chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 74.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: tested positive; tested positive; This is a spontaneous report received from a Consumer or other non HCP.  A 74-year-old female patient (not pregnant) received BNT162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 30Sep2023 as dose 1, single (Batch/Lot number: unknown) at the age of 74 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "high blood pressure" (unspecified if ongoing); "high cholesterol" (unspecified if ongoing); "neuropathy" (unspecified if ongoing); "essential tremor" (unspecified if ongoing); "posterior tibial tendon disfunction" (unspecified if ongoing); "depression" (unspecified if ongoing); "Known allergies: penicillin" (unspecified if ongoing). The patient's concomitant medications were not reported. Vaccination history included: BNT162b2;BNT162b2 omi ba.4-5 (DOSE 4 (BOOSTER), SINGLE, Vaccine brand=Pfizer / BioNTech, Batch/Lot No: Unknown. Not available/provided to reporter at the time of report completion), administration date: 16Mar2023, when the patient was 73-year-old, for COVID-19 immunization; Covid-19 vaccine (DOSE 3 (BOOSTER), SINGLE, Unknown Manufacturer), for COVID-19 immunization; Covid-19 vaccine (DOSE 2, SINGLE, Unknown Manufacturer), for COVID-19 immunization; Covid-19 vaccine (DOSE 1, SINGLE, Unknown Manufacturer), for COVID-19 immunization. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "tested positive". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Negative, notes: I tested positive 5 days after 2 negative tests, 48 hours apart; Negative, notes: I tested positive 5 days after 2 negative tests, 48 hours apart; Positive, notes: I tested positive 5 days after 2 negative tests, 48 hours apart; Positive, notes: I tested positive 5 days after 2 negative tests, 48 hours apart; Positive, notes: I tested positive 5 days after 2 negative tests, 48 hours apart; Positive, notes: I tested positive 5 days after 2 negative tests, 48 hours apart; Positive, notes: I tested positive 5 days after 2 negative tests, 48 hours apart. 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: 43.0
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 Consumer or other non HCP from product quality group.  A 44-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 09Sep2022 at 17:00 as dose 4 (booster), single (Lot number: GH9694) at the age of 43 years, in left arm for covid-19 immunisation; BNT162b2 (BNT162B2), on 13Jan2021 at 15:30 as dose 1, single (Lot number: EL3247), in left arm, on 04Feb2021 as dose 2, single (Lot number: EM9809), in left arm and on 04Dec2021 at 12:00 as dose 3 (booster), single (Lot number: FJ1611), in left arm for covid-19 immunisation. The patient's relevant medical history included: "Hashimoto's Thyroiditis" (unspecified if ongoing); "elevated platelet count" (unspecified if ongoing); "Allergies: Penicillin" (unspecified if ongoing). The patient's concomitant medications were not reported. Past drug history included: Bactrim, reaction(s): "Allergies: Bactrim". The following information was reported: COVID-19 (medically significant), VACCINATION FAILURE (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, notes: Covid-19 treatment. Therapeutic measures were taken as a result of covid-19, vaccination failure.
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a Consumer or other non HCP.  A 28-year-old female patient (not pregnant) received BNT162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), as dose 1, single (Batch/Lot number: unknown), in left arm for covid-19 immunisation. The patient's relevant medical history included: "Mild cerebral palsy" (unspecified if ongoing). The patient's 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 Treatment". 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: 61.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: Tested positive for Covid; Tested positive for Covid; This is a spontaneous report received from a Consumer or other non HCP.  A 61-year-old male patient received BNT162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 27Oct2023 at 16:15 as dose 1, single (Batch/Lot number: unknown) at the age of 61 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Acid reflux" (unspecified if ongoing); "Penicillin allergy" (unspecified if ongoing); "Sulfonamide allergy" (unspecified if ongoing). The patient's concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Dose 1, Single , Unknown Manufacturer), for COVID-19 Immunization; Covid-19 vaccine (Dose 2, Single , Unknown Manufacturer), for COVID-19 Immunization; Covid-19 vaccine (Dose 3 (Booster), Single , Unknown Manufacturer), for COVID-19 Immunization; Covid-19 vaccine (Dose 4 (Booster), Single , Unknown Manufacturer), for Covid-19 immunization. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 27Dec2023, outcome "unknown" and all described as "Tested positive for Covid". