chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Fever; Sore arm; fatigue; Headache; This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (Fever), MYALGIA (Sore arm), FATIGUE (fatigue) and HEADACHE (Headache) in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 022B21A) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concomitant products included High cholesterol medication, High blood pressure medication, Medication for digestion and PAROXETINE for an unknown indication.    On 08-Jun-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 08-Jun-2021, the patient experienced PYREXIA (Fever), MYALGIA (Sore arm), FATIGUE (fatigue) and HEADACHE (Headache). On 10-Jun-2021, PYREXIA (Fever), MYALGIA (Sore arm), FATIGUE (fatigue) and HEADACHE (Headache) had resolved.
Skin infection. Pt was put on cephalexin. Rash on patient arm appear after shot and pt was seen by a physician two days after.
Initial reaction of splotchy, itchy rash over body which diminished but returned on 3/4/21 with severe pain and swelling in legs and rash from feet to buttocks/back area.  Patient went to hospital on 3/7/21; negative for blood clots, lab work was normal; Prescribed Hydroxyzine, PCN-(for mild sore throat), Multi V, Areds 2
Pt recvd Engerix-B vax & 10 mins p/inject exp a h/a, paced around & numbness in face; nurse could not tell whether rxn was a drug allergy, anxiety-venting or caused by other things in life;
Client received the COVID19 Janssen vaccine (Lot# 205A21A) at 12:17. The client was with a friend and after receiving the vaccine they proceeded to the observation area.  Once seated in a chair, the client?s friend waived to the EMT, that the client was ?feeling dizzy like he is going to pass out.?  The EMT waived and the Vaccine Monitor RN, went to assist.  He also radioed to Lead RN to come over, and she arrived at 12:22.  Co-Lead RN went to assist the client as well.  Lead RN observed that the client was diaphoretic and a little pale while Vaccine Monitor RN was asking the client questions.  Lead RN observed that the client was oriented to person, place, time, and situation.  Client stated he had no shortness of breath, difficulty breathing, or chest pain.  Lead RN and Vaccine Monitor RN transferred the client into a zero-gravity chair and positioned the client at a 45-degree angle.  Lead RN also got 2 ice packs and placed them on the back of the client?s neck and forehead.  The client?s friend assisted with the ice packs to hold them in place.  Vaccine Monitor RN brought the client a bottle of water, which he started drinking.  EMT took the client?s vitals at 12:23 (BP: 100/50, HR: 76 & SPO2: 99%).  Client stated he has no underlying health conditions, takes no medications, and has no allergies.  He stated he took a couple of Advil before he came to prevent his arm from becoming soar.  Client kept apologizing saying he would be OK and was starting to feel better.  Client stated had eaten and drank before he came.  He also indicated he felt ?like a twinge? in his heart, like fluttering, but that he had drank coffee and an energy drink earlier.  Client did not know what his blood pressure normally was, but he did indicate that he has a history of fainting when getting blood draws.  Lead RN gave the client a juice box, which he gulped down.  EMT took the client?s vitals again at 12:32 (BP: 102/50, HR: 76 & SPO2 98%).  Client continued to state that he was feeling much better.  Co-Lead RN educated client on both the potentially normal and adverse side effects of the vaccine and the client stated he understood.  Lead RN observed that the client was less diaphoretic, and his color was coming back to his face.  Lead RNs adjusted client?s chair to have him sit in an upright position and requested the client sit for an additional 15 minutes.  The client agreed.  At 12:55 EMT took client?s vitals (BP: 105/60, RH: 72 & SPO2: 98%).  Lead RN asked client if he felt he was ready to stand up to which the client replied, ?yes.?  Once standing, the client stated he felt fine and was ready to go.  Lead RN observed the client leave with his friend at 12:58. Client was walking with a steady gait.
Unable to hold patient firmly during point of vaccination, needle went in arm but only half of the vaccine was administered but the other half squirted out due to the abrupt patient movement. Staff was able to fully revaccinate patient after with no adverse affects.
PATIENT CALLED TODAY AND REPORTED THAT LAST NIGHT HE STARTED GETTING RUNNY NOSE AND SORE THROAT WITH MUCUS.
