chrisvoncsefalvay/vaers-outcomes huggingface dataset:
joint discomfort on right and left side of calf and behind knee/ discomfort at joints when he "goes to get out of a chair" or "if I have to squat low"; elbow, forearm flare ups of joint discomfort and pain / "Feels like arthritis that comes and goes"; This spontaneous case was reported by a consumer and describes the occurrence of MUSCULOSKELETAL DISCOMFORT (joint discomfort on right and left side of calf and behind knee/ discomfort at joints when he "goes to get out of a chair" or "if I have to squat low") and ARTHRALGIA (elbow, forearm flare ups of joint discomfort and pain / "Feels like arthritis that comes and goes") in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 021A21A and 012M20A) for COVID-19 vaccination.     No Medical History information was reported.   On 30-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 28-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In 2021, the patient experienced MUSCULOSKELETAL DISCOMFORT (joint discomfort on right and left side of calf and behind knee/ discomfort at joints when he "goes to get out of a chair" or "if I have to squat low") and ARTHRALGIA (elbow, forearm flare ups of joint discomfort and pain / "Feels like arthritis that comes and goes"). At the time of the report, MUSCULOSKELETAL DISCOMFORT (joint discomfort on right and left side of calf and behind knee/ discomfort at joints when he "goes to get out of a chair" or "if I have to squat low") and ARTHRALGIA (elbow, forearm flare ups of joint discomfort and pain / "Feels like arthritis that comes and goes") outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In 2021, X-ray: normal (normal) normal.         Patient stated that  he had this type of discomfort in his life and that he was always healthy and wondered if this was due to the Moderna vaccine. Patient also was scheduled for MRI.  No concomitant medications were reported  Treatment medication included  anti-inflammatories
Started 6 hours after injection and lasted 24 hours that included - Chills, Nausea, Muscle & Joint aches, Severe headache, Fatigue. I didn't take any course of action other than rest and sleep.
Patient presented to the ED in town on 8/29/2021 with c/o shortness of breath and syncopal episode.  He completed his COVID vaccination in February 2021.  His O2 sats were 88% so he was started on oxygen and eventually required 6L of high flow.  He was started on steroids and remdesivir.  He was eventually on room air at rest, but still required 3L oxygen with activity.  He was discharged to home with Rx to complete a 10 day course of steroids.  No oxygen prescribed upon discharge.
This spontaneous report as received from a registered nurse refers to an 18 year old patient of unknown gender. The patient's medical history, concurrent conditions and concomitant medications were not reported. On 23-MAR-2017, the patient was vaccinated with the improperly stored (between 6 and 14 degrees Fahrenheit for 30 minutes) dose of VARIVAX (for prophylaxis, lot # L050561 with expiration date of 14-DEC-2017 or lot # M019841 with expiration date of 20-APR-2018; dose and route of administration were not reported) that was reconstituted with the properly stored sterile diluent. No adverse effects and no previous temperature excursion were reported. Data logger was involved. This is one of two reports received from the same source. Additional information has been requested.; Sender's Comments: US-009507513-1704USA009837:
Pt recvd vax in MAY92 w/no adverse reaction;  JUN92 pt was vaxed w/2nd dose of vax & devel burning sensation upon inject as well as soreness & or an aching sensation in the arm; heaviness in the arm;
Had a sudden bleeding from left nostril that took 30 minutes to to stop at 3:30 pm on 4/6/2021. On 4/7/2021 at 1:05 pm sudden bleeding from left nostril again took about 25 minutes to stop bleeding had a quarter sized blood clot come out of my mouth towards end of nose bleed. Do not typically get nose bleeds.  Called dr told to report incidents and to report to Ed if gets worse or happens again.
2 weeks, post vax, slurred speech, unstable gait, twitchy body movements, worsened X a few days then began to improve but intermittently worse. Took 2 months to resolve symptoms.
Dizziness; Palpitation; I had tingling in my face and my legs; Myalgia; Nausea; Headache; Fatigue; This is a spontaneous report from a contactable consumer (emergency department technician like a clinical assistant). A 22-year-old female patient received her first injection of BNT162B2 (Pfizer/ BioNTech Covid-19 vaccine, lot number EK9231) intramuscularly at a single dose on 17Dec2020 for Covid-19 immunization. The patient had a medical history of migraine. Concomitant medications included cyproheptadine for migraine and multivitamins. The patient experienced dizziness and palpitations initially and then little bit later on the day she had tingling in her face and legs and she had myalgia, nausea and headache and fatigue. The symptoms lasted for 2 days. The patient medicated with Benadryl and Famotidine. Outcome of the events was unknown. The patient had her second vaccine injection on 06Jan2021.
