chrisvoncsefalvay/vaers-outcomes huggingface dataset:
exacerbated fibromyalgia/extremely fatigued/constant full body pain/ Sleeping; gums changed color; teeth became sensitive to heat; This spontaneous case was reported by a patient and describes the occurrence of FIBROMYALGIA (exacerbated fibromyalgia/extremely fatigued/constant full body pain/ Sleeping), GINGIVAL DISCOLOURATION (gums changed color) and HYPERAESTHESIA TEETH (teeth became sensitive to heat) in a  patient of an unknown age and gender who received mRNA-1273 (Spikevax) for COVID-19 prophylaxis.     Concurrent medical conditions included Fibromyalgia.    On an unknown date, the patient received dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On an unknown date, the patient experienced FIBROMYALGIA (exacerbated fibromyalgia/extremely fatigued/constant full body pain/ Sleeping), GINGIVAL DISCOLOURATION (gums changed color) and HYPERAESTHESIA TEETH (teeth became sensitive to heat). At the time of the report, FIBROMYALGIA (exacerbated fibromyalgia/extremely fatigued/constant full body pain/ Sleeping), GINGIVAL DISCOLOURATION (gums changed color) and HYPERAESTHESIA TEETH (teeth became sensitive to heat) outcome was unknown.        The action taken with mRNA-1273 (Spikevax) (Unknown) was unknown.       No Concomitant medication was reported.  Patient  reported vaccination exacerbated fibromyalgia that patient did not know he/she had. Patient reported it has taken over 1 year and thousands of dollars to get treated and this may be a debilitating and he/she may not be able to work in a few years. Patient noticed something was wrong when gums changed color and teeth became sensitive to heat had constant full body pain and extremely fatigued. Patient reported free time is spent at doctors and sleeping. Patient  reached out when first had the side effects. It was reported that the patient want help financially as all his/her money was going to control these symptoms for an incurable illness. No treatment information was provided.  Company comment: This spontaneous case reported by a patient concerns a patient of unknown age and gender with relevant underlying condition of fibromyalgia, who experienced the non-serious unexpected AESI of Fibromyalgia (exacerbated fibromyalgia) which occurred unknown days after administration of a dose of mRNA-1273 vaccine. Patient's gums changed color and teeth became sensitive to heat. Patient had constant full body pain and extremely fatigued. Underlying condition of fibromyalgia remains confounding. The benefit-risk relationship of mRNA- 1273 vaccine is not affected by this report.
Information has been received from a physician concerning a male who is intolerant to regular formula and is on soy formula who on 26-JUL-2007 was vaccinated with a 2mL PO dose of Rotateq. Subsequently the patient experienced severe watery diarrhea after his feedings. The child's mother also has the same symptoms. The physician indicated that she will perform a stool culture test. The patient's severe watery diarrhea persisted. There was no product quality compliant. Additional information has been requested. Follow up information indicated that the patient's stool was negative for rotavirus and the culture showed normal flora. The outcome was recovered on 07-AUG-2007.
Patient ca,e to pharmacy complaining of rash, hives that would not go away after treatment with OTC Benadryl and hydrocortisone. Symptoms began 24 hours after vaccine and are ungoing. Patient reported to pharmacy 5/25/21
PALPATATIONS, SWEATY HANDS, BODY TINGLING. PALPATATIONS RESOLVED PATIENT STILL FELT COLD AND CHILLS STARTED. SHE WAS SENT TO THE ED FOR EVAULATION.
Soreness in left arm at injection site for days followed by fatigue, SEVERE VERTIGO causing nausea.
Injection site was sore and tender to the touch. Day 2 after there was a lump under my skin where injection was. Day 3 it was hot to the touch and the lump was still there. Currently it?s still hot to the touch and there?s a red ring around it. It?s itchy occasionally.
Blood Clot/DVT  Pain and swelling in lower extremity following left elbow reconstruction with contralateral gracilis autograft.
