chrisvoncsefalvay/vaers-outcomes huggingface dataset:
MUSCLE ACHES IN THE CALVES; This spontaneous report received from a patient concerned a male of unspecified age. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose was not reported, administered on 30-APR-2021 for prophylactic vaccination.  The batch number was not reported and has been requested. No concomitant medications were reported.  On 30-APR-2021, the subject experienced muscle aches in the calves. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of muscle aches in the calves was not reported. This report was non-serious.
Pt reported he was in his usual state of health, back to work following his surgery in Dec 2020 for intraabdominal abscess s/p small bowel resection when he reported sudden nausea developing the day after his second covid 19 vaccination which continued to progress to then development of abdominal pain resulting in ER visit on 3/20/2021 with resultant hospitalization(still hospitalized as of 4/2/21 with working diagnosis of mesenteric ischemia and AKI.
BLOOD CLOTS IN URINE; BLOOD IN URINE; STABBING BACKPAIN IN THE KIDNEY AREA ON THE RIGHT SIDE; SEVERE HEADACHE; This spontaneous report received from a patient concerned a 72 year old male. The patient's height, and weight were not reported. The patient's past medical history included healthy. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805020, expiry: 09-JUL-2021) dose was not reported, frequency 1 total administered on 05-JUN-2021 to left arm for prophylactic vaccination. No concomitant medications were reported. On 6-Jun-2021 the patient complaint of a severe headache at 2 am, followed by severe stabbing back pain in the kidney area on the right side and blood in urine. The blood started to clot after an hour. The patient went to the hospital emergency room (ER) twice once at night and the other in the evening. After four days due to persistent clotting, he visited a urologist where a catheter was inserted to help to empty the clots. On 18-Jun-2021, he was admitted to another hospital ER because the bleeding could not be stopped. He was hospitalized for 9 days. In order to stop the bleeding and clotting, a stent was placed in the kidney by a surgeon. On unspecified date in JUN-2021 Laboratory data included: Laboratory test COVID-19 virus test (NR: not provided) negative. The patient was discharged from hospital and came home on 26-Jun-2021.  The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from blood clots in urine, and stabbing backpain in the kidney area on the right side on 26-JUN-2021, and was recovering from blood in urine, and severe headache. This report was serious (Hospitalization Caused / Prolonged).; Sender's Comments: V0 20210725558-covid-19 vaccine ad26.cov2.s-Blood clots in urine, Blood in Urine ,Stabbing back pain in the kidney area on the right side. This event(s) is considered unassessable. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s).
Woke up with chest pain.  Presented to ER and was cleared after examination. I felt it was myocardia due to booster shot.  ER Physician agreed and told me to take OTC medication for swelling.  I am still feeling mild chest discomfort occasionally as of today, 3/24/22.
ITCHING IN FACE AND ARMS, FEW COUGH , HIGH BLOOD PRESSURE.
Muscle aches, Swelling of the lower lip Hives, redness, and itching on hands, arms, and feets  *These symptoms were noticed upon waking up in the morning.
Patient indicated on 11/20/12 had shoulder pain from receiving flu shot. Left shoulder rating a 9/10.  Has been in to clinic with continued pain.
Pt presented to clinic on 4/20/06 with axillar area of erythema and induration involving left bicep. Pt received immunizations of DTaP 0.5ml IM and IPV 0.5ml IM to left deltoid on 4/19/06, OT c/o pain but site is non tender. Warm to touch with no abscess noted. Pt is able to perform active ROM with left extremity with no difficulty. Pt placed on antibiotics Keflex 450mg PO TID x 7days, Ibuprofen 250 ml PO Q 6 hrs, PRN and Benadryl elixir 25mg PO Q 6 hrs x 2 days.
High fever started few hours after vaccination and continued for 2 days.  Chills, shivers, very uncomfortable. I felt the same way when I had Covid 2 months ago.
Initial unsolicited report received from a consumer on 24-Apr-2018. This case involves a 16-year-old female patient who was vaccinated with a 0.5 mL dose of MENACTRA (one dosage, batch number: U5841AA, expiry date, dose in series and site of administration were not reported) intramuscularly on 10-Apr-2018. The patient's medical history included allergy to Amoxicillin. Concomitant medication was not reported. On 10-Apr-2018, in the evening on the same day post vaccination, the patient developed headache, body aches, feeling extremely tired and listless. No other vaccinations given on that day. Relevant lab investigations and corrective treatment were not reported. On an unknown date, the patient was recovered from the events. List of documents held by sender: none.
