chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Violet spots under her armpit; This spontaneous case was reported by a consumer and describes the occurrence of SKIN DISCOLOURATION (Violet spots under her armpit) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. Unknown) for COVID-19 vaccination.     No Medical History information was reported.    On 27-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced SKIN DISCOLOURATION (Violet spots under her armpit). At the time of the report, SKIN DISCOLOURATION (Violet spots under her armpit) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant medications and treatment medications were not provided.  It was reported that the patient received the first dose of Moderna COVID-19 vaccine on 27APR2021 and a week later started having some violet spots under her armpit.
Mom states she noticed rash around neck around 9:00 PM. Also noticed he was warm to touch. (does not have thermometer) States baby was crying and could not be consoled. Mom administered Tylenol and baby stopped crying after 30 min- 1 hour. Mom states baby usually doesn't cry much. She has been giving Tylenol every 4-6 hours. Mom also states baby has not been eating as well as usual. When baby was assessed here around 2:00 PM today, rash was noted on trunk- abdomen, and upper back, upper thighs, arms, and face. Referred to MD.
Information has been received from a physician concerning an 18 week male with unspecified illness at the time of vaccination and no drug allergies who on 17-FEB-2009 was orally vaccinated with a dose of ROTATEQ (lot number not available). He was also vaccinated with a dose of PENTACEL and a dose of PREVENAR on 17-FEB-2009. On 17-FEB-2009 the patient experienced diarrhea after receiving ROTATEQ. He recovered on an unspecified date. The patient sought unspecified medical attention. Follow up information was received which reported the male patient's birth weight was 7 pounds 11 ounces and did not have sibling. He had upper respiratory infection at the time of vaccination. There was no drug allergy or medical history. At 10:00 on 17-FEB-2009 he was orally vaccinated with the second dose of ROTATEQ (lot #660425/0278X). At the same time he was also intramuscularly vaccinated with the second dose of PENTACEL (lot #C8180AA) into the left thigh and the second dose of PREVENAR (lot # C65929) into the right thigh. Subsequently, the patient experienced diarrhea and had a doctor visit. On 22-FEB-2009 he recovered. Additional information is not expected.
patient waited the 15 minutes sitting on a chair. He got up to make a second appt and passed out when he was being helped.  He fell and there was a loud thump.  When I ran out he was laying on his back and his eyes were open and looked glazed over.  He started talking as soon as I addressed him.  We called 911 because I was concerned of a head injury.  We elevated his feet and had him wait until help came.  He was able to get up and walk out with the policeman and had the paramedics look at him.  I don't believe he went with them to the hospital.
Fever (100 F) Fatigue Rash below injection site Body aches Headache
Chicken pox like rash on trunk of body, didn't seem itchy or bothersome at all. Mostly gone after 24 hours
Pt with hives/rash approx 30 minutes after receiving 2nd dose of Pfizer vaccine.  Pt also c/o of headache.  Blood pressure was elevated initially 185/112.  Multiple blood pressures taken with decrease to 174/105 then 154/95.  Rash and hives decreased 60 minutes post vaccine administration.
Miscarriage at 10 weeks gestation with estimated due date of 07/12/2022. Medical history: one previous successful pregnancy, no prior history of miscarriage.
This case was reported by a physician via call center representative and described the occurrence of headache in a female patient who received RABAVERT. On 6th December 2017, the patient received RABAVERT. On an unknown date, less than a year after receiving RABAVERT, the patient experienced headache, sensory loss, staggering, itchy rash, burning sensation, balance difficulty and bladder incontinence. On an unknown date, the outcome of the headache, sensory loss, staggering, itchy rash, burning sensation, balance difficulty and bladder incontinence were unknown. It was unknown if the reporter considered the headache, sensory loss, staggering, itchy rash, burning sensation, balance difficulty and bladder incontinence to be related to RABAVERT. Additional information was reported as follows: The patient received RABAVERT for post exposure prophylaxis. The age at vaccination was not reported. The healthcare professional was the patient herself, who reported that she was bitten at work. After receiving RABAVERT, the patient experienced a number of adverse events like balance issues, bladder leakage, sensory perception loss, itchy and burning rash on the body. Neurologist did not have a treatment option. The healthcare professional just wanted to know which part of the vaccine she had a side effect to. No additional information was provided.
