chrisvoncsefalvay/vaers-outcomes huggingface dataset:
PT broke out in a full body rash after 3 days of vaccine. No breathing issues.  . Start at feet and spread to full body.   Has benadryl at home and went to office today to get a medrol dose pack and started taking it.
adult dose of Havrix to a 14 year old; adult dose of Havrix to a 14 year old; This non-serious case was reported by a nurse via call center representative and described the occurrence of overdose in a 14-year-old male patient who received HAV (Havrix adult) (batch number 55M72, expiry date 13-DEC-2024) for prophylaxis.   On an unknown date, the patient received Havrix adult. On an unknown date, an unknown time after receiving Havrix adult, the patient experienced overdose (Verbatim: adult dose of Havrix to a 14 year old) and inappropriate age at vaccine administration (Verbatim: adult dose of Havrix to a 14 year old).  The outcome of the overdose and inappropriate age at vaccine administration were unknown.   Additional Information: GSK Receipt Date: 26-SEP-2023 A nurse called to ask for information about the administration of an adult dose of Havrix to a 14 year old male patient which led to overdose and inappropriate age at vaccine administration. The Healthcare professional asked for guidance on this situation. The reporter consented to follow up.
My grandpa was very lethargic after his 2nd vaccine.  The following day he started acting more awake, he had a better appetite but seemed to be breathing a little funny.  He was labored a bit.  He went to sleep on 2/24/21 and at 230 am was dead.
after the second shot was in bed for 5 days again with the vertigo to the point that he needed a walker to get to the bathroom.; after the second shot was in bed for 5 days again with the vertigo to the point that he needed a walker to get to the bathroom.; after the second shot was in bed for 5 days again with the vertigo to the point that he needed a walker to get to the bathroom.; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team for a Pfizer sponsored program. The reporter is the patient.  A 72 year-old male patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 2, single for covid-19 immunisation. Relevant medical history included: "dementia" (ongoing). The patient's concomitant medications were not reported. Vaccination history included: Bnt162b2 (first Pfizer Covid Vaccine), when the patient was 72 years old, for Covid-19 immunization, reaction(s): "felt drunk", "vertigo". The following information was reported: VERTIGO (non-serious), outcome "recovering", BEDRIDDEN (non-serious), GAIT DISTURBANCE (non-serious), outcome "unknown" and all described as "after the second shot was in bed for 5 days again with the vertigo to the point that he needed a walker to get to the bathroom.".  Additional information: it was reported that Patient was wondering whether if he gets a booster should he expect to feel the same or worse. He was suffering from a little bit of dementia that was ongoing prior to him being administered any doses of Pfizer Covid Vaccine. The patient queried if he should expect the same effect or worse if he were to get the booster dose? Patient indicated that he did intend to get the booster dose. He also stated that "after the second shot I was in bed for 5 days ". he was in bed with vertigo from the second dose of Pfizer Covid Vaccine for 5 days but was feeling better.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Lighthead, Dizzy, motion sickness, pain in right  ear, nausea- unable to walk in the dark, foggy headed
This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE MASS (Hard swollen knot from shoulder to where arm bends) and ILLNESS (She was ill) in a 76-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The patient's past medical history included No adverse event. On 06-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 06-Mar-2021, the patient experienced VACCINATION SITE MASS (Hard swollen knot from shoulder to where arm bends). On an unknown date, the patient experienced ILLNESS (She was ill). On 09-Mar-2021, VACCINATION SITE MASS (Hard swollen knot from shoulder to where arm bends) had resolved. At the time of the report, ILLNESS (She was ill) outcome was unknown. Not Provided. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. No Concomitant information  provided. No Treatment information  provided. Most recent FOLLOW-UP information incorporated above includes: On 04-May-2021: additional event added.
