chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Expired vaccine used; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) in an 87-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 11-Nov-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 11-Nov-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Expired vaccine used). On 11-Nov-2021, EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) had resolved. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No any concomitant medications were reported. No any treatment medications were reported.  It was reported that expired vaccine were given as booster shot to patient. The vaccines were stored in freezer and took out one to two vial and placed in fridge each day as needed.
On the third morning after vaccination, the patient observed swelling on her face, primarily around the  left cheek. She went to the local emergency room and was examined. No fevers, chills or eruptions  inside the mouth or anywhere on her body.
Patient received Varivax at approximately 11:45.  Per mother's report, patient developed diffuse rash, itching and congestion.  Patient medicated with Benadryl 25mg PO by mother at 12:30.  Patient arrived to office at 13:30 with diffuse urticarial rash, clear lung sounds, normal appearing throat.  Patient and mother instructed to monitor for respiratory involved, give Benadryl every 6 hrs prn and to call for change in symptoms or with any questions.
Stroke; A spontaneous report was received from a consumer concerning a female patient, who received Moderna's COVID-19 Vaccine (mRNA-1273) and experienced stroke/cerebrovascular accident.  The patient's medical history was not provided. Concomitant product use was not provided.  On an unspecified date, prior to the onset of the symptoms, the patient received their mRNA-1273 (Batch number not provided) for prophylaxis of COVID-19 infection.  On an unknown date, the patient had stroke. Treatment information was not provided.  Action taken with mRNA-1273 in response to the event was not provided.  The outcome of the event stroke was not reported.; 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.
Pt was admitted on 2/10/2022 for confusion, weakness, and multiple falls. patient's vital signs were stable with exception of tachypnea of 22 saturating 93% . Patient was noted to have generalized weakness, labs were obtained which revealed elevated creatinine at 1.6 (baseline 1.0), mild leukocytosis 11.39, troponins negative, head CT obtained revealed no acute process. Chest x-ray showed right lower lobe opacity, suggestive of pneumonia versus atelectasis. COVID-19 test positive. Patient did have an elevated procalcitonin at 0.95 and therefore admitted for further management of care.   Patient started on IV fluid hydration as well as ceftriaxone (completed 7days), azithromycin (completed 5 days) and remdesivir (completed 3d).    Patient continued to have mild shortness of breath above baseline, patient was started on Symbicort transitioned to Stiolto Respimat. He will be discharged on Spiriva.   At the time of discharge, the pt was afebrile, clinically stable without active complaints.  Warning signs for which to return to the hospital were discussed with patient who verbalized understanding and agreed with the plan of care.
Shot administration was unremarkable; pt. felt normal. Mom returned to office with pt. to report that pt. had a syncopal episode 30 minutes after shots were given; with dental injury to 2 top teeth and low lip abrasion. Bleeding had stopped on lower lip, pt c/o feeling slightly dizzy. Pt. was examined by physician, given po fluids, and rested. Vital signs were stable and once pt felt better he was sent to his dentist for dental repair.
Family stated she felt fine after shot. Had upset stomach night before her death. Took tums. Died in sleep.
~72 hrs after vaccination, developed painful, patchy, grouped papulo -vesicular rash on same arm as vaccination ( L arm) distal to vaccination site extending in apparent dermatomal distribution to fingers.  She was clinically diagnosed with shingles.
pain in the arm; pink rash at the site of injection; vomiting; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (pain in the arm), INJECTION SITE RASH (pink rash at the site of injection) and VOMITING (vomiting) in a 67-year-old female patient 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 VACCINATION SITE PAIN (pain in the arm), INJECTION SITE RASH (pink rash at the site of injection) and VOMITING (vomiting). At the time of the report, VACCINATION SITE PAIN (pain in the arm), INJECTION SITE RASH (pink rash at the site of injection) and VOMITING (vomiting) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Treatment information was denied   Reporter did not allow further contact
Within 2 hours of receiving the vaccine i had to leave work, abdominal pain, headache, exhausted, nauseated, neck pain. over the next weeks before my second dose, pain began to be all over, lots of nerve pain shooting down my legs. it got slightly better by the time i received my 2nd dose on May 20, 2021 BioNtech/Pfizer Lot# ER8736 also administered at a workplace clinic. within an hour the above symptoms came back stronger than before. I have not been able to work since. in addition to the above symptoms i have started getting dizzy, eyes hurt, and exhausted is putting it mildly.  The beginning of July I started having memory issues.
