chrisvoncsefalvay/vaers-outcomes huggingface dataset:
More energy,feels happy, no longer needs to take Adderall; This non-serious case was reported by a consumer via call center representative and described the occurrence of unexpected therapeutic effect in a 53-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.  Previously administered products included Adderall (no longer needs to take her Adderall).  On 07-FEB-2023, the patient received the 1st dose of Shingrix. In FEB-2023, an unknown time after receiving Shingrix, the patient experienced unexpected therapeutic effect (Verbatim: More energy,feels happy, no longer needs to take Adderall). The outcome of the unexpected therapeutic effect was unknown.  Linked case(s) involving the same patient: US2023AMR060467   Additional Information: GSK receipt date:21-APR-2023 The reporter stated that she had the complete Shingrix vaccination series.  With both injections the patient reported she felt happy and had more energy.  She felt happier than she had been in 20 years.  She no longer needs to take her Adderall.  The reporter said the feeling goes away after 31 or 32 days. The reporter consented to follow up. For tolerance to the 2nd dose refer case US2023AMR060467.; Sender's Comments:  US-GSK-US2023AMR060467:Same report/Other dose
Pt was accompanied by daughter, who drove pt to clinic. Pt was correctly identified, screened, given vaccine, monitored for appropriate time.  Pt left clinic as passenger of vehicle and was being driven  by daughter.  Pt started complainingg of Shortness of breath and not feeling right..  Daughter brought pt to local emergency room, Pt was later transferred to higher care hospital.  Information regarding symptoms and further medical care was relayed to clinic by family member.
Patient developed a permanent soft tissue swelling approximately 15mm diameter round indurated mass at site of injection both 11/19/03 and 10/13/2004. The lesion developed about 3 weeks post injection. Follow up report received 03/16/2005:  Checked with Allergist, no treatment, no sure about vaccine next year.
pt recvd vax & exp SOB, runny nose & cold sx; has been sick ever since shot; has malaise & cough;
This spontaneous medically confirmed report (initial receipt 04-Sep-2013) concerns a male patient. On an unspecified date, the patient was administered influenza vaccine (batch number and manufacturer not provided) and ZOSTAVAX (batch number not provided) concomitantly. Then on an unspecified date, he developed Bell's palsy. The overall event outcome was unknown.
At approx. 10 pm the evening after receiving the injection pt. noticed his upper (L) arm was itchy, red, slight swelling and painful. Pt was seen at the office 7-13-16. Dr checked his arm. Local reaction, no Rx given. *Pt requested both injections given in same arm because he plays sports - Mom in agreement*
Upper right arm erythema on 28May2019 to 05Jun2019; This is a spontaneous report from a contactable physician. A patient of unknown age and gender received on an unknown date meningococcal group b rlp2086 (TRUMENBA, Lot# 18-002303, Exp. Date 31Jan2020) at 0.5 ml single for immunization. Medical history and concomitant medications were not reported. At study visit (day 8), on 28May2019, the patient experienced upper right arm erythema that recovered on 05Jun2019.
Tuesday, March 30 - COVID19 vaccination / Friday, April 2 - severe headache, arm pit pain in left arm pit, sore arm / Saturday, April 3 headache (less than on Friday), chest constriction, back pain, anxiety, hives and itching, took Benadryl and hives went away / Sunday, April 4 anxiety, intermittent chest constriction & back pain / Monday, April 5 & Tuesday, April 6  intermittent headache, tired / Wednesday, April 7 swollen fingers and feet / Thursday, April 8 - fingers remain still swollen
ELEVATED GLUCOSE; ELEVATED ALT; ELEVATED AST; BALL LIKE AREA LIKE A LYMPH NOTE GETTING HARD ABOVE LEFT CLAVICLE SWOLLEN; LEFT ARMPIT LIGAMENT AREA TENDER AND SENSITIVE; LOWERED APPETITE; PAIN IN ARM RADIATING TO NECK AND CHEEK; TINGLING SENSATION; NAUSEA; TIREDNESS; MUSCLE PAIN; INJECTION SITE PAIN; FEVER; MUSCLE SPASM; MUSCLE TENSED UP; DISCOMFORT IN LOWER BACK; BODY TEMPERATURE WEIRD; This spontaneous report received from a patient concerned a male of unspecified age. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805029, and expiry: UNKNOWN) dose was not reported, administered on 20-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On 20-MAR-2021, the subject experienced muscle spasm. On 20-MAR-2021, the subject experienced muscle tensed up. On 20-MAR-2021, the subject experienced discomfort in lower back. On 20-MAR-2021, the subject experienced body temperature weird. On 20-MAR-2021, the subject experienced injection site pain. On 20-MAR-2021, the subject experienced fever. On 21-MAR-2021, the subject experienced pain in arm radiating to neck and cheek. On 21-MAR-2021, the subject experienced tingling sensation. On 21-MAR-2021, the subject experienced nausea. On 21-MAR-2021, the subject experienced tiredness. On 21-MAR-2021, the subject experienced muscle pain. On 22-MAR-2021, the subject experienced lowered appetite. On 22-MAR-2021, the subject experienced ball like area like a lymph note getting hard above left clavicle swollen. On 22-MAR-2021, the subject experienced left armpit ligament area tender and sensitive. On 25-MAR-2021, the subject experienced elevated glucose. On 25-MAR-2021, the subject experienced elevated alt. On 25-MAR-2021, the subject experienced elevated ast. Laboratory data (dates unspecified) included: Alanine aminotransferase (NR: not provided) ALT increased, Aspartate aminotransferase (NR: not provided) AST Increased, and Blood glucose (NR: not provided) Blood Glucose level high. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from muscle spasm, muscle tensed up, discomfort in lower back, pain in arm radiating to neck and cheek, tingling sensation, injection site pain, fever, and muscle pain on 21-MAR-2021, body temperature weird on 20-MAR-2021, and nausea, and tiredness on 22-MAR-2021, was recovering from lowered appetite, and ball like area like a lymph note getting hard above left clavicle swollen, and had not recovered from elevated glucose, left armpit ligament area tender and sensitive, elevated alt, and elevated ast. This report was non-serious.
Severe, Nausea, Diarrhea, Fatigue & Lost of Taste.   Some Weakness, Hot Sweats, Headaches, Hot Sweats,  Coughing,  Shortness in Breath.  Then after about a week I had, Loss of Smell,  Mild Sore Throat & Runny Noise.
got the 1st dose of the Pfizer COVID Vaccine on 26Apr2021 and then got sick; got sick with a cold; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program. The reporter is the patient.  A female patient received bnt162b2 (BNT162B2), administration date 26Apr2021 (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: ILLNESS (non-serious) with onset 2021, outcome "unknown", described as "got the 1st dose of the Pfizer COVID Vaccine on 26Apr2021 and then got sick"; NASOPHARYNGITIS (non-serious) with onset 2021, outcome "unknown", described as "got sick with a cold". Relevant laboratory tests and procedures are available in the appropriate section. Additional information: The patient got first dose of the Pfizer COVID Vaccine on 26Apr2021 and then got sick and asked if she would need to get first dose again or could she get the second dose. Stated her being sick was not associated with the Pfizer Covid vaccine and it had been four months since her first dose.  Stated when she got sick it was not an issue of the Pfizer vaccine and what happened was she had her second dose appointment scheduled and got sick with a cold and not covid and tested negative for covid. Caller stated that she did not feel the need to take a report and she had no adverse reaction but it was just timing related to her vaccine.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Migraine/headache through the night starting around 9pm and into the next day; Ache in arm; This is a spontaneous report received from a contactable consumer, the patient. A 54-year-old non-pregnant female patient received her first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EP7534), via an unspecified route of administration in the right arm on 20Mar2021 at 13:30 (at the age of 54-years-old), as a single dose for COVID-19 immunisation. Medical history included bronchiectasis and migraines due to winter/pressure (haven't had a migraine in weeks as winter was over). The patient did not have any allergies to food, medications, or any other products. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested positive for COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient did not receive any other medications within two weeks of vaccination. On 20Mar2021 at 21:30, the patient experienced migraine/headache throughout the night and into the next day (21Mar2021). The patient had no idea how long this would last. The patient also experienced ache in arm on 20Mar2021 but was not concerned. The events didn't result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The patient did not receive any treatment for the events. The clinical outcome of the events pain in arm and migraine headache was not recovered at the time of this report.  No follow-up attempts are needed. No further information is expected.
Sore throat, headache, runny nose, fatigue, & chills. Chills only lasted couple hours night of 11/14/2009. The sore throat lasted until morning of 11/15/2009. The headache lasted until the morning of 11/16/2009. Runny/stuffy nose and fatigue still present.
First Symptoms 1/14/21 7:30pm: Entire left arm pain unable to lift my arm. Left hip pain. Morning 1/15/21: Extreme exhaustion Early afternoon 1/15/21: Extreme joint pain unable to sit up  or walk. Had to hold on to walls to shuffle feet to restroom. All major joints in pain. Out of breath on standing. Afternoon 1/15/21: New onset of small joint pain throughout body in addition to previous symptoms. Chills began at 3:30pm. Unable to hold a phone or grasp items.  1/15/21 6pm: Able to get out of bed a walk a few steps Joint pain and exhaustion continued through 1/16/21 able to walk. 1/17/21: tiredness and medium joint pain 1/18/21: minor tiredness and very minimal joint pain 1/19/21: Feeling back to normal
inner elbow was sore; feels numb; I have terrible muscle pain in my upper left arm where I received the injection which radiates up my neck and shoulder blade; I have terrible muscle pain in my upper left arm where I received the injection which radiates up my neck and shoulder blade; I have terrible muscle pain in my upper left arm where I received the injection which radiates up my neck and shoulder blade; I have terrible muscle pain in my upper left arm where I received the injection which radiates up my neck and shoulder blade; This is a spontaneous report from a contactable other healthcare professional, (patient). A 53-years-old non-pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6201), dose 1 via an unspecified route of administration, administered in Arm Left on 11Feb2021 14:45 (at the age of 53-years-old) as a single dose for covid-19 immunization. Medical history included autoimmune thyroiditis: Hashimoto thyroid, hypertension. The patient did not have any allergies. The patient had no other vaccine within four weeks and other medications was received within 2 weeks of vaccination (not sepcified). Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On 16Feb2021, the patient experienced inner elbow was sore for a day. Since, I have terrible muscle pain in my upper left arm where I received the injection which radiates up my neck and shoulder blade. Sometimes it feels numb and radiates down my arm to my fingers. The patient did not receive any treatment. Outcome of the event was unknown. Follow-up attempts completed. No further information expected.
Presented to clinic 2 days after shot was given. RALT red and swollen over 3 1/2" diameter area with lg hard knot under it about 2 1/2" in diameter. C/O pain and itching. Temp WNL, but injection site is hot to touch. Advised to put ice on it, use cool bath, etc. May even use hydrocortisone cream to help with itching, as pt keep wanting to scratch it. Parent says child is acting normally.
At 1206 on 02/23/2023 patient was administered 0.25 mL of Moderna 6m - 5yr Bivalent booster. Patient tolerated injection well during the 15 minute observation period. Parents notified. Confirmed with Pediatrician that no harm will come to the patient.
Site: Pain at Injection Site-Medium, Site: Redness at Injection Site-Severe, Site: Swelling at Injection Site-Severe, Error: Infection / Cellulitis (diagnosed by MD), Additional Details: hot to touch arm, swollen, red, no fever
Stroke; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  An 82-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 10Oct2022 as dose number unknown (booster), single (Lot number: GJ6665) at the age of 82 years for COVID-19 immunization. The patient had no relevant medical history. There were no concomitant medications. Vaccination history included: Covid-19 vaccine (Primary immunization series complete; unknown manufacturer), for COVID-19 immunization. The following information was reported: CEREBROVASCULAR ACCIDENT (hospitalization) with onset 24Nov2022, outcome "unknown", described as "Stroke". The patient was hospitalized for cerebrovascular accident (start date: 24Nov2022, discharge date: 27Nov2022, hospitalization duration: 4 day(s)). The patient underwent the following laboratory tests and procedures: Lab work: unknown result, notes: Lab work: Reporter stated, "Many (Further name and results of lab tests were not clarified over the call). Therapeutic measures were taken as a result of cerebrovascular accident.  Clinical course: Reporter stated, he want to report an adverse reaction or he was not sure it is but he was reading on the CDC website and it said the new variant can cause Stroke.Then probed for the adverse event: Reporter stated, A stroke. And he was the one that had the stroke. Medical conditions and Concomitant medications Reporter stated, nothing, he has no health issues. Reporter stated, "Many (Further name and results of lab tests were not clarified over the call hence tab left unchecked). He was hospitalized. This event happened on 24Nov2022. Not today it happened. Treatment: Reporter stated, Nothing, you mean like TPA? He had no, no any sort of that kind of treatment. He is now taking a Baby Aspirin." Discharge date: Reporter stated, "Whatever, 4 days later. He was there 4 days, discharged on 27Nov2022 (27Nov2022) in the evening."
fever; chills; This is a spontaneous report from a contactable consumer (the patient). A 65-year-old male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/Lot number was not reported) via an unspecified route of administration on 18Mar2021 (reported as "yesterday") at age of 65-year-old at single dose for COVID-19 immunisation. The patient reported he received the vaccine "yesterday", and he had chills overnight since 18Mar2021 and on 19Mar2021 (reported as "today" ) he had a fever between 100-101.The caller would like to know whether he should get a COVID test due to his side effects from a COVID vaccine. The outcome of the events was unknown.  Information on Lot/Batch number has been requested.
Developed a ?scalded mouth? sensation in tongue and on roof of mouth. It was burning like raw and inflamed. Throat felt very dry, though no airway issues at all. Took 25 mg Benadryl with relief in 30 min. It is currently 4 hrs since that dose and it feels like the sensation is beginning to recur.
no adverse effect; multiple patients were vaccinated with improperly stored VAQTA on multiple dates; This spontaneous report was received from a medical assistant refers to a patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant medications were not reported. On 13-MAR-2019, the patient was vaccinated with improperly stored hepatitis a vaccine, inactivated(VAQTA) lot # R010369, expiry date 25-MAR-2019 for prophylaxis.  No adverse event was reported. Previous temperature excursion was reported. Data logger was involved.
Pt recvd 1st Engerix-B vax 9SEP91 & exp neck rash on 18SEP91; treated w/DPH; rash has improved;
FEVER; PASSED OUT/ 'FELT REALLY BAD/TERRIBLE/HORRIBLE, VITALS VERY LOW, FELT WARM, SWEAT, CHILLS, FELT WEAK, FEELING TIRED/EXHAUSTION; CRASHING TO THE FLOOR; LEFT BUTT CHEEK HURTS; This spontaneous report received from a patient concerned a 40 year old female.. The patient's height, and weight were not reported. The patient's past medical history included passed out, and other pre-existing medical conditions included the patient had passed out when getting blood work done previously. The patient was previously treated with influenza vaccine for prophylactic vaccination. The patient was not pregnant at the time of reporting. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 205A21A, and expiry: UNKNOWN) dose was not reported, 1 total dose administered on 09-APR-2021 13:15 in left deltoid for prophylactic vaccination. No concomitant medications were reported.  On APR-2021, Laboratory data included: Vital signs measurement (NR: not provided) Not reported.  On 10-APR-2021, the patient experienced passed out/ felt really bad/terrible/horrible, vitals very low, felt warm, sweat, chills, felt weak, feeling tired/exhaustion. On 10-APR-2021, the patient experienced crashing to the floor. On 10-APR-2021, the subject experienced left butt cheek hurts. On 11-APR-2021, the subject experienced fever. the patient woke up in the morning, and while washing her hands in the bathroom, she began to feel really bad and started to lower herself down and she passed out, then she ended up crashing to the floor, she did not hit her head, and her left butt cheek got hurt. Her husband called emergency medical services (EMS) who treated her until she regained consciousness. Patient also stated that she felt terrible and horrible. Emergency medical services recommended that she be taken to the hospital for further evaluation, but she declined. She had a history of passing out after bloodwork, but had never had this delayed of a reaction with bloodwork or any reaction to the flu shot. EMS called and her vitals were all very low. She did not go to the hospital. She felt improved and had been taking it easy at the time of this report. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from crashing to the floor on 10-APR-2021, and was recovering from passed out/ felt really bad/terrible/horrible, vitals very low, felt warm, sweat, chills, felt weak, feeling tired/exhaustion, left butt cheek hurts, and fever. This report was serious (Other Medically Important Condition).; Sender's Comments: V0: 20210420904-covid-19 vaccine ad26.cov2.s-Passed out. This event(s) is considered unassessable. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s).
No allergies. Syncope, HBP, broken nose, black eyes, split lip, Rx lisinopril. Four days acute care in hospital's cardiology department. Following discharge TeleSentry recorder revealed atrial fibrillation. Rx to follow. For 86 years, no Rx required.
I noticed a  lump under my left armpit after the second dose of the Pfizer vaccine. It's currently April 12,2021 9:21 pm.  It's been almost two weeks since my second dose (March 30,2021). It's not a huge concern. It's tender and hurts a little.  No treatments at the moment. I haven't contacted my doctor yet. If it hasn't gone away in another 2 weeks or so then I will contact my Doctor.
Pt usually faints when receiving a vaccination. However, after patient warned me of her passing out, she had a brief seizure instead. Lasting under 1 minute, clonic-tonic jerking.
Severe period cramps starting on 4/16, continued to get worse 4/17. Passing blood clots (does not normally happen).
Tues. became lethargic, felt like he had been stung by bees all over. In office 10/30 c/o pain Rt deltoid. Red, warm 7cm x 6cm area.
hot flashes; fever; feeling flush; sweating; shoulder achiness; This case was reported by a physician via call center representative and described the occurrence of shoulder pain in a 71-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Concurrent medical conditions included psoriatic arthritis. Concomitant products included tofacitinib citrate (Xeljanz).   On 23rd September 2020, the patient received Shingrix (intramuscular). On 23rd September 2020, less than a day after receiving Shingrix, the patient experienced shoulder pain. On 29th September 2020, the patient experienced hot flashes, fever, flushing and sweating. On an unknown date, the outcome of the shoulder pain was recovered/resolved and the outcome of the hot flashes, fever, flushing and sweating were not recovered/not resolved.   It was unknown if the reporter considered the shoulder pain, hot flashes, fever, flushing and sweating to be related to Shingrix.  Additional details were provided as follows: The physician called for his wife. The Patient currently taking Xeljanz for the treatment of psoriatic arthritis. The patient received Shingrix in the left deltoid and developed shoulder achiness that resolved on its own later that same day.  6 days after the Shingrix vaccine the patient developed fever, hot flashes, sweating, and feeling of flush which occurs every day in the afternoon and spontaneously resolves by the end of each day.  The events are reported as ongoing The reporter consented to follow up.
HUSBAND STATES THAT THE NEXT DAY (10/20/23) PATIENT COULD NOT GET OUT OF BED. HE SAID SHE WAS ABLE TO GET OUT OF BED THE FOLLOWING DAY (10/21/23), BUT THAT SHE FELT PROGRESSIVELY WORSE. SHE WAS ADMITTED TO ER AT FACILITY FOR ALTERED MENTAL STATUS ON 10/29/23. SHE WAS FOUND TO HAVE A HEMMORHAGE OF THE RIGHT FRONTAL LOBE AND WAS AIR LIFTED TO HOSPITAL WHERE SHE LATER PASSED.
One week after vaccination I?m experiencing a swollen  itchy, red, hard cystic like bump  at injection site.  There was initial pain. redness, and swelling but  symptoms went away  after 3 days and returned after 6 days.