chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: I avoid getting covid until last February, when she had Covid and it was very mild because I vaccinated so much; I avoid getting covid until last February, when she had Covid and it was very mild because I vaccinated so much; This is a spontaneous report received from a Consumer or other non HCP from medical information team.  An elderly female patient received BNT162b2 (BNT162B2 NOS), as dose number unknown, single (Batch/Lot number: unknown), in arm for covid-19 immunisation. The patient's relevant medical history included: "asthma" (unspecified if ongoing); "type 2 diabetes" (unspecified if ongoing); "Overweight" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Feb2023, outcome "unknown" and all described as "I avoid getting covid until last February, when she had Covid and it was very mild because I vaccinated so much". Clinical course: Reporter was concerned as was at very high risk, she was over 65 years old, and very overweight, and have asthma and type 2 diabetes, and had a wedding to go in 2 weeks, where she would not be wearing a mask. Patient was careful, and avoided getting covid until last February, when she had Covid and it was very mild because she vaccinated so much, had all the boosters, only ever used Pfizer, didn't mix them up, had every vaccine and was supposed to get, except the booster last spring because she felt safe enough and thought this was going to be a once a year thing and used a mask even when nobody else was using a mask.  Batch/lot number is not provided, and it cannot be obtained.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202400288956 Same patient/same product, different dose/event;
Sex: F
Vaccine: COVID19
Symptoms: Chills
Clinical narrative: chills a couple of times and lasts within 24 hours after vaccine administration; This is a spontaneous report received from a Consumer or other non HCP from medical information team.  A female patient received BNT162b2 (BNT162B2 NOS), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: CHILLS (non-serious), outcome "recovered", described as "chills a couple of times and lasts within 24 hours after vaccine administration". Additional information: Patient has been administered with Pfizer COVID-19 Vaccines ever since 2021, her last dose was on 23Sep2023. She experienced chills a couple of times and lasts within 24 hours after vaccine administration.  Batch/lot number is not provided, and it cannot be obtained.
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: his wife received the COVID vaccine and has experienced long COVID symptoms since then; his wife received the COVID vaccine and has experienced long COVID symptoms since then; This is a spontaneous report received from a Pharmacist.  An adult female patient (not pregnant) received BNT162b2 omicron (kp.2) (COMIRNATY (2024-2025 FORMULA)), as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "recovered with sequelae" and all described as "his wife received the COVID vaccine and has experienced long COVID symptoms since then". It was unknown if therapeutic measures were taken as a result of drug ineffective, covid-19. Clinical course: Husband disclosed that his wife received the COVID vaccine and has experienced long COVID symptoms since then.  The information on the batch/lot number for [BNT162B2 OMICRON (KP.2)] has been requested and will be submitted if and when received.; Sender's Comments: Based on the information currently available, a lack of efficacy with BNT162b2 omicron (kp.2) in this patient cannot be completely excluded.   Long COVID symptoms are known sequelae of COVID-19 some patients would experience after acute COVID 19 infection.
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: COVID positive 26Dec2023; COVID positive 26Dec2023 (symptomatic); This is a spontaneous report received from a Nurse.  A 66-year-old female patient received BNT162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Covid-19 Asymptomatic", start date: Oct2020 (unspecified if ongoing); "Asthma" (ongoing), notes: Seasonal controlled. Started 20 years ago; "osteoarthritis" (ongoing), notes: Started 10 years ago; "obesity" (ongoing), notes: Started 40 years ago; "essential hypertension-controlled" (ongoing), notes: Started 30 years ago; "depression" (ongoing), notes: Started at 55 years; "PTSD" (ongoing), notes: Started at 55 years; "Anxiety" (ongoing), notes: Started at 55 years; "Insomnia" (ongoing), notes: Started at 40 years; "GERD" (ongoing), notes: Started 10 years; "restless leg syndrome" (ongoing), notes: Started at 60 years; "OCD" (ongoing), notes: Started at 55 years; "Diverticulosis" (ongoing), notes: Started 10 years; "total left knee replacement", start date: Oct2020 (not ongoing); "Known allergies: Benzene" (unspecified if ongoing); "Known allergies: NSAIDS" (unspecified if ongoing); "chronic iron deficiency" (unspecified if ongoing); "UGI bleed x3" (unspecified if ongoing); "Gastric bypass surgery", start date: 2001, stop date: 2001; "pericarditis", start date: 2008 (unspecified if ongoing). The patient's concomitant medications were not reported. Past drug history included: Oral iron, reaction(s): "allergies". Vaccination history included: BNT162b2 (DOSE 1, SINGLE), administration date: 09Apr2021, when the patient was 63-year-old, for covid-19 immunization; Bnt162b2 (DOSE 2, SINGLE), for covid-19 immunization; Bnt162b2 (DOSE NUMBER UNKNOWN (BOOSTER), SINGLE), for covid-19 immunization. The following information was reported: DRUG INEFFECTIVE (medically significant) with onset 26Dec2023, outcome "unknown", described as "COVID positive 26Dec2023"; COVID-19 (medically significant) with onset 26Dec2023, outcome "unknown", described as "COVID positive 26Dec2023 (symptomatic)". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (26Dec2023) positive. Clinical Course: Patient had received all Pfizer vaccines and boosters since 09Apr2021. No known contact with any infectors individuals. Husband not ill.; Sender's Comments: Vaccine efficacy varies from person to person and is subject to many other factors. The association between the event lack of effect (COVID-19) with COMIRNATY (2023-2024 FORMULA) can not be fully excluded.,Linked Report(s) : US-PFIZER INC-202400260494 Same reporter/patient/vaccine, different dose/event.;
Sex: M
Vaccine: COVID19
Symptoms: Pruritus, Vaccination site bruising
Clinical narrative: Very itchy; injection site bruising; This is a spontaneous report received from a Consumer or other non HCP from License Party. Other Case identifier(s): 2023SA294794 (SANOFI), AE-016224 (BIONTECH).  A 73-year-old male patient received BNT162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 12Sep2024 as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation; dupilumab (DUPIXENT), since 28Jun2023) at 300 mg (300 mg, qow (every other week)), subcutaneous for dermatitis atopic. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: PRURITUS (non-serious) with onset 12Sep2024, outcome "unknown", described as "Very itchy"; VACCINATION SITE BRUISING (non-serious), outcome "unknown", described as "injection site bruising". The action taken for dupilumab was unknown.  Additional information: Three days before he is due for Dupixent, he starts itching and getting red spots (red spotty rash), (therapeutic response shortened), itching. He received vaccine on 12Sep2024, later that evening he started to get very itchy. Itching gradually tapered and last about 4-5 days. Couple of times after injecting himself, will get a bruise that will go away a day or two later (injection site bruising).  No follow-up attempts are possible. Batch/lot number is not provided, and it cannot be obtained.
