chrisvoncsefalvay/vaers-outcomes huggingface dataset:
8-18-08 10:30AM - Patient fainted. Revived with cool compresses, ammonia inhalant. Patient vomited. BP 98/58 P.60. 11AM. Patient still complains of nausea and continues to vomit intermittent color pink, talkative, sitting, up, still complained of nausea. Patient escorted out via wheelchair to car with mom and brother. Continued to vomit on and off thru the day. Patient went to work; no complaints next day.
3 days after 2nd dose I began to experience vaginal bleeding and ultimately 2 weeks later I had a miscarriage. I had to have a D&C on 4/23 and still have been experiencing heavy bleeding
Large, tender, tense erythematous patch on left thigh; warm to touch and weeping some transudate.
The evening of the vaccination I started experiencing severe pain in my forehead; headache; fatigue and tiredness and soreness at the injection site. I was diagnosed with a UTI in September was put on antibiotics for 7 weeks and am now on a course of antibiotics injections every day for 7 days. In addition, they have found some nodules in my lymph nodes that will need further testing.
Patient had emesis x 5-7 episodes 4 days after ROTATEQ vaccination; diagnosed with obstruction due to INTUSSUSCEPTION; required surgery to relieve obstruction and removal of small segment of ascending colon.  08/27/2008 MR received for DOS 7/26-30/2008 with D/C DX:  Intussusception. Pt presented with several day hx of vomiting with dehydration. Pt had bloody stool during eval. PE (+) for depressed fontanelle and abdominal distention. Enema attempted for reduction which resulted in a bowel perforation. Pt taken for emergent exploratory lap with small bowel resection of perforated segment with primary anastomosis. Pt developed mild ileus post-op which resolved spontaneously and diet then advanced.
After the vaccine, I've been taking MUCINEX to control my symptoms. I've been coughing daily. When it's cold, I cough more. I had to get a chest x-ray. It came back clean. I've been using my asthma inhaler throughout the day, but I use it mostly at night. Sometimes, when I cough, it feels like I'm choking. Around April of 2022, I was coughing a lot. I made another doctor's appointment because a blood vessel popped in my right eye due to coughing so much. I get migraines throughout the day. The last for multiple days. It feels like pressure in my forehead. Sometimes, I have muscle aches. I also experience dizziness from time to time. I'm to the doctor for the dizziness this month.
Patient hospitalized with SROM/labor at 37w5d gestation. Baby boy with apgars 6/8 at 1 and 5 minutes respectively. Birth weight 7 lb 4.9 oz. This was within 6 weeks of receiving covid booster vaccination.
twitching of one eye and one limb; This spontaneous report was received from a healthcare worker (patient's mother) via a company representative, regarding her 18-year-old son.  Information on patient's medical history, drug allergies/reactions and concomitant medication were unknown by reporter. The patient current condition included attention deficit disorder.  On an unknown date, the patient was vaccinated with one dose of quadrivalent human papillomavirus (types 6,11,16,18) recomb. vaccine (GARDASIL) or hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) (dose number, route, anatomical location, lot# and expiration date were unknown by reporter) for prophylaxis (It was unknown if the patient received quadrivalent human papillomavirus (types 6,11,16,18) recomb. vaccine (GARDASIL) or hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9).   On an unspecified date, within one month of receiving the vaccine, the patient began experiencing twitching of one eye and one limb (muscle twitching). It was unknown if the patient received any treatment. At the time of report, the patient did not recover from the event. Causality assessment for the event with respect to the therapy was not reported.
Information has been received from a physician concerning a female who at the beginning of September, on approximately 01-SEP-2008 was vaccinated with her first dose of GARDASIL. Four days after vaccination, on approximately 05-SEP-2008, the patient experienced tingling and numbness in all her extremities. The patient's tingling and numbness in all her extremities persisted. Additional information has been requested.
Dizziness - "head spinning" & shaking negative for rash, itching, SOB, vomiting gave pt dose 2 tsp of BENADRYL & glucose tablet & H2O pt sat for 30 minutes & felt better shortly after having glucose - vasovagal RXN? low blood sugar?
I had a headache, fatigue, small cough, the next my symptoms were a little bit worse. I took a home COVID-19 test that came back positive. I called my doctor to do a telehealth visit and get Paxlovid. I did the five-day regimen tested negative was back at work for one day came home started to feel bad. I took a home COVID-19 test the next day, it was positive. I am in a clinical trial, I have not been told if I received the placebo or the real Paxlovid, but my symptoms got better quickly. I am very happy as the rebound was so much worse than the first time having COVID-19. I am not sure my energy level is back up, but I am getting there.
