chrisvoncsefalvay/vaers-outcomes huggingface dataset:
diagnosed with cervical cancer in july 2022; This spontaneous report has been received from a physician assistant and refers to a 36-year-old female patient.  The patient's pertinent medical history, other drug reactions or allergies, concurrent conditions and concomitant therapies were not reported.  On an unknown date, the patient was vaccinated with hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) injection, 0.5 milliliters (mL), administered intramuscularly for prophylaxis. By an unspecified date in may 2022, the patient had completed all three doses. (strength, lot #, and expiry date were not provided).  On an unknown date in july 2022, the patient was diagnosed with cervical cancer (cervix carcinoma), which resulted in a hysterectomy to treat it. At the time of reporting, the patient was recovering from the event.  The causal relationship between the event and hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) was not provided.  Upon internal review, the event was determined to be medically significant.
This case was reported by a consumer via call center representative and described the occurrence of taste peculiar in a 51-year-old female patient who received FLULAVAL QUADRIVALENT (2018-2019 season) for prophylaxis. On 18th October 2018, the patient received FLULAVAL QUADRIVALENT 2018-2019 season .5 ml. On 18th October 2018, 2 hrs after receiving FLULAVAL QUADRIVALENT 2018-2019 season, the patient experienced taste peculiar, throat tightness, nasal congestion and headache. On 18th October 2018, the outcome of the taste peculiar, throat tightness and nasal congestion were recovered/resolved. On an unknown date, the outcome of the headache was not recovered/not resolved. It was unknown if the reporter considered the taste peculiar, throat tightness, nasal congestion and headache to be related to FLULAVAL QUADRIVALENT 2018-2019 season. Additional details were provided as follows: The patient received Flu shot in the left arm. The patient reported that after dose she had strange taste in mouth, head felt all stopped up and her throat began to feel tight. The patient stated at the of reporting she had a headache. The contact details of the physician was provided.
Pain on injection - raised - bleeding internally (Black/blue) about 1 inch around injection site started within 24 hour - raised knot at injection site - pain subsided.
cramped legs and feet; tired legs and feet/ tired left arm; Muscle pain; Joint pain; This spontaneous case was reported by a consumer and describes the occurrence of MUSCLE SPASMS (cramped legs and feet), MUSCULAR WEAKNESS (tired legs and feet/ tired left arm), MYALGIA (Muscle pain) and ARTHRALGIA (Joint pain) in a female 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 second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced MUSCLE SPASMS (cramped legs and feet), MUSCULAR WEAKNESS (tired legs and feet/ tired left arm), MYALGIA (Muscle pain) and ARTHRALGIA (Joint pain). At the time of the report, MUSCLE SPASMS (cramped legs and feet), MUSCULAR WEAKNESS (tired legs and feet/ tired left arm), MYALGIA (Muscle pain) and ARTHRALGIA (Joint pain) had not resolved.            No concomitant medications were reported   No treatment information was provided
Patient had a rash on neck and back and described the rash was very itchy and visible lines developed when scratched; This spontaneous case was reported by a patient and describes the occurrence of RASH PRURITIC (Patient had a rash on neck and back and described the rash was very itchy and visible lines developed when scratched) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced RASH PRURITIC (Patient had a rash on neck and back and described the rash was very itchy and visible lines developed when scratched). The patient was treated with LEVOCETIRIZINE DIHYDROCHLORIDE (XYZAL) for Itchy rash, at an unspecified dose and frequency. At the time of the report, RASH PRURITIC (Patient had a rash on neck and back and described the rash was very itchy and visible lines developed when scratched) had resolved.            No concomitant medications were reported. It was reported that on an unknown date the patient received first booster dose of mRNA-1273 and primary series of unknown product. The Rash was resolved within hours after the over-the-counter (OTC) treatment drug.   This case was linked to MOD-2023-720207 (Patient Link).
