chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This spontaneous report was received on 29-JUN-2017 from a registered nurse referred to a patient of unknown age and gender. Medical history, concurrent conditions, concurrent medications, and allergies were not reported. The registered nurse reported that on an unknown date, the unspecified patient was given an expired dose of GARDASIL injection (dose, dose number, route, site of administration, Lot number and expiration date were not reported) for prophylaxis. It had been confirmed that the product was GARDASIL. No further adverse experience information to report. Additional information has been requested.
Severe rash started on my hips and became beet red, burning and itching intensely.  Over the next 2 days the rash spread up my back, and to the top of my thighs.  The second day it spread down my legs to my feet (but not as severe) and on my arms down to my hands.  My head also began itching. This lasted for about 10 days and has now cleared up. I experienced extreme exhaustion and dry mouth. I still feel tired and have a dry mouth when arising.
Chest pain, elevated troponin.  Acute myocarditis confirmed by cardiac MRI
Pt reported welt at injection site, intense pain in legs and arms, and muscle weakness, unable to lift arm, referred for MD evaluation.
This spontaneous report as received from a pharmacist refers to a 67 year old female patient. The patient's drug reactions/allergies included anaphylaxis and codeine allergy. On 03-JUN-2013, the patient was vaccinated with ZOSTAVAX (lot number reported J001003, expiration date April 2014) 0.65 ml once only, subcutaneous in the right deltoid. Concomitant therapies included PRILOSEC, amitriptyline hydrochloride (manufacturer unknown), CRESTOR and sertraline hydrochloride. On 04-JUN-2013, the patient noticed "a red spot which was warm to touch and about the size of a half dollar" on her right deltoid area which was the vaccine site. On the same date, the patient was seen by her physician on for the injection reaction, and was told by her physician "that it was normal to have this type of reaction after the administration of a vaccine." 05-JUN-2013, the patient returned to the pharmacy to make this pharmacist aware of the injection site reaction. She also informed this pharmacist that her unspecified physician ordered topical cortisone cream and TYLENOL to be used as needed for the injection site reaction. No laboratory diagnostics studies were performed. The outcome of the events was reported as not recovered. Additional information has been requested.
mom didn't take temp thought it felt like 104;high pitched inconsolable crying & shaking & stiffening but not sz;crying last @ least 1solid hr & then through the rest of the noc @ intervals;mom gave APAP a/shot & then 12:00 MN;
aches, chills, 103 fever, diarrhea, severe headache, photophobia, severe tinnitus. at about 1:30 am on the 29th severe lower back pain started: I was not able to get up normally and had to roll out of bed, then stand with all my strength clenching my butt muscles...this continued until sunday when it finally began to subside. I was taking tylenol for the pain which barely did anything for this. I also used other OTC muscle rub ointments. I still have lower back pain but I can walk without pain, however, still difficulty getting up from a sitting position; still have tinnitus but not severe. headaches on and off also. concerned about the back pain and will be calling MD about
pt recv vax & w/in 2 hr devel fever of 101.4 w/c/o bad h/a & next day devel cold sx which lasted a few days;
Period bleeding for 2 weeks at a time, every 2 weeks. Bleed 2 weeks, stop for 2 weeks, then bleed again for 2 weeks
Information has been received from a nurse concerning a 22 year old female who on unspecified dates was vaccinated with 2 doses of GARDASIL vaccine (yeast). After the first vaccination, the patient developed yeast infection. After the second vaccination the patient developed another yeast infection. As of 18-JUL-2008, the patient was not recovered. The patient saw a doctor. Additional information has been requested.
5 hours after the shot body aches and fatigue set in. That last through the night. This is not a concern as everything indicates this is normal.    However, the next day on 4/17/2021 I have pain in my right leg calf. The pain is to the right of the calf and feels like a dull pain. The area is not warm or swollen so I don't expect it to be a blood clot, but thought it might be worth reporting just in case.
