chrisvoncsefalvay/vaers-outcomes huggingface dataset:
fainted; hit their heads; This spontaneous report was received from a registered nurse via a company representative referring to a 11 or 12 years old female patient. There was no information about the patient's concurrent conditions, drug reactions, allergies, medical history, and concomitant therapies provided.     In September 2018, the patient received a dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9)(strength, route, lot # and expiration date were not reported) for prophylaxis.  In September 2018(reported as after receiving the dose of the vaccine), the patient fainted in the office and hit her head. On an unknown date, the patient required medical attention from an unspecified hospital. It was unknown if the patient was admitted to the hospital. The patient was still in the doctor's office. The outcome of the events was recovered on an unknown date. The causality between the events and hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) was not provided.  Upon internal review, fainted was determined to be medically significant.  This is one of the two reports received from the same reporter.; Sender's Comments:  US-009507513-1911USA010728:
noted doses were affected & may have lost count; 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 TRANSCRIPTION MEDICATION ERROR (noted doses were affected & may have lost count) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031B21A) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form(s). On an unknown date, the patient experienced TRANSCRIPTION MEDICATION ERROR (noted doses were affected & may have lost count). At the time of the report, TRANSCRIPTION MEDICATION ERROR (noted doses were affected & may have lost count) had resolved. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medications were not provided.  Reporter stated that she thinks there were multiple vials that had a temperature excursion alert. Reporter stated that the quantity information is based on received dates of 6 different lot numbers of 031B21A, 017B21A, 007B21A, 044A21A, 030A21A, and 010A21A with all expiration dates of 31Dec2069 and combined possible number of 1,188 Doses per reporter between 23Feb2021 and 29Mar2021. Reporter stated it is a possibility that all noted doses were affected and because multiple people may have used some that they may have lost count but cannot be sure.
face underneath eye and around cheek is red extending to lips; Swelling / Affected area is also swollen; eye is swollen; diagnosed with shingles / both doses of Shingrix last year; Shingles; Eruptions; Headache; This case was reported by a consumer via call center representative and described the occurrence of vaccination failure in a 77-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis.   On 20th January 2019, the patient received the 1st dose of Shingrix (intramuscular) 50 ug. On 20th April 2019, the patient received the 2nd dose of Shingrix (intramuscular) 50 µg. On 1st October 2020, not applicable after receiving Shingrix and 530 days after receiving Shingrix, the patient experienced headache. On 9th October 2020, the patient experienced vaccination failure (serious criteria GSK medically significant), shingles, rash, erythema, swelling and eye swelling. On 7th October 2020, the outcome of the headache was recovered/resolved. On an unknown date, the outcome of the vaccination failure and eye swelling were unknown and the outcome of the shingles, rash, erythema and swelling were not recovered/not resolved.   It was unknown if the reporter considered the vaccination failure, shingles, rash, erythema, swelling and eye swelling to be related to Shingrix and Shingrix. It was unknown if the reporter considered the headache to be related to Shingrix.  Additional information was provided as follows: The reporter reported that series of events began on October 1, 2020 with a severe headache that lasted 7 days. After approximately 7 to 8 days swelling and eruptions occurred.  First eruption noticed on Friday, October 9, 2020 on the left side of nose near left eye.  Left eye was swollen, and left side of face underneath eye and around cheek was red extending to lips. Affected area was also swollen. The reporter consented to follow up.
PT REPORTED NUMBNESS OF THE TONGUE WITHIN 5 MINUTES OF ADMINISTRATION OF 2ND DOSE. SHE WAS MONITORED AND REPORTED THE NUMBNESS WAS SPREADING TO LIPS, CHEEKS AND DOWN HER THROAT. BENADRYL 50MG WAS GIVEN WITH NO BENEFIT.911 WAS CALLED. AS THE NUMBNESS SPREAD TO HER THROAT, SHE STARTED TO HAVE TROUBLE BREATHING. EPIPEN 0.3MG WAS ADMINISTERED WHICH PROVIDED QUICK IMPROVEMENT WITH PATIENT REPORTING THE TROUBLE BREATHING WAS IMPROVING ALONG WITH THE NUMBNESS RECEDING. EMS ARRIVED AND SHE WAS TRANSPORTED TO THE EMERGENCY ROOM.
