chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 46.0
Sex: M
Vaccine: COVID19, PNC20
Symptoms: Cellulitis, Feeling hot, Pain
Clinical narrative: Patient had cellulitis in the injection arm. Went to Urgent Care and got Keflex, Medrol Dosepack and clobetasol. Feeling warm and pain. Started the next day of the vaccination and progressed. Went to Urgent Care 2 days after the vaccination.
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Pruritus, Urticaria
Clinical narrative: Full body hives and itchiness and was not resolved at time of call
Age: 61.0
Sex: F
Vaccine: UNK
Symptoms: Pain, Pruritus, Scar, Swelling
Clinical narrative: BCG scar swollen. Pain, itching
Age: 57.0
Sex: M
Vaccine: FLU4, PNC20
Symptoms: Injection site swelling, Lymphadenopathy, Pain
Clinical narrative: Pt had swelling at the injection site that progressed up and down the extremity and into the shoulder. It also swelled the axillae and the lymph nodes in the axillae. Pt complained of pain. Stated that by the time I saw it, the swelling had gone down a little, but it was still visible.
Age: 26.0
Sex: F
Vaccine: TDAP
Symptoms: Wrong product administered
Clinical narrative: On 09/23/23 I called the patient to administer 3 vaccinations. I confirmed her name as well as the vaccines we were going to administer. The vaccines are kept in separate basins for each patient and as I administered her vaccines/interacted with her, another nurse placed the next patients? vaccines close to same area I was working on for the current patient. As I was administering her vaccines and speaking with the patient, I grabbed what I thought was her next vaccine from her basin (as they were the same color) and grabbed a TDAP vaccine that was ready for the NEXT patient. I immediately realized what had happened after administering and explained to the patient what had happened. I apologized to her and went over possible side effects of getting an extra TDAP vaccine.
Age: 46.0
Sex: F
Vaccine: UNK
Symptoms: Dyspnoea, Heart rate increased, Muscle spasms, Palpitations
Clinical narrative: Fast, pounding heart rate, breathlessness, muscle cramps in legs
Age: 65.0
Sex: M
Vaccine: COVID19
Symptoms: Heart rate increased
Clinical narrative: Rapid heartbeat and pulse
Age: 30.0
Sex: F
Vaccine: FLU4, TDAP
Symptoms: Hyperhidrosis, Loss of consciousness, Pallor, Seizure like phenomena, Syncope
Clinical narrative: Patient got pale, faint and passed passed out a few seconds after both the above vaccinations were administered into the same arm, around 4:30pm on 9/22/2023. Immunizing technician maintained communication with patient to try to keep her awake. Patient had a seizure like reaction for about 20 seconds, where she was shaking in the immunization chair, after which she was able to answer questions coherently.  A cold bottle was placed on back of her neck to help cool her down, as she was sweating profusely. EMT's were called and patient was evaluated, but chose not to leave with EMT's. Patient called boyfriend, who stopped by the store and walked patient out. Patient was able to walk on her own when leaving the store at around 5:20pm.   Patient reported having similar reaction to the first covid vaccination. Patient received 2 additional covid vaccinations later with no reaction. This information was provided after the reaction at the pharmacy.
Age: 30.0
Sex: F
Vaccine: FLU4, TDAP
Symptoms: Tremor
Clinical narrative: Patient got pale, faint and passed passed out a few seconds after both the above vaccinations were administered into the same arm, around 4:30pm on 9/22/2023. Immunizing technician maintained communication with patient to try to keep her awake. Patient had a seizure like reaction for about 20 seconds, where she was shaking in the immunization chair, after which she was able to answer questions coherently.  A cold bottle was placed on back of her neck to help cool her down, as she was sweating profusely. EMT's were called and patient was evaluated, but chose not to leave with EMT's. Patient called boyfriend, who stopped by the store and walked patient out. Patient was able to walk on her own when leaving the store at around 5:20pm.   Patient reported having similar reaction to the first covid vaccination. Patient received 2 additional covid vaccinations later with no reaction. This information was provided after the reaction at the pharmacy.
Age: 33.0
Sex: F
Vaccine: COVID19
Symptoms: Disability, Pain
Clinical narrative: Extremely severe, crippling widespread pain all over the body; OTC painkillers were ineffective at lessening pain severity; lasted approximately 2 days; only reason I did not go to the ER is I could not afford it.   THIS INFO FOR 2023 SHOT
Age: 42.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Erythema, Fatigue, Peripheral swelling, SARS-CoV-2 test positive
Clinical narrative: Arm swelling and redness, exhaustion, positive Covid test
Age: 43.0
Sex: M
Vaccine: FLU4
Symptoms: Blood test, Chronic fatigue syndrome, Electromyogram, Fibromyalgia, Lumbar puncture
Clinical narrative: Fibromyalgia and Chronic Fatigue Syndrome
Age: 43.0
Sex: M
Vaccine: FLU4
Symptoms: Magnetic resonance imaging, Neuropsychological test
Clinical narrative: Fibromyalgia and Chronic Fatigue Syndrome
Age: 45.0
Sex: F
Vaccine: COVID19
Symptoms: Oral herpes
Clinical narrative: I got the flu shot + Covid vaccine and now my fever is 101-102. That seems really high post vaccine. Is that normal?
Age: 36.0
Sex: F
Vaccine: COVID19, FLU4
Symptoms: Arthralgia, Injection site erythema, Injection site pain, Injection site pruritus, Injection site rash
Clinical narrative: Pain at injection site, referred pain on right side of neck and shoulder, injection sight redness, swelling, itching, itching/rash on left shoulder and chest
Age: 36.0
Sex: F
Vaccine: COVID19, FLU4
Symptoms: Injection site swelling, Neck pain, Pain, Rash
Clinical narrative: Pain at injection site, referred pain on right side of neck and shoulder, injection sight redness, swelling, itching, itching/rash on left shoulder and chest
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Balance disorder, Chronic inflammatory demyelinating polyradiculoneuropathy, Dysstasia, Gait disturbance, Hypoaesthesia
Clinical narrative: Sometime in 2022, I noticed that my toes were numb. My doctor said it was probably diabetes. But it wasn't. I found that I was losing my balance, usually when standing or starting to walk or getting up from a chair. I happened to mention it to my rheumatologist Dr. When I went to see him in February 2023, he told me I had Chronic Inflammatory Demyelinating Polyneuropathy. I was give IVIG infusions in July 2023 and have been getting infustions every 3 weeks.
