chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Information has been received from a medical assistant referring to unspecified patients of unknown age and gender. The patients' medical history, concurrent condition and concomitant medication were unknown. On unspecified dates, the patients were vaccinated with improperly stored RECOMBIVAX HB (dose and route unknown, lot# L026598, expiration date: 26-JUN-2017; lot# reported as M011839, expiration date: 13-SEP-2017). No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Patient is an 82 year-old male with history of NSCLC s/p IBRT (2012), LS- SCLC s/p carboplatin/etoposide and XRT (2017), COPD, type 2 DM, and cervical and  lumbar spinal stenosis s/p multiple cervical spinal fusions and lumbar  laminectomies c/b neurogenic bladder who presented to Facility on 5/10 with several  hours of chest pain, found to have STEMI s/p PCI, now transferred for further  management of NSVT.  Patient reports that he began to have dull left-sided chest pain around 4am on  5/10, associated with nausea and diaphoresis. He was taken to an Facility around 8am,  was found to have STEMI in V1-V4 and was taken emergently to the cath lab. There  was 80-90% stenosis of proximal LAD with ulcerated plaque. TIMI II flow  throughout LAD. There was 100% occlusion of distal left circumflex, OM2, and RCA  at bifucation of PDA with collaterals from LAD. EF 30-35% on LV gram. Stents  deployed to proximal and ostial LAD. He was started on ASA, ticagrelor,  metoprolol 12.5mg BID, and atorvastatin 20mg. He had runs of NSVT starting 5/10  and was started on amiodarone gtt. Echo showed EF 40-45%. Amiodarone was stopped  but restarted 5/12 for further runs of NSVT (<20 beats). He was transferred to  the Facility for further evaluation of NSVT and possible VT after MI.
12 hours after injection, I experienced exactly 12 hours of severe body ache, incredible headache, and extreme restlessness. Compared to experiencing actual Covid, this was much, much more magnified.
Loss of hearing in my right ear. Tingling sensation then couldn't hear anything. Had annual physical with primary care physician first , then waited a week or two to see if there was improvement. Went to ENT physician for audiology exam. Ear structure and everything internally appears to be normal. Audiology exam had abnormal results in the right ear. Left ear was fine.   Physician injected a steroid into the inner ear. Then prescribed methylprednisolone for a six-day course of therapy. Will see physician again in less than three weeks.  No improvement. Only less and less hearing in the right ear.
Discharge Physician: MD Primary Care Physician: DO  Date of Admission: 5/19/2023 Discharge Date: 5/23/2023   DETAILS OF HOSPITAL STAY:   PRESENTING PROBLEM: Acute urinary tract infection [N39.0] Acute respiratory failure with hypoxia (HCC) [J96.01] Altered mental status, unspecified altered mental status type [R41.82]   Patient is a 75 y.o. male who presented with shortness of breath and altered mental status.  He has a pertinent medical history for type 2 diabetes, hypertension, CVA with right-sided hemiplegia, CKD, hyperlipidemia, CHF, and presence of suprapubic catheter.  Patient is a resident at long-term care facility where there he was noticed to have increased confusion and shortness of breath.  Per report from long-term care facility patient tested positive for COVID on 05/02/2023 and was removed from COVID precautions.  He was sent to the ER due to having oxygen saturation of 80% on room air and increased confusion.   In the ER, patient was initially placed on non-rebreather and subsequently weaned to 3 L nasal cannula.  Initial labs showed BUN 37, creatinine 2.16, BNP 656, lactic acid 2.3, WBC 14.17, hemoglobin 11.7, D-dimer 1020. He tested positive for COVID 19 in the ER.  Initially UA was obtained from old indwelling suprapubic catheter however this was replaced and repeat UA was obtained.  Blood cultures and urine culture pending.  A CTA thorax was obtained however examination was significantly limited due to respiratory motion, no pulmonary embolism given limited evaluation however cannot exclude pneumonia or pulmonary edema.  Patient was given DuoNebs and ceftriaxone in the ER.  Patient was admitted to the hospitalist service for further management of acute respiratory failure, acute cystitis, and COVID-19.     CT thorax was completed which showed mild mediastinal air and hilar adenopathy.  Recommend 3 month follow-up to exclude neoplastic adenopathy.   Patient reported using oxygen nightly and was able to maintain oxygen saturation on room air during day without difficulty.  Patient had improvement of cough and appetite.  Patient was discharged to skilled nursing facility, stable and in improved condition with close hospital follow-up.  On day of discharge patient had COVID testing which was negative.