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (27Dec2023) Positive; (02Jan2024) negative; (04Jan2024) Positive; (09Jan2024) 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: 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 Consumer or other non HCP from product quality group. Reporter is the patient.  A 68-year-old female patient (not pregnant) received BNT162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 28Nov2023 as dose 1, single (Lot number: 206EZ232A) at the age of 68 years, in left arm for covid-19 immunisation. The patient had no relevant medical history. The patient's concomitant medications were not reported. Vaccination history included: moderna vaccine (DOSE 6 (BOOSTER), SINGLE, Vaccine location=Left arm), administration date: 14Aug2023, when the patient was 67-year-old, for COVID-19 immunization; moderna vaccine (DOSE 5 (BOOSTER), SINGLE, Vaccine lot number=AS7145B, Vaccine location=Left arm), administration date: 14Sep2022, when the patient was 67-year-old, for Covid-19 Immunization; moderna vaccine (DOSE 4 (BOOSTER), SINGLE, Vaccine administration date=18Apr2022, Vaccine location=Left arm), administration date: 18Apr2022, when the patient was 66-year-old, for COVID-19 Immunization; BNT162b2 (DOSE 3 (BOOSTER), SINGLE, Vaccine location=Left arm, Manufacturer: Pfizer/BioNTech), administration date: 05Oct2021, when the patient was 66-year-old, for COVID-19 Immunization; BNT162b2 (DOSE 2, SINGLE, Vaccine location=Left arm, Vaccine lot number=EP6955, Manufacturer: Pfizer/BioNTech), administration date: 27Mar2021, when the patient was 65-year-old, for covid-19 immunization; BNT162b2 (DOSE 1, SINGLE, Vaccine location=Left arm, Vaccine lot number=EN6202, Manufacturer: Pfizer/BioNTech), administration date: 06Mar2021, when the patient was 65-year-old, for covid-19 immunization. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset Dec2023, outcome "unknown" and all described as "COVID 19 Treatment". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were taken as a result of vaccination failure, covid-19.  Additional information: Patient had no known allergies. Patient received antiviral PAXLOVID from 30Dec2023 to 03Jan2024 for Treatment of COVID-19.   No follow-up attempts are possible.
Age: 72.0
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 a Consumer or other non HCP. A 72-year-old male patient received BNT162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), in Dec2023 as dose 1, single (Batch/Lot number: unknown) at the age of 72 years, in left arm for covid-19 immunisation. The patient had no relevant medical history. The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Dec2023, latency 10 days after the suspect product(s) administration, outcome "recovered" (04Jan2024) and all described as "COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (2023) Positive, notes: Treatment of COVID-19; (Jan2024) negative; (Jan2024) Positive. Therapeutic measures were taken as a result of drug ineffective, covid-19 which included Paxlovid from 29Dec2023 to 03Jan2024. Additional information: the patient received the vaccine at 01:00 pm. The patient has 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.
Sex: M
Vaccine: PNC20
Symptoms: Urticaria
Clinical narrative: Hives; This is a spontaneous report received from a Physician.  A male patient received pneumococcal 20-val conj vac (dipht CRM197 protein) (PREVNAR 20), as dose number unknown, single (Batch/Lot number: unknown) for immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: URTICARIA (non-serious) with onset 2023, outcome "unknown", described as "Hives".  Additional information: MD had a patient who had a reaction to the Prevnar 20 vaccine and MD did not know if because they had a reaction to that whether they could get the Abrysvo RSV Vaccine or whether should not prescribe that because of his reaction with the Prevnar 20. When paraphrased the concern, reporter stated, "Last year like last spring, he had hives".   The information on the batch/lot number for pneumococcal 20-val conj vac (dipht CRM197 protein) will be requested and submitted if and when received.
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a Physician.  A 52-year-old male patient received BNT162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 27Sep2023 as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (DOSE 5 (BOOSTER), SINGLE, MANUFACTURER UNKNOWN), for COVID-19 immunization; Covid-19 vaccine (DOSE 4 (BOOSTER), SINGLE, MANUFACTURER UNKNOWN), for COVID-19 immunization; 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), outcome "not recovered" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (07Jan2024) Negative; (09Jan2024) Positive. Therapeutic measures were taken as a result of vaccination failure, covid-19.  No follow-up attempts are possible. Batch/lot number is not provided, and it cannot be obtained.; Sender's Comments: Based on the compatible time association, the lack of efficacy cannot be excluded for suspect vaccine BNT162b2 omi xbb.1.5 administration.