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Immunoglobulin therapy, Nerve conduction studies abnormal, Nervous system disorder
Clinical narrative: Sometime in 2022, I noticed that my toes were numb. My doctor said it was probably diabetes. But it wasn't. I found that I was losing my balance, usually when standing or starting to walk or getting up from a chair. I happened to mention it to my rheumatologist Dr. When I went to see him in February 2023, he told me I had Chronic Inflammatory Demyelinating Polyneuropathy. I was give IVIG infusions in July 2023 and have been getting infustions every 3 weeks.
Age: 80.0
Sex: F
Vaccine: FLU4, RSV, FLU4, RSV
Symptoms: Allergy to vaccine, Blood test, Chest X-ray, Computerised tomogram, Dyspnoea
Clinical narrative: Patient has shortness of breath lasting for 3 weeks or more.   Initially had localized reaction at the site of injection
Age: 80.0
Sex: F
Vaccine: FLU4, RSV, FLU4, RSV
Symptoms: Dyspnoea exertional, Gait disturbance, Immediate post-injection reaction, Influenza virus test negative, Injection site pain
Clinical narrative: Patient has shortness of breath lasting for 3 weeks or more.   Initially had localized reaction at the site of injection
Age: 80.0
Sex: F
Vaccine: FLU4, RSV, FLU4, RSV
Symptoms: Laboratory test, Limb discomfort, SARS-CoV-2 test negative, Screaming, Somnolence
Clinical narrative: Patient has shortness of breath lasting for 3 weeks or more.   Initially had localized reaction at the site of injection
Age: 80.0
Sex: F
Vaccine: FLU4, RSV, FLU4, RSV
Symptoms: Sudden onset of sleep, Tendon rupture
Clinical narrative: Patient has shortness of breath lasting for 3 weeks or more.   Initially had localized reaction at the site of injection
Age: 80.0
Sex: F
Vaccine: FLU4, RSV, FLU4, RSV
Symptoms: Dyspnoea, Injection site reaction
Clinical narrative: Patient has shortness of breath lasting for 3 weeks or more.   Initially had localized reaction at the site of injection
Age: 79.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Asthenia, Disability, Gait inability, Pain, Peripheral swelling
Clinical narrative: 2 MONTHS AFTER THE INJECTION STARTED TO HAVE PAIN AND WEAKNESS TO MY RIGHT LEG. SINCE THEN I HAVE HAD A LOT OF PAIN IN THE RIGHT LEG AND CANNOT WALK. HAVE TO USE A WALKER ALL THE TIME TO GET AROUND - SOMETIMES A CANE TOO
Age: 79.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Syncope
Clinical narrative: 2 MONTHS AFTER THE INJECTION STARTED TO HAVE PAIN AND WEAKNESS TO MY RIGHT LEG. SINCE THEN I HAVE HAD A LOT OF PAIN IN THE RIGHT LEG AND CANNOT WALK. HAVE TO USE A WALKER ALL THE TIME TO GET AROUND - SOMETIMES A CANE TOO
Age: 79.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Gait disturbance, Muscular weakness, Pain in extremity, Walking aid user
Clinical narrative: 2 MONTHS AFTER THE INJECTION STARTED TO HAVE PAIN AND WEAKNESS TO MY RIGHT LEG. SINCE THEN I HAVE HAD A LOT OF PAIN IN THE RIGHT LEG AND CANNOT WALK. HAVE TO USE A WALKER ALL THE TIME TO GET AROUND - SOMETIMES A CANE TOO
Age: 65.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, Interchange of vaccine products
Clinical narrative: tongue swelling; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 67-year-old female patient (not pregnant) received bnt162b2 (BNT162B2), on 12Nov2021 as dose 3 (booster), single (Lot number: FH8028) at the age of 65 years, in right arm for covid-19 immunisation. The patient's relevant medical history included: "Hashimoto's Thyroiditis" (unspecified if ongoing), notes: Other Medical History: Hashimoto's Thyroiditis, in remission from breast cancer (IDC - Triple Positive); "in remission from breast cancer (IDC - Triple Positive)" (unspecified if ongoing), notes: Other Medical History: Hashimoto's Thyroiditis, in remission from breast cancer (IDC - Triple Positive); "Sulfa drugs allergy" (unspecified if ongoing), notes: Known allergies: Sulfa drugs, Tylenol. The patient's concomitant medications were not reported. Past drug history included: Tylenol, reaction(s): "Allergies: Tylenol". Vaccination history included: moderna (Dose 2, single, Batch/Lot No: 008B21-24, Location of injection: Arm Right), administration date: 04Apr2021, when the patient was 65-year-old, for COVID-19 Immunization, reaction(s): "Had increasingly severe allergic reactions to the mRNA vaccines"; moderna (Dose 1, single, Batch/Lot No: 040AZ1A, Location of injection: Arm Right), administration date: 11Mar2021, when the patient was 65-year-old, for COVID-19 Immunization, reaction(s): "Had increasingly severe allergic reactions to the mRNA vaccines". The following information was reported: SWOLLEN TONGUE (non-serious), outcome "unknown", described as "tongue swelling". Therapeutic measures were taken as a result of swollen tongue. Additional information:  After initial series (Moderna), the Pfizer booster was recommended and resulted in tongue swelling despite taking two antihistamines prior to the vaccination. No additional vaccines have been recommended.
