chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Site: Itching at Injection Site-Mild, Systemic: Allergic: Difficulty Breathing-Mild, Systemic: Allergic: Difficulty Swallowing, Throat Tightness-Mild, Systemic: Allergic: Itch (specify: facial area, extremeties)-Mild, Systemic: Dizziness / Lightheadness-Mild, Systemic: Exhaustion / Lethargy-Mild, Systemic: Headache-Mild, Additional Details: called 911 pt refused to be taken to hospital to be further treated gave pt benedryl due to sx of icthness and possible swelling. epipen was available but pt refused use (pt mentioned she had an epipen due to prior hx)
History of COPD, but not normally oxygen dependent and was having acute hypoxia at nursing facility.
2 weeks of low grade flu symptoms; including 2 days of being so bad that I couldn't get out of bed.; I couldn't get out of bed; This is a spontaneous report from a contactable consumer (patient). A 54-year-old male patient received BNT162b2 (PFIZER BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot number- ER8736) via an unspecified route of administration in left arm on 01Jun2021 as dose 2 single (at the age of 54-year-old) for COVID-19 immunization at Pharmacy or Drug Store. Medical history included Covid-19. Prior to vaccination, the patient was diagnosed with COVID-19. Patient had no allergies to medications, food, or other products. Concomitant medications were not reported. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient did not receive any other medications within 2 weeks of vaccination. Historical vaccine included BNT162b2 (PFIZER BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot number- unknown) via an unspecified route of administration in left arm as dose 1 single (at the age of 54-year-old) for COVID-19 immunization and It was awful after the first vaccine, including a day of vomiting and being in bed. On 23Jun2021, patient experienced 2 weeks of low grade flu symptoms, including 2 days of being so bad that patient could not get out of bed. No treatment was received for the adverse events. Since the vaccination, the patient had not been tested for COVID-19. The patient underwent lab tests and procedures which included sars-cov-2 antibody test: covid positive prior to vaccination. Device Date: 06Jul2021. The reported assessed the case as non-serious. The outcome of events was recovered.  Additional information is requested. Further information is expected.
Starting approximately at around 5:00 AM on October 19, I am experiencing a severe headache, fatigue, severe muscle and joint pain.
under 18 years old got first dose; This spontaneous case was reported by a pharmacist and describes the occurrence of PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (under 18 years old got first dose) in an 18-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 041B21A) for COVID-19 vaccination.     No Medical History information was reported.   On 18-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 15-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 18-Mar-2021, the patient experienced PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (under 18 years old got first dose). On 18-Mar-2021, PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (under 18 years old got first dose) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medications were reported. Patient did not receive any treatment drug.  This report refers to a case of Product Administered to Patient of Inappropriate Age for mRNA-1273 (Lot number: Not Provided) with no associated AEs. Patient received his second dose on 15 april  2021 with the batch number 041B21A through intramuscular route. Patient received his second dose 28 days apart from the first dose.   Most recent FOLLOW-UP information incorporated above includes: On 19-May-2021: Follow up was received on 19 may 2021significant case  included no new information- reporter talking about 17 year old patient not for this case.added second dose information; Sender's Comments: This report refers to a case of Product Administered to Patient of Inappropriate Age for mRNA-1273 (Lot number: Not Provided) with no associated AEs.
8/4/15-SORE NECK ON THE LEFT (CONTINUES), 8/5/15-A LUMP ON THE LEFT SIDE NEAR COLLAR BONE WAS FELT AND THERE FOR ALMOST 2 WEEKS. 8/5/15-ARM HAD RED PATCH AND WAS RAISED AND HARD ABOUT 2-3 INCHES BELOW WHERE THE SHOT WAS GIVEN (RESOLVED BY 8/12). 8/12/15- LEFT SIDE OF NECK AND SHOULDER STILL SORE AND NOW HAVE TINGLING IN ARM.
