chrisvoncsefalvay/vaers-outcomes huggingface dataset:
FEVER; NAUSEA; COLD LIKE SYMPTOMS; WINDED; CANNOT STAY AWAKE; HEART RATE A LITTLE ACCELERATED; PULSE OXYGENATION AVERAGED ABOUT 90PP; VERY TIRED; This spontaneous report received from a consumer concerned a male of unspecified age. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: Unknown, and batch number: UNKNOWN expiry: UNKNOWN) .5 ml, administered on 09-MAR-2021 for prophylactic vaccination. The batch number was not reported and has been requested.  No concomitant medications were reported. On MAR-2021, the subject experienced winded. On MAR-2021, the subject experienced cannot stay awake. On MAR-2021, the subject experienced heart rate a little accelerated. On MAR-2021, the subject experienced very tired. Laboratory data included: Body temperature (NR: not provided) Low, and Oxygen saturation decreased (NR: not provided) about 90. On 09-MAR-2021, the subject experienced cold like symptoms. On 11-MAR-2021, the subject experienced fever. On 11-MAR-2021, the subject experienced nausea. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the cold like symptoms, fever, nausea, winded, very tired, cannot stay awake and heart rate a little accelerated was not reported. This report was non-serious.
c/o pain & swelling 1 1/2cm x 1 1/2cm) @ inj site beginning 1APR97;states discomfort inc today;sl redness noted;referred to PMD;
This case was reported by a healthcare professional, via a GSK sales representative, and described the occurrence of pain in an adult female subject who was vaccinated with TWINRIX (GlaxoSmithKline). On 16 January 2008 and on an unspecified date, the subject received the 1st dose and 2nd dose of TWINRIX (1 ml, intramuscular, left arm). At an unspecified time after vaccination with TWINRIX, the subject experienced pain and reduced range of motion. The sales representative had limited information to provide, but stated that the same adverse events occurred following the 1st and 2nd doses of TWINRIX. At the time of reporting, the outcome of the events was unspecified. Follow-up information was received on 09 May 2008 via a healthcare professional, who indicated that this case was reported to a Regulatory Agency (VAERS ID #309493). The subject was a 57 year-old female who was taking the following concomitant medications at the time of vaccination with TWINRIX, CELEXA, LORAZEPAM, Glucosamine sulfate, SEROQUEL, Vitamins, VIVELLE-DOT, Aspirin, Calcium and GINKGO BILOBA. The subject had no history of adverse events following previous vaccinations. The immunization series was neither delayed, nor discontinued. The symptoms did not recur following subsequent vaccinations (dates and doses unspecified). The healthcare professional reported that the onset date of the earliest signs or symptoms occurred on 16 January 2008. The reporting healthcare professional indicated that the events were not serious, and considered the events to be unrelated to vaccination with TWINRIX. At the time of reporting, the outcome of the events was unknown.
Client noted swelling and warmth at site of infection left arm on Wednesday AM, 11/20/04.  States redness, warmth and swelling extends in area of arm and past elbow. States temperature was 99-99.2, took Tylenol. Reported over the phone 10/21/04.  10/22/04: Pt to client regarding status. Reports swelling less but still red, hot to touch. Now has redness and warmth to right arm and reports previous history of reaction to allergy shots.
About 24 hours later, I noticed a rash the size of quarter. On Tuesday, the rash was bigger and it was swollen underneath - the lump underneath it was the size of a golf ball. Wednesday and Thursday - Nurse measured it had rash top was 7 cm and the lump underneath was the size of my palm (much bigger). It was really painful and really itchy.  On Thursday, I did a telehealth video chat - and I showed it to the doctor and that's when I went to the clinic where the nurse measured it. Treatment was given: Steroid cream - called Triamcinolone. I used it that night and by the next day the redness had gone down 50% and the lump decrease, also. I have been using it twice a day since Thursday. Today the redness is gone and the lump is maybe the size of a quarter.  It's about 90% better but not completely gone.
12/29  Client began experiencing chills, cough, fatigue, muscle aches, H/A, sore throat,  congestion all of which resolved end of day 12/30.  Had nausea x 1 12/29.  Has ongoing chest discomfort as " like when you take a deep breath and it's cold outside".  States had this when she had Covid in October.
Received TWINRIX (Hep A/B) #3 vaccine IM (R) deltoid on 1/5/2017. Had pain on injection and on-going pain ever since in (R) upper arm. Pain worse with abduction >45 degrees of external rotation of (R) shoulder.
Pediatric vaccine was diluted with 0.13 ml instead of 1.3 ml so the patient got a more concentrated dosage than recommended. Patient presented pain at injection site and headache. She vomited aroun 6:00 am the next morning. She is fine and stable at the moment.
On third day after flu shot, sudden onset of deafness - nearly complete L. ear, partial R. ear. 8 hours later sudden and severe vertigo. Vertigo gradually diminishing over following weeks. 60 mg prednisone during week 5, no noticeable effect. Deafness and mild vertigo today 12/11.
Upon my return home, I felt very dizzy, weak, nearly  fainted, where  a sensation ran through the left side of the body. I then was assisted to the bed, where my left arm and left leg felt numb. I rested assuming this would fade away, being I has some numbness from the 1st vaccine.  On 3/24/21, as I attempted to get up from the bed,   I could not maintain my  balance and gait. The numbness was still in my entire left arm and entire left leg, yet I was able to raise move and wiggle my limbs, toes, fingers to a degree.
Atypical shoulder pain following administration of flu vaccine. Limited range of motion within a few hours and has lingered for weeks.  Feel as though shot was given too high on shoulder.
pt looking flush in the face; rash devel 1 wk p/vax; pt seen on 27DEC93 w/rash on face; no other sx present no fever, no vomiting;
Pt recv vax on 12/29/98; 3-4 hr post vax pt exp headache & malaise; tx=Acetaminophen
Patient reports she got the J&J vaccine Friday, had chills/fever/headache the next day.  All side effects have resolved without treatment
She had a slight headache; This is spontaneous report received from a contactable consumer (husband). This is the second case out of two cases in which reporter is reporting for his wife. A 31-years-old female non pregnant patient received unknown dose of BNT162B2 (COMIRNATY, Solution for injection) via an unspecified route of administration as an unspecified dose for covid-19 immunization. The patient medical history included her husband few months back had Covid and he experienced fever, weakness and soreness for a period of 3 days but it was gone after 3 days and then when he got tested, it came back positive and when he checked his blood pressure it went to 130/91 mmHg. He said that he followed instructions from the department and he noticed that his fever and weakness were gone after 3 days and after a week of isolation, he got himself tested and the results came back negative however, his soreness lasted for 3 to 4 weeks till he got tested for second time and it came back negative again. He also mentioned that his wife had the same symptoms she had when he had Covid but his wife did not get tested and then when he went back to get tested again after isolating they both tested negative. So, his wife took the vaccine 10 days ago and he noticed that she did not have any symptoms and also said that after his symptoms were all gone he decided to take the vaccine, (as patient had Covid before taking the vaccine, hence Covid not captured as event). The concomitant medications were not reported.  The Patient experienced headache on an unspecified date after the vaccination. The outcome of the event was unknown.   No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Approx onset 24 hrs after vaccination w/ weakness in legs and generalized malaise/myalgia, fell and diminished ability to ambulate -- > approx. 48 hrs after vacc was brought by EMS to ED for evaluation (2/19). Admitted to hospitalist service w/generalized weakness/ambulatory arrest, developed new onset urinary retention night of admission requiring straight cath intermittent. Increased weakness of leg, progressed to right arm/leg weakness > left leg weakness, so TELENEURO Consult initiated, hMRI w/o gado (2/21) checked, no CVA; recommendation for possible LP and EMG.  Progressed to apparent areflexia ; seen by NEURO consult onsite (2/23) -- > felt to toxic encephalopathy due to COVID vaccination, motor predominant and detrusor involvement.   Bladder atony resolved completely over approx. 3-4 days.  Leg strength recovered somewhat over 4-5 days, and patient was referred for SNF rehab discharge.  Developed low grade fever and pyuria on 2/24, urine cx grew ecoli ; initially treated with empiric ceftriaxone.  Then patient developed left elbow and left knee pain/erythema/edema/tenderness (2/25) and was seen by ID in consultation.  Got vancomycin empiric, and had aspiration of left knee joint effusion, revealing no crystals, 500cells monocyte predominant consistent with pseudogout.  Vanco d/c'd; NSAIDs contraindicated for frail elder so patient was treated with  prednisone short course.  Ceftriaxone iv transitioned to po Keflex for ecoli uti to complete 7d course.  Patient was discharged to SNF for rehab
Given 10 mcg dose of Moderna Bivalent instead of recommended 25 mcg.
Body aches, mostly in the lower legs; fatigue that lasted for 2 days; severe pain, swelling, and temporary immobility at injection site.
dizzy and lightheaded; opposite side shoulder he received the vaccine was sore; This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (dizzy and lightheaded) and ARTHRALGIA (opposite side shoulder he received the vaccine was sore) in a 77-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No reported medical history).    On 14-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 14-Jan-2021, the patient experienced DIZZINESS (dizzy and lightheaded) and ARTHRALGIA (opposite side shoulder he received the vaccine was sore). On 15-Jan-2021, DIZZINESS (dizzy and lightheaded) and ARTHRALGIA (opposite side shoulder he received the vaccine was sore) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications reported. Treatment included Heat
Employee stated that on the Friday 4/19  the day after she received the vaccine, which was 4/18,  she developed swelling to her bottom lip and an itchy rash all over her body.  She sought a medical provider and was prescribed steroid therapy for 5 days and zyrtec.  She states that the itching resolves when she takes the zyrtec.
Severe night sweats starting night after vaccination (Thursday night after Wednesday vaccination) sufficient to waken me.  Sheets and night clothes were wet.  Sweat would stop when I was awake, but quickly return as I dosed, resulting in multiple awakenings all night for a while down with a towel.
Patient arrived for appointment and requested a "Moderna booster." Screening personnel failed to notice that patient had recently received her first dose of Pfizer vaccine in the primary COVID-19 vaccine series on 09 Mar 2022. Patient inadvertently received a booster 0.25mL dose of Moderna vaccine per her verbal request instead of the appropriate Pfizer second primary series dose. Once error was identified, patient had already left vaccination site. Patient contacted and notified of error. Corrective action per CDC's guidance was to administer another 0.25mL dose of Moderna vaccine same day to make a full 0.5mL dose of Moderna and patient would be considered to have a complete primary mixed series. Patient was able to return and received a second dose of 0.25mL Moderna vaccine. When reviewing record to submit a patient safety report, it was observed that it had only been 23 days since first dose of Pfizer, and patient did not meet minimum spacing of 28 days for a mixed primary series. This dose was given 5 days too early. Recommendation is to repeat dose 4 weeks later to ensure patient is protected. No known adverse events at this time.
Systemic: Confusion-Severe, Systemic: Fainting / Unresponsive-Severe, Systemic: Seizure-Severe, Additional Details: patient had an abscense seizure immediately after sitting down
Red Rash; Injection site itch; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PRURITUS (Injection site itch) and RASH ERYTHEMATOUS (Red Rash) in a 66-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013M20A) for COVID-19 vaccination.     No Medical History information was reported.    On 05-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 11-Feb-2021, the patient experienced VACCINATION SITE PRURITUS (Injection site itch). On 12-Feb-2021, the patient experienced RASH ERYTHEMATOUS (Red Rash). At the time of the report, VACCINATION SITE PRURITUS (Injection site itch) and RASH ERYTHEMATOUS (Red Rash) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No relevant concomitant medications were reported. No treatment information was provided.
A syringe containing vaccine that was reconstituted up to 9hrs previously was used. The single use syringe was stored in the refrigerator once reconstituted.
really bad Migraine headache (really bad headache); (Scintillating Scotomas) visual disturbances, (saw lights were shimmering and wavy lines); Periodic chills, like the chills you get with flu or virus, but she doesn't have any fevers; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 12-Mar-2021 and was forwarded to Moderna on 12-Mar-2021.    This spontaneous case was reported by a consumer and describes the occurrence of MIGRAINE (really bad Migraine headache (really bad headache)), SCINTILLATING SCOTOMA ((Scintillating Scotomas) visual disturbances, (saw lights were shimmering and wavy lines)) and CHILLS (Periodic chills, like the chills you get with flu or virus, but she doesn't have any fevers) in a 79-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 002A21 and 010M20A) for COVID-19 vaccination.     Concurrent medical conditions included Platelet disorder (platelet disorder that's inherited, doesn't get better or worse.).   On 31-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 28-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 01-Mar-2021, the patient experienced MIGRAINE (really bad Migraine headache (really bad headache)). 01-Mar-2021, the patient experienced SCINTILLATING SCOTOMA ((Scintillating Scotomas) visual disturbances, (saw lights were shimmering and wavy lines)) and CHILLS (Periodic chills, like the chills you get with flu or virus, but she doesn't have any fevers). The patient was treated with PARACETAMOL (TYLENOL) on 01-Mar-2021 for Migraine, at a dose of two 650mg tylenol for 2 days. On 03-Mar-2021, MIGRAINE (really bad Migraine headache (really bad headache)) and SCINTILLATING SCOTOMA ((Scintillating Scotomas) visual disturbances, (saw lights were shimmering and wavy lines)) had resolved. At the time of the report, CHILLS (Periodic chills, like the chills you get with flu or virus, but she doesn't have any fevers) had not resolved.            Action taken with mRNA-1273 in response to the events was not applicable.   This case was linked to MOD21-051822 (Patient Link).
underwent temperature excursion; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (underwent temperature excursion) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (underwent temperature excursion). At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (underwent temperature excursion) had resolved.            No concomitant medication was provided. No treatment medication was provided.
This spontaneous report was received from a registered nurse referring to a patient of currently 61 years of age and unspecified gender. The patient's pertinent medical history and concomitant medications were not reported. On an unknown date, the patient was vaccinated with improperly stored dose of ZOSTAVAX, lot # L027322, expiry date unspecified (dose, route of administration and anatomical location not reported). The doses of ZOSTAVAX was involved in temperature incident. This is one of several reports from the same reporter. Additional information has been requested.
1 min. after receiving smallpox vaccine pt. complained of lightheadedness.  Immediately loss consciousness & fell to the floor hitting head on a shelf.  Became apneic, pale, & demonstrated tonic-clonic activity in the upper & lower extremities.  Epi X 1 given.  Ventilated with bag-valve mask, IV started, O2 applied per non-rebrather mask after about 2 minutes.  Regained consciousness in 4-5 minutes.  Transported to local ER per EMS.  Observed for 3 1/2 hours.  Given Peocid 40mg IVP, Solu-Medrol 125mg IVP, & Benadryl 25mg IVP.  Vital signs remained WNL.  Returned to medical Clinic that afternoon and the next morning for follow-up evaluation.  Review of systems all WNL.  Scheduled for a evaluation by Neurology in 1 week.
Positive for squamous cell carcinoma; Pustular rash; Colloid milia; This spontaneous case was reported by a physician assistant (subsequently medically confirmed) and describes the occurrence of SQUAMOUS CELL CARCINOMA (Positive for squamous cell carcinoma) in a 78-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.     No Medical History information was reported.   In February 2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 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 an unknown date, the patient experienced SQUAMOUS CELL CARCINOMA (Positive for squamous cell carcinoma) (seriousness criterion medically significant). an unknown date, the patient experienced RASH PUSTULAR (Pustular rash) and MILIA (Colloid milia). At the time of the report, SQUAMOUS CELL CARCINOMA (Positive for squamous cell carcinoma), RASH PUSTULAR (Pustular rash) and MILIA (Colloid milia) outcome was unknown. Not Provided    DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Biopsy: positive (Positive) Conducted three biopsies on patient and it was positive for squamous cell carcinoma..     For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant product use was not provided by the reporter.  Treatment information was not provided.  Company comment: 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
This spontaneous report was received from a pharmacist and refers to a 61 year old female patient. There was no information regarding the patient's medical history, concomitant medications, drug reactions and allergies provided. On 13-DEC-2017 (reported as one week ago), the patient was vaccinated with first dose of RECOMBIVAX HB, 40 micrograms, intramuscularly for hepatitis B virus prevention (lot number and expiration date was not reported). On 19-DEC-2017, the patient was vaccinated with second dose of RECOMBIVAX HB. The patient sought medical attention by contacting pharmacist. No adverse effect were reported.
Mild chronic dizziness and atlas joint is very sore and painful; Mild chronic dizziness and atlas joint is very sore and painful; This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (Mild chronic dizziness and atlas joint is very sore and painful) and ARTHRALGIA (Mild chronic dizziness and atlas joint is very sore and painful) in a 65-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 006B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 23-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 24-Mar-2021, the patient experienced DIZZINESS (Mild chronic dizziness and atlas joint is very sore and painful) and ARTHRALGIA (Mild chronic dizziness and atlas joint is very sore and painful). The patient was treated with IBUPROFEN (MOTRIN [IBUPROFEN]) at an unspecified dose and frequency. At the time of the report, DIZZINESS (Mild chronic dizziness and atlas joint is very sore and painful) and ARTHRALGIA (Mild chronic dizziness and atlas joint is very sore and painful) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No relevant concomitant medications were reported.
Itchy and swollen at injection site; hot to the touch; red circle, approximately 2" in diameter. I sought a virtual appointment and NP stated to take Tylenol, Zyrtec in the morning (10mg) and Benedryl at night (25mg). If symptoms did not improve in 48 hours, to make a new appointment for antibiotics and steroids.
RED RASH WITH ITCHING ON FACE (EAR, EYE, NOSE), THROAT/NECK, CHEST, B/L ARMS AND LEGS. NO WEEPING/OPEN SORES, NOT PAINFUL JUST ITCHY. NO SHORTNESS OF BREATH. PT STATES ONSET ABOUT 1HR AFTER ADMINISTRATION OF VACCINE WITH SYMPTOMS SPREADING/WORSENING EACH DAY. PT SOUGHT MEDICAL ATTENTION AND RECEIVED PRESCRIPTION FOR PREDNISONE 9/24/21
Information has been received from a health professional concerning a 67 year old male with benign prostatic hyperplasia and black appearing stools who on 10/22/2004 in the afternoon was vaccinated intramuscularly in the left deltoid with a first dose of PNEUMOVAX 23 (lot # 647029/0514P).  On 10/23/2004 the patient indicated that the area was sore and tender to touch for one day after injection.  The outcome was reported as recovered.
Vaccine administered in 9/1. Patient took a shower & washed hair on 9/3 & noticed a bald spot that she did not notice before. Although lamotrigine can cause 4% alopecia, she believes moderna caused the bald spot She has been on lamotrigine for >9 years and has seen routine normal hair loss. She has not noticed any "hair clump" loss on 9/1 or 9/2 but noticed the bald spot on 9/3.