chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Patient received covid vaccine Thursday. 48 hours later (Saturday) he was experience abdominal pain that worsened throughout the night.  Sunday evening he went to  childrens urgent care and an ultrasound revealed he had appendicitis. Child is healthy, up to date on all vaccines and has never had issues prior.
Received a Flu vaccine on 08/29/2013 and developed a painful red raised rash on the trunk of my body that following Sunday (09-01-13). The rash spread across my abdomen, left side and didn't feel well that day (aching, sweaty) so I was seen in the emergency room on 09/05/2013 where they ruled out shingles and chicken pox.   I didn't even think about the vaccine as a possible cause and made no mention of it. The rash continued to spread so I returned to the ER on 09-11-2013.  The ER MD sent me to a Dermatologist and he took a biopsy of one of the areas. I was give a prednisone taper which I completed and the rash seemed to subside.  The areas are now starting to return.  I wonder if the flu vaccine triggered some reaction in my body to cause the rash.  If I am sensitive to a flu strain in the vaccine will receiving the vaccine again next year trigger the same or even a worse reaction?  I appreciate any advice you could offer. Thank you.
Nausea and vomiting for the past week. He reported to triage RN that this is a/w generalized pain.
Pt came in for her second primary dose of Moderna. She denied having any issues with the first immunization.  Following the injection, she was going to wait for 30 minutes due to having an anaphylactic reaction to Penicillin in the past.  Pt had the immunization at 328pm. At 344pm I went up near reception and patient stated she was feeling dizzy. Dr. and I went out front to assess her. Per Dr. her pulse was in the 150?s. We took her to room 9 to lie down. VS at that time: BP 124/85, 96% pulse ox, 124pulse. She was complaining of some difficulty breathing. Dr. evaluated patient and listened to her lungs and determined she was not having anaphylaxis. Pt was given a bag and she vomited once. Pt had also been given grape juice which she vomited. She was then given water to sip. 348pm: 138/94 94 pulse, 92% pulse ox.  Patient?s husband was notified at 350pm to come pick her up. At 354pm 120/81 118 pulse. At 405pm 134/88 120 pulse. Dr. came in to talk with husband and patient to go to ED if symptoms continue or worsen tonight. He told them she needs to rest tonight. They both verbalized understanding. Pt left with her husband at 410pm.
About 2 days after the shot was given a 3 in wide x 2.5 in high swollen reddish spot appeared on the upper arm by where the shot was given that was very warm to the touch.  By 7 days after the shot, the spot had grown to 4 in wide by 7 in high and was very itchy.  Hydrocortisone lotion was being applied to reduce the itch.  Still warm to the touch, but not as warm as it was to begin with.  Still mostly red.
Rash on abdomen and back, noted approximately 1900 on day of injection.  No changes to laundry soap, body soap, or diet in last greater than a year.  Took Benadryl, rash resolved in the morning.
I developed a new and unexplained pain in my knees and elbows, feet, and hips. The pain feels like a stabbing knife into the area of pain. Most of the time it happens simultaneously with both knees and both elbows. Once it begins I get so bad I can barely stand or walk. I tried Bayer, Aleve, Aspercreme, Valteran, CBD, and vitamins. I went to a couple of doctors and they treated me with Prednisone and that has helped. If I try to go 3 days or more without the steroids I can not walk, get out of bed, work, walk, etc.
Vaccine was expired on 09-Nov-2021and administered on 10-Nov-2021 / expired vaccine was administered after the 30-day Use By Date or after manufacturer date of expiration; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Vaccine was expired on 09-Nov-2021and administered on 10-Nov-2021 / expired vaccine was administered after the 30-day Use By Date or after manufacturer date of expiration) in a 38-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 048C21A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 10-Nov-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 10-Nov-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Vaccine was expired on 09-Nov-2021and administered on 10-Nov-2021 / expired vaccine was administered after the 30-day Use By Date or after manufacturer date of expiration). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Vaccine was expired on 09-Nov-2021and administered on 10-Nov-2021 / expired vaccine was administered after the 30-day Use By Date or after manufacturer date of expiration) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant product use was reported.  Date the vial was initially stored in the refrigerator reported as unknown. Number of doses/vials was reported as 168 doses.   The vial did not undergo any temperature excursions.  No treatment information was provided.   Most recent FOLLOW-UP information incorporated above includes: On 08-Jun-2022: Follow-up received contains non significant information.
