chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Around 135pm patient was sitting in chair in a stiff position, bilateral arms to her side with wrist flexed out. 5 mins prior to incident patient just received her first shot of Moderna lot #031A21A , received in left arm. Stiff position lasted less the 1 min. nurse called out to staff to help and to call 911. Patient started to come back to her self and stated that she has had this happen before. Patients was oriented x3 to person place and thing. She denies and shortness of breath or difficulty breathing. Patient stated her husband was in the car and ask for him to come in. Husband stated she has had seizure activity in the past. Upon retrieving her vitals BP- 93/62 Temp- 98.4 Pules 60 Respirations- 16. Patient also stated her having a history of low blood pressure as well. Around 145 EMS arrived and patient was able to communicate feelings of incident. Patient and husband then walked outside with EMS. Doctor informed of incident and was gave the report of patients activity.
Says felt like she had congestive heart failure or a heart/ATF. Heart was weak and chest hurt she sat down - happened 2 days after the shot - slowly it went away - says her sister had the same symptoms.
Hives started about 2 1/2 weeks out and have persisted for several days despite Benadryl. Waxing and waning, worse at night, also exacerbated by pressure and heat. In addition, severe inflammatory acne much worse than baseline began about a week after the shot and persisted for a couple weeks before going back to baseline (this happened after the first shot as well)
PAIN AT INJECTION SITE; This spontaneous report received from a consumer 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, batch number: unknown) dose was not reported, administered on 07-MAY-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On 07-MAY-2021, the subject experienced pain at injection site. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of pain at injection site was not reported. This report was non-serious.
Soft ball sized, red, raised welt on the upper arm.  This lasted for 3 days.
At 1700, 11/09/01, Left arm , feet, hand and 30" later knee circle around arm then red and swollen, also chills times 2 days after within one eprsoal diarrhea, (amps).
pt recvd vax @ 10AM; 3PM began crying uncontrolably & high pitched; also had single jerking episode lasting about 1 sec w/o repetitive jerking or postictal period;
Fever the for two days after with injection site soreness that progressed to muscle insertion site. Then 6 days later mild fever again with marked axillary lymph node swelling and soreness around. Swelling took 2.5 days to resolve.
Muscle aches, fatigue, chills, headache, soreness of arm for about 24 hours
Right upper extremity erythema, pruritis surrounding injection site. Onset 12 hours after vaccination. Improving with BENADRYL, loratadine added. Erythema persistent > 1 week after vaccination.
Irregular menstruation starting the first cycle beyond my second dose and continuing until present month at the time of this document.  Continuous spotting daily with monthly heavy bleeding. .
Information has been received from a physician assistant and a certified medical assistant (CMA), concerning a 46 year old female patient with drug hypersensitivities to hydrocodone (Lortab), Percocet and minocycline (manufacturer unspecified), arthritis and environmental allergies, who on 19-OCT-2006 was vaccinated SW in the left arm with a dose of Pneumovax 23. Concomitant therapy included Advair, lisinopril (MSD), Nasonex, Nexium, Paxil, Robinul and Stahist. The day following the vaccination, 20-OCT-2006, the patient developed pain, redness, swelling, and warmth at the injection site; the patient also reported "not feeling quite right." The CMA added that "a few weeks ago," patient was treated with a 10-day course of Keflex. On 31-May-2007, the patient visited the physician's assistant, who identified a hard nodule of <1cm at the injection site; it was noted that lymphadenopathy was not present. At the time of this report, the patient's symptoms had not resolved. A follow up visit was planned for 3 weeks. The CMA considered one or more of the events to be significantly disabling/incapacitating. Additional information has been requested.