Age: 68.0
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 69-year-old female patient received BNT162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 21Sep2023 as dose 1, single (Batch/Lot number: unknown) at the age of 68 years, in right arm 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 "not recovered" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive, notes: negative, and on 4th day symptoms  returned and positive test; negative, notes: negative, and on 4th day symptoms  returned and positive test. 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.
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a Consumer or other non HCP.  A male patient received BNT162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 21Sep2023 as dose 1, single (Batch/Lot number: unknown), in right arm 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 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Negative, notes: took 5 days of Paxlovid, recovered for 3 days, negative; Positive, notes: on 4th day symptoms returned and positive test. 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.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202400010539 Same reporter/drug/event; different patient;US-PFIZER INC-202400010540 Same patient; different drug/event;
Age: 82.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Incorrect route of product administration, Vaccination site erythema
Clinical narrative: Large local reaction; large red angry looking rash on my right upper arm, that covers the entire right upper arm; more systemic allergic reaction; This is a spontaneous report received from a Physician.  An 82-year-old male patient received BNT162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 12Nov2023 as dose 1, single (Batch/Lot number: unknown) at the age of 82 years for covid-19 immunisation. The patient's relevant medical history included: "asthma" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: RASH ERYTHEMATOUS (non-serious), outcome "recovered", described as "Large local reaction; large red angry looking rash on my right upper arm, that covers the entire right upper arm"; HYPERSENSITIVITY (non-serious), outcome "unknown", described as "more systemic allergic reaction".  Additional information: The patient (retired physician) received the latest Pfizer COVID Vaccine at his local pharmacy and a day or two later he developed a large red angry looking rash on his right upper arm, that covered the entire right upper arm, it went away over by a week, and he had no other symptoms related to that. The patient reported having a more systemic allergic reaction, therefore inquired about if it was or not an allergic reaction.   The information on the batch/lot number for BNT162b2 omi xbb.1.5 will be requested and submitted if and when received.
Age: 82.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Hypersensitivity, Rash erythematous
Clinical narrative: Large local reaction; large red angry looking rash on my right upper arm, that covers the entire right upper arm; more systemic allergic reaction; This is a spontaneous report received from a Physician.  An 82-year-old male patient received BNT162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 12Nov2023 as dose 1, single (Batch/Lot number: unknown) at the age of 82 years for covid-19 immunisation. The patient's relevant medical history included: "asthma" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: RASH ERYTHEMATOUS (non-serious), outcome "recovered", described as "Large local reaction; large red angry looking rash on my right upper arm, that covers the entire right upper arm"; HYPERSENSITIVITY (non-serious), outcome "unknown", described as "more systemic allergic reaction".  Additional information: The patient (retired physician) received the latest Pfizer COVID Vaccine at his local pharmacy and a day or two later he developed a large red angry looking rash on his right upper arm, that covered the entire right upper arm, it went away over by a week, and he had no other symptoms related to that. The patient reported having a more systemic allergic reaction, therefore inquired about if it was or not an allergic reaction.   The information on the batch/lot number for BNT162b2 omi xbb.1.5 will be requested and submitted if and when received.
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: COVID-19; COVID-19; This is a spontaneous report received from 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 15Sep2023 at 17:00 as dose 1, single (Batch/Lot number: unknown) at the age of 55 years, in left leg for covid-19 immunisation. The patient's relevant medical history included: "Asthma" (unspecified if ongoing); "Seasonal allergies" (unspecified if ongoing), notes: Known allergies: Seasonal allergies. The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 01Jan2024, outcome "not recovered" and all described as "COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (01Jan2024) Positive; (04Jan2024) Negative; (05Jan2024) Negative; (06Jan2024) Negative; (07Jan2024) Negative; (08Jan2024) Negative; (09Jan2024) Negative; (10Jan2024) Positive. Therapeutic measures were taken as a result of drug ineffective, covid-19. Additional information: Tested negative 4 days after testing positive and taking paxlovid, tested negative for 6 days after, then tested positive 7 days after first testing negative.  The information on the batch/lot number for BNT162b2 omi xbb.1.5 will be requested and submitted if and when received.