Vial was stored in refrigerator on 02-Jun-2022 and administered on 07-Jul-2022; Moderna COVID vaccine from a vial that had exceeded its 30 day working expiration.; second dose given on 04-Jan-2022 and booster dose on 07-Jul-2022; This spontaneous case was reported by a pharmacist and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (second dose given on 04-Jan-2022 and booster dose on 07-Jul-2022), PRODUCT STORAGE ERROR (Vial was stored in refrigerator on 02-Jun-2022 and administered on 07-Jul-2022) and EXPIRED PRODUCT ADMINISTERED (Moderna COVID vaccine from a vial that had exceeded its 30 day working expiration.) in a 41-year-old male patient who received mRNA-1273 (Spikevax) (batch nos. 059M21A and 069H21A) for COVID-19 prophylaxis.     The patient's past medical history included Erectile dysfunction (No recent changes in condition status) on 10-Sep-2021. Concurrent medical conditions included Multiple sclerosis (No recent changes in condition status) since 22-Dec-2020, Chronic pain (Chronic pain/opioid dependence,No recent changes in condition status) since 07-Sep-2017, GERD (No recent changes in condition status) since 16-Apr-2016 and Hyperlipidemia (No recent changes in condition status) since 07-Dec-2015. Concomitant products included BUPRENORPHINE from 17-May-2022 to an unknown date for Chronic pain, FAMOTIDINE from 10-Feb-2021 to an unknown date for GERD, ATORVASTATIN from 07-Jan-2022 to an unknown date and GEMFIBROZIL from 10-Sep-2021 to an unknown date for Hyperlipidemia, GLATIRAMER ACETATE from 10-Sep-2021 to an unknown date for Multiple sclerosis.   On 04-Jan-2022 at 9:34 AM, the patient received first dose of mRNA-1273 (Spikevax) (unknown route) .5 milliliter. On 07-Jul-2022 at 9:11 AM, received second dose of mRNA-1273 (Spikevax) (unknown route) dosage was changed to .5 milliliter. On 07-Jul-2022 at 9:11 AM, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (second dose given on 04-Jan-2022 and booster dose on 07-Jul-2022) and EXPIRED PRODUCT ADMINISTERED (Moderna COVID vaccine from a vial that had exceeded its 30 day working expiration.). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Vial was stored in refrigerator on 02-Jun-2022 and administered on 07-Jul-2022). At the time of the report, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (second dose given on 04-Jan-2022 and booster dose on 07-Jul-2022), PRODUCT STORAGE ERROR (Vial was stored in refrigerator on 02-Jun-2022 and administered on 07-Jul-2022) and EXPIRED PRODUCT ADMINISTERED (Moderna COVID vaccine from a vial that had exceeded its 30 day working expiration.) outcome was unknown.        For mRNA-1273 (Spikevax) (Unknown), the reporter did not provide any causality assessments.   Acute illness at the time of vaccination and up to one month before was reported as none.  No adverse events noted at the time of reporting.  Number of doses and vials were reported as 15 doses and 3 red cap vials.   Vial was initially stored in the refrigerator on 02-Jun-2022   The vial did not undergo any temperature excursions.  Treatment details were not reported by the reporter.
Inconsolable crying, anorexia, extreme irritability that began < 8 hours, post vax. Pt was admitted, monitored and po intake improved in the next 48 hours. Crying and irritability resolved. Possible seizure occurred at 23:00 on 11/16/2000 with brief loss of consciousness and eyes rolled back with tonic/clonic movements.
Hep A injection received at approx. 1pm.  At approx. 7pm childs shirt removed and rash noticed covering trunk, front and back.  On one side of face and one arm also.  Child given Beandryl by mom per Dr. recommendation over phone and taken to ER.  Mom states childs throat appeared swollen.  Arrived to St. ER approx. 9pm, give Prednisone x3days.  Mom states rash gone next day.  Was told by ER doctor reaction was probably due to the Hep A vaccination.
pt recvd vax; fever to 102 for 6 days duration; c/o dizziness second day; arm swollen to elbow for 3 days;
Client was given Adult Hep A, but should have been given Pediatric Hep A.
