chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Nasal Swab Positive; Nasal Swab Positive; itchy Body rash; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 78-year-old female patient (not pregnant) received bnt162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 21Sep2023 at 15:00 as dose 1, single (Batch/Lot number: unknown) at the age of 78 years, in right arm for covid-19 immunisation. The patient's relevant medical history included: "Breast cancer" (unspecified if ongoing); "AFib" (unspecified if ongoing); "Known allergies: Sulfa" (unspecified if ongoing); "Known allergies: Penicillin" (unspecified if ongoing). No covid prior vaccination. Concomitant medication(s) included: FLU [INFLUENZA VACCINE] taken for immunisation, in Sep2023 as dose number unknown, single, at Right arm; RSV VACCINE taken for immunisation, in Sep2023 as dose number unknown, single, at Right arm; ELIQUIS; METOPROLOL; WELLBUTRIN XL; COLLAGEN. The following information was reported: RASH (non-serious) with onset 22Sep2023 at 03:00, outcome "recovering", described as "itchy Body rash"; DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 28Sep2023, outcome "unknown" and all described as "Nasal Swab Positive". The event "itchy body rash" required physician office visit. The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (28Sep2023) Positive. Therapeutic measures were not taken as a result of rash. Clinical courses: Next day appearance of very itchy Body rash starting back of knees, spreading to thighs. Gradually over the week rash spread to buttocks then elbows.  The information on the batch/lot number for bnt162b2 omi xbb.1.5 has been requested and will be submitted if and when received.
Initially couldn't taste or smell, with flu-like symptoms. I have not regained my sense of smell except for garlic. Taste has come back somewhat. Bad brain fog, couldn't keep up with my job. Still going on, but a little better. Hard to remember things. Went on disability, mental effects continue, diagnosed as long Covid.
Don't know if related to shot or not.  Friday night 11:50 pm woke up from sleep with upset stomach.  Took two rolaids and set on toliet in case I needed to throw up or had dirarerra.  Nothing happened so 30 minutes later took acid reducer pill and went back to bed.  Saturday morning pooped and it was black.  Extremely tired all day and about 11:00pm again got an upset stomach.  Threw up dark red liquid and had dirarerra and it was black.  Sunday again extremely tired and drank lots of water and avoided alcohol drinks.  (Had drank some beer on Friday and Saturday.)  Poop still black but no upset stomach.  Monday felt much better and poop became more brown.  By Tuesday I felt back to normal.
flu like side effects; Achy; Tired; nauseated; This spontaneous case was reported by a consumer and describes the occurrence of INFLUENZA LIKE ILLNESS (flu like side effects), MYALGIA (Achy), FATIGUE (Tired) and NAUSEA (nauseated) in a 76-year-old female patient 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 second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced INFLUENZA LIKE ILLNESS (flu like side effects), MYALGIA (Achy), FATIGUE (Tired) and NAUSEA (nauseated). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. At the time of the report, INFLUENZA LIKE ILLNESS (flu like side effects), MYALGIA (Achy), FATIGUE (Tired) and NAUSEA (nauseated) had resolved.            She mentioned the first one didn't bother her at all.  Concomitant product use was not provided by the reporter.  Action taken with mRNA-1273 in response to the events was not Applicable.
This spontaneous report as received from a healthcare professional refers to an unspecified number of patients. On an unknown dates, the patients received improperly stored doses of PNEUMOVAX 23 (batch/lot #, dose, route and site of administration were not reported). No adverse experiences were reported. This is one of several reports from the same reporter. Additional information has been requested.
On Oct. 12, clubs received an internal Urgent Removal Notice regarding Pfizer COVID-19 Vaccine- Pediatric 5-11 Years Tris-sucrose, Lot #FL2757 with manufacturer?s expiration date of Sept. 30.  Information has been received from the manufacturer indicating that stability data supports the use of this product through Oct. 19.
Patient contacted the Health Dpt. to notify of a burning sensation under her nose and above her lip. Patient describes itching/irritation in that area along with patches of redness. Patient describes area is swollen and red but denies respiratory distress at the time of reporting. No other areas of body affected. Adverse event, according to patient, started about 2 hours after receiving season Influenza vaccine listed above.  Patient also stated she received a PPD skin test about 20 minutes after influenza vaccine was administered. Spoke to patient over the phone who stated she is unsure if she will seek medical attention at this time.
