chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: COVID / could not smell or taste; COVID / could not smell or taste; This is a spontaneous report received from a Pharmacist from medical information team.  A 66-year-old female patient received BNT162b2 (BNT162B2 NOS), on 21Apr2023 as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 09May2023, outcome "not recovered" and all described as "COVID / could not smell or taste". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Negative; Negative; Negative; Negative; Negative. Clinical course: Consumer stated, "she was 66 years old, and her last Pfizer shot (later clarified as Pfizer COVID-19 Shot) was on 21Apr2023 (21Apr2023). Her first question was if there were another one after that she might have missed, bivalent, it has the number on the bottom, she wrote it. Pharmacist in the (name withheld) write down and underneath it, there is a number. That's one question. The other question is that she got it 21Apr2023 and on 09May2023 she came down with COVID and it wasn't as bad as her first time but since May2023 she still can't smell. So, if there is another one, she was just wondering should she take or get it or not." When paraphrased the concern, patient stated, "because of the loss of smell and she meant she can't even taste very well and it's since Apr2023. She doesn't blame it on the vaccine. It happened when we came off of a plane two days before and then she came down with it on 09May2023 and the kids were sneezing. So, she meant it was just one of those things. She tested negative five times for COVID but then at the end of the 7th day, she could not smell or taste and it's still in process. So, she was just wondering as a pharmacist what she was scheduled right now to have the RCA or HRC what was that called, its related shot, people do have it. She cannot find it. She was scheduled to get that today and they also scheduled her for Moderna and Booster (unspecified medications, hence suspect not made for MI) and she wants to know number one, should she wait for the Pfizer, or does she need it, would they advise her not to do it at one right now, since she was still having COVID. She was dealing with the loss of smell and taste these many months later or what do you think."  The information on the batch/lot number for BNT162b2 will be requested and submitted if and when received.; Sender's Comments: Vaccine efficacy varies from person to person and is affected by many factors. The association between the event drug ineffective (CoVID-19) with the suspect product BNT162B2 cannot be fully excluded.
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: he tested positive again and is still testing positive; he tested positive again and is still testing positive; This is a spontaneous report received from a Consumer or other non HCP from medical information team.  A 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. Vaccination history included: Bnt162b2 (DOSE 1, SINGLE), for COVID-19 immunization; Bnt162b2 (DOSE 2, SINGLE), for COVID-19 immunization; Bnt162b2 (DOSE 3 (BOOSTER), SINGLE), for COVID-19 immunization; Bnt162b2 (DOSE 4 (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 "he tested positive again and is still testing positive". Therapeutic measures were taken as a result of drug ineffective, covid-19. Additional information: Caller states her husband had covid on 16Jan and took Paxlovid until the 21st. He then tested negative on the 21st and the following Saturday he tested positive again and is still testing positive. She read about rebound and wants to know what he needs to do or take.  They both got the five Pfizer covid vaccines. She tested negative at home, then tested positive at the doctor's office but when she tested at home again, it was negative.  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: Based on available information, a lack of efficacy with the suspect vaccine BNT162b2 omi xbb.1.5 in this patient cannot be completely excluded.
Age: 35.0
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 35-year-old female patient (not pregnant) received BNT162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 06Oct2023 at 16:00 as dose 1, single (Batch/Lot number: unknown) at the age of 35 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "PCOS" (unspecified if ongoing); "undifferentiated connective tissue disease" (unspecified if ongoing); "obesity" (unspecified if ongoing); "Allergies: walnuts" (unspecified if ongoing); "Allergies: Sulfa, amoxicillin" (unspecified if ongoing). The patient's concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (DOSE 1; MANUFACTURER UNKNOWN), for Covid-19 immunization; Covid-19 vaccine (DOSE 2; MANUFACTURER UNKNOWN), for Covid-19 immunization; Covid-19 vaccine (DOSE 3 (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 Jan2024, outcome "unknown" and all described as "COVID 19 Treatment". Therapeutic measures were taken as a result of vaccination failure, covid-19 with treatment with Paxlovid from 18Jan2024 to 23Jan2024.  The information on the batch/lot number for BNT162b2 omi xbb.1.5 will be requested and submitted if and when received.
Age: 65.0
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 65-year-old female patient (not pregnant) received BNT162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 05Oct2023 as dose 1, single (Lot number: HH7595) at the age of 65 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Diabetes" (unspecified if ongoing); "higher than normal cholesterol" (unspecified if ongoing). The patient's concomitant medications were not reported. Vaccination history included: moderna, inc. (Dose Number: 5, Batch/Lot No: AS7170B, Location of injection: Arm Left), administration date: 19Jan2023, when the patient was 64-year-old, for COVID-19 Immunization; moderna, inc. (Dose Number: 4, Batch/Lot No: 059A22A, Location of injection: Arm Left), administration date: 14Jul2022, when the patient was 64-year-old, for COVID-19 Immunization; moderna, inc. (Dose Number: 3, Batch/Lot No: 041J21A, Location of injection: Arm Left), administration date: 22Dec2021, when the patient was 63-year-old, 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), outcome "unknown" and all described as "COVID 19 Treatment". Therapeutic measures were taken as a result of drug ineffective, covid-19.  No follow-up attempts are possible. No further information is expected.
