chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Information has been received from a physician concerning a 4 month old male child whose mother was Caucasian and father was Asian who was vaccinated with rotavirus G1 G2 G3 G4 P1 reassortant vaccine live 2ml PO (human-bovine) at the age of two months. In June 2007, when the patient was 4 months of age he was hospitalized with Kawasaki disease which occurred in June 2007. The physician reported that after the hospitalization the child received the rest of the rotavirus G1 G2 G3 G4 P1 reassortant vaccine live series. The patient fully recovered from Kawasaki disease. 5/12/08-records received for DOS 6/4-6/8/07-DC DX: Kawasaki Disease. HX of fever times 6 days, on bactrim for urinary tract infection. HX of conjunctival injection, red rash, red lips. Treated with IVIG.Watery stools 04/30/08-records received for DOS 6/2-6/04/07-transferred to another facility for treatment of Kawasaki disease. Presented with 3-4 day history of fever as high as 104. Conjunctival injection, maculopapular rash, cracked red lips. Irritability. Further information has been received concerning this male child with an allergy to BACTRIM who on 27-APR-2007 was vaccinated with ROTATEQ ( lot # 656382/0234U) first dose. Other suspect vaccines included COMVAX ( lot #655550/1416F) IM, first dose. Other concomitant vaccine included DTaP (unspecified) + RECOMBIVAX HB + Hib conj vaccine PREVENAR (Lot # B08690C) IM and IPOL (lot # 20547-2) (all first dose). The physician reported that on 01-JUN-2007 the patient developed Kawasaki disease approximately 5 weeks after the two month old vaccination including ROTATEQ). The patient was hospitalized for about four days. The physician reported that the patient recovered. Additional information is not expected.
Treatment of COVID-19; Treatment of COVID-19; Interchange of vaccine products; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 57-year-old male patient received BNT162b2 (BNT162B2), on 05Oct2021 as dose 3 (booster), single (Lot number: FF2587) at the age of 56 years for covid-19 immunisation; elasomeran (MODERNA COVID-19 VACCINE), on 02Jun2022 at 09:00 as dose 4 (booster), single (Lot number: o56M21A) for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown) and as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) included: ATORVASTATIN, stop date: 18Oct2022; OMEPRAZOLE; ASPIRIN LOW; MUCINEX; TUMS [CALCIUM CARBONATE]. The following information was reported: INTERCHANGE OF VACCINE PRODUCTS (medically significant) with onset 02Jun2022 at 09:00, outcome "unknown"; DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: negative, notes: had two negative covid self-tests; negative, notes: had two negative covid self-tests; positive (very faint line), notes: I had a positive (very faint line) self-test. Therapeutic measures were taken as a result of drug ineffective, covid-19.
Information has been received from a Licensed Vocational Nurse concerning a 24 month old patient who on 10-DEC-2008 was vaccinated with both PNEUMOVAX and PREVENAR. No adverse effect was reported. Additional information has been requested.
Information has been received from a registered nurse concerning a 60 year old female patient with asthma, hypothyroidism and no allergies who on 27-JUN-2007 at 13:30, was vaccinated IM into the deltoid with a dose of PNEUMOVAX 23 (Lot # 656233/0200U).  Concomitant therapy included LEVOTHROID, albuterol, and ASMANEX.  On 27-JUN-2007 in the evening, the patient developed a rash that presented with warmth, tenderness, and pain and was macular in form.  It was reported that the patient's left arm was painful, her skin was patch, red and tender to touch.  Her abdomen revealed a patchy, red rash to include her neck and right arm.  The patient was prescribed a MEDROL DOSE-PAC, ibuprofen and BENADRYL.  Laboratory diagnostic studies included a TSH level.  On 02-JUL-2007, the patient recovered.  It was also reported on 13-OCT-1998, the patient received a dose of the vaccine.  No product quality complaint was involved.  This is one of two reports from the same source.  Additional information is not expected.
Bilateral peroneal vein deep vein thrombosis involving the calves. (No deep vein thrombosis at or above the knees.)