Systemic: Fainting / Unresponsive-Medium, Systemic: Seizure-Medium, Additional Details: THE PATIENT FELL FROM A CHAIR IN THE POST-VACCINATION AREA AND WAS FACE-DOWN, NOT RESPONSIVE. THE PATIENT WAS TURNED ON HIS BACK WHEN HE BEGAN TO SEIZE, SO HE WAS PLACED  ON HIS SIDE. HE RECOVERED AND OPENED HIS EYES SHORTLY THEREAFTER. HIS BP WAS 120/59 MMHG, AND HE WAS PROVIDED CRACKERS AND WATER. THIS PATIENT DENIED ANY EPISODES LIKE THIS IN THE PAST BUT ALSO DENIED HAVING BREAKFAST THIS MORNING. THE PHARMACIST RECOMMEND FOLLOWING UP WITH HIS PCP, AND A RELATIVE PICKED HIM UP FROM THE CLINIC.
Administered patients the Moderna Covid 19 Bivalent 0.25mL, instead of 0.5mL; No adverse event; This spontaneous case was reported by an other health care professional and describes the occurrence of ACCIDENTAL UNDERDOSE (Administered patients the Moderna Covid 19 Bivalent 0.25mL, instead of 0.5mL) and NO ADVERSE EVENT (No adverse event) in an adult patient of an unknown gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) .25 milliliter. On an unknown date, the patient experienced ACCIDENTAL UNDERDOSE (Administered patients the Moderna Covid 19 Bivalent 0.25mL, instead of 0.5mL) and NO ADVERSE EVENT (No adverse event). At the time of the report, ACCIDENTAL UNDERDOSE (Administered patients the Moderna Covid 19 Bivalent 0.25mL, instead of 0.5mL) 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 ACCIDENTAL UNDERDOSE (Administered patients the Moderna Covid 19 Bivalent 0.25mL, instead of 0.5mL).    No concomitant medication information provided.   No treatment information provided.
Generalized muscle weakness (head lag, inability to sit, walk, hold spoon). MRI Spine - and enhancement, slight enhancement of nerve roots and cauda equina. CSF studies - pleocytosis - increased protein. No organism on CSF stain. CSF Cx - Neg. EMG - (+) subacute demyelinating polyneuropathy. Tx with IVIG x 4 days. Transfer planned to rehab for Physical therapy.
Information has been received from a lawyer regarding a case in litigation concerning a male patient (age unknown). The patient's medical history, concurrent conditions and concomitant medication use were not provided. On 13-OCT-2016, the patient went to a pharmacy to receive the influenza virus vaccine (unspecified) (FLU VACCINE). The pharmacy employee recommended that the patient also get the PNEUMOVAX and ZOSTAVAX vaccines. All three vaccines were administered to the patient that day. The patient was not informed of the possible side effects of drug interaction when receiving three vaccinations at the same time. Later that day the patient became violently ill. He developed a painful rash, headache, nausea, loss of vision, dizziness and fever. In response to these complaints the patient presented to his primary care physician, who diagnosed him with shingles, and postherpetic neuralgia.  The outcome of the events was not provided. Upon internal review loss of vision was considered a medically significant event. Additional information has been requested.
I began to have swollen lymph nodes which caused a sore throat.  It gets better, but then returns at times.  Seems to get better when I brush my teeth 2 times a day.  Sometimes I take Turmeric to decrease inflammation.
Imms rec'd 11-13-07. Noted reaction 11-14/15-07 (Arthus). Treated with ice, antihistamine and pt f/u on 11-17-07.
