chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Information has been received from a Certified Medical Assistant (C.M.A.) concerning a 72 year old male patient who on 30-OCT-2007 was vaccinated IM into left arm with a dose of PNEUMOVAX 23, lot # 655765/0061U.  Concomitant therapy included simvastatin (manufacturer unknown), FLEXERIL, flaxseed, "Omega 3", aspirin, LEXAPRO, calcium (unspecified), vitamins (unspecified), glucosamine, metoprolol, JANUVIA, fluticasone furoate, enalapril maleate (manufacturer unknown), omeprazole, terazosin hydrochloride and DHEA.  The next morning the patient had small hives and urticaria at the injection site that went over the shoulder and on to the chest.  The patient was seen in the office on 01-NOV-2007 and the reaction was improving.  She took BENADRYL for the reaction.  No other information reported.  The outcome of the patient was recovering.  Additional information has been requested.
Blood streaks and mucus in stool on 11/8 & 11/12-13/2011. Seen in office on 11/14/11 with positive fecal occult blood test.
Pt received Adult Pfizer 0.3 ml via IM at 1530.pt reports feeling flushed and stomach pain.Facial color pallor noted and vitals below  baseline noted. BP 74/34, Pulse 70, O2 98% Resp 18 . No SOB noted. Pt given fluids and tolerated well.Legs elevated and reported to physician.Pt awake and verbally responsive and transferred to Pediatric unit via wheelchair.
a fever; chills; This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (a fever) and CHILLS (chills) in an 81-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PYREXIA (a fever) and CHILLS (chills). At the time of the report, PYREXIA (a fever) and CHILLS (chills) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No Concomitant medications were provided No Treatment information provided
I was feeling the day before I tested positive I was feeling tired. I had a runny nose and I had a cough. I called the doctor and she suggested my symptoms were similar to Covid. She suggested I take a home test. After I tested positive, she prescribed an antibiotic and prednisone. After 2 days, my symptoms had totally gone away.
Initial misuse report received from a healthcare professional on 29 April 2013. A female patient, whose age, date of birth, medical history and concomitant medications were not reported, had received first dose of 0.05 (unit not reported) ADACEL vaccine (batch number: C3897A, expiry date: 11-02-2013), route and anatomical site of administration were not reported) on an unspecified date. It was reported that, when the technician went to administer the second dose of 0.45 (unit not reported) ADACEL vaccine, there was only 0.3 (unit not reported) in the vial so they were unable to finish the challenge as they had no more in hand. The doses in both syringes were tripled checked each time. The reporter stated that, the vial was incomplete. At the time of this report, no information regarding occurrence of any adverse event were reported. List of documents held by sender: None
Side effects after two months of the vaccine; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (Side effects after two months of the vaccine) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced VACCINATION COMPLICATION (Side effects after two months of the vaccine). At the time of the report, VACCINATION COMPLICATION (Side effects after two months of the vaccine) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were reported No treatment medications were reported
This spontaneous report as received from a healthcare worker refers to one unspecified patients of unknown age and gender. The patient's pertinent medical history, drug allergies and concomitant medications were not reported. On 14-JUL-2016 the patient received an improperly stored dose of VARVIAX (lot # L046888, expiry date 23-NOV-2017) (dose and route were unknown). No adverse effect was reported. This is one of several reports received from the same reporter. Additional information has been requested.
DEATH OF WOMAN IN MIDDLE AGE WITH CERTAIN BLOOD TYPE AFTER THE VACCINATION; This spontaneous report received from a consumer concerned a female of middle age. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included: The patient had the certain blood type. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: unknown) dose was not reported, 1 total, start therapy date was not reported for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On an unspecified date, the patient experienced death in her middle age with certain blood type after the vaccination. As per the reporter, "I only heard about one woman in her middle age with a certain blood type which resulted in death after receiving the Janssen Covid-19 vaccine." On an unspecified date, the patient died from unknown cause of death. Date of death were not reported. It was unspecified if an autopsy was performed. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. This report was serious (Death).; Sender's Comments: V0: 20211020266-covid-19 vaccine ad26.cov2.-Death of women in the middle age with certain blood type after the vaccination. This event(s) is considered unassessable. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s).; Reported Cause(s) of Death: UNKNOWN CAUSE OF DEATH
Swollen area (L) arm at VZV site. Small raised vesicles on face, trunk, back, itching.
