chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Symptoms onset 7/15/2021: cough, sore throat, fever, chills, headache, nausea, vomiting, abdominal pain, loss of smell and loss of taste. Tested 7/14/2021 for COVID-19 after being in close contact with a positive case.
received Janssen vaccine on 5/4/21. Tested positive for COVID-19 by PCR on 6/16/21. Symptoms of nausea, sore throat, H/A, anosmia, dysgeusia
Patient developed cellulitis as diagnosed by APRN.  Patient sought medical treatment 10/19/19. Prescribed cephalexin, prednisone, triamcinolone oint., and topical aspercreme w/lidocaine. When she reported to the pharmacy, area looks red and swollen. Patient reports pain in arm (deltoid/bicep) and armpit. Outcome TBD.
Injection site pain; Injection site redness; Injection site swelling; This case was reported by a nurse via sales rep and described the occurrence of injection site pain in a 61-year-old female patient who received Herpes zoster (Shingrix) (batch number X3M27, expiry date unknown) for prophylaxis.   On an unknown date, the patient received the 2nd dose of Shingrix .5 ml. On 20th April 2019, 1 day after receiving Shingrix, the patient experienced injection site pain, injection site erythema and injection site swelling. The patient was treated with benadryl (nos) (Benadryl) and medication unknown (Ice Pack (Nos)). On an unknown date, the outcome of the injection site pain, injection site erythema and injection site swelling were recovered/resolved.   It was unknown if the reporter considered the injection site pain, injection site erythema and injection site swelling to be related to Shingrix.  Additional details were provided as follows: The patient experienced of pain, redness and swelling at injection site 1 days after. The patient had 2 inch red band extended around inner arm from injection site. The patient came into clinic 3 days later as it had not improved. The patient was given Benadryl and ice pack. The event resolved on it own. The reporter was agreed to follow up from GlaxoSmithKline.
Systemic: Fainting / Unresponsive-Mild, Additional Details: PATIENT WAS UNCONSIOUS FOR ABOUT 10 SECONDS, ONCE HE CAME TO HE WAS ALERT AND ORIENTED. EMT ARRIVED WITHIN 5 MINUTES. BP118/82 HEART RATE 62 PULSE 100
Patient is under the age of 18 and was provided Moderna vaccine.  Per CDC guidance and in consultation with Infectious Disease Medical Director, the patient was provided a second dose of Moderna vaccine off-label. The patient conferenced with our leadership at the site before the second vaccination to discuss the recommendation before proceeding. Patient is doing well post vaccination.
High fever 102+ F. Fever has lasted 48 hrs. Drooling. Loss of appetite.
Patient received an expirated dose of Pediarix; This case was reported by a other health professional via call center representative and described the occurrence of expired vaccine used in a 2-month-old female 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 an unknown date, the patient received Pediarix and Pediarix Pre-Filled Syringe Device. On an unknown date, unknown after receiving Pediarix and Pediarix Pre-Filled Syringe Device, the patient experienced expired vaccine used. On an unknown date, the outcome of the expired vaccine used was unknown.   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 provided as follows: The reporter was a medical assistant. The patient received an expirated dose of Pediarix, which led expired vaccine used. The reporter consented to follow up.
This spontaneous report as received from an unspecified reporter refers to a patient of unknown age and gender. The patient's relevant medical history was not reported. On 27-OCT-2014 the patient was vaccinated with M-M-R II (therapy type, route, dose, frequency and lot # were not reported) which underwent an excursion. This is one of several reports received from the same source. Additional information has been requested.
No additional adverse event; The patient received a dose of ROTATEQ on 22-APR-2020 that had been improperly stored.; This spontaneous report was received from a medical assistan refering to a female patient of unknown age. Information regarding the patient's concurrent conditions, concomitant medications, drug allergies or reaction was not provided.      On 22-APR-2020 the patient was inadvertently vaccinated with a dose of rotavirus vaccine, live, oral, pentavalent (ROTATEQ), orally, for prophylaxis, lot number 1660947, expiration date: 16-APR-2021. (Dose, vaccination scheme frequency were not reported). The vaccine was at a temperature of 47.7 fahrenheit (F) for 12 minutes and also experienced a previous excursion of  58.3 F for 14 hours. It was reported that a Data logger was involved. No additional adverse event reported. (Product storage error).
