chrisvoncsefalvay/vaers-outcomes huggingface dataset:
soreness of the injected arm; 3x3 inches rash at the injection stie; sweating; fever; weekness; nausea; chills; neckache; headache; rash grew to involve the anterior part of her left arm from the shoulder to her elbow; This case was reported by a consumer via call center representative and described the occurrence of pain in arm in a 70-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st dose on unknown date).   On 25th November 2020 08:00, the patient received the 1st dose of Shingrix. On 25th November 2020 22:00, 14 hrs after receiving Shingrix, the patient experienced pain in arm, injection site rash, sweating, fever, weakness, nausea, chills, neck pain, headache and rash. On an unknown date, the outcome of the pain in arm, injection site rash, sweating, fever, weakness, nausea, chills, neck pain, headache and rash were recovered/resolved.   It was unknown if the reporter considered the pain in arm, injection site rash, sweating, fever, weakness, nausea, chills, neck pain, headache and rash to be related to Shingrix.  Additional details were provided as follows:   The patient received 1st dose of shingrix and experienced soreness of the injected arm, headache, neckache, chills, nausea, weakness, fever, sweating, 3x3 inches rash at the injection site and within two days the rash grew to involve the anterior part of her left arm from the shoulder to her elbow. The reporter mentioned that all events were resolved. This case has been linked with US2020236523, reported by the same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2020236523:same reporter
5 minutes after vaccination, patient suffered cardiac arrest in clinic.  CPR started immediately, shocked, EPI given.  EMS transported to hospital patient expired in ED.
Fever; Nausea; Vomiting; No appetite; Chills; body ache; Headache; Excessive sweat; Difficulty breathing; Hyperventilation; Exhaustion; This is a spontaneous report from a contactable consumer (patient, reported on himself).   A 47-year-old male patient received BNT162B2 (BNT162B2, solution for injection, Batch/Lot Number: EN5318 and expiration date not provided), via an unspecified route of administration in left arm on 01Feb2021 04:30 PM, as a single dose for covid-19 immunization. Medical history included depression, COVID in late Nov2020, she had two tests for COVID which were found to be negative. She was allergic to Fructans. Concomitant medications in two weeks included vortioxetine (Trintellix), esketamine hydrochloride (Spravato), rosuvastatin calcium (Crestor), Saw palmetto (SERENOA REPENS) Saw Palme and Fish Oil. 02Feb2021 Tuesday 09:00 AM, the patient experienced symptoms 85 percent similar in type and intensity to when she had Covid in late Nov2020. Beginning with fever 99-101 until Saturday. She also had nausea and vomiting. She had no appetite (no food Tuesday till Saturday). She experienced chills, body ache, headache, excessive sweat, difficulty breathing, hyperventilation and exhaustion. The patient did not receive treatment for the events. He did not have any other vaccine in four weeks. The patient was not tested for covid tested post vaccination. Vaccine facility type: Public Health Clinic/Administration facility. The outcome of the events was recovering.    Information on batch/lot number has been requested.
On 04/01/2021 I had a random nose bleed and passed a clot the size of half of a bean.
Right sided Bell's Palsy. Started on prednisone in the emergency department where she first presented. I added valacyclovir and prolonged steroid dosing. Patient then went on to develop severe right sided headache a week after the Bell's Palsy started. Her facial droop is starting to improve somewhat and the headache is lessening a little as of the time of this report.
No adverse event; Accidentally administered Moderna Covid 19 monovalent booster instead of bivalent booster; This spontaneous case was reported by a patient family member or friend and describes the occurrence of WRONG PRODUCT ADMINISTERED (Accidentally administered Moderna Covid 19 monovalent booster instead of bivalent booster) and NO ADVERSE EVENT (No adverse event) in an 8-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis.     Patient had no allergic condition. Patient had never tested positive for COVID-19.  Previously administered products included for Product used for unknown indication: Pfizer (Dose 2) and Pfizer (Dose 1). Past adverse reactions to the above products included No adverse event with Pfizer and Pfizer.    On 13-Oct-2022, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 13-Oct-2022, the patient experienced WRONG PRODUCT ADMINISTERED (Accidentally administered Moderna Covid 19 monovalent booster instead of bivalent booster). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, WRONG PRODUCT ADMINISTERED (Accidentally administered Moderna Covid 19 monovalent booster instead of bivalent booster) and NO ADVERSE EVENT (No adverse event) outcome was unknown.            Concomitant medication was not reported.  Treatment information was not provided.