Rec'd  2nd vaccine on Jan 28, 2021 at 2 pm; Woke up Jan 29- feeling OK by 9 AM chills, rising fever, eventually fever T 101.5 by 11 AM, generalized myalgias and extreme fatigue lasted next 24 hours Also, Redness, mild swelling and tenderness at injection site that lasted till Feb 2. Was tested on Jan 30 for SARS CoV2 by PCR which was NEGATIVE
This spontaneous report was received from an approximately 65 year old non pregnant female patient with no drug reactions or allergies and no medical history. The patient's concurrent conditions included asthma and degenerative arthritis. In December 2013 (exact date not provided), the patient was vaccinated with a dose (reported as 1 shot) of ZOSTAVAX, (dose, lot number, expiration date, route of administration and injection site were not reported). No concomitant medications were reported. In January 2014 (exact date not provided), the patient experienced "an itch in the lower rib area with no rash or eruption of the skin". The patient sought medical attention via visiting an unspecified dermatologist on an unspecified date in January 2014. Lab diagnostic studies included "complete blood work". No results were provided. No treatment for the event was given. The outcome of "an itch in the lower limb area with no rash or eruption of the skin" was reported as not recovered. The relatedness between the event and ZOSTAVAX was not reported. Additional information has been requested.
Hives on my inner left wrist; The area is still tender 12 hours after; This is a spontaneous report from a non-contactable consumer, the patient. A 21-year-old non-pregnant female patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EN6204), via an unspecified route of administration in the left arm on 18Mar2021 at 11:15 (at the age of 21-years-old), as a single dose for COVID-19 immunisation. Medical history included seasonal allergies and allergy to cats. Concomitant medications were not reported. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On 19Mar2021 at 20:00, around 33 hours after vaccination, the patient developed hives on inner left wrist, dimensions were approximately 10 cm x 5 cm but the area was still tender 12 hours after resolution. The patient did not receive treatment for the reported events. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The clinical outcome of the hives was recovered on an unknown date in Mar2021 and of the tenderness was not recovered at the time of the report.   No follow-up attempts are possible. No further information is expected.
pt recv vax 13JUN95 & pt was exposed to a sibling w/varicella;*JAN97 pt devel varicella which consisted of greater than 30 lesions, a low grade fever for 2 days & pruritus;
naseaa, headaCHE, VOMITiNG, HEart paLPATIATIONS, BLURRY VISION, TIA
Over course of 11 days worsening LE weakness and ataxia, low grade fever with chills and diarrhea, loss of sensation and proprioception; progressed to inbility to walk, diagnosis of Guillain-Barre Syndrome; impaired coordination.  Hospitalized 10/20/07, Discharged to home March 14, 2008 from rehab.  Unable to walk, confined to wheelchair and walker.  Requires assistance with all ADLS.  5/01/2008 MR received for ER visit 10/18/2007 and admission DOS 10/20-11/08/2207 with D/C DX: Guillain-Barre syndrome. Pt initially presented to PCP with lower extremity weakness and a shuffling gait. Pt had developed diarrhea, fever and chills initially, then lower extremity weakness with gait disturbance as well as constipation and bladder dysfunction. Dx: with GBS and instructed to go to ER if sx progressed. Pt presented with inability to stand or walk 2' to weakness. (+) numbness in stocking-glove pattern.  Decreased strength in feet, legs, arms and hands. Admited for ascending paralysis. Tx with plasmapheresis with some improvement in neuro fxn noted. D/C to rehab. 1/21/2010 Still disabled, recoverd some function.
This is in follow-up to report(s) previously submitted on 5/14/2007. Information has been received from a health professional concerning a 16 year old sexually active female patient who is a smoker of tobacco and marijuana who on 29-NOV-2006 was vaccinated with a first dose of Gardasil. On 29-NOV-2006 the patient was treated with Bactrim DS for 10 days for a urinary tract infection. On 14-DEC-2006 the patient was being treated with Omnicef for days and a single dose of Flagyl for trichomoniasis and a possible urinary tract infection. On 22-JAN-2007 the patient received a second dose of Gardasil, IM into the right deltoid. On 22-JAN-2007 the patient was being treated with Macrodantin, 100 mg twice a day for 10 days for a urinary tract infection. On 05-FEB-2007 the patient was taking Bactrim and clotrimazole. On 09-FEB-2007 the patient was treated with Flagyl for 10 days and Rocephin injection for Zithromax 1 gm for pelvic inflammatory disease. On 09-MAR-2007 the patient was using a Xopenex inhaler and Advair and on 15-MAR-2007 she was taking Flagyl for 14 days. On 29-MAR-2007 she was taking Flagyl 500 mg and doxycycline for 10 days. On 14-APR-2007 serial beta HCG test was 24529 and on 16-APR-2007 it was 54860. (See lab section for additional labs) Her LMP was approximately 28-FEB-2007 (reported as "late February 2007"). It was reported that the baby was born full-term, healthy and normal and both "she" and the mother are fine. There were no complications. Additional information has been requested.
