chrisvoncsefalvay/vaers-outcomes huggingface dataset:
8/16: Soreness at injection site, fever 101 degrees F, chills, tremors, bodily pains, tingling in fingers and toes, migraines, dry mouth, fatigue, blurred vision, ringing in both ears, coughing, and sneezing, reduced sex drive, inability to become erect 8/17: Soreness at injection site, fever 101 degrees F, chills, tremors, bodily pains, tingling in fingers and toes, migraines, dry mouth, fatigue, coughing, and sneezing, reduced sex drive, inability to become erect 8/18: Soreness at injection site,  bodily pains,  migraines, dry mouth, fatigue, reduced sex drive, inability to become erect 8/19: Soreness at injection site,  bodily pains,  migraines, fatigue, reduced sex drive, inability to become erect 8/20: Soreness at injection site,  bodily pains,  migraines, fatigue, reduced sex drive, inability to become erect 8/21: Soreness at injection site,  bodily pains,  migraines, fatigue, reduced sex drive 8/22: Soreness at injection site,  bodily pains,  migraines, fatigue 8/23: Soreness at injection site,  bodily pains,  migraines, fatigue 8/24: Soreness at injection site,  bodily pains,  migraines, fatigue 8/25: Soreness at injection site,  bodily pains,  migraines, fatigue 8/26: Soreness at injection site,  bodily pains,  migraines, fatigue 8/27: Soreness at injection site,  bodily pains,  migraines, fatigue 8/28: Soreness at injection site,  bodily pains,  migraines, fatigue 8/29: Soreness at injection site,  bodily pains,  migraines, fatigue 8/30: Soreness at injection site,  bodily pains,  migraines, fatigue 8/31: Soreness at injection site,  bodily pains,  migraines, fatigue 9/1: Soreness at injection site,  bodily pains,  migraines, fatigue 9/2: Soreness at injection site,  bodily pains,  migraines, fatigue
Received Covid Vaccine on 12/18/2020, 72 hours later on 12/21/2020 had left sided tongue numbness.
Tingling in leg; This spontaneous case was reported by a pharmacist and describes the occurrence of PARAESTHESIA (Tingling in leg) in a 43-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 049C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 21-Jun-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 21-Jun-2021, the patient experienced PARAESTHESIA (Tingling in leg). At the time of the report, PARAESTHESIA (Tingling in leg) outcome was unknown.        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.   Concomitant medications were not provided. Treatment information was not provided.
Abnormal CT of the abdomen Anemia due to GI blood loss CLL (chronic lymphocytic leukemia) (CMS/HCC) Abnormal EKG  Macrocytosis Anemia requiring transfusions Symptomatic anemia
Loss of appetite; Feel sick; Nauseous; This spontaneous case was reported by a consumer and describes the occurrence of DECREASED APPETITE (Loss of appetite), MALAISE (Feel sick) and NAUSEA (Nauseous) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced DECREASED APPETITE (Loss of appetite), MALAISE (Feel sick) and NAUSEA (Nauseous). At the time of the report, DECREASED APPETITE (Loss of appetite), MALAISE (Feel sick) and NAUSEA (Nauseous) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant product use was not provided by the reporter. Treatment information was not provided.
3 year old patient was mistakenly given QUADRACEL instead of DTaP, with no adverse event; Initial information received on 21-Dec-2022 regarding an unsolicited valid non-serious case received from a other health professional via call centre.  This case involves a 3 years old male patient was mistakenly given diphtheria-15/tetanus/5 hybrid AC pertussis/IPV (MRC5) vaccine [Quadracel] instead of DTaP, with no adverse event.  The patient's past medical vaccines included DTAP on 02-Jun-2021 and on 01-Jun2022 for prophylactic vaccination. The patient's past medical history, treatment(s) and family history were not provided.  Patient's concomitant medications included measles vaccine live (enders-edmonston), mumps vaccine live (jeryl lynn), rubella vaccine live (wistar RA 27/3), varicella zoster vaccine live (OKA/MERCK) (Proquad) for Immunisation.  On 03-Nov-2022, the patient mistakenly received 0.5 ml dose of suspect diphtheria-15/tetanus/5 hybrid AC pertussis/IPV (MRC5) vaccine, Suspension for injection (frequency - once, strength - standard, lot number - C5862BA and expiry date -not reported) instead of DTaP, with no adverse event (wrong product administered) (latency: same day) via intramuscular route in the thigh NOS (not otherwise specified) for Immunization.  Action taken: not applicable.  At time of reporting, the outcome was Unknown for the event.  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 guidelines. 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.
