chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Patient reported to clinic today for Covid Vaccination and denied having had previous vaccination. After the administration of her vaccine and upon entry to the EMAR it was realized that she had already obtained a J&J vaccine on 4/9/2021. Upon reviewing her medical record she was given a J&J Vaccine from lot #201A21A in her Left Deltiod IM by our staff at an off-site community vaccination clinic on 4/9/2021. She completed paperwork for the first vaccination under one name  and upon presentation today completed paperwork under a different name. She was contacted and advised that she had received a duplicate dose when only 1 dose is recommended. Upon being contacted she did state that she now remembered getting the first vaccine. She was advised to report to the clinic or ER with any concerning adverse reactions.
Patient received 3rd dose and did not need it...vaccine series was started at the age where only 2 doses were necessary.....no adverse effects to report
This is one case out of cumulative total of 226 cases solicited from the EDSS databases during the surveillance period from 01 January 2010 to 04 February 2014. These 226 cases represent children who received 3 or more doses of sanofi pasteur vaccines; cases of pertussis disease in children who received DTaP combination vaccines from other manufacturers are not reported as per study protocol. Initial report received on 04 February 2014 from the Investigator participating in a post-marketing study under the reference number M5A16. A case of pertussis in a 12-month-old female subject (initials not collected) was identified by the investigator based on review of data from the Electronic Disease Surveillance (EDSS) electronic database. The subject had received 3 doses of PENTACEL; (lot number C4358AA) received on 17 January 2013, (lot number C4359AA) received on 18 March 2013 and lot number C4358AA received on 17 May 2013, (routes and sites of administration not reported). The subject developed cold-like symptoms on 04 November 2013, approximately six months after the last dose. The subject developed a cough on 04 November 2013 and with a whoop on 02 January 2014. The subject also experienced post-tussive vomiting and apnea and sleep disturbance, date not reported. Laboratory testing included positive PCR on 22 November 2013. Chest x-ray findings were negative for pneumonia. Corrective treatments  consisted of azithromycin starting on 09 January 2014 for 5 days. The subject was not hospitalized. At the time of final contact on 10 January 2014, the subject's cough was still persisting. The duration of the cough was reported at that time as 67 days. According to the investigator, this case was not epidemiologically linked to a laboratory confirmed case. Investigator causality assessment is not required as per protocol. Documents held by sender: None.
pt was vax in 1997 & 1999 pt exp fever & a full blown outbreak of chickenpox. pt exp 250-300 lesions which were beginning to crust over at time of rpt
Injection site cellulitis. Injection site mass. Injection site redness. From initial information received on 20/aug/2003 from a health care professional regarding an adverse event occurring in the USA, it was reported that a four year old female patient received a fifth dose of DAPTACEL, lot number C1387AA, administered in the left upper thigh (route not reported), and a fourth dose of IPOL, lot number W1233, administered in the left lower thigh (route not reported) on 18/aug/2003. Reportedly, the patient's mother called the physician's office on 19/aug/2003, stating that the patient had developed a mosquito bite sized know with redness at the injection site. The patient's mother was instructed to apply cool compresses, administer Children's Tylenol and to call the physician if the symptoms worsened. On 20/Aug/2003 the patient's mother called to inform the physician that the reaction had worsened, increasing in size and redness to 11.5cm in diameter. The patient was seen by a physician and treated with Augmentin for cellulitis. The patient's recovery status was reported as unknown.
11JUL98 pt began running fever & vomited once;mom gave APAP & fever went down;12JUL98 pt was sick & fussy in morning;by noon, pt had hands & lips turning blue;went to ER:13JUL98 pt died of meningococcal meningitis;
Was given Vaccine by RN BSN. Client states he does not like needles. He went to sit in a chair. One of the workers states he made contact with the chair and was sitting but client does not remember, He fell to the side and his head hit the ground. He was diaphoretic and pale when I got to him. Thready pulse 62 O2Sat 96% BP 98/42 Blood sugar checked by EMT was 83 at 3:05. At 3:18 pulse was 67 BP 112/68 O2sat 100% Resp 16. He was given an icepack and put in recovery position at beginning. After a couple of minutes he was no longer diaphoretic. Color was back to normal. Talkative. Alert and oriented. Mother informed of signs of head injury and instructed to seek care if he exhibits any signs. Given cell number to call for any questions.
