chrisvoncsefalvay/vaers-outcomes huggingface dataset:
YF-Vax was administered to a patient after it was reconstituted with sterile water with no reported adverse event; Initial information received on 15-Jul-2022 regarding an unsolicited valid  non-serious case received from a pharmacist.  This case involves a patient of unknown demographics and it was reported that yf-vax (YELLOW FEVER VACCINE) was administered to a patient after it was reconstituted with sterile water with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On 14-Jul-2022, the patient received a dose of 0.5ml of suspect YELLOW FEVER VACCINE, formulation: powder, strength, route: unknown, lot UJ371AB, expiration date: 21-Jul-2022, in unknown administration site as Immunization.  On 14-JUL-2022 the yf-vax was administered to a patient after it was reconstituted with sterile water with no reported adverse event (product preparation error) same day following the administration of YELLOW FEVER VACCINE. The diluent used said "sterile diluent for live vaccines, contains no preservative." The nurse who administered the dose intentionally substituted the sterile water as the diluent because the diluent that came along with the Yf-Vax powder was already expired. Caller would like to know the clinical result of the vaccine with sterile water and if the patient needs to be revaccinated. Still using product-No  Action taken was not applicable.  It was not reported if the patient received a corrective treatment for the event.  At time of reporting, the outcome was Unknown for the event.  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 in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. 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.
(L) upper arm erythema, malaise, dizziness, chills x 1week after vaccine. Afebrile.
Patient received both doses of the Moderna COVID vaccine on 02/02/2021 and 02/26/2021. Patient tested positive for COVID on 03/25/2021 and was admitted to hospital 03/25/2021 - 04/23/2021. Patient was readmitted on 04/27/2021 for UTI. Patient died on 05/07/2021, suspected cause of death was multi organ failure.
Employee had vaccine on 12/22.  She reported to vaccine area today to show us that her arm had become red, warm and swollen at the injection site and she describes arm is hard to lift up.  She also describes feeling nauseous.  Vital signs were taken and stable.   Employee took some of her own ibuprofen and placed and ice pack.   She will let her leader know or report back to vaccine area if symptoms worsen
This spontaneous report as received from a registered nurse via company representative refers to a male patient of unknown age. On an unknown date, the patient was vaccinated with a dose of ZOSTAVAX (lot #, expiration date, dose and route were not reported). Concomitant therapies included prednisone 40 mg. On an unknown date, the patient experienced adverse reaction after the patient received ZOSTAVAX vaccination. The adverse experience was described as "a bad reaction" to the vaccination. The patient was in nurse office when the adverse event happened. It was not confirmed what type of "bad reaction" the patient had. Subsequently on unknown date the patient was admitted to the hospital. The outcome of adverse reaction was unknown. The reaction was related to ZOSTAVAX (reported as: reaction to the vaccine). Additional information has been requested.
Case number PHEH2016US033296, is an initial spontaneous report received from a nurse on 16 Dec 2016. This report refers to a 66 year old female patient. Past medical history and concomitant medications were not reported. The patient tolerated vaccine in past. The patient was vaccinated with one single dose of FLUCELVAX QUADRIVALENT (batch number: 186685) at a dose of 0.5 ml intramuscularly into left upper arm on 03 Nov 2016. On 06 Nov 2016 the patient experienced shooting pain up her arm for 4 weeks. It was reported that the symptoms of burning pain in left upper arm while lifting, pushing and pulling began 3 days after FLUCELVAX QUADRIVALENT injection. It was reported that the symptoms were getting better. It was reported that on an unknown date after administration, the patient wrote out report on 15 Nov 2016. The outcome of the event was complete recovery on 01 Dec 2016. Seriousness and causality of the event were not reported. Follow up information was received from a nurse on 07 Mar 2017. Outcome of the events was updated to complete recovery. Past vaccination history added. Patient weight and height. Vaccination site. Updated narrative accordingly.
