chrisvoncsefalvay/vaers-outcomes huggingface dataset:
318 patients received dose from vials beyond 30-day use by date; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (318 patients received dose from vials beyond 30-day use by date) in a 60-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 037C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 16-Jun-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 16-Jun-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (318 patients received dose from vials beyond 30-day use by date). On 16-Jun-2021, EXPIRED PRODUCT ADMINISTERED (318 patients received dose from vials beyond 30-day use by date) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications reported. No treatment medications reported. It was reported that 319 patients received the expired dose and the date of refrigeration of the dose used by the patient was on 07-May-2021.
Child presented to ED fever 101, R thigh with diffuse swelling and mottled redness, not indurated so doubt abscess or cellulitis, gave ibuprofen for pain.
Left-sided Bell's Palsy, left-sided facial drooping, unable to raise left eyebrow, close left eye, unable to raise left side of mouth. Tx'd with Prednisone and Valtrex.
Initial report received from healthcare professional on 17 SEPTEMBER 2014. A 33-year-old female patient, whose medical history and concomitant medications were not reported, had received a dose of FLUZONE QIV (batch number was unknown, dose number, route and anatomical site of administration were not reported) on 15 SEPTEMBER 2014. It was reported that on 15 SEPTEMBER 2014, on the same day after receiving FLUZONE QIV vaccine, the patient experienced fever up to 102 degree Fahrenheit then dizziness, nausea and feeling of Sinus pressure. The patient's corrective treatments and laboratory investigations were not reported. On an unspecified date the events fever, nausea and dizziness were recovered but feeling of sinus pressure was not recovered. Documents held by sender. none. Follow-up information received from healthcare professional on 3 NOVEMBER 2014. Patient's demographics updated. It was reported that, the patient received intramuscular dose of FLUZONE QIV (batch number: UI158AB) in right deltoid. It was reported that, the outcome was not recovered. Follow-up information received from a healthcare professional on 22 DECEMBER 2014: No new information was available.
Pt states she can not lift her arm in which she received the shot. She went to urgent care to be evaluated 2/16/16. No fever, no swelling.
FLU LIKE SYMPTOMS; BODY ACHES; CHILLS; This spontaneous report received from a patient concerned a female 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: Unknown, expiry: UNKNOWN) dose was not reported, administered on 08-APR-2021 to left arm for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On 08-APR-2021, the patient experienced flu like symptoms. On 08-APR-2021, the patient experienced body aches. On 08-APR-2021, the patient experienced chills. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the flu like symptoms, chills and body aches was not reported. This report was non-serious.
It was reported that an 18 y.o. male PT received a Menomune A/C/Y/W0135 vax., administered SC in the left arm at 12:05 p.m. on 8/21/01. He experienced headache 2-3 hrs later and took Tylenol PM at 10 p.m. PT awoke at 12 midnight w/restlessness and left arm tingling. PT awakened this morning w/persistent, but improved tingling in left arm.
Six days post vax the pt experienced strep throat. Three weeks later the pt developed chickenpox.  There were approximately 10-15 lesions widely spread on his face and back. A throat culture and sensitivity testing was performed, no results were provided.
Patient c/o redness and swelling at injection site for 2 days with blister.  Keflex prescribed.
Reports having a sore Left Shoulder starting in the evening of 10.6.23 when she had her vaccine. Patient is unable to lift her left arm greater then 30 degrees. Reports having pain all the time that is unbearable. Took medrol dose pack with no relief, following up with Occupational Health and then Ortho.
Day 7 and 8 after  receiving the vaccine, I felt a type of severe fatigue different than I had ever felt before. Suffered pain (4 on a scale of 1 to 10) in leg muscles and joints.
This non-serious spontaneous case, initially received on 17-Sep-2018, reported by other health professional (nurse), concerns a 50-year-old, adult female patient. On 17-Sep-2018, the patient (under age of 65 years) was administered FLUAD TIV [dose: 0.5 ml, route of administration: intramuscular, anatomical site: deltoid, batch number: 250791 and expiry date: 30-Apr-2019] (explicitly coded as inappropriate age at vaccine administration). No adverse effects were noted after administration.
Pt completed Engerix-B in OCT90; 4 pts had neg out of 6 that have been screened;
I think that is the lot number.   My husband was a dentist and the staff got the shots together.  That is the lot they had.  I have not found his card yet but will keep looking.  My husband was a dentist and still working, he was very active and got the shots as soon as possible to keep his office open as much as possible.  127 days after the second shot with no warning at all he went out side after eating lunch to work in the garage like every Sunday .  He was restoring a car with my brother in law.   He had got it started for the first time and he called for me to come out and join him for the first ride.  My brother in law filmed our maiden ride.  We were laughing and joking and I got out while he pulled the car back in the gargae.  I went back in the house but hardly sat down when my brother in law screamed for me to come out that patient was down and could not get up.  When I got there he was hitting his head and I looked at him and just knew it was really serious.  My neighbor had already called 911.  He was rushed to the ER and by the time we got there he was really bad.  Theey gave him the "stroke" shot but they told me at that time that half his brain was gone.  He died 7 days later.
