chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Patient left clinic almost immediately after vaccine, felt light-headed within 5 - 10 minutes, returned to clinic, but collapsed with syncope in parking lot. She hit her head on parking lot. Brought back into clinic by father and put in exam room. Vitals were stable, neurologically normal. She waited another 15 minutes with stable exam and vital signs. Had water and apple juice. She left feeling normal.
Adverse Reactions: Chills, Nausea, Low Grade Fever (100.5-100.6), Lethargy, muscle pain Treatment: Ibuprofen 200mg: 4 tabs (800 mg) taken once for single dose Outcome: Fever lowered, however, lethargy remained all day. The next morning (12/31/2020) I felt completely fine.
Patient said rash appeared over night and she woke up with it Tuesday morning.  She said it doubled in area by Wednesday. She went to doctors on 9/2/16 and the doctor wanted to try an antiviral to see if that would help.  Patient said the rash is not painful nor does it bother her.  It is mostly on her left side which is the side the vaccination was given.  She said the rash is minimum on her right side.
By early evening, the child developed a fever.  There was a small red mark on left arm where he recieved the injection, which he noticed on 10/16/2012, when he woke up.  By 10/17/2012, the mark had tripled in size and was warm to the touch.
C/O soreness, redness, burning, fever, increase in BP; couldn't sleep X 3 days.
At around midnight each night for about 3 days I was awakened with full body tremors and muscle spasms that lasted about 3 hours. After that it was just full body tension and sense of nervousness.  But the real problem is that it brought back a relapse of MS symptoms that were under control for 20 years.  Weak, burning heavy legs. This has been steady for 10 days now.  This has made me trepidatious about the second dose.
Upper respiratory issues; Coughing; Daughter in law gave covid to her son/Tested positive for covid; Tired for a couple of days; This spontaneous case was reported by a consumer and describes the occurrence of RESPIRATORY DISORDER, COUGH, COVID-19, and FATIGUE in a 35-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On 15-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 15-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient experienced RESPIRATORY DISORDER, COUGH, COVID-19, and FATIGUE. At the time of the report, RESPIRATORY DISORDER, COUGH, and COVID-19 outcome was unknown and FATIGUE had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available) on an unknown date, SARS-CoV-2 test Positive COVID-19 virus test.         Concomitant product use was not provided by the reporter.  No treatment information was provided.  Company Comment- respiratory disorder and fatigue. The benefit-risk relationship of Moderna COVID-19 vaccine is not affected by this report. Although the patient had 2 doses of Moderna vaccine in the correct interval (25-35 days), the events occurred on an unknown date and does not specify if COVID-19 disease is diagnosed 15 days or more after the second dose of the vaccine, so lack of efficacy situation cannot be properly assessed. This case concerns a 35-year-old male patient with no relevant medical history who experienced non-serious unexpected event of special interest COVID-19, non-serious unexpected events of respiratory disorder, cough, and expected non-serious event of fatigue. The events occurred on an unknown date after the second dose of the Moderna COVID-19 vaccine. The rechallenge was not applicable as the event occurred following the second dose. The concurrent event of COVID-19 is a relevant confounder for the events of cough, respiratory disorder, and fatigue. The benefit-risk relationship of Moderna COVID-19 vaccine is not affected by this report. Although the patient had 2 doses of Moderna vaccine in the correct interval (25-35 days), the events occurred on an unknown date and does not specify if COVID-19 disease is diagnosed 15 days or more after the second dose of the vaccine, so lack of efficacy situation cannot be properly assessed.
fever yesterday that went up to 102.4; This case was reported by a consumer via call center representative and described the occurrence of fever in a 6-month-old male patient who received DTPa-HBV-IPV (Pediarix) for prophylaxis.   Co-suspect products included dtpa-hbv-ipv vaccine pre-filled syringe device (Pediarix Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 14th December 2020, the patient received Pediarix and Pediarix Pre-Filled Syringe Device. On 15th December 2020, 1 days after receiving Pediarix and Pediarix Pre-Filled Syringe Device, the patient experienced fever. On an unknown date, the outcome of the fever was unknown.   It was unknown if the reporter considered the fever to be related to Pediarix and Pediarix Pre-Filled Syringe Device.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.  Additional details were reported as follows: The patient received the vaccine shot at the physician office on monday in his thigh and started having fever yesterday, a day before date of reporting that went up to 102.4 degree celsius and went down later on in the evening.  Limited information available from reporter as she was not with the patient.  The reporter did not know the status of the patient whether the fever resolved completely or not.  The reporter consented to follow up.
