chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Terrible sore arm for two weeks; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Terrible sore arm for two weeks) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 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 PAIN IN EXTREMITY (Terrible sore arm for two weeks). At the time of the report, PAIN IN EXTREMITY (Terrible sore arm for two weeks) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No relevant concomitant medications were reported.   Treatment information was not provided.
she is losing her vision completely; patient's vision went blurry after the first vaccine/few days later the patient took the second dose of the vaccine and its 3 months and no vision came back; vision became distorted; This is a spontaneous report from a contactable consumer (patient and her husband). A 79-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration, administered in left arm on 23Feb2021 (Lot Number: EN6201; Expiration Date: 30Jun2021) as single dose; dose 2 via an unspecified route of administration on 25Mar2021 (Lot Number: ER8727) as single dose, both at the age of 79-years-old for covid-19 immunisation.  The patient medical history was none.  The patient's concomitant medications were none. The patient had both doses of the Pfizer covid vaccine. After the first dose she complained of visual disturbance which affected her sight, she was losing her vision on 27Feb2021 which went away after 1 month. Patient proceeded to take the second dose, and since has had the same visual disturbance from the previous dose, but this time it has not gone away. The patient received the first dose on 23Feb2021 and on 27Feb2021 the patients vision became distorted. Reporter stated she has seen 3 specialists and was now calling to find out if this side effect has been reported. The patient had been seeing an Ophthalmologist. Then about 20Mar2021 or 21Mar2021, the patient was on bromfenac sodium (PROLENSA), which was like an ibuprofen for the eye, her vision came back. A few days later the patient took the second dose of the vaccine and its 3 months and no vision came back. The patients vision has worsened since March. The patients vision went blurry on 27Feb2021 after the first vaccine and now she was losing her vision completely. The reporter wanted to know what he can do to keep the patient from going blind. Outcome of the events was not recovered.
dose drawn from current mixed solution from 11/08/2021 and administered on 11/09/2021.
Right parotitis onset 12/15/2006 and fever. Hospitalized; surgery to remove abscess on neck, on Clindamycin; culture evidence of MRSA.  02/07/2007  VAERS report submitted with attached medical records for a 1 year old who developed fever 1 week post vaccines which persisted x 2 weeks. Also, development of worsening swelling below the right ear and spreading to the right cheek x 1 week.  Initially treated with antibiotics on an outpatient basis without improvement.  Child was brought to the hospital where an I&D of the right cervical mass was performed and he received IV antibiotics . He was discharged home on oral antibiotics. Discharge DX:  Right cervical lymphadenitis with abscess.
I had headache.; This is a spontaneous report from a contactable consumer, the patient. A 35-year-old male patient received unknown dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration on 13Jun2021 at 15:00 (at the age of 35-years-old) as a single dose for COVID-19 immunisation. Medical history and concomitant medications taken within two weeks of vaccination were not reported. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 14Jun2021 at 09:00, the patient had headache. No therapeutic measures were taken as a result of the event. The event did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Since the vaccination, the patient had been tested for COVID-19. On 02Jul2021, the patient underwent COVID-19 test via nasal swab and the result was negative. The clinical outcome of the event had headache was resolved on an unknown date in 2021.   The lot number for BNT162b2 was not provided and will be requested during follow up.
This report was received from a medical assistant (patient's mother) regarding 1 year old female patient as a part of Market Research. The patient's medical history, concurrent conditions and concomitant therapies were not reported. On an unknown date, the patient was vaccinated with a dose of VARIVAX (dose, route of administration and lot # were not reported). On an unknown date, the patient got shingles as a result of receiving the VARIVAX. The patient's outcome was reported as recovered/resolved with sequelae (on an unknown date). The reporter considered the event to be related to the VARIVAX. Additional information has been requested.
Vaccinations left one blackish-blue dot per vaccine in arm (about size of needle). No pain nor swelling. Will not go away even after exfoliation, scrubbing with soap, scraping, etc.
Paresthesia of the fingertips of thumb, index, and middle finger. Also, radial side of index finger.
This spontaneous report was received from a Licensed Practical Nurse and refers to a patient of unknown age and gender. There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided. On 27-FEB-2017, the patient was vaccinated with an improperly stored dose of GARDASIL lot #M037770 and expiration date 27-FEB-2017 (strength, route of administration, anatomical location and dose were unknown), which temperature excursion was more than 46 degrees Fahrenheit (8 degrees Celsius) but less than 77 degrees Fahrenheit (25 degrees Celsius) for 20 hours 25 minutes. Temperature was logged with a data logger, and there were no previous temperature excursions. No adverse effects were reported. Additional information has been requested.
