chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 24.0
Sex: F
Vaccine: COVID19
Symptoms: Blindness, Deafness, Dizziness, Hyperhidrosis, Nausea
Clinical narrative: Patient has had a history of fainting or other side effects in past vaccinations, so she sat down in our waiting area after the vaccine was administered. 5 minutes after receiving the vaccine; the patient reported feeling dizzy, nauseous and began sweating. She also reported to lose some vision, hearing, and requested an emesis bag, which was provided. The course of these symptoms lasted about 10 minutes and  she was well enough to stand up and go home with her mother after.
Age: 84.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Patient reports redness and swelling at the injections site that last about a week
Age: 62.0
Sex: M
Vaccine: FLU3
Symptoms: Pruritus, Urticaria
Clinical narrative: Got flu vaccine mid-day on 9/21/24, and that evening the back of my neck itched and I thought I had a whole bunch of bug bites because I had been working in yard. A couple of days later I figured out it was hives. It has been two weeks and the hives have not gone away. I scratch at them on and off through the day and night. They are on the upper half of the back of my neck and into my hair too going about as high as the top of my ears. 2 or 3 days ago (around Oct 4th) they appeared on my arms as well are persisting there. From about mid forearm to the arm bend. They itch on and off.
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Pyrexia, Rash erythematous, Rash papular
Clinical narrative: After vaccine, patient had a 104 fever and a red, raised rash.  Looks like possible cellulitis .
Age: 76.0
Sex: F
Vaccine: FLU3
Symptoms: Rash pruritic
Clinical narrative: rash ,itching its now going away
Age: 66.0
Sex: M
Vaccine: COVID19, FLU3, COVID19, FLUA4
Symptoms: Computerised tomogram head abnormal, Ischaemic stroke, Magnetic resonance imaging head abnormal
Clinical narrative: Suffered Stroke on 10/01.  Ambulence was taken to ER.  Admitted to Hospital.
Age: 66.0
Sex: M
Vaccine: COVID19, FLU3, COVID19, FLUA4
Symptoms: Myocardial infarction
Clinical narrative: Suffered Stroke on 10/01.  Ambulence was taken to ER.  Admitted to Hospital.
Age: 9.0
Sex: M
Vaccine: COVID19
Symptoms: Abdominal pain upper, Pain in extremity, Pyrexia
Clinical narrative: grandmother stated that patient's arm was sore (in morning) at 4 pm, grandmother reported that the child also was having stomach pains and had a fever of 102.
Age: 47.0
Sex: F
Vaccine: COVID19
Symptoms: Back pain, Lethargy
Clinical narrative: Lethargy started about 2 hours after the vaccine. Lower back pain started about 24hrs after the vaccine.
Age: 17.0
Sex: F
Vaccine: FLU3
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: NONE, ACCIDENTLY GIVEN TO PT WHO WAS 17 INSTEAD OF THE REQUIRED 18 AND UP
Age: 24.0
Sex: F
Vaccine: COVID19, FLU3
Symptoms: Apathy, Depression, Suicidal ideation
Clinical narrative: Symptoms: severe depressive episode experienced by two parties who received both vaccines together on the same day. Lack of motivation, apathy, and suicidal ideation were some of the specific symptoms experienced. Signs: n/a. Timeline: developed slowly starting around 24 hours post injection, hitting a peak at 30 hours.
Age: 39.0
Sex: M
Vaccine: COVID19
Symptoms: Migraine
Clinical narrative: Chronic migraines, very bad . Lasted around 18 months
Age: 37.0
Sex: F
Vaccine: COVID19
Symptoms: Cardiac stress test abnormal, Dyspnoea, Electrocardiogram ambulatory abnormal, Heart rate irregular, Ventricular extrasystoles
Clinical narrative: Irregular heartbeat. Started within weeks. Went to ER on 3/30/22 with strange heart rythm. Kept feeling this so went to cardiology. Would feel shortness of breath. I wore a heart monitor and went through a series of tests to find that I have PVCs. My hear beat at irregular beats regularly now.
Age: 49.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site erythema, Injection site nodule, Injection site pain, Injection site pruritus, Injection site warmth
Clinical narrative: Donor describes itching, redness, nodule formation, soreness, warmth at injection site developing within 2 hours of immunization.
Age: 80.0
Sex: M
Vaccine: RSV, VARZOS
Symptoms: Blood pressure increased, Gait inability, Guillain-Barre syndrome, Hypoaesthesia
Clinical narrative: Guillain-Barre; blood pressure spiked; having numbness in his fingers/the numbness went to his legs; could no longer walk; This is a spontaneous report received from an Other HCP from Regulatory Authority. Regulatory number: 2683554-1 (VAERS ID).  An 80-year-old male patient received rsv vaccine prot.subunit pref 2v (ABRYSVO), on 29Aug2023 as dose 1, single (Lot number: 8070117) at the age of 80 years intramuscular, in left arm for immunisation; varicella zoster vaccine rge (cho) (SHINGRIX), on 29Aug2023 as dose 1, single (Lot number: 2GG34) intramuscular, in left arm for immunisation. The patient had no relevant medical history. Concomitant medication(s) included: TRAMADOL; NADOLOL; NIFEDIPINE; SPIRONOLACTONE. The following information was reported: GUILLAIN-BARRE SYNDROME (hospitalization) with onset 03Sep2023, outcome "unknown", described as "Guillain-Barre"; BLOOD PRESSURE INCREASED (hospitalization) with onset 03Sep2023, outcome "unknown", described as "blood pressure spiked"; GAIT INABILITY (hospitalization) with onset 03Sep2023, outcome "unknown", described as "could no longer walk"; HYPOAESTHESIA (hospitalization) with onset 03Sep2023, outcome "unknown", described as "having numbness in his fingers/the numbness went to his legs". The patient was hospitalized for guillain-barre syndrome, blood pressure increased, hypoaesthesia, gait inability (start date: Sep2023). The events "guillain-barre", "blood pressure spiked", "having numbness in his fingers/the numbness went to his legs" and "could no longer walk" required emergency room visit. Clinical course:  the patient was approximate 80 years old (the age at vaccination was 80 years old), had no known allergies. 5 days after administration, blood pressure spiked and started having numbness in his fingers, the numbness went to his legs and could no longer walk. Patient went to Emergency Room and decided that he had developed Guillain-Barre from one of the vaccines. The events did not require physician office visit. The report received as serious with serious criteria hospitalization from Regulatory Authority.    Follow-up (01Oct2024): This is a spontaneous follow-up report received from the Other HCP via FDA (2683554-1).   Updated information: the reporter information updated, the patient details included age added and Concomitant drug (tramadol dose added).