This case was reported by a nurse via sales rep and described the occurrence of fatigue in a 61-year-old male patient who received SHINGRIX. Co-suspect products included SHINGRIX. On 28th March 2018, the patient received the 1st dose of SHINGRIX and the 2nd dose of SHINGRIX. On 28th March 2018, unknown after receiving SHINGRIX and not applicable after receiving SHINGRIX, the patient experienced inappropriate preparation of medication and inappropriate dose of vaccine administered. On 29th March 2018, the patient experienced fatigue, unable to walk, weakness, allergic reaction and joint pain. On an unknown date, the outcome of the fatigue, unable to walk, weakness, allergic reaction, joint pain, inappropriate preparation of medication and inappropriate dose of vaccine administered were unknown. It was unknown if the reporter considered the fatigue, unable to walk, weakness, allergic reaction and joint pain to be related to SHINGRIX. Additional details were provided as follows: On 29th March 2018 the administering health care professional did not understand that the elastic tags on both vials meant they needed to be reconstituted together, but thought since there were 2 vials that this was 2 doses of the vaccine. The health care professional only administered the adjuvant, which led to inappropriate preparation of medication, inappropriate dose of vaccine administered and vaccination error. After discovering that only adjuvant was administered they caught the patient in the parking lot and ask the patient to come back in when they administered appropriately reconstituted vaccine. The patient woke up the next day and went to work. He became so weak that he could not walk so a co-worker had to put him in his car. The patient did not complain of shortness breath. The patient reported severe joint aches and fatigue. The patient was taken to the emergency room where he was diagnosed with an allergic reaction, but the reporter listed above did not agree with this diagnosis as she thought he just experienced severe systemic adverse events as listed in the prescribing information.
Pt recvd vax & 3 wks p/3rd dose exp sinus infect & fever 99.6; 25FEB93 devel bronchitis;
Vaccinated with FLUARIX quadrivalent lot #67BL9 in (L) deltoid. No c/o prior to injection, other than anxiety R/T injection. 30 min later, c/o vertigo, feeling faint, numbness and tingling in upper extremities. These symptoms abated but returned at intervals and progressed to lower extrem. VSS. Taken to nearest ER at 10:30 AM.
Woke up & found dark red & inflamed cirle about 2 inches in diameter. By next morning, 1/2, it was still red & hot & redness was spreading out to about 5 inches in diameter. Still itchy too.
Pt had swelling, redness, fever, tenderness. DX was cellulitis. Treatment was elevation, cool compresses, Ibuprofen, Keflex for 5 days.
Toes started to itch; Was red; Soreness at injection site; This spontaneous case was reported by a consumer and describes the occurrence of PRURITUS (Toes started to itch), ERYTHEMA (Was red) and VACCINATION SITE PAIN (Soreness at injection site) in a 78-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included High cholesterol and Shellfish allergy.    On 12-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 12-Jan-2021, the patient experienced VACCINATION SITE PAIN (Soreness at injection site). On 19-Jan-2021, the patient experienced PRURITUS (Toes started to itch) and ERYTHEMA (Was red). At the time of the report, PRURITUS (Toes started to itch), ERYTHEMA (Was red) and VACCINATION SITE PAIN (Soreness at injection site) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant medications included high cholesterol medications. Treatment details was not reported by the reporter.
knee stopped hurting again and hip stopped hurting and she feels like she is 20 years younger; This spontaneous case was reported by a consumer and describes the occurrence of THERAPEUTIC RESPONSE UNEXPECTED (knee stopped hurting again and hip stopped hurting and she feels like she is 20 years younger) in a 66-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 031H21A, 038B21A and 031A21A) for COVID-19 vaccination.     Concurrent medical conditions included Blood pressure abnormal.   On 13-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 10-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 30-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced THERAPEUTIC RESPONSE UNEXPECTED (knee stopped hurting again and hip stopped hurting and she feels like she is 20 years younger). At the time of the report, THERAPEUTIC RESPONSE UNEXPECTED (knee stopped hurting again and hip stopped hurting and she feels like she is 20 years younger) outcome was unknown.            Concomitant medications include Blood pressure medication. No treatment information was provided.   This case was linked to MOD-2021-405732, MOD-2021-405734 (Patient Link).
