chrisvoncsefalvay/vaers-outcomes huggingface dataset:
3/14/2021 Vaccination. 3/18/2021 Flew to see family members, to see grandbaby. Complained of lower back pain and 'cotton balls' in ears. During vacation experienced dizziness and light headiness. Woke up with vertigo, rapid eye movement. 3/28/2021 severe vertigo, non stop vomiting, rapid eye movement. 4/1 PCP CT neg, labs good. Meclizine. No relief. Referred to ENT. Bilateral Ear infection 80 mg Decadron. 4/6 to see neuro for tremor in left land. DX BPPT with normal hearing age related loss and possible due to infection. Ordered MRI of canal with and without contrast.  Losartan to hold and to continue BP medication. 4/13 MRI of auditory canal. 4/16 ENT diagnosed sudden idiopathic hearing loss in the left ear with restrictive hearing in the right ear. And hear loss in the left ear. Vestibular weakness.  60 mg prednisone a day for 2 weeks. to taper to 10 mg every week. Valium 5 mg 1-3 x day for 14 days. To stop the other medication because it wasn't helping. 4/26 Neurologist. He told me to see the ENT. He said that he thought I had Parkinson's, no cure. To come back in 5 months. I went for a second opinion. 5/5/2021 ENT 24/7 nausea 50% improvement with vomiting. Dix-Hall pike on the L side with involuntary shaking and rapid eye movement. Epley maneuver diagnosed BPPV of the L ear. Injections over 3 weeks where they put Decadron in the L ear. 5/12/2021 2nd injection - diagnosed with sinus infection. 5/19 3rd injection. CT of sinuses were clear, R ear hearing loss, Prednisone for 14 days and taper by 50 mg every week. 5/26 Injections in R ear with Decadron. 6/2 2nd injection. 6/9 3rd injection Vertigo was worse and the nystagmus. Referred to physical therapy. 7/8 Started PT. 7/14 started steroids. They symptoms were worse. Tube in R ear and started prednisolone drops right into the middle ear for 30 days, 3x a day.  Talked about DMG. I had L weakness, Vestibular dysfunction. 9/3/2021 increased vertigo, L side hearing loss, stagma was worse, nausea was still 24/7. I had developed intermittent fever 100.4 every other day. The diagnosis that vertebral insufficiency and some hearing loss in both ears. Back on prednisone and ordered more testing. Thanksgiving I was admitted to the hospital. I went in on a Friday and was there for 7 days. Encephalitis was the diagnosis. MRI of the spine and brain; swelling. Spinal tap; protein and blood found. Then told me I was anemic. 12/08/2021 Christmas I had double vision. Sent blood work to a lab; abnormal results. Autoimmune encephalitis of the brain cell. I have to have 5-6 subtypes to rule out to make sure that is what it is. 3/21/2021 PET scan to look for tumor. *still going thru diagnosis process. Still experiencing vertigo, balance issues, nausea, double vision, nausea, etc.
No additional adverse event details; Pharmacist calling reports expired MMRII was administered to patient. Sterile diluent used to reconstitute was also expired. Date of administration 5/11/2022. No Additional AE details; This spontaneous report was received from a pharmacist, referring to a patient of unknown age and gender. The patient's historical drugs, medical history, concomitant therapies and concurrent conditions were not reported.  On 11-MAY-2022, the patient was vaccinated with an expired dose of Measles, Mumps, and Rubella (Wistar RA 27-3) Virus Vaccine, Live Albumin status rHA (recombinant Human albumin) (M-M-R II) lot# T013727, expiration date reported as 21-APR-2022, that was reconstituted with an expired sterile diluent lot# S025290, expiration date reported as 20-MAR-2022, for prophylaxis (strength, dose, route and frequency were not reported)(expired product administered). Neither vaccine nor sterile diluent experienced any temperature excursions. No additional adverse events details. No PQC.