Sex: U
Vaccine: COVID19
Symptoms: Ageusia, Anosmia
Clinical narrative: Patient lost taste and smell; Patient lost taste and smell; This is a spontaneous report received from a Consumer or other non HCP from medical information team, Program ID.  A patient (age and gender not provided) received BNT162b2 (BNT162B2 NOS), as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 nos (DOSE 1, SINGLE), for Covid-19 immunization; Bnt162b2 nos (DOSE 2, SINGLE), for Covid-19 immunization. The following information was reported: AGEUSIA (non-serious), ANOSMIA (non-serious), outcome "not recovered" and all described as "Patient lost taste and smell".  Additional information: The patient have had six of Pfizer COVID-19 Vaccine covid shots, After the third, patient lost taste and smell and still have none.  The information on the batch/lot number for BNT162b2 will be requested and submitted if and when received.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202400291189 Same Reporter/Patient/Drug/AE, Vaccine Dose;US-PFIZER INC-202400291190 Same Reporter/Patient/Drug/AE, Vaccine Dose;US-PFIZER INC-202400291191 Same Reporter/Patient/Drug/AE, Vaccine Dose;
Sex: U
Vaccine: PNC15
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional AE; HCP called to report T/E for VAXNEUVANCE (PFS) HCP stated it was administered to 7 patient.; This spontaneous report was received from a medical assistant and refers to a patient of unknown age and gender.  The patient's medical history, concurrent conditions, and concomitant therapies were not reported.  On 06-SEP-2024, a temperature excursion occurred at 13 C for 6 hours. On 10-OCT-2024, the patient was vaccinated with an improperly storage dose of pneumococcal 15v conj vaccine (crm197) (VAXNEUVANCE) injection, lot #X026480, expiration date: 12-JAN-2026, administered for prophylaxis (strength, dose, frequency, and route of administration were not provided) (Product storage error). No previous temperature excursion was reported. No additional adverse event reported.  This is one of several reports received from the same reporter. ; Sender's Comments:  US-009507513-2410USA012969: US-009507513-2410USA013415:
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: Arthritis, Rheumatoid factor, Rheumatoid factor increased
Clinical narrative: Inflamed hand joints and high RF factor (46); Inflamed hand joints and high RF factor (46); This is a spontaneous report received from a Consumer or other non HCP.  A 55-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 30Apr2021 as dose 2, single (Batch/Lot number: unknown) at the age of 55 years, in arm for covid-19 immunisation. The patient's relevant medical history included: "Hereditary spherocytosis" (unspecified if ongoing); "Known allergies: Penicillin" (unspecified if ongoing). There were no concomitant medications. Vaccination history included: Covid-19 vaccine (DOSE 1, MANUFACTURER UNKNOWN), for COVID-19 Immunization. The following information was reported: ARTHRITIS (non-serious), RHEUMATOID FACTOR INCREASED (non-serious) all with onset 15May2021, outcome "recovering" and all described as "Inflamed hand joints and high RF factor (46)". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were taken as a result of arthritis, rheumatoid factor increased. Clinical Course: No other vaccine on same date, no other vaccine in four weeks, and no other medications in two weeks.
Sex: U
Vaccine: COVID19
Symptoms: Arthralgia, Chills, Diarrhoea, Headache
Clinical narrative: Diarrhea; Joint pain; Headache; Chills; This is a spontaneous report received from a Consumer or other non HCP.  A patient (age and gender not provided) received BNT162b2 omicron (kp.2) (COMIRNATY (2024-2025 FORMULA)), as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DIARRHOEA (non-serious), outcome "unknown", described as "Diarrhea"; ARTHRALGIA (non-serious), outcome "unknown", described as "Joint pain"; HEADACHE (non-serious), outcome "unknown"; CHILLS (non-serious), outcome "unknown". Batch/lot number is not provided, and it cannot be obtained.  Additional information: Reporter was just calling to follow-up (further clarification unknown), it said if you have any adverse reaction of this Covid, you can follow-up. The reporter was just trying to follow-up on it because it said that somebody can get decreased appetite, diarrhea, vomiting and dizziness. Reporter stated that I am reading the information off of the form about the side effects, that's all I was stating. When probed the clarify about the side effects that reporter is reporting, reporter stated, "Diarrhea, joint pain, headache, chills.  Batch/lot number is not provided, and it cannot be obtained.
