chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Vial was initially stored in refrigerator on 4-Jun-2022 and administered past 30 day use by date; No adverse event; Administered the vaccine after the 30 day use by date; This spontaneous case was reported by a physician assistant and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Administered the vaccine after the 30 day use by date), PRODUCT STORAGE ERROR (Vial was initially stored in refrigerator on 4-Jun-2022 and administered past 30 day use by date) and NO ADVERSE EVENT (No adverse event) in a 67-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 058A22-2A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 06-Jul-2022, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. On 06-Jul-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Administered the vaccine after the 30 day use by date). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Vial was initially stored in refrigerator on 4-Jun-2022 and administered past 30 day use by date) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Administered the vaccine after the 30 day use by date), PRODUCT STORAGE ERROR (Vial was initially stored in refrigerator on 4-Jun-2022 and administered past 30 day use by 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 (Administered the vaccine after the 30 day use by date) and PRODUCT STORAGE ERROR (Vial was initially stored in refrigerator on 4-Jun-2022 and administered past 30 day use by date).    No concomitant medication was reported.  Total 35 vials were affected. Vial was initially stored in refrigerator on 4-Jun-2022 and did not undergo temperature excursion. Manufactory code for the lot was MOD. Patient got half dose.  No treatment medication was reported.
4 PINK CIRCLES. APROX. THE SIZE OF A DIME, NICKLE, AND  QUARTER.
FATIGUE; This spontaneous report received from a patient via a company representative concerned a patient of unspecified age and sex. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported. On an unspecified date, the subject experienced fatigue. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from fatigue. This report was non-serious. This case, from the same reporter is linked to 20210453743.
Patient started experiencing a "tingling" at the injection site.  There was also flushing of the left arm.  Then started to experience right flank and back pain. Never experienced respiratory difficulty or distress.  Patient was sent to the emergency department.  Patient received Solumedrol, Pepcid, and Zyrtec in the emergency department (allergic to Benadryl)
This spontaneous report as received from a physician and from a support services director via two company representatives refers to a patient of unknown age and gender. No information regarding the patient's medical history or concurrent conditions was provided. On 20-JUl-2015, the patient was vaccinated with an improperly stored dose of M-M-R II injection (lot# J003625, expiry date 11-MAR-2016, albumin status HSA; dose and route of administration were not reported). There were no concomitant therapies reported. The dose of the vaccine was exposed to six separate temperature excursions (dates unspecified), all of them concerning a refrigerator: the first lasting for 168 hours with the highest recorded temperature of 49 degrees Fahrenheit (9.44 degrees Celsius), the second one lasting for 336 hours with the highest recorded temperature of 59 degrees Fahrenheit (15 degrees Celsius), the third one lasting for 1172 hours with the lowest recorded temperature of -3 degrees Celsius, the fourth lasting for 80 hours with the lowest recorded temperature of 30 degrees Fahrenheit (-1.11 degrees Celsius), the fifth lasting for 416 hours with the highest recorded temperature of 47 degrees Fahrenheit (8.33 degrees Celsius), and the last lasting for 24 hours with the highest recorded temperature of 48 degrees Fahrenheit (8.89 degrees Celsius). The vaccine was stored in the refrigerator and/or in the freezer. No adverse effects were reported. There was no product quality complaint involved. This is one of several reports received from the same reporter. Additional information has been requested.
