chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Expired vaccine was expired to 13 patients./Expired vaccine was expired to 9 patients.; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Expired vaccine was expired to 13 patients./Expired vaccine was expired to 9 patients.) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 049E21A) for COVID-19 vaccination.     No Medical History information was reported.    On 26-Oct-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 26-Oct-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Expired vaccine was expired to 13 patients./Expired vaccine was expired to 9 patients.). On 26-Oct-2021, EXPIRED PRODUCT ADMINISTERED (Expired vaccine was expired to 13 patients./Expired vaccine was expired to 9 patients.) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No Concomitant medications were provided No treatment medications were provided.   Most recent FOLLOW-UP information incorporated above includes: On 26-Oct-2021: Significant Follow up; start date for vaccination given
They got sick; not able to receive the second dose on time; Because they got sick they were not able to receive the second dose at the appropriate time; This spontaneous case was reported by a pharmacist and describes the occurrence of ILLNESS (They got sick), PRODUCT DOSE OMISSION ISSUE (not able to receive the second dose on time) and INTENTIONAL PRODUCT USE ISSUE (Because they got sick they were not able to receive the second dose at the appropriate time) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. Unknown) 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) 1 dosage form. On an unknown date, the patient experienced ILLNESS (They got sick), PRODUCT DOSE OMISSION ISSUE (not able to receive the second dose on time) and INTENTIONAL PRODUCT USE ISSUE (Because they got sick they were not able to receive the second dose at the appropriate time). At the time of the report, ILLNESS (They got sick) outcome was unknown and PRODUCT DOSE OMISSION ISSUE (not able to receive the second dose on time) and INTENTIONAL PRODUCT USE ISSUE (Because they got sick they were not able to receive the second dose at the appropriate time) had resolved.        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.   Concomitant medicaitons are not provided. Treatment information does not provided.   Reporter did not allow further contact
Pt devel joint & muscle discomfort a wk p/recvd MMR vax; Pt tx ASA & responded completely;
Nausea; Vomiting; This is a spontaneous report from a contactable consumer, the patient. A 24-year-old male patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EP7534) via an unspecified route of administration in the left arm on 23Mar2021 at 18:15 (at the age of 24-year-old) as a single dose for COVID-19 immunisation. Medical history included asthma and allergy (not specified). Concomitant medications were not reported. 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. Since the vaccination, the patient had not been tested for COVID-19. The patient experienced nausea and vomiting on 24Mar2021 at 06.00. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The patient did not receive treatment for the reported events. The clinical outcome of nausea and vomiting was resolved on unknown date. No follow-up attempts are possible. No further information is expected.
Gum disorder; This spontaneous case was reported by a consumer and describes the occurrence of GINGIVAL DISORDER (Gum disorder) in an elderly female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) for Rheumatoid arthritis.    No Medical History information was reported.   On 01-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 30-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient started ADALIMUMAB (HUMIRA) (Subcutaneous) Unknown. On an unknown date, the patient experienced GINGIVAL DISORDER (Gum disorder). At the time of the report, GINGIVAL DISORDER (Gum disorder) had not resolved.            No concomitant medications were reported No treatment medications were reported. It was unknown if patient was enrolled in a COVID-19 Vaccine Trial. 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.
5 days after vaccine began experiencing chills, fever (up to 100.8), and diarrhea.  Fever lasted 2 days. Chills lasted 2 days. Diarrhea currently on day 3.
Flu shot administered in left deltoid 10/28/2004. On 10/29/2004 had pain in right hip/SI joint. Pain worsened over next week.  Patient believes that flu shot activated inflammatory response.
Mother states patient C/O pain on 9-28-17 in the evening, the follow day 9-29-17 patient continued w/pain and went to school. After school thats when mother noticed patient's arm was bruised and swollen. Mother did warm compresses. Then on Saturday Mother took patient to ER, pt. was given antibiotics and ibuprofen. Mother states patient had 102.0 of fever. Now today 10-2-17, pt. continues w/bruising, no more swelling, no fever.
Information has been received from a medical assistant concerning an infant who was treated with an incomplete dose of ROTATEQ because the patient vomited during or after administration of the vaccine.  It was unknown whether medical attention was sought.  The outcome was unknown.  There was no product quality complaint.  No further information is available.  This is one of several reports from the same source.
The lot number expired on 3/18/22 per Moderna.  The patient reports zero adverse events from the booster.