Per patient, she contacted doctor due to arm pain. They told her it is bursitis due to receiving vaccine too high in the deltoid muscle
Patient experienced etopic atrial tachycardia 1-2 weeks after the vaccine was administered.  She experienced incomplete right bundle branch block that resolved after a couple of months.
C/o feeling sick including swelling and redness in arm, fatigue, diarrhea, low appetite, body aches Denies taking her temp but having chills  Had third Covid injection 2 days ago and sx started same night as injection  C/o cough and congestion
35min after injection. Swollen, numb lips, hoarse voice, difficulty swallowing, nausea. Patient is RN and self treated with 50mg benadryl, zyrtec, and caffeine. Patient was somnolent for several hours with concurrent nausea. Reported full resolution of symptoms within 6 hours. .
Day after the vaccine I awoke with a very sore left arm which was to be expected.  Upon moving I experienced vertigo, dizziness, headache, and extreme pressure in the left side of my face to include sinus cavities and deep inner ear pressure.  I had some episodes of loose stools, not diarrhea, but not formed stools.  These symptoms still persist to today, 1/15/2021, except for loose stool, that has returned to normal.  I had a Dr. appointment today and the doctor would not rule out post vaccine side effects. I was tested for COVID on 1/11/2021 as a precautionary measure as I was displaying symptoms, but the test result was COVID not detected.
MY THYOID SWELLED UP OUT OF NO WHERE. I WENT TO MY DOCTOR. THEY DID BLOOD WORK WHICH MY LEVELS WERE NORMAL. TOOK ULTRASOUND SCAN AND SHOWED IT WAS ENLARGED ON THE RIGHT SIDE OF MY THYROID LOBE. SAID THAT IT WAS THYROIDITIS.  ALSO MY EKG CAME BACK ABONORMAL. THEY SAID I HAVE LEFT BUDDLE BRANCH BLOCK. I'VE NEVER HAD ABNORMAL PRIOR TO VACCINATION NOR HAD ANY NOTED HEART ISSUES. I'M NOW 44 YEARS OLD. I WAS 43 WHEN I HAD VACCINE. THIS IS VERY RARE AT MY AGE. I WAS HEALTHY PRIOR TO THE VACCINE.
4days p/vax pt taken to ER w/abd pain, fussiness, bilious emesis & bloody stool. barium enema revealed intussusception & was reduced by the enema.
This spontaneous report as received from approximately 66 years old male patient regarding himself. Pertinent medical history was none. The patient was allergic to Sulfa drugs. On 28-JUN-2012, the patient was vaccinated with ZOSTAVAX. Dosing details and the lot number were not reported. Concomitant medications included RAMIPRIL and CRESTOR. Approximately on 13-AUG-2012 (reported as a month ago) the patient experienced a spot on his arm that itches between his wrist and elbow after about 2 months of getting ZOSTAVAX. No medical attention was sought. No treatment information was reported. No lab diagnostics studies performed. The outcome of the event was reported as not recovered/not resolved. Additional information has been requested.
Patient came in for second dose of Shingrix vaccine one 12/31/20. Spoke with patient about concerns of first dose of vaccine. Patient stated significant pain in his arm/joint on and off since first vaccine but was okay with receiving second dose. He said he was unsure if it was due to the shot or recent physical activity he had in August. Described the pain as a dull ache with no sharp pains. Said it was significant enough to limit him in some physical activity and day-to-day activities. Patient said he went to physical therapy for the pain in his arm as recommended by his doctor.
