chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Vaccines administered beyound 30-day use by date; Vaccines administered after being in stored in fridge past 30 days; Patient that received first dose of primary series of Moderna Bivalent vaccine; no adverse event; This spontaneous case was reported by another health care professional and describes the occurrence of EXPIRED PRODUCT 1Q (Vaccines administered beyond 30-day use by date), PRODUCT STORAGE ERROR (Vaccines administered after being in stored in fridge past 30 days), WRONG PRODUCT ADMINISTERED (Patient that received first dose of primary series of Moderna Bivalent vaccine) and NO ADVERSE EVENT (no adverse event) in a 73-year-old patient of an unknown gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. AS7185B) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On an unknown date, the patient experienced EXPIRED PRODUCT ADMINISTERED (Vaccines administered beyound 30-day use by date), PRODUCT STORAGE ERROR (Vaccines administered after being in stored in fridge past 30 days), WRONG PRODUCT ADMINISTERED (Patient that received first dose of primary series of Moderna Bivalent vaccine) and NO ADVERSE EVENT (no adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Vaccines administered beyound 30-day use by date), PRODUCT STORAGE ERROR (Vaccines administered after being in stored in fridge past 30 days), WRONG PRODUCT ADMINISTERED (Patient that received first dose of primary series of Moderna Bivalent vaccine) 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 assessments were provided for EXPIRED PRODUCT ADMINISTERED (Vaccines administered beyound 30-day use by date), PRODUCT STORAGE ERROR (Vaccines administered after being in stored in fridge past 30 days) and WRONG PRODUCT ADMINISTERED (Patient that received first dose of primary series of Moderna Bivalent vaccine).    No concomitant medication was reported.  No treatment information was reported.   This case was linked to US-MODERNATX, INC.-MOD-2023-730541 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-730541:same reporter
Hive like rash developed over night after vaccine administered. Pt. stated within 15 min of administering throat felt sore. Left ear red and swollen per grandmother (BENADRYL given).
A nurse administered the vaccine. 5-10 minutes later, during the blood draw, patient felt pins and needles sensation throughout the body, traveling to the head. Patient also felt tired and face was pale at that time. 30 minutes after the vaccine was administered, patient felt generally weak but no fever or other symptoms. One day after vaccine administered, felt unwell and weak. Area around injection site was slightly red. Had malaise and headache. Three days after vaccine, back to baseline.
Patient presented to the ED on 4/4/21 with right upper quadrant pain and was subsequently hospitalized.  Patient presented to the ED on 4/16/21 with gallstones. Patient presented to the ED and was subsequently hospitalized on 4/17/2021.  Patient presented to the ED and was subsequently hospitalized 5/15/21 for hepatic encephalopathy. These visits are within 6 weeks of receiving COVID vaccination.
Pt. in observation area notified RN of dizziness and nausea. Pt. was put on cot. Diaphoretic, VS @ 2:15pm: RR 90/60 HR 124; SpO2: 96. Benadryl 50 mg administered PO @ 2:17pm. VS @ 2:20pm: RR 80/60 HR 112; SpO2: 99. Pt. c/o nausea getting progressively worse. Declined ambulance. 2:30pm: Epinephrine 0.3mg administered via EpiPen right thigh. VS @ 2:30pm: RR 120/80 HR 99; SpO2: 99. Patient condition improving over next 60 minutes in observation. Voided x2. At 3:02pm VS RR 140/80; HR 86; SpO2 99. Pt. ate 2 doughnuts and drank 2 bottles of water. Kept patient until 4:30pm. stable VS. Requested to go home. Discharge instructions given to stay at home and have a friend stay with patient overnight. LPN drove pt. home as pt. took bus to clinic. RN. checked in with pt. over the weekend and patient stated no further symptoms and "feels fine" after taking in some "edibles". RN checked in with pt. on Monday 7/25/22 @ 9am again and pt. is "up and about".