This spontaneous report was received from a registered nurse, referring to a 110 patients of unknown ages and genders. The medical history of the patients or concurrent conditions were not reported. On unspecified dates, the patients were vaccinated with improperly stored doses of PEDVAXHIB (60 patients with doses of lot number L030870, expiration date 10-JUN-2018, 50 patients with doses of lot number L030872, expiration date 11-JUN-2018) (doses, anatomical sites and routes were not reported). Concomitant medication of the patients were not provided. Additionally, no adverse effects were reported and there was not product quality complaint involved. This is one of several cases from the same reporter. Additional information has been requested.
Employee presented to Infection Prevention Officer on 10/7/15 after receiving influenza vaccination the previous day (10/6). After vaccination, patient (who is an RN) noticed lacy, red, slightly raised rash on her bilateral posterior shoulder area near armpits. The area of injection was without any rash or inflammation. The rash is not itchy or painful. She did not use any new soap, deodorant, or eat any new foods. Unsure if this is reaction to influenza vaccination or not. Patient took BENADRYL last night before going to bed. Pharmacy supplied her with a dose of cetirizine 10 mg po to be taken at work.
Local swelling with redness, redness continued after the swelling subsided after few weeks. No other sighs or symptoms reported.
6/6/2019:  10:30 AM vaccine.  11:30 lunch..  return home as the 1st dose 2/11/19 did make me feel a little like lying down.  Th e site of injection was very sore and had a red rash around for days.  pharmacy advised the 2nd dose would not be as bad, but the site would be sore    7:30 PM, I knew I had to throw up.  At that time diarrhea, belly pain, shivering and slight headache started.  I threw up and continued diarrhea til 3:00 AM.  Fever of 100.6 the next day (6//7/2019)  Burping, heartburn.  Heartburn continued for several days after.  I have had heartburn before, but not in a long time.  Was weak and fragile stomach for days later.
Sedation, Myalgia, Arthralgia, UrticariaPruritus, chills and fatigue.  Narrative:  Other Relevant History:
My grandpa had a stroke on the 15th of February. He claimed he had been feeling "off" for a few days, but didn't say anything. A blood clot had formed in his brain. He was doing better and about to go to rehab to strength his right side of his body. On the 22nd he took a turn for the worst. He was having trouble breathing and they sedated and partially paralyzed him to put a tube in his mouth. I believe another blood clot had formed and oxygen wasn't properly going through his body. They could not stabilize him, and he passed away the same day.
Has been on Risoerdone since he was 4. His prolactin levels are often checked. In 14 years we never had an elevated level. Two months after the shot was given he went for his routine bloodwork. The prolactin was high at 14.9. He was tested again in July and it came back at 36.4. As a result we had to discontinue the medication  he had been on for so many years. The only new thing in his body was the shot.
Doses administered past the published expiry date; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Doses administered past the published expiry date) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 047B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 25-Oct-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 25-Oct-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Doses administered past the published expiry date). On 25-Oct-2021, EXPIRED PRODUCT ADMINISTERED (Doses administered past the published expiry date) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported.  No treatment medications were reported.
shortness of breath, pelvic pain, joint pain, right hand paresthesias, axillary pain (R), fatigue, GERD
feeling nauseous; feel tired and weak; feel gassy; have no appetite; This spontaneous case was reported by a consumer and describes the occurrence of NAUSEA (feeling nauseous), FATIGUE (feel tired and weak), FLATULENCE (feel gassy) and DECREASED APPETITE (have no appetite) in a not specif patient of an unknown age 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) at an unspecified dose. On an unknown date, the patient experienced NAUSEA (feeling nauseous), FATIGUE (feel tired and weak), FLATULENCE (feel gassy) and DECREASED APPETITE (have no appetite). At the time of the report, NAUSEA (feeling nauseous), FATIGUE (feel tired and weak), FLATULENCE (feel gassy) and DECREASED APPETITE (have no appetite) 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.   No relevant concomitant medications were mentioned.   No treatment information is provided.; Sender's Comments: Based on the current available information and temporal association between the use of mRNA-1273 and the onset of the events, a causal relationship cannot be excluded. Nausea and fatigue are consistent with the product safety profile
Noticed rash on upper chest and shoulders on Fri pm while at work. After arriving home, discovered rash on upper trunk and back. Sat am the rash had spread up and down on my trunk. Primary care provider examined rash and checked in throat and lips for swelling. Prescribed OTC benadryl and provided scripts for hydroxyzine and prednisone if needed for itching.
Patient care technician pulled a wrong vaccine (Hepatitis B) accidentally and a provider gave that vaccine to patient.  Patient needed Tdap for school, not Hepatitis B.  This incidence found out  after patient left and then returned to the clinic regarding Hep B administration instead of Tdap vaccine.  This provider let patient stay in the clinic for at least 15 mins to see immediate adverse reaction.  No sings and symptoms observed so she left the clinic with mother without adverse reactions.