3/30 2:30pm: fever (99.8F), headache, fatigue
PATIENT RECEIVE THE ADJUVANT ONLY; PATIENT RECEIVE THE ADJUVANT ONLY; This case was reported by a nurse via call center representative and described the occurrence of inappropriate preparation of medication in a 56-year-old male patient who received Herpes zoster (Shingrix) (batch number Z7GH5, expiry date 25th January 2024) for prophylaxis.   On 15th November 2022, the patient received Shingrix. On 15th November 2022, unknown after receiving Shingrix, the patient experienced inappropriate preparation of medication and inappropriate dose of vaccine administered. On an unknown date, the outcome of the inappropriate preparation of medication and inappropriate dose of vaccine administered were unknown.   Additional Information: GSK receipt date: 15-NOV-2022 Reporter's comment: The nurse called to asked for information about the administration of only the adjuvant component of Shingrix to three patients.  The reported asked for information about safety and re vaccination. The reporter provided the identifiers of two patients and mentioned that she will call back once she get the data of the third patient. The reporter consented to follow-up. This case was for 2 of 3 linked patients reported by same reporter. Additional supportive information: The patient only received the adjuvant component of Shingrix, which led to inappropriate preparation of medication and inappropriate dose of vaccine administered.; Sender's Comments:  US-GSK-US2022170375:Same reporter US-GSK-US2022170378:Same reporter
Rash above injection site and a diaphragm the morning after vaccination. Felt warm. Rash spread and changed over the next 24 hours or so to red flushing on forearms, neck, head, chest, thighs, then upper arms/shoulders. Fatigued first day after injection. dozed on and off in afternoon; very fatigued on second day and slept around 18 hours total. Not very hungry for 2-3  days. Explosive diarrhea approximately 48 hours after injection. Redness/flushing began to fade starting on third day after injection, and was pretty much gone within a week.  Felt like rug burns 9 days after injection in left forearm below elbow for several hours, and briefly on left forearm under right elbow. May not be related, but I have never
Episodic uriticaria started 6 hours after 2nd dose and continue through the 36th hour post vaccination. Hives occur with very little palpation of skin. Benadryl has been used for symptomatic relief. Chills, low grade fever, and myalgias occurred at 20 hours post 2nd dose and resolved within 8 hours.
On Saturday 1/16/21 at approximately 4:15 pm my wife and I received the Moderna vaccine, lot number 041L20A. We waited the required 15 minutes to see if we had any reaction, we did not. After checking out we drove directly home. At approximately 5:10 pm, while driving to our home, about 45 minutes after receiving the injection, we both noticed that we were having difficulty swallowing and felt a swelling in the back of our throats. I experienced a metallic taste. The feeling of the swelling in our throats was similar to when a dentist uses a topical numbing gel prior to a dental procedure. The difficulty swallowing and the thickness in our throats lasted about 30 - 45 minutes. We monitored ourselves at home and did not feel that we needed medical attention. Because of my wife?s angioedema we had 2 Epipens at the ready. We both experienced soreness at the injection site (left arm), my arm sorer than my wife?s   The swollen throat and difficulty swallowing is the only reaction my wife had. I woke on Sunday morning and my arm was very sore, more so than what I had experienced with a flu shot. At approximately 12:15 pm on Sunday, 1/17/21, and about 21 hours after the vaccine was administered, I began to feel achy, like l was getting a cold. I took a nap and upon waking did not feel any better. My temperature was 97.6. I felt lethargic the rest of the day and went to bed early and sleep ok but woke up not feeling any better. I used a finger pulse oximeter and it registered 94/94. My temperature remains normal.  I am registering these reactions after reading about the adverse and severe reactions of persons at the site who received the same Moderna lot 041L201 as we did.
Father took pt. to routine follow up appt the same day, approximately 3 hours after receiving flu vaccine at his primary care clinic office during a routine physical.   Father reports nurses at Clinic noticed pt. had a "rash" on face.   Father had not noticed rash but did see rash when nurses pointed it out to them.  Reports pt. has been activing fine, not itching, and rash "cleared up" by the time he brought pt. back to clinic for follow up/re-eval (less than an hour).
Soreness at injection site; Headache for 12 hours; This case was reported by a consumer and described the occurrence of headache in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced headache and injection site pain. On an unknown date, the outcome of the headache was recovered/resolved and the outcome of the injection site pain was unknown.   It was unknown if the reporter considered the headache and injection site pain to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The age group was selected as per vaccination indication. The patient experienced Headache for 12 hours and soreness at injection site.
