chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Dermatomyositis; massive swelling on her face; weakness; weakness of her immune system; red rashes; This spontaneous case was reported by a consumer and describes the occurrence of DERMATOMYOSITIS (Dermatomyositis) in a 55-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    In February 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In February 2021, the patient experienced DERMATOMYOSITIS (Dermatomyositis) (seriousness criterion medically significant), SWELLING FACE (massive swelling on her face), ASTHENIA (weakness), DECREASED IMMUNE RESPONSIVENESS (weakness of her immune system) and RASH ERYTHEMATOUS (red rashes). At the time of the report, DERMATOMYOSITIS (Dermatomyositis), SWELLING FACE (massive swelling on her face), ASTHENIA (weakness), DECREASED IMMUNE RESPONSIVENESS (weakness of her immune system) and RASH ERYTHEMATOUS (red rashes) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Patient received the first dose of the vaccine on February but he said he might be wrong. Patient had stop working because of her symptoms. Her health care professional told her not to receive the second dose of the COVID19 vaccine. It was reported that she was so weak and was not able to shower, that she was now aware that she would have the disease for the rest of her life. Her health care professional stated that dermatomyositis was triggered by the shot.  Treatment included cancer drug injection, unspecified shots, medication, a vegetarian diet and steroids.  Company comment: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Inadvertently given to under 18.  We were supplied with incorrect  birth date so was processed and given.
Patient got dizzy, vision was blurry, body felt tingly and hot. Patient felt like he was going to faint. His face/lips turned a gray color. We called emergency number. Patient did not have anaphylaxis. Symptoms started within a few minutes of the dose.
Dizziness 30 minutes after injection.  Flushing of face for a few minutes and the severe headache starting 4 hours after injection.  On 8th day, I got COVID arm.  At that point, headaches, dizziness, blurred vision, brain fog worsened and continued for 4-5 months.  Now suffering from gastrointestinal issues and palpitations.
I received the vaccine at 8:45 am on 04/11/21.  By 3pm I was experiencing fatigue and full body muscle aches, which were temporarily helped by Tylenol.   By 5pm I had fatigue, very severe chills, a low grade fever (just under 100) and moderate to severe body aches.   Today, 4/12/21, I am fine except for some lingering fatigue.  I am very grateful to have received the vaccine, and am only reporting in case this is helpful to other people.  (My husband got it at the same time and had no ill effects.)
Shortness of breath, chills, and aches for 2 days at home. ED visit and admitted 2 days. returned to baseline oxygen while admitted.
Initial information received on 13-Nov-2018 regarding an unsolicited valid non-serious case received from a nurse. This case involves a 2 months old patient who received dose of each vaccines PENTACEL (HIB lot number C5507AA, expiration date: 05-Sep-2019, IPV lot number C5324AC, expiration date: 05-Sep-2019) via unknown route in the right thigh and ACTtHIB (lot UI910AA, expiration date: 18-Nov-2019) via unknown route in the left thigh on 13-Nov-2018. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. The subject received concomitant medication with ROTAVIRUS VACCINE and PREVNAR 13 on 13-Nov-2018. It was a case of actual medication error due to extra dose administered. It was not reported if patients had any adverse event. It was also reported that child did not receive Hep B at this appointment. This was the child's first dose in the series of PENTACEL. 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.