Sex: M
Vaccine: COVID19
Symptoms: Malaise
Clinical narrative: typically sick a good part of the day/felt not good; This is a spontaneous report received from a Consumer or other non HCP. Other Case identifier(s): MOC20241022000048 (Moderna).  A male patient received BNT162b2 (BNT162B2 NOS), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: MALAISE (non-serious), outcome "recovered", described as "typically sick a good part of the day/felt not good". Additional information: In the past, a couple times, the patient has gotten reactions the following day where he was typically sick a good part of the day/felt not good, then he was okay after that.  No follow-up attempts are possible. Batch/lot number is not provided, and it cannot be obtained.
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: Consumer got COVID despite getting COVID vaccine; Consumer got COVID despite getting COVID vaccine; This is a spontaneous report received from a Consumer or other non HCP, Program ID.  An elderly male patient received BNT162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "recovered" and all described as "Consumer got COVID despite getting COVID vaccine". The reporter has not considered event as caused by suspect product. No follow-up attempts are possible. Batch/lot number is not provided, and it cannot be obtained.
Age: 61.0
Sex: F
Vaccine: FLU3
Symptoms: Burning sensation, Sensitive skin
Clinical narrative: Burning and sensitive to touch. irritated by clothing.  has removed all jewelry
Age: 25.0
Sex: M
Vaccine: HEP
Symptoms: No adverse event, Underdose
Clinical narrative: Hep B pediatric dose given instead of adult dose. no adverse reaction noted or reported. There were no adverse events.
Age: 49.0
Sex: F
Vaccine: HEPAB
Symptoms: Dizziness, Immediate post-injection reaction, Pallor
Clinical narrative: patient immediately felt dizzy and light-headed as if she was going to pass-out as soon as vaccine was given. She got very pale too. She was put on the floor and laid there for approximately 20 minutes until she felt better.
Age: 68.0
Sex: F
Vaccine: PNC20, RSV
Symptoms: Extra dose administered, No adverse event
Clinical narrative: Vaccine of Prevnar 20 should not have been given. This is the second one that was given in the past year. Pt did not have any adverse reactions to the vaccine and was made aware this was her second one and shouldn't have been given.
Age: 4.0
Sex: M
Vaccine: DTAPIPV
Symptoms: Chills, Fear, Hallucination, visual, Tremor
Clinical narrative: Patient woke up in the middle of the night (early 29th) with shaking all over his body and rattling of his teeth. Parent administered chewable ibuprofen and it subsided after 10-15 minutes. Patient then complained of being scared and seeing "many moving colors and other things with his eyes closed as well as open. It went on for about 2 hours before he finally went to sleep and in the morning he felt normal."
Age: 51.0
Sex: F
Vaccine: UNK
Symptoms: Hypoaesthesia, Paraesthesia
Clinical narrative: TM called to report she had a Flu shot vaccine done on 10/28/24 by a Flu champion at work. TM stated her lower face was numb on 10/28/24 and progressively got worse over the next few days, as to where head and neck went numb.  TM spoke to her doctor on 10/31/24 who told her to go to a walk-in clinic. TM went to ED instead of walk in clinic  on 10/31/24 where she was given IV fluids and Benadryl and was told to come back if symptoms worsen. TM will f/u with her PCP. TM stated is better but still has a little numbness and tingling.
Age: 24.0
Sex: M
Vaccine: COVID19, FLU3
Symptoms: Fall, Lip haemorrhage, Tooth fracture
Clinical narrative: Patient came in for 2 vaccines. Got the Spikevax vaccine in his right arm first, then got the Flucelax vaccine in the left arm. Patient didn't state he was feeling ill once the vaccines were complete. He got up to move out of the vaccine room so the next person can begin their process. The next patient got one of the two vaccines they were here for, when the pharmacist administering the vaccines heard a loud noise. No employees witnessed the incident. It was around a five-minute window from when he was done with his vaccines to when he fell down. He was bleeding from his lower lip and broke a tooth.
Age: 36.0
Sex: F
Vaccine: COVID19, COVID19, FLU3
Symptoms: No adverse event, Underdose
Clinical narrative: Patient is an adult and received a pediatric dose of 0.25ml of Moderna vaccine 6mo-11yrs and fluzone seasonal vaccine. Patient responded well and feels fine. Had to discuss with medical director about dose error and read guidelines per CDC. See below. Product and dosage  Lower-than-authorized dose administered (e.g., leaked out of the syringe, equipment failure, recipient pulled away, incorrect product resulting in lower-than-authorized dose). Repeat dose immediately (no minimum interval). However, if a half-volume dose of vaccine is administered to a recipient recommended for the full volume, another half-volume dose can be administered on the same clinic day, and the 2 doses can count as 1 full dose.  Because of this, we re-administered the second half using another pediatric dose of 0.25ml. Patient responded well to second dose and was very happy to receive full amount. Patient was monitored, no other side effects were reported in 15 mins observation.
Age: 74.0
Sex: M
Vaccine: FLU3
Symptoms: Extra dose administered, Feeling cold
Clinical narrative: The patient received a second flu vaccine this flu season. The first on 9/25/24 and the second on 10/23/24. Patient complained of feeling sick (cold) after receiving the second one.
Age: 18.0
Sex: F
Vaccine: MNQ
Symptoms: Extra dose administered, No adverse event
Clinical narrative: Patient was given dose of Menquadfi on 10/22/2024. However, she already received 2 doses (10/04/2017 and 03/14/2023). The dose given on 10/22/24 was an extra dose. Pt is doing well, advised as per the provider that there will be no harm to the patient.
Age: 27.0
Sex: F
Vaccine: FLU3
Symptoms: Arthralgia, Inflammation, Mobility decreased, Neck pain
Clinical narrative: Patient saying she had a reaction to the flu shot she received from us yesterday. She states she woke up this morning a had a lot of shoulder and neck pain and could barely move her neck. She went to ER today and they told her that it was a major inflammatory response to the vaccine. She is feeling better now and is able to move her neck and shoulders much better. She said the ER told her this is a very rare reaction and she just wanted to report it. ER dr prescribed toradol, valium, and zofran.