5/26/2000 fever 102F for 48 hrs treatment Tylenol. 5/27/2000 Started Advil, 5/28/2000 small hives increased until 5/29.
Extreme skin itching about 1 week post Moderna booster resulting in Urticaria Dermatographia. Itching skin results in raised hives upon scratching skin surface.
This spontaneous report as received from a pharmacist refers to a 75 year old male patient. On 03-OCT-2014 the patient was vaccinated with an expired dose of ZOSTAVAX (Lot # unknown, expiration date: 20-SEP-2014) (dose and route not reported). No adverse effects were reported. It was also reported that ZOSTAVAX vial's label was "very lightly printed". Additional information has been requested.
No additional AE/PQC reported; Administered vaccine after temperature excursion; Information has been received from a other regarding a patient of unknown age and gender. The patient's medical history, drug allergies, previously drug reactions, concurrent conditions and concomitant medications were not reported.  On 17-JUN-2020, the patient was vaccinated with pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23)  0.5 mL injection, for prophylaxis, lot number S021740 with expiration date in 25-MAR-2021 (route of administration, strength and anatomical location not reported) that underwent a temperature excursion (incorrect product storage).  No adverse event was reported. combinationproductreport: Yes; brandname: PNEUMOVAX23 SYRINGE (DEVICE); commondevicename: Pneumococcal Vaccine, Polyvalent (23-valent); productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp & Dohme Corp. ; devicelotnumber: S021740; expirationdate: 25-MAR-2021; deviceage and unit: 0 ; malfunction: Unknown; productavailableforevaluation: No; deviceusage: Unknown; evaluatedbymfr: Not returned to manufacturer; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not suggest a causal association with the device or device constituent
it feels like my bones were hurting; Feels like my lymph node like it swelled up under my left arm/  my left armpit swelled up; I have is swollen lymph nodes; my arm, my left armpit swelled up; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A 54 year-old female patient received bnt162b2 (BNT162B2), administration date 09Oct2021 09:00 (Lot number: 30155BA) at the age of 54 years as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included: "Hypertension" (unspecified if ongoing). Concomitant medication(s) included: AMLODIPINE taken for hypertension; CARVEDILOL taken for hypertension. Vaccination history included: Bnt162b2 (Dose: 01), for Covid-19 immunization; Bnt162b2 (Dose:02), for Covid-19 immunization. The following information was reported: BONE PAIN (non-serious) with onset 09Oct2021, outcome "unknown", described as "it feels like my bones were hurting"; LYMPHADENOPATHY (non-serious) with onset 09Oct2021, outcome "unknown", described as "Feels like my lymph node like it swelled up under my left arm/  my left armpit swelled up; I have is swollen lymph nodes"; PERIPHERAL SWELLING (non-serious) with onset Oct2021, outcome "unknown", described as "my arm, my left armpit swelled up". Therapeutic measures were taken as a result of bone pain, lymphadenopathy.  Additional information: It was reported that patient receive the Pfizer booster on Saturday and it was about 9:00 clock. At Saturday patient was fine but after a while start getting it feels like bones were hurting and then it feels like lymph node like it swelled up under left arm. So is that normal for your lymph nodes to swell. Patient received treatment with Tylenol for the events. Patient arm feels like lymph node is swollen under left arm. Patients take blood pressure medicine. Patient did not receive other vaccine prior 4 weeks.  No follow-up attempts are possible. No further information is expected.
