chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Received expired 2nd booster dose after 30 day beyond use expiry date), PRODUCT STORAGE ERROR (Vaccine was initially stored in the refrigerator on 15-Jul-2022 and administered on 20-Aug-2022) and NO ADVERSE EVENT (No adverse event) in an adult patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 051B22A) for COVID-19 vaccination. No Medical History information was reported. On 20-Aug-2022, the patient received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 20-Aug-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Received expired 2nd booster dose after 30 day beyond use expiry date). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Vaccine was initially stored in the refrigerator on 15-Jul-2022 and administered on 20-Aug-2022) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Received expired 2nd booster dose after 30 day beyond use expiry date), PRODUCT STORAGE ERROR (Vaccine was initially stored in the refrigerator on 15-Jul-2022 and administered on 20-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 booster dose after 30 day beyond use expiry date) and PRODUCT STORAGE ERROR (Vaccine was initially stored in the refrigerator on 15-Jul-2022 and administered on 20-Aug-2022). No concomitant medication was reported.  The vial was initially stored in the refrigerator on 15-Jul-2022. The vial did not undergo any temperature excursions. No treatment information was reported. This case was linked to MODERNATX, INC.-MOD-2022-631699, MODERNATX, INC.-MOD-2022-631701 (E2B Linked Report). Sender's Comments: MODERNATX, INC.-MOD-2022-631699:Adult patient 1; MODERNATX, INC.-MOD-2022-631701:Adult patient 2
This spontaneous report was received from a consumer who refers to himself a 70 year old male patient with a medical history of herpes type 2 virus (since 1975). In 2013, the patient was vaccinated with ZOSTAVAX, "one shot" (dose and lot number not reported) intramuscular (considered incorrect route of drug administration) for prophylaxis at the recommendation of his physician due to his age. On the same date in 2013, within a couple of minutes of each other, the patient was also vaccinated with (unspecified)(INFLUENZA VIRUS VACCINE (UNSPECIFIED), (manufacturer, dose, frequency, route and lot number not provided) for prophylaxis. The patient reported within 36 hours after he was vaccinated with ZOSTAVAX, he developed one "major" herpes attack. The patient did not receive treatment for his "major" herpes attack but sought medical attention by visiting his physician. The patient had his blood count performed during his annual physical. Since being vaccinated with ZOSTAVAX, the patient has not had a herpes type 2 attack and feels like he has been miraculously cured of his herpes attacks which have plagued him for nearly 40 years. In addition, the patient thought the ZOSTAVAX somehow suppressed or possibly caused his herpes type 2 virus in his body to go into some kind of remission. The outcome of "major" herpes attack was reported as recovered/resolved. The reporter considered therapeutic response unexpected to be related to ZOSTAVAX and the relationship between "major" herpes attack and ZOSTAVAX was not provided. Additional information has been requested.
Day following vaccination  had significant diarrhea and nausea. Lasted about 24 hours. Then 7 days after vaccination, 1/6, awoke with large reddened area at injection site, warm to the touch.
This spontaneous report as received from a healthcare worker refers to an unspecified number of patients of unknown age and gender. There were no concomitant medications, concurrent conditions and medical history reported. Some doses of PROQUAD (Merck) lot# reported as L006389, exp. 25-AUG-2016 and lot# K023365, exp. 20-MAY-2016 (dose was not reported), which were exposed to temperatures outside of the recommended range, have been administered to unspecified patients on unspecified dates since 14-AUG-2015. No adverse experience has been reported. Additional information has been requested.
Child started c/o itching inside ears within 10 minutes of receiving the shot. States that this lead to rash all over body except at injection site. Zyrtec was given & symptoms improved. Has been doing fine since.
Tumor in spine; This is a spontaneous report from a Pfizer-sponsored program. A contactable consumer (patient's daughter) reported that a female patient of an unspecified age received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot Number and Expiration Date were not reported), via an unspecified route of administration, on 29Jan2021, at a single dose, for COVID-19 immunization. The patient's medical history included hip pain (prior to the first dose of the vaccine). The patient's concomitant medication included paracetamol (TYLENOL) for hip pain. The patient received the first dose of the Pfizer vaccine on 29Jan2021. The patient started taking 4 mg dexamethasone daily since 03Feb2021 (also reported as 02Feb2021 or 03Feb2021) for a tumor in spine on an unspecified date. The event was considered non-serious by the reporter. The patient received the second dose of the vaccine on 18Feb2021. The patient's daughter wanted to know if this will affect the efficacy of the vaccine as she has been seeing conflicting sources about it. The outcome of the event was unknown.  Information about lot number and expiration date for the suspect product will be requested in follow-up attempts.
dizziness, fainting feeling post vaccination, has hx DM on oral meds, no meds given, stable and DC AMA with son driving pt home
Vertigo, nausea, uncontrolled "shaking"- was given Meclizine by physician; stayed in bed for 3 days.
