chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Nausea; beat red; hot; Rash looked like a bullseye about 3inches in diameter going down her arm; pain in shoulder; swelling at the injection site; redness at the injection site; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 10-Feb-2021 and was forwarded to Moderna on 10-Feb-2021.    This spontaneous case was reported by a consumer and describes the occurrence of ERYTHEMA (beat red), INJECTION SITE WARMTH (hot), INJECTION SITE ERYTHEMA (redness at the injection site), RASH PAPULAR (Rash looked like a bullseye about 3inches in diameter going down her arm) and ARTHRALGIA (pain in shoulder) in a 71-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 0266204) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Hypothyroidism, Pancreatitis and Gastritis. Concurrent medical conditions included Drug allergy (Opiate drugs), Drug allergy (Demerol), Drug allergy (Diloxin), Drug allergy (Neurontin) and Allergy to chemicals (CT-scan dye). Concomitant products included LEVOTHYROXINE SODIUM (SYNTHROID) and OMEPRAZOLE (PROTONIX [OMEPRAZOLE]) for an unknown indication.    On 01-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 01-Feb-2021, the patient experienced INJECTION SITE ERYTHEMA (redness at the injection site), ARTHRALGIA (pain in shoulder) and INJECTION SITE SWELLING (swelling at the injection site). On 09-Feb-2021, the patient experienced ERYTHEMA (beat red), INJECTION SITE WARMTH (hot) and RASH PAPULAR (Rash looked like a bullseye about 3inches in diameter going down her arm). On an unknown date, the patient experienced NAUSEA (Nausea). At the time of the report, ERYTHEMA (beat red), INJECTION SITE WARMTH (hot), INJECTION SITE ERYTHEMA (redness at the injection site), RASH PAPULAR (Rash looked like a bullseye about 3inches in diameter going down her arm), ARTHRALGIA (pain in shoulder), INJECTION SITE SWELLING (swelling at the injection site) and NAUSEA (Nausea) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       The patient reported that she had swelling and redness at the injection site. She also was nauseas. 8 days later, she had pain in shoulder. She looked and noticed rash. It looked like a bullseye about 3 inches in diameter. It was hot and beat red and was going down her arm. She wanted to know if this was normal or not. Treatment details were not reported.
PT HAD A THIRD DOSE (BOOSTER SHOT) AT 15 YEARS INSTEAD OF 16. NO ADVERSE EFFECTS REPORTED.  PATIENT STATES HE IS OKAY.  MOTHER ALSO STATES THE PATIENT IS OKAY THE NEXT DAY WHEN WRITTER ENQUIRED
Initial unsolicited report received from a non healthcare professional (corrected) on 23 Oct 2014. This is an invalid case as the adverse reaction is not specified. A child patient, whose age, gender, medical history and concomitant medications were not reported, had received a dose of INFLUENZA VACCINE (batch number, dose, dose number, route and site of vaccination not reported) in the year 2014. The patient had previously vaccinated with FLUZONE QIV (lot number: U476AA) in 2013 and had developed a reaction (not specified). It was reported that patient had developed reaction (not specified) to this year's FLUZONE QIV on an unspecified date. Lab details and corrective treatments were not reported. The outcome of the event was reported as unknown. Documents held by sender: none. Follow Up information received by a non healthcare professional on 03-Feb-2015. It was reported that the initial report was incorrect. A 3 years old patient (age reported as 4 years) had received a dose of FLUZONE QIV (batch number: U4766AA, dose, dose number, route and site of vaccination not reported) on an unspecified date. On 09-Oct-2013, the patient had reacted to the FLUZONE QIV vaccine. Laboratory investigations included skin prick testing which showed positive responses to mercury, gelatin and neomycin on 13-Nov-2014. On 11-Dec-2014, the patient received "FLUARIX" vaccine (manufacturer, GSK, batch number: 5R9EG). It was reported that she tolerated the injection without any problem. She was observed for 1 hour and discharged in the usual state of health. She did not have a reaction to the flu vaccine in 2014.
