chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Patient received primary SPV on 3/26/2019 alone. He is a medical technician. He had normal body aches and site progression and about 4/5/2019 noted onset of small papules to both hands, elbows, forearms that progressed to pictures sent (pictures taken day 4). Patient advised pictures of his hands were taken with elbows yesterday (will track them down). Patient advised he had some axillary nodal swelling, and skin itched to point of being painful, so he took OTC Zyrtec and Benadryl at night. He denied any chest pain, sob, fever or other systemic symptoms. He denied any rash elsewhere on body and no history of any eczema, atopic derm, etc or any immunosuppressive disorders. He was on no routine medications using Zyrtec for allergic rhinitis (uses meds more for spring pollen/grass). He advised hx of hives/rashes and allergic rhinitis when contacting grasses, pollen as a child that he was given allergy shots for but doesn't recall specifics and has not required shots for years. He advised only new contact was with a new detergent for cloths, otherwise nothing else new. He is driving home and will send me updated pictures of hands (both sides), elbows, and SPV site (describes as umbilicated lesion with new scab forming in center). He states hands/forearms are much better after 3 doses of steroids, is using Zyrtec/Benadryl at night, and MD prescribed lidocaine 5% topical patch and 2.5% cream, clobetasol prop 0.05% topical cream and prednisone 20 mg (3 tab x 7 days) and then f/u on Monday before stopping steroids). He is keeping all sites covered with dressings
Patient was fine prior to vaccine. After administration of vaccine patient was seated for 3-4 minutes before experiencing heavy sweating and feeling faint/light headed. The male patient was given water to drink and had his neck cooled down with a wet towel. The patient's blood pressure was 120/76 with a heart rate of 82. After a few minutes, the patient improved and remained seated for a total of 30 minutes. Patient stated he had experienced the sweating and light headedness for his 1st Pfizer COVID vaccine as well. However both times the side effects went away after 30 minutes without the use of medications. Patient stated he had COVID twice with the most recent infection 3 months ago.
6 month old with history of seizure 12/17/02, about 13 hours after receiving PPV
blood pressue 240; hand and foot wouldn't move; weakness; very sick nauseous; mass of diarrhea; bad headache; very dizzy; very cold; This spontaneous case was reported by a consumer and describes the occurrence of DIARRHOEA (mass of diarrhea) in an 83-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 029L20A) for COVID-19 vaccination.     Concomitant products included ERGOCALCIFEROL, RETINOL PALMITATE (VITAMINS A & D), ACETYLSALICYLIC ACID (BABY ASPIRIN), LORAZEPAM, PROBIOTICS NOS, OMEPRAZOLE, METOPROLOL TARTRATE (LOPRESSOR) and ATORVASTATIN CALCIUM (LIPITOR) for an unknown indication.    On 19-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 20-Feb-2021, the patient experienced DIARRHOEA (mass of diarrhea). At the time of the report, DIARRHOEA (mass of diarrhea) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment medications were unknown.; Sender's Comments: Based on current available information and the temporal association between product use and the start date of the events a causal relationship cannot be excluded.
Pt recv vax on 11/9/98; on same day pt exp twitching w/ hand & eye deviation to the left x 2 min, screaming, crying & sleepiness; dx=partial complex seizure
(R) deltoid swelling, tenderness, multiple spreading areas of erythema, LOM to RUE. Recovering with ABX and steroid.
Information has been received from a physician referring to multiple unspecified patients of unknown age and gender. The patients' pertinent medical history, drug reactions/allergies and concomitant medication were not provided. On unknown dates, the patients were vaccinated with M-M-R II (lot #, expiration date and dose were unknown) via intramuscular injection which was outside of the prescribing information of administering via a subcutaneous injection. No adverse effects were reported. No product quality complaint (PQC) was involved. This is one of several reports received from the same reporter. Additional information has been requested.
Breakthrough chicken pox.  20 pustules/macules on abdomen.  Itchy.