Patient has swelling 2 inches in diameter from the site of the vaccine. It is red and war and tender to the touch. It is also a bit itchy. This started the evening after the vaccine and has slowly progressed since then. The patient cannot take motrin and has not taken anything to treat it.  Encouraged the patient to seek treatment if it continued to worsen or did not improve. Recommended Benadryl
Pt. has 7 vesicular spots/rashes randomly on his body. They don't seem to bother him and don't seem itchy.
This spontaneous report received from a medical assistant 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 was vaccinated with an improperly stored GARDASIL 9 (lot and expiry date: not reported). The vaccine was exposed to a temperature of 50F and a minimum temperature of 35F for an unknown time frame. No adverse effects were reported.  There was no prior temperature excursions. This is one of the four reports received from the same reporter. Additional information has been requested.
She has been having a lot of sweating; A lot of heat then a lot of cold; Having very strong effects/All the symptoms that you told me/All that you read me is what I had; In the lower part of her back she has a horrible pain; This spontaneous case was reported by a consumer and describes the occurrence of HYPERHIDROSIS (She has been having a lot of sweating), FEELING OF BODY TEMPERATURE CHANGE (A lot of heat then a lot of cold), VACCINATION COMPLICATION (Having very strong effects/All the symptoms that you told me/All that you read me is what I had) and BACK PAIN (In the lower part of her back she has a horrible pain) in a 58-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012H21B) for COVID-19 vaccination.     No Medical History information was reported.    On 01-Dec-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In 2021, the patient experienced HYPERHIDROSIS (She has been having a lot of sweating), FEELING OF BODY TEMPERATURE CHANGE (A lot of heat then a lot of cold), VACCINATION COMPLICATION (Having very strong effects/All the symptoms that you told me/All that you read me is what I had) and BACK PAIN (In the lower part of her back she has a horrible pain). The patient was treated with IBUPROFEN for Adverse event, at an unspecified dose and frequency. At the time of the report, HYPERHIDROSIS (She has been having a lot of sweating) and FEELING OF BODY TEMPERATURE CHANGE (A lot of heat then a lot of cold) had not resolved and VACCINATION COMPLICATION (Having very strong effects/All the symptoms that you told me/All that you read me is what I had) and BACK PAIN (In the lower part of her back she has a horrible pain) outcome was unknown.            No concomitant medications were mentioned. It was stated that taking ibuprofen helped her.    This case was linked to MOD-2021-404712, MOD-2021-404716 (Patient Link).
I was in the hospital for a few weeks, then I left the hospital, they gave me 4 vaccines and a booster, and two or three weeks after that I came down with Addison disease, and two weeks after that I was diagnose with Parkinsons. My Pcp sent me over to a doctor that deals with Parkinsons.
FEVER; This spontaneous report received from a patient concerned a 24 year old of unspecified sex. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included no known allergies.The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 043A21A, and batch number: 043A21A expiry: UNKNOWN) dose was not reported, administered on 07-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On 07-APR-2021, the subject experienced fever. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from fever. This report was non-serious.
Patient complaining of left arm severe pain since yesterday after her Covid vaccine. She had some pain after receiving her vaccine but today the pain became excruciating 10 out of 10. Also, she experienced tingling numbness on her fingers and hands and she got worried that she might have injury to her arm or other structure injection was given in the left arm just below the shoulder joint and with significant pain as per the skin itself there is no evidence of infection.  She took over-the-counter pain medication without any relief. Positive for arthralgias and myalgias.  Physician exam: Is been complaining of significant pain around the vaccine site on the left arm lateral area with limited shoulder movement particularly she can flex extend but she cannot raise and she cannot extend because of significant pain as well as neurovascular and circulation they have been intact her wrist and finger and elbow movements are normal. Skin itself at the injection site there is no evidence of redness or edema or any evidence of infection.   Patient received dilaudid, Zofran, Benadryl and hot/cold compression at home and follow up with PCP or return to ED with any worsening symptoms.
