chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Received expired 2nd dose, after 30-day Use By Date), PRODUCT STORAGE ERROR (Vial initially stored on 18-Jul-2022 and then administered on 22-Aug-2022) and NO ADVERSE EVENT (No adverse event) in a 3-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. AS1414B) for COVID-19 vaccination. No Medical History information was reported. On 22-Aug-2022 at 9:00 AM, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 22-Aug-2022 at 9:00 AM,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced EXPIRED PRODUCT ADMINISTERED (Received expired 2nd dose, after 30-day Use By Date). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Vial initially stored on 18-Jul-2022 and then administered on 22-Aug-2022) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Received expired 2nd dose, after 30-day Use By Date), PRODUCT STORAGE ERROR (Vial initially stored on 18-Jul-2022 and then administered on 22-Aug-2022) 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 EXPIRED PRODUCT ADMINISTERED (Received expired 2nd dose, after 30-day Use By Date) and PRODUCT STORAGE ERROR (Vial initially stored on 18-Jul-2022 and then administered on 22-Aug-2022). Concomitant drugs were not reported. It was reported that a 3 year of age patient received expired second dose on 22-Aug-2022 around 9AM which was initially stored in refrigerator on 18-Jul-2022 at 1:30PM.The 2 doses were given from 1 vial and the vial did not undergo any temperature excursions. Treatment medications were not provided. This case was linked to MODERNATX, INC.-MOD-2022-631763 (E2B Linked Report). Sender's Comments:  MODERNATX, INC.-MOD-2022-631763:Patient-1 case.
Headache; Sore Arm; Numbness in Lips; Numbness in Cheeks; Numbness in Tongue; weird feeling in sore throat; This spontaneous case was reported by a consumer and describes the occurrence of HYPOAESTHESIA (Numbness in Lips), HYPOAESTHESIA (Numbness in Cheeks), HYPOAESTHESIA (Numbness in Tongue), OROPHARYNGEAL PAIN (weird feeling in sore throat) and PAIN IN EXTREMITY (Sore Arm) in a 58-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 040A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Anxiety and Headache. Concomitant products included BUSPIRONE from 16-Feb-2019 to an unknown date for Anxiety, VENLAFAXINE HYDROCHLORIDE (EFFEXOR) and CODEINE PHOSPHATE, PARACETAMOL (MIGRALEVE [CODEINE PHOSPHATE;PARACETAMOL]) for Headache, VITAMIN D [VITAMIN D NOS] for an unknown indication.    On 20-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 20-Mar-2021, the patient experienced HYPOAESTHESIA (Numbness in Lips), HYPOAESTHESIA (Numbness in Cheeks), HYPOAESTHESIA (Numbness in Tongue) and OROPHARYNGEAL PAIN (weird feeling in sore throat). On 21-Mar-2021, the patient experienced PAIN IN EXTREMITY (Sore Arm) and HEADACHE (Headache). On 20-Mar-2021, HYPOAESTHESIA (Numbness in Lips), HYPOAESTHESIA (Numbness in Cheeks), HYPOAESTHESIA (Numbness in Tongue) and OROPHARYNGEAL PAIN (weird feeling in sore throat) had resolved. At the time of the report, PAIN IN EXTREMITY (Sore Arm) was resolving and HEADACHE (Headache) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No treatment medication was provided.   Most recent FOLLOW-UP information incorporated above includes: On 26-May-2021: Information about Patient's demographics added.Stop date of event (Lip, cheek ,tongue, arm, throat numbness) addedProduct (Buspirone, Effexor and Migraleve )dosage information, route and indication  mentioned.Second dose not taken yet.Vaccine facility information added.
Systemic: Fainting / Unresponsive-Mild, Additional Details: Called emergency, Paramedic came and patient felt fine after
This case was reported by a consumer via call center representative and described the occurrence of pain in a female patient who received TWINRIX. On an unknown date, the patient received the 1st dose of TWINRIX. On an unknown date, unknown after receiving TWINRIX, the patient experienced pain. On an unknown date, the outcome of the pain was unknown. It was unknown if the reporter considered the pain to be related to TWINRIX. Additional details were reported as follows: The age at vaccination was not reported. The patient felt a real stabbing pain after vaccination. This case has been linked with US2018GSK072862, reported by the same reporter, for same patient for 2nd dose.
pt devel an inject site react (3cm area of vesicular eruptions; 5x7 cm area of erythema & induration following pnu-imune vax on 19OCT93;
Information has been received from a nurse concerning a 4 year old female who on 03 MAY 2004 was vaccinated with a second dose of MMR.  On 15 MAY 2004 the patient developed a rash on the lower extremities.  The patient had some itching and some joint pain in her hands.  The rash progressed to the lower trunk and then to the upper body.  The patient did not develop a fever.  Unspecified medical attention was sought.  As of 24 MAY 2004 the rash had not resolved.  Additional information has been requested.
