chrisvoncsefalvay/vaers-outcomes huggingface dataset:
trouble breathing; felt bad; Vomit; This spontaneous case was reported by a patient and describes the occurrence of DYSPNOEA (trouble breathing), FEELING ABNORMAL (felt bad) and VOMITING (Vomit) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced DYSPNOEA (trouble breathing), FEELING ABNORMAL (felt bad) and VOMITING (Vomit). At the time of the report, DYSPNOEA (trouble breathing), FEELING ABNORMAL (felt bad) and VOMITING (Vomit) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No relevant concomitant medications were reported.  Treatment information was not provided.; Sender's Comments: Very limited information regarding these events has been provided at this time. No further information is expected at this time as patient didn't give consent for follow up
w/in approx 1/2hr p/vax pt c/o itchy @ lt inner forearm (from elbow distally to wrist area) observed sl small rough area on inner arm;no SOB, blurred vision, diff breathing observed;speech clear;
The patient waited in the store after receiving the vaccine as was instructed. After shopping she became lightheaded and dizzy/weak while checking out. She needed assistance to sit down and reported nausea. Paramedics were called, she was evaluated and taken to the hospital in an ambulance as a precaution.
fever 101.4; This is a spontaneous report from a contactable other healthcare professional (patient). A 54-year-old female patient started to receive second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot number: EL1284), intramuscular on 12Jan2021 12:00 PM at single dose on the left arm for COVID-19 immunization. The patient is not pregnant. The patient has no known drug allergies (NKDA). There were no medical history and concomitant medications. No other vaccines in four weeks and no other medications in two weeks. No COVID prior vaccination. The patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot number: EJ1685) intramuscular on  22Dec2020 12:00 PM on the left arm. Facility type vaccine was hospital. On 13Jan2021 12:00 PM, the patient experienced fever 101.4. No treatment for the event. Outcome of the event was recovered in Jan2021. Patient was not tested for COVID post vaccination.
Gout flare up in right foot, big toe joint.  Took colchicine and mobic at 10 PM on the same day which helped.  Took a subsequent dose of the same in the morning.
This situation is reported as a medication error due to temperature excursion that exceeded the stability data documented in the local labelling and additional supporting stability data with no reported adverse event; administered to patient with no reported adverse event; Initial information received on 12-Oct-2022 regarding an unsolicited valid  non-serious case received from a consumer/non-hcp.  This case involves a 59 years old and unknown gender patient and it was reported that this situation is reported as a medication error due to temperature excursion that exceeded the stability data documented in the local labelling and additional supporting stability data with no reported adverse event and administered to patient with no reported adverse event while receiving vaccine INFLUENZA QUADRIVAL A-B VACCINE [FLUZONE QUADRIVALENT].  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On an unknown date, this situation is reported as a medication error due to temperature excursion that exceeded the stability data documented in the local labelling and additional supporting stability data with no reported adverse event (product storage error)   On 22-Sep-2022 the patient received an unknown dose of suspect INFLUENZA QUADRIVAL A-B VACCINE (formulation, strength, route: unknown) lot UJ899AA, expiration date: 30-Jun-2023 in unknown administration site as Immunization.  On 22-SEP-2022 the vaccine was administered to patient with no reported adverse event (poor quality product administered) same day following the administration of INFLUENZA QUADRIVAL A-B VACCINE.  Action taken was not applicable.  It was not reported if the patient received a corrective treatment for the events (This situation is reported as a medication error due to temperature excursion that exceeded the stability data documented in the local labelling and additional supporting stability data with no reported adverse event, administered to patient with no reported adverse event).  At time of reporting, the outcome was Unknown for all.  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.
In evening swelling of eyes, face, mouth 11-03-05 still swollen 11-04-05.  Client was instructed to go to Physician took Benadryl 11-04-05 and went to school.  Sent home from school to go to Dr. 11/04/05.
Neck meets the back of the head on both sides; This spontaneous case was reported by a consumer and describes the occurrence of MUSCULOSKELETAL DISCOMFORT (Neck meets the back of the head on both sides) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 15-Jun-2021, the patient experienced MUSCULOSKELETAL DISCOMFORT (Neck meets the back of the head on both sides). At the time of the report, MUSCULOSKELETAL DISCOMFORT (Neck meets the back of the head on both sides) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No relevant concomitant medications were reported. No treatment information was provided.   This case was linked to MOD-2021-222262 (Patient Link).