pt recvd vax; fever of 101.6; rash bullous; anemia infectious p/ 12 days; low iron content; linear IgA; fatigue, weakness;
reddness, covering entire thigh area, swelling, pain, when applying pressure to area, marble size bump left wk p/vax;
PATIENT WAS IN FOR IMMUNIZATIONS AND IS NEEDING TO USE A CATCH UP SCHEDULE.  THE DOCTOR ORDER "IPOL" AS SHE NEEDED A POLIO AND IS ABOVE THE AGE OF 6 WHEN THE COMBINATION  Dtap IMMUNIZATIONS RECOMMEND NOT USING. THE IPOL WAS GIVEN AND WHEN WENT TO ENTER INTO REPORTING SYSTEM THE EXPIRATION DATE CAME UP EXPIRED. THE PATIENT SHOWED NO SYMPTOMS.
06 Oct...felt a little fatigued in the evening after receiving booster shot in the afternoon.  Symptoms were similar to side effect of 1st and 2nd dose of Pfizer vaccine in April 2021. 07 Oct...woke up around 7am with small red hives on my neck. The rash continued to spread down my left side if my back. I had shingles a few years ago, and that's where it started as well. At first, I thought it might be shingles, but then the rash started spreading to my right side. By app. 5pm, most of my neck and back had hives and red spots. I  purchased some extra strength Benadryl gel and took a higher dose of my over-the-counter allergy medicine to help me sleep. By app 7pm, I started to develop a low grade fever and I fell asleep. I woke at app midnight and had to vomit. The rash/hives had spread to my buttocks area and contributed to spread down both legs and into my feet. I went to the wslk-in clinic and received Pretnosone 20mg , 3 times per day for 7 days. The rash is finally going away slowly.
Muscle Pain     Chills   Fever of 100.2 for 5 hours   feeling unwell  joint pain can not raise legs without pain in groin area  Heavy legs started  Mon 4/12/21 at 7:15 a.m.chills followed later.  Muscle pain joint pain feeling unwell start Wed.4/15/21, still on going. Fever was on Thursday around 1:00 p.m. lasting about 5 hours. Took a dose of  flu medicine and fever went down.  Blood pressure running low and heart rate has increased from around 53-57 to 68-71.
Severe chills, body aches, headache, weakness, fatigue for 8 days, onset 2/28/21. Blood clot (DVT), pulmonary embolism, ER and hospitalization 6/30 - 7/1/21.
Patient was given the GARDASIL vaccine and now her hair is breaking off.  She has always had very healthy hair.  She has also developed asthma induced by exercise.
Fever, chills, severe injection site pain, dizziness, tenderness & swelling at site.
adverse experience; Temperature excursion involving GARDASIL 9; This spontaneous report has been received from a medical assistant (also reported as a nurse), concerning 11-year-old of female patient. The patient's concurrent condition, medical history and concomitant therapy were not reported.   On 13-DEC-2021, the patient was vaccinated with an improperly stored dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) lot # T039467, expiration date: 20-MAY-2023, which have been verified to be valid lot number for hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) administered in left deltoid(strength, exact dose and route of administration were not provided) for prophylaxis. The vaccine was exposed to a temperature excursion of below 36°F (30.4°F) for 0 hours 35 minutes on 08-DEC-2021. Digital data logger was involved. On an unknown date, the patient experienced unspecified adverse reaction (ill-defined disorder). The patient's parent agrred to revaccination. The outcome of the event of ill-defined disorder was reported as resolved on an unknown date.   The causality assessment between the event of ill-defined disorder and suspect vaccine was considered as unknown.  The reporter considered the event of ill-defined disorder to be important medical event (medically significant).  This is one of several cases received from the same reporter. ; Sender's Comments:  US-009507513-2201USA000582:
Patient developed local rash. Said it got worse 2 days following vaccine. No fever/pain associated with rash.
