chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Approximately 8x10cm area of erythema at (R) lateral upper arm w/ warmth, tenderness. Advised cool packs, APAP. ?Cellulitis --> BACTRIM 120mg TMP PO bid x 10 days. Discussed signs/sx of possible worsening cellulitis to monitor at home.
This case was reported by a consumer via call center representative and described the occurrence of red rash in a 43-year-old female patient who received SHINGRIX for prophylaxis. On 20th September 2018, the patient received the 1st dose of SHINGRIX (intramuscular). On 20th September 2018, unknown after receiving SHINGRIX, the patient experienced inappropriate age at vaccine administration. On an unknown date, the patient experienced red rash and itchy rash. On an unknown date, the outcome of the red rash and itchy rash were recovered/resolved and the outcome of the inappropriate age at vaccine administration was unknown. It was unknown if the reporter considered the red rash and itchy rash to be related to SHINGRIX. Additional details were reported as follows: The 43 years old patient received SHINGRIX on the left deltoid, which led to inappropriate age at vaccine administration. The patient had rash soon afterwards but the patient could not remember if it was on the same day or later. The rash was small, red and itchy. The events were went away after a few days. The contact details of the physician was provided. The reporter had given consent to follow-up.
Fatigue after second vaccine; Fever 99F  on & off after second vaccine; muscle aches and pain are on and off; This spontaneous case was reported by a patient and describes the occurrence of FATIGUE (Fatigue after second vaccine), PYREXIA (Fever 99F  on & off after second vaccine) and MYALGIA (muscle aches and pain are on and off) in a 77-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 003A21AT and 012M20A) for COVID-19 vaccination.     The patient's past medical history included Chronic fatigue syndrome (He had since 10 years ago and it went away).   On 05-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 05-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 05-Mar-2021, the patient experienced FATIGUE (Fatigue after second vaccine), PYREXIA (Fever 99F  on & off after second vaccine) and MYALGIA (muscle aches and pain are on and off). At the time of the report, FATIGUE (Fatigue after second vaccine), PYREXIA (Fever 99F  on & off after second vaccine) and MYALGIA (muscle aches and pain are on and off) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Body temperature: 99 (High) 99 F.         27AUG2021, He still has Fatigue. The Fever comes and goes, and the muscle aches and pain are on and off. He has not seen a doctor.  He is asking, "Did other people have similar prolonged side effects?". No Treatment medications were provided No  Concomitant medications were provided
Extreme muscle soreness in my entire body, headache, loss of appetite, 103 fever lasted approx 18 hours
Pregnant; This spontaneous prospective pregnancy case was reported by an other health care professional and describes the occurrence of MATERNAL EXPOSURE DURING PREGNANCY (Pregnant) in a 30-year-old female patient (gravida 2, para 1) who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011J20A) for COVID-19 vaccination.     The patient's past medical history included Alcohol use (socially) and Marijuana use (handful) in 2014. Concurrent medical conditions included Deafness right ear. Concomitant products included DOXYLAMINE SUCCINATE, PYRIDOXINE HYDROCHLORIDE (DICLEGIS) for Nausea and Vomiting, MINERALS NOS, VITAMINS NOS (PRENATAL VITAMINS [MINERALS NOS;VITAMINS NOS]) for Pregnancy, ESOMEPRAZOLE SODIUM (NEXIUM [ESOMEPRAZOLE SODIUM]) for an unknown indication.    On 08-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. The patient's last menstrual period was on 09-Aug-2020 and the estimated date of delivery was 16-May-2021. On 08-Jan-2021, the patient experienced MATERNAL EXPOSURE DURING PREGNANCY (Pregnant). The patient received mRNA-1273 (Moderna COVID-19 Vaccine) beginning around the  twenty-first week of the pregnancy. The delivery occurred on an unknown date, which was reported as Unknown. For neonate 1, The outcome was reported as Unknown. On 08-Jan-2021, MATERNAL EXPOSURE DURING PREGNANCY (Pregnant) had resolved. Not Provided    DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 03-Sep-2020, Pregnancy test: positive (Positive) positive. On an unknown date, Scan: normal (normal) Normal. On an unknown date, Ultrasound scan: normal (normal) normal.     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 treatment information was provided. Estimated date of conception was 23 Sep 2020.   Most recent FOLLOW-UP information incorporated above includes: On 12-Apr-2021: Follow up received and contains no new information; Sender's Comments: This is a case of product exposure during pregnancy with no associated AEs for this 30-year-old female patient. Patient will continue to be contacted for further monitoring of AEs during the pregnancy.