This spontaneous report was received from a medical assistant, concerning a patient of unknown age and gender. No information was provided regarding the patient's medical history, concurrent conditions or concomitant medications. On 25-JUL-2018, the patient was inadvertently vaccinated with an expired dose of PROQUAD, 0.5 ml once, subcutaneously, lot # M049122 and expiration date on 13-JUN-2018, for prophylaxis. Also on 25-JUL-2018, the patient inadvertently received a concomitant unspecified dose of VARIVAX, lot # N002204 and expiration date on 19-JAN-2019, for prophylaxis. Both vaccines were reconstituted with sterile diluent (MERCK), lot # R002715 and expiration date on 20-FEB-2020. No adverse events were reported and no product quality complaint was involved.
Extremely severe headaches and muscle aches, diarrhea, 2 different sets of fever, extreme weakness, shortness of breath, dizziness, pneumonia, bronchitis etc. While visiting I went to two hospitals within a few days and the last one kept me. The first hospital would not give me the H1N1 test unless I was admitted first, sent me home with antibiotics and oxycodone saying I have a bad cold and bronchitis. The second hospital admitted me with pneumonia and both hospitals would not say it was the swine flu but second hospital kept me in isolation, everyone wore mask and I had to wear masks initially until I was discharged. I required steroids which raised my blood sugar levels too high which then required insulin (which I do not normally take) which made me sicker, and I required pain medications and medication to breath which made my nerves shaky and caused me extreme anxiety which was resolved with a medication to calm my nerves. I am still sick and recovering at home which doctors say I will experience another week or more and hopefully I will not have a relapse because of my very weak immune system. 11/16, 11/17 and 11/18/09: Discharge summary, Hospital Records and PCP visit received from dates of service 11/12/09 to 11/14/09. Final Dx: Bilateral pneumonia with reactive airway.      Assessment:  Presents with fever, chills, productive cough, wheezing, appetite decreased, chills and malaise.  Placed on Levaquin IV and Solumedrol IV. No wheezing on morning of D/C.
I had covid in May 2020. Suspected second infection in October. Positive antibody test in January. Second vaccination 4/29. Positive antibody test 5/1. Became sick and tested positive for COVID 5/4. I have proof of all of this. I see some research suggesting people who?ve had covid do not need second shot. It seems important that I?ve had it and got it again after first shot (assuming I actually contracted it before my second). I am the sickest I?ve been. Sicker every time. No fever. Just headache, chills, chest pain, cough, runny nose, pain swallowing, sore throat, wheezing, weakness, fatigue.
Approx 90 mins post immunization, employee became anxious c/o ringing in his right ear, tingling in both legs (hips to toes), nausea, SOB (described as unable to get a good breath).
8/13- more somnolent, and SOB as well as confused. Tested positive for covid 8/14/22. Treatment includes potential paxlovid, albuterol, assessment, oxygen.
wakes up with cramps like they are going to have a period; This spontaneous case was reported by a consumer and describes the occurrence of MUSCLE SPASMS (wakes up with cramps like they are going to have a period) in a 63-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 058H21A) for COVID-19 vaccination.     The patient's past medical history included Menopausal in January 2011 and Surgery. Concurrent medical conditions included Bone disorder and Joint disorder.    On 15-Dec-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced MUSCLE SPASMS (wakes up with cramps like they are going to have a period). At the time of the report, MUSCLE SPASMS (wakes up with cramps like they are going to have a period) outcome was unknown.            Concomitant medications were not reported. Treatment medications were not reported. Patient did not take any medication to treat the side effects but thought about taking a rapid release Tylenol. Patient has comorbidities. Patient is not currently on any medications.   This case was linked to MOD-2022-446890, MOD-2022-446928 (Patient Link).
TX WITH TYLENOL 650MG AT HS OR IBUPROFEN 400MG HS.  DULL ACHE, HURTS TO RAISE ARM UPWARD, ESP ABOVE THE SHOULDERS.
At 10pm flu like symptoms started. Symptoms continued through the day on Sunday and At 10am Sunday 4/11, started vomiting and could not hold anything down (water, dry toast, pedialyte) until about 7pm on Sunday. After 7pm symptoms started going away. Vomited about 10 times on Sunday
Started out with some small itchy bumps on my left arm (same arm as injection). Bumps have continued to spread all up and down arm and I am starting to get patches on right arm and jaw bone line. Very itchy!!
