chrisvoncsefalvay/vaers-outcomes huggingface dataset:
fever; vaccinated after the 6 hour mark; A spontaneous report was received from a hospital office manager concerning a patient, who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced a fever and was vaccinated after the 6 hour mark.  The patient's medical history was not provided. No relevant concomitant medications were reported.   On 06 Jan 2021, it was reported that the facility was delivered 3 vials of the vaccine, with no documentation, from the Department of Public Health. Some vaccines were left out more than 6 hours punctured but were refrigerated. The vaccines were used to vaccinate staff and patients, approximately 20 people. Of the 20 people vaccinated at least 10 were vaccinated after the 6 hours mark.  On 06 Jan 2021, prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 intramuscularly for prophylaxis of COVID-19 infection and received vaccine that from a vial that had been punctured more than 6 hours previously.  On an undisclosed date, the patient also experienced a fever after receiving the vaccine.  No treatment information was provided.  Action taken with mRNA-1273 in response to the events was not reported.   The outcome of the event, fever, was not reported. The outcome of the event, was vaccinated after the 6 hour mark, was considered resolved on 06 Jan 2021.; Reporter's Comments: This report refers to a case of product administration error for mRNA, where the vaccine was administered from a vial punctured more than 6 hours. The event of pyrexia was associated with this case of out of specification product use.
Rash developed yesterday to Right thigh, red area about 2-3 cm, warm. Has spread to the face, dots on tummy and back. Occasional diarrhea, slight runny nose. Erythematous macular papular rash on face, chest, abdomen, back, extremities, spares palms and soles. Focal indurated erythema right anterior thigh, with warmth, approx 2-3 cm in diameter, no fluctuance, no discharge.
Developed shortness of breath with chest tightness 2 days after vaccination, accompanied by injection site pain, loose stools, and malaise. Chest tightness progressed over 1 day to become chest pain with diaphoresis, dizziness, and continued dyspnea. Patient evaluated twice at Pediatric ED; 1st time (2 days after vaccination): EKG and troponin were normal, discharged home on ibuprofen. 2nd time (3 days after vaccination): elevated troponin and ST-elevation on EKG; admitted to Pediatric ICU.
Patient noted immediate onset of anxiety different from anything previously experienced. She noted internal shaking. Lab work was ordered revealing hyperthyroidism and patient was referred to primary care and endocrinology for further evaluation and management. Patient noted sx started immediately after receiving covid vaccine dose #2. Unclear as to which vaccine she received.
Pt received DTAP-IPV-HIB, PCV7 Ct RV on 9-9-09. At 1:30 pm. At 4:10pm 9-9-09, Return to office with parents noting that his skin was reddened on back, chest and face. Had not been home since office visit. No new food, clothes or laundry soap. Breath sounds normal flat erythema blotchy on  chest and L face, more wide spread on back alert in no distress. No erythema or swelling at injection sites.
Few days after receiving vaccine patient experienced swelling at the injection site along with big red spots around the injection site. After seeing a physician, she was advised to take the Benadryl.
Rash,brushing,nose bleeds, confusion ,joint  pain and swelling,vision changes, stopped menstruating, unable to do school work, anxiety, unable to do sports or go to school, dizzy,reactivated Lyme disease and ehrichliosis, Epstein Barr virus, leg swelling, immune system dysfunction .
Excruciating pain in left side upper neck and back, eventually to left breast and under left armpit for 6 weeks. Advil did not help. Could hardly function. Also got sick with chills, fatigue, congestion, sinus infection for 2 weeks. Had to take antibiotics.
Patient came in on December 14, 2019 complaining of nerve damage that started after receiving his flu vaccination on November 27, 2019. Patient was seen by physician where he was told that the nerve damage seemed to be localized.
