chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Pain in her arm; This case was reported by a consumer via call center representative and described the occurrence of pain in arm in a elderly female patient who received Flu Seasonal QIV Dresden (Influenza vaccine Quadrivalent unspecified season) for prophylaxis.   On an unknown date, the patient received Influenza vaccine Quadrivalent unspecified season at an unknown dose. On an unknown date, unknown after receiving Influenza vaccine Quadrivalent unspecified season, the patient experienced pain in arm. On an unknown date, the outcome of the pain in arm was recovered/resolved.   It was unknown if the reporter considered the pain in arm to be related to Influenza vaccine Quadrivalent unspecified season.  Additional details were provided as follows: The age at vaccination was not reported. The patient stated that she had developed pain in her arm after receiving flu vaccines in the past (unknown manufacturer). The reporter did not consent to follow up. This case has been linked to US2019196474 (same patient) and US2019196508, reported by same reporter.
patient developed widespread severe rash and fever within 24 hrs of receiving 2nd COVID vaccine.  treated with steroids  as started to have mucosal involvement.  SOmewhat urticarial in nature as was itchy.   Turned into severe eczematoid appearing rash.
Girlfriend to patient who received the nasal flu vaccine showed multiple signs of virus including headache, sore throat, and nausea after interacting with patient.
I was told by guardian that the day after receiving his Tdap Boostrix and Mengococcal Menveo that patient had a grand mal seizure witnessed by patient's mother.
Wednesday morning he woke up with a rash on his back and legs. By Thursday morning it has covered him head to toe. Rash is red dots that blanche
Patient noted heaviness in chest and had to take deep breaths to feel she was getting any oxygen. She had an erratic heartbeat and could feel it jumping. She was pale with red eyes. Chest heaviness and erratic heartbeat were relieved by the morning of 01/06/01. Patient reported no wheezing or sore throat.
Patient presented to the ED as a stroke alert for aphasia that started 10 minutes prior. Symptoms started 10 min after the patient received her flu shot. She became diaphoretic and was having trouble speaking. Initially, the patient was able to listen and follow commands, but no longer is following as many commands or answering as many questions. A neurologist was consulted to see the patient. Initially, when interviewed, she rambled incoherences. She had significant difficulty naming. Her speech was nonfluent. Slowly over time, the quality of her speech and fluency improved, although remained impaired, even after a CAT scan was completed. An MRI of brain with and without contrast was subsequently performed and was found to be normal. No evidence of acute ischemia or abnormal enhancement. The patient remained in the ED for approximately 3 hours, received IV fluids and close monitoring. The patient's symptoms appeared to have been completely resolved by that time and considering the unremarkable CT and MRI, the team suspected that this is a complex migraine. The patient was sent home from the ED and will be re-evaluated as an outpatient for migraine treatment.
Patient developed fist size red knot on arm a few hours after vaccine was administered. The knot has decreased in size. On 11/6/17 started to itch all over and hives on face. Also trouble sleeping. Dr advised BENADRYL and pt doing better.
When I had first vaccine in July, I had flu-like symptoms, severe nausea and vomiting.  Side effects lasted approx. one wk.  Second vaccine in September gave same side effects, but also starting approx. 3 hrs. after vaccine was received:  severe pain in hands, fingers and feet.  My eyeballs hurt, as well as my inner ears.   This pain lasted from Friday thru Sunday.   On Sunday, pain lessened, but palms of my hands were extremely itchy!   No rash was seen.   This itching lasted 3-4 hrs.   Felt "shaky" and unsteady until Wednesday.
Information has been received from a physician and a registered nurse concerning a 7 y/o white male student with no medical history and no allergies who on 07Oct1996 was vaccinated SC in the right arm with a first dose of varicella virus vaccine live. There was no illness at the time of vaccination. On 10Mar2003 the pt was "seen here" and it was reported that had "broken out" with chickenpox which was complicated by impetigo. Medical attention was sought and the pt was treated with amoxicillin trihydrate (AUGMENTIN) and mupirocin (BACTROBAN) "(sister + strep)". There were no diagnostic or laboratory tests performed. Subsequently, the pt recovered. No further information is expected.
