chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
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 36-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: "Multiple sclerosis" (unspecified if ongoing). The patient's concomitant medications were not reported. Past drug history included: Versed, reaction(s): "Drug allergy: Versed.". Vaccination history included: 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: 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. Patient took Paxlovid from 25Jan2024 to 30Jan2024.  No follow-up attempts are possible. Batch/lot number is not provided, and it cannot be obtained.
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, Interchange of vaccine products
Clinical narrative: COVID treatment; COVID treatment; Dose 1-5: Moderna COVID-19 Vaccine, Dose 6: Pfizer BioNTech; 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)), in Oct2023, at 13:00 (as reported), as dose 1 , single (Batch/Lot number: unknown), in left arm for covid-19 immunisation. The patient's relevant medical history included: "penicillin" (unspecified if ongoing). The patient's concomitant medications were not reported. Vaccination history included: moderna (Dose 1, Single, Lot No: 004M20A, in the left arm, at 01:00), administration date: 06Feb2021, for COVID-19 immunization; moderna (Dose 2, Single, Lot No: 010A21A, in the left arm, at 01:00), administration date: 06Mar2021, for COVID-19 immunization; moderna (Dose 3 (Booster), single, Lot No: 091D21A, in the left arm, at 01:00), administration date: 25Oct2021, for COVID-19 immunization; moderna (Dose 4 (Booster), single, Batch/Lot No: 001M21A, Location of injection: Arm Left, Vaccine Administration Time: 01:00 AM), administration date: 29Apr2022, for COVID-19 immunization; moderna (Dose 5 (Booster), single, Lot No: 060F22A, in the left arm, at 00:00), administration date: 30Sep2022, for COVID-19 immunization. The following information was reported: INTERCHANGE OF VACCINE PRODUCTS (medically significant) with onset Oct2023, outcome "unknown", described as "Dose 1-5: Moderna COVID-19 Vaccine, Dose 6: Pfizer BioNTech"; DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID treatment". Therapeutic measures were taken as a result of interchange of vaccine products, 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.
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Vaccination failure
Clinical narrative: COVID 19 treatment; COVID 19 treatment; This is a spontaneous report received from an other HCP. A 57-year-old female patient (not pregnant) received BNT162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 27Oct2023 as dose 1, single (lot number unknown) at the age of 57 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "known allergies: penicillin" (unspecified if ongoing); "asthma" (unspecified if ongoing). The patient's concomitant medications were not reported. 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: 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 which included Paxlovid taken from 29Jan2024 to 03Feb2024.   Additional information: Suspect dose was also reported as "dose 5".  No follow-up attempts are possible. Batch/lot number is not provided, and it cannot be obtained.; Sender's Comments: Based on the information currently available, a lack of efficacy with BNT162b2 omi xbb.1.5 in this patient cannot be completely excluded
Age: 79.0
Sex: M
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 79-year-old male patient received BNT162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 15Nov2023 as dose 1, single (Batch/Lot number: unknown) at the age of 79 years for covid-19 immunisation. The patient's relevant medical history included: "Cardiac failure congestive" (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". The patient was treated with 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: Myocardial infarction
Clinical narrative: Heart attack; This is a spontaneous report received from a Consumer or other non HCP.  A female patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), as dose number unknown (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (DOSE 1, SINGLE; Manufacturer Unknown), for COVID-19 immunization; Covid-19 vaccine (DOSE 2, SINGLE; Manufacturer Unknown), for COVID-19 immunization.  The following information was reported: MYOCARDIAL INFARCTION (medically significant) with onset Jun2023, outcome "unknown", described as "Heart attack". Therapeutic measures were taken as a result of myocardial infarction. Clinical course: The patient stated, "I would just like to report something that is very odd and I have had all of the COVID shots. You want the report? I am just over 80 years, but I have been running and working out, eating right and not smoking, not drinking for lifetime. It has been very important to me. I have had no problem and going annually for physical and never to find anything that even put me on medication, so a clean bill of health and I am not totally sure, I can look it up at some point if I need to but the latter part of last year and a year before last year it would have been because last I guess it was June I had a heart attack, a very healthy women who worked out diligently, never problem, I had a heart attack and had open heart surgery. Could this have had anything to do with the Pfizer shot? I have had all of them."  When probed for the name of Pfizer shot, consumer stated, "I do not have a clue of the name of it. I do not know but got whatever was the most recent one every time and I think I had at least, I know I had at least 3 of them. The original one, plus at least 2 others."   The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5 will be requested and submitted if and when received.