PATIENT CALL ON 04/21/2023 AT 12:45PM. SHE EXPLAIN THAT SHE STARTED HAVING PAIN AND SWELLING AFTER ADMINISTRATION (04/14/2023). LAST NIGHT (04/20/2023) SHE STARTED HAVING MODERATE PAIN ON LEFT SHOULDER AND SEVERE SWELLING WITH HIVES AND ITCHING. ARM IS SWOLLEN AND STIFF. SHE TAKE APAP 250MG FOR PAIN WITH MILD RELIEF. PATIENT GO YESTERDAY (04/22/23) TO EMERGENCY ROOM, SHE CONTINUE WITH PAIN AND SWELLING IN HER SHOULDER.
11/4/19 1st shingles vaccine - 24 hr flu like symptoms pain in arm, muscle aches, 2/05/20 2nd shingles vaccine - 102° fever, aches, pain for 24 hr period arm swollen for 1 week & red After receiving the 1st shot my reaction was on of fever & aches but with no fever Upon receiving the 2nd shot (in the same arm) my reaction was more severe  102° fever for 24 hrs,  aches thru out body.  pain & swelling of left arm for 1 week (in area of shot only)
kept me awake all night; Pain; Very sore; Very tender all night long; This spontaneous case was reported by a consumer and describes the occurrence of SLEEP DISORDER (kept me awake all night), PAIN (Pain), MYALGIA (Very sore) and VACCINATION SITE PAIN (Very tender all night long) in a 78-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025J20A) for COVID-19 vaccination.     No Medical History information was reported.    On 03-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced SLEEP DISORDER (kept me awake all night), PAIN (Pain), MYALGIA (Very sore) and VACCINATION SITE PAIN (Very tender all night long). The patient was treated with PARACETAMOL (TYLENOL) for Adverse event, at an unspecified dose and frequency. At the time of the report, SLEEP DISORDER (kept me awake all night), PAIN (Pain), MYALGIA (Very sore) and VACCINATION SITE PAIN (Very tender all night long) outcome was unknown.            No concomitant medication was provided.
I reached out to my doctor on 6/23 because everyone in my family had been sick and received and PCR test and then PAXLOVID. I was asymptomatic except for a brief sore throat which developed on 6/25. I completed all of the PAXLOVID.
Patient came into the pharmacy requesting her second covid vaccine. She did not have her covid card and requested the Moderna vaccine.  She was given the information sticker to update her vaccine card. When patient returned to the pharmacy for her booster shot and presented her covid vaccine card it  revealed  that she had Pfizer for her first shot.  After consultation with our coordinator the patient was given the option of either covid vaccine and patient choose to receive the Moderna booster.
Rash all over on chest and back and spreading down legs; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP).  A 76-year-old male patient received bnt162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 30Oct2023 as dose 1, single (Batch/Lot number: unknown) at the age of 76 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "High Blood Pressure" (unspecified if ongoing). Concomitant medication(s) included: FLU VACCINE VII taken for immunisation, on 30Oct2023 as dose number unknown, single; AMLODIPINE taken for hypertension (ongoing). Vaccination history included: covid 19 vaccines: moderna (Dose 1), administration date: 30Jan2021, for Immunization; covid 19 vaccines: moderna (Dose 2), administration date: 27Feb2021, for Immunization. The following information was reported: RASH (non-serious) with onset 01Nov2023, outcome "not recovered", described as "Rash all over on chest and back and spreading down legs". Additional information: They just noticed it this morning and it is getting worse because it is spreading down his legs, at first it was just on his chest and back.  The information on the batch/lot number for bnt162b2 omi xbb.1.5 has been requested and will be submitted if and when received.
Information has been received from a certified medical assistant (CMA) concerning a 5 year old male who around the second or third week of August 2008, was vaccinated with the second dose of MMR II. On 25-SEP-2008, the CMA reported that the patient developed a rash and that rash may be a measles rash. The parent called the office but at the time of the report had not been seen yet in the office. No lab or diagnostic studies were performed. At the time of the report the patient's outcome was reported as not recovered/not resolved. A product quality complaint was not involved. Additional information has been requested.
