chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 61.0
Sex: F
Vaccine: COVID19, FLUC3, COVID19, FLUC3
Symptoms: Chills, Headache, Pain
Clinical narrative: chills; headache; body aches; This is a spontaneous report received from a contactable reporter(s) (Pharmacist). The reporter is the patient.  A 61-year-old female patient (not pregnant) received bnt162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 21Oct2023 at 10:30 as dose 1, single (Lot number: HG4664) at the age of 61 years, in right arm for covid-19 immunisation; for covid-19 immunisation; influenza vaccine inact sag 3v (FLUCELVAX), on 21Oct2023 as dose 1 (Lot number: 375291), in left arm. The patient's relevant medical history included: "MCTD" (unspecified if ongoing); "hypercholesterolemia" (unspecified if ongoing). Concomitant medication(s) included: ATORVASTATIN; PREDNISONE; PANTOPRAZOLE; CETIRIZIN. Past drug history included: Bactrim, reaction(s): "Drug allergy: Bactrim". Vaccination history included: Covid-19 vaccine (DOSE 1, manufacturer unknown), for COVID-19 IMMUNIZATION; Covid-19 vaccine (DOSE  2, manufacturer unknown), for COVID-19 IMMUNIZATION; Covid-19 vaccine (DOSE 3 (BOOSTER), manufacturer unknown), for COVID-19 IMMUNIZATION; Covid-19 vaccine (DOSE 4 (BOOSTER), manufacturer unknown), for COVID-19 IMMUNIZATION; Covid-19 vaccine (DOSE 5 (BOOSTER), manufacturer unknown), for COVID-19 IMMUNIZATION. The following information was reported: PAIN (non-serious) with onset 22Oct2023 at 06:30, outcome "recovering", described as "body aches"; CHILLS (non-serious) with onset 22Oct2023 at 06:30, outcome "recovering"; HEADACHE (non-serious) with onset 22Oct2023 at 06:30, outcome "recovering". Therapeutic measures were not taken as a result of chills, headache, pain. No follow-up attempts are possible. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: their arm was sore for a couple of days and no other symptoms; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP).  A male patient received bnt162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: PAIN IN EXTREMITY (non-serious), outcome "recovered", described as "their arm was sore for a couple of days and no other symptoms". It was unknown if therapeutic measures were taken as a result of pain in extremity.  Additional information: A person not known to the reporter mentioned they had gotten their latest Pfizer COVID-19 vaccine in casual conversation. They reported their arm was sore for a couple of days and had no other symptoms. The exact date of the vaccination and number of prior vaccines doses this person received was unknown. No other information was reported or collected.  The information on the batch/lot number for bnt162b2 omi xbb.1.5 has been requested and will be submitted if and when received.
Sex: U
Vaccine: COVID19
Symptoms: Arthropathy
Clinical narrative: I got the vaccine I just start having issues with my knees; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  An adult patient received bnt162b2 (BNT162B2), in 2020 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: ARTHROPATHY (non-serious), outcome "unknown", described as "I got the vaccine I just start having issues with my knees".   Additional information: Patient reported that during the COVID time, got the first vaccine and then the other two later. Patient was trying like, patient does not remember that the patient has vaccine card and since patient has got the first vaccine it was 2020 probably or does not remember exactly but some months after patient got the vaccine, patient just started having issues with knees but now after three years they found that the patient has arthritis and did not have a problem with the patient's knees, any problem in the patient's body. So, the patient was concerned how can the patient complain or ask questions that patient has right now because it's weird. The patient was 43 years old and now the doctor says that it was really not coming case that patient got this arthritis having right now and the patient was in pain everyday so the patient found now that it's not just the patient, many patients and the internet that they say probably the vaccine that they got for the COVID.   The information on the batch/lot number for bnt162b2 has been requested and will be submitted if and when received.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300340085 same patient and drug, different dose and events;
Sex: F
Vaccine: COVID19
Symptoms: Illness
Clinical narrative: extremely ill/horribly ill; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP), Program ID:. The reporter is the patient.  An elderly female patient received bnt162b2 (BNT162B2), as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Having covid three times" (unspecified if ongoing). The patient's concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose 1), for COVID-19 immunisation, reaction(s): "extremely ill/horribly ill". The following information was reported: ILLNESS (non-serious), outcome "unknown", described as "extremely ill/horribly ill". Additional information: Having covid three times was a better reaction than she had to having the covid vaccine times two and one booster. The patient stated the covid vaccine made her extremely ill and she was having long-term covid effects. The covid vaccine times two and the booster times one made her horribly ill.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-PV202300175426 same patient, drug and event with different dose;US-PFIZER INC-202300340351 same patient, drug and event with different dose;
