chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This spontaneous report as received from a register nurse refers to a 4 months infant, of unknown gender. Medical history and concurrent conditions were not reported. On 11-FEB-2014, the patient was vaccinated with dose 2 of ROTATEQ lot #J007283; expiration date: 27-SEP-2014 (dose, strength and route were not reported). Secondary and concomitant therapies were not reported. Nurse called and stated that improperly stored ROTATEQ was administered to patient. No adverse effects reported. The nurse reported that vaccine dose received by patient was a vaccine improperly stored as follows: On 13-JAN-2014, ROTATEQ was stored outside of recommended temperatures for 2 hours (2 pm - 4 pm) the temperature recorded was 50 degrees F. On 18-JAN-2014, ROTATEQ was stored outside of recommended temperatures for 2 hours (2 pm - 4 pm) the temperature recorded was 49.1 degrees F. On 10-FEB-2014, ROTATEQ was stored outside of recommended temperatures for 6 hours (12 pm - 6 pm) the temperature recorded was 51.8 degrees F. On 16-FEB-2014, ROTATEQ was stored outside of recommended temperatures for 5 hours (12 pm - 5 pm) the temperature recorded was 51.8 degrees F. On 22-FEB-2014, ROTATEQ was stored outside of recommended temperatures for 4 hours (2 pm - 6 pm) the temperature recorded was 52.7 degrees F. On 09-MAR-2014, ROTATEQ was stored outside of recommended temperatures for 2 hours (12 pm - 10 pm) the temperature recorded was 55.4 degrees F. On 15-MAR-2014, ROTATEQ was stored outside of recommended temperatures for 6 hours (8 am - 2 pm) the temperature recorded was 50 degrees F. On 16-MAR-2014, ROTATEQ was stored outside of recommended temperatures for 20 hours (2 am - 10 pm) the temperature recorded was 64.4 degrees F. On 17-MAR-2014, ROTATEQ the temperature reading on the morning was 64.8 degrees F. The total of hours stored outside of recommended temperatures was 55 hours. This is one of several reports from the same reporter. Additional information has been requested.
redness at the site; soreness at the site; have developed muscle aches; This case was reported by a consumer via call center representative and described the occurrence of injection site erythema in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   In June 2020, the patient received Shingrix. On an unknown date, couple of days after receiving Shingrix, the patient experienced injection site erythema, injection site pain and muscle pain. On an unknown date, the outcome of the injection site erythema, injection site pain and muscle pain were not recovered/not resolved.   It was unknown if the reporter considered the injection site erythema, injection site pain and muscle pain to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The patient received Shingrix and had the soreness and redness at the site and had a couple of other areas where had developed muscle aches which started a couple of days after the injection and it would be a week since received the injection. The reporter asked how long should the side effects last.
Undiluted Pfizer 5-11 y/o was given  to and 11 year old pt.
no adverse event. pediatric pfizer was given undiluted. dose given was 0.2ml
COVID-19 pneumonia Acute hypoxic respiratory failure secondary to COVID-pneumonia and acute congestive heart failure Presenting with bilateral opacities on chest x-ray, symptom onset 2 weeks prior to admission (9/27/22). No previous confirmed diagnosis and was vaccinated originally with Johnson & Johnson vaccine, no follow-up boosters. Infectious disease consulted currently on IV remdesivir, dexamethasone, Tocilizumab Tocilizumab started 10/16/2022 Initially requiring BiPAP then heated high flow oxygen then currently oxygen saturation maintained on 3 L of oxygen through nasal cannula.  Wean as tolerated.  Incentive spirometry.   Permanent atrial fibrillation Home medication include carvedilol 25 mg twice daily and digoxin 0.125 mg daily Currently rate controlled on digoxin 0.125 mg daily and low-dose carvedilol 6.25 mg twice daily CHA2DS2-VASc score 2  Coumadin pharmacy to dose, INR 2.4.   Acute congestive heart failure likely right-sided heart failure Acute diastolic congestive heart failure Cardiac diet Salt and fluid restriction Daily I's and O's and body weight IV then p.o. diuretics Heart failure education Echocardiogram 10/14/2022 showed EF 55% RV dilated with dilated aortic root 4.3 cm   Streptococcus salivarius bacteremia (1 out of 2 cultures) 10/12/2022 Repeat cultures negative Likely contaminant, status post discontinue ceftriaxone   Hypertension Home meds include lisinopril 2.5 mg daily and Coreg 25 mg twice daily initially on hold due to borderline hypotension.  Currently on lisinopril 2.5 mg daily and Coreg 6.25 mg twice daily.   Hyperlipidemia On statin therapy   History of coronary artery disease Nonobstructive coronary artery disease based on cardiac cath in 2011 Guideline directed medical therapy.   Morbid obesity Body mass index 48.9 Encourage weight loss and lifestyle modification Obstructive sleep apnea BIPAP nightly. Outpatient sleep study and follow-up with sleep medicine as an outpatient.   Chronic lymphedema and scaling lower extremity Topical Vaseline lower extremity. Patient denied any dressings.   Chronic thrombocytopenia Platelet count stable. ~80-100   We discharge patient home after improvement of general condition and shortness of breath.  Patient to follow-up with PCP in 1 week.  Follow-up with pulmonary/sleep medicine and ID as noted.
