chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Plaque psoriasis flare-up; discolouration on elbow; Sore arm; This spontaneous case was reported by a consumer and describes the occurrence of PSORIASIS (Plaque psoriasis flare-up), SKIN DISCOLOURATION (discolouration on elbow) and PAIN IN EXTREMITY (Sore arm) in an elderly female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product RISANKIZUMAB (SKYRIZI [RISANKIZUMAB]) for Plaque psoriasis.    Concurrent medical conditions included Plaque psoriasis (moderate to severe chronic plaque psoriasis).   On 01-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 30-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 11-Oct-2021, the patient started RISANKIZUMAB (SKYRIZI [RISANKIZUMAB]) (Subcutaneous) at an unspecified dose. On 20-Jan-2022, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient experienced PSORIASIS (Plaque psoriasis flare-up), SKIN DISCOLOURATION (discolouration on elbow) and PAIN IN EXTREMITY (Sore arm). At the time of the report, PSORIASIS (Plaque psoriasis flare-up) had not resolved and SKIN DISCOLOURATION (discolouration on elbow) and PAIN IN EXTREMITY (Sore arm) outcome was unknown.            No concomitant medication information was provided. Reporter's causality for event sore arm with Skyrizi was reported as no reasonable possibility. Reporter's causality for event discoloration on elbow with Skyrizi was not provided. Reporter's causality for event plaque psoriasis flare-up with Skyrizi was reported as reasonable possibility.  It was unknown if patient was enrolled in COVID-19 vaccine trial. No treatment medication were provided.
Information has been received from a healthcare worker concerning multiple unspecified patients. No concurrent condition, medical history and concomitant therapies were reported. On unspecified dates, the multiple unspecified patients received doses of improperly stored M-M-R II subcutaneous Injection (dose and frequency not reported) (lot # J006140 with expire date of April 2017). The conditions storage was 13.1 C Celsius degree for 15 hours. There was no previous temperature excursion. No adverse effects were reported. Additional information has been requested.
30yof, 36w pregnant, came to clinic on 6/1 with 2 week history of lower leg tenderness and edema.  Doppler confirmed on 6/1 that patient had an acute proximal DVT in the left lower extremity, with occlusive thrombus within the distal femoral vein.  She denies personal history of clot; this is her 2nd pregnancy; she notes no family history of clot; this pregnancy is complicated by excessive weight gain (current BMI 32.28 kg/m2).  Pt received Pfizer COVID vaccine on 4/24/21.
Patient was here for second dose of Pfizer COVID-19 vaccine; inadvertently given dose of Moderna COVID-19 instead
slept for 30hr p/getting tetramune 27FEB96;didn't drink much formula
10/11 - Evaluated in Immediate Care one hour after vaccine. Tx: zyrtec, pepcid, decadron. 10/16 - Rebound Rx - Immediate Care - epi-pen then transferred to hospital overnight epi drip/icu. 10/21 - 10/23 ED then hospitalization for rebound anaphylactic Rx
Severe sleepiness to the point of sleep paralysis continuing for about 24 hours from onset at 10 hours after vaccine.  Nausea, diarrhea, dizziness, lack of appetite, headache, swollen Left arm (size of grapefruit, hot hard, itchy, red) from hour 10 thru bedtime on day 2.  Swollen arm symptoms and diarrhea continuing thru day 3 and 4.
Two weeks after receiving the first vaccine, I noticed that my hands felt numb and tingly. It was a sensation of some sort that didn't go away. I was feeling that when I went to be seen at doctor's office and also I felt it in my toes. The doctor thought that it was nerve related, and he said that if it didn't go away, to come back and see him. He gave me a cream and said it could be paresthesia/ hand dermatitis. I used the cream and I sought a specialist (neurologist) to follow up. When I saw the neurologist, he wanted me to have 2 MRI's completed. The first one was for my neck and spine and my second scan was for my brain. I had several appointments with the specialist and I received a call about the first MRI that was abnormal. The doctor was leaning towards MS. They also performed a spinal tap and EMG testing. The doctor didn't want to rule out the vaccine because it could have been auto-immune. I had lesions along my spine, neck and brain. After I had all of my testing completed and after my spinal tap, I was diagnosed with MS.
