chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Pt had labs done at this visit prior to the flu vaccine. Pt tolerated lab draw well but soon after receiving the flu vaccine she stated that her vision was blurry and began to lose consciousness. I had pt lay down and elevate her feet. Gave pt a bottle of water and had her sit up to drink. Pt stated that she felt much better and wanted to go to the lobby to sit with her mom. I walked her to the lobby and she was laughing while telling her mom what happened. After several minutes, pt c/o blurry vision again and became very pale. She stated that she felt like she needed to lay on the floor and mom helped her. I informed Dr. and she came out of the exam room and stayed with pt until she felt better.
Received shots 10/5/04 mom called 10/8/04 stating that child's arm was red, swollen, and had fever and fatigue. Came for a visit. Saw PA and was administered an antibiotic for 10 days.
Hives, Difficulty breathing, light-headedness, vomiting and abdominal pain.  Had Benedryl 25mg PO then sent to ER.  At ER, had IV Benadryl, Pepcid, and possible atropine.  Breathing treatment and not put on Darvocet for pain.
WEDNESDAY EARLY AM RIGHT ARM FELT HEAVY. ARM FELT FROM THE SHOUDLER. JOINT PAIN STARTED FRIDAY 7/30/21 DULL ACHE AT THE BEGINING FROM VARIOUS JOINTS.  7/31/21 UNABLE TO GET OFF COUCH. 8/1/21 THRU TODAY THE JOINT PAIN RESOLVED. SHOULDER PAIN 8/1/21 TREATMENT FOR SHOULDER PAIN WAS IBUPROFEN. DID NOT TOUCH THE PAIN. TENS MACHINE WAS USED AS WELL TO TREAT THE SHOUDLER PAIN.  PT ONLY GOT RELIEF WHILE THE TENS MACHINE WAS IN PLACE.  8/2/21 WENT TO CHIROPRACTOR.  8/4/21 WENT TO  OFFICE BECAUSE PAIN CAUSED PT TO MISS WORK.  PATIENT WAS GIVEN  STERIOD SHOT AND INFLAMATION SHOT.  SHE ALSO PRESCRIBED  STERIOD DOSE PACK.  8/6/21 WENT BACK TO CHIROPRACTOR PT PUT IN TRACTION TO HELP GET MUSCLE RELIEF.   PT HAD TO BEGIN USING PERCOCET 5/325 ON 8/6/21. PT HAS GOTTEN RELIEF BUT THE PAIN IS STILL THERE.  8/10/21 PT WENT BACK TO  GOT X RAY AND LAB WORK.  PT STARTED ON PREDNISONE FOR 9 DAY THERAPY.  HAS BEEN REFERRED TO  PHYSCIAL THERAPY, HAS APPOINTMENT FOR 8/12/2021 . ALSO HAS BEEN APPLYING HEATING PAD TO TRY TO GET RELIEF. PAIN IS CURRENTLY IN SHOULDER AND DOWN ARM.  (8/1-CURRENT)
Shot administered at 13:30 PM Saturday 11/2/2002. Chills and fever at 02:00 Sunday. Patient noticed severe rash and elbow/shoulder swelling in arm. Fever 102. Forearm still tender. Grip strenth poor still.
unknown flu vaccine details as given at pmd, reported from Agency  erythema 11cm x 6cm over L arm at site at vaccine
softer bowel movements; gas; This spontaneous case was reported by a patient and describes the occurrence of FREQUENT BOWEL MOVEMENTS (softer bowel movements) and FLATULENCE (gas) in a 68-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013A21A) for COVID-19 vaccination.     The patient's past medical history included Gastrointestinal disorder (at least once a year prior to receiving Moderna COVID-19 vaccine.) and Hemorrhoids (Chronic). No concomitant medication was reported.  On 26-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced FREQUENT BOWEL MOVEMENTS (softer bowel movements) and FLATULENCE (gas). At the time of the report, FREQUENT BOWEL MOVEMENTS (softer bowel movements) and FLATULENCE (gas) outcome was unknown.     Treatment medication was not provided.    The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.    Patient states that he has had similar symptoms before and has gastrointestinal issues at least once a year prior to receiving Moderna COVID-19 vaccine. Patient also suffers from chronic hemorrhoids which have not resolved since onset of symptoms.