Case previously recorded as MA2009-4611. Case report received from a nurse, on 18 NOV 2009. 8 year-old male patient was vaccinated with an overdose (double-dose, one dose in each thigh) of S-OIV FLUVIRIN (batch no. 102041P1) i.m. on 17 NOV 2009. No adverse event was reported. Reference no.: NA09-008419.
My injection was about 6pm on 12/17/2018. I woke up the next morning, 12/18/2018, with soreness in the injection site, but no redness or swelling at the injection site. As the day wore on I felt more "spacey," tired and weak. By about 3 pm I had shivering and needed bedrest. By about 7pm I had a fever of 101 degrees and an elevated heart rate. I experienced no headache and no upset stomach. By bedtime the fever abated a little to 100.6 degrees. The fever abated during the night and I woke up with a temperature of 97.1 degrees. I have no "spacey" feeling as I write this (11am 12/19/2018).  However, I have a red rash on my left arm about the size of a tennis ball, about 2 inched below the injection site.  The rash is not blistering or peeling at this time, it does not actively hurt but is tender to the touch and is "warm" to the touch compared to the surrounding non-rash skin area. I had a mild reaction the first dose of SHINGRIX - a "uggy" feeling about a day or two after but my reaction to the second does was worse.
8/20/12 patient presents with cough & congestion x 9 days. Lab pertussis PCR obtained (+) on 8/22/12. Put on ZPACK.
20mins post vaccination, pt reported feeling hot/flushed in the face. Vitals: 11:36 108/71, 97, 18-20, 100% -- > 106/69, 92, 18-20, 100% Pt stable and released from the vaccination site @11:46.  Pt states she feels better.  Pt wishes to go home.
pt recvd vax 6SEP95 & that noc woke up w/n&v lasting a few hrs;mom states site of vax (lt arm) 2-3 days later started swelling & became infected;area size of quarter w/hole in middle of it;scab formed then came off & pus came out;rash;
tenosynovitis at the site of the biceps tendon; patient also developed tendinopathy; benign lipoma of the lateral deltoid musculature; discomfort; This spontaneous report was received from a nurse referring to a 68 year old male patient. The patient's pertinent medical history included neuropathy of hands and feet, hypertension, osteoarthritis of multiple joints. The patient's concomitant medication was unknown by reporter. The patient's drug reactions/allergies included codeine and cortisone.   On 06-OCT-2020, the patient was vaccinated with pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) (strength was not provided; lot# was T010293 and expiration date was 30-AUG-2021) 0.5 milliliter, intramuscularly in the left deltoid for prophylaxis.  On the same day (reported as since injection), the patient had problems. The patient developed upper left arm pain. The patient performed an X-ray but did not have results available. The patient also performed magnetic resonance imaging (MRI) which showed tenosynovitis at the site of the biceps tendon and a benign lipoma of the lateral deltoid musculature. The patient also developed tendinopathy. The patient was given gabapentin and naproxen for discomfort but it had not worked well for him. The patient was currently seeing an orthopedist but was to see a neurologist soon.  The outcome of the events was not recovered. The causality between the events and pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) was not provided.
fell asleep-could not wake pt for 5hr-MD advised that next time vaxed;pt must be hosp for observation;
Broke out with shingles; This case was reported by a consumer via interactive digital media and described the occurrence of shingles in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received the 2nd dose of Shingles vaccine. On an unknown date, several days after receiving Shingles vaccine, the patient experienced shingles. On an unknown date, the outcome of the shingles was unknown.   It was unknown if the reporter considered the shingles to be related to Shingles vaccine.     Additional Information: GSK Receipt Date: 28-SEP-2022 Reporter's Comment: The patient self-reported this case via interactive digital media. The patient broke out with shingles right after his/her 2nd shot. Terrible. Additional supportive information: The follow-up would not possible, as no contact, details were available.