pain in  arm; toungue feels thick; injection site bled a lot at the time of the injection; my throat began swelling a little bit; my lips got numb; I was short of breath; my voice changed; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE HAEMORRHAGE (injection site bled a lot at the time of the injection), PHARYNGEAL SWELLING (my throat began swelling a little bit), HYPOAESTHESIA ORAL (my lips got numb), DYSPNOEA (I was short of breath) and DYSPHONIA (my voice changed) in a 73-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 015M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 06-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 06-Feb-2021, the patient experienced VACCINATION SITE HAEMORRHAGE (injection site bled a lot at the time of the injection), PHARYNGEAL SWELLING (my throat began swelling a little bit), HYPOAESTHESIA ORAL (my lips got numb), DYSPNOEA (I was short of breath), DYSPHONIA (my voice changed) and TONGUE DISORDER (toungue feels thick). On 07-Feb-2021, the patient experienced PAIN IN EXTREMITY (pain in  arm). At the time of the report, VACCINATION SITE HAEMORRHAGE (injection site bled a lot at the time of the injection), PHARYNGEAL SWELLING (my throat began swelling a little bit), HYPOAESTHESIA ORAL (my lips got numb), DYSPNOEA (I was short of breath), DYSPHONIA (my voice changed) and TONGUE DISORDER (toungue feels thick) had resolved and PAIN IN EXTREMITY (pain in  arm) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were reported.  The patient received diphenhydramine 25mg as treatment.
Pt was fully vaccinated with the Pfizer COVID-19 vaccine (on 2/3/2021 and 2/24/2021 respectively).  Pt was seen in the ED on 10/5/2021 and tested positive via PCR for COVID 19.  She was transferred to hospital for admission, in general med/surg unit, to be treated for COVID.
small red spot on right eye; Pain in left arm; This is a spontaneous report from a contactable consumer, reporting for herself. A 34-year-old non-pregnant female patient received the first dose of the bnt162b2 (BNT162B2; Lot Number: ER87Z7), via an unspecified route of administration in the left arm on 29Mar2021 at 13:45 at a single dose for covid-19 immunisation. Medical history included polycystic ovary syndrome (PCOS), fibromyalgia, rheumatoid arthritis, Hoshimoto's, and hypothyroidism. There were no known allergies. Concomitant medications included unspecified thyroid prescription, pain reliever, vitamins and supplements (as reported), given in two weeks. There were no other vaccinations given in prior four weeks. On 29Mar2021, the patient experienced small red spot on right eye and pain in left arm for two days, which were non-serious. There was no treatment given in response to the events. There was no covid prior to or post vaccination. The clinical outcome of the events was recovering.   No follow-up attempts are needed. No further information is expected.
Arm began to itch - continue you present itself as a round, itchy, patch - similar to a hive but contained to vaccine site.  It started out about 2" - and now about 5" in diameter.  Also is hot to touch, raised, and itches.
Pt exp vision blurred, avascular migraine, lost vision, neg scotoma, optic neuritis, pos vers & MRI, spinal fluid has been found to be pos; trouble w/eyes, lt side of body intermittently & generalized fatigue; poss demylination;
Moderna COVID-19 Vaccine EUA  Ringing in ears began on April 5, 3 days after receiving vaccine on April 2. Has continued on/off for two weeks with varying degrees of severity.