Felt like I was unable to breath when lying down. I couldn't form sentences or walk properly because I couldn't get enough air in. I had severe chest pain and headaches. I wasn't able to return to normal for three weeks.
This person stated that she felt light headed about 15 minutes post her vaccine. V/S checked, gave apple juice and rested a little longer. The person stated that she feels better and left at 1:18pm.
WE RECEIVED A PHONE CALL FROM MOM THAT PATIENT HAD A SEIZURE ON SATURDAY, 2/11/23 AND WAS TAKEN TO HOSP, 2ND SEIZURE A WEEK LATER - FOLLOWING WITH NEUROLOGY -NO CONSULT NOTES RECEIVED FROM NEUROLOGY - PATIENT STARTED ON KEPPRA. PATIENT HAS HX OF BRAIN CYST AND ENDOSCOPIC BRAIN SURGERY. MOTHER ATTRIBUTING SEIZURE TO VACCINE . NO SEIZURES PRIOR TO VACCINE.
(4-25-12) Mother day patient c/o achy hands & legs before went to school. At school 11 AM pt. c/o dizziness - headache - became pale - walls seem to be moving when she was dizzy. All resolved by end of day except HA. She had a low temp around 99.1 3:40 p.m. Protein given for symptoms. 4/26 AM all resolved with no other, problems.
WOKE UP NEXT MORNING WITH A BIT OF A HEADACHE ( 6AM), WENT TO WORK,,, STARTED TO FEEL BAD AS THE MORNING PROGRESSED. BY NOON . I HAD A FEVER OF 105, SEVERE HEADACHE, CHILLS, BODY ACHES AND BY 1 PM , WAS EXPERIENCING SOB, MY COWORKER TOOK ME THE THE FAMILY PRACTICE IN THE SAME BUILDING. SHE VERIFIED MY SYMPTOMS AND ORDERED  A  RAPID COVID TEST AND FLU TEST,,BOTH WERE NEG.  HAD TO BE DRIVEN HOME,,MISSED THE NEXT 3 DAYS OF WORK. BREATHING ISSUE EASED LATER ON FEB 3, BUT REST OF SYYMPTONS  NOT TIL THE WEEKEND.
Patient entered Health Center at approx. 9 am during non-clinic hours and reported to Office Assistant that he had itchiness and rash at flu injection area from immunization he received on 10/23/19. she asked if felt in medical distress, he denied any distress. OA provided with a called client later same day on 10/29/19 to provide follow up assessment. He denied pain, headache, fever, and had no other symptoms. Stated he continued to have rash on posterior and anterior of left arm. Reports he was seen by a provider at Health Center and prescribed acyclovi
2 inch diameter area of redness, mild edema, and significant pruritis around the injection site.  Onset 5-6 days post dose 2 injection.  Appearance consistent with pictures of reported "Covid Arm" found online.  No treatment thus far. Will try topical cortisone cream for symptom (pruritis) relief.
Approximately 3 wks after injection a red dot followed by a fluid filled vesicle appeared at site of injection. Parent advised to keep patient at home for 5-7 days or until vesicle dries and scabs over. Injection site location: upper (L) arm.
Shortness of breath; Heart palpitations; "Feeling dizzy or as if I was about to faint"; This is a spontaneous report from a contactable consumer, the patient. A 43-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0179) via an unspecified route of administration in the left arm on 17May2021 at 19:00 (at the age of 43-years-old) as a single dose for COVID-19 immunisation. Medical history included DVT (deep vein thrombosis) more than ten years ago and an allergy to "possibly shrimp". The patient reported that she had no current health issues. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medications included ibuprofen (MANUFACTURER UNKNOWN) and multivitamins. The patient did not receive any other vaccines within four weeks prior to the COVID-19 vaccination. On 20May2021 at 22:00, the patient experienced shortness of breath, heart palpitations and felt dizzy as if she was about to faint. Since the vaccination, the patient had not been tested for COVID-19. The events resulted in emergency room/department or urgent care. Therapeutic measures were not taken as a result of the events. The clinical outcome of the events shortness of breath, heart palpitations and felt dizzy as if she was about to faint were resolved on unspecified date in May2021.  No follow-up attempts are needed. No further information is expected.