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Axillary pain, Chills, Fatigue, Headache, Interchange of vaccine products
Clinical narrative: first three doses of Moderna and the updated vaccine from Pfizer; headaches; chills; pain in the underarm; Tiredness; This is a spontaneous report received from a Consumer or other non HCP from medical information team.  A 60-year-old female patient received BNT162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation; elasomeran (MODERNA COVID-19 VACCINE), as dose 1, single), as dose 2, single) and as dose 3, single) 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 (non-serious), outcome "unknown", described as "first three doses of Moderna and the updated vaccine from Pfizer"; HEADACHE (non-serious), outcome "unknown", described as "headaches"; CHILLS (non-serious), outcome "unknown"; AXILLARY PAIN (non-serious), outcome "unknown", described as "pain in the underarm"; FATIGUE (non-serious), outcome "unknown", described as "Tiredness". Additional information: The patient reported that she got the first three doses of Moderna and the updated vaccine from Pfizer.   The information on the batch/lot number for BNT162b2 omi xbb.1.5 will be requested and submitted if and when received.
Age: 71.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Body temperature, 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 Consumer or other non HCP.  A 72-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 03Apr2023 at 16:30 as dose 5 (booster), single (Lot number: 577344009) at the age of 71 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 had no relevant medical history. Concomitant medication(s) included: LAMICTAL, start date: 01Feb2019, stop date: 10Jan2024. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 29Dec2023, outcome "unknown" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: Body temperature: (29Dec2023) 100 Fahrenheit; SARS-CoV-2 test: (29Dec2023) Positive, notes: Paxlovid started 3 days after symptoms and positive Ag (Antigen) test; (02Jan2024) Negative, notes: Negative test after 36 hours treatment started and negative for 5 days; (03Jan2024) Negative, notes: Negative test after 36 hours treatment started and negative for 5 days; (04Jan2024) Negative, notes: Negative test after 36 hours treatment started and negative for 5 days; (05Jan2024) Negative, notes: Negative test after 36 hours treatment started and negative for 5 days; (06Jan2024) Negative, notes: Negative test after 36 hours treatment started and negative for 5 days; (07Jan2024) Negative, notes: Negative test after 36 hours treatment started and negative for 5 days; (08Jan2024) Positive, notes: Retested positive 7 days post Paxlovid treatment. Therapeutic measures were taken as a result of drug ineffective, covid-19.
Age: 80.0
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.  An 81-year-old male patient received BNT162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 15Sep2023 as dose 1, single (Batch/Lot number: unknown) at the age of 80 years, in left arm for covid-19 immunisation. The patient's relevant medical history was not reported. Patient has no known allergies. There were no concomitant medications. 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; Covid-19 vaccine (Dose 3, Unknown manufacturer), for COVID-19 immunization.  The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "Treatment of COVID-19". Paxlovid was given from 01Jan2024 to 05Jan2024 as COVID-19 Treatment.  The information on the batch/lot number for BNT162b2 omi xbb.1.5 will be requested and submitted if and when received.
Age: 7.0
Sex: F
Vaccine: COVID19
Symptoms: Overdose, Pain in extremity, Product administered to patient of inappropriate age, Pyrexia
Clinical narrative: Fever; sore arm; 7-year-old child inadvertently received adult dose, 12 plus formulation Pfizer Covid-19 vaccine; 7-year-old child inadvertently received adult dose, 12 plus formulation Pfizer Covid-19 vaccine; This is a spontaneous report received from a Pharmacist. A 7-year-old female patient received BNT162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 05Jan2024 as dose 1, 0.3 ml single (Lot number: HM7010, Expiration Date: 10Apr2024) at the age of 7 years intramuscular, in left arm for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. The following information was reported: PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (non-serious), OVERDOSE (non-serious) all with onset 05Jan2024, outcome "unknown" and all described as "7-year-old child inadvertently received adult dose, 12 plus formulation Pfizer Covid-19 vaccine"; PYREXIA (non-serious) with onset 06Jan2024, outcome "recovered", described as "Fever"; PAIN IN EXTREMITY (non-serious) with onset 06Jan2024, outcome "unknown", described as "sore arm". Therapeutic measures were taken as a result of pyrexia, pain in extremity. Additional information: Caller is pharmacist reporting adverse event Pfizer Covid-19 vaccine. Provided by transferring agent that a 7-year-old child inadvertently received adult dose, 12 plus formulation Pfizer Covid-19 vaccine, last Friday. Inadvertently received adult dose: Clarified patient received this dose, last Friday, 05Jan2024. Seriousness criteria: In his clinical opinion, does not think it is serious. Suspect product: Covid-19 vaccine, 12 plus formulation: providing correct NDC as 0069-2377-10. Did speak to parent, patient's father, who said, patient experienced fever and sore arm after that shot, believes, the day after receiving the shot. Patient's father said, patient had no more fever. Treatment: patient's father gave patient Tylenol and Ibuprofen. Reporter seriousness for inadvertently received adult dose: Not Serious. Patient did not receive any previous doses Covid-19 vaccine. No prior vaccinations (within 4 weeks). AE required visit to: No, reporter did contact prescriber (patient's pediatrician), to let them know.
