chrisvoncsefalvay/vaers-outcomes huggingface dataset:
APPROXIMATELY 12 MINUTES AFTER THE VACCINE WAS GIVEN THE PATIENT STARTED TO COMPLAIN OF FEELING LIGHTHEADED AND HAVING BLURRED VISION ALSO ASSOCIATED NAUSEA.  SHE WAS BROUGHT BACK TO A STRETCHER AND VITALS WERE TAKEN AND STABLE.  SHE SUBSEQUENTLY STARTED TO HAVE SOME DRY HEAVES AND FEELING OF ITCHING IN THROAT WITH PROGRESSION OF HER SYMPTOMS.  HER PULSE OX WAS 93-98%, bp 110/82 AND HR 67.  iT WAS DECIDED TO ADMINISTER AN EPIPEN AND SHE HAD AN INCREASE OF HR TO 102; AT THIS POINT EMS WAS CALLED.  SHE DID START TO DEVELOP THROAT TIGHTNESS, ITCHING, AND COUGH AT WHICH TIME OXYGEN WAS ADMINISTERED.  SHE WAS TRANSFERRED TO ER AT THE MEDICAL CENTER FOR FURTHER EVALUATION.  REPORT FROM ER NOTES SHE DID HAVE SEIZURE WHILE ENROUTE WHICH WAS TREATED.  THE PATIENT WAS KNOWN TO HAVE UNDERLYING SEIZURE DISORDER.
This spontaneous report as received from a pharmacist refers to a patient of unknown age and gender. On 24-DEC-2014, the patient was vaccinated with ZOSTAVAX (dose, lot number, expiration date were not provided). On an unknown date, the patient experienced sinusitis. The patient was prescribed dexamethasone nasal spray. At the time of the report the patient did not recover from the event. Relatedness between sinusitis and ZOSTAVAX was not reported. Additional information is not expected as the pharmacist does not want to be contacted regarding the report.
Arms red, swollen Rt Lt, crying 3-4 hrs. Treated with Benadryl, better next day.
Severe posterior neck pain within hours of 2nd dose of JE vaccine. Then headache, and mental fogginess. Sx persisting 9 days. Abdom rash noted. Symptomatic RX.
Information has been received from a pharmacist regarding a patient of unknown age and gender. On 16-JUL-2014, the patient inadvertently received a dose of VARIVAX (Merck) (0.5 ml, subcutaneous), when they were supposed to received ZOSTAVAX. No adverse effects reported. Additional information has been requested.
within about 10 minutes she experienced flushing and numbness to her Right cheek. She states it spread to her neck. She opened her window to cool off. The symptoms progressed to a globus sensation of 'a marble in my throat'. She states she was breathing OK, could swallow and tried sips of fluid. EMS saw her, BP was OK, they inspected oral airway. EMS thought she was safe to drive to ER. Once at ER, she started coughing and throat clearing,. ER brought her right in and gave her an epipen. She states within minutes symptoms dissipated and were gone in about 5 minutes. She had no recurrence. She denies pruritis, urticaria, dyspnea, red/watery eyes, face /lip/tongue swelling, CP, n/v/d  ER documentation diagnosed allergy to vaccine. Treated her with epipen, famotidine, benadryl and solumedrol. VS and exam were documented as WNL
Patient previously received 2 doses of Moderna. She chose Pfizer as her booster. The following day, she began to experience sharp stabbing pain in her chest and slight shortness of breath. She said she is still experiencing these symptoms. Patient is currently monitoring her symptoms and will seek immediate medical attention should her symptoms persist or worsen.
