chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Mild urinary tract infection; This spontaneous case was reported by a consumer and describes the occurrence of URINARY TRACT INFECTION (Mild urinary tract infection) in a 92-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 12-Sep-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 19-Sep-2021, the patient experienced URINARY TRACT INFECTION (Mild urinary tract infection) (seriousness criterion hospitalization). At the time of the report, URINARY TRACT INFECTION (Mild urinary tract infection) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 16-Sep-2021, Blood glucose: low (Low) Low blood sugar (Below 50).     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 medication were reported. No treatment information was provided by the reporter.  Reporter stated that on 19-SEP-2021 patient was taken to the emergency room and found out that patient had mild urinary tract infection and a dirty diaper.  Company Comment: This case concerns a 92-year-old, male patient with no relevant medical history, who experienced the unexpected event of urinary tract infection. The event occurred approximately 8 days after the first dose of Moderna Covid-19 vaccine. The rechallenge was not applicable, as the event happened after the first dose. The benefit-risk relationship of Moderna Covid-19 vaccine is not affected by this report.; Sender's Comments: This case concerns a 92-year-old, male patient with no relevant medical history, who experienced the unexpected event of urinary tract infection. The event occurred approximately 8 days after the first dose of Moderna Covid-19 vaccine. The rechallenge was not applicable, as the event happened after the first dose. The benefit-risk relationship of Moderna Covid-19 vaccine is not affected by this report.
Fever over 103 degrees F. Very unusual crying and seizing for 5 hours. Head/skull doubled in size (from normal size) within one week. In shock for several days after the whole-cell DPT vaccine of January 7, 1987. Was never a normal baby or human being after administration of this vaccine.
Two vaccines injected at same site - site is too low for IM injection in deltoid (approx 3 " below).  Area  became red, hot, very swollen and tender.  Over next 24 hours symptoms spread to an area of redness, swelling and tenderness approximately 8" long and 6" wide around upper arm.
pt recvd vax & the next day inject had muscle soreness; 2 days p/inject exp extreme fatigue;
Had subjective fever on 5/16, 5/17, and 5/18, no fever on 5/19, developed erythematous rash on 5/20 - viral exanthema versus hives, no other associated symptoms.
2 patients were administered the Moderna vaccine from vials that experienced a temperature excursion; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (2 patients were administered the Moderna vaccine from vials that experienced a temperature excursion) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 003C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 24-Jun-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 24-Jun-2021, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (2 patients were administered the Moderna vaccine from vials that experienced a temperature excursion). On 24-Jun-2021, PRODUCT TEMPERATURE EXCURSION ISSUE (2 patients were administered the Moderna vaccine from vials that experienced a temperature excursion) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant product use was not provided by the reporter.  Treatment information was not provided.  Reported said that 20 doses of Moderna (two 10-dose vials) were administered to patients following the brief temperature excursion. The vaccine vials were stored in the refrigerator where the temperature range normally was 36 - 46 degrees Fahrenheit. The temperature excursion occurred when was door was kept open for cleaning the refrigerator. The temperature range of the excursion was 46.02 - 46.77 degrees Fahrenheit for a total of 14 minutes out of range. She says that the Moderna vaccine was administered from these vials to 2 patients on the same day of the excursion.   Most recent FOLLOW-UP information incorporated above includes: On 28-Sep-2021: Follow up received contains Non-significant information.
pt recvd vax;approx 2 wks later, devel a bad case of eczema;improving but still present at time of rpt;
One day after the shots, pt developed localized redness, swelling and some pain in her L upper arm where she got the shots. It worsened over the following day and hence brought to the clinic. Dx: Angioedema. Rx: IM decadron p/o benadryl resolved without sequale,
3:40 Went to Urgent Care  Symptoms: Chills, pelvis pain, nausea, vertigo,
I have had a very predictable, regular, 29-day period cycle for the past 1.5-2 years. I track my periods every month. After receiving the vaccine, I got my period 5 days early and had heavy, painful period symptoms that are normally mild for me. I normally do not get nauseated on my period, but feel very nauseated this time. I did not change anything in my diet, supplements, activity, or stress levels since my last period. The only outlier has been the vaccination.