Severe lymphedema on left side - Armpit, neck, and clavicle area. Site of injection very tender, painful, and hard.
Localized redness and swelling (hard, tight  at sight) blistering  soreness. fever chills mild.  TX: Prednisone and Doxycycline
Patient was supposed to receive a flu vaccine but was administered a Moderna Bivalent booster instead
C/o minor upper arm swelling and low grade temp of 100.3-100.4 degrees.
Redness appeared 5-6 hours after vaccine.  C/o redness, warmth & pain over his left proximal arm - not directly at injection site - but just distal to site.  Afebrile.  Cold application & BENADRYL & TYLENOL.
This case was reported by a healthcare professional and described the occurrence of acute hepatitis in a subject of unspecified age and gender who was vaccinated with HAVRIX (GlaxoSmithKline). Concurrent vaccination included Tdap vaccine (non-gsk); non-GSK manufacturer; unknown; unknown given on 1 March 2012; this vaccine was reported as a GSK manufactured vaccine but the Lot number U3561DA did not correspond to a GSK vaccine. There were no concurrent medications. On 1 March 2012 at 12:00 the subject received 1st dose of HAVRIX (1 ml, unknown, right arm). On 10 March 2012, 9 days after vaccination with HAVRIX, the subject experienced acute hepatitis, elevated aspartate aminotransferase, elevated alanine aminotransferase, jaundice and bilirubin total of 9. The healthcare professional considered the events were life threatening. At the time of reporting the acute hepatitis, elevated aspartate aminotransferase, elevated alanine aminotransferase, jaundice and bilirubin total of 9 were improved. Immunization series with HAVRIX was discontinued. The reporter declined to provide detail regarding the subject such as demographics. The healthcare professional stated she "already submitted a VAERS form regarding this."
Sweet taste in mouth, Exhaustion, body aches, fever, arm pain, mild pain in chest left side under the last rib. All this started on day of vaccine through the night and into the morning I still feel bad.
Rash consistent with chickenpox on face, mouth, trunk, arms, onset 1/17/06.  Date of diagnosis 1/18/06.  Benadryl PO and Caladryl topically.
exposed to 5°F, already administered / Administration of vaccine after temperature excursion; This case was reported by a pharmacist via call center representative and described the occurrence of incorrect storage of drug in a patient who received Herpes zoster (Shingrix) (batch number 95G27, expiry date 10th September 2023) for prophylaxis.   On an unknown date, the patient received Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced incorrect storage of drug. On an unknown date, the outcome of the incorrect storage of drug was unknown.   Additional Information: GSK Receipt Date: 05-JULY-2022 Reporter's comment: Pharmacist reported on July 5th 2022 that Shingrix was exposed to 5 degree F for between 10 or 12 days. 1st excursion. HCP stated that the vaccine was already administered to other patients more than 6 patients but they would have to confirm with their reports. No additional information on patients was provided by email
10 mins post/vax, pt became unconscious, pale, body stiff, tremors to hand & arms, eyes rolled back & pants soiled with urine. Took to ER by EMS.
24 hours after receiving the vaccine, I had a severe debilitating headache, serious enough to make my teeth hurt, I ran a fever of at least 101, had flu like symptoms. The injection site was very hot to touch, tender, and was quite enlarged. I seriously felt like I had the worst flu I had ever had.  The headache would not go away regardless of any medication I took. The fever was with me for a solid 24 hours. The headache has lessened in intensity but the feeling of being ill is still with me.
Difficult to arouse for approx 13 hours immediately following 4 month vaccines. Persistent and inconsolable crying starting approx 15 hours following vaccines. New onset of colic like crying and fussiness, lasting approx 4 weeks. Development of rash on chest, stomach and back 24 hours following vaccines, later developing into eczema in same generalized locations. Loss head control and loss of skills such as lifting head and chest off of ground while on stomach, loss of ability to roll from belly to back. Diminished tone. First noticed approx 48 hours following vaccines. Loss of vocal skills, no longer cooing and babbling. Drastic increase in GERD/vomiting symptoms, with no relief from Zantac regimen. No bowel movement for 13 days. New onset of apnea, episodes ranging 15-30 seconds. During the episodes patient would take a large and audible gasp of air after being picked up for arousal. Cold and cough symptoms appeared 48 hours after administering vaccines. Symptoms persisted for approximately 6 weeks.
