chrisvoncsefalvay/vaers-outcomes huggingface dataset:
A 47 year old male with history of HTN, obesity, hyperlipidemia, obstructive sleep apnea, depression and anxiety, presents to ER on 10/12/18 with chief complaints of fatigue, weakness and hematuria x 1 day. Pt reported symptoms began after getting the flu shot the day prior. 1 episode of diarrhea in ED but none at home. Returned from 5 week trip, about 3 weeks prior to presentation. He received a flu vaccine immediately prior to the onset of his Sx and associates his Sx with this event. He reported that following said flu vaccination, he began to feel ill with fatigue and nausea/vomiting. No other medication changes. GI was consulted and felt that his unconjugated hyperbilirubinemia was not due to biliary causes. His hemolysis labs (haptoglobin and LDH) returned positive. Heme/onc was consulted. His Hbg downtrended 12->  7.7->  4.9, and he was noted to spike fever on 10/14 prior to his significantly reduced Hb at 12:30 am. He received 2UPRBC with f/u Hb to 6.9. WBC trended up from 15 (PMN 12)-> 20.38 (PMN 17.39)-> 22.5 (PMN 18.93)-> 25.2 (PMN 55.67)->  29.02 (PMN 27.22). Bilirubin total (with indirect predominance throughout): 15.5->  19.5->  23. Patient initially stabilized with steroids, and determination was made to limit transfusion to keep Hbg greater than 6 to prevent worsening hemolysis. However, at approximately  23:00 10/14/18, patient had acute respiratory distress associated with bradycardia and hypotension, and then suffered cardiopulmonary arrest. He underwent multiple rounds of CPR and ACLS. Patient ultimately expired.
Developed redness (14.5 cm x 10 cm), swelling, and pain on left upper arm on 5/28/2020.
aching and tireness on Tuesday up to Thrusday. Itchy throat starting 11/18th and got worse on 11/19
Pt. fainted 5 minutes post injection. Vitals stable, MD notified. Pt didn't eat breakfast. Gatorade and OJ given. Pt lying flat, symptoms improved.
Experienced feverish chills, headache, fatigue.  Symptoms in area where vaccine administered (left upper arm): redness, rash (from armpit to part of elbow), swelling, hot to touch.  Also experienced severe pain on arm. Lasted several days.  Minor pain in area of arm where vaccine received persists, when touched.  Muscle also has a lump on it.
S/S: redness, swelling, warmth, LROM of arm, tenderness around injection site 6-19-13 to. TX: AUGMENTIN 400mg/5ml 2/2 tsp BID x 10d start 6-21-13 due to cost issues. BENADRYL Q 6-8h. TYLENOL/MOTRIN Q 4-6h.
I have had a reaction for my second shot; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (I have had a reaction for my second shot) 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.    In February 2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In February 2021, the patient experienced VACCINATION COMPLICATION (I have had a reaction for my second shot). At the time of the report, VACCINATION COMPLICATION (I have had a reaction for my second shot) outcome was unknown.            no concomitant and treatment medications are provided by the reporter.
This spontaneous report as received from a registered nurse refers to a 74 years old male patient with diabetes, hypertension, hyperlipidemia and penicillin allergy. The patient was intramuscularly vaccinated on left arm with lot # (672673/0492AE), 0.5 ml PNEUMOVAX23 on 10-JUL-2012. Concomitant medications included METFORMIN, COLACE, ASPIRIN, PRILOSEC and ZOCOR. On 11-JUL-2012 the patient developed fever 101.9F, swelling, pain and redness. The patient called the office and was advised to apply ice compresses to the area of the reaction, to take antihistamines and TYLENOL. The outcome of redness, pain, fever and swelling was reported as not recovered/not recovered. No lab diagnostics study was performed. The nurse was requesting a lot check. This is one of several reports from the same source (MARRS#1207USA002940). Additional information has been requested.
Information has been received from a licensed practical nurse concerning a male pt with no allergies who on 13Feb04, at birth, was vaccinated with a dose of hep B virus vaccine rHBsAg (yeast) (manf unk). Subsequently in 2004, the pt broke out in hives. Unspecified medical attention was sought, but treatment was not required. A product quality complaint was not involved. Additional information has been requested.
skin rash over body;to MD w/in 15min time course pt recovered well no tx;
MMR #1 3-21-07; MMR #2 11-5-07; rash, swelling L thigh.
Information has been received from a health professional concerning an approximately 66 year old female who on unspecified dates was vaccinated with a first, second and third dose of hep b vaccine recombinant. Subsequently, after the third dose, the pt experienced extreme urticaria, chilla, and possible peripheral neuropathy. The pt feels that the symptoms may have been present after te first and second dose, but to a lesser extent. It was reported on 03/21/2001, that the pt was still experiencing the symptoms. The pt sought unspecified medical attention. Additional info has been requested.
