chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Pt received flu vaccine in Nov and about 4 wks after starting feeling fatigue and very tired. Having staring spells - w/u for depression, sz, fatigue, finally diagnosed with narcolepsy by neurologist in Sept, 2013.
This spontaneous report was received from a physician referring to a 2 year old patient of unknown gender. No information about the patient's medical history, concurrent conditions and concomitant medications was reported. On 05-SEP-2017, the patient was vaccinated with an improperly stored dose of VAQTA injection, lot # N014945, expiry date 31-AUG-2018 (dose, route of administration and site of the vaccination were not specified) for prophylaxis. The administered dose of VAQTA underwent a temperature excursion. The lowest temperature was 32 Fahrenheit degrees and the higher was 54 Fahrenheit degrees for 70 hours. Data logger was not involved. No adverse effects were reported. There was no product quality complaint involved. This is one of several cases received from the same reporter. Sender's Comments: US-009507513-1709USA012770: US-009507513-1709USA012767: US-009507513-1709USA007325: US-009507513-1709USA012769: US-009507513-1709USA012765: US-009507513-1709USA012764: US-009507513-1709USA012766: US-009507513-1709USA012768.
This spontaneous report as received from a pharmacist refers to a patient of unknown age and gender. No concurrent condition, medical history or allergy/drug reactions were reported. On 24-DEC-2015 at 03:20, the patient was vaccinated with improperly stored RECOMBIVAX HB with lot number: L025738, expiry date: unspecified (dose and strength unspecified). No concomitant medications were reported. No adverse effects were reported. The high and low temperatures were 6.3 and 5.3 (units unspecified) respectively. There were no product quality complaints (PQC) involved. No additional information was provided. This is one of the several reports from the same reporter. Additional information has been requested.
On November 21, 2022, she was diagnosed with Roseola. She ran a fever for about 3 days of about 101. The rash lasted about 3 days that appeared after the fever. The rash was on her torso and her neck. On Thursday the 24th we noticed that she had a limp, favoring her left leg. It did not go away so on the 28th we went to the pediatrician because it was sore to touch. We were referred to the emergency department for evaluation. We needed to rule out a blood clot. Transient Synovitis.
Severe grade 3 swelling at the injection site; This case was reported by a physician via sales rep and described the occurrence of injection site swelling in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, less than a year after receiving Shingrix, the patient experienced injection site swelling. On an unknown date, the outcome of the injection site swelling was unknown.   It was unknown if the reporter considered the injection site swelling to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The reporter stated that the greater than 50 years of age patient received the first dose of Shingrix at an unspecified date in 2019 and she developed what he described as severe grade 3 swelling at the injection site. The reporter had no further information about the adverse event.
On April 10th, patient was traveling and noticed she was having a hard time drinking without spilling. Companions noted her smile was different. This started sometime in the morning. Had a hard time raising her eyebrows. Experienced jaw pain, severe headache and neck pain. Symptoms were mainly on the left side of her body. On April 10th she went into the Hospital Emergency room. At that time she was diagnosed with Bells Palsy. She was give a Rx for prednisone 60mg daily for 7 days. She started physical therapy  the week of May 3, 2021. She still has symptoms, but they are less severe.
Information has been received from the authors in a published literature article concerning a child patient who on an unspecified date was vaccinated with the three doses of ROTATEQ. On an unknown date, the patient experienced rotavirus and was hospitalized. At the time of the report the outcome of the patient was not reported. The article also discussed the experience of another child patients while on therapy with ROTATEQ (WAES # 1108USA01482, 1108USA02150, 1108USA02151, 1108USA02152 and 1108USA02154). Additional information has been requested.
Patient and I spoke on May 7th, 2021.  Her contact information was referred to me by one of the Call Center staff members.  Patient reported that she received her first COVID-19 vaccine (Pfizer) on 2/17/2021 at Health Department.  She reports that she is typically "fine with shots, no problem", but when she received her first dose of the Pfizer vaccine "it immediately started hurting".  She reported taking round the clock Advil/Motrin and "could feel a knot and radiating into crease of arm".  She reported difficulty raising arm to put bra on and awaiting in the middle of the night due to pain.  She stated she presented 21 days later for her 2nd dose (3/10/21- right arm) and still had persistent pain in left arm. She stated she has seen a surgeon due to the pain and that they x-ray was negative.  She states the surgeon told her that a nerve was affected and gave her a shot of steroids.  She reports this has not resolved the pain and that she is taking diclofenac 75 mg BID with pain unresolved.  States she has a f/u appt with provider 5/27/21 and will keep appointment.
