chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Booster doses with a plus 30 days refrigerated stored vial; Expired Booster Doses Administered; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Expired Booster Doses Administered) and PRODUCT STORAGE ERROR (Booster doses with a plus 30 days refrigerated stored vial) in a 63-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 007J21-2A, 036C21A and 036C21A) for COVID-19 vaccination.     No Medical History information was reported.   On 02-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 30-Aug-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 21-Feb-2022 at 12:44 PM, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to .25 milliliter. On 21-Feb-2022 at 12:44 PM, the patient experienced EXPIRED PRODUCT ADMINISTERED (Expired Booster Doses Administered). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Booster doses with a plus 30 days refrigerated stored vial). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Expired Booster Doses Administered) and PRODUCT STORAGE ERROR (Booster doses with a plus 30 days refrigerated stored vial) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant products were reported.  Reporter stated that on 21-Jan-2022 at 06:00 AM vial was initially stored in the refrigerator and the vial did not undergo any temperature excursions.  No treatment information was reported.   Most recent FOLLOW-UP information incorporated above includes: On 25-Feb-2022: Reporter information was updated On 28-Feb-2022: Follow-up received contains suspect product time, route of administration and dose volume and additional event of Product storage error were updated.
Patient began feeling a burning pain and itching at injection site the evening of the day she received the vaccine. She also developed a fever. The injection site was inflamed and red, and hot to the touch.  She used OTC hydrocortisone 1% cream on the area, but it did not provide relief. On 4/6/16, she started to develop two red spots on her forehead as well as the start of a blister on her upper lip. The injection site remains inflamed and red (roughly 2 inches in diameter), hot to the touch, itchy, and feels like a burning sensation.
Patient complained of itching approximately 15-20 minutes after receiving MENACTRA and GARDASIL.  Patient given 50 mg Benadryl p.o.  Cool compresses to neck and back.  Patient anxious, hyperventilating.  Patient placed in supine position.  P.O. 97, pulse 83.  Doctor at bedside.  Reduce of pulse OX 87, P 72.  Patient placed on O2.  SATS 99-100.  Code team called - SQ epinephrine given and patient transferred to ER. 5/29/08 Reviewed hospital medical records of 5/7-5/8/2008. FINAL DX: anaphylaxis to Gardasil or Menactra Records reveal patient experienced blurred vision, itch, hives, diaphoreses, dizziness, lightheadedness, SOB, nausea, palpitations, throat swelling, shaking & passed out.  Patient reported similar reaction to prior flu vaccination. Tx in ER & admitted for observation.  Ortho & psych consults done for old fx & anxiety related to anaphylaxis.  No further difficulties & d/c to home next day w/allergy med & epi-pen.
Patient developed lower extremity rash 4 days 10/26 after vaccine administered on 10/22.  Presents to clinic now on 11/03 with confluent lower extremity rash and mac/papular on trunk and upper extremities. Lower extremities with non-pitting edema and bullae forming and pt c/o lower ext. joint pain.
Dizzy, states feels like in a dream-like state.  Assessed by paramedic. Client denies difficulty breathing.  Assed by onsite paramedic.  Vital signs done.  Client observed for another 15 mins.   Stated felt much better, requested to leave.   Client instructed to seek medical attention should she experiences any further symptoms.
Pt. was at a pool and c/o SOB, tightness in chest, nausea and (L) arm swollen. Presented to office and lungs clear/no resp distress. Golf size swelling on (L) deltoid, 25 mg BENADRYL given.
This spontaneous report was received from a pharmacist and refers to a female patient of unknown age. The patient's medical history, concurrent conditions, drug reactions and allergies were not reported. On 06-AUG-2015, the patient was subcutaneously vaccinated with ZOSTAVAX (0.65ml, lot # L003218, expiration date:30-APR-2016; once). Concomitant therapies were not reported. On 07-AUG-2015, the patient developed swelling at the injection site and a headache. The patient sought medical attention, she called the pharmacy on 08-AUG-2015 or 09-AUG-2015 asking if there was anything she could do to help reduce the persistent swelling and headache had lessened. The pharmacist stated that the patient used BENADRYL cream on the area as a home remedy. The patient did not recover from the adverse events. The relatedness between the injection site swelling and headache and ZOSTAVAX was not reported. Additional information has been requested.
