chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This spontaneous report as received from a physician refers to a 9 week old patient of unknown gender. The patient's concurrent conditions, concomitant medications, pertinent medical history and drug reactions or allergies were not provided. On 30-MAY-2017, the patient was vaccinated with an improperly stored dose of PEDVAXHIB, lot # M046140 with expiration date on 27-SEP-2019 (dose and route of administration were not reported). Since 25-APR-2017, the administered dose of PEDVAXHIB underwent multiple temperature excursions between 32 degrees Fahrenheit and 49 degrees Fahrenheit, which lasted for 16 hours. A digital data logger was not involved in recording the excursion. No adverse effects were reported. There was no product quality complaint involved. This is one of several reports received from the same reporter. Sender's Comments: US-009507513-1709USA012766.
Swelling/discomfort above collarbone on right-side for a month. PCP recommends an ultrasound in another month if swelling is not gone.
01/31/2003 developed rash/hives- arms, legs, trunk, face. One week after administration.
Patient was initially injected with a syringe that had no vaccine in it. The pharmacist recognized that there was nothing in the syringe, notified the patient and re-administered with the correct vaccine in a new syringe.
Immediate swelling below site of vaccination followed by olecranon bursitis which has persisted now 2 weeks.
surgery due to infection; Injection site shoulder pain; headache; This spontaneous case was reported by a consumer and describes the occurrence of INFECTION (surgery due to infection), VACCINATION SITE PAIN (Injection site shoulder pain) and HEADACHE (headache) in a 64-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012L20A) for COVID-19 vaccination.     Concomitant products included FENTANYL, HYDROCODONE, PROMETHAZINE, MOMETASONE FUROATE (NASONEX), FLUTICASONE, SODIUM PROPIONATE (PROPIONATE), INSULIN, TRAVOPROST, DIAZEPAM, VITAMIN C [ASCORBIC ACID], METFORMIN, PREDNISONE, ACETYLSALICYLIC ACID (BABY ASPIRIN), HYDROCHLOROTHIAZIDE, MIRABEGRON (MYRBETRIQ), ATORVASTATIN, LISINOPRIL, VITAMIN D [VITAMIN D NOS], MULTIVITAMIN [VITAMINS NOS], MAGNESIUM, Co-Q10, SITAGLIPTIN PHOSPHATE (JANUVIA [SITAGLIPTIN PHOSPHATE]) and CURCUMA LONGA (TURMERIC [CURCUMA LONGA]) for an unknown indication.    On 24-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 24-Feb-2021, the patient experienced VACCINATION SITE PAIN (Injection site shoulder pain) and HEADACHE (headache). On an unknown date, the patient experienced INFECTION (surgery due to infection). At the time of the report, INFECTION (surgery due to infection), VACCINATION SITE PAIN (Injection site shoulder pain) and HEADACHE (headache) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medication also included PreserVision Areds 2 Eye Vitamin Mineral  No information about treatment was given.
Information has been received from a nurse referring to multiple unspecified patients of unknown age and gender. Information about patient's concurrent conditions and medical history was not reported. On unknown dates the patients were vaccinated with doses of VARIVAX (Merck) (dose and route not reported, lot number K011804 with expiration date 21-AUG-2016 and lot number reported as L042265 with expiration date 26-OCT-2017) that were improperly stored (temperature: -1C and time frame: 4 hours). It was reported that there was a previous temperature excursion (-6.7C for 2.5 hours). No adverse effects were reported. This is one of several reports received from the same reporter. Additional information is not expected because there was no consent for follow up.
