chrisvoncsefalvay/vaers-outcomes huggingface dataset:
ferritin was found to be > 40,000 mcg/L; ferritin was found to be > 40,000 mcg/L; hypertriglyceridemia to 2285 mg/dL; hepatocellular injury; deranged Liver function tests (LFT); Initial information received on 03-Oct-2019 regarding an unsolicited valid serious case issued from a literature article.  This case involves a 65 years old male patient who experienced ferritin was found to be > 40,000 mcg/l (Hyperferritinaemia), hypertriglyceridemia to 2285 mg/dl (Hypertriglyceridaemia) and hepatocellular injury (Hepatocellular injury), while he received vaccine INFLUENZA VACCINE.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  At the time of the event, the patient had ongoing nausea, vomiting, diarrhoea, in the setting of 15 lbs weight decreased, Hyperferritinaemia, Cytopenia and Liver function test abnormal.   On an unknown date, the patient received a dose of suspect INFLUENZA VACCINE produced by unknown manufacturer lot number not reported via unknown route in unknown administration site.  On an unknown date, the patient developed a serious ferritin was found to be > 40,000 mcg/l (hyperferritinaemia and condition aggravated), hypertriglyceridemia to 2285 mg/dl (hypertriglyceridaemia) and hepatocellular injury with deranged liver function tests (LFT) (liver function test abnormal), less than 24 hours following the administration of INFLUENZA VACCINE. The patient was hospitalized for these events.  Relevant laboratory test results included: Biopsy liver - On an unknown date:  [hepatocellular injury but no hemophagocytosis] Blood triglycerides - On an unknown date: 2285 mg/dL Serum ferritin increased - On an unknown date: >1000 mcg/L; on an unknown date: >40,000 mcg/L  It was reported that there was no lymphadenopathy on exam. Hemochromatosis DNA testing was negative. Magnetic Resonance Imaging of brain, Computed Tomography of chest, abdomen, pelvis, and upper and lower endoscopies were non-contributory. Test including, but not limited to, blood culture, hepatitis panel, human immunodeficiency virus, acetaminophen level, stool culture, C. difficile PCR as well as soluble CD25 returned negative.   Other relevant tests included Bone marrow biopsy was also without hemophagocytosis and otherwise normocellular.  Final diagnosis was hepatocellular injury, hypertriglyceridemia to 2285 mg/dl and ferritin was found to be > 40,000 mcg/l.  It was reported the patient did not received any corrective treatment.  The outcome of the events was reported as recovered (values returned to baseline spontaneously over the span of just 4 days).  List of documents held by sender: none.; Sender's Comments: This case involves a 65 years old male patient who presented with hyperferritinemia, hypertriglyceridemia, liver function test abnormal,  after vaccination. Time to onset is compatible with the role of vaccine. More details regarding patient's previous vaccination history,  etiological workup and investigation reports to identify alternative etiology are needed for complete assessment of the case. Based on the available information the role of vaccine cannot be assessed
Metallic taste, vaccinated arm feels numb/cold throughout entire arm "instant". BP 123/62; HR 97; RR 18, SpO2 100%, Temp 99.1F
The next day after receiving the vaccine and half of Friday, I was in bed with a headache, fever, chills and body aches. By Sunday morning, I had a rash on my back and I took pictures of it thinking it was shingles. I sent them to my doctor and they confirmed it was shingles. The shingles followed its normal course where the rash blistered then scabbed over. I have been fatigued the entire event. I'm on an antiviral medication for it currently.
Heart racing, extreme lightheadedness and dizziness, extreme sweating, numb/tingly arms and hands, moderately swollen tounge.
Patient was given Tdap at 2:50pm and complained of itching and burning sensation to right arm with erythema noted to right arm and hand immediately after the medication was given. Writer notified the provider who came in to assess patient. Patient was give BENADRYL 25mg by mouth at 3:05pm. At 3:08pm, patient complained of shortness of breath, throat itching, and a cough. At 3:10pm, the patient was give the Auto injector EPI-PEN 0.3mg IM in the left thigh. Within 3 minutes, patient stated the itching was resolving, no shortness of breath, and the erythema was resolving. Vital signs remained stable during event. After observation for approximately 1 hour, the patients symptoms resolved completely and left the center at 4pm.
