chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Guillain-Barre syndrome (GBS); paralyzed; Initial information received on 07-Oct-2020 regarding an unsolicited valid serious case from a consumer via social media.   This case involves female patient of unknown age had GBS (Guillain-Barre Syndrome) got paralyzed (paralysis) and was 10 years in a wheelchair, after vaccination with INFLUENZA VACCINE.  Medical history, medical treatment(s), vaccination(s), concomitants and family history were not provided.  On an unknown date, the patient received a dose of suspect INFLUENZA VACCINE produced by unknown manufacturer (batch number and expiration date not reported) via unknown route in unknown administration site or prophylactic vaccination.  On an unknown date, the patient developed serious events of GBS (Guillain-Barre syndrome) and got paralyzed from flu (paralysis) (unknown latency) following the administration of INFLUENZA VACCINE. These events were assessed as medically significant.  No laboratory data reported.  It was not reported if the patient received a corrective treatment.  The outcome was unknown for both the events.  It was reported by the reporter, that the Guillain-Barre syndrome is listed on the flu vaccine side effects.  Information on the batch number was requested.  Follow up information received on 06-Nov-2020 regarding an unsolicited valid serious case from a consumer via social media.  Event: Guillain-Barre syndrome was added and the case was corrected to valid serious case as it was incorrectly captured as non-valid case considering Sanofi Product Not otherwise specified (NOS). Corresponding fields were updated.; Sender's Comments: Follow up information received on 06-Nov-2020 does change the previous assessment of this case. This case concerns a  female patient of unknown age who had Guillain-Barre Syndrome and paralysis, after vaccination with INFLUENZA VACCINE. The time to onset is unknown. However, patient's medical condition at the time of vaccination and lab tests were not reported. Based upon the reported information, the role of vaccine cannot be assessed.
Sharp pains in left shoulder/ sharp pain in his left arm.; This spontaneous case was reported by a consumer and describes the occurrence of ARTHRALGIA (Sharp pains in left shoulder/ sharp pain in his left arm.) in a 71-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 031L20A and 011A21A) for COVID-19 vaccination.     Concomitant products included ACETYLSALICYLIC ACID (ASPIRIN 81), BUMETANIDE (BUMEX), DILTIAZEM HYDROCHLORIDE (CARDIZEM [DILTIAZEM HYDROCHLORIDE]), EZETIMIBE (ZETIA), FAMOTIDINE (PEPCID AC), FLUVASTATIN SODIUM (LESCOL FORTE), METOPROLOL SUCCINATE (METOPROLOL ACTAVIS [METOPROLOL SUCCINATE]), SOLIFENACIN SUCCINATE (VESICARE), TAMSULOSIN HYDROCHLORIDE (FLOMAX RELIEF) and WARFARIN SODIUM (COUMADIN) for an unknown indication.   On 25-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 25-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 ARTHRALGIA (Sharp pains in left shoulder/ sharp pain in his left arm.). At the time of the report, ARTHRALGIA (Sharp pains in left shoulder/ sharp pain in his left arm.) outcome was unknown. Not provided.          Treatment information was not provided.   Most recent FOLLOW-UP information incorporated above includes: On 23-Jul-2021: Follow-up received on 23-Jul-2021 contains patient demographics and concomitant medication information
Lost his hearing in a 90% for almost 5 hours/I couldn't hear anything/he hear himself with a squeaky voice, but patient wife mention could her Patient with regular normal voice; Lower back pain moved up to his neck; This spontaneous case was reported by a consumer and describes the occurrence of HYPOACUSIS (Lost his hearing in a 90% for almost 5 hours/I couldn't hear anything/he hear himself with a squeaky voice, but patient wife mention could her patient with regular normal voice) and NECK PAIN (Lower back pain moved up to his neck) in a 65-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 071F21A) for COVID-19 vaccination.     Previously administered products included for COVID-19 vaccination: COVID-19 VACCINE NRVV AD26 (JNJ 78436735). Past adverse reactions to the above products included No adverse event with COVID-19 VACCINE NRVV AD26 (JNJ 78436735). Concurrent medical conditions included Low back pain (treated with painkiller).    On 06-Jan-2022, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced HYPOACUSIS (Lost his hearing in a 90% for almost 5 hours/I couldn't hear anything/he hear himself with a squeaky voice, but patient wife mention could her Patient with regular normal voice) and NECK PAIN (Lower back pain moved up to his neck). At the time of the report, HYPOACUSIS (Lost his hearing in a 90% for almost 5 hours/I couldn't hear anything/he hear himself with a squeaky voice, but patient wife mention could her Patient with regular normal voice) had resolved and NECK PAIN (Lower back pain moved up to his neck) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, SARS-CoV-2 test: negative (Negative) Negative.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter considered NECK PAIN (Lower back pain moved up to his neck) to be related. No further causality assessment was provided for HYPOACUSIS (Lost his hearing in a 90% for almost 5 hours/I couldn't hear anything/he hear himself with a squeaky voice, but patient wife mention could her Patient with regular normal voice).    No concomitant product was provided. No treatment information was provided. The patient could hear himself with a squeaky voice, but patient wife mention she could hear the Patient with his regular normal voice. No expiration date available on vaccination card.
