chrisvoncsefalvay/vaers-outcomes huggingface dataset:
she had fillers in her face and they all just started swelling like crazy bad; Patient received first dose of Moderna COVID-19 vaccine, on 09Aug2021 and the second on 14Sep2021; This spontaneous case was reported by a consumer and describes the occurrence of SWELLING FACE (she had fillers in her face and they all just started swelling like crazy bad) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Patient received first dose of Moderna COVID-19 vaccine, on 09Aug2021 and the second on 14Sep2021) in a 49-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 006D21A and 003F21A) for COVID-19 vaccination.     No Medical History information was reported.   On 09-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 14-Sep-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 14-Sep-2021, the patient experienced SWELLING FACE (she had fillers in her face and they all just started swelling like crazy bad) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Patient received first dose of Moderna COVID-19 vaccine, on 09Aug2021 and the second on 14Sep2021). On 14-Sep-2021, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Patient received first dose of Moderna COVID-19 vaccine, on 09Aug2021 and the second on 14Sep2021) had resolved. At the time of the report, SWELLING FACE (she had fillers in her face and they all just started swelling like crazy bad) outcome was unknown.            Concomitant medications details were not reported by the reporter. Treatment details was not reported by the reporter.   Reporter did not allow further contact
Breast Engorgement: Patient is breastfeeding and began having nightly and daily engorgement starting the night after the first dose. It is every night and most days in both breasts. This stopped one day after receiving the second dose of the vaccine.  PCP said he had not heard of this and referred to Lactation Consultant who said the same thing and instructed patient to continue not pumping. No other recommendations how to treat the engorgment. (Unable to fill in other medications Item 9: Regular medications and supplements: clonidine, cromolyn sodium, ketotifen, montelukast, hydroxizine, cimetidine, Vit D, postnatal vitamin, NAC, Quercetin, Fish oil, Choline, Probiotics, B12)
This case was reported by a consumer via call center representative and described the occurrence of pain in arm in a 72-year-old female patient who received SHINGRIX for prophylaxis. On 30th November 2018, the patient received the 2nd dose of SHINGRIX. On 30th November 2018, less than a day after receiving SHINGRIX, the patient experienced pain in arm. On 1st December 2018, the patient experienced sickness, fatigue, chills and headache. On 1st December 2018, the outcome of the pain in arm was recovered/resolved. On 4th December 2018, the outcome of the sickness, fatigue, chills and headache were recovered/resolved. It was unknown if the reporter considered the pain in arm, sickness, fatigue, chills and headache to be related to SHINGRIX. Additional details were reported as follows: This case was reported by the patient's husband. On Friday, the patient received SHINGRIX on the left arm. The patient had pain in the arm of the shot and was sick for the next few days. The reporter explained sick as fatigue, chills and headache. The patient was in bed for Saturday and Sunday. At the time of reporting, the patient was felt back to like herself. The reporter had declined to provide the healthcare professional information. The reporter did not consent to follow-up.
After receiving HPV vaccine patient had a near syncopal episode with altered mental status lasting almost 45 minutes. After 45 minutes pt had returned to pre-vaccine status and was observed in office.
reports rt arm was the worse reaction, the left arm had some redness and swelling too but not as bad had fever for 72 hours, resolved day after admission on antibiotic doing better now chart reviewed, received trumemba rt arm, pneumovax and flu shot to the left arm
Patient notes dizziness around 10 minutes after vaccination while in waiting area. BP 150s/110. Notes hx of HTN with previous  pregnancy. Patient monitored for 30 minutes. Provider called. Encouraged to follow up with PCP.
Information was received from a registered nurse who reported that an unspecified number of patients may have received M-M-R II, GARDASIL, ROTATEQ, and VAQTA that were exposed to unknown temperatures for four hours and VARIVAX (Merck), measles virus vaccine live (Enders-Edmonston), mumps virus vaccine live (Jeryl Lynn), rubella virus vaccine live (Wistar RA 27/3), PROQUAD (Merck) and ZOSTAVAX exposed to unknown temperatures for five hours during interoffice transport. All vaccines were possibly administered to patients. No adverse symptoms reported. The nurse was unable to provide further temperature excursion details, dates of administration and lot number/expiration dates to inquire whether these patients need to be vaccinated. Additional information has been requested.