On April 16TH admitted to hospital for high heart rate, blood tests done and found out  thyroid was very high a problem I had never had. Sent home  with endocrinologist referral.  April 18th went to hospital heart rate over 200bpm, unable to sleep all weekend,  lost 10 lbs. Dr stated again thyroid off charts given metoprolol via IV and script for it.  Diagnosis hyperythyroid.
At 1552 Patient given Pfizer covid vaccine first dose lot#EW0178 0+3 ml to Left deltoid. Patient awake alert oriented x 3, with even and unlabored breathing , with clear speech, able to finish sentences without difficulty and ambulatory using a cane. At 1618 Patient stated " I feel that my tongue is swollen and when I bite I do not feel anything. I can breathe very well. "  At 1620 Dr. notified and evaluated patient and with verbal order to bring patient to emergency center. At 1625 Patient brought  to emergency center via wheelchair awake, alert, oriented x 3, with even and unlabored breathing, speech clear, able to finish sentences without difficulty and ambulatory using cane . Patient report given to RN-Triage.
Moderna 2/19/21, 3/19/21, 10/26/21. Positive on 11/10/22
On 9/2 in the afternoon pt developed a fever of 100.9. The fever went away by the time she woke up on 9/3. Also on 9/2 pt. developed diarrhea. It has been slowly resolving. When she woke on on 9/3 she had a rash on her chest and stomach. It has been slowly spreading to her face, back, and butt.
temp of 102/ abd pain,chills.diarrhea starting 5 days after injection and lasted 3 day
Patient started to notice trouble focusing with his eyes the day after getting vaccine. He was able to see normally, but if he tried to focus to read music (he is a musician) then he had trouble. Continued 7/12 with trouble focusing to read music until the evening. Felt like things were just out of focus. He does have bifocal glasses. He noticed if he tipped his glasses up and looked through the bottom of the lens, things became more clear, came back into focus. Seen in office 7/13/18. Felt his vision was completely back to normal. No headaches. No double vision or blurry vision. No eye pain.
Pain at injection site immediately. Swelling, redness, warmth at site with in 2 hrs. Chills and fever 99.6 with in 3-4 hrs, with nausea but no emesis. Used Benadryl, Tylenol, Hydrocortisone 1% cream and warm compresses.
Initial unsolicited report received from a consumer via other company (Pfizer) (Manufacturer Report Number: 2016247322) on 18-May-2016. This case involves a male patient (age not reported) who was vaccinated with a dose of Flu Shot (batch number, expiry date, route and site of administration: not reported) on an unspecified date. Patient's medical history and concomitant medications were not reported. On an unspecified date, following the vaccination, patient had allergy to flu shot ("knows that have flu shot and everything there and he was allergic to that"). Laboratory investigations and corrective treatment were not reported. The outcome of the event was not reported. List of documents held by sender: none.
Bi-lateral shoulder pain / discomfort / stiffness lasting 6 months, resulting in loss of motion, pain, discomfort, and loss of sleep
Swollen neck lymph node on the left side (same side as injection arm).  Symptoms lasted approximately 48 hours.
pt recv vax 7APR98 & no pain when recv vax;next day c/o pain to lt side of neck to ear et teeth, back tongue area;next day c/o pain to ear/teeth area but no neck pain;mom to notify pvt MD;
red patch; COVID arm; Frozen shoulder; This spontaneous case was reported by a consumer and describes the occurrence of ERYTHEMA (red patch), VACCINATION COMPLICATION (COVID arm) and PERIARTHRITIS (Frozen shoulder) in a 70-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 039K20A) for COVID-19 vaccination.     Previously administered products included for an unreported indication: VACCINES (Shingles).    On 08-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In February 2021, the patient experienced ERYTHEMA (red patch), VACCINATION COMPLICATION (COVID arm) and PERIARTHRITIS (Frozen shoulder). At the time of the report, ERYTHEMA (red patch), VACCINATION COMPLICATION (COVID arm) and PERIARTHRITIS (Frozen shoulder) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In February 2021, COVID-19 screening: positive (Positive) COVID-19 positive.         No concomitant medications were reported.  No treatment medications were reported.   This case was linked to (Patient Link).
