chrisvoncsefalvay/vaers-outcomes huggingface dataset:
arm was hot; her arm started to itch; again a large welt (3,25 inch diameter), pink in her arm; arm was Swollen; arm was swollen; she had a large welt,pink in her arm; arm was a little sore; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (arm was a little sore), VACCINATION SITE URTICARIA (she had a large welt,pink in her arm), VACCINATION SITE SWELLING (arm was swollen), VACCINATION SITE PRURITUS (her arm started to itch) and VACCINATION SITE WARMTH (arm was hot) in a 70-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013K20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concomitant products included WARFARIN for Clotting disorder, ACETYLSALICYLIC ACID (BABY ASPIRIN) and MONTELUKAST for an unknown indication.    On 05-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 05-Feb-2021, the patient experienced VACCINATION SITE PAIN (arm was a little sore). On 06-Feb-2021, the patient experienced VACCINATION SITE URTICARIA (she had a large welt,pink in her arm) and VACCINATION SITE SWELLING (arm was swollen). On 12-Feb-2021, the patient experienced VACCINATION SITE PRURITUS (her arm started to itch), VACCINATION SITE WARMTH (arm was hot), VACCINATION SITE URTICARIA (again a large welt (3,25 inch diameter), pink in her arm) and VACCINATION SITE SWELLING (arm was Swollen). On 06-Feb-2021, VACCINATION SITE PAIN (arm was a little sore), VACCINATION SITE URTICARIA (she had a large welt,pink in her arm) and VACCINATION SITE SWELLING (arm was swollen) had resolved. At the time of the report, VACCINATION SITE PRURITUS (her arm started to itch), VACCINATION SITE WARMTH (arm was hot), VACCINATION SITE URTICARIA (again a large welt (3,25 inch diameter), pink in her arm) and VACCINATION SITE SWELLING (arm was Swollen) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       The concomitant medications included high blood pressure medication and diuretic.  Treatment included ice and allergy pill.
This spontaneous report has been received from a registered nurse referring to an unspecified number of patients of unknown ages and genders. Medical history, concurrent condition, drug reactions and allergies were not reported. On an unknown date, the patients were vaccinated with improperly stored doses of with M-M-R II (lot # K011188 expiration date: 01-DEC-2016 and lot # K022284 expiration date: 01-DEC-2016) (dose, indication, route of administration and albumin status were unspecified). Concomitant therapies were not provided. No adverse symptoms were reported. No product quality complaint was involved. This is one of several reports from the same source (MARRS: 1511USA014672; 1511USA014712; 1511USA014714; 1511USA014715). Additional information has been requested.
pt was fine until 15 minutes into her waiting time at which she stated she felt faint and light headed.  Continued to worsen based on dialogue with patient.  Tried to take blood pressure manually as well as with automated cuff but too low to detect.  Pt stated she felt tingly all over, hot , clammy, dizzy and was made worse by opening her eyes.  Put ice packs on neck and forehead as well as wet cloth.  Pt requested water but we declined as to not knowing severity or extent of reaction yet.  Based upon pt not improving and lack of palpable pulse decision to involve EMS was made.  Upon ems arrival 10 min later pt was taken to their transport vehicle for further evaluation.   At that time they observed vitals to be normal, monitored for additional 10-15 minutes and determined pt had adverse reaction, not allergic reaction.  Pts caregiver called us to let us know she was fine on drive home and improved rapidly en route.  Noted pt drove 2-3 hours for appointment, in convertible with temps in mid -upper 70's and noted she was possibly hot upon arrival and this could have precipitated reaction to injection.
booster; fever; This is a spontaneous report received from a non-contactable reporter(s) (Other HCP).  A 16 year-old male patient received bnt162b2 (BNT162B2) (Lot number: FF8841) as dose 3 (booster), single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (Batch/lot number: EP6955, Dose number: 2), for Covid-19 immunization; Bnt162b2 (Batch/lot number: EP6955, Dose number: 1), for Covid-19 immunization. The following information was reported: IMMUNISATION (non-serious), outcome "unknown", described as "booster"; PYREXIA (non-serious), outcome "recovered", described as "fever".  Additional information: The patient had not been diagnosed with COVID-19 prior to vaccination and had not been tested since the vaccination.   No follow-up attempts are possible. No further information is expected.
