chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Vial was stored in the refrigerator post expiry; Expired vaccine administered to 155 patients; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Expired vaccine administered to 155 patients) and PRODUCT STORAGE ERROR (Vial was stored in the refrigerator post expiry) in a 63-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026L21B) for COVID-19 vaccination.     No Medical History information was reported.    On 18-Apr-2022, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. On 18-Apr-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Expired vaccine administered to 155 patients). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Vial was stored in the refrigerator post expiry). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Expired vaccine administered to 155 patients) and PRODUCT STORAGE ERROR (Vial was stored in the refrigerator post expiry) outcome was unknown. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications information was reported. It was reported that the vial was stored in the refrigerator on 04-APR-2022. The vial did not undergo any temperature excursion. Treatment information was not reported.   This case was linked to MOD-2022-551714 (Patient Link).
No additional AE/none of these patients had any type of adverse reaction; Vaccines had temperature excursion on 12/14/2021/was given VARIVAX in the left thigh on 17-DEC-2021; This spontaneous report was received from a certified medical assistant and refers to a 3-year-old patient. The patient's medical history, concurrent conditions and concomitant therapies were not reported.  On 14-DEC-2021, the vaccine experienced temperature excursion of 21 degrees Fahrenheit for 3 hours and 32 minutes. There was no previous excursion reported.  On 17-DEC-2021, the patient was administered a dose of improperly stored  varicella virus vaccine live (oka/merck) (VARIVAX) lot # U019908, expiration date: 24-JUN-2023, in the left thigh for prophylaxis (strength, dose, formulation and route of administration were not provided) (Improper storage of product in use).  No additional adverse event was reported - it was reported that none of the patients had any type of adverse reaction. No further information is available.  This is one of several reports received from the same reporter.  Lot Number U019908 is valid for varicella virus vaccine live (oka/merck) (VARIVAX).; Sender's Comments:  US-009507513-2202USA000908: US-009507513-2112USA007215:
Possible breakthrough infection  *1st dose (Pfizer) was administered at Hospital Inpatient & ED
Reaction site about 2 inches in size; Can't barely lift his arm; Pharmacist mistakenly administered Moderna COVID vaccine to 10 years old; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE REACTION (Reaction site about 2 inches in size), LIMB DISCOMFORT (Can't barely lift his arm) and PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (Pharmacist mistakenly administered Moderna COVID vaccine to 10 years old) in a 10-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 088D21A) for COVID-19 vaccination.     No Medical history were provided.  Concomitant products included ATOMOXETINE HYDROCHLORIDE (STRATTERA) for ADHD, MULTIVITAMINS [VITAMINS NOS] for Immune imbalance.    On 15-Sep-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 15-Sep-2021, the patient experienced VACCINATION SITE REACTION (Reaction site about 2 inches in size), LIMB DISCOMFORT (Can't barely lift his arm) and PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (Pharmacist mistakenly administered Moderna COVID vaccine to 10 years old). On 15-Sep-2021, PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (Pharmacist mistakenly administered Moderna COVID vaccine to 10 years old) had resolved. On 16-Sep-2021, VACCINATION SITE REACTION (Reaction site about 2 inches in size) and LIMB DISCOMFORT (Can't barely lift his arm) had resolved.        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.   No Treatment Information were provided by the reporter
Patient went to PCP to obtain second monovalent dose of primary COVID vaccine and was given Bivalent Booster instead on 2/3/23. Patient was unaware of this until she came into office for pre-employment appointment and immunization records were reviewed/confirmed on 2/17/23. Patient reports moderate localized swelling at site of injection x2 weeks starting a few hours after vaccination on 2/3/23.
Pt received vaccine 11/18/11. Pt came to pharmacy 11/21/11. Her upper arm was swollen, red, and hot to touch. There was no reaction at the administration site in the deltoid area. The area of concern is more at the bicep. Pt advised to see physician. Pt called back. Site & pain cleared without intervention within 48 hours.
