chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Information has been received from a pharmacist referring to a 60 year old female patient. The patient had unspecified reaction to fluoxetine. On 10-JAN-2016 the patient was vaccinated with a regular dose of ZOSTAVAX (lot # L015414, expiration date 01-AUG-2016, subcutaneous, vaccination site unknown). There was no concomitant medication. On an unknown date in 2016 (reported as a few days later) the patient experienced that the injection site was swollen and red. The pharmacist reported that patient saw an unspecified healthcare provider, who prescribed out of the counter (OTC) calamine lotion and other unspecified products, which the patient did not use. The pharmacist reported that "a week or so later" (on an unknown date in 2016) the patient experienced a purplish rash over her total body. Both injection site swelling and redness and the rash resolved with no treatment, on unspecified dates in 2016. The pharmacist reported that the patient was prescribed steroid eye drops, for an unspecified reason, on 08-FEB-2016, and received fluorometholone (adverse event). The outcome of the adverse event was unknown. Additional information has been requested.
Patient felt dizzy and hot for about 5-10 minutes. Gave some water to sip on and a cold pack to place on chest and she felt better in a couple minutes.
pt recvd vax & devel an abscess; reported was not sure of the location of the abscess;
On March 2, 2021, I received my first dose of the Moderna covid vaccine.  On the same day a few hours later, I had a red rash on my left arm close to the injection site.  Within two weeks, more similar red patches developed on my hips.  By two weeks, the rash had spread to my chest, arms, torso, back, neck, and thighs and legs. After the initial rash on my arm persisted, I applied lotrimin, which did not make a difference.  I visited an urgent care when the rash began spreading, and I was prescribed prednisone, which also did not help.  I spoke with a doctor on a telehealth appointment, and he said that it looked like an allergic reaction - he prescribed triamcinolone topical 0.1% topical cream, which didn't seem to help.  I visited a dermatologist in April.  He told me that it looked like asteatotic eczema, and it may have been caused by the moderna vaccine.  I have never experienced having eczema before this.  He also prescribed triamcinolone topical 0.1% topical cream, which I told him I tried and it didn't seem to help.  He then told me how to properly apply it so that the skin absorbs the medication, and it involved taking quick, cold showers, using a piece of wet pillow case to wet the rash, applying the cream, and then applying moisturizer on top.  This process did help over a few weeks, and the rash eventually went away.  However, it left stretch marks on areas that I had the rash and applied the cream.
shoulder became very sore several hours after injection, to the point where I could barely lift my arm, lasted about 48hours. also  about 8 hours after injection got chills, slight fever and body aches which lasted about 36 hours
LIPS TURNED BLUE; OXYGEN DROPPED TO 80; HANDS AND FEET TURNED BLUE; NIGHT OF MISERY; This spontaneous report received from a consumer via a company representative concerned a female of unspecified age. The patient's weight, height, and medical history were not reported.The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unk) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported. On an unspecified date, the subject experienced lips turned blue, oxygen dropped to 80, hands and feet turned blue, and night of misery. Laboratory data (dates unspecified) included: Oxygen saturation (NR: not provided) dropped to 80. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the lips turned blue, oxygen dropped to 80, hands and feet turned blue and night of misery was not reported. This report was non-serious.
Went out to dinner the evening after the vax.  Had 2 alcoholic drinks with dinner.  Following dessert, became extremely nauseous.  Walked across the street to the car and sat down nearby on the curb while family members tried to locate a bag in case of vomiting.  Fainted (unobserved by family members).  Walked to car and got in.  Fainted again, about 30 seconds duration.  Spouse drove home (about 30 min) with patient laying on the floor of the vehicle.  Considered ER room, but felt that ill advised on a Saturday night.  Upon arriving at home, walked into the entry way of the house and laid on the floor for a few minutes.  Then walked to the restroom and induced vomiting.  Felt marginally better and went to sleep.  No additional nausea, vomiting, or fainting the next day, but did feel "off".
Patient's wife called at 12:30 pm on 11/25 and stated that patient had a rash that started in the underarm and traveled a little down the arm. She stated the rash looked like little pimples with minor itching. I recommended that he take some BENADRYL. I spoke with them again at 1:20 pm.  She stated that the rash was not spreading and itch had decreased. Spoke with her again and 4:40 pm and she stated that the rash was going away. Spoke with them again at 9:30 am on 11/26 and wife stated that rash was almost completely gone and he was not having any symptoms.
Soreness at injection site.  Fatigue Body aches Chills  Only took ibuprofen   Rested   Symptoms lasted about 18hrs
DTAP on 1/13/11 - Evening of 1/14/11 redness & swelling to left upper arm - 1/15/11 - swelling & redness to elbow.
