chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Muscle soreness at the injection site; This is a spontaneous report received from a contactable reporter(s) (Pharmacist). The reporter is the patient.  A 56-year-old female patient (not pregnant) received bnt162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 19Sep2023 at 17:00 as dose 1, single (Batch/Lot number: unknown) at the age of 56 years, in left arm for covid-19 immunisation; influenza vaccine (INFLUENZA VACCINE), on 19Sep2023 as dose number unknown, single (Batch/Lot number: unknown), in right arm for immunisation. The patient's relevant medical history included: "Known allergies: Sulfa allergy" (unspecified if ongoing). Concomitant medication(s) included: PEPCID [FAMOTIDINE]. Vaccination history included: Covid-19 vaccine (DOSE 3; SINGLE, MANUFACTURER UNKNOWN), for COVID-19 immunization; Covid-19 vaccine (DOSE 2; SINGLE, MANUFACTURER UNKNOWN), for COVID-19 immunization; Covid-19 vaccine (DOSE 1; SINGLE, MANUFACTURER UNKNOWN), for COVID-19 immunization. The following information was reported: VACCINATION SITE PAIN (non-serious) with onset 20Sep2023 at 06:00, outcome "recovering", described as "Muscle soreness at the injection site". Therapeutic measures were not taken as a result of vaccination site pain.  Additional information: The patient had no covid prior vaccination and had no covid tested post vaccination. No other vaccine in four weeks. No other medical history.  The information on the batch/lot number for bnt162b2 omi xbb.1.5 has been requested and will be submitted if and when received.
Patient started running a fever in the afternoon and then experienced several short convulsions during dinner that we think were seizures. After consulting her pediatrician, we gave her Tylenol immediately (103 fever) and monitored her. Her temp came down to 100, and she went to bed. Her temp was still 100 at 11pm. At 1:45 am, she had a full tonic-clonic seizure lasting 3.5 mins. We again called the pediatrician and gave her Advil (103 temp). At the doctor's recommendation, we called 911 and went to the ER. Her temp came down quickly and all her vitals were normal at the hospital, so we brought her home. We visited a pediatrician on Friday. She was still doing well, responding to the fever meds and no other signes of seizures. We continued fever meds every 3 hours (alternating Tylenol and Advil) until Sunday morning to ensure that her fever wouldn't return. Her temp was normal from 2am on Saturday onwards. She now seems back to normal.
21Oct90 pt vax w/ hepta B; 25Oct90 exp diarrhea, tiredness, + aching in left arm.  aching lasted aprox. 1 month. pt recovered + elected not to continue series.
0950 - Administered vaccines. 0955 - Pt. fainted, slid out of chair onto floor with head coming to rest on chair seat. No head trauma or other injuries observed. Ice pack to back of neck and Sprite consumed. Pt. felt "fine" and left clinic at 1025 hrs.
4 hours after injection, client developed severe shortness of breath, with wheezing and tightness in chest. Took 3 (Benadryl PO) 2 hrs after symptoms developed and used Albuterol inhaler and symptoms were resolved in 24 hours.
toes started hurting. It was swollen, painful; toes started hurting. It was swollen, painful; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (toes started hurting. It was swollen, painful) and SWELLING (toes started hurting. It was swollen, painful) in a 75-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 048A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 10-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 10-Mar-2021, the patient experienced PAIN IN EXTREMITY (toes started hurting. It was swollen, painful) and SWELLING (toes started hurting. It was swollen, painful). At the time of the report, PAIN IN EXTREMITY (toes started hurting. It was swollen, painful) and SWELLING (toes started hurting. It was swollen, painful) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications was reported Treatment information was not provided
April  14, my sister was transported to hospital feeling faint and numbness in her left leg. As a result, she was admitted and treated for: ? blood pressure readings as low as 82/43, 76/50 while standing ? blood clots on her heart that traveled to her brain that were causing multiple mini strokes ? 95% blockage in her right heart vessel which required a stent  ? 50% and 60% blockage in other chambers that will require attention She was given heparin and then switched to a different blood thinner to dissolve the clots.  she was discharged on April 23rd with instructions to followup with her cardiologist and neurologist.