Information has been received from a medical assistant concerning an elderly female (age not reported) who on 18-DEC-2006 was vaccinated with Pneumovax 23 (lot # 651404/0352F) 0.5 ml.  On approximately 18-DEC-2006, the patient experienced fever 102-103 F, insomnia, sweating, redness and swelling at the injection site.  The patient sought medical attention.  The patient was treated with BENADRYL.  The outcome of the events was not reported.  Additional information has been requested.
I went to work 7-12am and around 7p I had muscle soreness, around 3am when I get home, I developed fever and I had body aches, chills, headache, l felt like I had the flu. The whole day I felt bad, and yesterday I took Tylenol, and the fever broke but I still had headache and body aches that lingered. Today I still have the headache that?s lingering.
after giving imz., i went over adverse effects then  after total of a few minutes i went to catch phone and counsel. patient was fine in room. my assistant(who is a retired nurse) walked by and said patient was slumped and pale. i went into room immediately patient was fainting. eyes fluttered and closed still breathing. no response from voice or slight shaking. we put patients legs on other chair to elevate, (patient too heavy to move) He revived after a few minutes and we had him lay on ground with legs elevated. bp was 116/61 and he had eaten only a cliff bar after working the night shift. I gave him glucose. after 15 minutes or so he felt fine and called his sister to pick him up, while waiting i gave him pop tarts and cold water (his stomach was growling).  He left with his sister and will return in 21 days for 2nd shot. I will call and check on him 24-48 hours from now.
PT RECEIVED PFIZER BOOSTER AT SITE. POST VACCINATION, EXPERIENCED DIZZINESS AND SAT DOWN. PT BECAME UNRESPONSIVE, HAD FACIAL MOVEMENTS CONSISTENT W/ TONIC-CLONIC SEIZURE AND LIMB STIFFNESS, LASTING <30 SEC. PT REGAINED CONSCIOUSNESS AND REMEMBERS EVENT.  PT HAD NO KNOWN SYNCOPAL HISTORY. EMS WAS ACTIVATED. PT WAS ADVISED TO SEEK MEDICAL TREATMENT. PT DENIED ALL INTERVENTIONS, TREATMENTS, AND TRANSPORT EXCEPT FOR PULSE CHECK; AND WILL FOLLOW UP W/ PRIMARY CARE
Only diluent/adjuvant was administered; Only diluent/adjuvant was administered; This case was reported by a nurse via call center representative and described the occurrence of inappropriate preparation of medication in a 18-month-old female patient who received Hib (Hiberix) (batch number 5P244, expiry date 21st March 2023) and (batch number of diluent vial F22GH, expiry date 21st March 2023) for prophylaxis.   On 1st March 2022, the patient received Hiberix. On an unknown date, the dose was an unknown dose. On 1st March 2022, unknown after receiving Hiberix, the patient experienced inappropriate preparation of medication and inappropriate dose of vaccine administered. On an unknown date, the outcome of the inappropriate preparation of medication and inappropriate dose of vaccine administered were unknown.  Additional details were provided as follows: The patient received Hiberix in right vastus lateralis. The patient had been given Hiberix incorrectly, only the vaccine diluent/adjuvant was administered without an active component, which led to inappropriate preparation of medication and inappropriate dose of vaccine administered. The reporter provided a consent to follow up with herself.  The reporter's contact information was collected. The reporter consented to follow up.
I woke up in the morning and the ankle area of my foot was red, swollen and painful to walk on. I?ve never had a problem there before. Two days after the occurrence, the pain is beginning to subside, after doing some home remedies.
pt recv vax 18OCT95 & was crying uncontrollably,going stiff,arching,inconsolable,temp unk low-high;went to ER that noc vomiting,LP revealed not meningitis;BC nl;elevated WBC count;poss bad rxn to vax
Pityriasis Rosea developed one month after booster vaccination given. First, a herald patch was observed, about the size of a nickel and raised, on my left arm. Over the course of the following week, smaller red spots began to appear all over torso and back and still remain 2 weeks later. Treatment is hydrocortisone topical cream.