Hives, facial swelling, throat and tongue swelling starting 3 hours after administration of dose. Benadryl taken at start of symptoms and every 4 hours for 24 hours after vaccine
Information has been received from a pharmacist referring to a 71 year old male patient. Concurrent conditions, pertinent medical history of the patient were not reported. The patient had no drug reactions/allergies. On an unspecified date in 2013 (reported as "2 years ago") the patient was vaccinated with a dose of ZOSTAVAX (lot#, dose, route unspecified). After receiving ZOSTAVAX, the patient had multiple outbreaks of shingles, accompanied by nerve pain. The patient sought medical attention via visit the pharmacy and was treated with gabapentin 300 mg. At the time of this report, the outcome of shingles and nerve pain was unknown. The relatedness between the events and therapy with ZOSTAVAX was not reported. Additional information has been requested.
Left thigh, bull's eye, hot, red, raised 20 cm area at injection site, warm to touch.
Swelling, redness and warmth at site. Cool compresses and Tylenol for discomfort. Area approx 8 cm x 8 cm.
chills, fever, muscle contractions/seizures, severe headache, joint pain, sweats,muscle weakness, acid reflux- time course: began approx 8 hrs after shot (12:15am) and continued until 5am,-acetaminophen 1000mg q8h, naproxen 220mg q12h,  gaviscon liquid 10ml, the headache, muscle pain has continued at a lower intensity until 12noon on monday 3/22/21
Bump came back after a week and was bigger; Bump came back after a week and was bigger, and hotter as well as more pronounced; Reaction that was red, warm to the touch and itchy; Reaction that was red, warm to the touch and itchy/ reaction was red and hot; Reaction that was red, warm to the touch and itchy/ reaction was red and hot; Developed a bump; Sore for a couple of days; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE MASS (Developed a bump), PAIN IN EXTREMITY (Sore for a couple of days), VACCINATION SITE MASS (Bump came back after a week and was bigger), VACCINATION SITE WARMTH (Bump came back after a week and was bigger, and hotter as well as more pronounced) and VACCINATION SITE PRURITUS (Reaction that was red, warm to the touch and itchy) in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 03-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 03-Feb-2021, the patient experienced VACCINATION SITE MASS (Developed a bump), PAIN IN EXTREMITY (Sore for a couple of days), VACCINATION SITE PRURITUS (Reaction that was red, warm to the touch and itchy), VACCINATION SITE WARMTH (Reaction that was red, warm to the touch and itchy/ reaction was red and hot) and VACCINATION SITE ERYTHEMA (Reaction that was red, warm to the touch and itchy/ reaction was red and hot). On an unknown date, the patient experienced VACCINATION SITE MASS (Bump came back after a week and was bigger) and VACCINATION SITE WARMTH (Bump came back after a week and was bigger, and hotter as well as more pronounced). On 05-Feb-2021, VACCINATION SITE MASS (Developed a bump), PAIN IN EXTREMITY (Sore for a couple of days), VACCINATION SITE PRURITUS (Reaction that was red, warm to the touch and itchy), VACCINATION SITE WARMTH (Reaction that was red, warm to the touch and itchy/ reaction was red and hot) and VACCINATION SITE ERYTHEMA (Reaction that was red, warm to the touch and itchy/ reaction was red and hot) had resolved. At the time of the report, VACCINATION SITE MASS (Bump came back after a week and was bigger) and VACCINATION SITE WARMTH (Bump came back after a week and was bigger, and hotter as well as more pronounced) was resolving.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were reported.  Treatment details were not provided.
Nausea; chills; fever 101 degrees  Lasted 10 hours. No treatment
Nausea, tongue feels tingly (no SOB, feels sore, HA. Advised to take Benadryl and monitor for any worsening of symptoms.
