chrisvoncsefalvay/vaers-outcomes huggingface dataset:
dose administered past the 30 day use; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (dose administered past the 30 day use) in a 23-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. Unknown) for COVID-19 vaccination.     No Medical History information was reported.    On 06-Oct-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 06-Oct-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (dose administered past the 30 day use). On 06-Oct-2021, EXPIRED PRODUCT ADMINISTERED (dose administered past the 30 day use) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported.  Treatment information was not provided.
Within 20 minutes my arm, neck, face, and scalp became itchy. The injection became red, swollen, and hot to the touch within thirty minutes of receiving vaccine. I took zyrtec and the rash and itchiness subsided a little. This morning, 2/6/2021 my arm is beat red swollen and warm.
Entire undiluted vial inadvertently administered. Error immediately identified. Patient immediately made aware 24 hours later, patient had expected post-vaccine response with sore arm, body ache, chills. Self-limited.
dry lips; back hurts; headache; muscular pain; nausea; dizziness; hands hot like when she has fever/face hot; pain on the arm of injection; swelling  two fingers below site of injection; redness two fingers below site of injection; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (pain on the arm of injection), PERIPHERAL SWELLING (swelling  two fingers below site of injection), ERYTHEMA (redness two fingers below site of injection), DIZZINESS (dizziness) and FEELING HOT (hands hot like when she has fever/face hot) in a 71-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 024M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Iodine allergy, Drug allergy (Sulfa Allergy) and Osteoporosis. Concomitant products included ROSUVASTATIN, LEVOTHYROXINE, ASCORBIC ACID (VITAMIN C PLUS [ASCORBIC ACID]), MULTIVITAMIN [VITAMINS NOS], VITAMIN D3 and CALCIUM for an unknown indication.    On 01-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 01-Mar-2021, the patient experienced PAIN IN EXTREMITY (pain on the arm of injection), PERIPHERAL SWELLING (swelling  two fingers below site of injection) and ERYTHEMA (redness two fingers below site of injection). On 02-Mar-2021, the patient experienced DIZZINESS (dizziness) and FEELING HOT (hands hot like when she has fever/face hot). On 22-Mar-2021, the patient experienced MYALGIA (muscular pain) and NAUSEA (nausea). On an unknown date, the patient experienced LIP DRY (dry lips), BACK PAIN (back hurts) and HEADACHE (headache). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. At the time of the report, PAIN IN EXTREMITY (pain on the arm of injection), PERIPHERAL SWELLING (swelling  two fingers below site of injection) and ERYTHEMA (redness two fingers below site of injection) had resolved and DIZZINESS (dizziness), FEELING HOT (hands hot like when she has fever/face hot), LIP DRY (dry lips), BACK PAIN (back hurts), HEADACHE (headache), MYALGIA (muscular pain) and NAUSEA (nausea) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Patient's concomitant medication also includes Injection for osteoporosis every 3 months.
Burning of back, from the neck to the upper hips, took a nap; stayed in bed all day.  Felt fine the next day.  Felt like my back was burning similar to a burn from hot water. Took anti inflammatory FOODS for the next 28 days to prepare for next injection.  Next injection was normal compared to the first.  Did not have a Physician to consult, so just toughed it out.  Glad I survived !!
after the 1st shot, left arm was sore; This spontaneous case was reported by a patient and describes the occurrence of PAIN IN EXTREMITY (after the 1st shot, left arm was sore) in a 57-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026A21A) for COVID-19 vaccination.     Patient had no allergy for medications, food and other products. Patient had not tested positive or diagnosed with COVID-19. Patient doesn't smoke.     On 21-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In 2021, the patient experienced PAIN IN EXTREMITY (after the 1st shot, left arm was sore). At the time of the report, PAIN IN EXTREMITY (after the 1st shot, left arm was sore) was resolving.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, X-ray: In the middle". little bit of closing, but nothing to be concerned about..     mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosing remained unchanged.       No concomitant medication was reported. Patient was a runner. Took no medications and was very healthy. No treatment information was provided.   This case was linked to MOD-2022-609261 (Patient Link).
dizzy and lightheaded diaphoretic brought to EMS room for observation discharged in stable condition
Systemic: Fainting / Unresponsive-Severe, Systemic: Flushed / Sweating-Medium, Systemic: Hypotension-Severe
Breakthrough COVID admitted 11/16/2021.  First dose 4/19/2021.  Patient fell down the night before the admission while  trying to go to use the bathroom with the lights off.  On the morning of admission, the sister noticed the patient was not speaking, had no appetite, and had a difficult time walking.  Patient came to stay with his sister 2 days ago because son, who she (said) takes care of the patient, was recently admitted to the hospital for Covid PNA.  Per sister, patient was vaccinated against COVID-19.  Patient denies headache, dizziness, change in vision, numbness, fever, chills, chest pain, palpitations, SOB, nausea, vomiting, abdominal pain, dysuria, diarrhea, constipation.
