chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Vertigo; Dizziness; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of VERTIGO (Vertigo) and DIZZINESS (Dizziness) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013A21A) for COVID-19 vaccination.     No Medical History information was reported.   On 02-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced VERTIGO (Vertigo) and DIZZINESS (Dizziness). At the time of the report, VERTIGO (Vertigo) and DIZZINESS (Dizziness) had not resolved.            Concomitant medications were not provided. Treatment information include the patient has visited her doctor and has been receiving physical therapy for the side effects.   This case was linked to US-MODERNATX, INC.-MOD-2021-029178 (E2B Linked Report).
Seizure approx. 10 hours after vaccination. Patient remains hospitalized. 11/25/08 MR received for 11/19-21/2008 with DX: Seizure. On the evening of 12 mon vax pt was noted to be staring off into space. R arm began shaking then progressed to R leg and whole body shaking. Lasted 7-10 min.  Difficult to awaken afterward. Temp 99.9'F. Sleepy in ER, otherwise exam WNL.
On the evening of 12/04/2022, I started to feel like I was getting sick and became relatively ill. By Monday morning, I was definitely ill. I was able to run my class virtually, but I was in rough shape. I had sore throat, cough, headache, chest congestion and tightness, body aches, joint pains, and my skin hurt. Monday and Tuesday were the worst days. Wednesday was bad also. I spoke with someone in my doctor's office that day but was not prescribed Paxlovid until 12/08/2022 due to a delay in the messaging system. I tested myself for COVID-19 the night that I began feeling badly and it was negative. I tested myself again on 12/06/2022 and it was positive. I work at a school, so I was not allowed to be on campus for a full five days. At this point, I still don't feel 100%. I'm still coughing and have some congestion. I feel like my symptoms have plateaued since this past Saturday or Sunday.
My daughter received the Hep B and Polio-OPV vaccines on July 10, 1999.  On July 12-13th she developed thrush in her mouth (she was 10 1/2 months old).  On July 14th she had lost 2 pounds from July 10th check-up (she only weighed 21 pounds at the time).  On July 16th her blood sugar was 685 and she was diagnosed as having Type 1 diabetes, just 6 days after her vaccines were administered. 60 Day Follow up: Pt is now a type 1 diabetic. She showed signs on 7/13/99 (3 days after vaccine) and was diagnosed 7/16/1999. Per follow up report-Diabetes Type 1
Patient administered Zostavax 4/25/08, contacted pharmacy 4/26/8 and said arm where injection was given became red, inflamed, & "hot."  Recommended patient to take 1 Benadryl & 600mg Advil & ice it.  Next day reported redness, soreness, swelling seemed to be dissipating, also noted headache.  Told patient to contact doctor, doctor's nurse practitioner prescribed Keflex 250 X7 days.  Spoke with patient 5/6/8-not getting better-told patient to contact doctor again.  Contacted doctor initially on 4/28/8 and again 5/6/8.  Contacted patient 5/6/8.  Saw nurse 5/7/8-wasn't prescribed more antibiotics, wasn't getting better or worse.  Still swollen & tender.
I received the Bivalent Pfizer booster for COVID-19 on 9/15/2022. When I woke up the morning of 9/16/2022, I had joint and body aches, headache, sweats, chills, and sore throat. Even though I woke up feeling bad, I thought that it wasn't bad enough to impede my ability to work, so I went to work. Before the end of the day, though, I felt worse and couldn't wait to get off from work. I was in so much pain that night that I had difficulty going to sleep. I took some Advil, which I think must have helped, because I did eventually go to sleep. On 9/17/2022, I continued to have the same symptoms. Since I felt bad, I decided to stay at home and rest. At one point, though, I suffered a muscle spasm in my back when I bent over to pick up laundry. It was so excruciating that I nearly blacked out. I tried to take it easy for the rest of the day, but the back pain worsened. I took more Advil, but it didn't really help. Not only that, but I took some methocarbamol, but it did nothing for the pain. When 9/18/2022 came, I was still in agony, so I went to an urgent care clinic.  When I got to the urgent care clinic, I had to wait for 4 hours to be seen, only to then be told that I needed to go to the ER. When I got to the ER, I underwent a urine test, and they concluded that it was probably a back spasm. They then gave me a Toradol injection and a couple of Valium, which helped. They told me to take 3 OTC ibuprofen every 4 hours afterwards. On 9/19/2022, I was still recovering  from the spasm, so I was unable to work. Instead, I went to a physical therapist. I underwent deep tissue work and was given some exercises to do, and then I was told to come back on 9/22/2022. I was able to return to work on 9/20/2022. At the time of this writing, I still have a sore throat and some back pain, which is now tolerable (for the most part). Whenever something needs to be picked up from the floor or other low-lying area, I just ask someone else to do it for me.