This case was reported by a consumer via call center representative and described the occurrence of hair loss in a 67-year-old female patient who received SHINGRIX for prophylaxis. On 3rd December 2018, the patient received the 2nd dose of SHINGRIX. On an unknown date, less than a year after receiving SHINGRIX, the patient experienced hair loss and dermatitis. On an unknown date, the outcome of the hair loss and dermatitis were unknown. It was unknown if the reporter considered the hair loss and dermatitis to be related to SHINGRIX. Additional details were provided as follows: The patient had two shingles vaccines two months apart. After 2nd dose, the patient has expressed scalp inflammation and hair loss. The reporter was not seeing scalp inflammation or hair loss listed as an expected side effect based on clinical trial data. The patient had a return appointment with her dermatologist. The patient not totally sure that she received SHINGRIX vaccine or another Shingles vaccine from market. The patient was required to get two and it was ordered by her primary care physician. The patient had to get injections from her pharmacist. The reporter said that it probably was SHINGRIX but perhaps there was a receipt that the patient might have that you can confirm or some other paperwork from the pharmacy nearby. The patient was traveling at the time of reporting. The patient asked that, should be able to get the answer within an hour.
This spontaneous report as received from a healthcare worker refers to a patient of unknown age. The patient's medical history was not reported. On an unknown date the patient was vaccinated with (Oka/Merck) VARIVAX. Concomitant medications were not reported. On an unknown date the patient was vaccinated with (Oka/Merck) VARIVAX stored at temperatures between -12 Celsius (C) to -10 C. No adverse effect reported. The outcome of vaccinated with (Oka/Merck) VARIVAX stored at temperatures between -12C to -10C was unknown. This case is linked to case #1406USA012262 (same reporter link). Additional information has been requested.
Agitation, Dizziness, Headache, Myalgia, Tachypnea, Fatigue, Heavy in bones, muscle pain, stiffness, "felt Like I was hit by a truck" Disoriented/confused increased heart rate. Narrative:
This spontaneous case was reported by a nurse (subsequently medically confirmed) and describes the occurrence of VACCINATION SITE ERYTHEMA (Redness around the injection site 8 days later), VACCINATION SITE SWELLING (Swelling around the injection site 8 days later) and VACCINATION SITE PAIN (It was painful) in a 43-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011J20A) for COVID-19 vaccination.     Concurrent medical conditions included Blood pressure (Reported as "high blood pressure"). Concomitant products included AMLODIPINE for Hypertension.    On 23-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 31-Dec-2020, the patient experienced VACCINATION SITE ERYTHEMA (Redness around the injection site 8 days later), VACCINATION SITE SWELLING (Swelling around the injection site 8 days later) and VACCINATION SITE PAIN (It was painful). At the time of the report, VACCINATION SITE ERYTHEMA (Redness around the injection site 8 days later), VACCINATION SITE SWELLING (Swelling around the injection site 8 days later) and VACCINATION SITE PAIN (It was painful) outcome was unknown.        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.   Treatment information provided as Unknown steroids and unknown antibiotics; Sender's Comments: This case concerns a 43-year-old female who experienced NS expected events of vaccination site pain, vaccination site erythema, and vaccination site swelling.  Event onset occurred 9 days after the first dose of mRNA-1273. Treatment with steroids and an antibiotic. Event outcomes unknown. Based on 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.
Arm where vaccine given was very sore; as I write this 2 days later, it is still extremely tender and painful and moving my arm hurts; skin is red. On the evening the vaccine was administered, I developed a severe rash and burning sensation on my ankles and tops of feet that lasted for about 4 hours. No treatment.
developed a circular rash at injection site/localized; This is a spontaneous report from a contactable physician. A male patient of unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration on 18Dec2020 at single dose for COVID-19 immunization. Medical history and concomitant medications were unknown. The reporting physician was inquiring about information related to development of a rash at the injection site, and to report an adverse event. The patient got vaccine on 18Dec2020. 10 days later, on 28Dec2020, the patient developed a circular rash at injection site/localized (circular "like lyme disease"). Localized rash was 3cm in diameter. Per reporter, the patient was "feeling otherwise okay". The patient had been tested negative for lyme disease. Outcome of the event was unknown.   Information on the lot/batch number has been requested.
dizziness within first 20 min of administration resting heart rate in the 100's all night while trying to go to sleep. Started about 30 min after  vaccination and lasted 5-6 hours. extreme exhaustion headache
(R) arm erythema tense & warm, burning sensation and enlarging (+) 11 x 13 cm area of firm erythematous skin with warm & TTP (area demarcated) tx: KEFLEX 500 QID x 10 days, MOTRIN 800 TID prn cold packs keep clean.