Mild itching in face, chest, abdomen, and arms; scratching sensation in throat; mild feeling of throat tightness; patient states this feels like the onset of previous mild allergic reactions
covid vaccine breakthrough case  dose 1 Pfizer 4/26/21  EW0176 dose 2 Pfizer 5/17/21 EW0186
MMR vaccination was accidentally administered via IM route instead of needed SC route. Pt was informed of this immediately, all questions and concerns were answered. Pt sustained no injuries, was monitored for 15 minutes post-vaccination. Pt encouraged to call with questions or concerns.
This spontaneous report as received from a healthcare worker and medical assistant refers to an unspecified number of patients of unknown age and gender. No information regarding the patient's medical history, concurrent conditions and concomitant medications was provided. On unknown dates starting on or after 29-JAN-2016, the patients were vaccinated with improperly stored doses of ROTATEQ, orally, lot # L013202, expiration date: 27-JAN-2017, (dose was not reported). According to the medical assistant, who came on the line to report adverse event details, the vaccines were stored at a temperature of 50.2 degrees Fahrenheit for 9 hours. There was no previous temperature excursion reported. No adverse effects were reported. Additional information has been requested.
Information has been received from a medical assistant concerning a 9 month old infant patient who on 12-APR-2010 was vaccinated with a dose of VAQTA instead of hepatitis B virus vaccine because the products looked the same. The reporter stated that the VAQTA "had the same looking packaging as the hepatitis B virus vaccine". No adverse effects were reported. Follow up information received from a registered medical assistant. It was reported that the 9 month old infant patient pre-existing allergies, birth defects, medical conditions and no illness at time of vaccination, who on 12-APR-2010 was vaccinated with a first dose of VAQTA (lot # 666030/1397Y, IM) instead of hepatitis B virus vaccine. There were no labs or diagnostic tests performed. No adverse effects were reported. This is an amended report. The answers to the questions of where the patient was vaccinated at and what the vaccine was purchased with were updated. Additional information is not expected.
A 29 year old female consumer reported that she received a dose of Flumist on 10/20/03. The pt experienced stuffy nose, chest congestion, and sleeplessness on 10/22/03. As of the date of this report, the reporter indicated that she has recovered from "chest congestion" and has not recovered from "stuffy nose" and "sleeplessness." No additional info was available at the time of this report.
COVID arm red mark was in the shape of a heart; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP), Program ID:  The reporter is the patient.  A patient (no qualifiers provided) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), in 2022 as dose number unknown (booster), single (Batch/Lot number: unknown), in arm for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (primary immunization series complete: unknown manufacturer), for COVID-19 immunization, reaction(s): "COVID arm". The following information was reported: VACCINATION SITE ERYTHEMA (non-serious) with onset 2022, outcome "unknown", described as "COVID arm red mark was in the shape of a heart".  Additional information: With the new booster COVID arm red mark was in the shape of a heart. So even body expressed it love. Patient would love to share a picture.  The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5 has been requested and will be submitted if and when received.
Sweating, aches, could not move body, felt like I had been ran over by a truck when I woke up, chills, rash on right elbow that was itchy later followed along with shortness of breath and nausea. Lasted a few hours then symptoms went away and and arm became increasingly more sore as the day went on. Tonight the arm hurts to lift it.
Sore arm, headache. body aches, fever 99.1 and coughing/breathing difficulties
Patient presented 36-48 hrs after 4 month immunizations with raised, erythematous, target like lesions, likely resembling erythema multiforme. There were no other illness symptoms, fevers, or other new exposures.
I have very high fever that runs from 101.01 to 103.7 with a severe headache. This has lasted 4 to 5 days now. The fever does not go away but does get lower. I went to the doctor about this. They tested for Covid-19 test, negative result. They are running more viral test to make sure that it is not the flu. But I don't know that result of the test at this moment.
Large raised lump. Infected site per doctor. Followed by indent in arm and loss of muscle.  2+ months later noticeable hollowed area in arm.
No adverse event took place. It was caught upon entering data and checking inventory that the individual received a monovalent vaccine instead of the bivalent booster. Department of Health was notified on 10/17/22 and they advised to contact the manufacturer (done on 10/19/22) and submit a VAERs report. No further guidance was provided at this time by the Pfizer manufacturer other than that the pt. may receive a bivalent vaccine 2 months after their last dose.
