chrisvoncsefalvay/vaers-outcomes huggingface dataset:
CHILLS; ARM TENDER/SORE ARM; HEADACHE; FATIGUE; This spontaneous report received from a patient concerned a 45 year old male. The patient's height, and weight were not reported. The patient's concurrent conditions included diabetes, high blood pressure, high cholesterol, and seasonal (dust and pollen) allergy. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805029, and batch number: 1805029 expiry: UNKNOWN) dose was not reported, administered on 09-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On 09-MAR-2021, the subject experienced chills. On 09-MAR-2021, the subject experienced arm tender/sore arm. On 09-MAR-2021, the subject experienced headache. On 09-MAR-2021, the subject experienced fatigue. Treatment medications (dates unspecified) included: oxycodone/paracetamol. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from chills, arm tender/sore arm, headache, and fatigue on 10-MAR-2021. The reporter causality between JNJ-78436735 and chills, arm tender/sore arm, headache, and fatigue was related. Company causality between JNJ-78436735 and chills, arm tender/sore arm, headache, and fatigue was possible. This report was non-serious.
Day 8 following 2nd Moderna vaccine shot, patient began experiencing heaviness, dull pain in chest. She layed down which seemed to help alleviate the chest issues.  Day 10 after receiving the second Moderna shot, patient died suddenly while sitting in her recliner of cardiac arrest. There were no symptom s leading up to the event.
pain at site and down most of deltoid....dark bruise enlarged for few days and got more spread out. Purple and 7 days later still size of a penny and starting to absorb and look slight yellow within the purple
Left thigh became swollen the morning after shots given - complaint of discomfort to leg.  Advised cool moist compress as needed for the next 24 hours, followed heat if needed there after.
Expired vaccine used; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) in a 71-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 047B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 15-Oct-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 15-Oct-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Expired vaccine used). On 15-Oct-2021, EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) had resolved. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medicines were reported.  No treatment medicines were reported.
insomnia.  Hypnic Jerks.  Can't get to sleep, very tired, try to sleep and jerk awake with increased heart rate -nightmares the first few days when actually slept.  Can only get a couple hours a night.  Have tried, Benedryl, Nyquil, Melatonin.  Contacted provider tried Trazodone, now using Melatonin and xanax to sleep.  ONLY way to get any sleep.
Vaccine administered 5-27-10. Pt woke up next morning with swollen arm at site. Dr assessed 1 1/2" indurated urticarial on right triceps non-tender - rash secondary to VARIVAX.
Information has been received from a RN concerning a 7 year old pt who on 07/24/97 was vaccinated with a dose of varicella virus vaccine live (Lot # 621197/0349E). On 01/14/04 the pt was seen at the office with chickenpox less than 50 lesions. It was noted that the pt had a fever of 100F which began on 01/12/04.  Treatment included Benadryl and Tylenol.  There was no product quality complaint involved. Additional information has been requested. A pt from the same source had a similar experience (WAES # 0401USA01049). **Follow up information it was noted that the patient recovered. No additional information is available.
23AUG91 pt recv vax begin to exp flu like sx 5 yr alter dx w/fibromyalgia, muscle pain, fatigue, depression, anxiety
Information has been received from a case in litigation via a case report concerning a male who in 1997, received the usual infant vaccinations that year and in early 1998. Beginning in 1998, the patient was treated five times in the emergency room for a variety of accidents that a respondent's expert said were the results of impulsive behavior and thus evidence of ADHD. A Special Masters ruled a petition alleging that thimerosal in vaccines, including the RECOMBIVAX vaccine (manufacturer unknown), caused attention deficit hyperactivity disorder (ADHD), saying symptoms that may not have been recognized at the time still trigger the Vaccine Act's 36-month statue of limitations. A Chief Special Master said that the experts agreed that the "first symptoms of manifestations" of the patient's ADHD was at the latest by 03-Nov-2001 when he was 4 years and 6 months old, which required a filing by 03-Nov-2004, under the statue. The Chief Special Master noted that the binding decision regarding onset timing, allows "retrospective" analysis even when such analysis identifies as the "first symptoms or manifestations" some innocuous episode in a child's health. The chief special master pointed out, the manifestation was "blinking." The undersigned disagrees with the petitioner's interpretation and finds that the correct reading is that the critical determination is focused solely upon when the first symptoms or manifestation of onset occurred. Chief Special Master said "whether this determination can be made contemporaneously with the symptoms first occurred or in hindsight utilizing the injured's complete medical record is irrelevant, as long as the determination was made utilizing the 'recognized standards of the medical profession at large. No further information is available.
