chrisvoncsefalvay/vaers-outcomes huggingface dataset:
A non-serious spontaneous report of inadvertent administration of expired H1N1 was received from a registered nurse/health professional concerning a nine-year-old male. Neither relevant medical history nor concomitant medications have been reported for this patient. The original expiration date was 08-Apr-2010, which was reassigned to 29-Mar-2010. On 31-Mar-2010, the patient received the second dose of expired H1N1, Intranasal for an unknown indication. There was no adverse event associated with this medication error; therefore, treatment and reporter causality assessments were not applicable and the event was considered to be resolved.
administered an expired moderna vaccine to a patient; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (administered an expired moderna vaccine to a patient) 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 dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) at an unspecified dose. On an unknown date, the patient experienced EXPIRED PRODUCT ADMINISTERED (administered an expired moderna vaccine to a patient). At the time of the report, EXPIRED PRODUCT ADMINISTERED (administered an expired moderna vaccine to a patient) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitants were provided. No treatment reported.
Joint and muscle aches, "butterflies" in stomach, flushed feeling, head ache, and soreness at injection site (left deltoid) extending to the neck.
This spontaneous report as received from a licensed practical nurse refers to an unspecified number of patients of unknown age and gender. Patients' pertinent medical history and drug reactions or allergies were not reported. On unknown dates, the patients were vaccinated with improperly stored VARIVAX (lot number reported as M002061 and expiration date 12-JAN-2018, lot number M000995 and expiration date 06-JAN-2018, dose and route of administration were not reported). Concomitant therapy was not reported. No adverse effects were reported. No product quality complaint (PQC) was involved. This is one of the two reports received from the same reporter. Additional information has been requested.
This spontaneous report as received from a registered nurse refers to a patient of unknown age and gender with no pertinent medical history/rug allergies or drug reactions reported. On 20-MAR-2015, the patient was vaccinated with an expired dose of M-M-R II (expiration date October 2014, exact date of expiry, route, dose and lot# were not reported). Concomitant therapy was not mentioned. No adverse experienced reported. Additional information has been requested.
10-12 cm diffused, red, warm, non tender, maculopapular rash over left lateral to medial thigh, at site of injection. TX: oral BENADRYL and ice pack per N.P.
muffled hearing; hyperacusis; headaches; vertigo; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 44 year-old male patient received bnt162b2 (BNT162B2), administered in arm right, administration date 18Mar2021 16:00 (Lot number: EN6208) at the age of 44 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "High blood pressure" (unspecified if ongoing). Concomitant medication(s) included: LISINOPRIL. Vaccination history included: Bnt162b2 (Dose 1; lot number: EN6198; administration time: 04:00 PM; vaccine location: Left arm), administration date: 25Feb2021, when the patient was 44 years old, for COVID-19 Immunization. The following information was reported: HYPOACUSIS (non-serious) with onset 19Mar2021, outcome "recovering", described as "muffled hearing"; HYPERACUSIS (non-serious) with onset 19Mar2021, outcome "recovering", described as "hyperacusis"; HEADACHE (non-serious) with onset 19Mar2021, outcome "recovering", described as "headaches"; VERTIGO (non-serious) with onset 19Mar2021, outcome "recovering", described as "vertigo". The events "muffled hearing", "hyperacusis", "headaches" and "vertigo" were evaluated at the emergency room visit. Therapeutic measures were taken as a result of hypoacusis, hyperacusis, headache, vertigo. Additional information: Clinical course: The patient experienced muffled hearing and hyperacusis for the next two days after the second dose. This led to headaches and vertigo. Prednisone was given as a treatment for the adverse events. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19 and since the vaccination, the patient has not been tested for COVID-19. The patient had no known allergies to medications, food, or other products.  No follow-up attempts are possible. No further information is expected.
