chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This spontaneous report as received from a physician via a company representative concerning a 17 year old female patient. The patient did not have a significant medical history and was not taking and concomitant medication. On 13-JUL-2017 the patient was vaccinated with the first dose of GARDASIL 9, (route unknown) (lot # M037770, expiration date 01-JUN-2019) for prophylaxis. The patient returned to the physician's office on 17-JUL-2017 with complaints of difficulty breathing (onset date not specified). The outcome of the event was unknown. Additional information has been requested.
Day 8. 2-22-21 at injection site had itchy red painful raised bump.  That went away after 3 days.
Hand lesions; enlarged groin node; dose 1: 30Jul2021, dose 2: 08Aug2021 This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 56 year-old female patient (not pregnant) received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), administration date 08Aug2021 (Lot number: Fa7485) at the age of 55 years as dose 2, single for covid-19 immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) included: LEVOTHYROXINE. Past drug history included: Iodine, reaction(s): "Iodine allergy", notes: IV. Vaccination history included: Bnt162b2 (Dose Number: 1, Batch/Lot No: Fa7485), administration date: 30Jul2021, when the patient was 55 years old, for COVID-19 Immunization. The following information was reported: SKIN LESION (disability) with onset 04Oct2021, outcome "not recovered", described as "Hand lesions"; LYMPHADENOPATHY (disability) with onset 04Oct2021, outcome "not recovered", described as "enlarged groin node"; INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (non-serious) with onset 08Aug2021, outcome "unknown", described as "dose 1: 30Jul2021, dose 2: 08Aug2021". The events "hand lesions" and "enlarged groin node" were evaluated at the physician office visit. Therapeutic measures were not taken as a result of skin lesion, lymphadenopathy. Additional information: Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient received levothyroxine within 2 weeks of vaccination. Prior to vaccination, the patient was diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19.
Injection site reaction (knotted, redness, warmth) followed by a quarter-sized rash on abdomen that "resembles chicken pox" and is blistering. Patient is currently treating with calamine lotion and was advised to use either hydrocortisone cream or lidocaine cream for symptom management.
Was given vaccine on 7/11/07. Developed hive like rash on 7/13/05. Started on Prednisone on 7/16/07 and Claritin on 7/18/07
Headache, extreme fatigue, nausea,  shortness of breath,  arm soreness.  All symptoms started within 3 hours of receiving vaccine.  Not sure about duration due to fact that this report has been filed too soon to know outcome
Information has been received from a 66 year old female patient with seasonal allergies concerning herself. On an unspecified date of January 2013 (reported as two years ago) the patient was vaccinated with ZOSTAVAX, 0.65 ml, subcutaneous (lot# and expiration date not provided). Concomitant therapies included tramadol hydrochloride and meloxicam. On approximately 29-DEC-2014 (reported as four weeks ago) the patient developed "a severe shingles reaction." The patient explained "I developed the shingles rash all over my body, I was in extreme pain, I felt very weak and was bedridden for days. I'm doing better now but I'm not fully recovered yet." The patient saw a physician several times for seeking medical attention. No lab diagnostics study was performed. "Antibiotics" (Product names and manufacturers were unspecified) was given for this event. At the time of reporting, the outcome of events was reported as recovering. Additional information has been requested.
Information has been received from a physician concerning a 47 month old female who was vaccinated with a first dose of varicella virus vaccine live (Oka/Merck), and subsequently developed a mild case of chickenpox. Unspecified medical attention was sought. There was no product quality complaint. Additional information has been requested.
pt recv vax 20OCT97 & devel brachial plexus neuropathy;
1 shot each in left arm. Pain when PCV13 injected. 1/2 hour later, arm tightened, swelled, redness, heat, bumpy, very sore shoulder to elbow. For 7 days.
15 month old - high fever 1-2 days after immunization then fever (105) and seizure on day 9 (4/23/03). Seen at ER.