This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a female patient of unknown age. No information was provided regarding concomitant medications, concurrent conditions or medical history. On or about 04-SEP-2012, the patient was inoculated with the ZOSTAVAX vaccine by a physician as recommended for routine adult health maintenance for the prevention of shingles (dose, route, and lot # not provided). The vaccine did not prevent shingles as intended and the patient subsequently contracted a persistent strain of herpes zoster. On or about 14-JUL-2016, she was treated by a physician for onset of a severe vesicular rash, which was diagnosed as severe herpes zoster, or shingles. As a direct and proximate result of ZOSTAVAX vaccine, and/or despite receiving ZOSTAVAX for long-term prevention of shingles, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages. The outcome of the events was unknown. Causality assessment was related. Additional information has been requested.
Pt received vaccine on 10/13/15. On 10/15/15, parent took pt. to immediate care with tender, swollen upper left arm. (Tricep area). Tx: Prednisone, KEFLEX, cool compress, BENADRYL. Left message w/ parent several times - No response.
Hives/bumps, swelling of hands and feet, tips of fingers and toes purplish. Mom treated with BENADRYL. Dr. treated patient with prednisone.
Patient stated she had swelling around the injection site later in the evening and the area also started to itch. She reported this event to the pharmacy 4 days later after her injection. She is using hydrocortisone cream and taking an anti-inflammatory by mouth. She says it is not hurting just she knows it is there and bothersome.
This spontaneous report was received from a medical assistant refers to patient of unknown age and gender. On 23-JUL-2014, the patient were vaccinated with GARDASIL (0.5 ml, lot# J011272, expiration date: 21-APR-2016) intramuscularly which underwent a temperature excursion. No adverse events were reported. At the time of the report action taken with GARDASIL was unknown. This is one several reports from the same source. Additional information has been requested.
A 49 year male patient received the first instillation of a second course of OncoTICE and Introl A 50 MIU. The next day he experienced fever, chills, urinary urgency, urinary frequency , hematuria and dysuria. After the second instillation the patient experienced the same events. The treatment is not discontinued.
Muscle soreness. 2 ibuprofen and bed rest. Ache went away.
wasn't old enough, and got it.; This case was reported by a consumer via interactive digital media and described the occurrence of inappropriate age at vaccine administration in a female patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced inappropriate age at vaccine administration. On an unknown date, the outcome of the inappropriate age at vaccine administration was unknown.   Additional Information: GSK receipt date: 26-Oct-2022 Reporter's comment: The case was received from the patient's parent via interactive digital media. The reporter reported that the day he/she got the shot, the patient, who was not old enough, got the vaccine. Additional supportive information: The patient received a dose of Shingles vaccine at inappropriate age, which led to inappropriate age at vaccine administration. The follow-up could not be possible as no contact details were available.
Patient stood up and walked over to register and said he didn't feel so well. I came around the pharmacy and he was fainting as I got to him. Technician called paramedics, store manager was called and when I asked him his name and if he knew where he was he said yes. We sat him up per his request. When he was well enough we sat him on a chair, I took his blood pressure and we got him water. He was on the phone with his dad who is a physician and dad said it sounded like a syncope and asked we give him gator aid. Paramedics arrived and they took his vitals and ran some tests.
Pt experienced projectile vomiting and fever, went to ER, given zofran. Symptoms better less then 24 hours after vaccine administration.
fell from chair to floor, face down;moved to exam table;EMS activated, 02 given;transported via EMS abm to hosp;
Patient was given another dose of RSV 1 month after his first dose. Patient did not present with any symptoms but will follow up with him this week.
I'm being diagnosed with Parsonage Turner Syndrome and have been in severe pain for over a week. I've also lost control of 3 fingers on my left hand making it difficult to perform normal tasks.