This spontaneous case was reported by a consumer and describes the occurrence of DYSPNOEA (experiencing shortness of breath, somewhat manageable,shortness of breath got worse, it was really tough at work,feels like she has to take really deep breaths.) and VACCINATION SITE PAIN (pain in the arm where she received injection, but that pain has subsided) in a 31-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 053E21A) for COVID-19 vaccination.No Medical History information was reported. On 24-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 25-Aug-2021, the patient experienced DYSPNOEA (experiencing shortness of breath, somewhat manageable,shortness of breath got worse, it was really tough at work,feels like she has to take really deep breaths.). On an unknown date, the patient experienced VACCINATION SITE PAIN (pain in the arm where she received injection, but that pain has subsided). At the time of the report, DYSPNOEA (experiencing shortness of breath, somewhat manageable,shortness of breath got worse, it was really tough at work,feels like she has to take really deep breaths.) had not resolved and VACCINATION SITE PAIN (pain in the arm where she received injection, but that pain has subsided) had resolved. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available):On an unknown date, SARS-CoV-1 test: negative (Negative) Negative.The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. No concurrent and treatment medication was reported by patient.Patient reported that shortness of breath got worse on 26 Aug 2021. Patient also mentioned that her kids have asthma and she wants to go home and use their asthma nebulizer.
Patient had onset of shortness of breath, chest tightness, elevated heart, diaphoresis.
Pt reports 1 hour after vaccination she developed tightness in her throat like it was closing  and chest tightness.  Pt took Benadryl at home since it didn't seem to be worsening and throat symptom resolved in 1-2 hours, Chest tightness lasted 2 days after. pt also reports he was extra sensitive to other triggers ( cutting celery- lips felt numb) after this as well. She also reports hot localized red rash vaccination area that resolved after 1-2 days.
53 y.o. female with a PMhx of asthma, CHF, CKD (not on HD), DM, HTN, hypothyroidism, methadone dependence for back pain, chronic bilateral foot ulcers presents with c/o one day of fever and admitted for sepsis of unknown origin on 3/9. Patient tested negative for SARSCOV2 on admission on 3/9. She was deemed a candidate for the vaccine and it was administered on 3/10 (Janssen Lot 1805031).  On 3/19, she tested positive for SARSCOV2. She developed worsening respiratory failure and required oxygen supplementation with gradual escalation until she was intubated on 3/29. She received 5 days of remdesivir and steroid therapy. She developed DIC for which she received supportive care (vitamin K, transfusions, etc) and an HLH-type picture for which the steroids treatment was prolonged. She was not a candidate for tocilizumab given the elevated LFTs > 5x the upper limit of normal. During the ICU course patient was started on hemodialysis. Patient gradually started improving around 4/5 with planning for spontaneous breathing trials in attempts to extubate after weaning of sedatives. On 4/8, during a dialysis session patient became hypotensive and bradycardic. After this episode, patient's mental status worsened and developed worsening metabolic acidosis and worsening shock refractory to vasopressors. Family decided for DNR and transition to comfort care. Patient expired on 4/12.
Bicep to forearm areas of redness, swelling, heat, and pain. No reaction at injection site.
Pt reports body aches, fatigue and a mild HA. Encouraged fluids, rest, nutrient dense meals and checking in if fever presents or HA not improved w self care/fluids.
49 yo female who developed a new onset seizure disorder while out of the country with temporal association to vaccine receipt of anthrax and influenza vaccine (neither vaccine is documented). The first documented seizure episode occurred on 19 OCT 2012 and a prior undocumented suspected seizure may have occurred 6-8 weeks earlier in late August or early September 2012. She reports she received anthrax vaccine prior to the August/September event and influenza vaccine within 1 day of the October event. Her October seizure event occurred while in a class, was witnessed and history and evaluation is well documented. The patient experienced tonic clonic activity of arms, legs and trunk for 3 minutes (estimated) causing fall from chair to ground and the incident description states "her head struck the surface of the desk and she sustained a large forehead contusion and developed a large facial bruise leaving the patient with bilateral raccoon eyes and the facial hematoma." She demonstrated a postictal state and only responded to painful stimuli for 5-10 minutes. She had no documented incontinence but tongue biting occurred. There were no identified provoking circumstances. She had no self or family history of seizures. She had a normal non-contrast brain CT (no MRI due to stent history), urine drug screen, CBC and chemistry panel. She initially complained of headache which was subsequently consistently documented, and of memory loss. She was medically evacuated to another location where she was evaluated by neurology, noted to have a normal neurological exam and a normal EEG. She was returned to a third location and a repeat awake and sleep EEG demonstrated on 30 Oct 2015 was abnormal and consistent with focal epileptiform discharges. This is less likely to be vaccine related.
