chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Information has been received from parents concerning their daughter who in April 2008, was vaccinated with the first dose of GARDASIL (LOT# not reported). The parents reported that their daughter was a healthy, energetic, outgoing, active beautiful girl until the April 2008 when she was administered her first GARDASIL shot. From that day forward, her quality of life has drastically deteriorated. It started when the plunger of the syringe hit the bottom of the tube and she turned pale white, her eyes rolled back in her head; she twitched (as if she was having a seizure) and fainted. For the past two years, their daughter has been suffering debilitating stomach pain, severe migraine headaches, severe hair loss, severe dizziness, severe muscle & joint pain, severe fatigue & weakness, severe seizures & fainting, severe cystic acne and severe menstrual abnormalities, every single one of these painful changes in her life are severe, not mild or normal. The parents stated that they have made numerous trips to doctor's offices, specialists, alternative medicine practitioners, dermatologists and ER room. She has made numerous CT scans of the stomach and brain as well as many blood tests and general evaluations. All of these tests hadn't been able to determine the cause of her problems but they started when she was given the GARDASIL shot. Their daughter's life had greatly deteriorated over the past 2 years and continued to do so. On her good days she felt sick to her stomach, tired and didn't want to do anything but lay around. She was starting to demonstrate signs of depression; she didn't want to go visit with her friends anymore because of the constant pain. She was falling behind in her school work because she couldn't concentrate. Her acne was so bad and she was ashamed to go outside of the house. The parents stated that their daughter (who was an actress) had lost much of her confidence, due to the acne and constant pain, and wasn't able to audition with the same sparkle she once had. She was a very active girl who loved skiing, 4 wheeling and running with her dog in the mountains behind their house. But now, she couldn't enjoy these normal activities because of the muscle pain and joint stiffness. This got much worse when it's cold so she was confined to the house in order to withstand the pain. The patient writhed around on the floor holding her stomach and crying from the pain, or sitting on the couch rubbing her joints to ease the pain. She had to deal with this every day. At this time of reporting, the patient's outcome was unknown. Upon internal review, severe seizures was considered to be an other important medical event and debilitating stomach pain and, joint and muscle pain were considered to be disabling. Additional information has been requested.
Shivering, chills, fatigue, nausea started at 11:59 progressing into fever >100F at 9:00 AM the next day. Symptoms mitigated by alternating ibuprofen/acetaminophen, but fever came off and on inverse to chills; felt extremely warm when temperature spiked, felt extremely cold when temperature was normal. Above symptoms completely abated ~72 hours after injection.  Tingling sensation in lower backed started 24 hours after dose and persisted for 72 hours thereafter, sensation moved up to neck for another 48 hours afterwards.