No additional AE reported; Inbound call from medical assistant who reports products that experienced temperature excursion were administered to patients. See below for details:         ?    Names of vaccines involved (including lot/exp) VAQTA  X004813  7/28/2024        ?; This spontaneous report was received from a medical assistant referring to a patient of unknown age and gender. Information about medical history, concurrent conditions and concomitant therapies was not provided.    On 12-JUL-2023, the patient was vaccinated with hepatitis a vaccine, inactivated(VAQTA) (lot # X004813, expiration date 28-JUL-2024; strength, dose, route were not reported) for prophylaxis. The temperature excursion was ABOVE 47 Fahrenheit degree (46.7 Fahrenheit degree) for 0 hours 25 minutes and 0 seconds (product storage error). There was no previous temperature excursion. No adverse event was reported.
Hospitalized with acute kidney failure due to multiple renal infarcts. Symptoms began with GI tract issues, diarrhea, abdominal pain, weight loss. Work up extensive and still in process. Symptoms persist.
Redness, swelling, warmth and itching from shoulder to elbow of left arm. Symptoms beginning to resolved 12/4/17.
SCRATCHY THROAT/SNEEZING/INCREASED BLOOD PRESSURE/HIVES/SOB. BENADRYL.
Patient lied about his previous vaccine. Pt claimed he never got J&J vaccine like RN saw in a system, he claimed he had an appointment but never got the vaccine. RN checked system after she vaccinated pt with Pfizer and found out he actually received J&J vaccine 3/10/2021. No adverse reaction known
Sedation, Myalgia, Arthralgia & NauseaVomiting Narrative:
This spontaneous report was received from a mother refers to approximately 5 month old daughter. On an unknown date in MAR-2013, the patient was vaccinated with a dose of ROTATEQ, (lot number, expiry date was not reported, route was oral). The mother stated that the child had two experienced with the ROTATEQ medication. The first event occurred on an unknown date in MAR-2013, when after 3 doses the child became extremely uncontrollable with shaking, irritable and lethargic. The second event occurred on an unknown date in MAY-2013 where the child displayed irritability for two to three days. The mother stated that the symptoms began to dissipate after the third day and the child appeared to be herself. The mother stated that her concerns were for potential future vaccine medications that might cause potential harm. There was no treatment rendered for the events. On an unknown date, the patient recovered from the events. The patient sought medical attention. Additional information has been requested.
Shingles - Herpes Zoster rash began - 12-13-09. I believe my daughter had a compromised immune system from having the 2 vaccines too close together in conjunction with the ear infection.  Her immune system was never allowed to come back 100%.
Immediately after I felt arm pain and fatigue. The next day the fatigue continued and I also had headaches this lasted a couple of days. Then I developed a nasty sore throat that lasted about a week. I decided to go to the doctor because of the sore throat and because my lymph nodes swelled up quite bad. I was diagnosed with strep throat and the lymph node swelling lasted for about 3 weeks before finally going away. I was given antibiotics to treat it.
Red, hot, hard patch on arm around area of injection. Very itchy. Started about a week after first shot.
Cellulitis to thigh-required ER visit, labs and ultrasound to r/o abscess. Treated with PO Clindamycin. Improving and afebrile on day 3 of abx.
Twelve hours after vaccination of DTaP on the left leg he developed significant pain and swelling in to his knee and initially refused to walk.  Since then he has had ambulation.  He has not had fever but the pain and the swelling has continued. It was palpated and it is going down to his knee. It is 31 cm in diameter.
Patient was reclined when vaccine given and remained that way for 15 minutes post vaccination without complaints of dizziness.  Upon walking out of the clinic, he became pale and dizzy.  Patient sat on the floor, was laid flat with feet elevated and cold compress applied to back of neck for relief.  Remained in that position for 10 minutes after which patient felt fully recovered.  Sat up, stood up, and ambulated out of office without further problems.
Mom called on 8.14.19 @ 1500 stating that child started with 102.3 temp a few hours prior. Sleeping a lot, not eating. Giving Tylenol q 4-6 hrs + pushing fluids.