Information has been received from a health department coordinator concerning a female who was vaccinated with a dose of GARDASIL vaccine (yeast) (lot number, injection site and route not reported). Subsequently the patient experienced tingling and numbness in the arm. The patient sought unspecified medical attention. Subsequently, the patient recovered from tingling and numbness in the arm. Additional information has been requested.
kept in refrigerator for that entire month at 41.3 f.; Expired vaccine used; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) and PRODUCT STORAGE ERROR (kept in refrigerator for that entire month at 41.3 f.) in an 81-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 049L21A, 012H21B, 022C21A and 047A21A) for COVID-19 prophylaxis.     No Medical History information was reported.   On 14-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .5 milliliter. On 12-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to .5 milliliter. On 15-Jan-2022, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to .25 milliliter. On 11-Jul-2022 at 10:30 AM, received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to .25 milliliter. On 11-Jul-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Expired vaccine used). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (kept in refrigerator for that entire month at 41.3 f.). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) and PRODUCT STORAGE ERROR (kept in refrigerator for that entire month at 41.3 f.) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported.  Drug thawed on 19-May-22 with a use by date of 18-Jun-22. Vial was kept in refrigerator for that entire month at 41.3 f.    The vial did not underwent any temperature excursion.   No adverse events was reported.  No treatment medications were reported.
Initial unsolicited report received from a Nurse on 14-Sep-2018. This case is linked to case 2018SA262249 (same reporter). This case involves a five months old male patient who was vaccinated with a 0.5 mL dose of IPOL (Batch number: N1A461M, expiration date: 30-Sep-2020) intramuscularly in left thigh on 06-Sep-2018. The patients past vaccination(s) included IPOL. The patient's past medical history, medical treatment(s) and family history were not provided. It was an actual medication error due to incorrect product storage. It was reported that the first excursion was at 47.5F for 36 minutes. The IPOL had been used before the excursion and was used after the excursion. It was an invalid dose. The second excursion was with the same vaccine, at 55.6 F for 5 hours and 12 minutes. It was unknown whether the patient experienced any adverse event following vaccination. 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 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. List of documents held by sender: none.
PATIENT FIRST NOTICE REDNESS AND WARM TO THE TOCH ON THE VACCINE SITE (RIGHT ARM, SC) WITHING 24 HOURS. PATIENT THEN PRECIDED TO TAKE MOTRIN 200MG AS DIRECTED IN THE BOTTLE. THEN 9 DAYS LATER PT EXPERIENCED SWEELING AND REDNES ALONG WITH ITCHINES ON HIS RIGHT INNER ELBOW. PATIENT WAS THEN ADVISE TO GO TO THE E.R. WHERE HE WAS TREATED FOR CELLULITIS. PATIENT RECIEVED KEFLEX AND BENADRYL. PATIENT SYMPTOMS THEN GOT RESOLVED SHORTLY AFTER.
Day 1 - Received 1st dose of vaccine at 4pm. Felt fine until 11pm when arm started to hurt, but not too bad. Had trouble sleeping. Day 2 - Woke up and entire arm hurt so bad, I could barely touch it and even the fabric from my loose shirt hurt my arm when the fabric put pressure on my arm. Had a large lump where the vaccine was administered in my arm. Was very tired all day and arm hurt. By 5 pm, I had a fever, my entire body ached, I had a sore throat and I was freezing and incredibly tired. Had trouble sleeping all night again.  Day 3 - Arm still in severe pain, woke up nauseous, and was very tired.  Had trouble sleeping again. Day 4 - Arm still hurt a ton, but less severe than previous days, very tired and slightly nauseous. Day 5 - Arm still hurt and tired.  Day 6 - Arm still sore, not as bad, still tired and worn out. Lump finally getting smaller on arm.  Day 7-  Arm still sore, but less than previous days. Tired still. Day 8 - Arm slightly sore. still tired.  Day 9 - (March 31st) Woke up and had bright red rash on arm where vaccine was given and rash was spreading across arm very quickly - it hurt and itched. Also developed a rash all over my entire face. Called Primary doctor and directed to take Benadryl and Motrin every 6 hours and go to the ER if it got worse.  Day 10 - Rash on arm and face persisted for 3 days, but kept under control by taking Benadryl.  Day 11 through Day 24 - rash still on arm but less severe/ red - skin where the rash is peels off and on (like when you get a sunburn). Mostly gone on day 24, but you can still see where the rash was on my arm when you look.    Note: Never had COVID so it's unclear why I had so many reactions to the 1st shot compared to other people.