It was reported that a 76 year old female patient received a Fluzone SV '01-'02 vaccination administered on 10/24/01. Within 24 hours, the patient develops shortness of breath, wheezing, achiness, a temperature (not specified). Patient reported these events on 11/03/01 on her routine visit. Th symptoms completely resolved and the patient recovered.
Pt vomited 4-5X 8.11.22, 3X 8.12.22 Pt with nausea 8.11.22, 8.12.22 Pt with headache 8.12.22
Fever, maculopapular rash to face and trunk occurring 3 days after receiving vaccines.
Severe headache, nausea, malaise, chills for 24-72 hours after second COVID dose
Pt recv vax on unspecified day;  post vax pt exp fussiness, arching back, crying x 2.5 hr
4" redness, swelling, tender to touch, itchy. Secondary conjuctivitis developed in left eye at same time as reaction. Patient had been exposed to conjuctivitis previously.
It was a day after holiday I was feeling very tired and coughing all day. I went to get tested and came back positive for COVID-19.
Bivalent COVID vaccine given on 9/27/22. 10/28/22 - 56-year-old female history of hypertension presents with flulike symptoms. Patient has had symptoms for 2 weeks (starting 10/14/22). Was seen at an urgent care and tested negative for COVID. Was treated supportively. Several days later was seen by primary care and treated with Mucinex and prednisone. Has continued to have cough myalgias fatigue and body aches. Has used over-the-counter medications with some relief. Denies any central chest pain but does note a left upper quadrant/left lower chest. With cough and shortness of breath. Cough is intermittently productive. She arrives EMS and was febrile in route. Is feeling faint and weak. She has not a smoker and has no cardiac history Patient presenting with fever palpitations and dyspnea. Concerning for myocarditis. No alternative source for infectious pathology given her elevated white blood cell count, fever, elevated CRP. Also with an elevated troponin and BNP with global ischemic changes on EKG that are also suggestive of cardiac pathology. Initially hypotensive and tachycardic which has improved with IV fluids. Her fever has resolved. Broadly cultured and provided IV antibiotic's to treat for empiric sepsis. No evidence of fulminant heart failure requiring vasopressors or respiratory support at this time. Cardiology consulted and will evaluate this morning for potential initiation of steroids for myocarditis. We will continue to treat supportively and monitor blood pressure and ensure no arrhythmias develop. Cardiology Note 10/29/22 PLAN/RECOMMENDATIONS: 1. Likely infective endocarditis of the aortic valve; 1 bottle thus far is positive for Streptococcus as transthoracic echo shows evidence of moderate size vegetation on the aortic valve 2. Acute kidney injury, resolved 3. Transient hypotension, resolved 4. Morbid obesity 5. Troponin elevation that have down trended with mild but flat elevation this a.m. Reviewed results with patient and overall plan of care and she understands that she is better served with transfer over to Medical Center for further evaluation to include further assessment with infectious disease service. Also potentially if patient requires CT surgery that is available. We will not perform transesophageal in our hospital as it will likely be performed at Medical Center. No further recommendations at this time
I had issues with breathing and would get tired.  I struggled for breath at times, but then was fine.  After several weeks of on again/off again symptoms, it got worse to the point that I went to urgent care and they gave me an inhaler and then to my PCP Dr. and I had a chest x-ray.  About 4 days later on Sunday, December 19, 2021, I went to the ER and was admitted.  I had fluid around my heart and lungs.  I was given an electrocardiogram, echocardiogram, stress test, etc. They determined that my left valve of my heart was only working at 15-20%.