On July 25 afternoon felt weakness a couple of times in the left leg. About 7 PM started to feel pins and needles in feet and hands. About 9 PM went to emergency room, About 2 AM, July 26 was transferred. About 10 AM could not walk without walker and fell with walker, from then on could not walk. After MRI and spinal tap confirmed Guillain-Barre Syndrome, about 7 PM administered IVIG. Over the following 4 days administered the remaining 4 doses of IVIG. On August 1 received a vascular ultrasound on left arm because of severe bruising due to several two arm lifts instead of using Hoyer lift . On August 4 at 3 PM was admitted to ICU because breathing was compromised. While in ICU contracted pneumonia. After breathing tube was removed experienced a reaction to Risperdal with thickening of tongue and facial swelling. August 9 at 11:30 PM was removed from ICU to regular floor room. Was discharged on August 13, 2019 to Rehab Hospital. During my stay there worked on OT and PT.  Released from rehab hospital on September 8, 2019 (27 days)  to Outpatient Rehab. Currently still in rehab.
persistent vomiting beginning approx 5hr p/vax given;IV fluids & Tigan supp & Phenergan & transported to hosp;
pt recv 11AM began high pitched screaming/crying @ 5PM & cried inconsolably for 4hr;MD notified & incident noted on chart;
Systemic: Dizziness / Lightheadness-Mild, Systemic: Flushed / Sweating-Medium, Additional Details: after receiving 2nd shot, patient feels dizziness and swating, feels like passing out. but he was alert. asked about diabetes issue and he denied. offered gatoraid and he said he would like to drink that and provided one bottle with store manager's authorization and after 20 minuts he was feeling better.
When I was given the 2 shots for shingles ( separately ) it gave me a headache like my head was full of broken glass for 3 days or more and that is exactly what it felt like.  The first shot really hurt and my arm swelled up and was very red for about 2 weeks.  The second shot was given by a different doctor.  He pointed the needle in a more downward position on the side of the shoulderand not that deep into the center of the tissue and this shot did not hurt or swell.  Just for your info.
July 27th @10:00pm  -Palpitations -Resting Heart Rate 150bpm -a blood Pressure 145/100 -Numbness in arms -Hives  July 28th @11:00pm -Resting heart Rate 140bpm -Blood Pressure 145/95 -Numbness in arms -Vomiting -Hives  July 31st @3:00pm -Vomiting -numbness in arms -Hives  August 1st-Present -Migraine-Like Headache
5/24 developed fever 103.4  given AX TYLENOL + a bath + noticed jerking spell x 2 lasting 2-3 seconds.  Taken to ER w/ temp 103.4 in ER had a seizure x2 minutes.  given TYLENOL x2, ROZEPHIN.  At 0135 Temp 99.4 Pt nl & P/c'd to home.  Had a rash c/o chickenpox on 5/26 when seen in office, fever gone.
This spontaneous report as received from an adult patient of unknown age and gender, refers to themselves. On 02-OCT-2015, the patient was intramuscularly vaccinated with the first dose of GARDASIL (dose, lot # and expiration date were not provided) in the buttock rather than in the deltoid. Additional information has been requested.
When Prevnar 13 was given, the patient's left thigh immediately begin to swell and bleed profusely.
pt recvd vax & 3 days later devel achy arms, upperback, neck; generalized muscle pain; t 100; went to chn recvd inject; to MD;
Diagnosed with Herpes Zoster Opthalmicus. First symptom-eye pain, 3/9/2021, followed by lesions above eye, forehead p, across scalp, 3/13-14/2021. All left side.
Almost immediately after receiving the HPV vaccine, my daughter fainted as she was walking.  She was unresponsive and lethargic.  She has a bump on her head from falling into the door.
Mom states left leg was swelled for a week.  She did not reach out for medical advise.