Age: 65.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Swollen tongue
Clinical narrative: tongue swelling; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 67-year-old female patient (not pregnant) received bnt162b2 (BNT162B2), on 12Nov2021 as dose 3 (booster), single (Lot number: FH8028) at the age of 65 years, in right arm for covid-19 immunisation. The patient's relevant medical history included: "Hashimoto's Thyroiditis" (unspecified if ongoing), notes: Other Medical History: Hashimoto's Thyroiditis, in remission from breast cancer (IDC - Triple Positive); "in remission from breast cancer (IDC - Triple Positive)" (unspecified if ongoing), notes: Other Medical History: Hashimoto's Thyroiditis, in remission from breast cancer (IDC - Triple Positive); "Sulfa drugs allergy" (unspecified if ongoing), notes: Known allergies: Sulfa drugs, Tylenol. The patient's concomitant medications were not reported. Past drug history included: Tylenol, reaction(s): "Allergies: Tylenol". Vaccination history included: moderna (Dose 2, single, Batch/Lot No: 008B21-24, Location of injection: Arm Right), administration date: 04Apr2021, when the patient was 65-year-old, for COVID-19 Immunization, reaction(s): "Had increasingly severe allergic reactions to the mRNA vaccines"; moderna (Dose 1, single, Batch/Lot No: 040AZ1A, Location of injection: Arm Right), administration date: 11Mar2021, when the patient was 65-year-old, for COVID-19 Immunization, reaction(s): "Had increasingly severe allergic reactions to the mRNA vaccines". The following information was reported: SWOLLEN TONGUE (non-serious), outcome "unknown", described as "tongue swelling". Therapeutic measures were taken as a result of swollen tongue. Additional information:  After initial series (Moderna), the Pfizer booster was recommended and resulted in tongue swelling despite taking two antihistamines prior to the vaccination. No additional vaccines have been recommended.
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: Incorrect product storage; No AE/PQC reported; This spontaneous report was received from a medical assistant referring to a patient of unknown age and gender. Information about medical history, concurrent conditions and concomitant therapies was not provided.       On an unknown date, the patient was vaccinated with two dose series of varicella virus vaccine live (oka/merck)(VARIVAX) (lot # W031813, expiration date 05-OCT-2024, 0.5 milliliter; route was not reported) for prophylaxis. The vaccine was improperly stored at temperatures above recommended range (product storage error). No adverse event was reported.       This is one of two reports received from the same reporter.; Sender's Comments:  US-009507513-2309USA001484:
Age: 4.0
Sex: M
Vaccine: MMRV
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional AE/no PQC.; PROQUAD was administered after it experienced a supported temperature excursion; This spontaneous report was received from a Medical Assistant referring to a 4 year old male patient. The patient's medical history, concurrent conditions, and historical drugs were not reported.  On 19-SEP-2023, the patient was vaccinated with a dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live(PROQUAD) 0.5 ml, lot # X009731, expiration date on 30-SEP-2024, albumin status as rHA (strength, dose number, route, and anatomical location were not provided) for prophylaxis after temperature excursion of 12.7°F during 45 minutes, 30 seconds (product storage error), there was no previous temperature excursion. Concomitant therapies included sterile diluent (manufacturer unknown). No adverse event reported.
Age: 16.0
Sex: M
Vaccine: MNQ, MNQ
Symptoms: No adverse event, Product preparation issue
Clinical narrative: administered a dose of MENACTRA that was mixed with the lyophilized component of MENVEO with no reported adverse event; Initial information received on 18-Sep-2023 regarding an unsolicited valid non-serious case received from a physician.  This case involves 16 years old male patient who was administered a dose of meningococcal A-C-Y-W135 (D CONJ) vaccine [Menactra] that was mixed with the lyophilized component of meningococcal vaccine A/C/Y/W CONJ (CRM197) [Menveo] with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included meningococcal vaccine B RFHBP/NADA/NHBA OMV (Bexsero) for Immunisation.  On 14-Sep-2023, the patient received a standard dose 1 of suspect meningococcal A-C-Y-W135 (D CONJ) vaccine [Menactra] Solution for injection at a dose of 0.5 ml total (lot number, strength, expiry date-  not reported) via intramuscular route in the left deltoid for Immunization that was mixed with the lyophilized component of meningococcal vaccine A/C/Y/W CONJ (CRM197) not produced by Sanofi Pasteur (lot number, strength, expiry date, dosage-  not reported) with no reported adverse event (product preparation error) (latency-same day). Information on the batch number was requested.  Reportedly, Caller reporting a patient was administered a dose of MENACTRA that was mixed with the lyophilized component of MENVEO. Caller asking if the dose is valid. Caller reporting she would also call GSK to see if they have any data. Menveo was given on 15-JUL-2019.  Action taken was not applicable.  At time of reporting, the outcome was Unknown for the event.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Age: 86.0
Sex: M
Vaccine: FLU4
Symptoms: Extra dose administered, No adverse event
Clinical narrative: fluzone hd that has been administered twice no reported adverse event; Initial information received on 19-Sep-2023 regarding an unsolicited valid  non-serious case received via other health professional.  This case involves a 86-year-old male patient and influenza quadrival A-B high dose HV vaccine [Fluzone High-DOSE QUADRIVALENT] that has been administered twice no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s), concomitant(s) and family history were not provided.  On 19-Sep-2023, the patient received a 0.7 ml (frequency: twice) dose of suspect influenza quadrival A-B high dose HV vaccine (strength, form: unknown) (lot: UT8057PA, expiry date: 30-Apr-2024) via intramuscular route in right side for immunization and fluzone hd that has been administered twice no reported adverse event (extra dose administered) (latency: same day).  Reportedly, Patient got the first dose on 12SEP2023 and got another dose today, 19SEP2023. No adverse reaction was reported by the patient.  it was unknown if any lab data/test results available.  Action taken with quadrivalent influenza vaccine (Fluzone High-Dose Quadrivalent) was not applicable.  Outcome: unknown    This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Age: 67.0
Sex: F
Vaccine: FLUA4, FLUA4
Symptoms: Erythema, Pruritus, Skin warm
Clinical narrative: redness and swelling , warm to the touch, 3 inches wide 2 inches long
Age: 67.0
Sex: F
Vaccine: FLUA4, FLUA4
Symptoms: Erythema, Skin warm, Swelling
Clinical narrative: redness and swelling , warm to the touch, 3 inches wide 2 inches long
Age: 49.0
Sex: F
Vaccine: COVID19
Symptoms: Syringe issue
Clinical narrative: Vaccine administration error. A large amount of liquid spilled down my arm when the technician pulled the syringe out. I am certain that I did not receive a proper dose. I tried to mention it to the technician but she just wiped up the liquid and ushered me out. I later noted it to the pharmacist on duty.