Patient came in with her daughter at the recommendation from a visiting pharmacist from a previous visit as well as a suggestion from her PCP - she was given a prescription for PCV 13 from the PCP.  Neither had received PCV 13, were eligible under Medicare Part B and decided to receive the immunization at this facility. The patient indicated that she had received a pneumonia shot (PPSV 23) previously without issue (PPSV 23 was given but not given within the past calendar year.)  The patient received the vaccination (PCV 13) intramuscularly to the left arm; she appeared lucid and did not report any unusual pain/soreness.  The patient's daughter returned on 6/6/2016 and mentioned that the patient experienced unusual chills and recorded a temperature of approximately 102F later that evening of the vaccination.  Subsequent to this 'reaction' the patient requested transport to the emergency room.  The patient was admitted through the emergency room and treated by a local facility where she remains.  The patient has been observed to have had local redness near/around the site of injection which has since resolved.  The patient has reportedly experienced some confusion.  The patient's daughter was hesitant to report the incident.  She indicated that the VIS given to her and her mother does indicate/acknowledge the possibility of redness at the site of injection as well as the chills/fever as a potential reaction.  The patient's PCP has been notified of the reaction/incident by the patient's daughter.
Eustachian tube dysfunction and tinnitus (constant high pitch squeal) in both ears.  It's sometimes louder than other times.  It is piercingly loud when exposed to loud noises.  It started the day after the vaccine injection. Other events are: - Frequent headaches (every 2 or 3 days).  They started the day of the injection and are current. - Sore throat.  It started 2 days after the injection and has decreased in the last few days. - Dry throat and chills.  They started a week after the injection and are current. - Soreness in the arm where injected.  This has gone away. I visited my healthcare professional about this.  No treatment was given.  The healthcare professional decided that we'll have to monitor the symptoms for any changes.  If the tinnitus gets worse or persists after a month, then it is suggested that I see an ENT (Ear, Nose, & Throat) doctor.
Large, hard, red lump at injection site and armpit pain starting 6 days post 1st dose of Moderna. Currently still monitoring symptoms.
MenACWY powder vial was pre-mixed with sterile diluent instead of MENVEO packaged diluent. MENVEO powder/sterile diluent combination was administered in the patient's left arm IM. After vaccine was administered staff RN immediately realized that mistake was made. Charge nurse was notified immediately. Charge nurse and staff RN who administered the vaccine explained the situation to the patient's mother. Education was provided to the mother regarding the medical error and that vaccine needed to be repeated. Education on possible side effects was provided and mother was asked to call 911 if patient experienced any shortness of breath, trouble swallowing, or tongue swelling occurs. Mother became very upset and emotional support was provided. Client was at the clinic under supervision for 15minutes after vaccine was administered. No acute distress noted. Typical local side effects explained to mom. Supervisor was notified.
Patient experienced dizziness after 1st dose of covid vaccine, BP was 153/68 and reported feeling anxious. Was taken to ED due to complaints of tongue and throat swelling wit some shortness of breath. No rash, abdominal pain, vomiting, or diarrhea. In the ED patient received diphenhydramine 50mg IV, epinephrine 0.3mg IM, famotidine 20mg IV, methylprednisolone 125mg IV, and 1000mL of normal saline. Discharged home with an EpiPen and 5mg prednisone daily for 5 days.
Complete hearing loss of my right ear.  A sudden zero percent hearing left after 7 days of taking the vaccine.
Patient felt very sleepy; This spontaneous case was reported by a patient family member or friend and describes the occurrence of SOMNOLENCE (Patient felt very sleepy) in a male patient of an unknown age who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On an unknown date, the patient experienced SOMNOLENCE (Patient felt very sleepy). At the time of the report, SOMNOLENCE (Patient felt very sleepy) outcome was unknown.            It was unknown if any treatment was given or if patient was under any concomitant or regular medication.   This case was linked to US-MODERNATX, INC.-MOD-2022-658060 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2022-658060:
Information has been received from a registered nurse concerning a patient who on 18-JUN-2012 was inadvertently vaccinated with a dose of improperly stored MMR II (lot # 670621/0568AA, expired on 15-APR-2012). No adverse effect reported. It was unknown if the patient had sought medical attention. This is one of several reports received from the same source. Additional information has been requested.