I started feeling kind of puny and sat down for supper - no taste or smell. After that I felt cold symptoms - and I had no energy whatsoever. I talked to the Dr online and he told me take Zinc Sulfate and Hydroxychloroquine; nebulized a medication but I can't remember what it was. I got pretty sick for about three days. I got to the point that I was so weak I could hardly move. I went to  ER and was there for 1/2 day. They gave me IV fluids. They said that my lungs still sounded good The illness ran it's course of about 10 days. I still feel winded two months later.  I have a little nagging cough yet. I can still go to work though.
really bad ringing in ears (tinnitus); whole ear system is swollen; heartrate to 125; hyperacusis; pressure in upper mouth; neck spasm; headaches/pulsating and pounding in the back of head; pressure headaches; This spontaneous case was reported by a consumer and describes the occurrence of TINNITUS (really bad ringing in ears (tinnitus)), EAR SWELLING (whole ear system is swollen), HEAD DISCOMFORT (pressure headaches), HEART RATE INCREASED (heartrate to 125) and HYPERACUSIS (hyperacusis) in a 62-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 002B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Tinnitus. Previously administered products included for Product used for unknown indication: Atorvastatin (ears worse). Past adverse reactions to the above products included Ear disorder with Atorvastatin. Concurrent medical conditions included Allergy, Sinusitis, Asthma and Tendonitis. Concomitant products included ALPRAZOLAM (XANAX) for Sleep difficult, FEXOFENADINE HYDROCHLORIDE (ALLEGRA) for an unknown indication.    On 16-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 22-Mar-2021, the patient experienced HEAD DISCOMFORT (pressure headaches). On 30-Apr-2021, the patient experienced HEART RATE INCREASED (heartrate to 125), HYPERACUSIS (hyperacusis), ORAL PAIN (pressure in upper mouth), MUSCLE SPASMS (neck spasm) and HEADACHE (headaches/pulsating and pounding in the back of head). On an unknown date, the patient experienced TINNITUS (really bad ringing in ears (tinnitus)) and EAR SWELLING (whole ear system is swollen). The patient was treated with PREDNISONE for Tinnitus, at an unspecified dose and frequency; VITAMIN D NOS at an unspecified dose and frequency; TRIAMCINOLONE ACETONIDE (NASACORT) at an unspecified dose and frequency; MOMETASONE FUROATE (FLONASE [MOMETASONE FUROATE]) at an unspecified dose and frequency and IPRATROPIUM BROMIDE at a dose of Nasal spray. On 30-Apr-2021, HEAD DISCOMFORT (pressure headaches) outcome was unknown. At the time of the report, TINNITUS (really bad ringing in ears (tinnitus)) had not resolved and EAR SWELLING (whole ear system is swollen), HEART RATE INCREASED (heartrate to 125), HYPERACUSIS (hyperacusis), ORAL PAIN (pressure in upper mouth), MUSCLE SPASMS (neck spasm) and HEADACHE (headaches/pulsating and pounding in the back of head) outcome was unknown. Not Provided    DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 30-Apr-2021, Heart rate: 125 (High) Increased.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Prednisone and vit D are used as treatment medications.   Most recent FOLLOW-UP information incorporated above includes: On 03-Jun-2021: Follow up received from the initial reporter: Patient's medical history, Concomitant medications, treatment medication and new events were added.
Pt reports itching injection site,pain to touch, 3cm soft swelling, 3cm red, tender,mild flu.
Severe pain under arm (armpit); Swelling on under arm (armpit) area; Body aches; Fever; This is a spontaneous report from a contactable consumer, the patient. A 50-year-old male patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0158) via an unspecified route of administration in the arm left on 04Apr2021 at 08:30 (at the age of 50-year-old) as a single dose for COVID-19 immunisation. Medical history and concomitant medications were reported as none. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER2613) via an unspecified route of administration in the arm left on 18Mar2021 at 09:30 (at the age of 50-years-old) as a single dose for COVID-19 immunisation. The patient previously took codeine (MANUFACTURER UNKNOWN) for unknown indication and experienced drug allergy on an unknown date. The patient did not receive any other medicines within 2 weeks of the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID -19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. On 10Apr2021 at 19:45, the patient experienced severe pain and swelling on under arm (armpit) area and fever and body aches. Pain and swelling persisted in under arm area on side of vaccination area (left armpit). 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 event(s). The clinical outcome of the events severe pain and swelling on under arm (armpit) area and fever and body aches were not resolved at the time of this report.  No follow-up attempts are needed. No further information is expected.
