chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This spontaneous report was received from a medical assistant and refers to an unspecified number of patients of unknown age and gender. The patients' medical history, concomitant medications and concurrent conditions were not reported. On unknown dates in 2017 (reported as from 27-JUL-2017 to 13-SEP-2017), the unspecified number of improperly stored doses of VARIVAX lot # N012487 with expiration date 20-APR-2019, or lot# N001530 with expiration date 13-JAN-2019 (dose and route not reported) reconstitute with properly stored sterile diluent (MRK), were administered to the patients. The doses were stored in temperature -3.5 degrees Celsius for 2 hours and 15 minutes. There was a previous temperature excursion reported (-12.5 degrees Celsius for 50 minutes). Digital data logger was involved. No adverse effects have been reported. Product quality complaint was not involved. This is one of two reports received from the same reporter.
Approximately fifteen days after immune was given patient developed ITP. Plt ct of 3; petechiae, admitted hospital received IVIG. Steroid given orally, plt counts monitored, visits to Hem/Onc.
This spontaneous report as received from a female consumer of unknown age refers to herself. The patient was vaccinated with ZOSTAVAX (lot number, route, dose not reported) on an unknown date. Other suspect therapies included PNEUMOVAX 23 (lot number unknown). No concomitant medications were reported. By the evening of 26-JUN-2012 the patient experienced a fever of 101 degrees and that her arm was sore and red. By the next day on 27-JUN-2012 her arm was extremely red and swollen. The patient went to the after hours clinic (and saw a different doctor) and was given antibiotics and a steroid. She had read the information about ZOSTAVAX and saw that ZOSTAVAX was not supposed to be given with PNEUMOVAX 23. She said the type of PNEUMOVAX that she was given did not have Polyvalent after the name. She didn't remember what it was but it was a word that reminded her of sodium. The outcome of the events was unknown. Additional information has been requested.
Patient developed a 7-8 cm area of diffuse erythema, swelling and slight tenderness on right deltoid. Patient was advised to treat with warm compresses to area.
extremely crampy in her feet/ankles/legs; feeling dizzy; Feeling disoriented; Sneezing non-stop (from her sinuses which gives her a headache); Sneezing non-stop (from her sinuses which gives her a headache); sore arm; This spontaneous case was reported by a physician assistant and describes the occurrence of PAIN IN EXTREMITY (sore arm), MUSCLE SPASMS (extremely crampy in her feet/ankles/legs), DIZZINESS (feeling dizzy), DISORIENTATION (Feeling disoriented) and SNEEZING (Sneezing non-stop (from her sinuses which gives her a headache)) in a 75-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medical history reported.    On 11-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-Feb-2021, the patient experienced PAIN IN EXTREMITY (sore arm). On 17-Feb-2021, the patient experienced MUSCLE SPASMS (extremely crampy in her feet/ankles/legs), DIZZINESS (feeling dizzy), DISORIENTATION (Feeling disoriented), SNEEZING (Sneezing non-stop (from her sinuses which gives her a headache)) and HEADACHE (Sneezing non-stop (from her sinuses which gives her a headache)). On 14-Feb-2021, PAIN IN EXTREMITY (sore arm) had resolved. At the time of the report, MUSCLE SPASMS (extremely crampy in her feet/ankles/legs), DIZZINESS (feeling dizzy), DISORIENTATION (Feeling disoriented), SNEEZING (Sneezing non-stop (from her sinuses which gives her a headache)) and HEADACHE (Sneezing non-stop (from her sinuses which gives her a headache)) outcome was unknown.      For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No relevant concomitant medications were reported.  No treatment information was provided.
Case number PHEH2014US019868 is an initial spontaneous report received from a consumer on 22 Sep 2014. This report refers to a female patient of unknown age. Her medical history and concomitant medication were not reported. Her current condition included egg allergy. She was vaccinated with an influenza (flu) vaccine (manufacturer and batch number: not reported) on an unknown date. On an unknown date after vaccination, she experienced cellulitis. The outcome, causality and seriousness were not reported.
This spontaneous report was received from a licensed practical nurse referring to a patient of unknown age and gender. The patient's pertinent medical history, concurrent conditions or concomitant medications were not reported. On 30-JAN-2017, the patient was inadvertently vaccinated with an expired dose of VARIVAX lot # L002215 with expiration date 21-JAN-2017, subcutaneously (dose and frequency were unspecified) for prophylaxis. No adverse effects were reported and no product quality complaint was involved. Additional information has been requested.