Over 1 month after immunization patient is experiencing pain on lateral movement of left arm. there is no swelling, no pain on contact. Pain on movement is severe enough to waken patient from sleep.
7 pm feeling of tiredness so I lay on sofa 11 pm  when I got up to go to bed, splitting headache, pressure behind both eyes, chills, fever 100.3, delirious dreams at night, not much sleep, fatigue 10 am Thur morning feeling of weakness, could not take a shower, could not concentrate, went to lay on sofa 12 noon made 2 eggs and lost energy again, back on sofa  11 pm went to bed, could not sleep, extreme pain in back (from laying down 28 hours?) walked around, drank water, took 2 tylenol
None- vaccine given 6 days post expiry; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (None- vaccine given 6 days post expiry) in a 60-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 046C21A) for COVID-19 vaccination.     No Medical History information was reported.   On 29-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 12-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 12-Nov-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (None- vaccine given 6 days post expiry). On 12-Nov-2021, EXPIRED PRODUCT ADMINISTERED (None- vaccine given 6 days post expiry) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported. No treatment medications were provided.   This case was linked to MOD-2021-395985 (Patient Link).
I had pain at the injection site that lasted a day. I had a slight fever and some sweating. I took a Tylenol and slept it off. I was fine the next day.
Patient was sent to ER 12/18/07 with cough and breathing difficulty.  No fever.  Diagnosed with pneumonia and bronchiolitis.  Child received influenza vaccine 12/12/07 - mother won't give 2nd influenza - feels this is cause. 1/17/08-records received for DOS 12/18/07-Assessment:Pneumonia. Broncholitis. Presented to ED with cough and difficulty breathing.  PE: some grunting respirations without stridor.
Rash on left arm, warm to touch, tingling sensation down left arm, neck tension/pain for past 3 days
5/21/20 - "oreo-size redness" at injection site on left upper arm. Then Redness spread to entire left upper arm from proximal shoulder area to elbow area with mild swelling  in a matter of 2 days. Anticipatory guidance given that this is a known reaction to DTaP and occurs 2-3% of time per Red Book and should resolve on its own.
The evening after receiving the shot my shoulder was very sore. By morning my entire arm was sore and throbbing. The pain is now constant in my upper arm and shoulder and has a throbbing sore feeling. I can't raise my arm over my head. Also have tingling in hand and wrist. Arm feels a little weak and has not improved over past month.
technician went to retract the needle and pulled the needle out of the consumer's skin the technician noticed there was leakage; plunger was difficult to depress; Initial information was received on 20-Sep-2021 regarding an unsolicited valid non-serious case from a pharmacist.  This case involves an infant male patient (age unknown) who experienced "technician went to retract the needle and pulled the needle out of the consumer's skin the technician noticed there was leakage" (injection site extravasation) and "plunger was difficult to depress" (syringe issue) while receiving vaccine INFLUENZA QUADRIVAL A-B VACCINE [FLUZONE QIV].  The patient's past medical history, medical treatment(s), vaccination(s), concomitant medication(s) and family history were not provided.  On 19-Sep-2021, the patient received a dose of suspect INFLUENZA QUADRIVAL A-B VACCINE (lot number and expiry date were not reported) via an unknown route at an unknown administration site for prophylactic vaccination.  On an unknown date the patient developed a non-serious technician went to retract the needle and pulled the needle out of the consumer's skin the technician noticed there was leakage (injection site extravasation) (unknown latency) following the administration of INFLUENZA QUADRIVAL A-B VACCINE.  It was also a case of syringe issue (latency-same day).  It was reported "Pharmacist is at home on her day off and states a technician yesterday attempted to give a male consumer the vaccine and stated to the pharmacist the plunger was difficult to depress and when the technician went to retract the needle and pulled the needle out of the consumer's skin the technician noticed there was leakage. Pharmacist stated there was no crack or anything with the syringe as far as the leaking. Pharmacist states she didn't give the injection and doesn't have any further details, but someone may call today from her pharmacy."  Details of laboratory data were not reported.  At the time of report outcome was unknown for the events.  There will be no available information on lot number for this case.
