chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Vaccine that administered beyond use date after the thaw process; This spontaneous case was reported by a paramedic and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Vaccine that administered beyond use date after the thaw process) in a 35-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 070H21A) for COVID-19 prophylaxis.     It was unknown if patient ever had tested or diagnosed positive for COVID. It was unknown if patient had Acute or Chronic/ long-standing illnesses at the time of vaccination or up to 1 month prior to vaccination. Information about other vaccines given within 1 month prior to Moderna COVID-19 vaccine was unknown.     On 12-Mar-2022, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .25 milliliter. On 12-Mar-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Vaccine that administered beyond use date after the thaw process). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Vaccine that administered beyond use date after the thaw process) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medication information was provided. On 10-Jun-2022, medical was notified about an audit that was done and they were then made aware of vaccines that were administered beyond use date after the thaw process.  Reporter stated that patient did not had any adverse reactions after the administration of vaccines.  No treatment medication was provided.   This case was linked to MODERNATX, INC.-MOD-2022-542869 (E2B Linked Report).; Sender's Comments:  MODERNATX, INC.-MOD-2022-542869:Crosslink case(MCN)
Seems like covid all over again; chills; Nausea; This spontaneous case was reported by a consumer and describes the occurrence of CHILLS (chills), NAUSEA (Nausea) and COVID-19 (Seems like covid all over again) in a 60-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 006B21A) for COVID-19 vaccination.     No Medical History was provided by the reporter.    On 20-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form.   On 21-Mar-2021, the patient experienced CHILLS (chills) and NAUSEA (Nausea). On an unknown date, the patient experienced COVID-19 (Seems like covid all over again). At the time of the report, CHILLS (chills), NAUSEA (Nausea) and COVID-19 (Seems like covid all over again) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 06-Nov-2021, SARS-CoV-2 test positive: positive Positive.   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 product use was not provided by the reporter. No treatment information was provided.
Patient was aware she has "white ocat syndrome" and anxiety. Brought her husband for support. Shortly after administration, patient became anxious and hyper ventilating. I had her breathe deep and slower and we put an ice pack on her neck. Time course was about 10 minutes I kept her in admnistration room with me. She did shake a little took a sip of drink they had brought and after @ 10 mintes did say she felt better and was able to walk to waiting room where I had them sit for 15 more imnutes
On 4-5 day after second vaccine developped bruising and purpura, on 10th day developped ulcers in the mouth. Came to PCPs office on 05.17.2021. Was sent to labs. On 05.18.21 had labs done. CBC has shown platelets  <5 K. Patient was called on 05.19. 2021  AM and sent to ER of Hospital.
Patient presented to the clinic during a COVID-19 vaccination clinic (primary for children 12 and older but walk in clinic is also active at this time).  He told me that he needed a vaccination card and for his kids to be vaccinated. I was helping another patient at the time and told him that I would be with him shortly. By the time I got to writing his card information down, seeing that he got a Moderna vaccine first,  he had already received his vaccine from another nurse. Nurse did not have access to a computer and states that the patient said he needed his second shot. The nurse asked the patient if he needed the Pfizer vaccine and the patient said yes.   I explained to the patient that he does not need to re-do his course of either vaccine and will be considered fully vaccinated on July 1st. He expressed understanding and went to wait for 15 minutes following vaccination. I contacted RN (vaccine clinic coordinator) to report that this error occurred and informed, PharmD (pharmacy director).
Pt started having dizziness, increased HR, extremities became pale, BP increased to 170/94, HR 144 30 mins after injection. Pt tolerated first vaccine s difficulty, sxs continued and BP and HR fluctuated off and on for 1hr. Pt was given an EPI pen, Solumedrol 125mg, Zyrtec (refused benadryl) , and Pepcid 20mg during the episode. HR and BP continued to increase - EMS was called and pt was take to the ED and released ~10pm at night to home.