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, Interchange of vaccine products, SARS-CoV-2 test
Clinical narrative: Treatment of COVID-19; Treatment of COVID-19; Dose Number: 1 Moderna; Dose Number: 2 Pfizer; This is a spontaneous report received from a Nurse.  A 61-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 26Jan2021 at 13:00 as dose 2, single (Batch/Lot number: unknown) at the age of 61 years, in right arm for covid-19 immunisation; davesomeran, elasomeran (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)), on 08Oct2022 at 13:00 as dose 4 (booster), single), in right arm for covid-19 immunisation; elasomeran (MODERNA COVID-19 VACCINE), on 28Dec2020 as dose 1, single), in right arm and on 03Nov2021 at 12:00 as dose 3 (booster), single), in right arm for covid-19 immunisation. The patient's relevant medical history included: "Hashimoto's" (unspecified if ongoing); "Menopause" (unspecified if ongoing); "Chronic fatigue syndrome" (unspecified if ongoing), notes: Hx (history) of CFS/ME (Chronic fatigue syndrome) (myalgic encephalomyelitis); "Myalgic encephalomyelitis" (unspecified if ongoing), notes: Hx (history) of CFS/ME (Chronic fatigue syndrome) (myalgic encephalomyelitis); "Closed angle glaucoma" (unspecified if ongoing); "Meniere's" (unspecified if ongoing). The patient has no known allergies. Concomitant medication(s) included: LEVOTHYROXINE, start date: Apr1990. The patient also took other concomitant therapy. The following information was reported: INTERCHANGE OF VACCINE PRODUCTS (non-serious) with onset 26Jan2021 at 13:00, outcome "unknown", described as "Dose Number: 1 Moderna; Dose Number: 2 Pfizer"; DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 18Sep2023, outcome "unknown" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (18Sep2023) Positive. Paxlovid was give from 19Sep2023 to 23Sep2023 as treatment of COVID-19.   The information on the batch/lot number for BNT162b2 will be requested and submitted if and when received.
Sex: M
Vaccine: PNC13
Symptoms: Drug hypersensitivity, Fatigue, Headache, Pain, Rash
Clinical narrative: fatigue; pain; headache; rash; This is a spontaneous report received from a Consumer or other non HCP from medical information team, Program ID.  A male patient received pneumococcal 13-val conj vac (dipht CRM197 protein) (PREVNAR 13), as dose 1, single (Batch/Lot number: unknown) and as dose 2, single (Batch/Lot number: unknown) for immunisation. The patient's relevant medical history and concomitant medications were not reported.The following information was reported: FATIGUE (non-serious), outcome "not recovered"; PAIN (non-serious), outcome "not recovered"; HEADACHE (non-serious), outcome "not recovered"; RASH (non-serious), outcome "not recovered". Additional information: Husband also got this vaccine (2 doses), but he stayed that way. He weighs 100 more pounds than wife does, and he did not have it as bad. The symptoms didn't go away". Neither of them can take a Z pack, even though we previously had no problems with it. Wife got two shots of Prevnar 13 and they were 6 months apart and so did her husband. The information on the batch/lot number for pneumococcal 13-val conj vac (dipht CRM197 protein) will be requested and submitted if and when received.
