chrisvoncsefalvay/vaers-outcomes huggingface dataset:
information has been received from a physician concerning a female who was vaccinated with a first dose of VARIVAX (Oka/Merck) prior to pregnancy. The patient did not receive the second dose. The patient is 4 months pregnant and has tested for a negative titer as 0.91. The patient had no symptoms. No further information was available. There was no product quality complaint. The is one report of several from the same source. In follow up the warned mother, reporting physician stated "Patient was pregnant and warned about unborn baby." The patient did not want to report, neither did the patient;s physician (reporting physician was covering person). reporting physician left the group and has no further contact with patient. No further information is available.
Upper respiratory tract infection; tested positive for COVID; This spontaneous case was reported by a consumer and describes the occurrence of UPPER RESPIRATORY TRACT INFECTION (Upper respiratory tract infection) and COVID-19 (tested positive for COVID) in a 79-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030L20A) for COVID-19 vaccination.     Concurrent medical conditions included Drug allergy (Sulfa).    On 29-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 15-Feb-2021, the patient experienced UPPER RESPIRATORY TRACT INFECTION (Upper respiratory tract infection) and COVID-19 (tested positive for COVID). At the time of the report, UPPER RESPIRATORY TRACT INFECTION (Upper respiratory tract infection) and COVID-19 (tested positive for COVID) was resolving.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were reported.  Patient went to the urgent care for an upper respiratory tract infection to avoid getting bronchitis in the future. Patient stated this was very common for her at this time of the year and did not have any symptoms she did not normally have. Patient denied any symptoms post vaccination and stated she had no fever after the vaccination. She has been taking medications prescribed by the urgent care and her infection has been improving. Treatment information was not provided. Patient reported feeling pretty good.    Reporter did not allow further contact   Most recent FOLLOW-UP information incorporated above includes: On 05-Apr-2021:; Reporter's Comments: Based on the current available information and the mechanism of action of mRNA-1273 vaccine, the events of URI and positive for COVID, are assessed as unlikely related.
Red swollen, hard arm where vaccine was given and bedwetting at night and during the day for 3 days after receiving vaccine.
The patient states she noted a red bump that looked like a mosquito bite on 10/13. The patient was seen in the ER on 10/27 and advised the bump was probably due to the vaccine. The patient was treated with Elocon cream. The patient now has a rash on her trunk and neck after changing detergent. The child was seen by the Dr and told she has probable ringworm. The patient was advised to use Lotrim AF. There was a 14mm x 13mm sized open patch noted on the patient's left arm.
This spontaneous report was received from a licensed practitioner nurse, referring to a patient of unknown age and gender. The patient's medical history and concurrent conditions were not reported. On 16-MAY-2016, the patient was vaccinated with improperly stored dose of PEDVAXHIB lot # L042257 with expiry date on 17-AUG-2018, (strength, dose, route and anatomical location were not reported). Concomitant medications were not reported. No adverse effects were reported and no product quality complaint was involved. This is one several reports received from the same reported. Additional information has been requested.
After the shot, which I received on a Saturday, I developed pain and redness in my right leg. Two days later, on Monday morning, I contacted my primary care physician's office, who told me to go to the ER to be evaluated for a blood clot. At the ER, they performed a doppler ultrasound on my right leg and found a superficial clot in the greater saphenous vein of my right leg. There was no evidence of a DVT in the right leg.
This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a female patient of unknown age. Information regarding medical history, concurrent conditions and concomitant medications was not provided. On or about 01-MAY-2016, the patient was inoculated with ZOSTAVAX for routine adult health maintenance and for the prevention of shingles (dose, route, and lot # not provided). The vaccine was administered by a physician. The vaccine did not prevent shingles as intended, and the patient subsequently contracted a persistent strain of herpes zoster, also known as shingles. During 2016, the patient was treated by the same physician for the onset of sever vesicular rash, which was diagnosed as herpes zoster, or shingles. As a direct and proximate result of ZOSTAVAX vaccine, and/or despite receiving ZOSTAVAX for long-term prevention of shingles, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages. The outcome of the events was unknown. Causality assessment was related. Additional information has been requested.
Lump (L) arm injection site red, hot, lump. Redness for a couple days.
I got diagnosed with Facial Paralysis (Bell's Palsy) on the left side of the face.  One of the signs were weakness on my face when trying to make gestures. The day before (May 15, 2021) I got a headache and when I woke up the other day I felt the weakness in my face. By the end of the day around 9:00 pm I went to the Emergency Room and got injected with Decadron, but the doctor didn't diagnosed me nothing only to see a Neurologist. The other day (May 17, 2021) I tried to get in contact with my primary doctor to explain the situation but I had to wait for the next day for an appointment. By the end of the day (May 17, 2021) I went again to another Emergency Room where the doctor Diagnosed with Facial Paralysis (Bell's Palsy). He ordered a CT Scan, blood sample and anti-inflammatory.
