chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: COVID19, COVID19
Symptoms: Pulmonary embolism, Swelling
Clinical narrative: multiple blood clots in both lungs; acute reaction of swelling; This spontaneous case was reported by a patient and describes the occurrence of PULMONARY EMBOLISM (multiple blood clots in both lungs) in a patient of an unknown age and gender who received SPIKEVAX NOS (SPIKEVAX NOS) for COVID-19 prophylaxis. The occurrence of additional non-serious events is detailed below.    Co-suspect product included non-company product Tozinameran (Comirnaty) for an unknown indication.    No Medical History information was reported.   On an unknown date, the patient received dose of SPIKEVAX NOS (SPIKEVAX NOS) (unknown route) 1 dosage form and dose of Tozinameran (Comirnaty) (unknown route) 1 dosage form. On an unknown date, the patient experienced PULMONARY EMBOLISM (multiple blood clots in both lungs) (seriousness criterion medically significant) and SWELLING (acute reaction of swelling). At the time of the report, PULMONARY EMBOLISM (multiple blood clots in both lungs) and SWELLING (acute reaction of swelling) outcome was unknown.            No concomitant medication was reported.  Patient only had Pfizer C-19 vac (normal reaction) then unknowingly was boostered with Moderna and had an acute reaction of swelling and multiple blood clots in both lungs.  No treatment medication was reported.   Most recent FOLLOW-UP information incorporated above includes: On 19-Dec-2024: Live follow-up received contains no new information.; Reporter's Comments: Company comment: The benefit-risk relationship of product is not affected by this report.
Sex: F
Vaccine: COVID19
Symptoms: Aphasia, Brain fog, COVID-19, Fatigue, Heart rate
Clinical narrative: stuff related to physical exhaustion/  post exertional malaise; I got COVID about 6 months ago; brain-fog; word-finding trouble; Fatigue/just a much greater physical exhaustion after previously normal activities; This spontaneous case was reported by a patient and describes the occurrence of MALAISE (stuff related to physical exhaustion/  post exertional malaise), COVID-19 (I got COVID about 6 months ago), BRAIN FOG (brain-fog), APHASIA (word-finding trouble) and FATIGUE (Fatigue/just a much greater physical exhaustion after previously normal activities) in a female patient of an unknown age who received SPIKEVAX NOS (SPIKEVAX NOS) for COVID-19 prophylaxis.     No Medical History information was reported.    In September 2023, the patient received dose of SPIKEVAX NOS (SPIKEVAX NOS) (unknown route) 1 dosage form. On an unknown date, the patient experienced MALAISE (stuff related to physical exhaustion/  post exertional malaise), COVID-19 (I got COVID about 6 months ago), BRAIN FOG (brain-fog), APHASIA (word-finding trouble) and FATIGUE (Fatigue/just a much greater physical exhaustion after previously normal activities). At the time of the report, MALAISE (stuff related to physical exhaustion/  post exertional malaise), COVID-19 (I got COVID about 6 months ago), BRAIN FOG (brain-fog), APHASIA (word-finding trouble) and FATIGUE (Fatigue/just a much greater physical exhaustion after previously normal activities) was resolving.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Heart rate: heart rate changes.         No concomitant medications were reported. The patient had taken all doses of Moderna vaccines.  It was reported that the patient had developed new and persistent symptoms after Covid  No treatment medications were reported.
Sex: F
Vaccine: COVID19
Symptoms: Malaise
Clinical narrative: stuff related to physical exhaustion/  post exertional malaise; I got COVID about 6 months ago; brain-fog; word-finding trouble; Fatigue/just a much greater physical exhaustion after previously normal activities; This spontaneous case was reported by a patient and describes the occurrence of MALAISE (stuff related to physical exhaustion/  post exertional malaise), COVID-19 (I got COVID about 6 months ago), BRAIN FOG (brain-fog), APHASIA (word-finding trouble) and FATIGUE (Fatigue/just a much greater physical exhaustion after previously normal activities) in a female patient of an unknown age who received SPIKEVAX NOS (SPIKEVAX NOS) for COVID-19 prophylaxis.     No Medical History information was reported.    In September 2023, the patient received dose of SPIKEVAX NOS (SPIKEVAX NOS) (unknown route) 1 dosage form. On an unknown date, the patient experienced MALAISE (stuff related to physical exhaustion/  post exertional malaise), COVID-19 (I got COVID about 6 months ago), BRAIN FOG (brain-fog), APHASIA (word-finding trouble) and FATIGUE (Fatigue/just a much greater physical exhaustion after previously normal activities). At the time of the report, MALAISE (stuff related to physical exhaustion/  post exertional malaise), COVID-19 (I got COVID about 6 months ago), BRAIN FOG (brain-fog), APHASIA (word-finding trouble) and FATIGUE (Fatigue/just a much greater physical exhaustion after previously normal activities) was resolving.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Heart rate: heart rate changes.         No concomitant medications were reported. The patient had taken all doses of Moderna vaccines.  It was reported that the patient had developed new and persistent symptoms after Covid  No treatment medications were reported.