Information has been received from a 78 years old female referring to herself, who had had a cancer (details unspecified). The patient's concurrent condition and concomitant therapy were unknown. On 24-JAN-2012, the patient was vaccinated with ZOSTAVAX (lot# , expiration date, dose and route were unknown). On 08-AUG-2016 (while on ZOSTAVAX), the patient developed shingles. The patient had sought for medical attention by visiting her doctor. At the time of the report. the patient did not recovered from the event, still had marks on her skin from the shingles. The causality assessment between the events and ZOSTAVAX was not reported. Additional information is not expected as there is no consent for follow up.
body temperature was 102.2 F; I started feeling body aches mainly of my legs; This is a spontaneous report from a contactable other hcp (Patient). A 46-year-old male patient received second dose of bnt162b2 (BNT162B2, solution for injection, Batch/Lot Number: 5318) dose 2 via an unspecified route of administration on 17Feb2021 as dose 2, single for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. Historical vaccine included received first dose of BNT162B2 (COMIRNATY, solution for injection, Batch/Lot Number: was not reported), via an unspecified route of administration on an unspecified date as single for COVID-19 immunization. On 18Feb2021 13:30 the patient started feeling body aches mainly of my legs and body temperature was 102.2 f. On 18Feb2021 the patient underwent lab tests and procedures which included body temperature result with 102.2 Fahrenheit. No other potential adverse events to report at this time. Patient was in good physical health. The outcome of the event was unknown.  Follow-up attempts are completed. No further information is expected.
Severe pneumonia/ Was very tired/ Feeling out of breath/ consumer's oxygen dropped/ is on a ventilator/ physician saw ground glass in bottom portion of lungs; consumer may have kidney stones; back pain; arm pain; blood pressure levels dropped; This spontaneous information has been received from the patient's daughter, concerning a 77-years-old male patient. The patient's pertinent medical history included diabetes, high blood pressure and an unspecified thyroid issue. The patient had no previous drug reactions or allergies. The patient's concomitant medications included famotidine, amlodipine, glimepiride, valsartan, torsemide, levothyroxine sodium, dulaglutide (TRULICITY), vitamins (unspecified), metformin, hydralazine hydrochloride, omega-3 marine triglycerides and ezetimibe (ZETIA).  On 25-SEP-2020, the patient was vaccinated with pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) route of administration reported as injection in arm, lot number S033516 with expiration date 29-JUN-2021, indication reported as elderly with diabetes (strength, dose and frequency were not reported).  On an unknown date in early October 2020, the patient began to feel out of breath and was very tired. The patient also reported that he experienced back pain and arm pain. On an unknown date in October 2020, the patient went to the physician's office for a computerized tomography (CT) scan of his pelvic area, and the physician thought the patient may have kidney stones (nephrolithiasis). The physician was also able to see that the consumer's bottom portion of lungs on the CT scan was ground glass (also reported as multiple pneumonias, completely white up to collar bone). Physician wanted the patient to have a CT scan of lungs and heart but he was admitted to the hospital prior to having the scan done. The patient experienced severe pneumonia and his oxygen and blood pressure levels dropped. The patient did not received treatment for the aforementioned adverse events. At the time of this report, the patient was still in the intensive care unit (ICU) at the hospital and had not recovered from pneumonia. The outcome of the aforementioned adverse events was unknown.  The causal relationship between pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) and the aforementioned adverse events was not provided.  Upon internal review, pneumonia and nephrolithiasis were determined to be medically significant events. combinationproductreport: Yes; brandname: PNEUMOVAX23 SYRINGE (DEVICE); commondevicename: Pneumococcal Vaccine, Polyvalent (23-valent); productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp & Dohme Corp.; devicelotnumber: S033516; expirationdate: 29-JUN-2021; deviceage and unit: 0; malfunction: Unknown; deviceusage: Initial; evaluatedbymfr: Not returned to manufacturer; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not suggest a causal association with the device or device constituent
Patient stated he got shortness of breath and rapid heartrate.  Went to the hospital where they performed cardioconversion and shocked heart into rhythm.
