chrisvoncsefalvay/vaers-outcomes huggingface dataset:
arm sore; received an expired shot; Fluzone was given on same day as BNT162B2; Fluzone was given on same day as BNT162B2; This is a spontaneous report received from contactable reporter(s) (Pharmacist).  An 11-year-old male patient received BNT162b2 (BNT162B2), on 20Oct2022 at 18:00 as dose 1 (orange cap), single (Lot number: FL2757, Expiration Date: 11Oct2022) at the age of 11 years intramuscular, in left deltoid for covid-19 immunisation; influenza vaccine (FLUZONE [INFLUENZA VACCINE]), on 20Oct2022 as dose number unknown, single (Lot number: UT77445A) intramuscular, in right deltoid for immunisation. The patient had no relevant medical history. There were no concomitant medications. The following information was reported: PRODUCT USE ISSUE (non-serious), OFF LABEL USE (non-serious) all with onset 20Oct2022 at 18:00, outcome "unknown" and all described as "Fluzone was given on same day as BNT162B2"; EXPIRED PRODUCT ADMINISTERED (non-serious) with onset 20Oct2022 at 18:00, outcome "unknown", described as "received an expired shot"; PAIN IN EXTREMITY (non-serious) with onset 21Oct2022, outcome "recovered", described as "arm sore". Therapeutic measures were not taken as a result of expired product administered, product use issue, off label use, pain in extremity.  Additional information: caller stated he is calling about the Pediatric Vaccine, verified Pfizer Pediatric Covid Monovalent Vaccine. Caller states he is calling from (name) because they gave an expired shot to someone last week, later clarified to two patients, and corporate told him he needed to reach out to Pfizer to get the stability information to fill out the VAERS form. Caller states he is wondering if there may be extended stability?. The patient provided information regarding the reported adverse event(s) with the use of the product. Pfizer product had no causal effect to the adverse event.  Follow-Up (27Oct2022): Follow-up attempts are completed. No further information is expected.  Follow-up (09Nov2022): This is a spontaneous follow-up report from the same contactable Pharmacist. This Pharmacist reported in response to HCP letter sent included that:  Updated Information Included: Reporter information updated, suspect product details (Dose start/stop time. Dose description. Anatomical Location, Vaccine Facility Information. Co-suspect product updated), event details (Event onset time. Event onset date. Event outcome. Treatment received updated) and additional information updated.  Follow-up attempts are completed. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202201253324 same reporter/product/AE, different patient; Report 1 of 2;
This spontaneous report was received from a licensed practical nurse refers to a patient of unknown age and gender. The patient's pertinent medical history, allergic reactions and concomitant medications were unspecified. On 12-OCT-2016, the patient was vaccinated with improperly stored (16.2 C for 8 hours) doses of M-M-R II lot # M016234, expiry date 31-MAR-2018, dose, dose number, vaccination site, route unspecified). There was no previous temperature excursion. Digital data logger was involved. No adverse effects were reported. Product quality complaint (PQC) was not involved. This is one of several reports received from the same reported. Additional information has been requested.
numbness at the site of M-M-R II injection; vertigo; Information has been received from a pharmacist referring to a 42 years old female patient who was not pregnant. The patient's concomitant medications and medical history were not reported. The patient had no drug reactions or allergies.  On 22-MAY-2019, the patient was vaccinated with a dose of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live(M-M-R II) (lot number: R024905; expiration date: 30-AUG-2020; strength was not reported), subcutaneously for prophylaxis. On 23-MAY-2019, the patient developed numbness at the site of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live(M-M-R II) injection. She also developed vertigo. There was no treatment given for events. Lab diagnostics or studies was not performed. The patient called the pharmacist to seek medical attention. At the time of reporting, the patient had not recovered. The causality between the events and measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live(M-M-R II) was unknown.
when removed from car seat @ sitter was limp & blue;3 rescue breaths given brought in by squad;adm to hosp;dx: GE reflux,  episode likely related to reflux; mother elected to decline further pertussis vax, DT given at 4 mon visit.
