chrisvoncsefalvay/vaers-outcomes huggingface dataset:
uveitis; canker sores oral; injection site colouration; wearing off effect; bone pain; pain; Injection site pain due to COVID vaccine; aching joints; This spontaneous case was reported by a consumer and describes the occurrence of UVEITIS (uveitis) in a 54-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.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) for Ankylosing spondylitis and Panuveitis.    No Medical History information was reported.   On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form and ADALIMUMAB (HUMIRA) (Subcutaneous) 1 dosage form. On an unknown date, the patient experienced UVEITIS (uveitis) (seriousness criterion medically significant), APHTHOUS ULCER (canker sores oral), VACCINATION SITE DISCOLOURATION (injection site colouration), THERAPEUTIC RESPONSE SHORTENED (wearing off effect), BONE PAIN (bone pain), PAIN (pain), VACCINATION SITE PAIN (Injection site pain due to COVID vaccine) and ARTHRALGIA (aching joints). At the time of the report, UVEITIS (uveitis) had not resolved, APHTHOUS ULCER (canker sores oral), VACCINATION SITE DISCOLOURATION (injection site colouration), THERAPEUTIC RESPONSE SHORTENED (wearing off effect), PAIN (pain) and VACCINATION SITE PAIN (Injection site pain due to COVID vaccine) had resolved and BONE PAIN (bone pain) and ARTHRALGIA (aching joints) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       The patient experienced canker sores, injection site pain due to COVID vaccine, shingle shot pain, injection left a purple mark, pain before HUMIRA, injection, episode of uveitis and bones and joints were achy with HUMIRA (ADALIMUMAB).  Company 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  No concomitant medication information was provided  No treatment product information was provided; 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.
I had a bad headache despite taking a 600mg Ibuprofen at initial onset of this headache,  and felt increasingly overheated and sweaty throughout the night, the headache starting around 1800 day of injection, trouble sleeping and too warm feeling starting closer to 2300, and both headache and overheating lasting through probably about 0300 the following morning. Had I been in the office I would have had to go home ill, and I could not do much but try to rest during this time. The headache through the following day was light and I felt mostly normal by evening.
I felt fine the rest of the day after I received the vaccine.  However, I woke up at 4am the next day with intense cold chills, suspected fever (no thermometer to confirm), and it felt like my arm had been stabbed (much worse pain than usual flu vaccine discomfort).  I took some ibuprofen and Nyquil.  The next morning when I woke up I felt extremely fatigued and had whole body muscle aches.  The cold chills returned around 2pm.  I had a slight head ache.  I took some Dayquil and rested.  The 2nd day after my vaccine I still had some fatigue and muscle aches, but no more episodes of cold chills or fevers.  I continued to take ibuprofen and Dayquil.  The 3rd day after my vaccine I woke up feeling a bit more back to normal and the pain at my injection site was pretty much gone.
Hives that began 11 days post vaccine, that is progressively getting worse including swelling of lips after taking 50 mg, Benadryl. EE referred to ER.
Redness, swelling, warmth & streaking of redness to left arm.  Pt denies fever.  Is going to urgent care.  SWM contacted & notified.  Pt given copy of VAER form
Sore arm, malaise, chills, vertigo, headache, low-grade fever (101 F).
No hx of asthma or allergies. 3 d after FLUMIST, cough in AM with exercise, began without intercedent illness.
Immediately after receiving vaccine the pt complained about a burning sensation down the entire length of her left arm. Checked with pt 2-3 hrs later and burning had ceased.
No sense of smell; This is a spontaneous report from a contactable consumer (patient's husband). This consumer reported same event for two patients. This is the first of two reports. A 62-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot: EL3302, expiry: unknown), via an unspecified route of administration in the left arm, on 04Feb2021 at a single dose for covid-19 immunisation. The patient has no medical history and concomitant medications. The patient got the Pfizer COVID vaccine on 04Feb2021. This morning (12Feb2021), she found out she has no sense of smell. Patient who no longer has a sense of smell noticed it a little while ago, about 9 AM. The reporter wanted to know since the patient had the vaccine if this would cause testing to come back positive. The outcome of the event was not recovered.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021196187 same reporter/drug/AE, different patient
Circulatory issues in patient. chronic pain and swelling in complete left side, toes going numb, pain in chest.