Dad made appt online for his son at 9AM on 6-8-21. He came in with no proof of age because he already acknowleged on-line that his son is 12 years old. After the shot was done, we tried to bill the insurance, and got the rejection of invalid DOB.  We changed year for DOB, it pulled another profile in our system with same address, phone number and name. We called doctor and verfied the age. They informed us that real dob is same as profile in our system.  We called the dad and he said that his son DOB is as he stated online and the insurance is wrong. He said he will call insurance to update the info.  We wont be giving 2nd dose unless he bring proof of age.
Lumps in my left breast became suddenly swollen, hard and painful. The pain extended to my arm pit.  The swelling of the breast was pronounced enough that the entire left breast was visibly larger than the right breast. The swelling took a week to subside, but has not gone. The pain subsided in a week, but remains as I fill in this form.  The pain is in both the breast and the arm pit of the left side.
A day after getting vaccination, mother noticed swelling and redness on his Rt thigh Rt anterior thigh 4x3 cm area of erythema without fluctuance. Rx Cephalexin Monohydrate 2ML PO QID for 10 days.
Arm very swollen; arm red and hot; fever in night; This spontaneous case was reported by a consumer and describes the occurrence of PERIPHERAL SWELLING (Arm very swollen), FEELING HOT (arm red and hot) and PYREXIA (fever in night) in a 66-year-old female 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 PERIPHERAL SWELLING (Arm very swollen), FEELING HOT (arm red and hot) and PYREXIA (fever in night). At the time of the report, PERIPHERAL SWELLING (Arm very swollen), FEELING HOT (arm red and hot) and PYREXIA (fever in night) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No treatment information was provided.
10 year old male who received hepathis B recombinant (Engerix-B) for the prophylaxis of hep B. This report was received from the vaccinee's mother and has been verified by a physician. Allergies were not specified, and concomitant medications were denied. The vaccinee's medical history included "adenoids", ear tubes and Lyme disease at age 5. On 08/31/2000, the vaccinee received his first 0.5 ml IM dose of Engerix-B. "A few days later", he experienced joint pain which did not resolve, according to the mother. The physician stated that the onset date of "transient arthritis with morning stiffness" was late sept, 2000. A doctor visit was required. Starting on 10/26/2000, the vaccinee was treated with ibuprofen (Advil) 100 mg orally as needed. Additionally, the vaccinee was treated with acetaminophen (Tylenol). The vaccinee's mother stated that the vaccinee was recently diagnosed with polyarticular juvenile rheumatoid arthritis. The physician stated that the vaccinee's diagnosis was "arthritis", and that this adverse event was moderate in intensity and possibly related to Engerix-B. The physician stated that the adverse events were disabling/incapaciting. As of April 18 2001, the patient was complaining of arthralgias, but had no objective swelling. As of 12/27 2001, the patient had not been seen in follow-up. His mother reported that he had intermittent joint pains but no swelling or stiffness.
