chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Patient states that beginning 9/8/14 she experienced significant dizziness, tiredness. On 9/9/14, she also began to have severe nausea. She went to an urgent care on 9/10/14 and then to the ER the night of 9/10/14.
arm bothered him; chills; fever; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 78-year-old male patient received BNT162b2 (BNT162B2), on 26Feb2021 as dose 1, single (Lot number: EN6202) at the age of 78 years for covid-19 immunisation. The patient's family history included: "Glaucoma" (ongoing), notes: Glaucoma. Concomitant medication(s) included: LATANOPROST taken for glaucoma (ongoing). Vaccination history included: Flu vaccine (Dose Number: Unknown, Manufacturer: Unknown), reaction(s): "Bad reaction", "was very achy", "would run a 102 fever". The following information was reported: LIMB DISCOMFORT (non-serious) with onset 2021, outcome "unknown", described as "arm bothered him"; CHILLS (non-serious) with onset 2021, outcome "unknown"; PYREXIA (non-serious) with onset 2021, outcome "unknown", described as "fever".  Additional information: the patient has been taking latanoprost 1 drop in each eye at night for about 25 years. On his first shot, his arm bothered him and had chills and a fever. He only took one medication for glaucoma for his eyes. He had no prior vaccination within 4 weeks. He usually gets a bad reaction from the flu shot and had not had it in years. He would run a 102 fever and was very achy and did not take it anymore.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202201277505 same patient/reporter, different event/dose;US-PFIZER INC-202201277506 same patient/reporter, different event/dose;US-PFIZER INC-202201277504 same patient/reporter/events, different dose;
Patient received the series of Gardasil vaccines beginning 6/07.  The second vaccine was administered 9/5/07.  Ten days following patient had a seizure for the first time in her life.  There is no family history of seizures. Patient was taken to the hospital, had a follow up appointment with her pediatrician and referred to a neurologist.  Testing completed at that time was within normal expectations.  A second seizure occurred in January '08.  After additional testing recommended by another neurologist in the same practice, patient has now been diagnosed with a seizure disorder and is taking medication to prevent the seizures from reoccurring.  The Gardasil vaccine was the only difference from her normal routine and without the family history of seizures, I question the vaccine.  8/19/2008 MR received from consulting neurologist including ER record from 9/15/2007 and OVs to 6/18/2008 with DX: Primary Generalized Epilepsy. Pt had 1st seizure 9/15/2007. Pt's eyes glassed over and pt developed full body shaking and stiffening. Pt fell off couch, bit tongue and was incontinent of urine. PE WNL except bite on tongue. DX: Seizure-new onset. Neuro consult 9/20/07 notes equivocal EEG, but will not start meds at this time. 2nd seizure 1/17/2008 lasting 2-3 minutes with post ictal confusion and disorientation. Started on anti-seizure med. F/U 2/22/08 now dx with generalized epilepsy, most likely juvenile myoclonic epilepsy without myoclonus. F/u 6/18/08 no further seizures.
3 to 5 minutes after the vaccine was given my tounge started to tingle and swell. Then the swelling progressed to my throat,  cheeks.  I advised th pharmacist about 5 min into the reaction and was told to buy benadryl and take "some". I took 50mg oral benadryl.  By this time I was having trouble swallowing.  I waited 10 more minutes of observation at the pharmacy.  By then my lips had become numb and no effect was had from the benadryl.  The pharmacist advised I go to ER or urgent care. I went to ER. I was evaluated.  BP, HR, SPo2, within normal range. Respirations 25/min. By this time my neck and chest was itching and heavy feeling and I felt my breathing effort was increased mildly. I was given IV decadon and IV pepcid. After about an hour and a half my symptoms slowly resolved. The last symptom to resolve was difficulty swallowing.  I was told to continue oral benadryl and or pepcid. I was discharged home after 4 hours under my own care.
Patient was coming in for Pfizer booster vaccination. The vial in stock was within a plastic ziplock with the number of doses taken out prior to recorded. I pulled out nearly 3 ml for a dose and realized that the vial was nearly gone (Should've been more doses). I brought this to the nursing staffs attention and was told to continue with the administration. Following administration it was found that 2.7 times the dose was administered. The patient was contacted and notified with instructions to monitor for more severe flu like symptoms and to come into urgent care if symptoms worsened/progressed.
Patient called and stated RA arm swelled to softball size. She complained of fever, chills and diarrhea. She stated swelling has improved over 2 days but still present. Pharmacy will follow up Monday to confirm s/sx continue to improve.