Positive for COVID-19; coughing; running nose; symptoms worsened with fever of 99.1; soreness at injection site; mild body aches; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of COVID-19 (Positive for COVID-19), PAIN (mild body aches), COUGH (coughing), RHINORRHOEA (running nose) and PYREXIA (symptoms worsened with fever of 99.1) in an 84-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013A21H) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medical history reported.  Concomitant products included CALCIUM CARBONATE, COLECALCIFEROL (VITAMIN D 2000), IRON, ACETYLSALICYLIC ACID (ASPIRIN (E.C.)), APIXABAN (ELIQUIS), METFORMIN, LEVOTHYROXINE, ROSUVASTATIN, AMOXICILLIN TRIHYDRATE, CLARITHROMYCIN, ESOMEPRAZOLE MAGNESIUM (NEXIUM 1-2-3), HYDROCHLOROTHIAZIDE, VALSARTAN (VALSARTAN/HYDROCHLOROTHIAZIDE), DOCUSATE SODIUM (STOOL SOFTENER), CALCIUM, ASCORBIC ACID, ROSA CANINA FRUIT (VITAMIN C & ROSEHIP), METOPROLOL, POTASSIUM and ASCORBIC ACID, HESPERIDIN, LYSINE, VITIS VINIFERA SEED (VITROCAP) for an unknown indication.    On 03-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 03-Mar-2021, the patient experienced PAIN (mild body aches) and MYALGIA (soreness at injection site). On 11-Mar-2021, the patient experienced COUGH (coughing), RHINORRHOEA (running nose) and PYREXIA (symptoms worsened with fever of 99.1). On 12-Mar-2021, the patient experienced COVID-19 (Positive for COVID-19). The patient was treated with CARVEDILOL (CARVEDIOL) at an unspecified dose and frequency; QUERCETIN at an unspecified dose and frequency; IVERMECTIN at an unspecified dose and frequency; METHYLPREDNISOLONE (MEDROL DOSEPAK) at an unspecified dose and frequency; ZINC at an unspecified dose and frequency and PROBIOTIC 10 at an unspecified dose and frequency. On 15-Mar-2021, PYREXIA (symptoms worsened with fever of 99.1) had resolved. At the time of the report, COVID-19 (Positive for COVID-19), PAIN (mild body aches), COUGH (coughing), RHINORRHOEA (running nose) and MYALGIA (soreness at injection site) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 12-Mar-2021, COVID-19: (Positive) positive.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment details included Medrol dose pak, ivermectin, zinc, probiotic, quercetin.   Reporter did not allow further contact
Red inflammation near injection site (left upper arm). Hot, itchy and swollen. Approximately 30 hours after shot.
Day 1- Fatigue, bad headache, body aches, hot flashes, sweats, arm soreness, fatigue Day 2- Severe flu symptoms included nausea, diarrhea, headache, body aches, restlessness, insomnia, fever, severe arm, neck and shoulder pain, sweats, fatigue Day 3- Nausea, loose stools, bloating, gas, headache, body aches, burning eyes, vertigo, fatigue, insomnia, anxiousness
PATIENT BEGAN ITCHING ALL OVER HER BODY SINCE 12/1/09 AND HAS CONTINUED.  NO RASH SEEN, ONLY ITCHING.
headache; felt like run over by a diesel, she could not walk, she was not feeling well; This spontaneous case was reported by a consumer and describes the occurrence of MALAISE (felt like run over by a diesel, she could not walk, she was not feeling well) and HEADACHE (headache) in a 65-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011A21A) for COVID-19 vaccination.     The patient's past medical history included No adverse event (NO HISTORICAL CONDITION REPORTED.).    On 22-Feb-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) at an unspecified dose. On 22-Feb-2021, the patient experienced MALAISE (felt like run over by a diesel, she could not walk, she was not feeling well). On 05-Mar-2021, the patient experienced HEADACHE (headache). On 24-Feb-2021, MALAISE (felt like run over by a diesel, she could not walk, she was not feeling well) had resolved. At the time of the report, HEADACHE (headache) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) was unknown.       No concomitant medication were reported.  No treatment medication were provided.   Reporter did not allow further contact
Started having itching within a few hours after vaccine administration that progressed to hives and difficulty breathing within 16-24 hours. Treated with EPIPEN and diphenhydramine at that time with a 10 day course of steroids. She states she has received the flu vaccine in previous years with no difficulty.
Herpes Zoster Ophthalmicus was diagnosed on 6/22 after receiving the shingrix vaccine on 6/16.  She actually was at her eye dr for a follow up for something else when it was diagnosed.  She did have some grittiness in her eye.