Age: 34.0
Sex: F
Vaccine: FLU3
Symptoms: Ocular discomfort
Clinical narrative: Patient called stating her left eye was pulsating for at least ten minutes with no other signs of swelling/redness. Told her to seek medical attention should symptoms persist.
Age: 7.0
Sex: M
Vaccine: COVID19
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: Incorrect vaccine administered. Patient should have received pediatric COVID vaccine however they received the adult Pfizer vaccine
Age: 40.0
Sex: M
Vaccine: COVID19
Symptoms: No adverse event, Underdose
Clinical narrative: Pt given pediatric dose of Moderna (6 months - 11 years old) instead of 12+ dose. Pt informed of error from RN. Pt advised to get 2nd dose to complete dosage and will reschedule with Clinic. Pt had no adverse reactions.
Age: 10.0
Sex: M
Vaccine: COVID19
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: Adult dose was inadvertently given to 10 year old when vaccine is authorized for 12 year old.
Age: 81.0
Sex: M
Vaccine: COVID19
Symptoms: Anaemia, Blood urine present, Cardiac failure congestive, Chills, Dehydration
Clinical narrative: Patient had chills and was shivering on the evening of 10/16/24 in the evening, and went to bed not feeling well.  He woke up in the middle of the night and had trouble getting out of bed, fell down.  EMTS were called and he was taken to  Hospital.  Discharged not long after getting there without a Dx.  On 10/17/24, he went to an urgent care and was Dx with dehydration upon discharge.  Later on 10/17/24 he went to Hospital.  After a 6 day hospital stay, was diagnosed with blood in urine (unknown cause), kidney failure (unsure of stage), and congestive heart failure.  He was also severely anemic.  Patient said that during his 6 day hospital stay, he did not mention he had the Moderna vaccine on 10/16/24.
Age: 81.0
Sex: M
Vaccine: COVID19
Symptoms: Fall, Malaise, Middle insomnia, Mobility decreased, Renal failure
Clinical narrative: Patient had chills and was shivering on the evening of 10/16/24 in the evening, and went to bed not feeling well.  He woke up in the middle of the night and had trouble getting out of bed, fell down.  EMTS were called and he was taken to  Hospital.  Discharged not long after getting there without a Dx.  On 10/17/24, he went to an urgent care and was Dx with dehydration upon discharge.  Later on 10/17/24 he went to Hospital.  After a 6 day hospital stay, was diagnosed with blood in urine (unknown cause), kidney failure (unsure of stage), and congestive heart failure.  He was also severely anemic.  Patient said that during his 6 day hospital stay, he did not mention he had the Moderna vaccine on 10/16/24.
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Pain, Paraesthesia, Rash pruritic
Clinical narrative: tingling in arms and legs and hands
Age: 7.0
Sex: F
Vaccine: HEPA, HPV9, TDAP
Symptoms: No adverse event, Product administered to patient of inappropriate age, Wrong product administered
Clinical narrative: Theis 7-year-old patient was mistakenly given HPV9, instead of a dose #3 of IPV. Client had no negative reactive to the HPV9 vaccine during the 15 minute waiting period post-vaccination, nor since the vaccine was administered. Clinical Nurse Supervisor, informed the family of the mistake (10/31), and informed them of the need for a follow-up appointment to receive the correct vaccine, IPV#3.
Age: 51.0
Sex: F
Vaccine: FLU3
Symptoms: Dyspnoea, Fatigue, Influenza virus test, Pyrexia, SARS-CoV-2 test
Clinical narrative: Fatigue, fever, shortness of breath within 5 hours of getting vaccine. Went to urgent care today.
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test positive
Clinical narrative: Sx of Covid - positive Covid test   Started on Paxlovid,
Age: 31.0
Sex: M
Vaccine: FLU3
Symptoms: Impaired work ability, Urticaria
Clinical narrative: I received Sanofi Pasteur Fluzone Trivalent Pre-filled syringe Lot# U8486BA from facility in Left Deltoid on 10/23/24. The next day around 6:00 pm two hives broke out onto my face. I took zyrtec allergy medicine as that was the only allergy medication at my house.  The initial two hive spots disappeared by the next day however two different spots manifested the next day. This has now been ongoing for a week as I type this message. I have visited Urgent Care Clinics and missed a week from work as a result of this injection. I am currently taking Benadryl and using a Benadryl anti-itch cream. As I type this message I currently have hives on my face.
