chrisvoncsefalvay/vaers-outcomes huggingface dataset:
1. First: Rash between breasts appears that evening. It is very very itchy and red. There are five raised hives which are white and dime-sized. They appear almost to have a pinhead sized pus in them. At the 36 hr mark, it remains the same in discomfort, but there are more hives and it has spread out by three inches across the chest and is halfway up to the neck. The rash does not improve or spread further and remains the same at the 4.5 day mark today.   2. Around day 1.5 or 2, a mucusy film fills throat making it necessary to constantly clear my throat in an almost violent way order to feel comfortable. It feels like there is lots of post nasal drip in my throat, however, I have completely clear sinuses. Sometimes this means coughing though I would not say I have a cough.   3. I need to use my inhailer in my car on Sunday, day 3.5 to breathe deeply. This is very unusual. I have shortness of breath and deep wheezing more than usual.   4. Day 3, I realize I am very very tired, which I had though was just because I have been busy, but with alight myalgias starting, now recognize that the fatigue is abnormal. I feel like if I let my eyes close at 3pm, which they feel like doing, I would fall asleep. This continues day 4. Ironically, I have trouble sleeping. ..  5. Day 4.5, Myalgias, see above. And skin also feels fender in spots. ..  6. Today started a general unease, day 4,. I had this with Covid. It is hard to explain. The feeling of just "bad" -- an experience I have only ever had with Covid. Like a dread mixed with a fear with a stomach bug. Maybe that helps.   7. Day 2 on -- Headache off and on. A tension headache.  Could be from not getting enough sleep but it was persistent throughout the day yesterday and today.
BP decrease. No LOC. 10:35, 108/72; 10:40, 92/58; 10:45, 80/52; 10:46, 88/54; 10:56, 90/62
flu; Initial information received on 12-Dec-2022 regarding an unsolicited valid serious case received via Social Media from a consumer/non-health-care professional.  This case involves an unknown age and unknown gender patient who experienced flu while receiving vaccine influenza vaccine.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  On an unknown date, the patient received a dose of suspect influenza vaccine produced by unknown manufacturer(site, route, form, strength, lot number, expiry date: not reported) for prophylactic vaccination.  On an unknown date the patient developed a serious event of flu (influenza) (latency: unknown) following the administration of influenza vaccine.  Action taken with influenza vaccine was not applicable.  It was not reported if the patient received a corrective treatment for the event.  At time of reporting, the outcome was Unknown for the event.  Seriousness criteria: The patient was hospitalized for this event.; Sender's Comments: Sanofi company comment dated 15-Dec-2022: This case involves an unknown age and unknown gender patient who experienced flu while receiving vaccine influenza vaccine. Furthermore, information regarding condition at the time of vaccination, medical history, lab data excluding other predisposing etiologies, intervention (if any), corrective treatment/medical management would be needed for complete assessment of the case. Based upon the reported information, the role of an individual vaccine cannot be assessed.
Rapid heart rate over 200 beats per minute and the duration is 2 minutes and I have to hold my breath or practice a bowel movement in order to stop the this from happening. It lasted from vaccination date through summer 2021.
Pt complained of dizziness, racing heart rate, face swelling/numbness and throat tightness. Zyrtec 10mg  given. MD recommended epinephrine injection. Patient refused. EMT called to bedside for EKG. MD recommends transfer via ambulance to ER. Patient declined after thorough education of importance of going to ER. Patient declined and signed to leave Against Medical Advise.
Client recieved booster shot on 2/7/22. Information was taken from his vaccination card, Upon looking in system it was discovered that he had a booster shot previous to this one on 12/9/21 at another facility. Contacted client on 2/10/22  @  2:00 pm by telephone. He reported that he didn't  know he had been given a booster at the other facility. He denied adverse effects at the time and presently.