Age: 70.0
Sex: M
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 male patient received BNT162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 25Sep2023 at 15:45 as dose 1, single (Batch/Lot number: unknown) at the age of 70 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: 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: DRUG INEFFECTIVE (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 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: 66.0
Sex: M
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 66-year-old male patient received BNT162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 09Oct2023 as dose 1, single (Batch/Lot number: unknown) at the age of 66 years, in right arm for covid-19 immunisation. The patient's relevant medical history included: "Known allergies: Bee stings" (unspecified if ongoing); "Ulcerative Colitis" (unspecified if ongoing); "Osteopenia" (unspecified if ongoing); "Hyperlipidimia" (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 "not recovered" 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.
Sex: M
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 67-year-old male patient received BNT162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Stroke" (unspecified if ongoing); "cardiomyopathy" (unspecified if ongoing); "atrial fibrillation" (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 Jan2024, outcome "unknown" and all described as "COVID-19 ". 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: F
Vaccine: COVID19
Symptoms: Drug ineffective, Suspected COVID-19
Clinical narrative: Patient stated she got all of the vaccine shots; Patient stated she got all of the vaccine shots; The initial case was missing the following minimum criteria: No adverse effect. Upon receipt of follow-up information on (08Feb2024), this case now contains all required information to be considered valid.  This is a spontaneous report received from a Consumer or other non HCP.  An 86-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. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Primary Immunization series complete;  unknown manufacturer), for COVID-19 immunization. The following information was reported: DRUG INEFFECTIVE (medically significant), SUSPECTED COVID-19 (medically significant), outcome "unknown" and all described as "Patient stated she got all of the vaccine shots".  Clinical information: patient stated she got all of the vaccine shots. As of 08Feb2024, at the time of the call, patient had not taken Paxlovid. The Adverse Event was initiated due to patient reporting having taken Pfizer vaccines and still contracting Covid.  No follow-up attempts are possible. Batch/Lot number is not provided, and it cannot be obtained.
Sex: U
Vaccine: COVID19
Symptoms: Fatigue, Headache, Malaise, Myalgia, Vaccination site pain
Clinical narrative: Mild injection site pain and no interference with activity/Mild injection site tenderness; Mild fatigue and no interference with activity; Mild malaise/feeling sick and no interference with activity; Mild muscle pain and no interference with activity; Headache and no interference with activity; 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: HEADACHE (non-serious) with onset 23Jan2024, outcome "unknown", described as "Headache and no interference with activity"; FATIGUE (non-serious) with onset 23Jan2024, outcome "unknown", described as "Mild fatigue and no interference with activity"; VACCINATION SITE PAIN (non-serious) with onset 23Jan2024, outcome "unknown", described as "Mild injection site pain and no interference with activity/Mild injection site tenderness"; MALAISE (non-serious) with onset 23Jan2024, outcome "unknown", described as "Mild malaise/feeling sick and no interference with activity"; MYALGIA (non-serious) with onset 23Jan2024, outcome "unknown", described as "Mild muscle pain and no interference with activity".  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: throat was bothering him multiple times / had 5 pfizer covid vaccine shots / Paxlovid; throat was bothering him multiple times / had 5 pfizer covid vaccine shots / Paxlovid; This is a spontaneous report received from a Consumer or other non HCP.  A 74-year-old male patient received BNT162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), 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), for COVID-19 Immunization; Bnt162b2 (DOSE 2), for COVID-19 Immunization; Bnt162b2 (DOSE 3 (BOOSTER)), for COVID-19 Immunization; Bnt162b2 (DOSE 4 (BOOSTER)), for COVID-19 Immunization. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "throat was bothering him multiple times / had 5 pfizer covid vaccine shots / Paxlovid". The event "throat was bothering him multiple times / had 5 pfizer covid vaccine shots / paxlovid" required physician office visit. Therapeutic measures were taken as a result of drug ineffective, covid-19. The patient was prescribed with PAXLOVID.  The lot number for BNT162b2 omi xbb.1.5, was not provided and will be requested during follow up.