FLU-LIKE SYMPTOMS (CHILLS, FEVER, MUSCLE ACHES).
Pt stated he felt dizzy and lightheaded. Pt fainted, laid pt down and elevated feet.
Patient reports left upper arm skin red and hot (large area) and swollen since receiving vaccine 6 days ago. MD prescribed Cetirizine 10mg daily and taper dose of prednisone for 5 days.
9 days following the first dose, I noticed a small red circle/patch on my left upper arm at the lower end of my deltoid muscle (injection site). It was approximately 1.5 inches in diameter. The following day is was 2 inches and slightly raised. At one point there was minor itchiness. The site has slowly begun to fade
Within seconds, I could start feeling my heart race and they told me to sit down for 15 minutes. I sat there for 20 minutes hoping it would go away. It didn't. I started walking away but went back in and reported it and they brought people to evaluate me. My heart rate and blood pressure were elevated. They brought in someone from the  St Joseph Medical Center ER dept and that person decided I needed to go over and be admitted to ER. I stayed there for 3-4 hours before it finally came down and they let me go home. No treatment at that time - just observed me. I did not experience re-occurrence of symptoms.  I went to see my doctor to follow up and she said everything was okay. I had different medical tests related to my asthma.
Severe headache days 1-10 Moderate headache days 11- 16 Brain fog- days 1-19
The primary reporter reported that the patient had "titers drawn on an unknown date which showed that the patient was not protected against hepatitis B.; This spontaneous report as received from a registered nurse refers to a male patient of unknown age. The patient's current conditions included diabetes and hypertension. Patient allergies included statins.   On unspecified date, an unknown patient was vaccinated with an unknown hepatitis B vaccine (manufacturer unknown) series at unknown facility for prophylaxis (dose, frequency, route of administration, lot number and expiration date were not reported).  On unknown date, the patient had titers drawn which showed that the patient was not protected against hepatitis B (viral titre decreased). The reporter states that patient went to doctor's office on 19-APR-2019, however no treatment was provided at that time.  At the time of this report the patient had not recovered from the adverse event viral titre decreased.  The causal relationship with hepatitis B vaccine (manufacturer unknown) and the adverse event was unknown.
I had the Chills for two nights and then pain in right chest muscle and down my right arm to my wrist for 3 days. After that my forearm and elbow joint continue to have pain. This is now week 5 of forearm and elbow joint pain.
About 30 min p/shots high-pitched screaming which lasted on & off 12hrs; Better next day states mom; Child was warm but mom did not check temp; Did not see MD; Gave APAP which didn't help;
11/6/12: At time of appointment (9:20 AM): Bright-eyed, healthy, happy, energetic baby. No runny nose or sneezing. During exam doctor comments: "You look like a lot of fun!" By 5 PM: Fever of 100.1, extremely irritable (cries when she attempts to move body), redness, hardness, tenderness at injection site. Decreased appetite. Before midnight: Seizure (violent jerking/spasming of body which woke baby and made her cry). Have never seen her do this before or since. 11/7/12: Fever of 100.2, extreme irritability -- cries and demands to be held all day. Seems to be in pain if she tries to move -- interferes with limb movement. Decreased appetite. 11/8/12: Fever of 102.5. Extreme drowsiness -- falls asleep repeatedly, even shortly after waking from a long nap. Diarrhea. Extremely irritable, demands to be held all the time. Decreased appetite. Parent called doctor's office to report concerns, speaks to nurse. 11/9/12: Fever continues all night.  Back to normal in the morning.
Pt recv vax on 12/8/98; immediately post vax pt exp staring, near syncope, rigid, jerking, glossy eyes x 30 sec w/ loss of bladder control
Pt. received vaccine on 5/7/12 at 11:15, evening pt. experienced rapid heart beat, felt hot, had HA, tightness in throat and ears when swallowing, next day pt felt normal.