Hearing loss 6 weeks after varivax; This spontaneous report has been received from a physician, via a MR from a case in litigation for zoster vaccine live (ZOSTAVAX) (MARRS # 1806USA001202 original legal case), concerning a currently 68-year-old female patient. Information about medical history, concurrent conditions and concomitant therapies was not provided.   On an unknown date, the patient was vaccinated with varicella virus vaccine live (Oka/Merck) (VARIVAX) injection (strength, dose, route, lot# and expiration date were not reported) for prophylaxis.        On an unknown date, 6 weeks after varicella virus vaccine live (Oka/Merck) (VARIVAX), the patient experienced reaction of hearing loss (Deafness), which was a side effect of this vaccine. Outcome of deafness was unknown.   The causality between varicella virus vaccine live (Oka/Merck) (VARIVAX) and the event was related.  Upon internal review, deafness was determined to be medically significant.  This is one of two reports regarding the same patient.; Sender's Comments:  US-009507513-1806USA001202:
After receiving the shot in left arm, about an hour later my arm started to get sore, felt body chills, neck and low back pain/stiffness, chest felt funny. My son also complained about his arm hurting. I felt tired and stayed down for the day I received the shot and the next day I stayed mostly in bed.
Information has been received from a physician concerning a 6 month old male who on 27-DEC-2007 was vaccinated with the third dose of Rotateq.  On 04-JAN-2008 the patient experienced intussusception and was hospitalized for an unspecified period of time.  The patient had a "contrast enema" performed on an unknown date, results not reported.  Subsequently, the patient recovered from intussusception.  Upon internal review, intussusception is considered an other important medical event.  No product quality complaint reported.  Additional information has been requested.  01/22/2008 Vax record received and updated in database. 01/29/2008 MR received for DOS 01/4-5/2008 with DX:  Intussusception.  Child presented to ER with 1 day hx of diarrhea with screaming and abdominal pain. Reduced by Barium Enema. Pt tolerating diet and D/Cd next day.
Possible SIRVA. Injection was high on shoulder, possibly in bursa. Received flu vaccine in left arm. Felt pop when injected followed by burning, stinging sensation down arm to elbow. Pain began an hour later. By 5PM couldn't lift arm. Took 2 TYLENOL and went to bed. By 11:30 extreme pain and vomiting, headache nausea and weakness went to the emergency room. Was diagnosed as allergic reaction. Called Dr next morning at 8AM advised to see immediately. Dr said misdiagnosed by ER, was inflammatory reaction not allergic reaction. Severe pain persists along with headache and nausea thru Friday. Received a shot of Tramadol and took ZOFRAN and prescription for TORADOL. Told to exercise twice a day of left arm to keep from getting frozen shoulder, scheduled next appointment for October 23. Friday morning October 20 was vomiting called Dr to see about nausea and headache and requested MRI. Advised to stop TORADOL and see in office on Monday. By mid afternoon vomiting and headache unbearable and Dr office was closed. Went to Convenient care. Received shot of STADOL and ordered MRI to be done Monday. Saturday October 21 Headache persists. Convenient care prescribed FIORICET. Severe pain in shoulder has been persistent since shot.
No additional AE information; Office manager responsible for storage and handling of vaccines reported patient administered MMRII and VARIVAX that experienced supported temperature excursion.; This spontaneous report was received from an office manager referring to a patient of unspecified age and gender. The patient's pertinent medical history, concomitant therapies, concurrent conditions and previous drug reactions or allergies were not reported.   On 13-APR-2022, the patient was vaccinated with one dose of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live recombinant human albumin (rha) (M-M-R II) 0.5 milliliters (mL), once (lot number  T027937 has been verified to be valid, expiration date reported and established as 18-AUG-2022 ) and one dose of varicella virus vaccine live (Oka/Merck) (VARIVAX) 0.5 milliliters (mL), once (lot number U019904  has been verified to be valid, expiration date reported and established as 24-JUN-2023) (routes of administration, anatomical sites of vaccination, and vaccine schemes were not reported). Both vaccines were administered as prophylaxis.   It was reported that the vaccines were exposed to supported temperature excursion before being administered. No additional adverse event was reported (no adverse event).   This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-2204USA007198: US-009507513-2204USA007134:
Right arm from shoulder to elbow became extremely painful and was hard to move. Fell that night going to bathroom, became dizzy and tripped. Was seen the next morning in the ED and rt. arm was x-rayed. She continued to have pain in her arm for 3+ weeks. Went to her family doctor who recommended she see a dermatologist because she still has a quarter sized raised redden area with the center being a beige crusted center on the middle of her right deltoid muscle. She present to this site on 12/28/11 with the same described area. She has not been seen by a dermatologist.
administered Kinrix for a child aged 2yr, 5mo; This case was reported by a other health professional via call center representative and described the occurrence of inappropriate age at vaccine administration in a 2-year-old male patient who received DTPa-IPV (Kinrix) (batch number HB7L7, expiry date 31st August 2021) for prophylaxis.   Co-suspect products included dtpa-ipv vaccine pre-filled syringe device (Kinrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   Previously administered products included Dtap+IPV (received on 10th July 2019) and Dtap+IPV (received on 16th September 2019).   On 20th August 2021, the patient received Kinrix (intramuscular) and Kinrix Pre-Filled Syringe Device. On 20th August 2021, unknown after receiving Kinrix and Kinrix Pre-Filled Syringe Device, the patient experienced inappropriate age at vaccine administration. On an unknown date, the outcome of the inappropriate age at vaccine administration was unknown.     This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.  Additional details were provided as follows: The health care provider mistakenly administered Kinrix for a child aged 2 years and 5 months old patient, which led to inappropriate age at vaccine administration. The reporter stated that, the patient had been delayed by caregivers. The reporter consented to follow up.