Patient received vaccine on 3/2/21 and began to experience symptoms within 12 hours. Reported symptoms include: injection site pain (within 6 hrs of shot), fever (101 F), chills, headaches, body aches, fatigue, nausea, as well as "a shooting pain below right cage x 3 short episodes the day after shot (3/3/21), and increased vaginal discharge 4 days later (3/6/21). Patient reported use of Tylenol 500mg x 1 dose on 3/3 for fever. Has fully recovered.
11/15/11 1:00 PM Became tired in few hours. Began ache all over and muscle jerks and arm pain around 6:00 PM. Fever began at 10 PM and lasted 12 hrs (always over 100 degrees). Blood pressure lowside from 54 to 92. Awake every other hr. In bed 2 1/2 days off work. Stomach cramps, swollen arm - exhausted. Weak for 5 days. Call Dr. 2nd day early. Returned call 4:00. BENADRYL.
Patient complained of being lightheaded after immunization. Patient checked out by EMS, she began feeling better shortly thereafter.  Patient advised to call 911 or go to the nearest emergency room for any additional issues as needed.  Also advised to sign up for v-safe.  Patient left site stating she felt better.
After the immunizations, patient became limp with weak cry alternating with loud cries. Change in color around lips. Vitals heart and lungs were normal. Transferred to pediatric ICU for 23 hour observation. Vitals stable. Patient went to sleep for an hour and recovered completely.
Rash, intermittent fevers, vomiting, decreased activity, increased sleep and lethargy beginning approximately 24 hours after 11/13/09 vaccinations, then 12/4/09 had tonic activity head deviated to left x 5 min, then limp, minimal responsiveness x 40 min. Transferred to Hospital for seizure. Temp 99.8, also AOM.
Patient's wife reported shooting pain in the left arm (arm of vaccination) with onset about 2 weeks after receiving shot
Following day around 8pm started having neck pain then numbness in left arm and face with slight headache.  Lasted two days.  Let up a little on third and 4th day.   Day 5 almost gone still lingering numbness in left side of face.
administered / first dose during september 2019; This case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in a male patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (1st dose received in September 2019 on an unknown date).   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the incomplete course of vaccination was unknown.  Additional details were provided as follows: The age at vaccination was not applicable for this report. Till the time of reporting the patient did not receive 2nd dose of shingrix, which led to incomplete course of vaccination. The reporter stated that, the patient 's age was unkown, only reported that the patient was older than 50 years old. The reporter consented to follow up.
Pt received the PC vaccine in his right thigh. Immediately following, the injection size became swollen & the entire leg was red. He began a high pitched, inconsolable, shrieking cry for over an hour (completely abnormal for this child & have never heard this type of cry before), he developed welting, raised hives right away on his face & trunk. I believe he was given Benedryl & the hives, crying & swelling resolved within 2 hours.
Patient started feeling wheezy and shortness of breath. She was feeling uncomfortable and was close to going to the hospital. She used her mother's albuterol inhaler. She did not go the emergency room.
This case involves a 22-year-old female patient who vaccinated with a 0.5 mL (total, once) dose of expired DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE [ADACEL] (solution, lot C5687AA, expiry date 09-Dec-2021) via intramuscular route in the left arm on 10-Dec-2021 for prophylactic vaccination (expired product administered). Medical history, past medical treatment, past vaccination and family history were not provided. Concomitant medication reported no other vaccines. It was a case of actual medication error due to expired vaccine used (latency was on same day). It was reported "Caller states he gave an expired dose of ADACEL today and wants to know if there is an extended time it can be good past the expired date and what to look and what he should do?" At the time of report, no adverse event reported. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
day 2 of the second dose - experiencing metallic taste, loss of taste symptoms current as of reporting future action may include rapid COVID testing
This case was reported by a nurse and described an adult female pt who did not respond to the Engerix-B immunization series. The nurse reported that the pt was a non-smoker and was "not older or obese". On unspecified dates, the pt received a series of 3 doses of Engerix-B. Approx. 1 month after the 3rd dose, on an unspecified date, a hepatitis B surface antibody titer indicated that the pt "did not become sero-protected".
