chrisvoncsefalvay/vaers-outcomes huggingface dataset:
dose given beyond 30-day expiration date; dose given beyond 30-day expiration date; No adverse event; This spontaneous case was reported by a physician and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (dose given beyond 30-day expiration date), PRODUCT STORAGE ERROR (dose given beyond 30-day expiration date) and NO ADVERSE EVENT (No adverse event) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. AR9236B) 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 EXPIRED PRODUCT ADMINISTERED (dose given beyond 30-day expiration date), PRODUCT STORAGE ERROR (dose given beyond 30-day expiration date) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (dose given beyond 30-day expiration date), PRODUCT STORAGE ERROR (dose given beyond 30-day expiration date) and NO ADVERSE EVENT (No adverse event) outcome was unknown.      For mRNA-1273 (Moderna COVID-19 Vaccine) (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 given beyond 30-day expiration date) and PRODUCT STORAGE ERROR (dose given beyond 30-day expiration date).    Concomitant products were not reported.  It was reported the vial was initially stored in the refrigerator on 13-Sep-2022 and administered on 18-Oct, 25-Oct, 01-Nov, 02-Nov and 08-Nov. The vial did not underwent any temperature excursion. It was unknown if individual vials or unbroken cartons were used. The vial size was unknown.  Treatment medications were not reported.
Patient presented to ED with Cough, ear pain and sore throat onset approximately 01/07/2022
Fourth dose in Pfizer series. I developed an extremely high fever. 105 degrees. Excruciating headache and had a very difficult time walking. This was the evening of the 8/8/22 (vaccination date). I was extremely cold. Eventually able to bring the fever down to 103.8 Fever and chills through the night. Fever and headache on the 9th. Again able to eventually bring the fever to 103 on the evening of the ninth. Fever abated the morning of the 10th.
Leg swollen, inflammed area of 6"x12", resp. difficulty and tightness of chest.
She got a little tired; This spontaneous case was reported by a consumer and describes the occurrence of FATIGUE (She got a little tired) in an 84-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030120A) for COVID-19 vaccination.     No Medical History information was reported.    On 15-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 15-Jan-2021, the patient experienced FATIGUE (She got a little tired). At the time of the report, FATIGUE (She got a little tired) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No Concomitant medications was provided.  No treatment medications was provided.   This case was linked to MOD-2021-293565 (Patient Link).
This spontaneous report as received from a nurse refers to a patient of unknown age and gender. No information regarding the patient's medical history was provided. On 13-MAR-2014 the patient was vaccinated with PROQUAD injection, with valid lot # H015630, which had been expired on 21-FEB-2014. No concomitant medication was reported. No adverse symptoms were reported. No outcome was reported. Additional information has been requested.
Minor allergic reaction to vaccine.; small patches of acute hives appearing and disappearing throughout the arms, legs, and back; This is a spontaneous report received from a contactable consumer (patient). A 21-year-old female patient received bnt162b2 (BNT162B2) via an unspecified route of administration, administered in Arm Right on 05May2021 14:45 (Lot Number: EW0158) as first dose, single for covid-19 immunisation. The patient medical history was not reported.  patient was not pregnant. The patient's concomitant medications were not reported. the patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient experienced minor allergic reaction to vaccine. The main symptom to confirm this is small patches of acute hives appearing and disappearing throughout the arms, legs, and back on 06May2021 08:30 AM. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. No treatment received for the events. Outcome of the event was recovering.   No follow-up attempts are needed. No further information is expected.
24MAY recvd measles/HIB vax; 26MAY inc fever; 27MAY broke out w/rash- tx;sponge bath-APAP;
red, raised, itchy, warm rash to upper left arm, more so to dorsal side. Student saw clinician, doxycycline prescribed.