expired doses of fluzone high dose qiv were administered with no reported adverse event; Initial information was received on 26-Sep-2023 regarding an unsolicited valid non-serious case received from a other health professional.  This case is linked to case 2023SA297201(CLUSTER).  This case involves a 81 years old female patient who was administered expired doses of influenza quadrival A-B high dose HV vaccine [Fluzone high-dose quadrivalent] with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On 25-Sep-2023, the patient received a 0.7 ml, once dose of suspect  influenza quadrival A-B high dose HV vaccine (unknown formulation) (lot UT7733CA, expiry date: 30-Jun-2023, unknown strength) via intramuscular route in the left arm for Immunization and expired doses of fluzone high dose qiv were administered with no reported adverse event (expired product administered) (Latency: same day).  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 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.
pt recvd vax 18OCT94 & w/in 24 hrs pt devel redness, induration, swelling & warmth @ the site of inj;
Facial twitching developed on the left cheek, under eye. Began three days after vaccine on 4/30/21 - continued intermittenly until 5/16/21.  This developed after the entire lower jar, teeth and eustachian tubes became sore within 18 hours after vaccination. Pain and soreness stopped on 4/29/21. Pain and soreness at the injection site occurred at the same time as well as low grade (101.5) degree fever - both ended on 4/29/21.
Four hours after flu vaccine injected in L deltoid muscle, her L upper arm started swelling, became bright red and very painful affecting the full circumference of the upper arm. Forty eight hours later the swelling resolved and the upper arm was purple and itched. Patient has history of overactive immune system and vasculitis.
Extreme body itching first 2 days, starting 2 hours after receiving the vaccine.  Mild body itching has continued from day 3 until now.
Fussy and feverish x 3 days. Was seen in ER 2 days ago with same symptoms. She has a small rash on the right thigh with pain, leg rash confirmed as site of Varivax injection on 3/26/08.
Began getting chills at *8 p.m. , body aches, headache, and nausea.  Temperature hit a high of 104 at 2 a.m. on 3/7/2021.  Symptoms continued until around 8 a.m. on 3/7/2021 and was left with dull headache for remainder of the day.
10/31/09 Patient developed severe diarrhea. Stool CX done 11/2/09 positive for salmonella (presumptive pos-sent to state lab to confirm. Also dev. blood in stool 11/3/09.
After 24-48 hours my cheeks looked flush, after 72 hours it was darker and had prickly bumps, after 96 hours bumps more pronounced with some small pimple sized and covering a larger portion of the cheeks . It was also warm to the touch and beginning to feel like a mild sunburn. It stayed this way until Monday morning , 6 days later when I contacted my doctor.  Doctor instructed me to take benedryl and see if this relieves it. Also informed me to take benedryl before I get my next injection. It is still ongoing at this level at the middle of day 6 as I am submitting this report.
1/15 vaccination I didn't have any problems except a super sore arm.  Tuesday afternoon, I had a rash, super bright red,  that covered where clothing was under my scrubs on my legs, partly on arm. Lasted until Friday afternoon, 1/22. Hives plus red areas. It did expand to my face, beyond where clothing was. It was not itchy, swollen uncomfortable.  1/22 Dermatologist. They took pictures and compared to the pictures online with the CDC. The doctor stated I should not take any more vaccines based on what we know right now with the vaccines.  I did go see an allergist. Dr. stated needed pics and notes. And she said yes, you should NOT have any more vaccinations. I kept taking the Zyrtec for week and half.
PATIENT WAS GIVEN VACCINE; PATIENT WAS ONLY 17 VACCINE IS 18+. PARENT WAS AWARE THAT THIS WAS NOT THE RECOMMENDED VACCINE.
Information has been received from a physician concerning a female patient who on an unspecified date was vaccinated with a dose of GARDASIL. On 15-MAY-2007 the patient experienced atypical squamous cells of undetermined significance (ASCUS) and HR HPV PAP. After that on unknown dates, the patient was vaccinated with three doses of GARDASIL. On 21-AUG-2009 again, the patient experienced atypical squamous cells of undetermined significance (ASCUS) and HR HPV PAP. The status of the patient was unknown. This is one of several reports received from the same source. Additional information has been requested.
no adverse effect. gave the Pfizer vaccine approved for 12 years and older to a 11 years old. patient is okay.
