chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Doses administered past the published expiry; This spontaneous case was reported by a physician and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Doses administered past the published expiry) in an 83-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 007B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 08-Oct-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 08-Oct-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Doses administered past the published expiry). On 08-Oct-2021, EXPIRED PRODUCT ADMINISTERED (Doses administered past the published expiry) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant information was not provided.   It was reported that the vials were stored in the freezer and taken out of the freezer and placed in the refrigerator on the date of administration. The vials did not undergo any temperature excursions.  Treatment information was not provided.
Shortly after receiving the vaccine, patient's mom told us patient had vomited a small amount into her mask.  Patient stated she was still nauseous and had a headache and proceeded to vomit again a much larger amount.  After this, she remained in the observation area and did not vomit again and left the pharmacy with mom and dad.
Chilling, could not get warm, then diarrhea, then vomiting. No treatment beyond heating pad. Seems to be OK at noontime, 10/31.
No adverse effect reported; hairline crack on the blue luer lock portion of the syringe; vaccine expelling from the syringe/patient likely did not get a full dose; This spontaneous report was received from a pharmacist referring to a patient of unknown age and gender. The patient's concurrent conditions, medical history, concomitant medications and drug reactions/allergies were not reported.  On 09-AUG-2019, the patient was vaccinated with an unspecified dose of pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) prefilled syringe (PFS), lot # S004548 and expiration date: 12-AUG-2020 for prophylaxis (strength, route and anatomical location were not reported) and it was reported that pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) prefilled syringe (PFS) had a small hairline crack on the junction between the syringe and needle which is on the blue luer lock portion of the syringe (syringe issue), resulting in vaccine expelling from the syringe and the patient likely did not get a full dose (vaccine underdose). The effect was noticed during the process of administration. The syringe was not broken into two or more pieces and it did not have a broken component. The tip of the syringe or leur lock adaptor was not loose or broken off of the syringe tip and there was no difficulty trying to attach the syringe needle to the syringe. The syringe tip cap was attached properly prior to use. The syringe tray and carton was not damaged prior to use. No adverse effect was reported. The outcome of syringe issue and vaccine underdose was unknown. Causality assessment of the event syringe issue was not provided.
Information has been received from a physician concerning a 64 year old female patient who on 22-OCT-2008 was vaccinated intramuscularly with a 0.5 ml dose of PNEUMOVAX (lot number 659199/1541U) (injection site not reported) and a dose of FLUVIRIN at the same injection site. concomitant therapy included CYMBALTA, TIZANIDINE HYDROCHLORIDE and BISOPROLOL FUMARATE/HCTZ. On 22-OCT-2008, later the same day of vaccination, the patient developed swelling, pain and redness at the injection site. The patient called the physician's office. Unspecified medical attention was sought. At time of the report, the patient's symptoms persisted. Follow up was received from the physician who reported the patient had swelling, severe pain and erythema at the injection site with radiation to the neck and down the length of the arm. In 2008, the patient recovered. No further information is expected.
Sx onset 7/24 nausea, fatigue, weakness. Tested on 7/26/21 which is positive.
Extreme vertigo upon rising the next morning. Dizziness throughout the day. Fatigue, feeling hot.
Possible vasovagal syncope 6 hours past the adminstration.  Lasted for 30 minutes.  Symptoms included extreme warmth (felt like whole body was on fire), dizzyness - laid down immediately so did not faint, nausea, lowered heart rate (44), unsure of blood pressure, paleness.  Cold compresses and laying down and raising legs was helpful.
This spontaneous report as received from a physician refers to a 6 month old patient. On an unknown date, the patient was vaccinated with ROTATEQ but the baby spit up ROTATEQ. The physician wanted to know if the dose to be repeated or not. Additional information has been requested.
Attack of Rheumatoid Arthritis; Patient received second dose 6 months after first one; This spontaneous case was reported by a consumer and describes the occurrence of RHEUMATOID ARTHRITIS (Attack of Rheumatoid Arthritis) in a 95-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 032L20A and 052E21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Macular degeneration.   On 21-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 04-Aug-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 01-Jun-2021, the patient experienced RHEUMATOID ARTHRITIS (Attack of Rheumatoid Arthritis) (seriousness criteria hospitalization and medically significant). On 04-Aug-2021, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Patient received second dose 6 months after first one). The patient was hospitalized from 01-Jun-2021 to 04-Jun-2021 due to RHEUMATOID ARTHRITIS. The patient was treated with CORTISONE for Rheumatoid arthritis, at an unspecified dose and frequency. On 04-Jun-2021, RHEUMATOID ARTHRITIS (Attack of Rheumatoid Arthritis) outcome was unknown. On 04-Aug-2021, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Patient received second dose 6 months after first one) had resolved.            No concomitant medications were reported. The patient took Tylenol before the shot and used CBD oil on her arm 2-3 days after the shot.  Company Comment: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.   Most recent FOLLOW-UP information incorporated above includes: On 18-Aug-2021: follow up received and it includes second dose details On 31-Aug-2021: Significant follow-up appended - serious event added; 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, a causal relationship cannot be excluded.