This is spontaneous report was received from a physician via two company representatives and from a practice manager (support services director) and refers to a patient of unknown age and gender. The patient's pertinent medical history, drug reactions or allergies and concomitant medications were not reported. On 11-NOV-2014, the patient was vaccinated with an improperly stored dose of GARDASIL injection, lot # K005083, expiration date 04-NOV-2016 (dose, route and site of administration were not reported). The administered dose of vaccine was exposed to temperature excursion (date unspecified) lasting for 48 hours, with the lowest recorded temperature excursion (date unspecified) lasting for 48 hours, with the lowest recorded temperature of 1 degree Fahrenheit (also reported as 1 degree Celsius. The vaccine was stored in a refrigerator. No adverse effects were reported. There was no product quality complaint involved. This is one of several reports received from the same reporter. Additional information has been requested.
upset stomach,drank water, refused EMS, stated was feeling better. observed for 15 minutes
pt recvd vax;pain in lt foot,ankle & then all joints;dx w/ arthritis;unable to write;back pain & joint pain;to specialist & had blood test;specialists were unable to dx a reason for arthritic condition;
NERVE PAIN; CANNOT MOVE ARM; ARM PAIN; This spontaneous report received from a patient via a company representative concerned a female of unspecified age. The patient's weight, height, and medical history were not reported.The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unk) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On an unspecified date, the subject experienced nerve pain, cannot move arm, and arm pain. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the arm pain, nerve pain and cannot move arm was not reported. This report was non-serious.
late for the second dose; This case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in a patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st dose on November 2021).   On an unknown date, the patient did not receive the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the incomplete course of vaccination was unknown.   Additional Information: GSK Receipt Date: 05-JUL-2022 Reporter's Comments: The pharmacist reported that a patient was late for the second dose of Shingrix.  No adverse event was reported.  Only 1st dose was administered, no patient's identifiers provided. No LOT number and expiration date were provided. No vaccination date was provided. The reporter consented to follow up. Additional supportive information: As the patient received only first dose and now late for second dose, which led to incomplete course of vaccination.
3 days of fever, 2 days of rash. Had CSF, blood & urine cultures & stool culture obtained & viral panel. Given CEFTRIOXONE X3 days.   5/18/09 ED records received DOS 4/29/09. FINAL DIAGNOSIS: Fever and diarrhea Post vaccination: fever, yellow diarrhea
The patient returned 45 min. after injection c/o feeling shaky and increased heart rate. Episode lasted for one hour. Hx of allergy shots with no problem. O - BP 150/60 (pt's norm 110/70), P-120. Pt was shaking. No respiratory involvement. No rash. No treatment; observation only. Does not remember coming to health services after shot.
Narrative: COVID infection following COVID vaccine series 04/30 Janssen, dose #1 08/04 pt cc: cough, fatigue, fever, headache, loss of taste or smell, myalgias, rhinorrhea exposure: unknown 08/06 COVID swab, result: detected 08/12 SARS-COV-2 LINEAGE result: AY.3 08/12 SARS-COV-2 CLADE results:21 A Delta
Total body numbness including head and tongue, worse in limbs, burning, prickling, pain, feels like finger are in ice yet they are warm to the feel. finger joints stuff and painful, feet feel like I?m walking on rocks or cactus. Balance affected have to use walker or fall.  Hemoglobin dropped to 8  all iron tests abnormal. Most blood test abnormal suddenly. Had 2 infusions of Iron.
Sore throat; Fever; A spontaneous report  was received from a type concerning a 79-years-old  patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced events sore throat and fever.  The patient's medical history was not provided. Concomitant medications reported were atorvastatin, Flomax, Metoprolol, hemocoel, ezetimibe, aspirin drugs used for unknown indication.  On 11 Feb 2021, prior to the onset of the events the patient received first of two planned doses of mRNA-1273 (lot/batch: 020M204) via unknown route for prophylaxis of COVID-19 infection.  On an unknown date, the patient experienced the event(s) sore throat, fever.  Treatment details included azithromycin since yesterday.  Action taken with mRNA-1273 in response to the events was not reported.   The outcome of events, sore throat and fever were unknown.
CLIENT STATES ABOUT 5-6 HOURS AFTER RECEIVING VACCINE, SITE BECAME RED, PAINFUL, ITCHY AND WARM.  OVER NEXT 2-3 DAYS BECAME WORSE AT SITE UNTIL SEEN BY DR WHO DX'D "CELLULITIS" AND GAVE RX FOR KELFEX (QID) AND INSTRUCTED TO USE BENADRYL FOR ITCHING.  SEEN AT FACILITY 8/5/2010 AT 1:30OM ONLY TREATMENT WAS ICE AND PREVIOUS 6 HOURS SITE SLIGHTLY PINK AND WARM WITH SWELLING ABOUT 12 CM AREA LEFT POSTERIOR ARM.  CALLED 8/6/2010 AT 5PM CLIENTS STATES MUCH BETTER.