This case was reported by a other health professional via sales rep and described the occurrence of injection site erythema in a female patient who received SHINGRIX. On an unknown date, the patient received the 1st dose of SHINGRIX .5 ml. On an unknown date, less than a year after receiving SHINGRIX, the patient experienced injection site erythema. On an unknown date, the outcome of the injection site erythema was unknown. It was unknown if the reporter considered the injection site erythema to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. The patient experienced redness at injection site which was similar to a ring. The patient's husband called to the practice to tell the physician.
very sick; very sick; This spontaneous case was reported by a physician and describes the occurrence of the first episode of ILLNESS (very sick) and the second episode of ILLNESS (very sick) 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 an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient experienced the first episode of ILLNESS (very sick) and the second episode of ILLNESS (very sick). At the time of the report, last episode of ILLNESS (very sick) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medications were reported.  It was reported that the patient was very sick after both the shots, however did not seek medical help. He recovered within a day both times. No information regarding corrective treatment was reported by the patient.
Also noticed increase in sense of smell persistent after both vaccine doses and still occurring; This is a spontaneous report from a contactable consumer (patient) who reported events after first and second dose of the vaccine. This case is for event after the first dose. A 43-year-old female patient (not pregnant) received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot number was not reported), via an unspecified route of administration on 18Jan2021 at 14:00 (at 43 years)at single dose for covid-19 immunisation . Medical history was none. Concomitant medication included metformin taken for an unspecified indication, start and stop date were not reported. On an unspecified date in 2021, the patient noticed increase in sense of smell persistent after vaccine and still occurring. The outcome of the event was not recovered. No follow-up attempts are possible, information about batch number cannot be obtained.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021194810 same  patient/reporter, different AE/second dose
I had NO adverse reaction to my 2nd Booster.  In fact three weeks after the booster I was extensively exposed to Covid (family members) and did NOT get Covid at that time.  BUT... However,  I was told to report that I had a breakthrough case of Covid on Sept. 7, 2022 after having had my 2nd booster on April 13, 2022.  I was in my second day of a 102.5 temperature when my Covid test was positive in my physician's office with a PCR test.   I was placed on Paxlovid on the second day of my symptoms.  Two days after starting Paxlovid, my four-day fever of 102.5 broke and I only had mild nasal congestion, and fatigue after that. One week later, I was feeling fine.
Left upper arm has erythema, approx. 2 in by 6 in encircling front part of upper arm distally from deltoid.
Child went for well child check up - MD office notified clinic that left arm - swollen, red, hot, firm to touch, MD sending child back to the reporting clinic for observation. 3/18/03 - PT never came to clinic for follow-up.
pt recv vax & fainted, fell & hit head;pt hosp for tx of a skull fracture & poss small brain hemorrhage;
Swollen lips, and struggling to breath. It reduced after approximately 30 minutes. Unusual behavior, also complaining of chest pain and headaches for several weeks. She died in her sleep april 10th 2022
day after vaccine 2-4-21, chills. about 24 hours after vaccine sob at rest and ambulation very difficult, which is unusual w/ episodes of at fib. fatigue, which is also a sx of a fib. improvement w/ dyspnea after flecaide and nsr next am when awakening. arose 2x during night as unable to sleep, still in a fib. the next day, around noon, another run of a fib which responded after several hour after flecainide. fatigue all day and napped. i usually am unable to nap during daylight.  sx of a fib i.e; dyspnea stage 4 chf was more severe evening 2-4 and it is very unusual to have runs of a fib 2 days in a row
Vaccination occurred 03/24/2021 03:30O the 03/25/2021 11:00A Bleeding became worse around 12:30P went to Dr. 1:00P treatment was limited activity. History of bleeding 8 weeks of this preganancy and adverse reaction occurred at 13 weeks of this pregnancy. About a week in half to fully recover and lifted from restrictions.
pt devel an inj site rxn characterized as red, raised, painful & warm area around the site, the day p/vax;this is one of three patients from this site who exp the above rxn coincident w/the use of lot# 4958068
Information has been received from a physician via a company representative concerning a 4 year old male patient, with no medical history reported, who on 23APR2003 at 09:30 am (previously reported as 22APR2003) was vaccinated into the right lateralis with a second dose of measles virus vaccine live + mumps virus vaccine live + rubella virus vaccine live (second generation) lot 644642/1126M, previously reported as lot 643751/0812M. Concomitant therapy on 23APR2003 at 9:30 am included a fifth dose of alum, potassium + diphtheria toxoid + pertussis vaccine + tetanus toxoid (TRIPEDIA) into the left lateralis and a fourth dose of polio virus vaccine IPOL into the left anterior lateralis. It was noted that there was no illness at the time of vaccination. Subsequently,the patient developed a "site reaction." In follow up information, it was noted that on 23APR2003 at 9:30 am, the patient developed localized swelling and redness to site and hives to face and neck. The pt was treated with diphenhydramine hydrochloride (Benadryl) 12.5mg (1.75 tsp.). The patient recovered on 23APR2003. No further information is expected. It was noted that 3 other pt's had similar experiences (WAES0305USA00(453-455).