COVID 19; COVID 19; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 49-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 23Mar2021 at 10:00 as dose 1, single (Batch/Lot number: unknown), in left arm and on 14Apr2021 at 10:00 as dose 2, single (Batch/Lot number: unknown) at the age of 48 years, in right arm for covid-19 immunisation; coviD-19 vaccine mrna (mrna 1273) (COVID-19 VACCINE MODERNA), on 28Oct2021 at 10:00 as dose 3 (booster), single (Batch/Lot number: unknown), in right arm for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. Past drug history included: Keflex, reaction(s): "known allergies: Keflex". Patient did not received other medication in 2 weeks. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 10May2022, outcome "recovered" (17May2022) and all described as "COVID 19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (10May2022) Positive, notes: That test was Tuesday 10May in the evening; (17May2022) Negative, notes: I tested negative Tuesday am 17May. Therapeutic measures were taken as a result of drug ineffective, covid-19. Felt great at end of five days. Symptoms returned on day 8 and 9 head congestion and fatigue. Patient will resolve but I wanted to report for the sake of collecting data about Paxlovid. She began treatment 24 hours after her positive test for covid 19. That test was Tuesday 10May in the evening. She tested negative Tuesday am 17May.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Cough, irritated throat, fever up to 101.8 off and on the last 24 hours, runny nose and fatigue.
Janssen COVID-19 Vaccine EUA: patient presents to emergency department with altered mental status and confusion three days after being discharged from a different hospital for COVID-19 infection.  In emergency department diagnosed with stroke, left ventricular thrombus, subacute anterior myocardial inferction with totally occluded mid LAD, and COVID-19 infection. Underwent cardiac catheterization and transferred to current facility for higher level of care and testing- currently remains hospitalized on anticoagulation and oxygen.
MOC reports seizure like activity evening after receiving immunizations. At time of episode was febrile to 101 per mother. MOC describes episode when patient "rigid" and "eyes rolled back." Parents did not take patient to emergency room.
Approximately 90 minutes difficulty in swallowing and a feeling of a large lump in throat, slight trembling appeared. I administered a Benadryl 25mg tablet. Few hours later severe swelling at injection site, ensuing chills and fever of 101 F.  Also experienced scrambled thinking, felt unclear in thoughts for over 24 hours. Normal blood pressures of 110/70 spiked to over 155/90 and caused great concern. Administered two 325 mg Tylenol throughout New Years Day. Fever continued throughout night and today am experiencing both left and right arm as if they are burning. I am calling my primary Dr. I understand many have symptoms of flu but what I experienced was above and beyond the reactions I had after 2nd Moderna.
Patient received his first covid shot this past Saturday and about 20 minutes following he noticed a right sided facial droop.  Droop began to worsen, and he had difficulty moving his right eye lid, so he decided to go to Urgent Care and was diagnosed with Bells Palsy.  He was started on Prednisone and Valtex which are reducing his symptoms.  Symptoms are almost resolved.  He does feel fatigued and slightly anxious.
pt mom reports pt cried for 4hr p/vax;called ER was instructed by MD to give extra dose of APAP;pt went to sleep w/o any further problems;
Unable to walk or talk x 4 days. Arm swelled and injection site turned black. Nausea and did not feel well.
dizzy, tunnel vision, weaving on chair, flushed, diaphoretic, cold & clammy
This spontaneous report as received from a pharmacy manager via company representative refers to a patient of unknown age and gender. The patient's medical history was not reported. In 2015 (reported as about middle of last week, near 01-APR-2015), the patient was vaccinated with a dose of ZOSTAVAX (lot #, dose and route of administration were not reported) in arm. No concomitant medication was reported. On 05-PAR-2015 (reported as 3 days ago), the patient returned to the pharmacy with tingling in arm at the injection site. There was no redness. No treatment was given and pharmacy had not heard back from patient at the time of report. The outcome of event was unknown. The relatedness between the event and ZOSTAVAX was not reported. Additional information has been requested.