Initial information received on 05-Feb-2019 regarding an unsolicited valid non-serious case received from a nurse through a specialty pharmacy via other company (Intercept Pharmaceuticals) under MFR number: PM2019000068. This case involves a 61 years old female patient who experienced pain, muscle aches, chills, injection site pain and injection site redness, nasal drip, head cold and fever, while she received vaccines FLUBLOK QIV (also reported as Flu Vaccine VII), PREVNAR 13 and OBETICHOLIC ACID [OCALIVA]. The patient's medical history included primary biliary cirrhosis, unspecified lung disorder, and allergies to penicillin, Bactrim (trimethoprim/sulfamethoxazole), and Ursodiol (ursodeoxycholic acid). Concomitant medications included B Complex (calcium pantothenate, cyanocobalamin, nicotinamide, pyridoxine hydrochloride, riboflavin, thiamine hydrochloride), aloe vera oil, Centrum Silver (ascorbic acid, biotin, calcium, calcium pantothenate, chlorine, chromium, colecalciferol, copper, cyanocobalamin, folic acid, iodine, iron, magnesium, manganese, molybdenum, nickel, nicotinamide, phosphorus, phytomenadione, potassium, pyridoxine hydrochloride, retinol, riboflavin, selenium, silicon dioxide, thiamine hydrochloride, tocopherol, vanadium, zinc), Hyzaar (hydrochlorothiazide, lorsartan potassium), Synthroid (levothyroxine sodium), calcium magnesium zinc, folic acid, Vitamin C (ascorbic acid), D3 (colecalciferol), Turmeric (curcuma longa), and fish oil. On an unknown date, the patient received a dose of suspect INFLUENZA QUADRIVALENT RECOMBINANT VACCINE lot number not reported. On an unknown date, the patient received a dose of suspect PREVNAR 13 not produced by Sanofi Pasteur lot number not reported via unknown route. On 19-Nov-2018, the patient started taking OCALIVA (OBETICHOLIC ACID) 5 mg QD oral (with an unknown batch number, 10-Nov-2019) for Primary biliary cholangitis. On an unknown date OCALIVA (OBETICHOLIC ACID) dosage was changed to 5 mg 3 times a week. On an unknown date, the patient experienced fever, chills, muscle aches, pain, nasal drip, a head cold, and injection site pain/redness following the doses of FLUBLOK QIV, PREVNAR 13 and OCALIVA. It was noted that these events could have been secondary to the patient's receipt of the PREVNAR 13 and influenza vaccines or her comorbidities which included an unspecified lung disorder. No lab test was reported. Final diagnosis was fever, head cold, nasal drip, injection site pain and injection site redness, chills, muscle aches and pain. It was not reported if the patient received a corrective treatment. The outcomes of the events were unknown. Sender's comment: Company Comment: Per the current reference safety information - USPI, the reported events of chills, muscle aches, pain, injection site pain, nasal drip, head cold, and injection site redness are listed, and the reported event of fever is listed. Based on the information available, the reported events were considered related to the co-administration of the vaccine injections but not with the obeticholic acid therapy. List of documents held by sender: none.
patient received moderna covid booster 10/7/23 without any signs of immediate allergic reaction. On 10/8/2023, she has a syncopal event while sitting at a table the following afternoon. Similarly, she experienced this within 24h after receiving first modern booster and two-series moderna vaccination approximately one year ago.
Diffuse body rash required outpatient treatment that included oral steroid and antihistamine.
Miscarriage confirmed on 12/21/21 after fetal heartbeat detected on 12/3/2021. Influenza vaccine administered 12/3/2021.
Developed redness, swelling, warmth at injection site requiring ER visit for antihistamine and antibiotic.
Constant dizziness, brain fog, head aches since  receiving the vaccine. Symptoms vary between  mild and severe   Makes working challenging. I was prescribed prednisone which didn?t help. I have increased vitamin supplements including vitamin c, zinc, omega 3 and vitamin d and quiet all caffeine none of which have help. Taking everything day by day.
tested positive for COVID-19; tested positive for COVID-19; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 69-year-old female patient received bnt162b2, bnt162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), as dose number unknown (booster), single (Batch/Lot number: unknown) for covid-19 immunisation; bnt162b2 (BNT162B2), as dose 1, single (Batch/Lot number: unknown) and as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "hypoglycemia" (unspecified if ongoing), notes: since caller was a kid; "bronchitis", start date: 2019 (unspecified if ongoing), notes: before COVID; "had rash" (unspecified if ongoing); "hives" (unspecified if ongoing); "respiratory issues" (unspecified if ongoing). There were no concomitant medications. Past drug history included: Toradol, start date: 1992, reaction(s): "allergic". Vaccination history included: Flublok (Stated this vaccine was not like Flublok, that caller was given years before), for Immunization; Tetanus vaccine, for Immunization, reaction(s): "Allergy". The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 30Aug2023, outcome "unknown" and all described as "tested positive for COVID-19". The event "tested positive for covid-19" required emergency room visit. The patient underwent the following laboratory tests and procedures: Heart rate: (unspecified date) went down into 40s; Respiratory rate: (unspecified date) was below 92; SARS-CoV-2 test: (30Aug2023) Positive. The information on the batch/lot number for bnt162b2, bnt162b2 omi ba.4-5, bnt162b2 has been requested and will be submitted if and when received.