This spontaneous report was received from another health professional regarding a patient of unknown age and gender. The patient's medical history and concurrent conditions were not reported. On an unknown date, the patient was vaccinated with a dose of improperly stored VARIVAX (Merck) (lot # K021935 expiry date 10-NOV-2016) (dose and route unknown). No adverse events were reported. Follow up information has been received from the reporting C.M.A. during a phone call on 04-NOV-2015. The medical assistant reported that she would have to research the request made for patient identifiers, lot numbers, expiration dates and dates of vaccination. This is one of the two reports received from the same reporter. Follow up information has been received from the C.M.A. via other source on 24-NOV-2015 concerning a patient of unknown age and gender. The reporter stated that the patient was vaccinated with a dose of improperly stored VARIVAX (Merck) on 18-MAY-2015. This was one of several reports received from the same reporter. Additional information has been requested. Reporter information, patient demographics, therapy start date, event onset date and narrative were updated.
Fatigue started on 7/16/20, chills and fever on 7/17/20 and 7/18/20, diarrhea started on 7/19/20 that last up to two weeks.  Also had poor appetite for approx 3 weeks after vaccine was given.  No aching noted.
Information has been received from two health professionals the authors of a literature article concerning a male patient who was vaccinated with a dose of MMR (lot # not reported). It was reported that the patient had received all recommended childhood vaccinations except hepatitis B vaccine. Subsequently, the patient had significant speech difficulties. Upon internal review, significant speech difficulties were considered to be other important medical events (OMIC). It was previously reported in a published article that the patient's brother has autism and the patient's mother had a miscarriage. No further information is available.
wheezing & cough since recv vax;severe behavioral problem;posturing sz like;although active & alert x 2 to 3min;
Since receiving my second dose of the vaccine, I have had 18 ER visits for hypertension, low magnesium, and low potassium with no medical explanation. My levels get low to the point that it causes cardiac arrest or seizures. For the last three months, I have also had diarrhea that has not been controllable by medication and the cause has not been discovered by doctors. I have tried multiple dietary changes as well with no success. Since having the second dose of Moderna, I did contract COVID and received Monoclonal antibody therapy treatment on 11/10/2021.
pt recv vax & was seronegative w/a standard ELISA;no further details were provided;
This spontaneous case was reported by a physician and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (This vial had spent more than 30 days in the refrigerator, and the 30 day BUD was 14 AUG 2022), INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (1st Dose-07-Jul-2022/ 2nd Dose-15-Aug-2022), PRODUCT STORAGE ERROR (more than 30 days in the refrigerator) and NO ADVERSE EVENT (No adverse event) in an 8-month-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. AR9237B and AR9237B) for COVID-19 vaccination. No medical history reported by reporter. Patient did not have allergies to medications, food and other products. Unknown whether the patient ever been diagnosed with/ tested positive for COVID-19. No acute illnesses at the time of vaccination and up to one month before. No chronic or long-standing health condition. No prescriptions, over-the-counter medications, dietary supplements, or herbal remedies being taken at time of vaccination and/or at the time of the adverse event. On 07-Jul-2022 at 12:35 PM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 25 microgram. On 15-Aug-2022 at 9:36 AM, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 25 microgram. On 15-Aug-2022 at 9:36 AM, the patient experienced EXPIRED PRODUCT ADMINISTERED (This vial had spent more than 30 days in the refrigerator, and the 30 day BUD was 14 AUG 2022) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (1st Dose-07-Jul-2022/ 2nd Dose-15-Aug-2022). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (more than 30 days in the refrigerator) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (This vial had spent more than 30 days in the refrigerator, and the 30 day BUD was 14 AUG 2022), INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (1st Dose-07-Jul-2022/ 2nd Dose-15-Aug-2022), PRODUCT STORAGE ERROR (more than 30 days in the refrigerator) and NO ADVERSE EVENT (No adverse event) outcome was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessments were provided for EXPIRED PRODUCT ADMINISTERED (This vial had spent more than 30 days in the refrigerator, and the 30 day BUD was 14 AUG 2022), INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (1st Dose-07-Jul-2022/ 2nd Dose-15-Aug-2022) and PRODUCT STORAGE ERROR (more than 30 days in the refrigerator). No Concomitant medications were provided. Patient race was reported as "private". Vial was initially stored in the refrigerator on 14JUL 2022 and vial did not undergo any temperature excursions. That vial had spent more than 30 days in the refrigerator and the 30 day BUD was 14 AUG 2022. No reported symptoms. No additional doses, medications, or treatments had been administered at that time. Most recent FOLLOW-UP information incorporated above includes: On 22-Aug-2022: Follow up received contains significant information included patient demographics and suspect product details were added.