This spontaneous report as received from a nurse refers to unspecified patients of unknown demographics. No information about medical history concurrent conditions and concomitant medications was reported. The nurse reported that on an unknown date an unspecified number of patients were administered with doses of VARIVAX (Merck) (therapy dates, strength, route not reported) that were improperly stored since an unspecified date in June 2012. No adverse events were reported. The outcome of the events reported is unknown. Additional information has been requested.
Approximately four hours after injection, had muscle soreness and spontaneous crying. Approximately five hours after injection, had muscle soreness. Approximately seven hours after injection, had chills and fever at 101 degrees. Went to sleep at that point, woke up several times with night sweats and chills.
I had lock jaw immediately following the vaccine for approximately 24 hours, in addition to fever and headache.  I also was in the ER due to extreme stomach pain and after CT scan showed my intestines were extrememly inflammed.
Loss of weight; Orbs around my eyes hurt; In bed almost 3 days; loss of taste; Loss of smell; Fever; Overwhelming Fatigue; Headache; Body aches; This spontaneous case was reported by a consumer and describes the occurrence of WEIGHT DECREASED (Loss of weight), EYE PAIN (Orbs around my eyes hurt), BEDRIDDEN (In bed almost 3 days), AGEUSIA (loss of taste) and ANOSMIA (Loss of smell) in a 76-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included COVID-19 from 03-Feb-2021 to 23-Feb-2021 and Pacemaker insertion (cardiac) since an unknown date. Concurrent medical conditions included Drug allergy, Diabetes, Drug allergy, Drug allergy and Drug allergy. Concomitant products included RIVAROXABAN (XARELTO), METFORMIN HCL, HYDROCHLOROTHIAZIDE, LOSARTAN POTASSIUM (LOSARTAN HCTZ), GLYBURIDE, SIMVASTATIN, METOPROLOL TARTRATE, FERROUS SULFATE (SLOW FE), COLECALCIFEROL (D3), LEVOCARNITINE HYDROCHLORIDE, UBIDECARENONE (Q10 + L-CARNITINE), ASPIRIN [ACETYLSALICYLIC ACID], BIOTIN, VITAMIN B COMPLEX and CANNABIDIOL (CBD OIL) for an unknown indication.   On 18-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 15-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 15-Apr-2021, the patient experienced WEIGHT DECREASED (Loss of weight), EYE PAIN (Orbs around my eyes hurt), BEDRIDDEN (In bed almost 3 days), AGEUSIA (loss of taste), ANOSMIA (Loss of smell), PYREXIA (Fever), FATIGUE (Overwhelming Fatigue), HEADACHE (Headache) and MYALGIA (Body aches). At the time of the report, WEIGHT DECREASED (Loss of weight), EYE PAIN (Orbs around my eyes hurt), BEDRIDDEN (In bed almost 3 days), AGEUSIA (loss of taste), ANOSMIA (Loss of smell), PYREXIA (Fever), FATIGUE (Overwhelming Fatigue), HEADACHE (Headache) and MYALGIA (Body aches) had not resolved.             Treatment medication was not reported.   This case was linked to MOD-2021-052125 (Patient Link).
It was reported that a 31 year old female pt received a TD Adult and a Fluzone UNSP '99-'00 vaccination on 3/20/00. Reportedly, on 3/21/00, the pt complained of redness, itching, soreness, warmth to touch and an induration of the left deltoid. From correspondence received on 3/29/00, it was reported that the pt recovered from this experience.
very bad headache; stomach bothered them/ached everywhere; This spontaneous case was reported by a consumer and describes the occurrence of ABDOMINAL PAIN UPPER (stomach bothered them/ached everywhere) and HEADACHE (very bad headache) in a 74-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 027A10A) for COVID-19 vaccination.     No Medical History was reported.  Concomitant products included FISH OIL, ACETYLSALICYLIC ACID and LISINOPRIL for an unknown indication.   On 16-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1. On 16-Mar-2021, the patient experienced ABDOMINAL PAIN UPPER (stomach bothered them/ached everywhere). On 16-Mar-2021 at 5:00 PM,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced HEADACHE (very bad headache). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. On 17-Mar-2021, ABDOMINAL PAIN UPPER (stomach bothered them/ached everywhere) and HEADACHE (very bad headache) had resolved.            The patient's concomitant medications included vitamins.