Age: 75.0
Sex: F
Vaccine: COVID19
Symptoms: Limb discomfort, Muscle discomfort, Pain in extremity, Polymyalgia rheumatica
Clinical narrative: polymyalgia rheumatica; had muscle problems; arm irritation; arm tenderness; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A 75-year-old female patient received bnt162b2 (BNT162B2), on 02Mar2021 as dose 1, single (Lot number: EN6205) at the age of 75 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "lupus" (ongoing), notes: was in 30s when started; "Hashimoto's" (ongoing); "Fibromyalgia" (ongoing); "Sjogren's" (ongoing); "Shrunk form back surgery" (unspecified if ongoing); "Shrunk form back surgery" (unspecified if ongoing). The patient's family history included: "Rheumatoid arthritis" (ongoing), notes: was in her late 30s. Caller's aunt had rheumatoid arthritis. There were no concomitant medications. The following information was reported: LIMB DISCOMFORT (non-serious) with onset Mar2021, outcome "unknown", described as "arm irritation"; PAIN IN EXTREMITY (non-serious) with onset Mar2021, outcome "not recovered", described as "arm tenderness"; MUSCLE DISCOMFORT (non-serious) with onset Mar2021, outcome "unknown", described as "had muscle problems"; POLYMYALGIA RHEUMATICA (medically significant) with onset Mar2021, outcome "not recovered". Clinical course included patient had the usual arm irritation, was very mild, with 1st dose on 02Mar2021. The vaccine triggered another autoimmune disease in body, PMR, polymyalgia rheumatica, as of Mar2021. Patient had muscle problems. Patient had tenderness, got progressively worse.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300337361 same patient/vaccine, different doses/event.;
Age: 76.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: Covid; Covid; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 77-year-old male patient received bnt162b2, bnt162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 31May2023 as dose 6 (booster), single (Batch/Lot number: unknown) at the age of 76 years, in right arm for covid-19 immunisation; covid-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown), as dose 3 (booster), single (Batch/Lot number: unknown), as dose 4 (booster), single (Batch/Lot number: unknown) and as dose 5 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Osteoporosis" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: COVID-19 (medically significant), DRUG INEFFECTIVE (medically significant), outcome "unknown" and all described as "Covid". Therapeutic measures were taken as a result of covid-19, drug ineffective included paxlovid therapy.  Clinical course: The known allergies were reported as no.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: M
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: Covid; Covid; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 49-year-old male patient received bnt162b2 (BNT162B2), on 21Dec2021 as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation; covid-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown) and as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient had no relevant medical history. The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "Covid". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical course: Known allergies were reported as No. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 67.0
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 contactable reporter(s) (Physician) from product quality group. The reporter is the patient.  A 67-year-old female patient (not pregnant) received bnt162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 19Sep2023 at 16:00 as dose 1, single (Lot number: HH7595) at the age of 67 years, in right arm for covid-19 immunisation. The patient's relevant medical history included: "Asthma" (unspecified if ongoing); "hypothyroidism" (unspecified if ongoing); "GERD" (unspecified if ongoing); "CKD" (unspecified if ongoing), notes: CKD (post renal donation). Concomitant medication(s) included: LEVOTHYROXINE, start date: 01Jan2000; MONTELUKAST, start date: 01Jan2000; OMEPRAZOLE, start date: 01Jan2000; ADVAIR, start date: 01Jan2000. Vaccination history included: Covid-19 vaccine (Dose: 5, Manufacturer: Unknown, Lot Number: Unknown), for COVID-19 Immunisation; Covid-19 vaccine (Dose: 4, Manufacturer: Unknown, Lot Number: Unknown), for COVID-19 Immunisation; Covid-19 vaccine (Dose: 3, Manufacturer: Unknown, Lot Number: Unknown), for COVID-19 Immunisation; Covid-19 vaccine (Dose: 2, Manufacturer: Unknown, Lot Number: Unknown), for COVID-19 Immunisation; Covid-19 vaccine (Dose: 1, Manufacturer: Unknown, Lot Number: Unknown), for COVID-19 Immunisation. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (23Oct2023) positive; (21Oct2023) negative. Therapeutic measures were taken as a result of vaccination failure, covid-19. Patient received Paxlovid from 13Oct2023 to 18Oct2023.; Sender's Comments: Based on the information currently available, a lack of efficacy with bnt162b2 vaccine in this patient cannot be completely excluded.
