chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from product quality group. The reporter is the patient.  A 62-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 23Dec2021 at 14:00 as dose 3 (booster), single (Lot number: Fj1611) at the age of 61 years intramuscular, in left arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown) and as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Graves' disease" (unspecified if ongoing); "Allergy: Peanut" (unspecified if ongoing), notes: known allergies Slight allergy to peanuts. Concomitant medication(s) included: SYNTHROID, start date: 09Dec2019, stop date: 10Jun2022. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Unknown results, notes: Treatment of COVID-19. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Investigational results were received on 13Jun2022. This is a notification generated from the gQTS system. As part of the LOE simplification process, the following Complaint Records were classified as Product Use Attributes // Lack of Effect and have been moved to Closed (No Investigation) state referencing a previously completed investigation for the same product and lot as per the 'One and Done' business process according to in PQS Q1215 and/or Q1252. Refer to the below table for details: Conclusion of Previously Completed Investigation (FCI/SI/OffCI): The complaint for lack of effect of the PFIZER-BIONTECH COVID-19 VACCINE lot FJ1611 was investigated. The investigation included reviewing manufacturing and packaging batch records, retain samples, deviation investigations, analytical release test results, and an analysis of complaint history for the reported lot. The final scope of this investigation is limited to the reported finished goods lot FJ1611, fill lot FH4344 and the bulk formulated drug product FJ8502. A complaint sample was not returned. No related quality issues were identified during the investigation. There is no impact on product quality. No root cause or CAPA were identified as the complaint was not confirmed. All release testing performed prior to the release of the reported batch was within specifications.
Developed Cellulitis and was hospitalized in extreme pain. 10/2/09 Medical records received for date of service 9/26/09 to 9/27/09. DC DX: Syncope secondary to vasovagal cause. Rt upper arm cellulitis.  Presenting Symptoms: Pt c/o 1 day post vaccination severe pain right upper arm, fell and passed out. 3 episodes of syncope while at home.  At time of incident c/o nausea, dizziness. Cellulitis on right upper arm at the injection site.
Significant pain, swelling, erythema at site of injection.  Occurred within 12 hours of injection.
a day after receiving dose, employee developed a localized mastitis to L nipple with engorged veins and swollen lymph nodes in axilla
dizziness upon standing; FEVER; headed h; chills; This a spontaneous report from a non-contactable consumer (patients father) via a sales representative. A 14-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE) via an unspecified route of administration on an unspecified date as a single for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient previously received first dose of BNT162B2 via an unspecified route of administration on an unspecified date as a single dose for covid-19 immunisation, (No reaction on previous exposure to vaccine). The patient experienced fever, dizziness upon standing, 'headed h' (as reported), chills for which Tylenol and EmergenC was taken. The symptoms were relieved but returned a few hours later and patient dosed Tylenol again. The outcome of the events was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Headache - 28 hours after first dose of Moderna, lasted for 5 hours  Nausea- 30 hours after first dose of Moderna, lasted for 2 hours Pain in injection site- left arm, 4 hours after first dose of Moderna, lasted for three days
This spontaneous report as received from a pharmacist to a patient of unknown age and gender. On 14-JUL-2014 the patient was vaccinated in error with a dose of expired ZOSTAVAX (dose not reported) subcutaneously, lot# H013940, expiration date: 25-OCT-2013. No known adverse effects reported. Additional information has been requested.
Projectile Vomit within 8 to 10 hours after the shot. Sense of smell and taste distorted, everything smells and tastes like gasoline and produces more nausea. It has continued for a month now.
