chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Initial information received on 26-Oct-2018 regarding an unsolicited valid non-serious case received from a nurse. This case involves a 7 years old patient (gender unknown) who received vaccines FLUBLOK QIV instead of FLUZONE. The patient's past medical history and family history were not provided. The patient did not receive any concomitant medication. On 24-Oct-2018, the patient received a 0.5ml dose of suspect INFLUENZA QUADRIVALENT RECOMBINANT VACCINE lot QFAA1826, expiry date not provided via unknown route in the left arm instead of suspect INFLUENZA QUADRIVAL A-B VACCINE lot number, expiry date not reported. It was an actual medication error due to wrong vaccine administered and inappropriate age at vaccine administration. It was reported that due to nearly identical packaging, a dose of FLUBLOK was inadvertently given to a 7-year-old child instead of FLUZONE. It was unknown whether patient experienced any adverse reaction after the injection. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holders compliance with the requirements set out in 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. List of documents held by sender- none.
Patient came in c/o right arm where flu vaccine was received.  Red whelp noted on right arm 21/4 inch x 3 inch . c/o no pain. but extreme itching.  Sent pt. to pmd. pt. called back and stated doctor said her arm was infected and put her on augmentin875mg bid. She is to f/u with him on Monday if not any better.  He stated she had adverse reaction to something in the vaccine
Fine pink rash (blanching) -scalp/face truck (suspected viral exanthem, no other symptoms)
he ringing and buzzing sound started in the right ear within 24 hours after receiving shot. Discondition continued in the hearing in this year became affected to the point where I was almost deaf after about two months  .  The hearing in the right here began to improve slightly during February 2022 . Hearing in the writer still impaired although some waterproof but the buzzing ringing in the ear continues
Severe bruising over entire body.  Requires multiple weekly blood tests for several months to monitor platlet count. 12/11/08-records received for DOS 8/19/08-seen for 11 day history of easy bruising and rash classic for petechiae.   Impression:classic childhood auto-immune thrombocytopenic purpura (AITP or ITP) likely trigger 4 weeks prior is VZV vaccine.
Vaccinated with Pfizer on 1/13/21 and 2/3/21.  Symptom onset 7/10/21 with cough, runny nose, shortness of breath, chills, nasal congestion, fever.  Tested positive for Covid-19 on 7./13/21.
Admit 5/22. Vaccine 3/1, 3/26. Admit for chest pressure, SOB, COVID PNA. CT showed mild opacities.Tx w/ antibiotics, zinc, singulair, Vit C. Used CPAP and BIPAP. DC home w/home health. Patient was admitted with COVID-19 pneumonia without respiratory failure.  He was treated with supplemental medications including vitamin-C, zinc, singular.  He did not required steroids.  CT scan of the chest showed mild viral pneumonia patches.  He was ruled out bacterial pneumonia and his antibiotics were discontinued at the time of discharge.  His culture remained all negative till the time of discharge.  He was feeling markedly better.  His chest pressure was presumed from COVID-19 pneumonia and he was ruled out of acute coronary syndrome.  Overall patient was feeling much better and he was discharged home with home health.
(L) posterior arm (LTR) erythema, tender with induration measures 4x3 cm in circumference, itchy warm to touch.
Hives on eyes and face. 2005 flu shot. I am not allergic to eggs or shellfish. Just wanted you to know. No need to follow up.
pt recv vax 23MAY96 & 24MAY96 pt exp a fever of 103, malaise & nausea;the pt fever lasted 2 days;
C/o dizziness, lightheadedness, pale, diaphoretic and nauseated. BP 98/60; denies eating this morning. No hx of previous sx's. Placed head down & asst after 10, to exam. BP 100/60; p/72; color pink, skin warm & dry. Advised f/u with DR.
Developed sore throat and slight congestion. Tested positive for COVID on Aug. 26. Symptoms worsened slightly over weekend. Started feeling better about 4 days later.