Approximately 3 minutes after he received J&J vaccine he passed out while sitting in a chair. He hit his head on the wall next to the chair. Staff immediately supported him and he stayed in the chair. He regained consciousness within a few seconds. A cot was brought to him, he was assisted by staff and laid on the cot, cool cloth applied to his forehead. Within 8 minutes he was feeling better, sitting up on the cot, drinking water. He did report that he has previously passed out at the sight of blood, and there was a small amount of blood at the injection site.  We observed him for another 25 minutes and he returned to baseline, stated he was feeling fine. He went home with his step Dad, who had given him a ride to the clinic. I called the patient 2 hours later to check on him. Step Dad reported he was outside and unavailable, but that he has been feeling fine since leaving the clinic.
redness, swollen arm at injection site about 3x it's normal size/ hot and red raised band at bottom of injection site
Reports local edema, erythema to include the right deltoid and trap area extending to the base of the head, near mid cervical area of neck. Also reports night sweats and chills
Injection site started as pea size bump at start and in 24 hours was size of egg. Area around injection site turned red. As day progressed entire left arm became achy.  48 hours after, redness better but still large knot at injection site and arm is achy.
This patient had a Influenza vaccine 01/26/01 (Friday), woke up (Sunday) 01/28/01, with numbness and cold sensation in feet and legs. Progressively increased upward to the waist over a weeks time. Describes current numbness as "80%" numb from waist down. Is seeking medical care from 2 physicians. MRI is scheduled.
Diarrhea; nausea; body aches; chills; 100.8 temp which lasted 24 hours.
No additional AEs; temperature excursion; This spontaneous report was received from a registered nurse and refers to a 12-month-old male patient. No information regarding the patient's medical history, concurrent conditions or concomitant therapies was provided.  On 06-DEC-2022, the patient was vaccinated with improperly stored doses of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live recombinant human albumin (rHA) (M-M-R II) subcutaneous injection, lot #U039549, expiration date: 14-DEC-2023, administered subcutaneously for prophylaxis (dose and strength were not provided); varicella virus vaccine live (oka/merck) (VARIVAX) subcutaneous injection, lot #W018825, expiration date: 14-JUN-2024, administered subcutaneously for prophylaxis (dose and strength were not provided); pneumococcal vaccine conj (PCV 13) lot #FN5555, expiration date: 31-JUL-2024, administered intramuscularly (strength, dose, formulation, and indication were not provided); and hepatitis a vaccine inact (HAVRIX) lot #94H52, expiration date: 30-NOV-2023, administered intramuscularly (strength, dose, formulation, and indication were not provided) (product storage error).  On an unknown date, before the administration, the vaccines underwent temperature excursion for unknown period of time. There was no adverse event reported.  The reporter considered temperature excursion to be not related to suspect vaccines.; Sender's Comments:  US-009507513-2212USA007828: US-009507513-2212USA007829: US-009507513-2212USA007830: US-009507513-2212USA007831: US-009507513-2212USA007832: US-009507513-2212USA007833: US-009507513-2212USA007834: US-009507513-2212USA007836: US-009507513-2212USA007837: US-009507513-2212USA007838: US-009507513-2212USA003061:
The assigned Medical Assistant administered the vaccine to the 10 year old after the parents signed the consent and policy stating the patient was 18 years or greater. The patient has not reported any side effects or issues.
Low grade temp 99.8 7-16-15; Rash - reddened raised over buttocks, itching legs, hands, mouth and feet, including bottom of feet early AM 7-17-15. BENADRYL Elixir, mom states age appropriate dose administered by mouth X 2 doses. Mom emailed picture of child's rash to primary care physician and diagnosed as Hand, Foot and Mouth disease. No treatment recommended. Rash resolved in a week's time.
she developed diarrhea and has had this symptom continue since then; She also reports a small headache in the middle night on most nights; This is a spontaneous report from a contactable consumer (patient). A 63-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, formulation: Solution for injection, Batch/Lot Number: unknown) via an unspecified route of administration on 12Mar2021 as single dose for COVID-19 immunisation. The patient medical history and concomitant medication was not reported. The patient received her first Pfizer Covid vaccine dose on 12Mar2021. A week or two after that dose, she developed diarrhea and has had this symptom continue since then. Her second dose was on 02Apr2021. She wants to know if this was normal and if Pfizer has anymore information about this side effect. The patient stated that she was going to start taking probiotics. She also reports a small headache in the middle night on most nights. The outcome of the event diarrhea was not recovered/not resolved. The outcome of the event headache was unknown.  No follow-up attempts are needed. Information about lot/batch number cannot be obtained.
