chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Note: Scheduled to see Dr. on 10/17/2019 for well-visit. No medical attn sought as of yet.   Fluad - Left Arm Pneumovax23 - Right Arm (System won't allow me to enter info in Box 17)  Itchiness started around 6pm into overnight, resulting in red patches all over body. Tried using ice/cold compress.  Believe it could be hives. No redness/itching around flu vax site, so could be related to Pneumovax. Pain at injection site of flu vax. Currently using calamine lotion and taking Benadryl.
received booster shots of the Moderna COVID-19 vaccine today (14Aug2021) because they are both immunocompromised.; Aches and Pains (first dose); Aches and Pains (first dose); This spontaneous case was reported by a consumer and describes the occurrence of IMMUNODEFICIENCY (received booster shots of the Moderna COVID-19 vaccine today (14Aug2021) because they are both immunocompromised.) in a 53-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 037K20 and 010M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 19-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 21-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient experienced IMMUNODEFICIENCY (received booster shots of the Moderna COVID-19 vaccine today (14Aug2021) because they are both immunocompromised.) (seriousness criterion medically significant), PAIN (Aches and Pains (first dose)) and MYALGIA (Aches and Pains (first dose)). At the time of the report, IMMUNODEFICIENCY (received booster shots of the Moderna COVID-19 vaccine today (14Aug2021) because they are both immunocompromised.), PAIN (Aches and Pains (first dose)) and MYALGIA (Aches and Pains (first dose)) outcome was unknown.            Concomitant medication use was not reported.   Treatment information was not provided.  Booster Dose Information: Lot# -  0881021A Expiration Date -Not available Indication - COVID-19  Patient said that he and his wife both received booster shots of the Moderna COVID-19 vaccine today (14Aug2021) because they are both immunocompromised.  Agent confirmed first dose and side effect information from previous case was correct. Caller confirmed that dose information was the same for he and his wife for all three doses. His wife experienced a few aches and pains with each of the first two doses but is fine so far after the booster dose. The caller mentioned that her second dose produced more severe side effects. It is unsure if the wife is currently on any concomitant medications at this time.  Company Comment:  Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.
Woke up the next morning with shooting pains in her back, arms and shooting down her left leg.  Pain was like a hot poker was in the center of her back and radiating outwards.  Left leg seemed to be numb at times.  We went to Primary Care Physician the morning of the shot and she was fine.  Took the shot after lunch and the pain started the next day.  We have been to two appointments at the Orthopedic doctor (took two x-rays...ordered two MRIs, yet to be done and to a dermatologist to rule out possibilities.    On Saturday, May 8, she broke out in a rash all over her front, all over her back and on the inside of both arms.  (I have pictures).  Since then we have used 60 mg. Cymbalta, 600 mg. gabapentin and even tried Transxene for two days.  All it did was make her sleep.  We have used Cortisone cream 2.5% to lesson the pain and itching.  Today is May 12 and the redness is dissipating somewhat.  Still itches and still using cortisone cream.  All of this started the day after she took the shot and is very hesitant about ever taking any more.
This spontaneous report as received from a physician refers to a 64 year old patient (gender unknown). Patient had no history of chicken pox or vaccination for varicella. In 2008, at unspecified time, the patient was vaccinated with VARIVAX (merck) single dose. Patient's concomitant medications were not reported. On an unknown date the patient experienced negative titer for varicella. No adverse effects reported. No further information provided. The outcome of negative titer for varicella was unknown. Additional information has been requested.
