chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Information has been received on 14-MAY-2018 regarding a case in litigation from a lawyer and a consumer of unknown age and gender. The patient's concurrent conditions, medical history and concomitant medications are unknown. On or about 13-JAN-2009, the patient was inoculated with ZOSTAVAX (lot number and expiration unknown) unknown route by a physician as recommended for routine adult health maintenance and for the prevention of shingles. The vaccine did not function as intended, and the patient subsequently contracted a persistent strain condition of herpes zoster. On or about 13-JAN-2016, the patient was treated by a physician for a blistering vesicular outbreak, which was diagnosed as herpes zoster, or shingles. As a direct and proximate result of the ZOSTAVAX and/or despite receiving the 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. Additional information has been requested.
TIGHTNESS IN HIS FACE, TROUBLE SWALLOWING, FLUSHED FACE, REDNESS, THROAT TIGHTENING  Narrative:
Kinrix given to a 4 month old, invalid dose as KINRIX is only approved for the 4-6 year old range; there was no adverse reaction
After dose once, I experienced two days of migraines so bad that I had to stay in bed (which I'd never experienced before). After that, for the three weeks between doses, I experienced some form of headache for at least half the days. After dose two, I experienced a seven-day migraine and have experienced persistent light sensitivity and prone to migraines for the remaining eight months. I've experimented with different treatments, and found relief for a couple months, but have relapsed again. My main symptom currently is persistent light sensitivity and light associated headaches.
Patient was c/o of increased HR and shaky.  HR ranging low 100s to 119.  BP: 172/107, HR: 102, O2: 95% (initial assessment).  EMS called, observed patient for further observation.  Patient recovered and was released.
This spontaneous report as received from a pharmacist refers to a male patient of unknown age. No drug reactions or allergies and pertinent medical history were reported. On an unknown date the patient was vaccinated with VARIVAX dose 2, subcutaneous (strength, dose and lot number were unspecified). Concomitant therapies were unspecified. On an unknown date, the patient experienced blood test (blood titer) showed negative anti-varicella antibody titers. No treatment was given for the adverse event. The outcome of blood test titers negative was unknown. Additional information has been requested.
Cg  received the Covid vaccine on 1/2/21 @ 1042.  At 1055, cg reported palpitations, HR of 140 (Fit Bit) and was flushed.  Vitals: 168/99 P 129, at 1102 155/94 P 109, at 1110 137/93 P 95.  At 1110 cg reporting feeling better and left the observation area at approximately 1115. VAERS completed.
Rash; This spontaneous case was reported by a consumer and describes the occurrence of RASH (Rash) in a female patient of an unknown age 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 first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced RASH (Rash). At the time of the report, RASH (Rash) outcome was unknown.        mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) dosing remained unchanged.       No relevant concomitant medications were reported. Treatment information was unknown.   This case was linked to MOD-2021-386359 (Patient Link).
Rash, widespread>60 papules/macules vesicles, Dx:varicella, Tx: Acyclovir.
- High Fever  - Slight Paralysis on right side of face  - Weakened leg muscles
Based on additional information received on 14 September 2015, this case became medically confirmed. Initial unsolicited report received from a consumer (patient parent) on 17-Aug-2015. A nine years old male patient, had received a first dose of IPOL (dose details, batch number: K1513-1, expiry date: 19-Sep-2016, route and site of administration were not reported) on 11-Aug-2015. There was no illness at the time of vaccination and there were no known allergies. Concomitant medications were not provided. It was reported that it was the first polio vaccine he ever had. On 11-Aug-2015, same day post-vaccination, the patient developed fever to 105 degree F; sore, red, swollen throat that was negative for strep throat test. He also experienced abdominal pain and lethargy and was sleeping more (like a nap in the afternoon) and felt tired. He was vaccinated at his own primary care physician's office. Corrective treatments were not provided. The patient required ER/doctor visit. At the time of this report, the patient improved and his symptoms had resolved. He recovered from the above mentioned events on an unknown date. Documents held by sender: none. Follow-up information received from a physician on 14 September 2015. The patient received first dose of IPOL in right deltoid. A patient did not receive any other vaccine within 4 weeks prior to vaccination. The patient's pre-existing physician diagnosed allergies, birth defects and medical conditions, illness at the time of vaccination were none reported.