I had the worst case of the flu ever. I had a fever of 104 for four days straight, even though I was taking Tylenol and ibuprofen at the maximum dosage. Whenever I took the medicine, the temperature would go down for a little while and then shoot back up. I had shivers, fever, cough, and severe difficulty breathing. I already had bacterial pneumonia before I also caught the flu. I had just begun taking 250mg of amoxicillin to treat the pneumonia when the flu came. When I just had the pneumonia, I had some difficulty breathing, but the flu exacerbated it. On 2/8/2023, I went to the doctor. I was tested for both COVID-19 and influenza. I was negative for COVID-19, but I was positive for influenza B. I was then prescribed Tylenol Rx and medication for the flu. On 2/9/2023, the fever was constant and wouldn't go down, no matter what medication I took. I was concerned by this, so I went to the urgent care to see if anything else could be done to treat the fever. The urgent care gave me more Tylenol Rx and told me that I could occasionally take a higher dose. I did this, and the fever started going down. After six days or so, I began to feel better. By day 10, the flu symptoms seemed to be gone. A couple of weeks after the onset of the first symptoms, I was back to normal.
The area I had a shot became hard, swollen and ached.  This started on the next day and lasted about 1 week.  A red rash appeared around the shot in the second week and lasted for 3-4 days. On the 3rd week, a cyst appeared under left armpit (the same arm where I got a shot)  and lifting the arm above shoulder level gives me a shooting pain, which still continues.
l DELTOID 4 INCH RED SWOLLEN AREA. ITCHY AREA.
pt exp flu-like sx & a stiff neck 24 hrs p/recvd dose 1 of Engerix-B;
Pt recv vax on 5/29/97; in 3/98 pt exp joint pain, skin rx w/ sun & fluorescent lights; dx=lupus; tx=Hydroxychloroquine &Dripolene, Annual follow-up received on 10/17/00 that a diagnosis of Lupus has been made.
pt recvd vax; 30jan95, pain in lt arm; 2-3 hives lt lower; at times w/ some paresthesia arm; no redness/swelling at inject site; no fever;1feb95 pain improving; hives present lt lower arm; sore throat today; no fever;
Nausea, vomiting, elevated heart rate, elevated blood pressure, chest pressure. Symptoms worsened throughout the day - peaked at approx. 2:30PM.
This spontaneous report as received from a female patient of unknown age refers to herself. No information regarding the patient's pertinent medical history, drug reactions or allergies and concomitant therapies was provided. On unknown date in January 2015 (reported as "2 years ago"), the patient was vaccinated with a dose of ZOSTAVAX injection (strength, dose, route of administration, lot # and expiration date were not reported) for shingles. On an unknown date in November 2016, the patient experienced shingles. No product quality complaint was involved. The outcome of the event was unknown. The relatedness between the event and ZOSTAVAX was not reported. Additional information is not expected, as no contact details were provided.
Vaccines administered after temperature excursion; This case was reported by a other health professional via other manufacturer and described the occurrence of incorrect storage of drug in a patient who received HBV (Engerix B) for prophylaxis.   Co-suspect products included DTPa-IPV (Kinrix) for prophylaxis, dtpa-ipv vaccine pre-filled syringe device (Kinrix Pre-Filled Syringe Device) injection syringe for prophylaxis, HEPATITIS B VACCINE (RECOMBIVAX) for prophylaxis, ROTAVIRUS VACCINE LIVE REASSORT ORAL 5V (ROTATEQ) for prophylaxis, INFLUENZA VACCINE INACT SPLIT 4V (FLUZONE QUADRIVALENT (INFLUENZA VIRUS VACCINE)) for prophylaxis, HIB VACCINE (ACT-HIB) for prophylaxis, MENQUADFI for prophylaxis, MENACTRA for prophylaxis, DIPHTHERIA VACCINE TOXOID + PERTUSSIS TOXOID + TETANUS VACCINE TOXOID (ADACEL) for prophylaxis, DIPHTHERIA VACCINE TOXOID + PERTUSSIS TOXOID + POLIO VACCINE + TETANUS VACCINE TOXOID (QUADRACEL) for prophylaxis, PENTACEL for prophylaxis and DIPHTHERIA VACCINE TOXOID + PERTUSSIS TOXOID + TETANUS VACCINE TOXOID (DAPTACEL) for prophylaxis.   