Patient received Tdap on 10/19/15. Felt injection was given too high. Was diagnosed with bursitis 1 week later. Treated with ibuprofen. If no improvement, will receive steroid injection.
Injection site reactions- Pain, warmth, soreness, redness, swelling down to elbow, hardening at injection site.
Patient received an accidental 4th dose of the Pfizer 6mo-4year dose.
Patient stated that the same night he had some momentary tremors in his hands, and felt soreness in the arms. He had stomach ache and had palpitations that lasted a short while. He has had tremors 2 more times albeit short lasting. He does have anxiety and my opinion was that this was anxiety related. He however stated that these started on the same night and hence I am reporting this.
Headache, aches and pains, flu like symptoms, hot flashes, chills Pregnant
BALD PATCHES ON HEAD; This spontaneous report received from a consumer via a company representative concerned a patient of unspecified age and sex. 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, and batch number were not reported) dose, start therapy date were not reported for covid-19 prophylaxis. The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported. On an unspecified date, the patient experienced bald patches on head. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of bald patches on head was not reported. This report was non-serious.
TODAY (7/10/2021 - VERY DIZZY FOR ALL DAYS AFTER SHOT, URINE BLOCKAGE, BEING SEEN ALSO BY DR , C FOR BLADDER CANCER, TREATMENT,  CYTOLOGY, NURSE WEEKLY, CATHETER TREATMENT 9 WEEKS. TODAY 7/10/2021 AFTERNOON BECAME VERY DEPRESSED, SCARY, DRY MOUTH, SOME KIND OF 'HIGH SPEED HUMMING IN MY HEAD AFTER VACC, BALANCE PROBLEMS BUT A LITTLE UPLIFTED AFTER 2ND VACC, INSOMNIA, EVEN WITH OTC SLEEP AIDS,  SUDDENLY, AROUND 7:00 PM PACIFIC, DEPRESSION 'FELL OFF' THANK GOD. VERY SELF-RELIANT, STRONG INDIVIDUA, NON-RELIGIOUS, EDUCATED, BA LITURATURE, AA COMPUTERS - PROFESSION NOW RETIRED
Hives all over Hives started on Neck Day 2>>Back Day 3>>Arms Day 4 >>Thighs & Buttocks Day 6>>Abdomen & Chest Day 7 Hives now decreasing in severity but still present Day 18  Using ice PRN, Benadryl 50 mg q 4 hours and Triamcinolone cream 0.1% BID
2 days p/vax face swelled & had a rash (only on the face) like a bad sunburn seen by MD;
Pfizer-BioNTech COVID-19 Vaccine EUA;  a few hours after the shot, arm pain.  Approx 11hrs later (10:30PM), very bad chills and body aches. Lasted about 6-7 hours to 4-5 Sunday AM, took my temp it was 100. took tylenol temp went down to 98.6...temp stayed normal, the rest of the day I was very tired until around 11:30PM Sunday night..I felt fine after that...
frequent headaches (daily for 3 months, inflammation throughout body lasting 3 - 4 days
Adverse issues - leg paralysis, both legs, unable to walk without walker.   Treatment - rest & icing.   Outcome - no improvement so far
The shot took my MS our off remission!; This case was reported by a consumer via interactive digital media and described the occurrence of multiple sclerosis relapse in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   The patient's past medical history included multiple sclerosis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced multiple sclerosis relapse (serious criteria GSK medically significant). On an unknown date, the outcome of the multiple sclerosis relapse was unknown.   The reporter considered the multiple sclerosis relapse to be related to Shingles vaccine.  Additional details were provided as follows: The patient had reported for him/herself. The age at vaccination was not reported. The patient reported that, the shingles shot took his/her multiple sclerosis out off remission.
Erythema, warmth, swelling. On day two, erythema significantly increased. Treated for presumptive cellulitis.