Age: 9.0
Sex: M
Vaccine: COVID19
Symptoms: Head discomfort, Overdose, Pain in extremity, Wrong product administered
Clinical narrative: soreness in his arms; head was heavy all day; Vaccine overdose; Wrong Vaccine used; This spontaneous case was reported by an other health care professional and describes the occurrence of PAIN IN EXTREMITY (soreness in his arms), HEAD DISCOMFORT (head was heavy all day), OVERDOSE (Vaccine overdose) and WRONG PRODUCT ADMINISTERED (Wrong Vaccine used) in a 9-year-old male patient who received mRNA-1273.712 (SPIKEVAX 2024-2025 PFS) (batch no. 8080469) for COVID-19 prophylaxis.     No Medical History information was reported.    On 16-Dec-2024, the patient received dose of mRNA-1273.712 (SPIKEVAX 2024-2025 PFS) (Intramuscular use) .5 milliliter. On 16-Dec-2024, the patient experienced OVERDOSE (Vaccine overdose) and WRONG PRODUCT ADMINISTERED (Wrong Vaccine used). On 17-Dec-2024, the patient experienced PAIN IN EXTREMITY (soreness in his arms) and HEAD DISCOMFORT (head was heavy all day). At the time of the report, PAIN IN EXTREMITY (soreness in his arms), HEAD DISCOMFORT (head was heavy all day), OVERDOSE (Vaccine overdose) and WRONG PRODUCT ADMINISTERED (Wrong Vaccine used) outcome was unknown.        The action taken with mRNA-1273.712 (SPIKEVAX 2024-2025 PFS) (Intramuscular use) was unknown.   For mRNA-1273.712 (SPIKEVAX 2024-2025 PFS) (Intramuscular use), the reporter did not provide any causality assessments.   No concomitant medication was reported.  No treatment information was reported.
Sex: F
Vaccine: COVID19
Symptoms: Pain, Pain in extremity
Clinical narrative: her arm was so sore; body aches; This spontaneous case was reported by a patient and describes the occurrence of PAIN IN EXTREMITY (her arm was so sore) and PAIN (body aches) in a female patient of an unknown age who received SPIKEVAX NOS (SPIKEVAX NOS) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received dose of SPIKEVAX NOS (SPIKEVAX NOS) (Intramuscular use) 1 dosage form. On an unknown date, the patient experienced PAIN IN EXTREMITY (her arm was so sore) and PAIN (body aches). At the time of the report, PAIN IN EXTREMITY (her arm was so sore) and PAIN (body aches) had resolved.        The action taken with SPIKEVAX NOS (SPIKEVAX NOS) (Intramuscular use) was unknown.       The concomitant medication was not reported by reporter. It was reported that patient got her COVID shot, and her arm was so sore she could barely move it. It lasted 5-6 days. It was hard for her to lift it. It was so painful even to the touch. She stated that Pfizer had too many problems in the beginning and, she didn't want it. She wanted to stick with Moderna. She felt really confident with Moderna. She stated that she did not have a temperature with her last COVID shot but she had the body aches. She states that it was a good thing to have the body aches because it means the vaccine was working and the body was fighting so she does not mind. It was unknown if the patient experienced any additional symptoms/events. The treatment medication was not reported by reporter.   This case was linked to US-MODERNATX, INC.-MOD-2024-779811 (E2B Linked Report).   Reporter did not allow further contact; Sender's Comments:  US-MODERNATX, INC.-MOD-2024-779811:multiple patients' case
Sex: U
Vaccine: RSV
Symptoms: Occupational exposure to product, Syringe issue
Clinical narrative: Leaking product came into contact with a staff member that grabbed it; Crack in plastic of diluent syringe; Leaking; product leaked; This is a spontaneous report received from a healthcare professional.  A patient (age and gender not provided) was exposed to RSV vaccine Prot.Subunit Pref 2v (ABRYSVO), as dose 1, single (Lot number: LG9827, Expiration Date: Oct2025) for immunisation, Device Lot Number: LG9827, Device Expiration Date: Oct2025. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: OCCUPATIONAL EXPOSURE TO PRODUCT (non-serious), described as "Leaking product came into contact with a staff member that grabbed it"; DEVICE BREAKAGE (non-serious), described as "Crack in plastic of diluent syringe"; DEVICE LEAKAGE (non-serious), described as "Leaking; product leaked".  Causality for "leaking product came into contact with a staff member that grabbed it", "crack in plastic of diluent syringe" and "leaking; product leaked" was determined associated to device constituent of RSV vaccine Prot.Subunit Pref 2v (malfunction).  Additional Information: The reporting healthcare professional had customer purchase product for Abrysvo (Abrysvo Carton or Package, NDC Number: 00069034405; Sterile Water Diluent Component (syringe that had crack in it): NDC Number: 0069025001, Lot Number: LG9827, Expiration Date: Oct2025; Abrysvo Antigen Powder: Lot Number: LG9827, Expiration Date: Oct2025, NDC Number: 00069020701). Opened container, 1 of the syringes was cracked, liquids had mixed together. When they opened package, sterile water diluent syringe had crack in the plastic. It was just 1 kit, syringe that was cracked. Noticed leaking then, once pulled it out of package, saw crack alongside, when first taken out of package. They clarified there was no patient involvement with this product. When the noticed that product leaked, they did not end up using it. However, the healthcare professional clarified that the leaking product came into contact with a staff member (patient) that grabbed it. The healthcare professional believes that a sample of the product is available to be returned.