Information has been received from a health professional concerning an adult female who was vaccinated with a pediatric dose of hep B vaccine recombinant. Subsequently the pt experienced pain at the site of vaccination during administration. Unspecified medical attention was sought. Additional info has been requested.
multiple patients were vaccinated with improperly stored VARIVAX; No adverse effect; This spontaneous report was received from a medical assistant referred to a patient of an unknown age and gender. The patient's medical history and concomitant medications were not reported. On 09-NOV-2018, the patient was vaccinated with 1 dose of improperly stored varicella virus vaccine live (oka/merck)(VARIVAX)(lot # R017642 and expiry date 20-JUN-2019) for prophylaxis and no adverse effects were reported (product storage error and no adverse event). Other suspect therapies included sterile diluent. There was a previous temperature excursion and the time frame and temperature was unknown. No PQC found.  This is one of several reports received from the same reporter.
pain in arm difficult breathing cant breath through mouth spine hurts lower legs hurt fever headache nausea diarrhea
Diarrhea; Body aches; Chest pain; Difficult breathing; Sick; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A patient (no qualifiers provided) received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 3 (booster), single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (DOSE: 1), for COVID-19 immunization; Bnt162b2 (DOSE: 2), for COVID-19 immunization. The following information was reported: DIARRHOEA (non-serious), outcome "unknown", described as "Diarrhea"; PAIN (non-serious), outcome "unknown", described as "Body aches"; CHEST PAIN (non-serious), outcome "unknown", described as "Chest pain"; DYSPNOEA (non-serious), outcome "unknown", described as "Difficult breathing"; ILLNESS (non-serious), outcome "unknown", described as "Sick".  Additional Context: Consumer stated, "I just want to report a adverse or side effects to Pfizer Booster shot." Side effect experienced: Consumer stated, "Diarrhea, sick, Body aches, Chest pains, difficult breathing."  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.  Follow-up (22Nov2021): This follow-up is being submitted to notify that the lot/batch number is not available despite the follow-up attempts made. Follow-up attempts completed. No further information is expected.
The day following vaccination, I experienced very sore throat and worst cough I can recall in past 30 years. Three days later I called the vaccine provider and was told that my symptoms could not have come from vaccines and must be coincidental cold. Sore throat subsided, but cough continued and even got worse. No serious fever -- maximum 100-101 deg F. After suffering for 10 days, I finally saw a doctor (11/17/08) who said I did not have either pneumonia or pleurisy and gave Rx for Azithromycin. He said pain in chest muscles was due to strain of coughing so hard. Cough cleared after 5 days, but pain in chest continued and became more severe. On 12/3/08, I saw same doctor again. Pain has gradually diminished during past 10 days, and 12/10 was first day I felt I could resume most of my normal activities. Still have twinges of pain in rib cage and shoulder blades with any quick motion. I have had mild chronic bronchitis for many years, but have never experience anything like the past 5 weeks. It may have been just coincidence, but I will never risk having another pneumonia or flu vaccination.
Child had been in distress at cardiology office - was transported to hospital. When intubated for transport child had vagal response with bradycardia - unable to resuscitate and child expired at ER.
This prospective report was received from a 24 years old female patient  reporting on herself via company representative. The patient's medical history and concurrent conditions were not reported. The primary reporter stated that she was administered her first dose of GARDASIL 9 injection or GARDASIL ( strength, dose , lot number, expiration date, route of administration were not provided). There were no concomitant medications reported. The patient was subsequently determined to be pregnant on unspecified date(vaccine exposure before pregnancy), the last menstrual period(LMP), estimated date of conception(DOC) and estimated date of delivery (EDD)were not reported. No product quality complain was involved. The outcome of the vaccine exposure during pregnancy was unknown. Additional information has been requested.