Approximately two weeks after receiving my first dose of the vaccine, I started experiencing upper body bilateral joint pain, primarily in shoulders and wrists.  This pain has continued since then for approximately six weeks now.  In addition, my right arm, hand, and fingers are swollen, and the tips of my fingers on the right hand feel slightly numb. I have been taking acetaminophen, ibuprofen, and naproxen, but still have the symptoms described above.
elevated WBC count one week after the first injection; elevated WBC count one week after the first injection; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of THERAPEUTIC RESPONSE UNEXPECTED (elevated WBC count one week after the first injection) and WHITE BLOOD CELL COUNT INCREASED (elevated WBC count one week after the first injection) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced THERAPEUTIC RESPONSE UNEXPECTED (elevated WBC count one week after the first injection) and WHITE BLOOD CELL COUNT INCREASED (elevated WBC count one week after the first injection). At the time of the report, THERAPEUTIC RESPONSE UNEXPECTED (elevated WBC count one week after the first injection) and WHITE BLOOD CELL COUNT INCREASED (elevated WBC count one week after the first injection) outcome was unknown. Not Provided    DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, White blood cell count: elevated (High) Elevated WBC count.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant product were not provided by the reporter.  Treatment medication were not reported by the reporter.
On ninth day following vaccination, a warm swollen tender red patch appeared at the injection site, approximately 3" x 2.5".   By today (five days later) it has begun to fade, and the swelling and tenderness are decreasing.  Some itching associated with lesion throughout, but primary sensation is pain.
PATIENT WAS GIVEN HIS FIRST DOSE OF MODERNA VACCINE ON 4/21/21 AT 11:00AM. NO KNOWN SEVERE ALLERGIES TO MEDICATIONS, OR VACCINES (HAS SEAFOOD ALLERGY BUT NEVER WENT INTO ANAPHYLAXIS). PATIENT STARTED FEELING DIZZY A FEW MINUTES AFTER AND STARTED SWEATING. NO SIGNS OF SWELLING OR REDNESS AROUND THE INJECTION SITE. HAD PATIENT LIE DOWN ON FLOOR WITH FEET ELEVATED. PATIENT'S RECOVERED WITHIN A MINUTE, NO LONGER DIZZY OR SWEATING WITH BLOOD PRESSURE AT 112/76. PATIENT WAS OBSERVED UNTIL 11:30 AM, CONDITION STAYED STABLE, AND THEN LEFT WITH HIS FAMILY MEMBER.
Dizziness and Headache within 10 minutes of immunization. Leg weakness within one hour. Tightness in chest and fatigue overnight.  Ringing in ears today.
About 30-45 min started feeling light headed, have a head ache, sore all over, joint pain, sore arm where the injected the vaccine, tired and just worn out and in pain.
Excessive arm pain, allergic dermatitis rash extending 6 inch diameter around injection site. Onset of reaction began approximately one week after initial injection. Evaluated in PCP office on 1/28/2021; erythematous rash still present despite use of oral benadryl and topical corticosteroid.
cough; This is a spontaneous report from a contactable consumer (patient). A 63-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE Solution for injection), via an unspecified route of administration, administered in the right arm, on 21Feb2021 15:30 (Batch/lot number: EL9266), at age 63 years old, as dose 1, single, for COVID-19 immunization, at a hospital. The patient was not pregnant at the time of vaccination. Relevant medical history included high blood pressure, sinus problems and known allergies to trees and grass, all from unknown dates, not reported if ongoing or not. The patient did not have COVID-19 prior to vaccination and was not tested for COVID-19 post vaccination. Concomitant medication included lisinopril 20/25 taken for an unknown indication, start and stop dates not reported. The patient did not receive other vaccine in four weeks. On 22Feb2021, the patient experienced cough. Treatment was not given for the event. The outcome of the event was not resolved.  No follow-up attempts are needed. No further information is expected.
Received Menactra vaccine 5/19/05. Presented in office 5/20/05 injection site red, swollen and hot to touch. Clarinex 2 tsp given in office. Advised to repeat dose tomorrow.
Information has been received from a physician concerning a 90 year old patient who in April 2007, "3 years ago", was vaccinated with a dose of ZOSTAVAX (Merck) (Lot# not reported).  The patient was currently hospitalized with a diagnosis of shingles.  It was unknown if the patient sought medical attention.  At the time of the report, the outcome of the patient was unknown.  Additional information has been requested.
Severe chills, fever of 100.7, vomiting, fatigue, weakness for less than 12 hours Chills, diarrhea, fatigue, weakness for three days
On 12/8/21 patient entered hospital with hypoxic respiratory failure from COVID-19 and bacterial pneumonia. On the 18th, intubation and mechanical ventilation was required. His condition continued to deteriorate and led to shock and continuous renal replacement.  He died 1/1/2022.