Tingling in hands(like pins and needles), dizziness,  slight swelling of lips occurred about 20 minutes after the vaccine was administered.  I was already on my way home. Tingling and dizziness dissipated after about 1 hour. Hives and itching on top of right foot and left forearm began later on in the evening (around 9:00pm). These reactions lasted for three days. I did not take benedryl, as it has an interaction with one of my medications. Fatigue and a mild temperature set in around 10:00pm.  On Saturday, September 11, at around 1:00pm I became very nauseous, achy and fatigued and developed intense chills and a fever of 102.6.  I took Ibuprofen.  By 5:00 pm My fever reached 103.2. This continued for the next 24 hrs. The temperature is now in the 99.8 range and I am still fatigued and have swollen lymph nodes.
death N17.9 - Acute kidney failure, unspecified D69.6 - Thrombocytopenia, unspecified chest pain
Dx with Bells Palsy on 5/5/21..   On 5/4 pressure behind right eye.. 5/5  r side facial paralysis.. affected speech.. loss of taste went to ER r/o stroke. Final diagnosis.. Bell?s Palsy
Terrible rash on both arms, hands and neck area. I was given Penicillin VK500 Mg tablets and injection, triamcinolone .1% cream. It?s only getting worse with mild itching
Redness and swelling in the armpit. Patient noted some pain and swelling in the armpit.
Dry mouth, swollen back of palate and extremely swollen uvula.   I woke up in the middle of the night with breathing trouble and slight gagging because of the size of my uvula.  The same symptoms were previously reported for dose 1 (VAERS report 600712).  Both events were reported on the same day because it now seems highly likely that they are related to the vaccine.
Breathing troubles - Was having some difficulty breathing and having some wheezing. Treatment - I used an inhaler - I already a  prescription for. It helped some. I had these for about 3 weeks.
June 19 2021 diagnosed with Perycarditis, treatment antiinflammatory medicines and pain killers, lasted until week of July 2 when diagnosed with puerleffussion  As of this date still experienceing weak condition
Reported that injection site became red, itchy  hard and warm to touch with hives going down arm, neck and half of torso. Benadryl given with some relief.
dizziness vitals taken stable 109/76, pulse 81, 98.3 , spo2 98% alert, water given. monitored for 30 min.  pt has a family member , took client home
Patient received the Moderna Vaccine on 5/19/21 and called and said she had started her period a week later and was a heavy flow. Patient stated she had not  had a period due to having the Mirena implant.  Told her to also contact her OB and let them know what had occurred and also take a pregnancy test this month and next to ensure she is not pregnant.
Developed a sizable rash in the deltoid which started a little more than 24 hours after the injection. This only occurred after my second dose. The rash was dark red, was warm to the touch, and felt tight. No increased pain or itching. I took a antihistamine the following day and these seemed to help reduce the rash. It was gone after 4 days.
Swollen and painful lymph nodes; Swollen and painful lymph nodes; Headache; Pain in the site of injection; This is a spontaneous report from a Non-Contactable Other health care professional reported that a 35-year-old female (Non-pregnant) received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Lot Number: EL9262), via an Intramuscular in left arm on 26Jan2021 at 12:30 and first dose (Lot Number: EL1283) via an Intramuscular in left arm on 05Jan2021 12:30 both at single dose for Covid-19 immunization. The patient's medical history and concomitant medications were not reported. No known allergies reported. No prior vaccinations within 4 weeks. The patient was not diagnosed with COVID-19 prior to vaccination. The patient tested with COVID-19 post vaccination. On 28Jan2021 18:00, the patient experienced swollen and painful lymph nodes, headache, and pain in the site of injection. On 11Jan2021, the patient underwent lab tests and procedures which included covid test type post vaccination, nasal swab result was negative. Patient did not received treatment for adverse event. The outcome of events was not unknown.   No follow-up attempts are possible. No further information is expected.