EFFECTS OF COVID VACCINATION/ARM WAS SORE; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (EFFECTS OF COVID VACCINATION/ARM WAS SORE) in an elderly female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product RISANKIZUMAB (SKYRIZI [RISANKIZUMAB]) for Rheumatoid arthritis.    No Medical History information was reported.   On 11-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In 2022, RISANKIZUMAB (SKYRIZI [RISANKIZUMAB]) (Subcutaneous) dosage was changed to at an unspecified dose. On an unknown date, the patient started RISANKIZUMAB (SKYRIZI [RISANKIZUMAB]) (Subcutaneous) at an unspecified dose. In 2021, the patient experienced VACCINATION SITE PAIN (EFFECTS OF COVID VACCINATION/ARM WAS SORE). At the time of the report, VACCINATION SITE PAIN (EFFECTS OF COVID VACCINATION/ARM WAS SORE) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medication was reported. Patient's arm was sore after her first Moderna vaccination. Treatment information was not provided. This case was identified as part of a retrospective clean-up activity where certain emails received in the Moderna mailbox were missed to be booked-in.   This case was linked to MOD-2022-632605.
6AUG92 recvd vax & 7AUG92 pt temp elevated 104.4 x 4 days; visited ER MD;
Patient was given the Moderna vaccine. Patient is under the age of 18. Patients is currently 17 years old.
Developed redness and quarter sized fluid filled blister at injection site two days after injection. Prescribed topical Diprolene AF 0.05% cream to apply twice a day.
Information has been received from a physician concerning a female who on an unspecified date was vaccinated with a dose of GARDASIL (lot # not reported). On an unspecified date, the patient experienced genital warts. The patient sought unspecified medical attention. At this time of reporting, the patient's outcome was unknown. This is the second of two reports from same source. Additional information has been requested.
The patient received the pneumococcal vaccine 9/20/10 at 6AM and later that day, the vaccination site (L deltoid) was swollen, red, and painful. Diagnosed with cellulitis and treated with Amoxicillin/Clavulanic Acid 500mg po bid.
Pt mom was notified of the multiple vaccines given and stated there was redness around the injection site. And pt had fever and warm to the touch.
localized rash at injection site, taking zyrtec and steroid cream, referred to allergist.
rt leg swollen & red extending almost completely around whole leg, screamed for 1 hr w/o stopping; mom states pt also given APAP & DPH;
Headache, Fever, NauseaVomiting,  1/7 HOT FLASHES; THAT EVENING FEVER 100..5, JOINT/MUSCLE PAIN, LEFT SIDE OF NECK PULSATING PAIN LASTED A FEW MINUTES ONCE. FATIGUE, PAIN AT INJECTION SITE LASTING 3 DAYS; FOR TWO MORE DAYS HAD JOINT/MUSCLE PAIN, HEADACE, DIZZINESS Narrative: 1/8 WENT TO CLINIC, WAS ADVISED TO HYDRATE, TAKE ADVIL/TYLENOL AROUND THE CLOCK, REST.
patient got sick; it got worse every year (sick); Initial information received on 12-Nov-2020 regarding an unsolicited valid non-serious case received from a consumer or non-health care professional.   This case involves patient of unknown demographics who got sick (illness) and got worse every year (condition aggravated), while patient received vaccine INFLUENZA VACCIN [Flu shot].   The patient medical history included Hospitalisation (2 times), sick and pneumonia (six times).  Past medical treatment, past vaccination, concomitant medication and family history were not provided.   On an unknown date in Oct-2016, the patient received a dose of suspect INFLUENZA VACCINE (produced by unknown manufacturer) [lot number and expiry date not reported] via an unknown route at an unknown administration site for prophylactic vaccination   On an unknown date, the patient developed a non-serious patient got sick (illness) and got worse every year (condition aggravated) unknown latency following the administration of INFLUENZA VACCINE.  It was reported that, patient got deathly after taking flu shot.  Details of laboratory data not reported.     It was not reported if the patient received any corrective treatment.  At the time of reporting, the event outcome reported as unknown for events.  There will be no information available on the batch number for this case.
sore throat; Headache; This spontaneous case was reported by a consumer and describes the occurrence of OROPHARYNGEAL PAIN (sore throat) and HEADACHE (Headache) in a 57-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 immunisation.     No Medical History information was reported.   On 14-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. 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 OROPHARYNGEAL PAIN (sore throat) and HEADACHE (Headache). At the time of the report, OROPHARYNGEAL PAIN (sore throat) and HEADACHE (Headache) outcome was unknown.        mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) and mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) dosing remained unchanged.       No treatment details were provided. No concomitant medication was provided.   Most recent FOLLOW-UP information incorporated above includes: On 06-May-2021: initial additional document. Telephone contact report added. 2nd dose details added. Action taken updated.