This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT ADMINISTRATION ERROR (Doses given after temperature excursion) and PRODUCT TEMPERATURE EXCURSION ISSUE (Had a 20 min excursion in the freezer) in a 71-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 039F21A) for COVID-19 vaccination. No Medical History information was reported. On an unknown date, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 28-Nov-2021, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Had a 20 min excursion in the freezer). On an unknown date, the patient experienced PRODUCT ADMINISTRATION ERROR (Doses given after temperature excursion). On 28-Nov-2021, PRODUCT TEMPERATURE EXCURSION ISSUE (Had a 20 min excursion in the freezer) had resolved. At the time of the report, PRODUCT ADMINISTRATION ERROR (Doses given after temperature excursion) had resolved. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.Concomitant information was not provided.The dose was administered from 29-Nov-2021 to 01-Dec-2021.Treatment information was not provided. Most recent FOLLOW-UP information incorporated above includes:On 03-Dec-2021: Follow up received contain patient demographics and dose details.
Systemic: Dizziness / Lightheadness-Medium, Systemic: Fainting / Unresponsive-Mild, Additional Details: EMS arrived at the site after patient had recovered from the episode. vitals were checked. BP: 120/90. pulse: 80.  Patient was fully responsive after episode.
Tennis ball sized lump (not circular) at the injection site; Sore to touch at the injection site; Red at the injection site; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE MASS (Tennis ball sized lump (not circular) at the injection site), VACCINATION SITE PAIN (Sore to touch at the injection site) and VACCINATION SITE ERYTHEMA (Red at the injection site) in a 64-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 047A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 19-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 19-Mar-2021, the patient experienced VACCINATION SITE MASS (Tennis ball sized lump (not circular) at the injection site), VACCINATION SITE PAIN (Sore to touch at the injection site) and VACCINATION SITE ERYTHEMA (Red at the injection site). At the time of the report, VACCINATION SITE MASS (Tennis ball sized lump (not circular) at the injection site), VACCINATION SITE PAIN (Sore to touch at the injection site) and VACCINATION SITE ERYTHEMA (Red at the injection site) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant product information was not provided. Treatment information was not provided.
Nausea; injection site soreness; fatigue; chills; general feeling unwell; This is a spontaneous report from a non-contactable healthcare professional. A 33-year-old female patient received bnt162b2 (BNT162B2; reported as COVID-19 vaccine; solution for injection; unknown lot number and expiration date), intramuscular right arm on 21Dec2020 04:30 at single dose for COVID-19 immunization. The patient had no medical history and concomitant medications. The patient was not pregnant at the time of vaccination. The patient has no allergies to medications, food, or other products. On 21Dec2020 at 08:30 PM, the patient experienced nausea, injection site soreness, fatigue, chills and general feeling unwell. The patient did not treatment for the adverse event. The patient had her most recent COVID-19 vaccine was administered in a hospital. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient had no other medications the patient received within 2 weeks of vaccination. The patient was not diagnosed with COVID-19 prior to vaccination and has not been tested for COVID-19 since the vaccination. The outcome of the events was not recovered.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
swelling, redness, & heat in lt deltoid started last noc; started having sx in aobut 4 hrs p/vax; 8 1/2 cm x 9 cm;
COVID 19; COVID 19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 65-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 15Sep2022 as dose number unknown, single (Batch/Lot number: unknown) at the age of 65 years, in right arm for covid-19 immunisation. The patient's relevant medical history included: "High blood pressure" (unspecified if ongoing); "glaucoma" (unspecified if ongoing); "migraine" (unspecified if ongoing). The patient's concomitant medications were not reported. Past drug history included: Erythromycin, reaction(s): "known allergies: Erythromycin", notes: known allergies: Erythromycin. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), all with onset 27Oct2022, outcome "not recovered" and all described as "COVID 19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (unspecified date) Positive; (28Oct2022) Positive, notes: Tested positive again for Covid. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Additional information: It was reported that the patient tested positive again for Covid on 28Oct2022. Event start date reported was 27Oct2022.   The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Patient complains of increased nausea and a very large red area around where she received the vaccine the size of a tennis ball. it is read and itchy and warm
Death; A spontaneous report was received from a nurse concerning a 91-year-old, female patient who received Moderna's COVID-19 Vaccine (mRNA-1273) and died two days later.  The patient's medical history included dementia.  Concomitant medications reported included paracetamol.  On 21 Jan 2021, approximately two days prior to her death, the patient received the first of two planned doses of mRNA-1273, intramuscularly for prophylaxis of COVID-19 infection.  On 23 Jan 2021, the patient died.  The nurse reporting the event stated that the patient's death was considered as due to "natural causes" and that she was not aware of any new-onset symptoms of illness prior to the patient's death.  The patient was described as "fragile" and was under hospice care at the time of her death.  An autopsy was not performed.  Action taken with the drug in response to the event is not applicable.  The patient died on 23 Jan 2021. The cause of death was natural cause of death related to dementia. Autopsy was not performed.; Reporter's Comments: This case concerns a 91-years-old female patient, with medical history of dementia, who experienced a serious unexpected event of death. This event occurred 2 days after first dose of mRNA-1273, lot # unknown. At the time of death, the subject was very fragile and was in hospice care. Concomitant medication included Tylenol. Treatment details were not provided. The doctor considered that the death was due to natural causes. However, autopsy was not performed. Very limited information regarding this event has been provided at this time.  Based on the limited information available, it is difficult to assess a cause and effect relationship. The benefit-risk relationship of Moderna's COVID-19 vaccine is not affected by this report.; Reported Cause(s) of Death: Natural cause of death related to dementia
Pt presented to clinic (six) days s/p vaccine administration. Pt presented = large area of induration. Minimal erythema and no drainage. (+) pain. (+) ecchymosis. (+) warmth.
