chrisvoncsefalvay/vaers-outcomes huggingface dataset:
On 08/12/2019 afternoon patient called to report soreness and decreased range of motion to left upper extremity. Patient stated that she started taking Tylenol. Patient instructed to Ibuprofen as directed, apply ice to area for no more than 10 minutes at a time and to follow up in physician's office for an appointment if needed.  On 08/15/2019 follow up with patient. She states that her pain and range of motion was much better. She states she has some tingling in her hand and a little shoulder pain that feels like spasms periodically. She states is performing usual activities of daily living.
immediate lesion at injection site on arm, followed by lesion on left foot following day which lasted hours and prevented me to put on boot and train that day in boot camp.  Heard the DI's state that they "were glad not to be getting these shots" lesions continued througout bootcamp progressively getting more frequent predominately on legs.  After completion of boot camp my DI pulled me aside to address his concerns for the reaction I had due to innoculations.  I continued on in the military and so did the lesions and I have had numerous visits to base clinics for the lesions.  After leaving the military, I continued the lesions which were leaving no area of my body untouched and went to numerous hospitals both emergency and non with no understanding of what the lesions were.  I also had a major change in that I developed anaphalytic shock to expectorants in cold medicine (I attribute this to the major disturbances in my body due to reaction to vaccine(s))  I did in approx 93 go to the hospital to make a claim for the lesions and the hospital did say they were service-connected but not compensatable. I continued to work for the next few years until 95 when I developed dvt in my left leg in my return vein to my heart and also is the time my lesions completly disappeared ( the lesions were so detrimental physically and mentally and I thought this sickness was killing me and probably was but I was actually relieved when I got to the hospital even with the blood clot??  So basically now I have an incompetent venous system and a blocked stent and recurring ulcers on left foot which I currently do have an open ulcer that won't heal and am currently applying for SSD benefits and reopened my VA claim with these current health problems.  I feel and have felt the need to report this years ago but have been reluctant to do so because of lack of supporting evidence but now with all the stories of sickness and death or the GWS of which I am on the gulf war registry?  I see too many parallels to myself through others who have determined or have been determined to have suffered reactions to the vaccines.  Thank You. The discharge summary received on 3/30/04 states diagnosis of deep vein thrombosis confirmed. Add hypercoagulation syndrome, edema of left extremity, accidental electric shock, pain L ankle, stiffness L ankle and ecchymosis L leg.
forty three children were administered varicella virus vaccine from a shipment that was stored out of the refrigerator for 5 day; This spontaneous report has been received from unspecified reporter via company representative concerning a children of unknown age and gender. The patient's medical history, concurrent conditions and concomitant medications were not provided.  On an unknown date, the patient was vaccinated with an improperly stored dose of varicella virus vaccine live (oka/merck)(VARIVAX) (dose, frequency, route, lot number and expiration date were not provided) for prophylaxis. The reporter stated that the patient was vaccinated from a shipment that was stored out of the refrigerator for 5 days.   This is one of 45 cases reported by the same reporter.
Patient passed out couple minutes after shot but became conscious in couple minutes. Patient legs were elevated and wet towels were placed on him and was given something to drink. Emergency response team cleared patient after checking all vitals.
arm was sore; painful; This case was reported by a consumer and described the occurrence of pain in arm in a 81-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   The patient's past medical history included shingles (she had a case of shingles during the decade of the 1990's). Previously administered products included Zostavax with an associated reaction of herpes zoster (believed that she had Zostavax vaccine on an unknown date ,after that episode of shingles).   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, less than 9 months after receiving Shingrix, the patient experienced pain in arm and pain. On an unknown date, the outcome of the pain in arm and pain were recovered/resolved.   It was unknown if the reporter considered the pain in arm and pain to be related to Shingrix.  Additional details were provided as follows: The case was reported by the consumer for herself. The age at vaccination was not reported. The patient stated that, she had received the 1st dose of Shingrix more than 6 months ago and her arm was sore. The patient had not received the 2nd dose of Shingrix because the 1st dose was painful. The patient stated that, her arm was sore for around 1 to 1 and 1 and half weeks. Not all information was available. The lot and expiration date were not available.  The patient did not provide consent to follow up with health care professional.