Patient found area of the skin red and warm. She put ice, took PANADOL and apply VICKS. Area still swollen. PREVNAR 13 adverse reaction after the third day of administration.
Severe vertigo and dizziness. Presented to the doctor's office within 9 hours of onset. Sent for physical therapy, which worsened the vertigo and nystagmus. Patient then told to report to the ER. She is unable to walk without holding on to things due to the extreme vertigo. She was told not to drive. She is unable to work.
At the time of the injection I noticed it bled more than normal. Within a couple hours I had developed a visible bruise that took 2.5 weeks to go away. My arm hurt which is to be expected but now it?s been 6.5 weeks and it hurts to lift or twist my arm, feels weak and painful. Some days worse than others.
Heavy chest, stabbing pain on left side of chest, numbness on the right side of face, dizziness, severe headaches, stiff muscles, very weak feeling, shortness of breath, unable to talk and walk for 2 weeks, rapid eye movement, eye twitching.
Tingling as I felt vaccines, Tdap left arm, Hepatitis B right arm, course through bloodstream, felt abnormally weird, felt funny, got up to walk down hall & saw spots & started leaning against wall, felt, weak, dizzy, nurse said I looked pale & yellow & like I was going to pass out, I had cold chills, & feet were very cold, had body aches, nurse laid me down for 10-15 min., checked HR which was normal, sat up & sat there another 15-20 min. before getting up, nurse have me Pepsi & peanut butter & crackers, I did not understand why just getting vaccines would make me feel so weird, still do not feel normal.
17 y/o female, at GA, EDD 6/27/2021, seen on 5/7/2021, as part of routine care provider ordered Covid Vaccine and it was administered by staff, both realized after the patient left that she was under 18 and should have received Pfizer vaccine instead.  Pt seen on 5/21/21 for routine care, no issues noted at this time from dose of Covid vaccine
Headache & NauseaVomiting Narrative: Pt experienced nausea and headache on day of vaccine administration relieved with ibuprofen 400mg oral
USUAL COURSE OF EVENTS WITH SMALLPOX VACCINATION--FORMATION OF PUSTULE WITH DRAINAGE. USUAL CARE PROVIDED; HOWEVER SCAB NEVER FORMED AND RESIDUAL AREA OF ERYTHEMA WITH SMALL VESICLES REMAIN 5 MONTHS AFTER INNOCULATION
pain, tenderness and soreness at injection site (left arm) Patient initially applied ice to affected area, but did not want to take any pain relievers. Recommended to see primary provider if symptoms worsen. Patient has an appointment to see provider in June.   Placed follow up call on 5/3/2021 at 1000 hours: Pt reports she is still having pain, tenderness and soreness on her left arm at the injection site. Pt advised she have an appt with MD 5/4/2021. Pt only applied ice pack and have not tried any Tylenol or Ibuprofen.  *NOTE* Please contact pt mid-morning.
Received 4th DTaP and 4th HIB 3/25/03 in left leg (different sites). PM of vaccine admin day, child developed knot (tangerine size), erythema and brusing at injection site. Child limping, feverish, irritable per mom. 3/26 Mom took to MD who diagnosed infection and began Augmentin which child vomited. 3/27 returned to ED and changed to Keflex. 3/28 child with limp, able to squat/bender over with problems. Left outer aspect of leg with 2 nickel size areas of dark erythema. 60 cm area of dark pink surrounding nickel size dark red areas progressing to outer aspect/back of left leg. Area hot to touch. Areas of edema not palpated as uncomfortable for child.
pain from top of head to bottom of feet, shivering, can't get warm; 24 hrs later running slight fever - about 2.5 degrees above normal temperature
Headaches, chills , fever and body aches for 3days . On fourth day a red blotchy lump appeared where vaccine was administered .