Person Took Pfizer Covid 19 vaccine  Booster on 03/18/2022 at Vaccine event, this the the 2nd time she has had a reaction to vaccine which previous was Moderna her 2nd Covid 19 vaccine, had the same side effect and reaction as this vaccine. She has Fever of 101, headache, nausea vomiting, body aches, left arm pain away from injection site swelling under both arm as in  lymph nodes pain.  She took Tylenol/ibuprofen to help with assisting in side effects helped with fever but still pain   and swelling.
Chills, fever, headache,  started about 9hrs after injection Fever peaked @ 100.8?  injection site very sore. And continues to be sore. Fever broke the following day. Weakness,  fatigue,  headache persisted until afternoon of 1/1 2021
no other adverse experiences reported; two doses of improperly stored VARIVAX was administered to two patients; This spontaneous report was received from a medical assistant and refers to a patient of unknown age and gender. No information regarding the patient's medical history, concurrent conditions or concomitant therapies was provided.  On 07-FEB-2022, the patient was vaccinated with improperly stored varicella virus vaccine live (oka/merck) (VARIVAX) 1 dose, lot # U015682, expiration date 18-MAY-2023 (site of administration was not provided) for prophylaxis. Administered dose of suspect vaccine experienced temperature excursion of 9.7 Fahrenheit degrees (F) for 40 minutes (Product storage error). No previous temperature excursions were reported. It was unknown if digital data logger was involved.  No other adverse experiences were reported (No adverse event).  This is one of two reports from the same reporter.; Sender's Comments:  US-009507513-2202USA002198:
pt recvd vax;exp numbness in hands,fingers & face about 2-3 hrs p/ vax;facial numbness still present;MRI performed; B12 deficiency noted & tx but without alleviating sxs;
A CAREGIVER CAME INTO THE PHARMACY ON 9/24/18 WITH PICTURES OF HER BRUISED ARM. IT WAS A LARGE BRUISE FROM UPPER DELTOID DOWN TO JUST ABOVE HER ELBOW. SHE SAID PATIENT HAS NO PAIN NOW AND THE BRUISE WAS KIND OF BETTER. SHE CLAIMED THAT THE PHARMACIST MAY HAVE GRABBED HER ARM SO TIGHT.
Pfizer covid19 shot. 12 hours after shot felt like I had the flu, weak and real achy muscles so I went to bed. Shortly after I began to have  muscle jerks of my torso every 5 seconds for several hours. That was Friday night. When I woke up on Saturday I had a few muscle jerks like the night before, then that was the end of them, but I still felt sick and had a fever so I stayed in bed all day. Finally Sunday afternoon I felt back to normal.
Expired vaccine used; This spontaneous case was reported by a health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED in a 57-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 19-Aug-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 ml. On 19-Aug-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED. On 19-Aug-2021, EXPIRED PRODUCT ADMINISTERED had resolved. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were provided.  No treatment medications were provided.
roughly 19 hours after receiving the Covid vaccine the patient said she experienced muscle spasms in her leg. The spasms were so bad that she couldn't walk and had to have her husband pick her up off the floor. She said using the aspercreme help temporarily but not for long. She has a follow up appointment with her doctor next week for a different issue but is going to ask him about the leg spasms as well if it is still happening.
a 18 month old patient administered to Adacel , no AE; Adacel was administered to an 18 month old patient for their 4th dose in the series instead of DTap, no AE; Initial information received on 19-Jun-2020 regarding an unsolicited valid non-serious case received from a physician.  This case involves a 18 months old patient who inadvertently administered DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE [ADACEL] instead of DIPHTHERIA, TETANUS AND ACELLULAR PERTUSSIS VACCINE [DTap] for fourth dose in DTAP series.  Medical history, medical treatment, vaccination and family history were not provided.  Concomitant medication was not reported.   On an unknown date, the patient received a dose of suspect DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE (lot number and expiry date: not reported) via an unknown route and administration site for prophylactic vaccination.  It was a case of actual medication error due to wrong vaccine administered and inappropriate age at vaccine administration.  At the time of report no adverse event was reported.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.  There will be no information available on the batch number for this case.
Left arm red, swollen and warm to touch from below shoulder to above elbow. Cold compresses, ibubrofen, watch for pain and increase redness.
c/o pain & numbness in whole lt arm 9arm where inj given) the day p/vax;
Chills and body aches. 101.7 Farenheight Fever.  Treatment: I took another Airborne and drank tea. About 15 min ago.
Client reported red, raised, pin-point rash on face, with two lesions on her right hand; non-red raised pin-point bumps on her neck, feeling of "itchy throat".
Reporter has had 3 cases of non-response following 3 doses of hepta B.