Information has been received from a nurse practitioner referring to a patient of unknown age and gender. No relevant medical history or concurrent conditions were reported. On 15-OCT-2014 the patient was vaccinated with 0.65ml dose of ZOSTAVAX (lot# and expiration date not reported) subcutaneously. On 26-MAR-2015 the patient was inadvertently vaccinated with a second 0.65ml of ZOSTAVAX (lot# and expiration date not reported), subcutaneously. No adverse effects were reported. Additional information has been requested.
Headache, severe body aches, malaise, nausea, diarrhea.
pt awoke from nap, lips, hands & feet were blue & teeth chattering, shivering;didn't' have fever initially then devel 101.6, was restless, awakening frequently w/T;in AM pt fine;
Injection site pain was very mild.  Symptoms began the next day with joint pain from my waist to my knees but most concentrated in the knees.   I describe it as suffering some sort of trauma and it was accompanied by crushing fatigue.   Symptoms have improved but persist until today 03/29/2021: knee pain, weakness in the knees and fatigue.   Difficulty functioning normally: walking, ascending & descending stairs and simply standing in place.   Symptoms worsen at night, knees become frozen and have to be adjusted with hands.
86 year old lady with hx PAF, sinus on eliquis, remote synope 2019, HTN, HLD, osteoporosis, glaucoma with right eye blindness, mantle cell lymphoma remotely, was in usual state of health up until 3 weeks ago her gait declined, used to walk with cane but has been weaker and has been wheelchair bound since. In the meantime her daughter-lives elsewhere and the son who lives with her noted her to be more confused and not herself, she is normally alert and oriented, has not been eating or drinking for the past week or so because she did not want to get out of the wheelchair to use the bathroom -did not want to burden her family to help. She got more confused and lethargic and was voiding small amounts of dark concerntrated urine.
Client presented to Clinic on 11/1/2022 for COVID-19 Moderna 12+ Bivalent Booster (0.5mL dose). Client inadvertently received COVID-19 Moderna 12+ Monovalent (0.5mL dose). Following CDC guidance, the recommendation is that providers may administer 1 bivalent booster dose as a repeat dose based on clinical judgement and patient preference. If a repeat dose is given it must be adminstered at least 2 months after the dose given in error.
On 1/28/2021, I woke from my sleep with legs cramps and muscle pain.  I went to the toliet to urinate and began to have multiple bowel movement.  I began to feel nauseated and very cold with shortness of breath and my heart racing.  I cleaned up, washed my hands and proceeded to check my temperature it read 91.5, I continue to check it and it continue to read 91.5.  I drank water and orange juice thinking it was my blood sugar.  I began to feel dizzy but did not want to lay flat on my bed due to the shortness of breath.  My heart rate was 120.  I checked my blood pressure it was 180/120.  I was fearful of shock.  I continued to pace and warm up with blankets and a space heater.  I took a warm bath and my temperature increased to 97.7.  I continued to feel my pulse racing.  I called Dr. office and got an appointment to see her 8:30 am 1/29/2021.  She checked my vitals signs B/P  - 143/87, P 80, T 98.1 O2Sat 99, heart and lungs.  She did labs and urinalysis.  She prescribed Clonidine 0.1mg TID take if BP greater 160/90 and Allergra 180 mg QD prn for itch and reaction.  I will return to see her 2/5/2021.
Soreness, inflamation, partial paralysis and muscle atrophy at vaccination site (upper right arm). In ability to raise arm above shoulder height.  Fully normal use of right arm returned after 4-5 months.  Still have "depression" in muscle at vaccine site.
This spontaneous report was received from a medical assistant and refers to a 12-month-old patient of unknown gender. The patient's pertinent medical history, concomitant medications and drug reactions or allergies were not reported. On 16-SEP-2016, the patient received an improperly stored dose of VARIVAX injection (lot # M002063 with expiration date at 12-JAN-2018; dose and route of administration were not reported). The administered dose of vaccine was exposed to a temperature of -3.5 degrees Celsius (C) for 1 hour and 6 minutes. No previous temperature excursion was reported. Data logger was used to track the temperature. No symptoms were reported. No product quality complaint (PQC) was involved. This is one of several reports received from the same reporter. Additional information is not expected as all relevant information has been received.; Sender's Comments:  US-009507513-1610USA011133:
Tinnitus started abruptly about 2 hours after my shot. I have had very low level tinnitus in the past, off and on. This was 1-2 levels more. 10 days later, the tinnitus became more pronounced, to the point where it affecting my ability to focus when working.