Muscle pain in upper arm and joint in the shoulder (7.5-8 on pain scale). Could not lift her arm at all for 3 days on it's own. Pain radiated to elbow (5 on a pain scale). Pain gradually diminished - currently (4 weeks later) pain is 1 on pain scale and only occurs sporatically if moves a certain way.
Large localized reaction with swelling, redness, warmth over entire, right upper outer arm.  Small localized reaction, quarter sized of redness.
Had shot at 12:43 PM and notified nurse at 12:53 PM of nausea, BP 154/64, pulse 88, stated she started a new migraine medication 2 weeks ago and she had not eaten in the past 24 hours, BP recheck at 12:58 PM 154/70 pulse 80, complained of lightheadedness and nausea at 1:00 PM, chilling, 1 dose of epipen given 1:01 PM to left leg. 911 notified, en route to ED 1:11 PM. Notified mom at 12:28 PM.  Dr. notified at 1:16 PM.
We thought he had RSV. He had a bad cough, runny nose, and a fever. This lasted for a week or longer. We took him to Urgent Care, and they tested for RSV, COVID-19, and Flu and he tested negative for all of them. They determined that he had a bad cold.
Information has been received from a physician, via a company representative, concerning a 10 year old female patient, who was vaccinated with the first dose of Gardasil (date and dose not specified). "About 1 to 2 days later" the patient developed "a pustular rash on her hairline, face and abdomen. " The physician indicated that the patient recovered from the event (date not specified). The patient sought unspecified medical attention. Additional information has been requested. 07/06/07 This is in follow-up to report(s) previously submitted on 5/14/2007. Initial and follow up information has been received from a physician, via a company representative, concerning a 10 year old female patient, who was vaccinated with the first dose of GARDASIL (date and dose not specified). "About 1 to 2 days later" the patient developed a "strange rash", described as "a pustular rash on her hairline, face and abdomen". The physician indicated that the patient recovered from the event (date not specified). The patient sought unspecified medical attention. No further information is expected.
Recurrent rash x8. Zovirax 200mg/5ml suspension. 1 teaspoon 5 times daily for 7 days.
Mother reported on day 4 after vaccine that child started having swelling and redness at injection site 1 hour after vaccine was given.  Softball sized knot at injection site after one day that was hot to touch and had pain from shoulder to elbow. Mom was told to apply cold compresses, give Benadryl and Tylenol and see MD if does not improve. On day 5 child was much better knot almost gone and only a little soreness in shoulder.
Redness/induration at injection site, silver color coin size; hardness/swelling/tenderness  at injection site- baseball size; itching at injection site and left calf, muscle soreness left leg, left arm; parasthesia left arm and leg
Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 73-year-old female patient (not pregnant) received bnt162b2, bnt162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 08Oct2022 as dose 5 (booster), single (Lot number: Gh9703) at the age of 72 years, in right arm for covid-19 immunisation; bnt162b2 (BNT162B2), on 02Feb2021 as dose 1, single (Lot number: EN5318), in right arm, on 24Feb2021 as dose 2, single (Lot number: EN6203), in right arm, on 14Oct2021 as dose 3 (booster), single (Lot number: Ff2593), in right arm and on 31May2022 as dose 4 (booster), single (Lot number: FM9992), in right arm for covid-19 immunisation. The patient had no relevant medical history. The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 2023, outcome "unknown" and all described as "Treatment of COVID-19". Therapeutic measures were taken as a result of drug ineffective, covid-19 which included Paxlovid from 04Oct2023 to 08Oct2023. Clinical course: Patient had no known allergies.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300329587 same patient, different drug and different event;
Fever of 102. Body aches and headache.  Nausea.  Started about 12 hours after injection.  Fever reduced to 100.4 with Tylenol.  Returned to doctor with instructions to 'just watch' for a couple of days.
fever, chills, headache, vomiting,  left axillary lymph node pain. 24 hours duration, tylenol
Reported allergy to COVID-19 MRNA vaccine. Medium severity reaction - joint pain.