Dose #1 Moderna 01/21/2021 Lot # 041L20A  Pt died while hospitalized
Informed CMA who states she will talk with  her provider. Let her know Kinrix is for 4 to 6 yr olds and that Hep A is for 1 yr +
Dizziness/ dizzy; got really sick/ got pretty sick; This is a spontaneous report from a contactable nurse (reported for herself). A 70-year-old female patient received the second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot/batch number and expiration date not specified), via an unspecified route of administration on an unspecified date at single dose in upper arm for COVID-19 immunization. Medical history included chronic obstructive pulmonary disease (COPD). Concomitant medication included fluticasone propionate, salmeterol xinafoate (ADVAIR). Nurse stated she took the second shot. She believed she had some adverse reactions to it. When probed for the adverse event Nurse stated, "Dizziness, horrible dizziness". She had the shot on Monday and this was Sunday. She didn't know if this was to be expected but it was really getting worse. She first noticed it on Friday it went too bad on Saturday but it's worse today. Right was that an expected side effect. She got really sick with that second shot, really sick but by Thursday she was going better, she got the shot on Monday but on Friday she noticed the dizziness but it was much worse today. She was just so dizzy. For Causality, Nurse stated she didn't know. She meant she immediately thought it was. She had a rough go with the second shot she got pretty sick so yes. She would think it could be. Nurse stated No Treatment, it just started. No Investigation Assessment. For lot number, the nurse stated, "It looks like EL1283 or it could be 083. But it looks like 1283". The outcome of the events was unknown.  Information on the lot/batch number has been requested.
Undiluted vaccine given to the patient.  Counseled parent to monitor for s/s of adverse reactions--TBD
It hurt; Influenza; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. Other Case identifier(s): US2022AMR156058.  A patient (no qualifiers provided) received BNT162b2 (BNT162B2), as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation; influenza vaccine (FLU VACCINE VII), as dose number unknown, single (Batch/Lot number: unknown) for immunisation. The patient's relevant medical history included: "COVID-19", start date: Jul2020 (unspecified if ongoing). The patient's concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (DOSE 1, MANUFACTURER UNKNOWN, Anatomical location: left arm, in September), for COVID-19 immunisation. The following information was reported: PAIN (non-serious), outcome "recovered", described as "It hurt"; INFLUENZA (non-serious), outcome "recovered".  Additional information: The patient got vaccinated in the left arm, and it did not hurt, in September, and after 2 months the second dose. They just applied, the new one from COVID and derivatives, from Pfizer, and the one from Fluo and it hurt. The patient had symptoms of both for 3 days.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Arthralgia; This spontaneous case was reported by a consumer and describes the occurrence of ARTHRALGIA (Arthralgia) in an 80-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 15-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 16-Mar-2021, the patient experienced ARTHRALGIA (Arthralgia). At the time of the report, ARTHRALGIA (Arthralgia) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       The patient's concomitant medication was not reported. The patient did not take any treatment medication.   Most recent FOLLOW-UP information incorporated above includes: On 09-May-2021: report contained no new information
Redness around injection site approx 4" diam, warm area and painful. Reaction began approx 6:00 pm after I had just returned from store. Area has steadily increased with approx size.
Patient received seasonal flu injection 10-27-2009. On 10-28-09 patient noticed a rash, raised on both arms, chest, neck and right leg. Also started having a low grade fever. Was seen by doctor was prescribed Methylprednisone. Patient called health dept. 11-5-09 arms,  chest better, right leg continues to spread rash.
3 inch red spot over injection site, no systemic complaints or fever tx: Bactrim 40/200 per 5 ML, 2 tsp PO every 8 hour x 10 D eval 4-2-07, sooner if problems.
He reports being in good health until approximately 1 1/2 weeks after receiving a smallpox vaccine when he began having chest discomfort with SOB and diaphoresis every morning, while walking from the parking lot to work (about 400 yards). He described the pain as sharp (9/10 on pain scale), mid-sternal, non-radiating lasting 5-10 minutes. He has a history of allergy to grass, so believing that to be the problem, he used his inhaler and within 3-4 mins his symptoms resolved, allowing him to perform all his daily activities without any difficulty. On 5/7/03 during the walk in from the parking lot he again experienced mid-sternal chest pain that increased "whenever I took a deep breathe or stretched my arm," SOB and sweating. Once in the ER, he had an EKG done "that showed very depressed ST segments." He was started on IV morphine, a cardiac catheterization was performed and he was taken to surgery where a double by-pass was done that day. He is scheduled for f/u w cardiology on 6/9/03. Local: LA-itchy, red lesion.
