chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: COVID19, FLUA3
Symptoms: COVID-19, Immunisation reaction, Pain in extremity, SARS-CoV-2 test
Clinical narrative: had a quite a reaction; Tested positive for COVID; both arms were sore; This spontaneous case was reported by a patient and describes the occurrence of IMMUNISATION REACTION (had a quite a reaction), COVID-19 (Tested positive for COVID) and PAIN IN EXTREMITY (both arms were sore) in a patient of an unknown age and gender who received mRNA-1273.815 (SPIKEVAX 2023-2024) (batch no. 8057965) for COVID-19 prophylaxis.    Co-suspect product included non-company product INFLUENZA VACCINE INACT SAG 3V (FLUAD) for an unknown indication.    Previously administered products included for COVID-19 prophylaxis: Moderna COVID-19 Vaccine (Dose 1, LOT: 010M20A) on 19-Feb-2021, Moderna COVID-19 Vaccine (Dose 2, LOT: 040A21A) on 19-Mar-2021, Moderna COVID-19 Vaccine (Dose 3) on 21-Aug-2021, Moderna COVID-19 Vaccine (Dose 4, LOT: 032H21A) on 08-Feb-2022, Moderna COVID-19 Vaccine (Dose 5 and LOT: 059A22A) on 21-Jun-2022; for Product used for unknown indication: Pfizer Covid-19 Vaccine (Dose 6 and LOT: GH9694) on 09-Sep-2022. Past adverse reactions to the above products included No adverse event with Moderna COVID-19 Vaccine, Moderna COVID-19 Vaccine, Moderna COVID-19 Vaccine, Moderna COVID-19 Vaccine, Moderna COVID-19 Vaccine and Pfizer Covid-19 Vaccine.   On 13-Oct-2023, the patient received seventh dose of mRNA-1273.815 (SPIKEVAX 2023-2024) (unknown route) 1 dosage form. On an unknown date, the patient received dose of INFLUENZA VACCINE INACT SAG 3V (FLUAD) (unknown route) 1 dosage form. On an unknown date, the patient experienced IMMUNISATION REACTION (had a quite a reaction), COVID-19 (Tested positive for COVID) and PAIN IN EXTREMITY (both arms were sore). The patient was treated with NIRMATRELVIR, RITONAVIR (PAXLOVID) for COVID-19 treatment, at an unspecified dose and frequency. At the time of the report, IMMUNISATION REACTION (had a quite a reaction) and PAIN IN EXTREMITY (both arms were sore) outcome was unknown and COVID-19 (Tested positive for COVID) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, SARS-CoV-2 test: Positive, Negative and Positive.         No concomitant medications were reported.  It was reported that patient tested positive, was put on Paxlovid. Tested negative after about a week. Patient reported that it was, or something and then patient got sicker a day or two after that and patient got pictures of all that and patient tested positive for a week after that. Patient was prescribed with one round of Paxlovid after patient tested positive and then after a couple of dates, after patient ended the Paxlovid and then patient tested negative and then patient tested positive for an entire week after that.  Anatomical location was unknown, patient did not remember on which arm patient received Moderna Vaccine and patient had flu (Fluad) shot in the other arm and both arms were sore, and patient had a quite a reaction.
Age: 69.0
Sex: M
Vaccine: COVID19
Symptoms: Cerebral haemorrhage, Cerebrovascular accident
Clinical narrative: the patient had a stroke 2 weeks after receiving the original Moderna vaccine and his brain was bleeding; the patient had a stroke 2 weeks after receiving the original Moderna vaccine and his brain was bleeding; This spontaneous case was reported by a pharmacist and describes the occurrence of CEREBROVASCULAR ACCIDENT (the patient had a stroke 2 weeks after receiving the original Moderna vaccine and his brain was bleeding) and CEREBRAL HAEMORRHAGE (the patient had a stroke 2 weeks after receiving the original Moderna vaccine and his brain was bleeding) in a 69-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced CEREBROVASCULAR ACCIDENT (the patient had a stroke 2 weeks after receiving the original Moderna vaccine and his brain was bleeding) (seriousness criterion medically significant) and CEREBRAL HAEMORRHAGE (the patient had a stroke 2 weeks after receiving the original Moderna vaccine and his brain was bleeding) (seriousness criterion medically significant). At the time of the report, CEREBROVASCULAR ACCIDENT (the patient had a stroke 2 weeks after receiving the original Moderna vaccine and his brain was bleeding) and CEREBRAL HAEMORRHAGE (the patient had a stroke 2 weeks after receiving the original Moderna vaccine and his brain was bleeding) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   The concomitant medication was not reported by reporter. The treatment medication was not reported by reporter.  