This case was reported by a healthcare professional, via GSK representative, and described the occurrence of cheek numb in a female subject of unspecified age who was vaccinated with TWINRIX (GlaxoSmithKline), BOOSTRIX. On 6 August 2010 at 11:30 the subject received unspecified dose of TWINRIX (unknown, unknown arm), unspecified dose of BOOSTRIX (unknown, unknown arm). On 6 August 2010, 5 minutes after vaccination with BOOSTRIX and TWINRIX, the subject experienced cheek numb and tingling in cheek. At the time of reporting the events were unresolved. The healthcare professional reported that one of the office employees was given a TWINRIX vaccine in one arm and a BOOSTRIX vaccine in the other arm. Within 5 minutes or so, minutes after the administration, the subject developed numbness and tingling in her cheek. The reporter stated that she had to take subject to an urgent care center for medical attention. No further details were provided. Follow-up received from reporting healthcare professional on 31 August 2010: The subject was 29 years-old. The subject was evaluated by a physician at the urgent care facility for "neuropathy (paresthesia and hypoesthesia of left cheek after immunization (side effect))" and was instructed to rest. This case was assessed as medically serious by GSK. The events resolved on an unspecified date. The healthcare professional did not consider that the events may have associated with medical history/concurrent illness, lack of efficacy, erroneous administration or suspected transmission of an infectious agent via a medicinal product.
Rash, redness, swelling, warmth to site. No c/o pain to site voiced. Site location left upper thigh 10 1/2cm x 8cm.
employee/patient vomited and had diarrhea 20 min after flu vaccine was injected. Lasted 3 hours. She was tested for COVID and is neg.
large red area around injection site , first noticed on 3/25/21. but i hadn't checked earlier
Shot received 5/14/21- Severe reaction, Weakness, Dizziness, Tiredness, Flu-like symptoms, Not feeling well to the point of not being able to think clearly. Overtime I observed an increased incidence of forgetfulness, irritation, combined with a lack of desire to be active. On 2/9/22, Stroke occurred, started slurring speech, and blood sugar levels 300.  From this point forward, hospitalization was continuous. On approximately 8/22/22 low hemoglobin occurred dropping to 6.5. She was then given blood transfusion. On approximately, 8/24/22-8/25/22, she was sent to ER at local Hospital to treat bleeding hand, blood thinners made it difficult to stop bleeding, however there was an unexplained sudden drop in platelet count from normal to approximately 20,000 and then to 6,000
19 day female old given oral rotavirus vaccine during wcc due to error per MA. Error was communicated to parents as well as risk factors and red flags. Vaccine was supposed to be given at 2 months of age. Vaccine information such as lot number and expiration date unavailable.
On the day I received the booster,  September 29,  I had no reaction.  On the evening of October 3 before getting into bed I started with my eyes swelling and I got hives on my body in many places.  I woke up with swollen lips and hives that seemed to go away during the day.  In the evening they appeared again.  I had swelling of my eyes and lips and hives and itching over my body most but not all days until January 26th.  It was overnight on the 25th/26th that I had a severe reaction (my throat felt like it was closing.  I went to the Hospital ER at 3:00 a.m.  They infused benedryl, ephemepheran (sp) and other drugs which stopped the reaction.  They admitted me for observation and placed me in the step down unit of the ICU overnight.  I have not had an allergic reaction since that date.  A visit to my doctors and an allergist fora firm diagnosis was not conclusive.  I saw that this reaction has been associated with the booster.
"little lines came back on both legs"; itching; blood blisters; (blood blisters)Couple of them breaking; "rash on both legs from knees down"; "couple of patches on the thigh"; This spontaneous case was reported by a consumer and describes the occurrence of SCRATCH ("little lines came back on both legs"), PRURITUS (itching), BLISTER (blood blisters), BLISTER ((blood blisters)Couple of them breaking) and RASH ("rash on both legs from knees down") in a 71-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 044A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 31-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 07-Apr-2021, the patient experienced SCRATCH ("little lines came back on both legs"), PRURITUS (itching), BLISTER (blood blisters), BLISTER ((blood blisters)Couple of them breaking), RASH ("rash on both legs from knees down") and RASH ("couple of patches on the thigh"). On 14-Apr-2021, SCRATCH ("little lines came back on both legs"), BLISTER (blood blisters), BLISTER ((blood blisters)Couple of them breaking), RASH ("rash on both legs from knees down") and RASH ("couple of patches on the thigh") had resolved. At the time of the report, PRURITUS (itching) was resolving.        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.   Starting 07Apr2021 (described as "after a week"), the patient experienced "rash on both legs from knees down" (described as "couple of patches on the thigh", "little lines came back on both legs with blood blisters with a couple of them breaking", and itching). The patient recovered from the rash on 14Apr2021, but is still recovering from itching.   Reporter did not allow further contact
Developed fever, the evening the vaccines were given. Shrieking and screaming episodes of brief duration then the night with brief episodes of jerking of legs. Seen in office the next day. PE: remarkable for fever and 50 cent-sized area of redness and tenderness at the site of the DTAP. Went to ER for further evaluation. Developed seizure requiring Ativan, phosphenyton and phenobarbital to stop activity. Total seizure duration unknown. No further seizure X 2 hospital days. Discharged on phenobarbital. ER diagnoses included leukocytosis.