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Lethargy, Pain in extremity, Pyrexia
Clinical narrative: lethargy; sore arm; slight fever; This is a spontaneous report received from a Consumer or other non HCP.  An elderly female patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 31Mar2022 as dose 4, single (Lot number: FK9893) at the age of 69 years, in arm for covid-19 immunisation. The patient's relevant medical history included: "mild asthma", start date: 2016 (ongoing); "OBESITY" (unspecified if ongoing). Concomitant medication(s) included: ZYRTEC ALLERGY oral taken for asthma, hypersensitivity (ongoing). Vaccination history included: BNT162b2 (Dose 1, lot EL9261), administration date: 26Jan2021, for COVID-19 immunization, reaction(s): "lethargy", "pain in arm", "slight fever"; BNT162b2 (Dose 2, lot EN6201), administration date: 16Feb2021, for COVID-19 immunization, reaction(s): "lethargy", "pain in arm", "slight fever"; BNT162b2 (Dose 3 (booster), lot 301358A), administration date: 25Sep2021, for COVID-19 immunization, reaction(s): "lethargy", "pain in arm", "slight fever". The following information was reported: LETHARGY (non-serious), outcome "unknown"; PAIN IN EXTREMITY (non-serious), outcome "unknown", described as "sore arm"; PYREXIA (non-serious), outcome "unknown", described as "slight fever". The events "sore arm" and "slight fever" required physician office visit.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300335763 same patient, different vaccine dose and events.;
Age: 67.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Lethargy, Pain in extremity, Pyrexia
Clinical narrative: lethargy; sore arm; slight fever; This is a spontaneous report received from a Consumer or other non HCP.  An elderly female patient received BNT162b2 (BNT162B2), on 26Jan2021 as dose 1, single (Lot number: EL9261) at the age of 67 years intramuscular, in arm for covid-19 immunisation. The patient's relevant medical history included: "Obesity" (unspecified if ongoing); "mild asthma" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: LETHARGY (non-serious), outcome "unknown", described as "lethargy "; PAIN IN EXTREMITY (non-serious), outcome "unknown", described as "sore arm"; PYREXIA (non-serious), outcome "unknown", described as "slight fever".; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300335763 for same patient, different vaccine dose and event;
Age: 67.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: lethargy; sore arm; slight fever; This is a spontaneous report received from a Consumer or other non HCP.  An elderly female patient received BNT162b2 (BNT162B2), on 26Jan2021 as dose 1, single (Lot number: EL9261) at the age of 67 years intramuscular, in arm for covid-19 immunisation. The patient's relevant medical history included: "Obesity" (unspecified if ongoing); "mild asthma" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: LETHARGY (non-serious), outcome "unknown", described as "lethargy "; PAIN IN EXTREMITY (non-serious), outcome "unknown", described as "sore arm"; PYREXIA (non-serious), outcome "unknown", described as "slight fever".; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300335763 for same patient, different vaccine dose and event;
Age: 67.0
Sex: U
Vaccine: COVID19
Symptoms: Lethargy, Pain in extremity, Pyrexia
Clinical narrative: lethargy; sore arm; slight fever; This is a spontaneous report received from a Consumer or other non HCP.  An elderly patient received BNT162b2 (BNT162B2), on 16Feb2021 as dose 2, single (Lot number: EN6201) at the age of 67 years intramuscular, in arm for covid-19 immunisation. The patient's relevant medical history included: "mild asthma" (ongoing); "OBESITY" (unspecified if ongoing). Concomitant medication(s) included: ZYRTEC ALLERGY. Vaccination history included: Bnt162b2 (Dose 1, lot EL9261), for COVID-19 immunization, reaction(s): "lethargy", "pain in arm", "slight fever". The following information was reported: LETHARGY (non-serious), outcome "unknown"; PAIN IN EXTREMITY (non-serious), outcome "unknown", described as "sore arm"; PYREXIA (non-serious), outcome "unknown", described as "slight fever".; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300335763 same patient, different vaccine dose and events;
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Lethargy, Pain in extremity, Pyrexia
Clinical narrative: lethargy; sore arm; slight fever; This is a spontaneous report received from a Consumer or other non HCP.  An elderly female patient received BNT162b2 (BNT162B2), on 25Sep2021 as dose 3 (booster), single (Lot number: 301358A) at the age of 68 years intramuscular, in arm for covid-19 immunisation. The patient's relevant medical history included: "mild asthma" (ongoing); "OBESITY" (unspecified if ongoing). Concomitant medication(s) included: ZYRTEC ALLERGY. Vaccination history included: Bnt162b2 (Dose 1, lot EL9261), for COVID-19 immunization, reaction(s): "lethargy", "pain in arm", "slight fever"; Bnt162b2 (Dose 2 lot EN6201), for COVID-19 immunization, reaction(s): "lethargy"; Bnt162b2 (Dose 2, lot EN6201), for COVID-19 immunization, reaction(s): "pain in arm", "slight fever". The following information was reported: LETHARGY (non-serious), outcome "unknown"; PAIN IN EXTREMITY (non-serious), outcome "unknown", described as "sore arm"; PYREXIA (non-serious), outcome "unknown", described as "slight fever".; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300335763 same patient, different vaccine dose and events;