Got break through cases; This spontaneous case was reported by a consumer and describes the occurrence of BREAKTHROUGH COVID-19 (Got break through cases) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis.     No Medical History information was reported.   On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced BREAKTHROUGH COVID-19 (Got break through cases). At the time of the report, BREAKTHROUGH COVID-19 (Got break through cases) outcome was unknown. Not Provided          No concomitant medications were reported.   No treatment medication was 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.  Company comment: This spontaneous case concerns a male patient of unknown age with no medical history reported, who experienced the adverse event of special interest of breakthrough COVID-19 an unknown time after a dose of mRNA-1273. Information regarding vaccine schedule, clinical evaluation, diagnostic tests, and treatment provided has not been disclosed. Outcome was unknown. The benefit-risk relationship of mRNA-1273 is not affected by this report.; Sender's Comments: This spontaneous case concerns a male patient of unknown age with no medical history reported, who experienced the adverse event of special interest of breakthrough COVID-19 an unknown time after a dose of mRNA-1273. Information regarding vaccine schedule, clinical evaluation, diagnostic tests, and treatment provided has not been disclosed. Outcome was unknown. The benefit-risk relationship of mRNA-1273 is not affected by this report.
fell, stay in the ICU for 2 days; hit head, stay in the ICU for 2 days; episodes of passing out; nausea; dizziness; This case was reported by a consumer via call center representative and described the occurrence of fall in a male patient who received Herpes zoster (Shingrix) for prophylaxis.   On 19th May 2022, the patient received the 1st dose of Shingrix. On an unknown date, less than 3 months after receiving Shingrix, the patient experienced fall (serious criteria hospitalization), head injury (serious criteria hospitalization), passed out (serious criteria hospitalization and GSK medically significant), nausea and dizziness. On an unknown date, the outcome of the fall, head injury, passed out, nausea and dizziness were not recovered/not resolved.   It was unknown if the reporter considered the fall, head injury, passed out, nausea and dizziness to be related to Shingrix.     Additional Information: GSK Receipt Date: 27-SEP-2022 Reporter's Comments: The patient self-reported this case. The patient received 2 doses of Shingrix. He received his first dose on 19th May 2022 and his second dose on 15th September 2022. He stated that after his first dose, he experienced dizziness, nausea, and episodes of passing out. He also stated that he fell and hit his head on the concrete which resulted in having to stay in the ICU (Intensive Care Unit) for 2 days. He was admitted to the hospital on 16th August 2022 The symptoms were not resolved.  The reporter did not consent to follow-up.
After vax began feeling  pain. Extreme soreness. Cant raise  up to shoulders length and cannot lift over 15 lbs
11/29/21 presents to EC ED for "shortness of breath, chills, fatigue, and cough". PMHx of "coronary artery disease, asthma, COPD, diabetes mellitus type 2, GERD, hypercholesterolemia, hypertension, morbid obesity, OSA, TIA, lumbar radiculopathy".
Breakthrough COVID-19 case. Symptom onset 7/17/2021:  Fever >100.4,  Subjective fever (felt feverish), Chills,  Runny nose/Congestion,  Cough (new onset or worsening of chronic cough),  Fatigue or tiredness,  Headache,  Diarrhea (>/=3 loose/looser stools in 24 hr period). Still symptomatic as of 7/28/2021. Hospitalized from 7/26/2021-7/27/2021.
Wheezing; cough; similar symptoms to a cold but more attributed to asthma. Prednisone to treat - two week course - I had saw two different doctors and they gave me two different dosages. The first one was two pills a day for five days. The second was six pills for seven days and then tapered off. Codeine with cough syrup and Singulair, as well, to treat. It's been two weeks and I'm just now hearing my voice kind of get back to my normal tone. Still having symptoms but milder.
passed out; fingers were tingling on both hands; very hot and sweating; breathing was labored; very hot and sweating; This is a spontaneous report received from a contactable consumer (patient) . A 45-years-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE) dose 1 via an unspecified route of administration, administered in Arm Left on 27Mar2021 (Batch/Lot Number: EP7533) as single dose (at the age of 45 years old) for covid-19 immunisation.  The patient medical history was not reported. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Concomitant medication(s) included magnesium citrate taken for an unspecified indication, start and stop date were not reported.  It was reported that about five minutes after the shot, the patient passed out in the observation area. When he awoke, his fingers were tingling on both hands, a was very hot and sweating, and his breathing was labored. Events onset date was 27Mar2021. The patient received lactated ringers as treatment. The outcome of the reported events was recovered. Since the vaccination, the patient has not been tested for COVID-19.