Patient had extreme side effects from the 3rd dose of original Moderna vaccine. He had stroke 2 weeks after receiving the vaccine and his brain was bleeding.  Company comment: This spontaneous case concerns a 69-year-old, male patient with no medical history information reported, who experienced the unexpected serious (medically significant) AESI of cerebrovascular accident and cerebral haemorrhage. The events occurred approximately 2 weeks after the third dose of mRNA-1273. As reported, the patient had a stroke 2 weeks after receiving the original Moderna vaccine and his brain was bleeding. No further information about the events was provided. The benefit-risk relationship of mRNA-1273 is not affected by this report.   This case was linked to US-MODERNATX, INC.-MOD-2024-763709 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2024-763709:Same reporter/different patient (AE2)
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Chest discomfort, Chills, Cough, Malaise, Nasopharyngitis
Clinical narrative: acrylic taste on her tongue; chills to the bone; feeling unwell; chest congestion; cold; cough; This spontaneous case was reported by a patient and describes the occurrence of MALAISE (feeling unwell), CHEST DISCOMFORT (chest congestion), NASOPHARYNGITIS (cold), COUGH (cough) and TASTE DISORDER (acrylic taste on her tongue) in a 66-year-old female patient who received mRNA-1273.815 (SPIKEVAX 2023-2024) for COVID-19 prophylaxis. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Diabetes and Blood pressure high. Concomitant products included DULOXETINE, AMLODIPINE BESILATE (AMLODIPINE BESYLATE), HYDROCHLOROTHIAZIDE, MONTELUKAST, CYCLOBENZAPRINE, PIOGLITAZONE, GLIBENCLAMIDE (GLYBURIDE), ATORVASTATIN, RISPERIDONE (RISPERDAL), CLONIDINE, INSULIN GLARGINE (BASAGLAR) and INSULIN LISPRO (LISPRO INSULIN) for an unknown indication.    In December 2023, the patient received fourth dose of mRNA-1273.815 (SPIKEVAX 2023-2024) (unknown route) 1 dosage form. On 07-Feb-2024, the patient experienced MALAISE (feeling unwell), CHEST DISCOMFORT (chest congestion), NASOPHARYNGITIS (cold), COUGH (cough) and CHILLS (chills to the bone). On an unknown date, the patient experienced TASTE DISORDER (acrylic taste on her tongue). At the time of the report, MALAISE (feeling unwell), CHEST DISCOMFORT (chest congestion), NASOPHARYNGITIS (cold), COUGH (cough), TASTE DISORDER (acrylic taste on her tongue) and CHILLS (chills to the bone) was resolving.            Patient did not receive any other vaccines in the 4 weeks prior to COVID-19 vaccine. Patient reported that she is not having cartilage in knees and mental health issue. No treatment information was reported.   This case was linked to MOD-2024-764315 (Patient Link).
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Taste disorder
Clinical narrative: acrylic taste on her tongue; chills to the bone; feeling unwell; chest congestion; cold; cough; This spontaneous case was reported by a patient and describes the occurrence of MALAISE (feeling unwell), CHEST DISCOMFORT (chest congestion), NASOPHARYNGITIS (cold), COUGH (cough) and TASTE DISORDER (acrylic taste on her tongue) in a 66-year-old female patient who received mRNA-1273.815 (SPIKEVAX 2023-2024) for COVID-19 prophylaxis. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Diabetes and Blood pressure high. Concomitant products included DULOXETINE, AMLODIPINE BESILATE (AMLODIPINE BESYLATE), HYDROCHLOROTHIAZIDE, MONTELUKAST, CYCLOBENZAPRINE, PIOGLITAZONE, GLIBENCLAMIDE (GLYBURIDE), ATORVASTATIN, RISPERIDONE (RISPERDAL), CLONIDINE, INSULIN GLARGINE (BASAGLAR) and INSULIN LISPRO (LISPRO INSULIN) for an unknown indication.    In December 2023, the patient received fourth dose of mRNA-1273.815 (SPIKEVAX 2023-2024) (unknown route) 1 dosage form. On 07-Feb-2024, the patient experienced MALAISE (feeling unwell), CHEST DISCOMFORT (chest congestion), NASOPHARYNGITIS (cold), COUGH (cough) and CHILLS (chills to the bone). On an unknown date, the patient experienced TASTE DISORDER (acrylic taste on her tongue). At the time of the report, MALAISE (feeling unwell), CHEST DISCOMFORT (chest congestion), NASOPHARYNGITIS (cold), COUGH (cough), TASTE DISORDER (acrylic taste on her tongue) and CHILLS (chills to the bone) was resolving.            Patient did not receive any other vaccines in the 4 weeks prior to COVID-19 vaccine. Patient reported that she is not having cartilage in knees and mental health issue. No treatment information was reported.   This case was linked to MOD-2024-764315 (Patient Link).