Age: 73.0
Sex: M
Vaccine: PNC20
Symptoms: Condition aggravated, Dizziness, Headache
Clinical narrative: Dizziness and headache. Patient has to take tylenol every 6 hours for headache, dizziness is constant not improving with meclizine. Doctor also prescribed benadryl to see if it helps
Age: 75.0
Sex: M
Vaccine: COVID19
Symptoms: Blood albumin, Blood phosphorus, Chest X-ray, Chest pain, Dyspnoea exertional
Clinical narrative: Short of breath with exertion and 2 sharp chest pains. Treated with albuterol with improvement. Started on maintenance inhaler
Age: 75.0
Sex: M
Vaccine: COVID19
Symptoms: Electrocardiogram, Full blood count, Metabolic function test, Troponin
Clinical narrative: Short of breath with exertion and 2 sharp chest pains. Treated with albuterol with improvement. Started on maintenance inhaler
Age: 16.0
Sex: M
Vaccine: FLUN3
Symptoms: Cough, Headache, Influenza A virus test positive, Influenza B virus test positive, Oropharyngeal pain
Clinical narrative: Started having a sore throat 2 days later(Fri. night), progressed to fever, headaches,cough and congestion. Still has low grade fever and cough on the 31st
Age: 16.0
Sex: M
Vaccine: FLUN3
Symptoms: Pyrexia, Respiratory tract congestion
Clinical narrative: Started having a sore throat 2 days later(Fri. night), progressed to fever, headaches,cough and congestion. Still has low grade fever and cough on the 31st
Age: 56.0
Sex: F
Vaccine: VARZOS
Symptoms: Contusion, Erythema, Pain in extremity, Peripheral swelling, Pruritus
Clinical narrative: UPPER ARM IS WARM, SWOLLEN, RED, BRUISED, ITCHY AND SORE
Age: 56.0
Sex: F
Vaccine: VARZOS
Symptoms: Skin warm
Clinical narrative: UPPER ARM IS WARM, SWOLLEN, RED, BRUISED, ITCHY AND SORE
Age: 21.0
Sex: F
Vaccine: FLU3
Symptoms: Dizziness, Fall
Clinical narrative: patient received shot and felt faint and dizzy afterwards. Patient fell off chair and briefly rested on ground
Age: 10.0
Sex: F
Vaccine: COVID19, FLU3
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: Vaccine administration error, patient is 10 years old, she was given the vaccine for  >12 year old dose.  The error has been reported to Pfizer safety, report #.
Age: 51.0
Sex: M
Vaccine: VARZOS
Symptoms: Unevaluable event
Clinical narrative: Warm showers, tylenol
Age: 90.0
Sex: F
Vaccine: FLU3
Symptoms: Extra dose administered
Clinical narrative: Duplicate Fluad vaccine administered. Previously vaccinated on 9/4/2024
Age: 90.0
Sex: M
Vaccine: FLU3
Symptoms: Injection site pain
Clinical narrative: Patient said he has pain in the injection site for about a week
Age: 65.0
Sex: F
Vaccine: FLU3, UNK
Symptoms: Gingival swelling, Oral mucosal blistering, Tongue blistering
Clinical narrative: Blisters in mouth  and on tongue, swelling around teeth. Started on Oct 15, 2024 and lasted until Oct 26,2024. ValACYclovir 1 gm. three times daily was taken for 7 days. It took the swelling down.
Age: 64.0
Sex: M
Vaccine: COVID19
Symptoms: Underdose
Clinical narrative: Pt had presented to the facility on Saturday 10/26/24 at 10:20AM where he was administered a pediatric dose of COVID-19.  When attempting to document vaccine administration in medical record the error was recognized. Due to limited management on Saturday I was unable to notify manager right away. I left all appropriate information (who, what, when, where and how) with our Clinical Quality Specialist to follow up on when she returned to clinic on Monday 10/28/24. When I returned to clinic Tuesday 10/29/24 I received an email from her with the appropriate steps that needed to be taken. First I submitted an Event Report to my Dept. manager. Second I notified the patient via telephone and documented this in his medical record. Lastly I submitted VAERS online with this electronic reporting system.
Age: 66.0
Sex: F
Vaccine: COVID19, FLU3
Symptoms: Rash, Rash erythematous
Clinical narrative: RED RASH ON ARM
Age: 78.0
Sex: F
Vaccine: FLU3
Symptoms: Immediate post-injection reaction, Injected limb mobility decreased, Injection site pain, Pain, Pain in extremity
Clinical narrative: Immediately when getting my shot, the injection burned the entire time.   Moved my arm around as instruction.  When I got home, my arm hurt.  The pain/discomfort got worse as the day went on.  Difficulty sleeping   Used Ice pack alternating with warmth.  Also took Ibuprofen.  Difficulty sleeping.  Limited use of arm and mobility.  At times throbbing pain from Shoulder to elbow. Tingling lower part of arm and fingers.  Saw Dr. and he said ice packs, no heat. Take ibuprofen and Tylenol.  Didn't provide much relief.  Still very painful and limited mobility.  Called for stronger pain meds because not sleeping.  It was one week before I received meloxicam.  That didnt help any more than over the counter meds.  Called to get appointment again. Doctor out of office.  Saw him 3 days later. He gave me steroid shot which does seem to help.  Pain level definitely better but still painful and hurts with movement. Have to plan my arm movement in advance or have shooting pain.  I also sought help T-shock treatment.  Really felt good at the time of treatment.   When received the steroid injection, doctor ask I postpone additional T-shock treatment for a week or so.  Not sure what's next.  Possible physical therapy.  Don't know if doctor is planning ultrasound or MRI.  Not sure if I could lay flat for an MRI at this time.  Still hurting but not near as bad as before the steroid injetion.
Age: 78.0
Sex: F
Vaccine: FLU3
Symptoms: Paraesthesia, Sleep disorder
Clinical narrative: Immediately when getting my shot, the injection burned the entire time.   Moved my arm around as instruction.  When I got home, my arm hurt.  The pain/discomfort got worse as the day went on.  Difficulty sleeping   Used Ice pack alternating with warmth.  Also took Ibuprofen.  Difficulty sleeping.  Limited use of arm and mobility.  At times throbbing pain from Shoulder to elbow. Tingling lower part of arm and fingers.  Saw Dr. and he said ice packs, no heat. Take ibuprofen and Tylenol.  Didn't provide much relief.  Still very painful and limited mobility.  Called for stronger pain meds because not sleeping.  It was one week before I received meloxicam.  That didnt help any more than over the counter meds.  Called to get appointment again. Doctor out of office.  Saw him 3 days later. He gave me steroid shot which does seem to help.  Pain level definitely better but still painful and hurts with movement. Have to plan my arm movement in advance or have shooting pain.  I also sought help T-shock treatment.  Really felt good at the time of treatment.   When received the steroid injection, doctor ask I postpone additional T-shock treatment for a week or so.  Not sure what's next.  Possible physical therapy.  Don't know if doctor is planning ultrasound or MRI.  Not sure if I could lay flat for an MRI at this time.  Still hurting but not near as bad as before the steroid injetion.