LEGS FEELING COLD; BLOOD SUGAR LOWER THAN NORMAL; SHOULDER HEAVINESS; BACK PAIN; ARM PAIN AT INJECTION SITE; TIREDNESS; SLEEPINESS; This spontaneous report received from a patient concerned a 63 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included type 2 diabetes., hypertension, and non smoker, and other pre-existing medical conditions included patient do not smoke. patient has type 2 diabetes for approximately 17 years. patient also has hypertension. The patient received metformin non-company (prolonged-release tablet, route of admin not reported, batch number: Unk) dose, frequency, and therapy dates were not reported for an unspecified indication. The batch number was not reported and has been requested. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported and batch number: 1805022 expiry: 25-MAY-2021) dose was not reported, administered on 06-MAR-2021 for prophylactic vaccination. Concomitant medications included amlodipine, atorvastatin, glipizide, hydrochlorothiazide/triamterene, insulin glargine, losartan, and sitagliptin. On FEB-2021, Laboratory data included: Blood test (NR: not provided) Results not specified. On 06-MAR-2021, the subject experienced tiredness. On 06-MAR-2021, the subject experienced sleepiness. On 10-MAR-2021, the subject experienced arm pain at injection site. On 11-MAR-2021, the subject experienced blood sugar lower than normal. On 11-MAR-2021, the subject experienced shoulder heaviness. On 11-MAR-2021, the subject experienced back pain. On 11-MAR-2021 17:44, Laboratory data included: Blood glucose (NR: not provided) 97 (unit not specified). On 12-MAR-2021, the subject experienced legs feeling cold. On 12-MAR-2021 06:00, Laboratory data included: Blood glucose (NR: not provided) 166 (unit not specified). On 12-MAR-2021 16:00, Laboratory data included: Blood glucose (NR: not provided) 79 (unit not specified). The action taken with covid-19 vaccine ad26.cov2.s was not applicable; and action taken with metformin non-company was not reported. The patient recovered from legs feeling cold on 12-MAR-2021, was recovering from arm pain at injection site, shoulder heaviness, and back pain, and had not recovered from blood sugar lower than normal, tiredness, and sleepiness. This report was non-serious.
Patient received 1st dose of vaccine, about 5 minutes later patient fainted/passed out in the chair during the observation period. Hit head on floor and had a hematoma form.  911 was called and patent went to hospital for observation. Blood pressure was running low after fainting in the 90/60 range.  When patient came too said this happens all the time, was asked about issues with previous vaccines before shot and said no issue and marked on cdc checklist and consent form no issues to vaccine.
tested positive; tested positive; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP) from medical information team, Program ID.  A male patient received bnt162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), 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: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "tested positive". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive, notes: however her husband tested positive.  Additional information: Caller, a patient got a Pfizer covid-19 vaccines shot with her husband however her husband tested positive. Caller wanted to know if it is the effects of a vaccine. When caller came on the line: stated: me and my husband had any covid vaccine available since the beginning of covid, we never had covid before, got the latest Pfizer covid vaccine 2023-2024 formulation and her husband tested positive and she is testing right now and looks like may be testing positive as well however not sure at the time of the call, asking if the antibodies in the vaccination are triggering the covid? Would them taking covid vaccination on Thursday make them test positive for covid after vaccination?  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
pt recv vax 14JUL97 & exp twitching went away in few days;
Arm pain; fast heart rate; fever; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Arm pain), PALPITATIONS (fast heart rate) and PYREXIA (fever) in a 91-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 016M20A) for COVID-19 vaccination.     Concurrent medical conditions included Hypertension.    On 23-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 23-Feb-2021, the patient experienced PAIN IN EXTREMITY (Arm pain), PALPITATIONS (fast heart rate) and PYREXIA (fever). At the time of the report, PAIN IN EXTREMITY (Arm pain), PALPITATIONS (fast heart rate) and PYREXIA (fever) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No treatment information provided.