Headache, Myalgia & NauseaVomiting Per nursing report: "received COVID injection @ 1000am on 1/27/21 and is now experiencing nausea, headache, and soreness all over"
swollen, painful left axilla area; swollen, painful left axilla area, gotten progressively worse; difficult to raise arm due pain; difficult to raise arm due pain, very tender to touch, felt like burning; This is a spontaneous report from a contactable Other HCP(patient). A 48-year-old female patient received first dose BNT162B2 (Pfizer BioNTech Covid 19 vaccine, lot number EL3248), via an unspecified route of administration at Arm Left on 16Jan2021 07:00 at the 48 years old at single dose for COVID-19 immunization.  The medical history included HTN(Hypertension), HLD(Hyperlipidemia), Migraines, Depression, Herniated Discs, Arthritis. There were concomitant medications but unspecified. The patient previously took Codeine and experienced allergy. On 22Jan2021 6 days after vaccine, the patient experienced swollen, painful left axilla area, gotten progressively worse, difficult to raise arm due to pain, very tender to touch, felt like burning had continued for 3 days. The patient taken Ibuprofen, Tylenol, and Iced area as treatment for all the events. There was no other vaccine in four weeks. There was no covid prior vaccination. There was no covid tested post vaccination. The outcome of the event was not recovered.
PT STATES WAS GIVEN FLU VACCINE AND DOES NOT KNOW NAME. TODAY HAD SEIZURE WHILE AT WORK. EMPLOYEE HEARD THUMP AND FOUND PT LEANING AGAINST WALL WITH SHAKING ACTIVITY. CONCEPTION 07/19/2018. EDC 04/25/2019.
Pt received Moderna COVID vaccines on 5/15/21 and 6/12/21. Pt presented to the ED on 08/30/21 with complaints of abdominal pain, nausea, vomiting, diarrhea, and SOB prior to arrival. Pt was found to be COVID positive.
This spontaneous report was received from a medical assistant regarding to a patient of unknown age and gender. The patient's concurrent conditions, historical conditions, past drugs and concomitant medications were unknown. On 21-DEC-2018, the patient was vaccinated with an improperly stored dose of ROTATEQ (dose, frequency and route were unknown) (lot# R015607; expiration date: 21-APR-2020) for prophylaxis. There was no adverse effect reported. The temperature and timeframe were below 32 Fahrenheit (29 Fahrenheit) for 1 hour 15 minutes. There were no previous temperature excursions. A digital data logger was involved. The outcome of product storage error and no adverse event was unknown. This is one of the three reports from the same reporter.
Patient was indicated for second dose in covid-19 primary series, however bivalent booster was accidently administered. Error was realized immediately after, no adverse events noted. No additional dose was administered under the guidance of CDC Covid-19 vaccine administration errors and deviations recommendations.
Information has been received from a lawyer regarding a case in litigation concerning a female patient of unknown age. No information was received regarding the patient's past medical history, concurrent conditions, or concomitant medication. On or about 25-FEB-2013, the patient was inoculated with the ZOSTAVAX (lot number, dosage and route of administration not provided) for routine adult health maintenance and the intended purpose of the long-term prevention of shingles and zoster-related injuries. The ZOSTAVAX did not prevent shingles and zoster-related injuries as intended. In 2016, the patient was treated by a physician for herpes zoster or shingles. As a direct and proximate result of the ZOSTAVAX, and/or despite receiving ZOSTAVAX for long term prevention of shingles and zoster-related injuries, the patient suffered painful injuries and damages and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages. The outcome of the events was unknown. Causality assessment was related. Additional information has been requested.
Pt received 2nd dose of Anthrax with minor local reaction which had abated. Pt developed itchy rash over shot site prior to visit. Has reaction consistent with local urticaria. Treated with cool compresses and oral Benadryl.