Inadvertently administered Pfizer Covid-19 vaccine to 11 year old boy. Mom was present with child and , when child and mom were asked via an interpreter if he was 12 they both stated yes. RN did not register client, he was checked in by the interpreter, while RN was vaccinating other family members.  Currently no adverse outcome. Family was called and informed.  Dose 2 due after 12th birthday.
Crying then vomited p/receiving OPV, then received DTP, 1 hr later mom reported twitching of face which lasted 1 min (would come & go). No tonic-clonic movements. Easily arousable but drowsy. On exam had fever 103. Next day Fever & Diarrhea
Ecchymosis right outer thigh. Firm 1.5cm nodule beneath ecchymosis. No evidence of infection, Referred to Dr.
Chest, back pain, palpitations, collapsed at work, went to ER for cardiac work up and pain control
Limited range of motion due to shoulder injury. Left shoulder has acute pain when reaching to full extension, removing and putting on shirt overhead. Will make appt. with general practitioner, probably physical therapy for treatment, initially.
Information has been received from a county health registered nurse concerning a 6 year old male who on 23-JAN-2002 was vaccinated with VARIVAX (Oka/Merck).  On 26-FEB-2007 the patient developed varicella < 50 lesions.  The nurse reported that an outbreak of varicella had taken place in the local school district in April 2007, and this student was identified during the county health investigation.  An immunization clinic was conducted in the school where students received a second dose of VARIVAX (Oka/Merck).  This is one of 28 reports received from the same source.  No further information is available.
PATIENT CAME IN IN JUNE 11,2021 FOR 18 MONTH & IMM WITH NO VACCINE CARD. PATIENT CAME IN DECEMBER 07,2021 FOR 24 MONTH WITH THE VACCINE CARD. I CHECK THE CURRENT VACCINE CARD AND SAW THA HE WAS NOT UP TO DATE WITH HIS VACCINES I ADMINSTER DTAP & HEP A. AT THE TIME I WAS PUTTING VACCINE ON SYSTEM I NOTICE PATIENT WAS UP TO DATE WITH VACCINES. SINCE HE DID NOT PRESENT THA VACCINE CARD BACK IN JUNE AT 18 MONTH. HIS VACCINE CARD WAS NOT UP TO DATE. CALLED MOTHER TO ADVISED ABOUT INCCIDENT SINCE PATIENT HAD LEFT AS PER MOM PATIENT IS OKAY AND SHE WAS AWARE THAT IN JUNE HE GOT VACCINE BUT FORGOT TO BRING VACCINE CARD SO WE CAN DOCUMENT IT. AS PER MOM PT NO SYMPTOMS. I ADVISED HER IF PATIENT STARTS WITH SOMETHING TO COME BY CLINIC OR CALL US.
Light aches; Arm pain; Tired; This is a spontaneous report received from a contactable consumer, the patient. A 28-year-old female patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: unknown) via an unspecified route of administration on the left arm on 19Mar2021 at 14:00 (at the age of 28 years), as single dose for COVID-19 immunisation. Medical history included allergic to penicillin. Concomitant therapies included ibuprofen (MANUFACTURER UNKNOWN), LUTERA and NAUZENE from an unknown date for unknown indication. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the COVID-19 vaccine. Since the vaccination, the patient has not tested for COVID-19. The patient experienced arm pain, tired and light aches on 19Mar2021 at 16:00. The patient did not receive any treatment for the reported events. The clinical outcome of arm pain, tired and light aches were recovering.   Information about lot/batch number cannot be obtained. No further information is expected.
No adverse event.  Janssen SARS-CoV-2 vaccine was administered to this patient before the age of 18.
Celulitis right thigh X 1 day sent to hospital for IV Ancef. 500 mg IVP q po and Protein 1.5 tsp po q 8 hours fir discomfort
Screaming > 90 min nonstop. Parents distressed.Pt taken to ER. Exam (-), except for tenderness Lt thigh.