This is a spontaneous report from a contactable nurse. This nurse reported similar events for three patients. This is the third of three reports. A 60-year-old male patient received the first dose of PREVNAR 13 (Lot Number F8804) intramuscularly, in the left deltoid on 09Mar2012. Relevant medical history, concomitant medications, and past product history were unknown. On 16Mar2012, following administration of the vaccination, the patient developed a red raised rash at the site of the injection. Treatment was not required for the event. The outcome of the event was unknown. Follow-up (06Apr2012): New information reported from a contactable nurse includes: Lot Number, patient information, and treatment details. Follow-up (26APR2012) Follow-up attempts completed. No further information expected.
soreness at injection site (left upper arm) expanding to most of upper arm beginning about 1 hour after injection and increasing for 24 hours, then decreasing to just tenderness at direct site after 48 hours.  headache beginning a few hours after injection and increasing in severity for about 12 hours, then diminishing/ending. rash on right forearm, sudden appearance about 3 hours after injection, diminishing after about 2-3 hours.
I was very tired, lost weight, and the blood test was done, they discovered Waldenstrom's macroglobulinemia in my bloodwork. The doctor is doing research to see how it's going to be treated. I have lost almost 30 pounds after the vaccine.
pt recv vax 4AUG95 & 11APR96 pt devel rash w/approx 30-40 lesions;exp was dx as active chickenpox;MD reported 3 patients w/the same exp;
Rash, ErythemaMultiform, UrticariaPruritus,  reaction started 7 days after injection  Narrative:  1 week after injection, site became swollen, red, hot and itchy. The area is described as a baseball sized area. She was prescribed a  steroid and an antibiotic for possible cellulitis.
Sore throat; headache; tiredness; This is a spontaneous report from a contactable consumer, the patient. A 19-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot Number: EW0171) via an unspecified route of administration in the arm left on 21Apr2021 at 16:30 (at the age of 19-year-old) as a single dose for COVID-19 immunisation. The medical history included allergy to penicillin and sulfa drug. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. The concomitant medications were not reported. On 22Apr2021 at 14:00, the patient experienced sore throat, headache and tiredness. The patient did not receive any treatment for the reported events. The adverse events did not result in a visit to the doctors or other healthcare professional office/clinic visit and emergency room/department or urgent care. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the event sore throat, headache and tiredness was unknown at the time of this report.   No follow-up attempts are needed. No further information is expected.
Vaccine Expired 1/30/23 - vaccine given 1/31/23 No harm to patient - no reaction
Duplicate administration of MENACTRA. Patient received dose on 7/29/16. It was documented in the EMR but not in the registry. Came back for f/u with different provider, vaccine was ordered and readministered.
initially "He states he then developed fevers which were subjective, chills.  States every morning when he wakes up he vomits.  Noticed runny nose and decreased sense of smell.  Has had 2 - Covid tests.  No chest pain or abdominal pain.  Does feel short of breath." was seen in the ED. Now 2 months later has 2 primary concerns he attributes to the Covid vaccine 1. persistent arm pain 2. tired, decrease exercise tolerance.
1.) immediate pain in injection site that lasted until the next day. Pain relieved after taking Tylenol the morning after 2.) elevated skin temperature at night documented as 3 degrees above baseline by Fitbit Sense 3.) headache felt 26 hours after vaccine administration; 101.7 degree temperature documented 26 hours after vaccine administration since Tylenol 500 mg taken in the morning 4.) symptoms resolved the next day
12/12/21 ID note: "Rt.flank pain : likely from passed stone. UA negative for infection. Pain subsiding. CT abd/pelvis with dilatation of the right proximal ureter and mild to moderate right-sided hydronephrosis. On Bactrim.  2. COVID-19 infection: Asymptomatic. Found during screen. Positive multiplex on 12/12/21.  Vaccinated in Feb/2021. No significant sick contacts except for prolonged time in the ED.  No current symptoms.  3. Mild renal insufficiency 4. Remote h/o TB, treated"
4/26/01, child had quarter-sized knot on left arm where shot was given. Complained of pain, had redness and warmth to touch and unable to sleep on that arm. Today knot a little larger. (Info-per mom of pt). If worsens, is to take to PMD and call and notify HD. On 4/30/01, telephone call to parent: states swelling went down that day and no problems now.
