chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Fainted in waiting office, found exhibing slight jerking movements on floor.  Sustained visable abrasion to cheek where impact was made with floor.  Needed 1 and 1/2 hour to recover from dizziness and lightheadedness.  Had vision changes and ringing in the ears prior to fainting.  Headache lasted until 7:00 PM on 6/27/12.
Myocarditis; chest pain; This spontaneous case was reported by a physician and describes the occurrence of MYOCARDITIS (Myocarditis) in a 22-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. Unknown) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 05-Aug-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 07-Aug-2021, the patient experienced MYOCARDITIS (Myocarditis) (seriousness criterion medically significant) and CHEST PAIN (chest pain). The patient was treated with IBUPROFEN at an unspecified dose and frequency. At the time of the report, MYOCARDITIS (Myocarditis) and CHEST PAIN (chest pain) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 07-Aug-2021, Heart rate: high (High) high rate beat. On 07-Aug-2021, Troponin: eelvated (High) Elevated troponin level. On an unknown date, Echocardiogram: normal (normal) normal echocardiogram. Diagnosis: Myocarditis.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant product use was not provided by the reporter.  Company comment: Based on the current available information and temporal association between the use of second dose of the product mRNA-1273 and the start date of the serious expected event of Myocarditis, a causal relationship cannot be excluded. Non-serious event of Chest pain was more consistent with the manifestation of Myocarditis.; Sender's Comments: Based on the current available information and temporal association between the use of second dose of the product mRNA-1273 and the start date of the serious expected event of Myocarditis, a causal relationship cannot be excluded. Non-serious event of Chest pain was more consistent with the manifestation of Myocarditis.
mom reports that pt broke out in rash day p/recvd vax; rash only lasted 1 afternoon; pt had no fever or other sx;
another provider prepped vaccine.  Vaccine labeled with 6 hour BUD but the inaccuracy was the 30 day BUD when removed from fridge. Expired 30 days from 12/27/2021 which would be expired on 1/25/2022.
Swollen left side of face after receiving intranasal FLUMIST. Treatment, amoxicillin and prednisone.
Information has been received from an office medical assistant concerning a 17 year old female patient with no pertinent history and no drug reaction or allergies who in 2007 (reported as "3 year ago"), was vaccinated with her three doses of GARDASIL. Concomitant therapy included DEPO. On an unspecified date, the patient came into the doctor's office with genital warts. She received Pap smear to determine if she had HPV, which she did (results not provided). Patient thought that she may had been sexually active prior to GARDASIL injection. It was reported that the adverse event did not improve. At the time of reporting, the patient had not recovered. No information is available.
Soreness of left arm at the injection site 6 hours post-administration.   18 hours after injection,  chest wall and 1/3 lateral area of left breast very tender. No adenopathy present.   Duration of the discomfort of Lt arm, left chest wall  and breast  was 48 hours
No additional AE reported; administered after a temperature excursion to patient on Dec 8, 2022; This spontaneous report was received from a physician and referred to a patient of unspecified gender and age. The patient's medical history, concurrent conditions and concomitant therapies were not reported.  On 08-DEC-2022, the patient was vaccinated with a dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) subcutaneous injection, once, rHA, with a valid lot #W023870, and expiration date of 24-JAN-2024, administered for prophylaxis (strength, and route of administration were not provided). The vaccine was administered after a temperature excursion to the patient on this date. No additional adverse event (AE) were reported. Temperature and time frame was of 5.9 Fahrenheit (°F) for 13 Minutes; 33.4°F for 1 Hour 54 Minutes and there were no previous temperature excursion. No further information was provided.
(Per injury report completed by patient). On Nov 19th 2013 I came up to employee health to get a flu shot, I received my flu shot in my right arm thinking its my dominate arm that is would be better in that one. I felt fine arm a little sore where shot was given normal. Wednesday morning I woke up and felt very stiff in my right shoulder and neck along with my arm still being sore from the shot. Thinking nothing of it thinking maybe I just slept wrong, and I proceeded with my day. As the day proceeded on, it got worse, I have put heat on the area and cold and ibuprofen, neither of any has helped with the situation. I had a friend massage that area, it gave a small amount of relief but it is still going on to the point at times its hard to breathe and turn my neck. It has become quite intolerable.