Pt was given high dose influenza immunization instead of standard dose for age (63 yrs); no adverse outcome, no treatment required
This spontaneous report was received from a physician regarding a 6 month old patient of unknown gender. The patient's relevant medical history, concurrent conditions and concomitant medications were not reported. On 09-SEP-2016, the patient was vaccinated with PEDVAXHIB (reported as Hib) lot # L051124 and expiration date 14-OCT-2018 (dose, route and frequency were not reported) for prophylaxis when refrigerator was out of range (Incorrect product storage). This is one of the several reports received from the same reporter. Additional information has been requested. Sender's Comments: US-009507513-1701USA004717: US-009507513-1701USA004718: US-009507513-1701USA004720: US-009507513-1701USA004721: US-009507513-1701USA004722: US-009507513-1701USA004723: US-009507513-1701USA004724: US-009507513-1701USA004725: US-009507513-1701USA004726: US-009507513-1701USA004566.
chills/intense shivering; nausea; vomiting; muscle cramps; exhaustion; heartburn/acid reflux even with only water; heartburn/acid reflux even with only water; lack of appetite; Feeling hot and cold; mild sore arm; This is a spontaneous report from a contactable consumer reporting for herself. A 55-year-old female patient (not pregnant) received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 31Mar2021 11:30 (lot number ER8752) on Left arm at single dose for COVID-19 immunization. Facility where the most recent COVID-19 vaccine was administered at Public Health Clinic/Veterans Administration facility. Medical history was reported as none. Concomitant medications included ibuprofen (ADVIL), cyclobenzaprine, guaifenesin, pseudoephedrine hydrochloride (SUDAFED). Historical Vaccine included first dose of BNT162B2 (lot number EN6208) on 12Mar2021 12:30 PM on Left arm for COVID-19 immunization. First night of second dose on 31Mar2021, the patient experienced mild sore arm. Morning after felt fine. First night was fine. 2nd night on 01Apr2021 the patient experienced chills, nausea, vomiting, muscle cramps and intense shivering. 3rd day and onward in Apr2021, the patient experienced exhaustion, muscle cramps, heartburn/acid reflux even with only water, lack of appetite, hot and cold flashes. No treatment was received for the adverse events. The outcome of event sore arm was resolved on 01Apr2021, outcome of other events were not resolved.  No follow-up attempts are needed. No further information is expected.
pt immunized at 12 noon and that same evening developed sweeling of left extremity and c/o chills and inability to walk. Pt to the ED and admitted to Hospital. Fever was a one point up to 103.9. Pt was discharge from hospital with diagnosis of bronchitis and a prescription for an antibiotic. Unknown reason for neurological symptoms.  12/18/07 Reviewed hospital medical records which reveal patient experienced cough, congestion, dizziness, chills/fever, SOB, ataxia, swelling & redness of left arm.  Admitted 12/1-12/4/2007. Tx w/IV antibiotics & nebs.  Improved & swelling/redness also improved.  D/C to home w/continued oral antibiotics. FINAL DX: Acute bronchitis, query reaction to pneumo shot.
a nurse reporting a temperature excursion, requesting stability data; This spontaneous report was received from a registered nurse referring to a patient of unknown age and gender. The patient's concomitant medication, pertinent medical history and drug reactions/ allergies were not reported.  On 20-OCT-2020, the patient was vaccinated with an improperly stored dose of varicella virus vaccine live (Oka/Merck) (VARIVAX) (1 dose, lot # S038700, expiration date 01-DEC-2021, strength and route were not provided) for prophylaxis. The vaccine underwent a temperature excursion of -6.6 degree Celsius for 1 hour and 45 minutes; no previous temperature excursion were reported. The call was made due to a digital data logger.   This is one of several cases received from the same reporter.; Sender's Comments:  US-009507513-2010USA010299: US-009507513-2010USA010518: US-009507513-2010USA010508: US-009507513-2010USA010384: US-009507513-2010USA010735: US-009507513-2010USA010348: US-009507513-2010USA010577: US-009507513-2010USA010526: US-009507513-2010USA010709:
Received Quadracel (R) thigh 5/28/20 - caregiver noted erythema + swelling in (R) thigh 5/28/20 evening 5/29/20 evening - patient with edema to right knee erythema, warmth, taught skin. Sent to ED by on call provider. Patient monitored in ED x 6 hours. Benadryl + Motrin temp max 100.4. Seen in clinic 5/30/20, 5/31/20, 6/2/20. Slow resolution of symptoms Edema to knee remains.
A spontaneous report was received on 14-NOV-2014 from a certified medical assistant who reported that doses of Oral, ROTATEQ and GARDASIL, which were exposed to a supported temperature excursion which was evaluated on 27-OCT-2014, had been administered to an unspecified number of patients on unspecified dates since 27-OCT-2014. No adverse effects have been reported or observed. Additional information has been requested.
Erythema left thigh with induration. Not tender, slight warmth. Measures 7 X 8 cm.
Day 2 after getting the vaccine the patient experienced a gooey substance in her eyes. Later in the day she started to experience pain and swelling in her face and ears. She went to Urgent Care and they told her to go to the ER if it got worse. The next day the swelling was much worse, pain was worse and she developed a fever. She was in the hospital for 4 days until the fever broke. Now she still have some swelling and red, raw skin in some areas on her face.