The morning after the second dose, Patient complained that his "heart hurt." He was okay after taking one Advil. The following morning, he woke up at 5am in tears complaining of extreme heart and chest pain. His breathing was ok. He had a fever (range of 99-101.3) for 2-3 days after each of the doses. I made an appointment with his pediatrician. Dr. exam didn't find irregularities but he ordered tests to be certain and to rule out the myocarditis being reported. Chest X-Ray and EKG were normal. The Echocardiogram showed mild TR but no other diagnoses. This was patients first echocardiogram, so there was no baseline to compare to.
Large red circle around injection site that was hard. The hardness/swelling has mostly gone away, but the large red circle is still there! There is no pain associated with it (only the first 2 days was there any pain) concerns that it won't go away.  The red circle is also warm to the touch compared to the rest of my arm. Even now, over a week later the area is still noticeably warmer.
Patient had raised hives on abdomen and both arms. Patient stated that she had tongue, lip, eye swelling on 3 different occasions.
I received the Pfizer Bivalent COVID-19 booster on 12/26/2022. On 1/5/2023, I began having pain inside the left nostril, which intensified to the point at which I couldn't wash or touch my face. I thought that maybe I had a pimple inside the nose, because the pain was concentrated in one spot. By 1/6/2023, though, the pain had spread throughout the left side of the nose, and I had pain and a little bit of swelling under the left eye. It felt like a sinus infection. On 1/8/2023, I still had pain on the left side of my nose, but then my nose started to run out of both nostrils. I then took a home antigen test, and the result was positive. I was surprised by this, so I took another test that day to see if I would get the same result, and the second test also yielded a positive result. Later that day, I had a virtual urgent care visit, and I was prescribed PAXLOVID, which I began taking that evening. It began to work quickly. The pain in the left side of my nose began to subside on 1/9/2023. At the time of this writing, I also no longer have a runny nose. Since getting COVID-19, I have had no symptoms besides the sinus pain on the left side, the slight swelling under the left eye, and the runny nose.
Mother reports that the day following the immunizations the child developed a runny nose, cough and fever that required a doctor visit. The child has subsequently been put on Pulmicort, Zyrtec, and Albuterol. He was hospitalized for 24 hours with a temp of 105 degrees in late May.  He has been seeing his primary physician almost weekly since April. Continues on medications and has coughing and wheezing symptoms. 11/07/05 Review of medical records indicates diagnosis of bronchiolitis. Additional symptoms include poor appetite and a candida diaper rash. 11/07/2005 hospital records reviewed. Added information that a blocked nasal lacrimal duct was noted on left.
hx of allergy to pineapple. Person started with itching to lips the same feeling she gets when eating pineapple. Urticiaria progressed to arms, legs, no visual hives. Person was given 50mg Benadryl PO by facility. 30 minutes later she was still itching. Person returned to work, but closely monitored.
This spontaneous report as received from a physician refers to a pediatric male patient. The patient was vaccinated with the first dose of VARIVAX (Merck) (lot number not provided). No other co-suspects were reported. No concomitant medications were reported. On an unknown date the patient experienced chickenpox like rash after receiving the first dose of VARIVAX (Merck). No laboratory diagnostics studies were performed. The outcome of adverse event was reported as recovered on an unspecified date. The patient was seen by the physician for medical attention. Additional information is not expected.
positive for Covid; positive for Covid; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A 68-year-old male patient received BNT162b2 (BNT162B2), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "he does have a history of sensitivity with side effects" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 2022, outcome "unknown" and all described as "positive for Covid". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (2022) Positive.  Clinical course: Caller was a scientist stating that he currently was positive for Covid, He was 68-year-old and was triple vaccinated so he had some immunity to covid. His friend that was a pulmonologist had encouraged him to start Paxlovid. He would like to know the statistics of the side effects with Paxlovid because he does had a history of sensitivity with side effects.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
I got chills, nauseated, dizzy, muscles ached, extreme tiredness, severe headache lasted 3 days  2 Nd shot same symptoms as well as actual throwing up  but only lasted about 24 hours blur the second shot but have been getting severe headaches since the first  shot
fever, muscle pain, severe rash, swollen tongue, ulcers/sores in mouth and throat, ongoing diarrhea and stomach pain, neurological effects, twiching, muscle spasms, seizure like activity with mini spikes, numbness in limbs, face and neck, slow stuttering speech, difficulty thinking, severe brain fog, drugged feeling, severe dizziness, loss of balance, adrenaline surges, night sweats, vision changes. inner ear disturbances, inability to drive for 3 months, inability to care for children for several months, new food sensitivities/food allergies, 30 lb weight loss. Two ER visits, numerous ongoing physician visits, rheumotologist, allergist, immunologist, neurologist *Development of Mast Cell Activation Syndrome
9:21 AM- Redness around injection site, anxiety 9:25 AM- Patient had increase respiration and became restless 9:28 AM- O2 sat. 99% on room air, 94 Pulse, water provided with talk therapy 9:40 AM- Vitals; 98% O2 sat on room air, 88 Pulse, decreased erythema  10:01 AM- Patient stated feeling better
Erythema 41mm by 43mm and itching at site. Warm upon palpation. Tender upon palpation. PT noted discomfort at approximately 1000 that morning and setup appointment 1230. HCP provided BENADRYL.
