chrisvoncsefalvay/vaers-outcomes huggingface dataset:
DIAGNOSTIC STUDIES: 1. Chest x-ray that was normal. 2. CT angiography of the chest showing no abnormalities. 3. Echocardiogram showing no significant abnormalities.  HOSPITAL COURSE: A 24-year-old male, primary care patient, received a second dose of the Pfizer COVID-19 vaccination 3 days prior to admission.  Following this, he had a fever, chills, body aches, and then developed severe chest pain.  The pain was worse lying flat, better when sitting up and leaning forward and worse with a deep breath.  He had gone to an urgent Care and was recommended going to the emergency room.  The patient's troponins were elevated and his EKG was fairly classic for pericarditis.  He was felt to have probably viral myopericarditis and was admitted for observation.  He was placed on aspirin and colchicine.  He seems stable from Cardiology to be discharged on this regimen as well as symptomatic treatment.  It was not known whether the COVID vaccine was implicated with this or not.  DISCHARGE DISPOSITION: CONDITION:  Stable and improved.  MEDICATIONS: 1. Colchicine 0.6 mg b.i.d. 2. Aspirin 650 mg t.i.d. 3. Oxycodone/acetaminophen 5/325 mg every 4 hours p.r.n. for pain. 4. Zofran 4 mg sublingual q.8 hours p.r.n. for nausea.  DIET: Regular.  ACTIVITY: As tolerated.  FOLLOWUP: With Cardiology on May 3rd.  If worsened pain, shortness of breath, or high fever, return for evaluation sooner.  In which case, steroids may be administered.
No adverse event; Patient took 1st dose on 5th march and 2nd dose on 3rd may 2021; This spontaneous case was reported by a consumer and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Patient took 1st dose on 5th march and 2nd dose on 3rd may 2021) and NO ADVERSE EVENT (No adverse event) in a 31-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Ankylosing spondylitis. Concomitant products included ADALIMUMAB (HUMIRA) for Ankylosing spondylitis.   On 05-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 03-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 03-May-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Patient took 1st dose on 5th march and 2nd dose on 3rd may 2021). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Patient took 1st dose on 5th march and 2nd dose on 3rd may 2021) and NO ADVERSE EVENT (No adverse event) outcome was unknown.            Treatment information was not provided.   This case was identified as part of a retrospective clean-up activity where certain emails received in the Moderna mailbox were missed to be booked-in   This case was linked to MOD-2022-619122 (Patient Link).
1550 Moderna 1st Bad itch and flushed feeling Benadryl  25mg po. 1600 Vital stable 97%  HR 88 1605 Itch continues, denies dysphagia and dyspnea 1610 Itch improve. 1615 Feeling well ready to go home.
Fever 101.0, at t+14,  duration 12hrs. Tinnitus both ears, intermittent (under 1 minute),  1-2 times daily,  persisting at day 6.
Information has been received from a RN concerning a male pt who is receiving dialysis who on 3/10/03 was vaccinated with a 40mcg dose of hep B vaccine (644028/1017M). On 3/12/03 hte pt presented for dialysis and complained of muscle "jerking" and weakness in the upper extremities, including the shoulders, neck and both arms. It was reported that these symptoms began on the 3/12/03. The condition worsens when the pt lifts his arms or tries to lift something. Unspecified medical attention was sought. Additional info has been requested.
This spontaneous report as received from a healthcare worker refers to a 9 week old patient of unknown gender. The patient's relevant medical history, current conditions and concomitant medications were not reported. On 17-NOV-2015 the patient was vaccinated with improperly stored ROTATEQ (dosing details were not reported) lot # L008053, with an expiry date of 30-NOV-2016, orally. The vaccine was administered at public health clinic or hospital with public funds. No adverse effects were reported. There was no product quality complaint involved. This is one of the several reports received from the same reporter. Additional information has been requested.
Development of superficial thrombophlebitis left saphenous vein and dorsalis pedis vein.