"Big welt, Redness, Itchiness, Soreness around injection site" per patient.  No treatment given at the clinic.  Symptoms resolved on its own.
no adverse effect; improperly stored VARIVAX; This spontaneous report was received from a registered nurse referring to a 4-year-old patient of unknown gender. No information was provided regarding the patient's medical history, concurrent conditions or concomitant medications.  On 12-AUG-2019 and 13-AUG-2019, vaccines had a temperature excursion.  On 30-AUG-2019, the patient was vaccinated with varicella virus vaccine live (oka/merck) (VARIVAX) lot # R006221 with expiration date on 29-FEB-2020 or R029517 with expiration date on 10-OCT-2020 (dosage schedule, route and anatomical location were not reported), for prophylaxis (incorrect product storage).  Administered doses of vaccine experienced temperature excursion of -14 degrees Celsius (C) to -10 C (-11.91 C) for 8 hours. There was no previous temperature excursion. Digital data logger was involved. Vaccines were reconstituted with a properly stored sterile diluent. No adverse effects were reported.
Narrative:  Patient COVID positive on 7/12/21 (fully vaccinated) and admitted with hypoxic respiratory failure secondary to COVID pneumonia. Patient was transferred to ICU on 7/15 and intubated on 7/21. Patient passed away on 7/26/21 following PEA arrest d/t COVID ARDs.
On 9/17/15, patient presented with a four-month history of knee pain, inability to climb, fatigue, and back pain. Myalgias continued, and extensive laboratory tests were run. Orthopedic consultation was obtained, and X-rays were normal and MRI was normal. On 1/26/16, patient presented with weakness of the right lower extremity and 3-week history of abdominal pain with melena. On 2/3/16, patient presented with a viral illness accompanied by high fevers and weakness. Since that time, patient has had recurrent joint aches (feet, knees) and neck pain when she awakens (causing her to get out of bed slowly).
This spontaneous case from, initially received from a pharmacist on 23-Aug-2018, concerning a 29-year-old, adult, male patient. On an unspecified date in 2017 (reported as last year), the patient was administered INN Flu Vaccine Seasonal (dose, route of administration, anatomical location, batch number, expiry date, manufacturer and trade name: not reported). On an unspecified date in 2017, one day after vaccination, the patient experienced redness in the eye. The patient reported that, he had no complains of pain, no discharge and no treatment was needed. After one day, the redness of the eye disappeared (recovered). The reporter assessed this case as non-serious. Update received on 29-Sep-2018: Significant case correction (IRD: 23-Aug-2018): As determined causality of the event 'red eye' was corrected from not related to related. The case comment was amended accordingly.
This spontaneous report as received from a patient grandmother refers to a 12 year old female patient. On unknown dates, the patient was vaccinated with first two doses of GARDASIL (dose, route, lot # and expiry not reported) and had not had any reactions to those shots. On an unknown date, the patient was vaccinated with her third shot in the GARDASIL, lot # J007354, expiration date 20-FEB-2016 (dose and route not reported), vaccine series, from the recalled lot of medicine. The reporter stated that, on an unknown date, the patient had an "adverse reaction from this third shot." The reporter did not specify what the reaction was, but the patient was put on some unspecified medication for that reaction. The patient sought unspecified what type of medical attention. The outcome of the event was unknown. Additional information is not expected.
Rt eye swelling and skin peeling around mouth on 1/9/00 so pt was admitted to hosp.Skin began to peel from chest,back,and rectal area on 1/10/00.Transfer. to ICU then to burn unit for tx of skin breakdown.Dxed w/ toxic epidermal necrolysis.
LARGE RED AREA AROUND INJECTION SITE, WARM AND SENSITIVE TO TOUCH.  APPROXIMATELY 3 TO 4 INCHES IN DIAMETER, LEFT UPPER ARM -- ASSESSMENT BY PT MD FELT IT WAS A REACTION TO THE VACCINE.  APPLIED COLD PACKS TO AREA.  PT WILL MONITOR SITE AND REPORT BACK IF AREA INCREASES IN SIZE OR CHANGES IN APPEARANCE.
Initial unsolicited report received from a consumeron 19 Oct 2016. This case involves a 79-year-old female patient who was vaccinated with a dose of FLUZONE HD (batch number, expiry date, site and route of administration was not reported) in shoulder on an unspecified date (reported as three weeks ago). Illness at time of vaccination and pre-existing physician diagnosed allergies, birth defects, medical conditions were reported as unknown. The patient concomitant medication was not reported. On an unspecified date (reported as three weeks ago) and unspecified timeframe following the vaccination, the patient had shoulder hurts. Laboratory investigation and corrective treatment were not reported. Patient was not recovered from events. List of documents held by sender: none.