Breakthrough case admission after 3 vaccines Pfizer 2/9/21 Lot# EL9267;  Pfizer 3/2/21 Lot# EN6205;  11/19/21 Moderna Lot# 033f;  THIS IS THE LOT# AS LISTED IN THE LOCAL STATE DATABASE
Information has been received from a licensed practical nurse referring to a 12 year old patient of unknown gender. On 12-OCT-2016, the patient was vaccinated with improperly stored dose of GARDASIL 9 (lot # M021407 with expiration date of 30-APR-2018; dosage, frequency and route of administration were unspecified). Temperature was 49 F and time frame was total cumulative 84 minutes. No adverse event was reported. This is one of several reports received from the same reporter. Additional information has been requested. Sender's Comments: US-009507513-1610USA009046.
Information has been received from a pharmacist concerning a 65 year old female consumer with no known allergies, bipolar disorder and insomnia who in March 2007, was vaccinated with zoster vaccine live (Oka/Merck). Concomitant therapy included lithium, WEROQUEL, AMBIEN, PREMARIN, and CELEBREX. Two days ago, on 05-MAR-2008 the patient developed a cold sore in the mouth. Medical attention was sought, the patient spoke to the pharmacist. There were no lab studies performed. At the time of the report the patient was not recovered. There was no product quality complaint involved. Additional information has been requested. This is one of several reports from the same source. Follow-up information from the pharmacist indicated that the patient was vaccinated a year ago at another facility, and that she did not think the patient's cold sore was related to the vaccination. No additional information was reported for this case.
Fever of 102,  muscular and joint pain over entire body, fatigue, headache.  Lasted 36 hours than stopped.  A single 200mg ibuprofen reduced fever and pain.  Repeated once after 8 hours.
Information had been received on 06-JAN-2017 from a female via social media who wrote, "Both of my boys have had their HPV vaccines will no ill side effects other than the typical complaints of the injection site hurts for a few hours (so they couldn't possibly go back to school that day and needed ice cream and video games)". HPV vaccine was unspecified. Date of vaccination and adverse event was not reported. No further adverse event information was reported. Additional information is not expected.
Mother reports patient received vaccines about 48 hours ago  at patient's pediatrician office and is experiencing a reaction that began about 20 hours ago. Mother reports he received TDaP (Boostrix) and meningitis (MenVeo) vaccinations in left deltoid. Mother report she noticed left deltoid now appears a little red and swollen. Patient reports left shoulder is sore. Mother states they do not have vaccine records with them today but is confident in the types of vaccines and location of vaccination.   Mother reports treating patient's symptoms with ice application and ibuprofen 100 mg (last about 2 hours ago).   Left deltoid with circular region of localized erythema and swelling  that expands approximately 9 cm x 9 cm. Patient is stable.  Advised to apply cold compress to the injection site for 20 minutes and repeat every 2-4 hours as needed. Reviewed safe use of OTC analgesic ibuprofen. Advised to wear lightweight clothing over the injection site. Follow up if condition worsens or does not improve with current plan.
Systemic: Dizziness / Lightheadness-Severe, Systemic: Fainting / Unresponsive-Severe, Systemic: Hypertension-Severe, Systemic: Seizure-Severe
Dizziness; Weakness; Nausea; This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (Dizziness), ASTHENIA (Weakness) and NAUSEA (Nausea) in a 60-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011M20A) for COVID-19 vaccination.     Concomitant products included LEVOTHYROXINE SODIUM (SYNTHROID) for an unknown indication.    On 09-Feb-2021 at 2:30 AM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 10-Feb-2021, the patient experienced DIZZINESS (Dizziness), ASTHENIA (Weakness) and NAUSEA (Nausea). On 10-Feb-2021, DIZZINESS (Dizziness), ASTHENIA (Weakness) and NAUSEA (Nausea) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Back pain, bilateral lower extremity neuropathy, paresthesias, lower extremity weakness, urinary retention, orthostatic hypotension
Developed fever and severe headache the evening he received the vaccine. The following day, fever up to 104 and would not respond to Tylenol or ibuprofen, was treated that afternoon in the ED. 2nd day the fever remained low grade. Mother stated it took him approx 3 days to recover.