Age: 39.0
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 40-year-old male patient received BNT162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 23Oct2023 at 08:00 as dose 1, single (Batch/Lot number: unknown) at the age of 39 years, in left arm for covid-19 immunisation. The patient's relevant medical history was not reported. There were no concomitant medications. Past drug history included: Codeine, reaction(s): "Known allergies: Codeine". Vaccination history included: Covid-19 vaccine (DOSE 1; MANUFACTURER UNKNOWN), for Covid-19 immunization; Covid-19 vaccine (DOSE 2; MANUFACTURER UNKNOWN), for Covid-19 immunization; Covid-19 vaccine (DOSE 3; MANUFACTURER UNKNOWN), for Covid-19 immunization; Covid-19 vaccine (DOSE 4; MANUFACTURER UNKNOWN), for Covid-19 immunization. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 30Jan2024, outcome "unknown" and all described as "Treatment of COVID-19". Therapeutic measures were taken as a result of vaccination failure, covid-19, which included Paxlovid on 23Jan2024 to 27Jan2024.   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
Clinical narrative: still got COVID after shots; still got COVID after shots; This is a spontaneous report received from a Consumer or other non HCP from medical information team.  A 24-year-old male patient received BNT162b2 (BNT162B2), on 08Sep2021 as dose 1, single (Batch/Lot number: unknown) and on 30Sep2021 as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "still got COVID after shots". The vaccines were given one the right and one on the left shoulder .  No follow-up attempts are possible. Batch/lot number is not provided, and it cannot be obtained.
Age: 69.0
Sex: F
Vaccine: 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 70-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 31Oct2022 at 13:00 as dose 5 (booster), single (Lot number: 59267-0304-01) at the age of 69 years, in left arm for covid-19 immunisation; BNT162b2 (BNT162B2), on 04Apr2022 at 14:00 as dose 4 (booster), single (Lot number: FJ9943), in left arm for covid-19 immunisation; BNT162b2 (BNT162B2), on 01Mar2021 at 12:00 as dose 1, single (Lot number: EN6203), in left arm, on 22Mar2021 as dose 2, single (Lot number: EP7534), in left arm and on 02Oct2021 at 14:00 as dose 3 (booster), single (Lot number: FF8839), in left arm for covid-19 immunisation. The patient's relevant medical history included: "Known allergies: Penicllin" (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". Therapeutic measures were taken as a result of drug ineffective, covid-19 which included PAXLOVID (lot number: GC0631) taken from 22Jan2024 to 26Jan2024 for treatment of Covid-19. The patient took PAXLOVID for 5 days which suppressed the virus.
Age: 65.0
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. A 65-year-old male patient received BNT162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 13Sep2023 as dose 1, single (Batch/Lot number: unknown) at the age of 65 years, in left arm for covid-19 immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) included: ZANUBRUTINIB BEIGENE, start date: 13Apr2023. 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. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset Jan2024, outcome "unknown" and all described as "COVID-19". Therapeutic measures were taken as a result of vaccination failure, covid-19- treated with Paxlovid, start date: 22Jan2024 and stop date: 26Jan2024. This was the patient's dose 3 of covid vaccine with lot number unknown since misplaced/discarded.  No follow-up attempts are possible. Batch/lot number is not provided, and it cannot be obtained.
Age: 46.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: treatment of COVID-19; treatment of COVID-19; This is a spontaneous report received from an Other HCP.  A 48-year-old male patient received BNT162b2 (BNT162B2), on 14Feb2022 as dose 2, single (batch/lot number: unknown) at the age of 46 years for covid-19 immunization; COVID-19 vaccine (COVID-19 VACCINE), as dose 1, single for covid-19 immunization. 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), outcome "unknown" and all described as "treatment of COVID-19". Therapeutic measures were taken as a result of drug ineffective, covid-19 which included Paxlovid from 23Jan2024 to 27Jan2024.  The information on the batch/lot number for BNT162b2 will be requested and submitted if and when received.; Sender's Comments: The efficacy of a vaccine varies individually and can be affected by different factors. However, a contributory role of BNT162b2 to the events Drug ineffective and Covid-19 cannot be ruled out.