Received a monovalent vaccine instead of bivalent; did not feel well; something was going on in his body that wasn't normal; tired; also had a headache; This spontaneous case was reported by a patient family member or friend and describes the occurrence of MALAISE (did not feel well), FEELING ABNORMAL (something was going on in his body that wasn't normal), FATIGUE (tired), HEADACHE (also had a headache) and WRONG PRODUCT ADMINISTERED (Received a monovalent vaccine instead of bivalent) in a 66-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. AR4504B and 033K21-CA) for COVID-19 prophylaxis.     The patient's past medical history included Bypass surgery (Heart). Previously administered products included for Product used for unknown indication: Pfizer vaccine (Dose 1), Pfizer vaccine (Dose 3) and Pfizer vaccine (Dose 2). Past adverse reactions to the above products included No adverse event with Pfizer vaccine, Pfizer vaccine and Pfizer vaccine. Concurrent medical conditions included Arthritis and Heart disease, unspecified.   On 01-Apr-2022, the patient received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 28-Sep-2022, received fifth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In 2022, the patient experienced MALAISE (did not feel well), FEELING ABNORMAL (something was going on in his body that wasn't normal), FATIGUE (tired) and HEADACHE (also had a headache). On 28-Sep-2022,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced WRONG PRODUCT ADMINISTERED (Received a monovalent vaccine instead of bivalent). At the time of the report, MALAISE (did not feel well), FEELING ABNORMAL (something was going on in his body that wasn't normal), FATIGUE (tired), HEADACHE (also had a headache) and WRONG PRODUCT ADMINISTERED (Received a monovalent vaccine instead of bivalent) outcome was unknown.            Concomitant medication was not reported. Patient had not taken any medications or treatments for his symptoms.   This case was linked to US-MODERNATX, INC.-MOD-2022-654632, US-MODERNATX, INC.-MOD-2022-654638 (E2B Linked Report). This case was linked to MOD-2022-654637 (Patient Link).; Sender's Comments:  US-MODERNATX, INC.-MOD-2022-654632:Wife's case US-MODERNATX, INC.-MOD-2022-654638:Wife's case
7hrs p/vax pt irritable & emesis many times;t104-105 no diarrhea;no meningismus;gastroenteritis
This spontaneous report as received from a registered nurse refers to multiple unspecified patients of unknown age and gender. There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided. On an unknown date, the patients might have been vaccinated with improperly stored dose of (Oka/Merck) VARIVAX lot # L010144, expiration date 24-MAR-2016 (dose and route of administration were not reported). There was no adverse effect reported. This is one of several reports received from the same source. Additional information has been requested.
Patient was sitting on the exam table and Medical assistant administered Men B (Bexsero) right arm and then administered MCV-4 (Menveo) Left arm, was administering the Flulaval on the left arm and patient started to go forward and feel and hit head on tile floor. Mom lay patient on the floor flat while Medical Assistant went to grab a provider.  When Medical assistant and provider enter the patient exam room patient was already on the exam table sitting up, provider told patient to lay down, asked patient if he was nausea, sweaty or felt hot and patient said yes to all 3 questions. Provider bent patient legs and had patient wait for about 10mins and provider was in the room the whole time. Provider wait till patient felt better and was not pale no more and escorted him to car.
Nasal congestion and runny nose the day after the vaccine. Started around 1 pm and lasted until next morning. Also big area around injection site in left arm became red and swollen and warm to the touch two days after injection and is still red and swollen and warm to the touch four days after injection.
6cm-8cm induration and redness around the injection site (Left arm). Area is itchy and warm to the touch.
Information has been received from a nurse concerning her 21 year old daughter who in July 2007, was vaccinated with GARDASIL vaccine. On February 2008, the patient had completed the GARDASIL series. Concomitant therapy included ORTHO TRI-CYCLEN LO. On 01-JUL-2008, the patient had her first abnormal PAP test. Further analysis of the sample will be available on or after 18-AUG-2008. The patient sought medical attention. Additional information has been requested.