Lightheadedness -  began at 9:00 AM Muscle pain - began at approximately 9:30 AM or 10:00 AM Diarrhea - began some time between 11:00 AM and 1:00 PM General feeling of being unwell - began some time between 2:30 PM and 4:00 PM Injection site pain - began some time between 12:00 PM and 4:00 PM Swollen neck lymph nodes - began at approximately 4:30 PM or 5:00 PM Inside of ears feel full - began at 5:30 PM   Still experiencing all of the above symptoms (the first injection was given only 9 hours prior to filling out this form)
Localized irritation and discoloring (red, black, blue) at site of injection. Patient took 1 dose of TYLENOL for discomfort.
1st dose Shingrix in left arm 8/10/2019 / 2nd dose not administered yet; did not feel well (malaise); Lethargic; Headache; This case was reported by a consumer via call center representative and described the occurrence of malaise in a 67-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis.   On 10th August 2019, the patient received the 1st dose of Shingrix (intramuscular). On an unknown date, the patient received the 2nd dose of Shingrix. On 11th August 2019, 1 days after receiving Shingrix and not applicable after receiving Shingrix, the patient experienced malaise, lethargy and headache. On an unknown date, the patient experienced incomplete course of vaccination. On 12th August 2019, the outcome of the malaise, lethargy and headache were recovered/resolved. On an unknown date, the outcome of the incomplete course of vaccination was unknown.   It was unknown if the reporter considered the malaise, lethargy and headache to be related to Shingrix.  Additional details were provided as follows: The patient received 1st dose on left arm and did not feel well (malaise) the next day, was lethargic, and had a headache that lasted a day and was resolved the following da. Till the time of reporting the patient had not receive 2nd dose of Shingrix, which led to incomplete course of vaccination. The reporter consented to follow up.
PATIENT EXPERIENCED AN ANXIETY ATTACK AFTER VACCINE WAS ADMINISTERED. PARAMEDICS WERE ON SITE TO ASSIST THE PATIENT. PATIENT RECOVERED WELL
This spontaneous report was received from a Registered nurse regarding a 16 year old patient of unknown gender. The patient's medical history, concurrent conditions and concomitant medications were not reported. On 21-JUN-2017, the patient was vaccinated with improperly stored dose of GARDASIL 9 lot# N004798 with expiration date: 31-OCT-2019 (dosing details and route of administration was not reported) for prophylaxis. No adverse effects were reported. The storage temperature was 47 degrees Fahrenheit to 77 degrees Fahrenheit (49F) and time frame was 14 hours. There was no previous temperature excursion. Digital data logger was involved. No product quality complaint was involved. This is one of the several reports from the same reporter. Sender's Comments: US-009507513-1804USA005153.
My periods since  getting the shot have been terrible.y bleeding has gotten so bad that I need to stay home from work at least 1 day during my period. Cramps & back ache shoot down my legs. Bad headaches & I used to be very regular with 28 day cycles & now I?m around 19-20 days with break through spotting & last month I bled for 2 weeks. Both of my daughters, ages 21 & 19, my 37 year old niece, & a 50 year old co worker are all experiencing horrible menstrual cycles post-vaccine.
It started off with whole body itchiness that would result in hives after itching. Erythema of the face and body. I got my allergy shot and my allergist suggested to take an antihistamine. That was responsive to it and I had also stopped taking PRISTIQ because I started that at the time this began. I also took a steroid to see if it would help and it did not. The antihistamine helped. After a month, it went from happening every day with no improvement, to being completely blocked by these antihistamines by taking them 3 times a day. Over time, this reduced to twice a daily, to once daily, and this last month, I've had to take an antihistamine every 36 hours to prevent itchiness and hives. I stopped the PRISTIQ because we thought it was temporarily associated with it. There was some improvement after stopping the medication, but the symptoms overall persisted after stopping. I didn't have any change in these symptoms when I got COVID.
This spontaneous report received from a patient concerned a 55 year old female. 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: 207A21A expiry: 23-JUN-2021) dose was not reported, administered on 11-MAY-2021 for prophylactic vaccination. No concomitant medications were reported.  On 12-MAY-2021, the subject experienced bruise as the size of the palm of the hand, dark, blueish-green, a little red in the middle. On 12-MAY-2021, the subject experienced bruising hurt while laying on right side. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from bruise as the size of the palm of the hand, dark, blueish-green, a little red in the middle, and bruising hurt while laying on right side. This report was non-serious.; Sender's Comments: V0:Medical assessment comments not required as per standard procedure as the case is assessed as non serious.
He had diarrhea, a diaper rash and vomiting. It lasted for about 5 days.
