chrisvoncsefalvay/vaers-outcomes huggingface dataset:
I haven't been able to eat anything because I am super Nauseous; Im in Just total pain; dizziness; I haven't been able to eat anything because I am super Nauseous; Fever of 102; Excruciating headaches; body aches; Extreme stiffness; This spontaneous case was reported by a consumer and describes the occurrence of MUSCULOSKELETAL STIFFNESS (Extreme stiffness), FEEDING DISORDER (I haven't been able to eat anything because I am super Nauseous), PAIN (Im in Just total pain), DIZZINESS (dizziness) and NAUSEA (I haven't been able to eat anything because I am super Nauseous) in a  patient of an unknown age and gender who received mRNA-1273.815 (SPIKEVAX 2023-2024) (batch no. ASKU) for COVID-19 prophylaxis. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 08-Nov-2023, the patient received dose of mRNA-1273.815 (SPIKEVAX 2023-2024) (unknown route) 1 dosage form. On 08-Nov-2023, the patient experienced MUSCULOSKELETAL STIFFNESS (Extreme stiffness), PAIN (Im in Just total pain), DIZZINESS (dizziness), NAUSEA (I haven't been able to eat anything because I am super Nauseous), PYREXIA (Fever of 102), HEADACHE (Excruciating headaches) and MYALGIA (body aches). On an unknown date, the patient experienced FEEDING DISORDER (I haven't been able to eat anything because I am super Nauseous). At the time of the report, MUSCULOSKELETAL STIFFNESS (Extreme stiffness), FEEDING DISORDER (I haven't been able to eat anything because I am super Nauseous), DIZZINESS (dizziness), NAUSEA (I haven't been able to eat anything because I am super Nauseous), PYREXIA (Fever of 102), HEADACHE (Excruciating headaches) and MYALGIA (body aches) had not resolved and PAIN (Im in Just total pain) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Body temperature: 102.     The action taken with mRNA-1273.815 (SPIKEVAX 2023-2024) (Unknown Route) was unknown.   For mRNA-1273.815 (SPIKEVAX 2023-2024) (Unknown Route), the reporter did not provide any causality assessments.   Concomitant medication was not reported. Patient got Moderna vaccine on 08-Nov-2023 and had severe side effects to it. Excruciating headaches, body aches, Dizziness. Extreme Stiffness. Patient haven't Left since yesterday. Patient haven't been able to eat anything because patient was super Nauseous. Patient was in just total pain and had a fever of 102. Treatment medication was not reported.   Reporter did not allow further contact
Employee complained of dizziness after sitting for 10 min in observation area. Employee became lethargic  and  was unable to stand. She  complained of R side chest pain and R sided weakness. Symptoms did not go away. Employee sent to ER.
Pt presents in clinic with complains of right thigh redness. Received DTaP in right upper thigh & Comvax in right lower thigh 5 inches x 5 inches. 4-5-04. Diagnosis: Shot reaction. Treatment: Ice to area & monitor.
I had my vaccination on 05/20/2022. I started to lose 50% of my hair in 08/2022 to include the top of my head and the hair on my legs. I also had joint pain that made it difficult to walk. It started to slow down in 11/2022. I had contacted my physician in 12/2022. There was no course of treatment. My hair is still not growing out on 05/23/2023.
Arm hurt immediately after injection.  Fever and chills started later in evening about 7pm Fever was up to 100.9 while taking  Tylenol for 38 hours The day after injection, my whole body ached and I could hardly move. I was exhausted and fever persisted.  My blood sugars were in the 50-60?s while I was sick.  By the 21st I was fever free but still very sore and very tired.
A non-serious spontaneous report of administered expired FLUMIST has been received from a nurse concerning a 12-year- old female. The patient's medical history included sinus problems; the patient was not taking any concomitant medications. On 04-Dec-2008, a certified medical assistant (CMA) in a community health inadvertently administered expired FLUMIST; the product was expired by nine days. The patient came into the clinic for sinus problems and the physician recommended the vaccine. Per the reporter, the CMA who administered the vaccine did not foll0w their internal clinic procedures. No adverse events have been reported since the vaccine error. There was no adverse event associated with this medication error; therefore, treatment and reporter/sponsor causality assessments are not applicable, and the event is considered resolved. Based on the results of the investigation, the root cause for the medication errors were caused by 1) customers not discarding product from the previous season and 2) product expiring during the peak of the flu season resulting in some medication errors that occurred shortly after the product expired. Additional information was received on 19-Dec-2009 that no delayed adverse events resulted from this error. Follow-up information was received on 09-Apr-2009: Product Complaint Investigation results.