angioedema; blistering on arms; swelling; arms continues to have flaking; arms continues to have blistering; welts on arms; A spontaneous report was received from a Health care professional, concerning a female patient of 37 year age, who received Moderna's COVID-19 vaccine and experienced angioedema, welts on arms, blistering on arms, swelling, arms continues to have flaking, arms continues to have blistering.  The patient's medical history includes chronic idiopathic angioedema, paroxysmal atrial fibrillation is noted. Patient has known allergy to benzyl peroxide. Concomitant product use includes cetirizine, famotidine metoprolol, epinephrine were provided by the reporter.  On 28 DEC 2020, prior to the onset of events, the patient received their first of two planned doses of mRNA-1273 (lot number unknown) via intramuscular route for COVID-19 infection prophylaxis. The treatment given were Cetirizine 10mg BID for angioedema, Famotidine 20mg BID for angioedema,2 doses of epinephrine 2 hours apart with no relief for angioedema, triamcinolone for welts and blistering, Benadryl (Diphenhydramine) 25mg-50mg for angioedema noted.  Action taken with mRNA-1273 in response to the event was unknown.  The outcome of the events such as angioedema, welts on arms, blistering on arms, arms continues to have flaking, arms continues to have blistering was considered to be not unknown at the time of this report.  The outcome of event swelling considered to be resolved at the time of report.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
MMRII administered on 3/4/03. Child broke out in diffuse rash on 3/14/03. Fever 100F. No other symptoms or complications. Child looked and acted well.
Received kindergarten shots.  Left leg swollen, red/warm; started later in day after immunizations.  Using TYLENOL/MOTRIN and cool compresses.
Pt slept most of the day, woke @ MN w/t104.7; Mom gave APAP & bathed pt; Pt woke 2 more times t102 & 101; Seem to be about 100 this AM;
began to get very ill; Headache; Fever; Chills; This spontaneous case was reported by an other health professional and describes the occurrence of MALAISE (began to get very ill), HEADACHE (Headache), PYREXIA (Fever) and CHILLS (Chills) in a 32-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Previously administered products included for an unreported indication: BOTOX COSMETIC on 11-Nov-2020 and BOTOX COSMETIC on 24-Feb-2021.    On 16-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In March 2021, the patient experienced MALAISE (began to get very ill), HEADACHE (Headache), PYREXIA (Fever) and CHILLS (Chills). At the time of the report, MALAISE (began to get very ill), HEADACHE (Headache), PYREXIA (Fever) and CHILLS (Chills) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       The patient received his 1st dose of the vaccine on 16Mar2021. 16 hours after, the patient began to get very ill, headache, fever and chills for 12 hours.
Painful arm, lump, redness and hot to touch circle around/on injection site (covid arm)
Hives stated on 5/31/18 on neck, chest, stomach, back, legs and arms. Hives were itchy and warm to touch and did not change much with BENADRYL or cool compresses. 6/2/18- hives not any better spreading. 6/3/18-- still has hives, not spreading at this point 6/5/18- hives starting to subside but pt developed a large whelp at injection site, approximately the size of a hand print and is warm to touch. 6/6/18- hives are pretty much gone but now he has a red strawberry mark where injections were given. Dr. believes it is an adverse reaction to MMRV vaccine.
Cellulitis of the left arm (numerous) versus a severe local reaction to PNEUMOVAX. Patient treatment on 6/26/08 with IV Rocephin
Soreness of left shoulder which peaked at 2 weeks post vaccination and declined but persists now at low level without significant improvement. Denies antecedent trauma/injury other than vaccination. Thank you! It turns out their symptoms have fully resolved.