This spontaneous report was received from a physician refers to a 11 year old female patient. The physician reported that on 26-AUG-2013 (reported as yesterday), the patient was inadvertently vaccinated with a dose of ZOSTAVAX 0.65 ml, subcutaneously in the right arm. No adverse effects reported. Physician stated that the child had previously been vaccinated with 2 doses of VARIVAX (Merck). The first dose was administered in the year 2002 and the second dose was administered in the year 2007. Physician stated she called VAERS, Vaccine Adverse Event Reporting System, but they said she does not have to report this incident, if no adverse effects occurred. Additional information has been requested.
Patient recieved first dose of COVID vaccine and left the clinic at 12:20.  By 1300 patient was very confused and unable to answer questions.  Patient was taken to the hospital and was diagnosed with a Non-Traumatic Intracranial Hemorrhage
Child with diabetes received 2009 H1N1 Flu Mist. Meaning received wrong type of vaccine. No immediate physiologic reaction.
Woke up the next morning after the shot and had mild fever, body aches, chills, sore arm and fatigue.  Fatigue and sore arm still continued the second day but the fever, body aches and chills went away. I took 4 tylenol every 4 hours which did not help at all.
Body numbness and tingling. Pt felt this almost immediately, but it subsided after 10 minutes. He was monitored for a total of 30 minutes and felt fine after that time period.
Hoarseness / Deeper Voice; Oral Thrush; Dry Mouth; white tongue; Rosy Cheeks; Warm Body; Sensitive Tongue; The white in mouth extended to the back of tongue and down throat; The white in mouth extended to the back of tongue and down throat; This case was reported by a consumer via call center representative and described the occurrence of dry mouth in a 68-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included cortisone (non-proprietary) (Cortisone) for inflammation.   Concomitant products included cortisone (non-proprietary) (Cortisone Shot).   On 8th August 2019, the patient received the 1st dose of Shingrix (intramuscular) and Cortisone at an unknown dose and frequency. On 9th August 2019, 1 days after receiving Shingrix, the patient experienced dry mouth and oral thrush. On 13th August 2019, the patient experienced hoarseness. In August 2019, the patient experienced tongue white, localized erythema, skin warm, sensitive tongue, pharyngeal disorder and oral mucosal discoloration. On an unknown date, the outcome of the dry mouth, localized erythema and skin warm were resolved with sequelae and the outcome of the tongue white, pharyngeal disorder and oral mucosal discoloration were unknown and the outcome of the oral thrush, sensitive tongue and hoarseness were recovering/resolving.   It was unknown if the reporter considered the dry mouth, tongue white, localized erythema, skin warm, oral thrush, sensitive tongue, hoarseness, pharyngeal disorder and oral mucosal discoloration to be related to Shingrix.  Additional information received were as follows: The patient reported that the following day after vaccination her mouth was drier than usual. Then a few days later reported her tongue was white and became progressively worse or whiter. The white in mouth extended to the back of tongue and down throat. The patient stated that after receiving cortisone shot her mouth may get a little dry, cheeks may become rosy, and her body may feel warm, but those three things occurred with a greater effect. The patient stated that thrush was almost gone, but her tongue was still sensitive, her throat feels hoarse and her voice was deeper than usual. The patient consented to follow up.