Age: 70.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 70-year-old male patient received bnt162b2, bnt162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 09Sep2022 at 10:00 as dose 5 (booster), single (Lot number: GH9694), in right arm and on 13Aug2023 at 12:15 as dose 6 (booster), single (Lot number: A57643E) at the age of 70 years, in left arm for covid-19 immunisation; bnt162b2 (BNT162B2), on 10Feb2021 at 15:00 as dose 1, single (Lot number: 01M20A), in left arm, on 10Mar2021 at 15:00 as dose 2, single (Lot number: 048A21A), in left arm, on 21Oct2021 at 13:00 as dose 3 (booster), single (Lot number: 011F21A), in left arm and on 05Jul2022 as dose 4 (booster), single (Lot number: 017B22A), in right arm for covid-19 immunisation. The patient's relevant medical history included: "Coronary artery disease" (unspecified if ongoing); "type 2 diabetes" (unspecified if ongoing); "nephrotic syndrome" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "Treatment of COVID-19". Therapeutic measures were taken as a result of drug ineffective, covid-19.
Age: 79.0
Sex: F
Vaccine: COVID19
Symptoms: Atrial fibrillation, Cardiac disorder, Heart rate, Heart rate irregular
Clinical narrative: AFib; I seem to have heart problem; Heartbeats irregular; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  An 80-year-old female patient received bnt162b2, bnt162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 15Oct2022 as dose number unknown (booster),single (Lot number: GJ3277) at the age of 79 years for covid-19 immunisation. The patient's relevant medical history was not reported. There were no concomitant medications. Vaccination history included: bnt162b2 (LOT# (EL9262)), administration date: 28Jan2021, when the patient was 78-year-old, for Covid-19 Immunization; bnt162b2 (EN6201), administration date: 24Feb2021, when the patient was 78-year-old, for Covid-19 Immunization; bnt162b2 (30135BA), administration date: 16Oct2021, when the patient was 78-year-old, for Covid-19 Immunization; bnt162b2 (FK9729), administration date: 09Apr2022, when the patient was 79-year-old, for Covid-19 Immunization. The following information was reported: ATRIAL FIBRILLATION (medically significant) with onset Mar2023, outcome "unknown", described as "AFib"; HEART RATE IRREGULAR (non-serious) with onset Mar2023, outcome "unknown", described as "Heartbeats irregular"; CARDIAC DISORDER (non-serious) with onset Mar2023, outcome "unknown", described as "I seem to have heart problem". The patient underwent the following laboratory tests and procedures: Heart rate: (Mar2023) irregular. Therapeutic measures were taken as a result of atrial fibrillation, cardiac disorder, and heart rate irregular which includes Diltiazem CD capsule orally once a day, and Eliquis 5mg tablet twice a day by mouth since 17Mar2023. Clinical course: Consumer stated, "So, I have taken, I have the Pfizer COVID vaccination since Jan2021. I have had my last booster 15Oct22 and it is very strange because in Mar2023. I seem to have heart problem I have irregular heartbeats, I have AFib and I was going to get another vaccine booster but I am not quite sure I should be doing that because I am wondering if after all the vaccines that accumulated and now it might have affected my heart. Is that possible? Have you heard of other cases? I just do not know what to do?" Furthermore, the patient stated that she had Afib a heart problem since March of this year and she was on medication for it. Patient stated that she has not been on medication after all. She has taken no medication before that. The patient has not taken any other vaccine 4 weeks prior to Covid vaccine.
Age: 92.0
Sex: F
Vaccine: COVID19, FLUX
Symptoms: Body height, Body height decreased, Pain in extremity
Clinical narrative: have shrunk a little bit; has a usual bit of a sore arm; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team, Program ID. The reporter is the patient.  A 92-year-old female patient received bnt162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 23Oct2023 as dose 1, single (Lot number: HG4675) at the age of 92 years, in left arm for covid-19 immunisation; for covid-19 immunisation; influenza vaccine (INFLUENZA VACCINE), on 23Oct2023 as dose number unknown, single (Batch/Lot number: unknown), in right arm. The patient's relevant medical history included: "Arthritis" (unspecified if ongoing); "Glaucoma" (unspecified if ongoing); "cholesterol just a little high" (unspecified if ongoing); "Thyroid" (unspecified if ongoing). Concomitant medication(s) included: ASPIRIN [ACETYLSALICYLIC ACID]; LEVOTHYROXINE [LEVOTHYROXINE SODIUM] taken for thyroid disorder; LIPITOR taken for blood cholesterol increased; LATANOPROST ophthalmic taken for glaucoma; TYLENOL. Vaccination history included: Bnt162b2 (Dose 1, single), administration date: Feb2021, when the patient was 90 years old, for COVID-19 immunization; Bnt162b2 (Dose 2, single), administration date: Mar2021, when the patient was 90 years old, for COVID-19 immunization; Bnt162b2 (Dose 3, single, Lot No FF2597), administration date: Nov2021, when the patient was 90 years old, for COVID-19 immunization, reaction(s): "blacked out for a number of seconds", "I have never fainted in my life like this". The following information was reported: PAIN IN EXTREMITY (non-serious) with onset 23Oct2023, outcome "unknown", described as "has a usual bit of a sore arm"; BODY HEIGHT DECREASED (non-serious), outcome "unknown", described as "have shrunk a little bit". Relevant laboratory tests and procedures are available in the appropriate section.  Additional information: Caller said that she took the COVID-19 vaccine booster shot yesterday and she forgot to sit down and rest for 15 minutes. Caller is wondering if that will cause a problem.   The information on the batch/lot number for bnt162b2 omi xbb.1.5  has been requested and will be submitted if and when received.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300347550 same patient, different dose number/event;