This spontaneous report as received from a registered nurse refers to a patient of unknown age and gender. The patient had received the first dose of VARIVAX (Merck) on 03-OCT-2005 and the second dose on 06-MAY-2009. Nurse reported that when the patient was seen in the office on 02-FEB-2016, there was only one documented dose of VARIVAX (Merck). The patient received VARIVAX (Merck) dose 3, (0.5 ml, lot # K015992, expiry date: 23-SEP-2016, subcutaneously), on 02-FEB-2016 and it was subsequently determined that the patient had received two prior doses of the vaccine (extra dose administered). No adverse effects were reported. The outcome was unknown. No product quality complaint was involved. Additional information has been requested.
A consumer report has been received. The report concerns an 8 year old, Male consumer, who had been receiving FLUMIST quadrivalent (intranasal). The patient's concurrent disease(s) included allergic to eggs. FLUMIST quadrivalent (intranasal) started on 18-Sep-2013. The patient experienced leg cramping in left leg and itching both legs which started on 18-Sep-2013 and muscle pain. The patient recovered from the event of leg cramping in left leg and itching both legs on an unspecified date and the outcome of the event of muscle pain is unknown. The report was considered to be non-serious.
he day after the vaccine, I ran a fever, had chills, body aches, headache, fatigue and diahrrea and arthralgia. I also had heart palpatations on lying down or reclining. The third day after the vaccine, I woke up with sharp chest pain on my left side. It felt like when you have gas or a stitch in your side, but it was up too high. I felt no crushing pressure, so I knew it wasn't a heart attack. I tried to breathe in deeply to see if it was gas, but the pain was worse the deeper I breathed. I had the urge to yawn all day to try to alleviate the pain. I also had headache, diziness upon standing, heart palpatations upon reclining or lyning down, and diarrhea. The fourth day after the vaccine, the chest pain was still there upon deep breathing.  Heart palpatations upon lying down or reclining and headache continued through the fourth and fifth day. I started taking NSAIDS the 3rd day and 4th day after reading about paracarditis and myocarditis, hoping that the asprin, ibuprofen and acetaminophen would bring down the swelling. By about 1:00 pm on the 5th day, the chest pain subsided. I still have heart palpatations upon lying down, but less frequently and not as strong when the beat returns.
Patient reported feeling faint after recieving dose 1 of Pfizer vaccine.  She was feeling hot and faint, needed to lay down. Her Blood pressure was 156/36 and temp 97.5. After no improvement we called 911. She also  reported feeling nauseaus.
Information has been received from a pharmacist concerning a patient who on 17-MAY-2012 was vaccinated with a dose of ZOSTAVAX (Merck) (lot# 670986/0730AA, exp. date: 17-AUG-2012). The pharmacist reported that on 17-MAY-2012 the patient received a dose of ZOSTAVAX (Merck) that had been reconstituted with expired sterile water dilution (lot# G000672, exp. date: 30-APR-2012). No adverse effect reported. It was unspecified if the patient sought medical attention. Follow up information was received from the pharmacist who reported that the patient received the third dose of ZOSTAVAX and there were no adverse events at the time of vaccination. The event was reported due to noticing on the next prescription for ZOSTAVAX that the sterile diluent expired at a different time (earlier date) than the live vaccine. The patient did not seek medical attention. Additional information is not expected.
Information has been received from a licensed visiting nurse concerning a 5 year old male patient with no known medical history or allergies, who on 16-JUN-2003 and 18-JUN-2007 at 16:30 PM was vaccinated SC in the left arm with a first and second 0.5mL dose of varicella virus vaccine live (Oka/Merck) (lot number 657109/0444U). On 20-JUN-2007, the patient developed water filled blisters and cellulitis 2 days after the vaccination near the injection site. The patient was seen 20-JUN-2007 and prescribed an antibiotic. No laboratory tests were performed. At the time of the report the patient's status was recovering. No product quality complaint was involved. Additional information has been received from the licensed visiting nurse who stated that the patient was 5 years old and had injection site reaction. It was reported that the office did not track the episode as they were told it was "normal". It was also reported that the incidence was with the varicella virus vaccine live (Oka/Merck) (MSD) and not with measles virus vaccine live (Enders-Edmonston) (+) mumps virus vaccine live (Jeryl Lynn) (+)  rubella virus vaccine live (Wistar RA 27/3) (+) varicella virus vaccine live (Oka/Merck upgrade process) (MSD). Additional information has been received from the licensed visiting nurse who stated that on 20-JUN-2007 patient developed red, hot induration area at injection site and developed vesicles that were tender and measured 9.5 cm. The patient was treat with Keflex for developing cellulitis at sites. At the time of report the patient had recovered. No further information is expected. This is one of several reports from the same source.