Age: 29.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Pyrexia
Clinical narrative: developed a 106 plus degree fever; This spontaneous case was reported by a patient and describes the occurrence of PYREXIA (developed a 106 plus degree fever) in a 29-year-old female patient who received mRNA-1273.815 (SPIKEVAX 2023-2024 PFS) (batch no. 3030540) for COVID-19 prophylaxis.     The patient's past medical history included COVID-19 in December 2020 and Narcolepsy. Concomitant products included MODAFINIL, VENLAFAXINE HYDROCHLORIDE (EFFEXOR), ARIPIPRAZOLE (ABILIFY), CLONAZEPAM, MONTELUKAST and LEVOTHYROXINE for an unknown indication.    On an unknown date, the patient received dose of mRNA-1273.815 (SPIKEVAX 2023-2024 PFS) (Intramuscular use) 1 dosage form. On an unknown date, the patient experienced PYREXIA (developed a 106 plus degree fever). The patient was treated with PARACETAMOL (TYLENOL) (oral use) for Fever, at an unspecified dose and frequency. At the time of the report, PYREXIA (developed a 106 plus degree fever) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Body temperature: developed a 106 plus degree fever / remained around 102-103 degrees for thean additional day and a half.     For mRNA-1273.815 (SPIKEVAX 2023-2024 PFS) (Intramuscular use), the reporter did not provide any causality assessments.   Date and time of start of suspect was reported as 2024.  Patient developed a 106 plus degree fever the night after receiving the booster. Patient temperature did decrease by morning but remained around 102-103 degrees for an additional day and a half. The patient did not experience any additional symptoms/events and medication details and reason for taking the medicine.   The patient did not have any additional medical history, concomitant disease or risk factor. There were no other lab data/results available.
Sex: F
Vaccine: COVID19, FLUX, COVID19, FLUX
Symptoms: COVID-19, Drug ineffective, Influenza, SARS-CoV-2 test
Clinical narrative: flu; This is a spontaneous report received from a Consumer or other non HCP.  A 77-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; influenza vaccine (FLU VACCINE VII), as dose number unknown, single) for immunisation. The patient's relevant medical history included: "Cholesterol" (ongoing), notes: takes repatha drug every two weeks for cholesterol. The patient's concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose 3 (booster), single), for Covid-19 Immunization; Bnt162b2 (Dose 2, single), for Covid-19 Immunization; Bnt162b2 (Dose 1, single), for Covid-19 Immunization. The following information was reported: INFLUENZA (non-serious), outcome "unknown", described as "flu". Relevant laboratory tests and procedures are available in the appropriate section.  Additional information: She (patient) received 4 Pfizer shots, she's 77 years old, she got covid vaccine and the flu at the same time, then she was tested and was positive for both covid and the flu.
Sex: F
Vaccine: COVID19, FLUX, COVID19, FLUX
Symptoms: Influenza, Influenza virus test, SARS-CoV-2 test
Clinical narrative: flu; This is a spontaneous report received from a Consumer or other non HCP.  A 77-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; influenza vaccine (FLU VACCINE VII), as dose number unknown, single) for immunisation. The patient's relevant medical history included: "Cholesterol" (ongoing), notes: takes repatha drug every two weeks for cholesterol. The patient's concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose 3 (booster), single), for Covid-19 Immunization; Bnt162b2 (Dose 2, single), for Covid-19 Immunization; Bnt162b2 (Dose 1, single), for Covid-19 Immunization. The following information was reported: INFLUENZA (non-serious), outcome "unknown", described as "flu". Relevant laboratory tests and procedures are available in the appropriate section.  Additional information: She (patient) received 4 Pfizer shots, she's 77 years old, she got covid vaccine and the flu at the same time, then she was tested and was positive for both covid and the flu.
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pruritus, Vaccination site vesicles
Clinical narrative: broke out in small blister on the same arm/Single fluid filled blister, on back shoulder of the same arm received vaccine; had one single fluid filled blister, on back shoulder of the same arm received vaccine. It's more in scapula area, but the area around it was very itchy; This is a spontaneous report received from a Pharmacist from medical information team.  A 75-year-old female patient received BNT162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 06Mar2024 as dose 1 0.3 ml, single (Lot number: HN0478, Expiration Date: 23Apr2024) intramuscular, in left deltoid for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: VACCINATION SITE VESICLES (non-serious) with onset Mar2024, outcome "unknown", described as "broke out in small blister on the same arm/Single fluid filled blister, on back shoulder of the same arm received vaccine"; VACCINATION SITE PRURITUS (non-serious) with onset Mar2024, outcome "unknown", described as "had one single fluid filled blister, on back shoulder of the same arm received vaccine. It's more in scapula area, but the area around it was very itchy".  Additional information: Reporter seriousness for Single fluid filled blister, on back shoulder of the same arm received vaccine was reported as non-serious. It was reported that a patient broke out into a small blister on the same arm where it was it injected. Patient had one single fluid filled blister, on back shoulder of the same arm received vaccine. It's more in scapula area, but the area around it was very itchy. Reporter stated, when she asked the patient when the blister erupted the patient informed her it was 2-3 days after she got the vaccine. So, either 08Mar2024 or 09Mar2024.  Outcome: Unknown to reporter. It had been at least 2 weeks. She did not know if it had gone away.  Seriousness Criteria: Confirmed as not serious, however it was concerning since it occurred a few days after received vaccine.