A report had been received from a Health Professional concerning a 37 year old, Female subject, who had been receiving FLUMIST quadrivalent (intranasal). FLUMIST quadrivalent started on an unknown date. It was reported that the patient had inadvertently administered an expired dose of FLUMIST quadrivalent which started on 08-Jan-2015. The outcome of the event of inadvertently administered expired dose of FLUMIST quadrivalent was unknown. The report was considered to be non-serious.
mom reported pt did not feel well last PM & was resting in chair;then had labored breathing, eyes rolled into head;pt jerked some;pt unresponsive for 1min;slept for a while; detailed hx revealed probable vasovagal rxn w/exercise & fasting
bedridden for 4 days; Very ill; Initial information was received on 12-Apr-2021 regarding an unsolicited valid serious case from a consumer/non-hcp (healthcare professional).  This case involves adult female patient who experienced bedridden for 4 days (bedridden) and very ill (illness), while receiving vaccine INFLUENZA VACCINE.  Medical history, past medical treatments, past vaccinations, 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 expiration date were not reported) via unknown route at an unknown administration site for prophylactic vaccination.  On an unknown date, the patient developed a serious bedridden for 4 days (bedridden) and very ill (illness), (unknown latency) following the administration of INFLUENZA VACCINE. These events were assessed as medically significant.  Laboratory data was not reported.  It was unknown if the patient experienced any additional symptoms/events, concomitant disease or risk factor.  It was not reported if the patient received a corrective treatment or not.  The outcome was unknown at the time of reporting.  Batch number has been requested for suspect product for this case.; Sender's Comments: This case concerns an adult female patient who experienced illness and was bedridden, after vaccination with INFLUENZA VACCINE. The time to onset is unknown. The patient's medical history, medical condition at time of vaccination and lab test ruling out alternate etiologies were not reported. Based upon the reported information, the role of vaccine cannot be assessed.
A Lymophoedema on the left side of the body, with 3mm eduration in the arm left, no erythema no suppuration o edema.
A non-serious spontaneous report of a patient was pregnant at the time of FLUMIST administration was received from a health professional concerning a 24-year-old female. Neither the patient's medical history nor obstetrical history was reported. The patient's concomitant medications were also not reported. On 29-Nov-2011, the patient received FLUMIST and on 08-Dec-2011 she was tested positive for pregnancy. She was actually pregnant at the time of FLUMIST administration. There was no adverse event associated with this pregnancy. Treatment and reporter causality assessments are not applicable and the event is considered resolved. The reporter was asked to inform when the pregnancy has ended and also to inform if the patient experience any adverse events during the pregnancy.
Patient developed a localized reaction to #4 DTAP characterized by a 5cm x 5cm red, hot area on left thigh.
Intern gave pt vaccine, afterwards when pt started to put his shirt on to button. He fainted.  His eyes were dialted.  We placed him on the bench. Tried to have him lay down to get more blood flow to his brain. Instead he was sitting upright.  He regained consciousness had him wait until he fully had the strength to move.  His pupils returned to normal. Intern was with the pt the entire time.  Pt went to the waiting area, left before we could ask more questions.  All of this took about 10 minutes.
sore arm; a bit of a headache; an uncontrollable urge to happy dance; This is a spontaneous report from a Pfizer-sponsored program from a non-contactable consumer (patient).  A patient of unknown age and gender received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, in Dec2020 at single dose for COVID-19 immunisation. Medical history and concomitant medications were unknown. Twenty-four hours later in Dec2020, the patient got a sore arm, a bit of a headache, and an uncontrollable urge to happy dance, but otherwise feeling pretty unchanged. Outcome was unknown. Information about lot/batch number cannot be obtained.   No follow-up attempts are possible. No further information is expected.
Patient states she experienced an increase in temperature all over her body. She states she could not move her arm up or down. Her arm looked red and swollen and is hot to the touch. I recommended for the patient to take some TYLENOL and BENADRYL and to also ice her arm.
Myalgia, NauseaVomiting, Chills/Fatigue Narrative:
This spontaneous report as received from an office supervisor  medical assistant refers to a patient of unknown age and gender. The patient's concurrent conditions, pertinent medical history and concomitant therapies were not reported. On unknown date in 2017,  the patient was vaccinated with an incorrect storage dose of GARDASIL 9, lot N002720, expiration date 12-MAY-2019 (dose and route were not reported) for prophylaxis. The vaccine was exposed from 32 Fahrenheit degrees (°F) to 35 Fahrenheit degrees (°F) for 1 hour. There was no temperature excursion. The call was made because there was a "data logger". No adverse effects were reported. No product quality complain was involved. This is one of several reports from the same reporter. Sender's Comments: US-009507513-1707USA006643.