This spontaneous report was received from an office manager via a company representative and refers to a 13 year old female patient. The patient's pertinent medical history, concurrent conditions, concomitant medications and drug reactions/allergies were not reported. On 21-JUL-2017, the patient was vaccinated with the first dose of GARDASIL 9 (dose, route, lot # and expiration date were not reported) for prophylaxis. Immediately after receiving the GARDASIL 9, the patient fainted. On an unspecified date, the patient recovered with no complications. On an unknown date, the patient received her second dose of GARDASIL 9 with no adverse reactions.    The causality between the event and hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) was not reported.
Information has been received on 14-SEP-2018 regarding a case in litigation from a lawyer and a male consumer of unknown age. The patient's concurrent conditions, medical history and concomitant medications are unknown. On or about 29-NOV-2012, the patient received the ZOSTAVAX (dose, route, and lot number not provided) for its intended purpose: the prevention of shingles. As a direct result of the vaccine, the patient suffered from a shingles outbreak, in addition to chronic pain, rash and lesions to various parts of his body. The patient did not have a shingles outbreak until 07-FEB-2017. As a direct result of the vaccine, the patient suffered mental and emotional distress due to resulting physical limitations and seriousness of his condition. As a result of use of ZOSTAVAX, the patient sustained severe and permanent personal injuries. Further, as a tragic consequence, the patient suffered serious, progressive, permanent, and incurable injuries, as well as significant conscious pain and suffering, mental anguish, emotional distress, loss of enjoyment of life, physical impairment and injury. The patient has incurred medical expenses and other economic harm as a direct result of use of ZOSTAVAX. Shingles outbreak was considered to be disabling. Additional information has been requested.
SEVERE ALLERGY ALL OVER THE BODY AND VERY ITCHY AND SWOLLEN AND ALSO ASHMA ATTACK, ALREADY 10DAYS
pt exp headache, nausea, & abdominal cramping on 6MAY92; pt receiving Engerix-B; poss ASA for h/a;
I did not get sick until 5/27 my nose runs constantly, my eyes watering all the time, dry cough, no fever. A real bad cold, a few days later it turned into Bronchitis, I coughed constantly, and went to the doctor, I was prescribed antibiotic and to take a cold medicine. It lasted for a couple of weeks. On June 9th I called the doctor because I wasn't getting any better, they prescribed other medications. I had COVID 19 test on May 27 at 7:00PM and tested positive.
Development of red, pruritic papules and hives beginning on her legs on the day of the immunization and spreading to her arms on the next day.  Pt seen in clinic 5 days later; pruritis treated with atarax.
Patient has had since the evening of the Shingrix vaccination a sore arm for her entire arm, swelling in axilla, hot at the site of injection
This spontaneous report as received from a healthcare student refers to a patient of unknown age. On 11-NOV-2015 the patient was vaccinated with expired ZOSTAVAX (lot # K010968, expiry date: 07-NOV-2015) (expired product administered). No adverse symptoms reported. ZOSTAVAX was supported with in-house post-expiry data. The outcome was unknown. No product quality complaint was involved. Additional information has been requested.
Pt c/o dizziness, anxiety, tingles in feet/legs 5 mins after vaccination. Breathing normally. Pt developed leg heaviness (40mins after vaccination). Pt notes that she did not eat after breakfast @10AM. @13:54 BP 158/110, HR 80, O2 Sat 99% -- > @14:00 148/96 -- > @14:40 126/76, 80, 99%.  Pt given water, juice, snacks and symptoms improved.  Pt stable and released from the vaccination site @15:10.
pt recvd vax 29JUL94 & seen @ hosp 29JUL94 for t105 & blotchy feet; ER MD advised family to tell the primary care provider of incident;
Pt called today 6-14-18 to say she broke out in hives over entire body 1 day after receiving vaccine.
Pt. had hives all over his body off and on.  The flu shot was administered by his pediatrician on September 30th Then by middle of the night had hives.  By Saturday night we took him to the Dr. listed above.  She recommended Benadryl to help with itching.  By Monday he went to school and by Tuesday they were gone.  Some of the hives were huge but they were all over from face to legs.  No other symptom.