Patient describes feeling dizzy, having visual trouble immediately receiving the vaccine, then slid onto the floor from the chair he was sitting on. Presents with mother who denies him hitting his head. LOC lasted 1-2 minutes before he was able to be roused. Upon regaining consciousness, he was pale, diaphoretic, weak. Reports feeling nervous with "needles". Observed for 30 minutes with mother. Escorted to car afterward and permitted to go home. Advised to seek medical attention if symptoms persist.
he was diagnosed with shingles 3 days later; This spontaneous case was reported by a consumer and describes the occurrence of HERPES ZOSTER (he was diagnosed with shingles 3 days later) in a 30-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    In February 2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced HERPES ZOSTER (he was diagnosed with shingles 3 days later). At the time of the report, HERPES ZOSTER (he was diagnosed with shingles 3 days later) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Reporter's coworker was diagnosed with shingles. No concomitant medications were reported. No treatment details were reported.   This case was linked to MOD-2021-209808 (Patient Link).
Patient presented with back pain for 2 weeks, with fall prior to arrival. Patient had evidence of discitis and UTI on admission. ID felt that the seeding of the discitis was related to cholangitis from recent cholecystectomy. Treated with IV antibiotics with plan for 6 weeks duration and discharged to SNF. Patient had significant pain treated with Percocet and Dilaudid with dramatic but incomplete esolution of pain. Per EAU, hospitalizations are to be reported irrespective of attribution to the vaccine
RED, RAISED, TENDER, SWOLLEN, WARM AREA APPROXIMATELY 2" ACROSS AT INJECTION SITE.  REDDENED, WARM AREA EXTENDS BEYOND SWOLLEN AREA-ENTIRE UPPER ARM IS RED, SWOLLEN.
DIED TWO DAYS AFTER TAKING VACCINE; This spontaneous report received from a consumer via social media via a company representative 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 (dose number in series1)(suspension for injection, route of admin were not reported, batch number: unknown, expiry: unknown) dose,1 total, administered ,start therapy date were not reported for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported.  On an unspecified date, the patient died two days after vaccine was taken due to unknown cause. It was unspecified if an autopsy was performed. The reporter stated, "My uncle died two days after taking your VAX(vaccine)" The action taken with covid-19 vaccine ad26.cov2.s was not applicable. This report was serious (Death).; Sender's Comments: V0 20211263315-COVID-19 VACCINE AD26.COV2.S- died two days after taking vaccine. This event(s) is considered unassessable. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s).; Reported Cause(s) of Death: UNKNOWN CAUSE OF DEATH
left arm was very sore; left sided facial numbness; left side of face was very sore; This case was reported by a other health professional via call center representative and described the occurrence of pain in arm in a 65-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, less than a week after receiving Shingrix, the patient experienced pain in arm, numbness facial and facial pain. On an unknown date, the outcome of the pain in arm, numbness facial and facial pain were recovered/resolved.   It was unknown if the reporter considered the pain in arm, numbness facial and facial pain to be related to Shingrix.     Additional Information: GSK receipt date: 23-FEB-2023 Reporter comment: The medical assistant stating that a patient came to the office and reported that after he got the first Shingrix vaccine in left arm a few weeks ago, he had left sided facial numbness a few hours later that lasted until the following morning.   The patient also reported that the next morning the left side of his face and his left arm were very sore and that lasted for a few days.   All of his symptoms had resolved. The reporter consented to follow up.