Age: 50.0
Sex: F
Vaccine: FLUR4, RSV
Symptoms: Guillain-Barre syndrome, Intensive care, Paraesthesia, Product administered to patient of inappropriate age
Clinical narrative: doctors believe to be Guillain-Barre syndrome/ tingling in her arms; patient age 50 years old; This is a spontaneous report received from a Consumer or other non HCP and an Other HCP from Regulatory Authority. Regulatory number: 2689122-1 (VAERS ID).  A 50-year-old female patient (not pregnant) received rsv vaccine prot.subunit pref 2v (ABRYSVO), on 13Sep2023 at 12:21 as dose 1, single (Lot number: HF5015) at the age of 50 years intramuscular, in left arm for immunisation; influenza vaccine rha 4v (baculovirus) (FLUBLOK QUADRIVALENT), on 13Sep2023 as dose 1, single (Lot number: U8058AA) intramuscular, in right arm for immunisation. The patient had no relevant medical history. The patient had no known allergy. There were no concomitant medications. The following information was reported: PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (non-serious) with onset 13Sep2023, outcome "unknown", described as "patient age 50 years old"; GUILLAIN-BARRE SYNDROME (hospitalization) with onset 21Sep2023, outcome "not recovered", described as "doctors believe to be Guillain-Barre syndrome/ tingling in her arms". Patient first experienced tingling in her arms. She continued to get worse and was now in ICU for what the doctors believe to be Guillain-Barre syndrome.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.  Follow-up (01Oct2024): This is a spontaneous follow-up report received from an Other HCP via FDA (MSB#: 2689122-1).  Updated information: New reporter, Relevant Medical History and co-suspect (influenza vaccine) added. Patient information and Vaccination Facility Type.
Age: 72.0
Sex: M
Vaccine: RSV, RSV, RSV
Symptoms: Arthralgia, Guillain-Barre syndrome, Malaise, Paraesthesia
Clinical narrative: guillain-barre syndrome/pins and needles in his arms and legs/Paraesthesia; general not feeling well/Malaise; shoulder pain/Arthralgia; This is a spontaneous report received from a Consumer or other non HCP from Regulatory Authority. Regulatory number: 2748681-1 (VAERS ID).  An elderly male patient received rsv vaccine prot.subunit pref 2v (ABRYSVO), on 18Jan2024 as dose 1, single (Lot number: HR4390) at the age of 72 years intramuscular, in right arm for immunisation. The patient's relevant medical history and concomitant medications were not reported. None known current Illness, none unknown medications at the time of vaccination or History/Allergies per last doctor visit. The following information was reported: MALAISE (hospitalization, disability, life threatening) with onset Jan2024, outcome "not recovered", described as "general not feeling well/Malaise"; GUILLAIN-BARRE SYNDROME (hospitalization, disability, medically significant, life threatening) with onset Jan2024, outcome "not recovered", described as "guillain-barre syndrome/pins and needles in his arms and legs/Paraesthesia"; ARTHRALGIA (hospitalization, disability, life threatening) with onset Jan2024, outcome "not recovered", described as "shoulder pain/Arthralgia". The patient was hospitalized for guillain-barre syndrome (start date: 22Feb2024); for arthralgia (start date: 29Jan2024, discharge date: 29Jan2024, hospitalization duration: 1 day(s)); for malaise (start date: 31Jan2024). The events "guillain-barre syndrome/pins and needles in his arms and legs/paraesthesia", "shoulder pain/arthralgia" and "general not feeling well/malaise" required physician office visit and emergency room visit. Therapeutic measures were taken as a result of guillain-barre syndrome, arthralgia, malaise. Clinical course: Patient presented to emergency department of local hospital on 29Jan2024 complaining of shoulder pain. He was discharged to home same day. He again went to emergency department on 30Jan2024 with complaints of general not feeling well. He was prescribed prednisone 20mg take 2 tablets by mouth daily for 5 days. He went again to emergency department on 31Jan2024 complaining of pins and needles in his arms and legs. He was admitted at this time. According to his wife, he is still in the hospital and has been diagnosed with Guillain-Barre syndrome. Reported 23 days in Hospital. Reporter was notified of this hospital admission as of 22Feb2024. Reporter had been in touch with Dr. Office who confirmed his diagnosis. Lab data was unsure.   No follow-up attempts are possible.  Follow-up (01Oct2024): This is a spontaneous follow-up report received from a same Consumer via FDA (MSB#: 2748681-1).  Updated information: patient age at vaccination and age group, vaccine facility and healthcare professional information.  No follow-up attempts are possible.