Narrative:  ASSESSMENT/PLAN: 1. Acute COVID - 19 infection in patient who has received 2 COVID vaccinations RA pulse ox 93-94% Start decadron Start remdesivir (LFTS are less than 5X wnl, GFR>30) 02 to keep sats >88% Albuterol MDI airborne precautions. 2. Mild acute hypoxic respiratory failure due to COVID 19 infection 02 to keep sats>88% continuous pulse ox 3. Right sided chest pain - related to fall/walker trauma - no rib fx on CXR or CT Incentive spirometry 4.Hx of multiple falls in the past, 2 falls in the past 24 hrs No head trauma or LOC Head CT negative for bleed/ischemia nonfocal neuro exam Neuro checks x 24 hrs PT/OT prior to discharge 5. Hx of CHF documented in the chart - but not by cardiology or EP. EF 55% on echo 2013 elevated BNP, bilateral lower edema on exam IV lasix Will order echo 6. Hx of PAF on apixaban, SSS s/p pacer, no evidence of active bleeding, hgb stable 7. Stage IIIA CKD - follow cr 8. Recent GI bleed s/p EGD 10/2021:no active bleeding but a small erosion in the distal body of the stomach, a clip was applied. Patient and wife deny any further bleeding hgb is stable cont PPI 9. HLD - hold crestor given elevated LFTS 10. DVT ppx- apixaban Day#8: S: Patient offers no complaints Denies cough or congestion 1. Acute COVID - 19 infection (s/p COVID vaccination x2, no booster) - improved S/P decadron and remdesivir x 5 days 02 to keep sats >92% Albuterol MDI airborne precautions Awaiting discharge
arm is swollen; hot to touch; redness is spreading down to her arm; arm is pain and sore; This spontaneous case was reported by a patient (subsequently medically confirmed) and describes the occurrence of PERIPHERAL SWELLING (arm is swollen), SKIN WARM (hot to touch), ERYTHEMA (redness is spreading down to her arm) and PAIN IN EXTREMITY (arm is pain and sore) in a 52-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 027L20A and 031L20A) for COVID-19 vaccination.     Concomitant products included GABAPENTIN, PANTOPRAZOLE, TOPIRAMATE, CITALOPRAM, ALLOPURINOL and RIZATRIPTAN for an unknown indication.   On 13-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 13-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 13-Mar-2021, the patient experienced PERIPHERAL SWELLING (arm is swollen), SKIN WARM (hot to touch), ERYTHEMA (redness is spreading down to her arm) and PAIN IN EXTREMITY (arm is pain and sore). At the time of the report, PERIPHERAL SWELLING (arm is swollen), SKIN WARM (hot to touch), ERYTHEMA (redness is spreading down to her arm) and PAIN IN EXTREMITY (arm is pain and sore) outcome was unknown.            No treatment information was provided.
Patient reported being in good health while traveling. He was given his primary smallpox vaccine on 3/6/2003. No other vaccines given. Approximately 9 days later (3/15/2003) during his return trip home, he began to itch behind his left knee and noticed he had "large red dots" going up the back of bilateral legs, abdomen, back and lower arms. He described these dots as quarter/half dollar size flat, red raised lesions - "hives". He presented to medical and was sent to emergency room on 3/17/2003 and treated with ATARAX, ALLEGRA and ZANTAC. (These records unable to be located by medical record staff x3). On 3/18/2003 he presented to dermatology for follow up where providers documented "erythematous plaques on abdomen and lower back fading on comparison to yesterday's exam. Lesions were no longer painful to palpation compared to when active". He was diagnosed with urticaria and instructed to continue with ZANTAC, ALLEGRA and ATARAX. He was then flown home. He advised symptoms resolved 2-3 days after treatment initiated and they have not re-occurred since. He also reported a normal take to SPV site with scabbing (no site swelling, streaking, lymphadenopathy, headaches, chest pain or shortness of breath). He did admit to feeling very fatigued with diffuse muscle aches 1-2 weeks after vaccination that resolved with use of MOTRIN/TYLENOL (began use after onset rash). He denied new clothing, soaps, detergents, lotions, uniforms/mustang dry suits, chemical or foods. He reported no further reactions with subsequent vaccinations (IE: influenza, Td, AVA, typhoid, YV, and hep B), medications, foods, etc since.