Resident did not express having any symptoms, the only thing that the POC observed abscesses in the arm, groin, thigh and knees after the first vaccination. After the second dose, he was hypoactive. On 2/27 at about 3:30 am he asked him to turn on his side, between 4 am and 5 am POC went to the room I notice it strange, because his head was wrapped in the sheet. When the POC removed the sheet, she observed that her mouth and nose were full of secretions. So he turned it and he himself did not react. He called the emergency who certifies that he had no vital signs. (emergency arrives within 5:45 am to 6:00 am)
Gave 0.5ml as 3rd dose (booster) instead of 0.25ml
initially while driving home, eye spasms and eye dryness, various sharp pains in leg and right foot, a feeling of heightened anxiousness. Following day the typical fatigue, unusual headache, full tunnel feeling in head and ears, off balance feeling, some muscle aches as well as previously mentioned symptoms. this lasted for about 3 days.  some mild relief in fatigue and headache but all of a sudden non stop ear ringing (Tinnitus) high pitched EEEEE with occasional low tone whistle sound. fast forward currently no relief in ear ringing and off and on mild pressure headaches, off balance,(some days worse than others) mild fatigue, some isolated off and on muscle aches. slight fainting feeling (occasional), don't feel grounded..... among other things
Shortness of breath, vomiting, severe fatigue, lightheadedness, chest pains, severe pain in left arm, fever, chills. Symptoms lasted until 3/23/2021 (48 hours). Since then, personality has changed - angry and irritable.
Soreness; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (Soreness) in a 62-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026A21A) for COVID-19 vaccination.     Concomitant products included RIVAROXABAN (XARELTO) for Anticoagulant therapy, VALSARTAN and AMLODIPINE for Blood pressure high, PRAVASTATIN and ACETYLSALICYLIC ACID (BABY ASPIRIN) for an unknown indication.    On 16-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 16-Mar-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced PAIN (Soreness). On 19-Mar-2021, PAIN (Soreness) had resolved. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       The patient's medical history weren't reported and relevant concomitant medication include "Complete multivitamin"   Treatment information was not provided.   This case was linked to MOD-2021-078088, MOD-2021-078059, MOD-2021-078068, MOD-2021-078029, MOD-2021-078048 (E2B Linked Report).; Sender's Comments:  MOD-2021-078088:Husband First dose case MOD-2021-078059:Wife First Dose Case MOD-2021-078068:Wife Second dose case MOD-2021-078029:Sons first dose case MOD-2021-078048:Son second dose case
Vomits, diarrhea, fever, body ache, shaking chills, lost of appetite for 3 days and counting.
Patient was given both Vaxelis and ActHIB in the same injection site; Patient was given both Vaxelis and ActHIB; This non-serious spontaneous safety report, with MSD Case ID: 02397640 (Interaction Number 02397630), was received by partner on 30-MAY-2023 and forwarded on the same day from other health professional.  The reporter did not provide an assessment of the causal relationship between Vaxelis and the reported events "Patient was given both Vaxelis and ActHIB in the same injection site and Patient was given both Vaxelis and ActHIB".  Further information is expected.
Taste and smell off. I used to love sour cream and noticed it tasted rotten in June and continues to taste that way to me. Sense of smell also affected.
The Pharmacist call about the administration of expired moderna vaccine that were given as booster shot to patient around 490 to 500 people on the date last Oct 20,2021 to Nov 29,2021.; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (The Pharmacist call about the administration of expired moderna vaccine that were given as booster shot to patient around 490 to 500 people on the date last Oct 20,2021 to Nov 29,2021.) in a 30-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 02-Dec-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 02-Dec-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (The Pharmacist call about the administration of expired moderna vaccine that were given as booster shot to patient around 490 to 500 people on the date last Oct 20,2021 to Nov 29,2021.). On 02-Dec-2021, EXPIRED PRODUCT ADMINISTERED (The Pharmacist call about the administration of expired moderna vaccine that were given as booster shot to patient around 490 to 500 people on the date last Oct 20,2021 to Nov 29,2021.) had resolved. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No Concomitant medications were reported. No Treatments were reported.
Left arm lymph soreness. Left leg (sometimes in both) warm sensation with numbness and tingling below knee in calf and foot, not constant. Standing and walking helps relieve symptoms at times but seems to be more constant then on 1/6 and 1/7.  Encouraged client to seek emergency medical treatment as to determine cause of the numbness and tingling.