The day after I received the vaccine I had pain in arm pit of arm that received the vaccine. I felt like I was coming down with the flu, aching, cold, muscle pain, chills. I don't know if I had fever. I didn't check. After soaking in a hot tub I still felt cold. I took 2 Tylenol Arthritis and about 2 hours later my skin was hot - almost like I did have a fever. On the second day (today) I still have some pain in my arm pit. However, all of the other symptoms have not reappeared.
Suspected vaccinia auto inoculation.  Received smallpox vaccine 2/24/03.  Symptoms started 2/13/03, red dots on abdomen.  2 weeks to form blister.  3/10/03 returned to clinic, 3/30/03 abdomen blisters started to "ooze".
This spontaneous report as received from a pharmacist via Pfizer Inc. (Reference # 2015346733) refers to a patient of unknown age and gender. Concurrent conditions and medical history were not reported. The pharmacist reported that a few years ago, the patient was vaccinated with a dose of PNEUMOVAX 23 (Lot number, expiration date, dose and route were not provided). Concomitant medication was not reported. On an unknown date, the patient experienced pain in extremity and peripheral swelling reported as "sore and swollen arm". The outcome of pain in extremity and peripheral swelling was unknown at the time of the report. The reporter did not assess the relatedness of PNEUMOVAX 23 to pain in extremity and peripheral swelling. Additional information is not expected because the reporter declined additional information to document adverse event (AE).
This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. A 43-year-old male patient received BNT162b2 (BNT162B2), as dose 2, single (Batch/Lot number: unknown) at the age of 43 years, in left arm for Covid-19 immunisation; CoviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown) for Covid-19 immunisation. The patient's relevant medical history included: "known allergies: Sulfa drugs" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "Pfizer / BioNTech: Dose Number: 2; Pfizer: Treatment of COVID-19". Therapeutic measures were taken as a result of drug ineffective, Covid-19. Clinical course: It was unknown whether patient took other medications in 2 weeks. The patient received Paxlovid from 10May2022 for treatment of COVID-19. On 11 May2022, the patient experienced swollen throat and horrible metallic aftertaste. The patient stopped Paxlovid 15May2022. Follow-up attempts are completed. No further information is expected.
very bad taste in his mouth and numbness in his throat; very bad taste in his mouth and numbness in his throat; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A patient (no qualifiers provided) received bnt162b2 (BNT162B2), administration date 06Apr2021 (Lot number: Not Provided) as dose 1 single for covid-19 immunisation. Relevant medical history included: "bronchitis" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: TASTE DISORDER (non-serious), HYPOAESTHESIA (non-serious), outcome "unknown" and all described as "very bad taste in his mouth and numbness in his throat".  No follow-up attempts are possible. No further information is expected.
bells palsy; This is a spontaneous report received from a contactable reporter(s) (Nurse). The reporter is the patient.  A 57-year-old female patient (not pregnant) received bnt162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 22Sep2023 at 15:45 as dose 5, single (Lot number: HG4628) at the age of 57 years intramuscular, in left arm for covid-19 immunisation. The patient's relevant medical history included: "diabetes type 2" (unspecified if ongoing). The patient had no known allergies. The patient didn't have covid prior vaccination and was not tested post vaccination. Concomitant medication(s) included: METFORMIN; SYNJARDY; TRULICITY. The patient didn't receive other vaccine in four weeks. Vaccination history included: moderna covid-19 vaccine (Dose 4, single, Batch/Lot No: as7146b), administration date: 21Sep2022, when the patient was 56-year-old, for COVID-19 immunization; Covid-19 vaccine (Dose 3, manufacturer unknown), for COVID-19 immunization; Covid-19 vaccine (Dose 2, manufacturer unknown), for COVID-19 immunization; Covid-19 vaccine (Dose 1, manufacturer unknown), for COVID-19 immunization. The following information was reported: BELL'S PALSY (medically significant) with onset 23Sep2023 at 18:30, outcome "not recovered", described as "bells palsy". The event "bells palsy" required physician office visit. Therapeutic measures were taken as a result of bell's palsy. On 24Sep2022, physician was notified, started on predisone 60 and Valacyclovir.; Sender's Comments: Based on the information available, a possible contributory role of the suspect drug for the reported event Bell's palsy cannot be excluded. The impact of this report on the benefit/risk profile of the Pfizer drug is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees, and Investigators, as appropriate.
This spontaneous report as received from a nurse refers to a 17 year old patient of an unknown gender. On 16-FEB-2015, the patient was vaccinated with improperly stored GARDASIL (lot # K007264 and expiry date: 02-MAR-2017). No adverse events were reported. No product quality complaint (PQC) was reported for GARDASIL. This is one of the several; reports from the same reporter.  Additional information has been requested.