Pt developed 2-5 raised, vesicular lesions and itching on scalp and left chest 10-14 days post vax. He had no fever.
presented with hypoxia and confusion; Covid + ED; Admit 9/15 to tele; to ICU 9/26 after RRT; tx: 9/15 maxipime, steroids,  9/16 lovenox,    9/17  Remdesivir, Actemra, O2 Requirements: 6 LPM in ED; 9/17 15 LPM oxymax 9/18 Bipap 100%; 9/20 Airvo 60L/100%; 6/26 Resp arrest & PEA intubated; Fio2 100%; AC Peep 10; tx to ICU; 9/27 developed aspiration PNA, 9/28 & 9/29 attempted HD; did not tolerate; 9/30 Coded again,  made DNR after PEA arrest; Died @ 07:12
Pt received yellow fever vaccine 15 Nov 2012 about 0804 am. Pt received VIS form, informed of adverse reactions, verified not possible pregnancy with disclaimer form. Pt waited read 30 min with no reaction. Pt states later she noticed red area at injection site the size of a small baseball and site was itching. Pt reported no other sx. Dr notified he said no intervention needed but to inform pt to watch for signs of anaphylaxis or other concerns and calling if needed.
Patient was given the Janssen vaccine on 4/08/2021 at 4:25pm. Patient reported feeling faint, dizzy and hears ringing in his ears less than a minute after. Had the patient laying back on chair against wall with feet elevated. Patient turned pale and started to break out in cold sweats. No signs of swelling or redness around the injection area. Patient did not report any itching or swelling in throat/tongue. After 2 to 3 minutes from time that vaccine was given, patient started to recover, no longer feeling faint nor sweating. Over the course of the next 30 minutes, the patient?s condition stabilized with pulse returning to 80 beats per minute.  Patient reported feeling fully recovered at 5:00pm.
vague headache; little chills; This spontaneous case was reported by a nurse and describes the occurrence of HEADACHE (vague headache) and CHILLS (little chills) in an 80-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 072A21A and 007B21A) for COVID-19 vaccination.     Concomitant products included LOSARTAN, AMLODIPINE and LEVOTHYROXINE for an unknown indication.   On 02-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 30-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient experienced HEADACHE (vague headache) and CHILLS (little chills). At the time of the report, HEADACHE (vague headache) and CHILLS (little chills) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No treatment information were reported.  Action taken with the drug in response to events was not applicable.   This case was linked to US-MODERNATX, INC.-MOD-2021-081929 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-081929:2nd dose case
2 seperate bruises; This spontaneous case was reported by a consumer and describes the occurrence of CONTUSION (2 separate bruises) 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 05-May-2021, the patient 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 received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced CONTUSION (2 seperate bruises). At the time of the report, CONTUSION (2 seperate bruises) outcome was unknown.            No concomitant medications reported. No treatment information was provided. .
Covid positive after the 1st dose of Comirnaty; Covid positive after the 1st dose of Comirnaty; This is a spontaneous report received from a contactable reporter(s) (Pharmacist) from medical information team for a Pfizer sponsored program.  A 8 year-old female patient received bnt162b2 (COMIRNATY), administration date 2021 (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "Covid positive after the 1st dose of Comirnaty". The patient got the 1st vaccine dose of the vaccine and between the 21 days period between there 1st and 2nd dose, she tested positive for the Covid 19. The caller wanted to know what the recommendation is for the patient's 2nd dose.  The lot number for bnt162b2 was not provided and will be requested during follow up.; Sender's Comments: Based on the known safety profile and Limited information in the case report a casual association between LOE events and suspect drug BNT162B2 cannot be excluded.