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 07-OCT-2016, the patient received an improperly stored dose of VARIVAX (exact dose and route of administration were not reported, lot # M009768, expiration date: 23-FEB-2018). It was reported that the administered dose of VARIVAX was improperly stored at -3.5 degrees Celsius (C) for 1 hour and 6 minutes. There was no previous temperature excursion. Data logger was involved. No symptoms were reported. 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:
The night of vaccination, pt developed a fever, headache, and chills which continued for three days. She was tested for COVID on the second day with a negative PCR result.
Vertigo/dizzy/room spins starting; dizzy/room spins starting; Fatigue; Sore body; HA (headache); Nausea; Racing thoughts; trouble sleeping; This is a spontaneous report from a contactable nurse (patient). A 43-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), intramuscular in left arm on 10Jan2021 14:45 at single dose for COVID-19 immunization. Medical history included seasonal allergies, anxiety, depression, high cholesterol, tinnitus and GERD; all from an unknown date and unknown if ongoing. Concomitant medication included valaciclovir hydrochloride (VALTREX), omeprazole magnesium (PRILOSEC), iron, atorvastatin (LIPITOR), melatonin and BCP. The patient was previously vaccinated with first dose of BNT162B2 via unspecified route in left arm on 20Dec2020 15:00 for COVID-19 immunization and experienced vertigo/dizzy/room spins starting on 08Jan2021 23:30. The patient was not pregnant. The experienced vertigo/dizzy/room spins starting 1-2 days prior to 2nd vaccine 10Jan2021 then it was worsened in Jan2021 after 2nd vaccine. The patient experienced fatigue, sore body, HA (headache), nausea, racing thoughts and trouble sleeping in Jan2021. No treatment was given to the patient for the events. The outcome of the events was not recovered. The facility where the most recent COVID-19 vaccine was administered was in the hospital. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19.  Information on the lot/batch number has been requested.
Approxiamately 6 months after shjot I developed Shingles on my scalp and Scalp Psoriasis. I nevered had any signs of shingles and scap psoriasis in my life. Still struggling with it. Just recieve the additional booster on Sept 21, 2023. Just keep on getting the shots hoping one of them will adjust my immune system to get rid of these things. When I asked my doctors if the Covid shots caused this outbreak, they where reluctant to admit it but said it was a possibility. Primary Care Physiscan and dermatologist.
Rash- reddened w/welt-like (hives), wheezing; resolved w/o admin of DPH or Adrenalin;
pt recvd vax; at 1am on 5jul94, pt ran fever;had sz;rt sided shaking & twitching on am of admission to hosp;has emesis;afebrile & crying;eyes turned towards back;dec muscle tone;lumbar puncture;wbcs were elevated at 157;viral encephalitis;r
Pt denied any chance of pregnancy, using condoms correctly. After missing period X 10 days, found she was pregnant. Advised to follow-up with OB/GYN and advised we would be reporting this.
36 y/o F who received primary SPV (LUE) ad Clinic on 13Aug13 (LUE). Calls at 8PM with concern re SPV site- very red, warm, itchy, with streak going toward left axilla and left axillary node enlargement and tenderness. General malaise, but no CP or SOB. Deploying. She is a teacher and is still working.
so the vaccine did not work; His Chronic Lymphocytic Leukemia did not work well with the vaccine; His Chronic Lymphocytic Leukemia did not work well with the vaccine; This is a spontaneous report received from a Pfizer Sponsored Program from a contactable consumer (patient). This male patient of unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) at the 1st dose (lot number: EL1284) on 13Jan2021, the 2nd dose (lot number: EL9263) on 03Feb2021; both via an unspecified route of administration at single dose for COVID-19 immunization. Medical history included immunosuppressed and chronic lymphocytic leukemia. Concomitant medications were unknown. The patient said his doctor found out that his chronic lymphocytic leukemia (CLL) did not work well with the vaccine. His physician took a blood test (for CLL) the other day and said that there was a problem with his CLL results and the vaccines (like interference). The patient stated he was seeing his HCP yesterday or the day before yesterday, they took blood work and told him his CLL did not work and the Pfizer vaccine did not work good on him. The patient was asking what can be done; stated they took his blood work again and the CLL did not work so the vaccine did not work; no further clarifying details provided by the caller. He wanted to know what he should do about this. Response included "CONS-use in immunosuppressed patients (v3.0)" and "CONS-what is the pfizer-biontech covid-19 vaccine (v3.0)." The patient wanted to know if he can stop wearing masks whenever he's around people who had already been vaccinated with both doses of the Pfizer-BioNTech Covid-19 Vaccine. He also wanted to know if he can still be a carrier of the virus. Response was "CONS - post-vaccination precautions - wearing a mask and social distancing after receiving the vaccine (v5.0)." Outcome of the events was unknown.