Age: 57.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, Interchange of vaccine products, SARS-CoV-2 test
Clinical narrative: Interchange of vaccine products; Has the patient ever been diagnosed with/ tested positive for COVID-19? Yes; Date: Sep2022; Has the patient ever been diagnosed with/ tested positive for COVID-19? Yes; Date: Sep2022; This is a spontaneous report received from a Consumer or other non HCP from product quality group. Other Case identifier(s): MOD-2023-726941.  A 58-year-old male patient received BNT162b2 (BNT162B2), on 07Dec2021 as dose 3 (booster), single (Lot number: FJ8757) at the age of 57 years intramuscular, in left arm for covid-19 immunisation; elasomeran (MODERNA COVID-19 VACCINE), on 01Apr2021 as dose 1, single (Lot number: 039A21A) intramuscular, in left arm, on 29Apr2021 as dose 2, single (Lot number: 045B21A) intramuscular, in left arm, on 03May2022 as dose 4 (booster), single (Lot number: 057M21A) intramuscular, in left arm and in Sep2022 as dose 5 (booster), single) for covid-19 prophylaxis. The patient's relevant medical history included: "Herpes virus infection", start date: 1992 (unspecified if ongoing), notes: Herpes symptoms came back; After the last 2 Moderna COVID-19 Boosters; "drinking  alcohol" (unspecified if ongoing). Herpes lesions broke out with different triggers as such drinking alcohol, and exercise. The patient has been having Herpes breakout issues for 40 years. Herpes lesions broke out with different triggers as such drinking alcohol, and exercise. When was 20 years old, was exposed to Herpes (Broke out at least once a month).The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Sep2022, outcome "unknown" and all described as "Has the patient ever been diagnosed with/ tested positive for COVID-19? Yes; Date: Sep2022"; INTERCHANGE OF VACCINE PRODUCTS (medically significant), outcome "unknown". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (Sep2022) Positive.  On 08Feb2024, investigation results for lot number FJ8757 was reported as follows: The complaint for lack of effect of the PFIZERBIONTECH COVID-19 VACCINE lot FJ8757 was investigated. The investigation included a review of manufacturing and packaging batch records, deviation investigations, and an analysis of complaint history for the reported lot. The final scope included the reported finished goods lot FJ8757, fill lot FJ1608, and formulated drug product lot FK2442. A complaint sample was not returned. No related quality issues were identified during the investigation. There is no impact to product quality. No root cause or corrective/preventative actions were identified as the complaint was not confirmed. All release testing performed prior to the release of the reported batch was within specifications.
Age: 57.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Disease recurrence, Herpes virus infection
Clinical narrative: Interchange of vaccine products; Has the patient ever been diagnosed with/ tested positive for COVID-19? Yes; Date: Sep2022; Has the patient ever been diagnosed with/ tested positive for COVID-19? Yes; Date: Sep2022; This is a spontaneous report received from a Consumer or other non HCP from product quality group. Other Case identifier(s): MOD-2023-726941.  A 58-year-old male patient received BNT162b2 (BNT162B2), on 07Dec2021 as dose 3 (booster), single (Lot number: FJ8757) at the age of 57 years intramuscular, in left arm for covid-19 immunisation; elasomeran (MODERNA COVID-19 VACCINE), on 01Apr2021 as dose 1, single (Lot number: 039A21A) intramuscular, in left arm, on 29Apr2021 as dose 2, single (Lot number: 045B21A) intramuscular, in left arm, on 03May2022 as dose 4 (booster), single (Lot number: 057M21A) intramuscular, in left arm and in Sep2022 as dose 5 (booster), single) for covid-19 prophylaxis. The patient's relevant medical history included: "Herpes virus infection", start date: 1992 (unspecified if ongoing), notes: Herpes symptoms came back; After the last 2 Moderna COVID-19 Boosters; "drinking  alcohol" (unspecified if ongoing). Herpes lesions broke out with different triggers as such drinking alcohol, and exercise. The patient has been having Herpes breakout issues for 40 years. Herpes lesions broke out with different triggers as such drinking alcohol, and exercise. When was 20 years old, was exposed to Herpes (Broke out at least once a month).The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Sep2022, outcome "unknown" and all described as "Has the patient ever been diagnosed with/ tested positive for COVID-19? Yes; Date: Sep2022"; INTERCHANGE OF VACCINE PRODUCTS (medically significant), outcome "unknown". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (Sep2022) Positive.  On 08Feb2024, investigation results for lot number FJ8757 was reported as follows: The complaint for lack of effect of the PFIZERBIONTECH COVID-19 VACCINE lot FJ8757 was investigated. The investigation included a review of manufacturing and packaging batch records, deviation investigations, and an analysis of complaint history for the reported lot. The final scope included the reported finished goods lot FJ8757, fill lot FJ1608, and formulated drug product lot FK2442. A complaint sample was not returned. No related quality issues were identified during the investigation. There is no impact to product quality. No root cause or corrective/preventative actions were identified as the complaint was not confirmed. All release testing performed prior to the release of the reported batch was within specifications.