Follow-up information was received that provided the recovery status of the nurse. Information regarding Prevnar was received from a healthcare professional regarding a female nurse who cut her hand when the syringe cracked and broke at the blue flange during administration to a patient on an unspecified date. Relevant medical history was not provided. Indication for Prevnar was immunization. Product was administered on an unspecified date. Dose regimen was 1 dose 1 time per day. Concomitant medications were not reported. Event Details: On an unspecified date, a Prevnar syringe cracked and broke at the blue flange during administration to a patient (pharmaceutical product complaint). Subsequently, the nurse cut her hand (limb injury). No cracks were noted prior to administration. The reporter noted that the patient was not injured. On an unspecified date, the nurse recovered from the event although the cut did not heal completely. No additional information was available at the time of this report.
Patient noticed swelling in the right arm 2-3 hours after administration. Patient reports that her entire arm and shoulder were swollen. She reports that she almost went to the emergency room, but ultimately decided not to. Patient has not had any breathing difficulty or swelling in the head or neck.
Flu vaccine given at approximately 11:00; pt presents with approximately localized swelling around injection site c/o; taking to both arms.
Chills started 4 hours after shot and continued for 24 hours. Fever of 100-101 degrees for 2 days. Body aches, headache, extreme fatigue for 2 1/2 days.  Used Advil and Tylenol.  No other treatment needed.
Approximately 2 weeks after my 2nd primary series Moderna Covid-19 vaccine, I developed anterior uveitis in both eyes (I experienced mild light sensitivity, eye irritation, floaters, and peripheral flashes. Saw retina specizlist 4/9/21, who referred me immediately for a same-day evaluation by uveitis specialist, who first diagnosed anterior uveitis in both eyes. Subsequent eye doctor follow-ups have been with uveitis specialist. I have been treated with eye steroid drops from 4/9/21 through present (and also pressure-reducing drops subsequent to increased IOP because of the steroids). I have had bloodwork and a chest x-ray to look for underlying causes of the uveitis (as detailed below), as ordered by my uveitis specialists, primary care physician, and rheumatologists ? no underlying causes have been identified, apart from the possible association with the Moderna Covid-19 vaccine. Treatment:  Prednisolone acetate 1% (4/9/21: 8 times/day x 1 week then 6x/day for 1 week then 4x/day for 1 week; Dr. 4/26/21: increase to 6x/day OD and continue 4x/day OS; Dr. 5/5/21 taper to 4x/day for 1 week then 3x/day for 1 week then 2x/day for 1 week then 1x/day and stay at that dose; Dr. 6/9/21: 6x/day both eyes for 1 week then 4x/day for 1 week then 3x/day for 1 week then 2x/day and stay at that dose). Difluprednate (Durezol) (Dr. 7/7/21: 2x/day OU; Dr. noted at 7/23/21 follow-up increased intraocular pressure due to Durezol; Dr. 8/18/21 no active inflammation, Durezol 1x/day, continue timolol prescribed after 7/23/21 visit 2x/day; Dr. 10/6/21 no active inflammation, continue Durezol 1x/day, change timolol to dorzolomide-timolol 2x/day OU. Prednisolone acetate 1% (Dr. 11/17/21: 1x/day, dorzolomide-timolol 2x/day; Dr. 12/15/21: continue prednisolone acetate 1% 1x/day, dorzolomide-timolol 2x/day, add latanoprost qhs OU).
This spontaneous report was received from a registered nurse regarding an unspecified number of patients of unknown demographics. No concurrent condition and historical medication was reported. On an unknown date the patients were vaccinated with improperly stored (Oka/Merck) VARIVAX, .5 ml, subcutaneous. No adverse event was reported. No product quality complaint was involved. The outcome of the event was unknown. This is one of several reports received from the same reporter. Additional information has been requested.