CONFIRMED CLINICAL VACCINE FAILURE; COVID-19 PNEUMONIA; VOICE NOT FULLY BACK; This spontaneous report received from a consumer concerned a 39 year old male. The patient's weight was 220 pounds, and height was 70 inches. The patient's pre-existing medical conditions included: the patient had no known allergies and the patient was pretty healthy up until COVID. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 206A21A expiry: 21-SEP-2021) dose was not reported,1 total administered to left arm on 23-AUG-2021 for prophylactic vaccination. No concomitant medications were reported. On 22-SEP-2021, the patient experienced covid-19 pneumonia (confirmed clinical vaccine failure).  On an unspecified date, the patient voice affected and voice was not fully back. Laboratory data (dates unspecified) included: Body temperature (NR: not provided) 103 F and COVID-19 virus test (NR: not provided) positive. Treatment medications (dates unspecified) included: remdesivir. On 27-SEP-2021, the patient was hospitalized for 4 days. the patient reported to still had low energy, lingering cough and the patient was no longer on supplemental oxygen when he was discharged from hospital. patient required nasal cannula and was not intubated. The consumer reports patient was recovering well, almost back to normal. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from covid-19 pneumonia, and affected voice, and the outcome of confirmed clinical vaccine failure was not reported. This report was serious (Hospitalization Caused / Prolonged).; Sender's Comments: V0:20211031970-COVID-19 VACCINE AD26.COV2.S- COVID-19 Pneumonia. This event(s) is considered unassessable. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s). 20211031970-COVID-19 VACCINE AD26.COV2.S-Confirmed clinical vaccination failure. This event(s) is considered not related. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event(s) than the drug. Specifically: SPECIAL SITUATIONS
Monthly menstrual period that started after the first shot has resulted in heavy bleeding to date and has never stopped making me anemic. My OBGYN has tried numerous options to get the bleeding under control and nothing has worked so far,
pt states that his arm was sore that day of the vax but when he woke up he had body aches and pain, fever and massive headache.  Pt is taking Advil. Pt has contacted his PCP regarding his symptoms and is waiting for a CB.
Pt received Pfizer vaccines on 03/01/2021 and 03/22/2021. Pt presented to the ED on 09/30/21 with complaints of difficulty breathing and found to be at 71% oxygen saturation on room air. Pt noted to test positive with COVID on 09/23/21. ID diagnosed pt with COVID pneumonitis requiring supplemental oxygen.
had blood on the urine; This is a spontaneous report from a Pfizer-sponsored program COVAX US Support. A contactable consumer reported that a 92-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, lot number was not reported), via an unspecified route of administration on 20Feb2021 as DOSE 1, SINGLE for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. Onan unspecified date, the patient experienced had blood on the urine. It was reported that reporter got the first dose yesterday together with elderly couple. She helped them to get the vaccine since they were of old age. The wife had blood on the urine, after the same dose. The outcome of event was unknown.   Information of lot and batch number has been requested.  Follow-up (13May2021): Follow-up attempts completed. No further information expected.
Vomited at 6pm 9/27 (after supper) at 10pm 9/27 felt a bit warm.  Awoke times 2 during the night crying which is unusual for child.  At 530 am 9/28 felt warm-temperature was not checked. 100 pm 9/28 rash "red dots" on back, face, legs, right thigh is tender.  Temperature 101 F axillary.
Pt developed Bell's Palsey(left facial droop, unable to close left eye. He stated symptoms developed on 4/21/2021 when he noticed he was drooling and liquid was coming back out of mouth while trying to drink fluids. Stroke was ruled out by MRI. He is currently recieving  these medications for treatment: Prednisone  60mg daily for 7 days, Acyclovir 400mg TID for 7 days and eye drops and lubricant
Swelling around injection area the morning after. A red, swollen rash appeared, and continued to grow in size. About 2 1/2 in in diameter. Left Sub Q arm.
Myalgia, NauseaVomiting,  fatigue, chills; Narrative: Myalgia, nausea, fatigue, chills; took aspirin, recovered.
Received influenza vaccine and received pneumovax vaccine on 11/6/02. Complained of redness in right arm on 11/7/02. Redness in right arm, with pain to elbow on 11/7/02. The discharge summary states cellulitis, and edema.
Hives; This spontaneous report was received from an adult female patient, concerning to herself via a plaintiff Fact Sheet from a case in litigation for zoster vaccine live (ZOSTAVAX) (Marrs# 2101USA001807). The patient's medical history, previous drug reactions or allergies and concomitant medications were not reported.     On and unspecified date in 2003, the patient was vaccinated with pneumococcal vaccine, polyvalent (23-valent) (manufacturer unknown) (reported as "pneumonia") for prophylaxis (strength, dose, route of administration, anatomical location, lot # and expiration date were not provided).  On an unknown date, the patient experienced hives (urticaria).   The outcome of urticaria and the causality assessment between pneumococcal vaccine, polyvalent (23-valent) (manufacturer unknown) and the aforementioned event were not reported.  This is one of two reports received from the same patient.; Sender's Comments:  US-009507513-2101USA001807:
12 1/2 hours after injection, had very fast pulse (104) and elevated blood pressure (164/94) and felt very hot, unable to sleep. Went to emergency room 11 AM on 7/7. Symptoms finally subsided in about 24 hours, and mild symptoms for a few days.
Has been experiencing 5-10 pink raised bumps on chest, abdomen, arms erupting daily - approx 1-3mm in site; c/o itching.
patient fell over while sitting on chair in observation area. He landed head first with head facing right. He lost consciousness for 5-10 seconds. CLient was rolled onto his back when he regained consciousness.  Client was aproppriate with responding to questions. Vitals taken and assisted back to chair. Reclining.Two abrasions noted on right side of face near eye from glasses. Small amount of blood noted in mouth following incident. small abrasion and bump on head top/right.
COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 38-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 26Mar2021 as dose 1, single (Batch/Lot number: unknown), on 16Apr2021 as dose 2, single (Batch/Lot number: unknown) and on 22Oct2021 as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Narcolepsy" (unspecified if ongoing); "Asthma" (unspecified if ongoing). Concomitant medication(s) included: BUPROPION; FLUOXETINE; SPIRONOLACTONE. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset Jul2022, outcome "recovered" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (unspecified date) Positive, notes: COVID 19 Treatment; (20Jul2022) Negative, notes: negative rapid test; (25Jul2022) Positive, notes: Positive rapid test and symptoms 6 days after completing course of Paxlovid. Therapeutic measures were taken as a result of vaccination failure, covid-19. Patient received  Paxlovid, Treatment start date:15Jul2022,Treatment stop date: 20Jul2022, Indication: Treatment of Covid-19  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Per Vaccinator, , while attempting to administer vaccination, needle separated from syringe and vaccine sprayed out. Due to less than half of the vaccine being received (vaccinator and patient agreed that it seemed that very little if any of the dose was received), a replacement dose was administered.
Contracted COVID-19  on 4/4/2021, Pt. demise 4/15/2021
Horrible hemorrhaging menstrual cycle going on 5+ days which shouldn't be possible because of Natazia. Dr. prescribed 1 week of Medroxyprogesterone 10 mg in place of Natazia to control hemorrhaging.
Transient ischaemic attack; Flickering lights; This spontaneous case was reported by a non-health professional (subsequently medically confirmed) and describes the occurrence of TRANSIENT ISCHAEMIC ATTACK (Transient ischaemic attack) in an 80-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 information was reported.    On 15-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 25-Apr-2021, the patient experienced TRANSIENT ISCHAEMIC ATTACK (Transient ischaemic attack) (seriousness criterion medically significant) and PHOTOPSIA (Flickering lights). At the time of the report, TRANSIENT ISCHAEMIC ATTACK (Transient ischaemic attack) and PHOTOPSIA (Flickering lights) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medications and treatment medications are not provided. The patient was taken to the emergency room, where the patient was evaluated and released without an overnight stay.  Company Comment: Very limited information regarding this event/s has been provided at this time.  Further information has been requested.; Sender's Comments: Very limited information regarding this event/s has been provided at this time.  Further information has been requested.
pt given Ipv, DTAP, MMR and Varivax at 9:50am. Mother noticed reaction at 10:05am.  Pt presented with swollen left eye and hand itching.  Pt given ice and 1016 physician's office contacted. Physician prescribed benedryl and 911 to be called. 10:18am 911 was called. Pt was observed and taken to emergency room for further observation.  Pt was released
Patient called at 6:25 pm 9/5/20 to report an adverse reaction to a Fluzone HD vaccination received on 9/1/20. Patient reports her arm started hurting the day she received the vaccination and has progressively gotten worse and more painful. Today she cannot lift her arm over her head without crying in pain. She took a hydrocodone (prescribed for her fibramyalgia) yesterday 9/4, as regular acetaminophen and ibuprofen were not helping with the pain. She has an appointment with a bone and joint doctor on Tuesday 9/8 to discuss the issue.
This spontaneous report as received from a registered nurse refers to a patient of unknown age and gender. Nurse reported that on an unknown date patient had a prescription written for ZOSTAVAX but (Merck) VARIVAX (route and dose unknown) was inadvertently administered to the patient rather than ZOSTAVAX (administered route unknown). No adverse effects reported. The outcome and action taken were not provided. No PQC (Production Quality Control) involved. Additional information has been requested.
pt recv vax 23SEP98 & child arm red below inj site & child doesn't want anyone to touch it;mom reports arm is red down to elbow w/circumference below inj site;dx cellulitis;to MD 29SEP98 d/t temp & MD states viral infect w/redness of arm
Fever temperature 102 for 48 hours following injection, panic attack 24 hours following vaccine, shooting nerve pain down legs started same day as vaccine and still happening today. B12 injections have helped lessen pain
found unresponsive in crib; no hx by er MD of problems preceeding arrest;
1 of 2 pts who was immunized on the same day from the same lot & exp an inject site react consisting of arm pain radiating into neck & swelling of the deltoid; pt also exp fever, chills & body aches;
Flu-like symptoms but did not get the Flu; This is a spontaneous report from a contactable consumer or other non hcp. This consumer reported for a patient. A patient of unspecified age and gender received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection, Batch/Lot number was unknown), via an unspecified route of administration on an unspecified date in Feb2021 at dose number unknown, single for covid-19 immunisation. Medical history and concomitant medications were not reported. Prior to vaccination, the patient was not diagnosed with COVID-19. It was unknown whether the patient has been tested for COVID-19, since the vaccination. On an unspecified date in Feb2021 the patient experienced flu-like symptoms but did not get the flu. It was unknown whether the patient received treatment for the adverse event. You have reported about an adverse regarding covid-19 vaccine, please help the first awareness date of this event. You filled as 02Mar2021, however the adverse event start date Feb2021, could you please help confirm the first awareness date when you knew about the events. Please also help confirm who told the events to you or how do you knew about it. Outcome of the event was unknown.  No follow-up attempts are needed, information about lot/batch number cannot be obtained.
fever; body ache; chills; nausea; fatigue; vomiting; This spontaneous case was reported by a health care professional and describes the occurrence of PYREXIA (fever), MYALGIA (body ache), CHILLS (chills), NAUSEA (nausea) and FATIGUE (fatigue) in a 31-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011J20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included No adverse event (No medical reported history). Concomitant products included AMFETAMINE ASPARTATE, AMFETAMINE SULFATE, DEXAMFETAMINE SACCHARATE, DEXAMFETAMINE SULFATE (ADDERALL) for an unknown indication.    On 24-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 24-Dec-2020, the patient experienced PYREXIA (fever), MYALGIA (body ache), CHILLS (chills), NAUSEA (nausea), FATIGUE (fatigue) and VOMITING (vomiting). On 25-Dec-2020, PYREXIA (fever), MYALGIA (body ache) and CHILLS (chills) had resolved. On 27-Dec-2020, NAUSEA (nausea), FATIGUE (fatigue) and VOMITING (vomiting) had resolved. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.   Reporter did not allow further contact; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Malaise, dizziness, nauseous, feeling light headed, feeling faint, chills, sweat, paresthesia, fatigue, lethargy, headache
extreme tinnitus in both ears; random incidents of vertigo; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 72-year-old patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 29Nov2022 as dose 4 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (DOSE 1, SINGLE), for Covid-19 immunization; Bnt162b2 (DOSE 2, SINGLE), for Covid-19 immunization; Bnt162b2 (DOSE 3 (BOOSTER), SINGLE), for Covid-19 immunization. The following information was reported: TINNITUS (non-serious) with onset Dec2022, outcome "unknown", described as "extreme tinnitus in both ears"; VERTIGO (non-serious) with onset Dec2022, outcome "unknown", described as "random incidents of vertigo".  Additional Information: Patient stated that, all Covid shots are Pfizer. Patient 4th one 29Nov started without concern. Mid Dec started having extreme tinnitus in both ears. Last week of Dec. Patient started random incidents of vertigo. Yesterday, contacted (facility name withheld), who administered the shot. They said numerous complaints of both symptoms have been reported back to this store. They had no solution said to contact my PCP. Patient did he advised to "wait it out". Can you tell me how long this could be? I'm 72. Awful unwanted side effects.  The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5 has been requested and will be submitted if and when received.
Pt started having nausea and vomiting and diarrhea about 24 hours after the vaccine. The patient feels tired and weak. Pt was advised to take IMODIUM, Gatorade, eat crackers/soup and go to the doctors if it doesn't resolve in 24 hours. Since it was the holiday pt wanted to wait it out. Since then pt has vomiting only (11/23/18) and was again advised that pt should seek MD care if it hasn't resolved as it may be a stomach bug or other issue. Pt is thinking it is related to the vaccine. No fever/cough or any other issue.