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: Got COVID after vaccine; Got COVID after vaccine; This is a spontaneous report received from a Consumer or other non HCP.  A 67-year-old male patient 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: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "Got COVID after vaccine". Therapeutic measures were taken as a result of covid-19 which included Paxlovid.  The information on the batch/lot number for BNT162b2 will be requested and submitted if and when received.
Sex: U
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: Might have Pfizer vaccine but still contracted COVID; Might have Pfizer vaccine but still contracted COVID; This is a spontaneous report received from a Consumer or other non HCP from product quality group.  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: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "Might have Pfizer vaccine but still contracted COVID".  No follow-up attempts are possible. Batch/lot number is not provided, and it cannot be obtained.
Sex: U
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: Patient took Paxlovid; COVID-19; This is a spontaneous report received from a Consumer or other non HCP.  A 79-year-old patient 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. Vaccination history included: Covid-19 vaccine (Primary immunization, manufacturer unknown), for COVID-19 immunization. The following information was reported: DRUG INEFFECTIVE (medically significant), outcome "unknown", described as "Patient took Paxlovid"; COVID-19 (medically significant), outcome "unknown". Therapeutic measures were taken as a result of drug ineffective, covid-19, patient took Paxlovid. No follow-up attempts are possible. Batch/lot number is not provided, and it cannot be obtained.
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: she gave her house guest covid; she gave her house guest covid; This is a spontaneous report received from a Consumer or other non HCP.  A 72-year-old female patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), as dose number unknown (booster), single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and 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 "she gave her house guest covid".Therapeutic measures were taken as a result of covid-19, drug ineffective, which included Paxlovid.  Additional information: Patient stated she had all of her boosters. She did not mention which booster. Patient also mentioned she gave her house guest COVID. No further information was given.  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, Drug ineffective, SARS-CoV-2 test
Clinical narrative: tested positive for Covid; tested positive for Covid; This is a spontaneous report received from a Consumer or other non HCP.  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: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "tested positive for Covid". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive, notes: tested positive for Covid.  Additional information: The patient has been vaccinated for Covid but was tested positive for Covid, she has no insurance and was given this number to call to see if the company could help.  No follow-up attempts are possible. Batch/lot number is not provided, and it cannot be obtained.
Age: 0.33
Sex: M
Vaccine: UNK
Symptoms: No adverse event, Product preparation issue
Clinical narrative: given only one of the Pentacel vials, the part that needs to be reconstituted was still in the box with no reported adverse event; vaccine was not reconstituted, Only liquid part was given and not lyophilized component with no reported adverse event; Initial information received on 01-Feb-2024 regarding an unsolicited valid non-serious case received from an other health professional.  This case involves 4 months old male patient of an unknown age and gender who had given only one of the diphtheria/tetanus/5 hybrid AC pertussis/IPV(Vero)/HIB(PRP/T) vaccine [pentacel (vero)] vials, the part that needs to be reconstituted was still in the box with no reported adverse event and was not reconstituted, only liquid part was given and not lyophilized component with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On 22-Jan-2024, the patient received 0.5 ml dose 2 of suspect diphtheria/tetanus/5 hybrid AC pertussis/IPV(Vero)/HIB(PRP/T) vaccine Suspension for injection (strength, expiry date and lot number not reported) (lot- UJ851AA and expiration date- 01-Apr-2024) via intramuscular route in the right thigh as Prophylactic vaccination (immunization) (single component of a two-component product administered) and (Product preparation issue) (same day latency).  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.  Additional information was received on 01-Feb-2024 from Other healthcare professional: Patient age, Therapy start date, dose, batch number, expiration date, anatomical location, concomitant medication (pneumococcal vaccine and rotavirus vaccine), Event (Product preparation issue) added; text amended accordingly.