Syncope,  patient did lose consciousness briefly but did not fall, her mother was able to lower her to the floor.  Woke up immediately but was very lethargic for approimately 15 minutes.   We did call 911 and her mother elected to go to hospital for evaluation.  Patient was discharged in good health.
This spontaneous report as received from a pharmacist/pharmacy manager refers to a 68-year-old female patient with penicillin allergy. The patient's medical history included anxiety and high blood pressure. On 05-OCT-2017, the patient was vaccinated with the first dose of PNEUMOVAX 23 (lot # N020501, expiry date: 03-MAR-2019), intramuscularly for prevention of pneumonia. Concomitant therapies included amlodipine, lisinopril (manufacturer unknown), hydrochlorothiazide and FLOXACIN. On 06-OCT-2017, the patient developed redness and warmth at the injection site. On 07-OCT-2017, the patient developed fever, chills, and general pain so she went to hospital and was diagnosed with cellulitis. Hematology laboratory test diagnostic, X-Ray and brain scan were performed (result not reported). It was reported that the patient missed a couple days of work. The patient was prescribed a treatment with cefadroxil 1000 mg by mouth twice a day for 5 days. The outcome of cellulitis was reported as recovering. Relatedness between cellulitis and the vaccination with PNEUMOVAX 23 was not reported. Upon internal review, the adverse event of cellulitis was considered to be medically significant. Additional information has been requested.
acute BOM which began 3 days p/flu vax;no antecedent URI;
mild fever beginning 10 hours after receiving vaccine, I fell asleep a couple of hours later and woke up feeling fine
Developed a 7 hour run of A-Fib today, May 7.  Booster was April 24th . Treated with 50mg Toprol XL PO. Resolved after 7 hours. I had never had this before
On Sunday (7/18/21) I went in to get my first dose of the COVID vaccine. Everything was fine until the evening of Wednesday (7/21/21) when I started to feel a tightness in my right Mid back. I didn't think anything of it at the time as it just felt like muscle tightness. The next morning I woke up and could barely get out of bed from the pain. It felt like a knife was in my back. I was able to get up and move around, but it was pretty debilitating as I sat around all day. I figured I slept wrong or a possible rib was out of place. I started to develop shortness of breath and rapid heart rate throughout the day as well. The symptoms got worse throughout the next few days and over the weekend. I pushed through the pain as I naturally have a high pain tolerance being a bigger athletically built guy. On Monday (7/23/21) I started to feel a bit better and thought I was recovering. It wasn't until the next day the pain came roaring back and at that point I knew something was going on. On Wednesday (7/28/21) I coughed up some blood in the morning. I was honestly in shock a bit and figured it was blood in my morning flem as a 'Bloody booger' or something. On Friday (7/30/21) I coughed up a significantly more amount of blood and immediately knew I had to go see my Doctor. I made an appt immediately and went in that morning. After doing some initial tests, my Doctor sat me down and told me he thinks I have a blood clot in my right lung and need to go to the ER immediately to get diagnosed. After being emitted to the ER, all the tests and scans came back positive that a blood clot in my lung was correct. They told me I actually have multiple blood clots in both lungs. I was in utter shock as I have always been a healthy individual. After being in the ER for a couple nights they put me on Eliquis blood thinner right away and have been taking two doses/day ever since. I was released from the ER on Sunday afternoon (8/1/21).