ARM WAS SORE AFTER RECEIVING BOOSTER COVID 19 VACCINE; INCREASED IN ITCHING; INCREASE IN PAIN; This spontaneous case was reported by a consumer and describes the occurrence of PRURITUS (INCREASED IN ITCHING), PAIN (INCREASE IN PAIN) and VACCINATION SITE PAIN (ARM WAS SORE AFTER RECEIVING BOOSTER COVID 19 VACCINE) in a 51-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) solution for injection for Psoriatic arthritis.    Concomitant products included TAVABOROLE, CLOBETASOL PROPIONATE (CLOBETASOL 0.05%), OMEPRAZOLE, ESTROVEN and ASPIRIN [ACETYLSALICYLIC ACID] for an unknown indication.   On 28-Apr-2021, the patient started ADALIMUMAB (HUMIRA) (Subcutaneous) 40 milligram every two weeks. On 03-Sep-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In 2021, the patient experienced PRURITUS (INCREASED IN ITCHING) and PAIN (INCREASE IN PAIN). On 03-Sep-2021, the patient experienced VACCINATION SITE PAIN (ARM WAS SORE AFTER RECEIVING BOOSTER COVID 19 VACCINE). At the time of the report, PRURITUS (INCREASED IN ITCHING), PAIN (INCREASE IN PAIN) and VACCINATION SITE PAIN (ARM WAS SORE AFTER RECEIVING BOOSTER COVID 19 VACCINE) outcome was unknown.            Concomitant product use was not provided by the reporter.   Treatment information was not provided. This case was identified as part of a retrospective clean-up activity where certain emails received in the Moderna mailbox were missed to be booked-in.
Headache, fever, chills, aches and soreness, slight nausea. Started approximately 5 hours after the shot and lasted until about 24 hours after the shot.
Injection site reaction x6 days. Redness and swelling, soreness at injection site.
I started having injection site pain, headache, fatigue, but also I couldn't sleep at all. I felt like for the next so many days I just could not fall asleep at all. I started to feel better, and as I got to Saturday, I started having really bad pain in my lower right abdomen. It was excruciating. I couldn't breathe because it hurt to breathe. It was so painful, it made me cry. I was already on a bad path with my chronic condition. I was very exhausted and worn out. I live alone. I was vomiting and I had diarrhea. I called someone to tell them what was going on but they could not take me to the hospital because their daughter had just been diagnosed with covid. Throughout that night, it kept happening. I couldn't figure out if maybe my appendix had burst, or if it was some weird thing from the vaccine. It was just really bad pain in my lower abdomen on the right side. It was where I couldn't basically move. I went to the hospital the next day (Sunday). They gave me IV meds and fluids. I was dehydrated. I was extremely nauseas and had been vomiting. They imaged me, CT scan. They couldn't really find anything that could be causing the pain. There was no validity to it being tied to a reaction to the vaccine. They believe it was just a coincidence. The hospital staff did some blood work, an MRI, and a stool study. I was in the hospital  for 6 days.
Receive flu vaccine Sunday, 09/11/16. Friday, 09/16/16, developed fever to 102 degrees F. Saturday, 09/17/16, developed papular rash on (R) calf and was seen in urgent care.
Pt is a 5 y/o with egg allergy. Received FLUMIST 10/18/11 with no reaction. Had FLUMIST 11/08/2012. Pt had reaction 45 min later with facial erythema, edema & conjunctival infection & pruritus, rx BENADRYL - lasted 24 hrs.
POSITIVE COVID TEST; This spontaneous report received from a patient concerned a 28 year old male. 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: 1802070, expiry: UNKNOWN) dose was not reported, administered on 13-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On 05-APR-2021, the subject experienced positive covid test. Laboratory data included: COVID-19 rapid POC test (NR: not provided) Positive. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of positive covid test was not reported. This report was non-serious.; Sender's Comments: V0 Medical assessment comment not required as per standard operating procedure as the case assessed as non-serious