chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Case number PHEH2015US021221, is an initial spontaneous report from a health care professional received on 19 Oct 2015. This report refers to a 12 years old female patient. Medical history and concomitant medications were not reported. The patients was inadvertently vaccinated with FLUCELVAX (batch number: 173991) at a dose of 0.5 ml intramuscularly on 15 Oct 2015. The case was assessed as non-serious. No adverse event was reported.
approx 20hrs p/vax pt devel hives @ inject site; spread to trunk; erythematous; macular w/reticular appearance, blanched w/pressure;rash resolved w/o tx w/in seconds of onset;no fever, resp distress or other sx;
died of blood clots; This spontaneous case was reported by a consumer and describes the occurrence of THROMBOSIS (died of blood clots) in a female patient of an unknown age 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 third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced THROMBOSIS (died of blood clots) (seriousness criteria death and medically significant). The reported cause of death was blood clots. It is unknown if an autopsy was performed.            Concomitant drugs were not reported. Treatment medications were not provided.  It was reported that patient developed a red circle on the lower inside part of the arm of the injection, Now it is more like a bigger bruise, like a bleed and it is painful and hurts. Caller also state the patient's fingers were tingling and this was also very painful. It was reported that patient died of blood clots after 30 days of vaccination.  Company Comment: This is a spontaneous case concerning  a female patient of unknown age, with no known medical history, who experienced the unexpected fatal event of thrombosis. The events occurred approximately on an unknown day after the third dose (booster) of mRNA-1273 COVID 19 Vaccine. The rechallenge was unknown since no information about the first dose was disclosed. The reported casuse of death was blood clots. It is unknown if autopsy was performed. The benefit-risk relationship of mRNA-1273 COVID 19 Vaccine, is not affected by this report.   This case was linked to MOD-2022-452725 (Patient Link).; Sender's Comments: This is a spontaneous case concerning  a female patient of unknown age, with no known medical history, who experienced the unexpected fatal event of thrombosis. The events occurred approximately on an unknown day after the third dose (booster) of mRNA-1273 COVID 19 Vaccine. The rechallenge was unknown since no information about the first dose was disclosed. The reported casuse of death was blood clots. It is unknown if autopsy was performed. The benefit-risk relationship of mRNA-1273 COVID 19 Vaccine, is not affected by this report.; Reported Cause(s) of Death: blood clots
Patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion); Patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion); This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (Patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion)) and POOR QUALITY PRODUCT ADMINISTERED (Patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion)) in a 57-year-old female patient who received mRNA-1273 (Spikevax) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Spikevax) (unknown route) .5 milliliter. On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion)) and POOR QUALITY PRODUCT ADMINISTERED (Patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion)). At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (Patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion)) and POOR QUALITY PRODUCT ADMINISTERED (Patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion)) outcome was unknown.        For mRNA-1273 (Spikevax) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported. No treatment medications were reported.  Reporter stated that there had been no power outages that would have impacted the Moderna vaccine. However, the reporter reiterated that because the facility was unable to download the digital data logger, they would need to treat this issue as a temperature excursion. The data logger was unable to download for the months of December-2021, January-2022, and February-2022. They were filling out a temperature excursion assessment with the State currently. Also reported that no adverse reactions were experienced by any patients.
having dizziness after getting the second flu vaccination; Initial information received on 24-Oct-2022 regarding an unsolicited valid  non-serious case received from a pharmacist.  This case involves an unknown age and unknown gender patient who experienced having dizziness after getting the second flu vaccination while receiving vaccine INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE [FLUZONE HIGH-DOSE QUADRIVALENT].  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   In September 2022, the patient received a  dose of suspect INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE (dose, formulation, strength, lot and expiry date: unknown) via unknown route in unknown administration site for prophylaxis vaccination.  In October 2022, patient received 2nd dose INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE.    On an unknown date the patient developed a non-serious having dizziness after getting the second flu vaccination (dizziness) (unknown latency) following the administration of INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE.  Action taken with QUADRIVALENT INFLUENZA VACCINE (FLUZONE HIGH-DOSE QUADRIVALENT) was not applicable.  It was not reported if the patient received a corrective treatment for the event (having dizziness after getting the second flu vaccination).  At time of reporting, the outcome was Unknown for the event having dizziness after getting the second flu vaccination.
