chrisvoncsefalvay/vaers-outcomes huggingface dataset:
COVID 19 infection but asymptomatic; A spontaneous report was received from a (Reporter like HCP and Consumer) concerning a 38 Years-old male patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced events COVID 19 infection but asymptomatic.    The patient's medical history was not provided. No relevant concomitant medications were reported.    On 19-JAN-2021, prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 (lot/batch: unknown) intramuscularly in the Anatomical location for prophylaxis of COVID-19 infection.  On 19-JAN-2021, The patient experienced the events COVID 19 infection but asymptomatic was given.   Laboratory details COVID 19 test positive was provided.  No treatment information was provided.   Action taken with mRNA-1273 in response to the events was not reported.   At the time of this report, the outcome of the event, which events are being referenced here was unknown.  The reporter assessed the events COVID 19 infection but asymptomatic as related to study drug.; Reporter's Comments: This case concerns a 38-year-old male who experienced a nonserious unexpected event of COVID-19 (COVID 19 infection but asymptomatic).  The event of COVID-19 test positive occurred the same day as the first dose of mRNA-1273. No additional information available. Further information has been requested. Based on current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.
My chin started to feel numb; My chin started to feel itchy; This spontaneous case was reported by a consumer and describes the occurrence of PARAESTHESIA (My chin started to feel numb) and PRURITUS (My chin started to feel itchy) in a 49-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011A21A) for COVID-19 vaccination.     The patient's past medical history included No adverse event (Medical history not provided).    On 02-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 02-Mar-2021, the patient experienced PARAESTHESIA (My chin started to feel numb) and PRURITUS (My chin started to feel itchy). At the time of the report, PARAESTHESIA (My chin started to feel numb) and PRURITUS (My chin started to feel itchy) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       This case was linked to MOD-2021-032226 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 09-Apr-2021: No new information was provided.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.
A couple of days post vax, this pt developed nausea and diarrhea and decreased appetite. The pt  self-medicated with Immodium without resolve. As of the date of this report, outcome is unresolved.
Patient started feeling pain in the right clavicle/shoulder 2 days after the shot.Thought she hurt her back.Then 3 days later she started feeling a sensation from her right elbow to fingers affecting her fingers.She went back to the emergency room to be treated.She is still having problems with her right side including her face feeling numb.
Patient received influenza vaccination on 11/26/2007 between 9-10am; patient has received the influenza vaccine for the past several years. At 1pm she began to experience puritis of the neck and edema of the eyelids. Difficulty with breathing and swelling of the tongue denied. Patient called her PCP for appointment but was unable to contact him and went home. Patient reports that this reaction had happen to her approximately 2 months ago when she had began a new medication (change from Avandament to Metformin) but the symptoms were worse. By 5pm the rest of her face began to swell and she had blisters on her eyelids and below her eyes; still no airway involvement. Patient denies any redness or swelling at site of injection. Patient saw her PCP 11/27/2207, at which time her symptoms had begun to subside. They did not perform any lab work or provide any treatment other than to instruct her not to ever receive the Influenza vaccine again. Patient is back to work today and states her symptoms are almost totaly resolved, with only mild puritis noted.
Stiffness; Sore arm at the injection site; This spontaneous case was reported by a consumer and describes the occurrence of MUSCULOSKELETAL STIFFNESS (Stiffness) and VACCINATION SITE PAIN (Sore arm at the injection site) in a 72-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 012A21A and 022M20A) for COVID-19 vaccination.     No Medical History information was reported.   On 03-Apr-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 03-Apr-2021, the patient experienced MUSCULOSKELETAL STIFFNESS (Stiffness) and VACCINATION SITE PAIN (Sore arm at the injection site). At the time of the report, MUSCULOSKELETAL STIFFNESS (Stiffness) and VACCINATION SITE PAIN (Sore arm at the injection site) outcome was unknown.            No relevant concomitant medications were reported. No treatment information was provided.
Pt states feeling flushed, lightheaded, tingling in hands, chest and feet, and heart racing/palpitations.
The pt experienced a 7 cm area of erythema, edema to upper left thigh, complained of pain when site was palpated. The pt was walking ok.
I have a history of genital herpes, no breakout for about a year. Three days after my vaccination, I developed a breakout.
A non-serious, spontaneous report of sprayed in the eye was received from a pharmacist regarding a 43 year-old female following administration of FLUMIST. The patient jerked her head during intranasal administration of FLUMIST, and a little amount of the vaccine was sprayed in her eye. There was no adverse event experienced; therefore treatment and reporter/sponsor causality assessment are not applicable and the event is considered resolved.
