chrisvoncsefalvay/vaers-outcomes huggingface dataset:
weakness in both legs; Fatigue; 3 to 4 naps per day; barely able to walk; experiencing pain at the injection site; This non-serious case was reported by a consumer via call center representative and described the occurrence of injection site pain in a 79-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 16-MAY-2023, the patient received the 1st dose of Shingrix. In MAY-2023, 2 days after receiving Shingrix, the patient experienced lower extremities weakness of (Verbatim: weakness in both legs), fatigue (Verbatim: Fatigue), sleepiness (Verbatim: 3 to 4 naps per day) and walking difficulty (Verbatim: barely able to walk). On 16-MAY-2023, the patient experienced injection site pain (Verbatim: experiencing pain at the injection site). The outcome of the injection site pain was resolved (duration 1 day) and the outcome of the lower extremities weakness of, fatigue, sleepiness and walking difficulty were not resolved.   It was unknown if the reporter considered the injection site pain, lower extremities weakness of, fatigue, sleepiness and walking difficulty to be related to Shingrix.     It was unknown if the company considered the injection site pain, lower extremities weakness of, fatigue, sleepiness and walking difficulty to be related to Shingrix.   Additional Information: GSK receipt date:26-MAY-2023 The reporter reported after receiving first dose of Shingrix at pharmacy she experienced pain at the injection site, fatigue, and weakness in both legs.She reported experiencing pain at the injection site, immediately which resolved the next day.  She reported onset of leg weakness and fatigue two to three days after receipt of Shingrix dose. She reported being so fatigued she took 3 to 4 naps per day. Prior to receiving Shingrix,she reported taking no naps or only one per day. She reported leg weakness in both legs, so she was barely able to walk.  She reported fatigue and leg weakness were ongoing. The reporter consent to follow up.
COVID Arm; COVID Arm (red, hard, itchy); COVID Arm (red, hard, itchy); COVID Arm (red, hard, itchy); Sore arm; This spontaneous case was reported by a physician and describes the occurrence of PAIN IN EXTREMITY (Sore arm), VACCINATION SITE REACTION (COVID Arm), VACCINATION SITE INDURATION (COVID Arm (red, hard, itchy)), VACCINATION SITE PRURITUS (COVID Arm (red, hard, itchy)) and VACCINATION SITE ERYTHEMA (COVID Arm (red, hard, itchy)) in a 53-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 026L20A and 004M20A) for COVID-19 vaccination.     The patient's past medical history included Genital herpes (Genital herpes IgG was Positive IgM was negative) in 2005.   On 12-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 09-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 12-Jan-2021, the patient experienced PAIN IN EXTREMITY (Sore arm). On 20-Jan-2021, the patient experienced VACCINATION SITE REACTION (COVID Arm), VACCINATION SITE INDURATION (COVID Arm (red, hard, itchy)), VACCINATION SITE PRURITUS (COVID Arm (red, hard, itchy)) and VACCINATION SITE ERYTHEMA (COVID Arm (red, hard, itchy)). On 12-Jan-2021, PAIN IN EXTREMITY (Sore arm) had resolved. On 21-Jan-2021, VACCINATION SITE REACTION (COVID Arm), VACCINATION SITE INDURATION (COVID Arm (red, hard, itchy)), VACCINATION SITE PRURITUS (COVID Arm (red, hard, itchy)) and VACCINATION SITE ERYTHEMA (COVID Arm (red, hard, itchy)) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No relevant concomitant medications were reported.  No treatment information was provided.   This case was linked to MOD-2021-207871 (Patient Link).
Per patient report, 1 hour after injection pain at injection site and pain continued to spread down the arm that day. On October 5th, 2019 patient went in to see physician and at that time physician prescribed an antibiotic for patient. Per patient the physician believed there was an infection near the injection site.
This spontaneous report as received from a certified medical assistant refers to a 4 year old patient. The patient medical history and concurrent conditions were not provided. On 11-FEB-2015, the patient was vaccinated with VARIVAX (Merck), lot # K008819, expiration date 19-JUN-2016 (route was not provided). Concomitant medication information was not provided. It was reported that on 11-FEB-2015, a dose of VARIVAX (Merck) which was exposed to an unsupported temperature excursion, was administered to the patient. No adverse experience had been reported. It was unknown if the patient sought medical attention. At the time of the report, the patient status was unknown. Additional information has been requested.