muscle discomfort on my left arm and leg; rapid heartbeat 106-120 sporadically; nausea; lightheadedness & tightness; lightheadedness & tightness; random dizzy episodes; intermittent muscle pains in my left arm & left leg; BP is high then low; fatigue; Sleeping is irregular; pressure headache/pressure pounding headaches; my booster 19Aug2021; my booster 19Aug2021; This is a spontaneous report from a contactable consumer. This 48-year-old female consumer (patient) reported that:  A 48-year-old female (Non pregnant) patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, solution for injection, Batch/Lot Number: FC3183) via an unspecified route of administration, administered in arm left on 19Aug2021 as dose 3, (age at the time of vaccination 48-years-old), single for covid-19 immunization. The patient previously took first dose of received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, solution for injection, Batch/Lot Number: EL9262) via an unspecified route of administration, administered in arm left on 22Jan2021 12:00 PM as dose 1, and dose 2 bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, solution for injection, Batch/Lot Number: EL9266) via an unspecified route of administration, administered in arm left on 12Feb2021 (age at the time of vaccination 47-years-old), single for covid-19 immunization. The patient medical history included Thyroid. Patient was known allergies to PCN and Tramadol. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Other medications in two weeks RX by my doctor. I have been having symptoms since my booster 19Aug2021. I was able to manage the first few days after my shot because I knew/researched what is expected. On 20Aug2021 07:00AM, the patient stated my pressure pounding headaches are continuous, rapid heartbeat 106-120 sporadically with nausea, lightheadedness and tightness, random dizzy episodes, and intermittent muscle pains in my left arm & left leg-same side as my shot, my BP is high then low. Sleeping is irregular/fatigue. This symptoms come in different phases and not all at once. As combination of shot 1 and 2, but this time its weeks not 48 hours. I had a CT scan just to check, it is normal. I am not worried because it is better then getting COVID. No treatment was received in response to the adverse events. The patient was not diagnosed with COVID-19 prior to vaccination. Since the vaccination, patient was not tested for COVID-19. On an unspecified date, the events were recovered with sequel. At the time of reporting, the events muscle discomfort on my left arm and leg and pressure headache/pressure pounding headaches was not recovered and event my booster 19Aug2021 was unknown.
extreme fatigue on the day following the injection; slept entire day; fatigue accompanied by fever from 99 - 100, slight nausea, and lack of appetite; on third day after injection slight fatigue, but no other symptoms none of these symptoms occurred after first injection -- then only very sore arm and some swelling at injection site
no adverse event; they inadvertently administered 15 doses of the bivalent vaccine which was beyond the 30 use by date; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (they inadvertently administered 15 doses of the bivalent vaccine which was beyond the 30 use by date) and NO ADVERSE EVENT (no adverse event) in an adult 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. AS7168B) for COVID-19 prophylaxis.   No Medical History information was reported.    On 09-Jan-2023, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On 09-Jan-2023, the patient experienced EXPIRED PRODUCT ADMINISTERED (they inadvertently administered 15 doses of the bivalent vaccine which was beyond the 30 use by date). On an unknown date, the patient experienced NO ADVERSE EVENT (no adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (they inadvertently administered 15 doses of the bivalent vaccine which was beyond the 30 use by date) and NO ADVERSE EVENT (no adverse event) outcome was unknown. Not Provided      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 assessment was provided for EXPIRED PRODUCT ADMINISTERED (they inadvertently administered 15 doses of the bivalent vaccine which was beyond the 30 use by date).    No concomitant medication information was provided.  Beyond use date 08-Jan-2023. Administration dates are as follows: 09Jan2023 (2 patients) 10Jan2023 (2 patients) 11Jan3023 (4 patients) 12Jan2023 (4 patients) 13Jan2023 (3 patients). All the patients were 12 years and above, but HCP did not have the information if some of them were below 17 years old.  No treatment medications were provided.  This case contains information for the 02 out of 15 patients as described by the reporter.   This case was linked to US-MODERNATX, INC.-MOD-2023-698566 (Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-698566:MASTER  CASE
Patient has no hx of flu shot reactions. Received flu shot in AM. By the afternoon, he developed "itching and diarrhea". The following afternoon he went to ED for PO prednisone.
Mother of child noted blood in stool.  NO other symptoms.  No abdominal distention, no distress, no fever, eating well.  Breast fed infant.  Stool sent for culture and positive for rotavirus.
I started with getting red, hard knots in my leg. They were hard, hard knots. Almost felt like  blood clot. My blood pressure rose extremely high like never before. Then I got edema. I went to the vein doctor. I saw the nurse assistant and they said it wasn't a blood clot. Finally, I got to see him at another visit and he thought it was bug bites. But it sounded odd like that I would have these red splotches up and down my legs and they were hard and he put me on Prednisone. The symptoms disappeared completely. About 4 -6 days after the medication was over, all the symptoms re-appeared. At some point, I went to the ER - because I was worried about blood clots. They gave me Cephlex - as they thought it was bug bites  - so I was on that for 6 or 7 days. And the symptoms got better with this medication - made it better but not disappear like Prednisone did. Then after that, it was horrible again - the symptoms. I have an appt tomorrow to get checked again. I have never have had this stuff before in my life. My blood pressure is elevated but not so high as it was in the beginning. My legs are in pain - I can't even touch them. My skin so red  - it looks like it's on fire. I went to Orthopedic doctor thinking it was related to a previous injury or sprain. But they said it wasn't related to that at all .The skin so tight gets so tight and sore that I can barely walk. The skin is broken like it's thin and very fragile. My left leg is  significantly worse than the right leg in the calf area (it's two times the size as the right calf).  Still have edema I can't hardly wear shoes. At the end of the day, it's worse, but still in the morning now they are still swollen.