Starting two weeks following my second vaccine shot, I been to feel pain in my left breast similar to the pain of fibrocystic breast disease (which I had as a younger woman before menopause.) I have also had an increase in the number and severity of headaches since I had both shots and my arthritis pains have been worse than usual.
Pt recv vax on 8/12/96; on 10/20/96 pt exp chicken pox
Myalgia, Fever, Diarrhea,  Injection site sore, stiff neck and upper back, feet& calves swollen, chills, temp 100.0 degrees
Patient came in to office stating they needed Moderna booster. Booster was administered. While documenting vaccine, staff member noticed that patient had already received booster on 11/08/2021. Dose administered today, 02/16/2022, was patient's fourth dose of Moderna (0.25 mL). Patient was monitored after vaccine, no adverse reaction noted.
Bell's Palsy onset on 03/30/2021 at around 9:30 p.m. Confirmed diagnosis on 03/31/2021 at an urgent care facility by a Certified Physician Assistant at around 10:50 a.m. - Started Prednisone 20mg, three tablets in the morning with breakfast for 7 days. - Started Valacyclovir 1g, one tablet three times daily for 7 days. - Referred to see a PCP after 7 days of the corticosteroid/antiviral therapy.
Patient became sweaty for about 10 minutes after getting the injection but became normal by 15 minutes after.
two hours after the vaccination the patient had a "psychotic break" described as the patient was seeing things and hearing things; only abnormal test result was a blood sugar of 69; Orthostatic blood pressure changes; This spontaneous report was received from a physician refers to a 19 year old female patient. The patient's concurrent condition, concomitant medication and medical history were unknown. On an unknown date in September 2019 (reported as "last week"), the patient was vaccinated with third dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) (frequency, route of administration, lot # and expiry date unspecified) for prophylaxis. On the same day, two hours after the vaccination the patient had a psychotic break described as the patient was seeing things and hearing things (psychotic disorder). The patient's mother took the patient to the emergency department and all tests were normal including testing for alcohol and drugs. The physician reported the only abnormal test result was a blood sugar of 69 (unit not reported) (blood glucose abnormal). The patient's computed tomography (CT) scan of head result was fine. The physician reported the patient stayed in a quiet room in the emergency department and went to sleep and when the patient awakened she was back to her normal mental baseline. The patient was seen in physician's office a couple days later and had orthostatic blood pressure changes (pressure orthostatic abnormal). The outcome of the events was reported as recovering. Causality assessment was not reported by the reporter.  This is one of two reports received from the same reporter.
Acute left shoulder/arm pain within 24 hours of the injection, pain level 9 out of 10.  Worst with movement, no swelling, ecchymosis, erythema. Pain has only slowly improved since the injection with patient using ice, heat, ibuprofen. Has not been referred to Physical Therapy.
redness all down his arm; tired; This spontaneous case was reported by a nurse and describes the occurrence of ERYTHEMA (redness all down his arm) and FATIGUE (tired) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 29-Oct-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In October 2021, the patient experienced ERYTHEMA (redness all down his arm) and FATIGUE (tired). At the time of the report, ERYTHEMA (redness all down his arm) and FATIGUE (tired) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant and treatment drugs were provided. It was reported that, patient didn't feel a thing when he got the shot in his right arm. There were no other problems with the other 2 shots. She stated he was tired but not sleepy.
at midnight experienced shivering for about 3 hours, uncontrollable for the first 30 minutes along with a dull headache
dose administered past the 30-day use by date; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (dose administered past the 30-day use by date) in a 43-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 22-Sep-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 22-Sep-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (dose administered past the 30-day use by date). On 22-Sep-2021, EXPIRED PRODUCT ADMINISTERED (dose administered past the 30-day use by date) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No relevant concomitant medications were reported. No treatment information was provided.   This case was linked to MOD-2021-355109, MOD-2021-354515 (Patient Link).