About 5 mins after vaccines were administered pt felt dizzy and stated that his leg "felt numb". He was clammy and nauseated. No LOC BP was 105/62 after 15 mins was feeling better.
After getting my 1st shot I began experiencing severe symptoms of ASIA syndrome, a sudden onset of multiple autoimmune disorders; I have rheumatology results from June pointing towards RA, sjogren's syndrome & lupus; I have rheumatology results from June pointing towards RA, sjogren's syndrome & lupus; I have rheumatology results from June pointing towards RA, sjogren's syndrome & lupus; This is a spontaneous report from a contactable consumer (patient). A 45-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) (batch/lot number was not reported) dose 1, via an unspecified route of administration, administered in arm right on 08Apr2021 14:00 (45-year-old at vaccination) as single dose for COVID-19 immunisation. Facility type vaccine was Public Health Clinic/Veterans Administration facility. Medical history included morbid obesity. No other vaccine in four weeks. Other medications in two weeks included levothyroxine. No Covid prior vaccination. Shortly after getting his 1st shot, he began experiencing severe symptoms of autoimmune/inflammatory syndrome induced by adjuvants (ASIA) syndrome, a sudden onset of multiple autoimmune disorders. He had rheumatology results from June pointing towards rheumatoid arthritis (RA), sjogren's syndrome & lupus. Adverse event start date was 12Apr2021. AE resulted in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care, hospitalization, life threatening illness (immediate risk of death from the event), disability or permanent damage. Number days hospitalization was 1. Treatment for AE included steroid injection. He got his 2nd shot of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on 29Apr2021 at 11:00 AM in right arm, because he didn't correlate his issues with the shot at that time. The patient was not recovered from the events. It was unknown if covid tested post vaccination.  The lot number for BNT162B2, was not provided and will be requested during follow up
Recieved vaccine without incident at 1630 on 7/8/09, on following day [7/9/09] child almost passed out about 1100 hours in am.  Reportedly child sat down, pale and c/o seeing black in corners of eyes. C/o arm pain at vaccine site on  7/9/09 and 7/10/09.  Also c/o headache on 7/9/09 Site/deltoid noted to be red, swollen and warm and tender to touch.  By 7/11/09 arm site noted to be less red and tender.  No further c/o fainting occurred.
Approx 48 hrs after flu vaccine in (R) deltoid I felt a stinging & burning at injection site. I looked to see if I had been bitten by an insect & there was a blister which shortly unroofed itself. Beneath was a 1 1/4 cm lesion which appeared as a smallpox vaccine. Induration approx 4 cm x 4 days.
FEVER OF 102.4F FOR 36 HOURS HEADACHE, DIZZINESS, AND NAUSEA FOR 48 HOURS
Injected Novartis FLUVIRIN vaccine (UT97840P1, exp 5/10) in Rt arm. Pt immediately complained of dizziness, then dry throat and cold feeling/tingling in extremities. BP was 159/99, then 145/89. Dizziness got worse. Gave pt 25 mg BENADRYL PO and called EMS. Pt never lost consciousness but dizziness worsened. EMS transported to hospital.