He has been followed by cardiology for history of atrial fibrillation. He received his booster COVID vaccine on 4/28/22 on the same day he saw his cardiologist. At which time, his Multaq was changed to flecainide and metoprolol as he was having some episodes of break-through atrial fibrillation. He reported to the ED on 5/1, three days later, for episodes of bradycardia with heart rates in the 40s and chest pain. Cardiology evaluated the patient in the ED, and thought myalgias could possibly be secondary to the vaccine, though it did seem to resolve with holding the metoprolol and flecainide.  He was discharged with a 48 hour Holter monitor and plans to follow-up with cardiology outpatient.
Patient had Pfizer vaccines on 1/6/21 and 1/28/21. Known exposure to COVID-19, tested positive for COVID 19 by PCR on 3/19/21. Symptoms of H/A, rhinorrhea
On 5/2/00, the pt received the fourth dose of Infanrix and approximately 24 hours later he experienced rapid swelling of the left thigh from hip to knee approximately one inch greater than the right thigh. His mother noticed redness "like an insect bite", erythema, induration and warmth at the injection site. 48 hours post vax, the pt experienced a fever of 103 degrees and was taken to the ER. He was treated with oral antipyretics. The ER physician noted the child's fever had improved, he did not appear to be clinically ill and his thigh was only slightly swollen. The most recent information received on 5/5/00 reported the symptoms were resolving.
tested positive for COVID; tested positive for COVID; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A 68-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Rheumatoid Arthritis" (unspecified if ongoing). There were no concomitant medications. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 19May2022, outcome "not recovered" and all described as "tested positive for COVID". Patient was tested positive for COVID on 19May2022. Patient had completed full course of Paxlovid. She experienced severe diarrhea on day 2 of Paxlovid. Rebound symptoms started 29May2022. Since rebound, testing positive for COVID. The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (19May2022) Positive; (29May2022) Positive.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
5 min post injection- nauseous for a few minutes 9 hrs post injection-  severe stomach pain and                 sudden onset vomiting lasting for several hours. Chills and  malaise throughout next day.
6 days after injection patient came back complaining of red mark at injection site. PharmD and Nurse examined site and there was approximately 3-4 inch red circle around injection site. Currently negative itching and the reaction was getting smaller. Patient stated it had covered entire back of upper arm. Patient was counseled to contact doctor if it did not clear up within a couple of days or got worse.
ABDOMINAL PAIN; POSSIBLE NEUROLOGICAL PROBLEM; WEAKNESS/WEAKNESS IN GIRDLE MAGNIFIED; MUSCULAR WEAKNESS; DIARRHEA; MUSCLE FELT ACHEY; LOWER LEG PAIN; MUSCLE FELT LIKE THEY NEED TO BE STRETCHED; PAINFUL URINATION; This spontaneous report received from a patient concerned a 55 year old male. The patient's weight was 180 pounds, and height was 68 inches. The patient's concurrent conditions included: type 2 diabetes, non smoker, no alcohol use, alcohol allergy, and weakness in girdle, and other pre-existing medical conditions included: The patient did not have history of 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: 043A21A, and expiry: UNKNOWN) dose was not reported, administered on 09-APR-2021 for prophylactic vaccination. Concomitant medications included atorvastatin calcium, and canagliflozin. On APR-2021, the patient experienced muscle felt like they need to be stretched. On APR-2021, the patient experienced lower leg pain. On APR-2021, the patient experienced muscle felt achey. On 10-APR-2021, the patient experienced diarrhea. On 16-APR-2021, the patient experienced muscular weakness. On 21-APR-2021, Laboratory data included: Duplex ultrasound (NR: not provided) did not had any significant results. On 02-AUG-2021, Laboratory data included: Urinalysis (NR: not provided) normal. On 02-AUG-2021, the patient experienced painful urination. On 03-SEP-2021, Laboratory data included: Complete blood count (NR: not provided) normal, Comprehensive metabolic panel (NR: not provided) normal, Fecal elastase test (NR: not provided) normal, Fibrin D dimer (NR: not provided) positive, Lipase (NR: not provided) normal, Plasma protein (NR: not provided) normal, Stool analysis (NR: not provided) normal, and Thyroid function test (NR: not provided) normal. On an unspecified date, the patient experienced abdominal pain, painful urination, possible neurological problem, and weakness/weakness in girdle magnified. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from diarrhea, and muscular weakness, and the outcome of abdominal pain, weakness/weakness in girdle magnified, muscle felt achey, muscle felt like they need to be stretched, lower leg pain, painful urination and possible neurological problem was not reported. This report was non-serious.