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Arthralgia, Pain in extremity, Paraesthesia, Vaccination site discomfort, Vaccination site pain
Clinical narrative: felt some injection site discomfort; Arm pain; pain in the injection site; pain from the elbow down to the hand and tingling in the fingers; pain from the elbow down to the hand and tingling in the fingers; This is a spontaneous report received from a Consumer or other non HCP from medical information team.  A 78-year-old female patient received BNT162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 18Mar2024 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: ARTHRALGIA (non-serious), PARAESTHESIA (non-serious) all with onset Mar2024, outcome "not recovered" and all described as "pain from the elbow down to the hand and tingling in the fingers"; VACCINATION SITE PAIN (non-serious) with onset 18Mar2024, outcome "unknown", described as "pain in the injection site"; PAIN IN EXTREMITY (non-serious) with onset 20Mar2024, outcome "not recovered", described as "Arm pain"; VACCINATION SITE DISCOMFORT (non-serious) with onset 24Mar2024, outcome "not recovered", described as "felt some injection site discomfort".  Additional information: Caller states she experienced pain in the injection site on the first day and a half in the morning of Saturday and still felt some injection site discomfort on the next day. She received the vaccine last Monday. She states she had arm pain on the 3rd day on Wednesday and it has gotten worse in the last couple of days and it did not happen in the first two days. She thinks it got worse in those couple days but not today. Caller is experiencing pain from the elbow down to the hand and tingling in the fingers. She wants to know if this has been reported and if it has been reported, is there any information about how long it would last.  The information on the batch/lot number for BNT162b2 omi xbb.1.5 will be requested and submitted if and when received.
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Pain in extremity, Paraesthesia, Vaccination site pain, X-ray
Clinical narrative: felt some injection site discomfort; Arm pain; pain in the injection site; pain from the elbow down to the hand and tingling in the fingers; pain from the elbow down to the hand and tingling in the fingers; This is a spontaneous report received from a Consumer or other non HCP from medical information team.  A 78-year-old female patient received BNT162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 18Mar2024 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: ARTHRALGIA (non-serious), PARAESTHESIA (non-serious) all with onset Mar2024, outcome "not recovered" and all described as "pain from the elbow down to the hand and tingling in the fingers"; VACCINATION SITE PAIN (non-serious) with onset 18Mar2024, outcome "unknown", described as "pain in the injection site"; PAIN IN EXTREMITY (non-serious) with onset 20Mar2024, outcome "not recovered", described as "Arm pain"; VACCINATION SITE DISCOMFORT (non-serious) with onset 24Mar2024, outcome "not recovered", described as "felt some injection site discomfort".  Additional information: Caller states she experienced pain in the injection site on the first day and a half in the morning of Saturday and still felt some injection site discomfort on the next day. She received the vaccine last Monday. She states she had arm pain on the 3rd day on Wednesday and it has gotten worse in the last couple of days and it did not happen in the first two days. She thinks it got worse in those couple days but not today. Caller is experiencing pain from the elbow down to the hand and tingling in the fingers. She wants to know if this has been reported and if it has been reported, is there any information about how long it would last.  The information on the batch/lot number for BNT162b2 omi xbb.1.5 will be requested and submitted if and when received.
Age: 64.0
Sex: M
Vaccine: FLUC3, RSV
Symptoms: Dyspnoea
Clinical narrative: Patient has a hard time taking a deep breath ever since the shot.; This is a spontaneous report received from an Other HCP.  A 64-year-old male patient received rsv vaccine prot.subunit pref 2v (ABRYSVO), on 30Nov2023 as dose 1, single (Lot number: HG1755) at the age of 64 years, in right deltoid for immunisation; influenza vaccine inact sag 4v (FLUCELVAX QUADRIVALENT), on 30Nov2023 as dose 1, single (Lot number: 944466), in left arm for immunisation. The patient had no relevant medical history. The patient's concomitant medications were not reported. The following information was reported: DYSPNOEA (non-serious) with onset 01Dec2023, outcome "not recovered", described as "Patient has a hard time taking a deep breath ever since the shot.". Therapeutic measures were not taken as a result of dyspnoea.  Additional information: The patient had no known allergies.