Shaking rigors, similar to grand mal seizure / Continuous shaking; Very cold; Sore arm; Got really hot; Chills / Rigors coming in waves; Headache; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 24-Mar-2021 and was forwarded to Moderna on 24-Mar-2021.    This spontaneous case was reported by a consumer and describes the occurrence of TREMOR (Shaking rigors, similar to grand mal seizure / Continuous shaking), NASOPHARYNGITIS (Very cold), PAIN IN EXTREMITY (Sore arm), FEELING HOT (Got really hot) and CHILLS (Chills / Rigors coming in waves) in an 83-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 027A21A and 031L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included COVID-19.   On 23-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 23-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 23-Mar-2021, the patient experienced TREMOR (Shaking rigors, similar to grand mal seizure / Continuous shaking), NASOPHARYNGITIS (Very cold), PAIN IN EXTREMITY (Sore arm), FEELING HOT (Got really hot), CHILLS (Chills / Rigors coming in waves) and HEADACHE (Headache). The patient was treated with PARACETAMOL (TYLENOL) for Symptomatic treatment, at an unspecified dose and frequency and DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) for Symptomatic treatment, at an unspecified dose and frequency. At the time of the report, TREMOR (Shaking rigors, similar to grand mal seizure / Continuous shaking), NASOPHARYNGITIS (Very cold), PAIN IN EXTREMITY (Sore arm), FEELING HOT (Got really hot), CHILLS (Chills / Rigors coming in waves) and HEADACHE (Headache) outcome was unknown.            No concomitant medications were reported.  Treatment information included pre-medicated with Tylenol and Benadryl two hours prior to vaccine and took again 6 hours after the vaccine. Took another Benadryl at 10 pm.   This case was linked to MOD-2021-056016 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 10-May-2021: Dosing details were updated.
Patient dropped dead 24 hours after receiving the vaccine. The vaccine killed her. She received the vaccine 2/16/2021 and died 2/17/2021
patient fainted after receiving pfizer vaccine. became alert after 1 minute. school nurse attended to patient and checked vitals and mother took patient home after recovery within 15 minutes
Pts. mother states pt. had fever 101.3 - 102 which lasted 2 days than resolved.  Rash "little red bumps" which faded 2 hrs. after onset.  Bruise on tongue still present 3 days after onset following IMM.  Mother states tongue bruising also happened after 4 mo. IMM. but not after 2 mo IMM.  Pts. other sx have resolved.
Swollen eyes, soreness around eyes, dry skin around eyes. Took antihistamines orally, cold compresses on eyes.
Patient described symptoms of swelling the next day. She also c/o achiness at site & was taking Ibuprofen. On 4/8/11, she stopped in office to show how much it had swollen (4"x2") was red & raised. Suggested she take BENADRYL/apply ice.
My son developed a rash sometime on Sunday, May 16 after receiving his first dose of the Pfizer shot on Saturday, May 15.  The rash is located near the injection site, the chest, stomach, legs, and opposite arm of vaccination site. Unfortunately, I do not know the exact time of the onset of the rash. The rash is very itchy and looks like hives. I took pictures and messaged the pediatrician. They were not sure if it was a reaction or contact dermatitis. My son has not changed soaps, laundry detergents, etc. the only new thing he encountered was the vaccine. The rash is still itchy and is improving a little bit every day. I expect him to be perfectly fine, but the rash is still present.
Within 10 minutes of receiving injection on right thigh pt developed redness and swelling, followed by fire red rash on hip, buttocks, back and neck. Child appeared to be in no distress.
Pt was administered his first dose of moderna. He had previously reported feeling a little lightheaded after shots in the past. Almost immediately after administration the patient briefly start shaking and started lying back in his chair. He reported feeling dizzy and thought he was going to faint. pt was given water and a wet paper towel and rested his head on the table. Our other pharmacist assisted in talking with patient making sure he was alright. He was given more water and some crackers. He sat down and we continued to monitor him for about 20 minutes afterwards until he was feeling completely better.