Sex: F
Vaccine: FLUX, TD
Symptoms: No adverse event, Wrong product administered
Clinical narrative: patient was inadvertently administered with tenivac with no adverse event; Initial information received on 05-Feb-2024 regarding an unsolicited valid  non-serious case received from a other health professional.  This case involves a 26 years old female patient who was inadvertently administered with Diphtheria-2/Tetanus-5 Adsorbed Toxoids No Preservative Adult [Tenivac] Vaccine instead of Influenza Vaccine with no adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On 05-Feb-2024, the patient was inadvertently administered a dose of 0.5 ml (dose 1) of suspect Diphtheria-2/Tetanus-5 Adsorbed Toxoids No Preservative Adult [Tenivac] Vaccine (Suspension for injection) (lot: U7927AA) (strength; expiry date unknown) via intramuscular route in the left deltoid instead of Influenza Vaccine produced by unknown manufacturer (lot number, expiration date, route, strength, dose: Unknown) for Immunization (wrong product administered) (Latency: Same day). It was reported that the patient was prescribed with Adacel and flu vaccine, and instead of the flu vaccine, patient was inadvertently administered with Tenivac  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: 1.08
Sex: M
Vaccine: HIBV, UNK
Symptoms: Inappropriate schedule of product administration, No adverse event, Wrong product administered
Clinical narrative: administered pentacel instead of act-hib with no reported ae; reporting that the 4th dose of pentacel was administered too early with no reported adverse ae; Initial information received 05-Feb-2024 regarding an unsolicited valid non-serious case received from a nurse.  This case involves a 13 months old male patient who was administered diphtheria/tetanus/5 hybrid AC pertussis/IPV(VERO)/HIB(PRP/T) vaccine [Pentacel (Vero)] instead of HIB (PRP/T) vaccine [ACT-HIB] with no reported ae and that the 4th dose of pentacel was administered too early with no reported adverse ae.  Concomitant medications included hepatitis a vaccine INACT (Havrix), measles vaccine, mumps vaccine, rubella vaccine (MMR), pneumococcal vaccine CONJ 15V (CRM197) (Vaxneuvance) and varicella zoster vaccine (Varicella Vaccine) for Prophylactic vaccination.  On an unknown date, the patient received a dose of 0.5 ml (dose 4) once of suspect diphtheria/tetanus/5 hybrid ac pertussis/IPV(Vero)/HIB(PRP/T) vaccine (Suspension for injection) (lot UJ973AA)(Expiry date: 19-NOV-2024) (Strength: standard) via intramuscular route in right thigh for Immunizaion.  On 05-Feb-2024 the patient was administered pentacel instead of act-hib with no reported ae (wrong product administered) and  reporting that the 4th dose of pentacle  was administered too early with no reported adverse ae (inappropriate schedule of product administration)  (latency: same day for both events)  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: 5.0
Sex: F
Vaccine: UNK
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: received a dose of Pentacel 3 months after her 5th birthday with no adverse event; Initial information received on 06-Feb-2024 regarding an unsolicited valid non-serious case received from a physician.  This case involves a 5-year-old female patient who had received a dose of diphtheria/tetanus/5 hybrid AC pertussis/IPV (vero)/HIB(PRP/T) vaccine [Pentacel (Vero)] 3 months after her 5th birthday with no adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  On an unknown date in Nov-2023, the patient received 0.5 mL Dose 2 of suspect diphtheria/tetanus/5 hybrid AC pertussis/IPV (vero)/HIB(PRP/T) vaccine, Suspension for injection (strength, batch number and expiry date: not reported) via unknown route in unknown administration site for Immunization, 3 months after her 5th birthday (product administered to patient of inappropriate age) (same day latency).  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.