Almost immediately after injection, I experienced a raspy voice.  My voice quality changed.  My throat was not itchy and I did not experience swelling and I did not feel as if my throat were closing.  The raspiness continued on my trip home, and I did not think too much of it other than the almost immediate onset.  I am guessing 4 minutes in onset, but it could have been immediate.  I experienced shortness of breath going up the stairs later in the evening, as well as tingly lips in the evening, similar to when I used to get migraines and felt that sensation.  I felt like I was operating in slow motion, with a headache, into the evening.   Fourteen hours after injection, I experienced temp of 101, chills, nausea, headache, dizziness.  The fever and chills subsided but the dizziness, headache, and unsteadiness on my feet have lasted through today and continue.
Pt c/o severe red, raised blister like hives all over body starting with right upper arm. Pt c/o burning and pain from rash x 2 weeks when seen in office 10/24/14.
CARDIAC ARREST (SEVER CHEST PAIN); CLOGGED VEIN; LEFT ARM GOES TO SLEEP; This spontaneous report received from a patient concerned a 62 year old white male. The patient's past medical history included blood clot, heart attack, lump in leg, and stents in main arteries, and concurrent conditions included heavy smoker, and heart issues.  The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1808025, expiry: UNKNOWN) dose was not reported, 1 total administered on 12-MAR-2021 to left arm as prophylactic vaccination. The patient was previously treated with clopidogrel bisulfate for blood clot.  On an unspecified date in 2021, Laboratory data included: Echocardiogram (NR: not provided) unknown, and Lab test (full workup)(NR: not provided) unknown. On an unspecified date in Mar-2021, a week later vaccination, the patient experienced that left arm went to sleep which felt worse next day, on 25-APR-2021, patient experienced severe pain in chest, called ambulance and was taken to hospital. On same day patient was hospitalized. Patient went to full cardiac arrest twice same day. It was stated that vein that was 60 percent good earlier was 100 percent clogged (clogged vein) in one month after getting the vaccine. They tried to put stent in, clear vein out, and put piece of metal and expanded it, to make alley way for blood flow. Patient stated that patient would not take Plavix this time. According to patient, stent was reacting with Plavix, and decided to take something different. They did same job twice. It was stated that patient was discharged on 05-May-2021 from hospital. On 12-MAY-2021, patient went to consult the health care professional to make sure everything was okay. The patient gave lot number 1808025, then stated that, patient thinks it is 180, and then either 5 or 8, and next it was either D or 0, and then after the space it is 25.  The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the cardiac arrest (sever chest pain), left arm goes to sleep and clogged vein was not reported. This report was serious (Hospitalization Caused / Prolonged).; Sender's Comments: V0: 20210523134-COVID-19 VACCINE AD26.COV2.S-CARDIAC ARREST (SEVERE CHEST PAIN), CLOGGED VEIN. This event(s) is considered not related. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event(s) than the drug. Specifically: MEDICAL HISTORY, UNDERLYING DISEASE
Patient received second dose of Moderna before recommended window (on day 21 instead of 28)
After receiving  flublok vaccine, patient reported her throat feeling funny and tickly. After 2 minutes, patient reported her throat closing and getting harder to breath. Patient was given Epi-pen. Called 911, paramedics came and took patient to emergency room.
This spontaneous report has been received from the medical assistant refers to a 12 months old male patient. The patient's concurrent conditions, medical history, drug reactions and allergies were not reported. Concomitant therapies administered to them included sterile diluent (MRK INJ) used to reconstitute the VARIVAX was properly stored. On 13-JUN-2018, the patient was vaccinated with improperly stored doses of VARIVAX (dose, units and frequency not reported) (lot# N035937 and expiration date: 18-DEC-2019), subcutaneously. The doses of VARIVAX were exposed to a temperature excursion of 6 degrees Fahrenheit (degree F) to 14 degree F (also reported as "9F") for a time frame of 10 minutes; and of 15 degree F to 46 degree F (also reported as "25F") for 20 minutes. The temperature excursion was not detected by the Digital Data Logger. There was no previous temperature excursion either. No adverse effects or product quality complaints were reported. This is one of the multiple reports received from the same reporter.