Blood Pressure is still "bouncing around" while on Lenvima; it's really knocked me out, it hit me like a ton of bricks, I had aches & pains, & fatigue; it's really knocked me out, it hit me like a ton of bricks, I had aches & pains, & fatigue; This is a spontaneous report from a contactable consumer or other non hcp. A female patient of an unspecified age received bnt162b2 (BNT162B2), dose 2 via an unspecified route of administration on 22Feb2021 (Batch/Lot number was not reported) as SINGLE DOSE for covid-19 immunisation; lenvatinib mesilate (LENVIMA), via an unspecified route of administration from 15Feb2021 (Batch/Lot number was not reported) to an unspecified date, at 20 mg, daily for uterine cancer. Medical History: "Diagnosis/ICD code: C55 Carcinosarcoma of uterus, arthritis prior to Lenvima. Concomitant medication(s) included pembrolizumab (KEYTRUDA) taken for an unspecified indication, start and stop date were not reported. Patient began Lenvima therapy on 15Feb2021, currently taking 20 milligrams daily, along with Keytruda. Patient reported she received her second "COVID vaccine" yesterday (22Feb2021), and reported "it's really knocked me out, it hit me like a ton of bricks, I had aches & pains, & fatigue" that all began last night (22Feb2021). Patient reported "I've been feeling good" while on Lenvima, and stated she thinks the symptoms were all from the vaccine. Cause was not related to Lenvima, but event occurred while on Lenvima. Advised Patient to notify & follow up with Health Care Provider. (Exact Event Onset Date was unknown, & Event end Date unknown) Patient reported her Blood Pressure is still "bouncing around" while on Lenvima. Cause thought to be related to Lenvima. Advised Patient to notify and follow up with Health Care Provider. Outcome of the events was unknown.  Follow-up attempts completed. No further information expected.
Had generalized vesicular varicella-like rash on 3/19/03. Had varicella vaccine on 3/4/03. Resolving on 3/24/03.
Injection site slight red and swollen for a day; Injection site slight red and swollen for a day; my taste was bitter. Then for the next 30 hours everything smelled and tasted like spoiled or rotting meat.  Even water tasted rotten.; everything smelled and tasted like spoiled or rotting meat.  Even water tasted rotten.; taste was bitter; This is a spontaneous report from a contactable Nurse (patient).  This 47-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot # EK9231), on 07Jan2021 at 10:00 AM in right arm at single dose for COVID-19 immunisation. Age at vaccination was 47-years-old. Historical vaccine included the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot # EH9899), on 17Dec2020 at 02:00 PM in left arm (age of vaccination was 46-years-old). Medical history included hypothyroidism. Known allergies included metoclopramide (REGLAN) and tramadol hydrochloride (ULTRAM). Concomitant medications were unknown. The patient was vaccinated at hospital. No other vaccine was received in four weeks.  The second injection was given in the AM. By the afternoon on 07Jan2021 at 04:00 PM noted that her taste was bitter. Then for the next 30 hours everything smelled and tasted like spoiled or rotting meat. Even water tasted rotten. No fever or chills. Injection site slight red and swollen for a day, no joint pain, no body pain. Outcome was recovering. No treatment was received for the events.
Patient came in to receive vaccine. Nurse did not notice that there was a yellow bar on the screen and administered vaccine, once the nurse went to hit administer a notification came up to say that it was too soon for them to receive the vaccine. Upon investigation it was realized that the patient had already received two vaccines previously making this one the third in the series. When asked the patient stated that he had received the first vaccine and he had spoken to someone at database that stated he needed to recomplete the series since he missed his scheduled follow up date. This RN called Dr. with infectious disease who stated there should not be any harm or adverse reactions to the patient and to document appropriately. Did inform patient of the error and to monitor for symptoms. Also created a new vaccine record card to reflect the actual administered vaccines and their dates and lots.