Pt received flu shot on 12/18/00. She notified me approx. 5 hours later, that she was having shooting pains up and down her arm. I told her to use Tylenol and ice. (Per her account, she was at the tail end of a 2 week cold and was feeling good and had no temperature.) The shooting pains progressed and radiated to her sternum by the  following day. The pain worsened, but was off and on until she sought medical care on 12/28/00. The ER doctor told her he had seen several cases of people getting this reaction after the flu shot following an infection. Her 2nd ER visit was on 1/3/01 with pain intensified in left arm and left chest and sweating. She was treated with Toprol and Vioxx but was discontinued. She was put on Xanax and Paxil. She was transferred to another hospital. After tests, she was released after 24 hours with no cardiac problems detected. She had a few faint spells and was tired. On 1/15/01 to 1/21/01 she had heavy bleeding and large clots on menstrual period. On 1/22/01, ER visit with complaint of arm numbness. She did have a panic attack going through this and saw a counselor or therapist. She was put on valium and Celexa. It was ruled that this was not a psychological problem and no situational problem present that would cause this. The doctor told her it was physiological in nature. There has been no clear cut answer as to what happened to her, only that a possible viral infection "messed up her nervous system, causing a chemical imbalance." She is currently taking valium and she states if she doesn't take this medicine by 15:00, her hands start shaking.
During monitoring period 5 minutes post Pfizer COVID-19 vaccine, pt experienced nausea, clammy skin,  lightheadedness, dizziness (slow/sluggish), body tremors, fainted x 3 seconds.  VS: 112/67, P 50, O2 on RA 96%. Pupils slightly enlarged. Patient arousable after 3 seconds Oriented x 4, pale. Patient states she does not take any medications normally and BP runs in 110s/70s. BP rechecked after -5 minutes 106/67, P 56, O2 on RA 98%. VS rechecked in other arm (L) BP 98/67, HR 50, patient placed in trendelenberg, ice applied, still somewhat nauseous.-15 minutes: BP 108/68, P 60, O2 on RA 98%, color returning to face, nausea lessened, still sweaty. -25 minutes: BP 109/72, P 60, O2 on RA 98%. After an hour and 30 minutes in Observation, patient was sitting upright in chair, stated she felt much better, no nausea, lightheadedness or dizziness, therefore, she decided to leave the clinic in the care of her family.
High fever, shaking, muscle pain and stiffness, subjective feeling of jaw locking, profuse diarrhea, nausea.
MMR on 10/12/2001. 10/25/2001 cough, rhinrhea and 3 by 5 cm cluster of macules right lower quadrant abdomen and 99.5 fever. No oral lesions.
Surge in intensity of tinnitus still continues as of today 3/15/2021 Stiffness, soreness in fingers has somewhat decreased but still present as of today 3/15/2021 "Brain fog" has somewhat decreased but still present
pt exp joint pain of lt elbow & lt knee;started 1wk p/vax;still having pain;was achy & feverish w/swollen glands of the rt cervical neck;took Ibuprofen;
Sudden chest pain on left side for about 1-2 mins. Unable to breathe deeply or talk, breathing caused more pain. Standing up/moving also caused more pain. Only happened once and felt fine afterwards.