Administered Expired vaccine; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Administered Expired vaccine) in a 69-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 006C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 22-Nov-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 22-Nov-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Administered Expired vaccine). On 22-Nov-2021, EXPIRED PRODUCT ADMINISTERED (Administered Expired vaccine) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No Concomitant medication was reported. Reporter stated that the vaccine was stored in freezer, and they take out one to two vials and place in fridge each day as needed. HCP was wanted to know next step after giving expired Moderna Vaccine. No treatment was given to patient.
temperatures out of the recommended storage temperature range / no AE; Initial information received on 29-Oct-2019 regarding an unsolicited valid non-serious case received from a other health professional.  This case is linked to cases 2019SA301577 and 2019SA301601.  This case involves a 6 years old female patient who received second dose of suspect IPV (VERO) (Expiry date 18-Nov-2019) lot N1K93 via intramuscular route in the right deltoid on 15-Oct-2019.  It was a actual medication error case due to incorrect product storage.  It was reported that temperatures out of the recommended storage temperature range.  At a time of reporting No adverse reaction reported.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Day of vaccine I felt perfectly fine. The next day i woke up with a swollen arm and very painful every time i loved it. Injection site was hot to the touch and it felt like a knot was under my skin. around 10:00am I began to feel feverish all over my body. I began to have the chills and began to feel tired. My body was achy as well and a headache developed. I slept from about 12:30PM to 6:30 PM and took acetaminophen at that time. Feverish feeling and chills broke after pill got into my system. Arm is still in major pain.
Upon shot being administered into left  arm, Immediate sensation of dripping down left arm;; increasing pain; frozen shoulder; loss of range of motion; constant pain since shot. Shot#2 in right arm had minor pain at site that went away in a few days.
(seizure/cyanosis/bradycardia)Within about 1 minute after pneumovax and hepatitis A vaccines were administered the child cried. When her mother hugged her to comfort her, the child threw her head back and appeared to have a syncopal episode hitting her head (not hard) against the wall. She then became cyanotic and had a myoclonic seizure lasting about 2 minutes. The child's 02 sat increased to 96%. HR 75, BP 96/62. HR decreased to 54. Oxygen administered 2L via nasal cannula. O2 sats increased 98-99. HR 68-72. Normal neuro recheck once patient regained consciousness (LOC lasted about 1 min) EMS called. EKG-WNL. Patient monitored about 1-2 hr.
sore arm; body aches; This case was reported by a consumer via interactive digital media and described the occurrence of pain in arm in a male patient who received Herpes zoster (Shingrix) for prophylaxis.   On 31st July 2020, the patient received Shingrix. On an unknown date, less than a week after receiving Shingrix, the patient experienced pain in arm and general body pain. On an unknown date, the outcome of the pain in arm and general body pain were recovered/resolved.   It was unknown if the reporter considered the pain in arm and general body pain to be related to Shingrix.  Additional details were provided as follows: The case was reported by patient's wife. The age at vaccination was not reported. The patient had the Shingrix vaccine. He had a sore arm and body aches for two days.
After receiving the four vaccines patient complained of being dizzy. Had client put head between legs. Had client sit like this for a few minutes. Asked client to sit up and asked if was still dizzy. He stated "no". Had client stand by seat to see if became dizzy when he stood up. He stated that he was not dizzy and client's cloring was normal.
My sister was fine the evening of the second dose.  The following morning she said she felt paralyzed, could not get out of bed.  She was taken from one hospital to another hospital and has essentially been bedridden ever since.  She cannot get out of bed and cannot walk since 6/25/21!