Rash lasted 3 days. Less than 50 pox. No fever. No antipyretics given. No complications. No Rx meds. given.
No additional AE reported; MMR-11 that expired on 2/20/2021 was administered to a consumer; This spontaneous report was received from a nurse and refers to a patient of unknown age and gender. No information regarding the patient's pertinent medical history, drug reactions or allergies and concomitant therapies was provided. On 25-FEB-2021, the patient was vaccinated with an expired dose of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live(M-M-R II), 0.5 milliliter (expiration date: 20-FEB-2021) (formulation, strength, frequency, route of administration and lot # were not reported) for prophylaxis. No additional adverse event reported.
flu virus; Initial information was received on 12-Jan-2022 regarding an unsolicited valid Social Media non-serious case received from a consumer.  This case involves an unknown demographics patient who experienced flu virus while receiving vaccine INFLUENZA VACCINE.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   In 2008 (14 years ago), the patient received a dose of suspect INFLUENZA VACCINE produced by unknown manufacturer (strength, formulation, dose, route, batch number and expiry date: unknown) in unknown administration site for prophylactic vaccination.  In 2008 the patient developed a non-serious event "flu virus" (influenza) (latency: 3 months) following the administration of INFLUENZA VACCINE.  It was reported " I once got the flu shot about 14 years ago (which most Drs do agree are only about 30% effective based upon which flu/viruses actually become active in any given year). Â  That year, within 3 months after getting the flu shot, I got a flu virus. Then, the following month, I got another flu/virus. Then, within a couple of weeks after recovering from that, I got a flu/virus again. Â  I've never got another flu shot since. Â  And, since then, I've had a flu/virus only just a few times over the course of 14 years. And, the 15 years prior to getting that flu shot, I'd only caught a flu/virus just a handful of times. Â  My worst year for getting a flu/virus (other than when I was a kid) was the year I got the flu shot."  Action taken with INFLUENZA VACCINE (INFLUENZA VACCINE) was not applicable.  It was not reported if the patient received a corrective treatment for the event (flu virus).  At time of reporting, the outcome was Unknown for the event flu virus.
Headache, stiffness, body aches, diarrhea, heartburn, fever 101.4 , feel extremely weak!!!
Sevwre headache die one week and then at one week Severe left sided knee arthropathy and could not work
L shoulder and wrist left like I needed to pop them, stretch them ......then progressed to painful and I just kept trying to do range of motion exercises to make the feeling go away.  Shoulder got better but L thumb got worse.  My joints on the thumb locked up to the pointe that I had to use my other hand to straighten it.  I took Ibuprofen and Tylenol, warm soaks, lodocaine patches to area etc until 4/9/21 when I went to urgent are.  She described it as trigger finger/ligament damage and prescribed meds and told me to tape it to my pointer finger and not use it at all.  That it when it started to get better....a month later.
Information has been received from a nurse refers to unspecified patients. No current or historical conditions were reported. On 29-SEP-2014 the patients were vaccinated with VARIVAX (Merck) (lot # J001181, expiration date 31-JAN-2015), dose, route unspecified which were improperly exposed to -4.9C for 109 hours. No adverse experience has been observed or reported. This is one of several reported received from same source. Additional information has been requested.
got shingles after taking the vaccine /Suspected Vaccination Failure; shingles; This case was reported by a consumer via interactive digital media and described the occurrence of suspected vaccination failure in a female patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure and shingles were unknown.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine.  Additional details were provided as follows: The reporter was the patient's sister or brother. The age at vaccination was not reported. The reporter stated that, his or her sister had shingles vaccination still got shingles. This case was considered as suspected vaccination failure, since the details regarding the completion of the primary immunization for shingles, time to onset for event and laboratory confirmation for shingles were not provided.
This is a spontaneous report from a Pfizer sponsored program, by a contactable consumer reported for himself. This male patient of an unspecified age and ethnicity received TRUMENBA, via an unspecified route of administration at 0.5 ml, single on an unspecified date for immunisation. The patient medical history and concomitant medications were not reported. The patient experienced neck stiff and drowsy on an unspecified date with outcome of unknown. "He did spray some "raid" (not clear over the call) and probably he had reaction and illness from that.
All day today after I took a shower, the area around the injection looks read and warm. I didn't notice this before but I wasn't really paying attention to it every day. I'm not sure if I scrubbed it too hard with a Lofa in the shower or itched it but it's been red all day. The color of redness has reduced as the day has gone on but it's still visable.