Positive COVID-19 test  >14 days post vaccination series.  Presents to ED with SOB, fever, fatigue, diarrhea, malaise, dizziness.
pt recv vax 7OCT96 to lt thigh on 9OCT96 reported large red pruritic indurated warm area to lt thigh @ site of inj;no systemic rxn;tx cool compress & DPH;
rash; headache; No appetite; chills; sweat; fever; body aches; This is a spontaneous report from a contactable consumer. A 78-year-old female patient received second dose of bnt162b2 (BNT162B2; Solution for injection; Lot number: EM9809) via unspecified route of administration on 09Feb2021 at single dose for covid-19 immunization. Relevant medical history and concomitant medications were not provided. It was reported that caller and his wife received the second dose of the Pfizer-BioNtech Covid-19 vaccine on Tuesday, he experienced a little of body aches that disappeared; however, his wife experienced a severe reaction: ongoing chills from 10feb2021, ongoing sweating from 10feb2021, ongoing headache from 10feb2021, from 10feb2021 to 11feb2021 experienced fever, ongoing body aches from 10feb2021 and today she broke out in rash on the front of her body from 11Feb2021 and ongoing no appetite from 10feb2021. They would like to know if there are any recommendations on what to do. Calling about the Covid 19 Vaccine. States that he and his wife had their 2nd doses of the vaccine on Tuesday afternoon. He had very little side effects; just body aches. But his wife woke up the first night after getting the shot with chills, fever, sweats, headache, and body aches. Today she is feeling a little better; her temperature this morning was 99.2, and she had a really bad headache. When she got in the shower, she noticed that she had a rash on her body; it doesn't itch. States that she has a little appetite today, which is good because she didn't eat at all yesterday. Asks, what does he need to do, if anything at all? States that he went on the Pfizer website and the side effects were listed there, one of the bad ones was a rash, so he would like to speak with Medical Information. Caller does not have the full contact information to provide for the prescribing physician. States that she got the shot about 2:15-2:30pm and the aide effects started about 12 hours later. States that she goes from being hot to cold to lukewarm, so the chills come and go. Her fever is gone, her temperature is now 97.5. The headache was really bad this morning, but she only feels a little pressure now. The rash is on her back and legs, but it has gotten better in the last hour. States that her appetite has improved; she just ate some breakfast. The lot number on the card is difficult to read due to the handwriting. Caller states that by comparing her card to his card, they think the Lot number is either EU9809 or EM9809. Caller later states that after looking at if for longer he really thinks it's EM9809. The outcome of the events for "Chills", and "Sweating" was "Not Recovered", for "Fever" was "Recovered", and for "Headache", "Body aches", "Rash", "No appetite" was "Recovering".  Follow-up attempts are completed. No further information is expected.
Varicella - Information has been received from a nurse practitioner concerning a 3 year old caucasian male patient who on 05 Dec 1997 was vaccinated with a dose of varcicella virus vaccine live.  On 12 Apr 2000 the patient developed varicella disease.  Subsequently, the patient recovered.  Additonal information has been requested.
Moderna COVID-19 Vaccine EUA Constipation even though I had taken Linzess on schedule. Constipation was also not relieved via MagO7, Miralax, Magnesium Citrate, and fleece enama. Relief only occurred after a trip to the emergency room.
Erythematous maculo-papular rash scattered from scalp to feet with mild periorbital edema.
Rash, heat at inj site; congestion; all-over body aches "flu-like;" fatigue; brain fog
MoP states that there is swelling at the injection site; Erythema; Hot to the touch.
Despite moving my arm frequently as recommended, arm pain started early afternoon, fever of 101 that night, all over aches and sensitivity, weakness. Fever subsided by early afternoon next day and all symptoms were gone by evening next day.
Note that I originally received the J&J one-shot vaccine on 4/9/2021; this shot I received on 10/29 was a booster.   Starting on the evening of 11/14, I started having a sore throat. The sore throat lasted for a little over a week, and also experienced some fatigue during that time. I did not have a fever or cough. Cough drops, fluids, honey etc did not really help. I took one dose of ibuprophen on 11/21, and that provided the most relief.
