chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This spontaneous report as received from a medical assistant refers to a patient of unknown age and gender. On 07-JUN-2016, the patient was vaccinated with incorrectly stored dose of M-M-R II lot # M001200, therapy type was not specified (dose and route of administration were not reported). This is one of several reports received from the same source. Additional information has been requested.
Side Effects after 1st Dose: - Strong Dizziness after 20-25 minutes of vaccine, almost fell in the street. They let me go after 13 minutes from vaccination. - Strong Sensitivity to Sun Light once the subway merged from underground, had to squint my eyes - Local mild pain - Light Dizziness days after vaccine  Side Effects after 2nd Dose: - No Side Effects right away, except for light local pain and light dizziness - 2 to 3 weeks after 2nd Dose I started having More Dizziness and Strong Joint and Muscle Pains and Aches in neck and lumbar areas that are persisting today, 8 months later. I had 20 sessions of Physical Therapy with no improvement on my affected areas.
This spontaneous report as received from a pharmacist refers to a patient of unknown age. On an unknown date the patient was vaccinated with (Oka/Merck) VARIVAX dose 1. On an unknown date the patient experienced patient received a first dose of VARIVAX on an unspecified date and would like to receive the second dose now. The second dose of the vaccine would be administered outside the recommended timeframe. No adverse symptoms reported. The outcome of patient received a first dose of VARIVAX on an unspecified date and would like to receive the second dose now and no adverse symptoms is unknown. Additional information has been requested.
Chills, extreme exhaustion, bad cough, no appetite, lack of taste, and headache. Given inhaler and steroids.
This spontaneous report as received from a physician refers to a 11 week-old patient of unknown gender. No information was provided regarding the patient's pertinent medical history, concomitant medications, drug reactions or allergies. On 03-JUL-2017, the patient was vaccinated with improperly stored dose of PEDVAXHIB (exact dose, dose number, route of administration were not reported; lot# reported as N00236 with the expiration date of 24-OCT-2019) for prophylaxis. The administered dose of PEDVAXHIB underwent multiple temperature excursion between 49 and 54 Fahrenheit degrees, which lasted for 16 hours, since 19-MAY-2017. Digital data logger was not involved to capture the temperature excursions. There were no previous temperature excursions reported. No adverse effects were reported. This is one of several reports received from the same reporter. Sender's Comments: US-009507513-1709USA012766.
I started to have abdominal pain that I think is my Crohn's acting up after being in remission for years. Inflammation throughout my entire gut.
Patient had seizure following gardasil injection. BP 156/86, pale, eyes rolling, rigid, diaphoretic, EMT called, blood sugar 82, refused transport to ER, appointment made with primary doctor for evaluation same day.
Pt reported huge red mark/reaction around injection site, hard, size of orange. No bruising; was not sick; no nausea; was not ill. Resolved, went away.
Fever (99.8), chills, headache, like having COVID all over again. I had and recovered from COVID in the beginning of April 2021
3/4, 10PM -- MUSCLE PAIN AROUND NECK AND SHOULDERS -- WENT TO BED AT MIDNIGHT 3/5, 5AM -- WOKE UP WITH CHILLS FOR ABOUT 2HRS. -- WENT BACK TO SLEEP 3/5, 9AM -- BOTH CHILLS AND MUSCLE PAIN WERE GONE -- INJECTION SITE WAS TENDER 3/7, 7PM -- LYMPH NODES UNDER MY LEFT ARM WERE SWOLLEN AND TENDER, BUT NOT PAINFUL 3/8, 4PM -- ITCHY, SWOLLEN SKIN ON LEFT ARM, BETWEEN INJECTION SITE AND ELBOW  TODAY:  3/9, 2PM -- INJECTION SITE STILL TENDER, LYMPH NODES AND LEFT ARM STILL SWOLLEN AND TENDER
Left axillary lymph node swelling. I am treating the swelling with Motrin 400 mg daily, and Tylenol 1000 mg daily for pain.
