chrisvoncsefalvay/vaers-outcomes huggingface dataset:
patient had shot in april 30, 2021 came in to store on 7/12/21 to report her arrhythmia problem starting the day after vaccine. she said the urgent care sent her to ER on the day she went after vaccine. she is under care of cardiologist  since then and her arrhythmia is not getting better
Unarousable. Pale, limp, lips blue. Seizure 5 minutes in length. Temperature 101.2 (R).
Systemic: Allergic: Difficulty Swallowing, Throat Tightness-Medium, Systemic: Hypertension-Medium, Systemic: Shakiness-Medium, Systemic: Tachycardia-Medium, Additional Details: Patient experienced throat tightness and dry mouth.  Benadryl administered, then Epipen 0.3mg.  Blood pressure was high, paramedics came to check her out.  BP went back to normal and patient was sent home
Patient left Vivotif dose out for 3 hours unrefrigerated; A spontaneous report was received from other health care professional on 12JUL2022. It described a female patient (unknown age) who "left Vivotif dose out for 3 hours unrefrigerated" (PT: Product storage error). The patient took the Vivotif (typhoid vaccine live oral Ty21A) (lot number: unknown) for immunisation. It was reported that the patient took the first dose of Vivotif after she left the dose out unrefrigerated for 3 hours. The outcome of the reported event was unknown.  Action taken with Vivotif with respect to the reported event was not applicable.  No additional information was reported.  Company comment: It was reported that a patient left Vivotif dose out for 3 hours unrefrigerated (product storage error). Vivotif should always be stored in the refrigerator at the recommended temperature, and the causality of product storage error is assessed as not applicable to Vivotif due to the nature of the event which was due to human error. The case is considered non serious as per medical assessment.; Sender's Comments: It was reported that a patient left Vivotif dose out for 3 hours unrefrigerated (product storage error). Vivotif should always be stored in the refrigerator at the recommended temperature, and the causality of product storage error is assessed as not applicable to Vivotif due to the nature of the event which was due to human error. The case is considered non serious as per medical assessment.
Killed in a car accident while pulling out of the street where the clinic was located. Was turning left onto a divided highway when the driver's side door was hit by an oncoming vehicle. Died on impact.
Pt reports generalized muscle aches and malaise lasting about 24 hours after evening of vaccination.
Received VZV #1 7-10-07 at a well child visit. On 7-20-07 fever 102 degrees, chills. Mom concerned about reaction to shot and does not want VZV #2.
Patient will receive the second dose of the vaccine 55 days after the first dose; This spontaneous case was reported by a pharmacist and describes the occurrence of INCORRECT DOSE ADMINISTERED (Patient will receive the second dose of the vaccine 55 days after the first dose) in a 69-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 040A21A) for COVID-19 vaccination.     No medical history reported.  Concomitant products included ACETYLSALICYLIC ACID (ASPIRIN 81), FAMOTIDINE, RIVAROXABAN (XARELTO), LISINOPRIL and ATORVASTATIN for an unknown indication.    On 24-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced INCORRECT DOSE ADMINISTERED (Patient will receive the second dose of the vaccine 55 days after the first dose). At the time of the report, INCORRECT DOSE ADMINISTERED (Patient will receive the second dose of the vaccine 55 days after the first dose) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Treatment information was not provided.
PATIENT PREVIOUSLY RECIEVED 1 DOSE OF PFIZER VACCINE (1/21/2021-LOT EL3249)
This case was reported by a other health professional via call center representative and described the occurrence of rash in a female patient who received SHINGRIX for prophylaxis. On an unknown date, the patient received SHINGRIX at an unknown dose. On an unknown date, less than a year after receiving SHINGRIX, the patient experienced rash. On an unknown date, the outcome of the rash was unknown. The reporter considered the rash to be unlikely related to SHINGRIX. Additional details were provided as follows: This case was reported by the physician's assistant via chat. The age at vaccination was not reported. The healthcare professional (HCP) reported that after receipt of SHINGRIX, the patient developed a rash on her abdomen. The healthcare professional (HCP) had no information other than gender of the patient. The patient did not receive the SHINGRIX vaccine at a pharmacy and not at the reporter's facility.
Client reports, "I got my vaccine on the 29th, and on the 3rd I found myself on the floor under my counter with a big bruise on my face.  I had blood on my pillow in the other room where I may have bitten my lip, but I don't remember anything about what happened.  I'm worried I may have had a seizure, and I've never had seizures." Client denies any event preceding this one, and is unsure of duration of event.  Purple and yellow hematoma noted to client's orbit of right eye and to right cheek.  Client denies ongoing signs or symptoms, at this time.