This writer (Covid/Flu Vaccine clinic Supervisor RN) and (Lead RN) were notified by clinic staff to check on patient.    Patient (accompanied by wife) received Pfizer Bivalent Booster Covid Vaccine at 10:46am. About 5 minutes post vaccination, patient was seated in the observation area when he felt light headed and passed out for a few seconds.    This writer (Covid/Flu Vaccine clinic Supervisor RN) and (Lead RN) assessed patient, took VS, elevated patient's legs, provided juice and water, and an ice pack to patient's neck. Shortly after these interventions, patient felt much better and VS stabilized.    However this writer advised recommendation is for him accompanied by wife to go to UC for further assessment to ensure medical stability/safety. Patient was also educated that for future vaccinations, recommendation is for him to receive it while lying down. Patient and patient's wife both verbalized understanding.
soreness in arm; This case was reported by a consumer via call center representative and described the occurrence of pain in arm in a 66-year-old female patient who received Flu unspecified (Influenza vaccine) for prophylaxis.   Previously administered products included Shingrix (Please refer the case US2019125959).   On an unknown date, the patient received Influenza vaccine at an unknown dose. On an unknown date, unknown after receiving Influenza vaccine, the patient experienced pain in arm. On an unknown date, the outcome of the pain in arm was recovered/resolved.   It was unknown if the reporter considered the pain in arm to be related to Influenza vaccine.  Additional details were provided as follows: The age at vaccination was not reported. The patient stated that, the flu shot always make her arm slightly sore. This case has been linked with cases US2019125959(same patient) and US2019125960 (husband case), reported by the same reporter.
She states that every time she got vaccinated, she got sicker and sicker; This spontaneous case was reported by a physician and describes the occurrence of ILLNESS (She states that every time she got vaccinated, she got sicker and sicker) in a 62-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 056A22A, 046C21A, 025J20A and 025J20A) for COVID-19 prophylaxis.    Co-suspect product included non-company product FAMTOZINAMERAN, TOZINAMERAN (PFIZER BIONTECH COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/5)) for an unknown indication.    No Medical History information was reported.   On 23-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 20-Jan-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1. On 18-Oct-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 16-May-2022, received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 14-Oct-2022, the patient received fifth dose of FAMTOZINAMERAN, TOZINAMERAN (PFIZER BIONTECH COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/5)) (unknown route) 1 dosage form. On an unknown date, the patient experienced ILLNESS (She states that every time she got vaccinated, she got sicker and sicker). At the time of the report, ILLNESS (She states that every time she got vaccinated, she got sicker and sicker) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported.  Reported that patient states that every time she got vaccinated, she got sicker and sicker. She had 5 vaccines mix of Pfizer and Moderna. She had side effects and felt sick after Pfizer and Moderna COVID-19 vaccination.   No treatment medications were reported.   This case was linked to MOD-2023-750035 (Patient Link).   Reporter did not allow further contact
24hr p/vax broke out w/gen hives the size of palm of hand, red & hot;hives circular, ring around face crossed over the nose;tx w/DPH;
Dizzy; Medicine taste in her mouth; Head and neck pain; Head and neck pain/pressure in the face and back of the neck/pressure in jaw and neck; Pressure in the face and back of the neck/pressure in jaw and neck; Pressure in jaw; Pressure in the face; Heaviness in her legs; Cold symptoms in her chest, almost like bronchitis; Cold symptoms in her chest, almost like bronchitis; Throat started getting scratchy/scratchiness in her throat; Itchy in her ear; Phlegm feeling in her throat; Allergic reaction; Getting twitches and surges/felt surges in her leg, like adrenaline shooting through her with no letting up; Tingling in her mouth near her lip and her foot and then in her hand; Tingling in her mouth near her lip and her