Approx 5 minutes after receipt of vaccine, patient reported experiencing palpitations.  Vitals signs were checked and HR elevated to the 130s (regular rhythm) and systolic BP elevated to the 160-170s mmHg;  pulse ox within normal limits.  Some mild tremors noted in left > right hand.   Patient placed in supine position and given 12.5mg IV benadryl and 4mg x2 doses =8mg total IV dexamethasone with symptomatic improvement and normalization of HR / BP.  No hypotension or hypoxia throughout the event.  No angioedema or urticaria.
Sore arm a day after, night sweats 3 days after, stomach cramps 10 days after, muscular aches/joint pain, body pain 17 days after, sinus drainage, sneezing etc, Headache,
Severe Fever. Body Aches. Chills. Lethargy (Slept most of the next day and most of the following day) Severe headache.
She reports that her arm was sore the night of receiving the second dose of SHINGRIX, but was resolved by day #2. However, in morning of day #2, patient had diarrhea and chills that lasted 1.5 days.  She states that she also had a redness that went spread from the injection site down her arm about 5 inches and then went across perpendicular, she said it resolved within 3 days. Patient denies any current side effects, states that it has all resolved at this time.
Information has been received from a health professional concerning a 12 month old patient who was vaccinated with PROQUAD. Subsequently the patient experienced rash. He sought unspecified medical attention. Reportedly the patient recovered from the rash. No product quality complaint was reported. Additional information was not available. This is one of two reports from the same source. Additional information is not expected.
Nearly 2 weeks after the first dose of Moderna vaccine, I received anal bleeding, which deepened within a few weeks and worsened after the second dose - 01.06.22. with fever - 39.5 and pain in the lower right half. After admission to the hospital and numerous tests, an unlocked autoimmune disease - ulcerative colitis - was established. After hospital treatment and several months of diet, the disease was controlled and put into remission. On 08.01.22 I put a booster dose and 7 days later I got another exacerbation of the disease, which consists of anal bleeding.
At 3:11pm, 5 minutes post injection, patient began to feel anxious with dizziness and blurred vision. Moved to lie down on floor. Patient states she has not eaten today. Brought by litter to observation area at 3:45pm. Patient laid down, vitals taken. Given water. Patient notes mild nausea. 4:08pm, patient reports normal vision. Denies nausea. Given crackers to eat. Moved to edge of bed, vitals rechecked. Feeling well. Patient released by wheelchair.
Red, warm to touch, swelling in (L) deltoid. No fever, no swelling of face, lips, tongue. No difficulty swallowing no respiratory distress.
child patient received ACTHIB vaccine about an hour ago that was expired with no reported adverse event; Initial information received on 17-Nov-2022 regarding an unsolicited valid  non-serious case received from a physician.  This case involves a 3 years old male child patient who received acthib vaccine about an hour ago that was expired with no reported adverse event while receiving vaccine hib (prp/t) vaccine [Act-Hib].  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On 17-Nov-2022, the patient received a dose 4 suspect hib (prp/t) vaccine Powder and solvent for solution for injection at a dose of  0.5 ml units total  ( lot UJ600AAB) (expiry date: unknown) via intramuscular route in the left thigh for Immunization.  On an unknown date the patient was diagnosed with non-serious event of "child patient received acthib vaccine about an hour ago that was expired with no reported adverse event" (expired product administered) (unknown latency) following the administration of hib (prp/t) vaccine.  Action taken was not applicable.  Outcome was Unknown    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 the 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.
Location of injection: Leg Right; Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a contactable reporter(s) (Nurse). The reporter is the patient.  A 53-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), as dose number unknown, single (Batch/Lot number: unknown), in right leg for covid-19 immunisation. The patient's relevant medical history included: "Known allergies: Crab, Lobster, sand fleas" (unspecified if ongoing), notes: Known allergies: Crab, Lobster, sand fleas. The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Jun2022, outcome "unknown" and all described as "Treatment of COVID-19"; PRODUCT ADMINISTERED AT INAPPROPRIATE SITE (non-serious), outcome "unknown", described as "Location of injection: Leg Right". Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical course: The patient received Paxlovid oral treatment from 30Jun2022 to 04Jul2022. The patient did not received any other medications the patient received within 2 weeks of vaccination.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.; Sender's Comments: Based on the information available , a possible contributory role of the suspect BNT162B2 cannot be excluded for the reported events of drug ineffective,Covid 19.