Anaphylactic reaction; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of ANAPHYLACTIC REACTION (Anaphylactic reaction) in a 34-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 046A21A) for COVID-19 vaccination.     Previously administered products included for Product used for unknown indication: Misoprostol on 01-Jan-2016 and Amoxicillin on 01-Jan-2019. Past adverse reactions to the above products included Anaphylaxis with Amoxicillin and Misoprostol. Concurrent medical conditions included Cystitis interstitial since 01-Jan-2004.    On 13-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 13-Apr-2021, the patient experienced ANAPHYLACTIC REACTION (Anaphylactic reaction) (seriousness criterion medically significant). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) (oral) from 13-Apr-2021 to 20-Apr-2021 for Antihistamine therapy, at a dose of 1 dosage form. On 13-Apr-2021, ANAPHYLACTIC REACTION (Anaphylactic reaction) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 13-Apr-2021, Heart rate: high (High) Fast heart rate.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       The patient had allergic side effect ongoing after vaccination for 1-2 weeks. In addition, the patient had allergic side effects to the Vitamin D3 supplement (SOB and tachycardia) and the Macrobid (anaphylaxis) which was after the moderna vaccine  Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.   Most recent FOLLOW-UP information incorporated above includes: On 13-Jul-2021: Follow up information was received from initial reporter: Patient demographics, medical history, and treatment medications were added. Events dyspnea, palpitations, dizziness, tremor, Blood Pressure fluctuation were deleted and subsumed under anaphylactic reaction. This case was upgraded from non-serious to serious due to the addition of new anaphylactic reaction.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Presented to ED with SOB and hyperglycemia, tested positive for Covid 19 on 02/02/2022.  Patient reports orthopnea and states her SOB get worse with exertion, also reports nausea, cough, productive.  In ED  patient was hypertensive.  Admitted with acute on chronic CHF, hyperglycemia, CKD, bilateral lower extremity edema and pain as well as erythema.  Placed on IV insulin and later changed to subcu insulin.  Placed on IV abx for mild cellulitis.  Did not require dexamethasone or remdesivir.  On 2/7/22, patient became hypoxic was started on dexamethasone, patient made comfort care.  Immediate cause of death: Covid PNA.
at approximately midnight (6 hours after receiving the shot) I woke up with a 101.5 fever and felt achy.  Took 2 tylenol, drank some water and went back to bed.  At approx 6 am woke up sweating, aching muscles, fever was 102.1 proceeded to take 2 more tylenol, drank more water, took some B-active Complex, and went back to bed.  This went on for 3 days.  During this time, I took 3 tylenol every 4 to 5 hours to help keep the fever down, along with  cold compresses on my neck and forehead.  I took B-active complex and vitamin D3 and L-Lysine1000mg daily during that time.  I also, drank plenty of juice and plain broth and could barely eat a few crackers.  My body hurt all over.  I felt as though I had the worst flu.  The fever finally went down to 101 on day 4 then down to 99 on day 5.  During this time, I took 2 tylenol every 4 - 5 hours during those days, but could not get out of bed due to my body aching all over.  Was finally able to get out of bed on day 6, when my fever was back down to normal.  The aches and fatigue finally was gone a week after the fever broke.
warm on the injection site; 3rd dose of Shingrix was administrated; fist dose  was administrated October 29 2019 / second dose administrated December 13 2019; This case was reported by a nurse via call center representative and described the occurrence of injection site warmth in a 76-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) (batch number 7Z29K, expiry date 15th April 2022) for prophylaxis.   Concomitant products included Herpes zoster (Shingrix).   On 13th December 2019, the patient received the 2nd dose of Shingrix. On 6th July 2020, the patient received the 3rd dose of Shingrix. On 13th December 2019, unknown after receiving Shingrix, not applicable after receiving Shingrix and an unknown time after receiving Shingrix, the patient experienced drug dose administration interval too short. On 6th July 2020, the patient experienced injection site warmth and extra dose administered. On an unknown date, the outcome of the injection site warmth was recovered/resolved and the outcome of the extra dose administered and drug dose administration interval too short were unknown.  Additional details were reported as follows: The age at vaccination was not reported. On 29th October 2019, the patient received 1st dose of Shingrix. On 13th December 2019, the patient received 2nd dose of Shingrix earlier than the recommended schedule, which led to shortening of vaccination schedule. The patient received 3rd dose of Shingrix, which led to extra dose administered. Less than a day after receiving 3rd dose of Shingrix, the patient experienced warmth on the injection site. The reporter consented to follow up.