Patient states that approximately 24 hours after receiving her Moderna Booster Covid Vaccination she was taking a shower and black floating spots appeared appeared in her vision. She has passed out previously, and sat down before she fell. She recalls losing consciousness, and her boyfriend witnessed her experiencing what appeared to be a seizure. Her eyes were open, her arms and legs were flailing, and she was unresponsive to prompts. She came to shortly thereafter. She did not seek medical attention following the event, but does have an upcoming appointment with her physician this week.
Pt was exposed to chickenpox and broke out with sores typical of chickenpox. Seen in office with approximately 70 pox some red papules, some clear blisters, and some scabbed, on trunk, neck and upper extremities. Rash itches. Pt afebrile.
A report has been received from a Health Professional concerning a 37 year old, subject of unknown gender, who had been receiving Nasal FLUMIST (INTRANASAL). FLUMIST (INTRANASAL) started on 12-Oct-2014. The patient experienced PATIENT ADMINISTERED FLUMIST ON 10/12/2014 TESTED POSITIVE WITH FLU A ON 01/2015. The patient experienced PATIENT ADMINISTERED FLUMIST ON 10/12/2014 TESTED POSITIVE WITH FLU A ON 01/2015 which started during Jan-2015. The outcome of the event of PATIENT ADMINISTERED FLUMIST ON 10/12/2014 TESTED POSITIVE WITH FLU A ON 01/2015 is unknown. The report was considered to be non-serious.
joint pain / Specifically migrating joint pain; injection site arm soreness; This spontaneous case was reported by a patient and describes the occurrence of VACCINATION SITE PAIN (injection site arm soreness) and ARTHRALGIA (joint pain / Specifically migrating joint pain) in an adult male patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. AS7163B) for COVID-19 prophylaxis.     Concomitant products included INFLUENZA VACCINE, ROSUVASTATIN, MELOXICAM, PANTOPRAZOL [PANTOPRAZOLE] and HYDROXYCHLOROQUINE for an unknown indication.    On 21-Sep-2022, the patient received fourth dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. In October 2022, the patient experienced ARTHRALGIA (joint pain / Specifically migrating joint pain). On an unknown date, the patient experienced VACCINATION SITE PAIN (injection site arm soreness). At the time of the report, VACCINATION SITE PAIN (injection site arm soreness) had resolved and ARTHRALGIA (joint pain / Specifically migrating joint pain) had not resolved.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter did not provide any causality assessments.   Patient received other vaccines in the 4 weeks prior to COVID-19 vaccine.  On 19-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 12-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 11-Dec-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form.  It was reported that, the patient had injection site arm soreness after his dose lasted for 2 days. In Oct-2022, the patient developed joint pain, specifically migrating joint pain. The patient has had a series of blood tests to rule out rheumatoid arthritis. Patient was still waiting for a final diagnosis of rheumatoid arthritis from his Rheumatologist.  No treatment medications were reported.   This case was linked to MOD-2023-705996 (Patient Link).
Inappropriate site of vaccine administration; shoulder pain; it may be affecting their shoulder movement as well; This case was reported by a pharmacist via call center representative and described the occurrence of shoulder pain in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   In June 2019, the patient received Shingrix. In June 2019, less than a week after receiving Shingrix, the patient experienced shoulder pain and joint range of motion decreased. On an unknown date, the patient experienced vaccine administered at inappropriate site. On an unknown date, the outcome of the shoulder pain, joint range of motion decreased and vaccine administered at inappropriate site were unknown.   It was unknown if the reporter considered the shoulder pain and joint range of motion decreased to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The age group was not reported but was selected as adult as per vaccine indication. The batch number was unknown. The patient received a dose of Shingrix too far above deltoid on 9th or 10th June 2019, which led to vaccine administered at inappropriate site. The patient experienced shoulder pain after this dose, and it may be affecting their shoulder movement as well.
2 y/o old came in ER with pain , swelling to the right thigh that began 3 days ago. No fever. Mild erythema in the right lateral thigh, No tenderness,. Mild induration at injection site.
28th - COVID symptoms were - extreme headaches and tiredness, diarrhea, and sinus pressure/congestion. I tested that day on the 28th and that was negative result. I tested again for COVID on the 1st of Sept and that came back positive. Doctor told me to continue with Mucinex and then Tylenol for headache. She released me to go back to work on the 11th and 12 as long as my symptoms don't worsen.  I have a really bad headache right now and still have pretty much the same symptoms - with post nasal drip and tiredness. I am still having diarrhea but not as bad. I am a bit better, I guess.
expired Pentacel was adminstered with no adverse event;Initial information received on 19-Oct-2021 regarding an unsolicited valid non-serious case from consumer/non-health care professional and physician via Media Information (under reference 00818759).  This case involves a 1 years old male patient who received an expired DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(VERO)/HIB(PRP/T) VACCINE [PENTACEL (VERO)] (expired product administered).  The patient's medical history, past medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included PNEUMOCOCCAL VACCINE CONJ (PNEUMOCOCCAL CONJUGATE VACCINE) via unknown route in an unknown administration site for prophylactic vaccination.  On 11-Oct-2021, the patient received 0.5 mL dose of suspect DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(VERO)/HIB(PRP/T) VACCINE (Total, lot UJ382AAA and expiration date: 01-Oct-2021) via intramuscular route in the left thigh for prophylactic vaccination.  It was an actual medication error due to an expired vaccine used (same day latency).  It was reported "Caller stated that expired Pentacel was adminstered to patients. Caller would like to know what to do next. She would like to know if Pentacel is considered a live vaccine."  At time of reporting, no adverse event reported.  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.