Sex: M
Vaccine: COVID19
Symptoms: Immunology test, Pemphigus
Clinical narrative: Pemphigus vulgaris; This is a literature report for the following literature source(s).  A 60-year-old male patient received BNT162b2 (BNT162B2 NOS), as dose 4 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "diabetic" (unspecified if ongoing). The patient's concomitant medications were not reported. Vaccination history included: Bnt162b2 (DOSE 1, SINGLE), for COVID-19 immunisation; Bnt162b2 (DOSE 2, SINGLE), for COVID-19 immunisation; Bnt162b2;bnt162b2 omi ba.4-5 (DOSE 3 (BOOSTER), SINGLE), for COVID-19 immunisation, reaction(s): "severe mouth ulcers". The following information was reported: PEMPHIGUS (hospitalization, medically significant, life threatening), outcome "recovered", described as "Pemphigus vulgaris". The patient underwent the following laboratory tests and procedures: Immunology test: confirmed 1200 fold higher anti-demoglein IgG. Therapeutic measures were taken as a result of pemphigus.; Sender's Comments: Based on the implied temporal association, a causal relationship between suspect drug and the reported event pemphigus vulgaris cannot be excluded.  The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.,Linked Report(s) : US-PFIZER INC-PV202400166180 same article/vaccine, different event;
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: had COVID (corona virus disease) three times since 2020, first time on an unknown date in 2021, second time on an unknown date in 2022; had COVID (corona virus disease) three times since 2020, first time on an unknown date in 2021, second time on an unknown date in 2022; This is a spontaneous report received from a Consumer or other non HCP.  A 70-year-old female patient received BNT162b2 (COVID-19 VACCINE NOS MANUFACTURER UNKNOWN), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Rheumatoid arthritis" (ongoing). Concomitant medication(s) included: ENBREL unknown taken for rheumatoid arthritis, start date: 2009; ENBREL, stop date: 02Dec2024. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "had COVID (corona virus disease) three times since 2020, first time on an unknown date in 2021, second time on an unknown date in 2022". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (03Dec2024) Negative; (06Dec2024) Positive; (11Dec2024) Negative.  Clinical course: The patient had COVID (corona virus disease) three times since 2020, first time on an unknown date in 2021, second time on an unknown date in 2022. There had been different variations, but she had been lucky because she has had very mild cases. On 03/DEC/2024, she felt a sore throat and the patient took a COVID test and the result was negative. On an unknown date in DEC/2024 (last week), she had COVID (third time). On 06/DEC/2024, she tested again the result positive for COVID. On 09/DEC/2024 (last week), she did not take her Enbrel injection because she was still testing positive and was waiting to stop testing positive. She was sick during the week and every time she had COVID she had been advised not to take Enbrel while she was sick because it suppresses the immune system. She was already over a week from when she should have taken the Enbrel dose. This has happened a lot over the time when she had the COVID vaccines and she was told to wait five days before she was getting her vaccine and to wait for another week after she had her vaccine. On 11/DEC/2024, she re-tested COVID and the result was negative. The physician was unaware of COVID.   No follow-up attempts are possible. Batch/lot number is not provided, and it cannot be obtained.
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, Platelet count
Clinical narrative: He noted that he had COVID-19 infection; He noted that he had COVID-19 infection; This is a literature report for the following literature source(s).  A male patient in his 30's received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), in May2022 as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation; BNT162b2 (BNT162B2), in Apr2021 as dose 1, single (Batch/Lot number: unknown) and in Apr2021 as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "hypertension" (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 Sep2022, outcome "unknown" and all described as "He noted that he had COVID-19 infection". The patient underwent the following laboratory tests and procedures: Platelet count: (Jul2021) 203 x10 9/l; (Sep2022) 22 x10 9/l, notes: thrombocytopenia.  Clinical course: A man in his mid-30s with a prior history of hypertension presented to the emergency room after an incidental finding of severe thrombocytopenia (22x109/L) on routine blood work. He noted that he had COVID-19 infection 2 weeks prior with mild cold symptoms and cough with intermittent blood-tinged sputum. He received two primary doses of Pfizer-BioN-Tech COVID-19 vaccine more than a year ago. Last documented platelet count before infection (203x109/L) was approximately a month after the completion of the two primary doses. A single booster dose with Pfizer-BioN-Tech COVID-19 vaccine, Bivalent was received 5 months prior to admission.; Sender's Comments: Vaccine efficacy varies from person to person and is affected by many factors. The association between the event drug ineffective (CoVID-19) with the suspect products BNT162B2, BNT162B2 OMI BA.4-5, and BNT162B2 cannot be fully excluded.,Linked Report(s) : US-PFIZER INC-202400330884 Same article, drug, patient and different event;
Sex: M
Vaccine: COVID19
Symptoms: Colon cancer, Neoplasm, Skin cancer
Clinical narrative: colon cancer; skin cancer; he has a tumor the size of a grapefruit growing underneath his ballsack; This is a spontaneous report received from a Consumer or other non HCP, Program ID.  A male patient received BNT162b2 omicron (kp.2) (COMIRNATY (2024-2025 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 (Dose 1; unknown manufacturer), for Covid-19 Immunization; Covid-19 vaccine (Dose 2; unknown manufacturer), for Covid-19 Immunization; Covid-19 vaccine (Dose 3; unknown manufacturer), for Covid-19 Immunization; Covid-19 vaccine (Dose 4; unknown manufacturer), for Covid-19 Immunization; Covid-19 vaccine (Dose 5; unknown manufacturer), for Covid-19 Immunization. The following information was reported: COLON CANCER (medically significant), outcome "unknown"; SKIN CANCER (medically significant), outcome "unknown"; NEOPLASM (medically significant), outcome "unknown", described as "he has a tumor the size of a grapefruit growing underneath his ballsack".  Clinical course: The patient stated he received all six shots of the Covid-19 vaccine, and he said he is going through the various stages of colon cancer, skin cancer, and he has a tumor the size of a grapefruit growing underneath his ball sack. He did not confirm he had the tumor before or after he received the Covid vaccines.  The information on the batch/lot number for BNT162b2 omicron (kp.2) will be requested and submitted if and when received.