Acute chest pain, cough and sinus congestion which began 3-4 days after MMR and Hep A vaccine administration. Cough is gaggingly persistent at bedtime and intervals during the day. Sputum production range from yellow, green, to dry. There is no wheezing or LR inflammation detectable.
Nerve pain throughout neck, shoulder, shoulder blade down into fingers and breast on left side with swelling throughout area, painful to touch, unable to raise arm above (neuroforaminal stenosis).
I have a relative that took the first dose and then he fell" and was not able to get to get the second dose; I have a relative that took the first dose and then he fell" and was not able to get to get the second dose; This is a spontaneous report from a contactable consumer reported that a male patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/Lot number and expiration date was not reported), first dose via an unspecified route of administration on an unspecified date as single for covid-19 immunization. The patient medical history and concomitant medications were not reported. The consumer reported that he had a relative that took the first dose and then he fell and was not able to get to get the second dose. 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
Fatigue; experienced chills; diarrhea; vomiting; pains in arms and legs; Aches; This non-serious case was reported by a pharmacist via sales rep and described the occurrence of fatigue in a 91-year-old female patient who received RSVPreF3 adjuvanted (Arexvy) (batch number G9577) for prophylaxis.   On 29-AUG-2023, the patient received Arexvy. In AUG-2023, 24 hrs after receiving Arexvy, the patient experienced fatigue (Verbatim: Fatigue), chills (Verbatim: experienced chills), diarrhea (Verbatim: diarrhea), vomiting (Verbatim: vomiting), pain in arm (Verbatim: pains in arms and legs) and pain (Verbatim: Aches).  The outcome of the fatigue, chills, diarrhea, vomiting, pain in arm and pain were resolved.   It was unknown if the reporter considered the fatigue, chills, diarrhea, vomiting, pain in arm and pain to be related to Arexvy.     It was unknown if the company considered the fatigue, chills, diarrhea, vomiting, pain in arm and pain to be related to Arexvy.   Additional Information: GSK Receipt date: 12-SEP-2023 A pharmacist reported that no other vaccines administered that day.  The patient experienced chills, fatigue, diarrhea, vomiting, aches and pains in arms and legs onset 24 hours after vaccination. The symptoms persisted for between 48 and 72 hours after onset of symptoms. The reporter agrees to follow up from GSK.
Information has been received from a registered nurse referring to unspecified number of patients of unknown age and gender. There was no pertinent medical history, concurrent conditions, concomitant medication or drug reaction described. On unspecified dates, in 2016, the patients were vaccinated with VARIVAX Lot # L043620 with expiration date of 02-NOV-2017 and Lot # M000760 with expiration date of 06-JAN-2018 (dose and route were not reported), which were stored at 10.7 F for 1 hour. The temperature excursion occurred on 09-MAY-2016, so the doses had been administered since that time to 09-JUN-2016. The vaccines did not have previous temperature excursion. No adverse effects reported. This is one of several reports received from the same source. Additional information has been requested.
Hives on B LE occurred on 10/01/2021; L sides Bell?s Palsy developed on 10/14/2021.