Blood in the urine after booster; This spontaneous case was reported by a consumer and describes the occurrence of BLOOD URINE PRESENT (Blood in the urine after booster) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included Discoloration urine (sometimes patient's urine was a little pink in the past). Concurrent medical conditions included Factor VII deficiency.    On an unknown date, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced BLOOD URINE PRESENT (Blood in the urine after booster). At the time of the report, BLOOD URINE PRESENT (Blood in the urine after booster) outcome was unknown.            No concomitant medications were reported. No treatment medications were reported.  Prior to the vaccination, the patient had not seen pink urine for a long time.
The pt was taken to a local ER for cardiopulmonary arrest less than 24 hours post vax. Autopsy gave final diagnosis of SIDS. Autopsy also shows pulmonary congestion, visceral congestion.
Unable to move arm where vaccine given. Continuing pain and loss of range of motion and function in the vaccinated arm.
31st - symptoms - stuffy nose; runny nose; cough didn't around the 3rd or fourth  and just a little fatigue but nothing major. They lasted until about the 11th or 12 of January. No fever.  Through insurance you fill out a form and they email you so I didn't speak to anyone - e-visit.
Information has been received from a physician concerning a 6 year old white female patient with no known drug allergies who on 08/05/1999 and 08/13/2003 was vaccinated with a first and second dose, respectively, of measles virus vaccine live, mumps virus vaccine live, rubella virus vaccine live and tested positive for mumps after showing undisclosed symptoms.  Unspecified medical attention was sought.  No product quality complaint was involved.  Follow up information indicated that the patient had a right swollen parotid on 01/12/2005.  Her serum amylase was 314 and MMR was noted.  The patient recovered on January 2005 and the experience is no longer being treated.  Additional information is not expected.
This spontaneous report as received from a physician refers to an unknown number of patients of unknown age. The patients were vaccinated with 0.5 ml doses of GARDASIL (Lot # not reported) IM at 0, 2 and 6 months intervals. No other co-suspects were reported. No concomitant medications were reported. The physician reported that there had been 3 instances where patients have passed out after receiving GARDASIL. The outcome of passed out was unknown. The relatedness for passed out was unknown for GARDASIL. Additional information has been requested.
Child attended Karate class and instructor was tapping the injection not knowing that the child had received immunizations the day before.  Red swollen the size of a baseball at site of injection on right deltoid.  Area was tender to touch.
This spontaneous report as received from a nurse, via company representative, refers to a patient of unknown age and gender. On an unknown date the patient was vaccinated with ZOSTAVAX (dose, route and lot number were not reported) for prevention of shingles. Concomitant medications were not reported. On an unknown date the patient experienced red circles and areas, and swelling around injection site. Nurse stated that the patient was prescribed Claritine. The outcome of swelling red circles and areas, and swelling around injection site was unknown. The relationship between the ZOSTAVAX and the events was not reported. This case is linked to case 1309USA000926 via same reporter link. Additional information has been requested.
Received vaccine 1/07/2021.  1/08/2021 had soreness to the injection site and the soreness continues Numbness then developed 5 days later on 1/12/2021.  Numbness starts at the infection site and runs down the arm and numbness extends to the left thumb and part of the left index finger. 1/18 Left thumb ridge started.  1/19/2021 PCP advised take naproxen 500 twice a day, vitamin B12, EKG unremarkable; 1/28/2021 reported to ED 5:00am as began experiencing numbness sensation on the bottom aspect of her face, bilaterally about 4 hours ago while working.  Still having persistent numbness in left arm.  Arm swelling.  CT unremarkable; 1/29/2021 Neurologist believes related to the vaccine and order EMG, treating conservatively; 2/17/2021 had EMG that was unremarkable
Pt was last seen on 4/26/11 for her #2 GARDASIL injection. She comes today complaining of "a rash and sore left arm" since the injection. She describes the rash "all over her lower left arm and a little on her right arm". She is wondering if it is a reaction from the vaccine. Pt denies any SOB, breathing problems, erythema, itch, fever, headache, nausea, environmental exposure or changes, no new medications, food, creams, lotions or soaps. Exam: Slight point tenderness but no erythema or induration at injection site on left upper arm; both lower arms have 1-2 dozen, 1-2 mm skin colored papules scattered on lower arms up to elbows with left arm papules in greater number than right arm, no erythema noted; full ROM in arms, hands and fingers bilaterally, muscle strength 4+ bilaterally in upper extremities. Impression: Mild dermatitis of unknown origin, most likely contact in origin. I reviewed the list of adverse reactions listed for GARDASIL and this presentation was not included. I told her I would report this to the toll free number for GARDASIL recipients. Her #3 GARDASIL will be given in her right deltoid if she decides to complete the vaccine series.