BL hip pain within weeks of shot, then BL shoulder, elbow and wrist pain. No fevers. ESR and CRP elevated. Responded to prednisone for presumed polymyalgia rheumatica (but requiring higher doses than expected) Rheumatology believes dx is "seronegative spondyloarthropathy" triggered by vaccination.
(translated from Spanish by FV) right p/vax pt became sleepy & vomited x3; skin began to swell; high fever; 6PM to ER; Rx DPH & APAP;...(illegible)
This spontaneous case was reported by a consumer and describes the occurrence of OROPHARYNGEAL PAIN (Sore throat and it's getting worse), DYSPHONIA (Voice started to sound weird), SINUSITIS (Sinuses are draining a little bit) and PRODUCTIVE COUGH (Hawking up loogies) in a 33-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. No medical history was provided by the reporter.  Concomitant products included ACYCLOVIR [ACICLOVIR], VENLAFAXINE HYDROCHLORIDE (EFFEXOR), LITHIUM, MIRTAZAPINE, CLONAZEPAM and COLECALCIFEROL (VITAMIN D [COLECALCIFEROL]) for an unknown indication. On 20-Apr-2021 at 10:00 AM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 20-Apr-2021 at 1:00 PM, the patient experienced OROPHARYNGEAL PAIN (Sore throat and it's getting worse). On 21-Apr-2021, the patient experienced DYSPHONIA (Voice started to sound weird) and PRODUCTIVE COUGH (Hawking up loogies). On an unknown date, the patient experienced SINUSITIS (Sinuses are draining a little bit). At the time of the report, OROPHARYNGEAL PAIN (Sore throat and it's getting worse) had not resolved and DYSPHONIA (Voice started to sound weird), SINUSITIS (Sinuses are draining a little bit) and PRODUCTIVE COUGH (Hawking up loogies) outcome was unknown. Not Provided. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. Concomitant product also included depot shots every three months. Treatment information was not provided.
28AUG recvd vax in lt deltoid;arm sore immed p/inj;no swelling, reddness or heat from inj site;cont aching week #2 post inj aching cont, when lifting arm a tingling sensation from elbow to fingertips;malaise,fatigue; AM lt arm cold
This spontaneous report was received from a physician via two company representatives and from a practice manager (support services director) and refers to a patient of unknown age and gender. The patient's pertinent medical history, drug reactions or allergies and concomitant medications were not reported. On 31-MAY-2016, the patient was vaccinated with an improperly stored dose of RECOMBIVAX HB 10 microgram/1 ml injection, lot # L044917, expiration date 05-OCT-2018 (dose, route and site of administration were not reported). The administered dose of vaccine was exposed to two temperature excursions (dates unspecified): one lasting for 72 hours, with the lowest recorded temperature of 31 degrees Fahrenheit (-0.555555556 degrees Celsius) and another lasting for 144 hours, with the lowest recorded temperature of 34 degrees Fahrenheit (1.111111111 degrees Celsius). The vaccine was stored in a refrigerator. No adverse effects were reported. There was no product quality complaint involved. This is one of several reports received from the same reporter. Additional information has been requested.
After client received her vaccine, client stated she feels dizzy.  Vital signs BP 170/72, HR-65, O2 sat 97.8, temp. 96.8. Client stated she feels better.  Client discharged home by EMS.
No adverse signs or symptoms noted. Person entering into the database realized that the flu vaccine was given at too early an age. patient is only 4 months old. Flu vaccine is approved for 6 months and older.
Hives; Swollen lymph nodes in neck; Rash on legs; This is a spontaneous report from a non-contactable consumer, the patient. A 71-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6200) via an unspecified route of administration in the left arm on 26Feb2021 at 16:00 (at the age of 71-years-old) as dose 1, single for COVID-19 immunization. Medical history included Chronic Obstructive Pulmonary Disease (COPD), asthma with many allergies and fibro. The patient was allergic to gatorade. Concomitant medications included valaciclovir hydrochloride (VALTREX), duloxetine hydrochloride (CYMBALTA), montelukast sodium (MONTELUKAST), esomeprazole magnesium (NEXIUM) and pravastatin sodium (PRAVASTATIN). The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient previously received sulfur and experienced allergy. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On 28Feb2021, the patient experienced hives, swollen lymph nodes in neck and rash on legs. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Therapeutic measures were not taken as a result of the events. The clinical outcome of the events hives, swollen lymph nodes in neck and rash on legs resolved on an unknown date in 2021.   No follow-up attempts are possible. No further information is expected.