Cluster of two cases of muscular pain at the site of injection and discomfort when moving arm which was vaccinated who had received FLUZONE (lot number U3198AA). Follow-up information received on 16 November 2009 from a healthcare professional. Information was provided for one of the patients, who was a 45 year old female. The patient consulted a physician and was found to have bursitis. The patient recovered. No other information was provided. Follow-up information was received from the pharmacist on 28 April 2010. Both patients fully recovered from the events. The reporter had no additional information to provide.
Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 40-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 06Oct2022 at 16:00 as dose 5 (booster), single (Lot number: GHR693) at the age of 40 years, in right arm for covid-19 immunisation; BNT162b2 (BNT162B2), on 23Mar2021 as dose 1, single (Lot number: ER2613), in right arm, on 14Apr2021 as dose 2, single (Lot number: EW0158), in right arm, on 20Oct2021 as dose 3 (booster), single (Lot number: 320308D), in right arm and on 13May2022 at 17:00 as dose 4 (booster), single (Lot number: FM9992), in right arm for covid-19 immunisation. The patient's relevant medical history included: "Hashimoto's thyroiditis" (unspecified if ongoing); "asthma" (unspecified if ongoing); "chronic rhinitis" (unspecified if ongoing); "bronchial inflammation/infection" (unspecified if ongoing); "recently acquired arthritis or other autoimmune connective tissue d/o (disorder)" (unspecified if ongoing); "Seasonal allergies" (unspecified if ongoing); "endometriosis" (unspecified if ongoing); "adenomyosis" (unspecified if ongoing); "Unclear autoimmune" (unspecified if ongoing); "immune compromised" (unspecified if ongoing); "Known allergies: Contrast dyes" (unspecified if ongoing). The patient's concomitant medications were not reported. Past drug history included: Gabapentin, reaction(s): "Known allergies: gabapentin"; Nuvaring, reaction(s): "Known allergies: nuvaring"; Quafacine, reaction(s): "Known allergies: quafacine". The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 25Feb2023, outcome "not recovered" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: Tested: (09Mar2023) Unknown results; SARS-CoV-2 test: (25Feb2023) positive, notes: Initial Covid positive test. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical course: Initial Covid positive test and significant symptoms; lasted 25Feb2023-09Mar2023. Paxlovid from 26Feb2023 pm to 04Mar2023 am. Remained symptomatic until 09Mar2023. Could not get in touch with medical providers.
No reported adverse reaction...Just that patient was given Moderna and is < 18 yrs of age.
Mother reported this incident to me when she saw me at a basketball game on 4/28/18. She did not come into the clinic, and I never saw the patient during the time of the reaction. Mother reports: Patient woke up on 04/20/18 with a "low grade" fever that became 104 by the afternoon. She kept the temp through Sunday afternoon. She also kept a severe headache, dizziness, and neck stiffness during this time. Monday morning, she had only a low grade fever again (no number provided). By Monday 4/23/18 symptoms were gone and Patient was feeling fine. Mother reports today 4/30/18 via follow up phone call that Patient has had no further problem.
Information has been received from a lawyer regarding a case in litigation concerning a female patient of unknown age. No information was received regarding the patient's past medical history, concurrent conditions, or concomitant medication. On or about 20-NOV-2009, the patient was inoculated with the ZOSTAVAX (lot number, dosage and route of administration not provided) for routine adult health maintenance and the intended purpose of the long-term prevention of shingles and zoster-related injuries. The ZOSTAVAX did not prevent shingles and zoster-related injuries as intended. In or around approximately August 2016, the patient was treated by a physician for herpes zoster or shingles. The outcome of the events is unknown. The patient suffered serious physical, emotional, and economic damages as a result of her shingles and associated injuries. As a direct and proximate result of the ZOSTAVAX vaccine, and/or despite receiving ZOSTAVAX for long-term prevention of shingles and zoster-related injuries, 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. Additional information has been requested.