After the vaccine, he was fine. He had a runny nose and a cough around July 2. On July 4 and July 6 he tested positive with the rapid test but tested negative on the PCR test on the same day. We had the PCR test done at the local ER. The ER doctor stated he had an ear infection and that our rapid test was wrong. They provided us with a prescription for amoxicillin. He is feeling better but he still has a runny nose.
During observation, pt reported blurry vision and numbness to both arms. Adult emergency called and transported to hospital for eval.
screamed from approx 10AM (when recvd vax) until 9PM; "Stopped breathing" several times next few dasy; seen by MD on 21DEC93 dx probable migraines; MD visit x 3 days;
Flu; Initial information regarding this unsolicited valid non-serious social media case received from a consumer (patient) on 06-Dec-2020.  This case involves a patient with unknown demographics who experienced flu (Influenza) when received vaccine INFLUENZA VACCINE.  Relevant medical history, past medical treatment, vaccination, concomitant medication and family history were not provided.  On an unknown date, the patient received a dose of suspect INFLUENZA VACCINE produced by unknown manufacturer (lot number and expiry date not reported) via unknown route in unknown administration site.   On an unknown date, (unknown latency) the patient experienced flu (Influenza), following the administration of INFLUENZA VACCINE (flu shot).  Relevant laboratory test not reported.  It was not reported if the patient received a corrective medication.  At the time of reporting, the outcome was unknown for the reported event.  There will be no information available on batch number for this case.
painful lump in armpit, can not put pressure on that arm.  fever, chills, joint and muscle aches especially the thighs, lower back
This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. A 64-year-old female patient received BNT162b2 (BNT162B2), on 16Apr2021 as dose 2, single (Lot number: EW0158) at the age of 63 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Hypertension" (unspecified if ongoing), notes: Hypertension. Concomitant medication(s) included: ENALAPRIL taken for hypertension. Vaccination history included: BNT162b2 (Dose 1, Lot No: ERZ613), administration date: 23Mar2021, when the patient was 63-year-old, for Covid-19 Immunization. The following information was reported: MYALGIA (non-serious), outcome "not recovered", described as "I have been having muscle pain"; ILLNESS (non-serious), outcome "unknown", described as "they made me sick". The events "i have been having muscle pain" and "they made me sick" required emergency room visit. Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were taken as a result of myalgia. Additional information: She went to the Emergency room and then they kept her and they sent her to another hospital of what they saying. Yeah, they gave her something for muscle spasm but they made her sick and she ended back in Emergency room. Yes, but they made her sick and She was supposed to take them.
pt recvd flu vax 25OCT95 next day looked in mirror when applying deoderant & lymph node in rt arm was swollen size of soft ball & tender & stayed tender about 2 dasy;saw MD 26OCT95 sait it was probably immune system reacting to shot
Pt experienced local reaction with erythema, induration outer upper arm from shoulder to elbow.
AE not witnessed but reported by MD. Dizziness, headache, redness at site.
First arm began to hurt. By that evening had a fever and chills. By next morning had a rash and couldn't get out of bed. Missed a day of work. By 8/25/15 had a terrible honking non productive cough and could not catch my breath.  Called Dr. and was prescribed a Solumedrol pack. Symptoms persisted although less severe until 8/29/16. Basically was incapacitated for 6 days.
feeling dizzy; most tired; This spontaneous case was reported by a non-health professional and describes the occurrence of DIZZINESS (feeling dizzy) and FATIGUE (most tired) in an 84-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 007M20A) for COVID-19 vaccination.     The patient's past medical history included Prostate implant brachytherapy (removed implant because of cancer.), Cancer, Urine incontinence, Carpal tunnel syndrome, Knee surgery NOS (He got both Right and Left Knee Replaced.), Back surgery (five surgeries in his back), Shoulder arthroscopy (On Both Right and Left Shoulders.), Prostatectomy (Prostate removed because of cancer.), Calcaneus fracture, Stent placement, Endolymphatic shunt placement (because of inner ear problems) and Tennis elbow. Concomitant products included CLOPIDOGREL BISULFATE (PLAVIX), ACETYLSALICYLIC ACID (BABY ASPIRIN), CELECOXIB, GABAPENTIN, PARACETAMOL (ACETAMINOPHEN), MULTIVITAMINS [VITAMINS NOS], EVOLOCUMAB (REPATHA), TESTOSTERONE and IRON for an unknown indication.    On 28-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 01-Feb-2021, the patient experienced DIZZINESS (feeling dizzy) and FATIGUE (most tired). At the time of the report, DIZZINESS (feeling dizzy) and FATIGUE (most tired) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Patient got the 2nd dose on 25Feb2021 with batch number 002A21A. No treatment medications were provided by reporter.   This case was linked to MOD-2021-292919 (Patient Link).