606 doses were given after expiration date; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (606 doses were given after expiration date) in a 35-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 043B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 02-Dec-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 02-Dec-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (606 doses were given after expiration date). At the time of the report, EXPIRED PRODUCT ADMINISTERED (606 doses were given after expiration date) outcome was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. No temperature excursion happened after vial was placed in refrigerator on 17-Nov-2021. No concomitant medication was reported by reporter. No treatment medication was reported by reporter.  No adverse event was reported.
Information has been received from a consumer concerning her husband who was vaccinated with zoster vaccine live (Oka/Merck). The patient developed a reaction at the injection site about 1.5" in diameter, that was red, warm, and painful. It was unknown if the patient sought medical attention. The outcome was not reported. This is one of several reports from the same source. Additional information is not expected.
Mom brought her daughter into clinic for immunizations on 04/25/05. On 04/27/05 9:15AM, mom called to report that her daughter's right arm was hot, red, and swollen. Nurse advised mom to mark the affected area to see if the redness increases and to call the DR . Apply cold pack to area.
Received phone call from client. C/o dizziness, HA, nausea (loss of appetite), and fever with onset 3/8/06. Reports has lost 5 lbs in 4 days. C/o cold symptoms prior to receiving vaccines on 3/6/06.
10/31/2022- in the morning, any kind of exertion, I was getting shortness of breath, I had to stop for a while before it could caught up. I was walking 6 to 7 miles prior to the vaccine. I had a sore arm for a while, but that kind of goes with any vaccination. I mentioned it to my oncologist and he said we need to check into that, but he must have forgot because he did not do anything about it. I have recovered partially, it is better, but I still get shortness of breath if I walk for more than 2 to 2.5 miles.
Moderna COVID-19 Vaccine EUA Swelling of face, mouth and throat; swollen lymph nodes near clavicle on left side; dizziness; vision impacted for a few hours; joint pain (ankles, knees and elbows)
Information has been received regarding a case in litigation concerning a 12 month old male child who was vaccinated with MMR II. Concomitant therapy included vaccinations containing the perservative thimerasol. It is alleged tat the pt received these vaccinations in or about January 1995 through May 1996, and every time he received a multi-dose vaccine. It is further alleged that as a result of the pt's exposure to thimerasol, he sustained severe and permanent personal injuries, including being diagnosed with severe autism and other neurological disorders as well as other severe and permanent health consequences as a result of exposure to high levels of mercury contained in thimerasol. It is further alleged that as a result of exposure to thimerasol and its highly toxic mercury component, the pt has also sustained further neurological insult from other vaccines including MMR II, which does not contain thimerasol, but caused further neurological insult and exacerbated the pt's neurological disorder from the prior thimerasol exposures. Upon internal review, severe autism, injuries, neurological disorders and  severe/permanent health consequences were considered to be other medical events. Additional info has been requested.
pt reported swelling on arm and pain in area under am since getting the shot. Pt was advised to seek further care from her primary care or urgent care doctor if symptoms do not improve and monitor for any worsening of symptoms
Under area and redness at injection site and swelling. Pt went to emergency room for evaluation dx. localized reaction. Consider cellulitis. Prescribed BACTRIM.
Extreme constipation and diverticultis.; Extreme constipation and diverticultis.; This is a spontaneous report from contactable consumer (patient).   A 62-years-old non-pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, lot number: 6206, expiry date: unknown) via unspecified route of administration, administered in left arm, on 07Apr2021 at 11:30 (age at vaccination: 61) as DOSE 2, SINGLE for Covid-19 immunisation. Patient took first dose of vaccination (lot number: 6198, expiry date: unknown), via unspecified route of administration, administered in left arm on 17Mar2021 at 11:15 AM (at the age of 62-years-old) as DOSE 1, SINGLE for Covid-19 immunisation. Medical history and concomitant medications were not reported. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. She did not receive any other medications within 2 weeks of vaccination. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. In Apr2021, the patient experienced extreme constipation and diverticulitis. Treatment was given with antibiotics for the adverse events. Device date was reported as 23Jun2021. The outcome of events was not recovered.   Additional information has been requested.