JOINT PAIN; HEAVINESS IN CALVES; DULL HEADACHE; SWELLING FOREHEAD/ SWOLLEN FACE/ LEFT CHEEK SWOLLEN; HEART RACING; PRESSURE IN HEAD; RED FACE; TINGLING IN CALVES AND FEET; NUMBNESS IN FEET; SHORT SHOOTING PAIN IN BACK; FEELING OF WARMTH/ LEFT CHEEK WARM; This spontaneous report received from a patient concerned a 56 year old female. The patient's weight, height, and medical history were not reported.  The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported and batch number: 1805018 expiry: UNKNOWN) dose was not reported, administered on 07-APR-2021 for prophylactic vaccination. No concomitant medications were reported.  On 07-APR-2021, the subject experienced swelling forehead/ swollen face/ left cheek swollen. On 07-APR-2021, the subject experienced heart racing. On 07-APR-2021, the subject experienced pressure in head. On 07-APR-2021, the subject experienced red face. On 07-APR-2021, the subject experienced tingling in calves and feet. On 07-APR-2021, the subject experienced numbness in feet. On 07-APR-2021, the subject experienced short shooting pain in back. On 07-APR-2021, the subject experienced feeling of warmth/ left cheek warm. On 07-APR-2021, the subject experienced joint pain. On 07-APR-2021, the subject experienced heaviness in calves. On 07-APR-2021, the subject experienced dull headache.  Treatment medications (dates unspecified) included: famotidine, prednisone, and diphenhydramine hydrochloride. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from heart racing, and short shooting pain in back on APR-2021, and had not recovered from pressure in head, dull headache, swelling forehead/ swollen face/ left cheek swollen, red face, joint pain, heaviness in calves, tingling in calves and feet, numbness in feet, and feeling of warmth/ left cheek warm. This report was non-serious.; Sender's Comments: V0: Medical assessment comment not required as per standard procedure as case assessed as non-serious.
Extreme Tinnitus. One week out and symptoms have not let up. Had mild Tinnitus prior. Now severe. Will not get 2nd shot. Very upset.
PALENESS, WEAKNESS, DIZZINESS FEELS LIKE MY EQUILIBRIUM IS OFF.
Pt c/o L/arm & fingerpain 15 minutes after injection in R/arm. No swelling, redness or tenderness noted. Strong grip bilaterally.  Also c/o congested nose.  BP 122/78 Heart Rate 68, Resp 16.  Rested 15 more minutes.   translator relay to pt if pain continues or worsens, she should go to urgent care or ER.   Husband & pt understood. Pt left w/o assistance with husband.
Approx 10 minutes post vax pt developed a HA began having soreness at site and achiness from left shoulder to fingers. Took Tylenol ES/Ibuprofen for relief. Went to work for entire 3 pm shift. During work had nausea no vomiting. abd cramping with diarrhea, flushing, fatigues weakness. Next am woke up with achiness of fingers wrists and ankles. Hands were swollen all day no fever.
Tachycardia >120, fever 101.3 , bp 169/104, difficulty breathing, atrial afib, headache patient had moderately severe covid disease 3/15/2020-4/10/2020
Extreme fatigue, brain fog, difficulty thinking, and increased anxiety since vaccination that continues >12 weeks.
w/in 10min of vax pt started screaming cont w/high pitched scream for 5 1/2-6hr;thigh also red & swollen hot;
HYPERtension Narrative:  BP 151/84  Other Relevant History:
Pt had single episode of extreme shortness of breathe lasting only a few minutes.  This was accompanied with nausea and pain starting center back and wrapping  around. Episode resolved itself in less then 5 minutes, Pt states reaction  atarted approx 25min after vaccination.
