chrisvoncsefalvay/vaers-outcomes huggingface dataset:
HIGH FEVER; This spontaneous report received from a parent concerned a male of unspecified age. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported.The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unk) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. The company was unable to perform follow-up to request batch/lot number. No concomitant medications were reported. On an unspecified date, the subject experienced high fever. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of high fever was not reported. This report was non-serious.
Saturday 10/6/12 c/o viral syndrome - body aches, low grade fever, H/A. Continued until Sunday 10/7. Came to ED with fever 100.7, severe body aches and felt generally ill. Blood cultures x1 bottle showed candida. Admitted to hospital.
This person sent an email to the Health Department relating the following:  She has a previous history of Bell's Palsy one year ago (March-April, 2020) which resolved.  She had new onset of Bell's Palsy on 4/2/21; 3 weeks after 2nd dose of Pfizer COVID19 vaccine dose.  She received her COVID19 vaccinations at Community Medical Center and she reported to me that she does not think anyone had submitted a VAERs on her behalf.  Patient states that her current episode of Bell's Palsy is NOT resolved and she is still having symptoms and treatment.  Details that she related to myself (via email) included that she has undergone 2 separate rounds of prednisone, facial rehab, and has an upcoming consultation with a neurologist scheduled in August.  I do not know the name of the physician she currently is under the care of for her Bell's Palsy.
On 1/2/2022, I got my first Moderna booster for COVID-19. On 5/16/2022, as I was getting ready for bed, I developed an extremely sore throat. On 5/17/2022, I had a headache, sore throat, fatigue, and chills. I ended up not getting out of bed for 3 days. On 5/17/2022, I took an at-home test for COVID-19, and the result was positive. I called my doctor's office to see if I should come in for a PCR test, as well, but I was told that this wouldn't be necessary, as I had already gotten a positive result and was experiencing symptoms. During the time I stayed in bed, I could hardly eat and I didn't even bother to shower. I spent most of the time sleeping. On 5/20/2022, I finally was able to get out of bed, so I just migrated to the couch. On 5/20/2022 or 5/21/2022, I had strange, intense pains that would flare up in certain joints at a time, then disappear, and then travel to other joints; this lasted for only about 12 hours. I had brain fog that was so severe that I even had trouble remembering my own address. From 5/17/2022 to 5/21/2022, I had a headache that started at the base of the neck and went into what felt like the center of my brain. It wasn't like a migraine, but it was bad enough that I took an EXCEDRIN, which helped. At one point, I had a fever of 100.6. On 5/22/2022, I felt perfectly fine and regained my appetite. However, on 5/23/2022, the fatigue and brain fog returned. The fatigue and brain fog persisted and almost made me unable to function. I had trouble with reading comprehension and other cognitive functions. On 6/7/2022, I saw the PA at my PCP's practice to see if I could get help. I requested blood work to be done, because I have the antibodies of Epstein-Barr virus and Lyme disease. I wanted to know if maybe the COVID-19 had reactivated them, plus I wanted my cortisol levels checked. On 6/8/2022, I had the blood work done. The results indicated that the Epstein-Barr and Lyme antibodies were not activated, though I did have high cortisol levels. My doctor just asked me what time of day I did the blood work, which was 7-7:30 AM. I never got any more calls from them and was just told that if no anomalies were found in the blood work, the way I felt was just something that could be attributed to COVID-19 and that it would just take a while to resolve itself. On 6/9/2022, I started to feel a little bit better; I felt some of my energy returning. I then called my homeopath, and I ordered a homeopathic remedy for fatigue, which was picricum acidum (200c), which I was instructed to take for 5-7 days. I took it for 7 days, and the brain fog and fatigue lifted; I became normal again. I stopped taking it, and at the time of this writing, I am experiencing the fatigue again. I am able to function, but I feel the fatigue mainly around my eyes; I often want to close my eyes. I am thinking of taking the picricum acidum again. I'm also someone who normally exercises, but I can't even do that now.
Rash/hive at injection site appeared one week after vaccination (today).  Rash was mildly itchy and mostly flat, with a white center.  Rash was about the size of a lemon.
Information has been received from a lawyer regarding a case in litigation concerning a patient of unknown age and gender. No information was received regarding the patient's past medical history, concurrent conditions, or concomitant medication. On an unknown date in 2016, the patient was inoculated with the ZOSTAVAX (lot number, dosage and route of administration not provided) at a pharmacy, as recommended for routine adult health maintenance for the prevention of shingles. The ZOSTAVAX did not prevent shingles as intended, and the patient subsequently contracted a persistent strain condition of herpes zoster. On an unknown date later in 2016, the patient was treated by a physician for a blistering vesicular outbreak, which was then diagnosed as herpes zoster or shingles. The outcome of the events is unknown. As a direct and proximate result of the ZOSTAVAX vaccine, and/or despite receiving ZOSTAVAX for long-term prevention of shingles, 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.