Initial information received on 20-Jun-2018 regarding an unsolicited valid non-serious case received from a nurse. This case involves female patient (gender not reported) who experienced extreme local reactions including swelling at injection site, while she received vaccine FLUZONE QUADRIVALENT. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. On an unknown date, the patient received a dose of INFLUENZA QUADRIVAL A-B VACCINE lot number not reported. On an unknown date, the patient developed a non-serious extreme local reactions including swelling at injection site, following the administration of INFLUENZA QUADRIVAL A-B VACCINE. Relevant tests were not reported. Final diagnosis was extreme local reactions including swelling at injection site. It was not reported if the patient received a corrective treatment. The outcome was reported as Unknown for extreme local reactions including swelling at injection site. List of documents held by sender: none.
Patient was given a booster dose of Pediatric Pfizer COVID vaccine (PEDS) (0.2mL) in right deltoid and was asked to wait for 15 minutes before leaving for home. Patient was sitting in the car with mother and siblings to wait their 15 minutes. Mom stated "he said he felt hot and then he threw up". Mother and patient came back into the facility where they alerted staff that he had thrown up. Patient was given an orange juice and monitored for another 15 minutes. He did not throw up again while being monitored. Patient stated he was feeling much better after sipping on orange juice and mother felt comfortable taking patient home at that time.
Pt devel circumferential raised erythematous lesion w/central clearing 1 wk p/immun; it measured 3-4" & had some urticarial component; Seen by MD;
Pt recvd 3 doses of Engerix-B vax  & w/2nd dose given 27DEC90 pt c/o pain @ inject site; site soreness, knot under skin @ site & some swelling @ site; poss exp tiny bleed in the muscle when inject given; p/vax arm only sore when touched;
Patient had general malaise  unknown cause  after vaccination . Onsite EMS was called vitals BP 120/76  98% O2 room air BG 95 HR 82. Patient Refused Evaluation/Care released against medical adive.
7.5 x 11 cm warm indurated erythematous with mild eccymosis at injection site of right thigh.
I tested positive for COVID-19 on 12/29/22. I had been testing because my husband tested positive, and I had been testing negative. I had a doctor appointment coming up and tested the day of the appointment and tested positive. I did not have COVID-19 symptoms at that time. Two days later, I developed terrible congestion and it developed into a sinus infection. My doctor prescribed azithromycin for the sinus infection and I was taking Nyquil. I am feeling better, but still have loss of smell.
Starting the morning of March 1, almost 2 weeks after my first vaccine injection, I have a large slightly swollen rash area around the injection site which is tender to the touch.  The only other reaction I have had is soreness around the injection site for the first 3 days after the initial injection which kept me awake at night.
joint pain; fatigue; headache; fatigue headache muscle pain joint pain (24 to 36 hs of duration of the symptoms) chills (10min of the symptom)nausea; nausea; chills; slight itching on her face and cheek bones,; a tingling sensation move down to the middle of her cheeks and to her chin area; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 19-Feb-2021 and was forwarded to Moderna on 19-Feb-2021.    This spontaneous case was reported by a consumer and describes the occurrence of PRURITUS (slight itching on her face and cheek bones,), PARAESTHESIA (a tingling sensation move down to the middle of her cheeks and to her chin area), ARTHRALGIA (joint pain), FATIGUE (fatigue) and HEADACHE (headache) in a 57-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 028L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concomitant products included MESALAZINE (PENTASA) for an unknown indication.    On 16-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 16-Feb-2021, the patient experienced PRURITUS (slight itching on her face and cheek bones,) and PARAESTHESIA (a tingling sensation move down to the middle of her cheeks and to her chin area). On 17-Feb-2021, the patient experienced ARTHRALGIA (joint pain), FATIGUE (fatigue), HEADACHE (headache), MYALGIA (fatigue headache muscle pain joint pain (24 to 36 hs of duration of the symptoms) chills (10min of the symptom)nausea), NAUSEA (nausea) and CHILLS (chills). On 16-Feb-2021, PRURITUS (slight itching on her face and cheek bones,) and PARAESTHESIA (a tingling sensation move down to the middle of her cheeks and to her chin area) had resolved. On 17-Feb-2021, ARTHRALGIA (joint pain), FATIGUE (fatigue), HEADACHE (headache), MYALGIA (fatigue headache muscle pain joint pain (24 to 36 hs of duration of the symptoms) chills (10min of the symptom)nausea) and CHILLS (chills) had resolved. At the time of the report, NAUSEA (nausea) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.