6cm induration & erythema rt deltoid area noticed by pt morning p/vax;
Sore left arm- immediately following injection and continuing into 48 hours post injection Migraine- started @ 1600 1/20 and lasted until 2200 1/20 (only relieved with rest and naproxen)
Information has been received from a nurse referring to multiple unspecified patients of unknown age and gender. There was no pertinent medical history, concurrent conditions, concomitant medications or drug allergies/drug reactions described. On unknown dates, the patients were administered improperly stored ROTATEQ orally (Lot # L029617 with expiration date of 19-MAY-2017), (dose not reported), which were stored at 1.8 C for 1 hour and 45 minutes. The vaccines did not have previous temperature excursion. No adverse effect was reported. This is one of several reports received from the same source. Additional information has been requested.
48 hours after administration of H1N1 vaccine, developed temp to 102 and cough. Temp for 3 days, cough for 7 days.
Rash and itching. Patient seen by PCP on 8/17/11. Dr Dx as adverse reaction to MENACTRA. Prescribed BENADRYL 25mg PO Q 6 hrs.
Lack of efficacy, Break though case of COVID-19; Lack of efficacy, Break though case of COVID-19; This is a spontaneous report from a contactable consumer or other non-HCP (patient). A 61-year-old male patient received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot number- EL3247) intramuscularly in right arm on 03Mar2021 14:00 as dose 1, single and received BNT162b2 (PFIZER BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot number- FP6955) intramuscularly in right arm on 24Mar2021 14:00 (at the age of 60- years-old) as dose 2, single for COVID-19 immunization. Facility where the most recent COVID-19 vaccine was administered was reported as clinic. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19 and had been tested for COVID-19, since the vaccination. Medical history included none. The patient has no known allergies. The concomitant medications included FLOWMAX, LIPITOR. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. No other vaccines were taken in four weeks. On 27Jul2021, the patient experienced lack of efficacy, break though case of COVID-19. On 01Aug2021, the patient tested positive for PCR. No treatment was received for the adverse events. The adverse event resulted in Doctor or other healthcare professional office or clinic visit. The patient underwent lab tests and procedures which included Sars-Cov-2 (nasal swab, rapid) test with result as positive on 01Aug2021. The outcome of the event COVID-19 was recovering.  Follow-up attempts are completed. No further information is expected.  Follow-Up (06Aug2021): Follow-up attempts are completed. No further information is expected.
Pt phoned office injection recvd 2/17/10. Reported on 2/18 area to injection red, warm to touch. Spoke with pt on 2/22/10. Problem resolving.
This spontaneous report as received from a other health professional refers to a female patient of unknown age. On 2013, the patient was vaccinated with ZOSTAVAX for prophylaxis. In July 2017, the patient experienced herpes zoster. The outcome of herpes zoster is unknown. Causality assessment was not provided. This is one of two reports from the same reporter. Additional information is not expected. Sender's Comments: US-009507513-1707USA009067.
Pt family member states that pt feels like lip tingling, swelling and she is thirsty and mouth dry. Pt with mild lip swelling, mild redness noted to face & arms. Lightheadedness with change in position. No respiratory distress noted. Pt move to monitoring area for closer observation. IV started. Benadryl 25mg IV given per Dr order. Vital sings monitoring Pulse ox and NIBP placed. EMS called. ER notified of pt coming to ED for adverse reaction.
Patient was unable to sleep last night because she experienced flushing/ redness with fever/chills all night. She has some slight redness around injection sites but nothing major. She was feeling better today but now has a minor headache.
Mom reported fever up to 105 & 24APR92 irritability beginning approx 10 days following vax & reoccuring for several days; mom took pt to MD who told mom was probably viral & not related to vax;
Otherwise tolerable symptoms of allergic skin reaction, except for the unusually large area affected and unknown vector.
Inability to walk. Extreme bee sting-like and burning pain in legs. It's week 9 and I still cannot walk and am in a wheel chair or using a walker with no answers after multiple hospital visits and doctor appointments. Intense pain behind the knees and loss of mobility in the ankles. Burning in the hands and arm weakness.
Headache - severe/migraine type, lasted 3 hours, then headache for 1.5 days moderate
Painful inflamed left armpit lymph node, swelling of the armpit, left pectoral and left lateral muscle. Heart palpitations, tightness in chest, feeling of anxiety, headache, body aches.
