chrisvoncsefalvay/vaers-outcomes huggingface dataset:
I experienced Shingles and was put on an anti-viral for 7 days and was diagnosed with pericarditis. I had to be put on  Mutlaq, Metoprolol, Eliquis, Prilosec, Indomethacin. The following Wednesday my heart went into A-Fib and went to the hospital (had to be media vac off the island and was taken to another hospital to perform a procedure TEE (shocked my heart heart). I stayed in the hospital for two days and had to go back to the hospital again because my heart went out of rhythm again and had to be shocked again.
thrombocytopenia; ITP; Petechia rash; Tiredness; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of THROMBOCYTOPENIA (thrombocytopenia) and IMMUNE THROMBOCYTOPENIA (ITP) in a 25-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Anxiety and Stomachache. Concomitant products included LAMOTRIGINE (LAMICTAL) for Anxiety, OMEPRAZOLE (PROTONIX [OMEPRAZOLE]) for Stomach discomfort.    On 28-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 12-Apr-2021, the patient experienced RASH (Petechia rash) and FATIGUE (Tiredness). On an unknown date, the patient experienced THROMBOCYTOPENIA (thrombocytopenia) (seriousness criteria hospitalization and medically significant) and IMMUNE THROMBOCYTOPENIA (ITP) (seriousness criteria hospitalization and medically significant). The patient was treated with IMMUNOGLOBULIN HUMAN NORMAL ongoing since an unknown date at a dose of 1 dosage form. At the time of the report, THROMBOCYTOPENIA (thrombocytopenia), IMMUNE THROMBOCYTOPENIA (ITP), RASH (Petechia rash) and FATIGUE (Tiredness) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No laboratory details was given.  Reportedly, the patient had to go to the hospital for a week and was still being monitored.  Treatment information was given as steroids   Most recent FOLLOW-UP information incorporated above includes: On 20-May-2021: Follow up information received on 20 May 2021 contain significant information includes updation of 2 more medically significant events and patient was hospitalized for the events too.; Sender's Comments: Very limited information regarding the events has been provided at this time.  Further information is not expected.
Severe pain in left arm, radiating down. Pain wakes her up at night. Doctor prescribed NSAID and Pain medication to help reduce pain. Possible nerve irritation. Pt has follow-up in three weeks.
Fever & rash began on 17JUL persisted for 3 days highest temp recorded ws 105 R seen by MD no other illness dx;
Vaccine administered that went under temperature excursion.; Vaccine administered that went under temperature excursion.; This spontaneous case was reported by a nurse and describes the occurrence of POOR QUALITY PRODUCT ADMINISTERED (Vaccine administered that went under temperature excursion.) and PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine administered that went under temperature excursion.) in a 56-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 065K21A) for COVID-19 prophylaxis.     The patient did not had an allergic reaction to polysorbate polyethylene glycol, or a previous dose of COVID-19 vaccine. The patient never had severe allergic reaction (anaphylaxis) to foods, pets, venom. environmental or oral medications. The patient did have a bleeding disorder, and was on a long-term aspirin therapy or taking other blood thinners. The patient never had Guillain-Barre Syndrome (a type of temporary sever muscle weakness) after receiving a vaccine. The patient never received any dermal fillers (Juvaderm, Restylane, etc) nor had a history of blood clots, nor had myocarditis or pericarditis, nor had heparin-induced thrombocytopenia(HIT), nor had Multisystem inflammatory syndrome known as MIS-C after a COVID-19 infection.  Concurrent medical conditions included Bleeding (on long-term aspirin therapy or taking other blood-thinners.).    On 15-Jun-2022, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. On 15-Jun-2022, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (Vaccine administered that went under temperature excursion.). On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine administered that went under temperature excursion.). At the time of the report, POOR QUALITY PRODUCT ADMINISTERED (Vaccine administered that went under temperature excursion.) and PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine administered that went under temperature excursion.) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Patient took the booster dose on 15-Jun-2022. No concomitant medications was reported. Patient did not have a fever on 15-Jun-2022 Reporter stated that the data logger was not set with correct parameters and excursion happened for 15 mins at the site +1.9 C. Storage condition at the time of the excursion: Refrigerator Maximum or minimum temperatures reached, as applicable: +1.9 C to +6.4C Excursion duration: 15 min Date vial moved from freezer to refrigerator: 08-Jun-2022 and 1 vial on 15-Jun-2022 Currently the vials kept in fridge (quarantined) Visual inspection noting any vaccine state change: Thawed Proposed desired use by date was reported as afternoon of the day of reporting. Number of doses/vials: 2 (1 punctured and 1 not punctured.) Date and time vial was first punctured: 15-Jun-2022 at 9.15 AM The vial was stored in a portable fridge post puncture. Was the vail exposed to room temperature for greater than 24 hours: All were in fridge. No treatment medications were provided.