Mother reports shots were given around 10 AM. She noticed swelling on patient's left thigh down to his knee around 5 or 6 pm. States he could have had it sooner but he had long pants on. No other signs/symptoms, no Tx given.
Excessive fluid discharge from ears, plugging them up temporarily.  Occasional earaches and swelling on affected side of face.  Pain while moving jaw when ear aches with the swelling.   Has been happening fairly regularly since the onset date and is still occurring.  Ear canal itches and tickles when fluid is running out.  Most noticeable at night while trying to sleep but occurs fairly continuously for days at a time.
thought it was cellulitis; 3 days after 2nd dose left ankle swelled up; was out of work for 4 months after 2nd Moderna dose; was in so much pain; Joint pain; This spontaneous case was reported by a consumer and describes the occurrence of CELLULITIS (thought it was cellulitis) in a female patient of an unknown age 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 information was reported.   On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced CELLULITIS (thought it was cellulitis) (seriousness criterion medically significant), JOINT SWELLING (3 days after 2nd dose left ankle swelled up), PAIN (was in so much pain) and ARTHRALGIA (Joint pain). an unknown date, the patient experienced IMPAIRED WORK ABILITY (was out of work for 4 months after 2nd Moderna dose). At the time of the report, CELLULITIS (thought it was cellulitis), JOINT SWELLING (3 days after 2nd dose left ankle swelled up), IMPAIRED WORK ABILITY (was out of work for 4 months after 2nd Moderna dose), PAIN (was in so much pain) and ARTHRALGIA (Joint pain) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Blood test: abnormal (abnormal) bloodwork out of whack, nothing in range.         No concomitant medication were reported.  Treatment medication included Antibiotics. The patient was out of work for 4 months after second Moderna dose. Patient stated that three days after second dose left ankle swelled up, doctors thought it was cellulitis, was in so much pain. The blood work was out of whack, nothing in range. Patient also experienced joint pain which was a side effect always experienced.  Company Comment: This case concerns a female patient of an unknown age, with no reported medical history, who experienced the unexpected events of Cellulitis, Joint swelling, Impaired work ability, Pain and the expected event of Arthralgia. The events occurred approximately 3 days after the second dose of mRNA-1273 Vaccine. At the time of the report the outcome of the events was unknown. The rechallenge is not applicable since no further dosing is expected. The benefit-risk relationship of mRNA-1273 Vaccine is not affected by this report.; Sender's Comments: This case concerns a female patient of an unknown age, with no reported medical history, who experienced the unexpected events of Cellulitis, Joint swelling, Impaired work ability, Pain and the expected event of Arthralgia. The events occurred approximately 3 days after the second dose of mRNA-1273 Vaccine. At the time of the report the outcome of the events was unknown. The rechallenge is not applicable since no further dosing is expected. The benefit-risk relationship of mRNA-1273 Vaccine is not affected by this report.
I have had many symptoms start right after the 2nd dose.  I have muscle spasms like 200 a day, numbness and tingling, lower back spasms, weakness, fatigue,  paralysis in from waist down.  Seen in ER for that on 6/27/21.  Treated with prednisone and Valium for spasms.  Got slightly better after that.  Now loos my balance, tripping, falling.  Doctors don't know what is going on.   I am having a Brain MRI tomorrow.
pinched colon; abdominal pain / pinched colon; This case was reported by a other health professional via sales rep and described the occurrence of intestinal obstruction in a male patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix with an associated reaction of abdominal pain (1st dose received on 21st September 2020, for tolerance refer case US2021AMR206096).   In January 2021, the patient received the 2nd dose of Shingrix. On an unknown date, less than 9 months after receiving Shingrix, the patient experienced intestinal obstruction (serious criteria GSK medically significant) and abdominal pain. The patient was treated with enema preparations (nos) (Enema (Unknown)). Rechallenge with Shingrix was positive. On an unknown date, the outcome of the intestinal obstruction was unknown and the outcome of the abdominal pain was recovered/resolved.   It was unknown if the reporter considered the intestinal obstruction and abdominal pain to be related to Shingrix.  Additional details were reported as follows: The age at vaccination was not reported. The patient had similar symptom symptoms as that of 1st dose after receiving 2nd dose in January 2021. The patient received diagnosis of pinched colon. Enema relieved the abdominal pain. The reporter consented to follow up. This case has been linked with the case US2021AMR206873 (patient's father case), reported by same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021AMR206873:same reporter US-GLAXOSMITHKLINE-US2021AMR206096:same patient
Six days post vaccination, 1/19/00, pt developed episodes of coughing, which progressed to apnea.  1/26/00, she was hospitalized.
Patient's husband reports having to take patient to emergency department one or two days after receiving vaccine due to dizziness and heart flutter. Patient was admitted for overnight observation and then released the next day. No specific treatment was reported by husband.