No signs of fever, rash, chills HA or muscle aches no bruising or redness to injection site. Influenza 0.5cc given instead of 0.25CC.
COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 48-year-old male patient received BNT162b2 (BNT162B2), on 09Mar2021 as dose 1, single (Batch/Lot number: unknown), in left arm, as dose 2, single (Batch/Lot number: unknown), as dose 3 (booster), single (Batch/Lot number: unknown) and as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 47 years for covid-19 immunisation. The patient's relevant medical history included: "allergies" (unspecified if ongoing). Concomitant medication(s) included: TYLENOL SINUS [PARACETAMOL;PSEUDOEPHEDRINE HYDROCHLORIDE], start date: 06Jun2022, stop date: 09Jun2022. The following information was reported: DRUG INEFFECTIVE (medically significant), SUSPECTED COVID-19 (medically significant), outcome "unknown" and all described as "COVID 19 Treatment". Therapeutic measures were taken as a result of drug ineffective, suspected covid-19. Clinical information: Anti viral details product for COVID 19 Treatment Paxlovid, treatment start date: 03Jun2022, treatment stop date: 04Jun2022, indication: Treatment of COVID-19.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
pt recv vax 5SEP97 & exp flu like sx such as nausea;pt recovered;2OCT97 pt recv 2nd dose of vax & there was no report of rxn;
Shingles onset 18Sep2021.  Valacyclovir started 21Sep2021
Patient said experiencing red, swollen arm days after injection. Had no problems at site prior.  She called it covid arm.
Paresthesia in lips, hands and feet 15 mins to 3 hours post vaccine Narrative:
Mother contacted sctp, reported elevated temp 103 last night and 101.  Now spoke with RN.  Instructed to call pediatrician.
Swollen lymph node under arm; soreness under arm; soreness of elbow and arm.
pt recv vax 16OCT96 & same day pt devel 2 inch lump redden area @ the inj site w/tenderness & swelling of arm from shoulder to elbow;pt was treated w/pred which alleviated sx & pt recovered by 22OCT96;
MUSCLE PAIN, JOINT PAIN, FATIGUE, DIARRHEA SEVERE INFLAMATION IN BOWELS. THESE SYMPTOMS HAVE CONTINUED NOW FOR 10 DAYS AND COUNTING.
Initial report was received from a consumer on 29 July 2013, who is also the patient. A 58-year-old female patient, with a history of Diabetes Mellitus and hypothyroidism, received a first dose injection of ADACEL vaccine on 19 June 2013 (lot number, route, site and side of administration not reported). On the night of the same day, the patient experienced chest pains, 9 -10 on the pain scale of 10 being the worst pain. The patient went to the emergency room (ER) and was given morphine and nitro tablets. Electrocardiograms, blood tests, and a chest x-ray were performed. The patient was not told she had a heart issue by the ER MD. The issue was resolved with no residual issue. Patient had no illness at the time of vaccination. The patient's outcome was reported as recovered. Documents held by sender: None.
shivers/ teeth chattering; feeling miserable; This case was reported by a medical representative via call center representative and described the occurrence of shivers in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix at an unknown dose. On an unknown date, less than 2 years after receiving Shingrix, the patient experienced shivers and feeling miserable. On an unknown date, the outcome of the shivers and feeling miserable were unknown.   It was unknown if the reporter considered the shivers and feeling miserable to be related to Shingrix.  Additional details were provided as follows: Adverse event receipt was given to the sales representative during the call. The adverse event which was made known to medical representative by a physician via email sent in March 2019. The age at vaccination was not reported. The age group was not reported, but was selected as adult as per vaccine indication. The physician's email reportedly quoted an email sent to him by a patient, which stated that the patient felt miserable and experienced shivering and teeth chattering after receiving Shingrix. The reporter did not consent to follow-up. The sales representative was reportedly on medical leave at the time and did not notice the email until recently. The sales representative stated that she wanted to call the adverse event into Medical Information instead to report the adverse event due to the adverse event being reported late. No other information was available, besides the healthcare provider's details. This case has been linked with US2019139663, US2019AMR141887 and US2019AMR141888 reported by the same reporter.