Mom can in today stated that pt had an adverse reaction from his second set of Vaccinations.  Mom states that she did not notice any change in the infant after his first set of vaccines.  Mom states that she began notciing changes in the infant the day after he recieved his second set of vaccines.  The s/s that Mom reports are as folows: No vocalization from September 24th to October 17th with the exception that he laughed very rarely. fussy for 3-4 days after the immunizations Mom states that pt continues to smile and interact with family.  Mom states that after the 17th of October vocalizations returned.  Mom also states that during the time of no vocalizations but was able to track family and conintued to smile.  Mom states that pt had no changes in his eating, voiding, bowel activity, or sleeping.  Mom denies noticing any other neurological changes.  Mom states that when pt did start talk that it appear that the pt need a large amount of concentration to vocalize.   Mom also denies any localize reaction at the sites of injection.
Rash as flat red and it starts from hand to neck and after halfand hour it goes to stomach and other parts of body.; rash and itching.on different body areas; This spontaneous case was reported by a consumer and describes the occurrence of RASH ERYTHEMATOUS (Rash as flat red and it starts from hand to neck and after halfand hour it goes to stomach and other parts of body.) and RASH PRURITIC (rash and itching.on different body areas) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 059H21A, 030A12A and 002B21A) 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 05-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 17-Dec-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In December 2021, the patient experienced RASH ERYTHEMATOUS (Rash as flat red and it starts from hand to neck and after halfand hour it goes to stomach and other parts of body.) and RASH PRURITIC (rash and itching.on different body areas). At the time of the report, RASH ERYTHEMATOUS (Rash as flat red and it starts from hand to neck and after halfand hour it goes to stomach and other parts of body.) and RASH PRURITIC (rash and itching.on different body areas) had not resolved.            No concomitant medications was reported.  No treatment drug details was reported.  Patient had no prior allergy and pre existing conditions.
Profound itching over entire body without rash, non-productive dry cough, fever spike of 101.1, body aches, chills. Fever x 36 hours, itching x 96 hours, cough continues.
On February 21, 2006, at 4 pm, student was interviewed by health clinic staff before coming to me for MMR immunization. I again interviewed student per protocol. She stated she understood all the questions. She answered no to all the questions and did not have any questions concerning the vaccine. She signed the consent form. I then administered the MMR vaccine 0.5mg s/c Lot #0428R. Student was instructed to sit for observation. Staff member in the clinic offered the student water and asked if she was alright. At this point, I got up from interviewing another student to check on patient because the privacy screen was blocking my view of her. This was approximately 2 minutes post receiving the vaccine. I noted her to be pale, cold and clammy. She was sitting but leaning to left side and appeared weak. I instructed staff member to call 911. After about one minute student began to respond. A staff member gave her sweetened tea to drink. She complained of nausea but did not vomit. When asked how she felt, she complained of feeling weak and state that she did no call for help because she was unable to speak. At this time, student was oriented to person, place and time. She repeatedly stated, "I'm okay." Student remained sitting during the entire episode BP 70/50 P 80. At 4:05 pm campus security arrived. Student refused to call parent as advised to do. At 4:15 pm EMS arrived and encourage student to go to ER. She then called her mother who instructed her to go to hospital. EMS left office at 4:30 pm with student.
sore arm; very tired; chills; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (sore arm), FATIGUE (very tired) and CHILLS (chills) in a 76-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 04-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In March 2021, the patient experienced PAIN IN EXTREMITY (sore arm), FATIGUE (very tired) and CHILLS (chills). The patient was treated with ASPIRIN [ACETYLSALICYLIC ACID] for Adverse event, at a dose of UNK dosage form. At the time of the report, PAIN IN EXTREMITY (sore arm), FATIGUE (very tired) and CHILLS (chills) had resolved.            No concomitant medications were reported.
pt reported cotton mouth, ball in throat, was monitored for 30 minutes post shot. did not progress. able to drink water and no vocal changes. Assessed by NP and sent home.