in bed for 48 hours; spasm; hot/hot on the outside; mild spasms in the limbs; muscles aches in back/ muscle aches in neck; felt tired/fatigue; chills; This spontaneous case was reported by a consumer and describes the occurrence of FEELING HOT (hot/hot on the outside), MUSCLE SPASMS (mild spasms in the limbs), MYALGIA (muscles aches in back/ muscle aches in neck), FATIGUE (felt tired/fatigue) and VACCINATION COMPLICATION (in bed for 48 hours) in a 78-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 029A21A and 024M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     patient medical history was not reported.  Concomitant products included CLOPIDOGREL, ATORVASTATIN and ACETYLSALICYLIC ACID (ASPIRIN 81) for an unknown indication.   On 08-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 10-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 08-Feb-2021, the patient experienced CHILLS (chills). On 10-Mar-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced MYALGIA (muscles aches in back/ muscle aches in neck) and FATIGUE (felt tired/fatigue). On 11-Mar-2021, the patient experienced FEELING HOT (hot/hot on the outside) and MUSCLE SPASMS (mild spasms in the limbs). On an unknown date, the patient experienced VACCINATION COMPLICATION (in bed for 48 hours) and MUSCLE SPASMS (spasm). On 09-Feb-2021, CHILLS (chills) had resolved. On 11-Mar-2021, MYALGIA (muscles aches in back/ muscle aches in neck) and FATIGUE (felt tired/fatigue) had resolved. On 12-Mar-2021, FEELING HOT (hot/hot on the outside) and MUSCLE SPASMS (mild spasms in the limbs) had resolved. At the time of the report, VACCINATION COMPLICATION (in bed for 48 hours) and MUSCLE SPASMS (spasm) outcome was unknown.            no treatment medications was reported patient medical history was not reported   This case was linked to MOD-2021-046390, MOD-2021-046390 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 12-Aug-2021: Significant follow-up appended: Concomitant medication was added. Newevents in bed for 48 hours and Spasm was added.
Headache, Diarrhea, Arm and Neck Pain, hard lump on arm
Pfizer vaccine was administered outside of clinic- reported by patient- ? NO LOT NUMBER WERE SUPPLIED ------------------------------------------------------------------------------------------------------------------------------------ HYPOXIA 10/11/2022 POSTOP FEVER HYPOXIA 10/11/2022 BILAT GLAUCOMA SUSPECT
I experienced a flare up of my Rheumatoid Arthritis a month after receiving the vaccine. I saw the Nurse Practitioner at the Specialist office they performed a hip X-ray and was given a prescription for Flexural 10mg which helped somewhat with my symptoms. I also went to a Neurosurgeon on 10/06/2021 and 10/27/2021 who performed injections in my Lumbar Spine (have had two of them) I have another appointment on 11/10/2021 as a follow up.
Acute myocarditis. Presented with palpitations. He had wide complex tachycardia (diagnosed as fasicular ventricular tachycardia). Required cardioversion. Started on metoprolol.  Hospitalized two days. Send home with LifeVest.
GI symptoms; This is a spontaneous report from a contactable consumer (patient's daughter). A female patient of an unspecified age received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number: unknown), via an unspecified route of administration on an unspecified date as single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient had GI symptoms after the COVID vaccine. It was not clarified what GI symptoms occurred. She felt like got off easy by not having their symptoms. The outcome of the event was unknown. The report is cross referenced to report ID: MF6J8PKN  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
One day, post vax, child had an episode of lethargy and didn't respond well. It seemed to parent/grandparent that child wasn't breathing (but no one reports blue color of skin) and decreased responsiveness. Called 911 and child was taken to ER. Did well after. The child had a mild cough, the day of the shot, but no cold symptoms to report at the time of this episode.
Narrative:  PER PATIENT ACCOUNT: PATIENT RECE'D PFIZER  VACCINE ON 01/12/2021, AND ON DAY 4 OR 5 AFTER INJECTION HE  PRESENTED WITH A RASH AND SEVERE BACK PAIN. PATIENT  PRESENTED TO ED ON 01/27/2021 WITH RASH TO RIGHT SIDE OF  TRUNK AND LOWER BACK PAIN. DIAGNOSED WITH SHINGLES  AND GIVEN VALCYCOLOVIR AND GABAPENTIN. PATIENT PRESENTED TODAY (02/02/21) FOR DOSE 2. RASH STILL PRESENT TO TRUNK, PER PT HAS IMPROVED, LOWER BACK PAIN STILL  PRESENT. PATIENT HELD X 1 WEEK AND WILL RETURN 02/09/2021 FOR DOSE 2.  Symptoms:    Myalgia, SkinRash & BACK PAIN  Treatment:
Pt states developed a bacterial infection in arm following vaccination. Infection diagnosed during ER visit and received antibiotics at hospital.