Incorrect birthday noted: System has wrong DOB, also, vaccinator documented the adult code (230425) instead of the 12 and up code (233599): On 5/10/2021, Pfizer was authorized for age 12 and up
PHARMACY NOTICED THAT PATIENT WAS GIVEN VACCINE AFTER ITS BEYOND USE DATE (BUD) OF 2/2/2023.  PHARMACY HAD REACHED TO MODERNA TO DETERMINE IF VACCINE MAINTAINED ITS EFFICACY AFTER THE BEYOND USE DATE.  MODERNA WILL CONTACT PHARMACY WITHIN 3-5 DAYS FOR RESULTS.  PHARMACY ASSOCIATES HAVE BEEN INFORMED OF ERROR CREATED BY PHARMACY.  PHARMACY ASSOCIATES WERE ALSO INFORMED AND REMINDED TO CHECK BUD WHEN PULLING A BOTTLE OUT OF THE REFRIGERATOR.
Reports that symptom of abdominal pain started that night. Since then w/ chronic abd pain that has required GI consultations with multiple exams including, CT scan, ultrasound, endoscopy. Was well child until that well visit.
This was an unnecessary vaccine given in the series.  Our records indicated it was needed, and state website not consulted.  Upon logging vaccine in website, it was discovered it was an unneeded dose.  No adverse reaction occurred.
The vaccinator used a 5/8" needle to administer the COVID-19 vaccine into the anterolateral thigh.
Client states she has problems with allergies that causes hives. Client received shot.  Took her seat for observation. Her face began to get splotchy and red. Hands turned red.  Itching started on neck, abdomen,legs and face. Although she complained about itching, only area with any visible signs was face and redness of hands.Benadryl was offered, but client refused.   Client was observed  for 1 1/2hr.  Client stated she was  not feeling any worse. Was very calm about situation and stated this happens to her all the time. Client left vaccine clinic, but stated she would not be alone.Upon interview 2/19/2021 she stated itching and splotches on face lasted about 4hr.
Information has been received from a physician concerning an 18 year old female with no relevant medical history or allergies who in approximately 2007, also reported as last year was vaccinated intramuscularly with a first, second and third 0.5 ml dose of GARDASIL (lot number and injection site not reported).  There was no concomitant medication.  The physician reported that the patient tested positive for GARDASIL.  The patient called the physician's office and unspecified medical attention was sought.  At time of this report, the patient's event persisted.  Additional information has been requested.
This case was reported by a influenza vaccine distributor and described the occurrence of throat closing up in a 27-year-old female subject who was vaccinated with FLULAVAL (GlaxoSmithKline). Concurrent medical conditions included latex allergy. On 3 November 2003, the subject received a dose of FLULAVAL (.5 ml, unknown, left arm). On 3 November 2008, 4 hours after vaccination with FLULAVAL, the subject experienced throat closing up and trouble breathing. The subject was treated with adrenal (pen). The subject experienced a reaction, clarified as, her throat was closing up and she was having trouble breathing approximately four hours after receiving FLULAVAL. The subject gave herself an injection with Epi Pen and went to the emergency room. The emergency room physician and her primary care physician attributed the reaction to a cross reaction to the thimerosal preservative in the FLULAVAL and her latex allergy. In November 2008, the events were resolved.
Event occurred during administration of the COVID vaccine due to equipment malfunction. As I was injecting the vaccine, a drop of it came out from the side of the syringe where the needle connects. Seems like the needle was not completely screwed on or the equipment was defective (not creating a seal between the barrel and the needle). A drop of the dose was lost. I let the patient know what happened and that I would have to re-administer the dose. But, according to the CDC guidelines, if more than half of the dose is administered, then re-administration in not necessary.
27-jan-87 pt vax dtp/opv. pt devel fever 105 def, local reaction and screaming episode.  duration of illness 3 days.
Pain in left arm started on 3/12/2021. Went to Dr.  on 03/15/2021. He did bloodwork, EKG, and chest x-ray. Started taking Gabapentin and Presnisone 6 day pack. Bloodwork showed a SED rate of 30. 3/17/2021 went to see Dr for heart. He did EKG and ruled out paricardicus. 3/18/2021 went to see Dr . He did shoulder x-ray and needed to see neurologist
Patient received high dose FLUZONE and PNEUMOVAX at 10:15 on 10/14/14; patient developed foreign body sensation in throat at which, bilateral conjunctival injection and tearing at or before 2pm.