Can side effects present themselves 4 days after receiving the vaccine; This case was reported by a consumer via call center representative and described the occurrence of adverse event in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   In March 2020, the patient received Shingrix. In March 2020, less than a week after receiving Shingrix, the patient experienced adverse event. On an unknown date, the outcome of the adverse event was unknown.   It was unknown if the reporter considered the adverse event to be related to Shingrix.  Additional details were provided as follows: The age group was not reported but was selected as adult as per vaccine indication. The patient experienced side effects and enquired that side effects can present 4 days after receiving the vaccine.
Syncopal event on 10-16.  Individual was found unresponsive in the hallway.  Emergency called.  Assessed in ER and discharged that same day. with mild dehydration, hypoglycemia, syncope, and near syncope.
Severe constant sharp ache from bicep to hand in right arm for nearly 24 hour period on 10/11/21.  Pain lessened on second day but still painful.  Continued to constantly ache in varying degrees of sharpness.  Tried rest, ice, compression and elevation but it did little to help with pain.  Went to doctor on 10/20/21.  Doctor determined that injection may have injured a nerve in the shoulder.  At this time, no action is being taken other than to keep an eye on it.
States SOB all night. Started almost immediately after receiving flu shot. Then vomited and had headache & nose bleed. "Almost called 911 because of SOB." "Hard to walk & wheezing." Pt was taken to ER via wheelchair from our office. No treatment was given at our office.
red, raised, hard, swollen. painful area at the site of injection. Area of swelling was approximately 3 inch circular shape. Treated with ice pack and Tylenol for pain After about 2 days, the pain and swelling gradually subsided
Dx: High fever of 101.6F, lethargic, irritable. On 4/10/01, follow-up pt still irritable and fever of 101.8F at office. Gave Ceftin antibiotics. On 4/12/01, follow-up, is still lethargic and fever is 101.8F. Sent to hospital for full work-up. Probable viral meningitis or adverse reaction to vaccine.
SOFT TISSUE UNDER TONGUE STARTED SWELLING.  EYE LIDS SWELLED, COUGHING, DIFFICULTY BREATHING.  EVENT OCCURRED APPROXIMATELY 2 1/2 HOURS AFTER ADMINISTRATION OF VACCINE.  BENADRYL/ZANTAC GIVEN WHICH REVERSED REACTION.  HAD TO BE REPEATED 4 HOURS LATER WHEN SYMPTOMS RESUMED.  NO EPINEPHRINE HAD TO BE ADMINISTERED. 10/20/08 Per hospital RN, pt was not treated at facility. Was administered Epipen at home by spouse who is an RN.
Pt was admitted on 7/26 for sepsis and hospital-acquired pneumonia. He tested negative for COVID at that time. He was retested for COVID on 8/4 due to his wife testing positive the day prior and having been visiting him in the hospital. He was positive at that time.
he is very cold; got tremors,/whole body is shaking; is not well; his temperature is  102.4°F; got the shivers; muscle hurt; joint  hurts; This spontaneous case was reported by a consumer and describes the occurrence of FEELING COLD (he is very cold), TREMOR (got tremors,/whole body is shaking), MALAISE (is not well), PYREXIA (his temperature is  102.4°F) and CHILLS (got the shivers) in a 70-year-old male 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.    On 17-Dec-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 17-Dec-2021, the patient experienced FEELING COLD (he is very cold), TREMOR (got tremors,/whole body is shaking), MALAISE (is not well), PYREXIA (his temperature is  102.4°F), CHILLS (got the shivers), MYALGIA (muscle hurt) and ARTHRALGIA (joint  hurts). At the time of the report, FEELING COLD (he is very cold), TREMOR (got tremors,/whole body is shaking), MALAISE (is not well), PYREXIA (his temperature is  102.4°F), CHILLS (got the shivers), MYALGIA (muscle hurt) and ARTHRALGIA (joint  hurts) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 17-Dec-2021, Body temperature: 102.4 (High) Body temperature is 102.4°F.         Patient was fine when got home after vaccination  but at time of reporting, he was  very cold,  temperature was 102.4°F, got the shivers, got tremors, whole body was shaking, muscle hurt, joint hurts. No concomitant medication were reported. No treatment information were given.