Bell's palsy- Patient was admitted on 4/15 for a left sided bell's palsy. Mom reports left sided facial weakness  started three days prior to admission. He was started on a course of prednisolone in the hospital, to be continued outpatient. Weakness unchanged at time of discharge, but he will continue to have close outpatient followup with neurology and his PCP.
Initial report received from a healthcare professional on 26 June 2013. A 36-year-old female patient, whose medical history and concomitant medication were not reported, had received an intramuscular first dose of ADACEL vaccine (lot number: U4612AA, site of administration was not reported) on 26 June 2013. The patient was pregnant at the time of vaccination. Last menstrual period date was 02 December 2012 and estimated date of delivery was 30 August 2013. The patient's health during pregnancy, specific risk factors (e.g.: alcohol, tobacco or recreational drugs) was not reported. At the time of this report, the patient had not experienced any adverse event. Documents held by sender: none.
Skin pink arm below vaccine site to elbow of (R) arm with red dots - warm, no pain, itching - recommended TYLENOL and ice compress to reduce reaction - RN looked at it and told her the same thing.
Doses administered after more than 1 temperature excursion; Doses administered after more than 1 temperature excursion; This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (Doses administered after more than 1 temperature excursion) and POOR QUALITY PRODUCT ADMINISTERED (Doses administered after more than 1 temperature excursion) in an 81-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 014M20A and 019B21A) for COVID-19 vaccination.     No Medical History information was reported.   On 27-Feb-2021 at 2:13 PM, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On 27-Mar-2021 at 2:20 PM, received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to .5 milliliter. In 2021, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Doses administered after more than 1 temperature excursion) and POOR QUALITY PRODUCT ADMINISTERED (Doses administered after more than 1 temperature excursion). At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (Doses administered after more than 1 temperature excursion) and POOR QUALITY PRODUCT ADMINISTERED (Doses administered after more than 1 temperature excursion) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Age of the patient at the time of vaccination was 81.19 years. No concomitant product reported by reporter.  The reported condition of the vial was not frozen.   Dose taken on 27 Feb 2021 with batch number 014M20A underwent multiple temperature excursion on 27 Feb 2021 from 33 to 35 degrees Fahrenheit from 09AM to 05 PM. Vaccine was moved to fridge on 24 Feb 2021 and Beyond Use Date for the vaccine was 26 Mar 2021. Product moved to clinic on 27 Feb 2021.  Dose taken on 27 Mar 2021 with batch number 019B21A underwent temperature excursion twice on 27 Mar 2021 till 35 degrees Fahrenheit at 09AM and 10 AM. Vaccine was moved to fridge on 23 Mar 2021 and Beyond Use Date for the vaccine was 22 Apr 2021. Product moved to clinic on 27 Mar 2021. Age of the patient at the time of vaccination was 81.26 years.   No treatment medication reported by reporter.   This case was linked to MOD-2022-566976 (Patient Link).
Eczema rash on face below right eye. Treated with topical steroid cream. Resolved in two days.  This rash also occurred three days after the first vaccine dose. It is unknown if the rash was related to the vaccine.
Hematoma at injection site. Large , red, swollen area on skin. Goofball , hardness, pain, itching, 2 inches in diameter.
5-6 hours after immunization developed high pitch cry and 50 cent piece eye swelling (R) upper thigh and redness in area of PEDVAX HIB.
I noticed a triggering of my arrhythmia of my heart within a few hours of getting the vaccine. Contacted doctor. Doctor diagnosed an arrhythmia and prescribed an increase in flecainide from 2x a day to 3x a day. Normal rhythm observed the next day, 10/14/2022.
Pain, headache, body ache, joint ache in L ankle, chills, loss of  appetite, redness on arm 3" diameter painful, lethargic, resolved in 24 hours Narrative:
Started as red lump. 1-14-12 Dx with cellulitis & abscess. Treated with AUGMENTIN.