Child c/o "everything looking black", harder to hear ("things got quiet"). Needed to sit down, was very pale. Episode began within few minutes of receiving vaccine. Child seated, given juice, rested x 20 min, felt much better - home with parent.
5/25 Received vaccine at 9:30 a.m. at the hospital. Sore arm developed about 3 hours later. Later that afternoon, had muscle aches and tiredness. 5/26 10:30 a.m. noticed a couple hives on my upper thigh and inside forearms. Realized they were there before I got to work, but didn't make note of it.  12:00 felt very tired, muscle aches, especially in neck, felt like mild flu. noticed hives/rash getting worse in the afternoon. They were not itchy. 8:00 p.m. Called on call doctor due to worsening rash/hives. "Breathing seemed fine. Dr. called back and advised 10 ml Benedryl along with nightly Zyrtec. Took 10 ml liquid Benedryl.  9:00 p.m. noticed breathing got a little easier, less constricted. Made sure my son's epi pen was available if needed.  Saturday, March 27 Had chills in the middle of the night, turned on electric mattress pad to get warm, making hives worse. 4:00 a.m. 10 ml Benedryl. Didn't notice breathing getting better, or not lasting very long. Contemplated ER if got worse. 8:45 a.m. 10 ml Benedryl. Temp is 98.8 10:00 took Zyrtec and ibuprofen Called Dr. in the morning, who suggested medrol dose pack of steroids. Due to past history with hives, requested 10 day course of steroids. 11:00 6 prednisone 1:30 p.m. 10 ml Benedryl possible less internal agitation 5:45 Benedryl 11:00 p.m. Zyrtec, temp 98.2. Hives continued to spread, but at much slower rate. Felt on face, ears and back of head. More prickly sensation form the hives. Some spots so many hives it is just one large red spot. Felt very hot. Tried to use ice pack to cool down and ease tingling irritation from hives. Sunday, March 28 1:10 a.m. Benedryl for restlessness (especially in legs), chamomile tea 4:00 a.m. magnesium, which finally settled the restless legs. 11:30 prednisone Called Dr. back since hives didn't seem to be dissipating, and feeling very agitated internally. We both agreed it was time to go to urgent care. Saw Dr. at Urgent Care. She offered steroid shot, but stated it would further decrease the effectiveness of the COVID vaccine. Observed that my back was looking better from the hives. Opted to try famotidine and hydroxyzine hcl for allergy and agitation.  2:45 took hydroxyzine and famotidine within an hour, started to have relief from the intensity. That night, I was finally able to  rest and sleep.  Over the next few days, the hives continued to go away, and I wasn't bothered internally by them again.
Break through infection on July 5th or shortly before, while attending a birthday party.  A number of other people also tested positive about the same time as I did (7/6/2022).  Dr. prescribed the Paxlovid treatment, which I completed this morning.  Currently feeling fairly good but occasionally coughup some mucus.
Had severe upper abdominal pain, back pain, fever, vomiting, acid reflux. Diagnosed with acute pancreatitis 3 days after symptoms started
Temperature Excursion Heplisav-B Administered to 15 Patients; Initial Report Received on 14-Sep-2021 and 15-Sep-2021  A Registered Medical Assistant reported that approximately 15 patients (age, gender, race and ethnicity not provided) received HEPLISAV-B (hepatitis B vaccine) for hepatitis B immunization after the vaccine was out of temperature range with multiple excursions over a maximum of 10 days.  This report is for patient 2 of 15.  No relevant medical history was reported.    No relevant concomitant medications were reported.    On an unspecified date, the patient 2 of 15 received a dose of HEPLISAV-B (Lot #, expiration date and NDC # not reported) after the vaccine was out of temperature range with multiple excursions over a maximum of 10 days. The route and site of vaccine administration were not reported.   No additional information was reported.   Company Comment: The company assessed the event as non-serious.; Sender's Comments: The company assessed the event as non-serious.
patient received 0.5ml dose instead of 0.3ml.  As of 9/19/22 patient has not had any adverse effect.
Guillain-Barre syndrome (severe weakness, numbness in all 4 extremities, worst in legs, hospitalized, given 5 d IVIG).