This spontaneous report as received from a pharmacist refers to a patient of unknown age and gender. No concurrent condition, medical history or allergy/drug reactions were reported. On 25-NOV-2015 05:58, the patient was vaccinated with improperly stored RECOMBIVAX HB with lot number: L016427, expiry date: 13-APR-2017 (dose and strength unspecified). No concomitant medications were reported. No adverse effects were reported. The high temperature and low temperature were 5.3 and -5.5 (6 hours 47 mins) respectively. There were no product quality complaints (PQC) involved. No additional information was provided. This is one of the several reports from the same reporter. Additional information has been requested.
Pt states day of 06/24/2021 after vaccination about 8:30 experiencing hot flashes, sweating, fatigued, loose stool, numbness in the leg, swollen feet tenderness. 06/25/2021 morning bloody stool, low appetite, very fatigued. States Monday 06/28/2021 plans to make an appt. with Primary.
Moments after the injection, I was experiencing a cold sensation in base of back of head. Has been happening randomly since the day of vaccination. Also after soreness in arm subsided, pink and ring finger will go numb several times through the the day.
Patient was seen at clinic on the morning of 11/17/16 and was ordered a regular flu vaccine and PCV13. However, he received a high dose flu vaccine. Patient and spouse called primary care clinic around 2:30PM to report a reaction to the flu vaccine including bloodshot eyes, sore throat, and other symptoms included above. He confirmed that he had had a reaction two years ago to the high dose vaccine. He was advised to go to the ER, but he stated that he felt okay and did not need to go. Symptoms had subsided in the afternoon.
Severe muscular pain in my left arm, swelling, itching, chills, 99.7 temperature, tiredness. I have been taking Aleve to mitigate the pain.
1 dose of Gardasil 9 given to a patient during a vaccine excursion; Information has been received from a vaccine coordinator referring to a 16 years old patient of unknown gender. The patient's concomitant medication, pertinent medical history, drug reactions or allergies were not provided.      On 28-OCT-2020, the patient was vaccinated with a dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) (lot # R029117, expiration date 10-JUL-2021, 0.5 milliliter; route was not reported) for prophylaxis. The vaccine was during a temperature excursion and was found supported after (incorrect product storage). The storage temperature of the vaccine was 0.7 degree Celsius for a time frame of 2 hours and 47 minutes. There was no previous temperature excursion. The call was not because of a data logger. combinationproductreport: Yes; brandname: GARDASIL 9 SYRINGE (DEVICE); commondevicename: HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast); productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp & Dohme Corp. ; devicelotnumber: R029117; expirationdate: 10-JUL-2021; deviceage and unit: 0 ; malfunction: Unknown; deviceusage: Initial; evaluatedbymfr: Not returned to manufacturer; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not meet the criteria for Reportability
12 inch rash on upper arm centering injection site. Lasting almost 3 weeks. Rash was warm to touch, slightly swollen and itchy.   Moderate swelling of roof of mouth, gums and throat with mild blistering on roof of mouth and throat. Lasting almost 3 weeks. No associated fever. Negative covid test results. Did start antibiotics for throat on 9/5/21. This did not resolve swelling or rash/blisters in mouth/ throat. It seemed to clear up significantly by 9/27/2021.   Diarrhea days 2-5 after vaccine.
I EXPECTED HAD ARM PAIN, REDNESS, SWELLING AND FATIGUE.  I ALSO HAD SHORTNESS OF BREATH, "BRAIN FOG," MILD PAIN IN UPPER MIDDLE CHEST AREA WHILE BREATHING, ELEVATED HEART RATE
pt recv vax 26JUL95 & 11FEB98 pt devel a few varicella lesions, no fever;
4 days after vaccination, patient woke up with severe chest pain, radiating to L arm. Presented to ED where he was found to have elevated troponins. Cardiac cath normal. Echocardiogram normal. Cardiac MRI with evidence of Myocarditis. COVID testing at the time of chest pain NEGATIVE.
Expired vaccine given.  No treatment. No need for revaccination. As per call to Merck these are supported through 6 mos after the date of expiration.  Potency remains unchanged.