Sore arm at vaccination site for 5 days. 16 hours after vaccination woke up with strong flu-like symptoms: joints sore, skin sensitive, headache, muscles sore, felt slightly feverish (not measured).   18 hours: started to cook breakfast but got too nauseous to continue. 20 hours: ate 1 slice of plain bread and 2 ibuprofen. 21 hours: the symptoms got better. For the next 3 days I took 1 aspirin plus 1 ibuprofen 3 times per day for headache. Tiredness throughout this period.
About 10 min after vaccination (tdap, MENVEO and HPV9) felt light headed and was presyncopal. Patient was placed on a bed, given some water and graham crackers, felt better after about an hour. Discharged home.
off label usage unintended.... 16 yr old minor received moderna vaccine only eua for 18+ yrs of age.
metallic taste in their mouth/this funny taste in their mouth that will not go away; This spontaneous case was reported by a consumer and describes the occurrence of DYSGEUSIA (metallic taste in their mouth/this funny taste in their mouth that will not go away) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    In February 2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In February 2021, the patient experienced DYSGEUSIA (metallic taste in their mouth/this funny taste in their mouth that will not go away). At the time of the report, DYSGEUSIA (metallic taste in their mouth/this funny taste in their mouth that will not go away) had not resolved.            No concomitant medications reported by reporter No treatment medications provided by the reporter.   This case was linked to MOD-2021-368853 (Patient Link).
pt recvd vax; wide spread rash on back,arms,abdo described by mom as small bumps which were not red & had no drainage; no fever;given vax given despite URI sxs because behind on 6 mon doses;
Global red raised rash/all over body/ extreme itchiness, lasted for approx. 48 hours; I reported to personnel at the time of administration that I have a history of severe  anaphylactic reaction to the ingredients found in Miralax.  I treated the condition with OTC Zyrtec and Benadryl and hydrocortisone topical cream.
johnson and jonson vaccine. He received on 4/1 through the state. that night got chills. ha, n/v. the next day just tired. 2 days later got two pink bumps on his R elbow then enlarged. then developed more on other areas on his body. some have been present in one spot for a week. NO sob or rep sx. no pain.          He carries an epipen for insect allergy.          on 4/9 he developed sensation of throuat closingand administred an epi pen with relief and went to er. At the er he was given iv prednisone, benedryl and pepcid. He was dischared on a medrol dose pack 7 day. taper (3 days left) and refilled epipen. told to take benedryl.         no sob.          rash is now stable, no new areas x 2 days, larger areas are much improved..
This spontaneous case, initially received on 02-Nov-2016, was reported by a health professional and concerns a 75 year old patient. Weight: not provided; Height: not provided. Concomitant medication: Not reported. Administration of company suspect drug(s): On 16-Sep-2016 the patient received AFLURIA. Dose regimen: Not reported, Route of administration: Intramuscular. Batch number: WT54306. No additional suspect drugs. Adverse event description: On 23-Sep-2016, a nurse reported that a refrigerator went in and out of (temperature) range while there was flu vaccine in it. On 16-Sep-2016, doses were administered (special circumstances: drug administration error without adverse event, incorrect product storage without adverse event). Flu vaccine was first delivered to the vaccination facility on 15-Aug-2016. As the nurse reviewed the refrigerator temperature log, she stated that another excursion occurred on 15-Sep-2016. The doses arrived at 09:00 and were placed in a refrigerator that was at 10 degrees Celsius in the morning. Then the temperature remained at 9 degrees Celsius throughout the 15th and 51 doses were administered on the 16th at a flu clinic. The refrigerator was not back in range until 19-Sep-2016 at a temperature of 8 degrees Celsius. Temperature excursion identified: Log documentation reflected temperature excursions from 31-May-2016 to 23-Sep-2016 which ranged between 8 to 10 degrees Celsius. Vaccines had been given to patients between 31-May-2016 and 23-Sep-2016. On 04-Oct-2016, the remaining 42 doses of lot number WT54306 were discarded. The patients will be contacted for revaccination.