Age: 48.0
Sex: M
Vaccine: COVID19-2
Symptoms: Headache, Injection site pain, Injection site rash, Pyrexia, Rash erythematous
Clinical narrative: Slight pain and red rash around injection site-2 days ongoing Chills-12 hours after injection, lasting 1 hour Slight fever (1 degree F)-1 day after injection, lasting 12 hours Slight headache (2/10 pain scale)-1 day after injection lasting 3 hours
Sex: U
Vaccine: MMR, VARCEL
Symptoms: Inappropriate schedule of product administration, No adverse event
Clinical narrative: No symptoms or further details reported / No other AE; VARIVAX was administered to a patient 26 days after receiving a MMR II vaccination; This spontaneous case was received from a registered nurse (also reported as health business professional (HBP)) referring to a patient of unspecified age and gender. Information regarding the patient's medical history, concurrent conditions, concomitant therapies and previous drug reactions or allergies was not provided.   On 18-AUG-2023, the patient was vaccinated with a dose of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) (dose, route of administration, anatomical site of vaccination, lot# and expiration date were not reported) as prophylaxis.   On 13-SEP-2023, the patient was vaccinated with the second dose of varicella virus vaccine live (Oka/Merck) (VARIVAX) (dose, route of administration, and anatomical site of vaccination were not reported; lot# X007373 has been verified to be valid, expiration date reported and established as 12-MAR-2025) as prophylaxis. The vaccine was administered 26 days (less than 4 weeks) after receiving another live vaccine (Inappropriate schedule of product administration).   No symptoms or further details reported (no adverse event).
Age: 11.0
Sex: M
Vaccine: HPV9, MEN, TDAP
Symptoms: No adverse event, Product storage error
Clinical narrative: Temperature Excursion; No further AE; This spontaneous report was received from a medical assistant referring to a male patient of unknown age. The patient's medical history, concurrent conditions and concomitant medications were not reported.  On an unspecified date in 2023, the patient was vaccinated with diphtheria vaccine toxoid, pertussis vaccine acellular 3-component, tetanus vaccine toxoid (BOOSTRIX) (manufacturer GlaxoSmith Kline [GSK]) (lot# DD7F7, expiration date: 06-DEC-2025) administered in the left thigh, and with meningococcal vaccine a/c/y/w conj (tet tox) (MENQUADFI) (manufacturer Sanofi) (lot# U7673AA, expiration date: 29-JUN-2025) administered in the right thigh. For both vaccines, indication, strength, frequency, vaccination scheme, and route of administration were not reported.   On 17-AUG-2023, the patient was vaccinated with an improperly stored of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9)  pre-filled syringe (lot # X005578 has been verified to be a valid lot number hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast), expiration date reported and established as 30-NOV-2024), administered in the left thigh for prophylaxis (strength, dose, vaccination scheme and route of administration). The temperature of storage, time frame of the excursion, if a digital data logger was involved and if the vaccine experienced a previous temperature excursion were not reported. It was stated that vaccine was safe to use. There was no further adverse event reported.
Sex: U
Vaccine: RVX
Symptoms: Arthralgia, Bedridden, Pyrexia, Sleep disorder
Clinical narrative: Bed-ridden for the next 24 hours after the shot; Headache; joint ache; Fever; Slept on and off for a day; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of bedridden in a patient who received RSVPreF3 adjuvanted (RSV vaccine) for prophylaxis.   On an unknown date, the patient received RSV vaccine. On an unknown date, an unknown time after receiving RSV vaccine, the patient experienced bedridden (Verbatim: Bed-ridden for the next 24 hours after the shot), headache (Verbatim: Headache), joint pain (Verbatim: joint ache), fever (Verbatim: Fever) and sleep disturbance (Verbatim: Slept on and off for a day). The outcome of the bedridden was resolved (duration 24 hrs) and the outcome of the headache, joint pain, fever and sleep disturbance were resolved (duration 1 day).   It was unknown if the reporter considered the bedridden, headache, joint pain, fever and sleep disturbance to be related to RSV vaccine.     It was unknown if the company considered the bedridden, headache, joint pain, fever and sleep disturbance to be related to RSV vaccine.   Additional Information: GSK Receipt Date: 16-SEP-2023 This case was reported by a patient via interactive digital media. The patient received RSV vaccine and experienced bed ridden for the next 24 hours, headache, joint ache, fever and slept on and off for a day. Follow-up would not possible as no contact details were available.