Shot received approximately 12pm on Tuesday May 19th, 2020. Approximately 2pm that same day my daughter started with a fever. On Tuesday the fever reached a maximum of approximately 101.5 degrees. On Wednesday the fever continued throughout the day and reached 103.0 degrees. Tylenol and Motrin were used piggy backed/rotated since the fever kept breaking through every 3 hours. At this point patient stopped walking normally and went back to crawling (she took her first steps at 10 months old and by her first birthday she was using walking as her main form of travel). Her gait became very unsteady and uncoordinated. Her fever continued throughout Friday in which i brought her to a pediatric urgent care where they listened to her lungs (clear), checked her ears (clear), and obtained a sterile urine sample via catheter (clear) to make sure there was not another infection causing this long lasting fever. The PA there also tried to get patient to walk in which she did take 2 steps but then fell into my arms. The injection site was not red or swollen. On Saturday morning the fever was gone - the maximum she got to that day was 100.3. That morning she broke out in an abdominal and back rash- red raises bumps that were causing her discomfort and itching. Advised to use Caladryl lotion and Benadryl when needed. Patient's walking continued to be unsteady and she is falling. It is now Monday May 25th and the fever remains gone, the rash is still present but not worsening, and she still is not walking normally. She can now stand again on her own but becomes shaky and uncoordinated and falls. I have reached out to her doctors multiple times.
Severe blood clotting in the bladder 2 days following 2nd injection. Led to my dad fainting and being sent to hospital by ambulance. He was in the hospital from 2/23/21 - 3/2/21. While there they flushed his bladder and removed the blood clots. Was diagnosed with bladder cancer, but the cancer in the bladder was now found to be prostate cancer. My dad was treated with low dose chemo therapy and targeted radiation therapy following these events.
Developed abnormally high amount of strange maladies ie; respiratory infections, colds, flue, achy joints, blurred vision, lesions on lips and headaches.
pt recvd vax & exp an elevated ALT approx 3 months p/3rd dose;
This spontaneous report as received from a nurse refers to an unknown number of patients of unknown age and gender. On an unknown date the patients were vaccinated with GARDASIL (lot number and expiry date unknown) (dosing regimen and frequency unknown) that was not stored correctly. No concomitant medications were reported. No adverse events were reported. No product quality issue was reported. This case is related to case number 1405USA008990 and 1405USA008991 via same reporter link. Additional information has been requested.
I experienced costochondritis inflammation. Stabbing pain on my sternum. I saw my PCP. I also did yoga stretches for about six months to clear up the inflammation. I can say the costochondritis is pretty much gone.
1) Transient dizziness, resolved.(2) Dysequilibrium, mild.  EMS ALS ASSESSMENT, RELEASE ON SCENE
After doses 1 and 2, his arm hurt for a few days.; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (After doses 1 and 2, his arm hurt for a few days.) in a 59-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 010A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 25-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In 2021, the patient experienced PAIN IN EXTREMITY (After doses 1 and 2, his arm hurt for a few days.). In 2021, PAIN IN EXTREMITY (After doses 1 and 2, his arm hurt for a few days.) had resolved.        mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) dosing remained unchanged.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were provided by the reporter. No treatment information was provided.   This case was linked to MOD-2022-465007, MOD-2022-464955 (Patient Link).
Tested + PTA. Presented w/ high fever, worsening cough and SOB. Fully vaccinated 1/2021. Dx w/ COVID pna. Remdesivir, lovenox, steroids, O2 by HFNC.  In terms of her COVID infection, she had received 10 days of remdesivir, toci, high-dose steroids, Lovenox. The patient passed away on September 6, 2021, at 1603.