child awoke with temperature of 104.9, abdominal pain, nausea; pt taking apap;
exacerbation of chronic graft versus host disease; This is a literature report.  A patient (no qualifiers provided) received BNT162b2 (COMIRNATY), as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "haematopoietic stem cell transplantation (HSCT)" (unspecified if ongoing). The patient's concomitant medications were not reported. Vaccination history included: Comirnaty (Dose 1), for COVID-19 immunization. The following information was reported: CHRONIC GRAFT VERSUS HOST DISEASE (medically significant), outcome "unknown", described as "exacerbation of chronic graft versus host disease".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Based on temporal association, the causal relationship between BNT162B2 and the event, chronic graft versus host disease cannot be completely ruled out. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.,Linked Report(s) : US-PFIZER INC-202200611693 Same reporter/product/event, different patient
1st Vaccine was given on 4/27/2021. 2nd dose was given on 5/11/2021. The vaccine was given too early.
Diagnosis by primary care physician was serum sickness; with 100.3 low grade fever, muscle and joint pain, difficulty chewing, dry cough without congestion, extremely dry eyes. Elevated CRP and ESR of 106. Progressed to inflammation of cartilage in both ears as of 11/22/13 and was diagnosed as relapsing polycondritis by clinic.  Symptoms went into spontaneous remission around 12/21/13 without use of prednisone.
Swelling of arm and redness reaction at site of injection. Recommended BENADRYL and ice. Checked in on 11/25/15- arm is significantly better and just sore at site of injection.
Saturday I did an intense workout and became exhausted which is definitely unusual for me. Next day woke up with double vision, The next day I went to see my optometrist confirmed double vision sent me to an opthamologist confirmed a TIA, he wanted me to go to ER,  and ER did a CT scan and abnormalities just confirmed TIA did an MRI to and it came out clean.
Mother reports redness blistering at area of varicella for 48 hours. No treatment given. Family did not notify provider until today, 5 weeks afterwards.
Patient came to the ED with increased congestion and cough.  Symptoms started 8 days prior and was Covid positive and treated with oral antiviral therapy.  He finished treatment and then progressively got worse.  Patient also has complaints of feeling weak and achy all over.  Patient was admitted to the hospital and treated with remdesivir.
pt recv vax; fever of 103.5; baby cried when moved ; entire body hurt; did not have inconsolable crying or sx of shock
ACCORDING TO RECORDS, PATIENT RECEIVED MODERNA VACCINE 1 DOSE ON 5/3/2021 PRIOR TO RECEIVING PFIZER DOSE ON 6/2/2021.
patient received dose of Moderna vaccine post excursion; patient received dose of Moderna vaccine post excursion; No adverse event; This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (patient received dose of Moderna vaccine post excursion), POOR QUALITY PRODUCT ADMINISTERED (patient received dose of Moderna vaccine post excursion) and NO ADVERSE EVENT (No adverse event) in a patient of an unknown age and gender who received mRNA-1273 (Spikevax) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (patient received dose of Moderna vaccine post excursion), POOR QUALITY PRODUCT ADMINISTERED (patient received dose of Moderna vaccine post excursion) and NO ADVERSE EVENT (No adverse event). At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (patient received dose of Moderna vaccine post excursion), POOR QUALITY PRODUCT ADMINISTERED (patient received dose of Moderna vaccine post excursion) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 (Spikevax) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessments were provided for PRODUCT TEMPERATURE EXCURSION ISSUE (patient received dose of Moderna vaccine post excursion) and POOR QUALITY PRODUCT ADMINISTERED (patient received dose of Moderna vaccine post excursion).    Concomitant medication was not reported. Treatment drug was not reported. This case contains information for the 4th of 19 patients reported by the reporter.   This case was linked to US-MODERNATX, INC.-MOD-2023-706941, US-MODERNATX, INC.-MOD-2023-706966 (Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-706941:pt 1 of 19 US-MODERNATX, INC.-MOD-2023-706966:Patient 4 of 19
He had a fever of 101.7 (on and off) for the next two days (from the 7th to the 8th). He had diarrhea and still has diarrhea now. He had a bloody stool from straining on 02/11/2017. He now has yeast (diaper rash) and in his mouth that we feel was perpetuated from possible the ROTO vaccine.