Muscle aches beginning evening 10/14. Next 2 days. Fever 102, malaise, all over aches, watery eyes, sneezing, deep cough, 3rd day symptoms continued without fever. 4th day felt better. 10/19 fever to 101 and aches resumed, not as bad as before. Today 10/21 feeling better but cough continues.
Narrative:  REQUIRE EMERGENCY ROOM VISIT FOR ANTIBIOTICS TO TREAT THE CELLULITIS
Patient contracted COVID after being fully vaccinated.  S/S: Headache, muscle aches, cough, fatigue, sore throat, congestion, runny nose, chills
Received vaccines 11/07/2005 mom states red and swollen at site of varicella vaccine starting 11/08/2005 am and 11/08/2005 pm, generalized rash and red, swollen arm.
In addition to a sore arm,  I developed  a yeast infection two days after the second Covid  shot.  After checking with my daughter, mother in law and a few friends, we all developed the same infection even after getting different vaccines.
Swelling & localized erythema approx 3/4 of upper arm L.
On Tuesday after receiving the shot I started developing a rash throughout my body especially near injection sire. The lymph node under my right armpit was swollen and tender. I let my doctor know and he suggested I take Tylenol for the pain. The Tylenol helped with the tenderness.
RAPID ON SET OF NASAL PRURITIS, CONGESTION, SNEEZING, EXCESS MUCOUS PRODUCTION AND EVENTUALLY SHORTNESS OF BREATH, EMESIS, AND MILD PERIORBITAL EDEMA.
Received dose 2 of the vaccine at 6w6d pregnant, ultrasound done at 8w4d (based on last menstrual period) showed the sac measured at 7w2d, which is just after I received the vaccine.  I realize this is just likely a coincidence, but I thought it important to report just incase it was not.
Pt received PPSV23 to LD yesterday. Here this AM for lab draw. He reports that a few hours after receiving vaccine, his arm became very painful and difficult to move. He had to drive with one hand yesterday. Also "felt like ants were crawling under his skin". Crawling sensation is resolved. Upon visual evaluation there is a 7" x 4.5" reddened, warm area distal and anterior to the injection site. It was itchy yesterday, but that is now resolved. ROM a little better this AM, but when he puts straight out to side or front it is painful/sore. He has taken ibuprofen which seemed to help slightly. Dr. came in to evaluate and confirms this not allergic reaction, just local. Advised to take acetaminophen/ibuprofen. Could also take BENADRYL if itching returns but beware of drowsiness. Alternate ice/heat for comfort. Advised pt to notify us if this does not improve, or if it gets worse.
Reporting administration error as per Agency.  We contacted Pfizer for expiration dates, pfizer vaccine specialist advised that the expiration dates are deemed viable at the time of vaccine adminstration. Pfizer vaccine vials only include manufactuarer dates on the box and vials. Therefore, we contacted pfizer to obtain expirations dates directly from them.  No adverse reaction reported from the patient at the time of vaccination. No adverse reaction reported since the administration of vaccination.
The pt. stated she received SHINGRIX in left arm and PNEUMOVAX in right arm. The next day, she was in a lot of pain (scale 10/10) and could not raise her arm at all. She said the pain radiated up her arm, through her shoulder, and into her neck. I advised her to see her md on 5-6-19 since she was still having trouble driving and still could not raise her arm very much. Her doctor prescribed pain medication. The doctor thought that the injection may have been given into the joint. Also, the pt. said the PNEUMOVAX was in her right arm and SHINGRIX was in her left arm so she thought the PNEUMOVAX was the causative agent. Upon looking at the rx's, it is documented on the screening form and in the dispensing screen that the SHINGRIX was in the right and PNEUMOVAX was in the left. (I marked off that this caused a disability on the next page because she is still having an issue at this time...her md didn't think it is permanent damage though).