Patient received the Menveo vaccine in her right deltoid and Tdap vaccine in her left deltoid- was given orange juice prior to vaccines- 2 min post vaccines pt fainted on exam room table- no injuries occurred- had LOC for 2-3 seconds - was monitored X 45 min in office - reviewed with APN and was discharged home. Pt has had a history of syncope not only related to vaccines.
7cmx10cm red raised hot to touch area on right lateral thigh. Dr ordered cool compresses and Benadryl 1 1/2 tsp PO Q 4-6 H PRN.
This spontaneous report as received from nurse refers to a 21-year-old male patient. Information about concurrent conditions and medical history was not provided. On an unknown date a client was inadvertently administered a fourth dose of GARDASIL (route, strength, dose, lot, batch # and expiration date not reported). Co-suspect and concomitant therapies were not reported. No adverse effects reported. Additional information is not expected because it is not possible to contact the physician.
pt presents with general malaise, nausea, decrease in appetite, dysuria; positive test for COVID, also dx with UTI; x-ray showed pneumonia; PMH:  A Fib, HTN, RA, DMT2; started on ABX; required O2 supplementation after experiencing SOB; found to have heart failure; family requested hospice; pt dc'd to home; per death certificate, pt died in a home with cause of death being COVID 19
Information has been received from a registered nurse concerning a 51 year old female who on 20-SEP-2005 was vaccinated SC with a 0.5 mL dose of pneumococcal 23v polysaccharide vaccine (lot # 650649/0790P). On an unspecified date in approximately September 2005, the patient went back to her physician and was diagnosed with localized allergic urticaria and was placed on methylprednisolone (Medrol) dose pack. A product quality complaint was not involved. Localized allergic urticaria was determined to be an other important medical event (OMIC) by the reporter. Additional information has been requested.
Developed severe non bloody watery diarrhea, 12-17 times per day; total body rash, lethargy, very poor oral intake, and change in behavior (not using words, fussy, fearful).
Lt upper arm/shoulder pain with adduction & abduction starting ~24 hours after vaccine administration. Pain Localized to injection site
Rash, redness and swelling, also itching around injection site. Saw primary physician who prescribed Keflex, but I learned that  symptoms would be short lived so I talked with MD and cancelled the RX.  Symptoms are gradually disappearing.
acute on chronic respiratory failure secondary to COVID, hypoxic, SOB, weakness, in hospital from 08/01/2021 to 08/12/2012 then discharged to long term care facility where he passed away
Pt. states that after receiving the 1st dose of Phizer 09/27/2021, started experiencing symptoms 09/28/2021 of a flair-up of Fibromyalgia. Primary communications haven't been established as of yet. Still experiencing symptoms, no other symptoms noted.
Case previously recorded as MA2009-5680. Initial case report received via healthcare professional on 20 Nov 2009. An 8-year-old male child was vaccinated with S-OIV FLUVIRIN (batch no. 1008145P) on 18 Nov 2009. The recommended age is 4+. No adverse events reported. Company reference no.: NA09-008579.
lightheadedness; tingling, slslight numbness right arm andd face. informed patient that if it continues to go to ER. Pataient leeft with understanding above.
administered Fluzone HD to a 44 year-old woman rather than the indicated Fluzone Quadrivalent, No AE; administered Fluzone HD to a 44 year-old, No AE; administered Fluzone HD to a 44 year-old , No AE; Initial information was received on 27-Feb-2020 regarding an unsolicited valid non-serious case from a nurse.  This case involves a 44 years old female patient who was vaccinated with 0.5 ml of dose of INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE [FLUZONE HIGH DOSE] (lot number: UJ252AA and expiry date: 01-May-2020) via intramuscular route in the left deltoid rather than INFLUENZA QUADRIVAL A-B VACCINE [FLUZONE QUADRIVALENT] on 26-Feb-2020 for prophylactic vaccination (PT: Overdose, Product administered to patient of inappropriate age and Wrong product administered).  Medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant vaccination included DIPHTHERIA VACCINE TOXOID, PERTUSSIS VACCINE ACELLULAR 5-COMPONENT, TETANUS VACCINE TOXOID (ADACEL) for prophylactic vaccination.  It was actual medication error case due to wrong vaccine administered, inappropriate age at vaccine administration and overdose.  At the time of report no adverse event was reported.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holders compliance with the requirements set out in 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.