Spikevax vaccine for patients 12 years old and above administered to 10 year old patient instead of age appropriate covid-19 vaccine.
Day 0: ten hours after shot: Fever 103.5F, horrible headache and neck, shoulder, upper back pain Day 1: Fever continued (approx 101-102) other ached diminished but pain in right shoulder (opposite injection arm) worsened. R shoulder pain became severe that night.  Took 600mg advil.  No relief.  Pain 8-10 of 10 Day 2: shoulder pain unbearable sought medical care in the morning.  Through out the day given hydrocodone, oxicodone, injection of tordol.  Developed tingling and numbness in pinky finger and forearm by late morning.  Tingling progressed to index finger and thumb and is extremely uncomfortable.  Needed ondancetron for vomitting.  Added lidocaine patch in the evening.  Pain finally manageable at 3-4 out of 10.  But symptoms have made me completely unable to function, difficulty sleeping. Diagnosis: brachial neuritis
Patient received vaccination at Pharmacy on 5/31/2018, and within a twenty four hour period developed a fever, chills, myalgia, shivers, dizziness and sought medication attention.
shingles; This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a female patient of unspecified age. No information was provided regarding medical history, concurrent conditions, or concomitant medications. On or around 16-DEC-2015, the patient was inoculated with zoster vaccine live (ZOSTAVAX) (strength, dose, route, lot# and expiration date not reported) for routine health maintenance and for its intended purpose: the prevention of shingles (herpes zoster). On an unknown date (reported as shortly after receiving zoster vaccine live (ZOSTAVAX)), the patient suffered an outbreak of shingles (herpes zoster). As a direct and proximate result of zoster vaccine live (ZOSTAVAX), the patient's symptoms had resulted in physical limitations not present prior to using the product. The patient also experienced mental and emotional distress due to resulting physical limitations and seriousness of her condition. As a result of zoster vaccine live (ZOSTAVAX), the patient sustained severe and permanent personal injuries. Further, as a tragic consequence of the Company's wrongful conduct, the patient suffered serious, progressive, permanent, and incurable injuries, as well as significant conscious pain and suffering, mental anguish, emotional distress, loss of enjoyment of life, physical impairment and injury. As a direct and proximate result of the Company's conduct, the patient had suffered and incurred damages, including medical expenses; the loss of accumulations; and other economic and non-economic damages. The outcome of shingles (herpes zoster) was considered not recovered. The event was considered related to zoster vaccine live (ZOSTAVAX).  Herpes zoster was considered to be disabling.
One and Half days after taking the vaccine I have being facing a continuos ringing on my ears.
fever of 100.4°C; This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (fever of 100.4°C) in a 78-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 01-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 01-Mar-2021, the patient experienced PYREXIA (fever of 100.4°C). The patient was treated with PARACETAMOL (TYLENOL) ongoing since an unknown date at an unspecified dose and frequency. At the time of the report, PYREXIA (fever of 100.4°C) outcome was unknown.            Patient called to report his adverse events of fever of 100.4°C, mid noon, yesterday, 01MAR2021, following his second shot of MODERNA COVID 19 Vaccine yesterday intramuscularly, on the left arm 01MAR2021. Consumer confirmed taking Tylenol, but would like to know if he should be concerned about his symptoms.
Initial information received on 20-Dec-2018 regarding an unsolicited valid non-serious case received from a other health professional. This case involves a 3 months old patient who was accidentally injected an expired PENTACEL while he/she received vaccine PENTACEL. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. Concomitant medications included PREVENAR 13 for Immunisation; and HEPATITIS B VACCINE for Immunisation. On 20-Dec-2018, the patient received a dose suspect PENTACEL lot C5456AA via intramuscular route in the right thigh. It was a case of actual medication error due to expired vaccine used. The patient outcome is reported as Not Applicable for accidentally injected an expired PENTACEL. 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 Directive and Module VI of the 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.
The lymph nodes under my left arm where I got my COVID-19 Bivalent shot became swollen and painful to the touch. The next morning around 4:30am I woke and was blind in my left eye. I also had a headache on the left side of my head when this happened. This lasted for about two hours and when I started being able to see I was a little hazy. My head is still sore with the headache pain and my left eye is tender and sore to the touch. I can now see but it is very distorted like a sheen is over my eye. I went to my doctor, and they sent me to my optometrist they did an Optomap screening which looks behind my eye and compared that to my last exam in August. We also did the testing where they do the puff of air to test the pressure in my eye. On 10/30/2022 my blood pressure was 143/83 yesterday the 31st it was at 112/72 so it has been higher than normal which is unusual for me. My eyesight is still blurry, and the tenderness is still prevalent.