Narrative:  Patient died after COVID vaccination dose #1. 11/06 hospitalization 12/20 hospitalization: COPD exacerbation with acute respiratory failure requiring bipap 12/29 hospitalization for SOB, acute on chronic hypoxic respiratory failure 12/31 discharged to home 01/02 hospitalization after hearing something "pop" near the groin area and associated SOB; Per patient stated that he woke up with increasing shortness of breath not improved with his nebulizer treatment. He also said that the night before had fever associated with chills, pain and swelling of his scrotum. At the hospital he was found to be tachycardic, tachypneic, febrile with initial labs showing white count of 21.0, lactic acid 1.4, BUN 38, creat 1.6, ABG with pH 7.451. bicarbonate 7.0 pCO2 38.7, PO2 49. 01/14 discharged from hospital 01/25 admitted to hospital w/ SOB; dx pneumonia and copd exacerbation 02/02 transferred to different hospital 02/18 COVID vaccine dose #1 02/18 discharged from hospital on hospice care 02/20 admitted to hospital via ambulance with diagnosis MI, noted that patient presented in asystole, then PEA, then ROSC 02/24 patient passed away
Headache; fever of 102.6; This is a spontaneous report from a contactable consumer (patient). A 13-year-old female (no pregnant) patient received the first dose of BNT162B2 via an unspecified route of administration on left arm on 14May2021 at 17:30 as single dose for COVID-19 immunization. Medical history was not reported. The patient not receive any other vaccines within 4 weeks prior to the COVID vaccine and not received the list of other medications within 2 weeks of vaccination. Prior to vaccination, the patient was not diagnosed with COVID-19 and hadn't been tested for COVID-19 since the vaccination. Concomitant medication was not reported. The patient experienced headache and fever of 102.6 on 15May2021. The outcome of events was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Patient died suddenly. Because there was no foul play, an autopsy was not done. ER doc guessed massive heart attack. Patient's cardiologist does not believe it was a heart attack because his labs were fine in July. His blood pressure was controlled.
About 20 min after receiving my Covid 19 vaccine, I left Hospital and began to feel numb in my throat, my lower face, and the tops of my shoulders. I had reduced sensation, but also felt as though I had no muscle control with movement. Examples of this are when I tried to flex my head forward as if in a nodding motion, or to elevate my shoulders like a shrug, or clench my jaw like when chewing. These were all extremely difficult and I felt as though I had no awareness of if I was even moving these parts of my body whatsoever when I tried to voluntarily do so. It was very strange and also upsetting. I also began to have blurred vision; it was difficult to focus or see properly, such as when you visit the eye doctor and they dilate your pupils and everything seems blurry and out of focus for a period of time afterwards. This all lasted for about exactly 1 hour post.  I did not seek medical attention for this as it did not worsen. I never had any difficulty breathing. It then completely went away.
Information has been received from a licensed practical nurse referring to multiple unspecified patients of unknown age and gender. Information regarding the concurrent condition or medical history was unknown. On unknown dates, the patients were each vaccinated with a dose of improperly stored ROTATEQ (lot # M038209 with expiration date 23-APR-2018, lot # M044399 with expiration date 25-JUN-2018, lot # reported as N003392 with expiration date 11-OCT-2018) (dose unknown) orally for prophylaxis. No adverse events were reported. The vaccines were stored under 0-1 degrees Celsius for 3 hours and 43 minutes and 9-25 degrees Celsius for 3 hours and 4 minutes. Data logger was involved. This is one of several report received from the same reporter. Sender's Comments: US-009507513-1707USA010619: US-009507513-1707USA010872.