My menstrual cycle this time is 58 days. At the same time, there was a lot of menstrual blood today, and four-quarter-sized blood clots continued to flow out.
patient's guardian provided the wrong date of birth, and imz was given to 11 year old pt. Pfizer only approved 12 and up.
Information has been received from a physician concerning an infant who was vaccinated PO with a 2.0 ml dose of rotavirus vaccine. The physician reported that the infant subsequently developed diarrhea. The physician noted that the baby's mother thought she saw blood in the diarrhea, but the pt was not seen in the office. At the time of this report, the outcome was unk. Upon internal review, blood in diarrhea was determined to be an other important medical event (OMIC). Additional information has been requested.
headache; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team.  A 23 year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE) (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: HEADACHE (non-serious), outcome "unknown", described as "headache".  No follow-up attempts are possible; information about lot/batch cannot be obtained. No further information is expected.
Information has been received from a lawyer regarding a case in litigation concerning a male patient of unknown age. No information was received regarding the patient's past medical history, concurrent conditions, or concomitant medication. The patient's healthcare provider recommended and/or prescribed the ZOSTAVAX to the patient for its intended purpose of permanent prevention and protection against shingles and zoster-related conditions. On or about 03-SEP-2009, a healthcare provider at a pharmacy administered the ZOSTAVAX to the patient (lot number, dosage and route of administration not provided). On or about 07-AUG-2015, the patient was treated by a healthcare provider for shingles. The patient was diagnosed with shingles and/or other zoster-related injuries after and despite being inoculated with the ZOSTAVAX vaccine, and suffered serious physical, emotional, and economic damages as a result of the patient's injuries. As a direct and proximate result of the ZOSTAVAX vaccine, the patient has and will continue to suffer ongoing injuries, including but not limited to: mental and physical pain and suffering; extensive medical care and treatment for these injuries; significant medical and related expenses as a result of these injuries, including but not limited to medical losses and costs including care for hospitalization (dates unknown), physician care, monitoring, treatment, medications, and supplies; diminished capacity for the enjoyment of life; a diminished quality of life; increased risk of premature death, aggravation of preexisting conditions and activation of latent conditions (unspecified); lost wages; loss of earnings capacity; and other losses and damages. The outcome of the events is considered to be not recovered. Additional information has been requested.
This is my 3rd time trying to complete the form.   Quick version.  8 hours later I'm experiencing soreness and discomfort in the my left arm.  Pain occured when shot was administered.  I felt needle moving in mass/muscle.  The pain increased the longer the needle was inserted.  I actually let out a muffled yell at the same time the nurse removed needle.   The pain is a 6/7 on a scale of 10.   I cannot lift my arm without experiencing pain.  When I walk my left side/shoulder is lowered.  The left side feels weighted.
Urticaria, wheezy, & periorbital edema which abated /p administration of subcut. epinephrine, Bendryl IV, Solumendrol IV
This spontaneous report was received from a Registered Nurse, concerning 19 year old patient, gender unspecified. In 2008, the patient was vaccinated with the first dose of VAQTA 25/0.5 (route and lot number not reported). On 18-JUN-2013, (also reported as 20-JUN-2013) the patient was vaccinated with the second dose of VAQTA 25/0.5 (route and lot number not reported). No other co-suspect therapy was reported. Concomitant medications were not provided. The reporting nurse was informed by unspecified staff member at unspecified, alternate office site, that the patient received a pediatric dose of VAQTA. The nurse reported that a patient had received a pediatric dose of VAQTA that was administered two days ago in error (as the second dose of VAQTA).  Additional information has been requested.
Patient called pharmacy around 11am stating she had a bump, redness, swelling. She came to the pharmacy around 415PM and it was warm to the touch so we called the doctor and doctor wanted her to be seen.
pt recv vax 2JUL98 & on 6JUL98 devel n/v, fever, myalgia lasted 1 1/2-2 days;
pain at injection site, red, swollen, itchy.  Little less each day, but still itchy today, 10/4/21.  Called Kaiser advice nurse today.  Since itch seems to be less each day I should eventually be okay.