Note this was a booster based on J&J given 6APR21 (Lot 041A21A). See additional info, but summary: New onset epilepsy 14 years after 2007 brain abscess and stroke s/p craniotomy with essentially full neurological recovery during the interval. Did self discontinue anticonvulsants (Klonopin, Topamax) > 10 years ago, but no interval seizures.  Resulted in 3 day hospitalization. Now having 3-4 partial seizures daily under the care of neurology. 39 year-old female with a PMH of left sided brain abscess and stroke in 2007 presenting ~ 2 weeks (onset 2/14/2022) after having a what was initially thought to be a left sided MCA stroke based on right-sided numbness and loss of motor function resulting in hemiparesis and hemianesthesia. While at work around 17:30 on 2/14/2022  she started feeling tingling/numbness in her right toe. Because she was seated, she tried repositioning her leg, but the symptoms progressed proximally until she could not feel or move or feel the entire right side of her body. At this time she also reports an expressive aphasia where she was either slurring her words or unable to speak, but understood other what was being said to her. She was evaluated in the emergency room where CT scan showed no acute intracranial hemorrhage/infraction/lesions/hydrocephalus/mid-line shift. She did have 4x2.6x4 cm area described as consistent with chronic left MCA infarction in the posterior frontal lobe from 2007. She was discharged without follow up with her PCP the following day. Instead, she was admitted to local hospital for 3 days (Feb 15-18, 2022) where she underwent EEG, labs, MRI brain, and neurology consultation that showed gliosis consistent with prior surgery and "sporadic irradiative focus in the right temporal region" on EEG. For the last month, she has had 3-4 seizures per day that cause right sided motor and sensory loss that are followed by a postictal state lasting 1-4 hours, but once up to 12 hours. She does not have loss of control of bowel or bladder function. Currently under the care of neurology taking Keppra to 1,000 mg BID and Vimpat 50 mg BID that are not controlling the seizure activity. For things that have changed in her life that could have led to the start of symptoms, she reports Having her 3rd child 4 months ago (Nov 2021) via uncomplicated vaginal delivery. Getting her COVID-19 booster ~1 month prior (1/12/2022); and returning from training and travel (~ 18 hours of flying) on 1/31/2022 and since that time she was "not feeling right" but cannot be any more specific in her description. In the middle of describing her history, she stated to her husband "one is coming." He stood up and maintained her airway as the right side of her body initially went limp, then started shaking in the hand and foot wither the patient's eyes rolling back in her head and the patient being unresponsive and unable to speak for 90 seconds. We maintained her airway and she recovered.  She appeared postictal for 10-15 minutes before completing her physical exam that had 4/5 strength on the right and hemianesthesia on the right side of the body including the right forehead.
The vial was stored in refrigerator on 17-May-2023 and was administered to patient on 23-Jun-2023; No adverse event; the vaccine was administered on day 37 to 2 patients, age group 6-months to 5yrs; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (the vaccine was administered on day 37 to 2 patients, age group 6-months to 5yrs), PRODUCT STORAGE ERROR (The vial was stored in refrigerator on 17-May-2023 and was administered to patient on 23-Jun-2023) and NO ADVERSE EVENT (No adverse event) in a child male patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 201L22A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 23-Jun-2023, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On 23-Jun-2023, the patient experienced EXPIRED PRODUCT ADMINISTERED (the vaccine was administered on day 37 to 2 patients, age group 6-months to 5yrs). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (The vial was stored in refrigerator on 17-May-2023 and was administered to patient on 23-Jun-2023) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (the vaccine was administered on day 37 to 2 patients, age group 6-months to 5yrs), PRODUCT STORAGE ERROR (The vial was stored in refrigerator on 17-May-2023 and was administered to patient on 23-Jun-2023) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessments were provided for EXPIRED PRODUCT ADMINISTERED (the vaccine was administered on day 37 to 2 patients, age group 6-months to 5yrs) and PRODUCT STORAGE ERROR (The vial was stored in refrigerator on 17-May-2023 and was administered to patient on 23-Jun-2023).    