This spontaneous report as received from a Registered Nurse refers to an unspecified number of patients of unknown age and gender. Between 09 to 23-SEP-2015, the patients received unspecified dose in (Oka/Merck) VARIVAX immunization series that were improperly stored (dose and route were not reported). The nurse provided potential lot information for doses administered: Lot # L017142 with exp. date on 13-MAY-2017; K015994 with exp. date on 23-SEP-2016 and L019130 with exp. date on 27-MAY-2017. No adverse effect reported. This is one of several reports received from the same reporter. Additional information has been requested.
accidental overdose in reported in a pt receiving fluogen; pt has a hx of alzheimer's disease; this is one of 30 cases reported from this site; no adverse effects noted;
This spontaneous report as received from a nurse refers to unknown number of patients of unknown age and gender. On an unknown date unknown number of patients was vaccinated with (Oka/Merck) VARIVAX (dose, route of administration and anatomical location unknown) which underwent a supported temperature excursion. Pertinent medical history and concomitant medications of patients were unknown. No adverse effects reported. The outcome of the events was unknown. No further information provided. This case is linked to case # 1407USA005729. 1407USA005730, 1407USA005731, 1407USA005295. Additional information has been requested.
The patient is a previously healthy 23-year-old male primary vaccinee who has been traveling to training via bus and received SPV vaccine 13 March 2018 = 13 days ago (Lot number the VVO4-003A) ; while midtrip he developed a generalized macular papular erythematous pruretic urticarial dermatitis which was treated with BENADRYL which has continued to evolve during today's evaluation. He has lesions to hands including palms, arms bilateral, chest, feet and legs. He has no shortness of breath, oral face throat tongue swelling, flushing although feels hot, chest pain, conjunctivitis, rhinorrhea, nausea or vomiting. He has no fever chills malaise, but does complain of headache.   As of this filing patient has recovered
chills, nausea, headache,dizziness, fatigue  (Most symptuns lasted 11 days)
Fel't like I was hit over the head and ruffed up my legs are very wobbly, never again. Feels like covid without the coughing.
Mom called to report worsening eczema 2 days after receiving the PENTACEL vaccine. Mom did not want to try a topical steroid. She would like to try an organic moisturizer. Referred to Allergist.
After 1st shot, initial day exhausted-rested. 5th day after shot started experiencing hot/cold profusely sweating, extreme pain of entire body, fatigue, swelling- head area is the worse causing bad headache. Heart palpitations or racing and problems breathing.  After the 2nd shot Is the same but the symptoms are worse. Sept 14, 2021 first day in which I slept 4 hours straight, pain  and breathing was better other symptoms are present might be a little better today
2/23/2021 Pfizer, Inc EN6200 1/31/2021 Pfizer, Inc EN5318  8/23/2023 - 9/1/2023 (9 days)  8/25/23 COVID +  completed course of remdesivir. presents for hematuria dysuria.
2 doses of the Moderna COVID-19 10FEB2021 and 16MAR2021 vaccine and now has "long covid."; Long covid started in September, which symptoms are continuing up until today; This spontaneous case was reported by a patient family member or friend and describes the occurrence of VACCINATION FAILURE (2 doses of the Moderna COVID-19 10FEB2021 and 16MAR2021 vaccine and now has "long covid.") and POST-ACUTE COVID-19 SYNDROME (Long covid started in September, which symptoms are continuing up until today) in a 35-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis.     No Medical History information was reported.   On 10-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 16-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 01-Sep-2022,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced POST-ACUTE COVID-19 SYNDROME (Long covid started in September, which symptoms are continuing up until today). On an unknown date, the patient experienced VACCINATION FAILURE (2 doses of the Moderna COVID-19 10FEB2021 and 16MAR2021 vaccine and now has "long covid."). At the time of the report, VACCINATION FAILURE (2 doses of the Moderna COVID-19 10FEB2021 and 16MAR2021 vaccine and now has "long covid.") outcome was unknown and POST-ACUTE COVID-19 SYNDROME (Long covid started in September, which symptoms are continuing up until today) had not resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported. Patient had received 2 doses of the Moderna COVID-19 10FEB2021 and 16MAR2021 vaccine and now had long covid. Long covid started in September, which symptoms are continuing up until today. No treatment information was provided.  Company Comment:  This is a spontaneous case concerning a 35-year-old, female patient with no reported medical history, who experienced the unexpected non-serious event of Post-acute COVID-19 syndrome and vaccination failure. Patient received 2 doses of mRNA-1273 vaccine and approximately 18 months later, experienced long COVID. No further information on clinical course, sars-Cov-2 tests and treatment received was available in the report. The benefit-risk relationship of mRNA-1273 Vaccine is not affected by this report.; Sender's Comments: This is a spontaneous case concerning a 35-year-old, female patient with no reported medical history, who experienced the unexpected non-serious event of Post-acute COVID-19 syndrome and vaccination failure. Patient received 2 doses of mRNA-1273 vaccine and approximately 18 months later, experienced long COVID. No further information on clinical course, sars-Cov-2 tests and treatment received was available in the report. The benefit-risk relationship of mRNA-1273 Vaccine is not affected by this report.