Rush, swelling under eye, eye inflammation.  Have been seen by dr. a week later and was prescribed antibiotics and steroid for acute dermatitis, conjunctivitis and beginning of cellulitis.
The patient developed a fainting episode after the administration of the Bexsero and Fluzone vaccines. The patient did not lose consciousness completely but he felt weak for about 10 minutes. We placed the patient in the Trendelenburg position and he recovered well. The patient left without any other incident.
Patient noticed some soreness in her right arm on evening of 10/20. on 10/21 it was a large red area, hot to the touch and itching. She was going to take benedryl.
skin lesions, mildly itchy, onset 26JUN98 3-4 lesions noted back, trunk, legs for 5-6 days;physical exam erythematous vesicular lesions c/w varicella;
This spontaneous report as received from a Licensed Practical Nurse refers to a patient of 11 years old child patient and unknown gender. On 17-JUL-2014 the patient was vaccinated with a dose of an improperly stored GARDASIL (lot H020901, expiration date 05-JUL-2015) (dose, route, were not reported). No adverse effect was reported. The outcome of events reported was unknown. No product quality complaint was involved. This is one of several reports received from the same source. Additional information has been requested.
It started as a very bad itch that when I scratch it it becomes very inflamed red all over my forearm(blisters formed), under arm, and on my left leg from the knee to the ankle. only happens in the evenings
Incessant crying/screaming started apprx. 3 hrs after injection. Baby exhausted himself to sleep after Motrin. had 2 episodes of screaming. MD recommended Motrin for tx.
recover from congestive lungs; After the second dose noticed that her lungs improved; feverish; This spontaneous case was reported by a consumer and describes the occurrence of PRE-EXISTING CONDITION IMPROVED (recover from congestive lungs), THERAPEUTIC RESPONSE UNEXPECTED (After the second dose noticed that her lungs improved) and PYREXIA (feverish) in an 117-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included Lung congestion.   On 01-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 28-Jan-2021, 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 experienced PRE-EXISTING CONDITION IMPROVED (recover from congestive lungs), THERAPEUTIC RESPONSE UNEXPECTED (After the second dose noticed that her lungs improved) and PYREXIA (feverish). At the time of the report, PRE-EXISTING CONDITION IMPROVED (recover from congestive lungs) and THERAPEUTIC RESPONSE UNEXPECTED (After the second dose noticed that her lungs improved) had resolved and PYREXIA (feverish) outcome was unknown. Not Provided          Action taken with mRNA-1273 related to events was not applicable.  Concomitant medication details was not reported by the reporter. Treatment details included Lasix 100 mg, blood thinner, lowdose of insulin.   Reporter did not allow further contact
This spontaneous report was received from a nurse referring to multiple unspecified patients of unknown age and gender. The patient's pertinent medical history, drug reaction/allergies or concomitant information was not reported. On an unknown date the patient was vaccinated with improperly stored M-M-R II lot #: M008589 with expiration date: 16-FEB-2018 and lot # reporter as: M022408 with expiration date: 02-MAY-2018 (dose and route were not provided). The reporter stated that the M-M-R II vaccine was exposed to 11.6 C for 42 hours 55 minutes. No adverse event was reported. There was no product quality complaint (PQC) involved. This is one of several reports received from the same reporter. Additional information has been requested.
Sharp pain in chest for a minutes the night of the injection and then went away. The next morning, sharp pain in the stomach for a few minutes and then went away.
pt recvd vax; became dizzy & fainted;exp temporary hearing loss & a low grade fever;cont to exp intermittent episodes of hearing deficit in the lt ear & periodic dizziness upon standing;
a little headache; blister on forearm; chills; fever; tiredness; This case was reported by a consumer via call center representative and described the occurrence of chills in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (1st dose received on an unknown date).   On 2nd January 2020, the patient received the 2nd dose of Shingrix (intramuscular). On 6th January 2020, 4 days after receiving Shingrix, the patient experienced headache and blister. In January 2020, the patient experienced chills, fever and tiredness. On an unknown date, the outcome of the chills and fever were unknown and the outcome of the tiredness, headache and blister were not recovered/not resolved.   It was unknown if the reporter considered the chills, fever, tiredness, headache and blister to be related to Shingrix.  Additional details were reported as follows: The patient received Shingrix and experienced chills, fever and tiredness the day after the vaccine, till the time of reporting the patient was tired and has a little headache. On 6th January 2020 at morning patient noticed a blister on her forearm on the arm where she received the vaccine. Reporter did not consent to follow-up.