Severe headache, nausea, chills, cold sweats, muscle aches for 2 days after receiving vaccine
Sore arm but 5 days later woke with subconjunctival hemorrhage Narrative:
This spontaneous consumer report (initial receipt: 02-Dec-2011) concerns a 66-year old female patient, who had no pertinent medical history or drug reactions/allergies. Concomitant medications included acyclovir and hydrocodone. On an unknown date the patient received flu vaccine at the same time as PNEUMOVAX 23 and ZOSTAVAX injection. On 20-Nov-2011 the patient developed shingles. The event outcome was recovered.
No adverse event; the Moderna COVID-19 bivalent vaccine was punctured on 16-Feb-2023 at 9:40 AM and was administered to a patient today, 17-Feb-2023, at 3:00 PM; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (the Moderna COVID-19 bivalent vaccine was punctured on 16-Feb-2023 at 9:40 AM and was administered to a patient today, 17-Feb-2023, at 3:00 PM) and NO ADVERSE EVENT (No adverse event) in a 50-year-old male patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 065H22A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 17-Feb-2023, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On 17-Feb-2023 at 3:00 PM,  after starting mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)), the patient experienced EXPIRED PRODUCT ADMINISTERED (the Moderna COVID-19 bivalent vaccine was punctured on 16-Feb-2023 at 9:40 AM and was administered to a patient today, 17-Feb-2023, at 3:00 PM). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (the Moderna COVID-19 bivalent vaccine was punctured on 16-Feb-2023 at 9:40 AM and was administered to a patient today, 17-Feb-2023, at 3:00 PM) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for EXPIRED PRODUCT ADMINISTERED (the Moderna COVID-19 bivalent vaccine was punctured on 16-Feb-2023 at 9:40 AM and was administered to a patient today, 17-Feb-2023, at 3:00 PM).    No concomitant medications were reported.The reporter stated that a vial of the Moderna COVID-19 bivalent vaccine was punctured on 16-Feb-2023 at 9:40 AM and was administered to a patient today, 17-Feb-2023, at 3:00 PM. Reporter said that because the dose was administered after 12 hours post puncture, it was considered an expired dose. Dose administered greater than 12(US)/24(CA) hours post puncture. It was unknown whether Individual vials or intact cartons. Vial size was unknown. On 14-Feb-2023, the vial was initially stored in the refrigerator. On 16-Feb-2023 at 9:40 AM the vial was first punctured. On 17-Feb-2023 at 3:00 PM vaccine was administered. The vial was stored post puncture in Refrigerator. The vial has not undergone any temperature excursions. Total amount of time the vial was exposed to room temperature range (8 degree to 25 degree Celsius equal to 46 degree to 77 degree Fahrenheit) was 5 minutes at most. If unknown was the vial exposed to room temperature for greater than 24 hours was no.Treatment information was not provided.
Less than 24 hrs started feeling nauseated, anxious and had chills. Still have anxiety and nausea.
pt recvd flu vax several yrs noticed major flare-up of rheumatoid arthritis following yearly flu shot; in 1995 exp flare-up both shoulders cont up the present;
Patient experienced formation of grape-sized subcutaneous nodule in location of vaccine receipt soon after vaccine receipt. Clinically consistent with a post-injection Granuloma.
Patient developed fluid filled blisters at site of injection, accompanied by redness and inflammation. See attached photos.
Most Severe: Day 3 or 52.5 hours after second dose had sever and immobilizing nausea. Could not be vertical. Vomited. This lasted 3 hrs+/-.  Less severe: starting  approx 9 hrs after shot I experienced intermittent tingling in right arm (had shot in left arm) as well as right bicep muscle soreness. This lasted through day 4.
Sinus pressure/headache, runny nose, fever/chills, cough, loss of taste & smell
Developed diarrhea which still exists; have been diagnosed with colitis after a colonoscopy
Itchy rash with and without corpuscles on various locations on body.  Prednisone prescribed.
HPV vaccine given instead of Menactra like the patient requested and consented to.  No treatment necessary as vaccine was age appropriate and due. Provider discussed error with patient. She was very understanding and still requested Menactra vaccine. Menactra was administered as well.