On 11/21/2021 at approximately 12pm Patient came in for her Moderna booster. Shortly after staff gave her booster. A few minutes after her immunization she stated that she had shortness of breath. She stated that this happened with the J&J immunization and it stopped within 30 min I asked if she would like to lie down and if she wanted me to call her an ambulance. She said no.  I stated that I had an Epi pen if needed. She called me over a few moments later and stated she wanted the epi pen and the ambulance. I gave her the Epi pen, called emergency. at approx. 1208 Fire truck came at approx. 1211, ambulance cam shortly after.   She stated the epi pen helped with the tightness of her throat. The ambulance then took her to the ER.
Shivers, chills, nausea, joint aches, muscle aches, headache, sweating, muscle spasms, shaking - Lasting overnight. Exhaustion and some aching next day.
This case was reported by a nurse via sales rep and described the occurrence of wrong vaccine administered in a 26-month-old male patient who received FLUARIX (batch number 7TJ92, expiry date 30th June 2015). On 14th November 2014, the patient received the 2nd dose of FLUARIX (unknown) .5 ml. On an unknown date, an unknown time after receiving FLUARIX, the patient experienced wrong vaccine administered and inappropriate age at vaccine administration. On an unknown date, the outcome of the wrong vaccine administered and inappropriate age at vaccine administration were unknown. Additional information received on 14 November 2014: FLUARIX QIV mistakenly given to a 26 months child as 2nd flu shot instead of another flu vaccine approved for that age group. No adverse event was reported.
Lymph nodes swollen over neck and axil of the left side, pain and redness on the shot side .
This spontaneous report was received from a pharmacist via company representative refers to a female patient of unknown age. The patient's concurrent conditions and pertinent medical history were not reported. On 02-MAY-2016, the patient was vaccinated with ZOSTAVAX, 1 shot, subcutaneously. Concomitant therapies included warfarin. On 04-MAY-2016, the patient experienced swelling, pain and redness at the injection site. She contacted her pharmacist, who advised her to take BENADRYL to alleviate the symptoms. The reaction subsequently healed. The reporter did not provide the relatedness of the events with ZOSTAVAX. Additional information has been requested.
Patient received his first COVID-19 vaccine on 2/12/2021 at approximately 11:30am at clinic. He is a resident there. He was initially monitored for 30 minutes without incident. Approximately an hour later (12:30pm) he returned complaining of sweating, feeling warm (no fever, normal blood pressure) and blurry vision. He was monitored for an additional 30mins (approximately 1pm). Symptoms did not resolve. The facilities manager called EMS and patient was taken to Hospital. No further information available at this time.
Pt administered PNEUMOVAX  on 5/14/13; erythema and edema at injection site; warm to touch. Tx- KEFLEX, warm compress BENADRYL.
arm was itching; arm was red; arm was ugly; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PRURITUS (arm was itching), VACCINATION SITE ERYTHEMA (arm was red) and VACCINATION SITE REACTION (arm was ugly) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No medical history reported).    On 10-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 18-Feb-2021, the patient experienced VACCINATION SITE PRURITUS (arm was itching), VACCINATION SITE ERYTHEMA (arm was red) and VACCINATION SITE REACTION (arm was ugly). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) for Adverse event, at a dose of UNK dosage form. At the time of the report, VACCINATION SITE PRURITUS (arm was itching), VACCINATION SITE ERYTHEMA (arm was red) and VACCINATION SITE REACTION (arm was ugly) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications reported. Other treatment details included applying ice.    This case was linked to MOD-2021-018425 (Patient Link).   Reporter did not allow further contact
approx 40 hrs p/vax pt felt pain in neck ie pulled muscle & fainted from pain & mom noticed twitching of rt hand for few seconds;
Pt had 3 hrs of inconsolable crying following vax given 24FEB92;
Badly swollen red arm - 4 days - iced it for 2 days Pain in chest that would come and go for 3 days Rattling sound in chest for 3 days Ached all over body - 2 days Persistent cough for 3 months
Patient has redness and swelling to injection site. The area is 4.5 cm x 6 cm on the left deltoid.