Sex: U
Vaccine: COVID19
Symptoms: Atrial fibrillation, Cardiogenic shock, Drug ineffective, Immune system disorder, Pain
Clinical narrative: Afib which is pretty serious; Had to have my heart shocked; It just did not work for me; Attacked my immune system; Pain everywhere; This is a spontaneous report received from a Consumer or other non HCP.  A patient (age and gender not provided) 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: ATRIAL FIBRILLATION (medically significant), outcome "unknown", described as "Afib which is pretty serious"; CARDIOGENIC SHOCK (medically significant), outcome "unknown", described as "Had to have my heart shocked"; DRUG INEFFECTIVE (medically significant), outcome "unknown", described as "It just did not work for me"; IMMUNE SYSTEM DISORDER (non-serious), outcome "unknown", described as "Attacked my immune system"; PAIN (non-serious), outcome "unknown", described as "Pain everywhere". Therapeutic measures were taken as a result of atrial fibrillation, immune system disorder, pain. Additional information:Patient stated, "I had the Pfizer shot (COVID-19 Vaccine) it was mandatory in our State and I had a bad reaction. I am not anti-shot, I believe in this shot and everything. It just did not work for me. I had nothing but troubles since I had that shot. Very adverse reactions including AFib which is pretty serious.  I have to take very expensive medicine probably for the rest of my life now. I was otherwise very healthy and now I am not.  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, Vaccination failure
Clinical narrative: Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a Physician.  A 38-year-old female patient (not pregnant) received BNT162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 07Oct2023 at 13:00 as dose 1, single (Batch/Lot number: unknown) at the age of 38 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "PCN" (unspecified if ongoing). The patient's concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (DOSE 4 (BOOSTER), SINGLE, Unknown manufacturer), 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: VACCINATION FAILURE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "Treatment of COVID-19". Therapeutic measures were taken as a result of vaccination failure, covid-19.  The information on the batch/lot number for BNT162b2 omi xbb.1.5 will be requested and submitted if and when received.; Sender's Comments: Vaccine efficacy varies from person to person and is affected by many factors. The association between the event vaccination failure (CoVID-19) with the suspect product BNT162B2 OMI XBB.1.5 cannot be fully excluded.
Sex: U
Vaccine: COVID19
Symptoms: Lymphadenopathy
Clinical narrative: throat glands swallows up and is in pain for months; This is a spontaneous report received from a Consumer or other non HCP, Program ID.  A patient (age and gender not provided) received BNT162b2 (BNT162B2 NOS), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: LYMPHADENOPATHY (non-serious), outcome "unknown", described as "throat glands swallows up and is in pain for months".  Additional information: Patient stated that every time he/she gets COVID shot, his/her throat glands swallows up and he/she is in pain for months. Patient wondered what to do because he/she traveling and he/she wants to get the booster shots but he/she do not want to be in pains for months.   Batch/lot number is not provided, and it cannot be obtained.
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: he got Covid; he got Covid; This is a spontaneous report received from an Other HCP, Program ID.  An adult 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 "he got Covid". No follow-up attempts are possible. Batch/lot number is not provided, and it cannot be obtained.; Sender's Comments: Based on available information, a lack of efficacy with the suspect vaccine BNT162b2 omi xbb.1.5 in this patient cannot be completely excluded.
Sex: F
Vaccine: COVID19
Symptoms: Blindness unilateral, Loss of personal independence in daily activities, Pain
Clinical narrative: blind in one eye; in lots of pain; can't use her hands; This is a spontaneous report received from a Consumer or other non HCP, Program ID.  A female 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: BLINDNESS UNILATERAL (medically significant), outcome "unknown", described as "blind in one eye"; PAIN (non-serious), outcome "not recovered", described as "in lots of pain"; LOSS OF PERSONAL INDEPENDENCE IN DAILY ACTIVITIES (non-serious), outcome "unknown", described as "can't use her hands".  Clinical course: patient got the covid-19 shot, and has been in lots of pain, is blind in one eye, and is in constant pain, and can't use her hands.   The information on the batch/lot number for BNT162b2 omi xbb.1.5 will be requested and submitted if and when received.