PATIENT SAID WOKE UP 10/27 WITH RED SWOLLEN ARM. ARM CONTINUED TO SWELL AND MONDAY 10/29 PATIENT WENT TO MD. WITH RED SWOLLEN ARM NOW WITH A RED STREAK GOING DOWN THE ARM.  MD PRESCRIBE KEFLEX.
Itchy rash over most of body iritable,onset date 03/23/2007 temp 97.6 benadryl prn follow up prn
Chills, fever,  fatigue, severe muscle aches in arm and elsewhere in body, headache
diabetes was high; seeing double vision; Headache on the right side; This is a spontaneous report from a contactable nurse. A patient of an unspecified age and gender received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number/expiration date unknown) dose number 1, via an unspecified route of administration on 18Dec2020 at a single dose for COVID-19 immunization. Medical history and concomitant medications were not reported. The patient had the vaccine in a hospital on a Friday (18Dec2020). No side effect was noted over the weekend. On 21Dec2020, when the patient woke up, s/he was seeing double vision, so s/he went to the doctor; they ran some test (unknown result). Because the patient was having headache on the right side in Dec2020, s/he went back to the doctor on 23Dec2020; the patient was sent to the eye doctor and they ran all kind of test. On 24Dec2020, the only thing they could find was that the patient's diabetes was high, so they kind of felt that what that could have been was kind of coincidental. The outcome of the events was unknown.  Information on the lot/batch number has been requested.; Sender's Comments: The mentioned "diabetes was high" is likely an intercurrent disease, unlikely related to the administration of BNT162B2, the COVID-19 immunization.   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 RA, IEC, as appropriate.
Narrative:  Patient was diagnosed with a substantial deep vein thrombosis from hip to ankle in Left leg.  Diagnosed by ultrasound. Patient denied any long car trips, plane trips, injury or surgeries, or hospitalizations. Patient does smoke. He was  advised to stop and he states that he will. Patient denies any family history of  blood clots. His platelet count was normal.
dyspnea, tachycardia, pain in arm with swelling, numbness, bruising
the vaccine MENACTRA had expired on 31-Jul-2021 and was administered with no reported adverse event;Initial information regarding an unsolicited valid non-serious case from a consumer/ non-health care professional via Medical Information (Reference number- 00711805) and transmitted to Sanofi on 05-Aug-2021 and live follow up received on 03-Aug-2021.  This case was linked with GMI ID 00707969 and ARTEMIS ID SAD20210803001152.  This case involves a 12-year-old female patient for whom it was reported that the vaccine MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE, solution for injection [MENACTRA] had expired on 31-Jul-2021 and was administered (expired product administered) (lot number: U6641AB) at 0.5 ml dose via unknown route in an unknown site for prophylactic vaccination on 02-Aug-2021.  Medical history, past medical treatments, past vaccinations and family history were not provided.  Concomitant medications were not reported.  It was an actual medication error case due to expired vaccine used (latency: same day).  At the time of reporting, the patient experienced no adverse event.  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 the 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.
Narrative: 89-year-old male with a h/o HTN, HLD, leukemia 2017, A.Fib, depression, anxiety, CAD s/p CABG and bioprosthetic aortic valve replacement in 11/04, mitral valve clip, bladder cancer s/p CTX, cardiac stents x 2, AAA repair, bilateral carotid endarterectomy, lung nodules died on 8/4/2021. Pt had received covid vaccinations on 1/12/2021 & 4/1/2021. This death is likely not related to the vaccinations due to other comorbidities, age, and length of time from vaccine administration.
Diarrhea, vomiting, low fever, indigestion, pain in abdomen
66 y.o. female who presents with DIZZINESS LIKE ROOM IS SPINNING.  PT STATES IMPROVES WITH CLOSING EYES AND LAYING STILL.  PT STATES HAS HAD SEVERAL TIMES BEFORE AND LAST TIME WAS ONE WEEK AGO AND TOOK A MOTION SICKNESS OVER THE COUNTER PILL AND DIZZINESS WAS RELIEVED.  TODAY PT WAS AT WORK WHEN BECAME DIZZY AND NAUSEOUS AND VOMITED.  PT DENIES CHEST PAIN BUT HAS PAST HISTORY OF CAD WITH PACEMAKER PLACEMENT.