Chicken pox looking very itchy bumps on abdomen, legs and arms. Next day also a rash more sand paper looking. 4 other children in classroom reported similar symptoms after vaccine.
Patient received first Gardasil vaccine, Meningococcal and Tdap vaccines and stood up and told mother she felt dizzy; then fell to floor. She was placed in supine position. She was first slow to respond but then was oriented to her name, recognized her mother, and where she was located. VS on assessment was 110/80, HR 64 apical, respiration was even and unlabored. After several minutes, she was assisted to sitting position; was feeling less dizzy and given water to drink. She recovered more and then assisted to chair where she was now alert and oriented. She reported dizziness had subsided.
SkinRash 2 days after vaccine onset of painful skin rash 2 inches below deltoid Narrative:  Mildly painful rash two inches below deltoid
Needle Leaked and the liquid ran down her arm; Sore Right Arm (Vaccinated Arm); This spontaneous case was reported by a consumer and describes the occurrence of ACCIDENTAL EXPOSURE TO PRODUCT (Needle Leaked and the liquid ran down her arm) and MYALGIA (Sore Right Arm (Vaccinated Arm)) in a 35-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 039A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 22-Apr-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 2 dosage form. On 22-Apr-2021, the patient experienced ACCIDENTAL EXPOSURE TO PRODUCT (Needle Leaked and the liquid ran down her arm) and MYALGIA (Sore Right Arm (Vaccinated Arm)). On 22-Apr-2021, ACCIDENTAL EXPOSURE TO PRODUCT (Needle Leaked and the liquid ran down her arm) had resolved. At the time of the report, MYALGIA (Sore Right Arm (Vaccinated Arm)) outcome was unknown. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.
Mom reports 2-3" of redness and swelling at injection site 2 days after injection. She will treat with 12.5 mg of BENADRYL q 4-6 hrs PRN. Resolved in one week.
Rec'd MMR, Varicella, Comvax, Prevnar on 4/5/05.  Presented afternoon of 4/6/05 with having slept well, but with longer nap and several hours of crying on 4/6.  PE significant for pharyngitis, normal TM's, no fever.  Mother called 4/15/05 to report overnight fever to 103 but child did not require visit.  After consideration, mother reports (2/08) memory of prolonged screaming, thrashing and fever over a period of 2 hours the evening of 4/14/05.  The child was fatigued but otherwise normal the next day.
PT. EXPERIENCED MAJOR HEADACHE,VOMITING, STOMACH PAIN, SWEATING,  Per Facility nurse patient was experiencing a severe allergic reaction.  UNABLE TO TELL EMT WHAT YEAR WE ARE IN (2019). EMT CALLED AND PT. TAKEN TO LOCAL HOSPITAL
top lip swollen  and as  of 03/28/21 lip is still slightly swollen. I called my dr's office on 3/22 and reported my symptom  and I was scheduled an appt to see a dr on 03/23. I went and was examined and she could see that my lip was swollen.  After she consulted with another dr they concluded that I shouldn't get the second dose.
Information has been received from a healthcare worker referring to a patient of unknown age and gender. On an unknown date the patient was vaccinated with improperly stored VAQTA (lot # L036300, expiration date 04-NOV-2016, dose and route were unknown). No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.