Patient called Friday 12/8/17 stating she had a itchy rash that started on her chest area Wednesday and by Friday had also started to break out on her legs. Patient stated if the rash didn't resolve by Monday, she would seek medical attention.
My 12 year old received her 1st shot of GARDASIL. Walking out of the MD office she told me she was dizzy. I helped her to sit and then she passed out. She twisted her hands and opened her eyes big in a letargid way and didn't blinking. Her skin turned pale and bit green. I called by her name but she didn't respond.MD and RNs assisted her laying down and gave her a candy; they also checked her blood pressure. She does not recalled any of it. I am not giving her the 2nd dose.I'm worry about long term/permanent side effect derive from the seizure.
About four after vaccination I had Tachycardia and lasted about four hours. This caused me to have an anxiety attack as well as being short of breath for the entire episode. I was also very dizzy.  I was also 32 weeks pregnant. I got the second dose and I did have a little Tachycardia for an hour but I had Anxiety medicine and I was ready for it.
Diarrhea, nausea, itchy rash, joint aches, weakness.
It began this morning with pain  in the muscle of my left arm just below the shoulder. I received the vaccine in my right arm. Then I began having pain and soreness in my scalp. Tonight the pain has become a headache, and my right eyelid is very sore. The area of pain and soreness in my scalp has grown larger. I am feeling kind of fluish.  Because I had polymialgia rheumatic a several years ago. My wife and I are concerned that I have Giant  Cell Arteritis. I am praying that this is not the case, and these symptoms are a temporary  reaction to the vaccine. But it is worrisome, because GCA needs to be treated early to avoid the possibility of blindness.
I had a dry patch on my back, rash on chest, abdomen, and back. The doctor prescribed me prednisone. It was getting better while taking it. When I was done taking it the rashes came back. I went back to the doctor they prescribed me more methylprednisolone for 2 weeks now my rashes are gone.
Pt stated he felt like his throat was closing up(severity scale 3/10 per patient). Mother happened to have Benadryl so patient was given Benadryl 50mg. Pharmacist and mother observed the patient for about 45 minutes in the pharmacy.  Pt felt better and left the pharmacy without incidence. followed up with the patient on 7-11-2010 again and spoke to the mother. Pt recovered from discomfort caused by throat closing but states his arm was sore.
Onset of chills, shivering, and headache about 8 hours after injection. Lasted about 32 hours. Fever reached 101.3 about 18 hours after injection. Treated first with naproxin sodium and later  with acetaminophen. Arm soreness lasted about a day with minimal redness.
This spontaneous report as received from a consumer refers to a patient of unknown age and gender. No information regarding the patient's pertinent medical history, concomitant medications, drug reactions or allergies was provided. On an unknown date, the patient was vaccinated with a dose of GARDASIL (dose, frequency, route of administration, lot# and expiration date were not reported) or a dose of GARDASIL 9 (dose, frequency, route of administration, lot# and expiration date were not reported). It was unknown if product was GARDASIL or GARDASIL 9. On an unknown date, the patient experienced adverse event unspecified. The outcome of adverse event was unknown. The relatedness between the adverse event and therapy with GARDASIL or GARDASIL was not reported. This is one of six reports received from the same source.; Sender's Comments:  US-009507513-1712USA013057: US-009507513-1712USA014393: US-009507513-1712USA014394: US-009507513-1712USA014395: US-009507513-1712USA014396:
Rec'd HPV #1 12-16-08- No reaction. HPV#2 2-16-09- 2 wks after- severe abd pain, and facial swelling, lips and extremities swollen, no resp diff. rash on abdomen. HPV #3 6-16-09- 9 days after same reaction. Rx BENADRYL.