Age: 72.0
Sex: M
Vaccine: RSV, RSV, RSV
Symptoms: Guillain-Barre syndrome, Hypoaesthesia, Myalgia, Paraesthesia
Clinical narrative: guillain-barre syndrome/pins and needles in his arms and legs/Paraesthesia; general not feeling well/Malaise; shoulder pain/Arthralgia; This is a spontaneous report received from a Consumer or other non HCP from Regulatory Authority. Regulatory number: 2748681-1 (VAERS ID).  An elderly male patient received rsv vaccine prot.subunit pref 2v (ABRYSVO), on 18Jan2024 as dose 1, single (Lot number: HR4390) at the age of 72 years intramuscular, in right arm for immunisation. The patient's relevant medical history and concomitant medications were not reported. None known current Illness, none unknown medications at the time of vaccination or History/Allergies per last doctor visit. The following information was reported: MALAISE (hospitalization, disability, life threatening) with onset Jan2024, outcome "not recovered", described as "general not feeling well/Malaise"; GUILLAIN-BARRE SYNDROME (hospitalization, disability, medically significant, life threatening) with onset Jan2024, outcome "not recovered", described as "guillain-barre syndrome/pins and needles in his arms and legs/Paraesthesia"; ARTHRALGIA (hospitalization, disability, life threatening) with onset Jan2024, outcome "not recovered", described as "shoulder pain/Arthralgia". The patient was hospitalized for guillain-barre syndrome (start date: 22Feb2024); for arthralgia (start date: 29Jan2024, discharge date: 29Jan2024, hospitalization duration: 1 day(s)); for malaise (start date: 31Jan2024). The events "guillain-barre syndrome/pins and needles in his arms and legs/paraesthesia", "shoulder pain/arthralgia" and "general not feeling well/malaise" required physician office visit and emergency room visit. Therapeutic measures were taken as a result of guillain-barre syndrome, arthralgia, malaise. Clinical course: Patient presented to emergency department of local hospital on 29Jan2024 complaining of shoulder pain. He was discharged to home same day. He again went to emergency department on 30Jan2024 with complaints of general not feeling well. He was prescribed prednisone 20mg take 2 tablets by mouth daily for 5 days. He went again to emergency department on 31Jan2024 complaining of pins and needles in his arms and legs. He was admitted at this time. According to his wife, he is still in the hospital and has been diagnosed with Guillain-Barre syndrome. Reported 23 days in Hospital. Reporter was notified of this hospital admission as of 22Feb2024. Reporter had been in touch with Dr. Office who confirmed his diagnosis. Lab data was unsure.   No follow-up attempts are possible.  Follow-up (01Oct2024): This is a spontaneous follow-up report received from a same Consumer via FDA (MSB#: 2748681-1).  Updated information: patient age at vaccination and age group, vaccine facility and healthcare professional information.  No follow-up attempts are possible.
Age: 67.0
Sex: M
Vaccine: RSV, RSV
Symptoms: Guillain-Barre syndrome, Paralysis
Clinical narrative: paralysis/ later diagnosed with Gullain-Barre syndrome; This is a spontaneous report received from a Consumer or other non HCP and an Other HCP from Regulatory Authority. Regulatory number: 2749169-1 (VAERS ID).  A 67-year-old male patient received rsv vaccine prot.subunit pref 2v (ABRYSVO), on 18Dec2023 at 14:40 as dose number unknown, single (Lot number: HH7643) at the age of 67 years intramuscular, in right arm for immunisation. The patient's relevant medical history included: "Multiple Sclerosis" (unspecified if ongoing); "type 2 diabetes" (unspecified if ongoing); "Known allergies: Milk" (unspecified if ongoing); "Known allergies: NSAIDS" (unspecified if ongoing). Concomitant medication(s) included: ATORVASTATIN; MOUNJARO; AMLODIPINE; CARBAMAZEPINE; ALBUTEROL [SALBUTAMOL]; LOSARTAN; HYDROCHLOROTHIAZIDE; OXYBUTYNIN. The following information was reported: GUILLAIN-BARRE SYNDROME (hospitalization, medically significant) with onset 31Dec2023, outcome "not recovered", described as "paralysis/ later diagnosed with Gullain-Barre syndrome". The patient was hospitalized for guillain-barre syndrome (start date: 31Dec2023, discharge date: 29Jan2024, hospitalization duration: 30 day(s)). Clinical course: patient was hospitalized 31Dec2023 with paralysis. Patient later diagnosed with Gullain-Barre syndrome. At first they thought it was his MS (Multiple sclerosis), but then the drs decided it was Gullain-Barre syndrome. Wife said he was in the hospital for a month and then was moved to rehab and he is still there. The patient never had an adverse event following any previous vaccine.  No follow-up attempts are possible. No further information is expected.  Follow-up (01Oct2024): This is a spontaneous follow-up report received from an Other-HCP from Regulatory Authority. Regulatory number: 2749169-1 (VAERS ID). Updated information included: new reporter added, vaccination facility address was updated, event was medically confirmed, and clinical details.
Age: 46.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Arthralgia, Bursitis, Loss of personal independence in daily activities, Pain, Sleep disorder
Clinical narrative: Patient reported deep, aching pain at time of injection. Facility reported to patient that injection was given in wrong location and may have caused bursitis. Patient is starting her 4th week of deep, aching pain at the injection site. Patient was encouraged to see primary care physician for treatment for arm pain. Patient is a teacher and is very concerned about ability to work given arm pain.
Age: 46.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Tenderness
Clinical narrative: Patient reported deep, aching pain at time of injection. Facility reported to patient that injection was given in wrong location and may have caused bursitis. Patient is starting her 4th week of deep, aching pain at the injection site. Patient was encouraged to see primary care physician for treatment for arm pain. Patient is a teacher and is very concerned about ability to work given arm pain.
Age: 46.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Bursitis, Injection site pain, Product administered at inappropriate site
Clinical narrative: Patient reported deep, aching pain at time of injection. Facility reported to patient that injection was given in wrong location and may have caused bursitis. Patient is starting her 4th week of deep, aching pain at the injection site. Patient was encouraged to see primary care physician for treatment for arm pain. Patient is a teacher and is very concerned about ability to work given arm pain.