Wrong formulation to patient. Patient 6mo-5yo: they should have administered 2 doses of 0.25ml from the Dark Blue Cap and Label with Gray Border but instead they administered 2 doses of 0.2ml from the Dark Pink Cap and Label with Yellow Box.; No adverse event; This spontaneous case was reported by an other health care professional and describes the occurrence of WRONG PRODUCT ADMINISTERED (Wrong formulation to patient. Patient 6mo-5yo: they should have administered 2 doses of 0.25ml from the Dark Blue Cap and Label with Gray Border but instead they administered 2 doses of 0.2ml from the Dark Pink Cap and Label with Yellow Box.) and NO ADVERSE EVENT (No adverse event) in an infant patient of an unknown gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) .2 milliliter. On an unknown date, the patient experienced WRONG PRODUCT ADMINISTERED (Wrong formulation to patient. Patient 6mo-5yo: they should have administered 2 doses of 0.25ml from the Dark Blue Cap and Label with Gray Border but instead they administered 2 doses of 0.2ml from the Dark Pink Cap and Label with Yellow Box.) and NO ADVERSE EVENT (No adverse event). At the time of the report, WRONG PRODUCT ADMINISTERED (Wrong formulation to patient. Patient 6mo-5yo: they should have administered 2 doses of 0.25ml from the Dark Blue Cap and Label with Gray Border but instead they administered 2 doses of 0.2ml from the Dark Pink Cap and Label with Yellow Box.) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for WRONG PRODUCT ADMINISTERED (Wrong formulation to patient. Patient 6mo-5yo: they should have administered 2 doses of 0.25ml from the Dark Blue Cap and Label with Gray Border but instead they administered 2 doses of 0.2ml from the Dark Pink Cap and Label with Yellow Box.).    No concomitant medication was reported.  No treatment information was reported  This case contains information for patient 9 out of 10.   This case was linked to US-MODERNATX, INC.-MOD-2023-731451 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-731451:Same reporter
Congestion, fever, common cold, severe neck pain, swelling and pain in index finger, headache
Patient said she experience an extremely painful headache and nausea, she commented that she almost went to the emergency room because her headache was so bad.
Pt developed blistery lesions at injection site 10 days post vax. 11 days post vax, more lesions appeared on forehead at ears. Lesions continued to appear the 12th and 13th day post vax.
PATIENT SAYS GOT SOME SWELLING OF EYES AND LIPS OF LEFT SIDE. DID NOT TAKE ANY MEDS.  WILL TAKE SOME LATER ON TODAY. CALLED PCP FOR ADVICE / FOLLOW UP.
Patient is 36 weeks pregnant and was administered the wrong RSV vaccine. No adverse reactions as of right now.
No adverse event; He got distracted and gave the patient two doses of the Moderna vaccine; This spontaneous case was reported by a pharmacist and describes the occurrence of EXTRA DOSE ADMINISTERED (He got distracted and gave the patient two doses of the Moderna vaccine) and NO ADVERSE EVENT (No adverse event) in a 76-year-old female patient who received mRNA-1273.815 (SPIKEVAX 2023-2024) (batch nos. 3030371 and 3030371) for COVID-19 prophylaxis.     Previously administered products included for COVID-19 prophylaxis: Moderna covid-19 vaccine (lot number 019H22A) on 01-May-2023. Past adverse reactions to the above products included No adverse event with Moderna covid-19 vaccine. Concurrent medical conditions included Respiratory disorder.   On 18-Sep-2023, the patient received dose of mRNA-1273.815 (SPIKEVAX 2023-2024) (unknown route) .5 milliliter. On 18-Sep-2023, received dose of mRNA-1273.815 (SPIKEVAX 2023-2024) (unknown route) dosage was changed to .5 milliliter. On 18-Sep-2023,  after starting mRNA-1273.815 (SPIKEVAX 2023-2024), the patient experienced EXTRA DOSE ADMINISTERED (He got distracted and gave the patient two doses of the Moderna vaccine). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, EXTRA DOSE ADMINISTERED (He got distracted and gave the patient two doses of the Moderna vaccine) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273.815 (SPIKEVAX 2023-2024) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for EXTRA DOSE ADMINISTERED (He got distracted and gave the patient two doses of the Moderna vaccine).    No concomitant medication was reported.  No treatment information was reported.