Age: 43.0
Sex: M
Vaccine: PNC20
Symptoms: Injection site erythema, Injection site mass, Injection site pruritus, Injection site swelling, Injection site warmth
Clinical narrative: Swelling / at the site of the injection; hot / at the site of the injection; itchy / at the site of the injection; red lump at the site of the injection; This is a spontaneous report received from a Consumer or other non HCP.  A 43-year-old male patient received pneumococcal 20-valent conjugate vaccine (diphtheria CRM197 protein) (PREVNAR 20), on 26Mar2024 at 13:00 as dose 1, single (Batch/Lot number: unknown) at the age of 43 years, in left arm for immunisation. The patient's relevant medical history included: "childhood Asthma" (unspecified if ongoing), notes: Mild; "known allergies: peanuts" (unspecified if ongoing); "known allergies / cats" (unspecified if ongoing); "known allergies / pollen" (unspecified if ongoing); "known allergies / dust mites" (unspecified if ongoing). Concomitant medication(s) included: ADVIL [IBUPROFEN]. The following information was reported: VACCINATION SITE SWELLING (non-serious) with onset 27Mar2024, outcome "not recovered", described as "Swelling / at the site of the injection"; VACCINATION SITE WARMTH (non-serious) with onset 27Mar2024, outcome "not recovered", described as "hot / at the site of the injection"; VACCINATION SITE PRURITUS (non-serious) with onset 27Mar2024, outcome "not recovered", described as "itchy / at the site of the injection"; VACCINATION SITE MASS (non-serious) with onset 27Mar2024, outcome "not recovered", described as "red lump at the site of the injection". Therapeutic measures were taken as a result of vaccination site swelling, vaccination site warmth, vaccination site pruritus, vaccination site mass.  Additional information: The patient did not receive other vaccines on the same date or in four weeks. The patient described the events as: "Swelling hot itchy and red lump at the site of the injection". The treatment received for the adverse events were IBUPROFEN and HYDROCORTISONE.  The information on the batch/lot number for pneumococcal 20-valent conjugate vaccine (diphtheria CRM197 protein) will be requested and submitted if and when received.
Age: 43.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a Consumer or other non HCP.  A 44-year-old female patient (not pregnant) received BNT162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), in Nov2023 as dose 1, single (Batch/Lot number: unknown) at the age of 43 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Asthma" (unspecified if ongoing); "Environmental allergies" (unspecified if ongoing); "Prior breast cancer diagnosis" (unspecified if ongoing); "Known allergies: Adhesives" (unspecified if ongoing), notes: Known allergies: Adhesives. The patient's 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; Covid-19 vaccine (DOSE 3 (BOOSTER) SINGLE, Manufacturer Unknown), for COVID-19 immunization; Covid-19 vaccine (DOSE 4 (BOOSTER) SINGLE, Manufacturer Unknown), for COVID-19 immunization; Covid-19 vaccine (DOSE 5 (BOOSTER) SINGLE, Manufacturer Unknown), for COVID-19 immunization. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 18Mar2024, outcome "recovered" (25Mar2024) and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (19Mar2024) Positive, notes: Positive test: 19Mar2024 night; (25Mar2024) Negative, notes: Negative test: 25Mar2024 night. Therapeutic measures were taken as a result of vaccination failure, covid-19 which included Paxlovid.  Clinical course: COVID rebound: sniffles and positive test. Symptoms onset: 18Mar2024 morning. Positive test: 19Mar2024 night. Paxlovid started: 19Mar2024 night. Negative test: 25Mar2024 night.  The information on the batch/lot number for BNT162b2 omi xbb.1.5 will be requested and submitted if and when received.
Age: 84.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a Consumer or other non HCP.  An 85-year-old female patient (not pregnant) received BNT162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 28Dec2023 as dose 1, single (Lot number: Hm7010) at the age of 84 years, in right arm for covid-19 immunisation. The patient's relevant medical history included: "Known allergies: Medicines" (unspecified if ongoing), notes: Known allergies: Medicines; "Asthmatic bronchitis" (unspecified if ongoing); "hypertension" (unspecified if ongoing); "osteoarthritis" (unspecified if ongoing); "diverticulosis" (unspecified if ongoing); "vestibular nephritis" (unspecified if ongoing); "fibromyalgia" (unspecified if ongoing). Concomitant medication(s) included: SYNTHROID. Vaccination history included: BNT162b2;BNT162b2 omi ba.4-5 (Vaccine dose number: 4, Vaccine lot number: 9703, Vaccine location: Right arm), administration date: 03Nov2022, when the patient was 83-year-old, for COVID-19 Immunisation; Covid-19 vaccine (DOSE 1; MANUFACTURER UNKNOWN), for COVID-19 Immunisation; Covid-19 vaccine (DOSE 2; MANUFACTURER UNKNOWN), for COVID-19 Immunisation; Covid-19 vaccine (DOSE 3; MANUFACTURER UNKNOWN), for COVID-19 Immunisation. 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.