Patient is a pleasant 66 y.o. male patient of DO with a PMHx of CAD s/p PCI in 2015, cAF on Eliquis presenting with hemoptysis, SOB.   Acute hypoxic respiratory failure d/t, resolved  Post-viral bacterial pneumonia +COVID-19 infection Hemoptysis  1 week of cough, malaise, body aches. Brief period of improvement before recurrence of worsening sxs. Cough now productive w small volume hemoptysis (streaked sputum) Afebrile, HR 75, BP 102/57, RR 27, satting 91% on 2L CBC w mild leukocytosis (WBC 12.6). Trop 7, ProBNP 1.2K. VBG 7.41/39.3.  COVID+, influenza neg. Vaccinated x2, no boosters CXR (AP/LAT) with RML/RLL consolidation. No vascular congestion Currently on 2L supplemental O2, wean to goal SpO2 > 92% Abx coverage with Rocephin and Azithromycin, transition to Augmentin 10/22/22 Cont decadron but hold off on Remdesivir, course c/w post-viral PNA Strep pneu urine antigen + Procal 2.76, CRP 137,  Scheduled Mucinex. Robitussin-DM, Tylenol, nebs PRN Vibratory PEP and IS ordered, encourage use Continue Augmentin and decadron for 10 days total  Return precautions discussed    Acute kidney injury, resolved  Initial Cr 1.4 (baseline ~1.0)  Likely prerenal from above in the setting of ACEi Gentle resuscitation with NS gtt @ 100cc/hr for 1L total Hold home Lisinopril Bladder scan w PVR if e/o urinary retention Avoid nephrotoxic agents, renally adjust meds Daily RFPs, strict I&Os, daily weights to monitor   CAD s/p PCI in 2015 Chronic AF on Eliquis Continue home ASA, Lopressor, statin, Eliquis Discussed hold parameters for Lopressor and ACEi
patient describes a 3 inch lump that is not red or hot, but very sore under her left arm.
The patient reported subjective sense of lip and tongue 'tingling', described in intensity of 6/10 prior to EMS arrival, down to 4/10 on EMS arrival, but without interventions. Per EMS report, the patient had stable vital signs and a normal physical exam. The patient refused transport to the hospital, and a refusal of medical aid (RMA) was taken by EMS. The patient was advised to seek medical care should symptoms return.
Patient received vaccine on October 26, 2017 and the next day the patient had erythema and muscle soreness. On October 30, 2017 the patient had a large rash that took up the whole lateral part of the arm. The patient was treated with Azithromycin that he started taking on October 27th.  By October 31, rash had been completely resolved.
This spontaneous report was received from a licensed vocational nurse and refers to a 5 year old female patient. No information regarding the patient's medical history and concomitant medications was reported. On 17-SEP-2015 at 02:46 pm, the patient was vaccinated with an improperly stored dose (it was the patient's first dose) of PROQUAD (Merck) lot # K008185, expiration date 05-DEC-2015, subcutaneous in the right thigh (strength and dose were not provided). Concomitant vaccinations included the fifth dose (reported as number of previous doses: #4 else) of IPV (unspecified) lot # reported as L4694, intramuscular in the left thigh and the first dose of HAVRIX pediatric dose, lot # reported as NK747, intramuscular in the right thigh (both given on the same time as the suspect vaccine). There was no illness at the time of vaccination. No adverse effects were reported. The patient was vaccinated at public health clinic/hospital and the vaccine was purchased with public funds. This is one of the several reports received from the same source. Additional information is not expected as all correspondence was received.
Pt presented today for 1st Pfizer mRNA COVID vaccine.  She received the vaccine at 11:06am and proceeded to the check out area and scheduled her second appointment and checked out at 11:10am.  She was sitting in the secondary seating area, she looked scared, then she indicated to the APP she felt dizzy, eyes fluttered back, and slumped back into the chair and into APP's arms.  With the assistance of another RN, we laid her down on the ground and lifted her legs.  She was arousable to sternal rub and complained of dizziness.  She was able to report her name and that her husband was outside in the car waiting for her, however, she was slow to answer questions and still appeared distressed.  We made several attempts to obtain a BP, however, it would not register on machine, O2 sat 100%, HR 42, manual HR 50 at pericordium.  Her bilateral upper extremities were cool to touch and appeared mottled.  We attempted to give her apple juice just she was only able to take a few sips.  We placed her on 100% non-rebreather.  Given low HR, unable to obtain BP, and semi-conscious state, we elected to call 911 at 11:30am.  Her husband was retrieved and at patient side when EMS responded.  He reported that she has fainted in the past with blood draws and has a past medical history of "leaky valve, low platelets" and later it discovered via her medical records that she has a history of seizures and was on vimpat and lisinoril.  EMS arrived, assessed the patient, and moved her to stretcher and transported patient at 11:39am.