No adverse Event. Mixed dose. 1st Moderna, now patient receives  Pfizer for 2nd dose. Moderna was unavailable. Patient is conceivably not able to follow-up with the series. It was prudent to vaccinate the patient now rather than have him follow up. Pt is PEH.
I woke up with mild chest pain around 2AM the next day. I was awake for a while then started getting chills. Even though my heated blanket was on, I felt so cold. I had body ache and nausea all day and had to take a sick day to rest in bed. I feel completely fine now that it?s the second day, but my friend who works in health care sector told me to report my symptoms to help CDC collect data.
Myalgia, Arthralgia, Diarrhea, tinnitus Narrative:
Red bumps on the face and top of his head, itchy eyes, sense of burning in the areas of the bumps
Patient came to pharmacy on 10/26/18, complained of injection site bruise on left arm still visible. Also she is still experiencing left arm soreness, nausea and weakness all symptoms she said started on 10/8/18.
Extremely itchy hives appeared at first on glutes and back of neck, and then overnight the hives spread over belly, thighs, groin, & armpits. After treating with Zyrtec (10mg) in the morning and evening, along with benadryl at night (25mg) has caused the worst of the itchy symptoms to subside along with lowering inflammation. This has not caused the hives to totally go away in any area, and a shower worsens the condition.
Received 3rd booster on OCT-2022 and 6 months after the 3rd booster she had COVID Disease; This spontaneous case was reported by a patient family member or friend and describes the occurrence of COVID-19 (Received 3rd booster on OCT-2022 and 6 months after the 3rd booster she had COVID Disease) in a 70-year-old female patient 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.    In October 2022, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. In April 2023, the patient experienced COVID-19 (Received 3rd booster on OCT-2022 and 6 months after the 3rd booster she had COVID Disease). At the time of the report, COVID-19 (Received 3rd booster on OCT-2022 and 6 months after the 3rd booster she had COVID Disease) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter did not provide any causality assessments.   No concomitant information was reported. Suspect product dosage text was reported as additional booster. No treatment information was provided.   Reporter did not allow further contact
Mom states within 2 days post MMR vaccine, lost verbal intelligence skills and babbles away (non?).
Received Shot at 8:47 AM. Went running after noon. Began to feel nauseated and light headed and hot. Went home and by that time arm was swollen and hot over injection site. Had localized hives in that area as well. Still felt nauseated and light headed and hot. Took Benadryl and went to sleep when she awoke a little while later felt fine. Has been fine today 06/12/12.
INJECTION SITES OF SHINGRIX AND COVID VACCINE ARE RED AND SWOLLEN. RECOMMENDED FOR PATIENT TO APPLY ICE TO INJECTION SITES AND TO TAKE ORAL BENADRYL 25MG.
Could not sleep; Sore Injection Site/ burning Injection Site; Red to Pink Injection Site size of an egg; Itching Injection Site; This spontaneous case was reported by a consumer and describes the occurrence of INSOMNIA (Could not sleep), VACCINATION SITE PAIN (Sore Injection Site/ burning Injection Site), VACCINATION SITE ERYTHEMA (Red to Pink Injection Site size of an egg) and VACCINATION SITE PRURITUS (Itching Injection Site) in a 91-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 027A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 08-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 09-Mar-2021, the patient experienced INSOMNIA (Could not sleep), VACCINATION SITE PAIN (Sore Injection Site/ burning Injection Site), VACCINATION SITE ERYTHEMA (Red to Pink Injection Site size of an egg) and VACCINATION SITE PRURITUS (Itching Injection Site). On 10-Mar-2021, VACCINATION SITE PAIN (Sore Injection Site/ burning Injection Site) had resolved. At the time of the report, INSOMNIA (Could not sleep), VACCINATION SITE ERYTHEMA (Red to Pink Injection Site size of an egg) and VACCINATION SITE PRURITUS (Itching Injection Site) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Sore arm; This is a spontaneous report from a contactable healthcare professional (patient). A 32-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number and expiration date were not reported) on 06Jan2021 (13:15) at a single dose, with route of administration unspecified, for COVID-19 immunization at the hospital. Medical history included abnormal Factor V; and kiwi allergy. Concomitant medication included ibuprofen (ADVIL). The patient previously took Ambroxol, and had drug allergy. The patient was not diagnosed with COVID-19 prior to vaccination, and has not been tested since the vaccination. On 06Jan2021 (16:00), the patient had sore arm. The patient did not receive any treatment for the event. The outcome of the event, sore arm, was unknown.  Information on batch/lot number was requested.