Age: 63.0
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 from product quality group.  A 64-year-old male patient received BNT162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 21Sep2023 as dose 1, single (Lot number: HH7595) at the age of 63 years for covid-19 immunisation. The patient's relevant medical history included: "Known allergies: Penicillin" (unspecified if ongoing); "Heart condition" (unspecified if ongoing), notes: Heart condition; "Celiac" (unspecified if ongoing); "Smoker" (unspecified if ongoing). Concomitant medication(s) included: ATORVASTATIN, start date: 01Feb2004; CARVEDILOL, start date: 01Feb2004; LISINOPRIL, start date: 01Feb2004. Vaccination history included: BNT162b2 (DOSE 1, SINGLE , Batch/Lot No: EN6198), administration date: 08Mar2021, when the patient was 60-year-old, for COVID-19 immunization; BNT162b2 (DOSE 2, SINGLE , Batch/Lot No: FR8732), administration date: 29Mar2021, when the patient was 61-year-old, for COVID-19 immunization; BNT162b2 (DOSE 4 (BOOSTER), SINGLE , Batch/Lot No: FK9895), administration date: 31Mar2022, when the patient was 62-year-old, for COVID-19 immunization; BNT162b2, BNT162b2 omi ba.4-5 (DOSE 5 (BOOSTER), SINGLE , Batch/Lot No: GJ2524), administration date: 26Sep2022, when the patient was 62-year-old, for COVID-19 immunization; Covid-19 vaccine (DOSE 3 (BOOSTER), SINGLE Unknown manufacturer), for COVID-19 immunization. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset Mar2024, outcome "unknown" and all described as "Treatment of COVID-19". Therapeutic measures were taken as a result of vaccination failure, covid-19 with Paxlovid.  Clinical course: The reporter assessed the case as non-serious. Anti-viral details: Paxlovid: treatment start date=19Mar2024, and treatment stop date=23Mar2024, indication=Treatment of COVID-19.
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a Consumer or other non HCP.  A 65-year-old female patient (not pregnant) received BNT162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 26Nov2023 as dose 1, single (Batch/Lot number: unknown) at the age of 65 years for covid-19 immunisation. The patient's relevant medical history included: "Asthma" (unspecified if ongoing). The patient's concomitant medications were not reported. Vaccination history included: BNT162b2;BNT162b2 omi ba.4-5 (Dose: 5), administration date: 29Jul2023, when the patient was 65-year-old, for COVID-19 immunization; BNT162b2 (Dose: 4), administration date: 11Jul2022, when the patient was 63-year-old, for COVID-19 immunization; BNT162b2 (Dose: 3), administration date: 28Feb2021, when the patient was 62-year-old, for COVID-19 immunization; BNT162b2 (Dose: 2), administration date: 13Feb2021, when the patient was 62-year-old, for COVID-19 immunization; BNT162b2 (Dose: 1), administration date: 11Jan2021, when the patient was 62-year-old, for COVID-19 immunization. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 20Mar2024, outcome "unknown" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (20Mar2024) Positive; (25Mar2024) Negative; (30Mar2024) Positive, notes: tested positive for COVID again. Therapeutic measures were taken as a result of vaccination failure, covid-19.  Clinical course: Patient had a rebound case of COVID after taking Paxlovid. She had a positive COVID test on 20Mar2024. Patient is 65 years old with mild asthma and started Paxlovid later that day. She completed the entire 5 day course of Paxlovid (BID). Symptoms began improving on 22Mar2024. Patient tested negative for COVID on 25Mar2024. She felt fine with no symptoms and good energy for 3 to 4 days. On the evening of day 4 She felt like she was having a bad seasonal allergy day after spending all day outside (with lots of spring blossoms). The morning of 30Mar2024 felt like she had a cold, took a home antigen test and tested positive for COVID again. She have been sick with cold-like symptoms and a headache since then. She had no known allergies. Patient had other medication in two weeks. Patient received treatment from 20Mar2024 to 25Mar2024 for 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: 70.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a Consumer or other non HCP.  A 71-year-old female patient (not pregnant) received BNT162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 07Dec2023 at 11:30 as dose 1, single (Batch/Lot number: unknown) at the age of 70 years, in left arm for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset Mar2024, latency 3 months 12 days 12 hrs 30 min after the suspect product(s) administration, outcome "unknown" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (Mar2024) Negative. Therapeutic measures were taken as a result of vaccination failure, covid-19.  Clinical information: Patient had no known allergies. Patient treated with Paxlovid from 20Mar2024, to 25Mar2024 for 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: 47.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a Consumer or other non HCP.  A 48-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 01Feb2023 as dose 5 (booster), single (Batch/Lot number: unknown) at the age of 47 years, in right arm for covid-19 immunisation; COVID-19 vaccine (COVID-19 VACCINE), as dose 1, single), as dose 2, single), as dose 3 (booster), single) and as dose 4 (booster), single) for covid-19 immunisation. The patient's relevant medical history included: "Multiple Sclerosis" (unspecified if ongoing). The patient's concomitant medications were not reported. Past drug history included: Clindamycin, reaction(s): "known allergies: Clindamycin". The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Mar2024, outcome "unknown" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (Mar2024) Negative, notes: testing positive on home antigen test after testing negative; (Mar2024) Positive, notes: testing positive on home antigen test after testing negative. Therapeutic measures were taken as a result of drug ineffective, covid-19.  The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5 will be requested and submitted if and when received.