had a low grade, achy and was dry heaving the morning of the 9th.  Low Grade and feeling fluish is typical for me after the covid shot but dry heaving was new.  the night of the 12th I noticed a tingliness in the back of my right leg and buttock (i was standing and chopping vegetables). did not hurt but felt like it was asleep and just starting to wake up. leg was fully functional. Morning of the 13th it was still there. i had been stressed with work so was concerned it could be a cardio event. I called my doctors office. they were concerned it was cardio related as well so they squeezed me in for an 11am appt that morning. by the time I got to my appt, the tingliness had moved up to the right side of my torso and right arm. BP, pulse and EKG was taken.  had a full body check, walked, had reflexes assessed. everything was normal and was ruled out it was cardio. I was told if anything begins to affect my motor skills go immediately to the ER. 2 hours later, the numb and tingliness moved up the right side of my neck and then my entire face where I felt the tingliness move into my earlobes, nostrils, eyelids and face. i had full command of facial movement. then the tingliness in my face left after 2 hours. the tingliness in my face happened the week before Christmas as well. right now my right arm, torso and leg have tingliness.
patient was nervous about getting vaccine. Asked him to wait in out waiting area to be checked on. after couple minutes he came upto register and said feeling dizzy. I brought him in consultation room,he sat on chair ,gave him water to drink. then I let him lay down on floor,he passed out,but was talking to me,answering my question,called 911,EMT came in few minutes,checked everything. They said he might got anxious about getting vaccine,checked BP everthing was fine
Bexsero in pregnant patient; This prospective pregnancy case was reported by a other health professional via call center representative and described the occurrence of vaccine exposure during pregnancy in a female patient who received Men B NVS (Bexsero) (batch number ABXC06AA, expiry date 31st March 2023) for prophylaxis.   Co-suspect products included meningococcal B recom vaccine + aloh + omv pre-filled syringe device (Bexsero Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 4th May 2022, the patient received Bexsero and Bexsero Pre-Filled Syringe Device. The patient's last menstrual period was on an unknown date and estimated date of delivery was on an unknown date. The patient received Bexsero at an unknown time during the pregnancy. On an unknown date, unknown after receiving Bexsero and Bexsero Pre-Filled Syringe Device, the patient experienced vaccine exposure during pregnancy. On an unknown date, the outcome of the vaccine exposure during pregnancy was unknown. The pregnancy was ongoing.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK Receipt Date: 24-JUN-2022 Reporter's Comments: The HCP (health care professional) reported that the use of Bexsero in pregnant patient.  The reporter consented to follow up. Additional Supportive Information: The case PR2022097869 was identified as duplicate of this case. The case PR2022097869 was deleted and all future correspondence would be added in the present case which stands as case of record for this patient.
JOINT PAIN, MUSCLE PAIN, MUSCLE BURNING, WEAKEND MUSCLES, INFLAMMATION, CRACKING, STIFFNESS, MOLBILITY, SWELLING, CONSTANT PAIN
I had fever and headache for 2 days and I'm still tired with irregular heart beats. I'm taking PAXLOVID.
Delayed local reaction to Yellow fever vaccine.  Reddened inflammed non raised approximately 6cmx4cm.
both ears were ringing consistently. I have prior "slight" hearing loss and thought that by cleaning my ears over and over again my hearing would improve. Drove up one of the streets that was a hill and ear "popped" and hearing improved, but then went back to the same ringing constantly and hearing loss as before. My arm was sore, but that went away in about a day and no adverse signs were noticed in the arm, no fever, just the ringing and loss of hearing. I can hear if someone talks loudly enough and I have to have the TV up to the loudest volume level. I am concerned now if I get the second vaccine that the loss will be permanent. It has been 5 days since the first dose and the ringing and hearing loss has not improved.
Exposed to somebody who is positive with COVID-19 in school; This is a spontaneous report from a contactable consumer (reporting for his son) via Pfizer Sponsored Program. A 17-year-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number: unknown), via an unspecified route of administration on 08Apr2021 as single dose for covid-19 immunization. Medical history and concomitant medications were not reported. It was reported that patient been exposed to somebody who is positive with COVID-19 in school. The patient was advised to do home quarantine and has not tested yet. The outcome of the event was unknown.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
No additional AE; Medical assistant reported MMRII was administered after temperature excursion.; This spontaneous report has been received from a medical assistant regarding a patient of unknown age and gender. The patient's pertinent medical history, concurrent conditions, concomitant medications, and drug reactions or allergies were not provided.  On 25-SEP-2023, the patient was vaccinated with measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live, recombinant human albumin (rha) (M-M-R II) injection, one dose (valid lot number W021191 [expiration date 29-MAR-2024]) (dose, dose number, frequency, vaccination scheme, route of administration, and anatomical location were not provided) after a temperature excursion of 8.9 degrees Celsius (C) with a time frame of 12 hours 20 minutes and 0 seconds on 14-AUG-2023 and 9.4 degrees C with a time frame of 8 hours 20 minutes and 0 seconds on 28-AUG-2023 (product storage error). No previous temperature excursion.   No additional adverse event (AE).