chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This case was reported in a literature article and described the occurrence of rhabdomyolysis in a 76-year-old male patient who received Influenza vaccine. Concurrent medical conditions included chronic kidney disease and hyperlipidemia. Concomitant products included Atorvastatin. On an unknown date, the patient received influenza vaccine (unknown). On an unknown date, 3 days after receiving Influenza vaccine, the patient experienced rhabdomyolysis (serious criteria hospitalization and GSK medically significant), Stevens-Johnson syndrome (serious criteria hospitalization and GSK medically significant), weeping rash (serious criteria hospitalization) and renal failure (serious criteria hospitalization and GSK medically significant). The patient was treated with medication unknown (Unspecified Treatment), SOLU-MEDROL and diphenhydramine. On an unknown date, the outcome of the rhabdomyolysis, Stevens-Johnson syndrome, weeping rash and renal failure were unknown. It was unknown if the reporter considered the rhabdomyolysis, Stevens-Johnson syndrome, weeping rash and renal failure to be related to Influenza vaccine. Additional information received: This case was reported in a literature article and it described the occurrence of rhabdomyolysis secondary to an Stevens-Johnson syndrome in a 76-year-old male subject who had previously received an unspecified influenza vaccine (manufacturers unknown). The subject's concurrent medical conditions included chronic kidney disease and hyperlipidemia. Concomitant medications included atorvastatin for the hyperlipidemia. His baseline creatinine level was 2.0 mg/dl. No further information on the subject's medical history, concurrent medical conditions or concomitant medication was provided. On an unspecified date, the subject received an unspecified influenza vaccine (dosage, route and administration site unknown; batch number not provided). On an unspecified date, 3 days after receiving the vaccine, the subject presented with a widely distributed and weeping rash. He later required renal replacement therapy and was diagnosed with rhabdomyolysis secondary to Stevens-Johnson syndrome. This is a serious case as the subject required admission to an intensive care unit. Initial blood tests revealed a creatinine level of 4.4 mg/dl and his creatinine kinase levels were found to be elevated at 2610 IU/L. Skin biopsy epidermal revealed sloughing, necrotic keratinocytes and vacuolar interface dermatitis that confirmed the diagnosis of rhabdomyolysis secondary to Stevens-Johnson syndrome. Treatment consisted of renal replacement therapy, SOLU-MEDROL and diphenhydramine. Outcome of the events was unknown at the time of reporting. The authors commented that the possibility of an influenza vaccination triggering rhabdomyolysis is rare. The authors concluded that "rhabdomyolysis triggered by an influenza vaccination is an important complication to be aware of, as early recognition can lead to better outcomes".
Felt like I was going to pass out; Jittery; Warm to the touch injection site; Itchy; Red,5-6 cm in size; Pain at site/very very sore to touch only; A spontaneous report was received from other healthcare professional  concerning a 51-years-old, female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced pain at site/ vaccination site pain, itchy/ vaccination site pruritus, painful/ pain and hot/ vaccination site warmth, red, 5-6 cm in size/ vaccination site erythema, very very sore to touch only, felt like was going to pass out/ loss of consciousness and jittery/ feeling jittery.  The patient's medical history included hypothyroidism.  Concomitant product use was not provided by the reporter.   On 11 Mar 2021, prior to onset of events, the patient received their first of two planned doses of mRNA-1273 (Batch Number: 002A21A) intramuscularly in the left non dominant arm for prophylaxis of COVID-19 infection.  On 11 Mar 2021, patient experienced pain at site, itchy, painful and hot, red, 5-6 cm in size, sore to touch. On 12 Mar 2021, patient felt like was going to pass out a medically significant event and jittery. Treatment details included arnaca cream and neosporin applied to location.  Action taken with mRNA-1273 in response to the events was not reported.   The outcome of the events felt like was going to pass out and jittery was resolved on 13 Mar 2021. The outcome of the events pain at site, itchy, painful and hot, red, 5-6 cm in size, sore to touch was not reported.; Reporter'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.
That day had the sore arm, then 4 days later got a big knot where the vx was given. Following week ( 01/21/2022)/ is when she noticed the nodule on her throat. Called Dr that morning and was advised to get a Thyroid ultrasound, results: Prominent left thyroid nodule was 3.5 cm was dominating left lobe. Then had a CT scan with contrast to further confirm diagnosis and to see if it was pressing into her voice box. Said both tests finding were moderately suspicious and ordered fine needle aspiration biopsy. Results: A benign Focular nodule and it was categorized Bethesda category. Then had me follow up with an Endocrinologist, but is having to wait until 3/1/2022.