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a Consumer or other non HCP from product quality group.  A 66-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 25Oct2022 as dose 5 (booster), single (Batch/Lot number: unknown) at the age of 64 years, in left arm for covid-19 immunisation; BNT162b2 (BNT162B2), on 22Apr2022 as dose 4 (booster), single (Lot number: FJ4989), in left arm for covid-19 immunisation; BNT162b2 (BNT162B2), on 05Feb2021 as dose 1, single (Lot number: EL3249), in left arm, on 26Feb2021 as dose 2, single (Lot number: EN6202), in left arm and on 17Aug2021 as dose 3 (booster), single (Lot number: FC3181), in left arm for covid-19 immunisation. The patient's relevant medical history included: "Cancer" (unspecified if ongoing), notes: 12 year cancer survivor; "Wegeners", start date: 2018 (unspecified if ongoing), notes: Wegeners diagnosed 2018; "Known allergies: Sulfa" (unspecified if ongoing). The patient's concomitant medications were not reported. Past drug history included: Claritin, reaction(s): "Known allergies: Claritin". The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset Dec2023, outcome "unknown" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (21Dec2023) Positive, notes: felt worse than week before after testing positive. Therapeutic measures were taken as a result of vaccination failure, covid-19.  The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5 will be requested and submitted if and when received.
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Vaccination failure
Clinical narrative: Covid; Covid; 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)), in Oct2023 as dose 1, single (Batch/Lot number: unknown), in left arm for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset Dec2023, outcome "not recovered" and all described as "Covid". Therapeutic measures were taken as a result of vaccination failure, covid-19 included: Paxlovid from 27Dec2023 to 31Dec2023.  No follow-up attempts are possible. Batch/lot number is not provided, and it cannot be obtained.
Age: 37.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, Interchange of vaccine products, SARS-CoV-2 test
Clinical narrative: vaccine brand other=Moderna/vaccine brand=Pfizer / BioNTech; Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a Consumer or other non HCP. A 38-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5, on 21Sep2022 as dose 4 (booster), single (Lot number: PF1261) at the age of 37 years, in left arm for covid-19 immunisation; elasomeran (MODERNA COVID-19 VACCINE), on 12Nov2023 at 14:00 as dose 5 (booster), single (Lot number: 3030535), in left arm 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 included: "Anxiety disorder" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: INTERCHANGE OF VACCINE PRODUCTS (medically significant), outcome "unknown", described as "vaccine brand other=Moderna/vaccine brand=Pfizer / BioNTech"; DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive. Therapeutic measures were taken as a result of drug ineffective, covid-19, treated with Paxlovid Pfizer from 03Jan2024 to 07Jan2024. The patient had no known allergies.
Age: 78.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: had a total of 6 Pfizer COVID vaccines, got Covid; had a total of 6 Pfizer COVID vaccines, got Covid; This is a spontaneous report received from a Consumer or other non HCP from medical information team and product quality group.  A 78-year-old male patient received BNT162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 26Sep2023 as dose 1, 0.3 ml single (Lot number: C-HD9835, Expiration Date: 24Nov2023, NDC: 00069-2362-10) at the age of 78 years, in left deltoid for covid-19 immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) included: CANDESARTAN oral taken for hypertension; NEXIUM [ESOMEPRAZOLE SODIUM] oral taken for gastrooesophageal reflux disease. Vaccination history included: BNT162b2 (DOSE 1, SINGLE, Lot: EN6206, Time: Always between 10AM and 11AM, Dose, route: Unknown, injection in left deltoid), administration date: 03Mar2021, when the patient was 75-year-old, for COVID-19 Immunization; BNT162b2 (DOSE 2, SINGLE, NDC: 59267-1000-03, Lot: ER8730, Expiry: 31Jul2021, Time: Always between 10AM and 11AM, Dose, route: 0.3mL, injection in left deltoid), administration date: 01Apr2021, when the patient was 75-year-old, for COVID-19 Immunization; BNT162b2 (DOSE 3 (BOOSTER), SINGLE, Lot: FH8020, Time: Always between 10AM and 11AM, Dose, route: Unknown, injection in left deltoid), administration date: 28Oct2021, when the patient was 76-year-old, for COVID-19 Immunization; BNT162b2 (DOSE 4 (BOOSTER), SINGLE, Lot: FM9992, Time: Always between 10AM and 11AM, Dose, route: Unknown, injection in left deltoid), administration date: 12Jul2022, when the patient was 77-year-old, for COVID-19 Immunization; BNT162b2 (DOSE 5 (BOOSTER), SINGLE, NDC: 592670304-02, Lot: GJ3275, Expiry: 20Dec2022, Time: Always between 10AM and 11AM, Dose, route: 0.3mL, injection in left deltoid), administration date: 29Oct2022, when the patient was 77-year-old, for COVID-19 Immunization. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 26Dec2023, outcome "unknown" and all described as "had a total of 6 Pfizer COVID vaccines, got Covid". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (26Dec2023) positive. Treatment Paxlovid were taken as a result of covid-19 from 26Dec2023 to 31Dec2023.
Age: 78.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Pain in extremity
Clinical narrative: had a total of 6 Pfizer COVID vaccines, got Covid; had a total of 6 Pfizer COVID vaccines, got Covid; This is a spontaneous report received from a Consumer or other non HCP from medical information team and product quality group.  A 78-year-old male patient received BNT162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 26Sep2023 as dose 1, 0.3 ml single (Lot number: C-HD9835, Expiration Date: 24Nov2023, NDC: 00069-2362-10) at the age of 78 years, in left deltoid for covid-19 immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) included: CANDESARTAN oral taken for hypertension; NEXIUM [ESOMEPRAZOLE SODIUM] oral taken for gastrooesophageal reflux disease. Vaccination history included: BNT162b2 (DOSE 1, SINGLE, Lot: EN6206, Time: Always between 10AM and 11AM, Dose, route: Unknown, injection in left deltoid), administration date: 03Mar2021, when the patient was 75-year-old, for COVID-19 Immunization; BNT162b2 (DOSE 2, SINGLE, NDC: 59267-1000-03, Lot: ER8730, Expiry: 31Jul2021, Time: Always between 10AM and 11AM, Dose, route: 0.3mL, injection in left deltoid), administration date: 01Apr2021, when the patient was 75-year-old, for COVID-19 Immunization; BNT162b2 (DOSE 3 (BOOSTER), SINGLE, Lot: FH8020, Time: Always between 10AM and 11AM, Dose, route: Unknown, injection in left deltoid), administration date: 28Oct2021, when the patient was 76-year-old, for COVID-19 Immunization; BNT162b2 (DOSE 4 (BOOSTER), SINGLE, Lot: FM9992, Time: Always between 10AM and 11AM, Dose, route: Unknown, injection in left deltoid), administration date: 12Jul2022, when the patient was 77-year-old, for COVID-19 Immunization; BNT162b2 (DOSE 5 (BOOSTER), SINGLE, NDC: 592670304-02, Lot: GJ3275, Expiry: 20Dec2022, Time: Always between 10AM and 11AM, Dose, route: 0.3mL, injection in left deltoid), administration date: 29Oct2022, when the patient was 77-year-old, for COVID-19 Immunization. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 26Dec2023, outcome "unknown" and all described as "had a total of 6 Pfizer COVID vaccines, got Covid". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (26Dec2023) positive. Treatment Paxlovid were taken as a result of covid-19 from 26Dec2023 to 31Dec2023.
Age: 65.0
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 65-year-old female patient received BNT162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 02Oct2023 as dose 1, single (Lot number: Hg4628) at the age of 65 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), as dose 4 (booster), single) and as dose 5 (booster), single) for covid-19 immunisation. The patient's relevant medical history included: "known allergies" (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 Dec2023, outcome "unknown" and all described as "COVID-19". Therapeutic measures were taken as a result of covid-19, which included nirmatrelvir, ritonavir (PAXLOVID) from 29Dec2023 to 03Jan2024.
Age: 25.0
Sex: M
Vaccine: 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 Consumer or other non HCP.  A 25-year-old male patient received BNT162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 19Oct2023 as dose 1, single (Lot number: HG4664) at the age of 25 years, in left arm for covid-19 immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) included: TRUVADA, start date: Jan2022, stop date: 30Dec2023. Vaccination history included: Covid-19 vaccine (DOSE 4 (BOOSTER); MANUFACTURER UNKNOWN), for COVID-19 immunization; Covid-19 vaccine (DOSE 3 (BOOSTER); MANUFACTURER UNKNOWN), for COVID-19 immunization; Covid-19 vaccine (DOSE 2; MANUFACTURER UNKNOWN), for COVID-19 immunization; Covid-19 vaccine (DOSE 1; MANUFACTURER UNKNOWN), for COVID-19 immunization. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive. Therapeutic measures were taken as a result of drug ineffective, covid-19.
Age: 50.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Vaccination failure
Clinical narrative: COVID 19; COVID 19; This is a spontaneous report received from a Consumer or other non HCP from product quality group.  A 50-year-old male patient received BNT162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 15Sep2023 as dose 1, single (Lot number: hh7595) at the age of 50 years for covid-19 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; Covid-19 vaccine (Dose 3 (BOOSTER), Unknown Manufacturer), for Covid-19 Immunization. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 2023, outcome "unknown" and all described as "COVID 19". Therapeutic measures were taken as a result of covid-19 included Paxlovid from 30Dec2023 to 04Jan2024.  No follow-up attempts are possible.