This case was reported by a consumer via call center representative and described the occurrence of injection site pain in a 45-year-old male patient who received FLUARIX QUADRIVALENT (batch number C75ES, expiry date 30th June 2016). Concurrent medical conditions included gout. Concomitant products included allopurinol. On 11th November 2015, the patient received the 1st dose of FLUARIX QUADRIVALENT (intramuscular) .5 ml. On 11th November 2015, less than a day after receiving FLUARIX QUADRIVALENT, the patient experienced injection site pain. On an unknown date, the outcome of the injection site pain was not recovered/not resolved. The reporter considered the injection site pain to be almost certainly related to FLUARIX QUADRIVALENT. Additional details were received as follows: This case was not previously reported to anyone. This case was reported by the patient himself. The patient experienced difficulty in sleep because of the pain in right shoulder. The patient was seen by an urgent care center for injection site pain. The patient had planned to follow up with his physician on an unknown date.
A large red, swollen rash on lymph nodes below right arm. A small red, swollen rash on lymph nodes below the left arm. Noticed the rash at 8:00 pm on Tuesday, March 30th - one day after receiving the Pfizer vaccine.  I called the local clinic I visit on Friday, April 9th at 8:30 am. The Nurse Practitioner advised me to take an antihistamine daily and contact them if my symptoms do not improve by Monday, April 12th.
PATIENT FAINTED AT WORK THE DAY FOLLOWING HER VACCINE. BLOOD SUGAR AND VITALS WE'RE CHECKED FOLLOWING THE FAINTING SPELL AND WERE IN NORMAL RANGE. SHE WAS PASSED OUT FOR "A FEW MINUTES" PER WITNESSES AND WRITTEN REPORT. SHE SLEPT WELL THE NIGHT BEFORE.  SHE WAS UNINJURED AS A COWORKER CAUGHT HER. AFTER HER VITALS WE'RE CHECKED SHE FELT WELL AND RETURNED TO WORK AND WORKED THE ENTIRE REST OF HER SHIFT WITHOUT INCEIDENT OR COMPLAINT.
tingling in the right arm/ tingling from arm to hand; The tingling in from arm to hand and it bothering; This spontaneous case was reported by a consumer and describes the occurrence of PARAESTHESIA (tingling in the right arm/ tingling from arm to hand) and LIMB DISCOMFORT (The tingling in from arm to hand and it bothering) in a 66-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 019B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 13-Aug-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 PARAESTHESIA (tingling in the right arm/ tingling from arm to hand) and LIMB DISCOMFORT (The tingling in from arm to hand and it bothering). At the time of the report, PARAESTHESIA (tingling in the right arm/ tingling from arm to hand) and LIMB DISCOMFORT (The tingling in from arm to hand and it bothering) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medication information was not provided by the reporter.  Treatment information was not provided by the reporter.  Patient reported that she was not allergic to any ingredients of the vaccine as far as she known.  Patient tried to get some medical evaluation and treatment at local emergency room. At the local emergency room patient was not evaluated and told to reach out to her HCP.
Patient stated the day she received the vaccine she developed a fever for about 3 hours which she thinks put her into a-fib (which she was able to get under control she said). She also had lots of discomfort and soreness in that arm which has gotten better since but said she is still having muscle aches and pains.
Pt c/o facial flushing and chest tightness 35 minutes after first dose of Pfizer. Brought to assessment area- vital signs assessed, lungs sounds auscultated, provided 50mg capsule PO diphenhydramine. Called Emergency Responders. Pt transported to ER for evaluation
soreness in arm, fatigue, body aches, headache, pressure behind eyes, blood blister to right arm. runny nose, scratchy throat, racing heart rate
Pregnant patient received both doses of vaccine; This spontaneous prospective pregnancy case was reported by a consumer and describes the occurrence of EXPOSURE DURING PREGNANCY (Pregnant patient received both doses of vaccine) in a female patient of an unknown age (gravida 1) who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On 22-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 19-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. Last menstrual period and estimated date of delivery were not provided. On 22-Feb-2021, the patient experienced EXPOSURE DURING PREGNANCY (Pregnant patient received both doses of vaccine). On 19-Mar-2021, EXPOSURE DURING PREGNANCY (Pregnant patient received both doses of vaccine) had resolved. Not Provided          Concomitant product use was not provided by the reporter.  Treatment information was not provided.
