chrisvoncsefalvay/vaers-outcomes huggingface dataset:
pain in back of neck; tingling in her extremities; tingling in her fingers/tingling in her toes; pain in her shoulders; soreness at injection site; This spontaneous case was reported by a consumer and describes the occurrence of NECK PAIN (pain in back of neck), PARAESTHESIA (tingling in her extremities), PARAESTHESIA (tingling in her fingers/tingling in her toes), ARTHRALGIA (pain in her shoulders) and VACCINATION SITE PAIN (soreness at injection site) in a 76-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011M20A) for COVID-19 vaccination.     Concomitant products included METFORMIN, PRAVASTATIN, LEVOTHYROXINE, LISINOPRIL, CYCLOBENZAPRINE and GABAPENTIN for an unknown indication.    On 15-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 15-Feb-2021, the patient experienced NECK PAIN (pain in back of neck), PARAESTHESIA (tingling in her extremities), PARAESTHESIA (tingling in her fingers/tingling in her toes), ARTHRALGIA (pain in her shoulders) and VACCINATION SITE PAIN (soreness at injection site). At the time of the report, NECK PAIN (pain in back of neck), PARAESTHESIA (tingling in her extremities), PARAESTHESIA (tingling in her fingers/tingling in her toes), ARTHRALGIA (pain in her shoulders) and VACCINATION SITE PAIN (soreness at injection site) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Most recent FOLLOW-UP information incorporated above includes: On 25-Apr-2021: TCR, NNI
Extreme fatigue (difficulty standing); confusion, aches, nightmares, lasting about 24 hours
Moderate to severe headache, chills, low grade fever, body aches, muscle aches, nausea, abdominal pain. All started very suddenly at 10:30am, and persisted throughout the rest of the day.
This spontaneous report was received from a registered nurse and refers to a 4 year old patient of unknown gender. The patient's medical history, concurrent conditions and concomitant medications were not reported. On 07-AUG-2017, the patient was vaccinated with an improperly stored PROQUAD at a dose of 0.5 (units not specified), lot # N012491 with expiry date 17-OCT-2018 (dose number, route and anatomical location not reported) for prophylaxis. Concomitant therapies included a properly stored sterile diluent (manufacturer unknown). The administered dose of vaccine was stored in the temperature between 6 degrees Fahrenheit and 14 degrees Fahrenheit for 20 hours and in the temperature between 15 degrees Fahrenheit and 46 degrees Fahrenheit for 6 hours. There were no previous temperature excursions. Data logger was involved. No adverse effects were reported. No additional information was provided. This is one of the several reports received from the same reporter. Sender's Comments: US-009507513-1707USA006208.
This spontaneous report received from a health care professional concerned a 51 year old female. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received COVID-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1808980, and expiry: 04-AUG-2021) dose was not reported, administered on 15-JUN-2021 for prophylactic vaccination. No concomitant medications were reported. On 15-JUN-2021, the subject experienced poor quality vaccine administered. On 15-JUN-2021, the subject experienced incorrect product storage. The action taken with COVID-19 vaccine ad26.cov2.s was not applicable. The outcome of the poor quality vaccine administered and incorrect product storage was not reported. This report was non-serious.
Brain fog, body aches, light headed, dizzy, metal taste in mouth, slight sore throat, headache, eye pain, flushed
Pt recvd 2nd dose of vax 25SEP92 & on 25SEP92 bone scan indicated that numerous joints demonstrated a focal inc in activity that was consistent w/synovitis of the involved joints, as might be seen w/rheumatoid arthritis;
My FLU shoT WAS given INTO MY UPPeR LeFT ARM on THe MORNiNG of OCT. 8, 2020, 11:10 AM. APPROX 3 hRs. LATeR, I FeLT A burning sensation ALONg wiTh paiN AT THe iNjecTioN site (upper (L) ARM. ThIs seemed ODD AS iN ALL The years I hAve gotten A FLu shoT, I hAve NeveR had a ReAcTioN! The PaiN seemed TO RoTATe between ReacTioN BuRNiNG and PaiN. The FLU shot was given on OCT. 8 2020 (THURS) By The NexT DAy, I NoTiced A RAsh by The iNjecTioN site (FRI) OCT. 9, 2020 I thoughT This ODD, buT Thought iT would go AwAy! By (SAT.) IN OCT 10 2020 The MORNINg, my (L) ARM was SwoLLeN wiTh A RAsh compLeTeLy WRAppeD ARouND My uppeR (L) ARM - From ELbow ALMOST To shouLdeR. On SuNDAy, OcT. 11th, I wenT To The pharmacy, because ThaT was wheRe I ThoughT The FLU vacine was DispeNseD FRom. My uppeR ARM was swolleN To Twice The size oF my RighT ARM. I expLaiNed to The PhaRMist ABout my ReacTioN. I Told him I Thought I had an alergic ReacTioN To TheiR vAciNe. The PhAR. Asked iF he could see my ARm. WheN I showeD him, he was coNceRNeD. He TypeD iNFoRmATioN iNTo A computeR RegARDiNg my ReacTioN. His woRDs weRe -- "IT's NoT The woRsT I have seeN, but it coNceRNiNg". I didN'T get his NAme howeveR he maDe A ReFerReNce iN his computeR aLoNg with my Name + ResiDeNce. He did Note ThaT The FLU MeD was FRom The sToRe LocATioN. AbouT Tues, OcT 13th, 2020, The swelliNg was aLmosT goNe. Due To CoviD, I was NoT comfoRTAble goiNg To a CLiNic, URgeNt CARe or HospiTaL. The Pharmacy was my choice ThaT day. IN ALL my years of FLu shoTs I hAve NeveR had a reactioN! Why now? NoThiNg is diFFeReNt. I will coNTiNue To go To my PhysiciAN, As iN The PasT...From NoW ON. BAD ReACTION LASTED 4-DAYS RASH AROUND ENTIRE UPPER ARM SWOLLEN - DOUBLE BURNING AND PAIN
Bilateral swelling of legs, induration and mild erythema See by Dr, instructed to apply ice to area. Referral to Allergist.