Age: 78.0
Sex: F
Vaccine: FLU4
Symptoms: Extra dose administered, No adverse event
Clinical narrative: an extra dose of fluzone high-dose quadrivalent was administered to a patient with no adverse event; Initial information was received on 24-Jan-2024 regarding an unsolicited valid non-serious case received from a pharmacist.  This case involves a 78 years old female patient to whom an extra dose of influenza quadrival A-B high dose HV vaccine [Fluzone high-dose quadrivalent] was administered with no adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On 24-Jan-2024, the patient received a 0.7 ml, twice dose of suspect influenza quadrival A-B high dose HV vaccine (unknown formulation) (lot: UT8137DA, expiry date: 30-Jun-2024, strength: 0.7 ml) via intramuscular route in the right deltoid of left arm for Influenza immunisation and extra dose of fluzone high-dose quadrivalent was administered to a patient with no adverse event (extra dose administered) (Latency: same day).  The batch number for the first dose was UT8131CA.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Age: 0.5
Sex: M
Vaccine: HIBV
Symptoms: No adverse event, Product preparation error
Clinical narrative: did not reconstitute the Act-hib vaccine properly and only administered the diluent to the patient with no adverse event; Initial information received on 26-Jan-2024 regarding an unsolicited valid  non-serious case received from a nurse.  This case involves a 6 months old male patient and reporter did not reconstitute the Haemophilus Type B (Hib) Vaccine (Act-Hib) vaccine properly and only administered the diluent to the patient with no adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On 25-Jan-2024, the patient received dose 3 of suspect Haemophilus Type B (Hib) Vaccine Powder and solvent for solution for injection (lot number: UJ992AA) (Expiry date: 28-Feb-2025) (Strength: Standard) (Frequency: once) via intramuscular route in unknown administration site for immunization.  On 25-Jan-2024, the reporter did not reconstitute the Haemophilus Type B (Hib) Vaccine properly and only administered the diluent to the patient with no adverse event (product preparation error) (latency: same day).  It was reported, A nurse is reporting that one of the nurses did not reconstitute the Act-hib vaccine properly and only administered the diluent to the patient. She is asking if they could request for a replacement diluent and administer it together with the left-over HIB portion.   This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Age: 74.0
Sex: F
Vaccine: MENB
Symptoms: Incorrect route of product administration
Clinical narrative: Bexsero was administered via intravenous; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of intramuscular formulation administered by other route in a 74-year-old female patient who received Men B NVS (Bexsero) for prophylaxis.   On 23-JAN-2024, the patient received Bexsero (intravenous). On 23-JAN-2024, an unknown time after receiving Bexsero, the patient experienced intramuscular formulation administered by other route (Verbatim: Bexsero was administered via intravenous). The outcome of the intramuscular formulation administered by other route was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK Receipt Date: 23-JAN-2024 The pharmacist reported that a patient received Bexsero vaccine via intravenous route, which led to an intramuscular formulation administered by other route. The reporter consented to follow up.
Age: 13.0
Sex: M
Vaccine: HEPA, HPV9, MNQ
Symptoms: Chest pain, Electrocardiogram ST segment elevation, Pericarditis, Pyrexia
Clinical narrative: Patient presented to clinic reporting chest pain and intermittent fevers, generally negative physical exam.  EKG ordered as part of eval.  Patient returned to clinic 2/1/24 as did not have results of EKG.  EKG reviewed and noted with ST elevation consistent with pericarditis.  Labs ordered but not yet back as of this reporting.
Age: 13.0
Sex: F
Vaccine: HPV9
Symptoms: Electrocardiogram normal, Syncope
Clinical narrative: syncope
Age: 16.0
Sex: F
Vaccine: FLU4, MENB, MNQ
Symptoms: Contusion, Erythema, Peripheral swelling, Pyrexia
Clinical narrative: Redness & swelling and bruise to both arms but more on the right arm. Had temperature of 38.5 C for 3 days. Cold pack is being applied Today swelling & bruising are less. No fever since 01-28-2024
Age: 72.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: PATIENT VACCINATED AFTER VIABILITY DATE.
Age: 74.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: PATIENT VACCINATED AFTER VIABILITY DATE.
Age: 11.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: PATIENT VACCINATED AFTER VIABILITY DATE.
Age: 80.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: PATIENT VACCINATED AFTER VIABILITY DATE.
Age: 74.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: PATIENT VACCINATED AFTER VIABILITY DATE.
Age: 1.58
Sex: M
Vaccine: DTAP, HEPA, HIBV, MMRV, PNC20
Symptoms: Injection site erythema, Injection site mass, Injection site reaction, Product administered at inappropriate site
Clinical narrative: Patient had injection site reaction, redness and lump. When patient was examined 2 days later the provider felt the injections were not administered in the right location.
Age: 58.0
Sex: M
Vaccine: VARZOS
Symptoms: Product storage error
Clinical narrative: Vaccine was frozen instead of refrigerated.
Age: 0.17
Sex: F
Vaccine: RSV
Symptoms: Discomfort, Product administered to patient of inappropriate age, Pyrexia
Clinical narrative: Infant given the adult RSV vaccine . She had a low grade fever and discomfort for 40 hours.
Age: 42.0
Sex: M
Vaccine: FLU4
Symptoms: Dyspnoea, Wheezing
Clinical narrative: Vaccine was given at workplace--- Clinic not same as providers clinic.  wheezing, SOB 30 minutes after vaccine.
Age: 15.0
Sex: M
Vaccine: COVID19
Symptoms: Incorrect dose administered
Clinical narrative: Given a pediatric 5-11 year dose when he needed a 12+ dose.
Age: 52.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: PATIENT VACCINATED AFTER VIABILITY DATE.
Age: 5.0
Sex: M
Vaccine: DTAPIPV, VARCEL
Symptoms: Injection site cellulitis, Injection site pain, Injection site papule, Injection site warmth, Pain in extremity
Clinical narrative: Patient came in office 1/30/24 for catch up vaccine schedule visit.  Recieved Kinrix in right thigh and varicella vaccine in left thigh (noted above).  Came back in office the next day, 1/31/24, with right leg pain, low grade fever per mom (in office temp 98.7F).  On exam had circumferential swelling from hip to knee.  MD noted papules at injection site.  Warmth and tenderness noted on right thigh.  No erythema on right thigh.  No concerns ROM or reflexes.