Patient got his initial Moderna vaccine on 8/6/21 and three days later both legs became swollen and painful.  They continue to be painful and swell daily.  He felt swollen all over and started having muscle spasms in most muscle groups.  Bilateral joint pain in his knees.  Due to the muscle spasms he is unable to sleep.  This continues to this day.  Labs and Ultrasound done to r/o thrombosis.
Patient was given vaccine 5 days early.  No adverse reactions reported. Instructed to report adverse reactions
slight headache; sneezing; This is a spontaneous report from a contactable consumer or other non hcp. A patient of unspecified age and gender received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection) via an unspecified route of administration on 03May2021 (Batch/Lot number was not reported) as 1ST DOSE, SINGLE DOSE for covid-19 immunisation. The patient medical history was not reported. The patient's concomitant medications were not reported. The patient experienced slight headache and sneezing on an unspecified date. The reporter stated that patient also in week 3 and patient felt like slight headache and sneezing. No fever." Could it be related to the pollen in the air. Patient use NASONEX every day and have been using it every day. Patient was sneezing. Maybe it's the vaccination completing the process. Patient was supposed to get my 2nd dose but now that it's authorized for kids, patient waited 20-25 minutes. The pharmacist said, "pharmacist was actually thawing it" (pharmacist felt like they were rushed). Pharmacist enquired do they need to be thawed within 30 minutes pharmacist didn't feel comfortable. Pharmacist felt like the pharmacy was rushing. " Therapeutic measures were taken as a result of sneezing and treatment included NASONEX. The outcome of the events was reported as unknown.   No follow-up attempts are needed; information about lot/batch number cannot be obtained
Patient received DTap/ Hep B/ IPV vaccine and needed Hep B/ IPV/ Tdap.
Chills; fever, lost of smell, lost of taste, hives and redness and swelling and ?hot to touch? all within 24 hours. One week after 1st dose, developed increase muscle aches, fatigue, and increase swelling and stiffness at site of injection with hives and itching. Went to urgent care and confirmed cellulitis and hives at site of injection.
This spontaneous report as received from a physician via Company Representative refers to a 11 year old male patient. On 11-JUL-2014, the patient was vaccinated with GARDASIL, intramuscular (dose, dose number and lot# not reported) and VAQTA (dose, lot# and route not reported). Concomitant therapies included meningococcal vaccine (unspecified). It was unknown which dose of GARDASIL the patient received and if he had completed the series. On 12-JUL-2014, the day after vaccination, the patient experienced sore throat and fever of 103 degrees Fahrenheit. On 14-JUL-2014, the patient went in for an office visit and was given ALEEVE for his symptoms. The patient's temperature went down to 98.4 degrees Fahrenheit on 14-JUL-2014. The outcome for sore throat was unknown. Relatedness between sore throat and fever of 103 degrees Fahrenheit and vaccination with GARDASIL and VAQTA was not provided. Additional information has been requested.
This patient was given a 50 mcg dose from the 6-11 year vial; 12 year old pediatric patient received a lower than authorized dose of the incorrect product; no adverse event; This spontaneous case was reported by an other health care professional and describes the occurrence of INCORRECT DOSE ADMINISTERED (This patient was given a 50 mcg dose from the 6-11 year vial), ACCIDENTAL UNDERDOSE (12 year old pediatric patient received a lower than authorized dose of the incorrect product) and NO ADVERSE EVENT (no adverse event) in a 12-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. ASKU) for COVID-19 prophylaxis.     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 INCORRECT DOSE ADMINISTERED (This patient was given a 50 mcg dose from the 6-11 year vial), ACCIDENTAL UNDERDOSE (12 year old pediatric patient received a lower than authorized dose of the incorrect product) and NO ADVERSE EVENT (no adverse event). At the time of the report, INCORRECT DOSE ADMINISTERED (This patient was given a 50 mcg dose from the 6-11 year vial), ACCIDENTAL UNDERDOSE (12 year old pediatric patient received a lower than authorized dose of the incorrect product) and NO ADVERSE EVENT (no adverse event) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered NO ADVERSE EVENT (no adverse event) to be not related. No further causality assessments were provided for INCORRECT DOSE ADMINISTERED (This patient was given a 50 mcg dose from the 6-11 year vial) and ACCIDENTAL UNDERDOSE (12 year old pediatric patient received a lower than authorized dose of the incorrect product).    Concomitant product use was not provided by the reporter.  Treatment information was not provided.  Health care professional did not want to provide any additional details on the patient at this time however consent follow-up was given.