Sudden nausea with fever and mild diarrhea and weakness and also achy joints. After about thirty minutes, symptoms past but had a tired/sleepy. Rested for about three hours and felt better. Did not take any medications.
Diarrhea, nausea, chills, extreme headache, chest pain, elevated hr & bp  -  transported via ems to er..
patient's caregiver called on 11/13 to state patient still complaining of soarness/tenderness/heat at injection sight more than 1 week after injection. limited range of arm movement also. advised caregiver to contact primary physician.
Associate complained of dizziness; BloodPressure was 189/94; HR 111; Associate denied chest pain or SOB; Blood Pressure was rechecked at 195/90; HeartRate was 87; ambulated and denied any symptoms; observed for 35 minutes; was evaluated by Dr. approved to leave facility and went home
Swelling, fever, chills, cough beginning approx 12 hours post vaccine and continuing up to time of report (57 hours post vaccine)
This case involves adult male patient (age unknown) who was supposed to get DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE [ADACEL] but was mistakenly given DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE [PENTACEL] (wrong product administered). The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. No other concomitant were given to the patient. On an unknown date, the patient received 0.5 ml dose of suspect DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE (lot UJ342AAA and expiration date :21-Jun-2022) via intramuscular route in the right deltoid for prophylactic vaccination instead of DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE (lot number and expiration date not reported). It was a case of an actual medication error due to wrong vaccine administered (same day latency) and they want to know what to do now. Later, states that the physician looked at the comparison and they know patient got more antigen than he needed.  At time of reporting, it was unknown whether the patient experienced any adverse event. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
appendicitis; This is a Spontaneous report from a non-contactable consumer (patient). A 43-year-old female patient (pregnant: no) received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration in left arm on 14Apr2021 (lot number: ewd153) at 14:25 at single dose for COVID-19 immunisation. The relevant medical history was reported as none. Concomitant medications included ascorbic acid (VIT C), zinc, ergocalciferol (VIT D), triamcinolone acetonide (NASACORT AQ) and montelukast sodium (SINGULAIR). The patient previously received the first dose of BNT162B2 (lot number: ep6955, administration time: 02:45 PM, vaccine location: Left arm) on Mar2021 at the age of 43 years old for Covid-19 immunisation. Symptoms of appendicitis started around 1pm the day after 2nd vaccine shot on 15Apr2021. The patient didn't know that they're related, but the timing was suspect. Admitted to the hospital on Friday on 16Apr2021, appendectomy performed that evening. The event resulted in emergency room/department or urgent care. The patient had been hospitalization for 1 day. The outcome of the event was recovering.  No follow-up attempts are possible. No further information is expected.
chills, fatigue, nausea, body ache, vomiting lasted 3 days. took Ibuprofen after 24 hours to help with symptoms.
Arm warm; Arm swollen; Could not sleep on arm; arm  really tender; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE WARMTH (Arm warm), VACCINATION SITE SWELLING (Arm swollen), PAIN IN EXTREMITY (Could not sleep on arm) and VACCINATION SITE PAIN (arm  really tender) in a 71-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030m20a) for COVID-19 vaccination.     The patient's past medical history included COVID-19. Concurrent medical conditions included Cholesterol. Concomitant products included BUPROPION HYDROCHLORIDE (WELLBUTRIN) for an unknown indication.    On 10-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 10-Feb-2021, the patient experienced VACCINATION SITE WARMTH (Arm warm), VACCINATION SITE SWELLING (Arm swollen), PAIN IN EXTREMITY (Could not sleep on arm) and VACCINATION SITE PAIN (arm  really tender). At the time of the report, VACCINATION SITE WARMTH (Arm warm), VACCINATION SITE SWELLING (Arm swollen), PAIN IN EXTREMITY (Could not sleep on arm) and VACCINATION SITE PAIN (arm  really tender) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Other concomitant medications included beta blockers and cholesterol medications. Treatment information was not reported.
