chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Five days ago, patient received her 2nd COVID vaccination.  Following that she had myalgias and some sedation/confusion.  She apparently stumbled and struck her head.  She did not lose consciousness.  She did recover from her symptoms by the next day.  She has some soreness on her scalp in the scratch but no significant hematoma.  However, she then developed some swelling and redness beneath her eyes.  She is here to evaluate that.  She she is back to her normal self.  Comments: Patient has ecchymosis in swelling beneath both eyes and the bridge of her nose.  It is nontender.  Scalp-minor area of tenderness in the right vertex.  There is a slight abrasion on the skin.  No signs of hematoma.   Assessment / Plan: 1. Contusion of scalp, initial encounter   Contusion right scalp-I suspect patient's lungs are delicate skin informed a small hematoma.  The swelling and bruising and 5th settle down into her eye sockets.  I reassured patient that this will resolve the next 1-2 weeks.  I believe patient had some severe myalgias and fatigue after a COVID shot.  I do not think this is a longstanding problem.  Expect her to get back to her normal self.  Patient did have COVID-19 approximately 3 and half months ago.  I told her that people have more significant reaction to the COVID vaccine after having had the illness.  At this point, I do not agree need further workup.
No adverse event; Administered Moderna Covid-19 Bivalent doses to treat long-haul COVID symptoms; This spontaneous case was reported by a physician and describes the occurrence of OFF LABEL USE (Administered Moderna Covid-19 Bivalent doses to treat long-haul COVID symptoms) and NO ADVERSE EVENT (No adverse event) in a patient of an unknown age and gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) for Long COVID.     No Medical History information was reported.    In 2023, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. In 2023, the patient experienced OFF LABEL USE (Administered Moderna Covid-19 Bivalent doses to treat long-haul COVID symptoms). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, OFF LABEL USE (Administered Moderna Covid-19 Bivalent doses to treat long-haul COVID symptoms) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for OFF LABEL USE (Administered Moderna Covid-19 Bivalent doses to treat long-haul COVID symptoms).    This case contains information about patient 41 out of 42 patients. No concomitant medication was provided by reporter. Reporter had been administering the 65 plus bivalent dose to patients who have symptoms of long-haul COVID and had seen 88-90% success rate which was resolved in the symptoms of long-haul COVID. It was reported that, vaccine was given to patients for long COVID between Mar-2023 and 01-Aug-2023. 42 Patients received bivalent booster with 38 having improvement of symptoms of 50 percent or more. Vaccine was given within current guidelines except seven were under 65. Patients were treated for skin lesions, brain related problem, systolic blood pressure was 220, Tachycardia greater than or equal to 150 and body aches. No adverse reactions occurred. Treatment information was not provided.   This case was linked to US-MODERNATX, INC.-MOD-2023-735199 (Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-735199:Master case
This case was reported by a other health professional via call center representative and described the occurrence of adverse reaction in a female patient who received SHINGRIX for prophylaxis. On an unknown date, the patient received SHINGRIX at an unknown dose. On an unknown date, unknown after receiving SHINGRIX, the patient experienced adverse reaction. On an unknown date, the outcome of the adverse reaction was unknown. It was unknown if the reporter considered the adverse reaction to be related to SHINGRIX. Additional details were reported as follows: The patient had a terrible reaction to the SHINGRIX vaccine. The patient also told me she had contacted an attorney and would be joining the class action law suit. The patient asked were you aware of this. The reporter did not have any additional information. This was a potential legal case. This case has been linked to case US2019GSK027998, reported by same reporter.
She got her vaccine around 11:30 AM on Friday 11/11/22, she went to the pharmacy and the pharmacist gave her the vaccine.  She was tired when she got home and took a nap.  About About 32-36 hours later at about 5-6 AM her left hip was swollen, in a lot of pain, had difficulty moving,.  She has a high tolerance for pain but she could not deal with the pain.  Her husband gave her ice packs and put some  Aspercream on it, and he brought her a cane which she had from knee replacement surgery.  She was able to get to the kitchen to take her medicines, and knows that the peak performance vitamins has inflammation reduction in them.  She took that pack and along with her other vitamins.  She did not take any other pain pills and went back to bed.  She then started to feel that she could move her left leg a bit and was not as painful.  She was then after a little time able to sit up some, and improved.  She takes 7 pills in the morning and 8 pills at night of the peak performance and she was able to get up this morning.  She does have a little tenderness on the left leg on the thigh, more so on the side, but she is able to walk, sit down and do what she needs to do now.  They also have friends who had the same exact reaction which he had within 24 hours for him.
1) Developed vasculltic lesions on legs/feet with pain/swelling & polyarthralgia onset approximately 11 days following receipt of AVA# 3;  diagnosed with polyarthralgia; 2)  20 days later noted to have protelnuria hematuria; diagnosed with leukocytoclastic vasculltis confirmed by skin blopsy 1/30/2008 (possible Henoch-Schoenlein purpura), also found to have PFO with small shunt & aneurysmal atrial septal wall defect;  3) one month later developed headaches with negative head CT & brain MRI;  4) IgA nephropathy diagnose May 2008, confirmed by renal blopsy.  History of recent URI prior to vaccination with positive ASO titer noted late Jan 2008;  treated with oral steroids, e-mycin;  rash resolved, arthralgia improved, renal function remained normal with residual persistent mild proteinuria & hematuria.  Symptoms: Headache, general, Muscle Pain, Lesions, macule, Swelling, Joint Pain, multiple joints.
Swelling/rash at injection site; gave Benadryl and Zyrtec.
Patient was inadvertently given a third dose of Bexsero which is only a 2 dose series.  No reactions or issues have been reported by patient.
Initially headache followed by mild fever, elevated heart rate(110-130) and diastolic pressure at slightest exertion, exhaustion next several days(stayed home next two days into weekend) with any physical activity 3-4 days skin irritations on right arm first now on left arm as well. injection site was hot and felt pressure, then skin irritation that lasted 5-6 days at sight.  Tiredness, hot/clammy, skin irritation on both arms and some on front chest slight heart rate elevation still exist at day 12.  First shot also in left arm,  lot 008B21A tiredness,experienced brief rash underarm area which I believed was heat rash or fiberglass insulation reaction from working in attic at mothers house (Texas freeze repairs).  It went away after 5-6 days.  Second dose side effects still remain.   Taking Tylenol/Ibuprofen to lessen effects and anti-itch cream.
pneumonia vax adm @ 330PM 21OCT92 severe itching began 1030PM on forearms only (bilateral); DPH po adm 12MN; no itching @ 1AM 22OCT92; no other sx since that time;
No additional AEs. no PQCs reported.; LPN calling for stability evaluation of vaccines with multiple TEs dating back to 03FEB2023. Caller reports that vaccines were administered.; This spontaneous report has been received from a nurse, concerning a 52-months-old female patient. The patient's pertinent medical history, concurrent conditions, previous drug reactions, allergies, and concomitant medications were not provided.  On 07-FEB-2023, the patient was vaccinated with the first dose of hepatitis a vaccine, inactivated (VAQTA) intramuscular injection, strength 50 over 1.0 units (U) per millimeter (ml), one ml once (valid lot number W017819 [expiration date 27-DEC-2023]) (vaccination scheme, anatomical location and frequency were not provided) for prophylaxis, after multiple temperature excursions (TEs) dating back to 03-FEB-2023 (product storage error).   No additional adverse events (AE) were reported.  This is one of several reports received from the same reporter. ; Sender's Comments:  US-009507513-2302USA004298: US-009507513-2302USA004552:
Fever began in afternoon on 7/3/06 as high as 103.0- headache- went to emergency room treated with Tylenol sent home. Called Health Dept. on 7/5/06 recommended trying Motrin and calling private doctor for care. Plans to see private doctor on 7/6/06 at 11:00am.
Hypothyroidism; Diabetes mellitus Type 1; Shortness of breath; Hyperlipidemia; This is a spontaneous report from a contactable consumer (patient). A 69-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number and expiration date not reported), via an unspecified route of administration on left arm on 22Jan2021 01:00 at single dose for COVID-19 immunization. Medical history included known allergies to latex. There were no concomitant medications. The patient was not pregnant at the time of vaccination. The patient was not diagnosed with COVID-19 prior to vaccination and has not been testes for COVID-19 post vaccination. The patient experienced hypothyroidism, diabetes mellitus type 1, shortness of breath, hyperlipidemia, and had a heart surgery (triple bypass) on an unspecified date. The events resulted in visit to doctor's office or another health professional and hospitalization for 11 days. The patient received treatment for the events. The outcome of the events was recovered with sequels.  Information on the Lot/Batch number has been requested.
had the shots and still got them internally/ Suspected vaccination failure; still got them internally; This case was reported by a consumer via interactive digital media and described the occurrence of suspected vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced suspected vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the suspected vaccination failure and shingles were unknown.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine.  Additional details were provided as follows: The patient self-reported this case. The age at vaccination was not reported. The patient reported he/she had the Shingles shots and still got shingles internally. The follow-up would not be possible as no contact details were available. This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule, time to onset and laboratory test confirming shingles were unknown at the time of reporting.
Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 68-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 14Sep2022 at 15:00 as dose 5 (booster), single (Batch/Lot number: unknown) at the age of 68 years, in left 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: "Hypertension" (unspecified if ongoing); "Osteoporosis" (unspecified if ongoing); "Hyperlipidemia" (unspecified if ongoing); "GERD" (unspecified if ongoing). Concomitant medication(s) included: LISINOPRIL; ATORVASTATIN; PEPCID [ALUMINIUM HYDROXIDE GEL, DRIED;MAGNESIUM CARBONATE]; PRESERVISION; BENADRYL; MUCINEX DM. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Nov2022, outcome "recovered" (Nov2022) and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (08Nov2022) Negative; (10Nov2022) Negative. Therapeutic measures were taken as a result of drug ineffective, covid-19. Clinical course: Treatment start date=02Nov2022, treatment stop date=06Nov2022. The patient tested negative for covid after paxlovid. She had a negative test on 08Nov and 10Nov. She had no symptoms. No Known allergies. Device timestamp: 13Nov2022.  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.
lymph node under armpit is enlarged; This is a spontaneous report received from contactable reporter (Consumer or other non HCP) from a Pfizer sales representative. The reporter is the patient.  A patient (no qualifiers provided) received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE) (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. Relevant medical history included: "Covid-19" (patient has tested positive for COVID-19 previously). The patient's concomitant medications were not reported. The following information was reported: LYMPHADENOPATHY (non-serious), outcome "unknown", described as "lymph node under armpit is enlarged".  Clinical course: Four days after receiving 1st vaccine dose, patient's lymph node under armpit was enlarged.  No follow-up attempts are possible. Information on the lot/batch number cannot be obtained. No further information is expected.
Swollen gums; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 69 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 16Feb2021 (Batch/Lot number: unknown) at the age of 69 years as dose number unnown,single for covid-19 immunisation. Relevant medical history included: "Sulfa allergy" (unspecified if ongoing). Concomitant medication(s) included: NORVASC; STATIN [ATORVASTATIN CALCIUM]; THYROID. The following information was reported: GINGIVAL SWELLING (non-serious) with onset 14Feb2021, outcome "not recovered", described as "Swollen gums". Therapeutic measures were not taken as a result of gingival swelling. No follow-up attempts are possible. No further information is expected.
pt vaccinated/boosted admitted for covid pna on dexamethasone/remdesivir
Initial report was received on 04 February 2013 from an unverified source via a company website from a consumer. A 56-year-old male patient received an injection of INFLUENZA VACCINE, manufacturer unknown, (lot number, route, site, side and dose in series not reported) on unspecified date in November, year not specified. On 11 November (year not specified), eight days post vaccination; the patient was diagnosed with Guillain-Barre syndrome (GBS). The patient felt tingling in his fingers and toes, and at end of day, knew something was wrong (date not specified). "The next morning, he could not walk" and "was staggering around like he was drunk". On an unspecified date, the patient had trouble breathing. His wife dialed 911. Shortly after the arrival of paramedics, the patient passed out. He was transported to a hospital. After an hour, his diaphragm shut down and he received a tracheotomy, "doctors cut a hole in his throat and put him on a breathing machine. Then his nervous system went haywire". The patient's past medical history was not reported. Three months prior to vaccination, the patient "could bench-press 275 pounds". The patient's outcome was reported as not recovered, "it will be many months before he can return to work", (also reported as recovering). Documents held by sender: None.
Rash-2-3mm pink, blanching macular rash distributed over trunk and head. Pink irregular raised blanching patches of variable size on left upper shoulder, left trunk and left waist. Nonpruritic.
Patient's Arm beneath the injection site was red, sore, tender to touch, painful but could still be moved. Pain and redness lasted for 3-4 days post vaccination.  Pain started the same day, several hours post vaccination.  Pictures were documented and sent to MD office.  Treated pain with celecoxib x 2.  Patient reported a  little itchy on day 6 and still a little red.