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Chronic fatigue syndrome, Fatigue, Interchange of vaccine products
Clinical narrative: patient had ME/CFS and had sever fatigue reactions to Pfizer and Moderna COVID-19 Vaccines; ME/CFS; ME/CFS; sever fatigue reactions; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). Other Case identifier(s): 2023NVX-US-000001262.  A female patient received bnt162b2 (BNT162B2 NOS), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation; elasomeran (MODERNA COVID-19 VACCINE), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: INTERCHANGE OF VACCINE PRODUCTS (non-serious), outcome "unknown", described as "patient had ME/CFS and had sever fatigue reactions to Pfizer and Moderna COVID-19 Vaccines"; POST VIRAL FATIGUE SYNDROME (non-serious), CHRONIC FATIGUE SYNDROME (non-serious), outcome "unknown" and all described as "ME/CFS"; FATIGUE (non-serious), outcome "unknown", described as "sever fatigue reactions".  Clinical course: On 06Oct2023, it was reported that a patient started treatment on an unspecified date with Pfizer BioNTech Covid-19 Vaccine, dosing and frequency not reported, for Covid-19 vaccination. It was reported the patient had ME/CFS and had sever fatigue reactions to Pfizer and Moderna COVID-19 Vaccines, lasting several months. No further follow-up is anticipated.  The information on the batch/lot number for bnt162b2 has been requested and will be submitted if and when received.
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Drug ineffective, Interchange of vaccine products, Suspected COVID-19
Clinical narrative: Had 3 Moderna vaccines, 3 Pfizer vaccines.; Had COVID, had the vaccines, this was the 6th dose.; Had COVID, had the vaccines, this was the 6th dose.; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 68-year-old male patient received bnt162b2 (BNT162B2 NOS), as dose number unknown, single (Batch/Lot number: unknown) and as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation; elasomeran (MODERNA COVID-19 VACCINE), as dose number unknown, single (Batch/Lot number: unknown), as dose number unknown, single (Batch/Lot number: unknown) and as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history was not reported. The patient took concomitant medications. The following information was reported: INTERCHANGE OF VACCINE PRODUCTS (medically significant), outcome "unknown", described as "Had 3 Moderna vaccines, 3 Pfizer vaccines."; DRUG INEFFECTIVE (medically significant), SUSPECTED COVID-19 (medically significant), outcome "unknown" and all described as "Had COVID, had the vaccines, this was the 6th dose.". Clinical course: Has medications he was on since before COVID, never had reaction. Had 3 Moderna vaccines, 3 Pfizer vaccines. Does not have any information for previous 5 doses, just that he had them.   The information on the batch/lot number for bnt162b2 has been requested and will be submitted if and when received.
Sex: U
Vaccine: COVID19
Symptoms: Neuralgia, Vaccination site nerve damage
Clinical narrative: the practitioner who administered the vaccine damaged the nerve in the shoulder; sharp nerve pains in my left arm/ severe pains every night and cannot sleep on the side where I took the shot; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP), Program ID:. The reporter is the patient.  A patient (no qualifiers provided) received bnt162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), in Oct2023 as dose 1, single (Batch/Lot number: unknown), in left arm for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Primary Immunization series complete;  unknown manufacturer), for covid-19 immunization. The following information was reported: VACCINATION SITE NERVE DAMAGE (non-serious), outcome "unknown", described as "the practitioner who administered the vaccine damaged the nerve in the shoulder"; NEURALGIA (non-serious), outcome "unknown", described as "sharp nerve pains in my left arm/ severe pains every night and cannot sleep on the side where I took the shot".  Additional information: The patient had been suffering from sharp nerve pains in the patient's left arm where the patient just received the new booster COVID about three weeks ago. The patient strongly believed the practitioner who administered the vaccine damaged the nerve in the shoulder. The patient suffered severe pains every night and cannot sleep on the side where the patient took the  shot.  The information on the batch/lot number for bnt162b2 omi xbb.1.5 has been requested and will be submitted if and when received.