He received his Johnson & Johnson vaccine around 1500 today in his left arm.  At 2300 today he started feeling fatigue.  He was last seen normal by his wife at 1045.  He had a syncopal episodes in the shower.  His wife helped him down.  EMS was activated.  He was hyperventilating and complaining of nausea and was given 4 of Zofran.  He is also complaining of chest pressure that radiates to the right side of his body.  He is complaining of right sided numbness from his ear all the way down to his feet.  He denies any focal weakness or neck pain.  Denies any back pain or abdominal pain.  Patient does not take any blood thinners.  In route with EMS, patient another syncopal episode.  For EMS patient was febrile to 100.9. Notes relative numbness involving RUE and RLL. All imaging, including brain MRI have come back reassuring.  Fluctuating paresthesias on the right hemibody. Imaging studies are negative for acute stroke or other concerning findings.  Neurological exam was normal on day of discharge but patient continued to report subjective sensory changes intermittently.
Left deltoid muscle pain, limiting range of motion continuing for past 2 1/2 weeks. Follow-up received:  Rather severe, ongoing pain, soreness at the site of the injection, beginning 1-2 days after injection administered on Nov 6th, and has not diminished or gone away as of today (12-4).  Only treatment:  IBUPROFEN.  (Also some brief dizziness and nausea)
A report has been received from a health professional concerning a four year-old male patient. The patient's medical history, concomitant medications and concurrent diseases were not reported. On 15-Oct-2012 the patient received nasal FLUMIST. The dose, frequency and indication for use of the indication were not reported. On 15-Oct-2012 the patient moved his head slightly when administering second half of dose and a few drops of the medication got into his eye. At the time of reporting the action taken with the suspect drug and the outcome of the event were unknown. The company physician assessed the report to be non-serious. Corrected report 13-Dec-2012: Coding of a few drops of FLUMIST got in his eye was changed from accidental exposure while administering drug to drug administration error.
Muscle pain, fatigue, lightheadedness, nausea, diarrhea. Symptoms lasted 6 days.
This case was reported by a consumer via call center representative and described the occurrence of injection site pain in a elderly female patient who received SHINGRIX. On an unknown date, the patient received the 1st dose of SHINGRIX. On an unknown date, less than a day after receiving SHINGRIX, the patient experienced injection site pain. On an unknown date, the outcome of the injection site pain was recovered/resolved. The reporter considered the injection site pain to be probably related to SHINGRIX. Additional details were reported as follows: This case was not previously reported to anyone. This case was reported by the patient's daughter who is also GlaxoSmithKline employee. The age at vaccination was not reported. No concomitant vaccines were reported and the reporter was not aware of any concomitant medications. The patient received SHINGRIX on an unknown arm. The reporter could not provide which arm was affected. The patient described the pain as her arm hurted for two days and the pain resolved two days after the vaccination. No vaccine admin facility information was provided. The reporter did not have lot number or expiry date of the vaccine. The reporter had denied hospitalization or need for hospitalization to treat this event. The patient denied permission to contact their physician.
Started having diarrhea for 2 days after immunization on 10/18/06. Had 3-4 diarrhea diapers a day for 1 week. Also had vomiting 4 times 1 day for one week. Some diarrhea persisted for an additional week. Did not see doctor. Talked to him by phone and he decided milk and put baby on Pedialyte for a few days.
Information has been received from a pharmacist regarding a 67 year old female patient. The patient's medical history, drug reactions or allergies were not provided. On 16-SEP-2103, the patient was vaccinated with the second dose of PNEUMOVAX23 (subcutaneously in the right arm) (lot # J004747, expiration date 20-JUL-2014). On the same day, the patient received concomitantly a dose of Influenza virus vaccine (unspecified) (in left arm). On 16-SEP-2013, the patient developed an injection site reaction after vaccination with PNEUMOVAX 23. This may have been the patient's 2nd dose of PNEUMOVAX 23. The patient initially developed bruising at the PNEUMOVAX 23 injection site which has developed into a "reddish rash moving toward her elbow". At the time of the report, the patient was recovering from the adverse event. Additional information has been requested.
Dizziness, extreme joint paint( almost unable to walk, nausea and fatigue  lasting 2 days full on and mild symptoms for 3 days following
chills; fever; This spontaneous case was reported by a patient family member or friend and describes the occurrence of CHILLS (chills) and PYREXIA (fever) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No medical history was provided by the reporter.     On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced CHILLS (chills) and PYREXIA (fever). At the time of the report, CHILLS (chills) and PYREXIA (fever) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant product use was not provided by the reporter. Treatment information was not provided.   This case was linked to US-MODERNATX, INC.-MOD-2021-155407 (Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-155407:
This spontaneous report as received from a nurse refers to a 13 years old patient of unknown gender. The patient's pertinent medical history, concurrent conditions and concomitant medications were not reported. No previous drug reactions or allergies were reported. On 01-NOV-2017, the patient was vaccinated with first dose of GARDASIL 9 and the second dose of GARDASIL 9 (0.5 ml) intramuscularly for prophylaxis (lot # N022728, expiry date: 31-MAY-2020), on 19-APR-2018 (inappropriate schedule of drug administration). No adverse effects reported. No product quality complaint involved.