4 month old was given Kinrix; This case was reported by a consumer via call center representative and described the occurrence of inappropriate age at vaccine administration in a 3-month-old male patient who received DTPa-IPV (Kinrix) (batch number YZ97N, expiry date 31st August 2022) for prophylaxis.   Co-suspect products included dtpa-ipv vaccine pre-filled syringe device (Kinrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 8th September 2021, the patient received Kinrix and Kinrix Pre-Filled Syringe Device. On 8th September 2021, unknown after receiving Kinrix and Kinrix Pre-Filled Syringe Device, the patient experienced inappropriate age at vaccine administration. On an unknown date, the outcome of the inappropriate age at vaccine administration was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.  Additional details were provided as follows: The case was reported by patient's mother. The patient's mother stated that 4 month old son was given a shot of Kinrix which was indicated for 4 to 6 year old children, which led to inappropriate age at vaccine administration. No health care professional information was provided. The reporter did not consent to follow up.
Diarrhea, vomiting. Treated with IV-D5 norm. M, Tylenol, lab work with 23 hours of hospitalization.
felt nauseated immed p/inj;felt weak @ 5" p/inj then said felt heart pounding-perspiring profusely;amb called-felt better by time arrived @ 12:45PM;
red spots on her chest; chest tightness; red face that developed today; This spontaneous case was reported by a consumer and describes the occurrence of RASH (red spots on her chest), CHEST DISCOMFORT (chest tightness) and ERYTHEMA (red face that developed today) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. Unknown and Unknown) for COVID-19 vaccination.     No Medical History information was reported.   On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced RASH (red spots on her chest), CHEST DISCOMFORT (chest tightness) and ERYTHEMA (red face that developed today). At the time of the report, RASH (red spots on her chest), CHEST DISCOMFORT (chest tightness) and ERYTHEMA (red face that developed today) outcome was unknown.            Concomitant information was not provided. Treatment information was not provided.
This is a frequency error as the patient had already received the same vaccine on 10/12/2022.  The patient reported mild itching at the site one day post injection.
uneasy and not feeling well, nausea,  tylenol 12/08/2020 and loose bowel movement,  12/09/2020 nausea, pain in L arm, soreness in body, very fatigue, L arm swollen and very red at injection site, large wept at site of injection, high fever, high blood pressure at work; seen at employee health and sent home. Went to urgent care after leaving work 12/09/2020, tested for flu and covid-19 -- results negative. Sent home to take tylenol, rest and plenty fluids. 12/10/2020 pain in L arm, soreness in body, very fatigue, L arm swollen and very red at injection site, large wept at site of injection,
Gave Pt his shot. He sat down. Got up to buy a water. Wendt and sat down before he bought water. He fainted. Didn't know what happened. He sat til he felt better.
Influenza vaccine, unknown brand. Chest pain and SOB that started 36 hours after vaccination and resolved 5 days later. No known Hx of CVD or respiratory diseases. No fever. PE 7 days after symptoms started was WNL.
had swelling, redness & rash on lt arm w/itching, no fever;mom took to MD @ ER was advised by MD that it was rxn to DTAP, instructed to give pt DPH & APAP;swelling & redness better, still has some rash;
Vial was initially stored in refrigerator on 4-Jun-2022 and administered past 30 day use by date; No adverse event; Administered the vaccine after the 30 day use by date; This spontaneous case was reported by a physician assistant and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Administered the vaccine after the 30 day use by date), PRODUCT STORAGE ERROR (Vial was initially stored in refrigerator on 4-Jun-2022 and administered past 30 day use by date) and NO ADVERSE EVENT (No adverse event) in a 59-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 058A22-2A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 16-Jul-2022, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. On 16-Jul-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Administered the vaccine after the 30 day use by date). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Vial was initially stored in refrigerator on 4-Jun-2022 and administered past 30 day use by date) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Administered the vaccine after the 30 day use by date), PRODUCT STORAGE ERROR (Vial was initially stored in refrigerator on 4-Jun-2022 and administered past 30 day use by date) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessments were provided for EXPIRED PRODUCT ADMINISTERED (Administered the vaccine after the 30 day use by date) and PRODUCT STORAGE ERROR (Vial was initially stored in refrigerator on 4-Jun-2022 and administered past 30 day use by date).    No concomitant medication was reported by reporter.  Total 35 vials were affected. Vial was initially stored in refrigerator on 04-Jun-2022 and did not undergo temperature excursion. Manufacture code for the lot was MOD. Patient was administered with half dose.  No treatment medication was reported by reporter.