1 week later developed scratchy throat bad cough wheezing and possible bronchitis or bronchial infection.   Lungs sounded clear except for upper respiratory
Information has been received from a physician concerning a 6 year old male with no illness at time of vaccination, who on 22-MAR-2007 was vaccinated SC in the left leg with a dose of varicella virus vaccine live (Oka/Merck) (lot number: 639899/0977L). There were no concomitant medications. On 19-JUN-2007, the patient experienced varicella. The outcome is reported as recovered. There was no product quality complaint. Additional information has been requested.
Got Tinnitus shortly after second shot of Moderna Covid 19 vaccine and continue to still have it a year later.
Headache for 2 weeks. Heartburn and stomach pain and sinusitis. Heartburn and stomach pain still ongoing.
Within 10 minutes, I had severe headache again (same as after the 1st Moderna COVID-19 vaccine) and within 30 minutes, I had dizziness and the dizziness is still present a week later. The chills have been ongoing since the first vaccine. I'm still cold all the time. The numbness in my leg and heel was getting better, and now it has gotten worse after getting the second dose. My fingers on left hand go numb from time to time. I have heart palpitations at time. I talked to my PCP last Friday, and he said to wait it out through the weekend.  I called him on Monday, and yesterday; I saw him, and he did EKG that came back normal. He ran blood tests and urine and I'm still waiting to hear back from him to hear about those results.  I have been taking Motrin or Tylenol for body aches and headaches. Those symptoms seem to be better now. Now, it's just the dizziness and the numbness in my leg, and heel, and fingers. The dizziness comes and goes. I haven't tried to drive or gone to work since the vaccine. I'm a dentist and I can't have a dizzy spell come over me when I am working on a patient.
Family returned at 11:30 am.  Infant's face was swollen and appears urticarial.  She has bulbar conjunctival swelling.  On exam, there were no wheezes or respiratory distress.  No tongue swelling or vomiting.  She was given Benadryl 3.75 p.o. in office and within 15 minutes she is sleepy and swelling is markedly improved.  She had no prior issues with her 2 month and 4 month vaccines.  Of note, mom fed the infant a small piece of egg for the 1st time, but mom says her face was already starting to turn red at theat point.  2:00 p., the father called stating she woke up and vomited x1.  Advised not to give egg again.  No other issues noted.
Information has been received from a health professional concerning a 28 year old female with no known drug allergies and no past medical history who in February 2000 was vaccinate with a first dose of varicella vaccine. In July 2000, the pt was vaccinated with a second dose of varicella vaccine. There were no concomitant medications or current illnesses. In August 2001, the pt was titered for serum varicella zoster antibody and test was negative. Unspecified medical attention was sought. No additional details were provided. Additional info has been requested.
I21.4 ACUTE NON ST ELEVATION MI 7/5/2023 CKD STAGE 3A (GFR 45-59) J96.00 ACUTE RESPIRATORY FAILURE 7/5/2023 CKD STAGE 3A (GFR 45-59)
During 15 minute observation period after vaccine, patient presented to pharmacist on duty with severe dyspnea and all-body erythematous blotches/hives. RPh administered epipen while staff called 911. Breathing improved and patient was taken to local emergency department.