2 days after vaccine patient felt very tired.  That has continued until 5 days ago when she became very exhausted.
2 weeks ago 1st dose; two days later pain in LT hip, progressively worse, moved over to middle of back
no symptoms following event time; Adult Patient was inadvertently administered the V AQT A Pediatric and Adolescent Formulation; V AQT A Pediatric and Adolescent Formulation; This spontaneous report as received from a a certified medical assistant and refers to a 59-year-old patient. No information regarding the patient's pertinent medical history, concomitant medications and drug reactions or allergies was reported.    On 20-SEP-2021, the patient was inadvertently vaccinated with pediatric and adolescent formulation of hepatitis a vaccine, inactivated (VAQTA) lot # T037329 was confirmed to be valid, expiry date 30-APR-2022; intramuscular in the right deltoid (exact dose was not reported for both; lot # and expiration date were not reported for the second vaccine) for prophylaxis (product administered to patient of inappropriate age and accidental overdose). No adverse effects were reported.
Pfizer Covid-19 Vaccine second dose  on 02/28/2021 at 1:00 P.M. Very chilly all day next day  on 03/01/2021.  Redness and pain on the arm at the vaccine site on 03/03/2021 at 9:00 A.M.
5/19/2021 muscle aches and chills noted at 5 am. 5/20/2021 rash developed around 10 am when muscle aches ceased.
1/26/22 Initial IM injection felt more painful than normal - in my 15-minute waiting period my shoulder ached, I looked at the injection site and it was very high, near the subacromion space on the proximal edge of my humerus. I noticed she injected with a 1.5" needle also. I was concerned it may have been in the joint, but I wasn't certain. I went home and did arm workouts to keep the injection spread out and limit pain in the shoulder over the next few days. Within 60 minutes of the shot, I already had shoulder pain with range of motion, my left shoulder hurt during movement which I did not experience during my previous 2 injections of Moderna. I stopped exercise and began to massage my deltoid muscle. I did this for about an hour and then stopped to take some medication and rest As predicted (similar to my previous two Moderna vaccines) I began to feel ill later that night - normal fatigue, fever, chills, body aches. I went to bed and got up in the morning for work after taking tylenol, ibuprofen and an anti-histamine to help me fall asleep.  1/27/22 - I felt better (no fever or chills, but still felt fatigued) my arm was of course still sore in the morning of the 27th, but after lunch I significantly worsened. I had tremendous rigors, chills and a temp of 102.1 with body aches. I rested (shook)  in my chair for an hour and then went home to hopefully recover.  I was ill though the night on the 27th with similar symptoms. And used NyQuil and Ibuprofen so treat in the PM 1/28/22 - I remained in bed all day on the 28th with continued fever of 101.4-102.1, body aches, shoulder pain, fatigue, no headache, cough, or congestion.  I had a 101.4 temperature at bedtime (10:00PM) on Friday the 28th, this surprised me now. I had never had side effects from the shot longer than 24 hours. I was moving into more than 48 hours of side-effects now.  1/29/22 The night of the 28th and early morning of the 29th I continued to sweat, have chills and body aches. I did not take my temperature. I woke up in the MA on the 29th with sweat throughout my sheets and pillows.  I began to improve significantly and took another nap on the afternoon of the 29th until 5:00PM. At this time i awoke, and would say my symptoms resolved. The first day I felt fully normal was Sunday the 30th of January.  Shoulder pain has resolved today 1/31/22
Shot 2 was given on 4/8/2021. Almost immediate bilateral ringing in ears. Approximately 5 days later a severe right earache in addition to the constant ear ringing.  At this writing on the 7th day the ear ringing is still constant with intermittent right ear pain.   Was advised by clinic staff to file this report so you were notified.  Plan to seek medical consultation should this persist.
Within 3-4 hours of the shot, my arm became red where the shot was administered. Probably about the size of a silver dollar. When I woke up the next day, it grew to about the size of a baseball. It was very hot, and I did a temp check, and it was 101.7 degrees. It was red, hot, and itchy. I also marked the border of where it was growing on Saturday evening. On Sunday it grew again and marked it again Sunday night. When I woke up Monday morning, it was even bigger, it was bigger than the size of my hand. I called my doctor and sent her pictures. And she recommended I take Zyrtec to help with the symptoms. And if it got worse, to come in and see her. And then on Tuesday, it was a little better, still growing but not as much. Wednesday the redness died down, but it was still swollen and painful. But definitely less than it had been. And then today 11/11 still painful still red but not as much.