I received my 2nd Pfizer vaccine on 1/15/21 at my workplace. I had no immediate symptoms in the first 15 minutes. Unfortunately had the fever, aches, etc over the weekend. on 1/24/21 I developed nearly full body hives that started at my Left elbow and spread to my abdomen, hips, and knees. This continued to develop through the week, spreading onto my arms, thighs, calves, and even ended up with hives on bilateral plantar feet. I started taking daily cetirizine in the morning and diphenhydramine at night, used hydrocortisone as well. The hives didn't exactly itch, but were sore and irritated. I did a virtual visit with my provider for any insight or recommendations, and she just told me to continue with what I was already doing. They finally resolved on 1/29/21 At first I thought it was an extreme hypersensitivity reaction to one of my allergens since I had recently gotten my 2nd COVID vaccine, but now that I'm hearing about "COVID arm" I'm wondering if it was more related to that instead.
Temp 102.4. not resolving with Motrin/Tylenol. No other s/s or known source of fever
PATIENT FAINTED. EMS CALLED. PATIENT ASSESSED UNTIL EMS ARRIVAL. PATIENT VITAL SIGNS TAKEN AND ARE AS FOLLOWS; PATIENT ALERT AND ORIENTED, PULSE 82, BLOOD PRESSURE 98/62, RESPIRATION 18, SP02 97%.  PATIENT LEFT UNDER CARE OF EMS.
Presented to ED c/o worsening SOB; admitted w/ COVID-19 pna; tx w/abx, remdesivir, steroids, zinc, O2; weaned to RA for dc
AFTER VACCINES WERE ADMINSTERED PATIENT LEFT, 15 MINUTES AFTER THEY HAD LEFT PATIENT WAS BROUGHT BACK INTO THE OFFICE. SWELLING AND REDNESS OF HIS FACE WAS PRESENT. PATIENT DID BECOME LIMP, PATIENT DID NOT LOSE CONSCIOUSNESS IN THE OFFICE AND WAS SENT TO EMERGENCY DEPARTMENT FOR FURTHER EVALUATION.
Vaccinations given at a school, school nurse completed paperwork and obtained parental consent prior to our arrival. Did not see until after vaccine was administered that the child was 12 years old and should have received the regular Pfizer instead of the pediatric dosing. We advised the parents to bring the child to health department to receive the second dose in the series because we have both kinds available, but they went through the school setting to receive the pediatric dose for both vaccinations.
First Covid vaccine on Jan 27.  I don't know the brand, Fatigue, SOB, Leg swelling, Tingling,  Hospitalized on 2/16 with bilateral LE and UE weakness MDs accessing for GBS?
decreased sense of smell; This is a Spontaneous report based on the information received by Pfizer from company (Manufacturer Control No: 2021-0405000266) via a contactable consumer (Patient).  A female patient of an unspecified age received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, formulation: Solution for injection, Lot number and expiry date was not reported), via an unspecified route of administration on 10Mar2021 as dose 1, single for COVID-19 immunization. Medical history included nasal polyps due to which she suffered decreased sense of smell or taste and increased pain/pressure in the face or ears over last month. Concomitant medications were not reported. The patient stated sense of smell returned for 1 month but then disappeared on 13Mar2021 (3 days after taking the Pfizer Covid Vaccine shot). Outcome of event was unknown.  No follow-up attempts are possible; information about lot/batch number cannot been obtained.
Day after vaccine administered mom notified leg red and swollen, no fever. Treatment - Supportive care ----> war, compresses, Tylenol PRN.
residents under the age of 65 receive Fluzone High Dose in error with no adverse event; Initial information received on 26-Oct-2022 regarding an unsolicited valid  non-serious case received from a other health professional.  This case involves an adult patients of unknown demographics who were a residents under the age of 65 receive fluzone high dose(INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE) in error with no adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On an unknown date, the patient received an unknown dose of suspect INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE (formulation, strength, route: unknown) lot number not reported in unknown administration site as Immunization.  On an unknown date the residents under the age of 65 receive fluzone high dose in error with no adverse event (product administered to patient of inappropriate age) same day following the administration of INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE. There were 3 residents.  Action taken was not applicable.  It was not reported if the patient received a corrective treatment for the event (residents under the age of 65 receive Fluzone High Dose in error with no adverse event).  At time of reporting, the outcome was Unknown for the event     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 guidelines. 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.