7 STROKES; This spontaneous report received from a consumer via media via a company representative concerned a female of unspecified age, race and ethnicity. 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: Unknown, expiry: unknown) dose, start therapy date were not reported,1 total administered for prophylactic vaccination. Dose number series was 1.The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported.  The reporter questioned "will it help me see my grandmother again" and added that her "grandmother got JANSSEN covid vaccine and had about 7 strokes in 3 months that ultimately took her life". On an unspecified date, the patient died from 7 strokes. It was unspecified if an autopsy was performed. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of stroke was fatal. This report was serious (Death, and Other Medically Important Condition).; Sender's Comments: V0- 20211203719-Covid-19 vaccine ad26.cov2.s-7 strokes. This event(s) is considered unassessable. The event(s) has an compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s).; Reported Cause(s) of Death: 7 STROKES
Fatigue; localized soreness; This is a spontaneous report from a contactable consumer (patient). A 29-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot number: EL3247), via an unspecified route of administration in left arm on 09Feb2021 at 11:00 as 2nd dose, single for COVID-19 immunization. Patient previously received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot number: EL3247), via an unspecified route of administration in right arm on 19Jan2021 at 11:15 AM as 1st dose, single for COVID-19 immunization. Patient age at vaccination was 29 Years. Medical history included seizure disorder (since age 2). Patient had no allergies to medications, food, or other products. Concomitant medications included valproate semisodium (DEPAKOTE), cetirizine hydrochloride (ZYRTEC), clarithromycin (CLARITIN), ascorbic acid, betacarotene, biotin, calcium carbonate, calcium pantothenate, chromic chloride, colecalciferol, copper sulfate, cyanocobalamin, ferrous fumarate, folic acid, lycopene, magnesium oxide, manganese sulfate, nicotinamide, phytomenadione, potassium chloride, potassium iodide, pyridoxine hydrochloride, retinol acetate, riboflavin, sodium molybdate, sodium selenate, thiamine mononitrate, tocopheryl acetate, xantofyl, zinc oxide (CENTRUM FORTE), dextromethorphan hydrobromide, guaifenesin (MUCINEX DM). Facility where the most recent COVID-19 vaccine was administered was workplace clinic. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On 09Feb2021 at 08:00 PM, patient experienced fatigue and localized soreness. No treatment was received for the adverse events. The outcome of the events was recovering.   Follow-up attempts are completed. No further information is expected.
Severe swelling, tenderness, redness and warmth over right deltoid appeared 2 days after injection. Mild erythema without warmth left upper arm.
OPTIC NEURITIS; This spontaneous report received from a patient concerned a 53 year old male. The patient's height, and weight were not reported. The patient's concurrent conditions included non-smoker, and other pre-existing medical conditions included patient had no known drug allergies. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: F1808980, and expiry: UNKNOWN) with unspecified dose on left arm, on 31-MAR-2021 for prophylactic vaccination. No concomitant medications were reported.  On 09-APR-2021, patient experienced loss of vision on the right eye that had not gotten better or worse since then. Patient went to ophthalmologist on 12-APR-2021 who diagnosed patient with optic neuritis and referred to neuro-ophthalmologist. On 13-APR-2021, patient went to emergency eye and ear. Patient was having upcoming appointments with primary doctor and neuro-ophthalmologist at the time of reporting.  On 12-APR-2021, Laboratory data included: Dilated pupils (NR: not provided) diagnose with optic neuritis by eye doctor. On 13-APR-2021, Laboratory data included: Blood test (NR: not provided) normal findings, and CT scan (NR: not provided) normal findings. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from optic neuritis. This report was serious (Other Medically Important Condition).; Sender's Comments: V0: 20210429417-covid-19 vaccine ad26.cov2.s-Optic neuritis. This event(s) is considered unassessable. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s).
Intense chills for approx. two hours.  Rested in bed for the next ten hours.
Circular rash at injection site, hot to the touch, swelling  The morning after receiving the second dose, I experienced all general side effects: swelling of lymph node in armpit of injected arm, fatigue, muscle/joint pain, chills, nausea vomiting, and vertigo severe enough to cause me to fall resulting in a bruise on right side lasting 2 weeks.
Patient stated that she has a history of allergic reactions to acetaminophen. Patient wanted to be monitored for an additional 15 minutes due to concern of possible allergic reaction.
Today is day 12 after his 2nd dosis and my son still has:   fever, tiredness, heavy cough, congestion, fatigue running nose,
Symptoms began 3 days after vaccine, disruption to daily life, extremely high fever lasting 7 days so far, lethargic, not eating or drinking much, sleeping most of the day
I63.9 ACUTE STROKE DUE TO ISCHEMIA, UNSPECIFIED TYPE AND ARTERY 2/13/2023 INFLUENZA I63.9 ACUTE STROKE DUE TO ISCHEMIA, UNSPECIFIED TYPE AND ARTERY 2/13/2023 ACUTE STROKE DUE TO ISCHEMIA, UNSPECIFIED TYPE AND ARTERY
Syringe error in right arm.  Technician tried to inject and medication was not coming out maybe due to a faulty syringe.  Technician redid the injection a second time and liquid came out of the syringe.  Almost all the medication came out onto the floor.  Pharmacist advised to redo the shot in the left arm because it would have been an incomplete dose.