Age: 5.0
Sex: M
Vaccine: DTAPIPV, VARCEL
Symptoms: Peripheral swelling, Pyrexia
Clinical narrative: Patient came in office 1/30/24 for catch up vaccine schedule visit.  Recieved Kinrix in right thigh and varicella vaccine in left thigh (noted above).  Came back in office the next day, 1/31/24, with right leg pain, low grade fever per mom (in office temp 98.7F).  On exam had circumferential swelling from hip to knee.  MD noted papules at injection site.  Warmth and tenderness noted on right thigh.  No erythema on right thigh.  No concerns ROM or reflexes.
Age: 17.0
Sex: F
Vaccine: MENB
Symptoms: Diarrhoea, Fatigue, Headache, Injection site erythema, Injection site pain
Clinical narrative: Developed headache, fatigue, nausea, body aches, vomiting, diarrhea an hour after receiving vaccine. Developed redness, pain, and swelling (3 x 2.5 in) at site of injection within 24 hours of vaccine. Supportive care was recommended including rest, hydration, ice to area of swelling/redness, and motrin or tylenol as needed. We also discussed the possibility of an acute infection at the time of receiving vaccine that could be causing the symptoms.
Age: 17.0
Sex: F
Vaccine: MENB
Symptoms: Injection site swelling, Nausea, Pain, Vomiting
Clinical narrative: Developed headache, fatigue, nausea, body aches, vomiting, diarrhea an hour after receiving vaccine. Developed redness, pain, and swelling (3 x 2.5 in) at site of injection within 24 hours of vaccine. Supportive care was recommended including rest, hydration, ice to area of swelling/redness, and motrin or tylenol as needed. We also discussed the possibility of an acute infection at the time of receiving vaccine that could be causing the symptoms.
Age: 63.0
Sex: F
Vaccine: UNK
Symptoms: Expired product administered
Clinical narrative: PATIENT VACCINATED AFTER VIABILITY DATE.
Age: 48.0
Sex: M
Vaccine: COVID19
Symptoms: Blood thyroid stimulating hormone normal, Computerised tomogram heart normal, Condition aggravated, Cortisol normal, Differential white blood cell count normal
Clinical narrative: Sudden onset of acute hypertension with > 60 mm HG BP increase within 24h following vaccination, leading to hospitalization. BP ranges became  180-230 systolic / 90-130 diastolic).  BP baseline prior to vaccination was  elevated at ~140/88 and being followed (verified at PCP prior to vaccination).
Age: 48.0
Sex: M
Vaccine: COVID19
Symptoms: Electrocardiogram normal, Full blood count normal, Hypertension, Lipase normal, Metabolic function test normal
Clinical narrative: Sudden onset of acute hypertension with > 60 mm HG BP increase within 24h following vaccination, leading to hospitalization. BP ranges became  180-230 systolic / 90-130 diastolic).  BP baseline prior to vaccination was  elevated at ~140/88 and being followed (verified at PCP prior to vaccination).
Age: 48.0
Sex: M
Vaccine: COVID19
Symptoms: Troponin normal, Urine analysis normal
Clinical narrative: Sudden onset of acute hypertension with > 60 mm HG BP increase within 24h following vaccination, leading to hospitalization. BP ranges became  180-230 systolic / 90-130 diastolic).  BP baseline prior to vaccination was  elevated at ~140/88 and being followed (verified at PCP prior to vaccination).
Age: 67.0
Sex: M
Vaccine: COVID19-2
Symptoms: Expired product administered
Clinical narrative: PATIENT VACCINATED AFTER VIABILITY DATE
Age: 50.0
Sex: M
Vaccine: HEP, HEPA
Symptoms: Product administered to patient of inappropriate age, Underdose, Wrong product administered
Clinical narrative: Patient's PCP ordered Hep A, HAVRIX, VAQTA(19+) for the patient as well as Energix-B.  Patient was not given the 19+ vaccine, was givin the pediatric dosage.
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: PATIENT VACCINATED AFTER VIABILITY DATE.
Age: 17.0
Sex: F
Vaccine: MENB
Symptoms: Diarrhoea, Headache, Injection site discolouration, Injection site erythema, Musculoskeletal stiffness
Clinical narrative: -red, purplish area on the site of the injection -had headache, diarrhea and neck stiffness
Age: 17.0
Sex: F
Vaccine: MENB
Symptoms: SARS-CoV-2 test positive
Clinical narrative: -red, purplish area on the site of the injection -had headache, diarrhea and neck stiffness
Age: 64.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: PATIENT VACCINATED AFTER VIABILITY DATE.