10 min after Vaccine administration, Pt. needed to.go to. Restroom. In Restroom she passed out for coulple seconds and then came out to mom.When hugging mom she again fainted. for seconds. Mom Laid her down. Rpn was by the childs side and child was awake and was.dizzy.wanted to just lie on floor. 911 were called. and Pt was OK
Migraine; Vertigo; not feeling good; This is a spontaneous report from a contactable consumer (patient). A 59-years-old non-pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot number: ER8735) via unknown route in Apr2021 at 11:00 AM at an unknown dose, dose 1, single for COVID-19 immunisation. Medical history was none. The concomitant medications were not reported. Patient had no known allergies. Patient had no covid prior vaccination and patient had not tested positive after vaccination. On 23Apr2021, patient experienced migraine, vertigo and not feeling good. Patient stated that "I got my first Pfizer vaccine in April and ever since I got it I had migraine and vertigo and I had 2 doctor suggest that I get an MRI and I don't have Insurance at the time and my doctor told me that may you guys may be able to help me with it." It was reported that "I have been experiencing severe migraines since the vaccine as well as vertigo. It is interfering with my work. I have 4-5 weekly. Patient did not receive any treatment for the events. The events were not resolved.
Upon injection, vaccine leaked out of syringe at hub site. Stopped injection after noticing after ~0.1mL expelled. Syringe removed, needle noticeably noted to have a curve and retracted into the syringe partially engaged safety.
Approximately 1 minute after receiving influenza vaccine, the patient states she lost her vision and hearing and felt dizzy.  She sat on the floor, was pale, tachypneic and bradycardic.  Patient gradually felt better and refused treatment after EMS was called.
Pt recv vax on 1/7/99; on same day pt exp headache; 1/8 pt exp dizziness, wheezing; thick tongue, tight throat & sore arm tx=Tylenol, Benadryl
No additional AE details; TE evaluation states vaccines have been administered to multiple patients; This spontaneous report was received from a certified medical assistant and refers to an 1-year-old male patient. No information regarding the patient's medical history, concurrent conditions or concomitant therapies was provided.  On 24-MAR-2022, the patient was vaccinated with an improperly stored dose of varicella virus vaccine live (oka/merck) (VARIVAX) lot #U025790, expiration date: 19-AUG-2023, administered subcutaneously (strength and exact dose were not provided) for prophylaxis (Product storage error). No adverse events were reported (No adverse event).  On 23-MAR-2022, the vaccine underwent temperature excursion from -14 Celsius degrees (C) to -10C for 3 hours and from -10C to 8C for 1 hour and 30 minutes. No previous temperature excursions were reported. Digital Data Logger was used.  This is one of several reports from the same reporter.; Sender's Comments:  US-009507513-2204USA009330:
Red, fluid-filled blisters on foot, and abdomen, about 12-13 total, itchy.
no adverse reaction; patient was given an expired dose of MMR II; This spontaneous report as received from a medical assistant and refers to a 12 month old female patient. On 07-MAY-2021, the patient was vaccinated with an expired first dose of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II)  (lot # S013683 exp date 05-MAY-2021) subcutaneously. The medical assistant reported that after vaccine was administered, it was discovered that the vaccine had expired. No adverse reaction was reported.
No additional adverse events; An expired Vaccine (VAQTA) was adminsitered to the patient; This spontaneous report was received from a register nurse refers to a patient of unknown age and gender. The patient's concurrent conditions, drug reaction or allergies, pertinent medical history and concomitant therapies were not reported      On 26-APR-2021, the patient was vaccinated with an expired dose of hepatitis a vaccine, inactivated (VAQTA) lot # T014590, expiration date 15-APR-2021, 0.5 milliliter (route not reported) for prophylaxis. The vaccine had never undergone a temperature excursion. No additional adverse events. combinationproductreport: Yes; brandname: VAQTA SYRINGE (DEVICE); commondevicename: Hepatitis A Vaccine, Inactivated; productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp & Dohme Corp. devicelotnumber: T014590; expirationdate: 15-APR-2021; deviceage and unit: 0 ; malfunction: Unknown; deviceusage: Initial; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not meet the criteria for Reportability
Mononucleosis; This is a spontaneous report received from a contactable reporter(s) (Other HCP) from medical information team. The reporter is the parent.  A 20 year-old female patient received bnt162b2 (BNT162B2), administration date 27Mar2021 (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: INFECTIOUS MONONUCLEOSIS (non-serious) with onset 05Mar2021, outcome "unknown", described as "Mononucleosis".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
PATIENT RECEIVED JANNSEN COVID VACCINE. TURNED PALE. FAINTED. VOMITED. COUGHED.  PATIENT CONDITION RESOLVED AFTER 20 MINUTES. ACTUAL SYNCOPE LASTED MAYBE 1-2 MINUTES
This spontaneous report was received from a nurse concerning to a 3 months old patient of unknown gender. No concurrent condition, medical history or allergy/drug reactions were reported. On 12-JUN-2015, the patient was vaccinated with an improperly stored dose of ROTATEQ injection (lot # K023534, expiration date: 22-MAY-2016) (strength and dose were unspecified), the route was defaulted to oral. No concomitant medications were reported. No adverse effect had been observed or reported. There were no product quality complaints (PQC) involved. No additional information was provided. This is one of several reports received from the same reporter. Additional information has been requested.