she has thin skin; Her skin pulled away from falling; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program. The reporter is the parent.  A 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 (First dose), for Covid-19 Immunization. The following information was reported: SKIN ATROPHY (non-serious), outcome "unknown", described as "she has thin skin"; SKIN DISORDER (non-serious), outcome "unknown", described as "Her skin pulled away from falling".  Additional Information: Reporters mom would have her second dose of the vaccine and she had thin skin. Her skin pulled away from falling and wanted to know if she can still have her second dose of the vaccine. Read Privacy statement.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Since April 16th, have a  headache(mostly left side seems to be paining more and crown area and forehead).  Bad Ear ache (left ear) and  feeling of nausea. Feel congested too Also feeling of fatigue
This spontaneous report was received from a pharmacist via company representative regarding 61-year-old female patient with sjogren's (shogren's) disease and hypertension. There was no concomitant medication reported. In approximately November 2016 (reported as six months ago), the patient was vaccinated with a dose of ZOSTAVAX. Other suspect therapy included the sterile diluent (dose, route, anatomical location, lot number and expiration date were not reported) for shingles prevention for both above therapies described. In December 2016, the patient developed "ophthalmic shingles (ophthalmic herpes zoster), seizures and meningitis." It was also reported that the patient was hospitalized in approximately December 2016 due to the ophthalmic shingles, seizures and meningitis and while the patient was hospitalized (date unspecified) a spinal tap (lumbar puncture) was performed (result was not provided). The patient was treated with prednisone (manufacturer unknown) and acyclovir for the ophthalmic shingles. On an unknown date, the patient was discharged from the hospital. At the time of the report, the patient did not recover from the ophthalmic herpes zoster, meningitis and seizure. The relatedness between the events and therapy with ZOSTAVAX and the sterile diluent was not reported. Upon internal review, ophthalmic herpes zoster, meningitis and seizure were determined to be serious due to medically significant events. The reporter considered the events to be serious due to disability and life threatening criterion. Additional information has been requested.
flu; Initial information was received on 12-Oct-2020 regarding an unsolicited valid non-serious social media case from a consumer via social media.  This case involves a patient (unknown demography) who got flu (influenza), while the patient received vaccine INFLUENZA VACCINE.  Medical history, medical treatment(s), concomitant medications, vaccination(s) and family history were not provided.  On an unknown date, the patient received a dose of suspect INFLUENZA VACCINE produced by unknown manufacturer (lot number and expiry date not reported) via an unknown route at an unknown administration site for prophylactic vaccination.  On an unknown date, the patient developed non-serious flu (influenza) (unknown latency) following the administration of INFLUENZA VACCINE.  It was reported as the patient quit taking the shots after retirement. At least for 10 years later got the flu, hence started taking shots without getting the flu because of new and improved vaccine  Details of laboratory data were not reported.  It was not reported if the patient received any corrective treatment.  At the time of report, the outcome was unknown for the event.  There will be no information available on the batch number for this case.
Chills, fever, nausea, dizziness, headache, diarhrea,  couldnt function,   loss of perception,   nothing in my lifetime I have experienced like this   Time of recovery    36 hrs Still not fully recoverd   dizziness   now tightness in throat and coughing...48 hrs later
pt recv vax 26APR96 & mom states that evening c/o itching @ site & noticed red area size of quarter;29APR96 mom noticed raised, red area approx 4" wide called PMD;MD ordered ATB;dx cellulitis;lymph node tenderness in arm;arm hard, bruised
Headaches, fatigue, light-headed "hang over", post vax. Symptoms started 24 hours, post vax and lasted about 72 hours. Also, had nausea and vomiting.
Gave an expired vaccine.  Unfortunately, there was one vial of Pfizer vaccine that was not disposed of following expiry.  The dose was accidentally given instead of the Pfizer bivalent vaccine.  I spoke with the client today and he had no adverse reaction.  He was provided the bivalent vaccine following the inadvertent dose of expired vaccine.