Hair is falling out; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 76-year-old female patient received BNT162b2 (BNT162B2), on 10Oct2021 as dose 3 (booster), single (Lot number: FB509) at the age of 76 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "blood pressure" (unspecified if ongoing). There were no concomitant medications. Vaccination history included: BNT162b2 (DOSE 2, SINGLE; Lot number: EW0151, Expiration Date: 31Mar2021, Anatomical location: left arm), administration date: 13Apr2021, when the patient was 75-year-old, for COVID-19 immunisation, reaction(s): "Hair is falling out"; Bnt162b2 (DOSE 1, SINGLE), for COVID-19 immunisation, reaction(s): "Hair is falling out".  Additional information: The patient did not had any other conditions. The patient has had all of the shots and everything, even the last one she had. Since she started getting vaccines the patient had noticed her hair was falling out. She started to do research and back tracking everything and noticed it was the vaccine. The patient wanted to know if anything she can do to prevent losing all her hair. The patient always had thick hair and now all of a sudden it was extremely thin. Several months later noticed hair was falling out, like noticed it 6 to 8 months after getting the vaccine. Her drain was full of hair and never had that. The patient was given a blood pressure medicine around this time by her doctor. The patient thought at first it was the blood pressure medicine. However, she stopped the medicine and her hair would continue to fall out and she realized it was not the blood pressure medicine. She confirmed she does not remember the name of the blood pressure medicine. The adverse event did not resulted in Physician Office or Emergency Room visit. The patient did not undergo any relevant lab tests.   The following information was reported: ALOPECIA (non-serious), outcome "not recovered", described as "Hair is falling out".; Sender's Comments: Linked Report(s) : 202201238945 Same patient/AE/drug, different dose of vaccine;
Heart attack after J&J vaccine -   My husband, complained of on and off chest/lung discomfort after two days getting the vaccine. This continued for about 3-3.5 weeks. On the night of Apr 16, he went to bed early not feeling well. Next morning he complained of heaviness in the chest area. We immediately consulted Dr., and mentioned that he got the vaccine. Dr. advised us to immediately go to an Emergency Room. Patient was found to be having a heart attack. His right artery was 100% blocked. The 3 left arteries had no blockage at all. Angioplasty was done and he had a stent placed in right artery. The clot was removed as part of angioplasty. He now needs to be on blood thinners for life.
About 8 hours after my vaccine I started experiencing full body aches, headache, nausea, chills, low grade temp 99.5 (while using Tylenol) and right arm pain  I had a positive covid test 11/24 but my employer said after 4 weeks from the positive test employees are safe to get the vaccine
Within 48 hours of receiving the vaccine on 17-MAR-21, my left arm became notably painful and weaker, seemingly an unusual shoulder pain.  On 24-MAR-21, my condition remained the same, so I attempted to contact Healthcare facility (vaccine administrator), but was then directed to consult my primary physician. The Clinic then directed me to contact the  Healthcare facility.  Eventually, I was able to get an appointment with the Clinic, and the dr proscribed me a 6-day steroid regime (Methylpredinsolone 4 MG tablet) to attempt to reduce pain.
Severe chills; Feels nausea; Dizziness; Not able to drink and eat; Headache; Fatigue; This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (Dizziness), DECREASED APPETITE (Not able to drink and eat), HEADACHE (Headache), FATIGUE (Fatigue) and CHILLS (Severe chills) in a 77-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031M00A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medical history was provided by the reporter.     On 17-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 17-Feb-2021, the patient experienced DIZZINESS (Dizziness), DECREASED APPETITE (Not able to drink and eat), HEADACHE (Headache) and FATIGUE (Fatigue). On an unknown date, the patient experienced CHILLS (Severe chills) and NAUSEA (Feels nausea). At the time of the report, DIZZINESS (Dizziness), DECREASED APPETITE (Not able to drink and eat), HEADACHE (Headache), FATIGUE (Fatigue), CHILLS (Severe chills) and NAUSEA (Feels nausea) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications reported. No treatment reported    Reporter did not allow further contact
presents for evaluation of tightness in her throat beginning approximately 20 minutes prior to arrival.  The patient states that approximately an hour ago she had her 1st COVID vaccine.  ED medications- famotidine (PEPCID) tablet 20 mg (20 mg Oral Given 5/7/21 1120)
Rash developed 12 hours after vaccine below injection site, red raised irregular area down to elbow on left arm.