Sex: M
Vaccine: COVID19
Symptoms: Illness
Clinical narrative: being sick; This is a spontaneous report received from a non-contactable reporter (consumer), Program ID:. The reporter is the patient. An adult male patient received bnt162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: ILLNESS (non-serious), outcome "unknown", described as "being sick". Additional information: The reporter considered the event was caused by the suspect drug.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 49.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: After recovery I experienced long Covid symptoms/ Paxlovid treatment start date: 07Oct2023; After recovery I experienced long Covid symptoms/ Paxlovid treatment start date: 07Oct2023; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 50-year-old male patient received bnt162b2 (BNT162B2), on 16Mar2021 at 11:00 as dose 1, single (Lot number: EN6208), in right arm, on 06Apr2021 at 12:15 as dose 2, single (Lot number: ER8734), in left arm and on 24Feb2022 at 15:15 as dose 3 (booster), single (Lot number: FM0698) at the age of 49 years, in right arm for covid-19 immunisation. The patient's relevant medical history included: "Pcn Penicillins" (unspecified if ongoing). The patient's concomitant medications were not reported. Past drug history included: Pneumococcal 20-val conj vaccine, reaction(s): "allergies"; Vancomycin, reaction(s): "allergies"; Cortisone base, reaction(s): "allergies". The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "After recovery I experienced long Covid symptoms/ Paxlovid treatment start date: 07Oct2023". Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical course: Patient did not received other medication in 2 weeks. Patient received COVID 19 treatment with Paxlovid Treatment start date was 07Oct2023 and Treatment stop date was 12Oct2023. It was reported that patient caught Covid 08Jan2022 after starting the vaccination process. After recovery patient experienced long Covid symptoms. Continuous joint pain, pain at injection sights, intense pain in the heart area. Patient was sent to the emergency room and was given treatment and released. Patient was also cleared from and complications. Chest X-ray and bloodwork and oxygen. The symptoms lasted about a year. Patient was rechecked regularly by his primary physician. After taking Paxlovid this past week patient started to have intense stomach pain and joint pain along with his long Covid symptoms coming back including chest pains, headaches that will not go away and loss of energy.
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: got COVID; got COVID; This is a spontaneous report received from a contactable reporter (Consumer or other non HCP, patient's father). The reporter is the parent. Other Case identifier: 2023NVX-US-000001269.  A female patient received bnt162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "got COVID". Clinical course: a patient started treatment on an unspecified date with Pfizer BioNTech Covid-19 Vaccine (dose/frequency not reported). It was reported the patient had "some trouble" (refused to elaborate) after getting the vaccine, and she got COVID. The information on the batch/lot number for bnt162b2 omi xbb.1.5 has been requested and will be submitted if and when received.
Sex: U
Vaccine: FLUX
Symptoms: Illness
Clinical narrative: eveytime I did, I got sick for 2 months straight; Initial information received on 18-Oct-2023 regarding an unsolicited valid social media non-serious case received from a patient.  This case involves an unknown age and gender patient who had got sick for 2 months straight after receiving Influenza Vaccine.  The patient's past medical treatment(s), vaccination(s) and family history were not provided. It is unknown if the patient had any medical history, concomitant disease or risk factor.  On an unknown date, the patient received unknown dose of suspect influenza vaccine produced by unknown manufacturer (strength, formulation, batch number, expiry date unknown) via unknown route in unknown administration site for Prophylactic vaccination (immunization).  On an unknown date the patient got sick for 2 months straight (illness) (unknown latency) following the administration of influenza vaccine.  Reportedly, patient don't do flu shots for 20 years. Because every time patient did, patient got sick for 2 months straight. When patient haven't it last 3 weeks.  It is unknown if the patient experienced any additional symptoms/events.  It is unknown if there were lab data/results available.  Action taken: not applicable.  It was not reported if the patient received a corrective treatment for the event (illness).  At time of reporting, the outcome was Unknown for the event illness.