Received call from pt on 6/2/10, requesting vaccine manufacturer and lot number. Pt reported that 3 days after vaccination she had "excruciating" pain and numbness. Pain radiated down entire arm at first and then entire left index finger and thumb became numb. Patient states she had surgery 5/20/10. Still experiencing some nerve pain and numbness.
COAGULOPATHY, UNSPECIFIED TYPE 1/17/2022 ALTERED MENTAL STATUS, UNSPECIFIED ACUTE NON ST ELEVATION MI 1/17/2022 ALTERED MENTAL STATUS, UNSPECIFIED ACUTE STROKE DUE TO OCCLUSION OF LEFT POSTERIOR CEREBRAL ARTERY 6/1/2021 ALTERED MENTAL STATUS, UNSPECIFIED COAGULOPATHY, UNSPECIFIED TYPE 1/17/2022 ANEMIA DUE TO CKD ACUTE NON ST ELEVATION MI 1/17/2022 ANEMIA DUE TO CKD ACUTE STROKE DUE TO OCCLUSION OF LEFT POSTERIOR CEREBRAL ARTERY 6/1/2021 ANEMIA DUE TO CKD
The patient reports that on 02/04/2016 when she was being treated for a left palm laceration she received a tetanus booster from the office staff upon orders of Dr. She states that within the last 1-2 days she noticed a hot, red patch spreading out from the injection site at the right deltoid. She reported that it was accompanied by a sensation of muscle stiffness in the right arm. She noted additional well-demarcated patches of red, raised skin of a smaller size spreading distally from the central lesion. She states that someone told her to try applying cortisone but this did not help with the problem. She denies difficulty speaking, tightness in the throat, chest pain, shortness of breath, or difficulty breathing. Examination reveals a large irregularly shaped raised erythematous lesion with maximum dimensions of 10 cm x 7 cm. There is no visible dimpling or injection site wound. There are 4 smaller patches better individually demarcated traveling distally down the arm to just above the elbow. They are also raised. All of these lesions are hot to the touch compared to the surrounding skin. There is no crusting, flaking, induration, exudate, or drainage. Dr. also examined the patient and we question whether or not his may be a case of erysipelas versus some sort of adverse reaction to a vaccine component or preservative. There is no indication that the patient is having an anaphylactic reaction or other life-threatening event. Possible infection spreading distally from infection site. Our POC is to treat with KEFLEX 500 mg p.o. b.i.d. x10 days. Prescription written for 20 capsules, 0 refills. Safer medication use was discussed with the patient. I discussed signs and symptoms of anaphylaxis with the patient and she was advised to seek emergent medical attention if they occur. Plan to recheck in our office in 72 hours otherwise.
Within half hour, started reacting, jerking, tongue sticking out; got progressively worse. Mother attempted to contact physician (child's) with no response. Finally spoke to a physician on 6/25/03 at 10:30 PM and took child to ER. Admitted, released 7/2/03. Ongoing seizure disorder. 60-day follow up on 02/05/04: "Pt has not recovered from adverse events. Mother states child continues to have seizures and is developmentally delayed. We are not part of a physician's office so we have not seen their child since 06/24/03. This is a immunization only clinic." Discharge summary states pneumonia, apnea, arrhythmia, vomiting. msv
initially stored in the refrigerator on 20 Jun 2023, date of administration 27 Jul 2023 and Dose administered after 30-day Use by Date; no adverse event; Dose administered after 30-day Use By Date; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Dose administered after 30-day Use By Date), PRODUCT STORAGE ERROR (initially stored in the refrigerator on 20 Jun 2023, date of administration 27 Jul 2023 and Dose administered after 30-day Use by Date) and NO ADVERSE EVENT (no adverse event) in an 18-year-old male patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 062F22A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 27-Jul-2023, the patient received first dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 2.5 milliliter. On 27-Jul-2023,  after starting mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)), the patient experienced EXPIRED PRODUCT ADMINISTERED (Dose administered after 30-day Use By Date). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (initially stored in the refrigerator on 20 Jun 2023, date of administration 27 Jul 2023 and Dose administered after 30-day Use by Date) and NO ADVERSE EVENT (no adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Dose administered after 30-day Use By Date), PRODUCT STORAGE ERROR (initially stored in the refrigerator on 20 Jun 2023, date of administration 27 Jul 2023 and Dose administered after 30-day Use by Date) and NO ADVERSE EVENT (no adverse event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (no adverse event) to be not related. No further causality assessments were provided for EXPIRED PRODUCT ADMINISTERED (Dose administered after 30-day Use By Date) and PRODUCT STORAGE ERROR (initially stored in the refrigerator on 20 Jun 2023, date of administration 27 Jul 2023 and Dose administered after 30-day Use by Date).    Concomitant medication not reported.   The vial did not undergo any temperature excursions.  Treatment medication not reported.