Age: 56.0
Sex: F
Vaccine: COVID19, COVID19-2
Symptoms: Blister, Hypersensitivity, Urticaria
Clinical narrative: Systemic: Allergic: Itch (specify: facial area, extremeties)-Medium, Systemic: Allergic: Rash (specify: facial area, extremeties)-Medium, Other Vaccines:  VaccineTypeBrand: FLU (Flulaval); Manufacturer: GSK; LotNumber: A555J; Route: IM; BodySite: Deltoid; Dose: 1; VaxDate: 09/28/2024
Age: 56.0
Sex: F
Vaccine: COVID19, COVID19-2
Symptoms: Pruritus, Rash
Clinical narrative: Systemic: Allergic: Itch (specify: facial area, extremeties)-Medium, Systemic: Allergic: Rash (specify: facial area, extremeties)-Medium, Other Vaccines:  VaccineTypeBrand: FLU (Flulaval); Manufacturer: GSK; LotNumber: A555J; Route: IM; BodySite: Deltoid; Dose: 1; VaxDate: 09/28/2024
Age: 55.0
Sex: F
Vaccine: COVID19, FLU3, COVID19
Symptoms: Blood pressure decreased, Dysgeusia, Fatigue, Feeling hot, Nausea
Clinical narrative: Systemic: Dizziness / Lightheadness-Medium, Systemic: felt warm-Medium
Age: 55.0
Sex: F
Vaccine: COVID19, FLU3, COVID19
Symptoms: Dizziness, Feeling hot
Clinical narrative: Systemic: Dizziness / Lightheadness-Medium, Systemic: felt warm-Medium
Sex: F
Vaccine: COVID19
Symptoms: Guillain-Barre syndrome
Clinical narrative: GUILLAIN BARRE SYNDROME; This spontaneous report received from a patient concerned a female of unspecified age. The patient's height, and weight were not reported. The patient's concurrent conditions included: guillain barre syndrome, and palmo pustular psoriasis on her hands and feet. The patient received covid-19 vaccine ad26.cov2.s (dose series 1) (suspension for injection, intramuscular, batch number was not reported) dose was not reported administered on 29-APR-2021 for covid-19 prophylaxis. The batch number was not reported and has been requested. No concomitant medications were reported.  On an unspecified date, following vaccination with covid-19 vaccine ad26.cov2.s, the patient experienced guillain barre syndrome (dose series 1) and was hospitalized (date unspecified). The patient reported that when she received the covid Johnson and Johnson vaccine, she got Guillain Barre Syndrome. She said, when covid first came out she got the JnJ shot and was one of the unfortunate ones and it took 2 weeks to get medical care. The patient physically collapsed because she was overtaken by the Guillain-Barre. She reported that the doctors in the ER did not know enough about it and kept sending her home and it never was reported to the vaccine adverse reaction place that was something the hospital should at done. She reported that she was hospitalized but did not provide the name of the hospital or dates.  The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of guillain barre syndrome was not reported. This report was serious (Hospitalization Caused / Prolonged, and Other Medically Important Condition).; Sender's Comments: V0;  Guillain-Barre syndrome;  The event has an unknown/unclear temporal relationship, and is labeled. There is no information on any other factors potentially associated with the event. Therefore, this event is considered consistent with vaccine administration.
Age: 76.0
Sex: F
Vaccine: COVID19
Symptoms: Hypersensitivity, Sinusitis
Clinical narrative: Stubborn sinusitis; I have very bad allergies so it has nothing to do; This spontaneous case was reported by a patient and describes the occurrence of SINUSITIS (Stubborn sinusitis) and HYPERSENSITIVITY (I have very bad allergies so it has nothing to do) in a 76-year-old female patient who received mRNA-1273.815 (SPIKEVAX 2023-2024) for COVID-19 prophylaxis.     No Medical History information was reported.    In May 2024, the patient received dose of mRNA-1273.815 (SPIKEVAX 2023-2024) (unknown route) 1 dosage form. In 2024, the patient experienced SINUSITIS (Stubborn sinusitis) and HYPERSENSITIVITY (I have very bad allergies so it has nothing to do). The patient was treated with PREDNISONE (oral use) from 13-Sep-2024 to 17-Sep-2024 at a dose of 40 milligram once a day and DOXYCYCLINE from 12-Sep-2024 to 21-Sep-2024 at an unspecified dose and frequency. At the time of the report, SINUSITIS (Stubborn sinusitis) and HYPERSENSITIVITY (I have very bad allergies so it has nothing to do) outcome was unknown.            No concomitant medication was reported. Suspect vaccine dosage text was reported as unknown.
Sex: U
Vaccine: RAB
Symptoms: Injection site erythema
Clinical narrative: just some localized reaction, redness at the site; Initial information received on 19-Sep-2024 regarding an unsolicited valid non-serious case received from a nurse.  This case is linked to 2024SA285966 and 2024SA285853.   This case involves patient of unknown demographics who experienced just some localized reaction, redness at the site after receiving rabies (HDC) vaccine [Imovax Rabies].  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On 16-Sep-2024, the patient received a 1 ml dose (dose 2) of suspect RABIES (HDC) Vaccine Powder and solvent for suspension for injection of lot W1C931M and expiry date: 31-Oct-2025 via intramuscular route in the arm nos (not otherwise specified) (strength: standard, frequency: twice). On 09-Sep-2024 he/she also received a dose 1 of same vaccine via intramuscular route in Arm nos for immunization.  On an unknown date in SEP-2024 the patient developed just some localized reaction, redness at the site (vaccination site erythema) (latency: few days approximately) following the administration of Rabies (HDC) Vaccine.  Reportedly, She just gave IMOVAX to 18 students for vet school. Four of them got a reaction. It was just some localized reaction, redness at the site. The nurse told them that most likely it was the 2nd dose. Healthcare professional also stated that the reaction showed up after the 2nd series on 16 Sep 2024.  Action taken was 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 just some localized reaction, redness at the site.; Sender's Comments:  US-SA-2024SA285966: US-SA-2024SA285853:
Age: 79.0
Sex: M
Vaccine: FLU3
Symptoms: Dry skin, Rash, Skin exfoliation
Clinical narrative: extremely dry skin; peeling; broken out into bumps all over his body; Initial information received on 19-Sep-2024 regarding an unsolicited valid  non-serious case received from a consumer/non-healthcare professional.  This case involves a 79-year-old male patient who experienced extremely dry skin, peeling and broken out into bumps all over his body after receiving vaccine Influenza USP Trival A-B High Dose Subvirion Vaccine [Fluzone HD].  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. At the time of the event, the patient had ongoing Drug hypersensitivity.   On 11-Sep-2024, the patient received an unknown  dose of suspect Influenza USP Trival A-B High Dose Subvirion Vaccine Suspension for injection in pre-filled syringe (expiry date, strength, lot number not reported) via unknown route in unknown administration site for immunization.  Information regarding batch number corresponding to the one at time of event occurrence is requested.  On an unknown date in SEP-2024 the patient developed extremely dry skin (dry skin), peeling (skin exfoliation) and broken out into bumps all over his body (rash) (latency: few days approximately) following the administration of Influenza USP Trival A-B High Dose Subvirion Vaccine.  Reportedly, She said he got the vaccine last Wednesday, and by the following weekend he had broken out into bumps all over his body, which has now changed to extremely dry skin, similar to a sunburn that is peeling.She said that her husband has a number of allergies and yesterday she called asking about two ingredients, polyethylene glycol and propylene glycol. She was told yesterday that the ingredients list specifically states there is no polyethylene glycol in the vaccine, but makes no mention of propylene glycol.The caller said she does not know for certain it was the flu shot that caused this Adverse event, but she is trying to look back at everything her husband was given or ate in that timeframe.  Action taken was not applicable.  It was not reported if the patient received a corrective treatment for all the events.  At time of reporting, the outcome was Unknown for all the events.