VACCINE TEMPORARILY WEAKENED IMMUNE SYSTEM; SORENESS IN THROAT; EAR PAIN; HEADACHE, ACHES, FATIGUE; .This spontaneous report received from a patient concerned a 62 year old male. The patient's height, and weight were not reported. The patient's past medical history included arthritis, bursitis, kidney issues, hernia, angioplasty, and dental implant, and concurrent conditions included microbial or viral present in jaw, and other pre-existing medical conditions included the patient was non alcoholic, non smoker and had no known drug allergies. The patient had no drug abuse or illicit drug usage. The patient received covid-19 vaccine ad26.cov2.s (form of admin, route of admin were not reported) dose was not reported, administered on 28-APR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported.  On an unspecified date, the subject experienced vaccine temporarily weakened immune system, soreness in throat, ear pain, and headache, aches, fatigue. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the soreness in throat, vaccine temporarily weakened immune system, ear pain and headache, aches, fatigue was not reported. This report was non-serious.
Fatigue; Fever; Gastro intestinal discomfort; This is a spontaneous report received from a contactable consumer(patient) from a Pfizer sponsored program. A Female patient of an unspecified age received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/lot number and Expiration date not reported) via an unspecified route of administration, on 06May2021, as a single dose for covid-19 immunization. The patient medical history and concomitant medications were not reported. The patient had experienced fatigue, fever, and gastrointestinal discomfort on an unknown date and now inquiring if it would be okay to eat. Outcome of the events was reported as unknown.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Started to feel minor pain on right wrist, the outside joint bone; Numb sensation through the outside rim of right palm as well; This is a spontaneous report from a contactable consumer, the patient. A 49-year-old non-pregnant female patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: unknown), via an unspecified route of administration in the left arm on 18Mar2021 at 14:58 (at the age of 49-years-old), as a single dose for COVID-19 immunisation. Medical history was not reported. The patient did not take any concomitant medications. The patient had no known allergies to medications, food, or other products. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. On 19Mar2021 at 08:00, the patient experienced minor pain on right wrist, the outside joint bone. When the patient washed hands, could feel the numb sensation through the outside rim of right palm as well. The bone pain persisted from 19Mar2021 to present day, 23Mar2021. The numbness on outside rim of palm also persisted. On a scale from 1- 10, the pain was assessed as 1 or 2, minor pain and the numbness was about the same category. The patient did not receive any treatment for the events. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The clinical outcome of the events wrist pain and numbness in hands was not recovered at the time of this report.   Information on the lot/batch number has been requested.
I had a visual aura seizure four days after the first vaccine.  It started with minor stars/auras in the right side of my right eye and within about 5 minutes, half of my vision was gone.  After resting and eating, my vision was restored and the aura stopped.  A couple of weeks later I had episodes of minor facial drooping, which lasted for a few hours each.
COVID 19; COVID 19; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 67-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 26Feb2021 as dose 1, single (Lot number: EN6198), in left arm, on 19Mar2021 as dose 2, single (Lot number: ER8730), in left arm, on 01Oct2021 as dose 3 (booster), single (Lot number: 30145BA), in left arm and on 12Apr2022 as dose 4 (booster), single (Lot number: FK9895), in left arm for covid-19 immunisation. The patient's relevant medical history included: "Known allergies: sulfa drugs" (unspecified if ongoing), notes: Known allergies: sulfa drugs. The patient's concomitant medications were not reported. The following information was reported: COVID-19 (medically significant), DRUG INEFFECTIVE (medically significant), outcome "unknown" and all described as "COVID 19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (11Jul2022) Positive; (15Jul2022) Positive. Therapeutic measures were taken as a result of covid-19. No follow-up attempts are needed. No further information is expected.