Per family pt grabbed his head and family held him up to keep from falling. Placed on bench with feet elevated. Vital signs taken, Pt given drink and brownie, mom stated he had not eaten since breakfast. Pt stated no longer dizzy after eating. Pt left facility.
Initial misuse report received from a healthcare professional on 04 December 2013. On unspecified date a 34 month-old patient had received 0.5 ml of FLUZONE. Wrong dose was administered to the patient. No adverse event was reported. List of documents held by sender: none.
Broke out in rash all over face. She received another vaccination on 06/09/2015 and broke out in a rash on her face, arms, and legs.
Patient received vaccine at 545pm. Administration noted as normal per pharmacist (rph), pt walked to waiting area chair. Approximately 7 minutes later pt asked for water. Pharmacist brought water to pt and asked if he was feeling okay. Pt stated he was having trouble hearing the rph. Rph walked back to pharmacy and continued to observe patient. approx 2 min later, pt passed out from seated position. rph did not see fall. both technician and rph ran out to pt. pt face down and water bottle spilled. assistant store manager reported as well. pt came to immediately and sat up on floor. He attempted to stand to sit in chair, but rph asked him to remain on floor. rph went to get emergency kit while tech observed patient. rph came back with instant ice pack. First pack did not activate but second pack did and had patient hold to his head as there was a visible red spot. Patient continued to be observed and was texting on phone during observation. Patient came up to pharmacist at 6:15 to ask to leave and Rph asked if pharmacy representative to could walk him to his car. Patient denied and Rph asked him to wait additional 5 minutes for observation. After 5 minutes, patient left. Today I called patient. He said he is feeling better and still has mild pain and a headache today.
Woke up at 7 a.m. and had a very, very hard time breathing.  When I could get a breath it hurt all over my chest and back.  Had slight fever. The right side of my chest really hurt.
fever began next day 11JUN92 p/vax; t104 was given med & tepid baths 12JUN92 fever still present 99.6 ax; seen by  MD stated ears minimal redness, throat white patches, skin red macula areas; dx rxn to pertussis, roseola, throat infect;
This spontaneous report as received from a registered nurse refers to an unspecified number of patients of unknown age and gender. There was no information about the patients' concurrent conditions, concomitant therapies or medical histories provided. In approximately 2016 (since 08-FEB-2016), the patients were vaccinated with improperly stored doses of VARIVAX (lot # L040421, expiration date 15-OCT-2017; lot # 043624, expiration date 03-NOV-2017; lot # L049532, expiration date 08-DEC-2017; lot # M002063, expiration date 12-JAN-2018; lot # M006156, expiration date 05-FEB-2018 (dose and route of administration were not reported). There was no adverse effect reported. Administered doses of vaccine experienced the temperature excursion of -13 degrees Celsius for 65 hours. Data logger was involved. There were no previous  excursions reported. This is one of several reports received from the same reporter. Additional information has been requested.
Information has been received from a female physician with a history of herpes zoster who on an unspecified date was vaccinated with zoster vaccine live (Oka/Merck). Subsequently, "a couple of hours after vaccination," the arm that she was vaccinated in was "very painful and very sore." The evening after vaccination, she developed a very large 4-6 inch wheal and flare with possible ARTHUS reaction. Unspecified medical attention was sought. The patient recovered on an unspecified date. She stated it "went away after a couple of weeks." There was no product quality complaint involved. Additional information requested.
Swollen from elbow to shoulder and severe pain (36 h). Pt using ice and ADVIL, slowly starting to improve.
5 by 6 cm pruritic urticarial plaque lasting 3 days
headache, muscle aches, chest tightness, lethargic, lightheaded for three days.