SUSPECTED CLINICAL VACCINATION FAILURE; SUSPECTED COVID-19 INFECTION; LIGHT CHILLS; SLIGHT HEADACHE; This spontaneous report received from a 53-year-old female. The patient's height, and weight were not reported. The patient's concurrent conditions included non smoker, and alcohol user (a few time in month to none). The patient had no known drug allergies and no drug abuse or illicit drug usage.  The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805022, and expiry: UNKNOWN) dose was not reported, 1 in total administered on 13-MAR-2021 into left arm between 13:00 hours to 14:00 hours for prophylactic vaccination. No concomitant medications were reported. On 13-MAR-2021, the patient experienced light chills and slight headache and took ibuprofen to relieve symptoms. By 21:00 hours, of the same day, patient felt normal and symptoms resolved. She travelled from 27-JUN-2021 to 01-JUL-2021. On 05-JUL-2021, the patient experienced COVID-19 symptoms of cough, fever (highest at 101.4F), congestion, body aches (felt like sunburn on inside and outside of body; skin hurt to touch), sore throat, extreme fatigue, severe weakness, nausea, diarrhea) and suspected clinical vaccination failure. She was sick for 2 weeks. On 08-JUL-2021, she tested positive for COVID-19. She received letter from Health department on 12-JUL-2021 to be in isolation through (16-JUL-2021). She went to the emergency room (ER) on 13-JUL-2021 , prompted by pain in chest and shortness of breath were severe. She was given antibiotics (unspecified) and inhaler at the ER. She made her primary care physician (PCP) aware and had follow up appointment on 16-Jul-2021. During time of sickness, she had congestion, which did not end until 23-JUL-2021. She was off work for another week. Laboratory data included: Body temperature (NR: not provided) 101.4 F and COVID-19 virus test positive (NR: not provided) positive. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from suspected covid-19 infection on JUL-2021, and light chills, and slight headache on 13-MAR-2021, and the outcome of suspected clinical vaccination failure was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0 - 20210763118- COVID-19 VACCINE AD26.COV2.S -Suspected clinical vaccination failure. This event(s) is considered not related. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event(s) than the drug. Specifically: SPECIAL SITUATIONS
Redness in left arm. Arm was hot. Area where PNEUMOVAX 23 was administered. Cellulitis. Patient is going to visit his Dr. for proper treatment
Chills, headache, nausea, tired, just a real sick and achy feeling- later had diarrhea. Went home and went to bed.
DEVELOPPED FEVER AND RASH AFTER 2ND DOSE OF SHINGRIX
This spontaneous report as received from a registered nurse refers to unspecified child of unknown age. The nurse reported that the child was administered with a dose of MMR II (Lot # not reported) 0.5 ml by subcutaneous injection with a 25 gauge 5/8 inch needle in the thigh and a dose of VARIVAX (Merck) (Lot # not reported) 0.5 ml by subcutaneous injection with a 25 gauge 5/8 inch needle in the thigh on the same day (17-SEP-2012). Additional information has been requested.
pt recv vax 21AUG97 & that evening pt c/o feeling tired & mom stated felt warm;no temp taken that noc;slept well 21AUG97 & woke up feeling OK but tired felt feverish all day given APAP;had abd soreness;t99 to 102;vomited;
2nd dose Patient medicine on 11-20-06 and complain of swelling in lips, hands, and feet.
Severe headaches, stomach and leg pain, shortness of breath.  Discussed symptoms with primary doctor on April 16, 2021, he advised to go to the ER. Headaches, leg pain (severe) and shortness of breath have not subsided as of day 14 following vaccine.