Erythema, swelling at site 8 cm x 6 cm (L) deltoid BENADRYL prn - monitor f/u prn.
pt recv vax & later that same day, pt exp flushing, fever, diaphoresis, & fatigue;
Initial misuse report received from health care professional on 19 Aug 2013. This is an invalid case as no patient identifiers were reported. It was reported that on 1 Aug years not specified the temperature of ADACEL, MENACTRA, TUBERSOL, DAPTACEL, IPOL, PENTACEL, DT Pediatric, FLUZONE was 26F (Fahrenheit) leading to incorrect storage conditions of drugs. No adverse event was reported. List of documents held by sender: none.
Temp 100.8F; extreme fussiness/irritability; swelling of left leg; redness, swelling at injection site; knot in leg at injection site; decreased appetite; trouble sleeping.
Vaccine vial was punctured beyond 12 hours and was given to a total of 8 patients; Vaccine vial was punctured beyond 12 hours and was given to a total of 8 patients; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Vaccine vial was punctured beyond 12 hours and was given to a total of 8 patients) and POOR QUALITY PRODUCT ADMINISTERED (Vaccine vial was punctured beyond 12 hours and was given to a total of 8 patients) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 939902) for COVID-19 vaccination.     No Medical History information was reported.    In August 2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In August 2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Vaccine vial was punctured beyond 12 hours and was given to a total of 8 patients) and POOR QUALITY PRODUCT ADMINISTERED (Vaccine vial was punctured beyond 12 hours and was given to a total of 8 patients). In August 2021, EXPIRED PRODUCT ADMINISTERED (Vaccine vial was punctured beyond 12 hours and was given to a total of 8 patients) and POOR QUALITY PRODUCT ADMINISTERED (Vaccine vial was punctured beyond 12 hours and was given to a total of 8 patients) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication were reported.  The Moderna vaccine vial what was punctured at 9:07am on 17-Aug-2021. This vaccine vial was punctured beyond 12 hours and was given to a total of 8 patients for their 3rd dose. Some patients received it on 19-Aug-2021 between 01 pm and 09 pm. Some patients received it on 20-Aug-2021 between 02pm-07pm and two patients received it on 23-Aug-2021, which was 6 days after the vial was punctured. Pharmacist provided BTIN number: 00380777273983. Pharmacist asked what they should do. Agent forgot to obtain safety follow up consent, but pharmacist consented to follow up from Medical Affairs.  Treatment information was not provided.
MENQUADFI was administered after experiencing a temperature excursion that was not covered by the extended data with no reported adverse event; Initial information received on 05-Sep-2023 regarding an unsolicited valid non-serious case received from a other health professional.  This case is linked to case 2023SA272367(CLUSTER).  This case involves a 12 years old male patient who was administered MENINGOCOCCAL A-C-Y-W135 (T CONJ) VACCINE [MENQUADFI after experiencing a temperature excursion that was not covered by the extended data with no reported adverse event   The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included HPV VACCINE VLP RL1 4V (YEAST) (GARDASIL) for Immunisation; and DIPHTHERIA VACCINE TOXOID, PERTUSSIS VACCINE ACELLULAR, TETANUS VACCINE TOXOID (TDAP) for Prophylactic vaccination.  On 28-Aug-2023, the patient received 0.5 ml of suspect MENINGOCOCCAL A-C-Y-W135 (T CONJ) VACCINE, Solution for injection lot U7633AB, expiry- 25-APR-2028  via intramuscular route in the left arm for immunization (strength: unknown) menquadfi was administered after experiencing a temperature excursion that was not covered by the extended data with no reported adverse event (poor quality product administered) (latency same day).  Action taken: not applicable.  At time of reporting, the outcome was Unknown for the event poor quality product administered  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 the 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.
Pt vaccinated with DTP 2-3 days later seizures began, eyes tremor, body jerky motions. Seizures occur approx evry 2-3 days w/ 2-3 seizures per day.
Warm to touch on injection site, sore, and a lumpy feeling with pain to the touch.