No adverse effects reported; An expired dose of PROQUAD was administered to the patient; This spontaneous report was received from a nurse concerning a patient of unknown age and gender. There was no information regarding the patient's medical history, concurrent conditions or concomitant medications.    On 29-JUL-2019, the patient was vaccinated with measles, mumps, rubella and varicella (oka-merck) virus vaccine live rha(PROQUAD) lot # N034561 with expiration date of 03-JUN-2019, for prophylaxis (dose, frequency, route of administration and anatomical location were not provided).
Choking sensation in my throat that lasted for about 5 to 6 hours, disoriented, brain fog, pain at the injection site, and fatigue.
heavier periods; Product origin unknown; This spontaneous report was received from a consumer and refers to a female patient of unknown age. The patient's medical history, concurrent condition, and concomitant therapy were not reported.   On an unknown date, the patient received human papillomavirus (HPV) vaccine administered (strength, dose, unit, lot number and expiry date not provided) for prophylaxis (Product origin unknown). On an unknown date, the patient had heavier periods due to the HPV vaccine. The outcome was not provided. The action taken was not applicable. The causality was considered as related.   This is one of several reports received from the same reporter.
Syncope approximately 10-15 minutes after vaccine, occurred shortly after patient had blood drawn. Patient hit head on floor and had to be transferred to ER for evaluation of head injury.
Immunizations were given starting the left arm then rotating to the left then the right etc. Five immunizations were given total. All 5 shots were given in 1 year 4 months time span from 03/28/2003 until the last was given 7/13/2004. Symptoms include burning for 24 hours in each arm for a full 24 hours after each shot occured. Arms breaking out in pimples that had never occured before, about a couple weeks after first shot. Other symptoms are ongoing soreness which affected mobility in both arms ocurring for up to 2 months after each shot. Also after 1st shot arthritis symptoms have appeared in both wrists. The wrist pain and acne are still occuring symptoms belived to be from the antrhax vaccine.
patient received 2nd pfizer covid vaccine and immediately passed out.  Patient would not come around, called 911 and gave 0.3mg of epi.  patient came around after epi.  fire and paramedics showed up.  patient was evaluated and it was decided between paramedics and father not to transport to hospital
Bell's Palsy.   Started getting pain in my neck and ear about 2 days before the onset then on January 3rd my face started feeling weak on my right side.  Noticed my smile was crooked and that's when I decided to go to the ER where I was diagnosed with Bell's Palsy.
Received TDAP then developed cellulitis at the injection site. Treated with Cephalexin 500mg one po QID x 7 days.
TINNITUS - growing worse each month.  There is no treatment for tinnitus.  The only thing that can be done is to track and document the hearing loss.  RINGING -- RINGING -- RINGING in my ears.    TINNITUS IS ALMOST UNBEARABLE -- AND NO CURE!!!  If I had it to do over again, I would NOT submit myself to another experimental vaccine.  There are too many side effects for this vaccine. I will not get the booster.  PLEASE, PLEASE DO NOT ALLOW OUR CHILDREN TO RECEIVE THE COVID VACCINE!!!  We don't know how they will be affected by the vaccine.
Since then the daughter has frequently been sick; This spontaneous report was received from a consumer via a company representative and refers to a female patient of unknown age, a daughter of a reporter's friend. There was no information concerning the patient's pertinent medical history, concomitant medications, concurrent conditions, drug reactions or allergies provided. It was reported that on 08-JUN-2019, reporter's friend told her that on an unknown date, a friend of hers, whom the reporter did not know, had gotten the unidentified Merck hpv vaccine administered (name and lot number not provided)(dose, route of administration, expiration date and indication were not provided) shot for her daughter (the reporter was not sure if she meant the original quadrivalent human papillomavirus (types 6,11,16,18) recomb. vaccine(GARDASIL) or hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9)).  Since an unknown date, reported as since then, the patient has frequently been sick, whereas before the shot she was generally healthy.  The reporter's friend was hesitating to vaccinate her own son with quadrivalent human papillomavirus (types 6,11,16,18) recomb. vaccine (GARDASIL) because of her friend's experience at the time of the reporting. The outcome of the event was unknown. The causality assessment was not provided.
The area around the injection site became red, inflamed, and tender/firm to the touch starting 1 day post vaccination. Patient consulted with pharmacist 2 days post vaccination stating that she was concerned since she did not have the same reaction to the 1st dose in the series. The pharmacist advised her to take an OTC NSAID, apply a cool compress if necessary, and to consult with her doctor if the reaction had not improved within 2 days. No further communication with the patient at this point.
pt recv vax 11MAR95 & devel Bell's palsy;weakness progressed to the sides of face;unable to close lt eye & face dropped to the right;
?COVID arm?. Red rash about 2 inch diameter, with a hard lump below the skin as well as itchiness at the injection site. Started a few hours after shot, continues today (3 days later).
Pre-filled syringes of Moderna sent in the wrong syringe and administered. Dose should be administered intramuscular, but dose of vaccine administered via subcutaneous syringe and not via intramuscular syringe.