Broke out with blisters; Shingles; Pain in her back; This spontaneous case was reported by a patient and describes the occurrence of BACK PAIN (Pain in her back), BLISTER (Broke out with blisters) and HERPES ZOSTER (Shingles) in a 74-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030A21A) for COVID-19 vaccination.     Concurrent medical conditions included Hypertension.    On 10-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-Mar-2021, the patient experienced BACK PAIN (Pain in her back). On 16-Mar-2021, the patient experienced BLISTER (Broke out with blisters) and HERPES ZOSTER (Shingles). The patient was treated with PREDNISONE at an unspecified dose and frequency; TRAMADOL at an unspecified dose and frequency and CALAMINE, GLYCEROL, ZINC OXIDE (CALAMINE LOTION) at an unspecified dose and frequency. At the time of the report, BACK PAIN (Pain in her back), BLISTER (Broke out with blisters) and HERPES ZOSTER (Shingles) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       On 19-Mar-2021, she went to a walk-in clinic and received an unspecified injection and was prescribed Prednisone and Tramadol. She also applied Calamine lotion. She continues to have blisters however they have stopped spreading.  The patient was taking medicine for blood pressure.
worsening neuropathy, inability to walk and severe pain, insomnia, felt inflamed
Pt. came in Saturday afternoon 9/7/13, presented with redness, soreness, hardness around injection site. RPh on duty advised ice, 20 min on, 20 min off. Then pt. called again and was told to use heat 20 min on , 20 min off. Pt. was contacted on Sun 9/8 bu RPh and she reported that her arm was "better" but still a little bit red and hard. Pt. came into pharmacy Mon 9/9/13 and shoed RPh her arm. She said it is better (still a bit red and hard).
pt was examined on 14JAN94 & found to be in good hlth; pt recvd vax 14JAN94 & 22JAN94 died of crib death according to the mom; atuopsy results pending; no fever or other sx noted p/vax;
HepA adult dose given to 16 year old instead of intended HepA pediatric/adol dose.
This spontaneous report has been received from a medical assistant referring to a 11 year old patient of unknown gender. Information about concurrent condition, concomitant medication and medical history was not provided. In 2017 (reported as someday during 31-JUL-2017 to 22-AUG-2017), the patient was vaccinated with GARDASIL 9 lot # N000326 / N002720, expiration date 14-OCT-2019 (dose and route unknown) for prophylaxis. The vaccine was exposed to temperature excursion of 34.6 degree Fahrenheit (F) to 34.9 F for 255 hours from 31-JUL-2017 to 22-AUG-2017. Data logger involved. There was no previous temperature excursion. No adverse effects were reported. This is one of several reports received from the same reporter. Sender's Comments: US-009507513-1708USA010748.
Vaccine gives 6/4, now have shingles. Symptoms started  6/10, full blown by 6/12.
The patient has not experienced an adverse event. This report is being submitted because the patient was given Moderna vaccine for his 2nd dose, but was supposed to receive the Pfizer vaccine.
12/30/12 dad noticed when he woke up he couldn't use his left arm to push himself up in crib. when he would sit he would fall over. He was unable to walk and was irritable.  He was seen at a Walk in Care and dx with an ear infection and started on Amoxicillin. 12/31/12 he developed decreased use of left arm and maintained it in flexed position with fisting of the hand.  He was able to walk at this point. 1/1/13 he was seen in Walk in care again and had a negative arm xray and had a nursemaid's elbow reduction with no improvement. 1/3/13 he showed increased use of his left arm. 1/4/13 he had episodic left arm and leg tremors. No alterations in consciousness or postictal state. Also had squinting of left eye with pinpoint pupils and episodic giggling.  He was admitted to hospital and noted to have hemiparesis. Tremors resolved the next day. 1/4/13 he had a normal EEG. 1/5/13 he had a brain MRI that demonstrated a lesion in his right basal ganglia (putamen) that was associated with restricted diffusion and subtle enhasement, he was dx with a subacute infarct. 1/6/13 had a normal MRA. Hematology was consulted. He was placed on Aspirin. He was seen at hospital on 4/5/13 by Dr.