p/vax pt exp  itching & a hot swollen area greater than 2 inches @ the inj site & tx w/DPH & ice;pt condition ongoing;
More than 36 days after the first dose and second dose was not given.; black eye on right side; Pain in right arm; Foggy mind; Scratching right eyebrow; feel disoriented; This spontaneous case was reported by a consumer and describes the occurrence of DISORIENTATION (feel disoriented), EYE CONTUSION (black eye on right side), PAIN IN EXTREMITY (Pain in right arm), CONFUSIONAL STATE (Foggy mind) and SEBORRHOEIC DERMATITIS (Scratching right eyebrow) in a 63-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 020M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Hyperlipidemia.    On 01-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 01-Feb-2021, the patient experienced DISORIENTATION (feel disoriented), PAIN IN EXTREMITY (Pain in right arm), CONFUSIONAL STATE (Foggy mind) and SEBORRHOEIC DERMATITIS (Scratching right eyebrow). On 02-Feb-2021, the patient experienced EYE CONTUSION (black eye on right side). On an unknown date, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (More than 36 days after the first dose and second dose was not given.). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. At the time of the report, DISORIENTATION (feel disoriented), EYE CONTUSION (black eye on right side), PAIN IN EXTREMITY (Pain in right arm), CONFUSIONAL STATE (Foggy mind), SEBORRHOEIC DERMATITIS (Scratching right eyebrow) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (More than 36 days after the first dose and second dose was not given.) outcome was unknown. Not Provided    DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In 2021, Blood test: normal (normal) Normal.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant medications reported were, Cholesterol Medicine and Diuretics.
The patient experienced right hip replacement; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. Other Case identifier(s): US-ABBVIE-22K-163-4252170-00.  A 78-year-old male patient received BNT162b2 (BNT162B2), on 11Feb2021 as dose 1, single (Batch/Lot number: unknown) and on 17Mar2021 as dose 2, single (Batch/Lot number: unknown) at the age of 77 years, all intramuscular for covid-19 immunisation; adalimumab (HUMIRA), (Lot number: 1158135) at 40 mg (40 mg (citrate free)), subcutaneous for psoriatic arthropathy. The patient's relevant medical history and concomitant medications were not reported.  The following information was reported: HIP ARTHROPLASTY (medically significant) with onset Dec2021, outcome "recovered", described as "The patient experienced right hip replacement". The patient underwent the following laboratory tests and procedures: Renal function test: (2022) High, notes: Kidney numbers [Renal function test], 2022, High; (unspecified date) abnormal. The action taken for adalimumab was unknown. Therapeutic measures were taken as a result of hip arthroplasty.  Clinical course: It was unknown if patient was enrolled in COVID-19-Vaccine Trial.  Causalities The reporter's causality for the event(s) of right hip replacement with Pfizer BioNTech COVID-19 vaccine (Tozinameran) was No Reasonable Possibility The reporter's causality for the event(s) of right hip replacement with Adalimumab Solution for Injection was Not Provided Alternative Etiology for right hip replacement with Adalimumab Solution for Injection: Surgical procedure performed; Most likely related to underlying Psoriatic arthritis in this elderly patient  Assessment Results Pfizer BioNTech COVID -19 vaccine Hip replacement,  Pfizer BioNTech COVID -19 vaccine Hip replacement, Non-Health Care Professional, Global Introspection, No Reasonable Possibility Humira Hip replacement, Global Introspection, No Reasonable Possibility Humira Hip replacement, Non-Health Care Professional, Global Introspection, Not Reported.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
localized redness 6 x 8 cm; not raised, red, hot & itchy x 3 days; MD gave Steroid;
I thought I had come down with a really bad cold. I didn't think anything of it since I had been vaccinated. I had a cough and nasal congestion. Overnight I came down with a fever of 100.3. I tested after I woke up with very bad chills and a fever. I took the test 3 COVID-19 home test. I called my doctor and they prescribed Paxlovid. I began the medication the same day and by the next day, my symptoms rapidly improved. I have since recovered after about 5 days.
On 11/13/14, went to pharmacy and wanted to get flu shot. Pharmacist gave me the shot. While given me the shot, she stated "oh your muscle rolled, I must have hit a nerve". I knew it smarted extra bad. When done, I went to put coat on, my arm would not raise all the way.