Sex: U
Vaccine: HIBV
Symptoms: No adverse event, Product preparation error
Clinical narrative: patient had the ACT-HIB with the wrong diluent with no adverse event; Initial information was received on 07-Feb-2024 regarding an unsolicited valid  non-serious case received from a nurse.  This case involves an unknown age and unknown gender patient who had the HIB (PRP/T) vaccine [ACT-HIB] with the wrong diluent with no adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On an unknown date, the patient received a 0.5 ml, total (1x) dose of suspect HIB (PRP/T) vaccine (Powder and solvent for solution for injection) (lot UK007AB, expiry date: 31-Dec-2024, strength: standard) via unknown route in unknown administration site for Immunization and patient had the act-hib with the wrong diluent with no adverse event (product preparation error) (latency: same day).   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: 2.0
Sex: F
Vaccine: COVID19, FLUC3
Symptoms: Vaccination site pain
Clinical narrative: Achy shot site; This spontaneous case was received on 05-Feb-2024 from other non-healthcare professional (reference number: SEQW24-00499) and concerned a 2-year-old female patient.  The patient's medical history and concomitant medications were reported as none. The patient had no known allergies.   On 26-OCT-2023, the patient was vaccinated with Flucelvax Quadrivalent (influenza vaccine inact sag 4v; route of administration: intramuscular (IM); anatomical location: left thigh (LT); dose and indication: not reported). The reported batch number was 373546.   On the same date, the patient was vaccinated with a non-company, co-suspect Moderna COVID-19 vaccine (elasomeran; dose: 0.5 ml, route of administration: intramuscular (IM); anatomical location: right thing (RT); indication: not reported). The reported batch number was A055588.  On an unspecified date, an unknown amount of time after receiving Flucelvax Quadrivalent and non-company co-suspect Moderna COVID-19 vaccine, the patient experienced achy shot site.  The outcome of the event was not reported.   The case was assessed as non-serious.  This case is linked with case 202306679 (the same reporter).  Company comment: The event of vaccination site pain is assessed as possibly related to Flucelvax Quadrivalent due to suggestive anatomical location..; Sender's Comments: The event of vaccination site pain is assessed as possibly related to Flucelvax Quadrivalent due to suggestive anatomical location.
Age: 67.0
Sex: M
Vaccine: FLUA4
Symptoms: Amylase, Antineutrophil cytoplasmic antibody, Antinuclear antibody, Arthralgia, Blood thyroid stimulating hormone
Clinical narrative: Rash from thighs to chest, joint pains, fatigue, weight loss, eyelid infection, break out on scalp. Eventually diagnosed with MPA Microscopic Polyanthiitis
Age: 67.0
Sex: M
Vaccine: FLUA4
Symptoms: Blood uric acid, C-reactive protein, Complement factor C3, Complement factor C4, Differential white blood cell count
Clinical narrative: Rash from thighs to chest, joint pains, fatigue, weight loss, eyelid infection, break out on scalp. Eventually diagnosed with MPA Microscopic Polyanthiitis
Age: 67.0
Sex: M
Vaccine: FLUA4
Symptoms: Double stranded DNA antibody, Eyelid infection, Fatigue, Full blood count, Hepatitis A antibody
Clinical narrative: Rash from thighs to chest, joint pains, fatigue, weight loss, eyelid infection, break out on scalp. Eventually diagnosed with MPA Microscopic Polyanthiitis
Age: 67.0
Sex: M
Vaccine: FLUA4
Symptoms: Hepatitis B core antibody, Hepatitis B surface antibody, Hepatitis C antibody, Metabolic function test, Microscopic polyangiitis
Clinical narrative: Rash from thighs to chest, joint pains, fatigue, weight loss, eyelid infection, break out on scalp. Eventually diagnosed with MPA Microscopic Polyanthiitis
Age: 67.0
Sex: M
Vaccine: FLUA4
Symptoms: Microscopy, Protein urine, Rash, Red blood cell sedimentation rate, Rheumatoid factor
Clinical narrative: Rash from thighs to chest, joint pains, fatigue, weight loss, eyelid infection, break out on scalp. Eventually diagnosed with MPA Microscopic Polyanthiitis
Age: 67.0
Sex: M
Vaccine: FLUA4
Symptoms: Scan with contrast, Urine analysis, Weight decreased
Clinical narrative: Rash from thighs to chest, joint pains, fatigue, weight loss, eyelid infection, break out on scalp. Eventually diagnosed with MPA Microscopic Polyanthiitis
Age: 76.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Bradycardia, Cancer screening abnormal, Cardiac failure acute, Cardiac failure congestive, Cardiac pacemaker insertion
Clinical narrative: Complained about SOB and congestion in October 2022 within a year following Moderna injections. Bradycardia and acute congestive heart failure was diagnosed by 10/12/2022. Myocarditis was the official reason for a year-long series of heart and pulmonary testing.  After 8 months of testing on 6/1/2023 Implantation of Pacemaker to control Bradycardia.