Almost died; Blood clots; This is a spontaneous report from a Pfizer-sponsored program received from a non-contactable consumer. A female patient of an unspecified age received bnt162b2 (BNT162B2), via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as dose number unknown, single for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. On an unspecified date, the patient experienced almost died and blood clots. It was further reported that the reporter wanted to know if the vaccine has been FDA approved and what are the difference between the 2 vaccines (not specified). She also mentioned that a friend had gotten blood clots after getting the vaccine and she almost died. The reporter also inquired what myocarditis and pericarditis are. The outcome of the events was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Heavy menstrual cycle; Longer menstrual cycle.; Then one week later another menstrual cycle; Tender breasts; Cold sore on mouth; This is a spontaneous report from a contactable consumer, the patient. A 47-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8737) via an unspecified route of administration in the left arm on 30Mar2021 at 12:00 (at the age of 47-years-old) as a single dose for COVID-19 immunisation. Medical history included cold sores on mouth 10 years ago. The patient had no known allergies. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any medication within two weeks of vaccination. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6285) via an unspecified route of administration in the left arm on 01Mar2021 at 12:00 (at the age of 47-years-old) as a single dose for COVID-19 immunisation. On 23Apr2021, the patient experienced heavy menstrual cycle, longer menstrual cycle, and one week later, she had another menstrual cycle. The patient also reported tender breasts and cold sore on mouth (had not had a cold sore in 10 years). The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Since the vaccination, the patient had not been tested for COVID-19. Therapeutic measures were not taken as a result of the event. The clinical outcome of the events longer menstrual cycle/heavy menstrual cycle, another menstrual cycle a week later, tender breasts and cold sore on mouth was resolving at the time of this report.   No follow-up attempts are needed. No further information is expected.
Systemic: Dizziness / Lightheadness-Mild, Systemic: Fainting / Unresponsive-Mild, Systemic: Weakness-Mild, Additional Details: PATIENT FELT DIZZY AND LIGHTHEADED SO I HAD HER STAY SEATED AND GAVE HER WATER TO DRINK. SHE ATTEMPTED TO STAND UP AT A FAST RATE AND FAINTED/FELL VERY BRIEFLY. I HAD HER STAY SEATED AFTERWARDS. AFTER SOME TIME SHE STATED SHE WAS FEELING BETTER
Five minutes after COVID-19 Moderna injection I started to feel chest pains, tingling/numbness on my left hand (injection site limp) my blood pressure was higher than my normal range, pulse ox was 93%. I was observed in ED for over an hour.  After wards at approximately 11:AM on Feb 1st 2021 I  broke in fever 104.1, chills, severe joint pain relieved only with high dose Advil 800mg  around the clock. Unable to get up from bed due to weakness.  I was given a doctors note to be off work for 4-days.
- few minutes after administering vaccine Patient passed out (syncope) - lay her flat on the floor and she came around - called 911 and was checked by Emt and released
I STARTED HAVING PAIN IN MY HANDS, HAD DIFFICULTIES BREATHING, LOW GRADE FEVER, FLU-LIKE SYMPTOMS, TIREDNESS, HOARSE VOICE, HEADACHE, ONE EPISODE OF VISION IMPAIRMENT WHEN MY VISION WENT WHITE.
Vomited; Felt fatigued; Headache; This spontaneous case was reported by a consumer and describes the occurrence of VOMITING (Vomited), FATIGUE (Felt fatigued) and HEADACHE (Headache) in a 66-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 016M20A) for COVID-19 vaccination.     No Medical History information was reported.    On 03-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced VOMITING (Vomited), FATIGUE (Felt fatigued) and HEADACHE (Headache). At the time of the report, VOMITING (Vomited), FATIGUE (Felt fatigued) and HEADACHE (Headache) outcome was unknown. Unknown      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No relevant concomitant medications were provided. No treatment information was provided.
morning blood sugar started creeping up; This spontaneous case was reported by a consumer and describes the occurrence of BLOOD GLUCOSE INCREASED (morning blood sugar started creeping up) in a 76-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concomitant products included METFORMIN, GLYBURIDE and SITAGLIPTIN PHOSPHATE (JANUVIA [SITAGLIPTIN PHOSPHATE]) for an unknown indication.   On 26-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 24-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 30-Jan-2021, the patient experienced BLOOD GLUCOSE INCREASED (morning blood sugar started creeping up). At the time of the report, BLOOD GLUCOSE INCREASED (morning blood sugar started creeping up) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Treatment information was unknown   This case was linked to MOD-2021-035990, MOD-2021-059395 (Patient Link).
Diffuse maculopapular rash (chest, abd, back, arms) x 4 days with feveer (100.7) x 2 days.