Beginning July 14, 2021 began to have episodes of palpitations, weakness, presyncope. Have had PVCs for over 10 years with no symptoms until that point. The only thing that had changed was the Covid vaccine. Began to continue having these episodes approximately once every other week. Ended up having to go to the ER on 09/07/2021 for heart rate over 160 and presyncope. Had to follow with cardiology and electrophysiology. Ended up having to have a cardiac ablation performed on 11/29/2021.
Patient got up from receiving shot and fainted on the ground-patient hit his head. EMS was called. Patient turned very pale and nausea, patients arms was swelling. Patient started to return to conscience but remined unwell. EMS did an evaluation. Father took son to hospital
Developed ?viral meningitis 4 days after 6 mo old check up and vaccines. Admit to hospital and suspect condition may link to DTaP vaccine per hospitalist.
This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (fever), CHILLS (Chills), NAUSEA (nausea) and HEADACHE (headache) in a 34-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013620A) for COVID-19 vaccination.     The patient's past medical history included No adverse event (no historical condition was reported).   On 03-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 04-Feb-2021, the patient experienced PYREXIA (fever), CHILLS (Chills), NAUSEA (nausea) and HEADACHE (headache). At the time of the report, PYREXIA (fever), CHILLS (Chills), NAUSEA (nausea) and HEADACHE (headache) outcome was unknown.
Upon returning for second dose of Moderna vaccine, patient stated that his right hand and ring finger, specifically, had gradually started to feel numb over the past two weeks. Patient stated that it was not bothering him but that he would go to urgent care or visit his primary care, if the symptoms worsened or if he had further concerns about them.
Pt presenting with symptoms consistent with acute stroke within 24hr after receiving vaccine. Pt has hx of prior strokes before.
patient previously received moderna on 05/13/2021 004C21A and Janssen on  06/23/2021 207A21A
Persistent rashes and blisters immediately following vaccination; Persistent rashes and blisters immediately following vaccination; This initial spontaneous report was received on 09-JAN-2020, from a lawyer regarding a case in litigation referring to an approximately 70-year-old male patient. The patient's pertinent medical history, concurrent conditions or concomitant medications were not reported. On or about 29-NOV-2017, the patient was vaccinated with zoster vaccine live (ZOSTAVAX) (dosage regimen information was not reported) for the long-term prevention of shingles and zoster-related conditions. Then, the patient suffered the following injuries and was diagnosed on the following dates as a result of the vaccination: persistent rashes and blisters immediately following vaccination. At the time of the report, the outcome of rash and blister was unknown. The reporter considered rash and blister to be related to Zoster Vaccine Live (ZOSTAVAX).
Patient was/is breastfeeding and child developed digestive issues. No other changes in diet, habits or environment for occurance other than the vaccine.
Vaccinated with shaken vaccine; pain at the injection site; A spontaneous report  was received from a pharmacist concerning a 36 year-old female patient who received Moderna's COVID-19 vaccine and experienced the technician shook the vial while administering the vaccine and pain at the injection site.                           The patient's medical history was not provided. No relevant concomitant medications were reported.  On an unknown date, the patient received their first of two planned doses of mRNA-1273 in the right arm for prophylaxis of COVID-19 infection.     On 04 Jan 2021, the reporter stated that the technician shook the vial while administering the vaccine. They also reported that symptoms included pain at the injection site.  No treatment information was provided.  Action taken with the second dose of mRNA-1273 in response to the event was not reported.    The event, technician shook the vial while administering the vaccine was considered resolved. The outcome of the event, pain at the injection site, was unknown.; Reporter's Comments: This report refers to a case of Out of specification product use for mRNA-1273 and concerns a 36 year-old, female patient, who experienced the event of injection site pain. The event occurred the same day after the first and last dose of mRNA-1273 vaccine administration. Based on the current available information and temporal association between the use of the product and the start of the event, a causal relationship cannot be excluded and the event is assessed as possibly related.; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-002862: US-MODERNATX, INC.-MOD-2021-002858: US-MODERNATX, INC.-MOD-2021-002848:
Fever of 100.00, muscle pain, head and neck pain, sore jaw, sore back, joint discomfort, chills, cold sweats.