This spontaneous report was received from a consumer refers to herself as a female patient of unknown age. On 22-JAN-2011, the patient was vaccinated with ZOSTAVAX (dose and frequency was not reported). On 06-DEC-2013, 1050 days after onset of therapy, the patient developed welt on her right trunk and 3 days later many more welts with blistering on the original ones. The patient experienced shingles and the shingles were 2 to 3 inches wide. The physician prescribed VALTREX to the patient on 11-DEC-2013. The outcome of the event shingles was unknown. The reporter did not provide the causality between the event and the suspect drug. Additional information has been requested.
?Moderna COVID-19 Vaccine EUA? I got up at approximately 9:45 am on 2/28/2021 and went in to use the bathroom, After I finished I was washing my hands and suddenly felt a wave of nausea. I gripped the sink and next I knew I woke up on the floor.  I suffered severe bruising from the fall. Only other side effects I had were a slight headache and chills a few hours after this incident.
Headache, dizziness, fatigue, fever of 101.2, muscle aches for 2 day, took alkaline seltzer cold Plus
Large local reaction on the arm; spreading erythema down the arm, painful; injection site very painful.
Pt vaccinated w/Influenza Virus Vaccine experienced vertigo, slurred speech, & excessive sweating. Hospitalized & found to be severely hypoglycemic.
PATIENT IS STATING THE DAY SHE RECEIVED THE VACCINE SHE FELT PAIN IN HER RIGHT ARM AND IT KEPT GETTING WORSE WITH SOME FEELING OF NUMBNESS AND TINGLING AND COULD BARELY MOVE HER ARM. WENT TO HOSPITAL AND RECVIED A PAIN MEDICATION AND WAS ADVISED TO PUT COLD COMPRESSES THEN WENT TO AN ORTHOPEDIC WHICH GAVE HER A STEROID SHOT ON 9/10/2019  AND PATIENT IS STATING SHE IS A LITTLE BIT BETTER BUT STILL IN PAIN WHICH IS LIMITING HER FROM PERFORMING A LOT OF ACTIVITIES
Bruise and pain at administration site. Nausea X 3 hours. Bruise and soreness X 4 days.
This spontaneous report as received from a other refers to a patient of unknown age. On an unknown date the patient was vaccinated with GARDASIL 9 for prophylaxis. Other suspect therapies included VAQTA, PNEUMOVAX 23, ROTATEQ and M-M-R II. On an unknown date the patient experienced adverse event. It was also reported that no patients affected by the issue. The outcome of adverse event was unknown. Causality assessment was not provided.
Pt vaccinated w/Hepatitis B vaccine developed painful edema & erythema of the legs.  Transaminases and ESR were increased.  Aft 3 wks of conservative treatment and immobilization, pt recovered.  MD felt edema, erythema & pain were vac relat
Patient used Sign Language, patient had two IZ and the wrong last name was written on the VAR, the clinic was understaffed for the number of patients I was seeing. In addition, I work on another project and was distracted when another coworker stopped by my station to ask questions while with a patient.