a 15 patients was vaccinated with flu vaccines via subcutaneously instead of intramuscularly using 5/8 inches needle, No AE; a 15 patients was vaccinated with flu vaccines via subcutaneously instead of intramuscularly using 5/8 inches needle, No AE; Initial information received on 21-Sep-2020 regarding this unsolicited valid non-serious case from a pharmacist.  This case is linked to 2020SA259700 (female patient case, same reporter).  This case involves a 15 patients (unknown demographics) who was vaccinated subcutaneously instead of intramuscularly using 5/8 inches needle with INFLUENZA QUADRIVALENT RECOMBINANT VACCINE [FLUBLOK QIV], INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE [FLUZONE HIGH-DOSE QUADRIVALENT] (batch number UJ467AB and expiry date 30-Jun-2021) and INFLUENZA QUADRIVAL A-B VACCINE [FLUZONE QUADRIVALENT] on an unknown date (batch number and expiry date not reported) at an unknown administration site for prophylactic vaccination (incorrect route of product administration) (wrong device used).  Medical history, medical treatment, vaccination, concomitant medications and family history were not provided.  It was a case of an actual medication error due to inappropriate route of vaccination and wrong device used (latency: same day).  At the time of report no adverse event was reported.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.  There will be no information available on the batch number of FLUBLOK QIV  and FLUZONE QUADRIVALENT for this case.
Patients mom stated her son got the vaccine on Tuesday 5/18/21 and about 4 days later he ate seafood and then started to get an allergic reaction about 2 hours later. Patient started to feel that his lips swelled up along with a rash all around chin, neck and around mouth, on forehead between eyes. He took Benadryl which helped symptoms subside. He also complained of a little chest pain that lasted less than an hour but no shortness of breath. As of Monday 5/24/21 he feels fine no other symptoms. No c/o fever, fatigue, nor headache, body aches. Pain at injection site from vaccine was also reported but that subsided.
Severe hives 4 hours after injection,  red and hot around injection site for 3 days now
pt recvd vax;devel 1 fluid-filled lesion on cheek;lesion on stomach that were very raised but not fluid filled;to md & given meds;dx of pink eye;exp first asthma attack;intermittent hives/chicken pox per mom;conjunctivitis;rhinitis;
Pt received vaccine 8/22/08, c/o frequent night sweats, general malaise, and body odor.
I had the vaccine and about 5 days later I started feeling a sore tenderness on my armpit and I had a bump growing there, it was painful, and over the days it grew and it was very painful and my arm also swell about twice it size. I was Covid arm. I went to a dermatologist and she gave me an antibiotic because she was afraid it was infected. I also called my primary doctor and they said to start the antibiotic.
Patients received an expired dose; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Patients received an expired dose) in a 24-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 09-Nov-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 09-Nov-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Patients received an expired dose). On 09-Nov-2021, EXPIRED PRODUCT ADMINISTERED (Patients received an expired dose) had resolved. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. No concomitant products were reported.No treatment information was reported by the reporter.
Information has been received from a physician concerning a 14 year old female, who, on an unspecified date, was vaccinated with a 0.5mL first dose of GARDASIL.  Subsequently, the patient experienced a syncope episode and a seizure.  The patient sought unspecified medical attention.  The patient recovered on the same day as the episode.  No product quality complaint was involved.  Upon internal review seizure was considered to be an other important medical event.  Additional information is not expected.
7/4/2022 evening, felt like a cold, congestion.  7/5 I had full body aches, congestion, low grade fever that ocellated between 99 and 101, nasal congestion and fatigue.  7/6 tested with At Home COVID 19 test, positive.  Sought unsuccessfully to get medical care.  7/7  Still feeling fatigue, 99.1 fever, and nasal congestion.
Pt was given TDAP lower/Lat (L) arm on 12/17/10 and noticed redness/blister type rash with discomfort next evening on 12/18/10 with progression. On exam she has blister type rash (L) lower arm at injection 1-2cm site with induration/tenderness with erythema of 5-6cm in surrounding tissue.