Fever next day; no treatment; fever resolved in one day Sore arm; Ibuprofen
Information was received on 31-AUG-2017 from a lawyer regarding a case in litigation concerning a female patient of unknown age. It is complained and alleged that the patient was inoculated with a dose of ZOSTAVAX vaccine (dose, route and lot # were not reported) on or about 17-JUL-2013 at a pharmacy, as recommended for routine adult health maintenance and for the prevention of shingles. The vaccine did not prevent shingles as intended, but rather caused the patient to contract a persistent strain of herpes zoster. On or about 21-JUL-2016, the patient was treated by a LPN and a physician for the onset of a severe vesicular rash accompanied by weakened immune symptoms, which was diagnosed as herpes zoster, or shingles. As a direct and proximate result of these malfunctions, the patient suffered painful injuries and damages and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, and pain and suffering and other damages. Additional information has been requested.
Moderna COVID Vaccine EUA: COVID-19 case resulting in Hospitalization / Death. Patient received Moderna Vaccine on 1/30/21 and 2/25/21. Covid + 1/29/22. Admitted for acute hypoxemic respiratory failure 2/2 Covid c/b suspected bacterial PNA superimposed on Covid PNA, afib, elevated ammonia, intermittent hypotension and AMS. Shortly after arrival she had respiratory arrest required intubation. Per pt COVID+ approx 10-12 days ago and chronically SOB on home O2. Labs: glucose 37, BUN 85, Cr 13.24,  K 5.7, CRP 160.5, Trop 0.13, CT 3.62, WBC 13.8, Hbg 9.5, Plts 112. CXR - bilateral pulmonary edema and/or bilateral infiltrates. CT chest abdomen and pelvis revealed concern for lung aspiration. Tracheostomy performed. Shortly therafter she became bradycardic and hypotensive.  She had cardiopulmonary arrest and required, transitioned to comfort care. Treated with rocephin and vancomycin. Expired on 2/08/22.
Information has been received from a registered nurse concerning a 6 year old white female with no pre-existing allergies, or pertinent medical history who on 09-JUL-2001 was vaccinated with a first dose of subcutaneously into the left thigh with varicella virus vaccine live (Oka/Merck) (Lot # 638248/0496L). Concomitant therapy that same day included a first dose, administered subcutaneously into the right thigh, of measles-mumps-rubella vaccine (M-M-R II) (Lot # 638599/0598L). There was no illness at the time of vaccination. On 30-JUN-2007 the patient developed less than 20 lesions on her face and trunk. The lesions did not itch. The patient was without fever, or any signs or symptoms of infection. There were no lab diagnostic studies performed. The patient recovered from less than 20 lesions on face and trunk on 02 JUL 2007. Additional information is not expected.
Yesterday at the injection site she noticed it was swollen, red, warm, and itchy.; Yesterday at the injection site she noticed it was swollen, red, warm, and itchy.; Yesterday at the injection site she noticed it was swollen, red, warm, and itchy.; Soreness at the injection site; Yesterday at the injection site she noticed it was swollen, red, warm, and itchy.; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE WARMTH (Yesterday at the injection site she noticed it was swollen, red, warm, and itchy.), VACCINATION SITE PRURITUS (Yesterday at the injection site she noticed it was swollen, red, warm, and itchy.), VACCINATION SITE SWELLING (Yesterday at the injection site she noticed it was swollen, red, warm, and itchy.), VACCINATION SITE ERYTHEMA (Yesterday at the injection site she noticed it was swollen, red, warm, and itchy.) and VACCINATION SITE PAIN (Soreness at the injection site) in a 64-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 041B21A) for COVID-19 vaccination.     Concurrent medical conditions included Drug allergy (Allergy to Sulfa drugs).    On 27-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 27-Apr-2021, the patient experienced VACCINATION SITE SWELLING (Yesterday at the injection site she noticed it was swollen, red, warm, and itchy.) and VACCINATION SITE PAIN (Soreness at the injection site). On 04-May-2021, the patient experienced VACCINATION SITE WARMTH (Yesterday at the injection site she noticed it was swollen, red, warm, and itchy.), VACCINATION SITE PRURITUS (Yesterday at the injection site she noticed it was swollen, red, warm, and itchy.) and VACCINATION SITE ERYTHEMA (Yesterday at the injection site she noticed it was swollen, red, warm, and itchy.). At the time of the report, VACCINATION SITE WARMTH (Yesterday at the injection site she noticed it was swollen, red, warm, and itchy.), VACCINATION SITE PRURITUS (Yesterday at the injection site she noticed it was swollen, red, warm, and itchy.), VACCINATION SITE SWELLING (Yesterday at the injection site she noticed it was swollen, red, warm, and itchy.), VACCINATION SITE ERYTHEMA (Yesterday at the injection site she noticed it was swollen, red, warm, and itchy.) and VACCINATION SITE PAIN (Soreness at the injection site) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were reported. No treatment medications were reported.