Within 5 seconds of injection I immediately experienced a triggered fight/flight reaction with perspiration that turned into the feeling of shock, within an additional 5 seconds. Full event lasted less than 1 minute. Then, I began feeling acid reflux which intermittently continued through the next 24 hours. The reflux lessened within 36 hours. Pain began in upper abdomen under lowest ribs, also mid back, on both sides all the way around my upper torso . This has continued to date. Otherwise, I experienced similar commonly reported side effects such as  joint pain, fatigue, malaise, muscle pain, nausea and a slight, short fever occurred within 3 hours of the time of injection, lasting through the first 48 hours.
Sore arm, major body pain in all joints (required oxycodone), headache, weakness, extreme fatigue and couldn't get out of bed for 48 hours
Feverish, nausea, head ache, at arround 6 pm. Today started at noon.
Developed nausea approximately six hours after receiving vaccine.  At approximately 2230 I started feeling like I could not breathe, began wheezing and began vomiting violently.  The feeling of being unable to breathe and wheezing was becoming worse. I took benadryl and symptoms began to lessen.  An hour later I was still wheezing and took another dose of benadryl and wheezing subsided.
Chills about 9 PM 10/28 to 4 AM 10/29. Upset stomach 9 PM 10/28 to 4 AM 10/29. Frequent urination, every hour 10 PM 10/28 to 4 AM 10/29. Rash appeared, upper body 4 AM 10/29. Slept most of 10/29 during day.
Pt called 11/24/09 and stated she started with sweating, lightheadedness, dizziness on Saturday. No redness, warmth noted any feels better today, was just wondering if related to injection.
Information has been received from a pharmacist referring to a 11 year old patient of unknown gender. The patient's concomitant medication, pertinent medical history and drug reactions/allergies were not reported. On 02-JAN-2019, the patient was vaccinated with VAQTA 50/1.0 units per millilitre (U/ml) (lot # R022982, expiration date 09-AUG-2019; dose and frequency were not reported) intramuscularly for prophylaxis (inappropriate dose of drug administered and adult product administered to child). No adverse effect was reported.
Soreness; Vomiting; Fever; Became sick; This case was reported by a consumer and described the occurrence of pain in a 78-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   On 13th September 2019, the patient received the 2nd dose of Shingrix. On 13th September 2019, less than a day after receiving Shingrix, the patient experienced pain, vomiting, fever and sickness. On an unknown date, the outcome of the pain, vomiting, fever and sickness were unknown.   It was unknown if the reporter considered the pain, vomiting, fever and sickness to be related to Shingrix.  Additional details were provided as follows: The patient received Shingrix and experienced soreness and became sick with fever and vomiting on the same day as the vaccine was administered. The outcome of the events was unknown. The GSK employee who reported the event noted that the patient exercised in the gym regularly and appeared to be in good health. The GlaxoSmithKline employee would request the patient contact GlaxoSmithKline with additional information.
Information has been received from an office manager at a physician's office concerning "as many as" seven patients who in 2001 were vaccinated with pneumococcal vaccine 23 polyvalent. The patients experienced redness, swelling/edema and warmth at the injection sites and localized joint pain. No further details were provided. Unspecified medical attention was sought. Additional information has been requested.
I got severe body aches and rash in my hands; I got severe body aches and rash in my hands; I was feeling so sick; severe and explosive diarrhea; I could not sleep; This is a spontaneous report from a contactable consumer or other non-HCP (patient herself). A 29-years-old female patient received BNT162B2 (PFIZER BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot number-UNKNOWN) via an unspecified route of administration in left arm on 06Apr2021 10:15 as dose 1, single (at the age of 29 years-old) for COVID-19 immunization. The patient was not a pregnant at the time of vaccination. Patient relevant medical history reported as none. The patient had no know allergies. There were no concomitant medications. The patient experienced severe and explosive diarrhea, he could not sleep on 06Apr2021, he was feeling so sick on 11Apr2021, and patient got severe body aches and rash in my hands on an unspecified date. Vaccination facility type reported as hospital and the vaccination facility country are united states. Patient was not tested COVID-19 prior vaccination and tested COVID-19 post vaccination. The patient visited emergency room visit for the events severe and explosive diarrhea and could not sleep. The patient underwent lab tests and procedures which included blood test, urine tests and a stool test with test results came back normal on an unspecified date in 2021 and sars-cov-2 test (Nasal Swab, rapid test): negative on 11Apr2021. Therapeutic measures were taken as Imodium for severe and explosive diarrhea (diarrhoea). The clinical outcome of the event severe and explosive diarrhea was recovered on 13Apr2021, could not sleep be recovering while that of severe body aches and rash in my hands and feeling so sick was unknown.  Information about lot/batch number has been requested.