miserable at night; pain on his left side; was weak and could not get out of bed; pain in the injection site; Fever; head pounding; This spontaneous case was reported by a consumer and describes the occurrence of FEELING ABNORMAL (miserable at night), PAIN (pain on his left side), ASTHENIA (was weak and could not get out of bed), VACCINATION SITE PAIN (pain in the injection site) and PYREXIA (Fever) in a 74-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Previously administered products included for Product used for unknown indication: Pfizer vaccine (for his other doses.). Past adverse reactions to the above products included No adverse event with Pfizer vaccine. Concomitant products included TRAZODONE and ROSUVASTATIN for an unknown indication.    On 12-Apr-2022, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 12-Apr-2022, the patient experienced FEELING ABNORMAL (miserable at night), PAIN (pain on his left side), ASTHENIA (was weak and could not get out of bed), VACCINATION SITE PAIN (pain in the injection site), PYREXIA (Fever) and HEADACHE (head pounding). The patient was treated with ACETAMINOPHEN at an unspecified dose and frequency. At the time of the report, FEELING ABNORMAL (miserable at night), PAIN (pain on his left side), ASTHENIA (was weak and could not get out of bed), VACCINATION SITE PAIN (pain in the injection site), PYREXIA (Fever) and HEADACHE (head pounding) was resolving.            The patient reported third concomitant medication which he could not remember. The patient took Acetaminophen in the middle of the night and then took two acetaminophen the afternoon of 13-Apr-2022.
Petechial rash noted in the lower legs (mostly anterior shins). Seen at ER and diagnosed with "vasculitis". Labs ordered (CBC/CMP/PT/INR wnl). other labs pending. Came to see me 8/24/10 for new rash, now raised, tender and reddish. Again petechial. Started on prednisone 20 mg daily. Case discussed with rheumatology, who will check patient in few days.
This spontaneous case was reported by a consumer and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (It is been 36 days since first dose), MUSCLE SPASMS (Cramps), ILLNESS (Got sick), INFLAMMATION (Inflammation) and ASTHENIA (Weak) in an 81-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. Concurrent medical conditions included Thyroid disorder. Concomitant products included VITAMINS NOS, OMEPRAZOLE and PARACETAMOL (TYLENOL ARTHRITIS) for an unknown indication. On 09-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 10-Apr-2021, the patient experienced MUSCLE SPASMS (Cramps), ILLNESS (Got sick), ASTHENIA (Weak), ABDOMINAL PAIN UPPER (Stomach aches), DYSPHAGIA (Swallowing issues), MYALGIA (Body aches), CHILLS (Chills), HEADACHE (Headaches) and FATIGUE (Fatigued). On 17-Apr-2021, the patient experienced ILLNESS (Sick for 3 weeks). On an unknown date, the patient experienced PRODUCT DOSE OMISSION ISSUE (It is been 36 days since first dose), INFLAMMATION (Inflammation) and FEELING ABNORMAL (Felt like somebody poisoned me). On 20-Apr-2021, MUSCLE SPASMS (Cramps), ILLNESS (Got sick), ASTHENIA (Weak), ABDOMINAL PAIN UPPER (Stomach aches), DYSPHAGIA (Swallowing issues), MYALGIA (Body aches), CHILLS (Chills), HEADACHE (Headaches) and FATIGUE (Fatigued) had resolved. At the time of the report, PRODUCT DOSE OMISSION ISSUE (It is been 36 days since first dose) outcome was unknown and ILLNESS (Sick for 3 weeks) had resolved. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. Concomitant medications include vitamins and thyroid medications. Treatment for the event included ibuprofen, omeprazole. Patient received the first dose of the Moderna COVID-19 Vaccine on 7Apr2021, since then she is been sick for like three weeks. She was scheduled for her second dose on 9May2021 but she did not receive the dose. It is now been 36 days since she took her first dose and she wanted to know how long can she wait after the first dose to receive the second dose and if she has to repeat the vaccine. Consent for safety team to follow-up was given. Most recent FOLLOW-UP information incorporated above includes: On 14-May-2021: significant follow up: Event added as missed dose, concomitant medications added. On 21-May-2021: non significant info received. On 21-May-2021: Significant follow up :- Events added :- inflammation, missed dose.
Rash, dizziness, flushed face, numbness to left side.  Occurred approximately 3-5 minutes after the dose.  Symptoms completely resolved after diphenhydramine within 75 minutes.  Patient signed out against medical advice.
patient claims to not have had her period after receiving the first vaccine on 8/8/21.  patient still reports not having her period upon returning on 9/3/2021.
Swelling 3/16/07 pt woke up 3/17/07 with blister, fever and arm warm to the touch. Pt given Tylenol for fever and pain per mom. Pt present today 3/20/07 with cellulitis 8/9 cm and sensitive to the touch. No fever noted. Pt given Keflex 250 PO Q 6 hr #21, Benadryl PRN itching.