Within one minute of giving vaccine to right thigh, MMRV, patient began to get itchy at the site. A cool wet gauze was applied, provider notified. Thought it may be reaction to bandaid but other leg looked ok. A welt was noted to appear almost immediately within one inch of the site. Patient was given a dose of Benadryl and observed for 20-30 min in exam room/waiting room. Without any worsening symptoms she was sent home and improved within a few hours.
3RD DOSE PFIZER COVID VACCINE GIVEN 10/7/21, #301558A; pt had a positive COVID test on 8/8/22 at Medical Center, transitioned pt to hospice care, where pt passed away
Systemic: Allergic: Itch (specify: facial area, extremeties)-Medium, Systemic: Allergic: Rash (specify: facial area, extremeties)-Medium, Systemic: Allergic: Swelling of Face / Eyes / Mouth / Tongue-Medium, Systemic: Flushed / Sweating-Medium, Additional Details: Patient reports his face is flushed with redness, he also has swelling in the face and itching of the face. He took benadryl. He did not have trouble breathing. This began about 24 hours after vaccination.
About 5min after vacination, patient fell  alert and verbalized that she fainted. The pharmacist called 911. While waiting for emergency team, he had an episode of seizure for 3mins.
pt in 1994 recv 1dose of varivax & subsequently 3 mo later presented w/varicella-like lesions & erythema predominantly on trunk & extremities. rash was non-pruritic & no systemic sx were noted
FEELING SICK; FEVER; This spontaneous report received from a patient concerned a female of unspecified age. The patient's weight was 68.2 kilograms, and height was not reported. The patient's concurrent conditions included secondary pulmonary hypertension. The patient received macitentan (tablet, oral, batch number: ZM021B0101 expiry: 30-NOV-2023) 10 mg, every 1 day, frequency, and therapy dates were not reported for secondary pulmonary hypertension. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin were not reported) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. The company is unable to perform follow up to request batch/lot number. Concomitant medications included tadalafil, and treprostinil diolamin. On an unspecified date, the subject experienced feeling sick, and fever. The action taken with covid-19 vaccine ad26.cov2.s was not applicable; and dose of macitentan was not changed. The outcome of the fever and feeling sick was not reported. This report was non-serious.
This spontaneous report as received from a medical assistant refers to a 12 year old male patient. The patient's concurrent conditions, medical history, historical drugs and concomitant therapies were not reported. On 02-OCT-2017, the patient was inadvertently vaccinated with GARDASIL 9 lot number N009801, expiration date 20-NOV-2019; dose 1, subcutaneous (drug use via unapproved administration route) for prophylaxis. No adverse events reported.
No AE; HCP calling to report PEDVAX HIB was accidentally administered subcutaneously to a 15moth old patient.; This spontaneous report was received from a medical assistant referring to a 15-month-old patient of unknown gender. Information about the patient's pertinent medical history, concurrent conditions and concomitant medications was not provided.  On 10-AUG-2023, the patient was accidentally vaccinated subcutaneously with haemophilus b conjugate vaccine (Meningococcal Protein Conjugate) (LIQUID PEDVAXHIB) intramuscular injection (subcutaneously, lot #W032686, expiration date 12-JUN-2025, exact dose and anatomical location were not provided) for prophylaxis (Intramuscular formulation administered by other route). No additional information. No adverse event (AE) or product quality complaint (PQC) reported (No adverse event).
Subdural hematoma without history of trauma - required admission to hospital on 10/12/21 and operation for right craniotomy for hematoma evacuation. Returned one week later with recurrent subdural hematoma requiring a repeat evacuation.
Fever (100), Chills, Fatigue, Vomiting around 8 pm.  All the day after the vaccine (4/21/2021)
Tenderness under right arm began on Fri. Feb. 12. The next day, the pain had increased enough that I looked in the mirror, to find a moderately large swelling. It increased in size overnight Sat. Feb. 13. Sunday, the swelling reduced a bit, to the same size I found it originally. It has remained  that size - a decent golf ball - since then, Sun. Feb., 13. Though localized tenderness in lymph nodes has decreased quite a bit, I'm now in a significant Fibromyalgia flare (which could also be explained by a change in weather).