The patient received duplicate Covid Vaccines. The pharmacy realized that a vaccine dose was missing from the Registry).  Upon further investigation, we found that the missing vaccine was due to the fact that the patient had already received a full series of the Pfizer vaccine.  Patient received her 1st dose of the Pfizer vaccine on 2/24/2021 lot #EN6203 Exp 6/30/21 and her 2nd dose on 3/17/21 Lot #EN6207 Exp. 7/31/21.  She then received her 1st dose of Moderna on 3/24/21.  The patient was contacted to verify the information.  The patient states that she had forgotten she had gotten the Pfizer vaccines.  We informed her that she will not be getting a second dose of Moderna, since she already received more vaccines than she needed.
Severe muscle ache, chills, sweating, severe headache, loss of sleep, low-grade fever
Positive Covide`19 on 5/7/2021 Symptoms: c/o sinus congestion,  productive cough, stomach" feels like I'm getting diarrhea," subjective fever,  HA, chills, body aches started with morning.  Temp 99.6 now,
pt called on 10/13/2022, to report after one hour he had a really puffed up  arm and he felt a scratchy throat. Took benadryl that evening and felt fine in the am. No redness at site or streaking. Provider notified.
Three days following 1st dose of vaccine patient developed leg pain and noted "spots " She sought care at Urgent Care Center. The Practitioner felt that the event was vaccine induced. No VAERS filed
Given expired HIB vaccine (exp 12/7/14). MOC informed. Doctor informed.
21FEB99 pt had enteric viral sx;1MAR99 pt devel cerebellar ataxia, gait abn, apraxia, inability to stand;dx acute cerebellar ataxia post viral infect;
Developed redness and swelling at MMRV site the evening after vaccination. Also developed slight fever. Redness swelling continued to increase after the next 3 days.
Vaccination error- patient under 65 administered Fluzone High-Dose: Patient was administered a Fluzone High-Dose vaccination at an immunization event due to incorrect date of birth written on patient questionnaire/consent form. Patient came to event with his wife, who's birth year is 1954 and filled out his own form with a DOB of 03/09/1954. Patient reports no adverse reaction from vaccination, reports he feels well as of 10/11/2020.
~18 hours after receiving the vaccine I work up with very severe tinnitus in the morning. I had 3 fans in my room for white noise and it was still so bad I could not fall asleep again.  This lasted for about 4 hours and and slowly went away. As i'm writing this it has been ~27 hours since my 2nd dose. Hopefully it does not come back again.   I've selected permanent damage below since I read online there is no cure for tinnitus. But there's not been enough time that has passed to determine if this is a one off occasion or I may experience this effect for life.
About 3-4 minutes after vaccine patient passed out. He was out for less than minute. Came to - didn't remember what just happened and very tired. Also chipped his tooth.
vaccine exposure during pregnancy; This spontaneous prospective pregnancy case was reported by a consumer and describes the occurrence of EXPOSURE DURING PREGNANCY (vaccine exposure during pregnancy) in a 31-year-old female patient (gravida 2) who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 001A21A) for COVID-19 vaccination.     The patient's past medical history included Induced abortion. Concurrent medical conditions included Asthma. Concomitant products included MINERALS NOS, VITAMINS NOS (PRENATAL VITAMINS [MINERALS NOS;VITAMINS NOS]) and AMFETAMINE ASPARTATE, AMFETAMINE SULFATE, DEXAMFETAMINE SACCHARATE, DEXAMFETAMINE SULFATE (ADDERALL) for an unknown indication.    On 25-Feb-2021 at 11:00 AM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. The patient's last menstrual period was on 13-Sep-2020 and the estimated date of delivery was 13-Jun-2021. On 25-Feb-2021, the patient experienced EXPOSURE DURING PREGNANCY (vaccine exposure during pregnancy). The patient received mRNA-1273 (Moderna COVID-19 Vaccine) beginning around the  twenty-third week of the pregnancy.  On 25-Feb-2021, EXPOSURE DURING PREGNANCY (vaccine exposure during pregnancy) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 05-Oct-2020, Pregnancy test: positive (Positive) positive.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       The date of positive pregnancy test was 05-Oct2020 and ultrasound was done on 25-Jan-2021. The patient has an established prenatal care. Treatment medications were not reported.