pt recv vax 21SEP95 & 1APR97 pt exp a failure to seroconvert;
Screaming synd - cried 2 hrs, no fever or swelling. Checked by MD- essentially negative. Recovered fine.
began 5/30/99 w/chickenpox lesions chest, stomach, axilla: arms approx 20 lesions 6/2/99;feels warm to touch but did not take temp;
Lethargic; fatigue; still sleepy all the time from second shot; This spontaneous case was reported by a consumer and describes the occurrence of SOMNOLENCE (still sleepy all the time from second shot), LETHARGY (Lethargic) and FATIGUE (fatigue) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 028A21A and 003AZ1A) for COVID-19 vaccination.     No Medical History information was reported.   On 03-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 31-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 2 dosage form. On 31-Mar-2021, the patient experienced SOMNOLENCE (still sleepy all the time from second shot) and FATIGUE (fatigue). On an unknown date, the patient experienced LETHARGY (Lethargic). At the time of the report, SOMNOLENCE (still sleepy all the time from second shot), LETHARGY (Lethargic) and FATIGUE (fatigue) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Drug specific antibody: non reactive (Inconclusive) Antibody - Non Reactive.         Concomitant medication was not provided.  Treatment medication was not provided.   Most recent FOLLOW-UP information incorporated above includes: On 23-Jul-2021: Follow up received contains significant information - adverse event lethargic updated.
Left arm localized redness at the site of Covid vaccination.  Also itching and swelling at the site. Doubled in size to 6 cm on 1-22-21.  Remains same today.  No other Rashes or symptoms noted
a lot of muscle and joint pain; a lot of muscle and joint pain/sore in her hip joint; stiff neck and shoulders and shortly after it went to her lower back and legs and she couldn't bend over; stiff and sore in her hip joint and lower back; stiff and sore in her hip joint and lower back; This is a spontaneous report received from a non-contactable consumer(patient). This 75-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on 30Mar2021 at single dose for COVID-19 immunisation. Medical history and concomitant medications were not reported. The patient got the first shot on 30Mar2021 and had been having a lot of muscle and joint pain. It started a couple of days after, she got a stiff neck and shoulders and shortly after it went to her lower back and legs and she couldn't bend over. It was still stiff and sore in her hip joint and lower back but she said it was somewhat maybe a little better. She is scheduled for the second shot tomorrow and is very hesitant. She asked how long this will last and if the second shot will make things worse. The outcome of events was unknown.   No follow up attempts are possible; information about lot/batch number cannot be obtained.
Quarter sized bruise at injection site. Arm ache - still sore 3 weeks later. Applied ice & ADVIL - which reduced pain & swelling.
Five days later I got Covid, confirmed by test; Five days later I got Covid, confirmed by test; This is a spontaneous report received from contactable consumer via Pfizer sponsored program. An unspecified aged male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection), via an unspecified route of administration on 12Mar2021 at 1st dose, single for COVID-19 immunization. The patient medical history and concomitant medication were not reported. Patient took the first dose of the Pfizer COVID vaccine on 12Mar2021. Five days later he got COVID, confirmed by test. He was symptomatic for 7 days. His next dose is scheduled for 02Apr2021. Should he postpone it and for how long. The outcome of events was unknown.  Lot/Batch number has been requested.
Sore throat, lethargic/fatigue, lump above my collarbone under the skin, swollen neck, could barely move neck, had pain shooting down and around my upper back and neck.
After receiving the shot, I felt normal flu like symptoms for about 36 hours.  Then, in the week following, I started to notice muscle twitching all over my body.  It happens every single day, all throughout the day.