Moderna covid -19 vaccine EUA  Sleepy 4;30 pm then flu symptoms nausea chills headache extreme fatigue went to bed 7pm to 9 am On the couch all day the 24 with ice and fatigue  Severe pain both sides of arm and front  of arm pain felt like awful deep pain like down to the bone ilimited range of motion abduction only to  70 degrees  flexion 80 degrees
Telephone call with c/o within 20 hour of receiving Tdap total body ache, unable to work. In Bed, felt better after 36 hours. No fever. alternated motrin and Tyenol x24 hours; Last Td 12/8/04
Employee received Pfizer booster instead of first dose of  Pfizer primary series.  New hire came to Employee Health to receive COVID vaccine (Pfizer primary series). Injection administered by RN. The next day when discarding opened vial RN noticed that vial opened was Pfizer Bivalent Booster. Pharmacy notified. Pharmacy instructed EH to follow instructions from the CDC which states:  "If a Bivalent vaccine is administered in error for a primary series dose: do not repeat the dose. The primary and booster dosages are the same; the bivalent dose can be counted as primary series dose. Continue with the recommended vaccination schedule."  Employee who received vaccine notified of error. Employee Health nurse explained situation. Employee denies questions at this time employee instructed to call Employee Health with any questions or concerns.   Primary series had been ordered from pharmacy. Booster vial dispensed from pharmacy in bag that did not indicate that it was a bivalent booster on label. EH RN spoke with pharmacy asked for form of vaccine to be indicated on label. Clinical Pharmacy Utilization Specialist agrees to label bag with form of vaccine moving forward.  Booster and primary series vials are the same size, shape and color. the only difference is the name on the label. Pharmacy and EH agree that this is increases potential for wrong dose to be administered.   Employee who administered vaccine will be notified and educated on verifying correct dose prior to administration.?
Very sick, throwing up, diarrhea, passing out, and not remembering. Headache and hurt all over.
Client's mother reported the client had only gotten 1 dose of Pfizer so far and needed a 2nd dose. It was not determined until after vaccination that the client had already received 2 doses of Pfizer.
Left Leg Sore, Swollen, Red and Hot to touch. Child refused to bear weight on leg. Crying. Parents gave Ibubrofen.
My left arm was sore about 2-3 hours after the shot. Later that evening, my arm was worse and I could not lift my arm up past my chest. Around about 11:00 p.m., I began to feel chills, aches and pains. I was sluggish, tired and had no energy. The next day when I woke-up around 10:00 a.m., I still had the aches and pains, all the way down to the bottoms of my feet. My body hurt to stand. The aches and pains continued that evening, along with diaherra and chest pains. The pains continued through Saturday and the chest pains got worse. The pain would radiate from my chest to my left arm, to my left shoulder, and into my back between my shoulder blades. Then by 7:00 p.m. or so on Saturday, my chest started to feel better and my aches and pains were not as bad. I was then woken up around 12:00 a.m. or so, on Saturday/Sunday with severe chest pains again with the radiation of pain. This also came along with the aches and pains and diahrrea. This has continued through to today, Monday. I tried to do simple putting my dishes away and loading up my dishwasher, and couldn't complete the task due to the chest pain and severe aches and pains all over my body. I have tried to treat the symptoms with over-the-counter medications which would include: Advil II, Pepto Bismal, Alka-Seltzer, hot showers, hot baths, luke warm baths, vapor bath soaks and a heating pad.
Inconsolable screaming for 45 minutes, followed by excessive sleepiness, unusual crying before passing gas or a bowel movement, and increased incidences of spitting up for over 48 hours.
I have 2 neighbors, they both got very sick after getting the Moderna shot.; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of ILLNESS (I have 2 neighbors, they both got very sick after getting the Moderna shot.) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) 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 22-Nov-2021, the patient experienced ILLNESS (I have 2 neighbors, they both got very sick after getting the Moderna shot.). At the time of the report, ILLNESS (I have 2 neighbors, they both got very sick after getting the Moderna shot.) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant medications details were not reported by the reporter. Treatment details was not reported by the reporter.   This case was linked to MOD-2021-395763, MOD-2021-395776, MOD-2021-395777 (Patient Link).