left arm and shoulder pain persisted; generalized itching; localized reaction distal to injection site (4 cm in circumference); Nearly debilitating joint, muscle and body aches and pain; Nearly debilitating joint, muscle and body aches and pain; severe headache; chills; night sweats; weakness; dizziness; lethargy; fever; body aches; nausea; Muscle soreness at injection site; This is a spontaneous report from a contactable nurse (patient). A 55-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot number: EK9231), intramuscularly in the left arm, on 23Dec2020 at 14:30 (at the age of 55-years-old) as a single dose for COVID-19 immunization. Medical history included hypertension, depression, and penicillin allergy. The patient was not pregnant at the time of vaccination. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medications, taken within two weeks of vaccination, included atenolol (MANUFACTURER UNKNOWN), hydrochlorothiazide (HCTZ) (MANUFACTURER UNKNOWN), sertraline hydrochloride (ZOLOFT), and simvastatin (MANUFACTURER UNKNOWN). The patient previously took bupropion hydrochloride (WELLBUTRIN) and experienced allergy. The patient did not receive other vaccines within four weeks prior to vaccination. The patient experienced fever, body aches, nausea, and muscle soreness at injection site on 24Dec2020 at 16:00; generalized itching, localized reaction distal to injection site (4 cm in circumference), nearly debilitating joint, muscle and body aches, severe headache, chills, night sweats, weakness, dizziness, and lethargy on 26Dec2020; and left arm and shoulder pain persisted on 03Jan2021. All of the events were reported as non-serious. The events were described as: Within 24 hours (as reported), fever, body aches, nausea, and muscle soreness at injection site occurred. Then within 72 hours (as reported), generalized itching, localized reaction distal to injection site (4 cm in circumference), nearly debilitating joint, muscle and body aches and pain for three days with onset of severe headache, fever, chills, night sweats, weakness, dizziness, and lethargy. On Day 11 (as reported), left arm and shoulder joint pain persisted. The patient underwent lab tests and procedures which included nasal swab: negative on 31Dec2020. The patient did not receive any treatment for any of the events. The clinical outcome of all of the events was recovering.
Not an adverse event, but a medication error. Pfizer vaccine was administered off-label to this 13 year old patient. However, the parent that completed her paperwork incorrectly listed her age as 16 and her DOB. When the vaccine was entered into system, we verified her actual DOB by cross checking with her pediatrician's EHR.
Patient passed out in bathroom at 5am and hit the floor.  She was not injured in the fall.  Passed out for a minute or two.  Had a fever of 101.7, got very sweaty, headache and lethargy.  Could not communicate very well. Could not walk on her own.  It took about 3-4 hours before she started feeling a bit better.  Was not able to go to work.  She is still lethargic at 8pm but is overall better.  Still does not care to eat much but mostly is drinking beverages. She is a nurse and we did not go to a medical facility
The first shot made my arm turn red. Then I bled a black paste for about 2 straight weeks ( I wasn't supposed to get my period for 2 more weeks) Then when I got my period I hemorrhaged for another week and a half. I only have 1 ovary and fallopian tube and this had been the worst bout of pain and blood since my hysterectomy.  I have never seen so much black goo come out of a body.  My periods are still not back to normal.
Site of injection remained swollen and sore until 10/6/14. Once injection site cleared there was an onset of complete body muscle soreness. Affected ability to walk, open doors, drive and lift items greater than 1 pound. Symptoms completely resolved on 10/14/14.
Patient was inadvertently given the Pfizer 6m-4y Bivalent vaccine as dose #2 instead of the Pfizer 6m-4y Monovalent vaccine. No adverse reaction up to this point.
Significant arm pain first day after vaccine, followed by large swollen lymph nodes under armpit the next day.
hidradenitis suppurativa flare up under left arm and right leg; Fatigue; Sore arm; This spontaneous case was reported by a consumer and describes the occurrence of HIDRADENITIS (hidradenitis suppurativa flare up under left arm and right leg), FATIGUE (Fatigue) and PAIN IN EXTREMITY (Sore arm) in an adult female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) solution for injection for Hidradenitis suppurativa.    No medical history was reported.  Concomitant products included DOXYCYCLINE for an unknown indication.   On 20-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 20-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 01-Nov-2021, the patient started ADALIMUMAB (HUMIRA) (Subcutaneous) at an unspecified dose. On 02-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient experienced HIDRADENITIS (hidradenitis suppurativa flare up under left arm and right leg), FATIGUE (Fatigue) and PAIN IN EXTREMITY (Sore arm). At the time of the report, HIDRADENITIS (hidradenitis suppurativa flare up under left arm and right leg) had not resolved and FATIGUE (Fatigue) and PAIN IN EXTREMITY (Sore arm) outcome was unknown. The patient received co-suspect Humira in formulation of solution for injection in pre-filled pen (batch no.: 1160294). The patient received Doxycycline at a dose of 100 mg and frequency of once in 2 days. The reporter's causality for the event of hidradenitis suppurativa flare up under left arm and right leg was reported as probable with the co-suspect product Humira. The reporter's causality for the events of sore arm and fatigue was reported as not related with the co-suspect product Humira.  No treatment medications were reported.