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19
Clinical narrative: hospitalized with COVID
Age: 52.0
Sex: M
Vaccine: COVID19
Symptoms: Blood bicarbonate, Blood calcium normal, Blood chloride increased, Blood creatinine normal, Blood gases
Clinical narrative: 6/11/21- developed shortness of breath and fatigue, then on 6/17/21 developed pain and tingling down left arm, which resulted in transport to ER via EMS and hospital admission. Diagnosed with new on-set congestive heart failure, hypertrophic obstructive cardiomyopathy, pulmonary edema and hypertension.
Age: 52.0
Sex: M
Vaccine: COVID19
Symptoms: Blood glucose normal, Blood magnesium normal, Blood pH normal, Blood potassium normal, Blood sodium normal
Clinical narrative: 6/11/21- developed shortness of breath and fatigue, then on 6/17/21 developed pain and tingling down left arm, which resulted in transport to ER via EMS and hospital admission. Diagnosed with new on-set congestive heart failure, hypertrophic obstructive cardiomyopathy, pulmonary edema and hypertension.
Age: 52.0
Sex: M
Vaccine: COVID19
Symptoms: Blood urea increased, Brain natriuretic peptide increased, Cardiac failure congestive, Chest X-ray abnormal, Dyspnoea
Clinical narrative: 6/11/21- developed shortness of breath and fatigue, then on 6/17/21 developed pain and tingling down left arm, which resulted in transport to ER via EMS and hospital admission. Diagnosed with new on-set congestive heart failure, hypertrophic obstructive cardiomyopathy, pulmonary edema and hypertension.
Age: 52.0
Sex: M
Vaccine: COVID19
Symptoms: Electrocardiogram ST segment abnormal, Electrocardiogram T wave abnormal, Fatigue, Fibrin D dimer, Glomerular filtration rate decreased
Clinical narrative: 6/11/21- developed shortness of breath and fatigue, then on 6/17/21 developed pain and tingling down left arm, which resulted in transport to ER via EMS and hospital admission. Diagnosed with new on-set congestive heart failure, hypertrophic obstructive cardiomyopathy, pulmonary edema and hypertension.
Age: 52.0
Sex: M
Vaccine: COVID19
Symptoms: Haemoglobin normal, Hypertension, Hypertrophic cardiomyopathy, International normalised ratio increased, Left atrial enlargement
Clinical narrative: 6/11/21- developed shortness of breath and fatigue, then on 6/17/21 developed pain and tingling down left arm, which resulted in transport to ER via EMS and hospital admission. Diagnosed with new on-set congestive heart failure, hypertrophic obstructive cardiomyopathy, pulmonary edema and hypertension.
Age: 52.0
Sex: M
Vaccine: COVID19
Symptoms: Lung consolidation, Lung opacity, PCO2 normal, Pain in extremity, Paraesthesia
Clinical narrative: 6/11/21- developed shortness of breath and fatigue, then on 6/17/21 developed pain and tingling down left arm, which resulted in transport to ER via EMS and hospital admission. Diagnosed with new on-set congestive heart failure, hypertrophic obstructive cardiomyopathy, pulmonary edema and hypertension.
Age: 52.0
Sex: M
Vaccine: COVID19
Symptoms: Platelet count decreased, Pulmonary oedema, Sinus tachycardia, Troponin, White blood cell count normal
Clinical narrative: 6/11/21- developed shortness of breath and fatigue, then on 6/17/21 developed pain and tingling down left arm, which resulted in transport to ER via EMS and hospital admission. Diagnosed with new on-set congestive heart failure, hypertrophic obstructive cardiomyopathy, pulmonary edema and hypertension.
Age: 77.0
Sex: M
Vaccine: RSV
Symptoms: Asthenia, Feeling cold, Muscle atrophy, Tremor
Clinical narrative: Shaking, feeling cold. Complete muscle loss, weak
Age: 3.0
Sex: M
Vaccine: DTAPHEPBIP, MMRV
Symptoms: Cellulitis, Injection site swelling
Clinical narrative: Patient's mother reported that the child's right  thigh became swollen after receiving vaccines.  This happened previously, back on March 24, 2023, when he received Pediarix and Varicella and the leg given the Pediarix became swollen to the point she took him to the ER twice.  He was given antibiotics and treated for cellulitis.  She took the child to the ER this time as well, and requested antibiotic treatment, as it reduced the symptoms previously.  He was given cephalexin and discharged home.
Age: 33.0
Sex: F
Vaccine: COVID19-2
Symptoms: Mechanical urticaria
Clinical narrative: Received covid vaccine and flu shot a week later and began dermatographia which has persisted through 2/2/2024 getting worse over time
Age: 52.0
Sex: F
Vaccine: VARZOS
Symptoms: Product storage error
Clinical narrative: Vaccine was frozen instead of refrigerated.