This spontaneous report as received from a registered nurse refers to an unspecified number of patients of unknown age and gender. On an unknown date, the patients were inadvertently vaccinated with doses of RECOMBIVAX HB (lot # reported as K007798 exp April 2016) that were improperly stored. No adverse effects were reported. This is one of several reports received from the same source. Additional information has been requested.
Suspected vaccination failure; Developed shingles on injection site arm; This case was reported by a physician via sales rep and described the occurrence of suspected vaccination failure in a male patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure and shingles were unknown.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The patient received Shingrix in an unknown arm. After receiving Shingrix, the patient developed shingles on injection site arm. The patient went to the dermatologist and followed up with the dermatologist regarding the outcome. This case was considered as suspected vaccination failure, since the details regarding the completion of the primary immunization schedule, time to onset for event and laboratory confirmation were not provided. The reporter consented to follow up.
Tdap given on 2/18.  C/o sitting soreness, muscle ache on 2/19.  On afternoon of 2/19 & 2/20 had fever 38-38.9 degrees C, generalized body ache, injection site soreness.  Resolved by 2/23/09.
Nausea,chills,headache,body aches. They went away after the 4th day . He started having symptoms the night he got the vaccine.
The clinician injected vaccine into my bursa. Dizziness  heart racing, Pain swelling. Unable to use left arm still. Had  Mri that confirmed. Had a cortisone shot, no change. Unable to sleep without it waking me up every time I move. Can?t use my arm for anything. Severe pain!!
This is a spontaneous report obtained from a contactable pharmacist through a sales representative. This pharmacist (mother) reported same event for two patients. This is the second of two reports. A 15-year old male patient received, on 17APR2015, TRUMENBA intramuscularly in deltoid, at 0.5 ml, single dose. Vaccines given on the same date along with TRUMENBA were none. Vaccines given within four weeks of administration of TRUMENBA were none. Relevant medical history and concomitant medications were unknown. On 18APR2015 at 1:30 AM, the patient experienced fever, chills. In the afternoon of the same day, on 18APR2015, the dizziness and blurred vision began. Clinical outcome of the events was unknown at time of this report.
blacking out; sweating; falling out of chair; spinning; This spontaneous case was reported by a consumer and describes the occurrence of LOSS OF CONSCIOUSNESS (blacking out) in a 30-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 054C21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 16-Jul-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 16-Jul-2021, the patient experienced LOSS OF CONSCIOUSNESS (blacking out) (seriousness criterion medically significant), HYPERHIDROSIS (sweating), FALL (falling out of chair) and VERTIGO (spinning). At the time of the report, LOSS OF CONSCIOUSNESS (blacking out), HYPERHIDROSIS (sweating), FALL (falling out of chair) and VERTIGO (spinning) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       It was reported that patient took Tylenol 1 hour before she got vaccination.  Concomitant product included Birth control medication.  Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded. No treatment information was provided by the reporter.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Throat closed could not swallow water, violently threw up 2 min after vaccine was given for  over a hour straight, feet welled and dizzy. .  Kept on-site for 3 hours after vaccination. has been in bed with a headache and flue symptoms for 3 weeks , intentional severe cramping and constant diarrhea.  Severe body aches requiringg pain medication. Still currently having side effects a month later
Blood clot on left brain causing paralysis on right side and loss of speech and loss of bladder function. Can no longer walk or control bowels. Severely depressed. Has catheter since 12/1/2023 that has destroyed his penis and bladder.
patient was diagnosed with cellulitis at ER at injection site. swollen, red, hot, painful arm
Gardasil/Menactra given IM yesterday at 10am. and promptly developed redness at shot site. Within hours developed hives. No fever, cough, runny nose, nor dizziness.