15 year old minor given COVID Vaccine Moderna as 2nd dose on 6/9/2021. 1st dose given on 5/16/2021 was Pfizer. Unauthorized age group for Moderna and mixed series error.
Acute ecephalopathy, mental confusion, trouble with motor skills (balance, can't walk, shaking, some paralysis, tremors), mood changes, delusions, possible hallucinations, etc.
This case was reported by a consumer via  interactive digital media and described the occurrence of sickness in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced sickness and hearing decreased. On an unknown date, the outcome of the sickness was recovered/resolved and the outcome of the hearing decreased was not recovered/not resolved.   It was unknown if the reporter considered the sickness and hearing decreased to be related to Shingles vaccine.  Additional details were provided as follows: The patient self-reported this case. The age at vaccination was not reported. The reporter stated that he/she took the shingles shot 4 or 5 years before the date of reporting and was sick for a while, also his/her hearing was terrible and the hearing had continually gotten worse. The follow-up would not be possible as no contact details were available.
Child first got a low grade fever for about 1 day, followed by a rash (measles-like spots) that began on his face and eventually spread down his neck and torso. Dr. seemed unconcerned by the side-effect and we are currently monitoring the rash.
Patient was given expired dose by 1 hour. No treatment needed. Patient was notified. Patient reported no signs/symptoms.
client complained of chest pain-shooting down left arm, rapid heart rate, lightheadedness, shortness of breath.
Sore throat within 20 mins. Chills within 3 hrs. along with muscle ache, severe soreness of all joints, back, neck, etc. Severe flu symptoms, cont'd. for 2 1/2 days then 1 day of weakness.
the right side of my neck begin to start hurting if I turn my head forward or sideways/general neck pain/also tender across the entire neck area; warm to touch; stabbing pain; muscular twisting; constant feeling of flushing; shaking/severe shaking at night; chilling; profuse sweating; This is a spontaneous report from a contactable healthcare professional (patient). A 58-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot and expiry were not reported), via an unspecified route of administration, administered in left arm on 19Mar2021 17:00 (at the age of 58-years-old) as single dose for covid-19 immunisation. The vaccination facility type was reported as other. No other vaccine in four weeks. The patient was not covid tested post vaccination. Medical history included neck and back injuries, and covid prior vaccination: Yes. The patient had no known allergies. Concomitant medication included gabapentin (NEURONTIN). On 19Mar2021 at 17:45 (approximately within one hour of the injection), the right side of the patient's neck begin to start hurting if he turned his head forward or sideways. It was warm to touch and also tender across the entire neck area. This only turned into a more severe that was excruciating one turning head in any direction. As well as lying down the patient had to sleep sitting up in a recliner. With absolutely no relief all the pain the stabbing pain and muscular twisting and general neck pain additionally there was a constant feeling of flushing but at the same time shaking and chilling with severe shaking at night and profuse sweating. Treatment included ibuprofen (MOTRIN), paracetamol (TYLENOL) to tizanidine. The events resulted in doctor or other healthcare professional office/clinic visit, disability or permanent damage. The outcome of the events neck pain, pain and muscle twitching was not recovered while for the remaining events was recovering.  Information on the lot/batch number has been requested.
Approximately 20 minutes after receiving the immunization patient developed itching, rash and hives on her chest, neck and arms. Denied any facial swelling, trouble breathing/swallowing, palpitations or chest tightness, nausea, HA. Moved patient from observation to an exam room, VS were 122/82,  98% on RA, 80bpm with no wheezing, rales, respiratory distress or facial/throat swelling. Gave Benadryl 50mg PO at 4:23pm. At 4:46pm she reported that her itching was improved but she felt light headed. Repeat VSD were 118/90, 99% on RA and 86bpm, with physical exam unchanged.