Sex: U
Vaccine: FLUX
Symptoms: Diabetic ketoacidotic hyperglycaemic coma
Clinical narrative: The flu shot put me in 9 dka comas .. I hate the flu; Initial information received on 18-Oct-2023 regarding an unsolicited valid social media serious case received from patient.  This case involves an unknown age and gender patient who experienced 9 dka (diabetic ketoacidotic hyperglycaemic) comas, after receiving Influenza Vaccine.  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 Influenza Vaccine produced by unknown manufacturer (form, strength: unknown) (lot number, expiry date: not reported) via unknown route in unknown administration site for prophylactic vaccination (immunization). Information on the batch number was requested.  On an unknown date the patient developed 9(dka) diabetic ketoacidotic hyperglycaemic coma (diabetic ketoacidotic hyperglycaemic coma) (latency: unknown) following the administration of Influenza Vaccine.   Reportedly, flu shot put patient in 9 dka comas.  It is unknown if there were lab data/results available.   Action taken: not applicable.  It was not reported if the patient received a corrective treatment for the event.  At time of reporting, the outcome was Unknown for the event.  Seriousness criteria: This event was assessed as medically significant.; Sender's Comments: Sanofi company comment dated 23-Oct-2023: This case involves an unknown age and gender patient who experienced 9 dka (diabetic ketoacidotic hyperglycaemic) comas, after receiving Influenza Vaccine. Furthermore, information regarding condition at the time of vaccination, medical history, lab data excluding other predisposing etiologies, intervention (if any), corrective treatment/medical management, family history would be needed for complete assessment of the case. Based upon the reported information, the role of an individual vaccine cannot be assessed.
Sex: U
Vaccine: FLUX
Symptoms: Illness
Clinical narrative: The one time I got the flu shot, I was deathly Ill; Initial information received on 18-Oct-2023 regarding an unsolicited valid social media non-serious case received from a patient.  This case involves an unknown age and gender patient who was deathly ill after receiving Influenza Vaccine.  The patient's past medical treatment(s), vaccination(s) and family history were not provided. It is unknown if the patient had any medical history, concomitant disease or risk factor.  On an unknown date, the patient received unknown dose of suspect influenza vaccine produced by unknown manufacturer (strength, formulation, batch number, expiry date unknown) via unknown route in unknown administration site for Prophylactic vaccination (immunization).  On an unknown date the patient was deathly ill (illness) (unknown latency) following the administration of Influenza Vaccine.  Reportedly, The one* time I got the flu shot, I was deathly I'll, like; c0V!* ill*..   It is unknown if the patient experienced any additional symptoms/events.  It is unknown if there were lab data/results available.  Action taken: not applicable.  It was not reported if the patient received a corrective treatment for the event.  At time of reporting, the outcome was Unknown for the event.
Sex: U
Vaccine: FLUX
Symptoms: Limb discomfort, Vaccination site pain
Clinical narrative: did flu shot a week ago, it felt like someone punched me in the arm afterward for several days; Initial information received on 18-Oct-2023 regarding an unsolicited valid Social Media non-serious case received from a consumer/non-hcp.  This case involves a patient of an unknown age and gender who received Influenza Vaccine shot a week ago, it felt like someone punched me in the arm afterward for several days.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. It was unknown if the patient had any concomitant disease or risk factor.   On an unknown date, the patient received a unknown dose of suspect Influenza Vaccine produced by unknown manufacturer (strength, formulation, expiry date and lot number not reported) via unknown route in unknown administration site as Prophylactic vaccination (immunization). Information on the batch number was requested.  On an unknown date the patient did flu shot a week ago, it felt like someone punched me in the arm afterward for several days (vaccination site pain) (unknown latency). It is unknown if the patient experienced any additional symptoms/events.  Action taken: not applicable.  It was not reported if the patient received a corrective treatment for the event.  At time of reporting, the outcome was Unknown for the event.
Age: 40.0
Sex: U
Vaccine: FLUX
Symptoms: Influenza
Clinical narrative: flu, nearly died from that; Initial information received on 18-Oct-2023 regarding an unsolicited valid social media non-serious case received from a consumer/non-hcp.  This case involves a 40 years old and unknown gender patient who had flu, nearly died from that after receiving influenza vaccine.   It is unknown if the patient had any medical history, concomitant disease or risk factor. The patient's past medical treatment(s), vaccination(s) and family history were not provided.   On an unknown date, the patient received suspect influenza vaccine produced by unknown manufacturer via unknown route in unknown administration site for prophylactic vaccination (strength, formulation, dose, batch number and expiry date: unknown). Information on the batch number was requested  On an unknown date the patient had flu, nearly died from that (influenza) (unknown latency).  It is unknown if there were lab data/results available  It is unknown if the patient experienced any additional symptoms/events  Action taken: not applicable.  It was not reported if the patient received a corrective treatment for the event (influenza).  At time of reporting, the outcome was Unknown for the event influenza.
Sex: U
Vaccine: FLUX
Symptoms: Feeling abnormal
Clinical narrative: got one and did feel like shit after; Initial information received on 18-Oct-2023 regarding an unsolicited valid Social Media non-serious case received from a consumer/non-healthcare professional.  This case involves an unknown age and unknown gender patient who experienced got one and did feel like shit after after receiving Influenza vaccine.  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 influenza vaccine produced by unknown manufacturer lot number not reported via unknown route in unknown administration site (dose, formulation, strength and expiration date: not provided) for Immunisation. Information on the batch number was requested.  On an unknown date the patient got one and did feel like shit after (feeling abnormal) (unknown latency) following the administration of influenza vaccine.  Action taken- not applicable.  It was not reported if the patient received a corrective treatment for the event.  At time of reporting, the outcome was Unknown for the event.