foot and then in her hand/jolt in her left leg; Not well/feeling of  unwell; Spaciness/doesn't feel like herself/feels off/Is in a fog/fogginess; Her mouth is shaky/shaking; Unsteady; She feels like she has a lot of adrenaline; Felt cold; Muscle weakness; Getting twitches and surges; Laborious to walk; Itchy sensation; This is a spontaneous report from a contactable consumer (patient). A 61-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number: EN6201; Expiration date was not reported) on the right arm on 08Mar2021 (08:30) as a single dose, with route of administration unspecified, for COVID-19 immunization at the hospital. Medical history included being allergic to sulfa drugs and x-ray dye; and had seasonal allergies. Concomitant medications included paracetamol (TYLENOL) and vitamin D3. The patient previously took doxycycline, and was allergic. On 08Mar2021, the patient had cold symptoms in her chest, almost like bronchitis; throat started getting scratchy/scratchiness in her throat; itchy in her ear; had a medicine taste in her mouth; head and neck pain; pressure in the face and back of the neck/pressure in jaw and neck; heaviness in her legs; and phlegm feeling in her throat. In Mar2021, the patient had an allergic reaction; getting twitches and surges/felt surges in her leg, like adrenaline shooting through her with no letting up; had tingling in her mouth near her lip and her foot and then in her hand; tingling in her mouth near her lip and her foot and then in her hand/jolt in her left leg; not well/feeling of unwell; spaciness, did not feel like herself/had felt off and was in a fog/fogginess; mouth was shaky/shaking; was unsteady; had felt like she has a lot of adrenaline; had felt cold; muscle weakness; was getting twitches and surges; was laborious to walk; and had itchy sensation. On 09Mar2021, the patient was dizzy. The events resulted into physician's office visit. The patient's blood test, electrocardiogram (ECG), electrocardiogram (EKG), "two other panels", metabolic and all tests showed everything was normal on an unspecified date. The outcome of the events was unknown. The patient's second dose of vaccination was scheduled on 29Mar2021.
pt recv vax 4/10/98 & 4/11/98 pt exp pustules on the rt thigh lt arm & chest w/secondary cellulitis;pt was started on cephalexin then changed to amoxicillin clavulanic acid (augmentin);
fairly severe headache starting 5 days after injection. headache lasted 5-6 days. i do have history of headaches so i'm not sure this was necessarily related to the vaccine.
Patient received shot, waited 15 minute time frame, was feeling well and left store. Received call from individual who was with patient about 10 minutes later reporting pt having left sided facial and arm numbness. Advised pt to seek emergency medical care, that this was not a normal side effect of vaccine but with concern for stroke should be followed up with immediately.
Patient received PNEUMOVAX 23 on 3/29/2011. Patient called the clinic the next morning complaining of redness and swelling around the injection site. Patient instructed to apply ice to the area and take MELOXICAM or ibuprofen. The patient called again on 3/31/2011 stating that his arm was getting worse. Patient was told to come in to be evaluated. It was confirmed that patient had an allergic reaction to the vaccine and was treated with PREDNISONE taper and CLARITIN. Improvement was noted on 4/1/2011.
01/05/2022 patient arrived to ED after syncopal episode at home.  No loss of consciousness, patient states he had a sore throat, body aches, headache and diarrhea x 2-3 days. Patient of note had baseline EKG with normal sinus rhythm first-degree AV block and left anterior fascicular block with anteroseptal infarct.  While awaiting testing in the ER, patient become unresponsive and patient was noted to have asystole for about 30 sec before CPR was initiated.  CPR was performed for less than a minute and patient woke up without any complaints.  Rhythm strip obtained, noted have episode of bradycardia prior to asystole.  Repeat EKG did not show concern for STEMI.  While getting a PICC line placed, the patient had another episode of bradycardia.  Patient's heart rate dropped to 35 and patient was difficult to arose and then responded spontaneously.  Another round of atropine was given.  Patient's heart rate has been stable since initiation of dopamine.  o2Saturations have been maintained above 95%.