Sex: F
Vaccine: COVID19, FLUX, RVX
Symptoms: Chills, Headache, Myalgia, Pain in extremity, Pruritus
Clinical narrative: SORE ARMS; chills, especially at night; muscle aches; headache; some itching on the top of her head; Initial information received on 19-Dec-2024 regarding an unsolicited valid  non-serious case received from a consumer/non-health care professional(patient).  The case is linked to US-SA-2024SA380026.  This case involves a 71 years old female patient (71.202 kg) who had sore arms, chills, especially at night, muscle aches, headache and some itching on the top of her head after receiving RSV vaccine, COVID-19 vaccine and Influenza Vaccine.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included Modafinil (Modafinil); Cetirizine hydrochloride (Zyrtec); Trazodone hydrochloride (Trazodone HCL); Clonazepam ; Fluoxetine hydrochloride (Prozac); Ascorbic acid (Vitamin C); Colecalciferol (Vitamin d3); and Calcium .  On an unknown date, the patient received a  dose of suspect Influenza Vaccine produced by unknown manufacturer lot number not reported via unknown route in unknown administration site, a  dose of suspect COVID-19 vaccine not produced by Sanofi Pasteur lot number not reported via unknown route in unknown administration site nd a  dose of suspect RSV vaccine not produced by Sanofi Pasteur lot number not reported via unknown route in unknown administration site for all the prophylactic vaccination (Immunization) (dosage, strength, expiry date formulation was unknown for all the suspects). The information on batch number and expiration date corresponding to the one at time of event occurrence was requested.  On 16-Dec-2024 the patient developed sore arms (pain in extremity), chills, especially at night (chills) , muscle aches (myalgia),headache and some itching on the top of her head (pruritus) (unknown latency) following the administration of Influenza Vaccine, COVID-19 vaccine and RSV vaccine.  Reportedly "PATIENT REPORTS HER DOSE WAS DUE ON 12/16/2024.SO SHE DID NOT TAKE HER DOSE.NO TEMPURATURE"  Action taken was not applicable for all the events.  It was not reported if the patient received a corrective treatment for the events (SORE ARMS, muscle aches, headache, chills, especially at night, some itching on the top of her head).  At time of reporting, the outcome was Unknown for all the events.; Sender's Comments:  US-SA-2024SA380026:link case id
Sex: U
Vaccine: FLUX
Symptoms: Hemiplegia
Clinical narrative: left side was paralyzed for 3 days; Initial information received on 21-Dec-2024 regarding an unsolicited valid Social Media serious case received from a other health professional.  This case involves Adult and unknown gender patient whose  left side was paralyzed for 3 days after receiving vaccine INFLUENZA VACCINE.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On an unknown date in 2022, the patient received a  dose of suspect INFLUENZA VACCINE produced by unknown manufacturer (dose, formulation, strength, lot, expiry and route: unknown) in unknown administration site for prophylactic vaccination.  Information on batch number and expiry date corresponding to the one at time of event occurrence was requested.  On an unknown date in 2022, the patient developed a serious left side was paralyzed for 3 days (hemiplegia) (latency 12 hours).   This event was assessed as medically significant.  Action taken: not applicable.  It was not reported if the patient received a corrective treatment for the event (left side was paralyzed for 3 days).  At time of reporting, the outcome was Recovered / Resolved on an unknown date for the event left side was paralyzed for 3 days.; Sender's Comments: Sanofi company comment dated: 25-Dec-2024:- This case involves Adult and unknown gender patient who experienced left side was paralyzed for 3 days after receiving vaccine INFLUENZA VACCINE. Based on the limited information provided regarding this case, causal role of the company suspect product cannot be excluded. However, lack of information of past and concomitant medication, any family history patient past medical history and concurrent condition precludes comprehensive case assessment.