Woke up at my usual time the day after vaccine. Felt a little warm but not feverish and did not take my temperature. After walking to kitchen to let cat in from garage I stopped at the nearby kitchen sink and began to shake ( I believe just my upper body). I had to grab onto sink to steady myself. Shaking was only seconds long.  Then I must have fainted as I awoke (quickly) on the floor  alongside the cupboards and sliding glass door.  I laid there conscious about 15 minutes till I felt confident I could get up on my own.  As result of fall I bit upper and lower lip on right (no blood just skin injured), must have clenched my teeth because my left posterior teeth were sensitive to cold and I injured my right ankle. After I got up and realized my ankle hurt with pressure I put on a support knee high to control swelling.  Injury seemed to be focused on the ankle bone. I applied ice for recommended 20 on 20 off protocol for most of both 2/25 and 2/26, elevated and took OTC Aleve as directed on package.  Bruising observed from heel, behind ankle bone and front of ankle.   Called PCP, she recommended continue as I have and she will contact me tomorrow, March 1
Fainted about 5 minutes after receiving HPV vaccine. Fell off table and hit head. About 10 minutes later after drinking water and eating crackers, nearly
Patient tolerated vaccination well for approximately 20 minutes after admin. Upon returning to pharmacy area to pay and sign, became weak in legs (could not stand, had to be seated). Very shaky hands, numbness in cheeks/face. Given water and seated, called ambulance and stayed w/ pt until medics arrived.
Day 9, red rash at injection site Itching, swelling Flu like symptoms- fever, aching, chills, diarrhea.
11-3-09 client notice (L) upper arm was sore & injection site now swollen. Exp. headache & felt tired. 11-4-09 came to facility. Redness & induration in (L) upper limb in posterior brachial area 4 1/2" by 4". Indurated red fine rash (40mm in diameter) around the injection site also. Tissue warm to touch & dry. Advised to use cold compresses & apply telpha dressing if area should become wet. Req client call us & or if reddened swollen area become larger. Client informed me her left shoulder & axillary area was a little sore.
Shortness of breath, weakness, headache ? Vaccine RXN  Orthostatic Hypotension  Nausea
Approximately a month after receiving my second, my CI-19 levels began to rise. They had been at 24 before that. They rose to 84 in June, 121 in August and 324 in September. I went to hospital to see my surgeon for a follow up in September. They tested it again there and it came in at 271. A month later it was run again, and it was at 355. The last three were kind of like a leveling off. There wasn't a dramatic incline anymore. I had a total body bone scan to see if it had metastasized to the bone. I've have multiple CAT scans. The last CAT scan showed retained secretions in my lungs. I was put on cortisone and an antibiotic to address the questionable cloudiness in my chest x-rays, MRI, and CAT scans. They noticed inflammation and retention, so I was put on the cortisone and antibiotic. I was given an inhaler and have been taking Guaifenesin which cleared things up, pretty much. When I saw my pulmonologist, he could still hear fluid in my lungs. I will be meeting again with him on 11/22. I have a history of bronchitis, so that didn't seem unusual to me. Around August 1st, my oncologist was also addressing the undefined area in my lungs, where they couldn't decide if it was inflammation or retention. In the end of September, first part of October, I was still coughing up yellow phlegm. I was given another Cortisone and antibiotic. I am now, also, taking Clonidine, Flonase Nasal Spray, Montelukast, Symbicort Inhaler and Albuterol Inhaler.
I think they administered a vaccine that had expired the day before; A spontaneous report was received from a 77-year-old female patient, who received Moderna's COVID-19 vaccine (mRNA-1273) and thought that she was administered a vaccine that had expired the day before (PT: expired product used).     The patient's medical history was not provided. No relevant concomitant medications were reported.    On 05-FEB-2021, the patient received her first of two planned doses of mRNA-1273 (batch number# 13M20A, expiration date: 04-FEB-2021) through an unknown route in an unknown arm, for prophylaxis of COVID-19 infection.   The patient believed that she was administered a vaccine that had expired.  Treatment information was not provided.  The outcome of the event was considered  recovered on 05-FEB-2021.; Reporter's Comments: This refers to a case of 77-year-old female patient, who had an "expired product administered" of  Moderna's COVID-19 vaccine (mRNA-1273)(Lot#13M20A ) with no associated AEs.