High Blood Pressure (up to 149/104), Increased Heart Rate (up to 114), Headache, Stomach discomfort and ache (bad GI issues), Tiredness, Pain and Swelling at injection arm, Extreme Muscle Pain, Chills, Fever, Nausea. Unable to focus and brain felt like fog or unclear, limited daily activities, unable to drive, cook, clean, work, do college work (online classes). Feeling of sadness, anxiety, Steep disorder (only slept for up to 3 hours at night), unclear thoughts, Depression. With arm, shoulder, chest and back inflammation I felt tightness in my throat and had bad burning sensation breathing. Today, still having having symptoms that limits me from functioning at full capacity.
shingles; Information has been received from a lawyer regarding a case in litigation concerning a female patient of unknown age. No information was received regarding the patient's past medical history, concurrent conditions, or concomitant medication.   On 13-NOV-2009 the patient was vaccinated with zoster vaccine live(ZOSTAVAX) (dose, route, lot# and expiration date were unknown) for the long-term prevention of shingles and/or zoster-related conditions (for prophylaxis). Subsequent to inoculation, the patient was treated for shingles.  As a direct and proximate result of patient's use of the zoster vaccine live(ZOSTAVAX) vaccine, patient has and will continue suffer ongoing injuries, including but not limited to: mental and physical pain and suffering; medical care and treatment for these injuries; significant medical and related expenses as a result of these injuries, including but not limited to medical losses and costs include care for hospitalization, physician care, monitoring, treatment, medications, and supplies; diminished capacity for the enjoyment of life; diminished quality of life; increased risk of premature death, aggravation of preexisting conditions and activation of latent conditions; and other losses and damages; and will continue to suffer such losses, and damages in the future.
Developed pain, swelling and redness at site of injection the following day.  This progressed to the point that child required an ER visit due to pain.  Patient has history of hemophilia so there was some concern that this was a muscle bleed, but his hematologist did not think that it was.  On 5 days after the injection, when I saw the patient, his entire upper arm had an erythematous almost ecchymotic appearance with several blister-like lesions.
okay on day 1.  2nd day sore and tired, 3rd day fatique and tired, 4th day hot flashes, dizzy, light headed, 5th day-migraine and achy.
An improperly stored dose of PEDVAX was administered to the patient; No adverse effects; This spontaneous report was received from a medical assistant referring to a patient of unknown age and gender. The patients' pertinent medical history, concurrent conditions, drug reactions, allergies and concomitant medications were not reported.   On an unknown date, the patient was vaccinated with improperly stored haemophilus b conjugate vaccine (meningococcal protein conjugate)(LIQUID PEDVAXHIB) for prophylaxis, lot # N024570 and expiration date 01-MAY-2020 (strength, dose, frequency and route of administration were not reported). No adverse effects were reported.   The temperature of excursion was reported as below 36°F to 32.1°F during a time frame of 8 hours. There was no previous temperature of excursion reported.   A Digital Data Logger was involved.
Nose Bleed; This is a spontaneous report from a contactable consumer (patient, self-reported).  A 24-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTEC COVID-19 mRNA VACCINE, Solution for injection, lot number and expiry date were not reported), via an unspecified route of administration, on an unspecified date, as DOSE 1, SINGLE for COVID-19 immunization. The patient medical history and concomitant medications were not reported. The patient stated that an hour after her first shot of the Pfizer Covid 19 vaccine, she experienced nosebleed on an unspecified date. She did go to an ER to get her blood tested and was told that everything looks normal and stated that she is unsure if her nose bleed is just a coincidence since the weather was hot. She spoke to her doctor already about this and referred her still to Pfizer and asking if she could take her second dose of the vaccine. The patient did not know the name of the doctor as it was only a triage doctor and asking if she could only take the first shot of the vaccine. The AE resulted in Emergency room. The lab test and procedure included blood test: everything look normal on unspecified date. Outcome of the event was unknown.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
pt recv vax 15OCT97 & it was red & hot spot as big as a coffee cup, it hurt, has a hard spot & APAP;h/a;hard spots that hurts;