I developed a rash of red, itchy patches on both arms and my right thigh.  The rash was splotchy. I woke up  with this rash about 44 hours after my 2nd dose of the vaccine and it lasted for approximately 12 hours before fading away.
Excruciating left arm pain. Could not move my arm, could not sleep. Arm was aching and throbbing. 3 days later still painful and cannot easily raise it.
Patient is DECEASED.  Hospitalized 1.30.22 - 3.14.22 (died).  COVID-19 positive (2.3.22).  Fully vaccinated (no booster) Discharge Provider: Withheld Primary Care Physician at Discharge: Withheld Admission Date: 1/30/2022 Date of Death: 3/14/22 Time of Death:  5:47 PM Preliminary Cause of Death: Respiratory failure with hypoxia  Discharge Disposition: Deceased DETAILS OF HOSPITAL STAY: PRESENTING PROBLEM: Acute respiratory failure  Pneumonia of both lungs due to infectious organism, unspecified part of lung  Sepsis, due to unspecified organism, unspecified whether acute organ dysfunction present Acute respiratory failure with hypoxia  HOSPITAL COURSE: Patient is a 74 year old female with past medical history significant for stage IV mantle cell lymphoma diagnosed 12/2019 on maintenance Rituxan, PVT on Xarelto, prior ESBL UTI, history of colovaginal fistula s/p sigmoid colectomy. She initially tested positive for COVID 12/14 and was treated with monoclonals without hospitalization. She was admitteed1/23-1/25 with leg pain and was found to be hypoxic - treated as possible pneumonia. She presented to the ED 1/30 with progressive SOB/dyspnea. Initial CTA w/o PE but did show patchy GGO through bilateral lung fields and new bronchiectasis involving RML and lung bases, and newly identified centrilobular emphysema. She was treated with broad spectrum antibiotics. She underwent bronchoscopy 2/3 - COVID positive on film array otherwise infectious workup negative. She had progressive worsening of oxygen needs progressing to HFNC. Repeat CTA 2/9 with worsening airspace disease. Repeat CTA again on 2/17 without remarkable changes. Patient transferred to the ICU 2/20 for worsening oxygen requirements. Failed HFNC and NRB with desaturations to 60% and was intubated 2/22 and subsequently paralyzed for vent dyssynchrony. Her course was complicated by AKI with hyperkalemia which improved with supportive care. Paralytic gtt was stopped 2/25.  Liver US with dopplers 2/26 showed cirrhotic morphology with sequela of portal hypertension and negative for PV thrombus. Doppler US on 3/3 (+) for left peroneal vein DVT. Lip lesions (+) for HSV. Trach placed 3/9, PEG placed 3/10. 3/11 echo was normal, although study was limited. Course now complicated by pneumomomediastinum with extensive sub Q air, hypotension, hypernatremia and Enterobacter VAP. Family mtng today with Dr. explaining clinical course as well as new VAP and pneumomediastinum.  Family was in agreement to transition to comfort care at this time.  Pt passed peacefully at 1747.
I felt fine at 3:30PM ET on April 18, 2022 when I received the vaccine. As I was receiving it I felt nothing. I got up about 2 minutes later and I felt like I was coming down with something. It felt strange. It passed about 2 hours later. Then 7 hours later I had 2 really bad muscle spasms on my back under my right and left shoulder blade. My back hasn't been giving me problems for over a month until now. My husband tried to help with the pain but that made no difference. When I got up I got extremely cold. My teeth started chattering. Both the right and left arm started having tremors. Then my hands started having tremors. I looked like I had Parkinson's disease. Then about 5 minutes later the whole trunk of my body started having tremors. I put on a jacket and heavy wool socks, and then I got under the covers and it stopped it right away. When I got out of bed, as soon as I got out, the tremors started again. Then I fell asleep. The next day my back was really bad. Then I got on my treadmill. I usually stay on for about 1 hour, but I couldn't do it because my knees hurt. Then for the next 2 weeks I was having muscle spasms. I felt bad so I went to the chiropractor to see if he could help my back pain. That made no difference at all. Then at the beginning of the 2nd week every place I had a back pain at turned into a burning, stinging pain. That was all over my back. The only way I was able to stand up straight was putting on a big wide belt on the worst part of my back. That would stop the stinging and burning on my back. I have a bone spur in my jaw since getting vaccine. I couldn't get the night guard in because there was too much pain. After 3 weeks it stopped. I thought it was over but starting in the 3rd week I started waking up in the night with an agitated feeling in my solar plexus area. I had a feeling of dread. Something happed at 3AM. I had several bowel movements, and that affected my sleep. About 9:30AM it will start again with agitation and jitteriness. I couldn't concentrate. I haven't been able to do regular house cleaning and get on treadmill because of the back pain. I have a recurring thought that what if this never goes away because it is hard to live with it because of periods where I can't function properly. I am sorry I took the shot. I wondered if I had waited 6 or 7 months if it would've made a difference. I went to see a endocrinologist. She said that I didn't have any issues with thyroid. She said I have post vaccine syndrome.