This case was reported by a pharmacist via call center representative and described the occurrence of rash in a 65-year-old female patient who received SHINGRIX (batch number C7B9P, expiry date 27th February 2021) for prophylaxis. On 30th August 2018 12:00, the patient received the 1st dose of SHINGRIX (intramuscular) .5 ml. On 2nd September 2018, 3 days after receiving SHINGRIX, the patient experienced rash, skin warm, swelling arm and erythema of extremities. On an unknown date, the patient experienced headache, fatigue and fever. On an unknown date, the outcome of the rash, skin warm, swelling arm, erythema of extremities and fever were recovered/resolved and the outcome of the headache and fatigue were unknown. It was unknown if the reporter considered the rash, skin warm, headache, swelling arm, fatigue, erythema of extremities and fever to be related to SHINGRIX. Additional details were reported as follows: The patient presented with swelling, hot, and red in left arm around the third day after receiving the SHINGRIX vaccination. The patient reported that there was a line of red dots on the swollen area, but this was determined to be a rash. The also experienced fatigue and headache. This case is linked with case US2018188581, reported by the same reporter.
one night he felt like his chest was going to explode/heart attack; Hypotension; Tachycardia; This is a spontaneous report received from a contactable reporter (Consumer or other non-HCP, daughter). A 93-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), administered in arm left, administration date 19Jul2021 (Lot number: FA6780) at the age of 93 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "Legally Blind" (unspecified if ongoing). Concomitant medications included: VITAMIN D [ERGOCALCIFEROL] (ongoing) and ongoing eye medication. Vaccination history included: Bnt162b2 (1st dose, Lot: FA6780), administration date: 28Jun2021, when the patient was 93 years old, for COVID-19 Immunization. The following information was reported: HYPOTENSION (hospitalization) with onset 12Sep2021, outcome "recovered" (2021), described as "Hypotension"; TACHYCARDIA (hospitalization) with onset 12Sep2021, outcome "recovered" (2021), described as "Tachycardia"; MYOCARDIAL INFARCTION (hospitalization) with onset 15Sep2021, outcome "recovered" (2021), described as "one night he felt like his chest was going to explode/heart attack". The patient was hospitalized for hypotension, tachycardia, myocardial infarction (start date: 15Sep2021, discharge date: 16Sep2021, hospitalization duration: 1 day(s)). The events "hypotension", "tachycardia" and "one night he felt like his chest was going to explode/heart attack" were evaluated at the physician office visit and emergency room visit. Therapeutic measures were taken as a result of hypotension, tachycardia, myocardial infarction included diltiazem, apixaban (ELIQUIS), acetylsalicylic acid (ASPIRIN) and cardioversion. Clinical course: Caller stated her dad had been fine and after he got the second vaccine he was struggling for 2 weeks after, maybe 3 and then maybe within last 3 days, she didn't realize what was going on, but after walking, he would stay in the bathroom for 40 minutes. Caller states this went unnoticed for a while. Caller stated when they would walk in the park, he would have to stop. Caller stated she was his caretaker, and one night he felt like his chest was going to explode, he was in tachycardia and hypotension and it went on for a couple of days and she was trying to get him to the doctors, they should have went to the ER they learned later. Caller stated after getting him to the Urgent Care, they rushed to him to the ER because he was having a heart attack. Treatment: Caller states they prescribed him diltiazem and apixaban, but diltiazem would lower his blood pressure and instead of apixaban he is just taking acetylsalicylic acid intermittently. Caller states the patient also had a cardioversion.   No follow-up attempts are possible. No further information is expected.
Patient had a seizure in February 2013 and was having light fevers with her teething.  After her shots in March she became lethargic and began repetitive behavior and lost language skills.  She also became severely sound sensitive.
Hive like symptoms that burn. Occurs once-twice a week. Has been reoccurring each week for 6 months. Burning and skin redness clears after 30-45 minutes.
local redness & swelling @ inject site-buttock-4 inches by 2 inches;
Inadvertently recieved 2nd dose of COVID vaccine on Day #20 rather than Day #28.  This is a vaccine error, no adverse effects.