Sex: F
Vaccine: UNK
Symptoms: Headache, Nausea
Clinical narrative: Headache; Nausea; This spontaneous case, initially received on 21-Sep-2024, was reported by a non health professional and concerns an elderly female patient.  Concomitant medication: refer to appropriate report section.  Administration of company suspect drug(s): On 20-Sep-2024 09:00, the patient received Fluad (TIV) for Influenza immunisation, Dose regimen: 0.5 ml, route of administration: Not reportyed Lot number: No batch number avialable.   No additional suspect drugs.  Adverse reactions/events and outcomes: On 21-Sep-2024, the patient experienced Headache (outcome: Not recovered / Not resolved) and Nausea (outcome: Not recovered / Not resolved).  On 20-Sep-2024, the patient received vaccine at 9am and the other day morning she woke up with a headache and since afternoon felt nauseous. The patient reported that she had had flublok last year and felt fine and did not had any issues with the past 6 vaccines.  Fluad (TIV) action taken: Not Applicable  Reporter's assessment: The reporter considered the events Headache and Nausea as non-serious and related to the administration of Fluad (TIV); Reporter's Comments: The events are considered related.
Age: 82.0
Sex: F
Vaccine: UNK
Symptoms: Decreased appetite, Dyspepsia, Nausea
Clinical narrative: Nauseous; Could not eat anything; Heartburn; This spontaneous case, initially received on 30-Sep-2024, was reported by a health professional and concerns an elderly female patient.  Administration of company suspect drug: On 26-Sep-2024, the patient received Fluad (TIV) for Active immunization for the prevention of influenza disease, Dose regimen: 0.5 ml, Route of administration: Not Reported Lot number: 388471.  No additional suspect drugs.  Adverse reactions/events and outcomes: On 27-Sep-2024, the patient experienced Nauseous (outcome: Not Reported), Could not eat anything (outcome: Not Reported), Heartburn (outcome: Not Reported).  Event description: The patient said the first day she felt fine, the next day after the shot, she was very nauseous, could not eat anything, she had Heartburn, that was it.  Fluad (TIV) action taken: Not Applicable  Reporter's assessment: The reporter considered the case non-serious and did not provide a causality assessment.; Reporter's Comments: All the events are related to Fluad (TIV) administration.
Sex: U
Vaccine: UNK
Symptoms: Urticaria
Clinical narrative: Reaction to the flu vaccine (Hives); This spontaneous case, initially received on 30-Sep-2024, was reported by a health professional and concerns a patient of unknown age/gender.  Administration of company suspect drug(s): On an unknown date, the patient received Flucelvax (TIV) for Active immunization for the prevention of influenza disease., Dose regimen: Not reported. Route of administration: Not reported. Lot number: 388518.  No additional suspect drugs.  Adverse reactions/events and outcomes: On an unknown date, the patient experienced Reaction to the flu vaccine (Hives) (outcome: Not Reported).  The 4 patients that had a reaction to the flu vaccine. The 3 patient's had a reaction the next day and to 1 patient the reaction happened while in the clinic. They all had hives.  Flucelvax (TIV) action taken: Not Applicable  Reporter's assessment: The reporter did not provide seriousness or causality assessment; Reporter's Comments: The event Reaction to the flu vaccine (Hives) was related to Flucelvax (TIV) administration.
Sex: M
Vaccine: UNK
Symptoms: Urticaria
Clinical narrative: Reaction to the flu vaccine (Hives); This spontaneous case, initially received on 30-Sep-2024, was reported by a health professional and concerns an infant male patient.  Concomitant medication: refer to appropriate report section.  Administration of company suspect drug(s): On 24-Sep-2024, the patient received Flucelvax (TIV) for Active immunization for the prevention of influenza disease., Dose regimen: Not reported. Route of administration: Not reported. Lot number: 388518.  No additional suspect drugs.  Adverse reactions/events and outcomes: On an unknown date, the patient experienced Reaction to the flu vaccine (Hives) (outcome: Not Reported).  The 4 patients that had a reaction to the flu vaccine. The 3 patient's had a reaction the next day and to 1 patient the reaction happened while in the clinic. They all had hives.  Flucelvax (TIV) action taken: Not Applicable  Reporter's assessment: The reporter did not provide seriousness or causality assessment  05-OCT-2024 (System Update): Linked Case ID(s):2024180923 (Patient Link); 2024180920 (Patient Link); 2024180922 (Patient Link); Reporter's Comments: The event Reaction to the flu vaccine (Hives) was related to Flucelvax (TIV) administration.