Mother reports at 4am 2/20/03, child woke up, but laid back don. At 4:20am he let out a screech, his father picked him up and he had a 30 second episode of shaking and eyes rolling back,911 was called. He was taken to the ER the temp was 103F. Temp decreased with motrin. Home from ER by 8am. Mother states happy and eating.
Difficulty breathing; Accelerated heartbeat; General weakness; Fatigue; This spontaneous case was reported by a consumer and describes the occurrence of DYSPNOEA (Difficulty breathing), HEART RATE INCREASED (Accelerated heartbeat), ASTHENIA (General weakness) and FATIGUE (Fatigue) in a 63-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031B21A) for COVID-19 vaccination.     Concomitant products included GLATIRAMER ACETATE, ATORVASTATIN, ACETYLSALICYLIC ACID (BABY ASPIRIN), TOLTERODINE, ZOLPIDEM and SERTRALINE for an unknown indication.    On 13-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 14-Apr-2021, the patient experienced DYSPNOEA (Difficulty breathing), HEART RATE INCREASED (Accelerated heartbeat), ASTHENIA (General weakness) and FATIGUE (Fatigue). At the time of the report, DYSPNOEA (Difficulty breathing), HEART RATE INCREASED (Accelerated heartbeat), ASTHENIA (General weakness) and FATIGUE (Fatigue) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment information was not provided.  For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Reporter did not allow further contact
Itchy throat, sweaty, "feels like under water", tinglng arm where vaccine was given.  Juice provided, monitored and released with Mom.  Phone call follow up later that day, she was doing well.
Narrative:  A 61yo male with PMH of multiple medical problems including Hypercholesteremia, Cholecystectomy, Gout, GERD, HTN, OA of Knee, Cervicalgia, BPH without urinary obstruction, OSA, ESRD and Right Inguinal Hernia. Per ED documentations; On October 19, 2022 the patient presented to the ED with chief complaint of vaccine reaction having pain at the injection site and body aches with chills , nausea, vomiting and watery diarrhea x 3 days. The patient reported he took some Pedialyte with mild relief and diarrhea improved slightly. Vaccine administering RN's documentation showed the patient received both Covid - 19 and Flu vaccine on the same day on 10/17/22. The patient also reported he missed his dialysis, which was due the previous day. He was found to be hyperkalemic and got admitted for hyperkalemia management and dialysis. On October 23, 2022, the attending on unit reported an observed ADR of Diarrhea post patient admission for vaccine reaction on 10/20/22. Patient's immunization record showed he's had four Pfizer Covid - 19 vaccine shots prior to this (On April 16, 2021, May 7, 2021, August 27, 2021 and April 11, 2022),
Arm pain, swelling at injection site 7 days after first dose. Red circular rash near injection site 11 days after first dose.
Beyond use date of vaccine given was 3/16/2023. Patient reported no signs or symptoms to the pharmacy.
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 HYPOAESTHESIA (numbness at tip of both thumbs. Later is started moving up to the hand and now in both arms) in a 60-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for an unknown indication.     Concomitant products included VITAMIN D NOS, ASPIRIN [ACETYLSALICYLIC ACID], METHOCARBAMOL, HYDROCHLOROTHIAZIDE, TRIAMTERENE (TRIAMTERENE & HCTZ), POTASSIUM CHLORIDE (K-DUR) and HYDROCODONE BITARTRATE, PARACETAMOL (HYDROCODONE BITARTRATE AND ACETAMINOPHEN) for an unknown indication.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced HYPOAESTHESIA (numbness at tip of both thumbs. Later is started moving up to the hand and now in both arms). At the time of the report, HYPOAESTHESIA (numbness at tip of both thumbs. Later is started moving up to the hand and now in both arms) outcome was unknown. Not Provided      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 concomitant medications were reported. No treatment related information has been reported.
passed out while using the rest room at 11:30 p.m. family member found me and woke me up. went back to bed.
