chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Pain and swelling in arm; Pain and swelling in arm; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Pain and swelling in arm) and PERIPHERAL SWELLING (Pain and swelling in arm) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 18-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PAIN IN EXTREMITY (Pain and swelling in arm) and PERIPHERAL SWELLING (Pain and swelling in arm). At the time of the report, PAIN IN EXTREMITY (Pain and swelling in arm) and PERIPHERAL SWELLING (Pain and swelling in arm) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications was reported by the reporter No treatment medications was  provided by the reporter.
RN administered half-volume dose of 0.25ml to patient instead of full-volume dose of 0.50ml. This RN, called patient to explain the event that occurred. Per CDC guidelines, another half-volume dose can be administered to the patient same day. Patient unable to come back same day and understands that they will not be considered fully vaccinated without the full-volume 2nd dose. RPh reached out to CDC via telephone to see what are the vaccination guidelines if patient comes back a different day. CDC representative will email RPh information regarding vaccination dosage for patient. Will reach out to patient when additional information is obtained.
This was not an adverse event.  Nurse discovered that our open HIB box was missing a HIB(power vial) which means a HIB was given with sterile water instead of saline diluent making the vaccine invalid.  Connected mom who was very understanding.  She'll make an appt after speaking with Dr.
two to three days after vaccine, started to have discoloration of skin; there is yellow discoloration around the area of injection and it extends down arm as well; Initial information received on 28-Nov-2022 regarding an unsolicited valid non-serious case via pharmacist.  This case involves a 79-year-old female patient and the reporter stated two to three days after vaccine, started to have discoloration of skin and  there is yellow discoloration around the area of injection and it extends down arm as well after receiving influenza quadrival A-B high dose HV vaccine [Fluzone High-Dose Quadrivalent].  The patient's past medical history, medical treatment(s), vaccination(s), concomitant(s) and family history were not provided.   On 23-Nov-2022, the patient received 0.7 ml total dose of suspect influenza quadrival A-B high dose HV vaccine injection (batch lot: UJ937AC) (expiry date: 30-Jun-2023) via unknown route in unknown administration site for Influenza immunization.  On an unknown date the patient had a non-serious events of two to three days after vaccine, started to have discoloration of skin ((skin discolouration) and there is yellow discoloration around the area of injection and it extends down arm as well (vaccination site discolouration) (unknown latency) following the administration of influenza quadrival A-B high dose HV vaccine.  Action taken with quadrivalent influenza vaccine (Fluzone High-Dose Quadrivalent) was not applicable.  It was not reported if the patient received a corrective treatment for the events.  Outcome: unknown for both the events.
Narrative: Completed Pfizer vaccination series in January 2021. Had 3 days of coughing before presenting to the hospital and tested positive 8/19/21. Treated for hypoxic pneumonia with dexamethasone and as needed oxygen. Discharged home 8/23/21. Re-admitted for fever, coughing, and shortness of breath 8/24/21 and diagnosed with super-imposed bacterial pneumonia. Continued dexamethasone treatment and added enoxaparin. Discharged home 8/27/21.
Tinnitus is "louder" than before.  Before my vaccination, the tinnitus was only noticeable when it was very quiet, and sometimes not even then.  Now it is an almost-constant background noise.  So far, it does not interfere with my hearing.
Bruise at vaccination site day after that has not gone away Red mark beneath vaccination site that grew in size. Yesterday was approximately 4 inches in diameter and red. Treated with hydrocortisone cream and redness has reduced slightly, but spot is still there and moderately itchy.
Case number PHEH2016US029303 is an initial spontaneous report received from a nurse on 07 Nov 2016. This report refers to a 55 year old male patient. Medical history and concomitant medication was not reported. The nurse stated that first temperature excursion of FLUCELVAX QUADRIVALENT on 18 Oct 2016 at 52 Fahrenheit (F) for 1 hour, second excursion of FLUCELVAX QUADRIVALENT on 23 Oct 2016 dropped low 6 times to 34 Fahrenheit (F) and lasted 30 minutes each time, it was unknown if vaccine was frozen. The patient was vaccinated with FLUCELVAX QUADRIVALENT (batch number: not reported) at a dose of 0.5 ml intramuscularly on 24 Oct 2016. Third time excursion on 02 Nov 2016 down to 32 Fahrenheit (F) 3 times over the course of 12 hour it was unknown if vaccine was frozen. Nurse did not know which lot was given to which patient. No adverse event was reported following this administration error (incurred product storage).