White blood cell count increased / elevated white blood cells to 12.6 K/microliter; Absolute lymphocyte count increased / elevated Absolute Lymphocytes to 5.7 1000cells/micro; This is a Spontaneous report based on the information received by Pfizer from Abbvie (Mfr. Control No. :21K-163-3904052-00) from a non-contactable consumer (patient). A 85-year-old male patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Lot Number: Unknown, and Expiration date: Unknown), via an unspecified route of administration on 16Feb2021 as dose 2, single for COVID-19 immunization. The patient also received co-suspect ibrutinib (IMBRUVICA), oral from an unspecified date in 2016 (Batch/Lot number was not reported) to an unspecified date, at 420 mg, 1x/day (1 in 1 D), oral from an unspecified date (Batch/Lot number was not reported) to an unspecified date in 2020, at 280 mg, 1x/day (1 in 1 D), oral from an unspecified date in 2020 (Batch/Lot number was not reported) and ongoing, at 140 mg, 1x/day (1 in 1 D) for chronic lymphocytic leukaemia (CLL). The patient medical history included chronic lymphocytic leukaemia (CLL), no alcohol use, non smoker, and no illicit drug use. Concomitant medications included zinc (ZINC), quercetin (QUERCETIN), clonazepam (CLONAZEPAM), and iodine (IODINE). Previously the patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Lot Number: Unknown, and Expiration date: Unknown), via an unspecified route of administration on 28Jan2021 as dose 1, single for COVID-19 immunization. Patient was not enrolled in a COVID-19 vaccine trial. It was reported on 05May2021, the patient experienced "white blood cell count increased / elevated white blood cells to 12.6 K/microliter" and "absolute lymphocyte count increased / elevated Absolute Lymphocytes to 5.7 1000cells/micro". The patient underwent lab tests and procedures which included lymphocyte count: 5.7 1000cells/micro and white blood cell count: 12.6 K/microliter on 05May2021. The events were reported as non-serious. The outcome of events was unknown. The reporter's causality for the events of elevated white blood cells to 12.6 K/microliter and elevated absolute lymphocytes to 5.7 1000cells/micro was not provided for ibrutinib (IMBRUVICA) and BNT162B2. Action taken for co-suspect ibrutinib (IMBRUVICA) was reported as dose decreased for first and second regimen and dose not changed for third regimen.  No follow-up attempts are possible; information about lot/batch number cannot been obtained.
This spontaneous report as received from a nurse refers to a 63 year old patient. Pertinent medical history and drug allergies/reactions were not reported. On 08-NOV-2013, the patient was inadvertently administered a dose of VARIVAX (lot number, dose and route were not reported) instead of the intended ZOSTAVAX. No adverse effects reported. Additional information has been requested.
Nausea; Fatigue; Muscle/joint aches; Muscle/joint aches; Unusually sour taste in saliva in the mornings; This is a spontaneous report from a contactable consumer (patient). A 42-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: 3302), via an unspecified route of administration on 15Jan2021 07:30 in Left arm at single dose at Workplace clinic for COVID-19 immunisation. Medical history included Rhinosinusitis, Thoracic Outlet Syndrome, Polycystic ovarian syndrome (irregular menstrual cycles) and CBC issues: low white blood cell count, low lymphocyte count, high MCV (Mean cell volume) (under current care), all from an unknown date. Concomitant medication included Multivit, ergocalciferol (VIT D), folic acid (FOLIC), fish oil, magnesium, biotin. There was no other vaccine in four weeks. The patient did not have COVID prior vaccination and not had COVID tested post vaccination. The patient experienced Nausea, fatigue, muscle/joint aches and unusually sour taste in saliva in the mornings on 15Jan2021 11:00. The patient did not receive treatment for the events. The outcome of the events was recovering.
This spontaneous report as received from a other health professional refers to a patient of unknown age. On an unknown date the patient was vaccinated with ROTATEQ, oral for prophylaxis. On an unknown date the patient experienced incorrect product storage and no adverse event. The outcome of incorrect product storage and no adverse event is unknown. The reporter considered incorrect product storage and no adverse event to be not related to ROTATEQ. Additional information has been requested. Sender's Comments: US-009507513-1707USA009900: US-009507513-1707USA009901.
developed redness, swelling,,,soreness, in arm where the vaccine was given a week later. Warm to touch
Sick; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of ILLNESS (Sick) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced ILLNESS (Sick). At the time of the report, ILLNESS (Sick) outcome was unknown. Not Provided          Concomitant product use was not provided by the reporter. No treatment information was provided.  The patient received both scheduled doses of mRNA-1273 prior to the events; therefore, action taken with the mRNA-1273 in response to the events was not applicable.   Most recent FOLLOW-UP information incorporated above includes: On 05-May-2021: No new information.
Post-injection, expected pain at injection site (left deltoid). On day 1, significant lymphadenopathy left side of neck.   Day 2 post injection 3/27/22, right sided facial numbness and  facial weakness neccessitating emergency evaluation at Hospital.