I have been experiencing high glucose readings since I received the Covid booster. Despite eating low carbs, or no carbs, and taking my insulin, my glucose readings are high and don't easily come down. Previous to the booster my glucose was under control, with only 10 units of insulin when needed.  Currently, I am on 15 units every day, and may have to increase to 20.
Itching that got progressively worse throughout the day until seen at Urgent Care, swelling, pain, redness and hot to the touch at injection site. Injection site is middle of the left arm.
Shortness of breath, wheezing - seen in ER, given Albuterol, Prednisone. Admitted overnight for observation. Home on Albuterol/Prednisone.  9/7/07 Reviewed hospital medical records which reveal patient experienced congestion, cough, itchy eyes, lightheaded, HA, cough, sore throat & SOB on 8/23 which worsened & was admitted 8/24-8/25/07.  Tx w/tapering steroids, nebs, antihistamine.  Remained tachycardic & tachypneic but breathing improved by d/c.  Left upper arm injection site noted to be tender & swollen. FINAL DX: Reactive airway disease secondary to viral infection vs protracted anaphylaxis.
Pain, redness and swelling at injection site, still unresolved 3 days post injection. Neck pain, resolved 2 days post injection (note, same reaction with first dose of this vaccine)
received an expired TENIVAC/vaccine was administered 5 days after the expiration date with no reported adverse event; Initial information received on 23-Oct-2023 regarding an unsolicited valid  non-serious case received from a other health professional.  This case involves a 50 years old male patient who received an expired tenivac/vaccine was administered 5 days after the expiration date with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On 29-Sep-2023, the patient received 0.5 ml (TOTAL) dose of suspect diphtheria-2/tetanus-5 adsorbed toxoids no preservative adult lot U7183AA, expiry date: 23-Sep-2023 via intramuscular route in the right deltoid for immunization, an expired tenivac/vaccine was administered 5 days after the expiration date with no reported adverse event (expired product administered) (latency same day).  Action taken: not applicable.   This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Vaccine Booster dose given. Pt ambulated to observation chair. While sitting, pt became dizzy and fainted. Placed in Trendelenbug position, immediately responsive to commands, VSS stable. Ice pack applied to head. Patient denies pain, Observed for 30 minutes. discharged home in stable condition.
pt pale p/vax; HR 130-140 range-pulse ox 91-92%;
Pt had fever of 101.8 at 3:30 in the afternoon, 101.4 in am. The same day child had immunizations child had twitching in legs and eyes. Child was taken to ER and hospitalized. The discharge summary received on 3/5/04 states febrile seizure.
Muscle pain extremely. Can't still raise my left arm. Hurts to lift it up. Doctor believes it was injected too high. Deltoid (into Bursa sac).
Moderna COVID- 19 Vaccine EUA: Three and four days after vaccination patient presented to the emergency department and primary care provider, respectively, for right upper arm inflammation, swelling, tenderness, warmth, pain, lymph node swelling,  and erythema. Patient reported fever and chills initially soon after vaccination that resolved prior to right arm symptoms. Vital signs all within normal ranges. Patient diagnosed with cellulitis and prescribed antibiotics.
diagnosed with stroke; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of CEREBROVASCULAR ACCIDENT (diagnosed with stroke) in a 74-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013A21A) for COVID-19 vaccination.     Concomitant products included MELATONIN for Difficulty sleeping, METFORMIN, ROSUVASTATIN, ESCITALOPRAM, QUETIAPINE, BUPROPION, VITAMIN D NOS and AMFETAMINE ASPARTATE, AMFETAMINE SULFATE, DEXAMFETAMINE SACCHARATE, DEXAMFETAMINE SULFATE (ADDERALL) for an unknown indication.    On 01-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 04-Jul-2021, the patient experienced CEREBROVASCULAR ACCIDENT (diagnosed with stroke) (seriousness criteria hospitalization, disability, medically significant and life threatening). The patient was treated with RIVAROXABAN (XARELTO) for Stroke, at a dose of 20 mg once a day. At the time of the report, CEREBROVASCULAR ACCIDENT (diagnosed with stroke) outcome was unknown.            Patient drove to the nearest hospital and  where she was diagnosed with a stroke. she was airlifted to a hospital where she stayed overnight and next evening she was moved to another hospital where she stayed for 15-19 days for therapy. On unknown date laboratory tests of  MRI, EKG, and cardiologist might have done an ECHO were performed and results were not reported.  Patient was treated with Blood thinner and some other medicine. she was discharged on antibiotic and florigen for stomach, change from pravastatin to rosuvastatin 20 mg  Company Comment: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.  Further information is expected.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.  Further information is expected.
got a flu shot and got really sick; Initial information regarding an unsolicited valid non-serious case received from a consumer (patient) via social media and was transmitted to Sanofi on 15-Dec-2020.  This case involved a patient of unknown age and gender who got a flu shot and got really sick (Illness), while he/she received vaccine INFLUENZA VACCINE.  The patient's medical history, medical treatment(s), vaccination(s) and family history were not provided.   Concomitant medications were unknown.  On an unknown date, the patient received a dose of suspect INFLUENZA VACCINE produced by unknown manufacturer lot number not reported for prophylactic vaccination.  On an unknown date, latency unknown, patient got a flu shot and got really sick (illness).  No laboratory data was reported.   It was not reported if the patient received a corrective treatment.  The patient outcome is reported as Unknown.  There will be no information available on the batch number.
Mother reported that patient hasn't felt well since the day he received the vaccine which was 6/24/2021. She reported that he has been having dizzy spells and blurry vision - vertigo. She reported that the night after the vaccine he couldn't walk or see. She reported that patient went to see his PCP and the doctor did not find anything medically wrong.
Injection given 2/9/06 without problem and mother noted malaise next day and minimal irritability with gradually increasing erythematous macule 2/10-11 at injection site. No dyspnea, wheeze, fever.
Bell's Palsy - 5/9/12. Vaccine received 4/30/12.
Patient received Moderna Covid-19 vaccine 31 days after the vaccine was placed in the refrigerator on 10JUN2022; The patient received vaccine past the 30 day use by date as his second booster dose of the Moderna Covid-19 vaccine; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (The patient received vaccine past the 30 day use by date as his second booster dose of the Moderna Covid-19 vaccine) and PRODUCT STORAGE ERROR (Patient received Moderna Covid-19 vaccine 31 days after the vaccine was placed in the refrigerator on 10JUN2022) in an 81-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 014B22A) for COVID-19 prophylaxis.     No Medical History information was reported.  On 11-Jul-2022, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 11-Jul-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (The patient received vaccine past the 30 day use by date as his second booster dose of the Moderna Covid-19 vaccine). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Patient received Moderna Covid-19 vaccine 31 days after the vaccine was placed in the refrigerator on 10JUN2022). At the time of the report, EXPIRED PRODUCT ADMINISTERED (The patient received vaccine past the 30 day use by date as his second booster dose of the Moderna Covid-19 vaccine) and PRODUCT STORAGE ERROR (Patient received Moderna Covid-19 vaccine 31 days after the vaccine was placed in the refrigerator on 10JUN2022) outcome was unknown.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant product use was not provided by the reporter.  Dosage text was reported as second booster dose.  Number of doses or vials were 4 doses. Date the vial was initially stored in the refrigerator was on 10-Jun-2022 at 10:38 PM. The vial did not underwent any temperature excursions.  The patient received the vaccine in his left arm shoulder deltoid muscle and reported no other adverse reactions or side effects.  Treatment information was not provided.   This case was linked to US-MODERNATX, INC.-MOD-2022-606358, US-MODERNATX, INC.-MOD-2022-606349, US-MODERNATX, INC.-MOD-2022-606336 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2022-606358:Same reporter US-MODERNATX, INC.-MOD-2022-606349:Same reporter US-MODERNATX, INC.-MOD-2022-606336:Same reporter
4:25 pm- Received MENACTRA vaccine- FLUMIST 8:30 pm- pain, swelling of upper arm (gave TYLENOL, *ADVIL throughout night for pain* applied ice). 1:00 pm next day- worsened arm pain, unable to use. 3:30 pm- Appt for check (arm fully numbness, pain, blanching on skin at site).
Information has been received from a physician concerning a 18 month old male pt with a history of a lung tumor at birth who on approximately 05/09/01 was vaccinated with varicella virus vaccine live The physician reported that subsequently, the pt developed herpes zoster. The pt received medical attention for the experience. Additional information has been requested.
On 12/20/2020 I got my first dose Pfizer: only symptoms slight headache and sore arm.  On 1/20/2021 I received my 2nd dose. First day, I only had a sore arm. On 1/21/2021 @800am my food was not tasting appetizing. Around 930am I started to feel nauseous, fatigue, headache. @1000am I started to feel really hot. I took my temp around 1020am and it was 100.2. I was immediately sent home from work. I continue to have the same symptoms the rest of the evening and slight body aches. @530pm I started to feel chills and felt like I was freezing. @8pm I started to feel better, only symptoms I had at that time was headache. @930pm-1200am I started to feel very hot and began to sweat.  On 1/22/2021 only symptoms I currently have is a headache.
pt is 14 yrs old and got pfizer 1st dose by no side effects and per pt's dad
Left arm soreness, chills, low grade fever, nausea, dizziness, fatigue/lethargic.  All symptoms went away on 02/5/2020 except dizziness. Dizziness went away on 02/06
30 weeks pregnant, estimated delivery date 4/30/18, very healthy normal pregnancy thus far, morning sickness until about five months, but completely dissipated months ago. Dtap was suggested by my doctor, and I accepted, being told that it was recommended that women at my stage of pregnancy get it. I go about the rest of my day just fine, go to bed around 8:30. Wake up at 11:30pm vomiting. I am then experiencing uncontrollable vomiting and diarrhea every 15 - 20 minutes until 5:30am. I arrive at the ER shortly after, and am admitted to Labor and Delivery for monitoring and an IV drip. Blood and urine cultures are run, the only discrepancies in my blood are my WBC, a count of 21.7 and my glucose, reading 129. Upon following up with my doctor's office today (2/23/18), I'm told that it could in no way be an adverse reaction where I'm now able to keep fluids down.
Received flu shot 10/22/03. 10/23/03 I broke out in hives all over my body. ARm swollen and red at the site of injection size of orange. Continued to get worse. 10/24/03 soon Dr put me on Viotaril. 10/28/03 clinic Prednisone and Zyrtec. No new spots 10/31/03. 11/11/03 still blotchy and peeling. Follow up on 12/10/2003: "
5" area of redness on left arm.  Warm & tender to touch. Had Fluzone and Tdap both in L arm.
Received Varivax on 8/1/07 reported to office on 8/3/07 of right arm with swelling, redness, hard area the size of a golf ball X2days. Parent giving motrin at home. Seen in office 8/3/07 with assessment of right arm red, firm swelling warm to touch that measured 11cmX9cm area at injection site. Ice anf Keflex 500mg 1 po tid x 10days.
Fever, chills, myalgias - 24hr of Sx. E.D evaluation and observation T  103-104.
Patient was given MMR instead of MMRV (Proquad). This was realized on 3/21/22 during a vaccine count.  Lot # of vaccine administered was  determined to be MMR and not MMRV. (The packaging on MMR and MMRV are very similar and the vaccine locations were switched in the fridge on accident.) Patient's mother was contacted. Appt for varicella vaccine scheduled 4/19/22.
paresthesia arms and legs for 2 days following Covid vaccine - Day 3 upper body only (has not gotten worse - just a mild tingling sensation)  - no pain
Child received H1N1 in AM 2nd dose intranasal. About 2 PM child sent to nurse T=100. Parent advised, T.C. to mother. 01/07/10 She kept him home due to sore throat but no fever. Advised MD if fever present w/sore throat.