This spontaneous report as received from a certificate medical assistant (C.M.A.) refers to a multiple unspecified patients of unknown age and gender. On an unknown date multiple unspecified patients were vaccinated with a dose of (Merck) PROQUAD (dose, frequency, lot number and expiration date were not reported) which were improperly stored. No adverse effects reported. Additional information has been requested.
Information has been received from a pharmacist concerning a female who was vaccinated with a dose of pneumococcal 23v polysaccharide vaccine. The reporter indicated that two weeks prior to vaccination, the pt was vaccinated with the flu vaccine. The pt developed cellulitis the next day after vaccination with pneumococcal 23v polysaccharide vaccine. The pt was treated with PO Keflex and completely recovered within 24 hours. The reporter did not know if pneumococcal 23v polysaccharide vaccine was given in the same arm that the pt received the flu vaccine. There was no product quality complaint involved.  The pharmacist also reported additional pts who had similar experiences following exposure to pneumococcal 23v polysaccharide vaccine. Additional info has been requested.
Head ache, ringing in the ears, Arthritis in the hands, Numbness in right finger, stiffness in body, feeling cold and feeling agitated.
swirled in between fingers/ No evidence of leakage in package; Product got on her hand; Product got on her hand; This case was reported by a pharmacist via call center representative and described the occurrence of occupational exposure while preparing product for administration in a 59-year-old female patient who received Herpes zoster (Shingrix) (batch number 4B53D, expiry date 10th October 2022) for prophylaxis. This case was associated with a product complaint.   On 17th May 2021, the patient received Shingrix. On 17th May 2021, unknown after receiving Shingrix, the patient experienced occupational exposure while preparing product for administration and exposure via skin contact. On an unknown date, the patient experienced pharmaceutical product complaint. On an unknown date, the outcome of the occupational exposure while preparing product for administration, exposure via skin contact and pharmaceutical product complaint were unknown.  Additional details were provided as follows: Age at vaccination was not applicable for this report. It was reported that the defect discovered while reconstituting. The reporter stated health care professional swirled in between fingers and unknown amount of air injected in vial, prior to turning upside to withdraw .The vial was held upside down. The product got on her hand, which led to occupational exposure while administering product and exposure via skin contact. No product was administered. The preparer was an experienced user. Rubber stopper/metallic skirt did not become loose on vial before handling. Flip-off cap was removed by HCP.  No evidence of leakage in package. The reporter failed to ask for picture.  The reporter did not consent to follow-up.
Diagnosed with paroxysmal atrial fibrillation on remote ICD monitoring on 3/13/2021.  Patient also had recent hospitalization for acute on chronic systolic heart failure and discharged on 3/28/2021.  03/31/2021: He presented to his local ED today with SOB and palpitations. His heart rate is in the 120s in Afib w/ RVR, and BPs are soft (80s-90s systolic)
felt flush; hands sweating; lightheaded; heart rate increased; chest tightness; blood pressure measurement: 141/101; This is a spontaneous report from a contactable nurse (patient). A 44-year-old female patient (not pregnant) received first dose of BNT162B2 (Lot number: Ek5730), via an unspecified route of administration in left arm on 23Dec2020 13:30 at single dose for COVID-19 immunization. Medical history included allergies: Bees, penicillin, hypertension, all from an unknown date and unknown if ongoing. Concomitant medication included olmesartan medoxomil (BENICAR), escitalopram oxalate (LEXAPRO), propranolol, colecalciferol (VITAMIN D). The patient experienced felt flush, hands sweating, lightheaded, heart rate increased, chest tightness all on 23Dec2020 13:45. 10 min post dose felt flush, hands sweating, lightheaded, heart rate increased, chest tightness all on 23Dec2020 01:45 PM. Given cetirizine hydrochloride (ZYRTEC). Subsided after 5-10 min. The patient underwent lab tests and procedures which included blood pressure measurement: 141/101, heart rate: increased, pulse: 85, Sats (oxygen saturation): 99 all on 23Dec2020. Facility where the most recent COVID-19 vaccine was administered: Hospital. The patient didn't receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. The adverse event result in Doctor or other healthcare professional office/clinic visit. The outcome of events was resolved on 23Dec2020.