Patient brought to ED on 12/2/22 by EMS for evaluation of weakness that began around bedtime that same night. He was unable to get up on his home, despite usual independence at baseline. His wife previously had COVID the week prior. Additionally, in ED patient reported increased urinary frequency and dark colored urine; he was admitted with acute cystitis. Patient admitted 12/2/22. During his admission on 12/3/22, COVID PCR test was preformed which resulted positive. He noted a mild cough and weakness but did not require supplemental O2 . Patient discharged 12/6/22.
received first dose from vial refrigerated more than 30 days; This spontaneous case was reported by a medical assistant and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (received first dose from vial refrigerated more than 30 days) in a 38-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 05ZEZ1A and 011FZIA) for COVID-19 vaccination.     No Medical History information was reported.   On 15-Sep-2021 at 2:59 PM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 13-Oct-2021 at 4:09 PM, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 15-Sep-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (received first dose from vial refrigerated more than 30 days). On 15-Sep-2021, EXPIRED PRODUCT ADMINISTERED (received first dose from vial refrigerated more than 30 days) had resolved. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter considered EXPIRED PRODUCT ADMINISTERED (received first dose from vial refrigerated more than 30 days) to have an unknown relationship.    No concomitant medication was provided.  No treatment information was provided.   Most recent FOLLOW-UP information incorporated above includes: On 10-Nov-2021: Reporter and patient initials updated. Batch number and expiry date of the suspect updated.
No adverse event, administration error only. Client received 2nd dose of Bivalent booster inadvertently, 8 weeks after previous Bivalent booster dose
APPROXIMATELY TWO WEEKS AFTER VACCINATION THE PATIENT EXPERIENCED A REDDNESS THE APPEARED ON HIS FACE THAT HAS PERSISTED UNTIL PRESENT WITH NOT MUCH PROGRESSION OR REGRESSION. NO COMPLAINT OF PAIN OR DISCOMFORT. PATIENT REPORTED USING DESONIDE CREAM PRESCRIBED FOR OTHER CONDITIONS THAT APPEARED TO HELP.
Information has been received from an approximately 30-year-old female registered nurse who was vaccinated with the first, second, third and fourth doses of Varivax. Subsequently, the patient did not develop any antibodies. The outcome was reported as not recovered. Unspecified medical attention was sought. There was no product quality complaint. Additional information has been requested.
Pregnant patient (28) year old at 26 weeks was administered Nasal live attenuated vaccine.
I think it was around 06/15/2022 that I started out with what I thought was allergy symptoms, like runny nose and sneezing. But it just continued until around 06/18/2022. I took at home COVID-19 tests, but they were negative. I just kept feeling worse, so I went to the local urgent care clinic. They thought that it was a sinus condition, so they gave me a prescription and advised that if I was no better after 4 days to have a second prescription filled. I did end up having to fill the second prescription and still did not feel better. I went back to the urgent care clinic, and they informed me that I had to be on the second prescription for at least 7 days before they would prescribe anything else. They did a second COVID-19 test and it was still negative. After the 7 days, I had begun to feel better, so there was no need for another prescription.
Around 6:00 pm on the day of vaccination the patient reported pain at the site of injection, feeling shaky, and loose stools.
1st period (post vaccine) she had a very heavy bleeding for 11 days,2nd period (post vaccine) very heavy bleeding for 10 days; This spontaneous case was reported by a consumer and describes the occurrence of HEAVY MENSTRUAL BLEEDING (1st period (post vaccine) she had a very heavy bleeding for 11 days,2nd period (post vaccine) very heavy bleeding for 10 days) in a 51-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    In 2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced HEAVY MENSTRUAL BLEEDING (1st period (post vaccine) she had a very heavy bleeding for 11 days,2nd period (post vaccine) very heavy bleeding for 10 days). At the time of the report, HEAVY MENSTRUAL BLEEDING (1st period (post vaccine) she had a very heavy bleeding for 11 days,2nd period (post vaccine) very heavy bleeding for 10 days) had resolved.            It was reported that the patient did not talk to her physician. It was also mentioned that both first and second dose were Moderna. After first period, patient didn't experienced bleeding for 2 weeks, then after 2 weeks again patient had heavy bleeding.  No concomitant medications were provided by the reporter.  No treatment information was provided by the reporter.
Slight headache, fever (100.4), reduced appetite.  It felt like a mild case of the flu.  I was allowed to leave work and go home.  I slept for a few hours, ate a little bit and went to bed very early (8:45pm).  By the next morning, the fever broke and I was fine.