After second dose of Moderna experienced difficulty walking in March which quickly got worse. Fell several times. Went to various doctors and was given EMG tests all of which were abnormal. In July was diagnosed with ALS. Recicing treatment now and have appointment at specialty Clinic in November.
Vaccine recieved 5/11/21 5/19/21 Presented to ED with respiratory failure. Noted bilateral ground glass opacity, respiratory failure 5/25/21 Intubated for respiratory failure with ARDS 5/30/21 Deceased
Sudden onset of brief, recurring  flashing lights in left eye visual field for 2 hours, then sudden onset of ring shaped floater in same left eye on the afternoon of  02/13/2021; one day after receiving first Pfizer-BioNTech vaccine at the COVID vaccine clinic on 02/12/2021 . No further lightening flashes since the initial day of symptoms (02/13/2021). Floater has persisted. Seen by ophthalmologist on Monday 02/15/2021 confirming posterior vitreous detachment.
This non-valid spontaneous report was received from a pharmacy technician and refers to multiple unspecified patients. No information regarding the patient's medical history and concurrent conditions was provided. On unknown dates in 2017, the patients were vaccinated with improperly stored doses of ZOSTAVAX injection (dose, route of administration, lot number and expiration date were not reported). The doses of ZOSTAVAX were reconstituted with sterile diluent (MERCK) (lot number and expiration date were not reported). It was unknown if sterile diluent (MERCK) had any prior temperature excursions. On 13-APR-2017, the vaccines underwent a temperature excursion of 6 to 14 degrees Fahrenheit (also reported as 9.7 degrees Fahrenheit) for 1 hour and 15 minutes. Digital data logger was involved in the recording of the excursion. No previous temperature excursions were reported. No adverse effects were reported. No product quality complaint involved. This is an amended report, as corrected. This is a non-valid report and should have been forwarded to the Non-valid workflow, instead of being distributed.
Information has been received from a registered nurse regarding a patient of unknown age and gender. On 23-OCT-2013 at 17:30, ZOSTAVAX lot # J004268 was exposed to -14C for an estimated total time out of range of 10.0 hours. On 25-OCT-2013 at 18:30, ZOSTAVAX lot # J004268 was exposed to an exact T not recorded but noted as equal to or >12C for an estimated total time out of range of 10.5 hours. On 04-NOV-2013, the patient was vaccinated with an out of range doe of ZOSTAVAX (dose and route administration were not provided) (Lot number J004268, Exp. Date: 12-JUL-2014). No adverse experience had been reported. This is one of 182 reports from the same source. Additional information has been requested.
Rheumatoid arthritis flare up; Vaccination site pain; FACILITATED COLLECT  This is a solicited report received from contactable reporter(s) (Consumer or other non HCP) for a sponsored program. The reporter is the patient. Other Case identifier(s): 22K-163-4272124-00.  An elderly female patient received bnt162b2 (BNT162B2), intramuscular (Batch/Lot number: unknown) as dose 3 (booster), single, intramuscular (Batch/Lot number: unknown) as dose 2, single and intramuscular (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation; influenza vaccine (INFLUENZA VACCINE) (Batch/Lot number: unknown); adalimumab (HUMIRA), subcutaneous (Batch/Lot number: unknown) at citrate free for rheumatoid arthritis. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: RHEUMATOID ARTHRITIS (medically significant), outcome "unknown", described as "Rheumatoid arthritis flare up"; VACCINATION SITE PAIN (non-serious), outcome "unknown", described as "Vaccination site pain". The action taken for adalimumab was unknown. It was unknown if patient was enrolled in a COVID-19 Vaccine Trial. The reporter's causality for the event(s) of some pain in arm after wards covid vaccinated and Flu shoot and rheumatoid arthritis flare up with adalimumab was not provided. The reporter's causality for the event(s) of vaccination site pain and Rheumatoid arthritis flare up with bnt162b2 was possible. The reporter's causality for the event(s) of vaccination site pain and Rheumatoid arthritis flare up with influenza vaccine was not reported.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Based on available information, a possible contributory role of the subject product, BNT162B2 vaccine, cannot be excluded for the reported events . There is limited information provided in this report. This case will be reassessed once additional information is available.