Woke up the next morning with fatigue, body/muscle aches, and headache. Took Tylenol. Symptoms gone the following morning. Symptoms started 12-16 hours after dose and lasted 24 hours.
This case was considered medically important (OMIC). Information regarding Hib Titer vaccine (haemophilus B conjugate vaccine (Diphtheria crm 197 protein conjugate) injection) was received from a registered nurse regarding a patient, who on an unspecified date, received a third dose of Hib titer. On an unspecified date, the patient developed autism. Relevant medical history was not provided. Indication for Hib Titer vaccine was immunization. Product was administered on an unspecified date. Dose regimen was 1 dose 1 time per day. Concomitant medications were not reported. On an unspecified date, the patient received a third dose of Hib Titer, on an unspecified date, the patient developed autism. the patient recovery status is unknown. As of 2/22/2006, the reporter had declined  to provide any further information and indicated the patient had declined to be contacted.
Large indurated pink/ brown / black area of skin at left thigh. Treatment: Atarax
PT DEVELOPED CERVICAL TRANSVERSE MYELITIS 7 DAYS AFTER VACCINATION
2 days p/vax pt devel a severe pruritic, macular rash from waist down especially groin, buttocks, & ankles;
THIS INCOMPOTENT, DOCTOR. NOT ONLY GAVE MY MOM, INFLUENZA. bUT GAVE HER  "PNEUMOCOCCAL", AS WELL !   mY MOTHER WAS SO SICK WHEN HE GAVE HER THIS . wE WERE THERE AT THE DOCTOR BECAUSE SHE HAD A SEVERE COLD,SHE HAD TROUBLE BREATHING .hE SENT US FOR CHEST X-RAYS,AND EVEN GAVE HER A VERY STRONG ANTIBIOTIC, called,( 2pack #1).He sent her for x-rays because of the sound in her lungs.He stated she sounds like pneumonia.""I FEEL,HE LITERLY KILLED MY MOTHER ""!!!!  HOW ARE YOU GOING TO GIVE SOME ONE NOT ONLY SICK WITH A COLD ,BUT SHE HAD CIRIOUS OF THE LIVER AND WAS VERY SICK WITH THAT AS WELL... pLEASE IF YOU CAN HELP ME ! OR KNOW SOME-ONE WHO CAN .BEFORE HE HAS THE CHANCE TO KILL SOME-ONE ELSE.. PLEASE  Thank You!  I am the pt's Daughter,I took care of her for the last 3years. She has had flu shots before but not while she was sick and never 2 vaccines in a row! She was very sick !!  Discharge Summary received stated patient experienced cyanosis, unresponsive, hypoxia, respiratory distress and melena.
Woke up to sore arm and throbbing headache in middle of the night. Today have had head aches, stomach pain, nausea (went pale and almost fainted) very very cold, body aches.
Tinnitus both ears but more so the right ear. Also happen after my second dose of the original vaccine series (also Pfizer).
Injection site very swollen,, about 7 inches in diameter,, red, and itchy, and tender ,,, and slight flaking of skin   A lot of stiffness in knee joints ,,,, lower back,, and the back of my neck
Chills, fever 100.9, headache, severe joint and muscle pain, extreme fatigue. (Difficulty getting out of bed).
Pfizer BioNTech COVID-19 Vaccine EUA: COVID-19 case resulting in Hospitalization / Death. Patient received Pfizer Vaccines on 11/2/2021 and 11/23/2021. Admitted for acute hypoxic respiratory failure second to COVID-19 pneumonia. Received: oxygen, antibiotics, remdesivir, steroids, pressors, tocilizumab. Became unresponsive and did not recover neurologically from the event. While undergoing workup for possible cardiac event, patient developed PEA arrest full code without ROSC. Expired 1/21/2022.
Patient got rash on the left side that has lasted for a few days. It is now getting better.  Patient did not report any other symptoms or needing an office visit as a result.
Resident passed away unexpectedly on 1/27/21 from presumed sudden cardiac death.
Severe swelling & pain/ pain severe enough that arm could not be touched/ patient could not lift arm/ swelling spread over an area of 3 1/2 inches by 2 inches/ redness over same area and the area warm to the touch.
This spontaneous report as received from a consumer refers to a female acquaintance patient that is in her 70's. Pertinent medical history and drug reactions/ allergies were not reported. On an unknown date (within the last 5 years), the patient was vaccinated with ZOSTAVAX (dose, lot number and route were not reported). Concomitant therapy was not reported. On an unknown date, after receiving ZOSTAVAX patient developed shingles. It was unspecified if the patient sought medical attention. The outcome of the event was unknown. This is one of two reports from the same source. Additional information has been requested.
