chrisvoncsefalvay/vaers-outcomes huggingface dataset:
pt recv vax 23JUL97 & that same day pt exp rash & swelling of the upper arm;pt reportedly recovered from this exp;
Abnormal vaginal bleeding started on cycle day 8 after my period had ended. Similar to having a second period all over again. This happened also after my first covid19 shot. Very unusual. Had smear test and pelvic ultrasound and all was clear.
24hrs after vaccination, the pt developed redness, warm to touch and edema below injection site to top of knee and halfway around diameter of leg. Pt started on Keflex. Cellulitis on left thigh.
Feeling a little bit cold; Body Aches; Pink Eye; Little bit of pain in arm; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Little bit of pain in arm), CONJUNCTIVITIS (Pink Eye), NASOPHARYNGITIS (Feeling a little bit cold) and PAIN IN EXTREMITY (Body Aches) 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. No concomitant medication reported.    On 20-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 16-Apr-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced PAIN IN EXTREMITY (Little bit of pain in arm). On 20-Apr-2021, the patient experienced CONJUNCTIVITIS (Pink Eye). On an unknown date, the patient experienced NASOPHARYNGITIS (Feeling a little bit cold) and PAIN IN EXTREMITY (Body Aches). On 18-Apr-2021, PAIN IN EXTREMITY (Little bit of pain in arm) had resolved. At the time of the report, CONJUNCTIVITIS (Pink Eye), NASOPHARYNGITIS (Feeling a little bit cold) and PAIN IN EXTREMITY (Body Aches) outcome was unknown. Not Provided      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.   This case was linked to US-MODERNATX, INC.-MOD-2021-082996 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-082996:First dose case
Local irritation and pruritis at injection site, left deltoid.  No respiratory compromise.  Denies other symptoms.  Benadryl given po.
Patient has been having extremely heavy periods. Soaking a super plus tampon every hour for multiple days when patient has never had that heavy of a period ever before.
Baby was a 30 wk preemie, now 38+5 wks on HFNC 2 liter flow/room air. Had is 2mo immunizations on 4/16 at 11am and required PPV for apnea in the eve of 4/16. He is okay now.
Myalgia, sore throat, body aches, fatigue, malaise Narrative:
Painful joints in feet and hands with swelling and redness, inflamation in bladder, exhaustion, restricted about of daily duties and chores due to pain in joints. The side effects have not gone away and my Rheumatologist is putting me on Humira to reduce this ongoing inflamation.
This spontaneous report as received from a healthcare worker/certified medical assistant refers to 4 patients of unknown demographics. The patients were vaccinated with improperly stored ROTATEQ (lot # L026741, expiry date: 18-MAY-2017) that was exposed to the following conditions: Temperature of 47.3F for 1 hour and 24 minutes. There was no previous temperature excursion. The temperature excursion was because of a data logger. It was confirmed that the improperly stored vaccine was administered to the patients. No adverse symptoms reported. The outcome was unknown. No product quality complaint was involved. This is one of several reports received from the same reporter. Additional information has been requested.
This spontaneous report was received from a registered nurse and refers to a patient of unknown age and gender. No information regarding the patient's pertinent medical history, drug reactions or allergies and concomitant medications was reported. On an unknown date, the patient was vaccinated with a dose of ROTATEQ (lot # N003392, expiration date: 11-OCT-2018; dose was not reported) orally. On an unknown date, the patient experienced a breath-holding spell for a few seconds. No lab diagnostic studies were performed. The patient quickly recovered from the adverse event on an unknown date and no treatment was necessary. No product quality complaint was involved.  The relatedness between the breath-holding spell and ROTATEQ was not reported. Additional information has been requested.
Patient received shot one day after the beyond use date. Patient says after this his health has gone down. He reports heart problems, hospitalization due to pneumonia, and fatigue.
Initial solicited report on 21 March 2017 from an investigator (Defense Health Agency/Immunization Healthcare Branch) in the trial. A 21 year-old male subject with no significant medical history. The subject's concomitant medication was not reported. The subject received a dose of ACAM2000 (lot number and route, site of administration not reported) on 01 February 2017. On 13 February 2017, 12 days after vaccination the subject was diagnosed with i30.9 acute pericarditis, unspecified. The subject's lab data included, Troponin I result was normal done on 09 February 2017, ECG was abnormal done on 10 February 2017, Echocardiogram was normal performed on 03 March 2017. Treatments were not reported. The subject's outcome was not reported. Relationship to investigational product according to company: associated. Additional information will be requested from the investigator. Note: There is no reporter causality assessment as this is a safety surveillance (data mining, non-interventional) study. List of documents held by sender: none.; Sender's Comments: This case involves a healthy 21-year-old male who developed acute pericarditis with favorable temporal association post vaccination with ACAM2000. Pericarditis is a listed adverse event that may occur following vaccination with live vaccinia virus smallpox vaccines. Alternative etiologies could be Myocardial infarction, pulmonary embolism, Pneumonia, Costochondritis and pneumothorax. History of allergies or trauma was not reported. In the absence of additional information on confirmation of diagnosis with CK-MB assays, biopsy, role of study vaccine can not be ruled out.
Information has been received from a registered nurse concerning a 43 year old female who at 11:00 AM on 26-SEP-2008 was vaccinated with PNEUMOVAX 0.5ml intradermally mistakenly (lot # 659487/1960U) instead of PPD (manufacturer unspecified).  At 12:30 on 26-SEP-2008 the patient experienced severe pain in arm, and continued to complain of pain in arm though not as severe throughout the week.  The patient sought medical treatment at ER.  This is one of several reports received from the same source.  Additional information has been requested.
Day3-nausea Day 4- Spotting, bleeding, outside of normal menstruation, nausea Day 5- extremely pale bowel movement color light tan, nausea
Information has been received from a lawyer regarding a case in litigation concerning a female patient of unknown age. No information was received regarding the patient's past medical history, concurrent conditions, or concomitant medication. In August 2013, the patient was inoculated with the ZOSTAVAX (lot number, dosage and route of administration not provided) to obtain permanent prevention and protection against shingles and zoster related injuries. In September 2013, the patient was treated by a healthcare provider for shingles. The patient was diagnosed with shingles and/or other zoster-related injuries after and despite being inoculated with the ZOSTAVAX, and suffered serious physical, emotional, and economic damages as a result of the patient's injuries. As a direct and proximate result of the ZOSTAVAX vaccine, the patient has and will continue to suffer ongoing injuries, including but not limited to: mental and physical pain and suffering; extensive medical care and treatment for these injuries; significant medical and related expenses as a result of these injuries, including but not limited to medical losses and costs including care for hospitalization, physician care, monitoring, treatment, medications, and supplies; diminished capacity for the enjoyment of life; a diminished quality of life; increased risk of premature death, aggravation of preexisting conditions and activation of latent conditions; lost wages; loss of earnings capacity; and other losses and damages. The outcome of the events was considered to be not recovered. Additional information has been requested. Additional information has been requested.
Sweating, shaking, chills, dizzy, fever (101 degrees F) weakness. This was the "newest" shingles vaccine.
received vaccine on 2/5, on 2/11 at 5pm he started to feel stiffness in hands, knees, feet, most joints. These all became very swollen. Couldn't use hands for about 2 weeks. saw md on 2/13 and they started a Medrol dose pack and also allegra 24 hour OTC. a week later he started taking meloxicam. About 3 weeks passed in total until his symptoms cleared up.
This is a spontaneous report received from a contactable consumer (patient). A 69-year-old female patient received 1st dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, LOT/Batch number and expiration date unknown) intramuscularly on arm left on 17May2021 at 09:45 AM at age of 69-year-old at single dose for COVID-19 immunisation. Patient was not pregnant at time of vaccination and events onset. Medical history included arthritis, penicillin allergy and latex allergy. Concomitant medications included levomilnacipran hydrochloride (FETZIMA) received within 2 weeks of vaccination. Patient experienced large painful lumps in breasts, pain in ribcage and across back. Patient was bedridden and this was the 6th day (23May2021). Onset date of events was 17May2021 at time of 02:15 PM (reported as 02:15). Events were reported as serious as disability. Outcome of the events was recovered with sequel. Prior to vaccination, the patient wasn't diagnosed with COVID-19. Since the vaccination, patient hasn't been tested for COVID-19.  Information on the lot/batch number has been requested.
Doses administered past the published expiry; This spontaneous case was reported by a physician and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Doses administered past the published expiry) in a 75-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 007B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 11-Oct-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 11-Oct-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Doses administered past the published expiry). On 11-Oct-2021, EXPIRED PRODUCT ADMINISTERED (Doses administered past the published expiry) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were provided. No treatment medications were provided.  The vials were stored in the freezer and taken out of the freezer and placed in refrigerator on the date of administration. The vials did not undergo any temperature excursions
Horrendous body aches/myalgia, fever, fatigue, chills, nausea, and pain at the injection site all started about 13 hours after the shot. Basically everything EXCEPT redness/swelling at the injection site. I had COVID in June 2020, and this was 20x worse than actual COVID. I couldn't eat/sleep/move for days. There was absolutely no way I could have gone to work at the medical center so I missed multiple days of work. I was initially alternating Ibuprofen & Tylenol but ended up taking oxycodone and cyclobenzaprine to get any relief at all.
My son states that he started to experience SOB, HA, tachypnea with shallow breathing, chest pain and weakness with general malaise. Fatigue. Started at 2100 hrs with no relief with albuterol given at 1 am. Was taken to ER arriving at  3 am.  Upon arrival was diphoretic, tachypnic, tachycardia with c/o HA, and difficulty in taking a deep breath. At 6 am was admitted to hospital for further observation. Chest X-ray and CAT scan of chest all negative. Remains on O2 via nasal cannula. Pulse ox I on arrival was 92%.
Approximately 4 days after my first vaccine dose I experienced tinnitus in my ears, especially the left one. It is a loud, high pitched hissing noise. I have had tinnitus before but not this loud. It has persisted to this date.
After about 10-15 Minutes after patient received his vaccine - He was in the line for the post 15 minute monitoring he began to vomit.  Patient continued to vomit (no blood noted ) for about 45 minutes.  He was continuously being monitored by the EMS staff.  He then called a friend - that came to see if she needed to take him home, he refused.  He ate crackers then drank a bottle  of water.  After EMS and nurse assessed him and he also stated he felt much better patient was allowed to leave.  He was given instructions to seek medical attention immediately if symptoms persisted or got worse - Client agreed and was discharged from the post monitoring line
fever, cough, SOB, loss of taste and smell, sore throat, congestion, chest pain, wheezing, (difficulty breathing), fatigue and muscle aches.
local site swelling, redness, warmth; local site swelling, redness, warmth; local site swelling, redness, warmth; local site swelling, redness, warmth; local site itching; Initial information was received on 15-Sep-2021 regarding an unsolicited valid non-serious case received from a Consumer. This case involves a 34-year-old female patient who experienced local site swelling, redness and warmth (Vaccination site swelling, Vaccination site erythema, Vaccination site warmth) and diagnosed with (Vaccination site inflammation) and local site itching (Vaccination site pruritus) while receiving DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE [ADACEL].  Medical history, medical treatment(s), vaccination(s), concomitant medications and family history were not provided.  On 07-Sep-2021, the patient received a 0.5 ml (total) dose of suspect DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE [lot U6969AB and expiry date 03-Apr-2023] via intramuscular route in the left deltoid for prophylactic vaccination.  On 07-Sep-2021 the patient developed non-serious local site swelling, redness and warmth (Vaccination site swelling, Vaccination site erythema, Vaccination site warmth) and diagnosed with (Vaccination site inflammation) and local site itching (Vaccination site pruritus) on the same day following the administration of DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE.  It was reported "They recently started giving out Adacel. They have never had an issue with Adacel until this particular lot. There are 5 doses in the box and 4 have been given. Three 3 people has had a reaction. and they have all been the same. It is local site swelling, redness, warmth and itching. Caller states that they have stopped giving the lot number'.  Details of laboratory data were not reported.  It was not reported if the patient received any corrective treatment.    At the time of report, the outcome of events was unknown.
Arm might be sore/arm is hurting; Running a fever of 100.4; Has not felt good since yesterday/not feeling good; When they gave him the shot, it hurts clear to the bone on his left arm; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Arm might be sore/arm is hurting), FEELING ABNORMAL (Has not felt good since yesterday/not feeling good), BONE PAIN (When they gave him the shot, it hurts clear to the bone on his left arm) and PYREXIA (Running a fever of 100.4) in a 32-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025L21D) for COVID-19 vaccination.     No Medical History information was reported.    On 27-Jan-2022, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 27-Jan-2022, the patient experienced FEELING ABNORMAL (Has not felt good since yesterday/not feeling good) and BONE PAIN (When they gave him the shot, it hurts clear to the bone on his left arm). On 28-Jan-2022, the patient experienced PYREXIA (Running a fever of 100.4). On an unknown date, the patient experienced PAIN IN EXTREMITY (Arm might be sore/arm is hurting). At the time of the report, PAIN IN EXTREMITY (Arm might be sore/arm is hurting), FEELING ABNORMAL (Has not felt good since yesterday/not feeling good) and PYREXIA (Running a fever of 100.4) had not resolved and BONE PAIN (When they gave him the shot, it hurts clear to the bone on his left arm) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 28-Jan-2022, Body temperature: 100.4 (High) fever of 100.4.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were reported. No treatment medication was reported. It was reported that patient had not done COVID-19 test.On 28 Jan 2022,the patient was not feeling good.
pt devel petechiae-CBC revealed platelets less than 5,000-recv IVGG to response in 3 days;
This spontaneous report was received from a pharmacist and refers to an unspecified number of patients of unknown age and gender. There was no information about the patients' concurrent conditions, concomitant therapies or medical histories provided. On unknown dates, the patients were vaccinated with improperly stored doses of PNEUMOVAX 23 (lot # M013156, expiration date: 15-OCT-2017, dose and injection site were not provided). No adverse effects were reported. Complete temperature excursion details were unknown, at the time of the report. The vaccines were exposed to below recommended temperatures for an unspecified period of time. Product quality complaint (PQC) was not involved. Additional information has been requested.
"A nurse reported that a 2 month old male, post vax, developed loose stools with gas and pain and crying. He was seen by the physician on 5/6/99 and a dx of formula intolerance, umbilical hernia and "constipation" was made. The mother was instructed to decrease administration of mineral oil and change the formula to Nutramigen."
"The onset was just prior to arrival. The course/duration of symptoms is constant. Associated symptoms: fussiness. Temperature is subjective. Risk factors consist of none. Prior episodes: occasional. Therapy today: none. 17-month-old boy with no significant past medical history who is vaccinated presents after a seizure at home. It lasted 30 seconds and resolved spontaneously. Prior to that mother noted that he felt very hot and was developing a fever. Patient is fully vaccinated he had no viral prodrome over the last 1-2 days. No ill contacts or recent travel. "
Menstrual period started unusually early, more than a week before it normally does for the patient, with a cycle of only 19 days. Also unusually heavy bleeding for the patient. However, the remainder of the period proceeded normally in length and flow, and the following cycle was normal
ON 7/12/14 FELL IN DRIVEWAY WHILE GETTING ON MY BIKE TO GO FOR A RIDE. ON 7/25/14 WOKE UP AT 3:00 AM WITH NUMBNESS AND TINGLING IN MY RIGHT FEET, LEGS ALL THE WAY UP TO MY WAIST. NEXT DAY ON BOTH SIDES. BY 5TH DAY I COULD HARDLY WALK. WENT TO ER ON 7/29/14. HAD A CAT SCAN OF LUMBAR AREA WHICH WAS NEGATIVE. SENT HOME ON IBUPROFEN AND ATIVAN AND BED REST FOR NEXT 3 DAYS. SAW MY DOCTOR ON 8/1/14 SENT UP FOR A CERVICAL, THORACIC AND LUMBAR MRI AND GOING TO BE REFERRED TO A NEUROSURGEON. ON 8/2/14 COULD NOT WALK. WENT TO ER WAS ADMITTED AND HAD ANOTHER MRI OF THORACIC AND LUMBAR WHICH WERE NEGATIVE. SAW A NEUROSURGEON WHO DID SPINAL TAP WHICH WAS ALSO NEGATIVE REFERRED TO A NEUROLOGIST. AFTER BEING EXAMINED NO REFLEXES AND NO BALANCE. HAD AN EMG ON BOTH LEGS AND WAS TO START TREATMENT ME ON NEURONTIN FOR SENSORY AND PERIPHERAL NEUROPATHY. I LAID IN BED FOR A MONTH, ELEVATING MY LEGS ALL DAY AND ALL NIGHT. HOLDING ON TO WALLS AND FURNITURE TO WALK. ASKED FOR PHYSICAL THERAPY WHICH I STARTED ON 8/18/14. STARTED USING A CANE TO HELP ME TO GET AROUND BETTER. NEURONTIN DID GET RID OF THE SENSORY FEELING IN MY LEGS. I WAS THEN REFERRED TO HOSPITAL ON 9/11/14. EXAMINED AND DIAGNOSED WITH WITH GUILLAIN BARRE SYNDROME AND SENT HOME ON SAME TREATMENT PT AND NEURONTIN MEDICATION. TWO DAYS LATER THE NUMBNESS AND TINGLING MOVED UP FROM MY WAIST TO MY CHEST WITH SENSORY FEELING BAD IN STOMACH AND BACK AREAS. AS OF TODAY 10/26/14 STILL HAVE NUMBNESS AND TINGLING IN BOTH FEET, LEGS AND UP TO CHEST NOW.
Patient was administered with vaccines that experienced more than 1 temperature excursion during 33 weeks on 2021; Patient was administered with vaccines that experienced more than 1 temperature excursion during 33 weeks on 2021; This spontaneous case was reported by an other health care professional and describes the occurrence of POOR QUALITY PRODUCT ADMINISTERED (Patient was administered with vaccines that experienced more than 1 temperature excursion during 33 weeks on 2021) and PRODUCT TEMPERATURE EXCURSION ISSUE (Patient was administered with vaccines that experienced more than 1 temperature excursion during 33 weeks on 2021) in a 61-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 014M20A) for COVID-19 vaccination.     No Medical History information was reported.    On 02-Mar-2021 at 1:20 PM, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On 02-Mar-2021 at 1:20 PM, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (Patient was administered with vaccines that experienced more than 1 temperature excursion during 33 weeks on 2021). On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Patient was administered with vaccines that experienced more than 1 temperature excursion during 33 weeks on 2021). At the time of the report, POOR QUALITY PRODUCT ADMINISTERED (Patient was administered with vaccines that experienced more than 1 temperature excursion during 33 weeks on 2021) and PRODUCT TEMPERATURE EXCURSION ISSUE (Patient was administered with vaccines that experienced more than 1 temperature excursion during 33 weeks on 2021) outcome was unknown. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   The age of patient was provided as 61.65 years.  On 24-Feb-2021, vaccines with batch number 014M20A were moved to the fridge. On 02-Mar-2021, 16 vials were sent to the clinic, on the same date, between 09 AM to 11 AM, vials underwent temperature excursion with temperature ranging from 27 to 32 degrees Fahrenheit and between 12PM to 03PM, vials underwent temperature excursion with temperature ranging from 33 to 36 degrees Fahrenheit. The condition of vaccine prior to vaccination was not frozen. The vaccine beyond use date was reported as 26-Mar-2021.  It was reported that, the storage condition at the time of the excursion was cooler storage during high-pace COVID-19 vaccination clinic.  The vials were only punctured right before administration and all doses were drawn from the vial due to high-pace clinic.  Temperature recordings were taken using a traceable temperature monitor at every hour.  It was reported that, the patient was administered with vaccine that experienced more than 1 temperature excursion during 33 weeks on 2021. The health care professional explained that each time a vial was put into a cooler, there was a period of 1 hour or 1 hour and a half approximately, when the temperature data logger registered 34- or 35-degree Fahrenheit.  Treatment medications were not reported.   This case was linked to MOD-2022-566976 (Patient Link).
The day after getting the vaccination, I developed a baseball-sized red patch on the inner, upper part of the vaccinated arm near the armpit. The second day after the vaccination, I also got multiple dime-sized, red spots on the upper arm near the injection site.