He reports that the same evening of the vaccine he noticed arm swelling, pain at the site and generalized body aches.  He also reports that his tongue and throat felt numb for four hours.  He also noticed a little cough, shortness of breath and a runny/stuffy nose.
Vaccines went into 2-8 C thaw state on or about 24-Dec-2021; Received vaccine past its 30-days expiry date; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Received vaccine past its 30-days expiry date) and PRODUCT STORAGE ERROR (Vaccines went into 2-8 C thaw state on or about 24-Dec-2021) in a 37-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 066h21a) for COVID-19 vaccination.     Acute illness at the time of vaccination and up to one month before was reported as unknown. Chronic or long-standing health conditions was reported as unknown.     On 12-Feb-2022 at 6:25 PM, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. On 12-Feb-2022 at 6:25 PM, the patient experienced EXPIRED PRODUCT ADMINISTERED (Received vaccine past its 30-days expiry date). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Vaccines went into 2-8 C thaw state on or about 24-Dec-2021). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Received vaccine past its 30-days expiry date) and PRODUCT STORAGE ERROR (Vaccines went into 2-8 C thaw state on or about 24-Dec-2021) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Prescriptions, over the counter medications, dietary supplements or herbal remedies being taken at time of vaccination or at the time of the adverse event were reported as unknown. Other vaccines given on the same day as Moderna COVID-19 vaccine and other vaccines received within one month prior to any dose of Moderna COVID-19 vaccine were reported as unknown.  No concomitant medications were provided by reporter.  No treatment medications were provided by reporter.  On 12-Feb-2022 at 18:25:36, patient received an expired booster dose.   This case was linked to MOD-2022-542869 (Patient Link).
Persistent lightheadedness, chest pressure, and shortness of breath. Transported to ED.
Felt like lump in patient's throat, then with in next 2 hours had chills, light-headedness, and nausea. Went to E.R. at approximately 2:30 p.m. - Blood Pressure was 70/20.
Information has been received from a health professional concerning a 10 year old male who in 1999 was vaccinated with a dose of varicella virus vaccine live (Oka/Merck). In November 2004, the patient presented "more than 100, but less than 200 pox that advanced to vesicles". the patient was treated with diphenhydramine HCl (BENADRYL). It was reported that the patient's event improved. No product quality complaint was involved.
hearing loss; This initial spontaneous report was received from a lawyer regarding a case in litigation referring to a female patient of unknown age. The patient's pertinent medical history, concurrent conditions or concomitant medications were not reported. In or around April 2014, the patient was inoculated with zoster vaccine live (ZOSTAVAX) (lot#, expiration date, dosage, route of administration and anatomical location were not provided) for routine health maintenance and for its intended purpose: the prevention of shingles (herpes zoster). On an unspecified date, shortly after receiving zoster vaccine live (ZOSTAVAX) vaccine, the patient suffered hearing loss. As a direct and proximate result of zoster vaccine live (ZOSTAVAX), the patient's symptoms have resulted in physical limitations and seriousness of her condition. As a result of the zoster vaccine live (ZOSTAVAX), she sustained severe and permanent personal injuries. Further, as a tragic consequence, the patient suffered serious, progressive, permanent, and incurable injuries, as well as significant conscious pain and suffering, mental anguish, emotional distress, loss of enjoyment of life, physical impairment and injury. As a direct and proximate result, she suffered and incurred damages, including medical expenses; the loss of accumulations; and other economic and non-economic damages. The outcome of hearing loss was considered to be not recovered. The reporter considered the event to be related to Zoster Vaccine Live (ZOSTAVAX).  Upon internal review, the event of hearing loss was determined to be medically significant and disabling.