Patient is a 53 y.o. male patient of Physician with history of morbid obesity, OSA/OHS, CHF, Afib presented to Hospital with chest pain, dyspnea, found to have Afib with RVR and Covid 19 .   Acute hypoxic respiratory failure  Peak 4 L 02, now on 2-3 Reports he has not been on chronic 02, but appears has been sent home on this in the past  Due to obesity, CHF , and covid  Discharged on 2L of oxygen, would attempt to cont to wean at convalarium    Covid 19  One day of nausea, chest pain  Positive test 2/28  Requiring 02, but likely multifactorial cause  Only received 1 moderna vaccine  Cant take paxlovid due to xarelto  CRP elevated  Given remdesivir during stay, stop on dc  Cont dexamethasone to complete course     Acute on chronic diastolic congestive heart failure, pulmonary HTN Body habitus makes exam difficult, but no sig pitting edema  BNP elevated, portable xray with some congestion  Echo 3/1 limited due to habitus, with diastolic dysfunction, EF 55 but with areas of hypokinesis, pHTN similar to prior 6/22  Taking lasix 80mg BID at home, given  IV lasix 40 BID, resume home dose    Afib with RVR  Rates initially 130's Improving, presume due to covid  Resume home cardizem 360mg daily, metoprolol 50 BID  Started on cardizem gtt on admission, now improving so stopped    NSTEMI Patient with atypical chest pain  Troponin peak  102 with positive delta  Ekg without ischemic changes  Cardiology consulted Given risk/benefit and difficult diagnosis given body habitus recommend continued medical therapy  Start asa, statin, cont BB    OSA CPAP/BiPAP with naps/sleeping    Obesity Severe debility Has bene at the Convalarium  for a year Has apparently not had medical follow up?  PT/OT/Social work assessed Prognosis poor if debility does not improve, would recommend therapy start or patient engage with palliative care
Shingrix rash at injection site; This case was reported by a other health professional via call center representative and described the occurrence of injection site rash in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced injection site rash. On an unknown date, the outcome of the injection site rash was recovered/resolved.   It was unknown if the reporter considered the injection site rash to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The age group was not reported but it was selected as adult as per the vaccine indication. The caller reported that the patient had a rash around the injection site for about 1 week after receiving Shingrix. The reporter did not consent to follow up. The caller refused to give any further information about the patient or the vaccine.
Missed 2nd dose.; This spontaneous case was reported by a consumer and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (Missed 2nd dose.) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PRODUCT DOSE OMISSION ISSUE (Missed 2nd dose.). At the time of the report, PRODUCT DOSE OMISSION ISSUE (Missed 2nd dose.) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medication was reported. No treatment medication was reported.
Approximately 2 weeks after second dose, I had consistent hot flashes, fever like feelings, but no actual fever or illness; lasting approximately 5-10 minutes. Happened for roughly 4-5 times a week for 6 months after second shot of Pfizer covid vaccine. Never more then one time per day. There was no consistent time frame though, it would randomly happen.
This spontaneous report as received from a registered nurse refers to an unknown number of patients of unknown age and gender. On an unknown dates, the patients were vaccinated with VAQTA (doses, routes, lot # and expiry dates not reported) that were stored at temperatures above (49F for 3 minutes) the recommended temperature range in the prescribing information. No adverse effect reported. No PQC involved. Additional information has been requested.
(L) deltoid -> DTaP-IPV. Within 48 hours: swelling/erythema/small induration.