Shoulder extreme pain. Can't lift shoulder after 7 days still. Unbearable pain
Evening of April 1, 2021, 10:00pm- Noticed "hard lump" on top of left foot.  Severe pain and tenderness on top of left foot.  Friday April 2, 2021, 2:00pm - Medical visit: Family Practice,  Diagnoses: Left Foot Pain, Subcutaneous Nodule Of Foot.  Ultrasound ordered. Tuesday April 6, 2021, 10:30am - Ultrasound of lower left foot, Diagnoses: Thrombophlebitis Of Superficial Lower Left Extremity Tuesday April 6, 2021, 4pm - Emergency Department.  Ultrasound of full left leg.   Additional pain, tenderness, and swelling.
The next day post vax child developed an injection site reaction characterized by redness and warmth. The patient was treated with warm compresses. She recovered. This is 1 of 3 patients from this facility who developed an injection site reaction following receipt of Acel-Imune lot 467011.
A non-serious spontaneous report of "29 patients received expired FLUMIST" was received from a physician concerning a 36-month-old female.  The patient's medical history included no history of asthma.  Concomitant medications were not available.  On 06-Jan-2009, twenty nine patients (26 children & 3 adults) were vaccinated at a military base and administered expired FLUMIST; the product was expired by 11 days (expiration date: 26-Dec-2008).  The reporting physician was concerned regarding efficacy and loss of potency due to the expired product.  Since the facility only administered the immunizations and does not care for the patients, they had limited medical history information (i.e. screening questions to confirm history of asthma, no detailed medical history to include all their concomitant medications).  There were no adverse events associated with these medications errors; therefore, treatment and reporter/sponsor causality assessments are not applicable, and the events are considered resolved.  This case is being submitted in accordance with MedImmune's post-marketing commitment on accelerated reporting for the newly indicated population of 2 years to 59 months of age for FLUMIST.  On 05-Feb-2009, the physician confirmed that there were no adverse events associated with the medication error. Based on th results of the investigation, the root cause for the medication errors were caused by 1) customers nto discarding product from the previous season 2) product expiring diuring the peak of the flu season resulting in some medication errors that occurred shortly after the product expired. Additional information was received on 05-Feb-2009 and incorporated into the narrative, physician confirmed that there were no adverse events associated with the medication error. Additional information was received on 31-Mar-2009 and incorporated into the narrative product complaint investigation results.
This spontaneous report was received from a certified medical assistant and refers to three unspecified patients of unknown genders and ages. The patients' concomitant medication, pertinent medical history and drug reactions/allergies were not reported. On 11-APR-2016, the patients were vaccinated with doses of improperly stored VARIVAX (which had the lot number of L043619 with expiration date 02-NOV-2017 and lot number L048467 with expiration date 02-DEC-2017) (dose, route of administration and injection site were not reported). The vaccines were exposed to 11 degrees Celsius for 48 hours. Data logger was involved. There were no previous excursions reported. No adverse effects were reported. Product quality complaint (PQC) was not involved. Follow-up information was received on 12-MAY-2016. All telephone attempts to obtain follow-up information have been unsuccessful. Follow up information has been received from a practice manager on 16-MAY-2016. The reporter referred about a 5 years, 8 months female patient. Additionally, it was reported that at opening time, at 8 am, the freezer temp was -13.5 C, and this was not discovered until 1:10 pm by the time of discovery 3 doses had been administered. However, no adverse reactions were reported. This is one of several cases from the same reporter. Additional information has been requested. General information, patient information and narrative were updated.
5/9/17 - 4:45 PM - child given PROQUAD to (L) arm sc. Child returned on 5/10/17 with (L) upper arm red, swollen, hot to touch - measured 5 cm in length and 2 1/2 cm wide. Painful to touch. Provider, RX'd hydrocortisone cream 1%, TYLENOL 120 mg prn suppository.
Patient admitted to hospital twice  within 6 weeks of covid vaccination. First admission on 3/3/21, second admission on 3/29/21.