Soreness and stiff at injection site. Could not lift up arm and some itching at the site.
Information has been received from a physician concerning a female who was vaccinated with Gardasil (yeast). Subsequently the patient experience rash on back. Additional information has been requested.
The patient developed a fever ranging from 100-102 for 7 days, severe swelling of the lymph glands bilatterally in the neck, sore throat, lethargy, vomiting on the 5th day a rash occurring on the trunk on the 8th day after onset of symptoms, hives on the trunk on the 9th day, loss of appetite, weight loss of 11 lbs. in one week. The patient tested negative for strep and monnonucleosis
distraught after receiving the booster dose of the Pfizer Covid vaccine; Humming that won't go away, in her head or ears non stop; worried and frightened; Humming that won't go away, in her head or ears non stop; worried and frightened; Caller states that she needs to talk to someone about her side effect that she has from the Booster Covid Shot.; Humming in my ears after the booster dose of the Pfizer Covid vaccine; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A 80 year-old female patient received bnt162b2 (BNT162B2), administration date 30Oct2021 (Batch/Lot number: unknown) at the age of 80 years as dose 3 (booster), single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (2nd dose), for COVID-19 Immunization; Bnt162b2 (1st Dose), for COVID-19 Immunization. The following information was reported: IMMUNISATION (non-serious) with onset 30Oct2021, outcome "unknown", described as "Caller states that she needs to talk to someone about her side effect that she has from the Booster Covid Shot."; TINNITUS (non-serious) with onset 30Oct2021, outcome "not recovered", described as "Humming in my ears after the booster dose of the Pfizer Covid vaccine"; AGITATION (non-serious), outcome "not recovered", described as "distraught after receiving the booster dose of the Pfizer Covid vaccine"; ANXIETY (non-serious), FEAR (non-serious), outcome "unknown" and all described as "Humming that won't go away, in her head or ears non stop; worried and frightened". The events "humming in my ears after the booster dose of the pfizer covid vaccine" and "distraught after receiving the booster dose of the pfizer covid vaccine" were evaluated at the physician office visit. Therapeutic measures were taken as a result of tinnitus, agitation.  Additional information: On 30Oct2021 had the Pfizer booster, and since then have this humming in her head and ear, like a distant air conditioner, and it wont go away. she want to know if this a symptom of this because it started up after the Pfizer booster. It is constant, and it sounds like it is out in the distance. she went to the doctors when it started and, they saw wax in it and they cleaned her ears, but it did not help, it has gotten worse, she need help, it is like a hummin in the background. Also reported Humming that wont go away has been there for 2 weeks now, in her head or ears nonstop: worried and frightened.  The lot number for bnt162b2 was not provided and will be requested during follow up.
This is an instance of breakthrough COVID-19 disease after which death occurred with a possible administration error, in the interval between first and second vaccine dose. The individual was vaccinated with the Pfizer product on 03/01/2021 and 03/18/2021. The individual became symptomatic on 08/20/2021. They tested positive at an urgent care clinic on the same day. They presented to emergency department on 08/27/2021 with primary complaints of shortness of breath and low oxygen (oxygen saturation in the 60's in at-home monitoring). The individual was admitted to hospital the same day. They experienced complications of COVID-19 pneumonia, ventricular tachycardia cardiac arrest, acute myocardial infarction, acute respiratory syndrome, acute hypoxic respiratory failure, and metabolic/respiratory acidosis.  They died on 09/06/2021.