Headache, Fever, Numbness, tingling, and pain in arm that received vaccine w/in 5-10 minutes of receiving vaccine ? Lasted all day 1st day and part day 2nd day o Fever of 101, chills, hot and cold sweats, headache, fatigue, weakness ? Started during the evening day 1 an Narrative:  Other Relevant History:
pt c/o deep muscle ache to lt leg-old injury @ age 18;skin grafts-pain is constant even when testing started on day of shot 17AUG98 cont w/pain taking Ibuprofen used warm packs for 1wk;cont w/pain, but leg is improving;
About 12 hours after receiving my second dose (around 10 PM) of Pfizer vaccine, I began to experience muscle soreness and aches, low grade fever,  nausea, and very frequent heart palpitations. I felt like my heart was "off rhythm"  with more palpitations than regular beats, and at times seemed like it was struggling to beat with a very forced heart beat.  My husband took my pulse and it was 98 bpm. We debated going to the ER due to the frequency of the palpitations, but I could not drive and with young kids at home I would have to go in an ambulance. We did debate calling 911. I could not take any medication to lessen some of my symptoms--like the muscle aches--  due to the nausea and dizziness. These symptoms all together were severe for me, and I have never experienced heart palpitations like that before in frequency and severity. All symptoms were short lived. By 2AM I felt good enough to take ibuprofen and then had complete resolution of all symptoms.
Very fatigued; Foggy brained difficulty focusing; swelling, redness and itching at the shot location; swelling, redness and itching at the shot location; swelling, redness and itching at the shot location; Foggy brained difficulty focusing; This is a spontaneous report received from a contactable consumer, the patient. A 48-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot number: EN6208) via an unspecified route of administration on left arm on 16Mar2021 at 12 hours (at the age of 48-year-old) as a single dose for COVID-19 immunisation. The medical history included known allergies of nutmeg, cayenne and lactose intolerant, autoimmune graves and hashimotos. The concomitant medications were not reported. The patient had not received any other vaccines within 4 weeks prior to the COVID vaccine. On 16Mar2021 at 17 hours, the patient felt very fatigued for approximately 36 hours after the vaccination and foggy brain, difficulty focusing, swelling, redness and itching at the shot location. Prior to vaccination, the patient was not diagnosed with COVID-19 and patient was not tested for COVID-19 since the vaccination. No treatment medications were taken for the reported events. The clinical outcome of the events was recovered on unknown date in Mar2021.  No follow-up attempts are needed. No further information is expected.
Increased fatigue, lightheadedness, nausea, intermittent left arm pain and underarm pain and swelling. Left sided chest discomfort - pain worse with breathing and coughing  non productive cough
15yr female patient received first dose of COVID19 Pfizer- Purple Top LOT#FL3198 Exp 2/18 in the left deltoid. LPN notified nursing supervisor LPN the vaccine expired by time. LPN notified Dr. of the possible medication error. LPN notified the patient and mother of the vaccine administration timing and error. Mother and patient understood and will wait for the patient to be monitored and for LPN to advise of next steps. Vaccine expired 22 hours prior to administration. LPN contacted Pfizer Biotech and to determine if the vaccine is viable. Pfizer notified LPN of the following: stored in the refrigerator at temperatures between 2-8c, drawn in an individual syringe, less than 24 hours. The vaccine will not harm the patient. Pfizer is unable to advise if another dose should be administered. Pfizer states, It is at the clinic discretion to provide another dose.?  Monitored the patient for 1 hour after administration. No signs or symptoms of distress. Patient tolerated well. Notified the patient of Pfizer information. Patient and mother understood and left the clinic. LPN notified (RN supervisor) immediately.
Narrative:  Symptoms:  Arthralgia, Fever, Angioedema & EAR ACHE Treatment:
Nausea; Headache; This is a spontaneous case was received on 18-Jan-2021, reported by other non-health professional to Med Communications (reference number: SEQW21-00213) and concerned a 26-year-old, female patient.  The patient's concurrent conditions were not reported. The patient was not taking any concomitant medications.  On 26-Oct-2020, the patient was vaccinated with Flucelvax Quadrivalent (influenza vaccine, subunit influenza virus vaccine polyvalent; dose: 0.5 ml, anatomical location and route of administration: not reported) for flu prophylaxis. The batch number reported was 283849 and expiry date reported was 30-Jun-2021.  On the same day, after receiving Flucelvax Quadrivalent, reported as ever since, the patient had been suffering from headaches and nausea.   On an unspecified date, the patient visited numerous medical specialists and underwent tests in search of a root cause. The patient's father stated she had done tons of blood works, cat scan of the brain and the pelvis. The treatment measures included steroids and migraine medicines.  At the time of initial reporting, the patient had not recovered from the events.  The reporter did not provide causality assessment.  Company comment: The events of nausea and headache are assessed as related to Flucelvax Quadrivalent.; Sender's Comments: The events of nausea and headache are assessed as related to Flucelvax Quadrivalent
RN drew up vaccines for twin siblings. They were both to receive 15 month shots (4 each). I set up the the vaccines in doubles and did not separate vaccines with each child, thus when I didn't add diluent to HIB - I didn't know which child received just the diluent and which the HIB.