Very sore and painful sholder and elbow.  Still occurring.  Seems worse.  Can't even sleep on that side.
headache started 4 hours after vaccine, ongoing shortness of breath, ongoing palpitations, resolved
"pt recv vax 11AUG97 & 12AUG97 430PM states pt arm is red & sore rt, vomited x2, h/a, & feels warm;mom feels all sx are from the inj;all sx went away p/1 days mom stated;"
SX: Raised Red hard lump at injection site approximately 10in diameter x 4 days         Nausea, lightheaded, fatigue, loss of appetite for 24 hrs Tx: Diphenhydramine 25 MG BID for 3 days
the patient had a serious reaction to her Moderna vaccination (second shot); This spontaneous case was reported by a consumer and describes the occurrence of IMMUNISATION REACTION (the patient had a serious reaction to her Moderna vaccination (second shot)) in a female patient of an unknown age who received mRNA-1273 (Spikevax) for COVID-19 immunisation.     No Medical History information was reported.    On an unknown date, the patient received second dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On an unknown date, the patient experienced IMMUNISATION REACTION (the patient had a serious reaction to her Moderna vaccination (second shot)) (seriousness criterion medically significant). At the time of the report, IMMUNISATION REACTION (the patient had a serious reaction to her Moderna vaccination (second shot)) outcome was unknown.            Concomitant medication of the patient was not reported.  No treatment medications were reported by the reporter.  Company comment: This is a spontaneous case regarding a female patient of an unknown age, with no reported medical history, who experienced unexpected and medically significant event of immunisation reaction after receiving the second dose of mRNA-1273 vaccine. Vaccination date and onset date of the event were not provided, latency cannot be assessed. It was reported that the patient had a serious reaction; no further details regarding clinical course, diagnostic tests, or treatment performed were disclosed. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.   Reporter did not allow further contact
Got shot, got shingles/Suspected vaccination failure; Got shingles; Hurts; This serious case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a female patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine, the patient experienced vaccination failure (Verbatim: Got shot, got shingles/Suspected vaccination failure) (serious criteria GSK medically significant), shingles (Verbatim: Got shingles) and pain (Verbatim: Hurts). The outcome of the vaccination failure was unknown and the outcome of the shingles was not reported and the outcome of the pain was recovered/resolved (duration 1 week).   It was unknown if the reporter considered the vaccination failure, shingles and pain to be related to Shingles vaccine.   It was unknown if the company considered the vaccination failure, shingles and pain to be related to Shingles vaccine.   Additional Information: GSK Receipt Date: 14-MAR-2023 This case was reported by a patient's parent via interactive digital media. The reporter stated that shingles vaccine did not stop shingles.  The reporter further stated that it only hurt for a week or so but shingles would stay with you for years. This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule, time to onset and laboratory test confirming shingles were unknown at the time of reporting. The case had been linked to US2023AMR046167, reported by the same reporter, for a different patient.; Sender's Comments:  US-GSK-US2023AMR046167:Same reporter - Friend case
Got Shingrix, she hasnt slept; This case was reported by a consumer and described the occurrence of insomnia in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced insomnia. On an unknown date, the outcome of the insomnia was unknown.   It was unknown if the reporter considered the insomnia to be related to Shingrix.  Additional Information: GSK Receipt Date: 09-JAN-2023 Reporter's Comments: The reporter stated that, his/her sister got the Shingrix vaccine and she had not slept.
p/2hrs diarrhea & vomiting; pt ate hamburger & fries; 6PM continued vomiting & was taken to clinic; dx gastritis or stomach flu;
Subject in pneumococcal vaccine trial, with severe COPD, was hospitalized on 8/13/2008 for right hip fracture. Vaccination took place on 11/07/2007. According to the physician, the relationship is 'None'. We would be happy to forward the Study's SAE reporting form upon request.  4/7/09 Received SAE reports which reveal patient experienced trip & fall while under hospice care for severe COPD.  Sustained right hip fracture, right periorbital ecchymosis & swelling on 8/13/08.  Had received Prevnar on 11/7/2007.  Admitted to hospital 8/13-8/19/2008.  Cardio & Ortho consults done.  Surgery for nail fixation 8/14.  D/C to nursing home for PT & continued hospice.
This spontaneous report was received from a registered nurse and refers to a patient of unknown age and gender. The patient's pertinent medical history and concomitant medications were not reported. On 04-NOV-2015, the patient was vaccinated with a dose of GARDASIL 9 (dose and route of administration were not specified; lot # L019287, expiration date on 14-SEP-2017) that "might" have been improperly stored (it was unknown if the vaccines underwent temperature excursion). No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.
HYPOTENSION ACUTE PULMONARY EMBOLISM 11/25/2022  &   11/26/2022  --  RECURRENCE OF HOSPITALIZATION WITH SAME SYMPTOMS