Patient was administered with a fluzone quadrivalent when she requested for Fluzone high dose/ No Ae; Initial information was received on 28-Aug-2020 regarding an unsolicited valid non-serious case received from a pharmacist.  This case involves a 75 years old female patient who was administered with the vaccine INFLUENZA QUADRIVAL A-B VACCINE [FLUZONE QUADRIVALENT] (lot number and expiry date not reported) via unknown route at an unknown administration site for prophylactic vaccination when she requested for INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE [FLUZONE HIGH DOSE] vaccine (wrong product administered).  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   It was an actual medication error case due to wrong vaccine administered.  At the time of report, no adverse event was reported.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holders 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.  There will be no information available on the batch number for this case.
I experienced an herpes simplex outbreak on my face which required an antibiotic.  I had sores with oozing and crusting which began appearing on Monday, November 8 and I was seen by my physician on Thursday, November 11th.  I was prescribed two doses of valACYclovir. The symptoms began residing the following day, Friday, November 12th.
Uti, kidney stones, shortness of breath, fatigue,  chest pain , decreased gfr, enlarged intrahepatic duct
No actual adverse events reported. Patient stated after being given her influenza vaccine that she only wanted her Covid-19 vaccine and not the influenza vaccine that was already administered. On follow-up patient current experiencing typical low grade fever and body aches that are typical with both vaccines.
Information has been received from a medical assistant concerning a 65 year old female who on 20-OCT-2008 was vaccinated with PNEUMOVAX (Lot#660718/0551X, therapy route, site unknown).  Subsequently, on 21-OCT-2008 the "patient had cellulitis from PNEUMOVAX".  The patient was treated with BENADRYL.  The patient outcome was unspecified.  This is one of several reports from the same source.  Additional information has been requested.
Fever and heartburn. Fever occurred the night that I received the vaccine (12h after). Heartburn lasted entire next day
17SEP97 2 days p/vax pt noted to have fever to 102, sore throat, listlessness & erythema lesions on back & extremities that were raised & clinically looked like erythema nodosum;illness resolved w/o sequela;
glucose was 246; BUN is high; creatinine is high; sodium is low; potassium is low; chloride is low; This spontaneous case was reported by a patient and describes the occurrence of BLOOD GLUCOSE ABNORMAL (glucose was 246), BLOOD UREA INCREASED (BUN is high), BLOOD CREATININE INCREASED (creatinine is high), BLOOD SODIUM DECREASED (sodium is low) and BLOOD POTASSIUM DECREASED (potassium is low) in a male patient of an unknown age who received mRNA-1273 (Spikevax) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Diabetic (severe diabetic that takes insulin.). Concomitant products included INSULIN for Diabetes.   On 30-Mar-2022, the patient received second dose of mRNA-1273 (Spikevax) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On an unknown date, the patient experienced BLOOD GLUCOSE ABNORMAL (glucose was 246), BLOOD UREA INCREASED (BUN is high), BLOOD CREATININE INCREASED (creatinine is high), BLOOD SODIUM DECREASED (sodium is low), BLOOD POTASSIUM DECREASED (potassium is low) and BLOOD CHLORIDE DECREASED (chloride is low). At the time of the report, BLOOD GLUCOSE ABNORMAL (glucose was 246), BLOOD UREA INCREASED (BUN is high), BLOOD CREATININE INCREASED (creatinine is high), BLOOD SODIUM DECREASED (sodium is low), BLOOD POTASSIUM DECREASED (potassium is low) and BLOOD CHLORIDE DECREASED (chloride is low) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Blood chloride: low Low. On an unknown date, Blood creatinine: high High. On an unknown date, Blood glucose: 246 246. On an unknown date, Blood potassium: low Low. On an unknown date, Blood sodium: low Low. On an unknown date, Blood urea: high BUN is High.         No concomitant medication information provided. No treatment medication information provided.   Reporter did not allow further contact
Information has been received from two Licensed Practical Nurse referring to unspecified number of patients (age and gender were unknown). Information regarding concurrent conditions and medical history was not provided. On 09-JUL-2014, ROTATEQ was improperly exposed to 10.9C for 17 hours. On unspecified dates after this, unspecified number of patients were vaccinated with doses of the improperly stored ROTATEQ, orally (strength, dose, dose number and lot # were not reported). Concomitant therapy was not reported. No known adverse effects. This is one of several reports received from the same source. Additional information has been requested.