Swollen and itchy injection site with warm, red rash about 3 inches in diameter Severe headache Fatigue
Patient reports Pfizer #1/2 on 10/14/21, worsened ulcerative colitis flare 10/18/21. Managed by GI
COVID-19; COVID-19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 60-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 18Oct2022 at 13:30 as dose 4 (booster), single (Lot number: GJ3277) at the age of 59 years, in right arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "high BP" (unspecified if ongoing); "allergies with shellfish" (unspecified if ongoing); "High cholesterol" (unspecified if ongoing); "Hashimoto's" (unspecified if ongoing); "Fibromyalgia" (unspecified if ongoing); "thyroid" (unspecified if ongoing), notes: All other normal meds was s on patient continued (for thyroid); "allergies wiith sulfa drugs" (unspecified if ongoing). The patient took concomitant medications. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "recovering" and all described as "COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive, notes: COVID 19 Treatment. Therapeutic measures were taken as a result of drug ineffective, covid-19.
Facial drooping, watering of the right eye, twitching of the right eye.  Diagnosed as Bell's Palsey. Rx for prednisone.
6/7 - patient received 2nd  dose of Pfizer vaccine.  6/8 - patient developed tactile fevers (for 2-3 days), diarrhea (4-5 days of non-bloody diarrhea) 6/9 - developed chest pain and tightness and mild cough  6/12 - few episodes of NBNB emesis, cough with blood tinged sputum  6/13 - presented to urgent care, referred to hospital and admitted to floor.  Patient found to have tachycardia and hypertension.  CXR with pleural effusion, renal US with medical renal disease.  Worsening renal function and concern for hyper coagulable state with worsening D-Dimer and possible pulmonary embolus but unable to obtain contrast images due to renal failure.    6/15 - transferred to ICU for heparin drip for worsening D-dimer.  Nephrology, rheumatology and infectious disease consulted.  Continued chest pain, cough with hemoptysis.  Remains afebrile and otherwise hemodynamically stable.  Started on ceftriaxone empirically.  Concern for MIS-C, vaccine related adverse event vs autoimmune vasculitis.
A report has been received from a Health Professional concerning a 10 year old, Female subject, who had been receiving FLUMIST, (intranasal). FLUMIST (intranasal) started on an unknown date. The patient experienced sneezing and runny nose. The outcome of the event of sneezing and runny nose is unknown. The report was considered to be non-serious by the company physician.
My legs were hurting, couldn't focus, very lightheaded and dizzy, tingling on my left side of body, couldn't eat, very nauseous, and clammy
Left Deltoid redness and warm to touch. Monitor. Use topic antibiotic and monitor.
At 1142, RN was made aware that patient was complaining of itching. RN went to patient and completed visual assessment. Patient states she had mild itching on her arms. Patient states no difficulty breathing. Patient relayed that she has had itching following flu vaccines in the past, as well (not relayed prior to receiving vaccine today). RN made "Medical Management of Adverse Reaction in Adult Standing Order" available for guidance, if needed. Epi Pen present in clinic, if needed. 1145 - Patient voluntarily took 25 mg of her personal Benadryl. States no difficulty breathing. 1148 - Patient voluntarily took 2 puffs of her personal Symbicort - stated some mild chest tightness. Patient states immediately resolved following medication. 1153 - Patient states no difficulty breathing. Patient states itching is still mild. Patient and co-workers state she has had similar symptoms after receiving flu vaccine in the past (not relayed prior to receiving vaccine today). 1157 - Patient states no difficulty breathing. Patient states itching has improved. Patient states mild dizziness. 1204 - Patient states she is feeling better and feels OK to go back to work. 1210 - Patient left the building with two co-workers. Patient assessed to look visually improved from beginning of situation.  Patient instructed to call 911 if any worsening of symptoms. Patient verbalized understanding.