COVID-19 breakthrough case. History: acute severe headach and neck pain especially on sitting and standing. presented to ED day prior with increased numbness and alteration of sensation of lower extremities in setting of recent COVID-19 infection. Covid testing at outside clinic approximately 4 days prior to admission. Admitted 8/24/21. Note: previously received Pfizer Covid-19 vaccine on 4/2/21 & 4/23/21. Diagnosed with Covid infection without respiratory symptoms. No treatment for this. paresethesia of hand/feet likely due to COVID infection. Discharged on 8/27/21.
Right shoulder: She exhibits decreased range of motion (on abduction of shoulder) and swelling. She exhibits no bony tenderness, no effusion, no deformity, normal pulse and normal strength. Right elbow: Normal. Lymphadenopathy: She has no cervical adenopathy. Neurological: She is alert. Skin: Skin is warm and dry. Capillary refill takes less than 2 seconds. No rash noted. There is erythema (circumferential erythema extending from right shoulder to elbow with moderate amount of swelling, warmth and tenderness). Vitals reviewed. Cellulitis of right upper arm - BENADRYL 12.5 mg/5 mL liquid; Give 10 mL by mouth three times daily for 2 days then every 6-8 hours as needed.  Dispense: 118 mL; Refill: 0 - KEFLEX 250 mg/5 mL suspension; Take 6.3 mLs (315 mg per dose) by mouth 2 (two) times daily for 10 days.  Dispense: 126 mL; Refill: 0 - Cool compresses PRN - Advised mom report will be made to VAERS to which she is in agreement - F/u in 2 days for recheck or sooner for worsening sx. Advised mom to mark area of erythema and strict f/u for worsening erythema or swelling - Educated re: dx etiology, mgmt, and f/u.
This spontaneous report was received from a registered nurse and refers to a 3 year old male patient. The patient's concurrent conditions, medical history and concomitant therapies were not reported. On 20-OCT-2016, the patient was vaccinated with an improperly stored PROQUAD lot # M022402 with expiration date of 01-NOV-2017 (dose, route and frequency were not reported) for prophylaxis. It was stated that the vaccine underwent a temperature excursion of 6 degrees Fahrenheit to 14 degrees Fahrenheit for 23 days. It was reported that there was no need to repeat vaccine. This is one of the several reports received from the same reporter. Sender's Comments: US-009507513-1705USA013888.
22AUG 6AM n,v, 630AM unable to breath properly; like diaphragm not working or muscle spasms for 10 mins, was hot & sweating, fever, coughing up phelgm, tickle in throat, joint aches, sore throat, abd cramps & pains, couldn't sleep, chills
cramps in stomach; chills; aches in joints; Diarrhea; This is a spontaneous report from a contactable consumer, the patient. A 77-year-old non-pregnant female patient received unknown dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EN6207) via an unspecified route of administration in the left arm on 10Mar2021 at 08:45 (at the age of 77-year-old), as a single dose for COVID-19 immunisation. Medical history included osteoporosis, hypertension, restless legs and low thyroid. Concomitant medications included levetiractan (MANUFACTURER UNKNOWN), ropinirole (MANUFACTURER UNKNOWN), baby aspirin (MANUFACTURER UNKNOWN) and valsartan (MANUFACTURER UNKNOWN) taken within last two weeks of vaccination for an unknown indication from an unspecified date. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested positive for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient had not tested positive for COVID-19 since the vaccination. On 18Mar2021 at 12:00 AM, the patient experienced chills, aches in joints, cramps in stomach, and diarrhoea. The patient did not receive any treatment for the adverse events. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The clinical outcome of the events chills, aches in joints, cramps in stomach, and diarrhoea was recovering.   No follow-up attempts are possible. No further information is expected.
Pt recv vax on 11/24/98; 1.5 wk post vax pt exp knot on leg
Elevated Heart rate/ Heart rate high; Dizziness; First dose janssen and second dose of Moderna COVID-19 vaccine; This spontaneous case was reported by a consumer and describes the occurrence of HEART RATE INCREASED (Elevated Heart rate/ Heart rate high), DIZZINESS (Dizziness) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (First dose janssen and second dose of Moderna COVID-19 vaccine) in a female patient of an unknown age who received mRNA-1273 (Spikevax) for Prophylactic vaccination.     Previously administered products included for Prophylactic vaccination: JANSSEN COVID-19 VACCINE (Dose1 with Batch no as 1805022 reported and Action taken was given as Not applicable.). Past adverse reactions to the above products included No adverse event with JANSSEN COVID-19 VACCINE.    On an unknown date, the patient received second dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On an unknown date, the patient experienced HEART RATE INCREASED (Elevated Heart rate/ Heart rate high), DIZZINESS (Dizziness) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (First dose janssen and second dose of Moderna COVID-19 vaccine). At the time of the report, HEART RATE INCREASED (Elevated Heart rate/ Heart rate high), DIZZINESS (Dizziness) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (First dose janssen and second dose of Moderna COVID-19 vaccine) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Heart rate: elevated (High) Elevated.         No concomitant medications reported  It was unknown if any adverse reactions took place after Dose 1.  No Treatment medications reported
This case was reported by a consumer via call center representative and described the occurrence of anemia in a 63-year-old female patient who received SHINGRIX for prophylaxis. In April 2018, the patient received the 1st dose of SHINGRIX (intramuscular). In April 2018, 1 day after receiving SHINGRIX, the patient experienced general body pain. In August 2018, the patient experienced anemia. On an unknown date, the patient experienced lethargy and tiredness. On an unknown date, the outcome of the anemia, lethargy and tiredness were not recovered/not resolved and the outcome of the general body pain was recovered/resolved. It was unknown if the reporter considered the anemia, lethargy, tiredness and general body pain to be related to SHINGRIX. Additional details were reported as follows: The patient received SHINGRIX on Left arm. The patient states that not long, less than a year after receiving the SHINGRIX dose, she experienced tiredness and lethargy. The patient states that she went to the physician and had blood work done in August 2018 and it showed that she was severely anemic. The patient states that in January 2018 her blood work was normal and she was not anemic. The patient states that she was not sure if it was related to the SHINGRIX vaccine or not, she was just trying to figure out what could be causing the anemia. The patient was going to see a hematologist in 2 weeks for the anemia. This case was linked with case US2018188575, reported by same reporter.
2/7 within one hour of vaccine, experienced throat and chest tightness which subsided after a couple hrs when severe chills and muscle aches began.   I had epi pen with me which was prescribed by my Dr as a precaution. 2/8, developed significant rash across trunk front and back/neck/face/left arm, numbness in left side of face, tongue and lips, and significant chest tightness.  Called nurse hotline and was instructed to go to ER.  Once at hospital, contacted staff inside and was evaluated remotely and instructed to take my medications and double dose of antihistamines and monitor from outside due to covid protocol at that time.  After 2 hrs, symptoms subsided and I was able to return home. 2/9, contacted my asthma/allergy specialist via remote session  and he advised continued monitoring and dosing of antihistamine as chest tightness was continuing and rash was intermittent.   2/10 Doctor recommend a Covid test to rule out any active infection.  Test results were negative 2/10-17  Doctor continued to follow up with me to monitor my condition which resolved after 10 days of treatment, with the exception of the numbness in part of my lips which persisted for approx 6 weeks. I was advised by Doctor and my primary physician, not to take the second dose of Moderna. 4/1    Doctor ordered antibody testing to see if I had gained any protection from the 1 dose of Moderna.  I was tested for both the disease antibody as well as the vaccine spike protein.  Results were negative for any antibody from prior infection, but did show vaccine response antibody at low level (9.6) Doctor followed up with recommendation that I could consider J&J shot.  I made an appt, but 2 days before that appt the J&J shot was put on pause due to clotting issues.  After consulting with Dr. again, my history of father having stroke at age 52 and that I have recently stopped using oral contraceptives, made J&J no longer a good option for me. Currently, my Dr has advised the Novavax or Sanofi vaccine types should be a safe option for me, so I am still maintaining masking and social distancing until I am able to receive one of those vaccines as soon as they become available.
pt. received  booster shot 5 months 4 days rather than 6 months
The evening after receiving the vaccine developed achiness, sore throat, fever, and chills. Next day developed rash on R neck and chest to breastbone. Symptoms resolved in 4 days.
Severe pain through entire left arm. Muscle weakness, unable to grip anything with left hand. Odd sensations of cold water or prickling running down arm.