A non-serious spontaneous report of "runny nose and low grade fever was received from a pharmacist concerning a four-year-old female patient subsequent to FLUMIST. This case is submitted in accordance with MedImmune's post-marketing commitment on accelerated reporting for the newly indicated population of 2 years to 59 months of age for FLUMIST. The patient's medical history and concomitant medications were not reported. The patients received FLUMIST on 23-Oct-2009. On the same same day, the patient experienced a runny nose and low grade fever. The events were ongoing. Required follow up attempts have been performed, requested information unable to be obtained.  23-Feb-2010.
Patient was seen a week after initial injection on 1/6/21 with a red, raised, and warm to touch area of injection that was sore and itchy
pt recvd vax 13OCT95 & 16OCT95 pt devel a rash, body aches, & fever;the pharm.D stated that doesn't believe it was due to the shot;No further details were provided;
Covid 19, I was diagnosed with long Covid symptoms, extreme exhaustion, severe diarrhea, constant coughing, dry cough, was prescribed tramadol for the coughing.
Redness, swelling, warmth, tenderness of right upper extremity above and below vaccine site. Covers entire tricep region.
Catastrophic Costochondritis onset during  exercise, 6 days after vaccination. Pain gradually increasing since event.
Pt received her first dose of the Moderna vaccine with no problem however about 20 minutes after the vaccination the pt reported tingling and pain in her arm which she received the vaccine in. Tingling progressed down her arm and was not resolving. Pt has a history of anaphylaxis to Penicillin as well as other medications including injectables. While pt was waiting in observation she reported the tingling had then moved to both of her hands. At that point in time pt began to get nervous. Pt was offered EMS evaluation to which she agreed. BP 128/90 HR 76 RR 16 O2Sat 98%. Normal neurovascular exam. EMS arrived and did their evaluation. Pt was feeling better at that point and signed a refusal for transport with. Pt was given ED precautions to which she verbalized understanding.
Day after injection noticed redness and swelling (arm). Arm was hot and some hives were apparent. Itching was terrible. Went to an internal medicine Dr. on 10/31/2018 and got a steroid shot. Also used cortisone cream. Symptoms lasted exactly 2 weeks. Although they did get less over time.
COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 68-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 16Jan2021 as dose 1, single (Lot number: EL0142), in left arm, on 10Feb2021 as dose 2, single (Lot number: EL3249), in left arm, on 28Sep2021 as dose 3 (booster), single (Lot number: 301358A), in left arm and on 26Apr2022 as dose 4 (booster), single (Lot number: FK9894) at the age of 67 years, in left arm for covid-19 immunisation. The patient had no relevant medical history. Concomitant medication(s) included: ATORVASTATIN, start date: 01Jan2020, stop date: 05May2022; CITALOPRAM HBR, start date: 01Jan2020, stop date: 12May2022. The following information was reported: VACCINATION FAILURE (medically significant) with onset 02May2022, outcome "unknown", COVID-19 (medically significant) with onset 02May2022, outcome "not recovered" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (02May2022) positive, notes: Tested positive for Covid on 02May2022; (08May2022) negative, notes: Tested negative for Covid with at-home test 08May2022; (11May2022) positive, notes: Tested positive for Covid at home on morning of 11May2022; (12May2022) positive, notes: Tested positive for Covid at (withheld) morning of 12May2022 (day I'm submitting this report). Therapeutic measures were taken as a result of covid-19. Clinical course: Adverse event: Purpose of this submission was to report rebound Covid after completing Paxlovid regimen. Patient not experiencing any symptoms at this time (other than positive Covid tests as detailed below). Tested positive for Covid on 02May2022. Began Paxlovid regimen on 5May2022. Tested negative for Covid with at-home test 08May2022. Completed Paxlovid regimen on evening of 09May2022. Tested positive for Covid at home on morning of 11May2022. Known allergies was reported as no.  No follow-up attempts are possible. No further information is expected.
Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 23-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 27Apr2021 as dose 1, single (Lot number: Ers737), in left arm and on 11May2021 as dose 2, single (Lot number: Fw0171) at the age of 21 years, in left arm for covid-19 immunisation; coviD-19 vaccine mrna (mrna 1273) (MODERNA COVID-19 VACCINE), on 10Dec2021 as dose 3 (booster), single (Lot number: 032h21a), in left arm for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset May2022, outcome "unknown" and all described as "Treatment of COVID-19". Therapeutic measures were taken as a result of covid-19.  Clinical course: The patient received vaccine. The patient received other medication in 2 weeks.  No follow-up attempts are possible. No further information is expected.
Patient developed cough, runny nose, loss of smell, disturbing vivid dreams, and  sore throat on 07/11.  Tested positive for COVID on 07/14
pain & swelling around inj site of rt arm (rt arm circumference 38cm;lt arm 34); tx started 17OCT96 w/Pred & ATB;total resolution 23OCT96;
Injection was in left arm. A few hours later, left armpit/gland began hurting and was sore. Armpit felt swollen. Lasted 3 days. Ibuprofen given prn. Resolved.
Information has been received from a pharmacist via a field employee referring to a patient of unknown age and gender. Information about medical history, concurrent condition and concomitant medication was not reported. On an unknown date the patient was vaccinated with  a dose of ZOSTAVAX 19400 PFJU (strength, dosage frequency and route unspecified. On an unknown date  the patient stated that she/he felt like they had bug bites and experienced tingling on her/his arms and legs after receiving ZOSTAVAX. The patient sought medical attention via contacting pharmacist. The outcome of the events was unknown. Additional information has been requested.
Patient with bilateral localized redness, swelling at the site of injection on exam, left thigh measuring 1 inch diameter, area of raised ecchymosis. Right thigh measuring 3 inch x 2.5 inch area of ecchymosis, no increase warmth noted, tender to palpation.
Vaccine administered after more than 1 temperature excursion; Vaccine administered after more than 1 temperature excursion; This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine administered after more than 1 temperature excursion) and POOR QUALITY PRODUCT ADMINISTERED (Vaccine administered after more than 1 temperature excursion) in a 38-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 019B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 27-Mar-2021 at 4:54 AM, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On 27-Mar-2021 at 4:54 AM, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (Vaccine administered after more than 1 temperature excursion). On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine administered after more than 1 temperature excursion). At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine administered after more than 1 temperature excursion) and POOR QUALITY PRODUCT ADMINISTERED (Vaccine administered after more than 1 temperature excursion) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   The age of patient was provided as 38.15  Concomitant products were not provided.  On 27-Mar-2021, Excursion time was 09 AM and 10 AM  temperature was 35 and 35, total doses given for the day was 195, condition of vaccine prior to administration was not frozen, vaccine was moved to fridge on 23-Mar-2021, vial was moved to clinic on 27-Mar-2021. 20 vials were sent to clinic. Vaccine BUD date was 22-Apr-2021.  The vials were only punctured right before administration and all doses were drawn from the vial due to high-pace clinic.  Temperature recordings were taken using a traceable temperature monitor at every hour.  After administration, the vial was returned to the freezer/refrigerator, or maintained at room temperature.  It was reported that the patient was administered with vaccines that experienced more than 1 temperature excursion during 33 weeks in 2021. The HCP explained that each time a vial was put into a cooler, there was a period of 1 hour or 1 and half hour approximately, when the temperature data logger registered 34 or 35 degree F.  Treatment medications were not reported.
Post vaccination patient received pediatric dose of Pfizer 0.2ml, which is not the recommended dose for 12 years and older. Patient stated he is feeling fine vitals assessed BP 140/85 RESP 16 Pulse 92 @ 4:45pm.  Patients mother has given the consent to give the 0,1ml dose to accommodate for the full dose of 0.3ml which is required for the 12 year old and up. . Educated parent to follow up with the pediatrician. Patient dispositioned with mother.