passed out; hurt her knee and ankle; tired; headache; chills; flu-like symptoms; A spontaneous report (United States) was received from a 70-years-old female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced passing out, tired, headache, chills  flu-like symptoms and hurt her knee and ankle.  The patient's medical history was not provided. No relevant concomitant medications were reported.  On 10-MAR-2021, prior to the onset of the events the patient received their second of two planned doses of mRNA-1273 (lot/batch: 030M20A) intramuscularly for prophylaxis of COVID-19 infection.  On 10- Mar-2021, after receiving the vaccine, the patient experienced tired, headache, chills like flu symptoms and passed out and hurt her knee and ankle. The patient felt better at the time of this report.  The seriousness criteria for the event passed out was considered as medically significant.  Action taken with mRNA-1273 in response to the events was not applicable.  The outcome of event(s) experienced passed out, tired, headache, chills like flu symptoms and hurt her knee and ankle was recovering/ resolving.  The reporter did not provide the assessment for the event's, passed out, tired, headache, chills like flu symptoms and hurt her knee and ankle.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded
headache; This spontaneous case was reported by a patient and describes the occurrence of HEADACHE (headache) in a 72-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 027L201A) for COVID-19 vaccination.     The patient's past medical history included Tooth extraction. Concurrent medical conditions included Hypertension. Concomitant products included QUINAPRIL for Hypertension.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced HEADACHE (headache). At the time of the report, HEADACHE (headache) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No treatment information was provided.
Large red circle appeared on week after vaccine at injection site on right arm. Lasted about 4 days.
A non-serious spontaneous report of flu has been received from a health professional concerning a 13-year-old male, subsequent to FLUMIST. Neither relevant medical history nor concomitant medications have been reported for this patient. The patient received FLUMIST on 31-Aug-2011. On 07-Sep-2011, the patient experienced flu symptoms of sore throat, headache and fever of 102 degrees F. On the same day, the patient was seen in the physician's office. On 07-Sep-2011, a Strep test and a throat culture were negative. On 12-Sep-2011, the patient returned to the physician's office. The outcome of the event was unknown.
The night after receiving the vaccine: Chills, body aches, nausea The day after receiving the vaccine: Chills, body aches, nausea The second and third day after receiving the vaccine: headaches
pt had ecchymosis S/P 14JUN95 injury;pt was advised to get TD by RN on 14thjun;pt came to clinic c/o swelling at inj site; was given ATB;warm compresses applied; 23rd june was more swollen; seen by surgeon;I & D was done;
Stroke; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of CEREBROVASCULAR ACCIDENT (Stroke) in a 45-year-old female 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 first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 05-Apr-2021, the patient experienced CEREBROVASCULAR ACCIDENT (Stroke) (seriousness criterion death). The patient died on 05-Apr-2021. The reported cause of death was Stroke. It is unknown if an autopsy was performed.            Concomitant medications were not reported. The patient was not hospitalized prior to or during the stroke. The reporter mentioned that the organs were donated as the patient was on a ventilator.; Reported Cause(s) of Death: Stroke
Heart palpitations; chills; myocarditis; Bells Palsy; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 47-year-old adult male received the first dose of intramuscular BNT162b2 (solution for injection; batch/lot reported as unknown expiry not provided) as a single dose in the left arm on an unspecified date in 2021 for COVID-19 immunisation. Relevant medical history included COVID-19 (diagnosed prior to vaccine). There were no concomitant medications reported. The patient denied receiving any other vaccine within four weeks of receiving this vaccine. The patient denied being tested for COVID since receiving the vaccine. On 01Dec2021 the patient experienced heart palpitations, chills, and myocarditis; which resulted/required visit(s) to Doctor or other healthcare professional office/clinic visit, Emergency room/department or urgent care and Hospitalization, Life threatening illness (immediate risk of death from the event), Disability or permanent damage. A few days later, on an unspecified date in Dec2021, the patient experienced Bell's Palsy: which resulted/required visit(s) to Doctor or other healthcare professional office/clinic visit, Emergency room/department or urgent care and Hospitalization, Life threatening illness (immediate risk of death from the event), Disability or permanent damage. The patient received unspecified treatment. The outcome of the events heart palpitations, chills, myocarditis, and Bell's Palsy was unknown.