In August 2021 I started experiencing a nasal sounding voice and around October 2021 I started wheezing. My mother was in hospice at this time and I may have contracted COVID while staying there but I was never diagnosed and did not have any other symptoms. I started seeing a pulmonologist and had a CT scan that showed ground glass in my lungs, like white dots on my lungs, and was told it was typical in people who have had COVID. I started on a medication that has helped my wheezing, but I still sound like I am congested.
received Infanrix instead of Boostrix; 13 year old received Infanrix; This case was reported by a other health professional via call center representative and described the occurrence of wrong vaccine administered in a 13-year-old female patient who received DTPa (Infanrix) (batch number 7KM94, expiry date 10th June 2023) for prophylaxis.   Co-suspect products included dtpa vaccine pre-filled syringe device (Infanrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 29th April 2022, the patient received Infanrix and Infanrix Pre-Filled Syringe Device. On 29th April 2022, unknown after receiving Infanrix and Infanrix Pre-Filled Syringe Device, the patient experienced wrong vaccine administered and inappropriate age at vaccine administration. On an unknown date, the outcome of the wrong vaccine administered and inappropriate age at vaccine administration were unknown.     This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK receipt date: 29-Apr-2022 Reporter's comment: Medical assistant reported that on the day of reporting 13 years old patient received Infanrix instead of Boostrix. Consented to follow-up. Additional Supportive Information: The patient received Infanrix instead of Boostrix, which led to wrong vaccine administered and inappropriate age at vaccine administration. This one of two linked case, reported by same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2022071959:Same reporter
8th day after vaccination, the area surrounding the  injection site  (2" x 3") became red and itchy.  On the 10th day (today) the area is about the same dimensions and a little less red and itchy.
This spontaneous case was reported by a consumer and describes the occurrence of OFF LABEL USE (Off label use) in a 77-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. Concurrent medical conditions included Arthritis and Anaemia. Concomitant products included CELECOXIB (CELEBREX) for Arthritis.On 22-Aug-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In August 2021, the patient experienced OFF LABEL USE (Off label use). In August 2021, OFF LABEL USE (Off label use) had resolved. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available)On an unknown date, Red blood cell count decreased: low (Low) Anemic. On an unknown date, White blood cell count: low (Low) Low.Patient states that also she takes an unknown medication to treat anemia and her healthcare provider advised her to get the third dose out of caution due to the medical conditions she has received third dose. She received first dose on JAN 2021 and Second dose on 09FEB2021. No concomitant medications were provided by reporter. No treatment medications were provided by reporter.Reporter did not allow further contact
Pregnant woman received the Fluarix Qiv; This prospective pregnancy case was reported by a nurse via call center representative and described the occurrence of vaccine exposure during pregnancy in a 34-year-old female patient who received Flu Seasonal QIV Dresden (Fluarix Quadrivalent 2022-2023 season) (batch number 4L5YX, expiry date 30th June 2023) for prophylaxis.   Co-suspect products included flu seasonal qiv dresden pre-filled syringe device (Fluarix Tetra Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 6th October 2022, the patient received Fluarix Quadrivalent 2022-2023 season and Fluarix Tetra Pre-Filled Syringe Device. The patient's last menstrual period was on an unknown date and estimated date of delivery was 1st January 2023. The patient received Fluarix Quadrivalent 2022-2023 season at an unknown time during the pregnancy. On an unknown date, unknown after receiving Fluarix Quadrivalent 2022-2023 season and Fluarix Tetra Pre-Filled Syringe Device, the patient experienced vaccine exposure during pregnancy. On an unknown date, the outcome of the vaccine exposure during pregnancy was unknown. The pregnancy was ongoing.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK Receipt Date: 06-Oct-2022 Reporter's Comments: The onsite nurse was reporting for documentation of the registry of pregnant woman that received the Fluarix Qiv. No other reactions were reported. The vaccine administration facility was the same as primary reporter.
On day 6 post vaccine pt woke up with swelling of upper lip. Took OTC loratidine. Denies difficulty breathing, emesis, throat itching. No hives noted.   No prior hf of allergies. No new foods. No new meds
pt recv vax 15APR95; lt arm became very swollen by 18APR95; tx Seldane; had episode of fainting, fever & hypotension on 11MAY95 requiring hospitalization; pt still has urticaria;
Lack OF Response - Information has been received from a registered nurse concerning a 26 year old while female reqistered nurse who on an unspecified date was vaccinated with a first and second dose of measles virus vaccine live (+) mumps virus vaccine live (+) rubella virus vaccine live (second generation).  Subsequently, the patient was tested only for antibodies to rubelin which were  negative.  The patient sought unspecified medical attention.  Follow up information received on 19 sep 2000 from a physician's assistant indicated that on 15 sept 2000 the patient received a third dose of rubella virus vaccine live (second generation no further information is available.
starting 10NOV92 have had hives every evening (mod to severe cases); no resp involvement just itching;
This spontaneous report as received from a certified medical assistant and from a healthcare worker refers to a patient of unknown age and gender. On 21-AUG-2014 the patient was vaccinated with (Oka/Merck) VARIVAX (dose, units, route of administration, anatomical location were not reported) which had been exposed to a supported temperature excursion on 15-AUG-2014. No adverse events were observed or reported. This is one of several reports from the same reporter. Additional information has been requested.