This spontaneous prospective pregnancy report as received from a Nurse referring to a 29 year old female patient. The patient was in the 2nd trimester of her pregnancy. None pertinent medical history nor drug reactions/ allergies were reported. On unknown date in 2017, the patient became pregnant. The last menstrual period (LMP) and estimated date of delivery (EDD) were unknown. The pregnancy outcome was pending. On 02-AUG-2017 the patient was vaccinated with M-M-R II (Lot # M045400, expiration date 14-NOV-2017) (dose and route of administration were not provided) for prophylaxis (vaccine exposure during pregnancy). Concomitant medication included Prenatal vitamins and folic acid. On 09-AUG-2017, an ultrasound was performed and the patient and her baby were OK. The primary reporter stated that the physician ordered this vaccine to be administered to the patient in error.
Patient came in for a booster, was administered Monovalent when was supposed to be Bivalent booster.
Difficulty breathing; Sore throat; Swelling of the right arm; Tingling in the right fingers; Some loss of movement in the right hand; Headaches; Injection site pain; Dizziness; Malaise; This spontaneous case was reported by an other health care professional and describes the occurrence of DIZZINESS (Dizziness), MALAISE (Malaise), DYSPNOEA (Difficulty breathing), OROPHARYNGEAL PAIN (Sore throat) and PERIPHERAL SWELLING (Swelling of the right arm) in a 35-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 047B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medical history was provided by the reporter.  Concomitant products included BUPROPION HYDROCHLORIDE (WELLBUTRIN) for an unknown indication.    On 13-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 13-Aug-2021, the patient experienced DIZZINESS (Dizziness), MALAISE (Malaise), HEADACHE (Headaches) and VACCINATION SITE PAIN (Injection site pain). On 14-Aug-2021, the patient experienced DYSPNOEA (Difficulty breathing), OROPHARYNGEAL PAIN (Sore throat), PERIPHERAL SWELLING (Swelling of the right arm), PARAESTHESIA (Tingling in the right fingers) and MOBILITY DECREASED (Some loss of movement in the right hand). The patient was treated with IBUPROFEN for Adverse event, at a dose of 1 dosage form; PARACETAMOL (TYLENOL) for Adverse event, at a dose of 1 dosage form and DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) for Adverse event, at a dose of 1 dosage form. At the time of the report, DIZZINESS (Dizziness), MALAISE (Malaise), DYSPNOEA (Difficulty breathing), OROPHARYNGEAL PAIN (Sore throat), PERIPHERAL SWELLING (Swelling of the right arm), PARAESTHESIA (Tingling in the right fingers), MOBILITY DECREASED (Some loss of movement in the right hand), HEADACHE (Headaches) and VACCINATION SITE PAIN (Injection site pain) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 14-Aug-2021, Blood pressure measurement: 87/60 (Low) 87/60.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Patient discontinued Wellbutrin Treatment medication included a steroid injection.
Anxiety; This spontaneous case was reported by a consumer and describes the occurrence of ANXIETY (Anxiety) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. Unknown) 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) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced ANXIETY (Anxiety). At the time of the report, ANXIETY (Anxiety) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No relevant concomitant medications were reported. No treatment information was provided.   Reporter did not allow further contact.