The patients received unspecified doses of LIQUID PEDBAXHIB that were improperly stored; This spontaneous report was received from a nurse, concerning unspecified patients of unknown gender and age. There were no concurrent conditions, medical history, drug reactions or allergies or concomitant medications reported. On unspecified dates between 05-APR-2017 and 01-MAY-2017, the patients were vaccinated with improperly stored doses of LIQUID PEDVAXHIB (dose, frequency and route were not reported) lot # M045206 with expiration date of 27-JUN-2019, for prophylaxis. The temperature excursion of the LIQUID PEDVAXHIB was 35 °F for a time frame of 44 minutes and 48.7 °F for a time frame of 1 hour and 15 minutes; no previous temperature excursion occurred. No adverse effects were reported. Data logger was involved. This is one of two reports received from the same reporter.  Additional information has been requested.; Sender's Comments:  US-009507513-1705USA001160:
1 -1/2 hours after vaccine I statred with a mild headache that is still lingering, Jan.1st I was fine, Jan 2nd I had fatigue, by night time I had mild body aches, mouth pain, sinus pressure, swollen gums, and extreme fatigue. Jan 3rd  mild sinus pressure, only left arm pain into arm pit area, neck pain and fatigue.
Sore rib cage on Left side, Sternum sore to touch.  Sharp pain with deep breaths.  Became worse each day until saw physician on 11/8/10.  Diagnosis of costocondritis.  Taking 600mg ibuprofen.  Have taken once with significant but not complete relief.
A 57 year old female received treatment with OncoTICE for recurrent bladder cancer. In August 2003 she reported fatigue, dysuria, urinary frequency, painful sexual relations and irritation in the area of the perineum. The patient had washed her external genitalia vigourously after each treatment. All adverse events, except the irritation resolved. The patient states she has now some lesions in this same area. FU information: At last visiton 22OCT2003 the labial/ perianal lesions were resolving.
I had a runny nose and cold-like symptoms over the weekend. Monday night (16Aug21) I started to get extremely itchy. By 0100 on 17Aug21, my entire waistline was swollen, I took OTC Benedryl and went to bed. When I woke up the next morning my entire face was swollen and my lips were triple the size.  I went to see my (medical provider), he documented the situation and diagnosed it as potentially being hives. He prescribed me Prednisone and Atarax and gave me calamine lotion. I continued seeing the same symptoms and kept up the same treatment. On Thursday I went to meet my medical provider again and during the exam, I said my throat felt swollen. He had me go to the ER at the medical center. By the time I got there, it was hard to talk. They immediately brought me into a room at the ER and stuck me with an EPI pen. My throat started to clear up and so did some of my symptoms. They started an IV about an hour after the EPI pen and gave me fluids with Benedryl. I was discharged from the hospital three hours later. I experienced the same skin reaction until Sunday morning (22Aug21).
This infant had a fever of 103 F, 50 - 100 chicken pox rash, refused to eat, and irritability.
Diffuse redness, swelling and itching that started 2 days after flu shot.
There were no adverse event after the Moderna Covid-19 Vaccine was given. Pt has 1st dose of Moderna on 1/15/21, 2nd dose of Moderna 2/12/2021 and booster of Moderna 10/26/21. Pt should have received Moderna Bivalent on 11/16/22 but was given regular Moderna instead.
blurred vision, hallucinations, rash around his eyes, HA, running nose, off balance patient refused going to emergency room, is waiting to consult with provider