Developed fever and headache on 1/8/21.  Patient with intermittent fevers and persistent headache.  Seen by PCP. Admitted to Facility from 1/21-1/22 for headache and dehydration; symptoms improved with IVF.   Increasing headache and complaint of urinary retention then occurred -- readmitted to Facility on 1/25/21.  Work-up consistent with myelitis.
inpatient on warfarin therapy for mechanical valve. INR = 2.5 (target range 2.5-3.5) on 5/20. Second Moderna vaccine given 5/21/21. INR on 5/22 = 2.8, 5/24 = 5.9, 5/25=7.2/8.0. Patient was complaining of headache and fatigue. Warfarin dose was held for 2 days and oral vitamin K 2.5mg administered x 1 dose. INR returned to normal range 5/26.
Within 2 days, he had shortness of breath, rapid heart rate, body aches, fatigue. Sought treatment at the ER on 6/24. Heart rate was 220 bpm upon arrival. Had to be defibrillated back into normal rhythm. Was admitted to ICU for 6 days and diagnosed with myocarditis caused by Moderna vaccine and parainfluenza virus 3.  Was in heart failure with heart function below 40%. Was released home on 6/29 with a life vest and 3 prescription medications to treat myocarditis.
Pt recvd 3 doses of Engerix-B JUN91, JUL91 & 18DEC91; 19DEC pt exp swelling @ inject site (3cm) & induration (1-2CM in depth); symptomatic tx was given;
side effect of Moderna is Belpalsey was diganosed May 17th er Hospital  taken medication  given to me follow up family dr check up with heart dr Moderna cause inflamation around  your heart
VZV given about 3:40 PM (child has received VZV, MMR, Fluzone in past without incident; no egg allergy). At about 4:30 PM, parent called office from car. Child complained of itching, throat feels funny. Mother instructed to go to ED as close to her home of call. Administered Epi Pen Jr. Mom carries for sibling with nut allergy). Mom did not give Epi Pen Jr. Arrived at ED triage about 5 PM. Symptoms: hives, SOB, wheeze, face/throat swelling.  Information from medical records state anaphylaxis.
She received the COVID-19 vaccine (Pfizer) in the L arm around 1000 on 14 Dec 2021. (Lot: FE3594). She reports no symptoms until around 1700 noted sensation of burning and fullness of the side of her tongue. She attributed symptoms to a spicy food she had eaten. The went to bed and the following morning she noted increased sensation of swelling and some pain on the sides and back of her tongue. She felt more mucous in her mouth and a need to clear her throat. She reports no other upper/lower airway symptoms or rash or swelling. She regained the ability to talk and swallow. She went to the ER that morning. Per ER note, exam notable for mild tongue swelling. Diagnosis made of angioedema. She was treated with IM epinephrine, and IV Solu-medrol and IV diphenhydramine. She was noted to have palpitations after that IV infusion in addition to sensation of heat in her neck and some pain in her throat. An EKG was obtained and only notable for sinus tachycardia. These symptoms gradually resolved after 20 minutes. She was discharged on oral steroids and diphenhydramine but called the allergy clinic for guidance and was started on Allegra and Zyrtec daily. She reports now only some sensation of fullness or slight swelling on the sides of her tongue in contact with her lower teeth.  She reports no throat tightness or dyspnea
Information has been received from a health professional concerning a 10 year old female who was vaccinated with a dose of Varivax. In March 2006, the patient experienced breakthrough. At the time of the report the patient was recovering. Unspecified medical attention was sought. No product quality complaint was involved. No other information was provided. The patient's sister experienced breakthrough following vaccination with Varivax (WAES# 0603USA03407). Additional information has been requested.
No adverse event; Expired dose administered to patient; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Expired dose administered to patient) and NO ADVERSE EVENT (No adverse event) in an elderly female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026L21B) for COVID-19 prophylaxis.     No Medical History information was reported.    In 2022, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. In 2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Expired dose administered to patient). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Expired dose administered to patient) and NO ADVERSE EVENT (No adverse event) outcome was unknown. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for EXPIRED PRODUCT ADMINISTERED (Expired dose administered to patient).    No concomitant medication information was provided. The vial was initially stored in refrigerator on 7-Jun-2022. The vial did not undergo any temperature excursions. The dates of administration of the vaccines was reported as 1Apr2022, 5Apr2022, 6Apr2022, 8Apr2022, 11Apr2022, 12Apr2022, 13Apr2022, 14Apr2022, 22Apr2022, 9Jun2022, 10Jun2022, 13Jun2022, 18Jun2022 and 22Jun2022.  The dates of vaccine administration were not reported and it was unknown whether patient took first, second or first and or second booster doses. No treatment medication information was provided.