Headache; achy; diarrhea; extremely sleepy; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A 54 year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection), administered in left arm, administration date 25Mar2021 (Batch/Lot number: unknown) at the age of 54 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "Type 2 diabetes" (unspecified if ongoing). The patient took concomitant medications. Vaccination history included: BNT162B2 (DOSE 1, SINGLE), for COVID-19 immunisation. The following information was reported: HEADACHE (non-serious) with onset 26Mar2021, outcome "recovered" (Mar2021), described as "Headache"; PAIN (non-serious) with onset 26Mar2021, outcome "recovered" (Mar2021), described as "achy"; DIARRHOEA (non-serious) with onset 26Mar2021, outcome "recovered" (Mar2021), described as "diarrhea"; SOMNOLENCE (non-serious) with onset 26Mar2021, outcome "recovered" (Mar2021), described as "extremely sleepy". Therapeutic measures were not taken as a result of headache, pain, diarrhoea, somnolence. Additional information: The patient was not diagnosed with COVID-19 prior to vaccination and has not been tested for COVID-19 since the vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient was concomitantly taking unspecified prescription medications.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
I have a large, red reaction about 2 or 2.5 inches long around the injection site. It itches and sometimes stings. I can also feel that it is hard underneath my skin. This showed up for the first time 3/13/21, which is exactly a week since my injection.
I started having increased pain under my left arm that increased to some chest discomfort, body aches, low-grade fever. When I woke up the morning of the 8th I had a swollen lymph node the size of a baseball under my left arm.
Patient received vaccination of Arexvy on 11/15/23. Patient presented to pharmacy on 11/19/23, and spoke to Pharm.D. Today (11/20/2023), Pharm.D. provided me the details of patient interaction. Patient complained of hyperalgesia that was so sensitive, cotton sheets caused discomfort.  Patient experienced intense itching that made patient feel like scratching their skin off. The swelling increased over the weekend. The patient started to have reddish/purple dots in hive like form.
Chills on Feb 12, day after shot. On Feb 16, left upper arm above elbow began to itch. Next day Feb 17, red and swollen, with a round, hard swelling the size of a half dollar around injection site. Continued Feb 18, VERY itchy, very red, continued Feb 19 and by Feb 20, subsided. On March 11, 2021, 2pm, same location, I received Covid shot #2, also Moderna, in right arm. Next day March 12, chills, March 13, 14, 15, arm red, swollen, itchy, as before, but onset sooner, same intensity, slightly briefer.
ADVERSE EVENTS: VERTIGO, DIARRHEA, VOMITING, &  CHILLS  TREATMENT: OTC TYLENOL/ IBUPROFEN, MECLINIZE
Bloody nose one hour after administration of Flumist.  Begin while patient was moving medical totes.  Patient stated totes were not heavy.
This spontaneous report received from a nurse via a company representative referred to a patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant medications were not reported. On an unknown date, the patient received GARDASIL (dose, frequency, route, lot number and expiry date were not reported) and experienced syncope. Outcome of the event was unknown and causality was not reported. Additional information has been requested.
Woke up thursday morning. I had a heaviness in my chest but thought I slept wrong. When I stood up I got really dizzy and nauseous. I then threw up twice that day and could barely eat or drink. I maybe got 4 oz of water in me that day. I got a massive headache. I was nauseous on Friday. and managed a little soup friday night. Saturday I was barely out of bed and still nauseous and had no energy through Sunday. Today (Monday) I am still fatigued, nauseous, brain fog and my vision is blurry and I can't seem to get my glasses to help me see clearly. I have some muscle aches too.