Sex: F
Vaccine: FLUX
Symptoms: Influenza
Clinical narrative: every time she gets it she gets the flu; Initial information received on 18-Oct-2023 regarding an unsolicited valid Social Media non-serious case received via consumer/non-healthcare professional.  This case involves an unknown age female patient and reporter stated every time she gets it she gets the flu after receiving influenza vaccine.  The patient's past medical history, medical treatment(s), vaccination(s), concomitant(s) and family history were not provided.  On an unknown date, the patient received an unknown dose of suspect influenza vaccine produced by unknown manufacturer (form, strength, lot number, expiry date: unknown) via unknown route in unknown administration site for prophylactic vaccination (immunization). Information on batch number was requested  On an unknown date the patient had an event of every time she gets it she gets the flu (influenza) (unknown latency) following the administration of influenza vaccine.  It was unknown if any lab data/test results available.  Action taken with influenza vaccine was not applicable.  It was not reported if the patient received a corrective treatment for the event.  Outcome: Unknown for the event.
Sex: U
Vaccine: FLUX
Symptoms: Influenza, Therapeutic response decreased
Clinical narrative: got the flu; it's a flu shot, It's only usually about 40%-60% effective anyway; Initial information received on 18-Oct-2023 regarding an unsolicited valid Social Media non-serious case received from a other health professional.  This case involves Adult and unknown gender patient who got the flu and it's a flu shot, it's only usually about 40%-60% effective anyway after receiving vaccine INFLUENZA VACCINE.  The patient's past medical treatment(s), vaccination(s) and family history were not provided. It was unknown if the patient had any medical history, concomitant disease or risk factor.  On an unknown date, the patient received unknown dose of suspect INFLUENZA VACCINE produced by unknown manufacturer (lot number, strength, expiry date not reported) via unknown route in unknown administration site for prophylactic vaccination (Immunization). Information on batch number was requested.  On an unknown date the patient got the flu (influenza) and it's a flu shot, it's only usually about 40%-60% effective anyway (therapeutic response decreased) (unknown latency).  It was reported that ".Last time I got a flu shot 14 years ago; I got the flu. Haven't had it since."  It was unknown if the patient experienced any additional symptoms/events.   It was unknown if there were lab data/results available.   Action taken: Not applicable.  It was not reported if the patient received a corrective treatment for the event (influenza).  At time of reporting, the outcome was Unknown for both the events.
Sex: U
Vaccine: FLUX
Symptoms: Tenderness
Clinical narrative: Site's a little sore; Initial information received on 18-Oct-2023 regarding an unsolicited valid Social Media non-serious case received from a Patient.  This case involves an unknown age and unknown gender patient who experienced site's a little sore after receiving vaccine Influenza Vaccine.  The patient's past medical history, medical treatment(s), vaccination(s), risk factor and family history were not provided.   On an unknown date, the patient received a  dose of suspect Influenza Vaccine produced by unknown manufacturer (lot number, strength, dose, expiry date not reported) via unknown route in unknown administration site as prophylactic vaccination.  On an unknown date the patient developed site's a little sore (tenderness) (unknown latency) following the administration of Influenza Vaccine.  It was reported "Got mine yesterday! Got the COVID BIOS update, too. Site's a little sore but I'm rubbing dirt on it and telling myself to grow a pair. And Motrin."  No lab data reported.  Action taken: not applicable.  It was not reported if the patient received a corrective treatment for the event.  At time of reporting, the outcome was Unknown for the event.
Sex: U
Vaccine: FLUX
Symptoms: Feeling abnormal
Clinical narrative: felt really bad; Initial information received on 18-Oct-2023 regarding an unsolicited valid Social Media non-serious case received from a Patient.  This case involves an unknown age and unknown gender patient who experienced felt really bad 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, the patient received a dose of suspect Influenza Vaccine produced by unknown manufacturer (lot number, strength, expiry date, dose not reported) via unknown route in unknown administration site as prophylactic vaccination.  On an unknown date the patient developed felt really bad (feeling abnormal) (unknown latency) following the administration of Influenza Vaccine.  It was reported "I felt really bad afterwards ,that's why I wont let them do it anymore."  Action taken: not applicable.  It was not reported if the patient received a corrective treatment for the event.  At time of reporting, the outcome was Unknown for the event.