Sex: U
Vaccine: UNK
Symptoms: Exposure via skin contact, Syringe issue
Clinical narrative: They put the needle on and when they went to inject the patient, underneath, where it connects the neck of glass vial to the Luer Lock it was leaking underneath; When they went to inject the patient the patient it squirted all over the arm of the patient; This spontaneous case, initially received on 20-Sep-2024, was reported by a health professional and concerns an patient of unknown age/gender.  Administration of company suspect drug(s): On an unknown date, the patient received Fluad (TIV) for Indication not reported, dose regimen; not reported; route of administration: not reported; lot number: 388496.  No additional suspect drugs.  Adverse reactions/events and outcomes: On an unknown date, the patient experienced They put the needle on and when they went to inject the patient, underneath, where it connects the neck of glass vial to the Luer Lock it was leaking underneath (outcome: Not Reported), When they went to inject the patient the patient it squirted all over the arm of the patient (outcome: Not Reported). The reporter wanted to report a Fault in one of Fluad. The product was actually leaking underneath the vial. They put the needle on and when they went to inject the patient, underneath, where it connects the neck of glass vial to the Luer Lock it was leaking underneath that and actually sprayed on the patient. When they went to inject the patient the patient it squirted all over the arm of the patient and then they examined the syringe and pressed on the plunger. Actually, saw the vaccine leaking out underneath where the plastic piece and the glass meets.  The patient administered full dose; they readministered after the issue happened. They used a totally new for the patient. This was the complaint sample. Reporter noticed when they went to inject the patient. They also noticed defect when administering the dose. The plunger was already in at that point. The needle was not place in shield. The leaking was Underneath, where it connects the neck of glass vial to the Luer Lock it was leaking. There were no signs of damage on the syringe.   Fluad (TIV) action taken: Not Applicable.  Reporter assessment: The reporter did not provide the seriousness and causality assessment for the events.; Reporter's Comments: The events was considered not related to the administration of Fluad (TIV).
Age: 36.0
Sex: M
Vaccine: COVID19
Symptoms: Chest pain, Feeling abnormal, Painful respiration
Clinical narrative: Background: I have had very strong responses in the past with the Pfizer vaccine (intense shaking for hours, chills, fatigue). On this occasion, I was expecting to get the same response, which I did, but I also had intense chest pain that was most severe for 2 hours (1-3 AM on 10/5/24), but lasted for about 12 hours. It gradually felt less bad, but during that 2 hour window I didn't know if I should go to the emergency room or not. I was afraid of the hospital bill that would accompany the visit, so I decided to wait and see if things got better. The pain was directly in the center of my chest and it hurt every breath I took. I did not take any medication prior to the vaccination, but around 8:30 PM on the day of the injection (10/4/24), I took 1000 mg of Tylenol. That is all I took prior to the intense chest pain. I put "1" for the dost number in series, but I don't really know what to put. I have had multiple vaccines in prior years, but this was my 1 shot for the 24/25 season. Hopefully that makes sense. Also, I got a flu shot on the same day, but don't know what type. The clinic would know.
Age: 58.0
Sex: F
Vaccine: COVID19, FLU3
Symptoms: Blood urine present, Computerised tomogram normal, Contusion, Corneal abrasion, Dehydration
Clinical narrative: Fatigue onset after 12 hours; mostly rested in bed; after total of 23 hours, entered shower; felt nausea; fainted; woke up in tub; hit head from right side; bruising around right cheek and both eyebrow; corneal abrasion; treated at local ED
Age: 58.0
Sex: F
Vaccine: COVID19, FLU3
Symptoms: Fatigue, Head injury, Nausea, Pupil dilation procedure, Syncope
Clinical narrative: Fatigue onset after 12 hours; mostly rested in bed; after total of 23 hours, entered shower; felt nausea; fainted; woke up in tub; hit head from right side; bruising around right cheek and both eyebrow; corneal abrasion; treated at local ED
Age: 75.0
Sex: F
Vaccine: COVID19
Symptoms: Blood test, Chest X-ray, Electrocardiogram, Malaise
Clinical narrative: When I woke up I didn't feel well. My pulse rate when taken by my KARDIA was 177. I went to the ER right away.
Sex: U
Vaccine: UNK
Symptoms: Exposure via skin contact, Syringe issue
Clinical narrative: Product leaked on the administrator or patient; The vaccine leaked from Luer Lok connection/ The Luer Lok device was lost and turned; This spontaneous case, initially received on 17-Sep-2024, was reported by a non health professional and concerns an patient of unknown age/gender.  Administration of company suspect drug: On an unknown date, the patient received Fluad (TIV) for Not reported., dosage Not reported, Route of administration: not reported. Lot number: 389307. There is a product complaint associated.  No additional suspect drugs.  Adverse reactions/events and outcomes: On an unknown date, the patient experienced Product leaked on the administrator or patient (outcome: Not Reported), The vaccine leaked from Luer Lok connection/ The Luer Lok device was lost and turned (outcome: Not Reported).  During administration of the dose, the vaccine leaked from Luer Lok connection. Per the complainant the Luer Lok device was loose and turns.  Fluad (TIV) action taken: Not Applicable  Reporter assessment The reporter did not provide the causality and seriousness of event.; Reporter's Comments: Both events are not related.