Itchy little bumps on both legs and arms; Low grade fever; Body aches; This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (Low grade fever), PAIN (Body aches) and PRURITUS (Itchy little bumps on both legs and arms) in a 79-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 037K20A) for COVID-19 vaccination.     The patient's past medical history included No adverse event.    On 25-Jan-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 26-Jan-2021, the patient experienced PYREXIA (Low grade fever) and PAIN (Body aches). On 05-Feb-2021, the patient experienced PRURITUS (Itchy little bumps on both legs and arms). At the time of the report, PYREXIA (Low grade fever), PAIN (Body aches) and PRURITUS (Itchy little bumps on both legs and arms) outcome was unknown. Not Provided          Treatment includes topical itchy medication. Concomitant medication was not provided.   Reporter did not allow further contact
After my second shot, during the month of May, I had a medical appointment with my gynecologist and I showed him the strange white patch I recently discovered under my left breast. He looked at it and said I had to go the dermatologist to have it checked.  I got an appointment and went to the dermatologist on June 29, 2021. They had a biopsy done on the patch and it came back consistent with vitiligo.
Redness on the area of injection 5x8 cm with 2x3 cm of - induration.
Brain fog; Body pain; Body achiness; Swelling and pain at the site of the injection; Swelling and pain at the site of the injection; This spontaneous case was reported by a consumer and describes the occurrence of FEELING ABNORMAL (Brain fog), PAIN (Body pain), MYALGIA (Body achiness), VACCINATION SITE SWELLING (Swelling and pain at the site of the injection) and VACCINATION SITE PAIN (Swelling and pain at the site of the injection) in a 48-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 006D21A) for COVID-19 vaccination.     No Medical History information was reported.    On 27-Jul-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In July 2021, the patient experienced FEELING ABNORMAL (Brain fog), PAIN (Body pain), MYALGIA (Body achiness), VACCINATION SITE SWELLING (Swelling and pain at the site of the injection) and VACCINATION SITE PAIN (Swelling and pain at the site of the injection). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE, PARACETAMOL (TYLENOL PM) for Pain, at a dose of Sometimes. At the time of the report, FEELING ABNORMAL (Brain fog), PAIN (Body pain), MYALGIA (Body achiness), VACCINATION SITE SWELLING (Swelling and pain at the site of the injection) and VACCINATION SITE PAIN (Swelling and pain at the site of the injection) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In September 2021, Ultrasound scan: normal (normal) Thought it was a blood clot. 3 months ago doctor performed an ultrasound ruling that out..     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       It was stated by patient that within 24-48 hours after receiving dose of the vaccine patient started to experience side effects that have continued up until today. Patient pain at the injection site was sometimes a slow dull pain, but also was sometimes sharper. Patient had thought it was a blood clot, but 3 months ago doctor who performed an ultrasound on her ruled that out. Treatment details stated taking of Tylenol PM sometimes to help her get to sleep with the pain No concomitant medications were mentioned. No other medications were reported.
Patient states at the initial time of the injection (11/20/18) she felt tingling and numbness radiating down her arm into her forearm and down to her wrist. She did not report it to anyone at that time. She came back to our pharmacy today (12/8/18) to tell us about it and to report that she is still continuing to have weakness in her arm and "carpal tunnel" like weakness/stiffness in her arm and wrist. She is also stating that it itches all of the time at the site of injection.
Large (10-inch wide x 6-inch high) red, itchy rash at (left buttock) injection site Treatment: Benadryl Cream 2x day on rash
Severe injection site pain that started 1/2 hour after injection, progressed to pain that radiated to left axilla and left fingers, described as tingling  pain.
itchy blister on the forearm of the same arm as I had my 2nd Shingrix shot; this could be considered a rash; Itch; This case was reported by a consumer via call center representative and described the occurrence of blister in a 58-year-old patient who received Herpes zoster (Shingrix) for prophylaxis.   On 2nd March 2020, the patient received Shingrix. On 3rd March 2020, 1 days after receiving Shingrix, the patient experienced blister, rash and pruritus. On an unknown date, the outcome of the blister, rash and pruritus were unknown.   It was unknown if the reporter considered the blister, rash and pruritus to be related to Shingrix.  Additional case details were reported as follows: The patient had a itchy blister on forearm on the same side of vaccination. The patient at a stretch could be considered a rash.