Age: 0.5
Sex: F
Vaccine: FLU3
Symptoms: No adverse event, Product storage error
Clinical narrative: FLUZONE prefilled syringes and Vaxelis was administered to patient after excursion with negative disposition and with no reported AE; Initial information received on 17-Dec-2024 regarding an unsolicited valid non-serious case received from a other health professional.  This case is linked to US-SA-2024SA376929 (master case).  This case involves a 6 months old female patient who was administered Influenza Usp Trival A-B Subvirion No Preservative Vaccine [Fluzone] prefilled syringes prefilled syringes after excursion with negative disposition and 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 an unknown dose of suspect Influenza Usp Trival A-B Subvirion No Preservative Vaccine, Suspension for injection prefilled syringes (lot U8523BA, expiry date- 30-JUN-2025, strength unknown) via unknown route in unknown administration site for Influenza immunization, after excursion with negative disposition and with no adverse event (poor quality 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.; Sender's Comments:  US-SA-2024SA373698:Same patient (Vaxelis case) US-SA-2024SA376929:master case US-SA-2024SA376277:related case
Age: 17.0
Sex: M
Vaccine: MEN
Symptoms: Expired product administered, No adverse event
Clinical narrative: expired dose of MENQUADFI was given with no reported adverse event; Initial information received on 19-Dec-2024 regarding an unsolicited valid  non-serious case received from a other health professional.  This case involves a 17 years old male patient who was given expired dose of meningococcal a-c-y-w135 (t conj) vaccine [Menquadfi] with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  On 18-Dec-2024, the patient received 0.5 ML expired dose of suspect MENINGOCOCCAL A-C-Y-W135 (T CONJ) VACCINE Solution for injection once (lot U7447AC, Expiry date: 20-Sep-2024, strength: standard, route, administration site was unknown) as immunization (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.
Age: 93.0
Sex: M
Vaccine: FLU3
Symptoms: Extra dose administered, No adverse event
Clinical narrative: received two fluzone hd this season with no reported adverse event; Initial information received on 20-Dec-2024 regarding an unsolicited valid non-serious case received from a other health professional.  This case involves a 93 years old male patient who received two influenza usp trival a-b high dose subvirion vaccine [Fluzone HD] this season 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 in Oct-2024, the patient received dose 1 of suspect INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE Suspension for injection in pre-filled syringe and on 20-Dec-2024 he also received a dose 2  dose of vaccine (batch number: UT84638A, Expiry date: 01-Jun-2025) via intramuscular route in the left arm as immunization (extra dose administered) (Latency: few months).   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: 47.0
Sex: F
Vaccine: UNK
Symptoms: Fatigue, Influenza A virus test positive, Vaccination failure
Clinical narrative: Vaccination failure; Tested positive for A-strain flu; Tiredness; This spontaneous case, initially received on 13-Dec-2024, was reported by a non-health professional and concerns an adult female patient.  No medical history and concomitant medication were reported.  Administration of company suspect drug: On 22-Oct-2024, the patient received Flucelvax (TIV) for Influenza immunization, Dose regimen: 0.5 ml, Route of administration not reported, Lot number: No batch number available and will be requested upon follow-up.  No additional suspect drugs.  Adverse reactions/events and outcomes: On an unknown date in 2024, the patient Tested positive for A-strain flu (Medically Significant, outcome: Not Reported), Vaccination failure (Medically Significant, outcome: Not Reported). Associated symptoms included: Tiredness.  Reporter wife received Flucelvax on 22-Oct-2024. Now tested positive for A-strain flu and doing well, typical tiredness. Treatment measures associated with events were unknown.  Flucelvax (TIV) action taken: Not Applicable  Reporter' s assessment:  The reporter did not provide seriousness and causality assessment.; Reporter's Comments: Causality: Due to the spontaneous nature of the case, it is considered related for reporting purposes. A lack of effect/vaccination failure can generally be expected for any medicinal/drug product/vaccine as a 100% success rate cannot be reasonably assumed in every patient treated.
Age: 12.0
Sex: M
Vaccine: UNK
Symptoms: Fatigue, Influenza A virus test positive, Vaccination failure
Clinical narrative: Vaccination failure; Tested positive for A-strain flu; Tiredness; This spontaneous case, initially received on 13-Dec-2024, was reported by a non health professional and concerns an adolescent male patient.  No medical history and concomitant medication were unknown.  Administration of company suspect drug:  On 22-Oct-2024, the patient received Flucelvax (TIV) for Influenza immunization, Dose regimen: 0.5 ml, Route of administration not reported, Lot number: No batch number available, and will be requested upon follow-up.  No additional suspect drugs.  Adverse reactions/events and outcomes: On an unknown date in 2024, the patient Tested positive for A-strain flu (Medically Significant, outcome: Not Reported), Vaccination failure (Medically Significant, outcome: Not Reported). Associated symptoms included: Tiredness.  Reporter stepson received Flucelvax on 22-Oct-2024. Now tested positive for A-strain flu, and doing well, typical tiredness. Treatment measures associated with events were unknown.  Flucelvax (TIV) action taken: Not Applicable  Reporter' s assessment: The reporter did not provide seriousness and causality assessment.; Reporter's Comments: Causality: Due to the spontaneous nature of the case, it is considered related for reporting purposes. A lack of effect/vaccination failure can generally be expected for any medicinal/drug product/vaccine as a 100% success rate cannot be reasonably assumed in every patient treated.
Sex: U
Vaccine: PNC20
Symptoms: Device connection issue
Clinical narrative: When pulling needle cap off, neck of pre filled syringe pulled straight off; The initial case was missing the following minimum criteria: No adverse effect. Upon receipt of follow-up information on 16Dec2024, this case now contains all required information to be considered valid.  This is a spontaneous report received from a Nurse from product quality group.  A patient (age and gender not provided) received pneumococcal 20-valent conjugate vaccine (diphtheria crm197 protein) (PREVENAR 20), as dose number unknown, single (Lot number: LJ5281, Expiration Date: 31May2026) for immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DEVICE BREAKAGE (non-serious), outcome "unknown", described as "When pulling needle cap off, neck of pre filled syringe pulled straight off".  Causality for "when pulling needle cap off, neck of pre filled syringe pulled straight off" was determined associated to device constituent of pneumococcal 20-val conj vac (dipht CRM197 protein) (malfunction).  Additional information: No patient involvement with this product, other than being in the room.