Night sweats daily since then.  8/17/2021 reacted to rare side effect of appendicitis
This spontaneous report was received from a nurse refers to unspecified number of unspecified patients of unknown gender and age. Information regarding patients' medical history, concurrent condition, drug reactions/allergies and concomitant therapy were not reported. On unspecified dates in 2016 (reported as starting on or after 09-FEB-2016), the patients were vaccinated with improperly stored doses of M-M-R II (lot # L024036, expiry date: 26-NOV-2016). Nurse stated that the mentioned lot number of the vaccine underwent temperature excursion at 22.7 and -1.2 degree Celsius for 10 hours 8 minutes and 37 hours 6 minutes, respectively. She also reported the details of unsupported vaccine administered to unspecified patients: lot # L019989 (expiry date: 01-JUN-2017; underwent a temperature excursion of 22.7 degree Celsius for 10 hours 8 minutes) was administered on 24-MAR-2016, lot # L032181 (expiry date: 25-AUG-2017; temperature excursion at 22.7 degree Celsius for 10 hours 8 minutes) on 25-MAR-2016, 28-MAR-2016 and 29-MAR-2016. No adverse effect was reported. This is one of the five reports received from the same reporter. This is one of the five reports received from the same reporter. Additional information has been requested.
Patient positive for COVID-19 on 3/26/21 after completing vaccination. Admitted for SOB. Treatment with Remdesivir.
5PM that night, I had horrible leg cramps , left hip and leg were sore. Bones hurts really bad. Overnight was the worst. I started vomit, the next day, 2days later like someone threw hot water on my shins. Tingling and weird, left leg stiff. Happening a lot and vertigo ( I had before) now its severe. Change in vision (had bad vision before but now I am wearing glasses). Tingling on my arms and legs. Could not work straight. The bottom of my feet burns in bed. Diaphragm will be tight. I had anxiety in the past and brain fog. I saw the doctor in 12 May2021. Food allergies had changed and now I cant have diary. Loss 10 pounds.
Growing red spot around injection site, hot to touch, itchy, growing skin depression immediately surrounding injection site.
Information has been received from a physician concerning a 2 year old male with no medical history who on 19Feb2003, was vaccinated SC in the left arm with a 0.5 mL dose of varicella virus vaccine live. There was no concomitant therapy. On 05Mar2003, the pt developed several vesicles surrounding the injection site on his left arm. No treatment was required. On 05Apr2003, the pt developed two firm papules at the injection site. At the time the pt was seen by the physician and was treated with a course of unspecified antibiotics which "did nothing". On 04Jun2003, the pt developed "brownish colored bumps" near the injection site with no vesicles. No laboratory tests were performed. The physician noted that the pt was a normal host, without immunosuppression and without known exposure to wild chickenpox. At the time of this report the pt had not recovered. Additional information has been requested.
fever (100.2F), chills, nausea, shortness of breath, tired, headache Nausea was first about 3 hours after shot (Tuesday). Then chills and body aches about 5 hours after shot. Very little sleep that night took Tylenol before bed. In morning (Wednesday) of next day had 100.2F fever and bad headache with body aches. Nausea left during day. Temp was 99.6F just before bed time Wed night. Fever broke around 2am Thursday with night sweats. Thursday - no fever or headache or aches, but still tired and feel feverish with activity. Right arm still sore.