Fever up to 102.5 degrees F starting 7 days after MMR vaccine, rash starting 8 days after vaccine.
Patient and caregiver in today for routine B12 injection, she's been getting these for a few months now. Caregiver brings up the fact that this patient's left arm at region of injection of her Flu shot in October was quite sore for a month or so, and still continues to have some tenderness even now, almost 2 months later. Site is not red, hot, swollen, and without bulge or bruising. She says now there is no palpable pain during  the peak of concern after vaccination, nor upon physical inspection today.  Caregiver reports that with her cognitive issues, she wasn't very concerned at first but after a couple of weeks of complaining of arm soreness daily after injection, she believes it's not a fixation or other confusion related issue.  Neither caregiver, patient, nor myself, have reason for immediate concern. I offered to report this for her and she and caregiver agreed.
soreness in his right arm; nasal congestion; running nose and sniffing; This is a spontaneous report from a contactable consumer (patient himself).  A 72-year-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, lot/Batch number: unknown) via an unspecified route of administration on 12Apr2021 as a single dose for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. On an unknown date, (after having breakfast today), the patient experienced soreness in his right arm, nasal congestion and running nose, sniffing and was annoyed by it. Patient was asking whether he can talk a medication with acetaminophen in it because he read on the fact sheet that Acetaminophen should be avoided after getting the shot. The patient further stated that he had 2 types of medicine now (Goodsense Nasal Decongestant and Cold & Flu day relief). The cold and flu day relief has Acetaminophen in it. Patient wants to know which medicine was safe to take now. The outcome of the events was unknown.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
body aches and pains for a week; This spontaneous report was received from a healthcare worker via a company representative referring to a 12 years old female patient. The patient's concurrent conditions included anxiety. Her medical history, concomitant therapies and drug reactions/allergies were not reported.    On an unknown date in 2018, reported as a year ago, the patient was vaccinated with the first dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) (lot# and expiration date were not reported), intramuscularly for unknown indication. Subsequently, the patient experienced body aches and pains for a week. No treatment was given for the event. No lab diagnostics/studies were performed. The patient did not seek medical attention. The outcome of the event was reported as resolved.   The causality between the event and the suspect vaccine was not reported.
This spontaneous report as received from a pharmacist refers to a 55 year old female patient with no drug reactions/allergies. Patients pertinent medical history was none. On 13-AUG-2013, the patient was vaccinated with ZOSTAVAX (lot # J001002, expiry date 25-APR-2014, route and dose were not reported). Concomitant therapies included simvastatin. On 15-AUG-2013, the patient developed fever as high as 101.7F and experienced gastrointestinal upset. The patient sought medical attention (contacted pharmacist). The event fever was treated with MOTRIN. The outcome of gastrointestinal upset and fever was reported as not recovered/not resolved. Additional information has been requested.
Odd sensation on tongue shortly after vaccination.  By the next day issues with taste - diminished and foods tasted "off".  The taste issues largely resolved within 7-10 days.  (Some fatigue on days 2-4 after vaccine.) Due to taste issue, had a covid test which was negative.  The sensation on the tongue is always present but sometimes feels like a sore in a particular location, sometimes, feels like the tongue was burned by a hot beverage, and sometimes is just a vague sense of discomfort. Typically on the left side (shot in left arm), sometimes in the middle, rarely on right.  Location is tip of tongue or the top of tongue near tip.   Have seen Family Medicine Doctor who thought taste buds were inflamed. Dentist and ENT have said tongue/mouth look normal on exam. Family Medicine doctor and ENT said to report as possible vaccine side effect, and ENT stated that he believes vaccine is cause.
Patient came in for reaction to Tetanus shot red, swollen, rash on left arm.
Pt recvd 1st Engerix-B vax on 16OCT91 & w/in a few days to 1 wk exp joint pain which is persisting; vax series indicated as not discontinued;
Got shot on Mar 29. Mar 30 felt very tired and entire body ached. Mar 31 had hives all over right thigh with one blister, hives above left knee, injection site sore, red and warm to touch.