WHEN I  RECEIVED THE PFIZER -BIONTECH COVID-19 VACCINE THE NEXT 2 DAYS 12: 45 AM I TOOKA SHOWER AND WENT TO BED THEN I FOUND MY LEFT SIDE OF THE BODY FROM MY AMPIT ALL THE WAY TO MY FEET ARE NAMBED AND ALSO SOMETIMES  MY LEFT LEG GIVE UP ON ME FEELS WEEK ON MY KNEE. I WENT TO MY DOCTOR AND ALSO I CONTACTED MY WORK PLACE THAT IS EMPLOYEE HEALTH AND THEY TOLD ME TO CALL THE AGENCY.
Initial information received on 10-Oct-2018 regarding an unsolicited valid non-serious case received from a nurse. This case involves a 50 years old male patient who received vaccine FLUZONE QUADRIVALENT and while treated with TUBERCULIN TEST [TUBERSOL]. The patients past medical history, concomitant medication and family history were not provided. On 10-Oct-2018, the patient received TUBERSOL (TUBERCULIN TEST) 0.5 mL intramuscular (lot - C5476AA, expiry date 16-Nov-2020) instead of suspect INFLUENZA QUADRIVAL A-B VACCINE lot number not reported. It was an actual medication error due to wrong vaccine administered. It was reported that Nurse practitioner ordered FLUZONE QUADRIVALENT but Nurse inadvertently gave Tubersol 0.5 mL IM to a patient. It was unknown whether patient experienced any adverse reaction after the injection. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holders 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. List of documents held by sender- none.
Swelling of lymph node in left arm pit.  Have had itching off and on ever since.  Swelling was painful and lasted about 36 hours.  Could not completely lower arm do to swelling.
Right arm with large area erythema, urticaria extending from mid upper arm to elbow.
On 5-15-21, the day after the vaccine, I started feeling dizzy (like being on a spinning ride non-stop; it wasn?t too bad in the morning, but progressed during the day), had a headache, chills, nauseous, and my thermometer said I didn?t have a fever, but my cheeks were red and hot. I went to bed by 8 PM and woke up this morning (5-16-21) just before 5 AM. A little dizziness remains. My arm also started feeling sore in the evening after receiving my vaccine. It?s still sore today, but the soreness has reduced.
Reported not feeling well and itchy throat, NP noted moderate swelling in throat. Was given BENADRYL and EPIPEN. Pt was sent to HCC.
Information has been received from a pharmacist referring to her daughter, a 19 year old female patient. There was no medical history or drug reaction reported. On unknown dates, when the patient was a child, she was vaccinated with three doses of RECOMBIVAX HB (dosage, strength, route and lot # were not reported). There was no concomitant medication reported. In 2015 the patient underwent serological testing for hepatitis B. The titer results were negative for hepatitis B. It was unspecified whether the patient sought medical attention or not. At the time of reporting, the outcome was unknown. This is one of several reports received from the same reporter (MARRS# 1508USA003160). Additional information is not expected because the reporter didn't wish to contact.
Next day noted numbness upper lip and beneath eye. Most pronounced for 1 hr. Has been improving
Patient developed Hives the evening they received the vaccine shot & despite taking Benadryl & Zyrtec are still exhibiting hives, Patient waiting to hear back from her PCP.
Within a few hours after injection, developed flu-like symptoms, joint pain, left arm swelling and discoloration, temp. Resolved with about 12 hours.