Age: 36.0
Sex: F
Vaccine: FLU4
Symptoms: Exposure during pregnancy, No adverse event
Clinical narrative: Vaccine exposure during pregnancy with no reported adverse event; Initial information received on 14-Sep-2023 regarding an unsolicited valid non-serious case received from other health professional.  This case involves a 36-years-old female patient who was exposed to influenza quadrival A-B vaccine [Fluzone Quadrivalent] during pregnancy with no reported adverse event.  The date of last menstrual period was reported as 18-Jul-2023. The estimated due date is 28-Apr-2024. 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 14-Sep-2023, the patient received unknown Dose 1 of suspect influenza quadrival A-B vaccine, suspension for injection (batch number: UT8040NA; expiry date unknown) via intramuscular route in unknown administration site for prophylactic vaccination (immunization) during pregnancy with no reported adverse event (exposure during pregnancy) (same day latency).  It is unknown if there were lab data/results available.  Action taken: not applicable.  At time of reporting, the outcome was Unknown for the event.  Additionally, at time of reporting, the pregnancy is still ongoing.
Sex: U
Vaccine: RVX
Symptoms: Cough, Dyspnoea, Pyrexia
Clinical narrative: cough; hard to breath; Fever; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of cough in a 78-year-old patient who received RSVPreF3 adjuvanted (RSV vaccine) for prophylaxis.   On an unknown date, the patient received RSV vaccine. On an unknown date, an unknown time after receiving RSV vaccine, the patient experienced cough (Verbatim: cough), difficulty breathing (Verbatim: hard to breath) and fever (Verbatim: Fever).  The outcome of the cough, difficulty breathing and fever were resolved (duration 3 days).   It was unknown if the reporter considered the cough, difficulty breathing and fever to be related to RSV vaccine.     It was unknown if the company considered the cough, difficulty breathing and fever to be related to RSV vaccine.   Additional Information: GSK receipt date: 17-SEP-2023 and 18-SEP-2023 This case was reported the patient via interactive digital media. The patient got an RSV shot by the physician and got severe side effects cough, hard to breath, fever about 3 days.
Sex: M
Vaccine: MNQ
Symptoms: Extra dose administered, No reaction on previous exposure to drug
Clinical narrative: received 2nd dose of Menveo; This non-serious case was reported by a physician via call center representative and described the occurrence of extra dose administered in a male patient who received Men ACWY-CRM NVS (Menveo) for prophylaxis.   On an unknown date, the patient received the 2nd dose of Menveo. On an unknown date, an unknown time after receiving Menveo, the patient experienced extra dose administered (Verbatim: received 2nd dose of Menveo).  The outcome of the extra dose administered was unknown.   Additional Information: GSK Receipt Date: 16-Sep-2023 The reporter is the patient himself who was MD physician but did not see patients currently and work in Medical Education.  The patient reported that he got the Menveo vaccine 2 months ago and had no reaction to it whatsoever, not even a mild inflammation, pain or anything at all. The pharmacy where he received the vaccine felt a bit unorganized.  He did some reading and decided to wait 2 months and get a second dose just in case. However, the second dose had not produced any reaction either at all. Given that he was an MD, he would assume that if he developed any antibodies from his first dose, there would at least be some kind of reaction against the vaccine, some inflammation or pain. But he had nothing at all. He enquired if he was missing something and would love to get an answer. The patient received 2nd dose of Menveo which led to extra dose administered. The reporter consented to follow up.
Age: 0.17
Sex: F
Vaccine: UNK
Symptoms: Expired product administered, Medication error, No adverse event
Clinical narrative: inadvertent administration of an expired product to a patient with no adverse event; Initial information received on 19-Sep-2023 regarding an unsolicited valid non-serious case received from other health professional.  This case involves a 2-months-old female patient who had inadvertent administration of an expired diphtheria/tetanus/5 hybrid AC pertussis/IPV(vero)/HIB(PRP/T) vaccine [Pentacel (Vero)] with no adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included pneumococcal vaccine conj 7V (CRM197) (Prevnar); rotavirus vaccine live reassort oral 5V (Rotateq); and hepatitis B vaccine for Prophylactic vaccination (immunization).  On 19-Sep-2023, the patient inadvertently received 0.5 mL (Dose 1) of expired suspect diphtheria/ tetanus/ 5 hybrid AC pertussis/ IPV (vero)/ HIB(PRP/T) vaccine, suspension for injection (Frequency: once; Strength: standard) (batch number: U7331AA; expiry date: 16-SEP-2023) via intramuscular route in the right thigh for Immunization with no adverse event (expired product administered) (same day latency).  Action taken: not applicable.  At time of reporting, the outcome was Unknown for the event.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Immunisation reaction, Induration, Rash erythematous, Rash pruritic, Skin warm
Clinical narrative: itchy red rash, hot to touch, underlying tissue firmer than surrounding tissue beginning approx 3436 hours after vaccination; "covid arm" aka "moderna arm".  first time for patient. Itch and rash increased in severity for next 24+ hours; symptoms began to decrease slowly at about day 3; rash is still faint at day 8.    patient first, second, third vax were Pfizer;  4th, 5th, 6th vax doses  were Moderna with NO reaction reaction occurred with the new Vax approved Sept 12, 2023
Age: 63.0
Sex: F
Vaccine: RSV
Symptoms: Mobility decreased, Pain, Skin reaction, Skin warm, Swelling
Clinical narrative: Extremely red,  hot to touch,  area very swollen Pain where I can barely lift my arm  Tylenol 325 2 tablets every 6 hours  Ice pack every 15 minutes
Age: 52.0
Sex: F
Vaccine: VARZOS
Symptoms: Rash, Rash pruritic
Clinical narrative: Itchy rash on face and torso. Currently ongoing but almost fully resolved.