This spontaneous report received from a consumer, concerns a 67-year-old female patient who received the Moderna COVID-19 vaccine (mRNA-1273) and experienced adverse events: Her arm is red and warm. The patient's medical history and concomitant product use not provided. On Feb 12, 2021, prior to the onset of the events, patient received the first of two planned doses of mRNA-1273 (batch/lot# 006M20A), unknown route, for prophylaxis of COVID-19 infection. On Feb  21, 2021, patient experienced: Her arm is red and warm. The patient treated with OTC Tylenol. Action taken with mRNA-1273 in response to the events not reported. The outcome of her arm is red and warm: not recovered/not resolved.
soreness, tighness in arm, extreme body ache, fatigue, throbbing headache, low fever,
Combined initial and follow-up report received from a health care professional on 04 Nov 2010 and via committee on 15 Nov 2010: This patient with an unknown medical history was vaccinated MENVEO (batch number unknown) intramuscularly on 30 Sep 2010. After vaccination with MENVEO, the patient experienced allergic reaction, itchy, fever, skin exfoliation, face edema, fatigue and malaise on 01 Oct 2010. The patient took chlorpheniramine maleate (CTM) (antihistaminic), dexamethasone, paracetamol and salicylic acid on 02 Oct 2010. In between 05 Oct 2010 and 12 Oct 2010, the reaction increased so patient stopped treatment with chlorpheniramine maleate (CTM), dexamethasone, and paracetamol. On 13 Oct 2010, the reactions were worsened and the physician advised to hospitalize but the patient refused. The physician gave antihistaminic (unspecified), ciprofloxacin (antibiotics), chlorpheniramine maleate (CTM) and dexamethasone. On 18 Oct 2010, the reaction was still continued and on 26 Oct 2010, the patient was hospitalized due to decrease in consciousness (according to patient's family). On 03 Nov 2010, the patient experienced bone pain and fatigue again. The outcome of the allergic reaction was reported as complete recovery. The causal relationship was under investigation by committee, whether it was related or not.
Temperature dropped to 94 degrees Celsius; not taking the 2nd dose because of the side effects; Little red rash on site of Injection; This spontaneous case was reported by a consumer and describes the occurrence of BODY TEMPERATURE DECREASED (Temperature dropped to 94 degrees Celsius), INTENTIONAL PRODUCT USE ISSUE (not taking the 2nd dose because of the side effects) and VACCINATION SITE RASH (Little red rash on site of Injection) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 005C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 06-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced BODY TEMPERATURE DECREASED (Temperature dropped to 94 degrees Celsius), INTENTIONAL PRODUCT USE ISSUE (not taking the 2nd dose because of the side effects) and VACCINATION SITE RASH (Little red rash on site of Injection). The patient was treated with Manual therapy (Rubbing alcohol) for Body temperature decreased and Manual therapy (Rubbing alcohol) for Vaccination site rash. At the time of the report, BODY TEMPERATURE DECREASED (Temperature dropped to 94 degrees Celsius) and VACCINATION SITE RASH (Little red rash on site of Injection) had resolved and INTENTIONAL PRODUCT USE ISSUE (not taking the 2nd dose because of the side effects) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Body temperature: 94 (Low) Temperature dropped to 94 degrees.     mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was withdrawn on an unknown date.       No concomitant medication reported. No treatment was provided.    Most recent FOLLOW-UP information incorporated above includes: On 09-Jun-2021: Follow-Up received contains No new Information On 26-Jul-2021: Significant follow up received included information about outcome of the events, new event added and action taken with suspect product was updated.
Right arm felt warm and heavy immediately after dose Eye pressure and mild headache 10 mins after dose: took Tylenol 1000 mg Cough, wheezing, postnasal drip and rhinorrhea after 4 hrs: used Albuterol and Trelegy (provided some Relief)
Approximately 3 months after finishing the 2 dose Covid 19 vaccination I developed severe eczema on both hands. I am being treated by an MD dermatologist and symptoms are gradually improving. I believe this condition is related to increased hand washing and sanitizing. I have no history of eczema.