been sick/sickness/I am pretty ill because I have symptoms; headache; sore throat; runny nose; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) for a sponsored program (002191; 159558). The reporter is the patient.  A male patient received bnt162b2 (BNT162B2), administration date 19Mar2021 (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: ILLNESS (non-serious), outcome "unknown", described as "been sick/sickness/I am pretty ill because I have symptoms"; HEADACHE (non-serious), outcome "unknown", described as "headache"; OROPHARYNGEAL PAIN (non-serious), outcome "unknown", described as "sore throat"; RHINORRHOEA (non-serious), outcome "unknown", described as "runny nose". Relevant laboratory tests and procedures are available in the appropriate section.  Additional information: He got his first dose on 19Mar, and he was due to take his second dose on Friday. However, he has been sick lately and took a rapid test but the results will come tomorrow. He wanted to know if he still needed to take the second dose if the results came back positive. He was pretty ill because he had symptoms and he was wondering if he takes the second shot; scheduled for rapid test. Dates for she was pretty ill because she had symptoms. Pharmacy details and treatment could not be probed over the call. Limited information available over the call and appropriate response could not be provided. He had the first dose of the Pfizer Vaccine on the 19Mar2021 and due to get the second dose on Friday 09Apr2021. But he was currently experiencing sickness symptoms, headache, sore throat and runny nose. No other side effects appeared. He called for the advice.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
This is a spontaneous report from a Pfizer sponsored program. A contactable female consumer (patient) reported for herself that, A 36-years-old female patient received tofacitinib citrate (XELJANZ XR, Formulation: Prolonged-release tablet, Strength: 11mg), via oral from Feb2021 (Batch/Lot Number: EA8738) and ongoing, at 11 mg, once a day (take 1 tablet by mouth once daily) for an unspecified indication; bnt162b2 (BNT162B2, Formulation: Solution for injection), via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as an unspecified dose for covid-19 immunisation. Medical history included rheumatoid arthritis from an unknown date and unknown if ongoing Patients indication for xeljanz: rheumatoid arthritis with rheumatoid factor multi site w/o org/sys involve. Concomitant medication included iron taken for an unspecified indication, paracetamol (TYLENOL) taken for an unspecified indication, prednisone taken for pain, hydroxychloroquine sulfate (HYDROXYCHLOROQUINE SULFATE) taken for an unspecified indication. Patient reported she received the 1st Pfizer covid vaccine and held Xeljanz for a week before and after the vaccine per her MDs instructions. Reports as a result she experienced manageable pain in h). CEP Xeljanz low risk month 6 call completed with HIPAA verified patient. Provided review of prescribed regimen, reviewed educational topics and completed the adherence medications scale (ARMS-7). Patient reported she received the 1st Pfizer Covid vaccine and held Xeljanz for a week before and after the vaccine per her MDs instructions. Reported as a result she experienced manageable pain in her waist and fingers in the morning but that the pain subsided as the day progressed. Reported her 2nd vaccine dose is due on 17Aug and she will be holding the medication again for 1 week before and after the vaccine. Reported she has an appointment with her RA tomorrow including bloodwork. Reports she takes prednisone as needed for severe pain. Agreed to educational mailers and declined to speak with a pharmacist. Warm transferred patient to patient care coordinator to schedule delivery. AE report completed. The action taken in response to the events for tofacitinib citrate was dose not changed. The outcome of events was unknown.  No follow-up attempts are needed. No further information is expected.
stomach nausea and abdominal cramping ~3/10, pt called PCP, unclear if seen by physician
Information has been received from a nurse via a company representative referring to a 17 years old female patient who was not pregnant. The patient's medical history, concomitant therapy and concurrent condition were not provided. On 24-OCT-2016, reported as last Monday, the patient was to be given an unspecified meningococcal vaccine (manufacturer unknown) and instead was administered GARDASIL 9, (patient's specific history with GARDASIL 9 was unspecified, therefore it was unknown if the patient had received prior doses within the series). It was reported that "over the weekend (29-OCT-2016 and 30-OCT-2016)",  the patient was having "nausea and abdominal pain". The patient called to physician to seek medical attention. The outcome of the events was unknown. Follow up information has been received from the same representative on 08-DEC-2016, to confirmed that the unspecified meningococcal vaccine was PNEUMOVAX 23 (lot#: M037669). Additional information has been requested. Product, event and narrative were undated. Sender's Comments: MERCK 1611USA000427: Mfr number.
had the shot/ still got shingles/suspected vaccination failure; got shingles; This case was reported by a consumer via interactive digital media and described the occurrence of suspected vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, less than a year after receiving Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure and shingles were unknown.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine.  Additional details were reported as follows: This case was reported by the patient. The age at vaccination was not reported. The patient had the shot last fall but still just had shingles.  The patient had shingles and said that they were not fun, also it was not a guarantee. This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule and laboratory confirmation were unknown at the time of reporting. No contact details were available.
One of the nursing students went to give the vaccine and once the needle was placed into the patients muscle the needle separated from the syringe - The student states that a very small amount (less than 1/2) of the dose entered into the patients arm. the student reported it right away, discussed with the instructor and research was conducted on what the recommendations were. Per MDH guidance - (syringe and needle separated during injection).  We did give the person an additional dose in the opposite arm based on the Dosage recommendation in the attached document.  https://www.cdc.gov/vaccines/covid-19/downloads/covid19-vaccine-errors-deviations.pdf
I had sore arm for about a day. I felt a little off for about 24 hours. A week later, I noticed my left hip, and chest around was ringworms. It was itchy and red. I had a herpes outbreak on my groin. I haven't had an outbreak since about 4 years. I went to the urgent care. They just did a clinic exam.