Vaccine administered after more than 1 temperature excursion; Vaccine administered after more than 1 temperature excursion; This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine administered after more than 1 temperature excursion) and POOR QUALITY PRODUCT ADMINISTERED (Vaccine administered after more than 1 temperature excursion) in a 31-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031L20A) for COVID-19 vaccination.     No Medical History information was reported.    On 13-Feb-2021 at 3:47 PM, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On 13-Feb-2021 at 3:47 PM, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (Vaccine administered after more than 1 temperature excursion). In 2021, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine administered after more than 1 temperature excursion). At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine administered after more than 1 temperature excursion) and POOR QUALITY PRODUCT ADMINISTERED (Vaccine administered after more than 1 temperature excursion) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   The age of patient was provided as 31.99.  Concomitant products were not provided.  On 13-Feb-2021, Excursion time was 09 AM, temperature was 32, total doses given for the day was 152, condition of vaccine prior to administration was not frozen, vaccine was moved to fridge on 09-Feb-2021, vial was moved to clinic on 13-Jan-2021. 30 vials were sent to clinic. Vaccine BUD date was 10-Mar-2021.  The vials were only punctured right before administration and all doses were drawn from the vial due to high-pace clinic.  Temperature recordings were taken using a Fisher brand traceable temperature monitor at every hour.  After administration, the vial was returned to the freezer/refrigerator, or maintained at room temperature.  It was reported that the patient was administered with vaccines that experienced more than 1 temperature excursion during 33 weeks in 2021. The HCP explained that each time a vial was put into a cooler, there was a period of 1 hour or 1 and half hour approximately, when the temperature data logger registered 34 or 35 degree F.  Treatment medications were not reported.   This case was linked to MOD-2022-566976 (Patient Link).
Feverish, chills, headaches, nausea, dry mouth, and sleepiness the day after the Vaccine was taken.  Started out slowly late morning around 9am and got worse by the afternoon.  Took Motrin to relieve symptoms and slept.  The next day felt better but in the evening on 2/5/21 felt itchy starting from arms and neck.  Then after about 10 min of itchiness in that area and started itchiness down to my stomach and legs.  I took allergy medication prescribed by my physician: Cetirizine HCL 10mg tablet (1 tablet).  No issues after that. Had some issue with the itchiness from the first dose around the 3rd-5th day after the first vaccine was given.  Didn't take any allergy medications and had a tiny bit of dark circular spots on limps and torso but wasn't severe.  Thought that was from something I ate, or clothes detergent, etc. so shrugged it off.
The day after the flu shot (10/24/18), I developed extreme aches and exhaustion. These symptoms stayed until 10/27/18, when they abated following 13 hours of sleep. However, that same day (10/27/18), I developed extreme itchiness in my arms, legs, neck, and face (not trunk or hands and feet). I treated the itchiness with Eucerin lotion (thinking it was simple dry skin initially), and eventually with BENADRYL, but nothing helped. Because I was being followed for possible autoimmune disease, I saw the rheumatologist 10/31/18 to see if the itchiness might be a symptom related to autoimmune disease. There's no rash, so the doctor ordered liver and kidney labs, which turned out normal, and recommended I add ZANTAC to the BENADRYL to cover all of the histamine receptors. There has been no reduction in itching since adding in the ZANTAC. Because the itching came on suddenly, doesn't have a rash, and seems unrelated to anything else, the doctor's best guess is that it may be related to the flu shot I received the previous week. He mentioned that because there had been a progression of symptoms following the flu shot from aches to exhaustion to itching, maybe they were all related? I decided to complete this form in case other people are experiencing similar symptoms post-flu shot. I also hope that you may have some suggestions for relieving the itching, which is unrelenting so far.
Patient experienced seizure like activity a little over a week after his second dose.  He has no prior hx of seizures.  He woke up from a nap groaning and then vomited.  He became unresponsive with his eyes open and deviating to the right.  He vomited several more times and remained unresponsive.  He had no response to painful stimuli.  An ambulance was called and after about 20 mins from the onset he closed his eyes and appeared to be sleeping.  Upon arrival in the ED he woke up.  He was slow to respond, complained of a headache and  vomited 2 more times.  He was admitted overnight for observation and did not experience any further episodes.  Over the next 5 days he appeared hyperactive and clumsy and has since returned to his normal self.
Headache, Fever & NauseaVomiting dose 2-day1-2-arm pain; day 1-2-ha; fever; chills; nausea for 28 hrs after vaccine
Site: Itching at Injection Site-Mild, Systemic: Tingling (specify: facial area, extemities)-Mild, Additional Details: arm
Shivering began in legs and spread up to hands - didn't feel cold - couldn't move fingers - fingers turned blue - slipped and fell getting into bed; couldn't move; lasted 4-5 hrs
Arm a little sore below injection site. Mild start of a headache for two days but never kicked in. Weird taste in my mouth 2 hours after shot that only lasted 2 hours.
pt recv vax 8JUL98 & the next day pt devel a fever of 99-100;inj site was red, warm & had pain in arm;sx lasted 3 days;