Sex: F
Vaccine: 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 Consumer or other non HCP.  A 55-year-old female patient (not pregnant) 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 included: "Autoimmune Disease" (unspecified if ongoing). Concomitant medication(s) included: TAMIFLU, start date: 01Jan2024, stop date: 03Jan2024; METHOTREXATE. Vaccination history included: Covid-19 vaccine (Dose 3 (Booster), Unknown Manufacturer), for Covid-19 immunization; Covid-19 vaccine (Dose 2, Unknown Manufacturer), for Covid-19 immunization; Covid-19 vaccine (Dose 1, Unknown Manufacturer), for Covid-19 immunization. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 28Dec2023, outcome "not recovered" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (28Dec2023) Positive; (03Jan2024) Negative; (09Jan2024) Positive. Therapeutic measures were taken as a result of drug ineffective, covid-19 which included Paxlovid.  The information on the batch/lot number for BNT162b2 omi xbb.1.5 will be requested and submitted if and when received.
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Vaccination failure
Clinical narrative: COVID 19; COVID 19; This is a spontaneous report received from a Consumer or other non HCP .  A 50-year-old female patient received BNT162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 15Sep2023 as dose 1, single (Lot number: hh7595) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (DOSE 3 (BOOSTER), SINGLE), for Covid-19 Immunization; Covid-19 vaccine (DOSE 2, SINGLE), for Covid-19 Immunization; Covid-19 vaccine (DOSE 1, SINGLE), for Covid-19 Immunization. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset Dec2023, outcome "unknown" and all described as "COVID 19". Therapeutic measures were taken as a result of vaccination failure, covid-19 included Paxlovid from 31Dec2023 to 05Jan2024.  No follow-up attempts are possible.
Age: 37.0
Sex: F
Vaccine: 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 Consumer or other non HCP.  A 37-year-old female patient (not pregnant) received BNT162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), as dose 1, single (Lot number: HH7595) at the age of 37 years, in right arm for covid-19 immunisation. The patient's relevant medical history included: "depression" (unspecified if ongoing); "anxiety" (unspecified if ongoing); "gastrointestinal" (unspecified if ongoing). The patient's concomitant medications were not reported. Vaccination history included: BNT162b2 (DOSE 4 (BOOSTER), SINGLE lot no. GH9694 on the arm right), administration date: 07Oct2022, when the patient was 36-year-old, for COVID-19 immunization; BNT162b2 (DOSE 3 (BOOSTER), SINGLE lot no. FF2593 on the arm right), administration date: 20Nov2021, when the patient was 35-year-old, for COVID-19 immunization; BNT162b2 (DOSE 2, SINGLE lot no. EW0170 on the arm right), administration date: 26Apr2021, when the patient was 35-year-old, for COVID-19 immunization; BNT162b2 (DOSE 1, SINGLE lot no. EW0150), administration date: 05Apr2021, when the patient was 35-year-old, for COVID-19 immunization. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 29Dec2023, outcome "unknown" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (29Dec2023) Positive; (08Jan2024) Positive. Therapeutic measures were taken as a result of drug ineffective, covid-19, patient received Paxlovid from 30Dec2023 to 03Jan2023.
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.  An elderly female patient (not pregnant) received BNT162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 10Oct2023 at 12:00 as dose 1, single (Batch/Lot number: unknown), in left arm for covid-19 immunisation. The patient's relevant medical history included: "CID" (unspecified if ongoing); "Penicillin allergy" (unspecified if ongoing); "sulphuric allergy" (unspecified if ongoing); "cephalosporins allergy" (unspecified if ongoing). The patient's concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Dose 4, single, Unknown Manufacturer), for Covid-19 immunization; Covid-19 vaccine (Dose 3, single, Unknown Manufacturer), for Covid-19 immunization; Covid-19 vaccine (Dose 2, single, Unknown Manufacturer), for Covid-19 immunization; Covid-19 vaccine (Dose 1, single, Unknown Manufacturer), for Covid-19 immunization. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID 19 Treatment". Therapeutic measures included Paxlovid from 01Jan2024 to 05Jan2024 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.