Information has been received from a licensed practical nurse concerning an approximately 14 year old female patient with migraine and no drug reactions/allergies and a history of acne who on 19-MAR-2008 was vaccinated with a first 0.5ml dose of GARDASIL (lot # 659655/1486U) via intramuscular route. It was reported that the patient possibly received the second dose on 29-MAY-2008. The patient's mother said that the office billed for this dose but it was not in the patient's chart. On 18-DEC-2008, the patient received the third dose of GARDASIL (lot # 661044/0548X), a dose of VARIVAX (MSD), HAVRIX, FLUZONE and TDAP. The fourth dose of GARDASIL (lot # 662518/0087Y) was given on 30-JUL-2009. Other concomitant therapy included BENZACLIN and RELPAX. The patient's mother also told the nurse that "daughter is having problems" but the nurse did not know if the problem was an adverse experience. The patient had sought medical attention by phone. No laboratory diagnostic study was performed. At the time of the report, the patient's outcome was unknown. Additional information has been requested.
I received the shot around noon 3/16 and by 10:30pm my blood sugar was 414.  I am type 1 Diabetic and inject insulin by pen.  I do not have a CGM, I have to test manually.  Today is 3/23 and the first four days of the injection, my sugars were in the 400's.  The last three days they have been in the high 200's.  Yesterday my endocrinologist had me increase my long-acting insulin.  I have bloodwork Friday and I have an appointment with her 4/2.
Pfizer vaccine mistakenly reconstituted with 0.8ml of sodium chloride instead of 1.8ml. Pt was administered 0.3ml of Pfizer IM in right arm. Pt was observed for 15 minutes and reports no adverse reactions.
Headache body aches; intense chills; fatigue; insomnia; mild nausea Narrative:  Employee had bivalent Moderna booster on 10/12/2022. He had very similar symptoms when he received his 2nd Moderna primary series vaccine. Within 7 hours of vaccine he started having body aches. Within 12 hours, he got intense chills, more pronounced body aches. intermittent headaches, fatigue, insomnia, and mild nausea. Within 24 hours of onset the symptoms were largely gone.
This spontaneous report as received from a nurse practitioner refers to an unspecified number of patients of unkonwn age and gender. On an unknown date those patients were vaccinated with an improperly stored M-M-R II (dose, units, route of administration, anatomical location, lot number was not reported). No adverse effects reported. This is one of several reports from the same reporter. Additional information has been requested.
On 1/18/03, Pt had sudden onset fever 103.4F and headache. Continued with fever ranging from 100F-102.3F for 4 additional days.
itching; rash/ rash in her hand; wheezing; Allergic reaction; This case was reported by a other health professional via call center representative and described the occurrence of pruritus in a 37-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Concurrent medical conditions included latex allergy.   On an unknown date, the patient received Shingrix at an unknown dose. On an unknown date, unknown after receiving Shingrix, the patient experienced pruritus, rash, wheezing and allergic reaction. On an unknown date, the outcome of the pruritus, rash, wheezing and allergic reaction were unknown.   It was unknown if the reporter considered the pruritus, rash, wheezing and allergic reaction to be related to Shingrix.  Additional details were provided as follows:  The age at vaccination was not reported. The reporter was a medical assistant at a physician's office.  The reporter said that another employee (Shingrix administrator) at their office administered Shingrix vaccine to a patient.  The administrator had developed itching and rash in her hands and also experienced some wheezing. The administrator was allergic to latex and they were suspicious that the administrator might develop those symptoms from having allergic reaction to the elastitag that comes with the vaccine.  The administrator was holding the elastitag in her hands. That elastitag had a number on it, which was 826-310.  The reporter couldn't clarify when the administrator administered the vaccine to the patient.
PATIENT WAS GIVEN A BOOSTER DOSE OF 0.5MLS INSTEAD OF 0.25MLS FOLLOWING THE JANSSEN VACCINE. PATIENT REPORTED NO ADVERSE EVENTS FROM THE VACCINE.
wheezing; out of breath/i had trouble catching my breath; felt terrible like i had COVID; This is a spontaneous report from a contactable consumer reported for herself. A 61-years-old non-pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ewo188), dose 1 via an unspecified route of administration, administered in Arm Left on 17May2021 14:00 (at the age of 61-years-old) as a single dose for covid-19 immunization. Medical history included cerebrovascular accident (stroke 5 years ago), drug hypersensitivity- known allergies: penicillin, covid-19 (Prior to vaccination, the patient was diagnosed with COVID-19). Concomitant medication(s) and received within 2 weeks of vaccination included baclofen fluoxetine oxybutynin clonidine benazepril. The patient had no other vaccine within four weeks. On 17May2021 22:00, the night she had vaccine she was wheezing and out of breath when used the bathroom. The next 2 days had trouble catching breath and felt terrible like had COVID again. She had it at christmas for 2 weeks. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any treatment. The seriousness of the event was considered as non-serious by reporter. Outcome of the event was recovered, at the time of this report.