a little freaked out; second dose moderna; This spontaneous case was reported by a consumer and describes the occurrence of FEAR (a little freaked out) and INTERCHANGE OF VACCINE PRODUCTS (second dose moderna) in a 43-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 001A21A) 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) (unknown route) 1 dosage form. On an unknown date, the patient experienced FEAR (a little freaked out) and INTERCHANGE OF VACCINE PRODUCTS (second dose moderna). The patient was treated with PARACETAMOL (TYLENOL) at a dose of 2 dosage form. At the time of the report, FEAR (a little freaked out) outcome was unknown and INTERCHANGE OF VACCINE PRODUCTS (second dose moderna) had resolved.            No relevant concomitant medications were reported. Action taken with mRNA-1273 in response to the events was not applicable. Patient received a dose of the Pfizer covid-19 vaccine by IM injection to the left arm on 4-Mar-2021 (batch:EH9899).
Headache the night I got the shot and then 2 days after I got a red rash the size of a quarter on my arm at the injection site along with itching and swelling. It went away shortly after (a day) and then returned on day 7 after the shot, this time bigger and lasted 3 days.
This spontaneous report was received from a registered nurse regarding an unspecified number of patients of unknown demographics. There was no information about concurrent condition and historical medication. On an unknown date the patients were vaccinated with improperly stored PNEUMOVAX 23 lot # L014458, expiration date- 11-FEB-2017, lot # L019836, expiration date- 24-MAR-2017 and lot # L017406, expiration date- 26-FEB-2017. No adverse event was reported. The outcome of the event was unknown. Temperature was 1.0 C, Time frame was 20 minutes. There was a previous temperature excursion- 1.2 C for 20 minutes and call was because of data logger. MMR II was in the product tab but did not experience a temperature excursion. This is one of several reports received from the same reporter. Additional information has been requested.
Lymphadenopathy discovered incidentally on CT scan following COVID positive test on 3/29/21. Placed on steroids for about 1.5 months. PET scan and biopsy performed showing signs of inflammation but not likely lymphoma. Latest PET scan following d/c of steroids showed normalized lymph nodes.
Information has been received from a nurse practitioner concerning an 82 year old female patient with allergy to ZITHROMAX who in 2008 was vaccinated with a dose of ZOSTAVAX (Merck) (dose, route and lot# not provided) "by an unspecified pharmacist". Concomitant therapy included SYNTHROID, metoprolol and unspecified supplements. It was reported that on approximately 23-APR-2012 "earlier last week", the patient developed shingles. The nurse stated that it was a horrible case of the shingles, it was in the genital areas and wide spread over entire dermatome area. The patient was treated with SILVADENE on lesion, acyclovir and hydrocodone. No laboratory tests were performed. At the time of the report, the patient had not recovered from the event. The patient contacted the nurse practitioner. Shingles was considered to be disabling by the reporting nurse practitioner, "the patient was in pain". This is one of several reports received from the same source. Additional information has been requested.
Multiple pink papules around site of Flu vaccine right deltoid area patient denied itching or pain in the arm. Patient was given 15 mgs of BENADRYL.
This spontaneous report as received from a registered pharmacist refers to a 65 year old male patient with no drug allergies. On 15-FEB-2013 the patient was vaccinated with a dose of 0.65 mL live ZOSTAVAX (Lot# reported as H020844, Exp: 20-FEB-2014) subcutaneous in the right arm. The pharmacist mentioned the patient received live ZOSTAVAX and on 16-FEB-2013 experienced injection site reactions of redness that is 4x5 inches in diameter, warm to the touch, pain at the injection site that was radiating to a good part of the upper arm, painful when area around injection site was touched or scratched (sensitive to the touch). The patient also had a rash on the shoulder of the right arm. The patient sought medical attention by visiting the pharmacist. No treatment was given and no lab diagnostics were performed. At the time of reporting, the patient was not recovered. Additional information has been requested.