A nurse reported the occurrence of vertigo in a 17 y.o. female who inadvertently received adult dose of Hep A vax inactivated for prophylaxis. The subject's medical history, concurrent conditions, and concurrent medications were unknown. She had no adverse experiences following receipt of her first injection of Havrix. On 8/27/02, the subject received her 2nd injection of Havrix. Later that afternoon, she experienced vertigo. As of 8/30/02, she was "doing ok" and her condition was reported to be "improved."
at 2245 started having light fever, hot and cold , finger tips are numb, body aches , left arm pain
Pt. received HPV-9 and T-dap at (L) deltoid on 7/25/17 that night she started to develop swelling at the site, with some pain, redness, also fatigue, mild SOB, mild sore throat, symptoms peaked on 7/29/17 then started to improve, currently all symptoms resolved, except a small bump at the site, nontender, no swelling.
ON AND OFF SHAKING HANDS; This spontaneous report received from a consumer concerned a 66 year old male. The patient's weight was 208 pounds, and height was 173 centimeters. The patient's past medical history included heart stent placement surgery, and concurrent conditions included high blood pressure, and cholesterol. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 206A21A, expiry: 23/JUN/2021) dose was not reported, administered on 30-APR-2021 for prophylactic vaccination. Concomitant medications included clopidogrel bisulfate for cholesterol. On 07-MAY-2021, the subject experienced on and off shaking hands. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from on and off shaking hands. This report was non-serious.
This case was reported by a physician, via a GSK representative, and described the occurrence of not responding to therapy in a child subject of unspecified age and gender who was vaccinated with hepatitis B (manufacturer unspecified). On unspecified dates, as an infant, the subject received 1st dose, 2nd dose and 3rd dose of hepatitis B vaccine (details unknown). At an unknown time after vaccination with hepatitis B vaccine, the subject experienced not responding to therapy ("no immunity/no protection"). The physician reported that four subject's, all children from the same family, were vaccinated with her hepatitis B vaccine series (unknown manufacturer) as infants, and as the children are not older (unknown ages) two of the children have tested positive for hepatitis B, and two of the other children were tested as having no immunity/no protection. This is case 4 of 4 (see case IDs A0938693A, A0939314A, A0939315A for details of the other reports).
Expired vaccine used; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) in a 62-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 038C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 18-Nov-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 ml. On 18-Nov-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Expired vaccine used). On 18-Nov-2021, EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant products were reported. No treatment information was reported by the reporter. Reporter stated that the box of vials was received on 14-Oct-2021. It was frozen when it was received and was immediately placed in the clinic vaccine freezer. The vials remained frozen until the date of use and were thawed in the vaccine refrigerator prior to use. The vials remained in the refrigerator between uses and each vial was discarded after the final appointment of the day. Only 1 vial was used per day between the hours of 8:00am to 4:00pm. I have attached a spread sheet with the patients that received the vaccine and the dates. Also stated that Sticker included Batch number as 035C21A and Expiry date as 30-Dec-2021 (extended expiration).
Approximately 6 hours after getting vaccines I began to get a fullness feeling in my left ear and within an hour I had lost all hearing in my left ear and had associated tinnitus. I saw the audiologist & ENT on 8/24, 9/1, 9/8 and 9/24/2020 (to date) and I still have profound / severe hearing loss. On 8/24/2020 ENT prescribed a high dose steroid (60 mg/day prednisone for a week tapered off over the next six days) and an anti-viral (1 g / 3X day of valacyclovir for a week). ENT did three intratympanic injections of dexamethasone on 8/24, 9/1 & 9/24/2020. Nothing has returned hearing or stopped tinnitus.  I have never had issues with the yearly flu vaccine so this is almost certainly Shingrix related.
Severely tired and achy and at injection site it was raised and enflamed and was extremely sore. By afternoon I started to get pins and needles up both arms from fingertips up arm thru my shoulders and up both sides of my neck. They also were throbbing with pain and hurt if someone was to grab my arms.