Day 10 hives developed covering both hands, upper and lower arms, the sid4es and small of the back and in patches on both legs. Hives resolved partially and flared again several times. By day 19 hives returned, given Benedryl by Corpsman. Patient developed shortness of breath and his "throat closed". Patient lost consciousness. Was given epinephrine, , Benedryl and O2. He wa transported to a medical facility by EMS.
Swelling, redness, itching, and pain in both knees. Treatment - ibuprofen / BENADRYL.
1st dose administered to 13 year old patient; This spontaneous case was reported by a pharmacist and describes the occurrence of PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (1st dose administered to 13 year old patient) in a 13-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 051C21a) for COVID-19 vaccination.     No Medical History information was reported.    On 24-Jun-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 24-Jun-2021, the patient experienced PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (1st dose administered to 13 year old patient). On 24-Jun-2021, PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (1st dose administered to 13 year old patient) had resolved.        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 received DTaP-HIB vaccine on 4/2/08 and returned on 4/3/08 with red, swollen, bruised arm.  Had pain but able to move.  Includes entire upper arm.
Caller returning call with patient information regarding improperly stored vaccine administration; This spontaneous report was received from a "purchasing assistant" and refers to a currently 4-year old patient of unknown gender and race. Information regarding the patient's concomitant therapies, concurrent conditions, medical history and historical drugs was not provided.   On an unspecified date, the patient was vaccinated withan improperly stored dose of Measles, Mumps, Rubella and Varicella (Oka-Merck) Virus Vaccine Live (rHA) (PROQUAD) 0.5 milliliter, lot # T005406, expiration date 12-AUG-2021 for prophylaxis (frequency and route of administration not reported) (product storage error).  The improperly stored suspect vaccine experienced a temperature excursion of - 9.5 Celsius degrees (°C) for 8 hours and 53 minutes, and -10.1°C for 6 hours and 40 minutes. The call was made due to a digital data logger. No previous temperature excursion was reported.; Sender's Comments:  US-009507513-2009USA008520: US-009507513-2009USA008353: US-009507513-2009USA008397: US-009507513-2009USA008398: US-009507513-2009USA008449: US-009507513-2009USA008475: US-009507513-2009USA008486: US-009507513-2009USA008553: US-009507513-2009USA008555: US-009507513-2009USA008557: US-009507513-2009USA008746: US-009507513-2009USA008761: US-009507513-2009USA008780: US-009507513-2009USA008804: US-009507513-2009USA008870:
After three Pfizer shots; I got the dreaded "Positive" on a COVID test last night and have some mild symptoms; I got the dreaded "Positive" on a COVID test last night and have some mild symptoms; This is a spontaneous report received from contactable reporter (Consumer or other non HCP). The reporter is the patient.  A patient (no qualifiers provided) received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 3 (booster), single, (Batch/Lot number: unknown) as dose 2, single and (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: IMMUNISATION (medically significant), outcome "unknown", described as "After three Pfizer shots"; DRUG INEFFECTIVE (medically significant), SUSPECTED COVID-19 (medically significant) all with onset 07Dec2021, outcome "unknown" and all described as "I got the dreaded "Positive" on a COVID test last night and have some mild symptoms". The patient underwent the following laboratory tests and procedures: sars-cov-2 test: (07Dec2021) positive, notes: got the dreaded Positive.  The lot number for bnt162b2 was not provided and will be requested during follow up.
Inflammation started on the right and left sides of my neck two days after the shot. The pain was dull and lasted for about two days. The pain then moved to the middle of my back at the spine and blades of my lower back shoulders. The pain has lasted for a little over a week now and has lessened over time but is still noticeable. If I tried to sneeze or inhale deeply, this was difficult due to the discomfort I felt in my back and the sides of my neck.