This spontaneous report as received from a physician via field representative refers to a patient of unknown age and gender. Last Friday, on 11-APR-2014 the patient was vaccinated with PNEUMOVAX 23 injection for unknown indication (lot #, expiry date, dose and route unknown). The physician reported that the patient experienced "not feeling right" after receiving PNEUMOVAX 23 (onset date unspecified, approximately in April 2014). The physician reported that the patient was also experiencing "trouble with memory" in April 2014. The patient got in contact with the physician, though it was unspecified if patient went to physician's office or if the patient called the physician on the phone. The physician sent the patient to the hospital (hospital unspecified). The hospital performed a CT (Computed Tomography) scan which found a pulmonary embolism in the patient's brain in April 2014. The outcome of pulmonary embolism, trouble with memory and not feeling right was unknown. Upon internal review, pulmonary embolism was considered to be medically significant. Additional information has been requested.
At 7:00pm noticed redness and today daycare called and stated also very swollen 3 inches wide 4 inches long on left leg.
within a week after my first Moderna injection, the injection site began to itch. Upon inspection I found a large area of my upper arm had a large, raised, red/rash patch, In addition, a small spot in my arm pit became very tender (lymph node?). While the rash went away, 27 days later and the tenderness in the armpit is still present.
Body aches- occurred around 4:00 pm  Chills- occurred around 9:00pm Headache- occurred around 7:00pm Vomiting- occurred at 01:00am the following morning g
Very pleasant 50-year-old female presenting today from the vaccination pod due to concern for allergic reaction.  She does have a history of MS, feels bilateral upper extremity weakness, throat tightness and a feeling of shortness of breath.  Fortunately her O2 sat is 100% on room air, she is not tachypneic.  Her lungs demonstrate no wheezing, her oropharynx is widely patent.  She was observed for 3 hours after given Benadryl, Pepcid and Solu-Medrol, was able to ambulate to the bathroom.  Still with some remaining symptomatology but appears more comfortable.  Will discharge with close outpatient follow-up with PCP and neurologist.  Recommended patient follow-up with her neurologist and her PCP regarding guidance regarding second vaccination dose as this did not truly represent an anaphylactic reaction but still symptoms could worsen with second vaccine.
Seen in ER on 6/4/03 with increased temp, 103.0 degrees, and slight erythema and induration at shot site, per ER report.
patient received vaccine at 16:45 and moved to observation area. prior to vaccine patient reported that she faints when she gets shots, in the observation area at 16:50 reported she felt nauseated and not well. patient sitting down, elevated feet, bp 143/85, hr 94, o2 sat 96%, drinking water, no reports of swelling, racing heart, shortness of breath. 17:00 glucometer 122, bp 147/97. hr 90, o2sat 98%, patient says she feels nauseated, drinking gingerale.  17:30 patient feet on floor and says she does not feel dizzy.  17:50 patient walking around and reports mild nausea
Large red swelling size of small grapefruit. 2 days after shot. Took to ER, said no infection, put ice and pain reliever on leg, had a small red area 5 hrs after.
In November 2022, I experienced a scratchy throat and I felt sick. I tested positive for COVID-19. I was prescribed with Paxlovid. In Jan 2023, I felt like I had a bad cold. I had a fever around 101, chills, and coughing. I was very sick. I went to Urgent Care. A week later, I went to the Emergency Room. I was diagnosed with Sepsis.
On 5/22/2021 presented to ER with abdominal pain and increased liver enzymes then again on 5/26/2021 with weight loss, abdominal pain and jaundice.  Work up revealed mass in pancreas and biliary dilation. Needed chemo and major surgery.  Surgery was on 05/05/2022
A 43 year old female reported that she received an IM injection of a flu vaccine in 2001, at the age of 42 years, and experienced "a red knot under her arm that would itch for several days and then resolve." In 2002, she experienced a similar but less severe reaction after receiving a flu vaccine. No additional info was available at the time of this report.
lymph node pain in my armpit; This spontaneous case was reported by a consumer and describes the occurrence of LYMPH NODE PAIN (lymph node pain in my armpit) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced LYMPH NODE PAIN (lymph node pain in my armpit). At the time of the report, LYMPH NODE PAIN (lymph node pain in my armpit) outcome was unknown.            No concomitant medications were reported. No treatment medications were reported.