Sore arm; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (Sore arm) in a 77-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concurrent medical conditions included Hepatitis C.   On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to at an unspecified dose. On an unknown date, the patient experienced VACCINATION SITE PAIN (Sore arm). At the time of the report, VACCINATION SITE PAIN (Sore arm) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) and mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) was unknown.       Concomitant medication include thyroid medication. No concomitant medication information was provided. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments
Site: Pain at Injection Site-Mild, Systemic: Confusion-Severe, Systemic: Fever-Medium, Systemic: Hypotension-Medium, Systemic: Stroke-Medium
Syncope rxn as nausea, eye rolling, shaking, loss of consciousness. Supportive care, pt was seated, held him preventing falling.
Evening I had the vaccine,  started stiffness and couldnt lift my arm, left arm.  Burning sensation in shoulders then went from arm to back of my neck. I felt a burning sharp pain. No fever, cause I thought it would wear off eventually. The pain is worse at night when I try to lay down for a couple of hours. The pain is now in both arms, but is worst in the left arm (at vaccine site).  Shoulders feel like I was lifting weights.  Back of left arm was red with pain.
Client called on 2/18/21 and stated 48 hrs after her vaccine she had extreme fatigue and chills that lasted 24 hrs, and body aches and sweating that lasted 48 hrs. Client felt "foggy" in the brain for 1 week and was tachycardic for this week. 1 week after the vaccination she had dizziness. The symptoms have since resolved. She will not be getting her 2nd dose of vaccine.
The site where both vaccines were given became red the next day, and by day 5 post vaccine, the site looked worse, increased redness and swelling. Contacted virtual MD on her computer, due to the fact it was the weekend. Virtual MD diagnosed a cellulitis and put her on antibiotics. Since being on antibiotics, the site is healing well.
left arm pain, right eye throbbing, right side headache, nausea, shortness of breath
Day 1, after the vaccine, my booster, 11/18/2021, site was a little sore, temperature 98.3. Day 3, site was a little tender, but everything was back to normal. 11/25/2021, sore throat. 11/26/2021, telehealth with a nurse practitioner, felt it was a Respiratory Virus. I am on a lot of preventative meds because I have Asthma. I just continued taking those medications. It took me about a week to feel like I was over it. I started having IBS, the following week and I had a bout on 12/08/2021 and that has resolved. On 12/04/2021, I had to go to the ER, a local hospital, because I had chest pain was not letting up. The paramedics transported me there. They found my sodium was low and they released me on the morning of 12/05/2021. They held me for observation overnight. I was not put in an inpatient bed. Subsequent to that, I had a follow up, I was not able to get in with my regular doctor, so I saw the nurse practitioner, on 12/13/2021, she felt everything was resolved. She did not order any lab work. 12/20/2021 my doctor ordered lab work because my kidney function was a little off. My electrolytes were back to normal. She had me do repeat lab work on 12/23/2021 and all that came back fine.
Pt had received 3 doses of Pfizer 6mo-4yr COVID vaccines, which completed their COVID vaccine series. A Moderna 6mo-5yr bivalent booster was incorrectly ordered for this pt. A monovalent dose of Moderna 6mo-5yr COVID vaccine was given. Pt mother was notified by office medical director. As of today, pt is currently well with no signs or symptoms of reaction. Staff re-education on COVID vaccination has been addressed.
patient was supposed to receive the updated booster for covid19 (bivalent) and ended up receiving the monovalent
Patient states feeling  "drained" with no energy the next day.  She had a slight headache and wanted to lay down she felt so exhausted.  Her neck hurt and she ached all over.
I have been having a lot of asthma attacks, it ha d been under control for 4 years and lost weight rapidly, extreme amount of energy. I have insomnia, I'm anemic. B12 and B9 deficiency. They upped my asthma meds. My menstrual cycle is off and I'm having heavy bleeding. I have a follow up with my gynecologist . i'm always nauseated. I have to force myself to eat.
Patient was administered a Pfizer Covid-19 vaccine that was exposed to a temperature excursion. (Vaccine was between 8-14.5 degrees C for 7hrs and 48 minutes). Pfizer was contacted and advised the clinic to consider the dose as invalid and to revaccinate. Patient was revaccinated on 03/19/21 to complete the series.
Patient was administered Menactra around noon on 10/01/2007. Patient by 7 PM developed severe Headache, nausea and chills, Numbness of hands and fingers,and remained afebrile. BY midnight vomited, felt better and slept with Benadryl and MOtrin for possible migraine. I checked with the family at 12 midnight and instructed to call me if she remains ill teh next day. By 10 AM on 10/02/2007 I received a call about pounding headache and back pain. I asked the mother to bend the neck and make her touch the chest with her chin.She complained of pain and stiffness. I triaged her via ER to get spinal tap. Her CSF showed 157 WBC, 6 RBC, 40 mgms protein and 60 mgms glucose with a blood glucose of 106 mgms%. CIE PCR for Western Nile Virus were negative for major pathogens. She still has severe Headache and is febrile now. She is receiving VAncomycin and IV Rocephin. We stopped Vancomycin today after 24 hours but continuing Ceftriaxone. Mono screen is negative.By cause and effect I do feel this is secondary to Menactra. Unusually rapid onset of Aseptic Meningitis.She has been in good health adn has good immune system.I want to know if possible, to obtain data if reported to you.How prevalent is this type of adverse effect?? 11/5/07-records received for DOS 10/2-10/6/07-DX: Aseptic meningitis.  Onset childs headache, fingers felt numb, eye pain when looking to side, neck pain, light bothers eyes. Seen by PCP on 10/1/07 for C/O lump under left arm/folliculitis, received vaccine on that day. 1/12/2010 Patient also developed aseptic meningitis subsequently with all tests being nogative in August 2008.