atient is fully vaccinated and boosted. Postive covid test at ED visit on 2/12/2022. 34-year-old female, denies any chronic medical problems presented to the ED with 10 days of URI symptoms.  Complains of a productive cough with discolored sputum, chest pressure, as well as periumbilical and lower abdominal pain.  The lower abdominal pain has been going on for weeks to months.  Currently has OB/GYN follow-up for this.  Had a temperature today, of 99.8.  Has not taken any medications prior to arrival. No headache vision changes, no shortness of breath.EKG reviewed and interpreted by myself, normal sinus rhythm, normal axis, no ischemic findings.  Chest x-ray is clear.  Blood work is within normal limits. No medications given.  Discharged home.
Vomiting every 15 minutes for 4 hours till ER doctor prescribed ZOFRAN. Vomiting under control after 4 hours. 24 hours after seeing ER Doctor but no appetite still. Also diarrhea has started 24 hours after vaccine.
apparent sterile abscess @ site of vax & devel swelling, redness w/in 24hrs p/vax;
This spontaneous report was received from a registered nurse regarding a 15 month old patient unknown gender. The patients' medical history, drug reactions/allergies and concomitant medications were not provided. On unknown dates, the patient was vaccinated with improperly stored doses of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (recombinant Human albumin)rHA(M-M-R II)  lot # N024696, expiration date 07-APR-2019 for prophylaxis. The vaccine was reconstituted with properly stored sterile diluent (manufacturer unknown). There was no adverse effect reported. Administered dose of vaccine experienced the temperature excursion of 9 to 25 (8.6) degrees Celsius for 16 minutes. Data logger was involved. There were no previous excursions reported. This is one of several reports received from the same reporter. Sender's Comments: US-009507513-1809USA009336: US-009507513-1809USA009329: US-009507513-1809USA009336: US-009507513-1809USA009345: US-009507513-1809USA009344: US-009507513-1809USA009343: US-009507513-1809USA009342: US-009507513-1809USA009341: US-009507513-1809USA009340: US-009507513-1809USA009339: US-009507513-1809USA009338: US-009507513-1809USA009337: US-009507513-1809USA009346: US-009507513-1809USA009335: US-009507513-1809USA009334: US-009507513-1809USA009333: US-009507513-1809USA009332: US-009507513-1809USA009331: US-009507513-1809USA009330.
Administered expired dose; This case was reported by a nurse via call center representative and described the occurrence of expired vaccine used in a 17-year-old female patient who received Men B NVS (Bexsero) (batch number unknown, expiry date 30th September 2022) for prophylaxis.   Co-suspect products included meningococcal B recom vaccine + aloh + omv pre-filled syringe device (Bexsero Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 3rd October 2022, the patient received Bexsero and Bexsero Pre-Filled Syringe Device. On 3rd October 2022, unknown after receiving Bexsero and Bexsero Pre-Filled Syringe Device, the patient experienced expired vaccine used. On an unknown date, the outcome of the expired vaccine used was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK Receipt Date: 03-OCT-2022 Reporter's comment: Nurse reported that the patient was administrated with an expired dose of Bexsero. The vaccine was expired on 30th September 2022. No adverse event was reported. The reporter consented to follow-up. Additional Supportive Information: The patient received a dose of Bexsero which was already expired, which led to expired vaccine used.
PAIN THAT NIGHT - REDNESS TO BOTH LEGS ON 8/23/11. BY 4 PM SWELLING, PAIN AND HARDNESS R/SQ 4 IN. L/IM 2 1/2 DIAMETER - SWELLING/REDNESS MOTRIN   ELOCON
Systemic: Other- per Nurse Practioner , patient seemed like a "zombie" with blank stares and not responsive
Large hive/welt the size of a fist over the vaccine site in my left arm for 2+weeks; Hot; Itchy; Had large lump underneath; This is a spontaneous report from a contactable consumer(patient) or other non hcp. A 44-years-old female patient received bnt162b2(PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number: EN6208), via an unspecified route of administration, administered in Arm Left on 16Mar2021 13:00 as DOSE 1, SINGLE for COVID-19 immunisation.  Medical history included hypertension, drug hypersensitivity for Sulfa. Concomitant medication(s) included losartan (LOSARTAN) and zolpidem (ZOLPIDEM). The patient previously took keflex [cefalexin monohydrate] and experienced drug hypersensitivity.The patient experienced large hive/welt the size of a fist over the vaccine site in his left arm for 2 plus weeks, hot, itchy and had large lump underneath on Apr2021. The events outcome was reported as not recovered.   No follow-up attempts are needed. No further information is expected.