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Cerebrovascular accident
Clinical narrative: Stroke 1/21/2022
Age: 62.0
Sex: F
Vaccine: COVID19, FLU3
Symptoms: Asthenia, Chest pain, Dizziness
Clinical narrative: Member complained of chest pain, feeling lightheaded and feeling weak right after administration of Flu and Covid vaccine. Checked vitals on site and team alert activated. Member was taken to ER for further evaluation.
Age: 13.0
Sex: F
Vaccine: COVID19, FLU3
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: given Moderna 6m-11 year old formula to a 13 year old Patient no complants. Mother was informed and new appt. was scheduled.
Age: 56.0
Sex: M
Vaccine: VARZOS
Symptoms: Chest discomfort, Musculoskeletal stiffness
Clinical narrative: Two days following administration, patient complained of stiff neck muscles and heaviness in the chest. He went to the  emergency room and received ketorolac and some sort of muscle relaxer which relieved the pain.
Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: Condition aggravated, Psoriasis, Rash, Sinusitis
Clinical narrative: After injection, within first few days, psoriasis flared after not having had it since I was 7, along with rash in arm and shoulder, upper torso.  This survey triggered an adverse event report after I reported a sinus infection about 1 month post-vaccine.
Age: 40.0
Sex: F
Vaccine: COVID19
Symptoms: Rheumatoid arthritis, Rheumatoid factor positive
Clinical narrative: Rheumatoid arthritis began after receiving vaccine. I had no symptoms or issues until after the shot.
Age: 0.33
Sex: M
Vaccine: DTAPIPVHIB, PNC20, RV5
Symptoms: Cardiac arrest, Death, Unresponsive to stimuli
Clinical narrative: Patient arrived in ED via EMS in cardiac arrest after being found unresponsive by mother after a nap.  Significant history was pt received 3 vaccines earlier this AM.  Pt received 2 doses of epinephrine and was pronounced dead at 1845.
Age: 68.0
Sex: F
Vaccine: RSV
Symptoms: Extra dose administered, No adverse event
Clinical narrative: Patient received a dose at her request of Arexvy on 12/22/24 in error. This was inappropriately administered because she received a dose of Arexvy in October 2023 at another pharmacy location. There was no immediate or delayed side effect noted by the customer at time of administration of vaccination. Patient was notified of error on 12/26/24 and she stated she did not experience an additional side effect after administration of the Arexvy on 12/22/24. Her primary care doctor, Dr, was notified via phone message of vaccine administration error.
Age: 76.0
Sex: M
Vaccine: RSV
Symptoms: Extra dose administered
Clinical narrative: patient received a 2nd dose of Arexvy on 12/21/2024. The first dose was given 10/19/2023 at a different location,
Age: 0.33
Sex: F
Vaccine: DTAPHEPBIP
Symptoms: Immediate post-injection reaction, Injection site mass, Rash, Rash erythematous, Rash macular
Clinical narrative: Patient had raised bump on leg at vaccination injection area immediately following and for at least one week. Additionally, broke out in blotchy red rashes all over body 5 days after. No fever, change in eating habit, or
Age: 26.0
Sex: M
Vaccine: COVID19
Symptoms: Feeling abnormal, Loss of consciousness
Clinical narrative: As soon as the patient received he vaccine along with flublok (influenza) vaccine, he started feeling awkward and he leaned on the chair and passed out
Age: 83.0
Sex: F
Vaccine: COVID19, FLU3
Symptoms: Fatigue, Hypertension, Pneumonia, Tremor
Clinical narrative: fatigue, shakiness, HBP, pneumonia
Age: 37.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Differential white blood cell count normal, Echocardiogram normal, Electrocardiogram normal, Feeling of body temperature change, Full blood count normal
Clinical narrative: tremor; muscle weakness; neuropathic pain; night sweats; burning and tingling skin; burning and tingling skin; tachycardia; teeth sensitivity; tinnitis; full body throbing; nausea; vomiting; loss of appetite; rapid hot and cold spells; This is a spontaneous report received from a Consumer or other non HCP.  A 37-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 06Nov2021 as dose 3 (booster), single (Lot number: FE3590) at the age of 37 years, in left deltoid for covid-19 immunisation. The patient's relevant medical history included: "ADD" (unspecified if ongoing); "Insomnia" (unspecified if ongoing). Concomitant medication(s) included: FLUZONE [INFLUENZA VACCINE] taken for influenza immunisation, on 18Sep2023 as dose number unknown, single. Vaccination history included: Covid-19 vaccine (DOSE 1; MANUFACTURER UNKNOWN), for COVID-19 immunisation; Covid-19 vaccine (DOSE 2; MANUFACTURER UNKNOWN), for COVID-19 immunisation. The following information was reported: SKIN BURNING SENSATION (disability), PARAESTHESIA (disability) all with onset 20Nov2021, outcome "recovering" and all described as "burning and tingling skin"; PAIN (disability) with onset 20Nov2021, outcome "recovering", described as "full body throbing"; DECREASED APPETITE (disability) with onset 20Nov2021, outcome "recovering", described as "loss of appetite"; MUSCULAR WEAKNESS (disability) with onset 20Nov2021, outcome "recovering", described as "muscle weakness"; NAUSEA (disability) with onset 20Nov2021, outcome "recovering"; NEURALGIA (disability) with onset 20Nov2021, outcome "recovering", described as "neuropathic pain"; NIGHT SWEATS (disability) with onset 20Nov2021, outcome "recovering"; FEELING OF BODY TEMPERATURE CHANGE (disability) with onset 20Nov2021, outcome "recovering", described as "rapid hot and cold spells"; TACHYCARDIA (disability) with onset 20Nov2021, outcome "recovering"; HYPERAESTHESIA TEETH (disability) with onset 20Nov2021, outcome "recovering", described as "teeth sensitivity"; TINNITUS (disability) with onset 20Nov2021, outcome "recovering", described as "tinnitis"; TREMOR (disability) with onset 20Nov2021, outcome "recovering"; VOMITING (disability) with onset 20Nov2021, outcome "recovering". Therapeutic measures were taken as a result of tremor, muscular weakness, neuralgia, night sweats, skin burning sensation, paraesthesia, tachycardia, hyperaesthesia teeth, tinnitus, pain, nausea, vomiting, decreased appetite, feeling of body temperature change. Clinical course: Patient also received BNT162b2 (BNT162B2), on 28Sep2023 as dose 5 (booster), single (Batch/Lot number: Unknown) for covid-19 immunisation. No other vaccine same date. No other medications in two weeks. Adverse events treatment as steroid, beta blocker. Patient had no known allergies.