Patient has nausea ,sweating and dizziness. Monitored her for 30 mts to check if symptoms have not worsoned.The patient went to urgent care to get treatment.
Right quadriceps pain, limiting functional activities,  normal imaging , symptoms persisting to this date.
This is a prospective pregnancy case. This 34-year-old female subject was enrolled in an open label study. The subject received the 1st dose of BOOSTRIX on 17th September 2015. The subject's past medical history included normal birth (The patient had 1 prior full term pregnancy). Concurrent medical conditions included bee sting hypersensitivity and fruit allergy (papaya allergy). Concomitant products included vitamins nos (Pre-Natal Vitamins). The subject's estimated date of delivery was 12th December 2015. The subject received BOOSTRIX during the third trimester of pregnancy. On 17th September 2015, 2 hrs after receiving BOOSTRIX, the subject developed burn of unspecified degree of unspecified site of hand (Non-serious). Additional event(s) included feeling hot on 17th September 2015, scar on 16th October 2015 and vaccine exposure during pregnancy. The outcome of burn of unspecified degree of unspecified site of hand was recovering/resolving. The outcome(s) of the additional event(s) included scar (recovering/resolving), feeling hot (recovering/resolving) and vaccine exposure during pregnancy (unknown). The pregnancy was ongoing. It was unknown if the investigator considered the burn of unspecified degree of unspecified site of hand, feeling hot and scar to be related to BOOSTRIX. Additional details were provided as follows: The patient received the vaccine in her left deltoid. The reported batch number of BOOSTRIX was 9N74F with expiry date as 19th August 2017. On the same day, all of a sudden about 2 hours after the vaccination, the patient experienced a burn on her right hand (burn of unspecified degree of unspecified site of hand) and she also felt heat on her right arm and hand with the skin bubbled up on her hand. There were no spills and the patient was not taking any other medicines. On 16th October 2015, 29 days after receiving the vaccine, the patient has scarring on her right hand, pointer finger and middle finger.
Pt received GARDASIL (L) arm IM on 5/20/13 at 10am that evening pt developed itchy red rash on (R) wrist which spread to (R) inner elbow and then to back and belly and finally to (L) arm near inj site. No difficulty breathing. Parent called MD. BENADRYL given at 10 pm 5/20 and 330 am 5/22. Rash gone by 7 am 5/21/13.
Headache, Arthralgia, chills, fatigue, injection site pain/arm pain Narrative:  Other Relevant History:
77 patients received Moderna bivalent booster doses that had undergone a temperature excursion.; 77 patients received Moderna bivalent booster doses that had undergone a temperature excursion.; No adverse event; This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (77 patients received Moderna bivalent booster doses that had undergone a temperature excursion.), POOR QUALITY PRODUCT ADMINISTERED (77 patients received Moderna bivalent booster doses that had undergone a temperature excursion.) and NO ADVERSE EVENT (No adverse event) in an adult patient of an unknown gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. AS7140C) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (77 patients received Moderna bivalent booster doses that had undergone a temperature excursion.), POOR QUALITY PRODUCT ADMINISTERED (77 patients received Moderna bivalent booster doses that had undergone a temperature excursion.) and NO ADVERSE EVENT (No adverse event). At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (77 patients received Moderna bivalent booster doses that had undergone a temperature excursion.), POOR QUALITY PRODUCT ADMINISTERED (77 patients received Moderna bivalent booster doses that had undergone a temperature excursion.) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Intramuscular), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessments were provided for PRODUCT TEMPERATURE EXCURSION ISSUE (77 patients received Moderna bivalent booster doses that had undergone a temperature excursion.) and POOR QUALITY PRODUCT ADMINISTERED (77 patients received Moderna bivalent booster doses that had undergone a temperature excursion.).    This case is for 16th patient out of 77 patients reported.  No concomitant medication information was provided.  It was reported that 77 patients received Moderna bivalent booster doses that had undergone a temperature excursion. The doses were administered before it was known if the vaccine was ok to use after the excursion.  No treatment information was provided.   This case was linked to US-MODERNATX, INC.-MOD-2023-696122 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-696122:case