Age: 76.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Dyspnoea, Laboratory test, Malignant melanoma in situ, Myocarditis
Clinical narrative: Complained about SOB and congestion in October 2022 within a year following Moderna injections. Bradycardia and acute congestive heart failure was diagnosed by 10/12/2022. Myocarditis was the official reason for a year-long series of heart and pulmonary testing.  After 8 months of testing on 6/1/2023 Implantation of Pacemaker to control Bradycardia.
Age: 4.0
Sex: M
Vaccine: DTAPIPV
Symptoms: Extra dose administered, No adverse event
Clinical narrative: Patient given DTap- IPV and Polio Vaccine. Patient has had no noted adverse reactions noted. Patients mother notifed, PCP notified
Age: 65.0
Sex: F
Vaccine: RSV
Symptoms: Pain in extremity
Clinical narrative: Patient came to pharmacy and said that she thinks that she had an adverse reaction to Arexvy vaccine which was given to her on 12/19/2023. She mentioned that she usually has arthritis pain but she believes that the pain that occurred to her 02/09/2024 is related to the vaccine that was given to her back in December 2023. Patient is been informed that  it could be not related to vaccine's administration, however pharmacy staff will report it. she had pain and soreness on her left arm.
Age: 26.0
Sex: F
Vaccine: COVID19
Symptoms: Condition aggravated, Dyshidrotic eczema
Clinical narrative: I experienced a sudden moderate flare in my dyshidrotic eczema Sunday morning on the 4th of February which was the fourth day of my vaccine, I believe. It was on my left hand which is the side I got my vaccine. My knuckles were red and new vesicles had sprung up overnight on my hands and started to spread to my palms which is rare for me. My eczema was pretty well managed at this time and I have medicines for it if I need to use them such as topical steroids so that's why this flare stood out to me. I did nothing different in my routine and have kept up my regimen of drinking 1.5L a day of water. I messaged my primary care office asking if I should report it and they said it is better to overreport than underreport. I selected that I recovered below because my eczema is going through a more aggressive period after my vaccine but it is calming down with steroid ointment. Thank you for reading.
Age: 59.0
Sex: F
Vaccine: PNC20
Symptoms: Arthralgia, Injection site erythema, Injection site induration, Injection site swelling, Neck pain
Clinical narrative: Swollen at site of injection. It's red and hard to touch. Patient complains of soreness on her arm, shoulder and neck
Age: 59.0
Sex: F
Vaccine: PNC20
Symptoms: Pain in extremity
Clinical narrative: Swollen at site of injection. It's red and hard to touch. Patient complains of soreness on her arm, shoulder and neck
Age: 64.0
Sex: F
Vaccine: VARZOS
Symptoms: Asthenia, Balance disorder, Chills, Cough, Diarrhoea
Clinical narrative: Chills, severe headache,  nausea,  diarrhea,  fatigue,  sweats, coughing, weakness, loss of balance (almost fell) - this was all on February 10th. On February 11th and 12th - headache, diarrhea,  fatigue,  weakness - but not as severe. These side effects were so bad, I wanted to report.  The worst I have ever experienced.  And I had very bad side effects from multiple Pfizer Covid vaccinations - but the Shingrix vaccine side effects were much more severe.
Age: 64.0
Sex: F
Vaccine: VARZOS
Symptoms: Fatigue, Headache, Hyperhidrosis, Nausea
Clinical narrative: Chills, severe headache,  nausea,  diarrhea,  fatigue,  sweats, coughing, weakness, loss of balance (almost fell) - this was all on February 10th. On February 11th and 12th - headache, diarrhea,  fatigue,  weakness - but not as severe. These side effects were so bad, I wanted to report.  The worst I have ever experienced.  And I had very bad side effects from multiple Pfizer Covid vaccinations - but the Shingrix vaccine side effects were much more severe.