Beginning 24 hrs post injection: every bone and joint in my body began to ache. Then incredibly painful bone pain in the chest - originally thought it was a heart attack.  It is random  and acute pain in the chest / rib area. It varies in duration and length of time between attacks. The pain is so acute it is hard to manage. Also this appears to have attacked my lungs as I am very short of breath and cannot do any exertion. The body ache, incredible chest bone pain, joint pain and difficulty breathing have continued as I finish day 6 post injection.
Fever chills, sweeting, slept for over 24 hours, swelling at the injection spot, achy diarrhea it has been over 2 weeks now I I have a itchy rash on my arm the site of the injection just appeared
Fever 103.6, headache, lethargy, malaise, skin sores, pustules.
Received 5 immunizations early in the day of 12-14-10. Mother stated child felt warm that afternoon & gave TYLENOL at 1600 & 2030. At 2130 pt. began episode lasting approx 10 min involving body shaking & bilateral lower extremity twitching. Had fixed forward gaze & did not respond to stimulus. Went to ED, monitoring & IV.
I started noticing an increase in odd behaviors and the appearance of new behaviors including: lining of objects, covering his ears to basic sounds, increased hand washing, trouble falling asleep at night (up to 2 hours), repeating his own and others phrases, obsessions such as color black, increased anxiety, decreased happy mood, rigid behavior such as not allowing us to put on a short sleeve shirt instead of long sleeve. These behaviors slowly started increasing over the first two weeks and were at their peak for approximately 2-3 months. Around mid March they slowly started decreasing and a few have almost disappeared, but several behaviors remain including reduced happy mood, increased anxiety, and increased rigidity.
Pt. called and said her hand was pink and warm. Pt was told to go to E.R.
PARTIAL DOSE; This spontaneous report received from a patient 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: Unknown) dose was not reported, administered on 10-MAR-2021 for prophylactic vaccination Batch number was not reported has been requested. No concomitant medications were reported. On 10-MAR-2021, the subject experienced partial dose. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of partial dose was not reported. This report was non-serious.; Sender's Comments: V0. medical assessment comment not required as per standard procedure as the case was assessed as non-serious.
burning sensation; itchy rash; This case was reported by a consumer via call center representative and described the occurrence of burning sensation in a patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced burning sensation and itchy rash. On an unknown date, the outcome of the burning sensation and itchy rash were recovered/resolved.   It was unknown if the reporter considered the burning sensation and itchy rash to be related to Shingrix.  Additional details were received as follows: The age at vaccination was not reported. The patient received Shingrix and developed a burning itchy rash that has lasted 5 days. The patient was inquiring that should they received 2nd dose. The reporter consented to follow up.
Debilitating heart palpitations/chest pain.  Dizziness/ fainted momentarily. Sought emergency care- no physical cause found-  not associated with any health issues. fever newly present at discharge from emergency room.
On Sunday 5/22/05 child broke out with a few spots around noon with a fever of 103.  Monday 5/23 around midnight broke out in sweat fever down to 101.  Continues to have fever Tuesday 5/24 - Mother is giving Motrin for the fever.
received shots after the 30-day use by date; received shots after the 30-day use by date; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (received shots after the 30-day use by date) and PRODUCT STORAGE ERROR (received shots after the 30-day use by date) in a 33-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 027H21B) for COVID-19 vaccination.     No Medical History information was reported.    On 21-Feb-2022, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 21-Feb-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (received shots after the 30-day use by date). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (received shots after the 30-day use by date). At the time of the report, EXPIRED PRODUCT ADMINISTERED (received shots after the 30-day use by date) and PRODUCT STORAGE ERROR (received shots after the 30-day use by date) outcome was unknown. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported. No treatment medications were reported.  The vial was initially stored in the refrigerator on 17-Dec-2021. Beyond use date of the vaccine was 16-Jan-2022. The vial did not undergo any temperature excursions.
side effects after the first dose; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (side effects after the first dose) in a 54-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012L20A) for COVID-19 vaccination.     No Medical History information was reported.    On 15-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced VACCINATION COMPLICATION (side effects after the first dose). At the time of the report, VACCINATION COMPLICATION (side effects after the first dose) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications provided. No treatment medications provided.   This case was linked to MOD-2021-374718 (Patient Link).
Reddness, itchy, edema localized to RD area 6x5 cm of redness- hard warm to touch. Benadryl 12.5-5ml 1/2 tsp q 4 hours