patient received Shingrix on 2/28/23.  On 3/5/23 she started having a fever >100 F and headaches, and is still having them as of today 3/8/23.  Patient has been taking her pain meds hydrocodone/apap as usual, in addition to extra doses of Tylenol.  patient has not received medical care but is calling her doctor today.  She is testing negative for COVID
She was taking  Claritin for the few days before this event. She normally takes it every fall and every spring. She had seasonal allergy symptoms on the days leading up to this event- she had sore throat, runny nose, a little headache and congestion and developed a cough; on the day of this symptoms she spiked a low grade fever - 100.5. I did a rapid test for COVID at home which was negative for her. Sudden onset: A bunch of knives poking her on the inside of her stomach - pokey from hips to ribs.  She started to double over and bend over. Within 10 minutes, she couldn't stand up. She was telling me that something was really wrong. This isn't her character so I knew it was very wrong. I took her to ER. I was still concerned about appendicitis or COVID. This episode lasted for 90 minutes and then it came and went for the rest of the night and then after that - she had runny nose and congestion (normal allergies after that). She was better before they gave her the medication but it didn't seem like she really needed them. She was improving before she got either of the medications: Zofran; Levsin. They gave her a dosage of each there and  sent home with a prescription but we never had them filled as she was feeling better. - As it started to improve - it ( being the pokey pain) it was located closer to her ribs and breastbone.
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. The patient's healthcare provider recommended and/or prescribed the ZOSTAVAX vaccine to the patient for its intended purpose of permanent prevention and protection against shingles and zoster-related conditions. On an unknown date in 2009, a healthcare provider administered the ZOSTAVAX vaccine to the patient (lot number, dosage and route of administration not provided). On an unknown date in 2012, the patient was treated by a physician for shingles. The patient was diagnosed with shingles and/or other zoster-related injuries after and despite being inoculated with the ZOSTAVAX vaccine, and suffered serious physical, emotional, and economic damages as a result of the patient's injuries. As a direct and proximate result of the ZOSTAVAX vaccine, the patient has and will continue to suffer ongoing injuries, including but not limited to: mental and physical pain and suffering; extensive medical care and treatment for these injuries; significant medical and related expenses as a result of these injuries, including but not limited to medical losses and costs including care for hospitalization (dates unknown), physician care, monitoring, treatment, medications, and supplies; diminished capacity for the enjoyment of life; a diminished quality of life; increased risk of premature death, aggravation of preexisting conditions and activation of latent conditions (unspecified); lost wages; loss of earnings capacity, and other losses and damages. The outcome of the events was considered to be not recovered. Additional information has been requested.
RN busy inside preparing vaccines to be administered and DOB of child was not noticed by EMTs giving vaccine and child was about 5ft 8 inches heavy set and requested JJ vaccine not knowing his age from volunteers helping run the POD gave information to  EMTs and grandfather replied no differently that he was with so JJ was administered . Reported to doctor. RN supervisor and entered into VAERS along with incident report.
APPROX 2 WEEKS AFTER 2ND pFIZER DOSE, MY ENTIRE BODY INSIDES FELT LIKE THEY WERE ON FIRE. ALSO, EVERY JOINT IN MY BODY WAS AT A HIGH PAIN LEVEL 10+.  THE BURNING AND PAIN WAS 24X7, NON-STOP. NOTHING WOULD TOUCH THE PAIN, REDUCE THE PAIN, ETC.   THE BURNING SENSATION CEASED SUDDENLY, JUST AS IT HAD STARTED SUDDENLY. AND THAT WAS OVER THANKSGIVING WEEKEND. THE JOINT PAIN HAS REMAINED ACTIVE, CONSTANT, AND ACUTE IN MY KNEES AND HIPS. HANDS, ARMS, SHOULDERS, ANKLES, ETC HAVE SETTLED DOWN AND REMAIN AS BEFORE THIS STARTED IN OCTOBER. i.e., I HAVE ARHTRITIS IN MY HANDS AND HAVE DAILY, MANAHEABLE PAIN.
10/13 evening injection site sore. 10/14 Injection site, red, swollen, warm, enlarged, mild itch briefly. 10/14 4pm assessed by NP, border of inflammation marked, advised cool compress to return for reassessment in am. Pt is without fever. 10/14 9:30pm, T 101.5-oral, associated with headache and nausea, inflammation has spread beyond marked border. Seeks eval at ED, diagnosed cellulitis, and possible vaccination reaction. Rx Keflex 500mg qid x7d, ice and elevation.