Facial numbness up to the right eye, swelling of the nasal cavity 25 minutes after injection. Benadryl stopped the progression.
MMR on 8/26/13.  Rash on trunk the next day lasted a few days.  On day 10 he had malaise, day 14 he was noted to have joint pain of fingers, wrists bilaterally, ankles, elbow(s) knee and hip. He has had a migratory joint pain ever since.  Exam is unremarkable for sx of arthritis (effusion, erythema, redness, warmth).  Nausea QD x 3 weeks.   Also c/o SA unrelated to eating.   Temp was low grade right after the MMR. He returned to our office with a rash consistent with HSP, joint pains and abdomenal pain on 1/2/14.  Mom reports his rash improved after only a few days. Denies hallucinations, stiff neck, joint swelling.
Pt was given PNEUMOVAX left arm first. Then Flushot right arm. Right after the flushot was given, pt was told to wait 15 mins, she got up and said she was having trouble breathing. She looked flushed.  Per Pt, she said she can taste the medicine in her throat. Pt was told to sit down as was given some water to drink. She then said she can feel the flushing radiating down to her kidneys. After about 3 mins she felt better and looks visibility better. She was given benadryl liquid 10ml just to be safe. She waited 35 mins and she was was feels ok but not herself. She waited 10 more mins before she said she was ok and wanted to leave.
12/7/2017 received immunization. 12/10/2017 noted right arm immunization site extremely sore and developed severe headache, nausea, vomiting, stiff neck, pain radiating down into right shoulder and arm especially with head movement. 12/13/2017 developed diplopia with worsening of all symptoms. Around 12/23 experiencing global weakness, mental status changes, confusion, difficulties of concentration, speech and balance. Completely incapacitated by 12/25 when he presented to the emergency department. CT of brain completed with evidence of acute right cortical vein thrombosis. Transferred emergently to another Hospital. He underwent intensive workup confirming right posterior, parietal and frontal cortical vein thrombosis with associated subarachnoid and subdural inflammation with effusions. Left complete sixth cranial nerve palsy. Evidence of right cervical neuralgia. Hospitalized 12/25-12/31/2017. Symptoms slowly improving except for a sixth nerve palsy which is unchanged.
Pt given vaccine on 12/26.  Began to experience generalized pruritis and mild rash on 12/17. By 12/28 had severe urticarial rash requiring oral steroids. Rash did not improved with steroids and antihistamines, and pt developed edema of hands, feet and eyes and some respiratory symptoms on 12/31. Given IV decadron with relief by an outside provider. Symptoms improving but persistent mild rash at time of my recent re-evaluation on 1/2/07. Her hands remain sore.
Moderna booster shot and I had a COVID test that came back positive; This spontaneous case was reported by a patient and describes the occurrence of COVID-19 (Moderna booster shot and I had a COVID test that came back positive) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis.     Previously administered products included for Product used for unknown indication: Pfizer vaccine (2nd dose) and Pfizer vaccine (1st dose). Past adverse reactions to the above products included No adverse reaction with Pfizer vaccine and Pfizer vaccine.    On 02-Nov-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 27-Nov-2021, the patient experienced COVID-19 (Moderna booster shot and I had a COVID test that came back positive). At the time of the report, COVID-19 (Moderna booster shot and I had a COVID test that came back positive) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 27-Nov-2021, SARS-CoV-2 test: (Positive) positive.         No medical history information was reported. No concomitant medications were reported. No treatment drugs were reported.  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.
Warmth and redness at injection site. Deep tender lumps noted in muscles at follow-up visit on 9/23/15, felt to be hematoma in/near muscles. No treatment required. No signs of secondary infection.