Covid-19 (probable) / her new symptoms overlap with Covid; body aches; chills; Headache; This case was reported by a physician via call center representative and described the occurrence of suspected covid-19 in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   Concomitant products included paracetamol (Tylenol).   On 12th November 2020, the patient received the 2nd dose of Shingrix. On 13th November 2020, 1 days after receiving Shingrix, the patient experienced suspected covid-19, general body pain, chills and headache. On an unknown date, the outcome of the suspected covid-19, chills and headache were unknown and the outcome of the general body pain was recovered/resolved.   It was unknown if the reporter considered the suspected covid-19, general body pain, chills and headache to be related to Shingrix.  Additional details were provided as follows: The reporting physician was the concerned patient. The age at vaccination was not reported. The reporter had the second dose of Shingrix administered on 12th November 2020 and someone at reporter's location had a positive test for COVID.  The physician pre and post medicated herself with Tylenol for her 2nd dose of Shingrix. Since the first dose provoked adverse reactions to the patient (left in bed for 3 days), and some of her new symptoms overlap with COVID, reporter wanted to know if the Shingrix vaccine could cause a false test result. The reporter called for information regarding the possibility of interference between the Shingrix vaccine and a COVID test. The reporter consented to follow up.; Sender's Comments:  US-GLAXOSMITHKLINE-US2020225587:same patient.
N/v/d beginning at 0245 on 02/05 going on 12+ hrs. Vx3, dx8.  Began use of peptobismal a 9:45 am with minimal improvement. Rehydration with pedialyte. Symptoms ongoing.  all over body aches and chills, possible low grade fever (temp unknown). Treated with Motrin and Tylenol. Mostly tesolved
Pt had fine red papular flat rash scattered moderately to trunk and neck. No whelps minimal itching. Treated by mom w/BENADRYL. Advised to monitor for worsening.
Allergic reaction; This spontaneous case was reported by a physician assistant and describes the occurrence of HYPERSENSITIVITY (Allergic reaction) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No medical history was provided by the reporter.     On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced HYPERSENSITIVITY (Allergic reaction). At the time of the report, HYPERSENSITIVITY (Allergic reaction) had resolved.        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.
temp elevation came on fast; By 5PM was rapidly going up; By 9PM temp was 104 ax; Mom gave APAP & pushed fluids;
had this vaccine, got shingles/suspected vaccination failure; shingles; This case was reported by a consumer via  interactive digital media and described the occurrence of suspected vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, 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 Shingles vaccine.  Additional details were reported as follows: The case was reported by the patient's friend. The age at vaccination was not reported. The patient had this so called vaccine, got shingles twice. This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule, time to onset and laboratory confirmation were unknown at the time of reporting. No contact details were available.
Fever; feels weak; tired; lightheaded; pain at the injection site; back and hip pain; back and hip pain; This is a spontaneous report from a contactable other healthcare professional (patient). A 47-year-old female patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: EK5730), via an unspecified route of administration on 29Dec2020 at a single dose for COVID-19 immunization. The patient's medical history included sick with coronavirus infection from 11Aug2020. There were no concomitant medications. The patient was experiencing the expected side effects fever, feels weak, tired, lightheaded, pain at the injection site in the right deltoid, hip and back joint pain on Dec2020. She does not know exactly when these events started but that she noticed them when she was trying to sleep last night. Outcome of the events was not recovered. The events were considered serious due to being medically significant.; Sender's Comments: Based on temporal association, the causal relationship between BNT162b2 and the events pyrexia, asthenia, fatigue, dizziness, vaccination site pain, back pain and arthralgia cannot be excluded.