Severe headache, body aches (especially right knee), swollen left bicep,  fatigue, loss of taste. Treatment - bed rest, ice packs. Pain diminished starting around 2:00 PM on April 3, 2021. Back to normal morning of April 4, 2021.
Taste &smell goes &comes,Extreme pain in Right Ear  Then Almost complete Hearing Loss as of 07/01/2021
usually get the flu; plain sick; This case was reported by a consumer via interactive digital media and described the occurrence of influenza in an unspecified number of patients who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patients received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patients experienced influenza and sickness. On an unknown date, the outcome of the influenza and sickness were unknown.   It was unknown if the reporter considered the influenza and sickness to be related to Shingles vaccine.     Additional Information: GSK Receipt Date: 09-MAY-2022 Reporter's comment: This case was reported by a consumer via interactive digital media. The pharmacy guy said people usually get the flu or are just plain sick.  Additional supportive information: Follow-up would not possible as no contact details were available. This case has been linked to the case US2022AMR076742, reported by the same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2022AMR076742:same reporter
After Dose 1 (3/5/21), Fever of 103, chills, body aches, & severe Migraine causing visit to the ER (4/6/21). IV meds given to lower fever, CAT scan of Liver due to increased Liver enzymes. After Dose 2 (3/31/21), Fever of 103, chills, extreme body aches, & severe Migraine causing visit to the ER. IV meds given to lower fever, ultrasound of liver due to increased Liver enzymes.  Entered ER at 8 am 4/1/21 and was admitted to the hospital. I was inpatient through 4/3/21.  Routine Lab work was completed by my PCP 10 days before the 2nd dose & Liver Enzymes were normal.
Red Hands and feet.  Slight Swelling of hands and feet.  White raised splotches on hands and feet.  Itchy hands and feet.  Looks like hives almost.  Had diarrhea and vomiting for several days prior.
Approximately 30 minutes after receiving the COVID booster shot patient began to display a red rash across both cheeks. The rash continued to spread across the cheeks, covering both cheeks from under the eyes to jawline. Rash also spread to splotches across the forehead. One splotch on each side of the neck. Splotches and rash were warm to touch. Child appeared tired, but remained fully responsive and conscious. Denied any evidence of respiratory concerns. Did not show any evidence of mouth swelling. Several places on the cheeks and above the eyebrow appeared slightly puffy, but unable to tell if this was actually puffiness/swelling or normal skin. Symptoms remained for several hours and then began to slowly dissipate. After the first hour they did not increase in intensity or severity. The administering facility was contacted and a message left for a return call. A RN returned the call and recommended monitoring and cool compress, and to seek emergency medical attention if symptoms worsen or trouble breathing or facial swelling. Also recommended to follow up with MD if symptoms do not dissipate. In hindsight, the previous 2 covid vaccine administrations also resulted in splotchy and red cheeks, however mild on the first dose, and moderate on the second and were attributed at the time to chapped skin from the cold wind and/or flushed due to warmth from jacket and scarf.
R06.03 - Respiratory distress J18.9 - Multifocal pneumonia K72.90 - Liver failure without hepatic coma, unspecified chronicity (CMS/HCC) U07.1 - COVID-19 A41.9 - Sepsis, unspecified organism
Moderate shoulder pain immediately, slowly developing to chronic severe shoulder pain persisting without any improvement for approximately 9 months.   Issue eventually mostly resolved after approximately 15 months.  Medical consultation indicated likely VIRSA tendonitis / bursitis due to poor needle location placement and depth.