Patient called and reported small red bumps all over body. Patient denied itchiness but reported that some of the bumps do pop.
42 yo female presented at urgent care 3 days after receiving covid 19 vaccine with migraines. Patient with past medical history of migraine in the past. Per provider assessing patient believes her symptom of headache was consistent with past migraine. Patient states she received vaccine 1/14/21 and had dizziness and chills for a day that resolved. Then yesterday she began to have a migraine which was similar to her migraine presentation in the past. Patient given ketorolac x1 and Zofran x1. Patient prescribed Zofran . Pt instructed to continue home Imitrex and follow-up with PCP.
A report has been received from a Health Professional concerning a 14 year old, Male subject, who had been receiving Nasal FLUMIST (INTRANASAL). FLUMIST (INTRANASAL) started on 28-Oct-2014. It was reported that several patients received only a half dose of FLUMIST which started on 28-Oct-2014. The outcome of the event of MULTIPLE PATIENTS RECEIVED A HALF A DOSE OF FLUMIST is unknown. The report was considered to be non-serious.
Mild itchy rash on chest and upper arms about 1-2 hours after the vaccine. Improved after Zyrtec
4 hours after receiving DTAP, PREVNAR, ROTAVIRUS & HIB vaccines child experienced right facial droop involving eye, lower face & mouth.  Symptoms lasted approximately 2 hours.  Symptoms resolved by time child seen by ED.
pt was dizzy, too weak to walk, she has not had any breakfast before receiving the vaccine; we provided  muffins, water and eventually called paramedics to check pt's vital making sure she is ok before she go home; pt's vitals are normal and went home without going to ER;
This spontaneous report as received from a registered pharmacist refers to a 61 year old female patient with diabetes and no drug reactions or allergies. On 27-OCT-2014, the patient was vaccinated with a dose of ZOSTAVAX (lot# K003595 exp 07-FEB-2015)  subcutaneously. The pharmacist reported that on 29-OCT-2014, the patient developed shingles above the right eye in the scalp. The patient did not receive treatment for the adverse event. There were no lab diagnostics or studies performed. The outcome of shingles above the right eye and on the scalp was reported as recovering/resolving. Additional information has been requested.
Pain at injection site, generalized arthralgias, fever. Symptoms began hrs after. At day 4 after symptoms improving.
This spontaneous report was received from a nurse regarding unspecified patients of unknown age and gender. Information regarding the pertinent medical histories, drug reactions or allergies and concomitant therapies were not provided. On unspecified dates, the patients were vaccinated with improperly stored doses of GARDASIL 9 (lot # M003659, Expiration date 20-SEP-2017; batch # M009378, Expiration date 23-APR-2018; lot # L037554, Expiration date 25-DEC-2017) (exact dose and route of administration were not reported). The administered doses experienced a temperature excursion of 46.8 degree Fahrenheit for 6 hours and 53 minutes and 33.2 degree Fahrenheit for 27 minutes. There was no previous exposures and no data logger. No adverse effects were reported. This is one of the two reports received from the same reporter. Additional information has been requested.
Upon returning timer to RN at 30 minute post-vaccination, patient reported feeling "scratchy throat" and left sided tongue numbness and tingling. Patient states she noticed this right after the vaccination was administered but felt that "it would just go away." RN assessed patient immediately at 0946. Vital signs were: BP 161/103, HR 78, SPO2 98%. No wheezing was present upon auscultation. No swelling was noted to tongue and no hives were present. Patient reported no other symptoms. Patient was walked to emergency room by this RN and pharmacist for further observation. Patient handoff report was given to ER nurse. Of note: patient's only known allergy is Zantac in which she states she develops a rash.  Patient was treated in the ER with 125 mg IV Solu-Medrol and 50 mg IV Benadryl.