After administration the patient developed swelling and redness at the site behind the left arm. The patient was given Benadryl and an ice pack.
This case was reported by a consumer and described the occurrence of swelling arm in a 55-year-old female patient who received SHINGRIX (batch number EK279, expiry date 31st March 2020). On 15th February 2018, the patient received SHINGRIX (intramuscular) .5 ml. On 15th February 2018, less than a day after receiving SHINGRIX, the patient experienced swelling arm, erythema of extremities, extremities hot feeling of and pain in arm. On an unknown date, the outcome of the swelling arm, erythema of extremities, extremities hot feeling of and pain in arm were recovered/resolved. It was unknown if the reporter considered the swelling arm, erythema of extremities, extremities hot feeling of and pain in arm to be related to SHINGRIX. Additional details were provided as follows: At the time of reporting, the patient was 56 years old.
pt recv 2 doses of vax & 5JUL96 lab eval revealed varicella antibody titer of ELISA 0.12 & pt exp a lack of response;
Information has been received from a physician regarding to a female patient of unknown age. The patient's medical history, drug reactions or allergies were not provided. On an unknown date, the patient was vaccinated with the second dose of VAQTA (dose, route and lot number were not provided), six days before the required 6 month interval from the first dose. No adverse effect reported. Additional information has been requested.
Post vax the patient experienced redness and soreness at the injection site. Approximately 1 month later the patient was noticing stiffness in his joints.
Pt. felt fine after the vaccination. Waited in the clinic for the full 15 minutes without issues. Went home and approximately 1 hour later began to feel short of breath and "couldn't seem to catch" her breath at all. Episode lasted approx. 4-5 minutes.  Over the course of the evening, she had a total of 4 such episodes of shortness of breath.  Denies any itching, swelling, rash, or issues with her throat.
Developed Bell's Palsy after receiving the Moderna COVID-19 vaccine.; This spontaneous case was reported by a patient family member or friend and describes the occurrence of BELL'S PALSY (Developed Bell's Palsy after receiving the Moderna COVID-19 vaccine.) in a  patient of an unknown age and gender who received mRNA-1273 (Spikevax) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On an unknown date, the patient experienced BELL'S PALSY (Developed Bell's Palsy after receiving the Moderna COVID-19 vaccine.). At the time of the report, BELL'S PALSY (Developed Bell's Palsy after receiving the Moderna COVID-19 vaccine.) outcome was unknown.        The action taken with mRNA-1273 (Spikevax) (Unknown) was unknown.       Concomitant medication information was not provided by the reporter.  Treatment information was not provided by the reporter.  Company comment.  This spontaneous case concerns a patient with no medical history reported, who experienced the expected, non  serious AESI of Bell´s palsy. Temporal association cannot be assessed due to lack of information on onset date of the event and the administration date of mRNA-1273 vaccine. The report stated that the patient developed Bell's Palsy after receiving the Moderna COVID-19 vaccine. No further details were provided for medical review. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.; Sender's Comments: This spontaneous case concerns a patient with no medical history reported, who experienced the expected, non  serious AESI of Bell´s palsy. Temporal association cannot be assessed due to lack of information on onset date of the event and the administration date of mRNA-1273 vaccine. The report stated that the patient developed Bell's Palsy after receiving the Moderna COVID-19 vaccine. No further details were provided for medical review. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.
On 09/04/2021, patient reports fever, chills and fatigue that resolved within 24 hours. On 09/06/2021, patient reports rash and swollen lymph nodes under both arms. Her swollen lymph nodes resolved within 1 week, but her rash still persists.
Administration of MENQUADFI post excursion with no reported adverse event; Initial information received on 10-Mar-2023 regarding an unsolicited valid  non-serious case received from a other health professional.  This case involves a 16 years old male patient who was administrated with vaccine Meningococcal a-c-y-w135 (t conj) vaccine [MENQUADFI].post excursion with no reported adverse event    The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.    On 16-Dec-2022, the patient received suspect Meningococcal a-c-y-w135 (t conj) vaccine Solution for injection at dose of 0.5 ml total (strength were not reported) (lot U7449AB and expiry date-23-sep-2024) via intramuscular route in unknown administration site for immunization after post excursion with no reported adverse event (poor quality product administered) (latency-same day).  Action taken was not applicable.  At time of reporting, the outcome was Unknown for the event.  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.; Sender's Comments:  US-SA-2023SA082418:
Site at injection was red, swollen hot to touch. No discharge seen in office on 2nd day area 16 1/2 cm x 10 cm and erythema with edges of small vesicles.