PATIENT WAS FEELING FAINT AFTER SHOT.  I TOLD HIM TO PUT HIS HEAD DOWN AND HE STARTED SWEATING.  HE ALSO STATED HE WAS HAVING PROBLEMS BREATHING.  I GOT A COLD COMPRESS WHICH HELPED SOME.  I MOVED HIM TO LAYING DOWN AND TOOK HIS BLOOD PRESSURE.  PRESSURE WAS GOOD.  PULSE WAS 49.  MONITORED PATIENT FOR A LITTLE.  HE STARTED FEELING BETTER AND GOT HIM BACK TO SITTING AND WAITED ANOTHER 20-30 MINUTES.  PATIENT LEFT WITH HIS FIANCE.
No symptoms reported.; Caller reports 6 mo old patient received three PEDV AX HIB vaccines. On 11/3/2020, 1/5/2021 and 3/9/2021.; This spontaneous report was received from a medical assistant and refers to a 6-month-old patient of unknown gender. There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided.  On 03-NOV-2020 and 05-FEB-2021, the patient was vaccinated with haemophilus b conjugate vaccine (meningococcal protein conjugate) (LIQUID PEDVAXHIB) 0.5 milliliter, intramuscularly, lot # T026959 and expiration date 11-MAR-2023 (anatomical location not provided). On 09-MAR-2021, the patient received a third dose of haemophilus b conjugate vaccine (meningococcal protein conjugate) (LIQUID PEDVAXHIB), which was considered to be inappropriate schedule of vaccination. All doses were administered for prophylaxis. No adverse event was reported.
DIZZY WHEN GETTING UP AND DOWN OR LOOKING UP AND DOWN, ALSO FAST HEART RATE - NOTICED WHEN EXERCISING IN AM - LASTED ALL DAY AT WORK - AT NIGHT DIZZINESS IN BED AND FAST HEART RATE - STILL SOME NEXT AM, BUT BETTER AS DAY WENT ON - COMPLETELY GONE BY NIGHT OF 9/18- NO DIZZINESS OR FAST HEART RATE IN BED THAT NIGH   THIS DID NOT HAPPEN LAST YEAR W/FLU SHOT.
23AUG pt was given vax in rt deltoid & on 24AUG mom called stating pt's arm was red & swollen; used cold compresses & APAP; 25AUG pt came in because arm was still swollen; MD told mom to use local heat & APAP;
acute genital ulcers; Body aches; Fatigue; chills; This spontaneous case was reported by a pharmacist and describes the occurrence of GENITAL ULCERATION (acute genital ulcers), PAIN (Body aches), FATIGUE (Fatigue) and CHILLS (chills) in a 27-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 071f21a) for COVID-19 vaccination.     Concurrent medical conditions included Immunocompromised and Rheumatoid arthritis. Concomitant products included RITUXIMAB (RITUXAN) from 06-Nov-2020 to 10-May-2021 for Rheumatoid arthritis, LEVOTHYROXINE SODIUM (SYNTHROID) and SPIRONOLACTONE for an unknown indication.    On 29-Oct-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 29-Oct-2021, the patient experienced PAIN (Body aches), FATIGUE (Fatigue) and CHILLS (chills). On 01-Nov-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced GENITAL ULCERATION (acute genital ulcers). The patient was treated with CLOBETASOL for Genital ulceration, at an unspecified dose and frequency. At the time of the report, GENITAL ULCERATION (acute genital ulcers), PAIN (Body aches), FATIGUE (Fatigue) and CHILLS (chills) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   The patient was wondering if she had severe reaction because the rituximab (Rituxan) infusion was not separated with the vaccine. The patient reported she did not produce antibodies, rheumatologist recommended to space out with infusion, rescheduled the infusion so she could get the 3rd dose of vaccine before her infusion.  After developing, the acute genital ulcers after 3rd dose, the patient had not seen a doctor yet. The patient used leftover clobetasol cream from previous treatment.  Treatment information for rest of the events were not reported by the reporter.   This case was linked to MOD-2021-370939, MOD-2021-371163 (Patient Link).
Initial documented seizure on 12/13/2001, associated with fever. Parents later informed us that infant has had a similar episode with fever 102.2 about 12 hrs after his 4 month immunization. Hospital d/c summary for subsequent hospitalization on 1/16/02 states diagnosis of epilepsy with recurrent seizures.
At 09:27 patient received 0.3mL undiluted dose of the Pfizer vaccine in the left arm. This was the patient's second Pfizer vaccine dose. Patient observed for 45 minutes. No adverse reactions displayed. Patient's mother at his side, fully aware of the error. This was the vaccinator's first time at the site and did not have the proper training at the time prior to incident error occurring. The mother of the patient is familiar with the policy and procedures. There was no on-site manager at the site at the time the incident occurred. Patient remained in stable condition throughout the duration of stay in observation.
Information has been received from a physician concerning a female who in January 2008, was vaccinated with her second dose of GARDASIL.  In January 2008, the patient experienced swelling, pain and redness at the injection site.  The patient's swelling, pain and redness at injection site persisted.  The patient sought unspecified medical attention in the office and had an MRI.  Additional information has been requested.
Pt came back 1 week later after receiving vaccination with complaints of redness/swelling/heat/itching/pain  at injection site. She said this occurred about  a day after receiving vaccination. She said reaction is improving and getting better and was coming to the pharmacy for recommendations. She was told to use ice, benadryl, tylenol or ibuprofen to help with symptoms. She was told to contact doctor and let them know and if reaction starts getting worse or doesn't get better (it is improving) to go see doctor and let us know.
8 days with vaccine lymph nodes developed on both sides neck, 13 days rash demyelination then overwhelming fatigue, intermittent sore throat, joints ache.
Call from mom, who states "pt is broken out all over", she has welts all over & her eyes are swollen. Mom was advised to call pt's Dr, immediately. Given Benadryl & Decadron IM, at Dr's office.
Mother called a little after 3 pm to report son was covered all over with a rash and wanted to know if she could give him BENADRYL or if we could give him a steroid shot. Says he woke up this morning with a rash on his arms and his legs and this afternoon it's on his neck and chest area. Explained to mother we did not give steroids and had no in house MD. Encouraged to take child to Dr or ER or walk in health care for further evaluation. Also requested she call back and let us know what happens. Stated it would probably be Monday before she called back.
Pain in left shoulder - Hand mobility reduced, cannot raise hand over head, Difficulty wearing shirt or touching head with left hand.
Patient reported to medical clinic 8 days after smallpox vaccination with cluster of clear vesicles on opposite deltoid.  Lesion had appearance of herpes zoster and cleared with administration of Acyclovir oral and topical medications.  Patient also received typhoid vaccine in same arm as vesicles and received anthrax vaccine in opposite arm.  Noted to have major reaction to smallpox vaccine with no satellite lesions or other adverse events.  Had previously been vaccinated against smallpox as a child without adverse reaction.  Also had history of chicken pox as a child and no exposure to varicella vaccine.
While waiting in observation after receiving first moderna vaccine, patient began to feel itchy and have redness on left arm.  Patient had no other symptoms and no trouble breathing.  Vitals signs, temp: 96.8, heart rate 81, and oxygen saturation 98%.  PHN administered 50 mg Benadryl PO.  Patient sent home in stable condition.
Fever on 2/29 afternoon, tactile hot, chills, and sore muscles, sore neck.
I have had a really odd series of symptoms that include daily headache, daily low grade fever, diarreha daily, distend belly.