Patient received her second covid dose (Moderna) 21 days from the first dose (Pfizer).
administered ActHIB with the incorrect diluent/no AE; Initial information received on 16-Jan-2020 regarding an unsolicited valid non-serious case received from a nurse.  This case involves a 15 months old female patient who received vaccine HIB (PRP/T) VACCINE [ACT-HIB] mixed with wrong solution.  The patient's past vaccination(s) included ACT-HIB with three doses on unknown dates. The patient medical history, medical treatment(s) and family history were not provided.  Concomitant medications included PNEUMOCOCCAL VACCINE CONJ 7V (CRM197) (PREVNAR) for Immunisation.  On 08-Jan-2020, the patient received a 0.5 ml single 4th dose of suspect HIB (PRP/T) VACCINE lot UJ112AA via intramuscular route in the left deltoid.  It was of actual medication error due to wrong solution used in drug reconstitution. The patient was administered an Act-Hib dose that had been reconstituted with Merck sterile water for injection diluent, rather than the diluent included with the ActHib.  It was unknown whether adverse event was experienced or not.  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 Directive and Module VI of the 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.
I have a number of metallic orthopedic implants:  L & R shoulder, L elbow, L & R femur and R knee.  After my first shot, I noticed that I developed a slight pain in my left shoulder and elbow at about day 3 post jab.  At about day 5 post jab, I started to have similar pain in my R femur and knee.  The pain was minimal (2 out of 10) and subsided in another 5 days.  Otherwise I had no reaction to the vaccine.  I received my second jab 3/9/21 and got an immediate bruising at the injection site with a little pain (2/10 again) but no further issues with my implants
This spontaneous case was reported by a consumer and describes the occurrence of NECK PAIN (Pain is going up the neck) and VACCINATION SITE PAIN (Her left arm started hurting like devil) in an 82-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011A21A) for COVID-19 vaccination.     The patient's past medical history included Mastectomy (Had a Mastectomy 40years ago).    On 03-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .5 ml. On 03-Mar-2021, the patient experienced NECK PAIN (Pain is going up the neck) and VACCINATION SITE PAIN (Her left arm started hurting like devil). At the time of the report, NECK PAIN (Pain is going up the neck) and VACCINATION SITE PAIN (Her left arm started hurting like devil) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant product use was not provided by the reporter.  No treatment information was provided.
Fainting about 5 minutes after vaccination, we gave patient water, let her rest and put her feet up. She recovered fully after 10 minutes.
Breakthrough case admission after 3 vaccines Pfizer 4/1/21 Lot# Ew0150;  Pfizer 4/22/21 Lot# Ew0170;  Pfizer 2/4/22 Lot# 330368D
Immediately after shots Pt was extremely fatigued and slept. The following day she was no longer babbling and instead squealing for all variable communication. The fatigue lasted 3 days and she needed to be awaken to eat. She was glassy eyed for 3-4 days. She stopped smiling, goggling, responding and no longer held her weight in a standing position. Pt had a flat affect and lost her ability to babble, smile, laugh and respond for many weeks. With a great deal of intervention from mom who is a school psychologist, Pt has slowly regained most of her signs.
09/25/2008 fever miday, later tingling in legs, 09/26/2008 bladder pain could not unrinate, 11:00am doctors office possible UTI 1:00pm emergency room Cath removal 1000cc urine. Tests neg for UTI told once able to urinate will release. By 6:00PM total paralysis in both legs, MRI, CAT, and spinal tap. Treatment of antibiotics and steriods. Still has some nuerological and unrological issues and being treated along with out patient theropy.  01/06/2009 MR received for DOS 9/26-10/08/2008 with D/C DX:  ADEM.  Pt presented with several day hx of  progressive paresthesias and weakness of the lower extremities, fever, urinary retention and abnormal gait. (+) nausea and vomiting. Cathed in ER for 800ccs urine. Increasing toe, back and neck pain as well as H/A. PE (+) for shotty adenopathy of the neck, decreased strength of all 4 ext-lower>than upper, downgoing toes, decreased sensation lower ext, hyperreflexia with clonus.  Some tingling of upper extremities. Tx with Solumedrol x2 courses with improvement. D/C to rehab.
This spontaneous report as received from a healthcare professional refers to an unspecified number of patients. In approximately 2015 (reported as since 13-MAR-2015), the patients were vaccinated with doses of PEDVAXHIB lot # K002746, K008878, K025002 (expiration dates, dose, route and site of administrations were not reported) that were exposed to temperatures outside of the recommended range. No adverse effects had been observed or reported. This is one of several reports from the same reporter. Additional information has been requested.