Patient came with mother, mother specifically requested moderna vaccine for his first dose, dose was given to the patient. Shortly after giving the dose the nurse remembered that the age for Moderna starts at 18, not 16. Nurse immediately notified supervisor of the incident while continuing to monitor the patient. Nurse spoke to the mother and explained that the adolescent should not have received Moderna since he is not 18. Mom stated that she is a nurse and she wanted him to get Moderna anyway stating that she had Moderna and has heard better things about it and still wished for the son to receive it. Nurse explained that the CDC has not yet approved it for anyone under the age of 18 and mom stated that she didn't care. Patient was continuously observed for 30 minutes without incident. Patient states that he feels "fine" and is not in any distress. Mom and patient left after the 30 minute observation and neither were upset.   *Patient experienced no adverse reaction to the Moderna dose
SORE ARM; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (SORE ARM) in a 73-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 004M20A) for COVID-19 vaccination.     No Medical History information was reported.    On 28-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 28-Jan-2021, the patient experienced PAIN IN EXTREMITY (SORE ARM). On 29-Jan-2021, PAIN IN EXTREMITY (SORE ARM) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 31-Jan-2021, Heart rate: (High) HR is higher than normal (from 60 to 80).     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.   No concomitant medications reported by investigator o No treatment medications provided by the reporter.
a red spot the size of a silver dollar at the vaccination site on her left arm; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE ERYTHEMA (a red spot the size of a silver dollar at the vaccination site on her left arm) in a 64-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 062G20A) for COVID-19 vaccination.     No Medical History information was reported.    On 31-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 08-Feb-2021, the patient experienced VACCINATION SITE ERYTHEMA (a red spot the size of a silver dollar at the vaccination site on her left arm). At the time of the report, VACCINATION SITE ERYTHEMA (a red spot the size of a silver dollar at the vaccination site on her left arm) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were reported. No treatment medication was reported.
First, general aches. Then almost violent chills, unable to get warm enough. Lasted for maybe two hours. Then, after a brief sleep, felt very hot, even without blankets.
Loss of appetite; Axillary lymph nodes swollen and tender; Axillary lymph nodes swollen and tender; Chills; Headache; Body aches; Nausea; Fatigue; Fever at 102.0; This is a spontaneous report from a contactable nurse (patient). A 38-year-old male patient received the second dose BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot Number: ECL284), via an unspecified route of administration in left arm, on 06Jan2021 at 08:00, at a single dose, for COVID-19 immunization. The patient's medical history included allergies to penicillin (PCN). The patient's concomitant medications included valaciclovir, zinc, ergocalciferol (VIT D), and an unspecified multivitamin. The patient previously took the first dose of BNT162B2 (Lot Number: EH9899) on 16Dec2020 (10 AM in left arm) for COVID-19 immunization. The patient was not diagnosed with COVID-19 prior to vaccination. The patient was not administered with other vaccine in four weeks. The COVID-19 vaccine was administered in a hospital. On 06Jan2021 at 08:30 PM (around 12 hours later), the patient experienced chills, headache, body aches, nausea, fatigue, and fever at 102.0. Symptoms went on for three days. Fever after initial fever was low grade fever. At day 3 (09Jan2021), left axillary lymph nodes swollen and tender. Some lingering fatigue and loss of appetite 6 days post vaccine (12Jan2021). No treatment was received for the adverse events. Post-vaccination, the patient has not been tested for COVID-19. At the time of reporting, the patient recovered from the events in Jan2021.
Patient is 7 years old and was administered 0.2ml dose of Pfizer BioNTech 12 years of age or older formulation
Information has been received from a health care worker concerning a female (age not reported) who on an unspecified date was vaccinated with a second dose of GARDASIL. Subsequently the patient fainted after receiving the second dose of GARDASIL. Unspecified medical attention was sought. At the time of reporting it was unknown if the patient had recovered. No further information is available. This report is one of two reports from the same source.
Fever Narrative:  Fever 102, 101 after receiving covid vaccine for 48 hours
Narrative:  Patient developed rash on right arm, states that is where he received the vaccine though it is documented he received it on left arm. Being reported to RN one month post vaccination. RN observes rash on right deltoid. No treatment was given, patient was educated he could use benadryl OTC if needed and to refrain from scratching it. No further issues noted.
Patient was elderly in nursing home but developed a high fever after shot was administered. She had numerous preexisting conditions prior to shot, but I was told by staff she developed, for sure, a high fever and was sent to local hospital a few days after it was given.
Fatigue,  chills, body ache, a little fever, night sweats,  felt something heavy on chest, felt like walking on clouds, felt out of place. Symptoms lasted about 1 day & a half.