Over 96 hours post vaccine increased soreness, redness, burning, itching right upper arm
flu-like symptoms; aching; vomiting; This case was reported by a consumer via call center representative and described the occurrence of influenza-like symptoms in a adult female patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, less than a day after receiving Shingrix, the patient experienced influenza-like symptoms, pain and vomiting. On an unknown date, the outcome of the influenza-like symptoms, pain and vomiting were recovered/resolved.   It was unknown if the reporter considered the influenza-like symptoms, pain and vomiting to be related to Shingrix.  Additional information was provided as follows: The case was reported by the friend of the patient. The age at vaccination was not reported but selected as an adult as per the vaccine indication. The patient experienced vomiting, aching and flu-like symptoms after the 2nd dose of Shingrix. The events lasted for a day or two and then were resolved. The reporter did not feel comfortable while providing any additional details regarding these events for her friend. The reporter did not consent to follow up. The case is linked with the case- US2020188892  and US20201888957, reported by the same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2020188892:Same Report US-GLAXOSMITHKLINE-US2020188897:Same Report
It was reported that pt (no other specifices reported) recv vax about 2wk prior to the report date of 21AUG98;some time p/vax pt adm to hosp w/fever & leukopenia;It was reportedthat prior to recv vax pt was recently treated for mult myeloma
Just passed 6 weeks from 1st dose and hasn't yet received 2nd dose; This spontaneous case was reported by a health care professional and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (Just passed 6 weeks from 1st dose and hasn't yet received 2nd dose) in a 69-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 19-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PRODUCT DOSE OMISSION ISSUE (Just passed 6 weeks from 1st dose and hasn't yet received 2nd dose). At the time of the report, PRODUCT DOSE OMISSION ISSUE (Just passed 6 weeks from 1st dose and hasn't yet received 2nd dose) outcome was unknown.        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.   Healthcare professional is calling from family practice with a question regarding the timing of the 2nd dose of the Moderna COVID-19 vaccine. She says she has a patient who received the 1st No concomitant medication were reported No treatment medication were reported.  dose on 19Apr2021. She says it just passed 6 weeks from the 1st dose and she is asking if she should still get the 2nd dose.
Fever 100.2, Generalized body aches, vomiting pain and weakness (R) shoulder/arm. Recommended TYLENOL and Bed Rest. Patient experience fever, localized body aches with pain/weakness in her right deltoid. Was seen at urgent care; Now Care; Dr. 10/7/16, who is documenting further. 10/7/16 RN.
continuous trouble breathing multiple trips to urgent cares but primary PA should have all follow up visits much worse migraines than before harder to get rid of started seeing different neurologist sees allergist more and more sinus infections too
pt recv vax & had poor appetite, diarrhea, perioral vesicles-crusts;s/p varicella vax 1mo prior;rash
This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (COVID-19 Disease after 2nd shot) in a 35-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. Concurrent medical conditions included Immunocompromised. On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In December 2021, the patient experienced COVID-19 (COVID-19 Disease after 2nd shot). At the time of the report, COVID-19 (COVID-19 Disease after 2nd shot) outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In December 2021, SARS-CoV-2 test: positive (Positive) Result: Patient reported positive PCR test after second shot. Company comment: This is a spontaneous case concerning a 35-year-old female immunocompromised patient, who experienced the non-serious unexpected event COVID-19, after receiving second dose of mRNA-1273. The benefit-risk relationship of mRNA-1273 is not affected by this report. Concomitant product use was not provided by the reporter. No treatment information provided. Sender's Comments: Company comment: This is a spontaneous case concerning a 35-year-old female immunocompromised patient, who experienced the non-serious unexpected event COVID-19, after receiving second dose of mRNA-1273. The benefit-risk relationship of mRNA-1273 is not affected by this report.
patient missed dialysis because he tested positive for covid. Came to hospital for further evaluation. pt will be discharged home.
Pt. called Health services 08/22/08, 5:00 PM. Reports fever 104 deg and vomiting with severe pain and redness to (L) arm with axillary tenderness and tender (L) breast. Pt. states she feels "lump" under (L) arm. Pt. advised to report to nearest Emergency room with escort. Pt. stated all sx. began night of 09/18/08-Unable to observe pt. Pt. called
REDNESS AROUND INJECTION SITE. TOOK BENADRYL AND SYMPTOMS IMPROVED.
Hepatitis A vaccine (VAQTA - Merck) was administered on 1/18/06  -was seen in ER on 1/19 with acute pericarditis. -pt still being treated with NSAIDs - issue has not entirely resolved.