On 15th December 2022, the patient received Engerix B, Kinrix, Kinrix Pre-Filled Syringe Device, RECOMBIVAX, ROTATEQ, FLUZONE QUADRIVALENT (INFLUENZA VIRUS VACCINE), ACT-HIB, MENQUADFI, MENACTRA, ADACEL, QUADRACEL, PENTACEL and DAPTACEL. On 15th December 2022, unknown after receiving Engerix B, Kinrix and Kinrix Pre-Filled Syringe Device, the patient experienced incorrect storage of drug. On an unknown date, the outcome of the incorrect storage of drug was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK receipt date: 02-Feb-2023 Reporter's comment: The reporter reported that the patients administered Engerix B, Kinrix, Kinrix Pre-Filled Syringe Device, Recombivax, Rotateq, Fluzone quadrivalent (influenza virus vaccine), Act-hib, Menquadfi, Menactra, Adacel, Quadracel, Pentacel and Daptacel that had total time of excursion to 2.75 hours and maximum temperature of excursion was 47 F with no reported adverse events. On 15th December 2022 it was total time of excursion to 2.75 hours. No laboratory data reported. Drug IPOL was removed as it was not involved in temperature excursion. Additional supportive information: As all vaccines experienced temperature excursion which led to incorrect storage of drug.   Follow-up information received on 19-FEB-2023 Reporter's Comments: The reporter called to cancel the adverse event because the incorrect information was given. The reporter stated no adverse event happened and asked to please cancel it. Summary of changes: case will be invalidated on follow up.
Vaccine was expired on 01-Apr-2022, refrigerated on 04-Apr-2022 and administered on 09-Apr-2022; Expired vaccine administered to 155 patients; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Expired vaccine administered to 155 patients) and PRODUCT STORAGE ERROR (Vaccine was expired on 01-Apr-2022, refrigerated on 04-Apr-2022 and administered on 09-Apr-2022) in a 25-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026L21B) for COVID-19 vaccination.     No Medical History information was reported.    On 09-Apr-2022, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. On 09-Apr-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Expired vaccine administered to 155 patients). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Vaccine was expired on 01-Apr-2022, refrigerated on 04-Apr-2022 and administered on 09-Apr-2022). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Expired vaccine administered to 155 patients) and PRODUCT STORAGE ERROR (Vaccine was expired on 01-Apr-2022, refrigerated on 04-Apr-2022 and administered on 09-Apr-2022) outcome was unknown. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications was reported. Reporter stated that he thought that the vaccine expired in Jun-2022, however it was expired on 01-Apr-2022. Date the vial was initially stored in refrigerator was 04 Apr 2022. Vial had not undergone any temperature excursion. No treatment medications was reported.
Patient received 2nd dose of Moderna COVID vaccine at approx. 10am on 03/10/21. At approx. 5pm on 03/10/21, he developed typical side effects including fever, chills, and lethargy. Additionally, he became confused. The next morning, he remained lethargic and minimally responsive. He was febrile to 106 F per daughter and somewhat hypotensive with SBP into the 80s. The afternoon of 03/11/21, he also developed right facial droop and weakness. EMS was called and he was found to have suffered a left MCA stroke. He was admitted to the hospital for this  and underwent thrombectomy. Of note, he was febrile and hypotensive on admission.
Fever; Aches and Pain throughout her body; This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (Fever) and MYALGIA (Aches and Pain throughout her body) in a 92-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 032L2OA) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concomitant products included OLMESARTAN MEDOXOMIL (BENICAR) for an unknown indication.    On 20-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 21-Jan-2021, the patient experienced PYREXIA (Fever) and MYALGIA (Aches and Pain throughout her body). At the time of the report, PYREXIA (Fever) had not resolved and MYALGIA (Aches and Pain throughout her body) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Based on the current available information and temporal association between the use of the product and the onset date of the reported events, a causal relationship cannot be excluded.  Advanced age is a confounder for the event of myalgia.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the onset date of the reported events, a causal relationship cannot be excluded.  Advanced age is a confounder for the event of myalgia.
Felt warm; bilateral scleral redness and eye swelling. Treated with Benadryl with relief.