This case was reported by a healthcare professional and described the occurrence of injection site reaction in a subject of unspecified age and gender who was vaccinated with diphtheria and tetanus toxoids and acellular pertussis vaccine adsorbed (Infanrix, GlaxoSmithKline) for prophylaxis. On an unspecified date on or before 08 September 2006, the subject received a dose of Infanrix at an unspecified site of injection (dose number and lot number not provided). At an unspecified time after vaccination with Infanrix, on an unspecified date on or before 08 September 2006, the subject experienced "a large localized reaction measuring 150 mm" at the injection site of Infanrix. The outcome of the event was not reported.
Patient felt dizzy, chest felt funny tired. Gave patient cheese, orange juice and monitored patient in observation area for 30 mins.
Patient states that the area that she received he vaccine was hard and red on her arm. Patient went to the Dr. to check if she could get the second vaccine. About a month ago she has been having burning in her hand. It will also spread to her right shoulder. Most pain stays in her left side.
Approximately 11 days (10-11 days) after patient received 1yr vaccines (MMR, Varicella, Hib, Hep A), she became fussy with decreased appetite. Today (7-24-14), she developed a rash which started on her back, then spread to her stomach, diaper area, arms, then face and behind her ears and behind her knees. See attached office visit note.
I gave a Vaxelis and a HIB both. I had forgotten that HIB was in the vaxelis. There was no adverse reaction.
Pt. states that after receiving the 3rd Booster of Phizer 10/27/2021, started experiencing symptoms of pain at injection site, warm to the touch, pressure in the left arm, nausea, dizziness, and dry vomiting. Lasting 36 hours, no noted Primary visit/communications. Still experiencing nausea and pain in the left arm.
during inj pt perceived that needle hit lt humerus bone & vax ran down along bone;devel lt rotator cuff type tendonitis w/in a wk of vax;rx relefen & xray & steroid inj;
10 days post admin of MMR and Varivax pt developed temp 103.5 had brief unresponsive episode thought to be febrile siezure. Treated and released without sequelae from ER. Developed papular vesicular rash on torso.
Received tetanus shot at the same time as covid vaccination. Legs began to swell, liver and kidneys began to shut down, faint feeling.
Patient received a dose of improperly stored PROQUAD; No adverse event; This spontaneous case was received from and healthcare professional regarding to a patient of unknown age, gender and ethnicity. The patient's concurrent conditions, medical history, drug allergies and concomitant therapies were not reported.   On 05-MAR-2021, the patient was vaccinated with an improperly stored dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) (lot # T027114 with expiration date reported as 07-FEB-2022) 0.5 (units not reported) (route of administration and anatomical location of vaccine were not reported) for prophylaxis. The vaccine was exposed to a temperature between 5.0 °F and 8.0 °F for 8 hours and 40 minutes. A previous temperature excursion was reported. No adverse effect was reported.  Albumin status has been verified for measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) (lot # T027114) to be recombinant human albumin (rHa).  This is one of several reports received from the same source.; Sender's Comments:  US-009507513-2103USA003425:
In April,  pt started to have reflux.  By July, diagnosed with esophageal cancer
REDNESS AND WARMTH AT INJECTION SITE LASTING ONE WEEK AND STILL PRESENT
Extreme chills with low fever (99.9 F) and lightheadedness on and off starting 14 hours after injection. I received the second dose on Saturday afternoon, had symptoms overnight, almost all day Sunday, overnight Sunday, was fine on Monday, but had them again overnight Monday.  It is Tuesday when I am reporting this, so I am hoping I am done. Ibuprofen and Acetaminophen are helping ease these symptoms.
Red raised lump, non-tender area around injection site. Started 2 wks post vaccine. Hard white head - now resolving, no fever, non-indurated,1cm area on R leg.  Follow up:  This information was not available-the family could not remember when it started.