10 days post vax the pt developed several varicella like lesions on her trunk. The next day she developed numerous additional lesions in a generalized distribution as well as a low grade temperature and malaise. At the time of the report the pt had approximately 175 generalized lesions.
Numbness in feet beginning 23 hours after 2nd vaccination. Toes white in color similar to what reynauds syndrome looks like. Massaging to see if that helps, but it's been about an hour with no change. Heart rate and forehead temp normal. No other significant symptoms.
Became very dizzy, started throwing up, became worse and went to the hospital around 3:00 AM
it was rpt pt p/ recv vax exp flu-like sx, sought unspecified medical attention
This spontaneous report was received from a registered nurse and refers to a patient of unknown age and gender. In February 2011, four years ago, the patient was vaccinated with the first dose of GARDASIL. On 02-FEB-2015, also reported as today, the patient received the second dose of GARDASIL (route of administration, lot number and expiration date were not reported). No adverse effect was noted. Additional information has been requested.
Two minutes after receiving injection , child became very pale, slightly diaphoretic, fainted but arms were jerking in movement. Doctors examined child. Alert and talking, wanting to sit up. V/S taken. Child remained in office x 35 minutes. Doctor examined child, all V/S were normal, color pink A+O x 3. Released home with mother.
Diagnosed with Bells Palsy (paralysis on left side of face) Acyclovir 400 mg-1 tab 5 times a day Prednisone 20mg-2 tabs for 3 days 1.5 3 days, 1.0 3 days, 0.5 3 day.  8/14/07 Received vax record & VAERS database updated w/same.  9/11/07 Received medical records from clinic for visit on 7/6/07 which reveals patient experienced left eye swelling, left tongue numbness & left lower lip numbness.  Had URI for approx 10 days, sinus congestion, rhinitisfatigued & easy bruising.  Exam revealed left side eyelid drooping, inability to completely close left eye, flattening of nasal labial fold & left side lip drooping.  Tx w/antiviral, prednisone.  Referred to hematology. FINAL DX: Bell's palsy, thrombocytopenia.
EXCESSIVE INJECTION SITE BRUISING (APPROXIMATELY 4 INCHES IN DIAMETER WITH NOTICEABLE SWELLING).
PMH:  DM, HTN, bilateral lower extremity BKA, chronic systolic heart failure; CAD, dilated cardiomyopathy; diagnosed positive for COVID on 9/3/21; admitted to hosp 9/9/21 with c/o SOB; took monoclonal antibodies earlier in the day and was having chills, increasing SOB, hypoxia (O2 sats 80%), hyperglycemia; treated with remdesivir, antiobiotis, steroids, bronchodilators, HFNC, baricitinib; condition slowly improving; renal function began to worsen and pt's condition declined; intubation due to refractory hypoxia; went into PEA cardiac arrest; pt died in the hosp
No additional AE; PNEUVMOAX 23 were administered after a supported temp excursion occurred; This spontaneous report was received from a medical assistant concerning a patient of unknown age and gender. The patient's medical history, concurrent conditions, and concomitant medication were not provided.   On 10-AUG-2022, the patient was vaccinated with Pneumococcal Vaccine, Polyvalent (23-valent) (PNEUMOVAX23), lot # U026796, expiration date 28-JAN-2023 for prophylaxis after a temperature excursion of 48 minutes at 9.2 degrees Celsius (Product storage error) (dose, route of administration, and injection anatomical location were not provided). No additional adverse events were reported (No adverse event).   This is one of several reports received from the same reporter. ; Sender's Comments:  US-009507513-2208USA005566: US-009507513-2208USA005605: