chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Arm is a little sore where the booster dose Vaccine was administered; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A female patient received bnt162b2 (BNT162B2), administered in arm (Batch/Lot number: unknown) as dose 3 (booster), single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (1st dose), for Covid-19 immunization; Bnt162b2 (2nd dose), for Covid-19 immunization. The following information was reported: PAIN IN EXTREMITY (non-serious), outcome "recovering", described as "Arm is a little sore where the booster dose Vaccine was administered".  Additional information: The caller and the caller's husband received the booster dose Pfizer Covid Vaccine. The caller and the caller's husband also received the first two doses Pfizer Covid Vaccine and had no problems. The caller states she is not having any problems after receiving the booster dose Pfizer Covid Vaccine. The caller clarifies, the caller's arm is a little sore where the booster dose Pfizer Covid Vaccine was administered. Reporter stated patient was fine.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
currently taking Mobic (meloxicam) and want to get 4th injection; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (currently taking Mobic (meloxicam) and want to get 4th injection) in a  patient of an unknown age and gender who received mRNA-1273 (Spikevax) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On an unknown date, the patient experienced VACCINATION COMPLICATION (currently taking Mobic (meloxicam) and want to get 4th injection). The patient was treated with MELOXICAM (MOBIC) ongoing since an unknown date at an unspecified dose and frequency. At the time of the report, VACCINATION COMPLICATION (currently taking Mobic (meloxicam) and want to get 4th injection) outcome was unknown.        The action taken with mRNA-1273 (Spikevax) (Unknown) was unknown.       No concomitant medications were reported.  Reportedly, patient was currently taking Mobic (meloxicam) and wanted to get 4th injection. Since Mobic is an NSAID, it was enquired if it would reduce the effectiveness of the vaccine similar to Advil or other NSAIDs.
No adverse event reported. This report is to inform patient received the vaccine beyond its use date. Patient received the vaccine after the 30 days stored under refrigeration. Vial moved to fridge on 4/3/23 and patient received vaccine on 5/9/23.
Patient developed left sided chest pain that lasted for approximately 12 hours.  It then improved but she still had it with lifting heavy objects.  Was seen in clinic.  Went home and has follow-up with Pediatric Cardiology tomorrow.
tongue and central facial numbness resolved within 3 hrs Narrative:  reports 3hrs of numbness but no medical f/u at time
pain on both quadriceps; leg pain/ pain in arm; muscle on fire; tenderness at vaccination site; burning sensation; stiffness in his R quadricep; fatigue; This spontaneous case was reported by a consumer and describes the occurrence of BURNING SENSATION (burning sensation), MUSCULOSKELETAL STIFFNESS (stiffness in his R quadricep), PAIN (pain on both quadriceps), PAIN IN EXTREMITY (leg pain/ pain in arm) and MYALGIA (muscle on fire) in a 50-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medical history was reported by the reporter.  Concomitant products included BISMUTH SUBSALICYLATE, CALCIUM CARBONATE (PEPTO BISMOL [BISMUTH SUBSALICYLATE;CALCIUM CARBONATE]) for an unknown indication.    On 21-Apr-2021 at 10:30 AM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 21-Apr-2021, the patient experienced FATIGUE (fatigue). On 22-Apr-2021, the patient experienced BURNING SENSATION (burning sensation) and MUSCULOSKELETAL STIFFNESS (stiffness in his R quadricep). On an unknown date, the patient experienced PAIN (pain on both quadriceps), PAIN IN EXTREMITY (leg pain/ pain in arm), MYALGIA (muscle on fire) and VACCINATION SITE PAIN (tenderness at vaccination site). At the time of the report, BURNING SENSATION (burning sensation), MUSCULOSKELETAL STIFFNESS (stiffness in his R quadricep), PAIN (pain on both quadriceps), PAIN IN EXTREMITY (leg pain/ pain in arm), MYALGIA (muscle on fire), VACCINATION SITE PAIN (tenderness at vaccination site) and FATIGUE (fatigue) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment details  included occasionally nausea medications. Event outcome details were not reported. Patient wants to know whether these side effects normal? and what should he do for the muscle aches?
Pt had MMR, VARIVAX and flu vaccine on 11/16/11. Pt developed fever night (11/16/11) and had febrile sz on 11/17/11.
ACUTE ONSET OF ATAXIA 08/13/2008. PATIENT AFEBRILE, NO INTERCURRENT ILLNESS, ACTING WELL IN ALL OTHER RESPECTS. NO HISTORY OF TRAUMA. PATIENT UNABLE TO KEEP BALANCE,UNABLE TO TAKE STEPS WITHOUT FALLING. SYMPTOMS PEAKED IN THE A.M. OF 08/15/2008, AFTER WHICH SHE WAS SEEN BY HER PRIMARY PEDIATRICIAN. AT THE TIME OF EVALUATION SHE WAS AFEBRILE, ALERT AND ACTIVE. SHE WAS ABLE TO TAKE A FEW STEPS BEFORE REELING AND FALLING, OCCASIONALLY LOSING BALANCE WHILE STANDING. PARENTS REPORTED THAT THIS EXAM WAS IMPROVED FROM EARLIER IN THE DAY. HER PHYSICAL EXAM WAS OTHERWISE WITHIN NORMAL LIMITS, INCLUDING NORMAL AND NON-FOCAL NEUROLOGIC EXAM. CRANIAL NERVES II-XII WERE GROSSKY INTACT, DEEP TENDON REFLEXES WERE PRESENT AND SYMMETRICAL THROUGHOUT UPPER AND LOWER EXTREMITIES, TONE WAS NORMAL-NO WEAKNESS IDENTIFIED, TOES WERE DOWNGOING, AND BEHAVIOR/INTERACTION/MENTAL STATUS WAS APPROPRIATE FOR AGE AND BASELINE FOR HER.
My child had gotten a fever last Thursday and I gave them an at home Covid-19 test and it was negative. The next day they started having congestion and a sore throat along with a slight cough. We did the test again and it was positive. Up until today they have experienced diminished taste and smell, so not fully lost them but they are less than normal. Today I will be contacting their PCP and following up with them as my child is still testing positive but symptoms have not changed.
Had a slight fever 24 hours later.  Two days later, felt great in the early morning, but around 9:00 a.m. experienced extreme vertigo, (over 4hours) vomiting, arms, hands and feet were tingling -- still dizzy. at 5:30 p.m.,    I have been drinking water all day to hydrate.
Paralysis of right face, loss of motor function; Inflammation of right face; loss of motor function; Excruciating pain in right eye; Pain in ear; Pain in teeth; Pain in jaw; Severe migraine; Headches; Lack of sleep; This case was reported by a consumer and described the occurrence of facial paralysis in a 67-year-old male patient who received Herpes zoster (Shingrix) (batch number 23YG7, expiry date unknown) for prophylaxis.   Concurrent medical conditions included bell's palsy. Concomitant products included prednisone and valaciclovir (Valacyclovir).   On 6th January 2023, the patient received Shingrix. On 7th January 2023, 1 days after receiving Shingrix, the patient experienced facial paralysis (serious criteria GSK medically significant and clinically significant/intervention required), skin inflammation (serious criteria clinically significant/intervention required), motor dysfunction (serious criteria clinically significant/intervention required), eye pain (serious criteria clinically significant/intervention required), ear pain (serious criteria clinically significant/intervention required), toothache (serious criteria clinically significant/intervention required), jaw pain (serious criteria clinically significant/intervention required), migraine (serious criteria clinically significant/intervention required), headache (serious criteria clinically significant/intervention required) and sleep loss (serious criteria clinically significant/intervention required). On an unknown date, the outcome of the facial paralysis, skin inflammation, motor dysfunction, eye pain, ear pain, toothache, jaw pain, migraine, headache and sleep loss were unknown.   It was unknown if the reporter considered the facial paralysis, skin inflammation, motor dysfunction, eye pain, ear pain, toothache, jaw pain, migraine, headache and sleep loss to be related to Shingrix.     Linked case(s) involving the same patient:  US2023AMR008523   Additional Information: GSK Receipt Date: 18-JAN-2023 Reporter's Comment: The case was self-reported by the patient. The patient received a dose of Shingrix and experienced inflammation or paralysis of right face with loss of motor function with excruciating pain in right eye, ear, teeth and jaw, also the patient had developed severe migraine headaches and lack of sleep. The reporter gave permission to contact. Additional Supportive Information: For tolerance of Pharma product refer link case US2023AMR008523, reported by same reporter for same patient.; Sender's Comments:  US-GSK-US2023AMR008523:Same patient/Pharma case
Rt vaginal labial edema, pain and pruritis. Rt axilla swelling and pruritus with fever per pt, unrecorded temp.
Arm soreness; Headache; This case was reported by a consumer via call center representative and described the occurrence of pain in arm in a 61-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   In June 2022, the patient received the 1st dose of Shingrix. On an unknown date, less than 3 months after receiving Shingrix, the patient experienced pain in arm and headache. On an unknown date, the outcome of the pain in arm and headache were recovered/resolved.   It was unknown if the reporter considered the pain in arm and headache to be related to Shingrix.  Linked case(s) involving the same patient:US2022AMR122951   Additional Information: GSK Receipt Date: 23-AUG-2022 Reporter's Comment: The reporter called at the time of reporting and stated that, she had her Shingrix about two months ago and experienced arm soreness and headache that resolved. The reporter consented to follow up. Additional Supportive Information: For tolerance of 2nd dose ,refer case US2022AMR122951.; Sender's Comments:  US-GSK-US2022AMR122951:Same reporter
Feeling terrible just like she felt when she had the virus; She hasn't eaten; has aches; Headache; Fever; This spontaneous case was reported by a consumer and describes the occurrence of FEELING ABNORMAL (Feeling terrible just like she felt when she had the virus), DECREASED APPETITE (She hasn't eaten), PAIN (has aches), HEADACHE (Headache) and PYREXIA (Fever) 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 09-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 09-Mar-2021, the patient experienced FEELING ABNORMAL (Feeling terrible just like she felt when she had the virus), DECREASED APPETITE (She hasn't eaten), PAIN (has aches), HEADACHE (Headache) and PYREXIA (Fever). At the time of the report, FEELING ABNORMAL (Feeling terrible just like she felt when she had the virus), DECREASED APPETITE (She hasn't eaten), PAIN (has aches), HEADACHE (Headache) and PYREXIA (Fever) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were provided by the reporter.  The patient was feeling sick since she received the vaccine. She was feeling terrible just like she felt when she had the virus. She had not eaten and experienced aches, headache, and fever.  Treatment information was not provided.
After I got vaccine, I can not rise up my left hand, I can not move my hand back, and I can not sleep on left side. After visiting doctor, Doctor give me some pills, but, it does not help me.
He had nothing but heart problems, He had to go to the hospital (Further clarifications unknown) Arrythmia; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the parent.  A 45-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Dose 1), for Covid-19 immunization; Covid-19 vaccine (Dose 2), for Covid-19 immunization. The following information was reported: ARRHYTHMIA (hospitalization, medically significant), outcome "recovering", described as "He had nothing but heart problems, He had to go to the hospital (Further clarifications unknown) Arrythmia".  Clinical course: He had to get all three shots (Clarified as COVID-19 vaccine). The third shot he got he had nothing but heart problems since then. He had to go to the hospital (Further clarifications unknown) Arrythmia and he had to go to the hospital twice. There was about 4 weeks maybe or so between he had to get shot and heart had to get paddled to get it back in rhythm again. Once he got it back in rhythm, he said he felt just fine now but did not know how long that's going to last. He was 45 years old. In response to probe safety report for son: Reporter stated, "reporter's son may have already filed one cause he was still in the navy and then he was still part of the navy so what he had done, Reporter did not know. Reporter just know he said 'thank god the hospital was only 2 miles away because he drove himself to hospital'.  The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5 has been requested and will be submitted if and when received.
Pain on right arm; Pain on left arm; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Pain on right arm) and VACCINATION SITE PAIN (Pain on left arm) in an 86-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 007MZ0A) for COVID-19 vaccination.     The patient's past medical history included Heart valve replacement and Pacemaker insertion (cardiac). Concurrent medical conditions included Sulfonamide allergy (Allergies to Sulfas). Concomitant products included METFORMIN, APIXABAN (ELIQUIS) and OLOPATADINE HYDROCHLORIDE (LOPADINE) for an unknown indication.    On 27-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 27-Jan-2021, the patient experienced PAIN IN EXTREMITY (Pain on right arm) and VACCINATION SITE PAIN (Pain on left arm). At the time of the report, PAIN IN EXTREMITY (Pain on right arm) and VACCINATION SITE PAIN (Pain on left arm) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No treatment information was provided.   Most recent FOLLOW-UP information incorporated above includes: On 21-Apr-2021: outcome of the events updated to resolved.
Expired Vaccine used; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Expired Vaccine used) in a 92-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 009C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 18-Oct-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 18-Oct-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Expired Vaccine used). On 18-Oct-2021, EXPIRED PRODUCT ADMINISTERED (Expired Vaccine used) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No Concomitant product use was reported. No treatment information was provided.   This case was linked to MODERNATX, INC.-MOD-2021-355973 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-355973:Cross linked case/ Original Cluster Case
thrombotic strokes; right cerebellar stroke; vertebral artery dissection/ tore a vertebral artery in her neck; two sub acute strokes; vertigo; nausea; weakness; fatigue; sore arm; mild chills; body aches; This is a spontaneous report from a contactable consumer (patient). A 37-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection; Lot Number: EN5318) via an unspecified route of administration, administered in Arm Left, at the age of 37-year-old, on 04Feb2021 16:30, as SINGLE DOSE for covid-19 immunisation.  Medical history was not reported. The patient did not receive any other vaccines 4 weeks prior. Concomitant medication included ongoing drospirenone, ethinylestradiol (DROSPIRENONE/ETHINYLESTRADIOL) taken for contraception.  The patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection; Lot Number: EL3302) single dose, at the age of 37-year-old, on 14Jan2021 1500PM in the left arm, for covid-19 immunisation and experienced fatigue and a sore arm. On 05Feb2021, the patient experienced fatigue, sore arm, mild chills, and body aches. On 08Mar2021, the patient was hospitalized because of vertebral artery dissection after an intense workout that morning/ she tore a vertebral artery in her neck which she immediately clotted and led to her having a stroke. The patient had vertigo, nausea and weakness on 08Mar2021 and went to the ER and they found she had a thrombolytic stroke in the cerebellum as a result of the vertebral artery dissection. The patient was admitted to the hospital on 08Mar2021 then she was discharged 11Mar2021. While she was in the hospital, they did an MRI and found two sub-acute thrombolytic strokes or blood clots in her brain. The patient tore the artery in her neck which led to the right cerebellar stroke; her blood was really clotty but they could tell by the imaging that the two subacute blood clots that led to having the other two strokes were there approximately three weeks before but not much older than that (without exhibiting symptoms, so she had three thrombotic strokes in total). Since she was discharged she has been out of work and will be on FML for two to three months and going to physical therapy from the effects of the strokes. Adds while she was in the hospital they were trying to determine the cause of the two sub-acute strokes that were unrelated to the dissection. They did several tests including: EKG which was normal; TEE scope down her throat to look at her heart which was normal; and blood work to check for a clotting disorder which was also all normal.  So far nothing has been found. Outcome of mild chills, body aches, and sore arm was recovered on 06Mar2021; outcome of vertebral artery dissection and right cerebellar stroke was recovering; while it was unknown for the other events.
Pt received Moderna x2. Pt admitted on 8/8 for stroke code. Found to be TIA. Pt did receive a dose of remdesivir and dexamethasone as desaturated on RA. Found that pt has chronic respiratory failure and on chronic O2, so remdesivir and dexamethasone stopped.
Two days after first Pfizer vaccine for covid, started developing a hive like rash on both forearms. Over the next two days, rash spread to legs, back and stomach area. This hive like rash is a burning itch. It gets better one place and then moves somewhere else on body. It has been 5 days since vaccination and still have this rash or hives.
This was my second injection in the SHINGRIX series. I had a similar reaction with the first. Pain and stiffness at the site of the injection; flu-like symptoms beginning at night and peaking in the morning: pain in joints and muscles, weakness in muscles, lethargy, chills, mild nausea, headache, redness and swelling at the injection site, no appetite. Most of the flu-like symptoms had resolved by 4pm, 24 hrs from receipt of the vaccination, except for the redness and swelling at the injection site, which is still present at 7:30 am the next day.
Janssen COVID-19 Vaccine EUA  Low- grade fever between 100 - 101 for 24-hours. Sore achy body. Slight headache. Low energy.
Nauseous, right arm pain, itchy throat, numb limbs (arm and leg - both on right side), tired - symptoms went away within 24 hours.
4 weeks after having been administered the 3rd Gardasil vaccine, my daughter started having unusual severe joint pain, and headaches.  Initially it was causing costochondritis and she was uncomfortable receiving a hug or being touched. This pain & inflammation progressed to her knees, elbows, shoulders, back, spine, and hands. She was miserable with pain and could barely walk up 1 flight of stairs to her bedroom.
25JUL91 pt recvd 1 dose Engerix B; 8AUG91 pt reports "allergic reaction" described as tingling in tongue, urticarial rash across buttocks, rash on arms & sides & generalized edema; 9AUG91 pt seen by MD; rt arm hurt unable to lift objects;
Patient came to office for 2nd dose of Pfizer COVID vaccine.  She was only 12 days from her first dose.  Physician counseled patient and let her know she was too early to receive the second dose.  Patient was extremely insistent that she receive her second dose and declined to schedule another appointment. Patient decided to go ahead and receive dose two even though she was early.
Patient started having blurred vision immediately after sitting down for the 15 minute wait. Afterwards he began experiencing muffled hearing, lightheadedness, tingling fingers, and was observed being pale and sweaty. Patient was instructed to lie down and place feet upon a chair and vitals were taken (BP: 110/61, Pulse: 75). Patient reported he had no food/water for some time and was immediately given something to eat and drink. Symptoms resolved within 5-10 minutes.
Treatment of COVID-19; Treatment of COVID-19; Dose 1/Dose 2/Dose 3: Moderna; Dose 4: Pfizer / BioNTech; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 56-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 23Jul2022 as dose 4 (booster), single (Lot number: FP7150) at the age of 56 years for covid-19 immunisation; elasomeran (MODERNA COVID-19 VACCINE), on 05Feb2021 as dose 1, single (Lot number: 004M20A), on 05Mar2021 as dose 2, single (Lot number: 023M20A) and on 29Oct2021 as dose 3 (booster), single (Lot number: 0047C21A) for covid-19 immunisation. The patient's relevant medical history included: "asthma" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: INTERCHANGE OF VACCINE PRODUCTS (medically significant) with onset 23Jul2022, outcome "unknown", described as "Dose 1/Dose 2/Dose 3: Moderna; Dose 4: Pfizer / BioNTech"; DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive, notes: Treatment of COVID-19. Therapeutic measures were taken as a result of drug ineffective, covid-19.  No follow-up attempts are possible. No further information is expected.
Patient was administered the Moderna vaccine at 1325 and was instructed that she needed 30 minutes of observation.  At ~1335 patient left the building- reporting that she could not breath in her mask and was found on sidewalk outside.  Patient was placed on a stretcher and vital signs were obtained [BP 94/62, HR 90, RR 26], anxious oriented x4.  Visible muscle twitching/spasms of face then extending to limbs.  Transported to ED via ambulance.  Patient was evaluated and monitored in the ED.  Patient continued to have mild twitching in upper extremities.  Patient was treated and discharged.
spots on lt wrist, rt eye, behind neck;1/2 tsp dimetap po per MD;