PATIENT WAS VERY NERVOUS ABOUT GETTING A SHOT AND HAS FAINTED IN THE PAST FROM A TETANUS SHOT WHEN SHE WAS 12.  SHE FAINTED ABOUT 10 MINUTES AFTER VACCINATION AND THEN PROCEEDED TO VOMIT.  EMT WAS CALLED TO THE STORE AND THEY CHECKED PATIENT OUT AND RELEASED HER WHICH WAS ABOUT 30 MINUTES AFTER VACCINATION WITHOUT FURTHER INCIDENT
7/16 received ZOSTAVAX. 7/21 broke out in rash-classic shingles appearance ((L) T.O dermatome) elected against antiviral Rx
Face became very hot and I had a bright red face flush within 20 minutes of injection. Remained bright red for about three hours, then slowly faded to normal. No breathing issues, no raised bumps. Called my doctor's office, received an after-hours callback from nurse who advised taking a Benadryl and coming into urgent care if flush became raised bumps, or if a fever or other severe symptoms occurred. Fever started overnight, but flush had diminished by then, so I took no further action other than taking acetaminophen.
Fussiness all night, became apneoic on the way to ER. CP arrest on arrival to ER, died at 13:50 7/2/06. 7/17/06 Received provisional autopsy report which revealed COD as sudden unexplained infant death.  Pathologic dx of cardiomegaly.  7/27/06 Received medical records from PCP which reveal patient had normal c-section delivery.  Newborn blood screen revealed acylcamitine profile abnormality & was referry to genetists.  Had frequent spitting up & runny nose.  On day of vax, had diarrhea, diaper rash & continued to spit up.  Had been fussy for several days with decreased appetite & episode of emesis. PCP sent patient to ER & arrested on the way.  7/27/06 Arrived at ER in full arrest & resuscitation was unsuccessful.  7/5/07 Received t/c from coroner stating has received final autopsy report & will mail copy to VAERS.  States COD as SUDS.  Also stated 2nd child in family died approx 2 wks ago from apparent cardiac condition as heart size was approx 2x normal.  ALthough suspicious, deaths are probably unrelated. 7/11/07-final autopsy report received-COD-Sudden Unexplained Infant Death Syndrome.  Parent stated patient had been irritable all day & had wheezing & difficulty breathing.  Parent took to ER where patient was found to be unresponsive. Intubated w/much effort due to very swollen trachea & resuscitation efforts were unsuccessful.
Soreness at the site of the injection, muscle aches, fever, shivering, fatigue.
On Sat morning upon arising and taking a shower I noticed a red line almost welt on my arm by afternoon there were 2 lines and they were getting longer and wider. By Monday morning the area covered with puffiness and redness was about  at least 4 inches wide and going  almost entirely around the arm. It hurt and was very warm to touch along with starting to itch. It was not hard at the\at time. Placed a call to my doctor and was advised to see him or urgent care. I choose the later to do. In checking it out they mentioned that they have been seeing the quite often in the last couple weeks. Take an aspirin, tylenol or ibuprophn  and put cold conpresses on for 20 minutes as often as I can. This morning (Tuesday 23rd of February) it has enlarged again some redness is gone but it apprears to be black and blue now. Still itching, I have not itched it as of yet.
Sixth Nerve Palsy; This spontaneous case was reported by a consumer and describes the occurrence of VITH NERVE PARALYSIS (Sixth Nerve Palsy) in a 74-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   In February 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In March 2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 17-Feb-2022, the patient experienced VITH NERVE PARALYSIS (Sixth Nerve Palsy) (seriousness criterion medically significant). At the time of the report, VITH NERVE PARALYSIS (Sixth Nerve Palsy) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Magnetic resonance imaging: normal (normal) Everything is fine.         Feeling abnormal is a consequence of the event Diplopia which is subsumed under the event Sixth nerve paralysis. The demographic detail of the patient was reported as  5' 6.5''.Patient had no allergies or any acute or chronic illness. Also patient had not tested positive for COVID-19 and did not receive any other vaccine within one month prior to Moderna. It was reported that patient received booster dose on 28-Oct-2022.  No treatment medications was reported. The patient was taking some unknown concomitant medications  Company Comment: This spontaneous case concerns a 74 year old female Patient, with no medical history reported, who experienced the unexpected, serious (medically significant) event of VIth nerve paralysis which occurred approximately 11 months after the second dose, 12 months after the first dose and unspecified days after the Booster dose of mRNA vaccine administration. Patient experienced double vision and was unable to drive. She underwent MRI which showed normal results. The outcome of the event was reported to be unknown. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.; Sender's Comments: This spontaneous case concerns a 74 year old female Patient, with no medical history reported, who experienced the unexpected, serious (medically significant) event of VIth nerve paralysis which occurred approximately 11 months after the second dose, 12 months after the first dose and unspecified days after the Booster dose of mRNA vaccine administration. Patient experienced double vision and was unable to drive. She underwent MRI which showed normal results. The outcome of the event was reported to be unknown. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.