I had a headache, fatigue, body aches congestion. Something didn't feel right so I decided to use my home COVID-19 test that came back positive. I contacted my doctor online, I then had a virtual appointment, she prescribed Paxlovid that I started taking immediately. I feel much better, like myself.
FELT CRUMMY; DELTOID PAIN/ SORE DELTOID; This spontaneous report received from a patient concerned a 59 year old female. 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: unknown) dose was not reported, administered on 13-MAR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On 13-MAR-2021, the patient experienced felt crummy. On 13-MAR-2021, the patient experienced deltoid pain/ sore deltoid. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from felt crummy, and deltoid pain/ sore deltoid on 14-MAR-2021. This report was non-serious. This case, from the same reporter is linked to 20211047299.
Symptoms:  Fever of 106.5 F, chills, muscle and joint pain, skin sensitivity, headache.  Treatment:  Packed in ice packs for 30 minutes to an hour, and alternating Ibuprofen and Tylenol until fever reduced to 103.5 F.  Transported to local Emergency Room.  Doctor said high fever would have no adverse effects if caused by body's immune system, and patient must have gotten exposed to the flu to cause the fever, couldn't be the vaccine.
1/28 1st Pfizer > 1/29 Onset, dizziness, nausea, h/a, eye pressure, "heaviness" in legs, altered taste 2/3 Cough, mild congestion Seen in ER on 2/5 for evaluation of cough.  Reports 3 days of upper respiratory congestion, mild nonproductive cough.  Diffuse body aches.  Mild nausea associated with coughing, however no emesis.  Denies chest pain/abdominal pain.  ROS positive for: fatigue, congestion, cough, myalgias.
307pm - feels sick, double vision, nausea. 308pm - took 1 Benadryl 25mg. 319pm - dry heaves.  320pm - headache. 325pm - took another Benadryl 25mg. 330pm - dry heaves gone. 338pm - double vision improving. 339 pm - headache worsening. 345pm - double vision gone, nausea improving, still has headache. 415pm - still headache, but improved.
allergic reaction; A spontaneous report was received from pharmacist concerning a patient of unknown age and gender, who received Moderna's COVID-19 vaccine and experienced allergic reaction.   The patient's medical history was not reported. Concomitant product use was unknown by the reporter.    On an unknown date, the patient received their first of two planned doses of mRNA-1273 (Lot number: A25L20A) for prophylaxis of COVID-19 infection.   On an unknown date, the patient experienced allergic reaction. The patient did not have any previous history of allergic reactions. Treatment information was unknown.   Action taken with mRNA-1273 in response to the event was unknown.   The event outcome for the event allergic reaction was unknown.   The reporter did not provide an assessment for the event allergic reaction.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.
This case was reported by a consumer via call center representative and described the occurrence of injection site pain in a 71-year-old female patient who received SHINGRIX for prophylaxis.  Concurrent medical conditions included fibromyalgia. Concomitant products included denosumab (Prolia). In May 2018, the patient received the 1st dose of SHINGRIX (intramuscular) .5 ml. In May 2018, less than a month after receiving SHINGRIX, the patient experienced injection site pain, injection site warmth and injection site erythema. On an unknown date, the outcome of the injection site pain, injection site warmth and injection site erythema were recovered/resolved.  It was unknown if the reporter considered the injection site pain, injection site warmth and injection site erythema to be related to SHINGRIX. Additional details reported as follows: The age at vaccination was not reported, however it could be 70 or 71 years. The patient received vaccine in her left arm and experienced injection site reaction. Only partial information was provided.  The patient had to disconnect for an appointment. For tolerance after 2nd dose refer case US2018GSK147073.
J96.11 CHRONIC HYPOXEMIC RESPIRATORY FAILURE 2/28/2023 ESRD (END STAGE RENAL DISEASE)    ALCOHOLIC HEPATITIS J96.11 CHRONIC HYPOXEMIC RESPIRATORY FAILURE 2/28/2023 ALCOHOLIC HEPATITIS
Two days after he was given his shots he was acting different. He was screaming and lethargic. I took him to the hospital on October 4, 2003. He was given a cat scan and they said he had a subdural hematoma. He was also diagnosed with hydrocephalus. He was admitted to the hospital and watched until October 6, 2003. He then was seen by an eye doctor on the 7th and I was told he had retinal hemmoraging. He then was removed from my home because they said it was shaken baby syndrome. I am writing to you so that I can rule out that it was not his vaccine. Ihave two other children in the home and they were not taken. These other two are teens. If at all possible please email me if there might be a connection with the vaccine or if this is actually a case of child abuse. I am afraid for my baby he has never been hurt or sick except for one cold and one ear infection.  He was also administered a shot called preznar, but I could not find it on the list. Also I do not know where each individual shot was given but he had two in each leg. Hospital discharge summary states vomiting.