Concomitant product use was not provided by the reporter.  Unknown if patient received other vaccines in the 4 weeks prior to COVID-19 vaccine. Suspect product dosage text was reported as unknown. The intact carton 0.4 ml did not undergo any temperature excursions. Vials were kept between 2-8 C for the entire time. It was reported that vials may be stored refrigerated between 2° to 8°C (36° to 46°F) for up to 30 days prior to first use, provided the expiration date was not exceeded. Moderna COVID-19 Vaccine, Bivalent should be used 30 days from the date the vaccine was exposed to temperatures above 36°F (2°C). Vials can be used by the end of day on day 30. Expired vaccine or vaccine past the 30-day beyond use date (BUD) will need to be discarded.  Treatment information was not provided.   This case was linked to US-MODERNATX, INC.-MOD-2023-730937 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-730937:Same reporter
ACHY; CHILLS; FEVER; NAUSEA; MUSCLE ACHES; FATIGUE; This spontaneous report received from a patient concerned a patient of unspecified age and sex. 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, and batch number were not reported) dose was not reported, administered on 05-MAR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On MAR-2021, the subject experienced achy. On MAR-2021, the subject experienced chills. On MAR-2021, the subject experienced fever. On MAR-2021, the subject experienced nausea. On MAR-2021, the subject experienced muscle aches. On MAR-2021, the subject experienced fatigue. Laboratory data included: Body temperature (NR: not provided) 99 and 100.7 degrees. The action taken with covid-19 vaccine ad26.cov2.s was not reported. The patient recovered from achy, chills, fever, nausea, muscle aches, and fatigue on MAR-2021. This report was non-serious.
inadvertently received a dose of expired Twinrix; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of expired vaccine used in a 52-year-old male patient who received HAB (Twinrix) (batch number 2KE55, expiry date 22-SEP-2023) for prophylaxis.   On 20-OCT-2023, the patient received Twinrix. On 20-OCT-2023, an unknown time after receiving Twinrix, the patient experienced expired vaccine used (Verbatim: inadvertently received a dose of expired Twinrix). The outcome of the expired vaccine used 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 Information: GSK receipt date: 24-OCT-2023 The pharmacist reported that, the patient inadvertently received a dose of expired Twinrix, which led to an expired vaccine used. The reporter consented to follow up.
A physician reported that an 18 year old male study participant experienced headache and diagnosed with viral meningitis 14 days after receipt of study vaccine on Oct 24 2005. He complained of headache on Nov 7 2005. On 11/08/2005, he went to the Emergency department where a spinal tap confirmed a diagnosis of viral meningitis. He was treated with unspecified medications and was discharged on Nov 11 2005. The patient recovered without sequelae. He went back to school on Nov 16 2005 and wad advised to follow up with his physician in a few weeks. No further information is available as the study participant refused to sign release of medical records. The investigator assessed the adverse events as possibly related to study vaccine.
Headache; This spontaneous case was reported by a pharmacist and describes the occurrence of HEADACHE (Headache) in an 82-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 028L20A) for COVID-19 vaccination.     No medical history was provided by the reporter.     On 04-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 08-Feb-2021, the patient experienced HEADACHE (Headache). At the time of the report, HEADACHE (Headache) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.
Periodically rash in shoulder and back, insomnia, continuous headaches. Duration symptoms since 2002.
Fully vaccinated with breakthrough COVID infection and inpatient hospital admit to a general patient unit.    Vaccine lot # 043L20A   and #022M20A
A non- serious spontaneous report of inadvertent administration of expired H1N1 was received from a registered nurse/health professional concerning a five-year-old female. Neither relevant medical history nor concomitant medications have been reported for this patient. The original expiration date was 08-Apr-2010, which was reassigned to 29-Mar-2010. On 31-Mar-2010, the patient received the second dose of H1N1, Intranasal for an unknown indication. There was no adverse event associated with this medication error; therefore, treatment and reporter causality assessments were not applicable and the event was considered to be resolved.