Narrative: COVID infection following COVID vaccine series 03/02, Pfizer, dose #1 03/23, Pfizer, dose #2 08/2 pt cc: cough, myalgias, rhinorrhea, bad sinus, exposure: unknown 08/03 - 08/24 pt symptoms continue 08/19 COVID swab, result: detected 08/19 SARS-COV-2 Variant Sequencing result: pending
4pper right arm red and itchy not at injection site. Reaction site is lower than injection site >50 mm wide and >50mm length.
Patient was given a 0.5 mL dose of influenza vaccine when age called for a 0.25 mL dose.
ringing in ears that began after the first dose; This is a spontaneous report received from contactable reporter (Consumer). The reporter is the patient.  A 66 year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), administration date 01Mar2021 (Batch/Lot number: unknown) at the age of 66 years as dose 1, single and administered in arm left, administration date 22Mar2021 (Lot number: EN6202) as dose 2, single for COVID-19 immunisation. The patient had no relevant medical history. The patient's concomitant medications were not reported. The following information was reported: TINNITUS (non-serious) with onset Mar2021, outcome "not recovered", described as "ringing in ears that began after the first dose". Therapeutic measures were not taken as a result of tinnitus. Additional information: The patient has no allergies to medications, food or other products. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. Patient reported that the ringing in his ears had continued and gotten worse at the time of reporting. The adverse event did not result in a visit to the doctors or other healthcare professional office/clinic visit, and emergency room/department or urgent care.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Starting around 2:00pm June 2, 2021 approximately 9 days after first dose I had terrible stomach cramps and my arm had a small itchy raised spot I took for a bug bite because I actually forgot about the vaccine at the time. It itched badly. After going to bed, all night it got worse and upon waking today there?s a large red itchy rash right below the injection site and a red spot AT the site. I also have had a headache nearly nonstop for 36 hours.
no additional AE reported; Medical assistant calling to report that a 4 month old patient was inadvertently administered PROQUAD. No additional information was provided. Caller reports no additional AE reported. No PQC.; This spontaneous report has been received from a medical assistant, concerning a 4-month-old patient of unknown gender. The patient's concomitant medications included diphtheria toxoid (+) hepatitis B virus vaccine rHBsAg (yeast) (+) Hib conj vaccine (OMPC) (+) pertussis acellular 5-component vaccine (+) poliovirus vaccine inactivated (Vero) (+) tetanus toxoid (VAXELIS), rotavirus vaccine, live, oral, pentavalent (ROTATEQ), and pneumococcal vaccine conj 13v (crm197) (PREVENAR 13). The patient's medical history, concurrent conditions, previous drug reactions and allergies were not provided.   On 15-NOV-2022, the patient was vaccinated with measles, mumps, rubella and varicella (oka-merck) virus vaccine live (recombinant Human albumin) (PROQUAD) (product administered to patient of inappropriate age) subcutaneous injection, at a dose of 0.5 milliliters (ml) (lot number W010063 has been verified to be valid; expiration date reported and established as 20-SEP-2023) (strength, frequency, vaccination scheme, route of administration, and anatomical locations were not provided).
Redness, swelling, itchiness noted below injection site on my left arm, not on the exact injection site itself.  The following day it increased in size, redness and hardness. I applied over the counter Cortisone cream and took an antihistamine.  I also applied cold compress to the site later in the day when the cream and antihistamine didn't seem to be helping. It has increase in size to 51/2 inches by 5 inches.
Redness that spread down arm from injection site starting 2/2. Still present on 2/11. Patient went to doctor and states she was told her lymph nodes were enlarged as well.
Patient administered the vaccine beyond use date after the thaw process; This spontaneous case was reported by a paramedic and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Patient administered the vaccine beyond use date after the thaw process) in a 35-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030h21b) for COVID-19 prophylaxis.     It was unknown that the patient had been diagnosed/tested positive for COVID-19. It was unknown that the patient had acute illness at the time of vaccination and up to one month before. It was unknown that the patient had chronic or long-lasting illness and patient had taken any prescriptions, over the counter medication, dietary supplements or herbal remedies at the time of vaccination.     On an unknown date, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .25 milliliter. On an unknown date, the patient experienced EXPIRED PRODUCT ADMINISTERED (Patient administered the vaccine beyond use date after the thaw process). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Patient administered the vaccine beyond use date after the thaw process) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   The age of the patient was reported as 35 years 5 months.  No concomitant medications were reported.  The clinic date was mentioned as 11-Jan-2022.  The patient had no adverse reaction after the vaccine administration.  No treatment medications were reported.
Developed severe left arm pain and several days later it was both arms. Diagnosed with polymyalgia rheumaticus.