This case was reported by a other health professional via call center representative and described the occurrence of deafness in a 74-year-old female patient who received SHINGRIX for prophylaxis. On 2nd April 2018, the patient received the 1st dose of SHINGRIX. On an unknown date, less than a year after receiving SHINGRIX, the patient experienced deafness (serious criteria GSK medically significant), hearing decreased, influenza, upper respiratory tract infection, pain, headache, debility, vertigo and fluid in middle ear. The patient was treated with steroids nos (Steroids). On an unknown date, the outcome of the deafness, hearing decreased, influenza, upper respiratory tract infection and fluid in middle ear were unknown and the outcome of the pain, headache, debility and vertigo were recovered/resolved. It was unknown if the reporter considered the deafness, hearing decreased, influenza, upper respiratory tract infection, pain, headache, debility, vertigo and fluid in middle ear to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. The patient experienced hearing difficulties further explained as muffled hearing in left ear and almost deaf after flying with an upper respiratory tract infection and after 2 bouts with flu. There was no specific timing of events known. The consumer was seen by and ENT 6 weeks later and treated with steroids and then 3 weeks after that visit a myringotomy was performed to release fluid in the ear. GlaxoSmithKline would reach out for additional information and encouraged consumer to call. All issues were reported, it was unknown what events occurred first. Follow up received on 21st August 2018 from consumer, the patient reported that after her 1st SHINGRIX vaccine she was laid out for 3 to 4 days with symptoms similar to previous cases of the flu. The patient had severe aches and pains, headaches, debilitation and vertigo for a full day. Shortly after this she flew on an airplane when traveling and since then had problems with fluid in her ear. She still had depleted hearing in her left ear. For tolerance to 2nd dose of SHINGRIX, refer linked US2018GSK152734 ( for same patient).
CLIENT COMPLAINS OF NAUSEA AND VOMITING EVERY 1 TO 2 HOURS ON DAY OF VACCINATION. ON THIS DATE, 05/18/2010, CLIENT REPORTS VOMITING EVERY 30 MINUTES.  ALSO, COMPLAINS OF ITCHING AT INJECTION SITE AND GENERAL MUSCLE ACHES.
left collar bone lymph node; This spontaneous case was reported by a consumer and describes the occurrence of LYMPHADENOPATHY (left collar bone lymph node) in a 55-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 032B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 19-Apr-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 20-Apr-2021, the patient experienced LYMPHADENOPATHY (left collar bone lymph node). At the time of the report, LYMPHADENOPATHY (left collar bone lymph node) outcome was unknown. Not Provided          No concomitant medication was reported.Treatment medication was not provided. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was not applicable.
p/vax pt devel mul organ failure-liver, kidney & pulmonary;unk etiology;pt hosp for 21 days;pt recovered from this exp;
Headache, joint pain, queasy stomach.  Continues into next day time of report is 9:02 am, 2.11.17.
Left upper arm swollen, red, and client states it is painfu.l MD at ED prescribed KEFLEX for infectious process.
This is a spontaneous report from a contactable physician who was also the prescribing physician. A 48-year-old female patient received PREVNAR 13 (lot. H86680; expiration date Oct2015; NDC# 0005197102), on 03Oct2014 at 0.5 ml, single as Preventive for Pneumonia. Medical history included ongoing diabetes from 2014 (since maybe six months) and ongoing high cholesterol since over a year. The patient had no other illness at the time of vaccination. Concomitant medication included losartan 25mg daily for preventive renal protection for diabetes, metformin 500mg (two tablets) twice a day for diabetes and pravastatin 10mg (one tablet) every evening for high cholesterol. On 08Oct2014 the patient had inflammation at the site of injection, fever and malaise. The events were non-serious with outcome was recovered. The physician mentioned that the adverse events did not require any kind of emergency visit. The physician believed that the inflammation at the site of injection and fever were caused by PREVNAR 13 vaccine. Follow-up (04DEC2014): Follow-up attempts completed. No further information expected.
Shortly after receiving the vaccination, patient  experienced syncope.    Pharmacist attended to the patient and ambulance was called.  Patient regained consciousness before ambulance arrived.    Patient was evaluated by the paramedics.    As per paramedics patient was stable and was released to go home.  Patient sat in the pharmacy until she was comfortable to go home.  Patient was escorted by her children
Information has been received from a physician's assistant concerning a patient who was vaccinated SC with a 0.5 mL dose of varicella virus vaccine live (Oka/Merck) instead of a dose of zoster vaccine live (Oka/Merck). No symptoms were reported. The incident was reported as a medication error not a product confusion. A product quality complaint was not involved. Additional information has been requested.