This non-serious initial spontaneous case, was received from a Pharmacist on 21-Nov-2017, concerning a 36-year-old, adult, female patient. The patient was allergic to latex. On 30-NOV-2016, the patient was administered with FLUVIRIN (dose: 0.5 ml, route of administration: intramuscular, anatomical location: left deltoid, batch number: 158901 (as reported), expiry date: May-2017). It was reported that the patient with latex allergy received FLUVIRIN PFS (explicitly coded as contraindicated product administered) but no adverse event was reported. The reporter assessed the event as non-serious.
pt recvd vax & had high pitched shrill cry for 3-4 hrs; t 102; was lethargic for 1-2 days; PE now entirely nl;
Terrible back pain and cramps, headache, chills, 102 fever, throat hurts.
She got her vaccine, 6-8 hours she started feeling piercing hot, flashing pains, very light to begin with in the outside of her left breast, right under the shot site.  Then the first signs of rash that she noticed was on Saturday on 3/19/22 and then she saw a spot on her back following the nerve on the following Tuesday.  She went to see her GP on 3/23/22 and she gave her a  prescription for an antiviral and stated she had shingles.  The prescription did not help.  The pain continues after the scabs have gone away, and she continues to have pain in the same areas as the rash were, across the outside of the left breast and underneath the shoulder blade.    The reason she got the vaccine as her brother encourage her, she decided not to get chemotherapy so that she would not get shingles, and she then got it.
**Patient verbatim statement**  Immediately following injection the area of treatment swelled up. On Friday, I woke up with severe pain in the left shoulder. I could not pin point the exact location as it was throughout the entire shoulder. I did see my local doctor in March and was issued an anti inflammatory which has reduced the pain significantly and helped the healing process. As of 12 May 2019 the pain is declining but still exists. Will continue to monitor.
Immediately following immunizations: low grade fever off/on for 3.5 weeks; also diarrhea, irritability that also lasted over 3 weeks.
Right arm soreness, chills, muscle aches, fatigue, redness at injection site 2 days after vaccine administration
Fever; Chills; Body ache from the joints; my whole body and that side of my body swelled; I develop a mass; under my armpit towards my breast; This is a spontaneous report from a contactable Nurse (patient). A 57-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number was not reported) via an unspecified route of administration on 01Sep2021 (at the age of 57-years-old) as dose 2, single for COVID-19 immunisation. Medical history included DVTs (deep vein thrombosis), Pulmonary emboly for which she currently being treated (not appropriately clarified). Concomitant medication included atorvastatin calcium (XARATOR) taken for an unspecified indication, valproate semi sodium (DEPAKOTE), zonisamide (MANUFACTURER UNKNOWN) taken for cluster headache, gabapentin (MANUFACTURER UNKNOWN) taken for neuropathy on the left side, start and stop date were not reported. The patient was on Xarelto (further clarification about xarelto was unknown). The patient previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number was not reported) via an unspecified route of administration in Aug2021 (at the age of 57-years-old) as dose 1, single for COVID-19 immunisation. The patient had not received any other vaccine within 4 weeks. On an unspecified date in Sep2021, probably about 6 hours after vaccination, the patient started experiencing fever, body ache from the joints, chills, whole body and that side of her body swelled, develop a mass; under her armpit towards her breast. The patient reported that she had second injection on Wednesday and she had like the fever the chills the body ache from the joints but then on she thought it was Friday or Thursday night, she develop a mass and she would say it was definitely a mass underneath her more under armpit towards breast and the same side of where she got the injection. It seemed like her whole body and that side of her body swelled. The mass was like probably the size of her fist. The treatment taken in response to adverse events the nurse stated, right now she is trying to just take self- treatment. Everybody thinks they should go to the emergency room but she was just trying to take self-treatment as a nurse you know how we are. Just Tylenol around the clock.The patient do have a history of DVT and TEs and she was on Xarelto (further clarification about xarelto was unknown, hence not captured as suspect) and so that's why patient choose the Pfizer so that was one of the big concerns specially when she developed this mass. The patient knew it's very common with the mass and for lymph nodes but she didn't know of it's in relationship to any other the vascular system. The patient not undergone any lab test. The outcome of the events was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
7APR95 sz, t101.7; 25APR95 sz t102; 2MAY95 nl CT Scan; 2MAY95 nl EEG;
HPV#2 and varicella vaccines given and within a few minutes he became light headed and his face became pale. Had him lie down, have a drink and a snack. B/P initially 88/60 and back up to 110/68 after resting for 15 minutes. Entire event lasted 15 minutes.