This spontaneous case was reported by a consumer and describes the occurrence of HERPES ZOSTER (She began having pain & soreness then a rash that a chiropractor told her was shingles. She broke out on right side on her front just under breastbone & it wrapped around to her back), MUSCLE SPASMS (She was having spasms just like when she was pregnant with her son, & he would kick), PAIN (She began having pain & soreness then a rash that a chiropractor told her was shingles) and RASH (She began having pain & soreness then a rash that a chiropractor told her was shingles) in a 61-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. Concurrent medical conditions included Epidermolysis bullosa (she has a history of a rare skin condition called epidermolysis bullosa that causes skin blistering), Fibromyalgia, Chronic fatigue and Diabetes mellitus insulin-dependent (Patient uses insulin). Concomitant products included INSULIN for Diabetes mellitus, SILVER (COLLOIDAL SILVER), LINUM USITATISSIMUM OIL (FLAXSEED OIL [LINUM USITATISSIMUM OIL]) and VITAMINS NOS for an unknown indication. On 23-Dec-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In January 2021, the patient experienced HERPES ZOSTER (She began having pain & soreness then a rash that a chiropractor told her was shingles/She broke out on right side on her front just under breastbone & it wrapped around to her back). In January 2022, the patient experienced MUSCLE SPASMS (She was having spasms just like when she was pregnant with her son, & he would kick), PAIN (She began having pain & soreness then a rash that a chiropractor told her was shingles) and RASH (She began having pain & soreness then a rash that a chiropractor told her was shingles). At the time of the report, HERPES ZOSTER (She began having pain & soreness then a rash that a chiropractor told her was shingles/She broke out on right side on her front just under breastbone & it wrapped around to her back), MUSCLE SPASMS (She was having spasms just like when she was pregnant with her son, & he would kick), PAIN (She began having pain & soreness then a rash that a chiropractor told her was shingles) and RASH (She began having pain & soreness then a rash that a chiropractor told her was shingles) 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. Other concomitant medications included herbs. No treatment information was provided. The patient stated that 15 days after 1st dose she experienced the events. She broke out on her right side on her front just under breastbone & it wrapped around to her back.  She thought it was a gall bladder attack or that she had a rib out.  She was having spasms just like when she was pregnant with her son, & he would kick.
Information regarding Prevnar (pneumococcal 7 valent conjugate vaccine (diphtheria crm197 protein) injection) was received from a public health nurse regarding a 35 month old male pt who experienced negative titers after his third dose in 2002. He was given a fourth dose on 16Apr04. Relevant medical history was not provided. Indication for Prevnar was immunization. Product was administered on 16Apr04. Dose regimen was 1 dose (IM). Concomitant medications were not reported. A public health nurse reported that a 35 month old pt completed his primary series of Prevnar on 16Apr04. At 8 months of age, after his third dose, the child's family practice physician had a titer test drawn, which revealed negative titers (antibody test (results: negative). The child's mother reported that the physician said that the child may be immunocompromised. Antibody test was done on an unspecified date in approx 2002. No additional information was available at the time of this report.
PT RECEIVED HER VACCINE AND THEN WENT TO SIT FOR A WHILE.  AFTER 15-20 MINUTES SHE GOT UP AND WENT SHOPPING WITH HER FAMILY.  THEY RETURNED BACK LATER AND SAID SHE HAD PASSED OUT INTO HER MOTHER'S ARMS.  SHE VOMMITED INTO THE TRASHCAN AND PHARMACIST STAYED WITH HER TO MAKE SURE SHE WAS OK FOR AROUND 30 MINUTES.  HE GOT HER SOME WATER AND HAD HER CONTINUE TO SIT IN THE IMMUNIZATION AREA.  SHE SAID SHE WAS FEELING BETTER AFTER SOME TIME AND LEFT.  SHE ASKED THAT HER NAME NOT BE MENTIONED TO THE REPORTING SYSTEM.  PHARMACIST CALLED HER THE NEXT DAY AND SHE SAID SHE WAS STILL FEELING FIND, BUT STILL DID NOT WANT HER NAME REPORTED TO SYSTEM.