She was at school.  In the class that she was in, the teacher turned off the lights and put an audio only video on for the class to listen to.  A couple minutes into it she had sitting at her desk.  Her hands fell forward and hit the child in front of her.  He turned around thinking she was trying to get her attention.  Her eyes were very wide open and staring to the right.  She did not respond to him.  The teacher can to her and she started swaying back and forth and still not responding to anyone.  They helped her to the floor, with no response.   About after 4 minutes she started responding.  She was very sleepy.  She did not know where she was or what had just happened for another 2-3 minutes following that.  After she figured out where she was, her mother can and picked her up from school and took her to ER.  EKG, EEG and blood work all normal
Son received vaccine in the evening. The next day he had diarrhea (4x within an hour and a half). Unknown if related to vaccine or not.
ON 10-14-2005 PATIENT RETURNED TO PHARMACY FOR ANOTHER RX AND TOLD ME OF REACTION.  INJECTED UPPER ARM WAS VERY RED AND SWOLLEN. PATIENT REPORTED IT WAS VERY "TIGHT" BUT SWELLING HAD GONE DOWN AND SHE WAS IMPROVING.
Narrative: Pt was an 82 YO male with PMH of aortic valve regurgitation, CHF, bladder cancer, recurrent pneumonia, cognitive impairment, DM2, HLD, CAD, HTN, PD, and depression was admitted to hospital for heart attack and passed away during attempted stent placement.
Extreme fatigue, rapid heart beat ( between 95-99 bpm) for 4 days (October 8, 9, 10, 11 2021) even when doing nothing and lying down.  When standing and moving heart beat went much higher.  Unable to keep up with normal daily activities without sitting or lying down frequently.  Improved little by little over the next 6 days (October 12, 13, 14, 15, 16, 17).  Visited cardiologist, did EKG, put heart monitor on me from October 14, 2021 to October 21, 2021.  Cardiologist saw some extra heart beats but nothing too alarming in the heart monitor results.  Since I was feeling better and better, follow up in 3 months.
Patient tested COVID positive on 3/6/21, after receiving the Pfizer COVID-19 vaccine on 1/4/21 and 1/25/21.
Patient experienced light headedness, dizziness and passed out for about 2-3 seconds.  Minor convulsions during unconsciousness.
Fever, chills, fatigue, muscle aches. I felt like I had the flu and was in bed all day. I was down for the count. This is completely unlike me. Not only am I not prone to being sick in general, but I've never had an adverse reaction to a vaccine.  I am feeling much better today, so it was short lived, only about 24  hours, thank goodness. I'm still not 100% back to normal, but I am much better today. It's been 45 hours since my vaccine.
Patient went to ER on 3/19/21 for sudden idiopathic hearing loss, right ear. was given prednisone and meclizine and followed up with Dr. on 4/6/21. pt is now receiving ongoing treatment from ENT specialist for steroid injections in ear to try and regain hearing.
Got The Vaccine And 2 Weeks Later Got The Shingles; This case was reported by a consumer via interactive digital media and described the occurrence of shingles in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, 2 weeks after receiving Shingles vaccine, the patient experienced shingles. On an unknown date, the outcome of the shingles was unknown.   It was unknown if the reporter considered the shingles to be related to Shingles vaccine.  Additional details were provided as follows:  The age at vaccination was not reported.  The patient received Shingles vaccine and got the shingles.