shingles; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A male patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose number unknown (booster), single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (DOSE NUMBER UNKNOWN, Manufacturer Unknown), for Covid-19 Immunization. The following information was reported: HERPES ZOSTER (non-serious), outcome "unknown", described as "shingles".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
No adverse events noted.  Documentation of COVID vaccine given in error. Per Immunization Registry, patient received a dose of Pfizer Bivalent on 10/12/22 at Pharmacy, was then give a dose of Pfizer bivalent on 10/17/22 at 9:11AM  at facility.   10/12/22 Pfizer was reconciled into patient's EMR on 10/17/22 at 3;09pm.   This was identified by report.
Hives; This spontaneous case was reported by a consumer and describes the occurrence of URTICARIA (Hives) in a 72-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) (unknown route) at an unspecified dose. On an unknown date, the patient experienced URTICARIA (Hives). At the time of the report, URTICARIA (Hives) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No relevant concomitant medication and treatment information provided.
Cough, chills, cannot lift arm without pain, nauseous, severe headache. Could not get out of bed last night. Went to facility this morning. Sore arm at time of shot. Felt ok until 4-5 hours after shot. Probably feverish, sweating all night but no thermometer.
Patient complained of chest pain about 45 minutes after receiving vaccine.  Mother stated similar reaction occurred after receiving first dose of Pfizer vaccine.
It began in the morning with muscle aches, which progressed to chills and a 102 degree fever in the evening.  The fever came down to a low grade (around 100 degrees) by the morning of 10/31/11 with repeated doses of acetaminophen.  The right arm, which is the arm in which the Pneumovax was given, was sore, red, and swollen.  Symptoms completely resolved by the morning of 11/1/11.
Severe hives started on arm and spread throughout body concentrating on ankles, back, buttocks, and arms
Patient awoke to fever (100°), chills, headache, body aches. Patient noted that the back of her neck and shoulders were very achy. These effects resolved within 36 hours. Patient remained fatigues through 7/11. On 7/12 patient observed in mirror that area over right trapezius was swollen and squishy to the touch. The back of her neck remained sore. The area was still swollen and squishy and her neck still sore at the time of this report
This spontaneous report as received from a consumer refers to a 43 year old female patient with a history shingles in the past. The patient is allergic a Vicatin, Demoral, Amoxicillin and Sulfa. On 28-OCT-2013 the patient was vaccinated with ZOSTAVAX (dosing information and route were not provided). Concomitant therapies included Valtrax. Since 01-NOV-2013, the patient has had 3 episodes of shingles. The first episode of shingles lasted a few days, consisted of minor blisters with minor nerve pain. The second breakout was worse, consisted of the blisters and the nerve pain was a more intense. The third breakout is extreme blistering and intense nerve pain. Usually shingles came in the same area, on her stomach area. The third breakout was on her back. No treatment was provided. The outcome of second and the third breakout of shingles is unknown. Reporter causality was not provided. No reporter details available. Additional information is not expected.
Severe case of brain fog; Itchy tiny little red bumps at injection site , red mark; Itchy tiny little red bumps at injection site , red mark; itchy tiny little red bumps at injection site , red mark; Fatigue; This spontaneous case was reported by a consumer and describes the occurrence of FEELING ABNORMAL (Severe case of brain fog), VACCINATION SITE MASS (Itchy tiny little red bumps at injection site , red mark), FATIGUE (Fatigue), VACCINATION SITE PRURITUS (Itchy tiny little red bumps at injection site , red mark) and VACCINATION SITE ERYTHEMA (itchy tiny little red bumps at injection site , red mark) in a 54-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 027A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 09-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 10-Mar-2021, the patient experienced FATIGUE (Fatigue). On 19-Mar-2021, the patient experienced FEELING ABNORMAL (Severe case of brain fog), VACCINATION SITE MASS (Itchy tiny little red bumps at injection site , red mark), VACCINATION SITE PRURITUS (Itchy tiny little red bumps at injection site , red mark) and VACCINATION SITE ERYTHEMA (itchy tiny little red bumps at injection site , red mark). The patient was treated with HYDROCORTISONE at a dose of 1 dosage form. On 11-Mar-2021, FATIGUE (Fatigue) had resolved. On 20-Mar-2021, FEELING ABNORMAL (Severe case of brain fog), VACCINATION SITE MASS (Itchy tiny little red bumps at injection site , red mark), VACCINATION SITE PRURITUS (Itchy tiny little red bumps at injection site , red mark) and VACCINATION SITE ERYTHEMA (itchy tiny little red bumps at injection site , red mark) 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.   No concomitant medications was reported.