On 01/01/2021 I began to feel excessive itching, redness and swelling in the vaccination area. It appears to be cellulite. Also I present mild daily headache from that day.
Do I have gulf war syndrome?  I've had body aches, severe digestive problems, new onset anemia 4-5 months following vaccines once home from deployment (not overseas) and depression since vaccinated in 1991. This 40 year old reported receiving several vaccines in 1991 as part of pre-deplolyment preparations. He was not deployed overseas.  He reported receiving gamma globulin, PPD, HepA, Hepatitis B series, TD and a few others. Within the next few hours he stated he began to "feel on fire", tingled all over, his tongue became heavy and fat, sweating, slurred speech due to tongue denying shortness of breath, problems swallowing, chest pain, fevers, or rashes.  His wife transported him to the hospital where he was given IV Benadryl with resolution of symptoms. He was discharged on oral Benadryl for 2 days. He stated the feelings of being on fire lasted 2 days with no other symptoms. Over the next few months he began to notice digestive problems to include crampy diarrhea (brown watery stool) 20 minutes after eating which he attributed to stress due to finals and thoughts of leaving military. He denied any prior history of bowel or gastrointestinal difficulties. Triggers included eatting red meat (continues as of 8/06) and "heavy solid meals" (eating a large meal) ... causing severe cramps with resulting diarrhea. He also complained of bilateral knee and elbow stiffness upon arising daily since 1992 that persists today (8/06). He described this pain as a dull achey sensation that eases with movement throughout the day. Advil reliefs the pain. He also complains of increased fatigue, exhaustion, being worn out and "unable to function after 2 pm" due to this fatigue for the last 3-4 years. This has become worse in the last few months to where he is "falling asleep driving home and can not go out at night due to chronic fatigue". He advised his PCP in 2006 who was concerned about depression recommending follow up at the VA hospital "before he does a work up as it may be military related."
Two minutes after I gave patient her vaccine, she fainted. Her mother and brother caught and sat her in the chair. Patient became alert as she sat in the chair. Then patient became pale in the face and hot, so her brother bought her some water to drink and place bottle on her head to keep cool. Patient then began to have blurry vision and upset stomach. I called the ambulance. After the ambulance checked on her, mother said that patient was okay and she was taking her to the doctor.
Patient presented on 3/6/19 with a knot on her upper arm. Patient stated that the knot formed after her flu shot in August and is painful, raised and tender to the touch. Pharmacist felt the arm and verified the presence of a knot approximately the size of a quarter on her deltoid.
Patient received both doses of Pfizer vaccine (1/15/21 & 2/5/21) and on 4/9/21 received a positive Covid result through Covid-19 testing. Patient is currently asymptomatic.
I WOKE UP AT 9:30 PM WITH CHILLS, FOLLOWED BY SHIVERING, FOLLOWED WITHIN MINUTES OF EXTREME SHIVERING AS IF I HAD HYPOTHERMIA. I HAD TO CONCENTRATE ON KEEPING MY BREATHING SLOW TO TRY TO CALM MY BODY. I HAD ON FLANNEL PAJAMAS, A ROBE, SOCKS, A KNITTED SKI HAT, A POLYESTER BLANKET, A DOWN BLANKET AS I LAY IN BED TRYING TO STOP SHAKING AND SHIVERING. IT LASTED 3 HOURS. I CAN ONLY DESCRIBE IT AS IF MY BODY WAS GOING TROUGH HYPOTHERMIA. I HAVE NEVER EXPERIENCED THIS PRIOR IN MY LIFE. MY WHOLE BODY WAS FREEZING AND SHAKING.  IT TOOK PLACE 11 HOURS AFTER MY VACCINE. THE SORE ARM I HAD WAS THE SAME AS I HAD EXPERIENCED AFTER DOSE 1 AND DOSE 2.  I HAD BODY ACHES THE NEXT MORNING, HOWEVER, IT WAS MORE LIKELY DUE TO THE SHAKING AS MOST OF MY ACHE WAS IN MY BACK.