Positive for covid; Lethargy; Body aches; Got sick with Fever; Chills; This spontaneous case was reported by a health care professional and describes the occurrence of COVID-19 (Positive for covid), LETHARGY (Lethargy), PAIN (Body aches), PYREXIA (Got sick with Fever) and CHILLS (Chills) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included COVID-19 since 17-Jan-2021.    On 07-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 14-Jan-2021, the patient experienced LETHARGY (Lethargy), PAIN (Body aches), PYREXIA (Got sick with Fever) and CHILLS (Chills). On 15-Jan-2021, the patient experienced COVID-19 (Positive for covid). At the time of the report, COVID-19 (Positive for covid), LETHARGY (Lethargy), PAIN (Body aches), PYREXIA (Got sick with Fever) and CHILLS (Chills) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 17-Jan-2021, SARS-CoV-2 test: Positive.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route), the reporter did not provide any causality assessments.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events of lethargy, fever, chills and pain, a causal relationship cannot be excluded. Limited information regarding the COVID-19 event was provided. The patient probably experienced asymptomatic COVID-19 infection before being administered with the mRNA-1273 vaccine
Received the 2nd injection of SHINGRIX 50MCG. Arm became very sore throughout the afternoon and evening. By 11pm, I started getting chills and my hands were very cold. I woke up throughout the night with chills, headache, body aches and pains, nausea, sore arm, pain on my left side. I could not get out of bed until 7pm the next day where I had a small amount of food and then went back to bed after a couple hours with a fever around 100 degrees. Most of my temperature subsided over the night and I felt much better this morning, but still tired throughout today.
Dry mouth; Migraine headaches; Dizziness; Weak; Chills; This spontaneous case was reported by a consumer and describes the occurrence of DRY MOUTH (Dry mouth), MIGRAINE (Migraine headaches), DIZZINESS (Dizziness), ASTHENIA (Weak) and CHILLS (Chills) in a 60-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 037A21B) for COVID-19 vaccination.     Concomitant products included AMLODIPINE for an unknown indication.    On 24-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 24-Mar-2021, the patient experienced DRY MOUTH (Dry mouth), MIGRAINE (Migraine headaches), DIZZINESS (Dizziness), ASTHENIA (Weak) and CHILLS (Chills). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. At the time of the report, DRY MOUTH (Dry mouth), MIGRAINE (Migraine headaches), DIZZINESS (Dizziness), ASTHENIA (Weak) and CHILLS (Chills) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Reporter did not allow further contact
None documented Narrative: An 88yo male with history of HTN, DM, Hyperlipidemia and GERD Per nursing immunization note he received his first Covid- 19 vaccine on January 13, 2021 and the second shot on February 3, 2021 and both times without complications, per Policy/protocol. He was advised to remain in the facility for 15 minutes post vaccination, was also provided information regarding side effects and how to report ADR
Rash x 2 days (48 hours) around 100 small papular, vesicles, come crusting.
The patient fainted for a few seconds roughly 8  minuets after administration.  The patient got up off the floor and waited for the ambulance.  He told us he did want any treatment or care; he said he was fine.  We call 911 and had the ambulance come to the pharmacy.  The patient refused any treatment multiple times.  Patient got up from their chair and  left.
It's been 2 years since my first shot didn´t get the 2nd; This case was reported by a consumer via interactive digital media and described the occurrence of incomplete course of vaccination in a patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st dose on an unknown date 2 years ago).   On an unknown date, the patient did not receive the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the incomplete course of vaccination was unknown.   Additional Information: GSK receipt date: 07-JUN-2022 Reporter's comment: The case was received from the consumer via interactive digital media. The patient enquired that its been 2 years since he/she received first Shingrix shot so he/she need to start the series from scratch.           Additional Supportive Information: Till the time of reporting, the patient did not receive 2nd dose of Shingrix, which led to incomplete course of vaccination. Follow-up could not be possible as no contact details were available.
has not had a period since her shots; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 15-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 05Jan2022 at 11:00 as dose 1, single (Lot number: FJ8762) at the age of 15 years, in left arm for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. The following information was reported: MENSTRUATION DELAYED (non-serious) with onset 05Jan2022, outcome "not recovered", described as "has not had a period since her shots". The event "has not had a period since her shots" required physician office visit. Therapeutic measures were not taken as a result of menstruation delayed.  Additional information: There was no other vaccine in four weeks.  There was none other medication in two weeks. There was no covid prior vaccination and did not tested covid post vaccination. There was no known allergies. There was no other medical history.  Follow-Up (11Jul2022): Follow-up attempts are completed. No further information is expected.