This spontaneous report as received from a physician via a company representative refers to a female patient of unknown age. On an unknown date, the patient was vaccinated for prophylaxis with GARDASIL.On an unknown date, the patient experienced abnormal Papanicolaou (PAP) smear. The outcome of abnormal PAP smear was unknown. Causality assessment was not provided.
histamine response - watery, red, itchy eyes, nasal congestion, runny nose, itchy skin
Erythema, induration and heat and "pain" at and below injection site of left arm - greater than 3 inches in diameter and length. Mother denied illness but child heard to cough. Mother brought child to Health Center, today, 2/8/08 - to have nurse check left arm.
pt recvd vax 21JUL94; pt cried, then wimpered & was irritable during noc; approx 16-18 hrs later pt exp generalized macular papular eruptions; seen by MD 22JUL; no fever; no itching; MD rpts pt has no known viral illness;
Vaccine Administered at Inappropriate Route; This non-serious case was reported by a consumer via call center representative and described the occurrence of intramuscular formulation administered by other route in a 52-year-old male patient who received DTPa (Reduced antigen) (Boostrix) for prophylaxis.   On 22-JUN-2023, the patient received Boostrix (intravenous). On 22-JUN-2023, an unknown time after receiving Boostrix, the patient experienced intramuscular formulation administered by other route (Verbatim: Vaccine Administered at Inappropriate Route). The outcome of the intramuscular formulation administered by other route was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK Receipt Date: 26-JUN-2023 The reporter was a pharmacy student. The reporter called on behalf of healthcare professional to inquire that for Boostrix, anything to look for and it did need to be re-administered. The reporter was unable to provide vaccine Lot number or expiration date. The reporter did not consent to follow-up. The reporter reported that a patient was inadvertently administered a Boostrix vaccine given IV instead of Intramuscularly, which led to intramuscular formulation administered by other route.
23 hours after vaccine administration I developed a mild sore throat and fatigue followed by abdominal pain that felt similar to pulled abdominal muscles. over the next 5 days my abdomen was extremely firm and distended and tender to the touch. I had difficulty sleeping due to 7/10 abdominal pain and considered going to the emergency room. I had a normal bowel movement prior to this episode but took a laxative just to be sure that was not the issue. the laxative did not help. the pain worsened on days 2-4 and began to subside on day 5. I had begun taking the Escitalopram at the end of January. my dose was increased from 5 mg per day to 10 mg per day on the day following my covid vaccine on the 26th. I immediately stopped taking this medication so my last dose was on the same day my symptoms began (Feb. 26th). I am unsure how long that medication remains in a person's system but my symptoms persisted for a total of 5 days after stopping this medication. I am unsure if the vaccine was responsible for this reaction or if it might have been due to the increased dose of Escitalopram. I declined my 2nd dose of the covid vaccine due to this experience.
Developed breathing problem/tightness of chest around a month later. Went to my Dr.  (5/6/21) who put me on a COPD inhaler for two weeks.
I was planning on going to get lunch. I had been very hungry but after the vaccine and taking the subway, by the time I got to the restaurant-- I had lost my appetite. So I left the restaurant and ate when I got home. The next day, I had some oatmeal and I could barely eat any. I didn't have much of an appetite. Around 1pm, I tried eating an apple and couldn't eat much more after a couple of bites. I started having cold sweats and something was bothering my stomach. It lasted for 3-4 hours. I have a phobia of vomiting and the last time I vomited was 4 years ago; around 4pm, I started vomiting and couldn't stop. I vomited profusely until around 6pm when I called the ambulance. It was mostly water in my vomit, and I had a bad ache and developed a sore in my mouth after. I was hospitalized for 3 days and put on a liquid diet. While there, they ran MRI, Xrays, blood work, COVID tests to see what was wrong with me. It didn't appear anything was wrong with me other than a severe reaction to the vaccination. I only had body chills after my first dose so this disturbed me when this happened after my second dose.