Headache; Sore around injection area; Hard around injection site; This is a spontaneous report from a contactable consumer, the patient. A 41-year-old male patient received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot number: ER8727) via an unspecified route of administration in the left arm on 24Mar2021 at 09:30 (at the age of 41-years-old), as a single dose for COVID-19 immunisation. Medical history included high blood pressure, obesity and bicuspid aortic valve. The patient received unspecified medication within two weeks of vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID-19 vaccination. The patient had no known allergies to medications, food, or other products. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not tested for COVID-19. On 24Mar2021 at 16:00, the patient experienced headache, sore around injection area and hard around injection site. No therapeutic measures were taken as a result of the event. The event did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The clinical outcome of headache, vaccination site pain, vaccination site reaction was recovering at the time of this report.   No follow-up attempts are needed. No further information is expected.
Felt faint and light headed. Warm and clammy. No hives or shortness of breath. Carries an epi pen for Toradol allergy.  At 1110 Good color, conversational, Awake. and alert.
DIARRHEA; NAUSEA; HEADACHE; TIRED; LIGHT FEVER; ACHES/PAINS; This spontaneous report received from a consumer concerned a 52 year old female. 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: 1808980, and expiry: UNKNOWN) dose was not reported, administered on 06-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On APR-2021, the subject experienced aches/pains. On APR-2021, the subject experienced nausea. On APR-2021, the subject experienced headache. On APR-2021, the subject experienced tired. On APR-2021, the subject experienced light fever. On 17-APR-2021, the subject experienced diarrhea. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from aches/pains, diarrhea, nausea, headache, tired, and light fever. This report was non-serious.
This spontaneous report as received from a nurse refers to a 45-year-old patient of an unknown gender. There was no information about the patient's pertinent medical history, concomitant therapies or drug reactions and allergies provided. On 15-MAR-2018, the patient was vaccinated with a dose of PROQUAD injection, subcutaneously, lot # N02061 (not valid), expiration date 22-JAN-2019 (dose was not reported), for prophylaxis. PROQUAD was reconstituted with a sterile diluent (manufacturer unknown). No adverse effects reported.
Severe headache, fever up to 103.6, body aches, joint aches, abdominal pain, fatigue, nausea,
This spontaneous report was received from a Registered Nurse refers to a 4 year old male patient. No pertinent medical history was reported. On an unknown date, the patient was vaccinated with improperly stored PROQUAD (Merck) (lot # K004860 and expiration date 04-OCT-2015 also reported as 10-APR-2016) (dose and route were not reported). No adverse effects reported at that time. This is one of the two reports from the same source. Additional information has been requested.
4-5 hrs p/receiving vax, eyes became very red, drainage in eyes, eyelids swelled, t101, chills, lungs felt congested, was SOB;
Headache and vomiting starting one week later (4/3/2021); seizure due to hemorrhagic stroke 04/ 5/2021; continued bleeds 04/06/2021, 04/07/2021; life support removed 04/08/2021.
Patient with 2 Pfizer vaccinations who admitted with COVID complications.  Provider d/c note below:  "86 year old female who presented to the ED on 1/3/2022 due to shortness of breath and cough. She was diagnosed with COVID and pneumonia. She was started on antibiotics and COVID directed therapies. She did require oxygen but her requirements continued to decrease during the course of her stay. She did also have significant weakness and poor appetite which improved. She was seen by PT/OT who agreed she could go home with home care and family on discharge. On day of discharge patient was feeling much better and was ready to go home. "
?Covid arm? - large red enflamed area around injection site, itches, tender to touch
Patient stated that he started to feel itchy, dizzy, and fainted when he bent over. Fell asleep and said he was dreaming when we woke him up a few seconds later. It started happening around 5 minutes after he received the vaccine. He stated that he felt fine and back to normal after he was woken up. Had him stay until paramedics came to check him out. Was cleared to go home.
Information has been received from a consumer concerning an 86 (also reported as 88) year old male who in approximately 2007 "about 2-3 years ago" was vaccinated with a first dose of PNEUMOVAX 23 (route and lot # invalid). On 06-OCT-2010 the patient went to his HCP for a respiratory illness and was placed on amoxicillin. On 10-OCT-2010 the patient received a flu shot at church (manufacturer unknown). On 21-OCT-2010 the patient received a chest x-ray and electrocardiogram from HCP (result unknown) and received a second dose of PNEUMOVAX 23 (route and lot # invalid). On 22-OCT-2010 the patient had trouble breathing, felt cold, no fever reported. On 23-OCT-2010 to 24-OCT-2010 the patient experienced foot and joint swelling. On 21-OCT-2010 to 25-OCT-2010 the patient reported 8-10 pound weight gain. On 25-OCT-2010 nurse practitioner sent patient to the emergency room. The patient was admitted to the ICU with diagnoses of congestive heart failure and fluid retention. On 29-OCT-2010 to 30-OCT-2010 was further diagnosed with pneumonia. The patient was discharged to home with medications for asthma, diuretics and antibiotics. On 04-NOV-2010 the patient continued with persistent cough labored breathing and wheezing. Fluid retention resolved. At the time of this report, the patient's outcome was not recovered. Congestive heart failure, pneumonia and fluid retention were considered to be other important medical events by the reporter. Additional information has been requested. The patient was hospitalized.