Patient was administered a flu shot and later reported he had received a flu shot 3 wks prior.
none, patient was given the wrong vaccine for their age group.  At 4 months patient should have been given Pentacel, but patient was given Kinrix which is for children ages 4 to 6 years.  Pt had  no side effects/adverse reactions from the vaccine.  Patient is scheduled to follow up with his PCP to be revaccinated.
Patient is the breastfeeding infant to a mother that received the Moderna vaccine.  The infant had symptoms of decreased appetite, elevated temperature 99.8 degrees, mottled skin, inconsolable crying, and diarrhea all that occurred within 48 hours after the mother received the vaccine and started within a few hours after vaccine administration in the mother.  The mother also had symptoms of fatigue, headache, and body aches during the 48 hours after vaccine administration.
Rash on arms and thighs on 9/30/01 at 22:30. Took Atarax 10mg prn itching.
Information has been received from a registered nurse regarding an unknown age and gender patient. On 03-MAR-2012 at 11:30am, ZOSTAVAX, lot # 672477/1604AA was exposed to -12 C for an estimated total time out of range of 4 hours. On 17-APR-2012 at 7:30am, ZOSTAVAX, lot # 672477/1604AA was exposed to -12 C for an estimated total time out of range of 14 hours. On 26-APR-2012, the patient was administered an out of range dose of ZOSTAVAX, lot# 672477/1604AA expiration date: 13-JAN-2013 (dose and route were not reported). No adverse experience had been reported. This is one of 182 reports from the same source. Additional information has been requested.
Pt had headaches, body aches and muscle aches, post vax. He was seen by health professional. He states that he still has muscle aches and weakness. He has been referred to an MD for further testing and follow-up.
got shingles twice after getting the shot; got shingles twice; This case was reported by a consumer via interactive digital media and described the occurrence of suspected vaccination failure in a male patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure and shingles were unknown.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine.  Additional details were provided as follows: The reporter was patient's wife. The age at vaccination was not reported. The patient got the shot and he got shingles twice after getting the shot. This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule, time to onset for target disease and laboratory confirmation were unknown at the time of reporting.
The pt received the Varivax vaccine #1 and MMR #1 on 8/24/00. The pt developed papulo-pustular lesions (21) on the arms, trunk and legs on 9/15/00. He had no fever.
Moderna COVID-19 Vaccine EUA: seven months after vaccination patient admitted to hospital for orthostatic hypotension, diarrhea, and falls with COVID-19 breakthrough infection. Patient hydrated, received PT/OT, remdesivir, and discharged to home medically stable.
Extreme mucous; Throwing up; Fever; Chills; Congestion; Coughing; This spontaneous case was reported by a consumer and describes the occurrence of NASAL CONGESTION (Congestion), COUGH (Coughing), SECRETION DISCHARGE (Extreme mucous), PYREXIA (Fever) and CHILLS (Chills) in a 21-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Fish allergy (Fish allergy).    On 02-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 03-Aug-2021, the patient experienced NASAL CONGESTION (Congestion), COUGH (Coughing), PYREXIA (Fever) and CHILLS (Chills). On an unknown date, the patient experienced SECRETION DISCHARGE (Extreme mucous) and VOMITING (Throwing up). On 04-Aug-2021, NASAL CONGESTION (Congestion), COUGH (Coughing), PYREXIA (Fever) and CHILLS (Chills) had not resolved. At the time of the report, SECRETION DISCHARGE (Extreme mucous) and VOMITING (Throwing up) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medications were not provided by the reporter. Treatment information was not provided.
12/01/2021 Diagnosed with Metastatic breast CA 12/17/2021 Vaccination 06/09/2022 I had a little cough after a running event. I noticed I kept waking up coughing. I went to run in my crossfit class. I woke up Sat morning and took a test, it was COVID+.  *Wed I had tested at home and it was neg prior to the + test.  **I called Oncology after hours, they gave me a Zpac and Paxlovid (2 doses)
Left arm: red, hot to touch, pea size knot, slightly swollen, some itchiness, no soreness as reported by parent.