Stomach discomfort; headache; fever; chills; Myalgia; nauseas; fatigue; Tingling lips; Eyes heavy feeling of; This spontaneous case was reported by a consumer and describes the occurrence of PARAESTHESIA ORAL (Tingling lips), ASTHENOPIA (Eyes heavy feeling of), ABDOMINAL DISCOMFORT (Stomach discomfort), HEADACHE (headache) and PYREXIA (fever) in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 22-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 22-Mar-2021, the patient experienced PARAESTHESIA ORAL (Tingling lips) and ASTHENOPIA (Eyes heavy feeling of). On 23-Mar-2021, the patient experienced ABDOMINAL DISCOMFORT (Stomach discomfort), HEADACHE (headache), PYREXIA (fever), CHILLS (chills), MYALGIA (Myalgia), NAUSEA (nauseas) and FATIGUE (fatigue). On 22-Mar-2021, PARAESTHESIA ORAL (Tingling lips) and ASTHENOPIA (Eyes heavy feeling of) had resolved. At the time of the report, ABDOMINAL DISCOMFORT (Stomach discomfort), HEADACHE (headache), PYREXIA (fever), CHILLS (chills), MYALGIA (Myalgia), NAUSEA (nauseas) and FATIGUE (fatigue) outcome was unknown. Not Provided    DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 13-Jan-2021, SARS-CoV-2 test: positive (Positive) Positive. On 07-Feb-2021, SARS-CoV-2 antibody test: positive (Positive) Positive. On 23-Mar-2021, Body temperature: 102.6 (Inconclusive) 102.6.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       The patient reported  that 12 hours after the injection she experienced events headache, fever of 102.6, chills, body ache, nauseas, fatigue and sick to her stomach feeling.  Concomitant product use was not provided by the reporter. No treatment information was provided.   Most recent FOLLOW-UP information incorporated above includes: On 10-May-2021: Contact Information Updated.
Patient came to staff approximately 15 minutes after receiving his vaccine and stated that he was feeling lightheaded and believed he may pass out.  Patient was seated then assisted to the floor as he had a brief (5 second) vasovagal response.  EMS was activated and patient was assessed on scene.  After speaking with paramedics and resting, patient stated that he was feeling perfectly fine and signed an EMS refusal of service, leaving on his own accord.
THE POLICE OFFICER CALLED US TODAY TO NOTIFY US THAT THE PATIENT PASSED AWAY WITH NO FURTHER INFORMATION WHETHER THE DEATH IS RELATED TO THE VACCINE OR NOT.
This spontaneous report received from a parent concerned a 34-year-old male. The patient's height, and weight not reported. The patient's pre-existing medical conditions included: No known allergy. The patient received COVID-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch/lot# 1805031, expiry: unknown), dose not reported, administered Mar 16, 2021 for immunization. No concomitant medications reported. On Mar 17, 2021, patient experienced soreness in injection arm. On Mar 17, 2021, patient experienced tirednesss. On May 5, 2021, patient experienced severe itchy rash from scalp to foot all over large patches 4-6 inches in width with raised especially on chest and back/COVID-19 rash. On Jun 17, 2021, laboratory data included: Skin biopsy (NR: not provided) COVID rash. On an unspecified date, patient bled from itching (even with the medications). Treatment medications (dates unspecified) included: prednisone, clobetasol propionate and betamethasone dipropionate. The action taken with COVID-19 vaccine ad26.cov2.s: not applicable. The patient recovered from soreness in injection arm, and tirednesss on Mar 18, 2021; but has not recovered from severe itchy rash from scalp to foot all over large patches 4-6 inches in width with raised especially on chest and back/COVID-19 rash, and bled from itching (even with the medications).
Dizzy, headache, nausea, red face & neck, itchy/scratchy throat, labored breathing, swollen lips, very sweaty, chills, labored breathing, swollen muscle/injection site
expired dose administered to patients; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (expired dose administered to patients) in a 45-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031H21A) for COVID-19 vaccination.     No Medical History information was reported.    On 11-Jan-2022, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 11-Jan-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (expired dose administered to patients). On 11-Jan-2022, EXPIRED PRODUCT ADMINISTERED (expired dose administered to patients) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.
Headache, Myalgia, Fever, NauseaVomiting, Fatigue, Chills Narrative:
Acute nausea/vomiting, nonbloody diarrhea, abdominal pain, generalized myalgias, and subjective fevers on the day after vaccine administration (vaccine administered 8/17/2021, symptom onset 8/18/2021). Presented to ED 8/20/2021.   Initial T 37.5, HR 148, BP 129/99, SpO2 100% on RA.