Post vaccination: feels faint, and diaphoretic. Medical monitoring x30min, rest and hydration offered; pt feels better, released from facility and sent home. with husband.
Patient seen and diagnosed by Dr.; described event as rash on right arm, shoulder, face, and scalp about 4mm skin lesions - possible herpes zoster. Tx: Zyrtec, Valtrex
pt noticed tenderness swelling redness & warmth @ inject site about 6-12 p/the inject; 7MAY93 pt has 60mm swollen area that is redened & warm to touch on lt deltoid;
On 8-9-2010 client was given H1N1 0.1ml. intradermally instead of TB-PPD in the left inner forearm. 8-11-2010 - left forearm area at site is slightly reddened - 3cm size. No complaints of discomfort. 8-13-2010 - No redness visible.
Vial was stored in refrigerator on 17-FEB-2022, expired on 01-APR-2022 and administered on 05-APR-2022; 21 patients administered with expired vaccines/25 Patients Identifiers Update for Safety; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (21 patients administered with expired vaccines/25 Patients Identifiers Update for Safety) and PRODUCT STORAGE ERROR (Vial was stored in refrigerator on 17-FEB-2022, expired on 01-APR-2022 and administered on 05-APR-2022) in a 68-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026L21B) for COVID-19 vaccination.     No Medical History information was reported.    On 05-Apr-2022, the patient received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 05-Apr-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (21 patients administered with expired vaccines/25 Patients Identifiers Update for Safety). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Vial was stored in refrigerator on 17-FEB-2022, expired on 01-APR-2022 and administered on 05-APR-2022). At the time of the report, EXPIRED PRODUCT ADMINISTERED (21 patients administered with expired vaccines/25 Patients Identifiers Update for Safety) and PRODUCT STORAGE ERROR (Vial was stored in refrigerator on 17-FEB-2022, expired on 01-APR-2022 and administered on 05-APR-2022) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant products were reported. Date the vial was initially stored in refrigerator: 17-Feb-2022 10:00 AM and vial didn't undergo any temperature excursion. Patient didn't had adverse events. It was reported that the vaccine administered on April 5, 2022 from lot number 026L21B likely did not maintain the activity necessary to fully protect against the SARS-CoV-2 (COVID-19) virus at time of administration. No treatment information was reported.   Most recent FOLLOW-UP information incorporated above includes: On 11-Apr-2022: Follow-up contain non-significant information.
Patient is 17 1/2 and received his first dose of Covid vaccine (Moderna) which is used for ages 18 and up.  Mother  called and she is aware of error and will call PCP for follow up.  Reviewed standard work flow with nurse to always verify age on the front of the registration form, now what age the vaccine she is giving is used for and verbally verify age with client when appropriate.  Mother reports patient has Down's Syndrome.
Site: Pain at Injection Site-Medium, Systemic: Exhaustion / Lethargy-Severe, Systemic: Numbness (specify: facial area, extremities)-Medium, Systemic: Tingling (specify: facial area, extemities)-Medium, Additional Details: Patient is having sciatica like pain, nerve radiating pain down arm and up into the neck area. It comes and goes but is still persisting after 9 days.
Tested positive for COVID-19; This spontaneous case was reported by a patient and describes the occurrence of COVID-19 (Tested positive for COVID-19) in a 30-year-old female patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) for COVID-19 prophylaxis.     Concurrent medical conditions included Ulcerative colitis. Concomitant products included TOFACITINIB CITRATE (XELJANZ XR) for Ulcerative colitis.    On 10-Oct-2022, the patient received third dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On 21-Oct-2022, the patient experienced COVID-19 (Tested positive for COVID-19). At the time of the report, COVID-19 (Tested positive for COVID-19) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 21-Oct-2022, SARS-CoV-2 test: Positive.         Concomitant product use was not provider by the reporter.  Patient's all prior COVID vaccines were from Moderna.  Patient had been on Xeljanz XR 11 mg daily for approximately 1 year and was doing well.  Patient had not had any UC symptoms for over 1 year. Patient had mild headache which has resolved. Patient felt well and had been working remotely. The dose patient received on 10-Oct-2022 was 3rd booster.  Treatment information was not provided.