Within 30 minutes of having the vaccine shot in my right shoulder I had a reaction in my left leg in the ligament all the way down my leg with pain . It has been difficult to walk and is still hurting on Monday September 11.
Received a dose from a vial first punctured more than 12 hours ago; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 10-Sep-2021 and was forwarded to Moderna on 10-Sep-2021.    This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Received a dose from a vial first punctured more than 12 hours ago) in a 59-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 046C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 10-Sep-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced EXPIRED PRODUCT ADMINISTERED (Received a dose from a vial first punctured more than 12 hours ago). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Received a dose from a vial first punctured more than 12 hours ago) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medication was provided.   Most recent FOLLOW-UP information incorporated above includes: On 10-Sep-2021: Follow up received on 10-Sep-2021 updated suspect lot number and expiration date.
After I got it, I got dizzy. I got a rash on my right arm past my elbow. Then I got major muscle pain, nausea, fever off and on, I had pain and my arm and ankle swelled up. After 10 days it cleared up. But then again it started after 3 days, both of my arms were itching, and red and brown sports were popping out. Both of my arms hurt like I got a shot on both arms, dark purple marks on my heel and symptoms were getting worse. Almost 21 days with this. I was also producing a lot of saliva and had a ringing loud noise in between both ears.
Moderna COVID-19 Vaccine EUA: COVID-19 case resulting in Hospitalization / Death. Patient received Moderna Vaccines on 1/28/2021, 2/26/2021, and 11/1/2021. Presented to emergency department on 01/08/21with complaints of nausea, emesis, and diarrhea which began 5 days prior. Admitted in hypovolemic shock, acute viral gastroenteritis 2/2 Covid19, acute renal failure and acute hypoxemic respiratory failure due to COVID19. Received dexamethasone, anticoagulation, and oxygen supplementation. Patient went into cardiac arrest and expired shortly after arrival on 1/9/22 without ROSC.
rash is a little bigger today; noticed some rash below the site where they injected; redness; sore arm; raised area; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE RASH (noticed some rash below the site where they injected), ERYTHEMA (redness), PAIN IN EXTREMITY (sore arm), VACCINATION SITE SWELLING (raised area) and RASH (rash is a little bigger today) in a 54-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 037A21B) for COVID-19 vaccination.     The patient's past medical history included No adverse event. Concomitant products included CETIRIZINE HYDROCHLORIDE (ZYRTEC ALLERGY), ROSUVASTATIN, IBUPROFEN and MORPHINE SULFATE for an unknown indication.    On 25-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 25-Mar-2021, the patient experienced VACCINATION SITE RASH (noticed some rash below the site where they injected), ERYTHEMA (redness), PAIN IN EXTREMITY (sore arm) and VACCINATION SITE SWELLING (raised area). On 26-Mar-2021, the patient experienced RASH (rash is a little bigger today). At the time of the report, VACCINATION SITE RASH (noticed some rash below the site where they injected), ERYTHEMA (redness), PAIN IN EXTREMITY (sore arm), VACCINATION SITE SWELLING (raised area) and RASH (rash is a little bigger today) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.
PATIENT STATES REDNESS AND SWELLING AT INJECTION SITE, DEEP PINK TO PURPLE COLORING WITH WHEELS AT INJECTION SITE,WITH SHIVERING CHILLS OF PROLONGED DURATION.
Around 8:00 PM on 11172021, my wife noticed hives between the legs, buttocks, arms, face and hands. The hives caused the skin to itch and burn turning into scales and lost of skin.  The hands still feel burning at times and sensitive to touching objects.  Around the 29 of November an onset of diarrhea started and persists today.
Joint pain - aches, knees, hips, shoulders, back. Expected some joint pain/body aches following vaccine, however it?s been over 1 week and pain aches are continuing
Body aches and chills..temperature sustained at 100.1 for 4plus hours...slight nausea and slight dizziness.  400mg of ibuprofen taken at 8:45...no effect on symptoms until I went to bed at 10:30pm and slept well.
I got a headache right away, but an Aleive took that away, but around 9Pm I started running a fever and had severe nausea all night.  When I got up this morning I vomited and felt much better immediately.  The fever is gone and I never had trouble breathing or heart racing.
Patient states she has had muscle fatigue and achiness of her entire body since receiving the Moderna spikevax vaccine and the fluad vaccine on Nov 2, 2023.  She also stated she had soreness not only at injection site but all around the injection sites.