Servicemember had the immediate sensation of pruritus, warmth in the contralateral arm on the posterior aspect where she had received her progesterone injection. There was an observable reaction  of redness and warmth with pt reported urticarial. This reaction diminished over a day - when I saw her 1 day afterward, there was a persistent elliptical area of redness, approximately 10cm x 3cm with a macopapular eruption and persistent redness, pruritus, and warmth. Pt reports 'egg sensitivity' with oral itching, but no systemic reaction. Pt is pregnant, other information is unknown at this time. Reaction was improving at the time I saw her.
Administered vaccine after 33 days in the refrigerator; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Administered vaccine after 33 days in the refrigerator) in an 82-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 005C21A) for COVID-19 vaccination.     No Medical History information was reported.   On 20-Sep-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 18-Oct-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 18-Oct-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Administered vaccine after 33 days in the refrigerator). On 18-Oct-2021, EXPIRED PRODUCT ADMINISTERED (Administered vaccine after 33 days in the refrigerator) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No symptoms reported. No concomitant medication were provided. No treatment information were provided.
Information has been received from a registered nurse concerning an 18 year old female patient who on 15, Jan 2007 was vaccinated with a first dose of HPV rL1 6 11 16 18 VLP vaccine (yeast) (lot # 655619/1427F). Concomitant suspect vaccination included a dose of diphtheria toxoid (+) pertussis acellular 3-component vaccine (+) tetanus toxoid (BOOSTRIX) and a dose of meningoxoccal ACYW conj vaccine (dip toxoid) (MENACTRA). On 15, Jan 2007, within 2 minutes after her vaccinations. the patient became pale and fainted. The nurse also reported that while unconscious, the patient had jerking motions which lasted a couple of seconds. The patient was reported to have rested in the office for 15 minutes and then went home recovered. Additional information has been requested. This is in follow-up to report(s) previously submitted on 4/6/2007. On 07-May-2007 follow-up information was received from a registered nurse who indicated that the patient, after immediately receiving the vaccine, became lightheaded and appeared to faint. Her eyes rolled back and she became pale with twitching and jerking motions of the upper extremities which lasted for less than 5 seconds. The patient spontaneously recovered after lying down. No further information was provided.
pt tested positive for covid on 8/1/21. had cough starting  for 1 week
Patient had recurrent episodes of febrile seizures that occurred on 05/15 and in early June.
Patient wife called on 3/11/21 to state that she would like us to cancel her husband second dose appointment for his COVID-19 Moderna vaccine. Wife stated that 24 hours after receiving vaccine patient died. Hospital told patient wife that it could be due to receiving COVID-19 vaccine. Unable to get anymore pertinent information from patient representative.
Serious headache, fatigue, aches throughout the body particularly from the hips down, and fever  Took acetominophen,  ibuprofen, rested in bed all day
Information has been received from a physician concerning a 24 year old female who was vaccinated with Gardasil.  Subsequently the patient experienced numbness in her lips and drooling.  This occurred mostly on the side of the body where the injection was given (not further specified).  The numbness lasted 2 hours but a tingling sensation lasted for the rest of the day.  Subsequently, the patient recovered from numbness in her lips and drooling.  The patient sought medical attention.  Additional information has been requested.
Chest Pain/Tightness started at around 1am on Tuesday 7/27. Went on throughout the day, got worse with deep breaths. Went to an Urgent Care at 6pm on 7/27, EKG was normal, BP was high after 4 rechecks went to a normal number. Was diagnosed with chest pain as a side effect from the vaccine.
Headache, Myalgia, Fatigue Narrative:  missed work following second dose due to above symptoms.
Patient was given first COVID19 vaccine at around 1800 with no obvious signs or symptoms. Patients mother explained the history of fainting after vaccinations with pharmacist, when around 1810 patient started feeling dizzy and fainted. Patient was able to be aroused seconds after feeling dizzy. Patients blood pressure was taken - 88/44 - and water was given.  Patient started feeling better minutes after drinking water and was asked to stay in the store for 30 additional minutes.  Patient had no additional problems.