pt called stating that after the vaccine she was experience significant soreness in her opposite arm (right) and could barely move it over her shoulder, she was also experience swelling around the right eye, inside of eye was clear and vision not affected, just swelling,  pt was counseled to see if anything else could be going on but she said it must be due to the vaccine
Narrative:  04/10/21 COVID (J&J) vaccine dose #1 04/21/21 Pt flew back to 1st home (lives there 6 months and 2nd home 6 months), 05/27/21 Pt seen in ED, c/o "left eye pain with a blue/purple filter on his eye; left eye pressure and pain started a week ago, states he lost vision 2 weeks ago, sees light and objects but not clear, peripheral vision is lost;" stated "flew back to 1st home ~4/21/21, soon after noted visual aberrance as if a dark spot lt eye bottom field of vision, past 2 weeks has worsened, cannot see well from left eye," BP 179/75, dx: central retinal vein occlusion likely secondary to uncontrolled HTN; per Eye doctor note, patient reports symptoms started ~4/15 with a "brown spot" in his vision inferiorly, progressing a couple days later to a large "purple spot" that obscured central vision and has remained, states to poorly controlled BP, Avastin administered 06/16/21 F/u with retina MD, reports mild improvement in vision, less purple, things are brighter 07/07/21 F/u with retina MD, reports vision in middle has worsened, more clear peripherally, received 2nd Avastin dose 08/13/21 F/u with retina MD, reports vision stable, received 3rd Avastin dose 09/08/21 F/u with retina MD; reports feeling overall 30% better, spot in middle of vision is less blurred and less purple, received Eyelea dose, pt reported plan to return to 1st home x 6 months 05/18/22 F/u with retina MD, did not have f/u care, dx COVID in 1/2022, "hospitalized 2 weeks, had bloody noses x 1 week after, then 3 days ago woke up with decreased vision, barely sees light, red eyes and eye pain, had been coughing prior to event," found to have active ocular hemorrhage 05/18/22 COVID (Moderna) vaccine dose #2 05/19/22 F/u with retina MD, improvement in vision, no eye pain, received Avastin dose 05/23/22 F/u with retina MD, Vision stable, some improvement in pain since started eye drops 06/09/22 F/u with retina MD, mild improvement in vision 06/23/22 F/u with retina MD, thinks vision clearing up a bid, received Avastin dose 06/23/22 COVID (Moderna) vaccine dose #3 06/27/22 Seen by glaucoma specialist, dx with neovascular glaucoma secondary to CRVO, potential FH of glaucoma, no mention of relationship to COVID vaccine
A STRONG HEADACHE; DID NOT EAT MUCH; UNEXPECTED THERAPEUTIC BENEFIT/ ROSACEA SYMPTOMS IMPROVED/DISAPPEARED; This spontaneous report received from a patient concerned a 76 year old female. The patient's height, and weight were not reported. The patient's past medical history included bruising on thumb, and concurrent conditions included rosacea, iodine allergy, dust allergy, pollen allergy, pustules mostly present on her face and nose, and ocular rosacea. The patient was previously treated with acetylsalicylic acid for bruising on thumb; and experienced drug allergy when treated with dextropropoxyphene hydrochloride. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805029, and expiry: UNKNOWN) dose was not reported, administered on 14-MAR-2021 for prophylactic vaccination. Concomitant medications included doxycycline for ocular rosacea, rosacea, and pustules mostly present on her face and nose, and clindamycin. On 14-MAR-2021, the subject experienced unexpected therapeutic benefit/ rosacea symptoms improved/disappeared. On 15-MAR-2021, the subject experienced a strong headache. On 15-MAR-2021, the subject experienced did not eat much. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from a strong headache on 16-MAR-2021, and the outcome of unexpected therapeutic benefit/ rosacea symptoms improved/disappeared and did not eat much was not reported. This report was non-serious.
MIGRAINE; FATIGUE/EXHAUSTED; HEADACHE; DIZZY, EQUILIBRIUM OFF, ROOM SPINNING; REDNESS TWO X  TWO AREA; ACID REFLUX IN STOMACH; NAUSEA; ARM SWELLING, REDNESS TWO X TWO AREA, HARDNESS AT SITE; This spontaneous report received from a patient concerned a 47 year old female. The patient's height, and weight were not reported. The patient's past medical history included cholecystectomy, and birth control pill, and concurrent conditions included arthritis, herniated discs C5 & C6, knees pain, neck pain, major depressive disorder, hashimoto's disease, hypothyroid, asthma, latex allergy, non-smoker, non-alcoholic, and autoimmune disorder, and other pre-existing medical conditions included patient had no drug abuse or illicit drug usage. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, and batch number: 042A21A expiry: UNKNOWN) dose was not reported, administered on 10-APR-2021 11:00 for prophylactic vaccination. Concomitant medications included montelukast sodium for asthma, salbutamol for asthma, levothyroxine sodium for hashimoto's disease, hypothyroid, and auto-immune, ibuprofen for herniated discs C5 and C6, cortisone for knees and neck pain, bupropion hydrochloride for major depressive disorder, and sertraline hydrochloride for major depressive disorder. On 10-APR-2021, the subject experienced redness two x two area. On 10-APR-2021, the subject experienced acid reflux in stomach. On 10-APR-2021, the subject experienced nausea. On 10-APR-2021, the subject experienced arm swelling, redness two x two area, hardness at site. On 10-APR-2021 12:30, the subject experienced dizzy, equilibrium off, room spinning. On 11-APR-2021, the subject experienced headache. On 13-APR-2021, the subject experienced fatigue/exhausted. On an unspecified date, the subject experienced migraine. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from dizzy, equilibrium off, room spinning, acid reflux in stomach, and nausea on 11-APR-2021, and headache on 12-APR-2021, had not recovered from redness two x two area, arm swelling, redness two x two area, hardness at site, and fatigue/exhausted, and the outcome of migraine was not reported. This report was non-serious.
Right arm had broken out in rash and was getting worse. The pharmacist on duty recommended calamine for the itch.
Vitals Stable.  BP  150/89     /    BP 150/89      /   BP147/88 HR  70          /     HR 64           /     HR 64 RR  16         /      RR 16          /      RR 16.
Noted with numbness on left arm within 24 hrs of receiving TRUMENBA vaccine on 2/3/2018. On 2/5/2018 he was seen by PA and he was able to move 30% but today 2/12/2018 he was unable to lift elbow or forearm, no sensation on left arm and forearm, very limited movement on left hand and no movement on arm and forearm.
This spontaneous report was received from a nurse referring to a patient of unknown age and gender. The patient's pertinent medical history, concurrent conditions, concomitant therapies and drug/allergies reactions were not reported. On 07-NOV-2016, the patient was vaccinated with a expired dose of GARDASIL intramuscular, lot # K005083 and expire date 04-NOV-2016 (dose number and area of administration were not reported0. No adverse event were reported. No product quality complaint (PQC) was involved. Additional information has been requested.
This spontaneous report as received from a medical assistant refers to 4 years old child patient of unknown gender. The medical assistant stated there was a power outage on 12-APR-2014 and the VARIVAX doses from the freezer needed to be transported to unspecified hospital for proper storage. She stated VARIVAX was exposed to 46F for 1 hour, at worst. The patient received VARIVAX dose 0.5 ml, intramuscularly, lot J006358 expiry 23-MAY-2015, between 12-APR-2014 and 24-APR-2014. There was a site visit from local health department on an unspecified date. No adverse effects was reported. This is one of several reports from the same source. Additional information has been requested.
Knees hurting while walking and running; ringing in ears; excessive tiredness hard to wake up.
This spontaneous report as received from a healthcare worker and certified medical assistant refers to a patient of unknown age and gender. On 25-AUG-2014, the patient was vaccinated with a dose of VARIVAX (Merck) (dose, units, route of administration, anatomical location were not reported) which was exposed to a supported temperature excursion on 15-AUG-2014. No adverse events had been observed or reported. No product quality complaint (PQC) involved. This is one of several reports from the same reporter. Additional information has been requested.
DOSE ADMINISTERED AFTER BEING STORAGE FOR 30 DAYS BETWEE 2-8 DEGREE C
2 Days later had wrist pain & generalized urticaria progressing to erythema multiforme
This spontaneous report was received from a medical assistant referring to an unknown number of patients of unknown age and gender. The patients medical history and concurrent conditions were not provided. Since 01-NOV-2016, an unknown number of patients were vaccinated with improperly stored doses of M-M-R II, lot number not reported. Other vaccines improperly stored included VAQTA, RECOMBIVAX HB, GARDASIL 9, PEDVAX HIB and ROTATEQ. No adverse effects reported. No further information provided. This is one of several reports from the same source. Additional information is not expected.
pt recvd vax; awoke w/ dec head control, poor balance, unable to walk or sit w/ support; improved over 48 hrs;
Two days after the first shot, my father's cognition, memory, and neuromuscular coordination all took a deep dive.  He started sleeping late into the day, waking up forgetting to make his morning coffee, having trouble picking up the phone when I rang him.  These are the classic symptoms of narcolepsy, a common vaccine injury.  I alerted the agency that he had been injured.  My sisters ignored me and took him for the 2nd shot on February 9, 2021 and he was dead in exactly 4 months from heart failure, leading to sepsis and pulmonary edema.  The doctor's exam of a 94 year old man with brain damage, consisted of asking him if he had "any side effects" from the first shot, to which he replied "NO".  That is the answer he would have given if his two ears had fallen off after the first shot.  He had exchanged his childhood worship to worship of the medical industrial system.
3/22/19 c/o of continued left arm pain with certain movement since flu vaccine given in Nov.  Offered shoulder XR with PT or Ortho consult -pt declined.
I had a sore throat, my wife and I had just come back from vacation, so I thought I better test for COVID-19 just in case. I used a home COVID-19 test, that came back positive. I decided to wait to call the doctor but a week later I had to call her as I couldn't breathe. We had a telehealth visit, she prescribed me a Methylprednisolone for the infection. It did take a couple of days, I am feeling better, I am left with a lingering dry nonproductive cough.
Within minutes my head started to itch, then I was itching all over s time went on, I thought it was just because I was nervous to get the vaccine- But I went back to work and brushed it off-I had long sleeves and long pants so I did not look but later on I had rash and hives all on my arms, trunk, legs, and back this lasted a few days- It was very itchy and I tried not to take anything because I wanted to make sure I got the full benefit of the vaccine.
fever like symptoms; slight shortness in breath; headache; not feeling to good for about 3 days; This case was reported by a consumer via call center representative and described the occurrence of fever in a patient who received Herpes zoster (Shingrix) for prophylaxis.   In March 2020, the patient received the 1st dose of Shingrix. On an unknown date, less than a day after receiving Shingrix, the patient experienced fever, shortness of breath, headache and malaise. On an unknown date, the outcome of the fever, shortness of breath, headache and malaise were recovered/resolved.   It was unknown if the reporter considered the fever, shortness of breath, headache and malaise to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The age group was not reported but it was selected as adult as per the vaccine indication. The patient received shingrix and experienced fever like symptoms and slight shortness in breath the first 24hrs. The headache and just not feeling too good for about 3 days. At the time of reporting with covid 19 on the table the patient reluctant to get the second one. The reporter asked could he/she wait till the whole covid thing was over.
Soreness in arm for 4 days following the injection (beginning within a few hours of the injection), headache for one day, fatigue for four days (through the present), brain fogginess, and starting three days after, hives and throat tightness. Still going on.
Immediate face flushing, hot red.  Itching and face remained hot for evening, welts/hives developed and continues.  Rash on face spreading up to eye lids lids now swollen on day 4.  Hot red face and rash continues.  Taking antihistamines without relief.
Seven days following the injection I felt a lump in my arm at the injection site which was accompanied by a giant circular red rash. The rash was painful,  itchy, and hot to the touch. The rash grew to be about the size of a large orange throughout the course of three days. I have been experiencing other side effects including nausea, fatigue, and muscle pain in the rest of my arm. I am reaching day four and am starting to see some fading in the rash color, though the other side effects (itchiness, pain, and fatigue) are getting worse.
Extremely heavy menstrual cycle beginning a few days after first vaccine.  Menstrual period after 2nd dose also much heavier than usual.  Extremely heavy meant heavy flow, larger clots than normal (smal avocado sized clots).
Fever,chills,dizziness,coughing, headache, arm swelling, stiffneck,insomnia,burning eyes,itching injection site and arm.