No additional adverse effects reported; received improperly stored dose of VARIVAX; This spontaneous report was received from a physician referring to a patient of unknown age and gender. The patient's pertinent medical history, concurrent conditions, previous drug allergies, and reactions were not reported.    On 24-MAR-2020, the patient was vaccinated with a first dose of an improperly stored varicella virus vaccine live (oka/merck)(VARIVAX) lot # S025609 with an expiration date on 18-AUG-2021 (strength, dose, anatomical location, and route of administration were not reported) for prophylaxis, which was reconstituted with a sterile diluent (MERCK STERILE DILUENT) properly stored.      The dose of varicella virus vaccine live (Oka/Merck)(VARIVAX) was exposed to a total time in the range of 15 Fahrenheit (°F) to 46°F (-9 Celsius degrees (°C) to 8°C): -5.48°C for 7 hours, which was detected by the data logger. There was no prior temperature excursion and no adverse events were reported.
pt receiving his vaccine and he vasovagalled. He fell off the table hit his head and left knee. Landed on the floor.
SOFTBALL SIZED BLOOD CLOT IN ARM; THOUGHT GOING TO DIE; This spontaneous report received from a consumer via company representative via social media and concerned a male patient of unspecified age of unknown race and ethnicity. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown, expiry: Unknown) 1 total, dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported. On an unspecified date, the patient got a "softball sized blood clot in arm and thought was going to die" for four days from vaccine The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the softball sized blood clot in arm and thought going to die was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0: 20210936181-Covid-19 vaccine ad26.cov2-Softball sized blood clot in arm . This event(s) is considered unassessable. The event(s) has an unknown/unclear temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s).
The night that I got vaccinated my left arm was very painful. I had chills and fever and that lasted 24hours. 3 weeks later I developed shingles I had the worst pain. I couldn't sleep. I had nerve pain and a rash on my left side of my body. I went an urgent care and they said it was shingles and I  followed up with my doctor where they prescribed me medication.
This spontaneous report as received from a pharmacist via Poison & Drug Center refers to a 14 year old male patient. The patient started Oka/Merck VARIVAX on an unknown date years ago for vaccination. The patient's concomitant medications, medical history and relevant labs were unknown. On 08-AUG-2018, the patient was vaccinated with expired Oka/Merck VARIVAX (lot # M025864 with expiry date of 24-MAY-2018) 0.5 ml, subcutaneously on the arm(frequency reported as once) for prophylaxis. As of 08-AUG-2018 it was unknown if the patient will continue Oka/Merck VARIVAX and the outcome of expired vaccine administration was unknown.
Within a week following receipt of the first vaccine, I began having chronic loose stools, which to date have not been resolved.  I have not had a solid bowel movement since April.
Site: Bruising at Injection Site-Mild, Site: Pain at Injection Site-Severe, Site: Redness at Injection Site-Severe, Site: Swelling at Injection Site-Severe, Systemic: Fainting / Unresponsive-Severe, Systemic: Joint Pain-Severe
4/20/20: post vaccine - tingling in my eyelids, cheeks; head fog/feeling out of it 4/21 - 4/22: mild soreness in arm, head fog but overall feeling good 4/23: tingling/numbness in cheeks and face comes and goes throughout day 4:26: Appt with Nurse Practitioner at PCP/Internist office 4/24-5/4: feeling puffy/inflamed/joint stiffness; continued tingling/numbness in face; weakness in quads feeling like my legs would give out; feeling vibrating/pressure feeling in head; feeling disconnect between brain and legs as if I needed to think hard to move them; worried I'd fall down going up the steps or walking; electric feeling in legs while resting; sensitivity to sounds and lights that would last for less than 30 minutes; pressure in head would come and go in short periods and not relieved by Tylenol 5/3: Appt with Rheumatologist 5/8: ER Visit 5/5-6/1: continued symptoms as above; muscle tightness in lower back, right back and into shoulders; goosebump/chills felt very intense and would linger as if nerves were working overtime/highly sensitive; cold feeling in face would sometimes spread to ears; tight feeling in tongue; random muscle twitches in legs at night.  5/18: Appt with Internist 5/27: Appt with Neurologist - conducted EMG on right leg; for several weeks post test the right leg symptoms improved dramatically; did not have the same sensitivity as before the test.  June - August: many symptoms have subsided except for weak feeling and restless/electric feeling in both legs; still occasionally sensitive to light/sounds;