Vaccine administered after more than 1 temperature excursion; Vaccine administered after more than 1 temperature excursion; This spontaneous case was reported by an other health care professional and describes the occurrence of POOR QUALITY PRODUCT ADMINISTERED (Vaccine administered after more than 1 temperature excursion) and PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine administered after more than 1 temperature excursion) in a 21-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 03-Apr-2021 at 4:29 PM, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On 03-Apr-2021 at 4:29 PM, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (Vaccine administered after more than 1 temperature excursion). On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine administered after more than 1 temperature excursion). At the time of the report, POOR QUALITY PRODUCT ADMINISTERED (Vaccine administered after more than 1 temperature excursion) and PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine administered after more than 1 temperature excursion) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   The age of patient was provided as 21.27.  Concomitant products were not provided.  On 03-Apr-2021, Excursion time was 9 AM with temperature as 34. Total doses given for the day was 210. Condition of vaccine prior to administration was not frozen. Vaccine was moved to fridge on 30-Mar-2021. Vial was moved to clinic on 03-Apr-2021. 20 vials were sent to clinic. Vaccine BUD date was 29-Apr-2021.  On 03-Apr-2021, vials were stored in cooler 1, at following time and temperature respectively, 8 AM: 38, 9 AM: 34, 10 AM: 38, 11 AM: 42, 12 AM: 41, 1PM: 41, 2 PM: 41, 3 PM: 40, 4 PM: 40 and 5 PM: 41. The vials were only punctured right before administration and all doses were drawn from the vial due to high-pace clinic.  Temperature recordings were taken using a traceable temperature monitor at every hour.  After administration, the vial was returned to the freezer/refrigerator, or maintained at room temperature.  It was reported that the patient was administered with vaccines that experienced more than 1 temperature excursion during 33 weeks in 2021. The HCP explained that each time a vial was put into a cooler, there was a period of 1 hour or 1 and half hour approximately, when the temperature data logger registered 34 or 35 degree F.  Treatment medications were not reported.
Tested positive for COVID on 06/23/2022. Symptoms: sore throat, weakness and fatigue. I went to urgent care where I was prescribed antiviral medication. I was informed by the Pharmacist at the pharmacy that the antiviral medication would cause a drug interaction with my FLONASE medication. Physicians should verify that the medications that they prescribe will not cause drug interactions.
1hr post vax pt devel vigors, myalgias, n/v & lightheadedness;pt was observed medically, given IVF;
Within 2 minutes of administering patient reported feeling lightheaded. Before I could get patient laid down she slumped over in her chair and then became unresponsive. Patient does have history of seizures but there was no tonic clonic activity, this was more of a syncope type event. Patient was laid down and become aware and responsive within a couple minutes but pupils remained dilated. Patient reported continued to feel nauseous, had a headache, shaky and blurry vision. Vitals were taken Pulse- 84, Spo2 - 99 Blood pressure-124/70 Blood Sugar-99. Patient was monitored for 2 hours before feeling well enough to leave.
Started having an altered taste for some foods and drinks; This is a spontaneous report from a contactable consumer or other non-hcp (Patient). A patient of unspecified age and gender received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot Number: Unknown), dose 2 via an unspecified route of administration on an unspecified date as dose 2, single for covid-19 immunisation.  The patient medical history and concomitant medications were not reported. Patient previously took first dose bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE).  Historical Vaccine includes bnt162b2 (COMIRNATY, Solution for injection, Batch/Lot number was not reported), dose 1 via an unspecified route of administration on an unspecified date as dose 1, single for covid-19 immunisation. The patient experienced started having an altered taste for some foods and drinks on an unspecified date. It was reported that Patient had the Pfizer two shots vaccine for Covid-19 and patient had it for a while but about a month ago, started having an altered taste for some foods and drinks, patient haven't lost any smell or anything and patient had a Covid test recently just to see if there is anything going on with that but patient just can't figure out, patient talked to some doctors about why having an altered taste on some foods and drinks and I was just wondering, do you know of any cases or is there any information regarding people having that side effect. When probed if the result of Covid test that consumer had was negative, consumer stated, Correct. The patient underwent lab tests and procedures which included sars-cov-2 test: negative. The outcome of event was Unknown.  Information on the lot/batch number has been requested.
The nurse asked me if I had dermafillers and I told her that I do. She asked when I got them, I told her that it has been 2 years, so she said that it?s too old to show effects and did the vaccine. 1-1,5 days later my lips got swollen as if they were going to explode. it was like that for 3 days until it started going back down. It was scary.