Age: 79.0
Sex: F
Vaccine: COVID19
Symptoms: Anticoagulant therapy, C-reactive protein, COVID-19, Chest X-ray normal, Computerised tomogram abdomen abnormal
Clinical narrative: Presented with fever, N/V, headache, myalgias; +covid in ED; CXR without infiltrate; CT abd/pelvis with possible enterocolitis; Labs: D-dimer 0.84, CRP  9.27, Ferritin  436.7 Tx: Decadron, Femdesivir, Rocephin, Maxipime, Vit C, vit D3, Lovenox, Singulair, Zinc; No supplemental O2 needed; remained on Room air during stay
Age: 79.0
Sex: F
Vaccine: COVID19
Symptoms: Fibrin D dimer, Headache, Myalgia, Nausea, Pyrexia
Clinical narrative: Presented with fever, N/V, headache, myalgias; +covid in ED; CXR without infiltrate; CT abd/pelvis with possible enterocolitis; Labs: D-dimer 0.84, CRP  9.27, Ferritin  436.7 Tx: Decadron, Femdesivir, Rocephin, Maxipime, Vit C, vit D3, Lovenox, Singulair, Zinc; No supplemental O2 needed; remained on Room air during stay
Age: 79.0
Sex: F
Vaccine: COVID19
Symptoms: SARS-CoV-2 test positive, Serum ferritin increased, Vomiting
Clinical narrative: Presented with fever, N/V, headache, myalgias; +covid in ED; CXR without infiltrate; CT abd/pelvis with possible enterocolitis; Labs: D-dimer 0.84, CRP  9.27, Ferritin  436.7 Tx: Decadron, Femdesivir, Rocephin, Maxipime, Vit C, vit D3, Lovenox, Singulair, Zinc; No supplemental O2 needed; remained on Room air during stay
Age: 18.0
Sex: M
Vaccine: HEP
Symptoms: Incorrect dose administered
Clinical narrative: Pt was given adult dose instead of pediatric
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Rash
Clinical narrative: Patient noted a rash on throat and torso, that developed post vaccination,  not painful and is subsiding as of 09/26/23 12:45PM
Age: 83.0
Sex: F
Vaccine: RSV
Symptoms: Injection site erythema, Injection site reaction, Injection site swelling, Musculoskeletal stiffness, Myalgia
Clinical narrative: sore muscles and stiffness neck thru shoulder blades and upper left arm: which is red and slightly sollen. I  had a negative Covid-19 test on Monday morning, 9/25/2023.   I contacted my PCP who prescribed 20mg prednisone/day for 2 or 3 days as needed in addition to my daily antihistamine (Zyzal/Claritin/ Zyrtec)  & Tylenol.
Age: 83.0
Sex: F
Vaccine: RSV
Symptoms: SARS-CoV-2 test negative
Clinical narrative: sore muscles and stiffness neck thru shoulder blades and upper left arm: which is red and slightly sollen. I  had a negative Covid-19 test on Monday morning, 9/25/2023.   I contacted my PCP who prescribed 20mg prednisone/day for 2 or 3 days as needed in addition to my daily antihistamine (Zyzal/Claritin/ Zyrtec)  & Tylenol.
Age: 37.0
Sex: F
Vaccine: FLU4
Symptoms: Rash, Rash pruritic
Clinical narrative: Employee received flu vaccine for the first time around 12pm.  Employee states she started to develop a rash at 10pm.  Employee states rash started on arms first then torso, then legs.  Rash began to itch the next morning.  EE took anti histamine (employee is unsure of name).  Symptoms lasted  3 days then resolved.
Age: 84.0
Sex: M
Vaccine: COVID19
Symptoms: Angiogram pulmonary normal, Back pain, C-reactive protein, COVID-19, COVID-19 pneumonia
Clinical narrative: Onset symptoms 1/25. Increase SOB. CP. Pain in middle of back. Dry cough. + covid test 1/28; Pneumonia due to COVID-19 virus; follow inflammatory markers CRP better ferritin all improving; completed remdesivir, Decadron and empiric antibiotics, discharged on doxycycline and Decadron for 3 more days per Infectious Disease recommendations; Elevated  D Dimer possibly error because only elevated for 1 day and normal after; CT angio chest and venous Dopplers negative for pulmonary embolism or venous thromboembolism; Remained on room air during stay
Age: 84.0
Sex: M
Vaccine: COVID19
Symptoms: Chest pain, Cough, Dyspnoea, Fibrin D dimer increased, Inflammatory marker test
Clinical narrative: Onset symptoms 1/25. Increase SOB. CP. Pain in middle of back. Dry cough. + covid test 1/28; Pneumonia due to COVID-19 virus; follow inflammatory markers CRP better ferritin all improving; completed remdesivir, Decadron and empiric antibiotics, discharged on doxycycline and Decadron for 3 more days per Infectious Disease recommendations; Elevated  D Dimer possibly error because only elevated for 1 day and normal after; CT angio chest and venous Dopplers negative for pulmonary embolism or venous thromboembolism; Remained on room air during stay
Age: 84.0
Sex: M
Vaccine: COVID19
Symptoms: SARS-CoV-2 test positive, Serum ferritin, Ultrasound Doppler normal
Clinical narrative: Onset symptoms 1/25. Increase SOB. CP. Pain in middle of back. Dry cough. + covid test 1/28; Pneumonia due to COVID-19 virus; follow inflammatory markers CRP better ferritin all improving; completed remdesivir, Decadron and empiric antibiotics, discharged on doxycycline and Decadron for 3 more days per Infectious Disease recommendations; Elevated  D Dimer possibly error because only elevated for 1 day and normal after; CT angio chest and venous Dopplers negative for pulmonary embolism or venous thromboembolism; Remained on room air during stay
Age: 67.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Pyrexia, Sepsis, Urinary tract infection
Clinical narrative: Workup significant for sepsis (sirs criteria met with fever T-max 103.1°, HR 103), due to acute UTI, COVID-19 infection, patient is status post 1 L sepsis fluids -normal oxygen saturation on room air on admission -will initiate Rocephin for acute UTI and obtain urine culture, blood cultures  -hold off on remdesivir as patient is not hypoxic.
Age: 60.0
Sex: F
Vaccine: FLU4
Symptoms: No adverse event, Wrong product administered
Clinical narrative: High dose Quadrivalent administered to individual less than 65 years of age. Call placed to individual 3 days following injection to inform of error. She denies any sign or symptoms of concern; no adverse reaction reported as result of error.