I had a very sore arm immediately after the shot. The morning after the shot I got up, did some brief exercise, then I started to feel really bad. It was a rapid onset with vomiting and dizziness. I laid down and for the next several hours I was shivering very hard under the covers. I was sweating and shivering and was trying to sleep throughout the day. I did not take my temperature as I mostly felt extremely chilled. I had a severe headache and body aches throughout the day. The headache and nausea subsided slightly after 6 or 7 hours but the shaking and chills continued throughout the day. The temperature was 78 degrees in my house and I had to wear a sweater, I felt freezing. My thinking was extremely foggy for the day, nausea and headache persisted, extreme lethargy. When I went to sleep that night, over 24 hours after the vaccination, sleep was fitful, sweating was profuse along with shaking. I had to get up in the middle of the night to change clothes as they were soaked. The following day I was fairly well recovered but still had lingering headache and lethargy, the shaking stopped. I could not eat throughout the 48 hour period except for very bland food. I was also unable to hydrate much throughout the 48 hours.
pt recv vax 11SEP95 & on 13SEP95 1AM pt fell shaking stiff; eyes rolled back in head, rescue squad arrived in 2 mins; T103.6 in ER; 15SEP95 pt devel viral-type rash;
This report is concerning a 13 month old female who received Prevnar and Varivax vaccines on 7/30/00 and on 8/10/00, developed a fever, pain, "red papules, and vesicles". She was seen by the physician. The next day, the child's fever was 102F and she experienced a febrile seizure which lasted for 2 to 3 minutes.
Information has been received from a physician assistant concerning an "about 18 month old" patient who was vaccinated with a first dose of VAQTA.  The physician assistant reported that the patient developed a "measles like rash" after receiving the dose of VAQTA.  The patient recovered on an unspecified date.  The patient sought medical attention, but it was unspecified if the patient was seen in the office.  Additional information has been requested.
Client vaccinated with Pfizer vaccines on May 2 and June 2, 2021.  Not boosted.  Symptoms started on 12/28/2021 - chills, nasal congestion, cough, myalgia.
This spontaneous report was received from a medical assistant and refers to an unspecified number of patients of unknown age and gender. The patient's concurrent conditions and medical history were not reported. On an unknown date, the patient was vaccinated with unspecified improperly stored doses of GARDASIL which had a lot# reported as "K006962" and an expiration date of 19-FEB-2017 (concentration, dose, route, and anatomical place of vaccination were not provided). Which were exposed to a temperature of 32.7 F for 31 hours. There were no previous excursion and a data logger was involved. Information regarding concomitant therapies was not reported. No product quality complaint was involved. This is one of several reports from the same reporter. Additional information has been requested.
has not received his 2nd dose; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 20-Jul-2021 and was forwarded to Moderna on 20-Jul-2021.    This spontaneous case was reported by a consumer and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (has not received his 2nd dose) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    In April 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PRODUCT DOSE OMISSION ISSUE (has not received his 2nd dose). At the time of the report, PRODUCT DOSE OMISSION ISSUE (has not received his 2nd dose) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant product use was not provided by the reporter.   No treatment information was provided.
Disseminated Herpes Zoster. Symptoms w/o rash in right trigeminal, bilateral torso (right > left). Characteristic shingles rash in left T5-6 distribution. Famciclovir x 7 days started at onset of rash (symptomatic Day 5). Symptoms gradually resolved over about 2 months.
Patient developed right arm swelling 1 day post-vaccines administration with associated erythema warm, tenderness and fever (suggestive of cellulitis). Right deltoid area extending 10 cm vertically(from acromium to humerus measuring 21.5 cm in circumference compare with 8.75 cm in left arm). Tx: Cephalexin 300mg PO every 12 hrs. x 5 days, cold compresses and acetaminophen when needed for fever.
pt recv vax 16OCT97 1040AM states approx 130PM same day @ home passed out & had trouble moving;daughter called 911-pt was discharged same day on 17OCT97 states feels fine, just tired;
Fever 100 - 101.5 24+ hours Chills 3.5 hours at noon 2-28, dizziness, nausea 2-3 hours one episode syncope with fall, no injury extreme lassitude 24 hours
Patient was 17 at the time of administration of the vaccine.  Patient is now calling to obtain 2nd dose and age confirmed of <18.  Have noted on website to proceed with vaccine and complete VAERS report.  No adverse effects noted from initial dose.
Extreme flu like symptoms. Fever of 100° - 24 hrs three days of reaction, close to making 911 call at 3:00 am, but waited it out until evening of Feb 12th. I live in rural area w/o urgent care facility. 1st injection 2 mos. prior or w/o adverse event. If so, would not have 2nd done.
Patient had nausea, flushing/sweating, dizziness. BP 163/83, HR 66, RR 18, O2 100%. Patient stable, released from vaccination site.
Myalgia in both legs, hips, and ankles. Described as "deep muscle pain".