The report was first received from a practice manager on 07-SEP-2018, and it was recognized as non-valid because report did not obtain any patient identify. Follow-up information has been received from the practice manager on 18-SEP-2018. This spontaneous report refers to a patient of unknown age and gender. Information of concurrent condition, medical history and concomitant therapy was not provided. On 24-OCT-2017, the patient was vaccinated with a dose of GARDASIL 9 (strength and route were unknown) (lot# N019923 and expiration date 28-APR-2019). On 27-FEB-2018, the patient was vaccinated with an improperly stored dose of GARDASIL 9 (strength and route were unknown) (lot# N020352 and expiration date 10-APR-2020) for prophylaxis (Incorrect product storage). No adverse event was reported. The excursion temperature on 08-NOV-2017, 16-NOV-2017, 23-JAN-2018, 06-JUN-2018, 03-JUL-2018 and 14-AUG-2018 was 47 degree Celsius for maximize 15 hours. The excursion temperature on 07-DEC-2017 was 50 degree Celsius for maximize 8.75 hours. The call was not because of data logger. This is one of several reports received from the same reporter. Sender's Comments: US-009507513-1810USA001951: US-009507513-1810USA001952: US-009507513-1810USA001953: US-009507513-1810USA001954: US-009507513-1810USA001955: US-009507513-1810USA001957: US-009507513-1810USA001958: US-009507513-1810USA001959: US-009507513-1809USA003709.
22 year-old male with skin rash X 3 weeks found only on anterior trunk from the umbilicus to his pubic area.  The lesions are non-pruritic without erythema, no pain, no discharge associated with these lesions.  Patient reports the lesions appeared just a few at a time and are spreading downward toward his genitalia.  He reports the lesions appeared 7-14 days after receiving smallpox vaccine.   20-30 individual pustular lesions along anterior trunk down into pubic hair area without surrounding erythema, scale, or drainage.  Lesions appear to be post-vaccinia follicular pustulosis.
chickenpox; This spontaneous report was received from a female pharmacy technician of unknown age who was also the patient via a company representative. Her pertinent medical history, concomitant medications and drug reactions or allergies were unknown.  On an unknown date (also reported as "it was many, many years ago"), the patient was vaccinated with varicella virus vaccine (manufacturer unknown) (formulation, strength, exact dose, route of administration, lot # and expiration date were not reported), 1 dosage form (1 injection), for prophylaxis. On an unknown date, the patient developed chickenpox. It was unknown which specific varicella vaccine the patient received as this was many years ago. The outcome of the event was unknown. It was unknown whether the patient sought medical attention, received treatment or had lab diagnostics performed.  The relatedness between the suspect therapy and the event was not provided.
2/24- 5 minutes after vaccine pt got a blotchy red rash that covered forehead and temples. 2/26- began getting red pimple dots on face, doctor said it was probably due to varicella vaccine; began to show loss of appetite; until date symptoms have not diminish; sleep interrupted 2 times at night; behavior change: cranky and clingy. 2/28-3/4- runny nose; pink eye (Left eye) for 1 day; sensitivity in mouth maybe due to teething, no sores were noticed in mouth. 3/3- Fever of 101 degrees F for 12-15 hours. 3/7- Scalp had red blotches at 8 pm. 3/8- Doctor diagnosed pt with measles. Pt had raised spotty rash on trunk all around behind ears forehead and temples.
Pt states she waited for 25 min, then went outside to" get fresh air", then came back inside and told observer she was feeling itchy/throat felt tight. Observer contacted clinical lead who did initial assessment. Pt observed to be scratching arms, shrugging shoulders repeatedly (pt states shoulder shrug is from ADHD condition), throat pink, no noticible swelling.Breathing at normal rate. No adventitious breath sounds. No rash noted on arms, abdomen, neck. No facial or other swelling noted.  Benadryl 25mg po prn for itch given per standing orders for itch. Pt then reported that she felt the benadryl was "stuck in her throat". Pt drank water, but still stated it felt "stuck". ED called for further eval and treat.
I starting having sore throat and a dry cough on 06/03/2022 .  On 06/05/2022 I tested positive for COVID-19 at my doctors office.  The next day I started feeling tired and weak and that went on around 10 days  and I isolated additional days to make sure.  My doctor gave me Paxlovid at a lower dose because of my current health conditions. I am still having weakness, joint pain and feeling tired.