Age: 35.0
Sex: M
Vaccine: COVID19
Symptoms: Mechanical urticaria, SARS-CoV-1 test
Clinical narrative: Skin itching/Dermatographitism; This is a spontaneous report received from a Consumer or other non HCP.  An adult male patient received BNT162b2 (BNT162B2), on 20Dec2021 as dose 3 (booster), single (Lot number: FH8030) at the age of 35 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Sinusitis" (unspecified if ongoing). The patient took concomitant medications. Vaccination history included: pfizer COVID-19 vaccine (Dose Number: 2, Batch/Lot No: EH6207, Location of injection: Arm Left), administration date: 24Apr2021, for Covid-19 immunisation; pfizer COVID-19 vaccine (Dose Number: 1, Batch/Lot No: ER8737, Location of injection: Arm Left), administration date: 03Apr2021, for Covid-19 immunisation. The following information was reported: MECHANICAL URTICARIA (non-serious) with onset 08Feb2022, outcome "not recovered", described as "Skin itching/Dermatographitism". The event "skin itching/dermatographitism" required physician office visit. Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were taken as a result of mechanical urticaria.  Additional information: Treatment received for the adverse event includes antihistamine. Patient not receive any other vaccines within 4 weeks prior to the COVID vaccine. Concomitant medication includes multivitamins.
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: Nasal Swab: Positive; Nasal Swab: Positive; This is a spontaneous report received from a Consumer or other non HCP.  A 35-year-old male patient received BNT162b2 (BNT162B2), on 03Apr2021 as dose 1, single (Lot number: ER8737), in left arm, on 24Apr2021 as dose 2, single (Lot number: EH6207), in left arm and on 20Dec2021 as dose 3 (booster), single (Lot number: FH8030), in left arm for covid-19 immunisation. The patient's relevant medical history included: "Sinusitis" (unspecified if ongoing). The patient took concomitant medications. Other medications in two weeks included multivitamin. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 20Sep2022, outcome "unknown" and all described as "Nasal Swab: Positive". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (20Sep2022) Positive.
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: Patient (her mother in law living in another state) using Paxcess to receive free paxlovid to treat a case of Covid in Mar2024. She indicated patient had received Comirnaty.; Patient (her mother in law living in another state) using Paxcess to receive free paxlovid to treat a case of Covid in Mar2024. She indicated patient had received Comirnaty.; This is a spontaneous report received from a Pharmacist.  A 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 and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 27Mar2024, outcome "unknown" and all described as "Patient (her mother in law living in another state) using Paxcess to receive free paxlovid to treat a case of Covid in Mar2024. She indicated patient had received Comirnaty.". The event "patient (her mother in law living in another state) using paxcess to receive free paxlovid to treat a case of covid in mar2024. she indicated patient had received comirnaty." required physician office visit. The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (Mar2024) Positive. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical information: Pharmacists sent in a success story for patient (her mother in law living in another state) Using Paxcess to receive free paxlovid to treat a Case of Covid in Mar2024. She indicated Patient had received Comirnaty (formulation nor Date of vaccination indicated). If covid prior vaccination reported unknown. If covid tested post vaccination reported yes.  The information on the batch/lot number for BNT162b2 omi xbb.1.5 will be requested and submitted if and when received.; Sender's Comments: The efficacy of a drug varies from patient to patient and can be affected by varied factors; however, a contributory role of the suspect product comirnaty to the reported Drug ineffective, COVID-19 cannot be ruled out.
Age: 74.0
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 74-year-old female patient (not pregnant) received BNT162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 10Oct2023 as dose 1, single (Batch/Lot number: unknown) at the age of 74 years for covid-19 immunisation. The patient's relevant medical history and 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), outcome "unknown" and all described as "COVID 19 Treatment". Therapeutic measures were taken as a result of vaccination failure, covid-19. Paxlovid was administered from 22Mar2024 to 01Apr2024.  No follow-up attempts are possible. Batch/lot number is not provided, and it cannot be obtained.