At 11:30PM on the 14th of September I  started with extreme intestinal cramping followed by explosive diarrhea at 4AM the diarrhea turned bloody and ran out of diarrhea it but the blood  sporadically continued until stopping at 9PM September 15 2022.  At 8AM on the 15th of September 2022 my Primary care physician instructed me to go to the emergency room, I was examined and given fluids, blood work and urine tests were given which resulted in a hospital admission for observation. Colonoscopy recommended.
Patient administered moderna covid vaccine while temperature excursion was ongoing(possible temperature excursion); Patient administered moderna covid vaccine while temperature excursion was ongoing; This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (Patient administered moderna covid vaccine while temperature excursion was ongoing(possible temperature excursion)) and POOR QUALITY PRODUCT ADMINISTERED (Patient administered moderna covid vaccine while temperature excursion was ongoing) in a 75-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Patient administered moderna covid vaccine while temperature excursion was ongoing(possible temperature excursion)) and POOR QUALITY PRODUCT ADMINISTERED (Patient administered moderna covid vaccine while temperature excursion was ongoing). At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (Patient administered moderna covid vaccine while temperature excursion was ongoing(possible temperature excursion)) and POOR QUALITY PRODUCT ADMINISTERED (Patient administered moderna covid vaccine while temperature excursion was ongoing) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication were reported.  No treatment medication were reported.
Per patient on her return for her second dose of Pfizer she marked  on her registration form that she had no allergies.  The Vaccinator questioned  her on how she did after her first Pfizer vaccine. The patient stated "after receiving the Pfizer vaccine I did feel my throat slightly close and my ears itched".  She had stated that it lasted maybe 1 1/2 hours and then she was fine.  She experienced no shortness of breath, or had any breathing trouble. "Nothing else."  Second dose was not given.  Was advised to contact her Doctor for evaluation.
approximately 1 hour post injection, patient felt diaphoretic, syncopated and  experienced Ventricular fibrillation/ cardiac arrest requiring CPR and defibrillation. he has no known history of similar
Mitral valve leaking; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of MITRAL VALVE INCOMPETENCE (Mitral valve leaking) in a 78-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012L20A) for COVID-19 vaccination.     The patient's past medical history included Pacemaker insertion (cardiac). Concurrent medical conditions included Aortic valve disease.    On 18-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 16-Mar-2021, the patient experienced MITRAL VALVE INCOMPETENCE (Mitral valve leaking) (seriousness criterion hospitalization). The patient was hospitalized on 16-Mar-2021 due to MITRAL VALVE INCOMPETENCE. At the time of the report, MITRAL VALVE INCOMPETENCE (Mitral valve leaking) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications information was provided. Treatment information was not included.  Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.
On 10/5/21 I started to experience swelling in my face, this was coming on rapidly and followed by an itchy rash all over my body. I took 50 mg of Benadryl and went to bed. I woke up at 2:30 in the morning and had swelling in my tongue and throat as well as the continued rash and itchiness and swelling of the face. At 8 AM I called the urgent care where I got my vaccination and then I went in for an evaluation. They gave me an injection of decadron and a prednisone dose pack. As the day progressed the swelling in my throat cleared and almost all the swelling in my tongue. My foot is swelling minimized but was still there and the rash minimized.
Patient called on 10/28/2019 to report an adverse event. Patient reports that she received the flu shot on Saturday 10/26/19 in the afternoon. She received the vaccine in the left deltoid. She reports that her left shoulder feels weak and hurts like it hit her bone or muscle. The patient has received flu shots in the past and denies past adverse events. The patient reported pain when getting dressed, putting hair up in a ponytail and using any movement of her arm above her elbow. She denies pain when arm is rested. Patient reports that it feels like her shoulder has popped. She reports that the pain has stayed relatively stable since yesterday, 10/27/19. She was encouraged to continue to monitor her pain and other symptoms. This pharmacist called her primary care physician and left a voicemail to explain the situation.