Age: 76.0
Sex: M
Vaccine: FLU3
Symptoms: Injected limb mobility decreased, Pain in extremity, X-ray
Clinical narrative: Patient reported severe pain in right  arm for first 3 days. He also reported having trouble moving his arm.  He went to clinic and was x-rayed and examined, I am not sure when he was seen at the providers office. He reported all this to me on 10/31/2024.  He reported he was given oral steroids and the problem has resolved.
Age: 67.0
Sex: F
Vaccine: FLU3
Symptoms: Headache, Pyrexia
Clinical narrative: Fever102.4,  headache
Age: 33.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal pain upper, Chest pain, Fatigue, Lymphadenopathy, Pyrexia
Clinical narrative: Extremely swollen lymph nodes, left side, from knee to clavicle. Fever 101.2. LUQ pain. Chest pain. Fatigue.
Age: 79.0
Sex: F
Vaccine: FLU3
Symptoms: No adverse event
Clinical narrative: Patient did not have any adverse reaction at this moment.
Age: 31.0
Sex: M
Vaccine: ANTH
Symptoms: Arthralgia, Bone pain, Chest discomfort, Dyspnoea, Myalgia
Clinical narrative: Muscle pain, chest tightness, shortness of breath, teeth pain and bone/joint pain
Age: 31.0
Sex: M
Vaccine: ANTH
Symptoms: Toothache
Clinical narrative: Muscle pain, chest tightness, shortness of breath, teeth pain and bone/joint pain
Age: 77.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Back pain, Fatigue, Flatulence, Pain in extremity
Clinical narrative: Severe pain in lower back, right hip and thigh, stomach gas,  for about 18 hours. Fatigue for about 40 hours
Age: 6.0
Sex: M
Vaccine: DTAP, HIBV, IPV, PNC15
Symptoms: Injection site mass
Clinical narrative: Knot in Rt lateral thigh
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Antinuclear antibody increased, Antiphospholipid syndrome, Blood pressure increased, Cardiac monitoring, Cerebrovascular accident
Clinical narrative: Vaccine 5/8/2021. In < 24 hours of getting the vaccine? on 5/9/21. She woke up with visual hallucinations which lasted 15-30 minutes.  She then was emotional for 60? after that. This occurred daily until the end of September 2021.     She saw neurology.  She started to have CVAs in October 2021.    July/August 2021 saw neurologist, Dr.  She was started on Depkaote which caused extreme fatigue.   EEG at that time was negative.    Dr  did 24 hour ambulatory EEG which was negative.   10/21: She had first time CVA symptoms which involved left arm and leg. She was hypertensive at the time.  A few days after the symptoms she went to Trauma Center and she was told that she had had 3 strokes.     10/21: She had 3 separate CVAs. Her body would go numb.   Body went numb.  It was temporary -- quick.  Could have been pinched nerve and watched BP and BP was up.  Left side went numb arm and leg but not face for 5' numbness. BP 180/?? Went to UC after a few days and then ER. They told her she had had 3 strokes. They did MRI.  6/24: MRI showed 2 old CVAs and now 3 new ones.  Spouse said it looked okay in the mirror.  Spouse remembers the face looking normal.    6/27/24: She had another CVA.  Dr neurologist said she had a stroke on left and a previous one in 2021 right frontal and left occipital.    CT angiogram 6/24: demonstrated Fibromuscular dysplasia.     MRI 6/24: showed: 3 very small tiny areas.  Anterior and posterior circulation: right frontal, right cerebellum, left occipital.   9/6/24: Dr, Neurologist: told her she has had a total of 10 CVAs. He ordered a cardiac monitor.  She did it for 10 days and was supposed to do it for 30 days. Dr wants her to try again and have a 30 day monitor.     Lupus SLE 1988 first diagnosed and then rechecked in 2022. No sx. ANA was high and now has lupus and sjogrens and anti phospholipid syndrome.  Emotional and psychological stress since receiving the vaccine and dealing with all the diagnoses.  Loss of livelihood.  Hasn?t been able to do her work since that time.
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Computerised tomogram abnormal, Electroencephalogram normal, Emotional disorder, Fibromuscular dysplasia, Hallucination, visual
Clinical narrative: Vaccine 5/8/2021. In < 24 hours of getting the vaccine? on 5/9/21. She woke up with visual hallucinations which lasted 15-30 minutes.  She then was emotional for 60? after that. This occurred daily until the end of September 2021.     She saw neurology.  She started to have CVAs in October 2021.    July/August 2021 saw neurologist, Dr.  She was started on Depkaote which caused extreme fatigue.   EEG at that time was negative.    Dr  did 24 hour ambulatory EEG which was negative.   10/21: She had first time CVA symptoms which involved left arm and leg. She was hypertensive at the time.  A few days after the symptoms she went to Trauma Center and she was told that she had had 3 strokes.     10/21: She had 3 separate CVAs. Her body would go numb.   Body went numb.  It was temporary -- quick.  Could have been pinched nerve and watched BP and BP was up.  Left side went numb arm and leg but not face for 5' numbness. BP 180/?? Went to UC after a few days and then ER. They told her she had had 3 strokes. They did MRI.  6/24: MRI showed 2 old CVAs and now 3 new ones.  Spouse said it looked okay in the mirror.  Spouse remembers the face looking normal.    6/27/24: She had another CVA.  Dr neurologist said she had a stroke on left and a previous one in 2021 right frontal and left occipital.    CT angiogram 6/24: demonstrated Fibromuscular dysplasia.     MRI 6/24: showed: 3 very small tiny areas.  Anterior and posterior circulation: right frontal, right cerebellum, left occipital.   9/6/24: Dr, Neurologist: told her she has had a total of 10 CVAs. He ordered a cardiac monitor.  She did it for 10 days and was supposed to do it for 30 days. Dr wants her to try again and have a 30 day monitor.     Lupus SLE 1988 first diagnosed and then rechecked in 2022. No sx. ANA was high and now has lupus and sjogrens and anti phospholipid syndrome.  Emotional and psychological stress since receiving the vaccine and dealing with all the diagnoses.  Loss of livelihood.  Hasn?t been able to do her work since that time.