Pt. was given GARDASIL #2. Immediately after giving vaccine and removing needle she stated, "I'm going to pass out." Laid her back on exam table, called for assistance. Pt. began moaning, eyes rolled back, arms and legs stiffened and she arched up from table. Within 30 seconds she relaxed, opened eyes. We rolled on side and when she was alert we elevated her legs.
This spontaneous report was received from a consumer and refers to three patients of unknown gender and age. The patients' pertinent medical history and concomitant therapies were not reported. On 19-NOV-2016, the 5 year old male, who was a son of the reporter, was vaccinated with a dose of VARIVAX (dose, route of administration, lot# and expiration date were not reported). On 30-NOV-2016, also reported as approximately 10 days after receiving the vaccine, the patient transmitted the vaccine strained virus to three patients, who were household family members. The outcome of the event and the causality between the event and VARIVAX were not reported. Additional information has been requested.
On 02/06/2023, I had fever and headache.  I took a Z-Pac and I went to the clinic 3 times. I started Levaquin and took it 5 days.  I had a temperature every day for 5 days. I have recovered. Three COVID and flu tests were negative.
12 minutes after vaccination, pt experienced jaw discomfort on left side and sharp intermittent pain in L ear.; 12 minutes after vaccination, pt experienced jaw discomfort on left side and sharp intermittent pain in L ear.; This is a spontaneous report from a contactable pharmacist. A 44-year-old female patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number: EL0140), intramuscular at the left arm on 22Dec2020 at a single dose for COVID-19 immunization. The patient medical history was not reported. The patient was not pregnant at the time of vaccination. Concomitant medications included baclofen, vitamin d3 and pitavastatin. The patient previously took tramadol and experienced drug allergies. On 22Dec2020, 12 minutes after vaccination, the patient experienced jaw discomfort on left side and sharp intermittent pain in L ear. The patient was not hospitalized for the events. It was unknown if patient receive any treatment for the events. The events were reported as non-serious. The patient has not received any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination the patient was not diagnosed with COVID-19. Since the vaccination, it was unknown if the patient has been tested for COVID-19. The outcome of the events was unknown.
Anaphylactic Reaction (Anaphylactic reaction, Anaphylactic reaction) Face oedema (Face oedema, Face oedema). Throat swelling (throat swelling, Oropharyngeal swelling). Case Discription: This 20 year old male patient was vaccinated with Vivotif Berna vaccine (Lot No. 015090.16) on 20 FEB 1999 at 09.30 am. Two hours later the patient developed nausea and diarrhoea and 10-12 hours he experienced itchiness, increased agitation, facial edema and closing throat swelling. At Emergency room visit the patient was given Benadryl (diphenhydramine) 25 mg peroral. Because of recurrence of the closing throat swelling the patient returned to the Emergency room and received Epinephrin (adrenaline) and Benadryl (diphenhydramine) 50 mg p.o. The symptoms resolved within 3 days. This case was forwarded by the FDA, VAERS No. 120863
I dropped patient off at daycare and shortly after lunch time, she was acting very emotional and not wanting to play with anyone which is not like her. She went down for her nap and by the time she woke up she had a high fever and was crying non-stop. She was responding very little when I got to the daycare. She was burning up and her eyes were glassy looking. I brought her to the ER and her fever was 102.5 (4 hours after vaccine). She had no other symptoms besides high fever (went up to 103.4 that night) and very lethargic. She started perking up after several hours but the high fever continued. It finally went down to 100-101 yesterday. She still shows no other symptoms of illness (no runny nose or cough). ER doctor said it was a probably immunization reaction. She has not yet fully recovered (as stated in Box 9).
Rash on face, neck and stomach started last pm. Giving BENADRYL 3/4 tsp po q6h.