Swollen lymph node and puffy neck area about 2" x 4" that increased and decreased in size each day. Condition has improved but not yet normal.  Swollen nodes inside of my mouth on the left lower and upper lip.  Knot also found on right thigh near genetalia.
Information has been received from a consumer concerning her 14 month old daughter with atopy, lactose intolerance, and allergies to peanuts, eggs and tree mix, who in September 2007, was vaccinated with a dose of PEDVAXHIB. There was no concomitant medication. Within an hour of receiving the PEDVAXHIB the patient experienced redness and rash at the injection site on her left leg. The patient was given BENADRYL, and it took a couple of days for the experience to go away. No laboratory studies performed. The patient sought unspecified medical attention. The patient had recovered a couple of days after received the PEDVAXHIB. Additional information is not expected.
The night she received the vaccine she developed dysuria, hematuria, urinary urgency, and urinary frequency
Initial and follow-up information has been received from a healthcare worker concerning her 12 month old son with a history of hernia surgery on 04-MAR-2008 and no drug allergies who on 14-JAN-2008 at 16:15 was vaccinated subcutaneous in the right thigh with his first 0.5 ml dose of PROQUAD (lot# 656891/0914U).  There were no illnesses at the time of vaccination.  Concomitant vaccines administered on 14-JAN-2008 at 16:15 included a second intramuscular dose of FLUZONE administered in the right leg; an intramuscular "3+2" dose of TRIHIBIT administered in the left leg; an intramuscular fourth dose of PREVNAR administered in the right leg and an intramuscular first dose of VAQTA administered in the left leg.  On 23-JAN-2008, 9 days post vaccination, the patient experienced a febrile seizure that lasted 15 minutes.  The patient was evaluated at a hospital emergency room and transported via ambulance to be admitted to another medical center on that same day.  Lab diagnostic studies included testing for two strains of Influenza and respiratory syncytial virus which were negative and a negative chest x-ray.  The patient was prescribed breathing treatments, TAMIFLU, MOTRIN, TYLENOL, XOPENEX and PULMICORT.  The patient was discharged from the hospital on 24-JAN-2008.  Subsequently, the patient recovered.  There was no product quality complaint.  Additional information is not expected.
Redness outline rash oval 4 inches wide, 5 inches long around injection site. Warm to touch, initially itchy. Outline 0.5 inches wide, color pink and slightly raised, interior skin a little more yellow than normal.
Information has been received from a LPN concerning a 13 year old female pt who on 08/04/03 was vaccinated with a second dose of varicella virus vaccine live. Subsequently on approximately 08/04/03, the pt developed an induration and swelling at the injection site. Unspecified medical attention was sought, but no treatment was required. A product quality complaint was not involved. Additional information has been requested.
HEADACHE, IMPROVEMENT WITH IBUPROFEN, NO IMPROVEMENT WITH TYLENOL
Pregnant and received LAIV. Found through quality assurance review of records.11/10/2009 OB-GYN records note prenatal w/up normal, patient received vaccine 10/26/2009, no side effects noted at this time.   1/30/09 Medical records received for DOS 11/10/09.  Final DX:  rash, vaginitis, pruritus skin, macrocytic anemia Rash all over. 2mm papules.  Vaginal redness, white discharge, small lymph node ant neck, lower abd pain.  wrm hands/feet, heaviness, chills, mild sore throat. Rash resolved.  ICD 9 codes: 782.1, 616.10, 698.9, 285.9
On Monday 1/11, I began to feel ill, Achy, Headache, Stuffy nose, extreme Tiredness and Fatigue.
Approx 5 minutes after receiving the vaccine,  the patient experienced syncope and slid out of her chair.  She was unconscious for approx 10 seconds.  After lying down for approx 10 minutes and using a cold compress on her forehead, she felt better and was able to walk unassisted.  Her mother is taking her to Care to be checked.
11/24/09 3:00am - Sore arm, hot, cold - heart palpitations, resolved within 24 hours. 11am - "Feels fine now"
The next morning after the vaccine I woke up with severe body aches, fatigue and scalp tenderness. The scalp was so painful even my own hair hurt my head which lasted for about 2 day. I had really bad night sweats all the week prior resulting in me being soaked when I did get up. On 12/20 I developed a sinus pressure type headache, a stuffy nose, a mild cough, sore throat and a little chest congestion. 12/26 I lost my sense of taste and smell resulting in me going to the see my PCP but nothing was done. 12/28 I performed a home Covid test on myself and it came back positive. Today I am still a little down but almost back to myself.