He reports he initially developed cold-like symptoms with a cough and shortness of breath 1 week ago. He did test positive for Covid-19 and 4 days ago received sotrovimab in clinic. Yesterday evening he developed low-grade temps and today was febrile to 102. He has been checking his pulse oximetry at home and has been hypoxic down to 89%.  He does not wear any supplemental O2 at baseline. He reports progressive chest heaviness and shortness of breath with exercise intolerance. He is currently in cardiac rehab and has been doing well until his symptoms began 1 week ago. He denies any increased lower extremity pain or swelling. Denies prior history of PE or DVT. He has been compliant with his home Eliquis. Currently, he is on 5 mg of prednisone daily. He reports feeling similar chest heaviness with prior episodes of pneumonia and was concerned that that may be the case prompting his evaluation in the ED.
No adverse event; 113 Bivalent doses administered after the BUD to patients 12 and up.; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (113 Bivalent doses administered after the BUD to patients 12 and up.) and NO ADVERSE EVENT (No adverse event) in a 50-year-old female patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. AS7148B) for COVID-19 prophylaxis.   No Medical History information was reported.    On 17-Nov-2022, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On 17-Nov-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (113 Bivalent doses administered after the BUD to patients 12 and up.). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (113 Bivalent doses administered after the BUD to patients 12 and up.) and NO ADVERSE EVENT (No adverse event) outcome was unknown.     For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for EXPIRED PRODUCT ADMINISTERED (113 Bivalent doses administered after the BUD to patients 12 and up.).    No concomitant medication information was provided.  Total 113 Bivalent doses administered after the BUD to patients 12 and up. 51 doses from Lot AS7140C, and 60 doses from Lot AS7148B.  It was unknown patient received any other vaccines in the 4 weeks prior to COVID-19 vaccine.  No treatment medication was provided.
Stevens Johnson syndrome - rash, mucous membrane involvement, hypotension time course about 1.5 wks. in ICU x 2 days.
Information has been received from a physician concerning a 19 year old female patient who on 10-JUL-2007 was vaccinated with a first dose of Gardasil. Concomitant therapy included Hepatitis B vaccine, recomb (manufacturer unspecified). The physician stated that patient developed an unusual rash after she got her injection. He stated that the rash was in the injection site area, and it was perfectly circular and flat and approximately 5 cm in diameter. There was also a smaller rash of approximately 1.5 cm which overlapped the larger rash. Unspecified medical attention was sought by the patient. The patient had not recovered. Additional information has been requested. This is in follow-up to report(s) previously submitted on 9/17/2007. In follow up report the physician indicated that patient had "Tinea corporis at the injection site. We thought to be coincidence and reported that there was no adverse reaction". Additional information is not expected.
Two days after receiving the Pfizer second dose, I broke out with shingles on my face.  I have never had shingles in the past.  I had chicken pox as a child and  I received the Zostavax vaccine 6 years ago.  I contacted a physician and started on a 7 day, three times per day, course of Acyclovir and the rash disappeared over the next 6 days.
Extremely sore muscle in upper arm lasting to present (6 weeks). seemed to be a semi-paralyzed muscle. It is just now easing.
Prior to receiving both Pfizer COVID19 shots I had been diagnosed with New Daily Persistent Headache since 07/20/17. This primary headache condition has left me with a constant tension headache, heavy fatigue and related cognitive issues. I had no side effects after receiving my first Pfizer COVID19 shot on 4/1/21.  I had my 2nd Pfizer COVID19 shot on 5/3/21 and the only side effect has been a substantial increase in head pain within 5 hours of receiving the shot. The baseline pain was a 4 out of 10 prior to the 2nd shot and has been a 7 out of 10 since 5 hours after my 2nd shot. I've had no other side effects and the pain has been unrelenting and indefinite.
Aching muscles over entire body.  Particular soreness at injection site.  Head ache, chills. lasted 36 hours.
pt cried off & on during noc p/vax; next day mom called 3PM & stated pt had been crying all day, would not take bottle; had given APAP 3 times that day for fever (did not actually take temp); crying ceased by 5PM & the next day pt was nl;