I experienced intense nerve pain down my left leg and foot from about 8:15am-10:15am. I hadn?t experienced pain like that since my injury was new (7.5 years ago). After enduring for two hours I took ibuprofen which did help. The pain continued with reduced frequency for about 24 hours from onset.
First, I had a mildly sore throat. I had very quick onset chills, Fever of 102, headache and O2 level of 90%. My muscles were very fatigued and painful. I had a negative PCR test on the 16th at 10AM in the morning. I completed an antigen PCR COVID-19 test and it was positive. My oxygen seemed to be better on this date. I called my doctor and had a telemedicine visit. He prescribed PAXLOVID and I started to take it the same day. My symptoms gradually improved but the headache lingered. Once the fever and headache improved, my muscles continued to be sore for 3 to 4 weeks. I was given a CPK in December 2022 and it was normal. I took TYLENOL to treat the symptoms. It impacted my gate, but it was normal by Christmas. I had an odd, strange hospitalization on January 28, 2023. I woke up on the 28th and I was very dizzy. I could not stand up due to feeling dizzy around 7AM. I called my doctor's office and was advised to go to the ER. They did a blood panel which was normal as well as a CTA that was normal. I had a brain MRI on the January 29th that was normal along with Vestibular testing which also was normal. My symptoms resolved in about 8 hours. I was discharged around noon on the 29th. They gave me 1 meclizine around 3 PM and that's when my symptoms dissolved. I have been fine since then. My physician indicated that he did not know why this happened.
Information has been received from a licensed practitioner nurse concerning an 11 year-old patient of unknown age. There was no pertinent medical history, concomitant medication or drug allergies/drug reactions described. The reporter stated that on 14-AUG-2015, the patient was vaccinated with a dose of improperly stored GARDASIL (lot # K023432, expiration date 18-JUN-2016 (dose and route were not reported), which underwent supported temperature excursions. It was unknown if the patient sought medical attention. Product quality complaint (PQC) was not involved. This is one of several reports received from the same source. Additional information has been requested.
Arrived for SOB, N, weakness and black stools. Dx with COVID 9 days PTA. Tested positive on arrival. Given O2 intermittently but did not require other target therapies. Treated for upper GIB. DC home.
This case was reported by a healthcare professional and described the occurrence of burning pain at injection site in an adult subject of unspecified gender who was vaccinated with Fluarix (GlaxoSmithKline). The subject had received previous immunizations with influenza virus vaccine with no subsequent adverse events. On an unspecified date on or after 21 October 2007 and before 8 November 2007, the subject received 1st dose of Fluarix (.5 ml intramuscular, unknown deltoid). Within 24 hours after vaccination with Fluarix, the subject experienced burning pain at injection site, pain radiating up arm and reduced range of motion. The healthcare professional reported that there were no signs of cellulitis, no induration, no warmth or redness at the injection site. The subject was treated with Medrol Dosepak, muscle relaxants, pain medication and physical therapy. The healthcare professional considered the events were clinically significant (or requiring intervention). At the time of reporting the events were unresolved. The healthcare professional considered the events were probably related to vaccination with Fluarix.
Extreme fever, vomiting, dehydration, headache, severe chills, intense muscular pain to the point of it affecting motor function, dizziness, and hallucinations.
Mom witnessed pt quit breathing, turned blue, was given CPR in route to hosp; recovered spontaneously;
Went to ER that evening and was given prednisone for hive welps on right arm
5 days after flu shot, I developed a rash.  This rash was all over my body except my face.  The dr's that treated me were dermatologist, family dr.,  Allergist, dermatologist. dermatopathology.  Report 11-20-08 reaction to flu vaccine (THIMEROSAL) Rash lasted 6 months
After 1st dose of ROTATEQ pt. had vomited in the office and then contiued diarrhea at home.  After 2nd and 3rd doses vomited the next day and then diarrhea for 1 week.