approx. 5 min after administration, patient experienced blurred vision, nausea, and dizziness. patient was seated, given a cold water bottle to drink and one placed behind her neck. her legs were raised onto another chair and was given a garbage can upon vomiting.  A fan was turned on placed to blow on the patient when she stated she felt hot. Father approved calling EMS. EMS arrived. Father then stated the patient has experienced this before when she has received other vaccines and then recovers with no issues. Father refused medical transport from EMS.
The patient reports intense arm pain starting at the injection site and radiating down his entire arm to two of his fingers.  He said there's a lump on his arm at the injection site as well.  He cannot put his arm in any position that will reduce his pain.  He reports being unable to do certain physical activities (push-ups) that he could do before the vaccination.
Within 24 hours of receiving Menactra, patient developed temperature of 100.5, headache, nausea/vomiting and photophobia.
Woke up to a large round rash/hive like on my left arm near the vaccine site.  Also a smaller one just below it.  It was warm, a little itchy but mostly non specific.
COVID-19; COVID-19; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 28-year-old male patient received BNT162b2 (BNT162B2), on 07Apr2021 at 09:30 as dose 1, single (Lot number: EW0158), in left arm, on 28Apr2021 at 09:00 as dose 2, single (Lot number: ER8736), in left arm and on 03Dec2021 at 11:00 as dose 3 (booster), single (Lot number: 33030BD) at the age of 28 years, in left arm for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID-19". Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical course: Covid-19 treatment received of Paxlovid from 14Jul2022 to 17Jul2022 of lot number GC8236.   No follow-up attempts are possible. No further information is expected.
Patient received the MMR vaccine and subsequently developed what was initially though to be a chalazion but over the course of a few months was deemed to become a granulomatous disorder discovered by biopsy with  immunohistochemistry positive for rubella virus protein suggesting rubella virus-associated granulomatous disease.
SORE ARM; This spontaneous report received from a patient via a social media via a company representative concerned a 58 year old male of unspecified ethnic origin. The patient's height, and weight were not reported. The patient's concurrent conditions included: non smoker, and controlled high blood pressure. The patient previously received covid-19 vaccine ad26.cov2.s (Dose number in series 1) (suspension for injection, route of admin not reported and batch number: unknown and expiry: unknown) dose was not reported, 1 total, administered on JUL-2021 for prophylactic vaccination. On JUL-2021, following vaccination with first dose of covid-19 vaccine ad26.cov2.s, the patient had sore arm (Dose number in series 1). The patient recovered from sore arm in JUL-2021. The patient received additional covid-19 vaccine ad26.cov2.s (unspecified manufacturer) (Dose number in series 2) (suspension for injection, route of administration, and batch number were not reported) dose was not reported, 1 total administered on 22-JAN-2022 for prophylactic vaccination. The batch number was not reported. Per procedure, no follow-up will be requested for this case.  On 22-JAN-2022, following vaccination with covid-19 vaccine ad26.cov2.s, the patient had sore arm (Dose number in Series 2). Concomitant medications included ascorbic acid, and vitamin B complex. It was reported that "I received the J & J in July 2021. No side effects other than a sore arm a few hours. Had the booster Jan 22. Same thing. Haven't tested positive ever for COVID. I don't wear mask unless required. I wash my hands and use common sense. I take vitamins c, B complex. Male nonsmoker 58 years old. High blood pressure under control with daily meds 10 years now". The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from sore arm on 22-JAN-2022. This report was non-serious. This case, involving the same patient is linked to 20220210398.  Version created to amend previously reported information on 03-FEB-2022. Upon review the following information was amended: Amendment Adverse Event (the case validity assessment was updated to valid from the previously incorrect assessment of non-valid).