Nausea; Numbness under left chin; Numbness in left cheek; Numbness to whole left side; Pain at injection site; Red at injection site; Chills; Fever; Headache; This spontaneous case was reported by a consumer and describes the occurrence of HYPOAESTHESIA (Numbness under left chin), HYPOAESTHESIA (Numbness in left cheek), HYPOAESTHESIA (Numbness to whole left side), VACCINATION SITE PAIN (Pain at injection site) and INJECTION SITE ERYTHEMA (Red at injection site) in a 31-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.     No Medical History information was reported.    On 12-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-Feb-2021, the patient experienced HYPOAESTHESIA (Numbness under left chin), HYPOAESTHESIA (Numbness in left cheek), HYPOAESTHESIA (Numbness to whole left side), VACCINATION SITE PAIN (Pain at injection site), INJECTION SITE ERYTHEMA (Red at injection site), CHILLS (Chills), PYREXIA (Fever) and HEADACHE (Headache). On 16-Feb-2021, the patient experienced NAUSEA (Nausea). The patient was treated with LORATADINE, PSEUDOEPHEDRINE HYDROCHLORIDE (BENADRYL 24 D) at an unspecified dose and frequency. At the time of the report, HYPOAESTHESIA (Numbness under left chin), HYPOAESTHESIA (Numbness in left cheek), HYPOAESTHESIA (Numbness to whole left side), VACCINATION SITE PAIN (Pain at injection site), INJECTION SITE ERYTHEMA (Red at injection site), CHILLS (Chills), PYREXIA (Fever), HEADACHE (Headache) and NAUSEA (Nausea) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No relevant concomitant medications were reported.
Extreme fatigue for 24 hours; Extreme fatigue for 24 hours then stomach upset 3 days later, over a month later, still having regular upset stomach; Extreme fatigue for 24 hours then nausea 3 days later, over a month later, still having nausea; Extreme fatigue for 24 hours then dizziness 3 days later; Extreme fatigue for 24 hours then diarrhea 3 days later, over a month later still having diarrhea; This is a spontaneous report from a contactable consumer, the patient. A 37-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: unknown) via an unspecified route of administration in the right arm on19Mar2021 at 18:00 (at the age of 37-year-old) as a single dose for COVID-19 immunisation. Medical history included asthma, penicillin allergy and iodine allergy. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. Concomitant medications included budesonide/formoterol fumarate (SYMBICORT), sertraline (MANUFACTURER UNKNOWN); norethisterone acetate/ethinylestradiol (AUROVELA) and fexofenadine hydrochloride (ALLEGRA); all taken for an unknown indication from an unknown dates and unknown if ongoing. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: unknown) via an unspecified route of administration in the left arm on 26Feb2021 at 18:00 (at the age of 37-year-old) as a single dose for COVID-19 immunisation. On an unknown date in Mar2021, the patient experienced extreme fatigue for 24 hours then stomach upset, nausea, dizziness and diarrhea 3 days later. Over a month later, still she had regular upset stomach, nausea and diarrhea. The events did not result in doctor or other healthcare professional office or clinic visit, emergency room or department or urgent care. No therapeutic measures were taken as a result of the events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events extreme fatigue was recovered on an unknown date in Mar2021, while the events stomach upset, nausea, diarrhea were not recovered and the event dizziness was unknown at the time of this report.  No follow-up attempts are required; information about lot/batch number cannot be obtained. No further information is expected.
08:15 am - Pt reports "feeling flushed and my heart is beating fast". HR 96 08:23 am - Pt states "I really don't feel very good. I feel very dizzy". Assisted to supine position on cot. HR 100 08:26 am - No longer feeling dizzy, but still feeling flush. HR88 BP 156/93 (L) arm 08:30 am - HR 92 BP 161/101 (L) arm. Symptoms unchanged.  08:33 am - HR 97 BP 173/100 (L) arm. Symptoms unchanged.  0841 - HR 94 BP 170/98 (L) Pt reports "No longer feeling flush, but still shaky and still feeling my heart beating fast with palpitations. 0842 - HR reg 90 BP 164/95 (R) arm 0845 - HR reg 84 BP 163/93 (R) arm 0848 - Pt reports that she is still feeling like she has a rapid heart rate. 0850 - Pt sitting up on side of cot.  HR reg 83.  BP 163/95 (R) arm.