This spontaneous report as received from a physician via a company representative, refers to a patient of unknown age and gender. The patient's concurrent conditions and medical history were not reported. On 17-NOV-2015, the patient was vaccinated with an improperly stored dose of GARDASIL 9 which had a lot number of L001312 and expiration date on 23-FEB-2017 (route of administration and anatomical location were not reported). There were no concomitant medications provided. No adverse effects reported. No product quality complaint was involved. On an unspecified date, the GARDASIL 9 vaccine had a temperature excursions of 48 hours. The highest recorded temperature was 52 F (11.11111111 Celsius). The vaccine status was reported as "in excursion". The vaccine storage criteria and the vaccine excursion were reported as "Refrigerator(R)". This is one of several cases from the same reporter. Additional information has been requested.
Received flu shot Thursday. We saw patient 10/29/03 with fever, sore throat. Left arm where she got flu shot is very sore and is unable to lift left arm at all. Tender to touch. On exam, serious otitis media. Positive pain posterior bursa left arm.
Received Pfizer as 1st and 2nd dose; Experiences shortness of breathing; Extreme exhaustion; Fever for 1 day only (about 104F).; Slept for 36 hours / barely stay awake and sleeps for 18 hours a day; This spontaneous case was reported by a consumer and describes the occurrence of INTERCHANGE OF VACCINE PRODUCTS (Received Pfizer as 1st and 2nd dose), HYPERSOMNIA (Slept for 36 hours / barely stay awake and sleeps for 18 hours a day), DYSPNOEA (Experiences shortness of breathing), PYREXIA (Fever for 1 day only (about 104F).) and FATIGUE (Extreme exhaustion) in a 34-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product TOZINAMERAN (PFIZER BIONTECH COVID-19 VACCINE) for COVID-19 vaccination.    Concurrent medical conditions included Lactose intolerant. Concomitant products included BUPROPION, MELATONIN, PARACETAMOL (TYLENOL A), TILACTASE (LACTASE PLUS), VITAMIN D NOS, MULTIVITAMIN [VITAMINS NOS], PANTOPRAZOLE and COLESEVELAM HYDROCHLORIDE (WELCHOL) for an unknown indication.   On 19-Aug-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient started TOZINAMERAN (PFIZER BIONTECH COVID-19 VACCINE) (unknown route) at an unspecified dose. On 19-Aug-2021, the patient experienced HYPERSOMNIA (Slept for 36 hours / barely stay awake and sleeps for 18 hours a day). On 20-Aug-2021, the patient experienced PYREXIA (Fever for 1 day only (about 104F).). On an unknown date, the patient experienced INTERCHANGE OF VACCINE PRODUCTS (Received Pfizer as 1st and 2nd dose), DYSPNOEA (Experiences shortness of breathing) and FATIGUE (Extreme exhaustion). At the time of the report, INTERCHANGE OF VACCINE PRODUCTS (Received Pfizer as 1st and 2nd dose) had resolved and HYPERSOMNIA (Slept for 36 hours / barely stay awake and sleeps for 18 hours a day), DYSPNOEA (Experiences shortness of breathing), PYREXIA (Fever for 1 day only (about 104F).) and FATIGUE (Extreme exhaustion) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Body temperature: 104f (High) 104F. On an unknown date, Electrocardiogram: normal (normal) Normal.         Biomarkers were came normal.  Adderall 5mg and Suppressant drugs were used by patient as concomitant medications