Vaccination error (Vaccination error). A non-serious spontaneous report of FluMist administration to 23-month old was received from a non health-care professional in the United States concerning a 23-month-old male.  The patient was administered FluMist. There was no adverse event associated with this inappropriate age administration: therefore, treatment and reporter/sponsor causality assessments are not applicable, and the event is considered resolved. This case is 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.
IMOVAX for pre-exposure, incorrect schedule, dose on day 0, day 3, and day 7, no AE; Initial information received on 14-Jul-2021 regarding an unsolicited valid  non-serious case from a pharmacist via Global Media Information (under reference number: 00681667).  This case involves a patient of unknown age and gender patient who received RABIES (HDC) VACCINE [IMOVAX RABIES]'s incorrect schedule; that is on day 0, day 3, and day 7.  The patient's past medical history, medical treatment(s), vaccination(s), concomitant medication(s) and family history were not provided.   The patient received first, second and third dose of suspect RABIES (HDC) VACCINE (lot number and expiration date not reported) via unknown route in an unknown administration site for pre-exposure immunization on day 0, day 3 and day 7 respectively (dates unknown) (inappropriate schedule of product administration).  It was an actual medication error case due to inappropriate schedule  vaccine administered.  It was reported: "Pharmacist asked about the dosing series of IMOVAX for pre-exposure. An incorrect schedule was given to a patient. Patient was given a dose on day 0, day 3, and day 7. They are wondering if a 4th dose should be given, or would the patient be fully protected already. Pharmacist does not have the patient information at the moment."  At time of reporting, it was unknown whether the patient had any adverse event 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 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.  There will be no information on the batch number for this case.
Slight redness and soreness at injection site.  The wrist of the injection arm is swollen at the joint to roughly double that of the opposite arm.
Chest pain a few weeks after injection 1/28/21.  Next day after injection headache, dizziness, nausea
Swollen nodule located on left side of soft tissue of neck; This is a spontaneous report from a contactable consumer, the patient. A 45-year-old non-pregnant female patient received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, lot number ER 8727), via an unspecified route of administration in the left arm on 25Mar2021, at 10:00 (at the age of 45-years-old), as a single dose for COVID-19 immunisation. Medical history included obesity. The patient did not have any allergies to medications, food or other products. The patient had received unspecified medications within 2 weeks of vaccination. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, lot number EN 6205), via an unspecified route of administration in the left arm on 04Mar2021, at 10:00 (at the age of 45-years-old), as a single dose for COVID-19 immunisation. The patient did not receive any other vaccines within 4 weeks prior to the COVID-19 vaccine. Prior to the vaccination, the patient was not diagnosed with COVID-19. On 29Mar2021 the patient underwent nasal swab test for COVID-19 virus test and the test result report was pending. On 27Mar2021 at 22:00, the patient experienced swollen nodule located on left side of soft tissue of neck. The event resulted in doctor or other healthcare professional office/clinic visit. The patient did not receive any treatment for the events. The clinical outcome of swollen nodule located on left side of soft tissue of neck was not recovered at the time of reporting.   No follow-up attempts are needed. No further information is expected.
Vaccine mixed with a non-GSK diluent; Patient received vaccine mixed with a non-GSK diluent; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of inappropriate preparation of medication in a 13-year-old female patient who received Men ACWY-CRM NVS (Menveo) (batch number AMVA859A, expiry date 31-JAN-2024) for prophylaxis.   On 21-MAR-2023, the patient received Menveo. On 21-MAR-2023, an unknown time after receiving Menveo, the patient experienced inappropriate preparation of medication (Verbatim: Vaccine mixed with a non-GSK diluent) and inappropriate dose of vaccine administered (Verbatim: Patient received vaccine mixed with a non-GSK diluent). The outcome of the inappropriate preparation of medication and inappropriate dose of vaccine administered were unknown.   Additional Information: GSK Receipt Date: 21-APR-2023 The reporter reported that the patient was received Menveo vaccine that was mixed with non GSK diluent. The vaccine administration facility was the same as primary reporter. The reporter did consent to follow up. The reporter gave by error Menveo  vaccine mixed with non GSK diluent portion,which led to inappropriate preparation of medication and inappropriate dose of vaccine administered
Acute respiratory failure with hypoxia - Her treatments at outside hospital included dobutamine, nitroglycerin iv, furosemide, metolazone, clindamycin, and azithromycin. Her presentation here seemed most consistent with acute CHF, but she was also treated for possible community acquired pneumonia. She also had E. Coli in her urine and was treated for possible UTI. She was diuresed, and treated with antibiotics, and had gradual improvement. ED visit and hospital admission within 6 weeks of receiving the COVID vaccine.