12/13/13 3:28pm Patient stated after the flu-shot was given in her left deltoid muscle she claims that 15 days after the area (site) is still hurting and she's in pain. She also stated she has problem lifting that specific arm. She stated she has taken ibuprofen 600mg. The area is tight on the left shoulder.
fever; pain in her arm; This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (fever) and PAIN IN EXTREMITY (pain in her arm) 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 27-Apr-2021, the patient experienced PYREXIA (fever) and PAIN IN EXTREMITY (pain in her arm). At the time of the report, PYREXIA (fever) and PAIN IN EXTREMITY (pain in her arm) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       This case was linked to US-MODERNATX, INC.-MOD-2021-092478 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-092478:wife case
nl devel including language prior to MMR stopped talking 5 days p/vax;slowly devel signs of classic autismover the ensuing 3 to 4 wk (loss of eye contact, interaction, appropriate toy play;devel chronic non specific diarrhea;
Extremely sleepy and blurred vision. The blurred vision has continued now 3 days.
Site: Redness at Injection Site-Medium, Site: Swelling at Injection Site-Medium, Systemic: Allergic: Rash (specify: facial area, extremeties)-Medium, Additional Details: rash and swelling on upper arm
Vaccine given to me around 9:30 AM this morning, I felt a never-before-experienced [[name]] sensation of the fluid entering and flowing down my arm.  The nurse left room, within 30 seconds after shot there were [[name]] pains throughout my arm followed by extreme dizziness and faintness.  I struggled in the room for around five minutes to not pass out and fell on the floor once.  I was experiencing extreme blacking out of vision and loss of consciousness.  When I stumbled my way down the hall to the waiting room I collapsed in a chair and two nurses placed me in a wheelchair.  I was sweating intensely, was very pale, and my pupils were completely dilated.  The remainder of the day I experienced bad sinus pain that only occurred after the vaccine, a sharp [[name]]ache, shakes and nausea.  This evening I feel pressure in my [[name]], am dizzy whenever I stand, my arm is still painful, weak and numb.
12 y/o presents for covid vaccine(pfizer dose 1) accommanied by 18 y/o brother with verbal consent from parent  patient, after receiving the Pfizer injection seemed to be in no apparent distress upon standing from the exam bed she demonstarted no synptoms of dizzinesxs or being light headed in observation area after 15 minutes of receiving the vaccine we noticed she appeared to be sleepiung but when aroused she seemed ome what larthagic and complained of a headache while observing her gait she appeared to be unsteady   BP was taken at 124/75   Pulse 85    res 16   lungs were clear bilaterally and denies any respiratory distress  no rashes present no flushing or swelling  of the face   denies pruritus   denies swelling of tongue or mouth and no skin rashes noted  because she still seemed some what lethargic and unstaedy with her gait EMS was contacted  and patient was transported to  hospital Mother was called and agreed that patient be screened at ED
Tested positive for COVID-19 with symptoms; A spontaneous report  was received from pharmacist concerning a male patient, who received Moderna's COVID-19 vaccine (mRNA-1273).  The patient's medical history was not provided. No relevant concomitant medications were reported.  On 22 Dec 2020, prior to the onset of the events, the patient received their dose of mRNA-1273 (Batch Number: Unknown) for prophylaxis of COVID-19 infection.  On 30 Dec 2020, the patient tested positive for COVID-19 with symptoms.  No treatment information was provided.  Action taken with the second dose of mRNA-1273 in response to the event was not reported.    The outcome for the event, tested positive for COVID-19 with symptoms, was not reported.; Reporter's Comments: Very limited information regarding this event/s has been provided at this time.  Further information has been requested
This spontaneous case was reported by a physician and describes the occurrence of PYREXIA (Fevers) in a 20-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. unknown) for COVID-19 vaccination. No Medical History information was reported. On 02-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PYREXIA (Fevers). The patient was treated with PARACETAMOL (TYLENOL) for Fever, at an unspecified dose and frequency and IBUPROFEN for Fever, at an unspecified dose and frequency. At the time of the report, PYREXIA (Fevers) had not resolved. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Laboratory test: normal (normal) normal. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. Concomitant product use was not provided by the reporter. Within 24 hours of receiving the vaccine, the patient started to have daily fevers. This situation was ongoing for more than 2 weeks currently. The healthcare professional (HCP) ran laboratory and conducted studies, but everything looked normal. Patient took Tylenol and Ibuprofen to treat this, but not regularly. Patient had an 'IDU'.
pt recvd vax & devel fever to 99-102 which lasted 1 wk; work-up was unrevealing; Reporter refused to provide pt or MD info;
Nanny of this pt given Smallpox vaccine on 2/22/03, without incident. This pt has severe erythema treated routinely by nanny. Now with outbreak of itchy/painful growing vesicles on erythematous base.