No adverse event is being reported at this time. However, Zostavax was administered instead of Varivax.
Drug ineffective; COVID-19; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 49-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 28Oct2022 as dose 5 (booster), single (Lot number: GJ6665) at the age of 49 years, in right arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown), as dose 3 (booster), single (Batch/Lot number: unknown) and as dose 4 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "chronic hives" (unspecified if ongoing), notes: unexplained chronic hives; "hypothyroid" (unspecified if ongoing); "Previous long covid lasting 1.5 years" (unspecified if ongoing); "Previous long covid lasting 1.5 years" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), outcome "unknown"; COVID-19 (medically significant), outcome "unknown". Therapeutic measures were taken as a result of drug ineffective, covid-19. Clinical course: Patient took Paxlovid for COVID-19 treatment from 31Mar2023 to 05Apr2023.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300148518 Same patient/ reporter, Different drug (Paxlovid)/ event.;
nausea; Fatigue; headache; fever 100 F; This is a spontaneous report from a contactable consumer (Patient). A 12-years-old male patient received second dose of bnt162b2 (BNT162B2), via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as single dose for covid-19 immunisation. Medical history included migraine. The patient's concomitant medications were not reported. The patient previously received first dose of bnt162b2 (BNT162B2), via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as single dose for covid-19 immunisation. It was reported that patient did not have fever after first dose of vaccine. On an unknown date, after second dose of vaccine administration, the patient experienced nausea, fatigue, headache and fever 100 Fahrenheit. Events occurred after the use of product. Laboratory tests and procedures included body temperature 100 Fahrenheit on an unknown date. Outcome of the events nausea, fatigue, headache and fever 100 Fahrenheit was reported as unknown at the time of this report.   Information about lot/batch number has been requested.
Tinnitus (ringing in ears), higher than before blood pressure, pain in extremities, brain fog, plantar fasciitis, inflammation.  Have been under a doctors care for remedies.  Nothing has made substantial difference, however, the pain and inflammation has subsided a bit.
pt states from site of inj (lt deltoid) flare up of fibromyalgia started w/soreness in deltoid, aching generally in all muscles lasting 3 days;described as typical fibromyalgia flare up;
Weird "zaps" In head; Headaches every day; Migraines; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 56 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 06Dec2021 17:30 (Lot number: FJ8757) at the age of 56 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "Autoimmune overlap Disease: Hashimotos" (unspecified if ongoing); "Autoimmune overlap disease: Apls" (unspecified if ongoing); "Autoimmune overlap disease: Sjogrens" (unspecified if ongoing); "Known allergies: shell fish" (unspecified if ongoing); "known allergy: Bee stings" (unspecified if ongoing); "Known allergy: Iodine" (unspecified if ongoing), notes: Known allergy: Iodine. Concomitant medication(s) included: SYNTHROID. Past drug history included: Plaquenil, reaction(s): "Known allergy: Plaquenil", notes: Known allergy: Plaquenil. Vaccination history included: Bnt162b2 (previous dose product=COVID 19, brand: Pfizer, lot number: FH8030, administration time: 05:30PM , dose number 1, vaccine location: Left arm), administration date: 15Nov2021, when the patient was 56 years old, for COVID-19 immunization. The following information was reported: FEELING ABNORMAL (non-serious) with onset 07Dec2021, outcome "not recovered", described as "Weird "zaps" In head"; HEADACHE (non-serious) with onset 07Dec2021, outcome "not recovered", described as "Headaches every day"; MIGRAINE (non-serious) with onset 07Dec2021, outcome "not recovered", described as "Migraines". Therapeutic measures were not taken as a result of feeling abnormal, headache, migraine.  Additional Information: Patient did not receive other vaccine in four weeks. Did not had covid prior vaccination and not tested for covid post vaccination. No follow-up attempts are possible. No further information is expected.
T103.7-104.4, abd pain, h/a, hip pain, jerking movement approx 36hr p/vax;hx of epilepsy;off phenobarbital x 3yr;mom took child for medical attention; pt place on augmentin;
pt c/o dizziness, alert and verbal - no change vitals  151/92 Pulse -94 bpm, 98% RA,  RR-18cpm  Patient rested and avised to take some fluids. Drank water. patient stable before going home.  Patient stable before going home. patient verbalized releif from dizziness after resting.
Mastitis Breast tenderness, Erythema, chills Started Augmentin Sat. 10-31-09, compresses Improvement starting 8PM 11-2-09 Decreaseing Pain Erythema
Gave 10 year and 9 month old 12 and over dose of vaccine. Mother contacted, said that patient had no adverse effects.
Itching eyes, inner nose, scalp, top of hands and top of thighs. Itch was mild but treated with over the counter benadryl