIFEROL], start date: Sep2021. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset Feb2024, outcome "unknown" and all described as "COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (26Feb2024) Positive; (20Feb2024) Negative. Therapeutic measures were taken as a result of vaccination failure, covid-19. Clinical course: The patient was treated with Paxlovid from 12Feb2024 to 17Feb2024. No known allergies.
Age: 57.0
Sex: M
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: very little effects when he first got the vaccine except a little pain where the shot was given; This is a spontaneous report received from a Consumer or other non HCP.  A 57-year-old male patient received BNT162b2 (BNT162B2), on 16Apr2021 as dose 1, single (Lot number: EW0161) at the age of 57 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "COVID-19" (unspecified if ongoing). The patient's concomitant medications were not reported. Past drug history included: Chloroquine for COVID-19; Hydroxychloroquine for COVID-19, notes: in his nose and eyes about 7-8 times; Cortisone for COVID-19. The following information was reported: VACCINATION SITE PAIN (non-serious), outcome "unknown", described as "very little effects when he first got the vaccine except a little pain where the shot was given".; Sender's Comments: Linked Report(s) : US-PFIZER INC-202400051045 same patient/suspect drug, different vaccine dose/event;
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: COVID-19; COVID-19; This is a spontaneous report received from an Other HCP.  A 49-year-old male patient received BNT162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID-19". Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical information: The patient received Paxlovid since 16Feb2024 to 20Feb2024 for treatment of COVID-19. Patient had no known allergies.  The information on the batch/lot number for BNT162b2 omi xbb.1.5 will be requested and submitted if and when received.; Sender's Comments: The efficacy of a drug varies from patient to patient and can be affected by varied factors; however, a contributory role of the suspect product BNT162b2 omi xbb.1.5 to the reported events covid 19 and drug ineffective cannot be ruled out since no other alternate explanation is present.
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal pain, Cough, Diarrhoea, Diverticulitis, Fatigue
Clinical narrative: Caused inflammatory response to diverticulitis; Fatigue; headache; runny nose; jitters; abdominal pain; diarrhea; cough; This is a spontaneous report received from a Consumer or other non HCP.  A 73-year-old female patient received BNT162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 10Aug2023 at 20:00 as dose 1, single (Batch/Lot number: unknown) at the age of 73 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Cancer (now clear)" (unspecified if ongoing); "High BP" (unspecified if ongoing); "High Cholesterol" (unspecified if ongoing); "Allergies: Sulpha" (unspecified if ongoing). The patient's concomitant medications were not reported. Past drug history included: Oxycodone, reaction(s): "Drug Allergy"; Percocet, reaction(s): "Drug Allergy"; Dilaudid, reaction(s): "Drug Allergy"; Ultracet, reaction(s): "Drug Allergy"; Mobic, reaction(s): "Drug Allergy"; Gentamicin, reaction(s): "Drug Allergy"; Nitrofurantoin, reaction(s): "Drug Allergy". 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 (BOOSTER); MANUFACTURER UNKNOWN), for Covid-19 immunization. The following information was reported: DIVERTICULITIS (medically significant) with onset 11Aug2023 at 06:00, outcome "not recovered", described as "Caused inflammatory response to diverticulitis"; FATIGUE (non-serious) with onset 11Aug2023 at 06:00, outcome "not recovered"; ABDOMINAL PAIN (non-serious) with onset 11Aug2023 at 06:00, outcome "not recovered"; COUGH (non-serious) with onset 11Aug2023 at 06:00, outcome "not recovered"; DIARRHOEA (non-serious) with onset 11Aug2023 at 06:00, outcome "not recovered", described as "diarrhea"; HEADACHE (non-serious) with onset 11Aug2023 at 06:00, outcome "not recovered"; FEELING JITTERY (non-serious) with onset 11Aug2023 at 06:00, outcome "not recovered", described as "jitters"; RHINORRHOEA (non-serious) with onset 11Aug2023 at 06:00, outcome "not recovered", described as "runny nose". The events "caused inflammatory response to diverticulitis", "fatigue", "headache", "runny nose", "jitters", "abdominal pain", "diarrhea" and "cough" required emergency room visit. Therapeutic measures were taken as a result of diverticulitis, fatigue, headache, rhinorrhoea, feeling jittery, abdominal pain, diarrhoea, cough.  Clinical course: The patient did not take any vaccine in four weeks and had taken several other medications in 2 weeks. The patient was not tested for COVID prior to and post vaccination. Antibiotics and dietary restrictions were recommended as treatment for the events  The information on the batch/lot number for BNT162b2 omi xbb.1.5 will be requested and submitted if and when received.
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Feeling jittery, Headache, Rhinorrhoea
Clinical narrative: Caused inflammatory response to diverticulitis; Fatigue; headache; runny nose; jitters; abdominal pain; diarrhea; cough; This is a spontaneous report received from a Consumer or other non HCP.  A 73-year-old female patient received BNT162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 10Aug2023 at 20:00 as dose 1, single (Batch/Lot number: unknown) at the age of 73 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Cancer (now clear)" (unspecified if ongoing); "High BP" (unspecified if ongoing); "High Cholesterol" (unspecified if ongoing); "Allergies: Sulpha" (unspecified if ongoing). The patient's concomitant medications were not reported. Past drug history included: Oxycodone, reaction(s): "Drug Allergy"; Percocet, reaction(s): "Drug Allergy"; Dilaudid, reaction(s): "Drug Allergy"; Ultracet, reaction(s): "Drug Allergy"; Mobic, reaction(s): "Drug Allergy"; Gentamicin, reaction(s): "Drug Allergy"; Nitrofurantoin, reaction(s): "Drug Allergy". 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 (BOOSTER); MANUFACTURER UNKNOWN), for Covid-19 immunization. The following information was reported: DIVERTICULITIS (medically significant) with onset 11Aug2023 at 06:00, outcome "not recovered", described as "Caused inflammatory response to diverticulitis"; FATIGUE (non-serious) with onset 11Aug2023 at 06:00, outcome "not recovered"; ABDOMINAL PAIN (non-serious) with onset 11Aug2023 at 06:00, outcome "not recovered"; COUGH (non-serious) with onset 11Aug2023 at 06:00, outcome "not recovered"; DIARRHOEA (non-serious) with onset 11Aug2023 at 06:00, outcome "not recovered", described as "diarrhea"; HEADACHE (non-serious) with onset 11Aug2023 at 06:00, outcome "not recovered"; FEELING JITTERY (non-serious) with onset 11Aug2023 at 06:00, outcome "not recovered", described as "jitters"; RHINORRHOEA (non-serious) with onset 11Aug2023 at 06:00, outcome "not recovered", described as "runny nose". The events "caused inflammatory response to diverticulitis", "fatigue", "headache", "runny nose", "jitters", "abdominal pain", "diarrhea" and "cough" required emergency room visit. Therapeutic measures were taken as a result of diverticulitis, fatigue, headache, rhinorrhoea, feeling jittery, abdominal pain, diarrhoea, cough.  Clinical course: The patient did not take any vaccine in four weeks and had taken several other medications in 2 weeks. The patient was not tested for COVID prior to and post vaccination. Antibiotics and dietary restrictions were recommended as treatment for the events  The information on the batch/lot number for BNT162b2 omi xbb.1.5 will be requested and submitted if and when received.