Sex: U
Vaccine: RSV
Symptoms: Headache, Pyrexia
Clinical narrative: headache; fever; This is a spontaneous report received from a Physician, Program ID.  An 89-year-old patient received respiratory syncytial virus vaccine prot.subunit pref 2v (ABRYSVO), as dose number unknown, single (Batch/Lot number: unknown) for immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: HEADACHE (non-serious), outcome "recovered"; PYREXIA (non-serious), outcome "recovered", described as "fever". The events "headache" and "fever" required physician office visit.  Additional information: The patient reported headache and fever to the doctor following the respiratory syncytial virus vaccine prot.subunit pref 2v. Issue was minor and resolved with 1-2 days. The reporter considered the event as caused by the suspect product.  No follow-up attempts are possible. Batch/lot number is not provided, and it cannot be obtained.
Age: 4.0
Sex: F
Vaccine: IPV
Symptoms: No adverse event, Product storage error
Clinical narrative: a patient was administered with an opened IPOL after a temperature excursion with no reported adverse event; Initial information received on 20-Mar-2024 regarding an unsolicited valid  non-serious case received from a Nurse.  This case involves a 4 years old female patient who was administered with an opened IPV (Vero) [Ipol] after a temperature excursion with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included Measles, Mumps, Rubella Vaccine (MMR) for Prophylactic vaccination.  On 14-Mar-2024, the patient was administered an opened (dose 4) 0.5 ml of suspect IPV (Vero) (Suspension for injection) [lot W1C751M, strength: standard, Frequency: once, expiry date: 18-Nov-2025) via intramuscular route in the right thigh for Immunization after a temperature excursion with no reported adverse event (poor quality product administered) (latency: same day) with no reported adverse event.    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: 4.0
Sex: M
Vaccine: IPV
Symptoms: No adverse event, Product storage error
Clinical narrative: patient who was given the vaccine after the excursion with no reported adverse event; IPOL (Max/low temperature reached: -58F (-50C)Duration out of labelled range: 4 hours with no reported adverse event; Initial information received on 27-Mar-2024 regarding an unsolicited valid non-serious case received from an other health professional.  This case involves a 4 years old male patient who experienced patient who was given the vaccine after the excursion with no reported adverse event and IPV (vero) [Ipol] (max/low temperature reached: -58f (-50c) duration out of labelled range: 4 hours with no reported 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 dose of suspect IPV (VERO) Suspension for injection (lot- V1B891) via unknown route in unknown administration site (dose, strength, lot/batch number and expiration date: not provided) for Immunisation (poor quality product administered) (latency- same day) (product storage error) (unknown 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.
Age: 29.0
Sex: M
Vaccine: TYP
Symptoms: Expired product administered, No adverse event
Clinical narrative: 29-year-old male was administered with an expired dose of TYPHIM VI, with no reported adverse event; Initial information received on 27-Mar-2024 regarding an unsolicited valid  non-serious case received from a Nurse.  This case involves a 29 years old male patient who was administered with an expired dose of Typhoid VI Polysaccharide Vaccine [Typhim VI] with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On 27-Mar-2024, the patient was administered with an expired (dose 1) 0.5 ml of Typhoid VI Polysaccharide Vaccine (Solution for injection) (strength: Standard, lot: V2A121M, frequency: once, expiry date: 26-Mar-2024) via intramuscular route in the left deltoid for Immunization (expired product administered) (latency: same day) with no reported adverse event.   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 and Regulatory Authority 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: 1.0
Sex: M
Vaccine: HIBV
Symptoms: Expired product administered, No adverse event
Clinical narrative: patient was inadvertently administered an expired dose of ActHib intramuscularly into the right thigh, as the fourth dose in the series with no reported adverse event; Initial information received on 27-Mar-2024 regarding an unsolicited valid  non-serious case received from a other health professional.  This case involves a 1 years old male patient was inadvertently administered an expired dose of HIB (PRP/T) Vaccine [ACT-HIB] intramuscularly into the right thigh, as the fourth dose in the series with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included Measles Vaccine, Mumps Vaccine, Rubella Vaccine (MMR) for Prophylactic vaccination; Hepatitis A Vaccine (Hepatitis A) for Prophylactic vaccination; Pneumococcal Vaccine Conj (Pneumococcal Conjugate Vaccine) for Prophylactic vaccination; Influenza Vaccine (Influenza) for Prophylactic vaccination; and Varicella Zoster Vaccine (Varicella Vaccine) for Prophylactic vaccination.  On 25-Mar-2024, the patient received a dose 4 of 0.5 ml of suspect HIB (PRP/T) Vaccine (Powder and solvent for solution for injection) lot UJ862AA ,Expiry date: 24-Mar-2024, strength was unknown via intramuscular route in the right thigh for Prophylactic vaccination (Immunization) and patient was inadvertently administered an expired dose of acthib intramuscularly into the right thigh, as the fourth dose in the series with no reported adverse event (expired product administered) (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.