no adverse event; multiple patients were vaccinated with an improperly stored vaccine; This spontaneous report was received from a medical assistant and refers to a patient of unknown age and gender. The patient's concurrent conditions, medical history and concomitant therapies were not reported.  On 23-MAY-2019, the patient was vaccinated with an improperly stored dose of rotavirus vaccine, live, oral, pentavalent (ROTATEQ), 2 ml, orally (LOT# R034700, expiry date 16-JUN-2020) for prophylaxis. The vaccine was exposed to a temperature of 34.2 Fahrenheit degrees (F) for 4 hours and 54 minutes. Digital data logger was involved. There were no previous temperature excursions. No adverse effects were reported.  This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-1907USA000862: US-009507513-1907USA000882: US-009507513-1907USA000883: US-009507513-1907USA000884: US-009507513-1907USA000885: US-009507513-1907USA000886: US-009507513-1907USA000887: US-009507513-1907USA000888: US-009507513-1907USA000889: US-009507513-1907USA000890: US-009507513-1907USA000891: US-009507513-1907USA000892: US-009507513-1907USA000893: US-009507513-1907USA000894: US-009507513-1907USA000895: US-009507513-1907USA000896: US-009507513-1907USA000897: US-009507513-1907USA000898: US-009507513-1907USA000899: US-009507513-1907USA000900: US-009507513-1907USA000901: US-009507513-1907USA000902: US-009507513-1907USA000903: US-009507513-1907USA000904: US-009507513-1907USA000905: US-009507513-1907USA000906: US-009507513-1907USA000907: US-009507513-1907USA000908: US-009507513-1907USA000909: US-009507513-1907USA000910: US-009507513-1907USA000911: US-009507513-1907USA000912: US-009507513-1907USA000913: US-009507513-1907USA000914: US-009507513-1907USA000916: US-009507513-1907USA000917: US-009507513-1907USA000918: US-009507513-1907USA000919: US-009507513-1907USA000920: US-009507513-1907USA000921: US-009507513-1907USA000922: US-009507513-1907USA000923: US-009507513-1907USA000924: US-009507513-1907USA000925: US-009507513-1907USA000926: US-009507513-1907USA000927: US-009507513-1907USA000928: US-009507513-1907USA000929: US-009507513-1907USA000930: US-009507513-1907USA000931: US-009507513-1907USA000932: US-009507513-1907USA000933: US-009507513-1907USA000934: US-009507513-1907USA000935: US-009507513-1907USA000936: US-009507513-1907USA000937: US-009507513-1907USA000938: US-009507513-1906USA011674:
Patient given pneumococcal vaccine polyvalent pneumovax 23 0.5cc sub cutaneously in left arm 10/23/2003.  Patient called 10/24/2003 AM to wake with left arm should be swollen and painful.  Nurse had patient come in for evaluation.  Fount 98.4 temperature.  Left arm swollen, painful, red and warm to touch.  Swelling left deltoid to pain upper arm.
Serological test results negative for antibodies following completed series; This spontaneous case was reported by a health care professional and describes the occurrence of ANTIBODY TEST NEGATIVE (Serological test results negative for antibodies following completed series) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 011M20A and 026L02A) for COVID-19 vaccination.     No Medical History information was reported.   On 09-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In February 2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 12-Mar-2021, the patient experienced ANTIBODY TEST NEGATIVE (Serological test results negative for antibodies following completed series). On 12-Mar-2021, ANTIBODY TEST NEGATIVE (Serological test results negative for antibodies following completed series) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 12-Mar-2021, Serology test: negative (Negative) The serological test results for IgG, IgA and IgM Covid-19 antibodies were negative on 12Mar2021, after she had already completed the Moderna Covid-19 series.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No relevant concomitant medications were reported. No treatment information was provided. Action taken with mRNA-1273 in response to the events was not applicable. Patient reported that, she got her second dose of vaccination in February 2021, but was not sure whether it was on 02 Feb 2021 or 07 Feb 2021. Patient was serologically tested while she was on a vacation.  Most recent FOLLOW-UP information incorporated above includes: On 11-May-2021: Additional information was received on 11-May-2021 and contains no new information.
Rash & UrticariaPruritus  Narrative:  Developed rash in well demarcated square shape (about 1x1 inch) around site of injection 6 days after vaccination, which persisted for 2 weeks. The  rash was associated with pruritus, warmth, swelling, induration and erythema. No  other adverse effects noted. Applied warm compress to area, which did not assist with the symptoms.
Patient fainted approximately 2 minutes after receiving flu vaccine.  He fell into a wall and bruised his forehead, shoulder and arm.
This spontaneous report as received from a pharmacist refers to unspecified patients of unknown demography. No concurrent condition, medical history or allergy/drug reactions were reported. On unspecified dates, unspecified number of patients were vaccinated with improperly stored doses of ZOSTAVAX vial, 19,400 PFU (plaque-forming units), lot # L011534, exp. date: 03-JUL-2016; lot# K011002, exp. date: 11-JUL-2015 and lot# L003601, exp. date: 03-JUL-2016 (dose and route unspecified). No concomitant medications were reported. No adverse effects were reported. The outcome of the event was unknown. There were no product quality complaints (PQC) involved. No additional information was provided. Additional information has been requested.
Client was given 3rd dose of Pfizer after initial 2 dose series with Moderna vaccine