Gastrointestinal distress: chronic diarrhea lasting to date, Abdominal pain, fatigue, mental/brain fogp
On Friday morning, I was feeling fatigued and my nose started running severely, with post nasal drip. As the day went on, the fatigue got worse, I started getting muscle aches all over and a headache. These continued through Saturday and I started getting chills. These still continued today (Sunday) along with diarrhea.
16 years of age, received the first dose; A spontaneous report  was received from a Pharmacist concerning a 16-year-old, female patient who was administered Moderna's COVID-19 vaccine (mRNA-1273), resulting in the event, 16 years of age, received the first dose/product administered to patient of inappropriate age.  The patient's medical history was not provided. No relevant concomitant medications were reported.  On 09 Feb 2021, the patient received their first of two planned of mRNA-1273 (Lot number: 011M20A) Intramuscularly in the right arm for prophylaxis of COVID-19 infection  Pharmacist called in 09-FEB-2021 to report giving first dose of mRNA-1273 to a female patient 16 years of age. The pharmacist inquired if the dose regimen should be discontinued or completed with the second dose when due. Treatment information was not provided.  Action taken with mRNA-1273 in response to the event was not reported.  The event, 16 years of age, received the first dose, was considered resolved on 09 Feb 2021.; Reporter's Comments: This report refers to a case of Product administered to patient of inappropriate age for mRNA-1273, lot # 011M20A with no associated AEs.
p/vax pt vomited & became very pale 7 limp approx 6hr p/vax pt perked up p/an hr T104 R;pt irritable & whining;T1030194;MD not called;
Patient received 1st dose of Moderna Covid-19 vaccination.  5 minutes after injection patient briefly fainted while sitting.  Patient lost consciousness for about 5 seconds. Upon awakening patient felt nausea and hot.  Patient appeared very pale.  He asked if he passed out and reported a history of fainting after injections since childhood, last age 11. Vital signs remained stable while resting, BP 112/80, P 72, 02 sat 100%, temp 99.5.    After resting for 30 minutes patient left on his own willpower with his wife.
Pt recv vax on 7/20/98; immed exp upper torso seizure activity.Pt head went back, eyes rolled back, and upper body, arms, head, and hands jerked.Ambulance came and pt had recovered.F/U w/ Dr  advised seizure w/u if exp again.
Swelling and pain in the testicles; Swelling and pain in the testicles; This is a spontaneous report received from a contactable consumer (patient). A 41-year-old male patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection), via an unspecified route of administration, administered in left arm on 09Mar2021 15:30 (at the age of 41-year-old) as single dose for COVID-19 immunization. The patient medical history included asthma. Concomitant medication (in two weeks) included albuterol [salbutamol] (ALBUTEROL). The patient had no other vaccine in four weeks. The patient had no known allergies. The patient had no COVID prior vaccination. The patient was not tested for COVID post vaccination. On 10Mar2021 at 07:00am, the patient experienced swelling and pain in the testicles. The patient did not receive any treatment. The outcome of the events was reported as recovering.  No follow-up attempts are possible; information about lot/batch number cannot be obtained
Three days post vax, the pt developed neck stiffness, a sore throat, and pain radiating across her forehead. She recovered in 2 days without treatment.
Extremely high blood sugars for at least 8 days, it is coming down but still high. Severe headache for at least 8 days.  Overall feeling like crap.