Age: 65.0
Sex: M
Vaccine: COVID19-2
Symptoms: Breakthrough COVID-19, Chest X-ray normal, Nausea, SARS-CoV-2 test positive, Vomiting
Clinical narrative: Reported Symptoms: 10054112:HOSPITALISATION; 10067923:VACCINE BREAKTHROUGH INFECTION; 10084268:COVID-19; Narrative: Patient admitted presented to the ED with intractable nausea and vomiting. Found to be COVID-19 positive without hypoxia and treated with remdesivir. N/V resolved while inpatient. Patient discharged to home in satisfactory condition. Other Relevant HX: PMH of chronic pancytopenia, ETOH/Hep C cirrhosis , HCC, esophageal varices, SBP, ascites, chronic portal vein thrombus, T2DM, COPD, HTN, MRSA recurrent right hip area wound infection with abscess in previous hematoma cavity Other: Hospitalization due to the Covid-19 infection after having received Covid-19 Vaccination
Age: 75.0
Sex: M
Vaccine: COVID19
Symptoms: Injection site erythema, Injection site pruritus, Rash
Clinical narrative: Reported Symptoms:  10015150:ERYTHEMA; 10037087:PRURITUS; 10037844:RASH; Narrative: Patient went to clinic and reported red itchy area where vaccine was given. Denies any sever allergic reaction symptoms. Patient was taking daily zyrtec for allergies. Symptoms getting better. Other Relevant HX:  Other: ERYTHEM; PRURITUS
Age: 31.0
Sex: M
Vaccine: FLUX
Symptoms: Guillain-Barre syndrome, Wheelchair user
Clinical narrative: Reported Symptoms: 10018767:GUILLIAN-BARRE SYNDROME; Narrative: Patient develop Guillain Barre syndrome after receiving influenza vaccination in 1978, remains wheelchair bound today. No documentation from the time of the reaction. Other Relevant HX: Other: GUILLAIN BARRE
Age: 77.0
Sex: M
Vaccine: COVID19-2
Symptoms: Acute kidney injury, Breakthrough COVID-19, Chest X-ray abnormal, Chronic kidney disease, Chronic obstructive pulmonary disease
Clinical narrative: Reported Symptoms: 10054112:HOSPITALISATION; 10067923:VACCINE BREAKTHROUGH INFECTION; 10064268:COVID-19; Narrative: Patient admitted for respiratory viral syndrome due to COVID-19 without hypoxia due to significant comorbidities, COPD exacerbation, mild, secondary to respiratory virus, and AKI on CKD3A. Patient treated with dexamethasone and remdesivir for COVID-19. Patient discharged to home with improvement and a course of dexamethasone outpatient. Other Relevant HX: Past medical history significant for diabetes, hypertension, A. fib, CKD, chronic pain syndrome, COPD, CAD, CABG, BPH Other: Hospitalization due to Covid-19 infection after having received Covid-19 Vaccination
Age: 77.0
Sex: M
Vaccine: COVID19-2
Symptoms: Condition aggravated, SARS-CoV-2 test positive, Viral infection
Clinical narrative: Reported Symptoms: 10054112:HOSPITALISATION; 10067923:VACCINE BREAKTHROUGH INFECTION; 10064268:COVID-19; Narrative: Patient admitted for respiratory viral syndrome due to COVID-19 without hypoxia due to significant comorbidities, COPD exacerbation, mild, secondary to respiratory virus, and AKI on CKD3A. Patient treated with dexamethasone and remdesivir for COVID-19. Patient discharged to home with improvement and a course of dexamethasone outpatient. Other Relevant HX: Past medical history significant for diabetes, hypertension, A. fib, CKD, chronic pain syndrome, COPD, CAD, CABG, BPH Other: Hospitalization due to Covid-19 infection after having received Covid-19 Vaccination
Sex: M
Vaccine: FLUX
Symptoms: Lymphadenopathy
Clinical narrative: Reported Symptoms: 10025197:LYMPHADENOPATHY;  Narrative:Patient's allergy report was added to the computer system when he established care in Janury 2024. Reports he has the same reaction to eggs. Other Relevant HX: Othe: LYMPHADENOPATHY
Age: 59.0
Sex: M
Vaccine: VARCEL
Symptoms: Chills, Pyrexia, Vomiting
Clinical narrative: Reported Symptoms: 10016558:FEVER; 10040559:SHIVERS; 10047700:VOMITING; Narrative: Other Relevant HX: Other: Shivers
Age: 77.0
Sex: M
Vaccine: FLUX
Symptoms: Unevaluable event
Clinical narrative: Reported Symptoms: 10054112:HOSPITALISATION; Narrative; patient reported to nurse he was hospitalized after influenza vaccine in 2008, no data in database of hospitalization Other Relevant HX: Other: Patient reports hospitalization
Age: 71.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Chills, Cough, Pyrexia, SARS-CoV-2 test positive
Clinical narrative: Reported Symptoms: 10054112:HOSPITALISATION; 10084268:COVID-19; Narrative: patient reported to ED with fever and chills. Previously in ED 2 days prior due to UTI and was given cephalexin, but sxs did not improve. Upon admission patient found to be COVID + without PNA. Reported mild cough and wheezing. Did not require treatment outside of PRN albuterol. Discharged after resolution of UTI. Other Relevant HX: Other: hospitalization due to covid 19
Age: 71.0
Sex: M
Vaccine: COVID19
Symptoms: Urinary tract infection, Wheezing
Clinical narrative: Reported Symptoms: 10054112:HOSPITALISATION; 10084268:COVID-19; Narrative: patient reported to ED with fever and chills. Previously in ED 2 days prior due to UTI and was given cephalexin, but sxs did not improve. Upon admission patient found to be COVID + without PNA. Reported mild cough and wheezing. Did not require treatment outside of PRN albuterol. Discharged after resolution of UTI. Other Relevant HX: Other: hospitalization due to covid 19
Age: 76.0
Sex: M
Vaccine: COVID19-2
Symptoms: Acute kidney injury, Breakthrough COVID-19, Cardiac failure, Chronic kidney disease, Condition aggravated
Clinical narrative: Reported Symptoms: 10024112:HOSPITALISATION; 10067923:VACCINE BREAKTHOUGH INFECTION; 10084268:COVID-19; Narrative: Patient admitted for acute heart failure exacerbation, COVID-19, AKI on CKD stage 3b and UTI. Patient treated with dexamethasone and remdesivir. Patient discharged home in stable condition. Other Relevant Hx: PMH HFrEF s/p ICD placement, paroxysmal A. fib on anticoagulation with apixaban s/p AVN ablation, OSA not on CPAP, PTSD, OA, fibromyalgia opioid use disorder currently on suboxone, unspecified pituitary adenoma, urinary retention 2/2 neurogenic bladder, hypothyroidism, hypertension, coronary artery disease status post CABG 2015, hyperparathyroidism, CKD stage IIIb, Type 2 diabetes Other : Hospitalization due to Covid-19 infection after having received Covid-19 vaccination