Patient did not have any adverse reactions after either vaccine was given. Her second dose was not the same vaccine as her initial dose.
he was swelling; felt sick for a whole day; it appears as if he is reacting to allergies in a more significant way than he has ever reacted to / after the second shot, he has been waking up and the allergies are really getting to him / the allergies are a constant thing; received both shots in April2021 (about 2-3 weeks apart); This spontaneous case was reported by a consumer and describes the occurrence of SWELLING (he was swelling), ILLNESS (felt sick for a whole day), ALLERGY TO VACCINE (it appears as if he is reacting to allergies in a more significant way than he has ever reacted to / after the second shot, he has been waking up and the allergies are really getting to him / the allergies are a constant thing) and INCORRECT DOSE ADMINISTERED (received both shots in April2021 (about 2-3 weeks apart)) in an 80-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Seasonal allergy. Concomitant products included EPINEPHRINE (PRIMATENE [EPINEPHRINE]) for Allergy, VITAMIN C [ASCORBIC ACID] and MULTIVITAMIN [VITAMINS NOS] for an unknown indication.   In April 2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In April 2021, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In April 2021, the patient experienced SWELLING (he was swelling), ILLNESS (felt sick for a whole day), ALLERGY TO VACCINE (it appears as if he is reacting to allergies in a more significant way than he has ever reacted to / after the second shot, he has been waking up and the allergies are really getting to him / the allergies are a constant thing) and INCORRECT DOSE ADMINISTERED (received both shots in April2021 (about 2-3 weeks apart)). At the time of the report, SWELLING (he was swelling), ILLNESS (felt sick for a whole day) and ALLERGY TO VACCINE (it appears as if he is reacting to allergies in a more significant way than he has ever reacted to / after the second shot, he has been waking up and the allergies are really getting to him / the allergies are a constant thing) outcome was unknown and INCORRECT DOSE ADMINISTERED (received both shots in April2021 (about 2-3 weeks apart)) had resolved.            Patient took first dose vaccine on same month of April about 2-3 weeks prior to second dose. No treatment information was provided   Most recent FOLLOW-UP information incorporated above includes: On 13-Aug-2021: significant follow received and contains events outcome updated to recovered.
This spontaneous report was received from a pharmacist refers to a patient of unknown demographics. On 16-MAR-2015 the patient was vaccinated with an expired dose of ZOSTAVAX, .65 ml, once, subcutaneous, which expired on 06-MAR-2015. No adverse events were reported. Outcome of the event was unknown. No product quality complaint (PQC) was involved. Reporting pharmacist considered the event to be related to ZOSTAVAX. Additional information has been requested.
fever of 101 degrees, blurred vision, nausea,  extreme fatigue, headache, dizziness, sleeplessness due to pain and terrifying nightmares, pain and tenseness in abdomen , itchiness at injection site (red patch 4" in diameter), chills , general achy feeling, and sharp pains that would feel like they would move around and hit in odd places. The heels of the feet for instance, the sensation of charley horses over and over on the morning  after  the vaccine. The second day was the worst. Most painful and most fatigued. By the third day, I was starting to feel better pain-wise, but the dreams were worse. The dreams are so bad, I am afraid to sleep. This is the 4th day, and I only have pain at the injection site (mild), sporadic dizzy spells, sporadic nausea. I monitored my fever and took extra strength Tylenol for fever and pain.
"Covid arm"  large softball size swollen lump on arm.  Hot to touch, very painful and itchy.
She started sweating; Chills; Started to shiver,; Very cold; Temperature of 101.7; Nausea; Sore muscles in her neck; fatigue; a little sneezing; Coughing; fast heart beat; Fever went down to 99.3degrees; This spontaneous case was reported by a consumer and describes the occurrence of CHILLS (Chills), CHILLS (Started to shiver,), FEELING COLD (Very cold), PYREXIA (Temperature of 101.7) and NAUSEA (Nausea) in a 49-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. unknown) for an unknown indication. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included No adverse event.   On 28-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) at an unspecified dose. On 01-Mar-2021, the patient experienced CHILLS (Chills), CHILLS (Started to shiver,), FEELING COLD (Very cold), PYREXIA (Temperature of 101.7), NAUSEA (Nausea), NECK PAIN (Sore muscles in her neck), FATIGUE (fatigue), SNEEZING (a little sneezing), COUGH (Coughing), PALPITATIONS (fast heart beat) and PYREXIA (Fever went down to 99.3degrees). On 02-Mar-2021, the patient experienced HYPERHIDROSIS (She started sweating).        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) and mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported. Treatment information was unknown.