Vaccine administered at outside facility. Patient is a 16 yo girl, admitted on 4/19 with myocarditis, s/p IVIG (4/19) after presenting with progressive new onset chest pain. She was in usual state of health up until 2 days ago when she started developing body aches, and chest pain. Patient received her 2nd Pfizer COVID vaccine last week (4/15). No known history of COVID infection. Parents brought her to the ED yesterday after she complained of dizziness, SOB, chest pain, and had a near syncopal event. EKG showed non-specific ST abnormalities with labs showing elevated troponin, mildly elevated CRP, normal CXR, negative COVID PCR. Denies fever, GI symptoms, GU symptoms, headache, rash. Once transferred to our PICU, she was worked up for myocarditis vs MIS-C. Troponin has been trended q6 and is trending up (now 11). Of note, there have been no fevers. Patient is a 16 yo girl, s/p admission (4/19-4/23/21) with myocarditis, s/p IVIG (4/19), has now been readmitted on 5/10 with myocarditis after presenting with headache and neck pain for 2 days. Following discharge from the PICU on 4/23, patient states that symptoms have lingered (low grade fevers, feeling tired, on and off chest pain). After developing a progressive headache and neck pain, she came back to the ER for re-evaluation. Upon readmission, her troponin was elevated (2.06 on 5/10). Her CBC and CMP were reassuring. Blood culture collected on 5/11 and urine culture collected on 5/10. ID consulted for workup.
heart rate over 100 beats per minute; panic, anxiety attack lasting 1/2-1 hour; panic, anxiety attack lasting 1/2-1 hour; Blood pressure reading 142 over 100; Panic/Anxiety attack lasting 1/2-1 hour with elevated heart rate over 100 beats per minute, reaching 144 beats per minutes at it's worse; This is a spontaneous report from a contactable consumer (patient). A 77-year-old female patient (not pregnant) received the third dose of BNT162B2 (PFIZER COVID) via an unspecified route of administration on the left arm on 20Oct2021 at 11:00 AM (Lot Number: FF2590) at the age of 77-year-old as single dose for COVID-19 immunization. Medical history included atrial fibrillation and high blood pressure. The patient didn't received other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient wasn't diagnosed with COVID-19. Since the vaccination, the patient hadn't been tested for COVID-19. Known allergy was none. Concomitant medications included rivaroxaban (XARELTO), nebivolol hydrochloride (BYSTOLIC), amlodipine, olmesartan medoxomil (OLMESAR) and atorvastatin. The patient previously received the second dose and the first dose of BNT162B2, the second dose on 26Feb2021 at 11:00 AM (Batch/Lot Number: EN6203), the first dose on 05Feb2021 at 11:00 AM (Batch/Lot Number: EL9265), both via an unspecified route of administration on the left arm at the age of 77-year-old as single dose for COVID-19 immunization. On 23Oct2021 at 19:30, the patient experienced panic, anxiety attack lasting 1/2-1 hour with elevated heart rate over 100 beats per minute, reaching 144 beats per minutes at it's worse, blood pressure reading 142 over 100. Hospitalization prolonged was none. Treatment was received included Clonazepam 0.5 mg & Amlodipine Besylate 2.5mg. The outcome of events was recovering.
This spontaneous report as received from a health professional refers to a patient of unknown age and gender. There was no information about the patient's concomitant medications, allergies and pertinent medical history reported. On 19-APR-2016, the patient was inadvertently administered an expired dose of RECOMBIVAX HB lot # K003533, expiry date 07-FEB-2016 (dose, route and site of administration were not reported). No adverse effects were reported. Additional information has been requested.
About 10 days after !st shot started getting a rash on back and stomach areas, treated with Hydrocortisone 2.5% , Hydoxyzine HCL 55mg/Predisone.  After 2nd shot still treating as before and after a few days rash has got a lot worst and is all over body about 90%.  as of today no change in rash and medication has ran out and doctor contacted
right upper arm is not functioning properly and cannot lift the right arm above the waist.; tingling in wrist and hand as well; This is a spontaneous report from a contactable consumer, the patient. A 63-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8737), via an unspecified route of administration in the right arm on 05Apr2021 at 16:00 (at the age of 63-year-old), as a single dose for COVID-19 immunisation. Medical history and concomitant medications were not reported. The patient previously took the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6208), via an unspecified route of administration in the right arm on 15Mar2021 at 16:00 (at the age of 63-year-old), as a single dose for COVID-19 immunisation. Prior to the vaccination, the patient was not tested positive for COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On 16Apr2021 at 14:00, the patient experienced right upper arm was not functioning properly, cannot lift right arm above the waist and had some tingling in the wrist and hand. The clinical outcome of the events right upper arm was not functioning properly, cannot lift right arm above the waist and had some tingling in the wrist and hand was not resolved.   No follow-up attempts are needed. No further information is expected.
pt devel tonic/clonic sz which lasted for bout 5 mins-no fever; brought to ER; pt presently still in ER: