chrisvoncsefalvay/vaers-outcomes huggingface dataset:
injection site became more warm; left breast hurt; sore left under arm; injection site became more tender; got worse and more red; Home sick; not feel well; rash on rib cage and stomach; oval rash on injection site of left arm; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE WARMTH (injection site became more warm), ILLNESS (Home sick), BREAST PAIN (left breast hurt), MALAISE (not feel well) and RASH (rash on rib cage and stomach) in a 64-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013F21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Glaucoma. Concomitant products included LATANOPROST and DORZOLAMIDE for Glaucoma, GABAPENTIN for an unknown indication.    On 19-Nov-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In November 2021, the patient experienced MALAISE (not feel well), RASH (rash on rib cage and stomach) and VACCINATION SITE RASH (oval rash on injection site of left arm). On 10-Dec-2021, the patient experienced ILLNESS (Home sick). On an unknown date, the patient experienced VACCINATION SITE WARMTH (injection site became more warm), BREAST PAIN (left breast hurt), AXILLARY PAIN (sore left under arm), VACCINATION SITE PAIN (injection site became more tender) and VACCINATION SITE ERYTHEMA (got worse and more red). The patient was treated with IBUPROFEN (MOTRIN [IBUPROFEN]) for Adverse event, at an unspecified dose and frequency and DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) for Adverse event, at an unspecified dose and frequency. At the time of the report, VACCINATION SITE WARMTH (injection site became more warm), ILLNESS (Home sick), VACCINATION SITE PAIN (injection site became more tender) and VACCINATION SITE ERYTHEMA (got worse and more red) had not resolved, BREAST PAIN (left breast hurt), MALAISE (not feel well), AXILLARY PAIN (sore left under arm) and VACCINATION SITE RASH (oval rash on injection site of left arm) outcome was unknown and RASH (rash on rib cage and stomach) had resolved.            This case was linked to MOD-2021-408614, MOD-2021-408621 (Patient Link).
I have severe pain in my leg muscles and  bi-ceps in both arms,  I'm extremely lethargic at all times of day. I also have burning sensation in my  leg calf nerves and forearms. I have also slight pain in my chest.  I also have finger cramping when I wake up in the morning. slight lost in memory.
pt recvd vax 14SEP95 & exp rash all over body;pt devel a full blown case of chicken pox w/in 2 wks of receiving vax;had 20-40 lesions over body, including head, face, trunk, buttocks & thighs;
Right side of neck broke out in some sort of hives resembling shingles. Rash seems to get worse at night and has been there for over 48 hours.
Initial and follow-up information has been received for the Merck Pregnancy Registry for GARDASIL from a nurse concerning a 22 year old female with food allergies to sunflower oil, eggs and mayo, no illnesses at the time of the vaccination and a history of irregular menstruation related to the past use of medroxyprogesterone acetate (DEPO PROVERA) who on 08-FEB-2008 was vaccinated IM with the first dose of GARDASIL (Lot# 644322/1211U) in the left deltoid.  Concomitant therapy included a first dose of ENGERIX-B (lot# AHBVB367AA) IM in the right deltoid and a first dose of DECAVAC (U1923HA) IM in the left deltoid.  On 08-FEB-2008 a urine pregnancy test was performed.  The test was positive for pregnancy (>.25mlu/mol).  Medical attention was sought in the office.  The nurse also reported that this patient might elect to terminate this pregnancy (unrelated to vaccines received).  The patient's outcome is unknown.  No product quality complaint was involved.  On an unspecified date the patient had an elective abortion which was reported as having "nothing to do with receiving the vaccine".  The patient's outcome was unknown.  Upon internal review elective abortion is considered to be an other medical event.  Additional information is requested.
This spontaneous report has been received from a 59 years old female pharmacy technician, who is also a healthcare worker referring to herself. The patient's concomitant medication, pertinent medical history and drug reactions/allergies were not reported. In September 2018, the patient was vaccinated with GARDASIL 9 (dose 1; route, batch/lot# and expiration date were unknown) for prophylaxis (inappropriate age at vaccine administration). In October 2018, the patient was vaccinated with GARDASIL 9 (dose 2; route, batch/lot# and expiration date were unknown) for prophylaxis. No adverse effects reported. The outcome of the events was unknown. No product quality complaint (PQC) presented.
PRESENTS WITH HA, N/V, FEVER, BODY PAIN FOR 3 DAYS PTA
Soreness at site of injection (left arm) from neck area to elbow. Patient also had a headache the first night. No redness, just sore and painful.
Immediate pain at injection, patient states seemed to subside over a few day, then got worse. Now having problems lifting and using affected arm.
Patient reports that her arm was sore off and on since receiving her flu shot. This week, she was in the water and the arm was sunburned and slightly swollen. She states that only the arm that received the flu shot was burnt. She also states that now it is sore again since getting the sunburn and it feels like she just got the flu shot again. She has been taking pain reliever (TYLENOL) and putting ice on it which has been helping.
Received a shot at workplace in Oct. Does not recall exact date. Since early Dec has had severe colds which is unusual for him. Developed pneumonia by next day. In late Dec. had more resp. illness. In March developed which was bacterial. All of these illnesses are unusual for this person.
Within 2 hours after shot, headache, dizziness and fever.  Within 12 hours arm painful and swollen.  After headache and fever next 48 hours saw MD and was told allergic reaction to pertussis - antihistamines relieved symptoms.
starting the morning after vaccination (12/9) patient had pain and tingling in his hands, then starting the night after vaccination (12/9) patient started to also have tingling and pain in his feet
Employee (patient) received Hep B vaccine 7/12/2019 and developed signs and symptoms 7/14/2019. Employee (patient) stated that she felt weakness, had a fever (no temperature recorded), shallow breathing, oxygen saturation 89%, heart rate 122 bpm, restlessness, shivering, intensive achy bones, sweating.  Employee (patient) reported to Occupational Health 7/18/2019. Employee (patient) was sent to the Emergency Department for an evaluation.
This case was reported by a consumer via call center representative and described the occurrence of injection site discoloration in a adult female patient who received BEXSERO. Previously administered products included BEXSERO (1st dose received on an unknown date). On 25th January 2018, the patient received the 2nd dose of BEXSERO (intramuscular). On 26th January 2018, 1 days after receiving BEXSERO, the patient experienced injection site discoloration. On an unknown date, the outcome of the injection site discoloration was unknown. The reporter considered the injection site discoloration to be probably related to BEXSERO. Additional details were reported as follows: This case was previously reported to a doctor. The reporter was the patient's mother. The age at vaccination was not reported. A college age patient experienced a white ring around the injection site on her right arm. The date of the first dose was not known at time of report. The patient had denied permission to contact their physician.
Patient's arm is red, warm to touch. It is about 4 inches below the injection site. It is about 5-7 inches in diameter. It is sore and sensitive to touch.
Right Deltoid, vaccination site swollen and red.  Approxiametly the size of a half dollar.  Discomfort in arm, with difficulty lifting arm.  Will apply cold compress to help symptoms.  Due date 2/21/2022.
Information has been received from a physician and the mother of a 15 month old white female with no relevant medical history who on 4/17/02 was vaccinated with a third dose of Haemophilus B conjugate vaccine (+) Hepatitis B vaccine recombinant (yeast) IM in the right deltoid (lot 641319/1366L). On 4/17/02, the patient was concomitantly vaccinated with a fourth dose of Streptococcus pneumoniae vaccine (PREVNAR) IM in the right deltoid (lot # 484208). The patient had no illnesses at the time of vaccination. On 4/18/02, the patient woke up with eye swelling and redness. The patient was to see a physician on 4/18/02. The physician reported that the patient's symptoms were gone a few hours later on 4/18/2002 without treatment. No additional information is expected.
As of 8/13/2021 : He received an infusion on 08/05/21. He continued to feel worst, so he went to the ER on 08/10/21. He was admitted to Hospital and is currently still there. He stated he is only on 2 liters of oxygen, and still having a productive cough. He stated 3 years ago he had MRSA in his lungs and the doctor said he only uses about 25% of his lungs due to MRSA scaring.
PATIENT WAS ADMINISTERED VACCINE OUTSIDE GUIDELINE. HE HAS NO MEDICAL CONDITION AND IS UNDER 65 YEARS OLD
Around 6PM the night of the vaccination the person started experiencing pain from the back of the right shoulder and radiating to the front. Swelling and redness developed at vaccination site. Fingers on right hand swelled. Patient ran fever of 101 degrees overnight. The fever was gone the morning of Dec. 14, 2006 and by Dec. 18th, all symptoms were gone.
This spontaneous report was received from a medical assistant 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 therapies was provided. On 18-JAN-2019, the patient was vaccinated with improperly stored dose of PROQUAD (lot # R017800, expiration date: 19-DEC-2019, dose and route of administration were not provided) for prophylaxis. The vaccine was reconstituted with properly stored sterile diluent. No adverse effects were reported. Administered dose of PROQUAD experienced temperature excursion between -14 to -10 Celsius degrees for 30 minutes. There was no previous temperature excursion reported. Digital data logger was involved. This is one of seven reports received from the same reporter. Sender's Comments: US-009507513-1901USA009706: US-009507513-1901USA009707: US-009507513-1901USA009708: US-009507513-1901USA009709: US-009507513-1901USA009710: US-009507513-1901USA009711.
No reaction until 48 hours after shot then pt developed 3 cm x 3 cm swelling and redness around immunization site and severe pain radiating into forearm.
Localized left upper arm erythema and edema with pruritus. Antihistamine recommended OTC.
fatigue and muscle pain on wednesday Sept 1, no appetite. began vomiting on the 5th and was seen at urgent care and found to have dark urine and sent to er
Sometime between 1 am and 7am left eye and cheek swelled. Eye mostly shut. Could open a slit. Hot shower compress helped. Only slight swelling by 4 pm.
Shaking chills, muscle aches, nausea, headache, fever.  Soreness and erythema at site of injection; local inflammation and warm to touch.  Fatigue.  Treated with: ice to site.  PREDNISONE 10 mg taper - 5,5,4,4,3,3,2,2,1,1.
hand in pain on the same arm as injection; 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 MYALGIA (hand in pain on the same arm as injection) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No medical history provided by the reporter.     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 MYALGIA (hand in pain on the same arm as injection). At the time of the report, MYALGIA (hand in pain on the same arm as injection) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No treatment information provided by the reporter. No  concomitant medications  provided by the reporter.
Pt recv vax on 10/14/98; on 10/15/98 pt exp swelling of LA to chest; red streaks to red mass at vax site x 6 day; fever (101); chills x 4 day; tx=Advil & ice pack
About 9 days after the injection I noticed my arm was itchy, day 10 - red and swollen site about 2x5? area of redness. Very itchy.  By 14Feb no new symptoms, by today 16 Feb the redness and swelling is gone.
Inflammation causing muscle tension in neck and collar bone pain/ flair up of past issues. I had tension headaches and costochondritis in the past. The vaccine made both come back/flair up.
This case was reported by a mother of a consumer and described the occurrence of injection site soreness in a 17-year-old male who was vaccinated with FLULAVAK. A physician or other health care professional has not verified this report. There were no concurrent medications. On 8 October 2008, the subject received unspecified dose of FLULAVAL at 0.5 ml. On 8 October 2008, less than one day after vaccination with FLULAVAL, the subject experienced injection site soreness. Administration of FLULAVAL to this subject was considered to be a drug administration error as FLULAVAL is not indicated for use in subjects under the age of 18 years. At the time of reporting, injection site soreness was resolved. Follow-up via mother indicated that the subject has experienced no other side effects.
11 am March 8 onset of fatigue, body aches, "brain fog" which increase over course of afternoon and persist rest of day/evening Body temperature climbs to 99.5 in late afternoon Focused pain in hip joints, left side neck and jaw Unable to work/pursue normal daily activities entire day of March 8 Symptoms resolve as of March 9, when temp returns to normal, fatigue and aches abate
REDNESS AND SWELLING AT INJECTIONS SITE. PATIENT SOUGHT MEDICAL ATTENTION AND WAS GIVEN CEPHALEXIN 500MG SAYING IT WAS AN INFECTION FROM THE INJECTIONS.
Pt here 4/15/2013 for TDAP and MCV4 on L/D IM. 4/17/13 L/D swollen and light red site of 11 x 6 cm. Here seen by doctor.
pt recv vax 27JUL95 & 29MAY96 pt devel a blistery rash which was scattered over entire body;@ the time of the report, pt had not yet been seen by a MD;
It weighed me down a little; This spontaneous case was reported by a consumer and describes the occurrence of FATIGUE (It weighed me down a little) in a 70-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 003B21A and 025A21A) for COVID-19 vaccination.     No Medical History information was reported.   On 01-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 29-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 29-Mar-2021, the patient experienced FATIGUE (It weighed me down a little). On 30-Mar-2021, FATIGUE (It weighed me down a little) had resolved. Not Provided          Concomitant medications details were not reported by the reporter. Treatment details was not reported by the reporter.   This case was linked to US-MODERNATX, INC.-MOD-2021-083276 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-083276:Wife case
On or around April 15th I developed a pain in my left calf.  As a senior citizen and avid golfer I chalked this up to age and activity. But the  problem didn't go away and on some days would be more painful than others. Additionally, the point where my calf hurt seem to move around and sometimes be higher on my calf behind my knee.  Some days the pain was gone altogether only to return the later that same day or the next.   At the beginning of May I started to develop a cough.  I had no fever or other symptoms so I thought it might be seasonal allergies.   The cough continued to get worse so I made an appointment with my doctor on 5/26/21 and was seen that day. I was given a COVID test even though I had taken the vaccine and scheduled for an ultrasound on Friday 5/28/21. During the ultrasound they discovered a DVT in my left calf that extended from my ankle to behind my knee.  Since I was also coughing they scheduled me for a CT scan that same day. The CT scan showed multiple PE's in both lungs. They sent me to the hospital.
Administered Gardasil 0.5 ML IM in left upper deltoid while patient was sitting upright on exam table.  Nurse walked to patient right side.  Patient mumbled something, eyes rolled back into head and pt had a + LOC. Nurse called for assistance. Assisted pt to a lying position. Patient began having jerking movements of extremities x 5 seconds. Patient regained consciousness quickly and became alert and oriented to person, place and time. PA and MD made aware and assessed patient. Patient assisted to a sitting position after 15 minutes of lying down, he immediately complained of chest pressure and pain.  EKG obtained. PA made aware of results. EMS called. Patient transfered to ER via EMS.
This spontaneous report as received from a physician refers to a patient of unknown age. On an unknown date, the patient was vaccinated with ROTATEQ, lot #, dose, route and frequency unspecified. The patient experienced projectile vomiting in the office immediately after administration of ROTATEQ. The outcome of the patient was unknown. This one of several reports received from the same reporter. Additional information is not expected.
Fever; tired; This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (Fever) and FATIGUE (tired) in an 80-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 0121.20A) for COVID-19 vaccination.     The patient's past medical history included COVID-19.    On 12-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 13-Jan-2021, the patient experienced PYREXIA (Fever) and FATIGUE (tired). On 14-Jan-2021, PYREXIA (Fever) had resolved. At the time of the report, FATIGUE (tired) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Treatment included acetaminophen.  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.   Reporter did not allow further contact; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
ACUTE ST ELEVATION MI, UNSPECIFIED 2/19/2022 PAROXYSMAL ATRIAL FIBRILLATION
Site soreness started a few hours after injection, then spread throughout body. Woke up in the middle of the night with nausea, vomiting, body aches, and headache. Vomiting and body aches lasted about 48hrs, but nausea and headache continued with the addition of stomach cramps and diarrhea. Stomach cramps and diarrhea lasted about 8hrs while headache and nausea persisted. Lost sense of smell and taste, still experiencing mild headache and nausea.
Had a 101.7 fever & body aches the next day. Felt like I had the flu.  Took Tylenol and went to sleep and fever went away.  I woke up and felt better. Temperature started to rise later in the day but i took more Tylenol and my temperature went back down.
LIGHT HEADED, ITCHY ALL OVER, DIZZIE WHEN TRYING TO WALK, STOMACH ACHE, HEAD ACHE, NAUSEATED,AND SWEATY LASTED TWO DAYS, WAS TAKEN TO THE EMERGENCY ROOM BOTH TIMES
sore arm and bruising at injection site; sore arm and bruising at injection site; This is a spontaneous report from a contactable consumer.  A 54-year-old female patient received first dose of bnt162b2 (BNT162B2), lot number not reported, via an unspecified route of administration on 30Jan2021 12:00 as SINGLE DOSE for COVID-19 immunisation.  The patient's medical history and concomitant medications were not reported. On 30Jan2021, the patient experienced sore arm and bruising at injection site. The patient is not pregnant at the time of vaccination. The outcome of the events was recovered. No treatment was given for the events. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19.  Information on the lot/batch number has been requested.
No additional AE; the patient was inadvertently administered an expired dose of PNEUMOVAX 23; This spontaneous report was received from a pharmacist concerning a patient of unknown age and gender. No information was provided regarding the patient's pertinent medical history, concomitant medications and drug reactions/allergies.  On 10-OCT-2020, the patient was vaccinated with and expired dose of pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) (lot # S025133, expiration date: 15-SEP-2020) dose reported as 1 shot (dose number, route of administration and anatomical location were not reported) for prophylaxis. No additional adverse event details were provided. combinationproductreport: Yes; brandname: PNEUMOVAX23 SYRINGE (DEVICE); commondevicename: Pneumococcal Vaccine, Polyvalent (23-valent); productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp & Dohme Corp. ; devicelotnumber: S025133; expirationdate: 15-SEP-2020; deviceage and unit: 0 ; malfunction: Unknown; deviceusage: Initial; evaluatedbymfr: Not returned to manufacturer; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not meet the criteria for Reportability
Patient stated swelling and pain at the injection site for 2 days post vaccine. After 2 days until present patient complains of inability to life her arm above her head. Patient states a tremor has developed gradually in her left arm in addition to continued tenderness at the injection site
We are in constant pain; arm is in constant pain,our arms both hurt so bad; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (We are in constant pain) and PAIN IN EXTREMITY (arm is in constant pain,our arms both hurt so bad) 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.    In July 2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PAIN (We are in constant pain) and PAIN IN EXTREMITY (arm is in constant pain,our arms both hurt so bad). At the time of the report, PAIN (We are in constant pain) and PAIN IN EXTREMITY (arm is in constant pain,our arms both hurt so bad) had not resolved.            No concomitant medications were provided by the reporter. No treatment information was provided by the reporter.
Took Flu shot in January 2013 - the next day could not walk. Went to hospital was told had bladder infection - Live about 13 months. Could never walk again. Had flu shot in January 2013 - could not walk or stand the next day - was in a wheelchair until her death 1-2-14.
A non-serious spontaneous report of inadvertent administration of expired H1N1 was received from a registered nurse/health professional concerning a nine-year-old male. Neither relevant medical history nor concomitant medications have been reported for this patient. The original expiration date was 08-Apr-2010, which was reassigned to 29-Mar-2010. On 31-Mar-2010, the patient received the second dose of H1N1, Intranasal for an unknown indication. There was no adverse event associated with this medication error; therefore, treatment and reporter causality assessments were not applicable and the event was considered to be resolved.
PATIENT REPORTS THAT AFTER RECEIVING ZOSTAVAX IN HER LEFT ARM, SHE HAD A CASE OF SHINGLES WITHIN 24 HOURS ON HER RIGHT ARM.