glaucoma; stool turned black; constipation; clay like stool; heart spasm; chest and abdomen feels hard; movement under skin; euphoria; Looking at things looked so far away. Had no thought in her head.; dryness behind her eyeballs; sensitive to light; teeth felt weak; vivid dreams; heart beating on top of chest; Feels movement under skin, like getting shingles or herpes in different places, face, arms, right side of chest; Feels movement under skin, like getting shingles or herpes in different places, face, arms, right side of chest; felt like getting hemorrhoids; high blood pressure; pupils are very large; horrid dreams; whistling in her chest; chest and abdomen feels hard; This is a spontaneous report from a non-contactable consumer (patient) from a Pfizer-sponsored program. A female patient of an unspecified age received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as single dose for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient had the first dose of vaccine. Side effects reported included stool turned black, constipation, clay like stool, heart spasm, heart beating on top of chest, chest and abdomen feels hard, feels movement under skin, like getting shingles or herpes in different places, face, arms, right side of chest and felt like getting hemorrhoids. Next day, the patient has feeling of euphoria, like on drugs; looking at things looked so far away and had no thought in her head, like taken Vallum but she never took vallum but that's what she thinks it would be. The patient has high blood pressure and takes beta blocker. On the day of vaccine, pulse went to 79, like it reversed medication. The patient has glaucoma, felt dryness behind her eyeballs, the socket, pupils are very large and sensitive to light. Her teeth felt weak, 1 tooth broke from tortilla chip. In sleep, she had horrid and vivid dreams. All stress went into her dreams. 3 days she had no thoughts or stress but would have in dreams. Also, when waking up she had whistling in her chest and feeling like having heart spasm. The outcome of the events was unknown.  No follow-up attempts are possible, information about lot number cannot be obtained. No further information is expected.
Petechaie erythematous rash on lower extremities first seen on 05/22/02, some flat lesions, some raised without discomfort-dermatology referral; seen 05/22/02. Rash increased when seen 06/03/02 -using topical steroids area of rash increasing up legs and elbows slight edema of elbows, complaint of ankle/elbow pain, also large amount of blood in urinalysis. 06/04/02 admitted by rheumatologist , no steroids and diagnosis of H-S-purpura. Follow-up information: Ulcerated lesions of ankles, vesiculated lesions 1-2 cm of ankles.  Palpable purpura of ankles and feet.  Large 5-10mm flat macules of legs.  Smaller 2-5mm flat maccules of hands and forearms.  Patient received Meningococcal vaccine on 05/07/2002.  10 days later developed a palpable purpuric rash on her ankles.  She went to a dermatologist who gave her hydrocortisone cream.  Over the next several days the rash spread up her legs and she developed-ankle knee, and elbow swelling.  Referred to rheumatology and performed a skin biopsy which revealed Leucoclastic vasculitis.  She was given diagnosis of HSP and admitted for evaluation.  On the day of admit she began complaining of epigastric abdominal pain and blood was seen on U/A.
Fever, chills, headache, body ache, fatigue, sore arm, swollen lymph node on left armpit
patient complained of left ear pain (dull ache) x 2-3 days, then noticed mild hissing tinnitus left ear that progressed to full blown loud left tinnitus that persists
Client came into clinic today with a bright red raised rash in large patches on both arms, hands, legs and feet.  His back was nearly covered with rash.  Client had a sore throat also.  He complained of a lot of itching.  He was referred to ER for evaluation and treatment.