Age: 66.0
Sex: F
Vaccine: RSV
Symptoms: Arthralgia, Back pain, Injection site pain, Neck pain, Pain
Clinical narrative: left upper arm pain extending to left shoulder, neck and upper back starting 1 day after vaccine. still present 5 weeks later with extension to rt shoulder
Age: 74.0
Sex: F
Vaccine: RAB
Symptoms: Injection site erythema, Injection site induration, Injection site pain, Injection site pruritus, Injection site swelling
Clinical narrative: A red area developed by 6 pm the same day, about 1" BELOW the actual injection site. Normal skin appearance in the inch between this red area and the injection site. Area was moderately red, easily seen, slightly swollen, itchy, burning, hard in most places and about 3 inches in all dimensions. It didn't resolve and continued to be way more painful than an injection site has ever been for me so I went back to the pharmacy where the vaccine was administered. I spoke to the pharmacist & showed him my arm and the red area. He said use warm compresses and if not resolved by Thursday, 2/1/24, to see a doctor. I saw doctor at 3:30 on 2/1/24 when the reaction was only slightly better, despite warm compresses on Weds evening & Thurs morning and early afternoon. The Physician's Assistant at County Medical Center wrote me Rx for low dose prednisone; 4 tablets; one taken each day for 4 days. I took the first tablet about 6 pm on 2/1/24. Today, 2/2/24, the redness hasn't lessened much, however the itching, burning, pain when moving arm etc. has lessened.  I expect the reaction to be gone by 2/5/24, after I've taken the 4th tablet at 6 pm on 2/4/24.
Age: 74.0
Sex: F
Vaccine: RAB
Symptoms: Pain
Clinical narrative: A red area developed by 6 pm the same day, about 1" BELOW the actual injection site. Normal skin appearance in the inch between this red area and the injection site. Area was moderately red, easily seen, slightly swollen, itchy, burning, hard in most places and about 3 inches in all dimensions. It didn't resolve and continued to be way more painful than an injection site has ever been for me so I went back to the pharmacy where the vaccine was administered. I spoke to the pharmacist & showed him my arm and the red area. He said use warm compresses and if not resolved by Thursday, 2/1/24, to see a doctor. I saw doctor at 3:30 on 2/1/24 when the reaction was only slightly better, despite warm compresses on Weds evening & Thurs morning and early afternoon. The Physician's Assistant at County Medical Center wrote me Rx for low dose prednisone; 4 tablets; one taken each day for 4 days. I took the first tablet about 6 pm on 2/1/24. Today, 2/2/24, the redness hasn't lessened much, however the itching, burning, pain when moving arm etc. has lessened.  I expect the reaction to be gone by 2/5/24, after I've taken the 4th tablet at 6 pm on 2/4/24.
Age: 57.0
Sex: M
Vaccine: VARZOS
Symptoms: Product storage error
Clinical narrative: Vaccine was frozen instead of refrigerated.
Age: 69.0
Sex: M
Vaccine: COVID19, COVID19, COVID19, COVID19
Symptoms: COVID-19, Chills, Cough, Pyrexia, SARS-CoV-2 test positive
Clinical narrative: Fever, Chills, Cough, Positive home test
Age: 75.0
Sex: F
Vaccine: COVID19, RSV
Symptoms: Abdominal pain, Diarrhoea, Dizziness, Full blood count, Nausea
Clinical narrative: Flew from East to West 12/28/2023. At 6:30 am 12/29/2023, the phone rang.  I sat up on the bed to get up to answer it and became very dizzy.  Grabbed onto the bed mattress. Thought I was going to fall off the bed.  Thought maybe an earthquake, but there was no shaking.  Waited a few minutes.  Needed to use the bathroom due to nausea and abdominal cramps. Had two bowel movements.  symptoms faded.  Rested then went down stairs and ate breakfast.  Felt better.  Went for a walk.  All seemed fine as long as I didn't lie on my back.  Decided it was just something that will pass.  Woke up the next day at 4:40 am to use the bathroom.  Symptoms much worse.  Vomited and had diarrhea.  Went to urgent care.  Blood tests done were all negative. Advised that symptoms were probably from the flight.  Given Meclizine and Eply exercises to realign rocks in my ears. On M0nday, I had my weekly RSV check from the CDC study.  They told me to fill out a VAERS report. Texted my PCP.  She agreed with doctor.
Age: 75.0
Sex: F
Vaccine: COVID19, RSV
Symptoms: Vomiting
Clinical narrative: Flew from East to West 12/28/2023. At 6:30 am 12/29/2023, the phone rang.  I sat up on the bed to get up to answer it and became very dizzy.  Grabbed onto the bed mattress. Thought I was going to fall off the bed.  Thought maybe an earthquake, but there was no shaking.  Waited a few minutes.  Needed to use the bathroom due to nausea and abdominal cramps. Had two bowel movements.  symptoms faded.  Rested then went down stairs and ate breakfast.  Felt better.  Went for a walk.  All seemed fine as long as I didn't lie on my back.  Decided it was just something that will pass.  Woke up the next day at 4:40 am to use the bathroom.  Symptoms much worse.  Vomited and had diarrhea.  Went to urgent care.  Blood tests done were all negative. Advised that symptoms were probably from the flight.  Given Meclizine and Eply exercises to realign rocks in my ears. On M0nday, I had my weekly RSV check from the CDC study.  They told me to fill out a VAERS report. Texted my PCP.  She agreed with doctor.