Reason for test: day 5 travel. Last day worked: 6/11/21 full work day. EE no longer employed. Did an exit interview 6/25/21. Day called in sick ?day absent?: 6/11/21EE then was on PTO 6/13-6/21. Date Tested/Results: 6/25/21. COVID-19 Vaccine Yes/No: 2 doses. Date of last dose: 1/23/21. Notes: Received call stating EE is COVID Positive. EE day 5 post travel testing, 6/25/21 resulted COVID Positive. EE travelled from 6/15/21-6/20/21. EE is fully vaccinated for COVID, last dose received 1/23/21. Called EE to notify her that she is COVID positive and will need to quarantine. She is asymptomatic. EE was at the beach with her kids when notified. Instructed EE that she will need to leave the beach and begin quarantine. EE stated that she is no longer a Employee. She did her exit interview on 6/25/21. EE did not do QUASAR study. EE states she now works at Medical Center. Employee Health notified. Instructed EE that she will be contacted for further follow up and contact tracing. She should also let her current employer, Medical Center, know of her positive COVID result and to only return after she is released.
My voice has changed, mean to say it's higher; It is red and inflamed; It (rash) is red and inflamed; This is a spontaneous report received from a contactable pharmacist (Patient).   A 81-years-old male patient received second dose of BNT162B2 (BNT162B2, Solution for injection, Batch/Lot Number: EL9264), via an unspecified route of administration on an unspecified date as single dose for COVID-19 immunization. Medical history included ongoing atrial fibrillation. The patient's concomitant medications were not reported. Patient stated that his voice has changed, it seems very, mean to say it's higher. he donot know if that is from it but the main thing he was calling about was a rash that I developed. Patient was treated with Benadryl for the itchy rash and he started a dose of Methylprednisolone. Reporter stated that the rash was red and inflamed. The outcome of the events was unknown.
I Received my 1 dose on 01/16/2021 and my adverse event started on the same day. My left arm was painful to move. I through it was normal for few days but gradually the pain started to increase. After the 2nd dose the pain was more  severe and I said to myself something was wrong. So I decided to go to see my doctor for it. My doc referred me to an orthopedic doctor. I did physical therapy for over 1 year. At the specialist office that's were they gave me to take steroids, injections on my left arm which didn't help with the pain. I had an acupuncture on fall of 2021. I also had a surgery on 12/27/2021. They gave me massage on my left arm for 1 hour for every month. I also had cervical  injections and the pain went from arm to left side of my neck. I still have the pain as of now 02/25/2022. It's basically more than 1 year. I am going to physical therapy for this problem.
Rashes on her back; Rash on neck and little on arm; This spontaneous case was reported by a consumer and describes the occurrence of RASH (Rashes on her back) and INJECTION SITE RASH (Rash on neck and little on arm) in a 78-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 023M20A) for COVID-19 vaccination.     No Medical History information was reported.   On 18-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 18-Feb-2021, the patient experienced RASH (Rashes on her back) and INJECTION SITE RASH (Rash on neck and little on arm). The patient was treated with XIPAMIDE (AQUAPHOR [XIPAMIDE]) for Rash, at an unspecified dose and frequency. At the time of the report, RASH (Rashes on her back) and INJECTION SITE RASH (Rash on neck and little on arm) had resolved.            No relevant concomitant medications were reported.   Most recent FOLLOW-UP information incorporated above includes: On 14-Jul-2021: Follow-up information received on 14-JUL-2021 and the outcome of the events has been updated from unknown to resolved.
A spontaneous case report was received from a pharmacist on 27-Jun-2018 for two consumers. Based on the information obtained from the pharmacist, two individual case safety reports PVX201806-000641 (PVX2018-2075; female) and PVX201806-000642 (PVX2018-2091, male) were created and cross-linked in the database. This case report describes a female consumer who "took VAXCHORA inspite of being among an unapproved age group to take it". The consumer was receiving VAXCHORA for cholera prophylaxis. It was reported that the consumer administered VAXCHORA but she was over the age of 64 years and under 81 years of age. The action taken with VAXCHORA with respect to event "took VAXCHORA inspite of being among an unapproved age group to take it" was not applicable. The clinical outcome of the event "took VAXCHORA inspite of being among an unapproved age group to take it" was unknown.; Sender's Comments: The causality of the event "took VAXCHORA inspite of being among an unapproved age group to take it" was considered as not applicable.
Vaccine administration error - mixed series.  Patient received Moderna vaccine as 1st dose on 4/3/2021, and received Pfizer vaccine as 2nd dose on 5/1/2021.  He had no adverse reaction or symptoms at the time of administration or during the observation period.  The patient and his family (wife and son present with him on site) were notified of the vaccine administration error, the current CDC guidance for mixed series deviation was reviewed with them, and all questions were answered.  An interpreter was used for this discussion.
Fainted within a minute of receiving shot. Very pale, clammy vitals normal. He layed down gave him a snack fine within 30 minutes.