Information has been received from a nurse concerning a female who in February 2007, was vaccinated IM with 0.5 ml Gardasil. In approximately February 2007, the patient developed a flesh-colored, dry, flakey, itchy rash on her face a couple days after administration of Gardasil. The rash resolved in about 5 days. Additional information has been requested.
Full body rash within 4 days after vaccine. Red bumpy Rash is from shoulders to ankles and very itchy. There are some areas that have a white spot on the tip of the bump. No respiratory issues. He is in ER right now getting checked out 11/2/23 @ 230pm
Pt was given a second flu vaccine in a 2 1/2 month period by mistake.
Flumist expired 12/26/2022 and was administered 12/28/2022. No symptoms reported at this time.
Dose left out at room temperature for more than 24 hours; This spontaneous case was reported by a pharmacist and describes the occurrence of PRODUCT STORAGE ERROR (Dose left out at room temperature for more than 24 hours) in a 75-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 18-Oct-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 18-Oct-2021, the patient experienced PRODUCT STORAGE ERROR (Dose left out at room temperature for more than 24 hours). On 18-Oct-2021, PRODUCT STORAGE ERROR (Dose left out at room temperature for more than 24 hours) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   The pharmacist had a vial of Moderna COVID19 Vaccine that was open on 17-Oct-2021 around noon.They administered 2 doses of that vial on 18-Oct-2021 around 11:30 EST. No concomitant medications were reported. No treatment medications were reported.  .
Flu syndrome; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP).  A patient (no qualifiers provided) received bnt162b2 (BNT162B2), administration date May2021 (Batch/Lot number: unknown) as dose number unknown, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: INFLUENZA (non-serious) with onset 14May2021, outcome "recovered" (May2021), described as "Flu syndrome".  Additional information: Adverse event: Flu syndrome following Covid vaccination recovered spontaneously reported to family member. The effect has occurred after the use of product.  No follow-up attempts are possible. No further information is expected.
Swelling of throat. Cramp/numb/loss use of left arm - June 2012. Debilitating pain incapacitation - left shoulder arm. Presently 15 1/2 mos. 10-12 ER visits.
Pt. stated she felt nauseous 15 minutes after getting vaccinated.   Pt also stated she is terrified of needles.  Vitals taken.  HR 95, O2 sat 99%, BP 153/74, R 20.  At 2:47 pt. stated she is feeling better and wants to go home.
Patient stated that she just received her last Covid vaccine. Patient stated that she is tired and sleepy today; Patient stated that she just received her last Covid vaccine. Patient stated that she is tired and sleepy today; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program (086396). The reporter is the patient.  A 71 year-old female patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 2, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose 1, Single, Lot number- UNKNOWN), for COVID-19 immunisation. The following information was reported: FATIGUE (non-serious), SOMNOLENCE (non-serious) all with onset 12Mar2021, outcome "unknown" and all described as "Patient stated that she just received her last Covid vaccine. Patient stated that she is tired and sleepy today". Additional information: Patient reported for herself. Patient stated that she just received her last Covid vaccine. Patient stated that she is tired and sleepy today.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
A nurse reported that a male inadvertently received a 1.5 ml injection of Cholera Vaccine. Subsequently the pt experienced dizziness. The reporter declined to provide further information and declined to grant permission for a follow up investigation.
This employee reports that she experienced soreness and redness at injection site beginning approx 5-6 hours after dose; followed by total body aches and generalized muscular pain that lasted approx 72 hours after dose. Symptoms relieved with MOTRIN 400mg p.o.
This spontaneous report was received from a physician via Pfizer (2015074370) regarding a female patient of unknown age. There was no information on medical history and concurrent conditions. The physician reported that on an unknown date, the patient was vaccinated with PNEUMOVAX 23 (product details not reported). There was no information on concomitant medications. Approximately on an unknown date in 2008 (reported as 7 years ago), she had severe reaction following the vaccination with joint pains, rash and severe fatigue. The physician also enquired if a reaction to PNEUMOVAX23 was a contradiction to getting vaccinated with PREVNAR 13. The outcome of the events was unknown. The causality was also unknown. Additional information has been requested.