Patient received PREVNAR 13 on 10/29/15 w/o any reaction. Around approximately 1 week noticed it was red w/margins and sensitive to touch. Left arm. Went to her son/Dr. and he diagnosed it as infected.
Extremely painful arm (from shoulder to wrist), fever ranging from 100 to 103 for three days, body aches and stiffness.
No adverse event; 35 patients received a 0.25 ml dose as booster from booster dose only presentation vial; This spontaneous case was reported by a pharmacist and describes the occurrence of ACCIDENTAL UNDERDOSE (35 patients received a 0.25 ml dose as booster from booster dose only presentation vial) and NO ADVERSE EVENT (No adverse event) in a 39-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis.     No Medical History information was reported.    In July 2022, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 25 microgram. In July 2022, the patient experienced ACCIDENTAL UNDERDOSE (35 patients received a 0.25 ml dose as booster from booster dose only presentation vial). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, ACCIDENTAL UNDERDOSE (35 patients received a 0.25 ml dose as booster from booster dose only presentation vial) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for ACCIDENTAL UNDERDOSE (35 patients received a 0.25 ml dose as booster from booster dose only presentation vial).    No concomitant product use was reported.   Vaccination dates reported as between 22-Jul-2022 and 28-Jul-2022.  Patient received booster dose (0.25 ml).  It was unknown if patient experienced any symptoms after getting the vaccine.  Treatment information was not provided.
01/07/22 presents to EC ED for "evaluation after fall". PMHx of "PE on Xarelto, alcohol and heroin abuse"
In September 1999 before her first vaccination, the patient showed a negative titer. In December 2000 the patient again showed a negative titer. The patient sought unspecified medical attention. Additional information has been requested.
2nd day after 2nd vaccine shot felt sluggish drowsy sleepy  Felt feverish but temp was 97.5 or close  Still after 4 weeks feel the sluggishness or drowsiness prevail  Does not impact routine life or activities  But sense of sluggishness prevail most of time
Post vax, the pt experienced redness and hardness at the injection site of the left arm. *Follow-up report on 2/12/03: From add'l info. received on 9/24/99, it was reported, "This is an expected outcome with this particular vaccine, but not an adverse event. See attached. The 2 girls in question presented at the health center accompanied by their manager and she demanded I fill out this report, so I did." From add'l info. received on 10/4/99, it was reported that the PT recovered from this experience. From follow-up #1 correspondence returned on 5/7/01, no further info. was provided. This case is closed.
night sweats; Headache; chills; This is a spontaneous report received from a contactable consumer. A 45-years-old male patient received his first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot number: unknown) via an unspecified route of administration on 17Mar2021(at the age of 45-years-old) as a single dose for COVID-19 immunisation. The patient's medical history included COVID-19, gout and fatty liver. The concomitant medications were not reported. The patient had not received any other vaccines within 4 weeks prior to the COVID-19 vaccine. Prior to the vaccination, the patient was diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On 17Mar2021, the patient experienced headache, night sweats and chills for 3 days which was reported as ongoing. The patient did not receive any treatment for the reported events. The adverse events did not result in a visit to the doctors or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The clinical outcome of events headache, night sweats and chills were not recovered at the time of this report.   Information about lot/batch number cannot be obtained. No further information is expected.
Patient described feeling of warmth, facial flushing, tremors, nausea, tingling in roof of mouth and hands 30 minutes following vaccine.
EMS reported sudden onset of shortness of breath, patient grabbed his chest and collapsed. He stopped breathing. Wife began CPR with chest compressions at 5:00. Fire dept. arrived resumed CPR and attached AED but there was no shock advise. They placed an OPA as well (inserted an airway) and started ventilation. Asystole was confirmed, they continued CPR. After 5:25 they gave 3 rounds Epineferin and ended CPR at 5:46. They also checked his blood sugar and it was 136. Possible reaction to covid vaccine. Possible death due to history of cardiac issues. His PCP is requesting an autopsy