Received vaccine and refused to stay in observation area.  Developed Tingling in throat and tightness in facial area drove back around building to entry point and sent to medical observation area. Wife and children present. No hives, rash, respiratory impact.  VS 118/76 88 bpm, 98% Room Air, No external symptoms of reaction.  Symptoms resolving over observation period of 45 minutes. Vital signs continued to be stable.  Talkative and no distress noted.  Medical Director MD consulted by phone and patient released. May return for second dose with a 30 minute to 1 hour observation period.
Have a soreness in the armpit of my left arm as well as a small lump  at the base of my neck on the left side.  I had the same type of reaction 40 years ago to a Tetanus vaccination.
getting hives on body ever since got the vaccine; This spontaneous case was reported by a pharmacist and describes the occurrence of URTICARIA (getting hives on body ever since got the vaccine) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced URTICARIA (getting hives on body ever since got the vaccine). At the time of the report, URTICARIA (getting hives on body ever since got the vaccine) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant drug details were reported. No treatment details were reported.
10/4/2022  Reported to Public Health today.  He flew to state on a trip arrived on 4/28/2021.  Became weak and tired on 4/29 or 4/30/2021.  Went to an urgent care there and they did a "complete" workup and found nothing.   Upon return he went to see his primary care person and a second work up was done on 5/25/2021  He tells me he had a high white count and low HGB.
generalized rash on arms, chest, back, abdo upper thighs w/severe itching resulting in vs to MD on 10JUL93; rash & itching persisted despite starting Medrol pak, came to ER on 12JUL93 for further eval;
Patient was diagnosed with OM & Bell's palsy on 2/24/12 at ER.
recvd vax & w/in 10 mins began anaphylactic reaction; dizziness hard to breath, sore throat; adm to ER for visual inspection of throat; 02 steroids, blood gases & was adm for observation;
Child awoke with redness and swelling to left arm. Mom gave Ibuprofen. Later at school, her temp had risen and the school nurse recommended she be brought in to the clinic. Her temp here is 101 and the redness and swelling is approx. half dollar sized. She was very anxious.
a patient was given an expired dose of Adacel with no AE; Initial information received on 22-Oct-2020 regarding an unsolicited valid non-serious case received from the other health care professional.  This case involves a 16 years old female patient who received 0.5 mL an expired dose of DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE [ADACEL] Single-dose vial (lot number: C5519BA, expiry date: 12-Sep-2020) via intramuscular route in the right arm on 21-Oct-2020 for prophylactic vaccination (expired product administered).  The patient's medical history, medical treatments, vaccinations and family history were not provided.  Concomitant medications included MEASLES VACCINE, MUMPS VACCINE, RUBELLA VACCINE (MMR).  It was a case of an actual medication error due to the expired vaccine used (latency same day).  At the time of report, no adverse event was reported.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
covid symptoms SOB > 14 days after vaccine ( 4/21/21) covid test positive
Treatment of COVID-19; Treatment of COVID-19; Moderna: Dose Number: 6/Pfizer / BioNTech: Dose Number: 5; This is a spontaneous report received from a contactable reporter(s) (Physician). The reporter is the patient.  A 75-year-old male patient received bnt162b2, bnt162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 15Sep2022 at 14:00 as dose 5 (booster), single (Lot number: GH9694) at the age of 74 years, in left arm for covid-19 immunisation; elasomeran (MODERNA COVID-19 VACCINE), on 31May2023 at 15:00 as dose 6 (booster), single (Lot number: AS7185B), in left arm for covid-19 immunisation; covid-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown), as dose 3 (booster), single (Batch/Lot number: unknown) and as dose 4 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "HTN" (unspecified if ongoing). The patient's concomitant medications were not reported. No known allergies. The following information was reported: INTERCHANGE OF VACCINE PRODUCTS (medically significant) with onset 31May2023 at 15:00, outcome "not recovered", described as "Moderna: Dose Number: 6/Pfizer / BioNTech: Dose Number: 5"; DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "Treatment of COVID-19". Therapeutic measures were taken as a result of drug ineffective, COVID-19 which included Paxlovid from 29Aug2023 to 04Sep2023.; Sender's Comments: Based on available information, a lack of efficacy under interchange of vaccine products with the suspect vaccine BNT162B2 in this patient cannot be completely excluded.