MMR/Varicella/HepA # 1 given on 7/11/08. On 7/21/08, pt. developed fever and rash which lasted x 1 week. Pt not examined for this complaint
Burning sensation to palm of both hands, duration about 12-14 hours. No treatment recommended by ER physician.
The morning after my dose I woke up feeling like I would pass out while laying in my bed. I believe I did since I know the feeling after waking up. Ringing in ears and sweaty. I then began to vomit and contributed vomiting most of the day if I stood up I got dizzy. I could not hold anything down in my stomach. I had fever of 100.0  about 6 pm I began to be able to have a small amount of food in my stomach.
approx 7hr p/vax pt became floppy;pt in infant chair w/arms extended loosely @ side, legs flopped apart;pt did not seem to respond to mom voice;mom picked child up & child did not seem to hold self nl;
Moderna Vaccine administered after Pfizer vaccine administered; This spontaneous case was reported by a pharmacist and describes the occurrence of INTERCHANGE OF VACCINE PRODUCTS (Moderna Vaccine administered after Pfizer vaccine administered) in a 53-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 017B21A) for COVID-19 vaccination.     Previously administered products included for an unreported indication: PFIZER BIONTECH COVID-19 VACCINE in February 2021.    On 02-Jul-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 02-Jul-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced INTERCHANGE OF VACCINE PRODUCTS (Moderna Vaccine administered after Pfizer vaccine administered). On 02-Jul-2021, INTERCHANGE OF VACCINE PRODUCTS (Moderna Vaccine administered after Pfizer vaccine administered) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications and no treatment medications were reported.   Most recent FOLLOW-UP information incorporated above includes: On 20-Sep-2021: Follow-up Information received contains no new information
Narrative:  Arthralgia in both hands -- did not start until 9-10 days post-vaccine. Correlation unknown
fever, chills, aches, pains, ear ache & every tooth in head ached;myalgia cont weeks;toothache all winter; neuralgia all winter;insomnia, head got sickness through DEC; pt states allergies all getting worse & worse;will not take flu v
No symptomatic AEs reported during call. No additional AE details or PQC; Inbound call from HCP reporting a VARIVAX dose was inadvertently given intramuscularly instead of subcutaneously. No symptomatic AEs reported during call. No additional AE details or PQC.; This spontaneous report has been received from a medical assistant, regarding a 34-years-old female (also reported as 24-years-old, conflicting information). The patient's pertinent medical history included condylomas as current condition, previous drug reactions or allergies and concomitant medications were not reported.    On 16-JAN-2023, the patient was vaccinated with the second dose of varicella virus vaccine live (Oka/Merck) (VARIVAX) subcutaneous injection, (lot number: W003819, which was determined to be valid, with an expiration date on 02-FEB-2024), with an sterile diluent, Solution for injection/infusion (lot number: W010871, which was determined to be valid, with an expiration date on 17-NOV-2024), inadvertently given intramuscularly instead of subcutaneously in the left deltoid as prophylaxis (strength and, doses were not reported). (Incorrect route of product administration). The outcome of Incorrect route of product administration was reported as recovered.   It was reported that a repeat dose was not needed, and no adverse reactions were noted.
Swelling, pain, warmth erythema 8cm by 7cm at injection site.
Patient developed a lump on left shoulder where vaccine was administered. (+) tender. Suspect sterile abscess, put has "soft" center with ring around it that is firm.
MUSCLE PAIN IN BOTH ARMS; This spontaneous report received from a patient 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) 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 muscle pain in both arms. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of muscle pain in both arms was not reported. This report was non-serious.