This spontaneous report was received from a Registered nurse regarding a 16 year old patient of unknown gender. The patient's medical history, concurrent conditions and concomitant medications were not reported. On 03-AUG-2017, the patient was vaccinated with improperly stored dose of GARDASIL 9 (lot# N004798 with expiration date: 31-OCT-2019) (dosing details and route of administration was not reported) for prophylaxis (product storage error). No adverse effects were reported. The storage temperature was 47 degrees Fahrenheit to 77 degrees Fahrenheit (49F) and time frame was 14 hours. There was no previous temperature excursion. Digital data logger was involved. No product quality complaint was involved. This is one of the several reports received from the same reporter. Sender's Comments: US-009507513-1804USA005153.
p/recv vax pt devel urticaria & rash around the eyes & on the arm
The booster dose was given to the patient, and then later we found out that there is less than 6 months interval between second dose and the booster.  No side effects happened to the patient.
Shortness of breath; coughing; low oxygen; This is a spontaneous report from a contactable consumer (patient). A 34-years-old female patient received first dose of BNT162B2 (Pfizer COVID 19, Solution for injection, lot number: unknown) via an unspecified route of administration on 20Feb2021 at 12:30 PM on left arm as a single dose for COVID-19 immunization. The patient is not pregnant. Medical history included COVID-19 (prior to vaccination). Concomitant medications were not reported. Patient had no known allergies. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient was not tested for COVID-19 since the vaccination. On 21Feb2021 at 12:30 PM, patient experienced shortness of breath, low oxygen and coughing which resulted in emergency room/department or urgent care. Patient received morphine for pain. Outcome of the events was not recovered.  Information on lot and batch number has been requested.
pt exp t100.9, anaphylaxis & convuls, stiffness & loss of speech; pts eyes rolled back, had sz
Itching, redness, swelling, and hot to the touch at site of the injection that started 8 days after the injection. I had no reactions the day of the shot - none until this showed up one week later. I have taken tylenol and iced the spot.
Seem to have lapse in categorizing or focus on task; This is a spontaneous report from a contactable consumer (patient). This 59-year-old male patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE) (Lot# EL3248), via an unspecified route of administration on 14Jan2021 15:00 at single dose on the left arm for COVID-19 immunization. The patient medical history included COVID prior vaccination, high blood pressure and cholesterol. No known allergies. The patient's concomitant medications were not reported. Facility type vaccine was hospital. No other vaccine received in four weeks. The patient experienced seem to have lapse in categorizing or focus on task on 14Jan2021 16:00, reported as disability. AE resulted in Emergency room/department or urgent care, Disability or permanent damage. No COVID tested post vaccination. AE treatment included emergency room call and treatment to left hand. Outcome of the event was not recovered.
A couple hours after shot developed pain in (R) arm. Describes as hot and throbbing. Then became hot, throbbing went away. Now complaining of pain (muscle tightness) when moves arm. States she has limited range of motion + pain from injection site. Across arm to inner elbow. Constantly aches at #5 when moves it is a 10.
12:19 - states throat feels like "when the dentist gives you novacaine", that kind of numb 12:20 - given 25 mg benadryl by mouth 12:26 - now feels dizzy, throat a little better, escorted to EMTs 12:30 - less dizzy, throat better 12:36 - snack given 12:51 - feels better, throat better, feels fine to drive, declined to call daughter for ride home. supervisor notified that patient is going home for the day. 12:53 - home on her own.