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Acute kidney injury, Anion gap normal, Blood creatinine increased, COVID-19, Metabolic acidosis
Clinical narrative: resides at assisted living facility, DNR, on hospice Workup significant for SIRS (HR 105, RR 24), questionable respiratory failure as patient is on supplemental oxygen on admission however no documented or reported hypoxia, positive COVID-19 infection, acute renal failure (serum creatinine 1.3 (baseline <1), normal anion gap metabolic acidosis
Sex: F
Vaccine: COVID19, COVID19
Symptoms: SARS-CoV-2 test positive, Systemic inflammatory response syndrome
Clinical narrative: resides at assisted living facility, DNR, on hospice Workup significant for SIRS (HR 105, RR 24), questionable respiratory failure as patient is on supplemental oxygen on admission however no documented or reported hypoxia, positive COVID-19 infection, acute renal failure (serum creatinine 1.3 (baseline <1), normal anion gap metabolic acidosis
Age: 98.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Chest pain, Influenza virus test negative, Legionella test, Positive airway pressure therapy
Clinical narrative: Patient is a DNR, currently tolerating BiPAP.  Started on IV steroids, bronchodilators.  Respiratory panel negative for influenza, positive for COVID-19.  Sputum culture ordered.  Check urine antigens for Legionella and strep.  Empiric treatment for CP with azithromycin and cefepime.
Age: 98.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: SARS-CoV-2 test positive, Sputum culture, Streptococcus test
Clinical narrative: Patient is a DNR, currently tolerating BiPAP.  Started on IV steroids, bronchodilators.  Respiratory panel negative for influenza, positive for COVID-19.  Sputum culture ordered.  Check urine antigens for Legionella and strep.  Empiric treatment for CP with azithromycin and cefepime.
Age: 62.0
Sex: M
Vaccine: COVID19
Symptoms: C-reactive protein normal, COVID-19, Chest X-ray abnormal, Fibrin D dimer normal, Hyponatraemia
Clinical narrative: Presented with low b/p; hyponatremia; + covid in ED; Ferritin 1676; CRP & D-dimer normal; CXR ? atypical infection vs edema; No supplemental O2 needed; Tx: Zithromax, Rocephin
Age: 62.0
Sex: M
Vaccine: COVID19
Symptoms: Hypotension, Pneumonia, Pulmonary oedema, SARS-CoV-2 test positive, Serum ferritin increased
Clinical narrative: Presented with low b/p; hyponatremia; + covid in ED; Ferritin 1676; CRP & D-dimer normal; CXR ? atypical infection vs edema; No supplemental O2 needed; Tx: Zithromax, Rocephin
Age: 29.0
Sex: F
Vaccine: UNK
Symptoms: Fatigue, Headache, Injection site pain, Lip swelling, Nausea
Clinical narrative: Initially HA, tired, nausea, sore site. Took Tylenol.  Itchy around 1600, hives and lump in throat, took Benadryl. Went home. Took more Benadryl. Had lip swelling and hives in throat. Went to UC on 9/21/23. Per UC prescribed oral Prednisone, continue with Benadryl as needed and Pepcid as needed.  Currently, all hives gone (as of Sunday, 9/24/23). Continues on meds. Advised to follow up with PCP.
Age: 29.0
Sex: F
Vaccine: UNK
Symptoms: Pruritus, Sensation of foreign body, Urticaria
Clinical narrative: Initially HA, tired, nausea, sore site. Took Tylenol.  Itchy around 1600, hives and lump in throat, took Benadryl. Went home. Took more Benadryl. Had lip swelling and hives in throat. Went to UC on 9/21/23. Per UC prescribed oral Prednisone, continue with Benadryl as needed and Pepcid as needed.  Currently, all hives gone (as of Sunday, 9/24/23). Continues on meds. Advised to follow up with PCP.
Age: 57.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Chest pain, Electrocardiogram abnormal, Headache, SARS-CoV-2 test
Clinical narrative: Presented with CP/headache; + Covid; EKG with suspected viral pericarditis; No PNA; tx with supportive care, no antibiotics; Tx: Vit C, Vit D3, Lovenox, hydroxychloroquine, singulair, zinc, prednisone; minimal supplemenat O2 during stay; on room air at d/c
Age: 57.0
Sex: M
Vaccine: COVID19
Symptoms: Viral pericarditis
Clinical narrative: Presented with CP/headache; + Covid; EKG with suspected viral pericarditis; No PNA; tx with supportive care, no antibiotics; Tx: Vit C, Vit D3, Lovenox, hydroxychloroquine, singulair, zinc, prednisone; minimal supplemenat O2 during stay; on room air at d/c
Age: 79.0
Sex: F
Vaccine: COVID19
Symptoms: Anticoagulant therapy, Atrial fibrillation, C-reactive protein, COVID-19, Cardiac arrest
Clinical narrative: Presented with AMS, mild dyspnea, tachycardia, Dx recent Covid and sepsis; Labs: D-dimer 8.31; CRP 2.87; cpmpleteed Remdesivir PTA; CXR Bilat opacities may represent infection and/or pul congestion Tx: Zithromax, Maxipime, Decadron, Rocephin, heparin; Started on levo with admission; Pt intubated on 12/15; 11/27/21 pt with RRT; intubated, levo gtt; moved to ICU; 11/28 CRRT initiated; 11/29 afib - amio gtt started; 12/7 remains on CRRT, on and off levo; remains intubated, failed weaning trials; 12/9 Changed to DNR; 12/13 off CRRT; transitioned to HD; 12/15 trach placed; eventually weaned to t-collar but then back on vent on 1/5/22; Pt continued to decline and on 1/7 went into asystole
Age: 79.0
Sex: F
Vaccine: COVID19