PT CAME TO THE PHARMACY AND ASKED FOR THE FLU SHOT. HE WAS GIVEN FLUZONE HD. AFTERWARD WE FOUND HE HAD ALREADY HD ONE IN OCTOBER AND HE DIDN'T KNOW AND HAD CAME FOR A SECOND ONE. i IMMIDIETLY CALLED THE PATIENT TALKED WITH HIM, CONSULTED THAT IF HE HAS ANY REACTION CALL EMS IMMIDIETLY AND HAVE SOME BENADRYL HANDY . HE SAID HE IS DOING OK AND HAS NO PROBLEMS. I CHECKED ON HIM 4 TIMES THAT DAY ( 11/9/220 AND TODAY AGAIN I CALLED HIM TWICE AND HE IS DOING GREAT . HE ONLY SAID HE FEEELS A LITTLE TIRED BUT HE HAD JUST CAME BACK FROM A WALK
20-year-old professional athletes that died; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP) from medical information team.  A 20-year-old patient received BNT162b2 (BNT162B2), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DEATH (death, medically significant), outcome "fatal", described as "20-year-old professional athletes that died". The date and cause of death for the patient were unknown. It was not reported if an autopsy was performed.  Clinical course: It (vaccine) was clearly not working. It was not safe and so many people were died from it. Stop allowing it under 30-year-old, and definitely under 18. There were 20-year-old professional athletes that died, it was crazy. It was not happened in 2020. People said the amount of deaths based in 2021 and 2022, not during the actual virus in 2020, it was crazy.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Reported Cause(s) of Death: 20-year-old professional athletes that died
On 4/6/00, the pt developed malaise and measles like rash, and visited a physician due to the experience that same day.
after 1 day and lasting over 1 week, itching and oval shaped rash at injection site
Feel very sick; This spontaneous case was reported by a consumer and describes the occurrence of MALAISE (Feel very sick) 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 third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced MALAISE (Feel very sick). At the time of the report, MALAISE (Feel very sick) outcome was unknown.            Concomitant information was not provided.Treatment information was not provided.
On 10/22/2022 at approximately 2:20PM, the patient called to report local injection site pain, minor swelling around the area, and erythema extending from top of shoulder and down to about the start of the elbow.    Patient reports no itchiness, no difficulty breathing, and no spreading of other individual rashes about her body.    Patient was informed that erythema is not uncommon with the high dose flu shot, but that it was important to monitor her symptoms.  Patient was advised to mark the furthest edges of the rash with a marker or other similar implement so as to track the rate of grown or contraction of the rash.  Patient was also advised to seek immediate medical care in the event that she experienced anaphylactic symptoms.  Patient was advised to consult with their PCP if the rash seems to continue to get worse, but has not worsened to the point where immediate medical care was advisable.
Patient began experiencing moderate dizziness upon waking up at 6:30 a.m. the morning after booster administered.  Dizziness persisted throughout the day.  Prior vaccination was Johnson and Johnson in February of 2020.
Inflamed lymph node on collarbone (hard as a rock and sore), sore arm, extreme headache, fever, bad night sleep.
Possibly given compromised vaccine ( vaccine reconstituted and administered with sterile water instead of manufacturer's diluent). No reported adverse health events by patient at this time.   Decision to not revaccinate was determined by local medical team with advice from the following medical professional(s).    *Item 5 was filled due to form requirement but it is unknown if patient has experienced an adverse health event. This VAERS form is being filled out for documentation and education purposes.   -22JUL2019
Obtained cellulitis in my right breast implant. Redness and fever in rt breast along with feeling lathargic.  Was seen by my oncologist and told that they couldn't say it was from the vaccine but they couldn't rule it out either
The patient stated that she has experienced pain and decreased mobility in the shoulder of the arm in which she received shot. She states she has had to attend physical therapy.