Patient is fully vaccinated. COVID positive on admission on 3/21/2022. 64-year-old male with history of atrial fibrillation anticoagulated on Xarelto presents with shortness of breath and hypoxia.  Patient states that he has been experiencing intermittent shortness of breath that is worse on exertion over the course of the past year, but that his symptoms have been significantly worsening over the course of the past month. O2 sat in the 70s. Positive fatigue and leg swelling. Positive for tachypnea and bradycardia. Troponin normal. Chest: cardiogenic pulmonary edema. Treatment:  Lasix. Lovenox.  Decadron and antibiotic. Remdesivir. Remains hospitalized at data input.
Information has been received from a consumer for VARIVAX (Merck), a Pregnancy Registry Product, concerning his 30 year old wife with a history of chicken pox "as a child" and no drug allergies or reaction who on 01-MAR-2011 was vaccinated with a 0.5 ml dose of VARIVAX (Merck). There was no concomitant medication. On 17-MAY-2011 the patient found out she was pregnant. There was no AE reported. The patient was seeing her OB/GYN on Tuesday. The patient sought unspecified medical attention and the patient's pregnancy had been confirmed by pregnancy test. Her last LMP was on 08-MAR-2011. Expected date of delivery was 13-DEC-2011. Follow up information was received from the consumer in regards to his wife's pregnancy outcome. He reported that his wife, the patient, gave birth to a healthy baby boy on 09-DEC-2011 that was full term. The baby weighed 8 lbs, 2 oz.; length was 22 inches. He stated his son had no difficulties or anomalies. He reported the delivery was a C-section. When asked why his wife had a C-section, he stated that he did not really know. His wife and baby suffered no complications of the cesarean birth. He verified that his wife only had one dose of VARIVAX (Merck) and that she did have chickenpox as a child. He did not know if VARIVAX (Merck) titers were done on his wife. Upon internal review, cesarean section delivery was determined to be an other important medical event. No further information is available.
She got her vaccine, her arm was swollen and mother had to keep her home, was not feeling well like she had a cold.  Then a couple of months of that in May of 2023, she was diagnosed with diabetes.  She was sick the entire year after getting the vaccine, her immune system was very low and she got sick a lot, had to miss a lot of school.She took her to the pediatrician who told her to rush her to the ER.  Her Blood sugar at that time was in the 300 range.   She is now taking Humalog and Lantus Insulin.  It is under control with those medicines.    She was fine prior to the vaccine.  There is no family history of diabetes in the family.
Client was sitting talking with a friend after vaccine and complained of not being able to swallow  and became a little panicky.   Color was pink, breathing was fine. BP 150/64 Pulse was normal. Eyes became fixed and no response but still breathing fine. stimulated and cool cloth to her back and she responded. continued to talk to client. Speech was slurred. EMS was called. Arms dropped to the side at one time and then reflex returned. Continued to talked to the client to take slow easy breathes. No diaphoresis noted. EMS arrived BS 130, Benadryl IV given. EKG regular sinus rhythm. Pulse Ox 95%. Transported to a local HCF ER.
Itchy throat within 4 hours of administration, initially small pea-sized reaction which has continued to grow to the size of an orange and still continues to grow larger each day. The swelling protrudes by 1 cm and causes pressure to radiate towards my fingers.
MMR vaccine given on 08/19.  Redness, itching, hot area developed that evening.  Got larger over zole.  9 x 9.5 inch red hot swollen area on right upper thigh on 08/21/2003.  Cellulitis.
Patient had history of asthma attack acutely after booster of Pneumovax (given because patient has inability to respond to polysaccharide vaccines and this was done by immunologist to diagnose). Therefore I gave Prevnar 0.05cc as test dose. Two and a half hours later, had acute hives, asthma attack, and throat tightness. Given Epinephrine and oxygen with complete resolution. Had recurrent asthma and hives 36 hours later also.  Nurse follow up on 09/01/04 states: "IGg Deficiency; allergic reaction; itching."
Severe injection site swelling, inflammation, redness, and itchiness. Rash. Swollen Lymph nodes in neck. Sore throat. Body aches and pain. Blood in urine - gross hematuria. Lethargy.