terrible headaches; sore arms; This is a spontaneous report from a contactable consumer (Patient, reported for herself). A female patient of an unspecified age received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/Lot number was not reported), dose 2 via an unspecified route of administration on 25Feb2021 as 2ND DOSE, SINGLE for covid-19 immunization. The patient medical history and concomitant medications were not reported. It was reported that after second dose patient experienced sore arms and terrible headaches. The outcome of events was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Received PPV shot around 10:45 a.m. after a yearly physical with Dr. I have asthma, therefore should benefit from getting the vaccination. I was feeling normal until about 3:30 p.m. when I started to feel dizzy and got a hive on the lower part of my right cheek. The hive went down and the dizziness continued before letting up after a few hours. I was fine that night, but by Friday mid-morning, I was freezing cold, chilled so badly my teeth were chattering. I also started to get a very bad headache. My right arm, where I received the vaccination, was so sore I could barely move it or lift it. Also, the injection site was red and swollen. When I got home from work, I went straight to bed, so dizzy I could not stand, and very weak. Every muscle in my body ached and I was alternating between freezing cold and sweating profusely. Saturday, the next morning, was worse. The headache, right between my eyebrows and into my upper forehead, was so bad that I could barely move my head without wanting to vomit and without getting dizzy. The muscle aches and feverish chills/sweating continued as well. I wasn't getting any relief from rest and ibrupofen, so I made a call to the triage nurse for MMG, and after hearing my symptoms, she suggested I go to the emergency room. The ER doctor assessed me and said the site of injection was 'pretty impressive' and noted that I had had an allergic reaction to the shot, given all the aches, pain, dizziness and swelling.
Pt received vaccine on 2/6/21 and began with localized injection site itching on 2/15/21. Pt did have about a 40mm ring around where injection was supposedly given. Pt c/o area red, warm to touch, and severely pruritic.
Fever 102 started Friday. Fever off and on Saturday and Sunday up to 104.6. TYLENOL and Ibuprofen given scheduled round the clock. Cool rag and cool baths given. Lethargic and loss of appetite all weekend. Fussy and increase in sleeping.
Hospitalized (11.30.21);  COVID-19 positive (11.30.21); fully vaccinated Admission Date: 11/30/2021 Discharge Date: Dec 3, 2021 DETAILS OF HOSPITAL STAY: PRESENTING PROBLEM: COVID-19 [U07.1] HOSPITAL COURSE: Patient is a 84 y.o. y.o. male who presented with a chief complaint of feeling tired, mild shortness of breath, cough, and headache with onset of symptoms about 11 days ago.  He is vaccinated. In the ED, patient was mildly hypoxic requiring 2 liters nasal canula so he was admitted for further management and treated with decadron. He was quickly weaned off oxygen and was doing well. He was also noted to have a supratherapeutic INR for which his home Coumadin which she is on for atrial fibrillation was held.  INR remained elevated throughout hospital stay.  Coumadin was held on discharge and PCP office was contacted and INR check was scheduled for Monday.  Patient will have INR checked again resume Coumadin once instructed so by PCP office.  Patient was discharged home in stable condition with home physical therapy.  He was also given 6 more days of Decadron to complete a 10 day course.