Age: 37.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Headache, Hyperhidrosis, Magnetic resonance imaging normal, Metabolic function test normal, Muscular weakness
Clinical narrative: tremor; muscle weakness; neuropathic pain; night sweats; burning and tingling skin; burning and tingling skin; tachycardia; teeth sensitivity; tinnitis; full body throbing; nausea; vomiting; loss of appetite; rapid hot and cold spells; This is a spontaneous report received from a Consumer or other non HCP.  A 37-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 06Nov2021 as dose 3 (booster), single (Lot number: FE3590) at the age of 37 years, in left deltoid for covid-19 immunisation. The patient's relevant medical history included: "ADD" (unspecified if ongoing); "Insomnia" (unspecified if ongoing). Concomitant medication(s) included: FLUZONE [INFLUENZA VACCINE] taken for influenza immunisation, on 18Sep2023 as dose number unknown, single. Vaccination history included: Covid-19 vaccine (DOSE 1; MANUFACTURER UNKNOWN), for COVID-19 immunisation; Covid-19 vaccine (DOSE 2; MANUFACTURER UNKNOWN), for COVID-19 immunisation. The following information was reported: SKIN BURNING SENSATION (disability), PARAESTHESIA (disability) all with onset 20Nov2021, outcome "recovering" and all described as "burning and tingling skin"; PAIN (disability) with onset 20Nov2021, outcome "recovering", described as "full body throbing"; DECREASED APPETITE (disability) with onset 20Nov2021, outcome "recovering", described as "loss of appetite"; MUSCULAR WEAKNESS (disability) with onset 20Nov2021, outcome "recovering", described as "muscle weakness"; NAUSEA (disability) with onset 20Nov2021, outcome "recovering"; NEURALGIA (disability) with onset 20Nov2021, outcome "recovering", described as "neuropathic pain"; NIGHT SWEATS (disability) with onset 20Nov2021, outcome "recovering"; FEELING OF BODY TEMPERATURE CHANGE (disability) with onset 20Nov2021, outcome "recovering", described as "rapid hot and cold spells"; TACHYCARDIA (disability) with onset 20Nov2021, outcome "recovering"; HYPERAESTHESIA TEETH (disability) with onset 20Nov2021, outcome "recovering", described as "teeth sensitivity"; TINNITUS (disability) with onset 20Nov2021, outcome "recovering", described as "tinnitis"; TREMOR (disability) with onset 20Nov2021, outcome "recovering"; VOMITING (disability) with onset 20Nov2021, outcome "recovering". Therapeutic measures were taken as a result of tremor, muscular weakness, neuralgia, night sweats, skin burning sensation, paraesthesia, tachycardia, hyperaesthesia teeth, tinnitus, pain, nausea, vomiting, decreased appetite, feeling of body temperature change. Clinical course: Patient also received BNT162b2 (BNT162B2), on 28Sep2023 as dose 5 (booster), single (Batch/Lot number: Unknown) for covid-19 immunisation. No other vaccine same date. No other medications in two weeks. Adverse events treatment as steroid, beta blocker. Patient had no known allergies.