Large red rash, very warm to the touch, slightly tender. Red hard wheal, approximately 8 inches.
Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from contactable reporter(s) (Other HCP). The reporter is the patient.  A 60-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), in Apr2022 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 59 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) and as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Known allergies: Sulfa drugs" (unspecified if ongoing). There were no concomitant medications. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (01Jul2022) Rebound Covid-19 5 days after finishing Paxlovid. Therapeutic measures were taken as a result of drug ineffective, covid-19. The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.; Sender's Comments: Based on available information, a possible contributory role of BNT162B2 vaccine cannot be excluded for the reported events of COVID-19 and Drug ineffective.
Palpitations with presyncopal episodes.   Ecg performed. No interventions required
Syncope; Vasovagal reflex; This case was received via a company (Reference number: 2021TJP092479) on 10-Sep-2021 and was forwarded to Moderna on 21-Sep-2021.    This case, initially reported to a regulatory authority by a physician, was received via another regulatory authority (Ref, v21126402).  Syncope was assessed as a serious.  On an unknown date, body temperature before examination: 36.5 degrees Celsius.  On 09-Sep-2021, the patient received the 1st dose of this vaccination in the afternoon.  The patient had a sick feeling during follow-up observation after vaccination.  Around 14:30, vasovagal reflex developed, which led to syncope.  The patient recovered with the leg elevation.  The symptoms remitted.  The outcome of vasovagal reflex and syncope was reported as recovered.  Follow-up investigation will be made.  Company Comment:  The events developed after the administration of COVID-19 vaccine mRNA (mRNA 1273) and there is temporal relationship.; Reporter's Comments: Vasovagal reflex accompanied by syncope.; Sender's Comments: This case concerns a 30-year-old, female patient with no relevant medical history, who experienced the unexpected event of syncope. The event occurred on the same day after the first dose of Spikevax (Moderna COVID-19 vaccine). The rechallenge was not applicable as the event occurred after the first dose. The event was considered unrelated to the vaccine per the reporter's assessment. The benefit-risk relationship of Spikevax (Moderna COVID-19 vaccine) is not affected by this report. Event seriousness assessed as per Regulatory Authority reporting.
Uncontrollable shaking at 2:00 am the following morning after the vaccine. Shaking lasted about an hour and from 3:00am to 6:00am hot flashes and body aches. Temperature was 100 degrees.
12-9-16 1530 Clients mother called and spoke to PCA. States client was in for influenza vaccine on 12-9-16 at 11:25AM. States at 3:30pm client started having stomach aches, vomiting, and has a headache. Mother stated client has not eaten or done anything out of the normal. States she has not taken client to the doctor yet. Education provided to take client to PCP or clinic if worried client had a reaction. Educated mother most reactions happen within the first 15 minutes after vaccination. Mother states she is taking client to clinic when clients father gets home. Educated mother would call and check on client before 5 pm today. Mother verbalized understanding. -RN 12-9-16 1641 PCA called clients mother. Mother states she has not taken client to clinic yet. Client still having vomiting, stomach ache and headache. Educated mother will check on client next week per phone call. Mother verbalized understanding. RN 12-13-16 1315 Attempted to contact mother, no answer, message left by PCA to call CHD-RN 12-15-16 1400 Attempted to contact clients mother, no answer, message left by PCA, to contact CHD -RN.
pt devel nausea, vomiting, sore throat, dry cough & a dime size site erythema, during the day post vax;
The patient had nausea and general lethargy, and fatigue . He works at home but says he was not very productive for approx. 10 days
Cellulitis left arm with redness. Pt seen at hospital 10/22/03. Seen at physician office 10/24/03. Given Rocephin 1 gram intramuscular right gluteal. Pt given Rx Cephalexin 500mg from hospital.