Patient with history of COVID vaccines who admitted to hospital with COVID detected PCR.  Provider d/c note:  "62yr old male with a history of HTN, CAD, HFrEF, COPD, PAfib, Depression, Cirrhosis, Seizures, cardiomyopathy s/p AICD who presented from facility with difficulty breathing. EMS had pt on 6L NC. Pt stat was 46% upon arrival to ED, now maintaining adequate saturation on 4-6 L. Patient was previously admitted from 12/22 to 12/28 for anasarca, fluid overload and was treated with aggressive diuresing. He was discharged on an increased dose of torsemide and lactulose titrated to have 2-3 bowel movements a day. He was admitted this time due to acuute hypoxic respiratory failure likely multifactorial secondary to COPD, CHF, recent covid. His home medications were continued. He was given duonebs and prednisone and improved overnight and is saturating at 3L of O2 with baseline mentation. He will be discharge back to prior living arrangements as he is clinically stable from a respiratory status, volume status, and mentation. He should use oxygen as needed and wean as tolerated to baseline. He should also finish his course of steroids. "
Patient has raised bumps rash on both arms. Started approximately 3 days after getting vaccine per conversation with patient.   Spoke with her about follow up with  and what treatment she was getting. She mentioned she is getting Prednisone from
Beginning on 11/2 my back felt as though I pulled a muscle to the left of my spine. The next day my back continued to hurt and began to itch accompanied with pain around my left side to my lower abdomen. By Wednesday, red itchy bumps began to appear and turned into clusters of red, painful, blistery bumps covering my lower abdomen, left side, and along the left side of my spine, over the following days. The diagnosis of Shingles was confirmed on Monday 11/9 and treated with steroid cream along with 1gram 3x per day for 7 days of valacyclovir.
Bad headache, fatigue, loss of appetite, chills sore arm at point of injection.
24 yo male with initial visit to clinic on 11/16/11 began having lower extremity weakness and tingling approximately 2 weeks after vaccination. With continued weakness had MRI that was abnormal. Went to OR 2/27/12 for release of tethered spinal cord. Lower extremity symptoms persisted and a diagnosis of CIDP was made 4/10/12. Pt underwent IVIG x 5 days. Still with significant disability.
Upon receiving the vaccine, I had immediate pain in my left shoulder, which I understood to be "normal". The pain last for days and then several weeks and the pain increased to severe pain and very limited amount of movement and rotation. I went to a orthopaedic doctor at work approximately 5 weeks after receiving the vaccine and he confirmed that I had a shoulder injury (impingement/frozen shoulder) from the way that the vaccine was administered.
woke from nap approx 2pm day of morning 2nd dose with heart palpitations in neck. had never experienced such heartrate palpitations.
08/29/22 presents to ED for "chills, fever, fatigue, cough". PMHx of "lung cancer as well as colon cancer, currently on chemotherapy"
Pt was administered a Pfizer Bivalent Booster approximately two weeks prior to being eligible for a Bivalent Booster. The pt was notified today about the error and when contacted, the  pt also reported that she was having some influenza-type symptoms such as fever, muscle aches, and fatigue. Per the patient, she is not allergic to any mediations and pt is instructed to alternate Tylenol and ibuprofen as well as increase fluids for symptoms. Pt also notified to follow up with her PCP if symptoms persist or become worse.
Initial misuse report received from a healthcare professional on 08 August 2013. A patient (no information was provided regarding the patient) had received a dose of MENACTRA vaccine that had expired in February (year not specified). No adverse event was reported. Documents held by sender: None.
DONOR CONTACTED THE CENTER TODAY 06/10/2018 TO DISCLOSE THAT ABOUT FIVE HOURS AFTER RECEIVING THE VACCINE (ON 061018)THE DONOR STATED SHE BEGAN TO ITCH ALL OVER AND HAD HIVES ALL OVER HER ARMS, TRUNK (FRONT AND BACK) AND LEGS. DONOR STATED SHE WENT TO WORK AND A CO WORKER "WHO IS A NURSE" GAVE HER SOME BENADRYL. DONOR STATED THE HIVES AND ITCHING KEEPS RETURNING AND SHE IS HEADED TO THE URGENT CARE AND WILL NOTIFY THE CENTER AFTER SHE HAS BEEN SEEN. DONOR STATED SHE HAD A TETENUS INJ  AND HAD THE SAME REACTION ABOUT 3 OR 4 MONTHS AGO. DONOR HAS NOT CONTACTED THE CENTER AFTER GOING TO URGENT CARE.