Age: 37.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Neuralgia, Neurological examination normal, Night sweats, Palpitations, Paraesthesia
Clinical narrative: tremor; muscle weakness; neuropathic pain; night sweats; burning and tingling skin; burning and tingling skin; tachycardia; teeth sensitivity; tinnitis; full body throbing; nausea; vomiting; loss of appetite; rapid hot and cold spells; This is a spontaneous report received from a Consumer or other non HCP.  A 37-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 06Nov2021 as dose 3 (booster), single (Lot number: FE3590) at the age of 37 years, in left deltoid for covid-19 immunisation. The patient's relevant medical history included: "ADD" (unspecified if ongoing); "Insomnia" (unspecified if ongoing). Concomitant medication(s) included: FLUZONE [INFLUENZA VACCINE] taken for influenza immunisation, on 18Sep2023 as dose number unknown, single. Vaccination history included: Covid-19 vaccine (DOSE 1; MANUFACTURER UNKNOWN), for COVID-19 immunisation; Covid-19 vaccine (DOSE 2; MANUFACTURER UNKNOWN), for COVID-19 immunisation. The following information was reported: SKIN BURNING SENSATION (disability), PARAESTHESIA (disability) all with onset 20Nov2021, outcome "recovering" and all described as "burning and tingling skin"; PAIN (disability) with onset 20Nov2021, outcome "recovering", described as "full body throbing"; DECREASED APPETITE (disability) with onset 20Nov2021, outcome "recovering", described as "loss of appetite"; MUSCULAR WEAKNESS (disability) with onset 20Nov2021, outcome "recovering", described as "muscle weakness"; NAUSEA (disability) with onset 20Nov2021, outcome "recovering"; NEURALGIA (disability) with onset 20Nov2021, outcome "recovering", described as "neuropathic pain"; NIGHT SWEATS (disability) with onset 20Nov2021, outcome "recovering"; FEELING OF BODY TEMPERATURE CHANGE (disability) with onset 20Nov2021, outcome "recovering", described as "rapid hot and cold spells"; TACHYCARDIA (disability) with onset 20Nov2021, outcome "recovering"; HYPERAESTHESIA TEETH (disability) with onset 20Nov2021, outcome "recovering", described as "teeth sensitivity"; TINNITUS (disability) with onset 20Nov2021, outcome "recovering", described as "tinnitis"; TREMOR (disability) with onset 20Nov2021, outcome "recovering"; VOMITING (disability) with onset 20Nov2021, outcome "recovering". Therapeutic measures were taken as a result of tremor, muscular weakness, neuralgia, night sweats, skin burning sensation, paraesthesia, tachycardia, hyperaesthesia teeth, tinnitus, pain, nausea, vomiting, decreased appetite, feeling of body temperature change. Clinical course: Patient also received BNT162b2 (BNT162B2), on 28Sep2023 as dose 5 (booster), single (Batch/Lot number: Unknown) for covid-19 immunisation. No other vaccine same date. No other medications in two weeks. Adverse events treatment as steroid, beta blocker. Patient had no known allergies.
Age: 37.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Platelet count normal, Sensory disturbance, Skin burning sensation, Tremor
Clinical narrative: tremor; muscle weakness; neuropathic pain; night sweats; burning and tingling skin; burning and tingling skin; tachycardia; teeth sensitivity; tinnitis; full body throbing; nausea; vomiting; loss of appetite; rapid hot and cold spells; This is a spontaneous report received from a Consumer or other non HCP.  A 37-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 06Nov2021 as dose 3 (booster), single (Lot number: FE3590) at the age of 37 years, in left deltoid for covid-19 immunisation. The patient's relevant medical history included: "ADD" (unspecified if ongoing); "Insomnia" (unspecified if ongoing). Concomitant medication(s) included: FLUZONE [INFLUENZA VACCINE] taken for influenza immunisation, on 18Sep2023 as dose number unknown, single. Vaccination history included: Covid-19 vaccine (DOSE 1; MANUFACTURER UNKNOWN), for COVID-19 immunisation; Covid-19 vaccine (DOSE 2; MANUFACTURER UNKNOWN), for COVID-19 immunisation. The following information was reported: SKIN BURNING SENSATION (disability), PARAESTHESIA (disability) all with onset 20Nov2021, outcome "recovering" and all described as "burning and tingling skin"; PAIN (disability) with onset 20Nov2021, outcome "recovering", described as "full body throbing"; DECREASED APPETITE (disability) with onset 20Nov2021, outcome "recovering", described as "loss of appetite"; MUSCULAR WEAKNESS (disability) with onset 20Nov2021, outcome "recovering", described as "muscle weakness"; NAUSEA (disability) with onset 20Nov2021, outcome "recovering"; NEURALGIA (disability) with onset 20Nov2021, outcome "recovering", described as "neuropathic pain"; NIGHT SWEATS (disability) with onset 20Nov2021, outcome "recovering"; FEELING OF BODY TEMPERATURE CHANGE (disability) with onset 20Nov2021, outcome "recovering", described as "rapid hot and cold spells"; TACHYCARDIA (disability) with onset 20Nov2021, outcome "recovering"; HYPERAESTHESIA TEETH (disability) with onset 20Nov2021, outcome "recovering", described as "teeth sensitivity"; TINNITUS (disability) with onset 20Nov2021, outcome "recovering", described as "tinnitis"; TREMOR (disability) with onset 20Nov2021, outcome "recovering"; VOMITING (disability) with onset 20Nov2021, outcome "recovering". Therapeutic measures were taken as a result of tremor, muscular weakness, neuralgia, night sweats, skin burning sensation, paraesthesia, tachycardia, hyperaesthesia teeth, tinnitus, pain, nausea, vomiting, decreased appetite, feeling of body temperature change. Clinical course: Patient also received BNT162b2 (BNT162B2), on 28Sep2023 as dose 5 (booster), single (Batch/Lot number: Unknown) for covid-19 immunisation. No other vaccine same date. No other medications in two weeks. Adverse events treatment as steroid, beta blocker. Patient had no known allergies.