Sore arm 4 hours post vaccination so far...; is pregnant: Yes; is pregnant: Yes; is pregnant: Yes; This is a spontaneous report from a contactable consumer or other non hcp.  This is a maternal report. A 34-years-old pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot Number: EP7534), dose 1 via an unspecified route of administration, administered in Arm Left on 15Mar2021 at 11:30 (at the age of 34-years-old) as dose 1, single for covid-19 immunisation. The patient medical history was not reported. The patient had no known allergies The patient received no other vaccine in four weeks. Last menstrual date was provided as 10Nov2020. Concomitant medication included ascorbic acid, betacarotene, biotin, calcium carbonate, calcium pantothenate, chromium, colecalciferol, copper, cyanocobalamin, ferrous fumarate, folic acid, magnesium oxide, manganese, nicotinamide, potassium iodide, pyridoxine hydrochloride, riboflavin, selenium, thiamine hydrochloride, tocopheryl acetate, zinc (PRENATAL [ASCORBIC ACID;BETACAROTENE;BIOTIN;CALCIUM CARBONATE;CALCIUM PANTOTHENATE;CHROMIUM; COLECALCIFEROL;COPPER; CYANOCOBALAMIN; FERROUS FUMARATE;FOLIC ACID;MAGNESIUM OXIDE;MANGANESE;NICOTINAMIDE;POTASSIUM IODIDE;PYRIDOXINE HYDROCHLORIDE;RIBOFLAVIN;S); fish oil. On 15Mar2021 at 14:30, the patient experienced sore arm 4 hours post vaccination so far and  "is pregnant: yes." The mother reported she became pregnant while taking bnt162b2.  The mother was 19 Weeks pregnant at the onset of the event. The mother was due to deliver on 04Aug2021. The patient was not COVID prior vaccination and did not test for COVID post vaccination. Outcome of the event sore arm was not recovered.   Follow-up activities closed. No further information expected.
No direct adverse reaction to the vaccine itself; however, I was diagnosed with covid on Sunday July 31st 2021.  Symptoms from covid included: running/stuffy nose, nasal pressure, chills and sweats, low grade fever, achiness, weak
This spontaneous report as received from a physician refers to a female patient of unknown age. The patient's medical history was unknown. On 12-JUL-2013, the patient was vaccinated with ZOSTAVAX, to prevent shingles. The dose was 0.65 ml. No co-suspected or concomitant medications were reported. On 28-JUL-2013, the patient experienced hives. The patient called the physician and was instructed to come to the office for an evaluation on 29-JUL-2013. The physician prescribed the patient an unspecified corticosteroid to help manage the symptoms. The outcome of hives is unknown. The physician did not provide a causality assessment for ZOSTAVAX and the adverse event hives. Additional information has been requested.
Vaccine site swollen and warm to touch. Redness at site - taking Ceflin and Benadryl
High Fatigue; This spontaneous case was reported by a consumer and describes the occurrence of FATIGUE (High Fatigue) in a 40-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 008B21A) for COVID-19 vaccination.     Concurrent medical conditions included Anemia. Concomitant products included IRON and MINERALS NOS, VITAMINS NOS (CENTRUM A TO ZINC) for Anemia.    On 01-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 01-Apr-2021, the patient experienced FATIGUE (High Fatigue). At the time of the report, FATIGUE (High Fatigue) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No treatment information was provided.   Reporter did not allow further contact
Patient called to Report  that "a couple months" after second vaccine his left ear skin became red and tender. after a few weeks his entire body (skin) became red and sore. His civilian doctor then dx him with Atopic Dermatitis , and also squamous cell carcinoma on his knee. Patient wants this tracked CDC as a possible after effect of receiving his Covid vaccine. Veteran does not have access to the web site. I informed him i would submit on his behalf. Veteran gave verbal consent to release his demographics info in report so that CDC could contact him if they needed to.
development of an erythematous/purple vesicular rash on S2 dermatomal distribution on R c/w zoster 36 hours after immunization
This spontaneous report as received from a pharmacist refers to a 60 year old patient of unknown gender. Current conditions and other medical history were not reported. On 21-OCT-2014 the patient was vaccinated with ZOSTAVAX (Subcutaneous injection, 0.65 ml, subcutaneous, batch # reported as K00888, lot # not reported, expiration date reported as 20-SEP-2015, anatomical location not reported). Concomitant therapies were not reported. The reporter informed that the patient, on 21-OCT-2014, received ZOSTAVAX that was stored at 5 (units not reported). No adverse effects were reported. Additional information has been requested.
he developed a fever and fever lasted for 10 days/2 days after receiving the second dose, he developed a low grade fever; This is a spontaneous report from contactable consumer (Patient). A 78-years-old male patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/Lot Number: EL9262), via an unspecified route of administration on 02Feb2021 as single dose for COVID-19 immunization. The patient previously received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/Lot Number: EH9899) via an unspecified route of administration on 12Jan2021 as 1st single dose for COVID-19 immunization. Medical history included hypertension. The patient's concomitant medications were not reported. On 22Jan2021, ten days later of first dose, he developed a fever and fever lasted for 10 days and on 03Feb2021, a day later receiving the second dose, he developed a low grade fever. Patient tested for COVID 5 times, did full bloodwork, chest x-ray, steph and flu test all tests were negative. On 01Feb2021, patient tested for hepatitis, urine analysis, CBC (full blood count) result was negative for all. The patient received treatment for the event was took Tylenol and Advil. The outcome of the event was not recovered.  Follow-up attempts are completed. No further information is expected.
Within 3 hrs, she experienced eye irritation, eye redness, blurry vision, nausea.