Dad reported patient blacked out and was shaking and unresponsive in the care after leaving office. EMS was called and patient was transported to ER where he was later diagnosed with vasovagal syncope.
Received expired vaccine; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Received expired vaccine) in an 83-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 047C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 11-Nov-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 11-Nov-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Received expired vaccine). On 11-Nov-2021, EXPIRED PRODUCT ADMINISTERED (Received expired vaccine) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medications were not reported. Treatment medications were not reported.  Reporter stated that the vaccines had remained in their freezer at -24 degree Fahrenheit up until the day of the vaccine administration, then added each vial to refrigerator as needed. The temp of the refrigerator was 4 degree Celsius.
fever - headaches- shortness of breath-nausea-ears clogged- tingling in hands and feet-diarrhea- sweats
ADMINISTERED VACCINE WAS LEFT AT ROOM TEMPERATURE FOR 4 HOURS; This spontaneous report received from a pharmacist concerned a 21 year old male. The patient's weight, height, and medical history were not reported.The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 042A21A, expiry: 21-JUN-2021) dose was not reported, administered on 10-MAY-2021 for prophylactic vaccination. No concomitant medications were reported. On 10-MAY-2021, the subject experienced administered vaccine was left at room temperature for 4 hours. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of administered vaccine was left at room temperature for 4 hours was not reported. This report was non-serious. This case, from the same reporter is linked to 20210520992.
Pt became fussy PM p/shot; Went for nap awaken & cried high pitch for 25min; MD ordered Ped DT;
Pain and swelling at injection site, nausea, loose stools, generally draggy (no energy), want to sleep most of the day.
Increased heart rate immediately after injection and continued until arrived at ER Weak legs while leaving clinic and continued until arrived at ER Dizziness/lightheaded Sensation of throat swelling while leaving clinic and continued until arrived at ER Difficulty breathing while leaving clinic and continued until arrived at ER
09/06/2021 The patient presents with 3 week hx of intermittent worsening shortness of breath with mid back pain, cough, fevers, diarrhea, peripheral edema. EMS services were called as symptoms were worsening. At arrival, pt was 83% room air, placed on nonrebreather and went up to 93%. Reported hx of COPD and CHF per EMS but pt denies.  Back pain currently 10/10.
Pt developed rash approx 10 days post SPV inoculation. Petechiae also noted. Pt also had a dental surgery the day following SPV inoculation and was treated with AMOXY, and MOTRIN and PERCOCET. Rash may have been drug eruption related to these meds.
Had my flu vaccine Oct. 7, 2016, and had TB shot the same day the next day my left arm swollen, had lumps, pain, tingling and nerve on my left arm was inflamed. I was prescribed Methylprednisolone 4 mg on 11/15. On 11/30/16 ER. Prescribed Prednisone 20mg and Tramadol 50mg for pain. On 11/28/16 prescribed 3 times a day.