In September, I went for a monthly checkup and the Dr noticed my BP was rising.  A month later it went up higher.  They put me on BP medication.  In December, my BP began to creep up again, so they upped my dose.  My BP didn't lower so they approved a higher dosage via a cardiologist.   Around holiday I felt really sick and was having trouble sleeping.  The week after holiday my BP was still high so my Dr sent me to the hospital.  I was diagnosed w/ superimposed pre-cogsnia.  They added another BP medication at max dosage.  They induced me on date to try to do a natural birth but it failed so they performed a c-section.  Afterward, they noticed my BP had began to drop. And by mid Jan, my BP was back to normal.
Adverse reaction to shingles vaccine 1.  Dec 12, 2007: Injection of Zoster Vaccine Live 2. Dec 13-14 red rash on left upper scalp  3.  Dec 15-16 hives and shingles lesions on left forehead, scalp, nose, and around left eye 4.  Dec 17, 2007 Went to PA who diagosed Shingles, prescribed Valtrex 1 gm, Hydroxzine HCL 25 mg, and Hydrocodone/APAP Tab 5-500 mg  5.  Refered to Optomologist for left eye swelling, who prescribed Pred Forte 1% drops and Alphagan 0.1% drops.  6. Dec 19, 2007: Returned to opthomologist, found eye pressure 34, more drops.  7. Dec. 20, 2007:  Returned to optomologist, eye pressure dropped to 25.  Some viral lesions and cell involvement in left eye.
L upper arm, very swollen, red, slight bruising at injection site and warm to touch. Mother did not feel it was necessary to bring child to office. Will tx symptoms and observe at home. 9/19/02 no problems.
Limp attack /p DTP. RX: Benadryl for rxn, Rec. (sic) no more pertussis.
This spontaneous report was received from a physician assistant refers to a 41 year old male patient with asthma. On 13-NOV-2015, the patient was vaccinated with PNEUMOVAX 23 lot # L027732. On 14-NOV-2015, the patient had a fever of 102F, was achy with the injection site unspecified deltoid swollen and tender from deltoid to elbow. The reporter stated that on 15-NOV-2015, the patient went to the local unspecified emergency room for the events and was prescribed unspecified steroids, unspecified anti-inflammatory medication, and unspecified antihistamine. The reporter stated on 17-NOV-2015 she ordered the patient AUGMENTIN (manufacturer unspecified) for an unspecified reason. The outcome of the events were reported as recovered/resolved. The patient sought medical attention. This is one of two reports from the same reporter. Additional information has been requested.
feeling whot & pinkeak ,tired ,threw up twice , restless could not sleep ,fever at night of 100 . Shot arm swollen and hot and pink . Was feeling better 2 days later . Never had a reaction from any shots i`ve had ever.And I always get my vacines on time.
This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a female patient of unknown age. No information was provided regarding concurrent conditions, medical history, or concomitant medications. On or about 09-FEB-2011, a healthcare provider at a medical group administered ZOSTAVAX to the patient to obtain permanent prevention and protection against shingles and zoster-related injuries/conditions (dose, route, and lot # not provided). On or about 23-MAR-2012, the patient was treated by a healthcare provider at the same medical group office for shingles. The patient was diagnosed with shingles and/or other zoster-related injuries after and despite being inoculated with ZOSTAVAX, and suffered serious physical, emotional, and economic damages as a result of the patient's injuries. As a direct and proximate result of ZOSTAVAX, the patient has and will continue to suffer ongoing injuries, including but not limited to: mental and physical pain and suffering; extensive medical care and treatment for these injuries; significant medical and related expenses as a result of these injuries, including but not limited to medical losses and costs including care for hospitalization, physician care, monitoring, treatment, medications and supplies; diminished capacity for the enjoyment of life; a diminished quality of life; increased risk of premature death, aggravation of preexisting conditions and activation of latent conditions; lost wages; loss of earnings capacity; and other losses and damages. The outcome of the events was not recovered. Causality assessment was related. Additional information has been requested.
Arm/shoulder pain, chills, low-grade fever (100.2) from approximately 3:30 a.m. - 3:30 p.m.