Upper shoulder soreness; chills; Headache; This spontaneous case was reported by a health care professional and describes the occurrence of PAIN IN EXTREMITY (Upper shoulder soreness), CHILLS (chills) and HEADACHE (Headache) in a 42-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 016M20A) for COVID-19 vaccination.     No Medical History information was reported.   On 07-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 10-Feb-2021, the patient experienced PAIN IN EXTREMITY (Upper shoulder soreness), CHILLS (chills) and HEADACHE (Headache). At the time of the report, PAIN IN EXTREMITY (Upper shoulder soreness), CHILLS (chills) and HEADACHE (Headache) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medication details were not reported by the reporter. Treatment details was not reported by the reporter.
Patient arrived at 1pm for Pfizer "booster" vaccine.  Primary vaccinator was at lunch. PharmD,  prepared 0.3ml of vaccine from a diluted vial on pharmacy counter, located in the traditional area where daily diluted Pfizer vaccine is kept (for up to 6 hours).  It was later discovered the vial was reconstituted 12-5-2021, not 12-6-2021. Patient was notified when it was discovered she was given expired vaccine and asked to notify pharmacy if any s/sx of infection become present.  Patient stated she was doing well as of 7:30pm on 12-6-2021.
Due to pt's PCN allergy, pt monitored for 30 minutes after receiving the 1st dose of the Covid vaccine. 15 minutes into monitoring, pt developed a throbbing HA and described feeling like his lower extremities had weights tied to them. Pt's BP 140/90. Pt denied any cardiac or neuro. EMS called for further evaluation. While waiting for EMS, pt developed tingling sensation in both hands and had vision changes. Pt transported to hospital upon EMS arrival. Called pt to f/u 4/9. Stated that he was monitored at Hospital ER for several hours. Was given Fioricet for HA and Reglan for stomach. No scans done. Stated that he was feeling much better and was released from the ER the same day. Has a f/u appointment with PCP, on 4/15.
At first patient was complaining of stinging, after the shot was done patient said she was feeling fine, when patient came back on Sunday the injection site was red, swollen, elevated.
On 3/7 the patient presented to the ED after having 3 episodes of presyncopal staring events in the past week, and reports having them over the past year and a half.  Reason for admission: syncope and collapse. Per, EUA all hospitalizations must be report after recently receiving a vaccine. This patient has had a history of syncope and this hospitalization does not seem to be related to the vaccine.
Initial information received on 05-Mar-2019 regarding an unsolicited valid non-serious case received from a nurse. This case involves a four months old male patient who received a second 0.5 ml dose of the vaccine PENTACEL (lot C5515AA, M035268 and Exp. Date- 15-Sep-2019) via unknown route in the left thigh, on 12-Feb-2019. And was given only the HIB part of the vaccine and the DTAP- IPV part was not administered. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. Concomitant medications included Rotavirus Vaccine and PREVENAR 13 for Immunisation. It was an actual medication error case due to inappropriate reconstitution technique. It was reported that a four month old child came for his 2nd dose in the series of PENTACEL. This child was given only the HIB part. The HIB vial was diluted with sterile water and given and the DTap- IPV part was not given. It was unknown whether the patient had any adverse reactions. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error. List of documents held by sender: none.
Joint pain primarily in knees. Started day after vaccine was administered and is still happening.; This is a spontaneous report from a contactable consumer, the patient. A 58-year-old non-pregnant female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EN6206), via an unspecified route of administration in the left arm on 10Mar2021 at 15:00 (at the age of 58-years-old), as a single dose for COVID-19 immunisation. The patient's medical history included Diabetes. Concomitant medication included Several diabetic related medicines (names unknown). Patient was allergic to penicillin. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccination. On 11Mar2021 at 00:00, the patient experienced Joint pain primarily in knees. Started day after vaccine was administered and is still happening. The clinical outcome of the event knee pain was recovering.    No follow-up attempts are needed. No further information is expected
Vaccine administered from refrigerated vial that was approximately 14 hours post expiration. Recipient of vaccine notified of error on 6/11/21. No adverse reaction noted on 6/22/21. Follow up with customer over phone done at 10:00am 6/12/21. Customer stated arm was sore at injection site but no further adverse reaction or complaints noted. Customer did state that he does not have a PCP.
c/o swelling and warmth from left anterior neck to left shoulder  Narrative: Employee states she has contacted her PCP for further evaluation.
Tiredness, chills, hot sweat, swelling at the site of injection. Narrative:
Bell's Palsy 24 hours after receiving Menactra, had been healthy prior to receiving vaccine.