The pt stated that on 9/28/00 he felt a "bump" on the back of his head. The following day he "broke out" with bumps on chest, both ears and right foot. The pt was treated with Famvir.
Pt fainted for a minute or two, was pale, shaking and grasping for air and was dizzy. Paramedics came, evaluated vital signs and BS; everything was ok at that time.
Pt experienced tachycardia, lightheaded, sweaty, nausea, and near syncope.  Pt says she is anxious and feels this was anxiety-related.
Arm, back, and chest pain. Patient received the Covid vaccine booster 8 days ago and about a day later he started having pain in his left arm where he received the vaccine that moves down to his hands, pain in his back, and chest pain. Patient said it feels like sharp pains shooting through his body.
Started as very swollen lump on arm. Swelling lessened over the following couple of days but raised red area remained, about 4.5 inches wide. Itchy and hot.
Presented with periumbilical pain to emergency department (patient works at Medical Center).  Admitted to hospital for small bowel obstruction.  Labs were consistent with dehydration (Hct 55, Cr 1.25), as well as CRP 1.10. A CT Abd/Pelvis identified proximal dilation and fecalization of small bowel, with a transition point in the left lower quadrant. Distal to the transition point, the small bowel appears thick, with hyperenhancement and inflammation progressing into the cecum. General Surgery was consulted and patient admitted to hospital for management of this small bowel obstruction.
Felt fine after injection; waited 15 minutes felt fine. Got up at 4 am to assist my mom in using the bathroom and everything was spinning in the room. I sat down on floor for about a minute and thought it passed, stood up and took two steps, and from what I?m told I went flat down on the ground without trying to even break my fall. I was out cold. Taken to hospital where I had four ct scans, numerous xrays done; all okay minus pulled muscles/ligaments and possibly some fractures in my foot. I had surgery on it in January and they couldn?t tell if it was old or new fractures.
pain in  left arm, facial swelling , headache,dizzness, crying , high feavers
9:45 AM Pt received DTaP, Hib, IPV, Prevnar. 9:50 AM Pt has hives to head which were progressing to thorax. Pt was given Benadryl 10mg IM at 9:55 AM. 10:00 AM Pt given Solu Medrol 10mg IM. 10:05 AM Rash to thorax abating. 10:10 AM Rash to head abating.
This spontaneous report as received from a nurse practitioner refers to a multiple unspecified patient of unknown age and gender. No information on patient's medical history, concurrent conditions or concomitant medications was provided. On an unknown dates, the patients were vaccinated with the doses of improperly stored ROTATEQ orally, lot # L008997, expiration date 04-DEC-2016 (dose was not provided). No adverse effects were reported. This is one of the two reports from the same source. Additional information has been requested.
Ocular Migranes- 6 ocular migranes total- 4 of them just ocular- 2 turned into full blown migraine- Date of onset was 2/13/2021 and the last one at the moment was 1/21/2021
This spontaneous report as received from a patient's wife refers to a 59 year old male patient with no drug reactions/allergies and no pertinent medical history. On 29-NOV-2014, the patient was vaccinated with a dose of ZOSTAVAX (route, site of administration, lot# and expiration date were not provided). There was no concomitant medication. On 06-DEC-2014, the patient experienced soreness at the injection, that spread to his shoulder and elbow, across the back to the other arm, accompanied by severe joint pain. No lab diagnostic studies were performed. The patient had an office visit on an unspecified date and was treated with ibuprofen. The outcome of events was reported as not recovered/not resolved. The relatedness between the events and ZOSTAVAX was not reported. Additional information has been requested.