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Hypertension, Hypoaesthesia, Impaired work ability, Laboratory test, Magnetic resonance imaging head abnormal
Clinical narrative: Vaccine 5/8/2021. In < 24 hours of getting the vaccine? on 5/9/21. She woke up with visual hallucinations which lasted 15-30 minutes.  She then was emotional for 60? after that. This occurred daily until the end of September 2021.     She saw neurology.  She started to have CVAs in October 2021.    July/August 2021 saw neurologist, Dr.  She was started on Depkaote which caused extreme fatigue.   EEG at that time was negative.    Dr  did 24 hour ambulatory EEG which was negative.   10/21: She had first time CVA symptoms which involved left arm and leg. She was hypertensive at the time.  A few days after the symptoms she went to Trauma Center and she was told that she had had 3 strokes.     10/21: She had 3 separate CVAs. Her body would go numb.   Body went numb.  It was temporary -- quick.  Could have been pinched nerve and watched BP and BP was up.  Left side went numb arm and leg but not face for 5' numbness. BP 180/?? Went to UC after a few days and then ER. They told her she had had 3 strokes. They did MRI.  6/24: MRI showed 2 old CVAs and now 3 new ones.  Spouse said it looked okay in the mirror.  Spouse remembers the face looking normal.    6/27/24: She had another CVA.  Dr neurologist said she had a stroke on left and a previous one in 2021 right frontal and left occipital.    CT angiogram 6/24: demonstrated Fibromuscular dysplasia.     MRI 6/24: showed: 3 very small tiny areas.  Anterior and posterior circulation: right frontal, right cerebellum, left occipital.   9/6/24: Dr, Neurologist: told her she has had a total of 10 CVAs. He ordered a cardiac monitor.  She did it for 10 days and was supposed to do it for 30 days. Dr wants her to try again and have a 30 day monitor.     Lupus SLE 1988 first diagnosed and then rechecked in 2022. No sx. ANA was high and now has lupus and sjogrens and anti phospholipid syndrome.  Emotional and psychological stress since receiving the vaccine and dealing with all the diagnoses.  Loss of livelihood.  Hasn?t been able to do her work since that time.
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Neurological symptom, Scan with contrast abnormal, Sjogren's syndrome, Stress
Clinical narrative: Vaccine 5/8/2021. In < 24 hours of getting the vaccine? on 5/9/21. She woke up with visual hallucinations which lasted 15-30 minutes.  She then was emotional for 60? after that. This occurred daily until the end of September 2021.     She saw neurology.  She started to have CVAs in October 2021.    July/August 2021 saw neurologist, Dr.  She was started on Depkaote which caused extreme fatigue.   EEG at that time was negative.    Dr  did 24 hour ambulatory EEG which was negative.   10/21: She had first time CVA symptoms which involved left arm and leg. She was hypertensive at the time.  A few days after the symptoms she went to Trauma Center and she was told that she had had 3 strokes.     10/21: She had 3 separate CVAs. Her body would go numb.   Body went numb.  It was temporary -- quick.  Could have been pinched nerve and watched BP and BP was up.  Left side went numb arm and leg but not face for 5' numbness. BP 180/?? Went to UC after a few days and then ER. They told her she had had 3 strokes. They did MRI.  6/24: MRI showed 2 old CVAs and now 3 new ones.  Spouse said it looked okay in the mirror.  Spouse remembers the face looking normal.    6/27/24: She had another CVA.  Dr neurologist said she had a stroke on left and a previous one in 2021 right frontal and left occipital.    CT angiogram 6/24: demonstrated Fibromuscular dysplasia.     MRI 6/24: showed: 3 very small tiny areas.  Anterior and posterior circulation: right frontal, right cerebellum, left occipital.   9/6/24: Dr, Neurologist: told her she has had a total of 10 CVAs. He ordered a cardiac monitor.  She did it for 10 days and was supposed to do it for 30 days. Dr wants her to try again and have a 30 day monitor.     Lupus SLE 1988 first diagnosed and then rechecked in 2022. No sx. ANA was high and now has lupus and sjogrens and anti phospholipid syndrome.  Emotional and psychological stress since receiving the vaccine and dealing with all the diagnoses.  Loss of livelihood.  Hasn?t been able to do her work since that time.