BRAIN ANEURYSM; BRAIN DEAD; BLOOD CLOT; FALL; NEEDLE BROKE OFF THE SYRINGE; NEEDLE BROKE OFF THE SYRINGE UNSURE OF THE FULL VOLUME THAT WAS INJECTED; This spontaneous report received from a consumer concerned a 57 year old White Hispanic/Latino male.. The patient's height, and weight were not reported. The patient's concurrent conditions included blind, diabetes, cancer, congestive heart failure, and penicillin allergy.  Nurse came to patients house to administer the vaccine due to patient disability, patient usually does have a home aid. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number:  Unknown) dose was not reported, 1 total, start therapy date were not reported for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported.  Upon administering the vaccine, the needle broke off the syringe, unsure of the full volume that was injected. On 21-MAY-2021 patient experienced dizziness, vomiting, and fall. Blood pressure and sugar was fine after the wife had checked it (BP 120/75, glucose 112). They called the ambulance because the symptoms were unrelenting and a headache began on 21-MAY-2021. Patient required and emergency surgery to relieve pressure on the brain, drilling of the skull where ultimately patient was pronounced brain dead. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient died of brain aneurysm due to blood clot and brain dead on 25-MAY-2021, and the outcome of fall, blood clot, needle broke off the syringe, needle broke off the syringe unsure of the full volume that was injected was not reported. This report was serious (Death, Hospitalization Caused / Prolonged, Other Medically Important Condition, and Disability Or Permanent Damage).; Sender's Comments: V0: 20210708201-COVID-19 VACCINE AD26.COV2.S-Brain Aneurysm, Brain Dead, Blood Clot, Fall. This event(s) is considered unassessable. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s).; Reported Cause(s) of Death: BRAIN ANEURYSM DUE TO BLOOD CLOT
About 18 hours following the injection (Tues), I got common symptoms (body and head ache, fatigue, but no fever). The following day all of those symptoms were gone, but my arm/shoulder where I got the injection had become swollen and developed a rash along my bicep. My lymph nodes in my left armpit were extremely swollen, painful, and tender to the touch. The rash and swelling went down within 24 hours (still there but significantly less) but the lymph nodes are still very large and painful.
This spontaneous report was received from a pharmacist refers to a 4 months old patient. On 05-OCT-2012, the patient was inadvertently vaccinated with a dose of oral ROTATEQ intramuscularly (lot # not reported). No concomitant medications were reported. No adverse effect were reported. It was unspecified if the patient had sought medical attention. Follow up information has been received from a physician refers to the 4 months old male patient (weight 18lb 2.5oz, height: 25in) (birth weight; 8lb6oz). On 05-OCT-2012 at 18:17, the patient was vaccinated with the first dose of oral ROTATEQ orally (lot # 672509/0277AE, exp. date: unspecified date). There was no pre-existing allergies, birth defects, medical conditions. The patient had one sibling. On 05-OCT-2012 at 18:16, the patient was vaccinated intramuscularly with a dose of pneumococcal vaccine (unspecified) (manufactured by Wyeth) orally (lot # F45119, exp. date: unspecified date). There was none illness at time of vaccination. Additional information is not expected.
Migraine, high fever,sore throat, chills,ear ache, toothache, body aches, can't swallow,can't eat
Day nine after second shot experienced chills; headache; nausea; Puked from 3am-1am every 15-30 min; Around 2 PM "my" arms started vibrating. It was a very strong sensation, "I" put my arms up and rotated in effort to release; This is a spontaneous report from a contactable consumer, the patient. A 49-year-old non-pregnant female patient received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 22Apr2021 at 08:30 (at the age of 49-year-old) as a single dose for COVID-19 immunisation. The patient did not have any relevant medical history. The patient had no known allergies. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient did not receive any other medications within two weeks of vaccination. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 01Apr2021 at 10:30 (at the age of 49-year-old) as a single dose for COVID-19 immunisation. On 01May2021 at 03:00, day nine after second shot, the patient experienced chills, headache, nausea, puked from 3:00 to 1:00 (as reported) every 15-30 minutes, could only find relief in a hot bathtub, around 14:00 her arms started vibrating. It was a very strong sensation, she put her arms up and rotated in effort to release. 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. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events chills, headache, nausea, puked, arms started vibrating was resolving at the time of this report.  No follow-up attempts are required; information about lot/batch number cannot be obtained. No further information is expected.