Age: 76.0
Sex: M
Vaccine: COVID19-2
Symptoms: SARS-CoV-2 test positive, Urinary tract infection
Clinical narrative: Reported Symptoms: 10024112:HOSPITALISATION; 10067923:VACCINE BREAKTHOUGH INFECTION; 10084268:COVID-19; Narrative: Patient admitted for acute heart failure exacerbation, COVID-19, AKI on CKD stage 3b and UTI. Patient treated with dexamethasone and remdesivir. Patient discharged home in stable condition. Other Relevant Hx: PMH HFrEF s/p ICD placement, paroxysmal A. fib on anticoagulation with apixaban s/p AVN ablation, OSA not on CPAP, PTSD, OA, fibromyalgia opioid use disorder currently on suboxone, unspecified pituitary adenoma, urinary retention 2/2 neurogenic bladder, hypothyroidism, hypertension, coronary artery disease status post CABG 2015, hyperparathyroidism, CKD stage IIIb, Type 2 diabetes Other : Hospitalization due to Covid-19 infection after having received Covid-19 vaccination
Age: 60.0
Sex: M
Vaccine: COVID19-2
Symptoms: Arthralgia, Breakthrough COVID-19, COVID-19 pneumonia, Chest X-ray abnormal, Cough
Clinical narrative: Reported Symptoms: 10054112:HOSPITALISATION; 10067923:VACCINE BREAKTHROUGH INFECTION; 10084268:COVID-19; Narrative: Patient with past medical history most notable for PTSD and OSA presented to the ED with lethargy associated with cough and arthralgias. Had recently returned from a trip with family for a professional football game. The patient returned from the trip and began feeling unwell with development of cough, sneezing, headache, and arthralgias. Diagnosed with COVID-19 pneumonia. Treated with 1L O2, 10mg dexamethasone and 100mg remdesivir x3 days. Prior to discharge to home, patient was stable and no longer needed supplemental O2. Patient also found to have moderate mitral regurgitation with no other overt abnormality noted. Outpatient cardiology follow up was scheduled. Other Relevant HX: PMH PTSD and OSA Other: Hospitalization due to Covid-19 infection after having received Covid-19 Vaccination
Age: 60.0
Sex: M
Vaccine: COVID19-2
Symptoms: Headache, Lethargy, Lung opacity, Malaise, Mitral valve incompetence
Clinical narrative: Reported Symptoms: 10054112:HOSPITALISATION; 10067923:VACCINE BREAKTHROUGH INFECTION; 10084268:COVID-19; Narrative: Patient with past medical history most notable for PTSD and OSA presented to the ED with lethargy associated with cough and arthralgias. Had recently returned from a trip with family for a professional football game. The patient returned from the trip and began feeling unwell with development of cough, sneezing, headache, and arthralgias. Diagnosed with COVID-19 pneumonia. Treated with 1L O2, 10mg dexamethasone and 100mg remdesivir x3 days. Prior to discharge to home, patient was stable and no longer needed supplemental O2. Patient also found to have moderate mitral regurgitation with no other overt abnormality noted. Outpatient cardiology follow up was scheduled. Other Relevant HX: PMH PTSD and OSA Other: Hospitalization due to Covid-19 infection after having received Covid-19 Vaccination
Age: 60.0
Sex: M
Vaccine: COVID19-2
Symptoms: SARS-CoV-2 test positive, Sneezing
Clinical narrative: Reported Symptoms: 10054112:HOSPITALISATION; 10067923:VACCINE BREAKTHROUGH INFECTION; 10084268:COVID-19; Narrative: Patient with past medical history most notable for PTSD and OSA presented to the ED with lethargy associated with cough and arthralgias. Had recently returned from a trip with family for a professional football game. The patient returned from the trip and began feeling unwell with development of cough, sneezing, headache, and arthralgias. Diagnosed with COVID-19 pneumonia. Treated with 1L O2, 10mg dexamethasone and 100mg remdesivir x3 days. Prior to discharge to home, patient was stable and no longer needed supplemental O2. Patient also found to have moderate mitral regurgitation with no other overt abnormality noted. Outpatient cardiology follow up was scheduled. Other Relevant HX: PMH PTSD and OSA Other: Hospitalization due to Covid-19 infection after having received Covid-19 Vaccination
Age: 2.75
Sex: M
Vaccine: FLU3
Symptoms: Injection site erythema, Injection site oedema, Injection site warmth
Clinical narrative: (R) upper arm 12 cm x 9 cm erythema edema and warmth
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Dehydration, Vomiting
Clinical narrative: Reported Symptoms: 10021113:HYPOTHERMIA; 10042772:SYNCOPE; 10047700:VOMITING; Narrative: Patient was a 56 yo female at the time of the event. Patient has early onset dementia. She had loose stools for 6 weeks prior to injection to Pfizer COVID vaccination at a local hospital clinic. Within 24 hours of the vaccination, she developed weakness and vomited. She was in the hospital for hydration for 2 days before returning back to ALF. Other Relevant HX: Other: VOMITING; HYPOTHERMIA; SYNCOPE
Age: 81.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Asthenia, Mental status changes
Clinical narrative: Reported Symptoms: 10047862:WEAKNESS; 10049294:MENTAL STATUS CHANGES;  Narrative: This is a historic ADR to moderna COVID-19 vaccination. Patient received primary COVID-19 series with Moderna on 2/4/21 and 3/4/21 at an outside facility. Limited information in 2 different systems as to the nature of the ADR. Unknown whoch of the two vaccines in the series is related to the ADR. Placed information for both the vaccines in the series earlier in the report. Other Relevant HX: Other: ALTERED MENTAL STATUS; WEAKNESS