3" red circle raised, ice pack within 24 hrs 4/30.  3" spot hard an dark red spreading down arm, tender and warm 5/1. Redness spreading down elbow 5/2. Urgent care antibiotic and steroid 5/2.
Information has been received from a health professional concerning a female who was vaccinated with Gardasil. Subsequently the patient experienced tingling down in her arm and she fainted shortly thereafter. The healthcare worker also reported on another patient (WAES # 0705USA01651). No further information is available.
Erythematous, pruritic, warm  rash on the upper left arm since Day 7. As of Day 11, rash is spreading and getting more pruritic; also some ache in left arm, primarily in left wrist. Currently taking antihistamine and using hydrocortisone cream for symptom relief.
This spontaneous report as received from a medical assistant refers to a patient of unknown age who on 03-JUL-2012, date was vaccinated with a dose of (Merck) VARIVAX (dose, route and lot number not reported) instead of ZOSTAVAX. Medical assistant stated that the physician placed an order for ZOSTAVAX and (Merck) VARIVAX was on the invoice and it was shipped. The patient was not experiencing any known symptoms. Additional information has been requested.
Pt reports immediate numbness in her left arm which traveled traveled down to her pinky finger, this symptom persisted for mand days. Within 24 hrs after vaccination her left axillary region was very sore and she couldn't move her arm for a few days. it was (and still is) tender at the injection site. she is having intermittent pain sensations in her left hand/pinky and FA and still has tenderness at the injection site which she locates to just inferior and posterior to the deltoid muscle.
This spontaneous report as received from a physician refers to a female patient of unknown age with no drug reactions or allergies. Pertinent medical history was none. Approximately on an unknown date in 1993(Reported as 20 years ago) the patient was vaccinated with a first dose of VARIVAX (Merck) (Lot number, expiry date, route and dose were not reported)as she never had chicken pox and wanted to get pregnant. No concomitant medications were taken. Approximately on an unknown date in April 2013 (reported as now) a blood test was performed and the patient has negative immunity titers to varicella. The patient sought medical attention(office visit) and no treatment was provided. The outcome of negative immunity titers to varicella was reported as not recovered/not resolved. Additional information has been requested.
50 y/o Israeli female c/o "I don't feel good", numbness and tingling to left side of neck, left arm, and left leg after receiving the first dose of the vaccine in her left arm. She reported that she had Hx of HTN for which she takes Lisinopril 20 mg daily, took this morning. She was assessed and monitored by NP, EMT, and paramedic. She was anxious and crying. Alert, oriented to person, place, time and situation. PERRL, size 4, move all extremities, sensation intact to dull and sharp stimuli. BP - 180/115, HR - 68, Resp - 22, O2 sat - 96%. She was instructed on relaxation techniques, offered H2O, she refused the H2O. She remained with symptoms and still anxious and cried,"I don't want to die" and and c/o chest pain. EMS was called and she was transported from site via stretcher to go to ED for eval and tx. She was accompanied by husband and paramedics who were given full report on the pt.
Reported headache that started the day after vaccine which he felt was common until headache continued sporadically for several days. He has no additional symptoms and stated he just wanted to let someone know. He has not taken anything for his symptoms and was unsure if he could or should. He has been directed to take Tylenol and if symptoms persist to F/U with his PCP and keep me informed. He has been given VAERs website for adverse reactions in the future. I have explained that his headache could be a side effect of the vaccine; however, if his symptoms worsen to seek additional medical evaluation.
Nausea; Vomiting; This spontaneous case was reported by a pharmacist and describes the occurrence of NAUSEA (Nausea) and VOMITING (Vomiting) in a 75-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030B21A) for COVID-19 vaccination.     The patient's past medical history included COVID-19 in November 2020.    On 07-Apr-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 07-Apr-2021, the patient experienced NAUSEA (Nausea) and VOMITING (Vomiting). The patient was treated with ONDANSETRON (ZOFRAN [ONDANSETRON]) at a dose of 1 dosage form. At the time of the report, NAUSEA (Nausea) and VOMITING (Vomiting) was resolving. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant medications were not provided by reporter.