Symptoms: Chest X-ray abnormal, Dyspnoea, Endotracheal intubation, Fibrin D dimer, General physical health deterioration
Clinical narrative: Presented with AMS, mild dyspnea, tachycardia, Dx recent Covid and sepsis; Labs: D-dimer 8.31; CRP 2.87; cpmpleteed Remdesivir PTA; CXR Bilat opacities may represent infection and/or pul congestion Tx: Zithromax, Maxipime, Decadron, Rocephin, heparin; Started on levo with admission; Pt intubated on 12/15; 11/27/21 pt with RRT; intubated, levo gtt; moved to ICU; 11/28 CRRT initiated; 11/29 afib - amio gtt started; 12/7 remains on CRRT, on and off levo; remains intubated, failed weaning trials; 12/9 Changed to DNR; 12/13 off CRRT; transitioned to HD; 12/15 trach placed; eventually weaned to t-collar but then back on vent on 1/5/22; Pt continued to decline and on 1/7 went into asystole
Age: 79.0
Sex: F
Vaccine: COVID19
Symptoms: Haemodialysis, Haemofiltration, Intensive care, Lung opacity, Mechanical ventilation
Clinical narrative: Presented with AMS, mild dyspnea, tachycardia, Dx recent Covid and sepsis; Labs: D-dimer 8.31; CRP 2.87; cpmpleteed Remdesivir PTA; CXR Bilat opacities may represent infection and/or pul congestion Tx: Zithromax, Maxipime, Decadron, Rocephin, heparin; Started on levo with admission; Pt intubated on 12/15; 11/27/21 pt with RRT; intubated, levo gtt; moved to ICU; 11/28 CRRT initiated; 11/29 afib - amio gtt started; 12/7 remains on CRRT, on and off levo; remains intubated, failed weaning trials; 12/9 Changed to DNR; 12/13 off CRRT; transitioned to HD; 12/15 trach placed; eventually weaned to t-collar but then back on vent on 1/5/22; Pt continued to decline and on 1/7 went into asystole
Age: 79.0
Sex: F
Vaccine: COVID19
Symptoms: Mental status changes, Sepsis, Tachycardia, Tracheostomy, Weaning failure
Clinical narrative: Presented with AMS, mild dyspnea, tachycardia, Dx recent Covid and sepsis; Labs: D-dimer 8.31; CRP 2.87; cpmpleteed Remdesivir PTA; CXR Bilat opacities may represent infection and/or pul congestion Tx: Zithromax, Maxipime, Decadron, Rocephin, heparin; Started on levo with admission; Pt intubated on 12/15; 11/27/21 pt with RRT; intubated, levo gtt; moved to ICU; 11/28 CRRT initiated; 11/29 afib - amio gtt started; 12/7 remains on CRRT, on and off levo; remains intubated, failed weaning trials; 12/9 Changed to DNR; 12/13 off CRRT; transitioned to HD; 12/15 trach placed; eventually weaned to t-collar but then back on vent on 1/5/22; Pt continued to decline and on 1/7 went into asystole
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Aspiration pleural cavity, Atelectasis, C-reactive protein, Chest X-ray abnormal, Computerised tomogram thorax abnormal
Clinical narrative: Presented with increasing dyspnea over 2-3 weeks; CXR with mod pleural effusion and/or infiltrate/atelectasis; Labs: D-dimer 3.14; CRP 4.89; Ferritin 195; Tx: Maxipime, vit C, Decadron, Zithromax, Vit D3, Lovenox, Zinc; Minimal supplemental O2 via NC; back to room air by d/c; pt with thoracentesis on 1/19; pleural fluid was exudative; sent for cytology; CT chest with pulm nodules, right sided pleural based masses, bulky mediastinal lymphadenopaty and multiple liver lesions all concerning for metastatic disease.
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Cytology, Dyspnoea, Fibrin D dimer, Hepatic lesion, Lung infiltration
Clinical narrative: Presented with increasing dyspnea over 2-3 weeks; CXR with mod pleural effusion and/or infiltrate/atelectasis; Labs: D-dimer 3.14; CRP 4.89; Ferritin 195; Tx: Maxipime, vit C, Decadron, Zithromax, Vit D3, Lovenox, Zinc; Minimal supplemental O2 via NC; back to room air by d/c; pt with thoracentesis on 1/19; pleural fluid was exudative; sent for cytology; CT chest with pulm nodules, right sided pleural based masses, bulky mediastinal lymphadenopaty and multiple liver lesions all concerning for metastatic disease.
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Lymphadenopathy, Pleural effusion, Pleural mass, Pulmonary mass, Serum ferritin normal
Clinical narrative: Presented with increasing dyspnea over 2-3 weeks; CXR with mod pleural effusion and/or infiltrate/atelectasis; Labs: D-dimer 3.14; CRP 4.89; Ferritin 195; Tx: Maxipime, vit C, Decadron, Zithromax, Vit D3, Lovenox, Zinc; Minimal supplemental O2 via NC; back to room air by d/c; pt with thoracentesis on 1/19; pleural fluid was exudative; sent for cytology; CT chest with pulm nodules, right sided pleural based masses, bulky mediastinal lymphadenopaty and multiple liver lesions all concerning for metastatic disease.
Age: 74.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Full blood count, Muscle spasms, Pain, Pyrexia
Clinical narrative: Started with rash from neck and shoulder down back on left side. Severe pain, fever, chills. Symptoms ongoing, skin feels like it is burning and spasms. Three weeks later not resolved. Trying an increase in gabapentin dosing for pain. Valcyclovir given as well.
Age: 74.0
Sex: F
Vaccine: VARZOS
Symptoms: Rash, Skin burning sensation
Clinical narrative: Started with rash from neck and shoulder down back on left side. Severe pain, fever, chills. Symptoms ongoing, skin feels like it is burning and spasms. Three weeks later not resolved. Trying an increase in gabapentin dosing for pain. Valcyclovir given as well.