Headache, Myalgia, Arthralgia, Fever, : Pain/swelling to injection site. Fatigue/headache 24hours after dose. Chills during the night. Temp 100.0 next morning 1/21. Temp/HA/Fatigue stopped 24hr after symptoms started. Injection site, tenderness, swelling, itching, redness lasted 5-6 da Narrative:
EARS HURTING; COUGH; HEADACHE; CONGESTION; TESTED POSITIVE FOR INFLUENZA TYPE A; A LITTLE LETHARGIC; FEVER; DECREASED APPETITE; A solicited report has been received from a health professional via Other. The report concerns a female patient (age 4 years, height 111 cm, weight 19 kg).    No medical history was reported. The following demography was reported for the patient's parent:   Sex: Unknown    No concomitant products were reported.    The patient received Flumist Quadrivalent (influenza vaccine live reassort 4v) (batch number PH3533) (expiration date 27-NOV-2022) once/single administration, via nasal route, on 08-NOV-2022.     No malfunction has been reported for FLUMIST QUADRIVALENT.    On 10-NOV-2022, the patient experienced fever (preferred term: Pyrexia), decreased appetite (preferred term: Decreased appetite) and a little lethargic (preferred term: Lethargy). On 14-NOV-2022, the patient experienced tested positive for influenza type a (preferred term: Influenza A virus test positive). On an unknown date, the patient experienced ears hurting (preferred term: Ear pain). On an unknown date, the patient experienced cough (preferred term: Cough). On an unknown date, the patient experienced headache (preferred term: Headache). On an unknown date, the patient experienced congestion (preferred term: Nasal congestion).     It is unknown if any action was taken with Flumist Quadrivalent (influenza vaccine live reassort 4v).     The patient recovered from the event(s) of fever, decreased appetite, ears hurting, cough, a little lethargic, headache and congestion on an unspecified date. The outcome of the event(s) of tested positive for influenza type a was unknown.     The events were considered non-serious.     The company physician did not consider that there was a reasonable possibility of a causal relationship between Flumist Quadrivalent and the following event(s): ears hurting, tested positive for influenza type a, a little lethargic, fever, headache, cough, congestion and decreased appetite.     Device Information:     Combination Product Report: Yes    Product As Reported: FLUMIST QUADRIVALENT  Common Device Name: Nasal Spray  Procode: CCQ  Product Role: Suspect
DEATH; This spontaneous report received from a consumer via media via a company representative concerned a patient of an unspecified age, sex, race and ethic origin. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported) 1 total, dose and start therapy date were not reported administrated for covid-19 prophylaxis. The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported.  On an unspecified date, the patient died from an unknown cause of death. It was unknown if an autopsy was performed. The reporter stated that "You killed my friend with your clot shot" The action taken with covid-19 vaccine ad26.cov2.s was not applicable. This report was serious (Death).; Sender's Comments: V0: 20221139927-Death. Insufficient information is available to make a causality assessment. Therefore, this event is considered unclassifiable.; Reported Cause(s) of Death: UNKNOWN CAUSE OF DEATH
INJECTION SITE PAIN; This spontaneous report received from a patient concerned a female of unspecified age. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported.  On an unspecified date, the patient experienced injection site pain. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from injection site pain. This report was non-serious.
Painful down arm, entire arm red, swollen, arm stiff couldn't raise arms, nausea couldn't eat, headache, diarrhea.
This spontaneous report as received from registered nurse refers to patients of unknown age. The patients were vaccinated with doses of (Merck) VARIVAX (Lot# and route not reported) in March 2012. No other co-suspects were reported. No concomitant medications were reported. The nurse called to report that approximately 5 to 9 unspecified patients received (Merck) VARIVAX which was reconstituted with expired sterile water diluent which expired in "February of 2012" and were administered in "March of 2012". No adverse effects reported. Attempts are being made to obtain additional identifying information to distinguish the individual patients mentioned in this report. Follow-up information has been received from a registered nurse concerning 9 patients, who received (Merck) VARIVAX, subcutaneously, which was reconstituted with an expired sterile water diluent (lot # of the diluent reported as E010104). this is one of the several reports received from the same source. The report is linked with cases 1207USA011490 and 1207USA011497. Additional information is not expected.
Sharp pain down the side of my left arm. Shortness of breath, pain when lifting shoulder.  Anytime my heart rate increases I have shortness of breath and feel like I don't get enough oxygen to my brain.  Symptoms started within a few hours of second dose of vaccine. Symptoms have gotten worse over the course of weeks. Breathing has become more difficult. I had to stop all forms of physical activity due to issues with catching my breath. The pain has gotten worse over the course of weeks that I had to go to the Emergency room on Friday, February 18th.
This spontaneous report as received from a health care worker refers to an unknown number of patients with unknown demographics. Approximately on an unknown date in the year 2014, unknown number of PEDVAX HIB vaccines undergone temperature excursion and improperly stored had been administered to an unknown number of patients. No adverse effects were reported. No additional information was provided. No product quality complaint was involved. Additional information has been requested.