Heart palpitations for 2 months so far, more pronounced closer to vaccination date and seem to be getting better finally but are still present. In the two weeks immediately after shot in addition to palpitations experienced cold sweats. Period irregularity was experienced as well including frequent bleeding and spotting multiple times a month.
CHEST PRESSURE; FAST HEART RATE; TEETH PAIN; GUM PAIN; JAW PAIN; LOW BLOOD PRESSURE; MUSCLE ACHES; FATIGUE; SLIGHT HEADACHE; This spontaneous report was received from a 41-year-old, female patient of other (unspecified) race. The patient's height, and weight were not reported. The patient's concurrent conditions included high cholesterol, non alcohol user, and non smoker. The patient had no known allergies and no drug abuse/illicit drug use. The patient was not pregnant at the time of report. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of administration was not reported, batch number: 2021421A, and expiry: unknown) dose was not reported, 1 total, administered on left arm on 08-APR-2021 for prophylactic vaccination. No concomitant medications were reported.  On 09-APR-2021 (1 day post vaccination), the patient experienced symptoms of fatigue, muscle aches, chest pressure, fast heart rate, teeth/gums/jaw pain, low blood pressure, slight headache. The patient's doctor had a suspicion of blood clots and hence, on 14-APR-2021, the patient was hospitalized. The patient got her blood work, chest X-ray, electrocardiogram (EKG), and heart monitoring done and results of all tests were normal and she was cleared. No blood clots were found. On 14-APR-2021, the patient was discharged from the hospital. On 15-APR-2021, she felt a little bit better and then on 16-APR-2021 (two days post hospitalization), her symptoms completely subsided. The patient was hospitalized for 1 day. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from chest pressure, fast heart rate, teeth pain, gum pain, jaw pain, low blood pressure, muscle aches, fatigue, and slight headache on 16-APR-2021. This report was serious (Hospitalization Caused / Prolonged).; Sender's Comments: V0: 20210702888-COVID-19 VACCINE AD26.COV2.S-chest pressure, fast heart rate, teeth pain, gum pain, jaw pain, low blood pressure. 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). 20210702888-COVID-19 VACCINE AD26.COV2.S-muscle aches, fatigue, slight headache. This event(s) is labeled per RSI and is therefore considered potentially related.
Swollen lymph node in left armpit; This is a spontaneous report from a contactable consumer, the patient. A 47-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER 8732) via an unspecified route of administration in the left arm on 31Mar2021 at 12:00 (at the age of 47-year-old) as a single dose for COVID-19 immunisation. Medical history and concomitant medications were not reported. The patient previously took Septra and experienced allergy. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN 6208) via an unspecified route of administration in the left arm on 10Mar2021 at 12:00 (at the age of 47-year-old) as a single dose for COVID-19 immunisation. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 01Apr2021 at 19:00 the patient experienced swollen lymph node in left armpit for at least one week. The patient did not receive any treatment for the event. The adverse event did not result in a visit to the doctors or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The clinical outcome of the event swollen lymph node in left armpit for at least one week was unknown at the time of this report.   No follow-up attempts are needed. No further information is expected.
Swelling at the injection site that occurred 7 days after the first injection and has persisted now for two days. Arm is swollen, larger than a baseball in size. Arm is red and very itchy
Several days after receiving the vaccine, I noticed my left arm was itching at the injection site and it is red and warm.  The redness seems to be getting worse and now my left arm feels a little sore/burning feeling.  Almost like getting hives.
Patient indicated she had tingling neck, throat, mouth.  Provided oral diphenhydramine (Benadryl) 50 mg at 0625 and monitored.  At approximately 0650 patient indicated the tingling was gone and she was ready to return to work. Vitals were WNL through this period. Patient worked for the medical hub, believed to be run by Contract employees.  Her supervisor was notified of situation and cleared to return to work.