Patient received vaccine after the BUD; Vaccine stored in refrigerator on 23-Dec-2022; No adverse event; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Patient received vaccine after the BUD), PRODUCT STORAGE ERROR (Vaccine stored in refrigerator on 23-Dec-2022) and NO ADVERSE EVENT (No adverse event) in a child patient of an unknown gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 216K22A) for COVID-19 prophylaxis.     No Medical History information was reported.  On an unknown date, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On an unknown date, the patient experienced EXPIRED PRODUCT ADMINISTERED (Patient received vaccine after the BUD), PRODUCT STORAGE ERROR (Vaccine stored in refrigerator on 23-Dec-2022) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Patient received vaccine after the BUD), PRODUCT STORAGE ERROR (Vaccine stored in refrigerator on 23-Dec-2022) and NO ADVERSE EVENT (No adverse event) outcome was unknown.     For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessments were provided for EXPIRED PRODUCT ADMINISTERED (Patient received vaccine after the BUD) and PRODUCT STORAGE ERROR (Vaccine stored in refrigerator on 23-Dec-2022).    No concomitant medications were reported. It was unknown if the patient receive any other vaccines in the 4 weeks prior to COVID-19 vaccine. Vial size was reported as.4 ml per vial. The vial was initially stored in the refrigerator 23-Dec-2022. The vial did not undergo any temperature excursions. The patient received vaccines on 26-Jan-2023, 27-Jan-2023, 30-Jan-2023, 31-Jan-2023, 2-Feb-2023, 6-Feb-2023, 8-Feb-2023, 10-Feb-2023, 13-Feb-2023, 14-Feb-2023, 16-Feb-2023, 17Feb2023 and 21-Feb-2023.  No treatment medications were reported.  This case contains information for the 33th of 42th patients described by the reporter.   This case was linked to US-MODERNATX, INC.-MOD-2023-718298 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-718298:Master case
Patient presented for flu shot. Approximately 5-10 minutes after injection pt stated having tightness of throat and chin numbness. Was seen by Dr., given 25 mg BENADRYL IM. No improvement given 25 mg BENADRYL IM again. Pt not improved - sent by EMS to ER.
Approximately 30 minutes after receiving the vaccine, I felt a numbness and tingling sensation in my left lower lip. Pain at the injection site increased throughout the next 48 hours.  Numbness and tingling spread to the left side of my face and left hand, in the first 24 hours.  I was unable to reach a health care professional at the clinic, but left several messages that were not responded to. By the eve of the following day, I experienced increased swelling of my lower lip, tongue, throat, and left eye, at which point I consulted with a relative in the health care profession who suggested I try an oral dose of ibuprofen.  It was nearing 9 pm and we started to drive to the nearest emergency medical location, in the event that the ibuprofen did not  help. I took two 25ml capsules at that time.  After about 30 minutes, I felt some relief.  I took one more 25ml capsule before going to bed.  The next day, symptoms began to disappear by midday.
With her first shot all she had was a sore arm; This is a spontaneous report from a contactable consumer (patient).  An 80-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot Number: EC3247, Expiry date was not reported), via an unspecified route of administration on 29Jan2021 (at the age of 80-year-old) in left arm as DOSE 1, SINGLE for COVID-19 immunization. No relevant medical history was reported. The concomitant medications were not reported. The Patient was not received other products. On an unspecified date in 2021, the patient experienced sore arm. The outcome for the event was unknown.  No follow-up attempts are needed. No further information is expected.
pt recvd vax & exp h/a 2 hrs following inject; h/a were progressively more evere p/each dose; tx APAP PRN;