Itching, redness, swelling within 2 minutes of injection. Dr examined site and assured patient it is an allergic reaction. Pt was then given 50 mg diphenhydramine IM to right deltoid and 250 mg methylprednisone IM to right buttock. Dr called the patient at home at the end of the shift to check on her. Patient was stable with no complaints.
redness at injection site on arm. following day, similar redness appeared on cheek under eye. two days later, redness has not resolved on arm
318 patients received dose from vials beyond 30-day use by date; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (318 patients received dose from vials beyond 30-day use by date) in a 20-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 037C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 09-Jun-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 09-Jun-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (318 patients received dose from vials beyond 30-day use by date). On 09-Jun-2021, EXPIRED PRODUCT ADMINISTERED (318 patients received dose from vials beyond 30-day use by date) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant information provided by the reporter. No treatment information provided by the reporter. Date of refrigeration was reported to be 07-MAY-2021.   This case was linked to MOD-2021-363730, MOD-2021-364245, MOD-2021-363245, MOD-2021-364385, MOD-2021-364699, MOD-2021-364890, MOD-2021-365040 (Patient Link).
Patient feeling lightheaded, sweat and blurred vision.  He also reported numbness, tingling  bilateral hands. dizziness and blurred vision subsided within 5 minute. Patient was encouraged to hydrate and wait full 15 minutes prior to leaving. Patient was feeling well enough to leave and mother was able to drive him home
no additional AE/PQC.; HCP called to state that the patient was given VARIVAX after a TE event.  Reference AE case numbers 02356234, 02356417,02356418, 02356419, 02356420, 02356421, 02356422, 02356423, 02356425 . no additional AE/PQC.; This spontaneous report was received from a nurse and referred to a 12-month-old male patient. The patient's medical history was not reported. The patient's concurrent conditions were not reported. Concomitant therapies were not reported.  On an unknown date, the patient started therapy with measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) subcutaneous injection, lot #W001519, expiration date: 13-JAN-2024, subcutaneously administered at right thigh for prophylaxis (strength were not provided); and  pneumococcal 15v conj vaccine (crm197) (VAXNEUVANCE) injection, lot #W027250, expiration date: 09-JUL-2024, administered intramuscularly at left thigh  for prophylaxis (strength was not provided). On 16-MAR-2023, the patient started therapy with varicella virus vaccine live (oka/merck) (VARIVAX) subcutaneous injection, lot #W021740, expiration date: 10-JUL-2024, administered subcutaneously at right thigh for prophylaxis (strength was not provided).  On an unknown date, HCP called to state that the patient was given varicella virus vaccine live (oka/merck) (VARIVAX), after a temperature excursion event. No additional adverse event was reported.
P/1 min of the inject, pt suddenly fainted fell forward & landed on frontal area injuring mandible/abrasion below lt nare & corner of mouth.Noticed irregular movements of muscles of mouth & neck,loss conscious less than 1 min, then recover.
Chills, nausea, and weakness. Shot was in the morning, symptoms started late afternoon, worsening in the evening and overnight.  Felt a little better in the morning.
Significant pain at injection site; onset of migraine headaches; joint pain; nerve-like pain (stabbing pain) in hands, arms, legs and face; enlarged painful lymph nodes in neck; numbness in hands, arms legs and face; dizziness; general malaise.
"PFIZER COVID 19 VACCINE EUA". Patient received first dose Pfizer vaccine (right deltoid) today at vaccination site. Due to Pt's hx of moderate allergice reaction to IV iodine during a medical procedure "years ago", pt placed on 30-minute ovservation period. Approx 10 minutes into observation, pt notified staff that she felt some itching on her right arm in crease of elbow. Pt. also saw what she described as bumps or hives the size of a half dollar. Pt moved to private restroom and redness and swelling found progressing behind pt's right knee 5 minutes later. IM Benedryl administered to patient and transport medic unit called. Full report given to transport crew. Pt transported to ED.
Fevers of 102 starting less than 24 hours after shot. Fevers lasting for approx 48 hours. Extreme lethargy for 48-72 hours. Continued tiredness on days 4 and 5. Injection site soreness and "fog brain" continues on day 5 post treatment.
Headache, Myalgia, RespDepression, INJECTION SITE PAIN Narrative:
On 6/14/00, the pt developed whelps and fever at injection site; says the whelps started out as some bumps but increased to the size of a baseball. Pt also has arm pain and swelling. She was encouraged to see physician.