swollen glands-extreme-posterior neck, behind ears, under jaw-down neck on rt & lt sides & clavicle; throat swelled-impairing breathing w/nodules (red)-started approx 1 wk p/vax;
discomfort moving his arm or pushing on the muscle; muscle pain and soreness/moved from the main side of the muscle up to the back of the arm muscle too; Tenderness; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 64-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), administered in arm right, administration date 03Mar2021 13:42 (Lot number: EN6202) at the age of 64 years as dose 1, single for COVID-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. The following information was reported: MYALGIA (non-serious) with onset 04Mar2021, outcome "recovered with sequelae" (Mar2021), described as "muscle pain and soreness/moved from the main side of the muscle up to the back of the arm muscle too"; LIMB DISCOMFORT (non-serious) with onset 19Mar2021, outcome "not recovered", described as "discomfort moving his arm or pushing on the muscle"; TENDERNESS (non-serious) with onset Mar2021, outcome "recovering", described as "Tenderness". Therapeutic measures were taken as a result of myalgia, limb discomfort, tenderness. Additional information: The patient did not receive any other vaccines within 4 weeks and on the day of the vaccination. The patient experienced muscle pain and soreness for a couple of days and was fine until 19Mar2021. The patient states it was the same pain and discomfort again like he previously had after receiving the shot. The patient took ibuprofen as a treatment but has not talked to his doctor. The patient was planning to get the second dose of the vaccine in the other arm (left arm) on 24Mar2021.   No follow-up attempts are possible. No further information is expected.
A physician reported that a female, now 42 years of age, received an injection of Tetanus Toxoid approximately 20 years ago and subsequently developed a rash and puffy eyes. She recovered.
The child did not have an adverse reaction, he was fine after receiving the vaccine and had no side effects.  The child was inadvertently given the vaccine at a mass event. Upon verifying information with mother of  the child, she insists that he was born in 2005 despite the fact that he has a complete immunization record with date birth 01/26/2006.  Mother also insists that the child receive his second dose of Moderna regardless of his age and current ACIP recommendations.
extreme fatigue; burning at injection site; sore feeling like bruise; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program. The reporter is the patient.  A 50 year-old patient received bnt162b2 (BNT162B2), administered in arm left, administration date 02Oct2021 19:00 (Lot number: FF8839) at the age of 50 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "back injuries", start date: 27Feb1995 (ongoing), notes: No surgical procedure; "endometriosis", start date: 1984 (ongoing), notes: Diagnostic laparoscopies; "internal adhesions", start date: 1998 (ongoing), notes: Diagnostic laparoscopies. There were no concomitant medications. The following information was reported: FATIGUE (non-serious), outcome "unknown", described as "extreme fatigue"; VACCINATION SITE PAIN (non-serious), outcome "unknown", described as "burning at injection site"; CONTUSION (non-serious), outcome "unknown", described as "sore feeling like bruise". Relevant laboratory tests and procedures are available in the appropriate section.  Additional information: Patient stated that just reporting side effects from the Covid-19 vaccine. The patient reported that symptoms are extreme fatigue and moderate fever. Patient was (O-NEGATIVE) blood type our temperature runs lower at (96.1-96.4) and fever was standing at 99.4. O Negative blood attacks certain viruses, vaccines, etc. causing extreme fatigue. Patient stated that many O-neg people do not have a tendency report symptom. 1st vaccine side effects were awful. Patient had extreme fatigue for 2 days after injection, upon injection there was burning at injection site and the expected sore feeling like a bruise. Patient was not sure if the side effects with the 1st vaccine are due to blood type, O negative. Relevant Test: None. Prior vaccination: None.  No follow-up attempts are possible. No further information is expected.
Onset: 3-4 hours after administration. Developed itching followed by rapidly progressive confluent erythema, swelling and warmth spreading around injection site and circumferentially around entire upper arm/biceps area. Felt feverish. Temp 100 in office next day.  Treated with dicloxacillin to cover possible cullulitis and Benadryl for allergic component. To follow-up next day.
This spontaneous report was received from a nurse and refers to unspecified number of patients of unknown age and gender. No information regarding the patients' medical history, concurrent conditions, drug reactions and allergies was reported. On 21-APR-2015, the patients were vaccinated with doses of ROTATEQ (route of administration defaulted to oral; dose, lot# and expiration date were not reported), which were exposed to temperatures outside of the recommended range. No adverse events were reported. This is one of several reports received from the same source. Additional information has been requested.