SERIOUSNESS CRITERIA: OTHER - MEDICALLY SIGNIFICANT. Initial report received from a physician on 12 October 2006. A 33 year old female patient received on 25 September 2006, intra-muscular, 0.5 ml booster of Adacel (lot number C2559AA, expiry date 12 August 2008), while she was 1 week pregnant (LMP was 10 June 2007). The patient did not receive any concomitant vaccines. The patient's past obstetric history included one previous pregnancy and subsequent full term delivery with a normal outcome. At the time of the report (12 October 2006), the patient did not have prenatal testing yet. No information about prior exposures to Adacel was provided. The patient did not experience any adverse reactions following receipt of Adacel on 25 September 2006. Follow-up information received on 11 May 2007. The patient received Adacel in the left deltoid and she did not have any illness at that time. The patient's past obstetric history included one previous pregnancy and subsequent full term delivery with a normal outcome in 2004. The patient's last menstrual period was 04 September 2006 and her expected date of delivery is 11 June 2007. The patient was last seen on 06 October 2006 for confirmation of pregnancy and was lost to follow-up by the reporting physician. She was referred to an OB/GYN for prenatal care. The reporting physician was not aware of the current pregnancy outcome. Follow-up information received on 02 July 2007 from a health care professional, Date of last menstrual periods was 11 September 2006. The estimated date of delivery was 11 June 2007. Past obstetric history included: 1 live birth, previous pregnancy with no pre-term / congenital anomalies. The patient received one intramuscular dose of Fluzone (lot# U2201AA) on 30 October 2006. Prenatal testing included serologies on 25 October 2006, which was normal and ultrasound on 03 November 2006, which showed no fetal cardiac activity. Outcome of the pregnancy was missed abortion on the first trimester with Dilation and curettage (D&C).
As per clinic progress notes. Dec 17, 2009- Pt has had an unknown rxn to influenza vaccine with Guillain Barre Syndrome.
After receiving the vaccine, two days later while I was working on my computer, I couldn't see my right hand on my computer. I was waving my right hand in front of my face and realized it was blur spot in my eye. I went to the emergency room and they put me on stroke protocol. After the MRI and CT scan, they diagnosed me with an ocular migraine. The neurologist informed me if I continued to received migraines after diagnosis, I would be prescribed migraine medication. The blurred vision was reduced before being discharged so no medication was given to me to help relieve the problem.
I developed shingles a couple days after receiving the vaccine. I had chickenpox when I was a child. My immune system being suppressed by the vaccine likely resulted in a shingles flare up.
Had Covid 03/03/2023 sore throat, stuffed head and nose, achy all over earache; stomachache symptoms continue.
Legs went numb couldn't walk . went to ER and was admitted on 09/2/21 -09/7/21 diagnosed with Guillans Barre Syndrome. transferred to rehab on 9/7 21 . had breathing problems on the 9/12/21 and went back to hospital . then transferred bat to rehab and still there now .
RED, ITCHY, BURNING RASH DEVELOPED ON 12/4/21, EARLY MORNING ON UPPER BACK ACROSS SHOULDERS AND BUE.
This spontaneous report was received from a licensed practical nurse, concerning a patient of unknown age and gender. The patient's medical history, concurrent conditions, concomitant medications, drug reactions or allergies were not provided. On 28-JUN-2018, the patient was inadvertently vaccinated with an expired dose of VARIVAX (strength or anatomical location were not provided) from lot # M027344 with expiration date on 01-JUN-2018, which was administered subcutaneously for prophylaxis. The vaccine never underwent a temperature excursion and no adverse effects were reported.
Patient felt sick starting the evening of the vaccination (nauseous, fatigued). Next day, soreness at site-redness from shoulder to elbow
Woke up Day #2 with joint pain and neck pain. Subsided after about 12 hours.
Sore throat, cough, shortness of breath, chest tightness. Nebulizer treatment, steroids, azithromycin
Pt c/o anxiouse to needle, 10minute after vaccinated c/o heavyness/shakyness of feet & feeling hot face. Minium assisted by staff to stretcher, monitored v/s were normal limit exsept SBP inceased to 234 to 182, DBP 60 TO 80's.  Tx-benadryl 225mg 1 cap, cold compress on face, offered emotional supports. out come- no more s.sx of above symptoms. Pt's conditon improved reduced redness on face & no heavy and shaky to feet.   D/C'd with daughter, recommended to further exam by PCP or urgent care.
Very achy all over. Tired. Whole body aches. Typical fibromyalgia but more severe than normal. I didn?t feel well mid day the day prior. Still wasn?t better Monday the day of shot, I feel much worse now.
This spontaneous report as received from a other health professional refers to an approximately 15 year old female patient with no reported medical history. On 04-APR-2013 the patient was vaccinated with GARDASIL (route, dose and lot number unknown) dose 4. On unknown dates the patient was vaccinated with GARDASIL (route, dose and lot number unknown) dose 1,2 and 3. No other suspect therapies or concomitant medications were reported. The patient erroneously received a 4th dose of GARDASIL on 04-APR-2013. Since then she has had a heavy menstrual period. The outcome of heavy menstrual period is unknown. The reporters relatedness of heavy menstrual period to GARDASIL is unknown. Additional information has been requested.
Site and arm swelling, nausea, headache, body ache, chills, weak, fatigue, fever, near fainting, diarrhea.
Starting the day after the injection she has had a rash on her neck. It does itch and intermittently gets more red.