On 12/30, patient had subjective fevers, body aches, joint pain (bilateral elbows and knees) and posterior cervical headache as well as fatigue that lasted until 1/8/20.
hives over entire body started on elbows , knees , neck, face scalp , elevated heart rate.
This spontaneous report as received from a currently 39 year old female respiratory therapist refers to herself. Concurrent conditions included shellfish and iodine allergy. There was no pertinent medical history. In 2001 or 2002, the patient was vaccinated with MMRII (lot #, dose and route not provided). There were no concomitant medications. In the year 2001 or 2002, the patient developed a mild anaphylactic reaction following administration of MMRII. The respiratory therapist developed difficulty breathing, swelling of the tongue and swelling of the throat following vaccination with MMRII (time frame unspecified). On an unspecified date, the patient was treated with BENADRYL. No laboratory tests were performed. The consumer reported that in 2001 or 2002, within a couple of hours she was recovered. The consumer reported that when she was a child, she had received MMRII (unspecified how many doses and dates). Additional information is not expected.
vomiting; arm is sore; Stomach issue; motion sickness; temp was 99/temperature went up to 100/checked her temperature again and it is 99.1; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (arm is sore), ABDOMINAL DISCOMFORT (Stomach issue), MOTION SICKNESS (motion sickness), PYREXIA (temp was 99/temperature went up to 100/checked her temperature again and it is 99.1) and VOMITING (vomiting) in a 29-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012M208) for COVID-19 vaccination.     No Medical History information was reported.    On 09-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 10-Mar-2021, the patient experienced PAIN IN EXTREMITY (arm is sore), ABDOMINAL DISCOMFORT (Stomach issue), MOTION SICKNESS (motion sickness) and PYREXIA (temp was 99/temperature went up to 100/checked her temperature again and it is 99.1). On an unknown date, the patient experienced VOMITING (vomiting). The patient was treated with PARACETAMOL (TYLENOL) for Fever, at an unspecified dose and frequency. At the time of the report, PAIN IN EXTREMITY (arm is sore), ABDOMINAL DISCOMFORT (Stomach issue), MOTION SICKNESS (motion sickness), PYREXIA (temp was 99/temperature went up to 100/checked her temperature again and it is 99.1) and VOMITING (vomiting) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 10-Mar-2021, Body temperature: 99 (High) 99, 100 (High) 100 and 99.1 (High) 99.1.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medication was reported.  Treatment for the events included acetaminophen (Tylenol), ginger and motion sickness medicine unspecified.   Reporter did not allow further contact
left deltoid swelling and erythema status post vaccine injection evaluated in ER 8/20/2019
Tested positive for COVID; Tested positive for COVID; Dose number: 3; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from product quality group.  A 41 year-old male patient received bnt162b2 (BNT162B2), intramuscular, administered in arm left, administration date 22Nov2021 (Lot number: FH8027) at the age of 41 years as dose 3 (booster), single, intramuscular, administered in arm left, administration date 11Apr2021 (Lot number: EP6955) as dose 2, single and intramuscular, administered in arm left, administration date 20Mar2021 (Lot number: EP6955) as dose 1, single for covid-19 immunisation. The patient had no relevant medical history. The patient had no known allergies. There were no concomitant medications. The patient did not receive any other medications in two weeks. The following information was reported: IMMUNISATION (medically significant) with onset 22Nov2021, outcome "unknown", described as "Dose number: 3"; VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 19Jan2022, outcome "recovering" and all described as "Tested positive for COVID". The patient underwent the following laboratory tests and procedures: sars-cov-2 test: (19Jan2022) positive, notes: Nasal Swab. Therapeutic measures were not taken as a result of vaccination failure, covid-19. The facility where the most recent COVID-19 vaccine was administered was Pharmacy or Drug Store. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had been tested for COVID-19. The case was assessed as non-serious.
Localized swelling, erythematous treated with Benadryl and follow-up tomorrow to rule out cellulitis. Complete involvement of deltoid.