pt recvd vax; rash noted on face, neck,arms;swelling to hands;seen in hosp; dx: allergic rxn to HBV; hands still swelling;
On day 4 when initial symptoms, sore arm, tired, rash on left upper arm, went away. The rash came back for 2 weeks, loss of appetite for 1 week. My WBC is around 100 with lymphocytes in 80's at this point in my disease. Axillary nodes that the oncologist could feel but I couldn't. Left Axillary node went to a size between walnut and lemon and very uncomfortable. Went to see oncologist day 13-14. I'm a RN so I waited to see if symptoms would go away. After history and exam, we both agreed that it was probably the vaccine not my leukemia. I opted not to have labs done. Now 4 1/2 weeks nodes finally down to pre injection size. It was only the nodes on the side of the injection
Expected symptoms began the following day: achy/flu-ish, fever, headache, sore/swollen arm, very lethargic.  On the fourth day following the injection, injection site and surrounding area became red and began intensely itching .
COVID-19 Vaccine Johnson and Johnson Covid vaccine yesterday 1330 Chest hurts, nasal congestion, chills last night after the vaccine Pt had negative covid test 5 days ago pt had screening while in the hospital for chest pain pt had normal ekg then Pt has achy and tingling in chest and body aches denies fever states does have chills also c/o diarrhea one to two episodes last night and not today is drinking water well Pt states was very tired last night   Since yesterday patient has worsening symptoms,  Today she has increased her oxygen use and continues to feel that she cannot breathe, she presents with chest pain, fatigue, nose is running, chills, cold sweats, cough, abdominal pain  and dizziness. She received the Johnson Covid vaccination four days ago and is concerned this is related to her  blood clotting disorder.  She needs transportation to the ED. Hospital admission on 4/16/21 - remains inpt.  Diagnosis patient iss is a 51 y.o. female with complex past medical history. Including chronic obstructive pulmonary disease currently on 4 L nasal cannula at night. Active tobacco use, remote history of alcohol and polysubstance abuse she has been in remission for 20-25 years from crack cocaine and alcohol. She used methamphetamine 6 months ago. Benign essential hypertension and insulin dependant diabetes mellitus, gastroparesis, bipolar disorder, schizoaffective disorder, psychogenic nonepileptic seizure.  Presented to the emergency department with chief complain of worsening shortness of breath along with right side lower abdominal pain and urinary symptoms including dysuria and burning sensation.  Upon arrival to the emergency department patient was hypertensive and her oxygen saturation was 87 on room air, with moderate respiratory distress.  Initial ABG showed pH of 7.25 with pCO2 of 98 following ABG showed 7.1 and pCO2 of 104  she was placed on BiPAP which has improved her breathing and respiration follow-up ABG showed pH of 7.3 with pCO2 of 73. CT angiogram was negative for pulmonary embolism, showed finding of acute bronchitis/aspiration, CT of the abdomen and pelvis was unremarkable. Urinalysis was negative. Patient was giving 125 mg Solu-Medrol along with magnesium and DuoNeb breathing treatment, and admitted for further management.
Chills; This spontaneous case was reported by a consumer and describes the occurrence of CHILLS (Chills) in a 72-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 007M20A) for COVID-19 vaccination.     No Medical History information was reported.   On 01-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 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 01-Mar-2021, the patient experienced CHILLS (Chills). At the time of the report, CHILLS (Chills) outcome was unknown.            No relevant concomitant medications were provided. No treatment information was provided. The action taken for mRNA-1273 was not applicable.   This case was linked to US-MODERNATX, INC.-MOD-2021-030319 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-030319:crosslink - wife case
pt recv vax & devel h/a, malaise, & gen body aches approx 1k p/vax;pt is being treated w/Toradol PO & sx persist;
circumscribing inject site on lt thigh, macular, hardened, warm area covering lt groin crease distally to mid thigh from medial anterior thigh around laterally to medial posterior thigh;
This spontaneous report as received from a registered nurse refers to a 13 year old female patient. No information regarding the patient's medical history, concurrent conditions and concomitant medications was provided. On 27-AUG-2015, the patient was vaccinated with an expired dose of GARDASIL, lot # K001502, expiration date 06-AUG-2015, (dose, route of administration and injection site were not reported). The nurse stated that the dose received was the patient's first dose in her Human Papilloma Virus (HPV) vaccination series. It was also reported that the patient had not experienced any adverse effects. Additional information has been requested.