After the vaccine I had a headache. With the headache I became nausea and had serve diarrhea. I was always hot or cold and ran a fever. and also experienced chills. I also did not have a appetite.
Two to four weeks after receiving the second covid vaccination, (she reports she received it in her right arm, but documentation says left arm), she noted a lump in her right upper arm where she received the shot. She noted itching at the right sided injection site two weeks after the shot, and then noted numbness in the right bicep and also right thumb. She was having trouble doing holding her knitting needle but could still knit, and had dropped a plate from her right hand. She had a great deal of trouble raising her right arm to do her hair. She had tenderness on exam in the right bicep area, which was also somewhat swollen. Tingling in her right thumb and forefinger.
On the day of my third (booster) Moderna shot, my arm began hurting almost immediately after the injection, which was of no concern, as this happened with the first two doses. About three hours later, I noticed heart palpitations, which are abnormal for me. I lay down to rest, then the palpitations began again not long after I got up a couple of hours later. My husband and I both felt my pulse and talked about whether I should go to the ER, but decided to wait until the next day to see if the problem would go away. The next morning, I felt fine until I had been up for a few hours and the palpitations began again. I called the local Urgent Care clinic to ask what I should do, and they suggested starting directly at the Emergency Room based on my symptoms, so I went to the ER at around 1:30pm. An EKG taken soon after my arrival indicated abnormalities, so I was admitted and taken back to a patient cubicle where numerous tests began. I was given 4 BAYER aspirin, then when the symptoms abated I was released around 5:30pm. Once I began moving around again, the palpitations started up, but they abated after I took a 10mg dose of Propanolol  prescribed at the ER. The next day, I started the day with a beta blocker, and palpitations began again after around 9 hours, so I took another one before bed. The day after that (the fourth day after my vaccine), I did not take a beta blocker until palpitations began around 2pm, then I swam laps. That night, my pulse registered an alarming 36 BPM, and I thought about returning to the ER, but decided against it, as I had an appointment with my primary care physician to discuss the ER visit and subsequent concerns. At that visit on October 27, my doctor decided to refer me to a cardiologist, and my appointment with that provider is scheduled for November 3rd.  I have stopped taking the beta blockers, and I continue to have low heart rates beginning mid day, alternating with palpitations throughout the day.
On April 16, my left arm started to itch at site of injection; began to scratch at site of injection and realized it was probably due to the vaccine and stopped myself from scratching - this only lasted a few minutes. On April 17,  my left arm started to itch again and upon examining my arm, I noticed it was red, hot to the touch, and a few bumps appeared at the site of injection.  I googled this information and realized I had COVID arm so I immediately applied Cortizone cream which helped immenseley.  I continued applying Cortizone cream for the next 4 days until this issue was resolved.
Around midnight on day of vaccine, 12/23/20,  patient experienced pain at the injection site, which lasted about 20 hrs. Patient also had a severe headache, which he says has abated as of today, 12/28/20. Patient starting having the following problems around midnight on 12/23/20 and is still experiencing them:  fever (99+), occasional chills, difficulty in breathing, restless sleep, coughing, burning sensation in nose and sinuses.
Subsequent to receiving first and second doses of varicella virus vaccine live laboratory evaluation revealed varicella zoster IgG less than or equal to 0.90.
Reported to team member health 5 hours post vaccine with red itchy rash; Benadryl administered (12/29/20)
This case was reported by a mother of a consumer and described the occurrence of injection site soreness in a 13-year-old male subject who was vaccinated with FLULAVAL. A physician or other health care professional hs not verified this report. There were no concurrent medications. On 8 October 2008, the subject received unspecified dose of FLULAVAL at 0.5 ml. On 8 October 2008, less than one day after vaccination with FLULAVAL the subject experienced injection site soreness. Administration of FLULAVAL to this subject was considered to be a drug administration error as FLULAVAL is not indicated for use in subjects under the age of 18 years. At the time of reporting, injection site soreness was resolved. Follow-up via the mother indicated that the subject has experienced no other side effects.
The night of the vaccine Sleep disturbance, sore muscles, can't get comfortable, left arm ache,  body aches  -- neck, legs, hands, feet.  Overall tiredness.  Chills, but no fever.  These symptoms carried over into the second day of having the vaccine.