PATIENT DESCRIBED LATER IN EVENING HAVING A RASH AT INJECTION SITE SIZE OF COIN AND LATER HAVING DIARRHEA. NO SHORTNESS OF BREATH AND NO OTHER SYMPTOMS.  PATIENT TOOK BENADRYL.  NEXT DAY RASH AND DIARRHEA RESOLVED. NO FURTHER ISSUES
Mother stated child woke up with arm where injections given with rash, hard, swollen, and warm to touch.
Rash the size of a pop can top. Said felt a pinch when given and also new complains of pain when touching only. Red and inflamed. Started evening of 8-15-17. Pt before notifying us said they put hydrocortisone on the area. Told pt to take BENADRYL orally and ice and keep an eye on it.
VERY considerable urination morning after vaccine - caused significant dehydration. Resolved with electrolytes.
I received the flu shot while at the doctor's office. Since and ongoing, I am experiencing flu like symptoms mimicking pneumonia. I am cold (all the time), coughing with phlegm expectorating, am in pain and am suffering malaise.
Flu; Initial information received on 11-Dec-2020 regarding an unsolicited valid non-serious case received from a consumer (patient) via social media.  This case involves patient (age and gender unspecified) who experienced flu, while patient received vaccine INFLUENZA VACCINE [Flu shot].   Medical history, medical treatment, vaccination, concomitant medication and family history were not provided.   On an unknown date, the patient received a dose of suspect INFLUENZA VACCINE (produced by unknown manufacturer) [lot number and expiry date not reported] via an unknown route at an unknown administration site for prophylactic vaccination.  On an unknown date, the patient developed a non-serious flu (influenza) unknown latency following the administration of INFLUENZA VACCINE.  Details of laboratory data not reported.   It was not reported if the patient received any corrective treatment.  At the time of reporting, the outcome of event was reported as unknown.  There will be no information on the batch number to be requested for this case.
Patient was given VZV #2 vaccine on 3/18/15, later that evening 15 yo patient experienced localized rash, pain, redness to injection site; no fever, no difficulty breathing; no known hx of similar reaction to VZV #1 vaccine; on 3/20/15 pt examined and treated for localized cellulitis.
Pt. states received Phizer 07/06/2021 and 07/07/2021 started experiencing a rash developing on both hands and continuing up the arms. No primary visit but with Cardiologist who recommended Benadryl and calamine lotion. Plans to schedule visit with Primary in the near future.
WITHIN 24 HRS OF IMMUN., CHILD EXP AND INJECT SITE REACT
dropped dead; This is a spontaneous report from a Pfizer-sponsored program. A contactable consumer reported that a patient of unspecified gender in 20s received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection) via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as a single dose for covid-19 immunization. The patient medical history was not reported. The patient's concomitant medications were not reported. The reporter reported that someone in town in their 20s that had the Pfizer vaccine in the morning and dropped dead in the afternoon for no reason. Between all 3, there have been quite a bit of deaths in the last few months. The patient died on an unspecified date.  It was not reported if an autopsy was performed.  Information on the lot/batch number has been requested.; Reported Cause(s) of Death: dropped dead
Initial unsolicited report received from other healthcare professional on 18-Oct-2017. This case involves a 71-year-old female patient, who was vaccinated once with 0.5 ml FLUZONE HIGH-DOSE via intramuscular route (batch number, expiry date not reported) on 11-Oct-2017 in right deltoid. Patient had no previous adverse reactions to a flu vaccine. Patient handled the initial administration well. Patient's medical history and concomitant medications were not reported. On an unknown date, two days following the vaccination, the patient's both of her legs became very weak and painful. On an unknown date, few days after the vaccination, patient could barely stand without the use of her walker; patient was confined to her bed for almost an entire day. Patient also reported soreness in her right shoulder. Lab test and corrective treatment not reported. On an unknown date, patient's symptoms resolved post 5 days after initial symptoms started. Case was reported as serous due to permanent or significant disability/incapacity events. Documents held by sender: none. Sender's Comments: The patient experienced pain and weakness in legs, pain in right shoulder, difficulty in standing and was confined to her bed almost entire day post vaccination with FLUZONE HD. Time to onset was compatible. The patient had tolerated previous influenza vaccination without events. No other information regarding medical history and coexisting medical conditions was reported. Additional information regarding patient's medical history and medical condition at the time of vaccination would be required to assess the case. There is a possibility of an underlying etiology unrelated to vaccination that might have caused the events. Based upon reported information the role of the vaccine cannot be assessed.