4 days - COViD fingers and toes (blue discoloring skin) 4 days - Numbness in fingers and toes 1 day-Rash 1-day - Bumps 1 day - Itching 2 days - Back Pain 1 day - Nausea  1 day - Chills 2 days - Fatigue  1 day - Sweating 2 days - Foul Smelling Urine 4 days - Body Aches 4 days - Joint Pain 2 days - Loss of Appetite Treatment - increased water intake, ibuprofen, Benadryl and Tylenol
Initial information received on 28-Dec-2018 regarding an unsolicited valid non-serious case received from a pharmacist. This case involves a female patient who received an expired dose of vaccine ADACEL. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. No concomitant vaccine received. On an unknown date, the patient received a dose of suspect DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE lot number not reported via unknown route in unknown administration site. It was a case of actual medication error due to expired vaccine used. It was unknown if any adverse event occurred. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in 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.
No injection site pain. Cephalgia, intermittent and primarily occipital and suboccipital in location with worse  pain 01/12/2021. Rated at 5-6 over 10. General arthralgia
Slight rash that turned into fever. As days went by rash got worse. All over back, stomach, face and was spreading to limbs. Puffy and swollen eyes.
This spontaneous report has been received from a registered nurse concerning an unspecified patient of unknown age and gender. The patient's medical history, drug allergies, concurrent conditions and concomitant therapies were not reported. The reporter stated that on 09-OCT-2017, the patient was inadvertently vaccinated with an expired dose of properly stored M-M-R II with lot number L039613 and expiration date on 08-OCT-2017 (dose, dose number and anatomical location were not provided), administered subcutaneously for prophylaxis. No adverse effects were reported. Follow up information was received from the vaccine provider referring to a 34 years old female patient on 31-OCT-2017. On 09-OCT-2017, the patient was vaccinated with M-M-R II single dose vial on the left arm. The primary care physician followed up and spoke with the patient. The patient responded no adverse reactions. No prescription drug treatment for the experience was required. The patient would be following up in clinic on 13-NOV-2017.
vaccine was administered subcutaneously instead of intramuscularly with no reported adverse event; Initial information received on 09-Nov-2022 regarding an unsolicited valid  non-serious case from other health professional.  This case involves a 13 years old male patient to whom INFLUENZA QUADRIVAL A-B VACCINE [FLUZONE QIV] was administered subcutaneously instead of intramuscularly with no reported adverse event.   The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included HEPATITIS A VACCINE (HEPATITIS A), HPV VACCINE, HEPATITIS B VACCINE (HEPATITIS B [HEPATITIS B VACCINE]) and MENINGOCOCCAL VACCINE for Immunisation.  On 24-Oct-2022, the patient received a  dose of suspect INFLUENZA QUADRIVAL A-B VACCINE at a dose of 0.5 ml once (lot UT7695LA, expiry date: 30-Jun-2023) via subcutaneous route in the left arm for prophylactic vaccination.  On 24-Oct-2022 the patient developed a non-serious vaccine was administered subcutaneously instead of intramuscularly with no reported adverse event (incorrect route of product administration, latency: same day).  It was reported that a patient was administered the vaccine with a 5/8 inch needle instead of the recommended needle and the vaccine was administered subcutaneously instead of intramuscularly. Wanting to know if the dose needs to be repeated.  Action taken: Not applicable.  Outcome: Unknown.   This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Fever - Information has been received from a physician concerning a male patient who on 03 Jan 1994, at 2 months old was vaccinated with a first dose of measles virus vaccine live (+) mumps virus vaccine live (+) rubella virus vaccine live (second generation).  Subsequently the patient experienced a fever.  Unspecified medical attention was sought.  The patient received the next two doses of measles (+) mumps (+) rubella virus vaccine live (second generation)  according to the schedule.  The physician inquired as to whether or not there would be a problem with administering a fouth dose of mealses (+) mumps (+) rubella virus vaccine live (second generation).  Additional information has been requested.
4 hours after vaccines patient has had frequent hypertonic episodes lasting a few seconds to minutes. No loss of consciousness.
I didn't have any side effects with the vaccine but I did notice a change in my  menstrual cycle and I will be seeing someone about this soon.