Age: 26.0
Sex: F
Vaccine: JEV1
Symptoms: Exposure during pregnancy, Inappropriate schedule of product administration
Clinical narrative: Patient was unaware of pregnancy status, but arrived to receive their 2nd dose and disclosed about pregnancy status. Vaccination was deferred, at this time.  Estimated delivery : 09/20/2024, no complications or symptoms thus far.
Age: 54.0
Sex: M
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pain, Injection site rash, Injection site swelling
Clinical narrative: wife called to state patient had rash, redness, pain, and some light swelling around injection area. she stated no breathing issue. Instructed to have patient take claritin, tylenol, an ice i needed. Informed to followup with PCP if necessarry
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Atrial fibrillation, Atrial flutter, Electrocardiogram ambulatory
Clinical narrative: Atrial fibrillation and atrial flutter
Age: 50.0
Sex: F
Vaccine: HEPAB
Symptoms: Injection site pain, Injection site pruritus
Clinical narrative: Pain on injection site, itching on area
Age: 0.33
Sex: M
Vaccine: IPV
Symptoms: Eczema
Clinical narrative: Following his first dose he developed a skin rash diagnosed as baby ezcema.  It had begun improving and was nearly gone until this second dose.  That night it started coming back and day after day its gotten worse since Thursday covering most of his body.
Age: 73.0
Sex: F
Vaccine: RSV
Symptoms: Arthralgia, Asthenia, Body temperature increased, Chills, Diarrhoea
Clinical narrative: Woke near midnight the same night (Jan. 29, 2024) with severe chills, teeth chattering, shivering that made the bed shake, cold extremities. Could not sleep. Put on robe and socks in bed and slept after a half hour of shivering. Aching all over in the morning, possibly due to the shivering. Had loose stools the next day and extreme fatigue, resting most of the day. Went to work on Jan 31 with no energy and still feeling miserable with aching muscles and pain that had settled in my joints. My smart ring reports that I have had an elevated temperature the night of the vaccination, up 2.9 degrees Fahrenheit from my normal, and up 1.4 degrees the following night. Today, Friday, is the 5th day of feeling tired and unwell. 15 minutes after 9 am shot (9:15am Jan. 29) I got left temporal headache & left eye pain I hope to feel better after the weekend and before work on Wednesday next week.
Age: 73.0
Sex: F
Vaccine: RSV
Symptoms: Eye pain, Fatigue, Feeling abnormal, Headache, Insomnia
Clinical narrative: Woke near midnight the same night (Jan. 29, 2024) with severe chills, teeth chattering, shivering that made the bed shake, cold extremities. Could not sleep. Put on robe and socks in bed and slept after a half hour of shivering. Aching all over in the morning, possibly due to the shivering. Had loose stools the next day and extreme fatigue, resting most of the day. Went to work on Jan 31 with no energy and still feeling miserable with aching muscles and pain that had settled in my joints. My smart ring reports that I have had an elevated temperature the night of the vaccination, up 2.9 degrees Fahrenheit from my normal, and up 1.4 degrees the following night. Today, Friday, is the 5th day of feeling tired and unwell. 15 minutes after 9 am shot (9:15am Jan. 29) I got left temporal headache & left eye pain I hope to feel better after the weekend and before work on Wednesday next week.
Age: 73.0
Sex: F
Vaccine: RSV
Symptoms: Malaise, Myalgia, Pain, Peripheral coldness, Sleep disorder
Clinical narrative: Woke near midnight the same night (Jan. 29, 2024) with severe chills, teeth chattering, shivering that made the bed shake, cold extremities. Could not sleep. Put on robe and socks in bed and slept after a half hour of shivering. Aching all over in the morning, possibly due to the shivering. Had loose stools the next day and extreme fatigue, resting most of the day. Went to work on Jan 31 with no energy and still feeling miserable with aching muscles and pain that had settled in my joints. My smart ring reports that I have had an elevated temperature the night of the vaccination, up 2.9 degrees Fahrenheit from my normal, and up 1.4 degrees the following night. Today, Friday, is the 5th day of feeling tired and unwell. 15 minutes after 9 am shot (9:15am Jan. 29) I got left temporal headache & left eye pain I hope to feel better after the weekend and before work on Wednesday next week.