Patient arrived in our office stating that she felt like her throat was closing and trouble swallowing after receiving COVID vaccine Today at Pharm. Patient given 0.3mL EPI IM and Transported via EMS to ED.
I ran a fever; sick; I was very nauseated and ran a fever; This is a spontaneous report from a contactable consumer or other non hcp. A 83-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/Lot number and expiration date was not reported), via an unspecified route of administration on 01Oct2021 as dose number unknown, single for covid-19 immunization. The patient medical history and concomitant medications were not reported. On 02Oct2021 the patient ran a fever and was very nauseated patient would need but patient was fine today and just wanted to know if she can be around people if there's any danger. The outcome of the events was recovered on 03Oct2021.     The lot number for the vaccine, [bnt162b2], was not provided and will be requested during follow up.
pt recv vax APR95 & w/in 24hr exp fever, chills, h/a, dizziness, malaise;
PM p/5min of vax;started crying w/breathing diff, cough & gaging;noted to have wheezing bilat given albuterol neb & Epi;
bad chills, fever overnight, severe headache, body aches, shot site pain, and lymph node swelling and soreness
This spontaneous report was received from a registered nurse and refers to a 12 months old patient of unknown gender. No medical history, concurrent conditions and concomitant therapies were reported. On 29-MAY-2015, the patient was vaccinated with an improperly stored dose of (Oka/Merck) VARIVAX lot # K021933, expiration date 10-NOV-2016, dose 0.5 ml, subcutaneously (anatomical location was not reported). No adverse effects were reported. This is one of several reports received from the same reporter. Additional information is not expected, as all required information has been received.
Patient with jitteriness and inconsolable crying and decreased intake (but 1 hour). pt evaluated approximately 7 hours after vaccination. had received X1 dose Tylenol about 30 minutes prior to visit.  No fever on PE, all WNL, injection site without problem.
extreme fatigue; diarrhea; chills; This is a spontaneous report received from contactable reporter(s) (Physician) from a sales representative. The reporter is the patient.  A patient (no qualifiers provided) received pneumococcal 20-val conj vac (dipht CRM197 protein) (PREVNAR 20), as dose number unknown, single (Batch/Lot number: unknown) for immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: FATIGUE (non-serious), outcome "recovered", described as "extreme fatigue"; DIARRHOEA (non-serious), outcome "recovered", described as "diarrhea"; CHILLS (non-serious), outcome "recovered".  Additional information: The patient experienced extreme fatigue, diarrhea, and chills for 3 days following administration of pneumococcal 20-val conj vac (dipht CRM197 protein). Event took place after use of product.  The information on the batch/lot number for pneumococcal 20-val conj vac (dipht CRM197 protein) has been requested and will be submitted if and when received.
Nonspecif skin erupt NEC on 2012-12-27, clinician comment: rash was noted at injection sites as well as other places.
Had sciatic pain in left butt. Has also been on right side. Started hours later and has continued intermittently. Have had numbness and tingling in all 4 extremities intermittently,  starting with the right foot and leg. All symptoms have continued daily.
Mononucleosis; This spontaneous case was reported by a consumer and describes the occurrence of INFECTIOUS MONONUCLEOSIS (Mononucleosis) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No medical history was provided by the reporter.     On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced INFECTIOUS MONONUCLEOSIS (Mononucleosis). At the time of the report, INFECTIOUS MONONUCLEOSIS (Mononucleosis) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       It was reported that patient received Moderna COVID-19  vaccine 3 weeks ago and after that he had mononucleosis.  Concomitant product use was not provided. Treatment information was not provided.   Reporter did not allow further contact
Narrative: COVID infection following COVID vaccine series 03/01 Janssen, dose #1 08/18 pt cc: No symptoms exposure: unknown 08/18 COVID swab, result: detected.