Sex: U
Vaccine: FLUX
Symptoms: Influenza
Clinical narrative: flu; Initial information received on 18-Oct-2023 regarding an unsolicited valid Social Media non-serious case received from a Patient.  This case involves an unknown age and unknown gender patient who experienced flu after receiving Influenza vaccine.  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 influenza vaccine produced by unknown manufacturer lot number not reported via unknown route in unknown administration site (dose, formulation, strength and expiration date: not provided) for Immunisation. Information on the batch number was requested.  On an unknown date the patient developed flu (influenza) (unknown latency) following the administration of influenza vaccine.  The last time I took a flu shot I got the damn flu and never had it b4 the shot.   Action taken- not applicable.  It was not reported if the patient received a corrective treatment for the event (flu).  At time of reporting, the outcome was Unknown for the event.
Sex: U
Vaccine: FLUX
Symptoms: Influenza
Clinical narrative: flu; Initial information received on 19-Oct-2023 regarding an unsolicited valid Social Media non-serious case received from a consumer/non-hcp.  This case involves a patient of an unknown age and gender who experienced flu after receiving Influenza Vaccine.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. It is unknown if the patient had any concomitant disease or risk factor.  On an unknown date in 2009, the patient received a unknown dose of suspect Influenza Vaccine produced by unknown manufacturer (strength, formulation, expiry date and lot number not reported) via unknown route in unknown administration site as Prophylactic vaccination (immunization). Information on the batch number was requested.  On an unknown date the patient developed flu (influenza) (unknown latency).  It is unknown if the patient experienced any additional symptoms/events.   It is unknown if there were lab data/results available.  Action taken: not applicable.  It was not reported if the patient received a corrective treatment for the event.  At time of reporting, the outcome was Unknown for the event.
Age: 52.0
Sex: F
Vaccine: FLUX
Symptoms: Pyrexia
Clinical narrative: low grade fever; Initial information received on 18-Oct-2023 regarding an unsolicited valid non-serious case received from a consumer/non-hcp (patent).  This case involves a 52 years old female patient who experienced low grade fever after receiving Influenza vaccine.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. is unknown if the patient had any  concomitant disease or risk factor.   On an unknown date, the patient received a unknown dose of suspect Influenza vaccine produced by unknown manufacturer (strength, formulation, expiry date and lot number not reported) via unknown route in unknown administration site as Prophylactic vaccination (immunization). Information on the batch number was requested.  On an unknown date the patient developed low grade fever (pyrexia) (unknown latency). It was unknown if the patient experienced any additional symptoms/events  It was unknown if there were lab data/results available.   Action taken: not applicable.  It was not reported if the patient received a corrective treatment for the event.  At time of reporting, the outcome was Unknown for the event.
Sex: U
Vaccine: FLUX
Symptoms: Illness
Clinical narrative: got very sick; Initial information received on 18-Oct-2023 regarding an unsolicited valid Social Media non-serious case received from a consumer/non-hcp.  This case involves Adult and unknown gender patient who experienced got very sick after receiving INFLUENZA VACCINE.  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 Influenza Vaccine by unknown manufacturer (strength, formulation, dose, route, batch number and expiry date: unknown) in unknown administration site for prophylactic vaccination.  Information on the batch number was requested.  On an unknown date the patient developed a non-serious got very sick (illness) (unknown latency).  Action taken: not applicable.  It was not reported if the patient received a corrective treatment for the event (got very sick).  At time of reporting, the outcome was Unknown for the event got very sick.
Age: 61.0
Sex: F
Vaccine: FLU4
Symptoms: Diarrhoea, Weight decreased
Clinical narrative: diarrhea; she has lost 8 or 9 pounds; Initial information received on 16-Oct-2023 regarding an unsolicited valid  non-serious case received from a consumer/non-healthcare professional.  This case involves a 62 years old female patient who experienced diarrhea and she has lost 8 or 9 pounds, after receiving vaccine Influenza Quadrival A-B Vaccine [Fluzone Qiv].  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included Covid-19 Vaccine (Covid-19 Vaccine) for Prophylactic vaccination.  On 11-Oct-2023, the patient received a  dose of suspect Influenza Quadrival A-B Vaccine, suspension for injection (strength: unknown) (lot number, expiry date: not reported) via intramuscular route in the left deltoid for prophylactic vaccination (immunization).  On 11-OCT-2023 the patient developed diarrhea (diarrhoea) and she has lost 8 or 9 pounds since this started (weight decreased) (latency: same day) following the administration of Influenza Quadrival A-B Vaccine.  No lab data reported.  Action taken: not applicable.  The patient was treated with Loperamide Hydrochloride (Lomotil) and Loperamide Hydrochloride (Imodium) for Diarrhoea.  At time of reporting, the outcome was Not Recovered / Not Resolved for the event diarrhea.