Great pain and over weeks loss of range of motion in left shoulder.  Both the first shot and the second were given at the tip of my shoulder.  I had to take my shirt off to give the persons giving the shots the access they wanted. When I asked why so high up the arm both ladies told me this was "per CDC guidelines" like it was a rehearsed response.  My doctor and everyone I talked to said the shots should have been in the muscle lower down the arm from the shoulder. Savon has bad information as to how to correctly give the shot.
1 wk p/receiving a dose of Influenza vax, pt turned bright red color all over body; Reporter feel rxn may be due to niacin;
pt recvd vax & appeared drunk, cranky & walking into walls;event lasted approx 2wks; pt 2 1/2yo cannot talk, can't feed self;doesn't play w/toys;still has motor skills;EKG is abn;pt had acute OM @ time of vax
swelling, redness w/varivax administration 2 1/2 x 1 inch
Systemic: Nausea-Mild, Systemic: Vomiting-Mild, Additional Details: Patient complaint of need to vomit and nausea approximately 5 to 10 minutes after administration. Patient recovered approximately 10 minutes later. Patient reported a history of reacting this to needle and injections.
Patient had full body itching and facial swelling .  She came back to the pharmacy about 4-5 hours after vaccination. She was given Benadryl to take by mouth and said she was feeling better.  Patient sat for 15 more minute or so and was feeling better and not swollen .  She was going to contact her doctor for follow up advice
Severe shoulder pain -starting 12/16/2016 after shot given in upper right arm.
Three days after I received a subcutaneous Xolair injection in my left arm and Pfizer intramuscular in my right arm, a severe fibromyalgia flare-up began. I had alternating days of severe fatigue and severe pain. I took tramadol, pregabalin, orphenadrine, bupropion to try to control the symptoms. This continued until August 21, when I started having severe pain in my right trochanteric bursa. After taking an increased dose of pregabalin with no relief, I saw Dr. on August 25 and received a steroid dose in the bursa. On August 28, I still had pain from bursitis when I developed post-shingles pain in my right sciatic nerve. I used lidocaine patches to try to relieve this pain. This pain has continued until September 8. I now feel better.
Small area of redness at right shoulder injection site. Tenderness at right upper arm and shoulder. Treated with Benadryl and analgesics. He was lost to further follow-up; unable to be contacted.
Dull red rash-beginning on hands day 8. Day 10 rash on arms, legs, chest and back taking Benadryl 50mg q 4 hrs. Urticarial or nonspecific rash, erythema multiforme minor.
Narrative: Wife got COVID and had to be hospitalized. Patient was placed urgently in HCF due wife being admitted. He declined regeneron. Patient remains in HCF
Information has been received from a registered nurse concerning a 25 year old female who on 09-MAY-2007 was vaccinated with a dose of Gardasil (lot# 657622/0388U).  Several hours post vaccination the patient developed a headache and joint pain.  The patient took OTC TYLENOL and the symptoms resolved within 24 hours.  Medical attention was sought.  The patient was recovered.  No product quality complaint was involved.  Additional information has been requested.
This spontaneous report as received from a healthcare worker refers to unspecified numbers of patients of unknown age. Healthcare worker reported an unspecified number of patients that may have been vaccinated with live ZOSTAVAX that experienced a temperature excursion however she was unsure of any lots or expiration dates and as to how many patients were vaccinated or when this world have occurred. The office was storing the ZOSTAVAX in refrigerator conditions for a greater length of time that would have been supported by stability information. The outcome of a temperature excursion was unknown. The relatedness for temperature excursion is unknown for live ZOSTAVAX. Additional information has been requested.
ADMINISTRATION ISSUES:  The vial was previously punctured on 11/30/2021.  The patient does not have any side effects. The patient was informed and will re-vaccinate as soon as possible.
pt recv vax & devel an inj site rxn characterized by erythema,sl welt,redness & itching;this is one of 6 patients from this site who devel this rxn