Information has been received from an office manager, concerning a 25 year old female patient who on an unspecified date was vaccinated with the second dose of GARDASIL.  The patient experienced pain and swelling in her left arm after the vaccine was given.  The patient was given GARDASIL in another clinic but she presented to the physician's office with this reaction.  The reporter stated the patient had pain and swelling after the first dose but was not this severe.  The pain and swelling lasted one week after this second dose was given.  The patient was sent to the hospital and admitted.  The patient recovered on an unknown date.  The patient sought medical attention at physician's office.  There was no product quality complaint.  Follow up information has been received from medical records and the office manager, concerning a 25 year old female patient who on an unknown date was vaccinated with 0.5 mL of the second dose of GARDASIL IM.  On 01-MAY-2008, the patient was seen in office for swelling and pain in arm which began on 28-APR-2008.  The patient was sent over for ultrasound and it was determined she had a hypoechoic thrombus that completely occluded and moderately expanded the left subclavian vein, axillary vein, mid and proximal basilic vein, mid and proximal brachial vein and proximal - most cephalic vein.  No blood flow identified within these particular structures.  The thrombus did not extend distal to the antecubital fossa.  The patient was hospitalized for an unspecified number of days.  Approximately, on 05-MAY-2008 (also reported as one week) the patient was recovered.  The reporter considered the event to be life-threatening and an other important medical event.  No further information is expected.  All available medical records will be provided upon request.  9/15/2008 MR received from PCP including some hospital records. Pt presented to PCP on 4/28/08 with c/o shoulder pain x 5 days, tingling fingertips.  Pain from shoulder to elbow with movement. DX: LUE radiculopathy. Sent for X-ray and CT-both (-). Acute thrombus dx by doppler/duplex exam.  10/20/2008 MR received for DOS 5/1-6/2008 and ER visit 7/22/08.  D/C DX: RUE DVT.  Pulmonary embolism.  Positive for lupus anticoagulant.  Pt presented with 1 week hx of progressive L shoulder pain and swelling of the L arm associated with L-sided chest pain and slight shortness of air. Tx with TPA followed by heparin and coumadin.  Labs c/w antiphospholipid syndrome. D/C on Lovenox. Pt returned to ER 7/22/08 with c/o chest pain and funny sensation of the L arm. W/u (-).
Migraine, extreme fatigue, no appetite, nauseous, muscle and joint aches. Spent 2-3 days in bed.
Red area around back of leg w/red streaks acending & decending fr inject site; Seen by MD in PM looked like a cellutitis;
About 24 hours after my shot on Thursday, I began to have shortness of breath, coughing, and needed to take my rescue inhaler.  I needed to take it 2 more times within the next 24 hours. I was coughing and it was leaving the taste of blood in my mouth.  I was not coughing anything up though. I wasn?t able to do a 3 minute task at home without coughing.   By Saturday 48 hour later, I was still having shortness of breath, my lungs felt like they were burning,  but it wasn?t as bad.  By 8:00pm Saturday night the shortness of breath was gone and I was breathing easier.  I still feel a slight tightness in my chest and coughing at the moment, but it feels like a residual cough like I would have after a cold. The only other effect I had was a sore arm after the shot which lasted about 4 hours and the next morning being slightly achy.
AFTER RECEIVING THE SHOT, SHE COMPLAINED OF TASTING THE METALIC TASTE, HER VISION WAS BLURRY, HER FEET WERE HEAVY. ON SITE EMS RESPONDED. SHE SAID SHE FORGOT  TO TAKE HER METOPROLOL THIS MORNING (PART OF HER NUMBERS TODAY). SINCE IT HAD BEEN AT LEAST AN HOUR SINCE SHE RECEIVED THE VACCINE AND HER VISION WAS STILL BLURRY, IT WAS RECOMMENDED TO GO TO E.R. FOR FURTHER EVALUATION AND SHE AGREED. EMS TRANSPORTED HER TO THE E.R.
Persistent fevers for 5 days of up to 103.2 F only partially relieved by Tylenol and ibuprofen to come down to 101F. Nausea and vomiting for 5 days. Night sweats still occurring at 7 days from vaccination. Abdominal rash from  day 3 still present day 8/present.
Client called clinic on 08/01/2019 with complaints of soreness to injection site, states she has alternated "cold and hot" compresses to site.  Client also states she has a "knot" at the injection site and stiffness in her neck that started on Wednesday.  Clinical staff instructed client to continue to monitor and to gently massage site in a circular motion as well as application of cool and warm compresses.  Client also asked if she could apply "Benadryl cream" to site as there is some slight itching and was told by staff that would be fine. Follow up call from clinic on 8/2 9:30am states itching better, redness and soreness the same. Instructed to perform stretches, continue massage and alternating cold packs for no more than 20 minutes at a time.  Denies hives, mobility issues, fever or chills.