A 53 year old male pt, with a history of previous atrial fibrillation, cardioversion, and depression, had received an injection of Fluzone SV 2006-2007, lot number unk, on 11/30/06. Route and site of administration were not reported.  Within one minute post vaccination, the pt went into ventricular fibrillation arrest. He was subsequently shocked times two. The pt was hospitalized and is now in atrial fibrillation. Illness at the time of vaccination was unk. Concomitant medications included daily aspirin and fish oil. Wellbutrin was discontinued. At the time of this report, the pt had not recovered.
Fainted 2 times; low blood pressure; dizzy; tachycardia; vertigo; nystagmus; body aches; fatigue; Felt nauseas; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of SYNCOPE (Fainted 2 times) in a 50-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 018821A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Hypothyroidism. Concurrent medical conditions included Allergy (anything cold.). Concomitant products included NSAIDS for Back pain, LEVOTHYROXINE for Hypothyroidism.    On 26-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 26-Mar-2021, the patient experienced SYNCOPE (Fainted 2 times) (seriousness criterion medically significant), HYPOTENSION (low blood pressure), DIZZINESS (dizzy), TACHYCARDIA (tachycardia), VERTIGO (vertigo), NYSTAGMUS (nystagmus), MYALGIA (body aches), FATIGUE (fatigue) and NAUSEA (Felt nauseas). At the time of the report, SYNCOPE (Fainted 2 times), HYPOTENSION (low blood pressure), DIZZINESS (dizzy), TACHYCARDIA (tachycardia), VERTIGO (vertigo), NYSTAGMUS (nystagmus), MYALGIA (body aches), FATIGUE (fatigue) and NAUSEA (Felt nauseas) outcome was unknown. Not Provided    DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 26-Mar-2021, Laboratory test: normal.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Treatment information included, meclizine 25 mg and metoclopramide was provided for vertigo and nystagmus.; Sender's Comments: This case concerns a 50-year-old female with a serious unexpected event of syncope, and nonserious unexpected hypotension, dizziness, tachycardia, vertigo, nystagmus, and expected myalgia, fatigue, nausea. Event onset the same day as first dose mRNA-1273. Event outcomes unknown. 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.
nausea; vomiting; diarrhea; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from a sales representative.  An elderly female patient received BNT162b2 (COMIRNATY), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported.  The following information was reported: NAUSEA (non-serious), outcome "recovered"; VOMITING (non-serious), outcome "recovered"; DIARRHEA (non-serious), outcome "recovered", described as "diarrhea".  Additional information: Reporter Reported that elderly mother in law had nausea, vomiting, and diarrhea for 48 hours following Pfizer COVID vaccine. Awareness Date 01Jun2022.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
pt devel a severe sore throat & fever 104 p/receiving flu vax; pt was ill for 2 wks; Pt seen by MD  9NOV91 & dx w/viral tonsillitis;
Information has been received from a registered nurse concerning a 9 year old hispanic male with attention deficit/hyperactivity disorder and no allergies who on 15-JUN-1998 was vaccinated SC with first dose of Varivax (lot # 625372/0057H). Concomitant vaccination on the same day included an IM fourth dose of HIBTITER (lot # M240R). Concomitant therapy included POCALIN, ZOLOFT, vitamins (unspecified), and "XR-20". There was no illness at the time of vaccination. On 08-MAY-2006, the patient developed varicella breakthrough on his trunk, arms, legs, and face. The nurse states the lesions were too numerous to count. Unspecified medical attention was sought and he was treated with calamine lotion. No diagnostic laboratory tests were performed. The patient recovered on an unspecified date. A product quality complaint was not involved. No further information is expected.
Severe abdominal pain, increased pain with food intake, fatigue, abnormal liver functions, inability to have bowel movements. Numerous medical testing, including blood work, allergy testing, colonoscopy, and upper GI were conducted to get to the root of the problem. The only thing doctors were able to come up with is IBS and severe allergies. Symptoms began within 3 weeks of the 3rd dose of the vaccine. First contact with doctor was in February 2014, and treatment continues to this day.
Patient developed erythematous rash below the injection site, red and  warm to the touch. Denies shortness or breath or swelling of lips/tongue/throat
COVID-19 treatment; COVID-19 treatment; 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 female patient received BNT162b2 (BNT162B2), as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation; covid-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown) and as dose 2, single (Batch/Lot number: unknown) 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-19 treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive. Therapeutic measures were taken as a result of drug ineffective, covid-19. The patient received treatment of Paxlovid tablets and for COVID-19.  Clinical information: The patient mentioned that she had the vaccination, 2 of them. Patient had one booster and had hearing loss from the booster, so patient cannot get vaccinated anymore to get a second booster.   The lot number for [BNT162b2], was not provided and will be requested during follow up.