She experienced heat at injection site; She experienced swelling at injection site; She experienced redness at injection site; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE WARMTH (She experienced heat at injection site), VACCINATION SITE SWELLING (She experienced swelling at injection site) and VACCINATION SITE ERYTHEMA (She experienced redness at injection site) in an 83-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 007M20A) for COVID-19 vaccination.     No Medical History information was reported.    On 11-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 12-Mar-2021, the patient experienced VACCINATION SITE WARMTH (She experienced heat at injection site), VACCINATION SITE SWELLING (She experienced swelling at injection site) and VACCINATION SITE ERYTHEMA (She experienced redness at injection site). At the time of the report, VACCINATION SITE WARMTH (She experienced heat at injection site), VACCINATION SITE SWELLING (She experienced swelling at injection site) and VACCINATION SITE ERYTHEMA (She experienced redness at injection site) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medication was reported.  No treatment medication was reported.
PATIENT HAD PFIZER VACCINE 12/29/2020 and 01/19/2021, AND TESTED POSITIVE TO COVID.
2/6/21 headache, muscle soreness, stiff neck, fever, earache 2/7/21 headache, fatigue, sore arm and neck  2/8/21 severe migraine, severe ear ache,   Daily headaches and ear aches over the next 2-3 weeks. Intermittent ear pain and migraines since vaccination. No history of migraines or ear pain.
Approximately 2 hours after administration, as I was Mall walking, I noticed more aches in my legs than usual. This continued as I walked. Drove to another location and had a hard time exiting the vehicle because of the muscle aches. These continued each time I sat down and arose during the evening. At bed time, I noted the arm was extremely sore to the touch and very warm. Woke up about 5AM and could barely roll over from the aches. Tried to rise, but I couldn't. Just too tired to move. Had to cancel an Doctor appointment as I couldn't get up. Dozed on and off until about 2:30 in the afternoon. Was able to rise about that time. After dinner, I kept dozing on and off in a chair. At 11:30 PM I retired. Could not sleep consistently all night. Rose about 9:00 AM on 6/22/2018 and felt better, but the arm was very sore to the touch and warm. Notified Dr of my condition. As the day progressed, I felt better and was able to do some activities (around the house) but was still lethargic the rest of the day. Napped a couple of times. As of 2:40 PM, I feel about 80% toward normal. Delivered a copy of this form to the Pharmacy. Will deliver a copy of this form to Dr on Monday, 6/25/2018.
At conclusion of H1N1 Clinic at preschool it was discovered vaccine recommended for age 4 and older was give to 3 yr. child.
Woken at midnight by severe chills with teeth chattering, temp of 101.5 with Advil. Dizziness, weakness, severe bone pain of entire right leg from ball of hip joint down to top of foot. Felt like the bone exploded from inside and was full of holes. Lasted for ten hours followed by extreme weakness. Two weeks later I am still weak and tired constantly. Also had weird nerve like pains in various parts of the body. Now still with body aches especially in right leg.
Patient stated she came back to pharmacy 2 days after administration. Arm was red and irritated, arm was hurting. Pharmacist on duty recommended bendryl cream. Patient came back to pharmacy on 08/14/19 with mild rash on arm, sensitive to touch, raised, and patch spots. Patient was sent to primary care physician for follow up. Primary Care physician Diagnosed as potential shingles.
This spontaneous report has been received from a pharmacist referring to a patient of unknown age. On 28-NOV-2015 the patient was vaccinated with improperly stored M-M-R II (dose and route not reported, lot # L012482, expiration date: 10-APR-2017) (Incorrect product storage). No adverse effects reported. This is one of several reports from the same reporter. Additional information has been requested.
Pain at injection site (approx. 4 hrs after injection) Chills, nausea, vomiting (approx 12 hrs after injection)
after vax inject pt devel headache, fever 106 temp, red & edematous 12x8cm