Age: 1.0
Sex: F
Vaccine: VARCEL, VARCEL
Symptoms: Expired product administered
Clinical narrative: No reported signs/symptoms of adverse effects from dose; MTM transferred HCP regarding expired VARIVAX that was administered to a patient on 10/07/2024. No reported signs/symptoms of adverse effects from dose. Limited information was provided. Permission to contact HCP was given. No additional AE/no PQC.; This spontaneous report was received from a medical assistant referring a 1-year-old female patient.  The patient's pertinent medical history, past drug reactions or allergies, and concurrent conditions were not provided. Concomitant therapies included Measles, Mumps, and Rubella (Wistar RA 27-3) Virus Vaccine, Live (M-M-R II) and influenza vaccine (FLUZONE).  On 07-OCT-2024 (reported as Saturday), the patient was vaccinated with an expired dose of varicella virus vaccine live (Oka/Merck) (VARIVAX) injection, first dose, administered intramuscularly (IM) in her left vastus lateralis, lot number: W031812 and expiration date: 05-OCT-2024 (strength and exact dose were not reported)(Expired product administered); along with the first dose of Measles, Mumps, and Rubella (Wistar RA 27-3) Virus Vaccine, Live (M-M-R II) injection, administered IM in her right vastus lateralis, lot number: X026404 and expiration date: 08-NOV-2025 (strength and exact dose were not reported); and with influenza vaccine (FLUZONE) second dose, administered IM in her right vastus lateralis, lot number: U8 and expiration date: 30-JUN-2025 (strength and exact dose were not reported); all vaccines administered as prophylaxis at Private Doctor's Office/Hospital. No reported signs or symptoms of the adverse effects from dose. No additional adverse event (no adverse event). Additionally, no temperature excursion occurred as a result of a reading from a digital data logger.
Age: 1.0
Sex: F
Vaccine: VARCEL, VARCEL
Symptoms: Expired product administered, No adverse event
Clinical narrative: No reported signs/symptoms of adverse effects from dose; MTM transferred HCP regarding expired VARIVAX that was administered to a patient on 10/07/2024. No reported signs/symptoms of adverse effects from dose. Limited information was provided. Permission to contact HCP was given. No additional AE/no PQC.; This spontaneous report was received from a medical assistant referring a 1-year-old female patient.  The patient's pertinent medical history, past drug reactions or allergies, and concurrent conditions were not provided. Concomitant therapies included Measles, Mumps, and Rubella (Wistar RA 27-3) Virus Vaccine, Live (M-M-R II) and influenza vaccine (FLUZONE).  On 07-OCT-2024 (reported as Saturday), the patient was vaccinated with an expired dose of varicella virus vaccine live (Oka/Merck) (VARIVAX) injection, first dose, administered intramuscularly (IM) in her left vastus lateralis, lot number: W031812 and expiration date: 05-OCT-2024 (strength and exact dose were not reported)(Expired product administered); along with the first dose of Measles, Mumps, and Rubella (Wistar RA 27-3) Virus Vaccine, Live (M-M-R II) injection, administered IM in her right vastus lateralis, lot number: X026404 and expiration date: 08-NOV-2025 (strength and exact dose were not reported); and with influenza vaccine (FLUZONE) second dose, administered IM in her right vastus lateralis, lot number: U8 and expiration date: 30-JUN-2025 (strength and exact dose were not reported); all vaccines administered as prophylaxis at Private Doctor's Office/Hospital. No reported signs or symptoms of the adverse effects from dose. No additional adverse event (no adverse event). Additionally, no temperature excursion occurred as a result of a reading from a digital data logger.
Age: 76.0
Sex: F
Vaccine: RSV, RSV
Symptoms: Erythema, Pruritus, Rash, Skin warm
Clinical narrative: Patient Developed Red Bright Red Rash with big Bumps the next day after receiving the vaccine. Rash very uncomfortable for pt. Went to primary care doctor & is being referred to an Allergist
Age: 76.0
Sex: F
Vaccine: RSV, RSV
Symptoms: Discomfort, Rash erythematous
Clinical narrative: Patient Developed Red Bright Red Rash with big Bumps the next day after receiving the vaccine. Rash very uncomfortable for pt. Went to primary care doctor & is being referred to an Allergist
Age: 82.0
Sex: F
Vaccine: COVID19, COVID19, FLU3, RSV
Symptoms: Amnesia, Asthenia, Decreased appetite, Dizziness, Dysstasia
Clinical narrative: Immunizations administered 9/25/24. On 10/3/24, patient was suffering from leg numbness and lack on strength. She was unable to walk. After going to the emergency room she was admitted to inpatient care. On 10/8/24 she was admitted to a rehab facility and was discharged on 10/24/24.  She is continuing rehab from home.  She is still has leg numbness and weakness and is unable to walk without the aid of a walker.  She will be seen in Mid-October for a test to rule out Gullain-Barre Syndrome.
Age: 82.0
Sex: F
Vaccine: COVID19, COVID19, FLU3, RSV
Symptoms: Fatigue, Gait inability, Laboratory test, Urinary incontinence
Clinical narrative: Immunizations administered 9/25/24. On 10/3/24, patient was suffering from leg numbness and lack on strength. She was unable to walk. After going to the emergency room she was admitted to inpatient care. On 10/8/24 she was admitted to a rehab facility and was discharged on 10/24/24.  She is continuing rehab from home.  She is still has leg numbness and weakness and is unable to walk without the aid of a walker.  She will be seen in Mid-October for a test to rule out Gullain-Barre Syndrome.
Age: 82.0
Sex: F
Vaccine: COVID19, COVID19, FLU3, RSV
Symptoms: Gait disturbance, Gait inability, Hypoaesthesia, Muscular weakness, Walking aid user
Clinical narrative: Immunizations administered 9/25/24. On 10/3/24, patient was suffering from leg numbness and lack on strength. She was unable to walk. After going to the emergency room she was admitted to inpatient care. On 10/8/24 she was admitted to a rehab facility and was discharged on 10/24/24.  She is continuing rehab from home.  She is still has leg numbness and weakness and is unable to walk without the aid of a walker.  She will be seen in Mid-October for a test to rule out Gullain-Barre Syndrome.