Information has been received from a lawyer regarding a case in litigation concerning a male patient of unknown age. No information was received regarding the patient's past medical history, concurrent conditions, or concomitant medication. On an unknown date in 2008, the patient was inoculated with the ZOSTAVAX (lot number, dosage and route of administration not provided), as recommended for routine adult health maintenance and for the long-term prevention of shingles. The ZOSTAVAX) did not prevent shingles as intended, and the patient subsequently contracted a persistent strain of herpes zoster or shingles. On or about 26-AUG-2014, the patient was treated by a physician for the onset of a vesicular rash, which was diagnosed as severe shingles. The patient was prescribed valacyclovir hydrochloride (VALTREX) and hydrocodone for management of his painful symptoms and excruciating pain. 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.
Information was received in a published literature article. This case concerns to a 72-year-old male patient, who had a history of well controlled type 2 diabetes mellitus on insulin, hypertension, stage 3 chronic kidney disease, oxygen dependent chronic obstructive pulmonary disease, a recent history of stage 1a adenocarcinoma of the lung surgically resected in January 2013, and current tobacco use. He has a history of hepatitis C virus and had been successfully treated with interferon and ribavirin alone. He had a distant history of heroin abuse and had been stable on methadone assisted treatment since the early 1990s. The patient continued care with frequently rescheduled or missed visits, he was determined in April 2014 to have an undetectable hepatitis B virus (HBV) DNA level. The patient was found to be not immune. In July 2014, the patient received the first dose and again in November 2015, the patient received the second dose of Hepatitis B Vaccine (Recombinant) (manufacturer unknown), (lot number, expiration date, dose, anatomical location and route were not reported), for prophylaxis. Between 2013 and 2015, his HIV RNA level ranged from 210 to 3539 copies/ml and his CD4+ absolute cell count was between 772 and 1425 cells/ml. He was offered antiretroviral therapy (ART) multiple times and declined because of his multiple other health conditions and already extensive pill burden. He received a surveillance chest CT in February 2015 which showed no recurrence of his lung cancer.
Lips and lower face started tingling then swelling - (no difficulty breathing - no injection site reaction) - occurred approx. 30 min. after injection.
Swelling of knees and ankles the day after vaccine administration, waxing and waning in severity throughout the day
anxiety attacked .. black out..  hypotension .. profusive sweating, pale, patient said can't talk but talking mentioned had headache through the back of his head...
After H1N1 vaccine given in left deltoid patient stood up and said he tasted something funny. He said I feel like I can't breathe and said Im not kidding I feel like its' getting tight. I grabbed the epipen and prepared to give it. Patient put out his hand to block me and said wait, its getting better. It lasted about 10-15 seconds. 911 came and took pt to the hospital. Pt was stable and in no distress. Tongues swelling had subsided. Called patient later and he had been released from ER and they did not dx him as having reaction to vaccine.
The shot made patient sick; Initial information received on 30-Nov-2020 regarding an unsolicited valid non-serious case from a consumer (patient) via social media.  This case involves a patient of an unknown demography for was sick (illness), while the patient received INFLUENZA VACCINE.  The patient's medical history, past medical treatments, vaccinations and family history were not provided.  No concomitant medication was reported.   On an unknown date, the patient received a dose of suspect INFLUENZA VACCINE (produced by unknown manufacturer) (batch number and expiry date not reported) via an unknown route and administration site for prophylactic vaccination.  On an unknown date (latency unknown) after receiving the suspect vaccine , the patient reported that shot made sick (illness) and the patient not had one in over 5 years. The patient used herbs to keep the immune system up (corrective treatment).  No laboratory data was reported.  At the time of reporting, outcome of the event was unknown.  There will be no information available regarding batch number in this case.