Patient experienced a little bit of INFLAMMATORY RESPONSE(Implant site inflammation) on right cheek only; This spontaneous case was reported by a nurse and describes the occurrence of IMPLANT SITE INFLAMMATION (Patient experienced a little bit of INFLAMMATORY RESPONSE(Implant site inflammation) on right cheek only) in a 37-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect products included non-company products HYALURONIC ACID, LIDOCAINE HYDROCHLORIDE (RESTYLANE LIDOCAINE) injection for an unknown indication and HYALURONIC ACID, LIDOCAINE HYDROCHLORIDE (RESTYLANE DEFYNE) injection for an unknown indication.    No Medical History information was reported.   On 26-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 24-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 16-Jul-2021, the patient started HYALURONIC ACID, LIDOCAINE HYDROCHLORIDE (RESTYLANE LIDOCAINE) (unknown route) 2 syringe and HYALURONIC ACID, LIDOCAINE HYDROCHLORIDE (RESTYLANE DEFYNE) (unknown route) 1 syringe. On 16-Jul-2021, the patient experienced IMPLANT SITE INFLAMMATION (Patient experienced a little bit of INFLAMMATORY RESPONSE(Implant site inflammation) on right cheek only). The patient was treated with CEFADROXIL from 17-Jul-2021 to 22-Jul-2021 for Adverse event, at a dose of 500 milligram. On 20-Jul-2021, IMPLANT SITE INFLAMMATION (Patient experienced a little bit of INFLAMMATORY RESPONSE(Implant site inflammation) on right cheek only) had resolved. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant products were reported. Patient stated that she had used Voluma filler to her cheeks in 2018 and had no other vaccine in the last 6-12 months or dental procedures. On 16-Jul-2021, the patient received treatment with 2 syringe Restylane Lyft with Lidocaine (lot 18723 (unknown injection technique and needle type) to cheeks (CK1, CK3, CK4 and bilateral angle of jaw),1 syringe Restylane Kysse (lot 18078,expiry Mar-2021) (unknown injection technique and needle type) to the upper and lower lips.The EXPIRED RESTYLANE KYSSE was used (Expired device used) and 1 syringe Restylane Defyne (lot 18671) (unknown injection technique and needle type) to chin divided between C2, C1 JW4 and JW5 bilaterally.
Eczema like skin rash; Eczema like skin rash; This is a spontaneous report from a contactable consumer (patient). A 17-year-old male patient received bnt162b2 (PFIZER-BIONTECH covid-19 vaccine, formulation: solution for injection and batch no: not reported/lot number: Ew0181) via an unspecified route of administration, in left arm on 12Jun2021 (at the age of 17-years-old) as dose 2, single for covid-19 immunization at Pharmacy or Drug Store. Patient was allergic to penicillin. Concomitant medication within 2 weeks of vaccination included naproxen. Historical vaccine included as patient received her first dose of bnt162b2 (PFIZER-BIONTECH covid-19 vaccine, formulation: solution for injection, batch no: not reported/lot number: Ew0178) via an unspecified route of administration, in left arm on 22May2021 as dose 1, single for covid-19 immunization. The patient had not received any other vaccines within 4 weeks prior to the covid vaccine. Prior to vaccination, the patient was not diagnosed with covid-19 and since the vaccination. The patient experienced eczema like skin rash on 23Jul2021. Patient had no treatment for events. The patient underwent lab tests and procedures which included sars-cov-2 test and results were pending. Outcome of the events was unknown.
Approximately 16 hours post vaccine, I was tired and achy all over. At exactly 25 hours I began having chills, the body aches became almost unbearable and my temperature started to rise Throughout the next 8 hours, I was very achy, temperature ranged between 99.6-101.6, I had chills then hot flashes. I was very tired and napped during this time. I noticed a few bouts of tinnitus, and what feels like sinus pressure in head/slight dizziness.  I went to bed 8 hours after onset of those symptoms and slept 8.5 hours.  Day 3 and 4 I still have bouts of tinnitus and head pressure/dizziness, but it is on and off. I am still tired, and not very hungry.