This spontaneous report was received from a physician refers to a 14 years old female patient with a history of one seizure as a child, who on 07-OCT-2011, 08-DEC-2011 and on 12-APR-2012, was vaccinated with the first, second and third dose of GARDASIL respectively (doses, routes and lot numbers not reported). No other co-suspects were reported. No concomitant medications were reported. The physician reported that about a month ago, in approximately July 2012, the patient developed unexplained alopecia after completion of the GARDASIL series. No treatment was given for the experience. No lab diagnostics studies were performed. At the time of the report, the patient had not recovered. The relatedness for the patient had developed unexplained alopecia after completion of the GARDASIL series was unknown for GARDASIL. This is one of several reports from the same source. Additional information has been requested.
This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a female patient of unknown age. Medical history, concurrent conditions, and concomitant medications were not provided. On or about 26-DEC-2013, at a pharmacy, the patient was inoculated with ZOSTAVAX, (by an unspecified healthcare professional) as recommended for routine adult health maintenance and for the prevention of shingles (dose, route of administration, site of administration and lot # were not provided). The vaccine did not prevent shingles as intended, but rather caused the patient to contract a persistent strain of herpes zoster. On or about 23-MAR-2015, the patient was treated at a hospital (by an unspecified healthcare professional) for the onset of a severe vesicular rash accompanied by weakened immune symptoms, which was diagnosed as severe herpes zoster. The female patient was prescribed acyclovir for management of her painful and persistent symptoms.  As a direct and proximate result of these malfunctions, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages. The outcome of the events was not recovered. The lawyer felt the events were related to ZOSTAVAX. Additional information has been requested.
Rash at injection site about the size of an orange...rash is all red.  Patient says the injection site is quite sore as well.  Injection was given on Thursday October 11th.
No adverse symptoms reported; the patient received an improperly stored dose of PROQUAD on 7/15/2020; This spontaneous report was received from a medical assistant and refers to a patient of unknown age and gender. No information regarding the patient's concurrent conditions, medical history, drug reactions or allergies and concomitant medications was provided.  On 15-JUL-2020, the patient was vaccinated with improperly stored dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) lot # S030206, expiration date reported as 24-MAR-2021, but upon internal validation established as 25-MAR-2021 (exact dose, dose number, vaccination site and route of administration were not provided) for prophylaxis. Other suspect therapies included sterile diluent.  Administered doses of vaccine was exposed to the temperature excursion of 10.3 degrees Fahrenheit for 46 minutes. There was previous temperature excursion, 52.1 degrees Fahrenheit for 3 hours. Digital Data Logger was involved. No adverse symptoms were reported.
pt started out w/a small fever on Wednesday noc, treated w/APAP q 4hr;By Thursday early afternoon it was rising to 103.5 w/in next hr it was up to 104.5;pt started vomiting & had a small sz then fine;taken to ER sz lasted over 1hr;
I had Hep A #1 and Hep B #1 yesterday about 6:30 pm and at 10 PM and started with vomiting and diarrhea.
COVID positive on 11/7/2021.  66-year-old female who presents to the emergency department secondary to productive cough.  She states she is due for chemotherapy on October 27, however October 28 had a fever, therefore did not undergo chemotherapy.  She has been having productive cough over the past week-and-half. She is currently not on any O2 and has not had any shortness of breath or chest pain. CXR negative for any consolidations, No indications for Decadron, Azithromycin given productive Cough, Albuterol Breathing RX, Lovenox 40mg Q 24hr. Discharged home.
Vasovagal episode for < 10 seconds, then vomited once and felt better.  Didn?t eat anything earlier. Ate crackers and juice and dad drove her home.
Large rash on injection site, approx 3" x 5", itchy left deltoid.
Pt was given 0.5 ml instead of 0.3 ml. pt states soreness in arm & headache the night of imz but said she thought it was normal. wasnt too concerned, I told her info I recieved from Pfizer, recommendations & that patients were given higher doses in trials with main adverse events being more pain at injection site than with 0.3 ml dose.
First night showed up as an approx 3 inch round rash on her thigh around the injection site. No other symptoms at the time. Second night (tonight) it has spread to around a 4 inch rash and it's now itchy.