Pt vaccinated with Rubella developed carpal tunnel synd, fatigue, neuropathy, joint pain, glands in neck achy & swollen, few spots on chest (red dots), rash, legs achy, tingling & numbness in both hands & arms.
Patient was vaccinated at a mobile clinic at school on 2/25/22. Patient's mom called on 2/28/22 and advised patient received first dose on 1/23/22. Mom states only side effect on 2/25/22 is headache which patient got on 1/23/22 as well.
According to mother patient has a red raised area in right arm size of 50 cent piece. Warm to touch. Local reaction slightly above site of injection. Immunization given subcutaneous. PHN recommended cool compress and consult primary medical doctor.
I was at the Urgent Care for stitches after cutting my hand on a glass while doing dishes. Around 10 a.m. I was given the vaccination and I had a seizure almost immediately after injection, given 2 mg ATIVAN. Then transferred down the hall to the ER. Dizziness and vomiting x2 for 24 hours after. 3/10/2019. I have never had a seizure before in my entire life.
severe dizziness; Initial information was received on 13-Oct-2020 regarding an unsolicited valid non-serious case received from a consumer.  This case involved adult patient who experienced severe dizziness (Dizziness), while patient received DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE [ADACEL].  The patient's medical history, medical treatment(s), vaccination(s) and family history were not provided.   On an unknown date, the patient received a dose of suspect DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE (lot number- U6737AA) via unknown route at unknown administration site for prophylactic vaccination.  On an unknown date, unknown latency after vaccination the patient experienced severe dizziness (Dizziness).  No relevant laboratory data was reported.   It was not reported if the patient received a corrective treatment.  The event outcome was unknown.
Pt had the shot on Friday and went to the ER on Saturday and was placed on KEFLEX and doxycycline for cellulitis. Rph used aseptic technique.
This is the second time in as many Covid vaccines that I have suffered 'major' adverse effects. I didn't have this much of a problem when I had the covid 19 infection back in late Dec. This is so out of whack, you professional health people types with all of your EXPERTS that can't agree  with what the truth is. So, now, after being stricken with the virus and a two time, suffering, pain writhing adverse ;and now you tell me that the mask thing is still needed ....  (and you know it is). You are all part of the systematic de-humanizing of responsible folks who are well aware of what's taking place. Not a day goes by when you can't see any number of articles with 'bad news' about these vaccines which were not approved by the FDA.  Shame on you all. So I've got at least two more nights of suffering to go through when I shouldn't have. PLEASE, take some of this pain from me. With all of your finger pointing, hospital travesties,  expert taking down expert .... what exactly is it you people are trying to do?
cried for 3 days, fever 24 hrs, eye spasms, blink-trying to focus, grimacing faces pattern of behavior (bang head on stuff);
end of March when she felt weakness on her legs; not able to get up without pulling herself up resting her hands on the table; After the second shot, her condition worsen she can hardly walk without any assistance; nauseated and really weak (first shot); pain in her arm (first shot); nauseated and really weak (first shot); This spontaneous case was reported by a physician and describes the occurrence of PAIN IN EXTREMITY (pain in her arm (first shot)), ASTHENIA (nauseated and really weak (first shot)), MUSCULAR WEAKNESS (end of March when she felt weakness on her legs), DYSSTASIA (not able to get up without pulling herself up resting her hands on the table) and CONDITION AGGRAVATED (After the second shot, her condition worsen she can hardly walk without any assistance) in a 32-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included No adverse event (no medical history reported).   On 02-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 02-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 02-Mar-2021, the patient experienced PAIN IN EXTREMITY (pain in her arm (first shot)), ASTHENIA (nauseated and really weak (first shot)) and NAUSEA (nauseated and really weak (first shot)). On 02-Apr-2021, the patient experienced CONDITION AGGRAVATED (After the second shot, her condition worsen she can hardly walk without any assistance). On an unknown date, the patient experienced MUSCULAR WEAKNESS (end of March when she felt weakness on her legs) and DYSSTASIA (not able to get up without pulling herself up resting her hands on the table). On 03-Mar-2021, PAIN IN EXTREMITY (pain in her arm (first shot)), ASTHENIA (nauseated and really weak (first shot)) and NAUSEA (nauseated and really weak (first shot)) outcome was unknown. At the time of the report, MUSCULAR WEAKNESS (end of March when she felt weakness on her legs), DYSSTASIA (not able to get up without pulling herself up resting her hands on the table) and CONDITION AGGRAVATED (After the second shot, her condition worsen she can hardly walk without any assistance) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 11-May-2021, Physical examination: to confirm Guillain Barre Syndrome coming from the Moderna Vaccine. On an unknown date, Nerve conduction studies: to confirm Guillain Barre Syndrome coming from the Moderna Vaccine.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.
rash on leg that lasted for a month; injection left a brown spot on left thigh; This is a spontaneous report from a contactable physician (the prescribing physician) via a Pfizer sales representative. A female patient of unspecified age received the 2nd dose of meningococcal group b rlp2086 (TRUMENBA) via an unspecified route of administration on 26Apr2019 at single dose at left thigh for physical. The patient's medical history and concomitant medications were not reported. The reported was reporting an adverse event regarding meningococcal group b rlp2086. She was made aware on 06Aug2020. The reporter did not have the product with them at the time of reporting. It was reported that a couple of years ago, a patient received the 2nd dose of meningococcal group b rlp2086 and developed a rash on her leg that lasted for a month. The injection also left a brown spot on her left thigh. The outcome of the event "rash on her leg" was unknown, for event "injection also left a brown spot on her left thigh" was recovered on an unspecified date.  No follow-up attempts are needed. Information on Lot/Batch number cannot be obtained.
Pt was seated in the waiting area for observation. When he started to feel unwell he stood up and became lightheaded and collapsed. By the time I reached him he was alert so he could not have loss consciousness for more than a few seconds. A customer witness him hit his head on the way down so we contacted the paramedics for evaluation.  We had him lay flat on his back with a pillow under his head until the paramedics arrived. He reported some head pain from the fall and was still dizzy when the arrived. His blood pressure and heart rate were elevated during the assessment. His blood sugar was within normal range. When they took his blood sugar his heart rate dropped in the 40s so they noted a vasovagal response. Because he was still dizzy and not able to drive the paramedics recommended he get evaluated at the hospital and took him to hospital. I told him to update us if there were any developments.
Pt reported swelling, warmth itching at injection site, currently 6cm X 6cm pt reports it was much larger. No other symptoms reported. Use ice as needed to provide comfort and continue to monitor.
Onset of headaches 24hrs post injection. Continued headaches every day since. Going on week 3 of headaches.
Presented to emergency department with chest pain, report symptoms a few days prior to presentation.  Reported mild shortness of breath, chills, and hot flashes. Was found to be COVID-19 positive upon admission to hospital floor. Symptoms are believed to not be related to COVID-19 infection and was not treated for infection.
pt had rash on her  arm.. not directly on the injection site. patient confirmed having alot of food and drug allergies
Information has been received from a pharmacist concerning her 11 year old daughter with allergic reaction to AUGMENTIN who on 21-APR-2008 was vaccinated into the arm (which arm not specified) with a dose of GARDASIL.  Concomitant suspect therapy included PNEUMOVAX 23 (manufacturer unknown) into the other arm.  The reporter reported that on 22-APR-2008, her daughter experienced allodynia or hyperestesia on the left thigh.  She sought medical attention from her physician father.  The patient had not recovered.  No other details available.  Additional information has been requested.
Patient fainted and hit her head, applied ice pack and examined by Dr. Waited in clinic for 1/2 hour after and was fine. Did have a bump on her forehead from fainting.