AE: Myopericarditis, Treatment: IV & Oral Steroid, treatment: in progress, Outcome: TBD
This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of ARRHYTHMIA (arrhythmia), TACHYCARDIA (tachycardia) and HEART RATE INCREASED (190bpm heart rate) in a 58-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 027A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Arrhythmia (No symptoms over the past six years.). Concomitant products included OLOPATADINE HYDROCHLORIDE for an unknown indication.    On 02-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 04-Mar-2021, the patient experienced ARRHYTHMIA (arrhythmia) (seriousness criterion hospitalization prolonged), TACHYCARDIA (tachycardia) (seriousness criterion hospitalization prolonged) and HEART RATE INCREASED (190bpm heart rate) (seriousness criterion hospitalization prolonged). On 23-Mar-2021, the patient experienced SUPRAVENTRICULAR EXTRASYSTOLES (premature arterio contraction) and SUPRAVENTRICULAR TACHYCARDIA (supraventricular tachycardia). On an unknown date, the patient experienced PRESYNCOPE (almost passed out), LIMB DISCOMFORT (legs feel heavy) and CHEST PAIN (chest feel sore). The patient was hospitalized on 08-Apr-2021 due to ARRHYTHMIA, HEART RATE INCREASED and TACHYCARDIA. At the time of the report, ARRHYTHMIA (arrhythmia), TACHYCARDIA (tachycardia), HEART RATE INCREASED (190bpm heart rate), SUPRAVENTRICULAR EXTRASYSTOLES (premature arterio contraction), SUPRAVENTRICULAR TACHYCARDIA (supraventricular tachycardia), PRESYNCOPE (almost passed out), LIMB DISCOMFORT (legs feel heavy) and CHEST PAIN (chest feel sore) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 04-Mar-2021, Tachycardia: 190 (High) increased. On 23-Mar-2021, Electrocardiogram ambulatory: abnormal (abnormal) abnormal. On 08-Apr-2021, Tachycardia: 190 (High) increased.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       On 23-Mar-2021, the patient saw the cardiologist and reported that testing, including Holter monitoring was performed.  On 14-Apr-2021, ablation surgery was performed.; 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.
Pt felt faint. Pt was helped to the floor and placed into supine position. Pt's legs elevated. Pulse checked. Cool wet rag placed on pt's  forehead. When pt felt better, pt sat up and drank water. Pt eventually felt well and resumed sitting in chair with cool wet rag on forehead. Pt was given crackers and juice. Pulse checked periodically throughout episode. Pt monitored for approximately 45 minutes. Pt's wife called and she came and gave him a ride home. Staff called Pt the following day to follow up. Pt reported feeling better.
Nausea, Body aches, and Headache  Symptoms subsided 24 hours post vaccine.
Myalgia, Arthralgia & Fever Narrative:  Day 1: Right deltoid and axillary discomfort up to 14 days after vax. Generalized flu like symptoms with nausea x three days post vax. Temp 100.4  Other Relevant History:
Fever; Aches; Nausea; Vomiting; Headache; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 08-Apr-2021 and was forwarded to Moderna on 08-Apr-2021.    This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (Fever), MYALGIA (Aches), NAUSEA (Nausea), VOMITING (Vomiting) and HEADACHE (Headache) in a 62-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 038B21A) for COVID-19 vaccination.     The patient's past medical history included No adverse event.    On 07-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 08-Apr-2021, the patient experienced PYREXIA (Fever), MYALGIA (Aches), NAUSEA (Nausea), VOMITING (Vomiting) and HEADACHE (Headache). At the time of the report, PYREXIA (Fever), MYALGIA (Aches), NAUSEA (Nausea), VOMITING (Vomiting) and HEADACHE (Headache) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medications include Thyroid medicine. No treatment was taken by patient.
GOT 2 SEVERE HIVE LIKE LESION APPEAR IN THE MIDDLE OF MY FOREHEAD, WHICH WERE PAINFUL, ACCOMPANIED BY TACHYPNIA AND FEELING OF SHORNESS OF BREATH. ALSO HAD AN IRRITATING NASAL SECRETION.  THE LESIONS ON THE FOREHEAD LEFT A SCAR IN THE MIDDLE OF MY HEAD.  PAIN IN LESION LASTED A FEW HRS. THE SOB ALSO LASTED A FEW HRS.  TOOK EXTRA BENADRYL AND WENT TO BED AS SOON AS I GOT HOME.
SAME DAY OF VACCINATION, SORE ARM, SWELLING AND REDNESS AT INJECTION SITE. DAY AFTER INJECTION: BODY ACHES, SORE THROAT AND FEVER.
10 days post vaccine developed a red, circular itchy rash around the vaccine site. the spot is slightly warm to the touch. this follows arm soreness in the several days right after the vaccine. no other adverse effects.