This is a spontaneous report received from a contactable consumer or other non-HCP (patient). A 46-year-old female patient received the 1st dose of BNT162B2 (Pfizer-BioNTech COVID-19 vaccine, batch/lot# unknown), at the age of 46, single dose, for COVID-19 immunisation. Medical history and concomitant medications not reported. The patient had pain in extremity (moderate arm pain), with outcome of unknown. No follow-up attempts possible. Information about batch/lot number cannot be obtained. No further information expected.
Information has been received from a patient with a history of chickenpox as a child who on 10-JUL-2007 was vaccinated in the left arm with a dose of varicella virus vaccine live (Oka/Merck). It was reported the patient was administered varicella virus vaccine live (Oka/Merck) to prevent shingles. No adverse experience was reported. A product quality complaint was not involved. Follow-up information was received on 10-SEP-2007. Follow-up information was received via a telephone call with a physician who stated: "I thought it was the same as the zoster vaccine live (Oka/Merck) (MSD)". When the physician was asked if this confusion was based on the storage, location, or packaging he re-stated that he took full responsibility for administering the varicella virus vaccine live (Oka/Merck). Further information is not expected.
Same exact signs and symptoms as Covid disease in April 2020. Fever, extreme headache, muscle pain, chills, joint pain, extreme fatigue, weakness, GI symptoms, muscle cramps,
I am sick; I think it's a cold; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 29-Jul-2021 and was forwarded to Moderna on 29-Jul-2021.    This spontaneous case was reported by a consumer and describes the occurrence of ILLNESS (I am sick) and NASOPHARYNGITIS (I think it's a cold) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On 04-Aug-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 02-Sep-2020, 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 experienced ILLNESS (I am sick) and NASOPHARYNGITIS (I think it's a cold). At the time of the report, ILLNESS (I am sick) and NASOPHARYNGITIS (I think it's a cold) outcome was unknown.            No concomitant medications were reported.   No treatment information was provided.  It was reported that the patient had a COVID-19 virus test, two days prior to this report and the result was not available.   Reporter did not allow further contact
Seizure like activity in nursing home transferred to ED where stroke was ruled out and transferred to a higher level of care.
The area around the injection sight started to ache, then itch.  By the afternoon there was a swollen circle the size of a baseball that was very red, swollen itchy and hot. Looked like it was infected.
Rash and redness right deltoid. Area hot to touch. Itching of site only. No fever. Treatment: Benadryl liquid by mouth. Cool compresses to area.
2 weeks after the second dose I had extreme issues focusing and consitrating.  These effects are ongoing today.
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 73-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 13Sep2022 as dose 5 (booster), single (Lot number: GH9694) at the age of 73 years, in left arm for covid-19 immunisation; BNT162b2 (BNT162B2), on 18Jan2021 as dose 1, single (Lot number: EC3249), in left arm, on 08Feb2021 as dose 2, single (Lot number: EL9269), in left arm, on 20Aug2021 as dose 3 (booster), single (Batch/Lot number: unknown), in left arm and on 29Mar2022 as dose 4 (booster), single (Lot number: FK9894), in left arm for covid-19 immunisation. The patient's relevant medical history included: "Prolapsed mitral valve" (unspecified if ongoing); "calcification of heart artery" (unspecified if ongoing); "ED" (unspecified if ongoing); "GERD" (unspecified if ongoing). The patient has no known allergies. The patient's concomitant medications were not reported. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset Nov2022, outcome "unknown" and all described as "COVID 19". Therapeutic measures were taken as a result of vaccination failure, covid-19 which included Paxlovid (treatment start date: 23Nov2022, treatment stop date: 27Nov2022).  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Fever; This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (Fever) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PYREXIA (Fever). At the time of the report, PYREXIA (Fever) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No Concomitant medication information was provided.   No Treatment medication s were provided.
I now have a large discolored area on my arm post vaccine; I had a large area the was swollen on my right arm; This is a spontaneous report from a contactable nurse reporting for herself. A 42-years-old female patient received the second dose of BNT162B2 Pfizer-BioNTech COVID-19 mRNA Vaccine, Lot number EL1283, Expiration date Apr2021, in Hospital, via intramuscular route in right arm on 10Jan2021 at 08:45 (at 42 years of age) at single dose for COVID-19 immunization. Medical history included asthma from an unknown date. The patient was not pregnant at the time of the report. She has not been tested for COVID-19 since the vaccination. The patient had received the first dose of BNT162B2 Pfizer-BioNTech COVID-19 mRNA Vaccine, Lot number EJ1685, via intramuscular route in left arm on 20Dec2020 at 10:00 AM. There were no concomitant medications. On 15Jan2021 the patient experienced a large discolored area on her arm and a large swollen area on her right arm. She wrapped it and applied an ice pack for 10 minutes on day 5 post vaccination. The darker area appeared after she iced it and has not gone away. The reported event had not resolved yet at the time of the report.