Awoke at 12:30 A.M. 11/10/07 with extreme itching and redness in left arm elbow joint. Itching progressed and spread to both arms, chest, neck and left side of face. 11/11/07 Hives broke out on arms, chest, back, neck and left side of face. Lasted until 11/14/07. Tried Benadryl.
Starting about 10 hours after receiving the second Modern vaccination I experienced a minor headache and drowsiness, which continued until about 30 hours after the vaccination. These symptoms resolved without treatment. Around 20 hours after the vaccination an itchy rash developed on the lower lip, around the left eye, and in the genital area (including: penis, testicles, and upper inner thigh). Rash continued to get worse until about 4 days after the vaccination. At this point I sought treatment at a local urgent care. The urgent care personnel said they believed the rash symptoms were caused by the Modern COVID-19 vaccination, did not identify any other possible causes, and encouraged me to report it to the VAERS system. The treatment followed was topical 1% hydrocortisone cream applied to the affected areas, and 12.5 mg of diphenhydramine taken orally before bed. The rash symptoms improved with treatment but have not fully resolved at 5 days after the vaccination.
This spontaneous case report was received from a pharmacist (PVX2018-3285) on 27-Nov-2018. The report describes a 38-year-old adult female consumer who "took the vaccine without the buffer component". The consumer was receiving VAXCHORA for an unknown indication. It was reported that the consumer took VAXCHORA but forgot to put the buffer component into the water, and drank only the active component. The action taken with VAXCHORA with respect to the event "took the vaccine without the buffer component" was not applicable. The clinical outcome of the event "took the vaccine without the buffer component" was unknown. Company's Comment: The causality of the event "took the vaccine without the buffer component" was considered as not applicable.
FEVER, HEADACHE, CHILLS, TREMORS. ABDOMINAL PAIN, NAUSEA, GENERAL MALAISE, ARTHRALGIA, ANERGY, VERTIGO, SOMNOLENCE, ARM PAIN (AREA OF INJECTION)
#1: RASH IN RIGHT HAND, DERMITOLOGIST SAID "WEIRD, LIKE FROM WITHIN BODY" - STAYED FOR 2 MONTHS TRYING DIFFERENT CREMES AND BENADRYL FOR ITCHING, FINALLY A STEROID CREME GAVE RELIEF, STILL POPS UP IN TIMES OF HEAT.  NEVER OCCURED BEFORE IN 57 YEARS  #2: NAUSEA, WEAKNESS, GAUNT APPEARANCE, TIRED, LACK OF APPETITE, LOW-GRADE FEVER
Did'nt work got it two weeks later, with no reported adverse events; Initial information received on 02-Dec-2022 regarding an unsolicited valid Social Media serious case received from a consumer.  This case involves an unknown age and unknown gender patient for whom influenza vaccine didn't work got it two weeks later, with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  On an unknown date, the patient received a dose of suspect influenza vaccine produced by unknown manufacturer (formulation, strength, dose and lot number not reported) via unknown route in unknown administration site for prophylactic immunization.  On an unknown date, the patient got influenza vaccine which didn't work got it two weeks later, with no reported adverse events (vaccination failure) (unknown latency) following the administration of influenza vaccine.   It was reported, Did't work got it two weeks later.  Action taken was not applicable.  At time of reporting, the outcome was Unknown for the event.  Seriousness criteria: The event of vaccination failure was assessed as medically significant.; Sender's Comments: Sanofi Company Comment dated 07-Dec-2022: This case involves an unknown age and unknown gender patient for whom influenza vaccine didn't work got it two weeks later, with no reported adverse event. Furthermore, information regarding condition at the time of vaccination, previous vaccination history, medical history of the patient, lab data excluding other predisposing etiologies, intervention (if any) and corrective treatment/medical management would be needed for complete assessment of the case. Based upon the reported information, the role of an individual vaccine cannot be assessed.
PATIENT COMPLAINED OF IMMEDIATE ARM PAIN, AND SINCE RECEIVING INJECTION HAS HAD TROUBLE LIFTING HER LEFT ARM IN WHICH SHE RECEIVED INJECTION, ALSO HAS COMPLAINED OF LETHARGY AND NOT WANTING TO GET OUT OF BED.