chrisvoncsefalvay/vaers-outcomes huggingface dataset:
given near the right scapula area; not in the deltoid; This case was reported by a other health professional via call center representative and described the occurrence of vaccine administered at inappropriate site in a male patient who received Flu Seasonal QIV Dresden (Fluarix Quadrivalent 2022-2023 season) for prophylaxis.   Co-suspect products included flu seasonal qiv dresden pre-filled syringe device (Fluarix Tetra Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 26th October 2022, the patient received Fluarix Quadrivalent 2022-2023 season and Fluarix Tetra Pre-Filled Syringe Device. On 26th October 2022, unknown after receiving Fluarix Quadrivalent 2022-2023 season and Fluarix Tetra Pre-Filled Syringe Device, the patient experienced vaccine administered at inappropriate site. On an unknown date, the outcome of the vaccine administered at inappropriate site was unknown.     This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK receipt date: 27-Oct-2022 Reporter's comment: The quality manager reported that patient was given Fluarix injection near right scapula area near right arm, not in the deltoid. No symptoms were reported. The reporter did not had the patient's date of birth or lot/exp at the time of report. The reporter stated that there might be more patients involved once she reviews all the records. The reporter consented to follow-up. This was for 2 of 2 linked patients, reported by same reporter. Additional supportive information: The patient received Fluarix vaccine at inappropriate site, which led to vaccine administered at inappropriate site.; Sender's Comments:  US-GSK-US2022155534:same reporter
Systemic: Dizziness / Lightheadness-Medium, Systemic: Flushed / Sweating-Medium, Systemic: Hypertension-Medium, Systemic: Shakiness-Medium, Systemic: Tachycardia-Medium, Additional Details: Ambulance called patient assessed left on her on own with husband
Moderate chills; hot flashes at 10 hours after vaccination; headache; muscle soreness; malaise from 14 hours after vaccination for 5 hours.; Mild injection site pain yesterday; This is a spontaneous report received from a contactable reporter (Consumer or other non HCP). The reporter is the patient.  A patient (no qualifiers provided) received BNT162b2, BNT162b2 (BNT162B2, BNT162B2 ), as dose number unknown, single (Batch/Lot number: unknown) for COVID-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: COVID-19 vaccine (Primary Immunization completed, Unknown manufacturer), for COVID-19 Immunization. The following information was reported: VACCINATION SITE PAIN (non-serious) with onset 13Sep2022, outcome "unknown", described as "Mild injection site pain yesterday"; CHILLS (non-serious), 10 hrs after the suspect product administration, outcome "unknown", described as "Moderate chills"; HOT FLUSH (non-serious), 10 hrs after the suspect product administration, outcome "unknown", described as "hot flashes at 10 hours after vaccination"; HEADACHE (non-serious), outcome "unknown"; MYALGIA (non-serious), outcome "unknown", described as "muscle soreness"; MALAISE (non-serious), 14 hrs after the suspect product administration, outcome "unknown", described as "malaise from 14 hours after vaccination for 5 hours.".  Additional information: Patient received the Pfizer BioNTech bivalent COVID booster. Patient experienced mild injection site pain yesterday (13Sep2022), moderate chills and hot flashes 10 hours after vaccination, headache, muscle soreness, and malaise 14 hours after vaccination for 5 hours.  The information on the batch/lot number for BNT162b2, BNT162b2 has been requested and will be submitted if and when received.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202101760602 same patient/drug, different dose/event;
Pt was irritable for about 7-10 minutes and then was rocked to sleep by the mother.
Donor states about an hour and a half to two hours after immunization was given started feeling nauseas, clammy with a headache. After s/s arised donor states had a meal and s/s resolved.
Patient went to primary care physician for well check-up 2/9/06 MD noticed bright red spots covering face and told patient "reaction to MMR". Per 2-14-07 phone conversation with patient's mother "Had fever 100-101.5" on day 8 after vaccination lasted 3-4 days. Child also very achy and cranky x 1 week. Patient is doing fine now, rash resolved.
Five minutes following vaccine, patient felt light headed, was noted to be pale and diaphoretic, helped to the floor to lie down. 136/84  P 84 rr 20, provided oxygen.  After resting for several minutes returned to stable condition.  Able to walk out of clinic on own accord.
Large local reaction in left thigh with redness, firmness-up to 6cm. Large firm lymph nodes in left groin, tender. Right side clear. Low grade temp up to 100 degrees F.
Developed symptoms after 2nd Covid vaccine dose: dry mouth, fever, sweats, thirst, dizzy. Symptoms persisted for over 3 weeks.
The morning after the 2nd dose, I vomited at least 3 times throughout the day and had diarrhea the 2nd day until the morning of the 3rd day.
New onset atypical Focal seizures HISTORY OF PRESENT ILLNESS:   13 year old female who began having seizure like episodes August 5th.  She was on a walk with mom, around the lake, and she looked around like usual and as mom was walking behind, child stopped, lifted the right arm slightly, slowly, then dropped to side, and she started walking off again.  Nothing else happened for about five to ten days later.  They were on a walk again, she did this again.  Mom was closer, saw her raise the arm, and put it back down.  They came home, later in the day, and she did it again that day.  Arm started raising up partially. Mom saw that her pupils dilated tremendously.  No head/eye deviation in that episode.  The first four were fairly mild.  Then they have become more impressive.  PMD was called. The only thing that has changed is that she had her COVID vaccine at the end of June or July 2021.  She did have a swollen lymph node on the left side for about a week.  The injection was on the left both times.  Swollen lymph node on clavicle after the shot.  Nothing then happened for a while.  Another two weeks went by and then she had another one.  This one was more dramatic.  Arm went up quicker, stiff.  Right leg stiffens, arm up, lasts 15 seconds.  There is a post-ictal 1 minute rubbing face, automatisms.  Video was sent today of this.  The day before the EEG was her last one until yesterday.  MRI was normal.  None until yesterday she had one and today another one right after she got up.  Very first thing mom sees is arm raising on right, sometimes right leg stiffen in the last 3 slightly.  Today both legs shot out, put on table.  Possible head deviation.  Blank look on face.  One of them she had been talking and she abruptly stopped talking.  There are some chewing movements, rubbing eyes afterwards, picking movements, and she looks uncomfortable a bit, like a bit of stress.  She is irritable for 30 to 60 minutes. She is cynical to begin with but always this type of personality.  She has a history of frustration, irritability since early childhood.  Sensitive to noises, feelings, emotions, etc.  Can get very aggravated easily.  Occasional headaches, rare.  No vomiting.  No other unusual signs or symptoms.   Patient has no awareness of events.  Patient had same event here, with dilation of pupils, arm and leg stiffening on right, last about 10 seconds, then some post-stiffening automatisms, chewing, picking, then back to normal within a minute , then complaining of being tired.
Very mild localized cellulitis - resolving spontaneously. No systemic symptoms. No treatment needed. F/U prn.
Mother called 11/17/10 - states child had low grade fever and did not feel well after getting nasal flu vaccine 11/16/10 then went to MD 11/18/10 MD Dx flu.
This is a spontaneous report from a contactable consumer, the patient. A 30-year-old patient of an unspecified gender received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8727) in the right arm on 31Mar2021 at 08:30 (at the age of 30-years-old) as a first dose for COVID-19 immunisation. The patient's medical history included type 1 diabetes mellitus. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. Patient was known allergic to watermelon, walnuts, almonds, bananas. The patient did not receive any other vaccine within four weeks prior to the vaccination.  Concomitant medications included metformin (MANUFACTURER UNKNOWN), bupropion (MANUFACTURER UNKNOWN) and ethinyl estradiol, norgestimate (TRI-SPRINTEC). On 31Mar2021, 10hours after the vaccination, the patient experienced upper lip swelling on the left side of lip. The patient did not receive any treatment for the reported event. The adverse events did not result in doctor or other healthcare professional office or clinic visit and emergency room or department or urgent care. The clinical outcome of the event upper lip swelling was not recovered at the time of this report. No follow-up attempts are needed. No further information is expected.
This spontaneous report was received from a Registered nurse regarding a 14 year old patient of unknown gender. The patient's medical history, concurrent conditions and concomitant medications were not reported. On 27-JUN-2017, the patient was vaccinated with improperly stored dose of GARDASIL 9 lot# N004798 with expiration date: 31-OCT-2019 (dosing details and route of administration was not reported) for prophylaxis (product storage error). No adverse effects were reported. The storage temperature was 47 degrees Fahrenheit to 77 degrees Fahrenheit (49F) and time frame was 14 hours. There was no previous temperature excursion. Digital data logger was involved. No product quality complaint was involved. This is one of the several reports from the same reporter. ; Sender's Comments: US-009507513-1804USA005153:
This spontaneous report as received from a nurse refers to a patient of unknown age and gender. Information regarding the patient's medical history, concurrent conditions, drug reactions/allergies and concomitant therapy were not reported. On 19-FEB-2018, the patient was vaccinated with properly stored but expired dose of M-M-R II (lot # M004063, expiry date: 25-JAN-2018) reconstituted with properly stored sterile diluent, for prophylaxis. No adverse effects were reported.
Frightening reaction; This case was reported by a consumer and described the occurrence of anxiety reaction in a 78-year-old patient who received Herpes zoster (Shingrix) for prophylaxis.   In August 2020, the patient received the 1st dose of Shingrix. On an unknown date, less than 9 months after receiving Shingrix, the patient experienced anxiety reaction. On an unknown date, the outcome of the anxiety reaction was unknown.   It was unknown if the reporter considered the anxiety reaction to be related to Shingrix.  Additional details were provided as follows: The patient was reported for him/herself. The age at vaccination was not reporter. After receiving 1st dose Shingrix, the patient experienced frightening reaction. Till the time of reporting, the patient did not receive 2nd dose. The patient also wanted to know if he/she was safe to get Covid 19 vaccine. The start date of Shingrix was reported as 2000 which seems to be discrepant (potentially 2020). Clarification could not be obtained.
This case was reported by a physician via sales rep and described the occurrence of seizure in a 18-year-old male patient who received BEXSERO. The patient's past medical history included seizures (the patient was not compliant to seizure medications). On an unknown date, the patient received the 1st dose of BEXSERO (intramuscular) .5 ml. On an unknown date, less than a day after receiving BEXSERO, the patient experienced seizure (serious criteria GSK medically significant and other: as per reporter). BEXSERO was continued with no change. On an unknown date, the outcome of the seizure was recovered/resolved. It was unknown if the reporter considered the seizure to be related to BEXSERO. Additional details were provided as follows: This case was reported by the sales representative. The age at vaccination was not reported. Concomitant medications included seizure medications. The patient experienced a seizure in the evening after vaccination with BEXSERO. The batch number for BEXSERO was not provided. The patient went to a neurologist who recommended the patient to get the 2nd dose of BEXSERO. The patient received a 2nd dose of BEXSERO without reoccurrence of seizures.
Site of injection, 10cm X 10cm, indurated, erythematous, warm and itchy area.
allergies; having stabbing pain the left eye; third dose 17Aug2021; third dose 17Aug2021; This is a spontaneous report from a contactable consumer. This 39-year-old female consumer (patient) reported for herself that:A 39-year-old female patient received third dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection, Batch/Lot number was not reported), via an unspecified route of administration on 17Aug2021 as single dose for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient's historical vaccine included first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection, Batch/Lot number was not reported), via an unspecified route of administration on 19Mar2021 as single dose for covid-19 immunisation and second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection, Batch/Lot number was not reported), via an unspecified route of administration on 09Apr2021 as single dose for covid-19 immunisation. Patient stated she received 3 doses of the Pfizer covid vaccine; first dose was on 19Mar2021, second dose 09Apr2021 and third dose 17Aug201. Patient stated since mid-Mar she has been having stabbing pain in the left eye, on and off, not consistent. she stated this time it was not with the headache/ migraine on an unspecified date (usually last 24 hours), no cluster headache which she usually gets. she has allergies on an unspecified date. Patient stated that its always the left eye not like other symptoms. The case assessed as non-serious by the reporter. The outcome of the event was reported as unknown.   The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow up
This spontaneous report as received from a healthcare student (also reported as Pharm D) refers to a patient of unknown age and gender. The reporter stated that on 28-AUG-2013 the patient was vaccinated with expired PNEUMOVAX23 lot # 1489AA, expiration date: 12-MAY-2013 (dose and route not reported). No adverse events were reported. The patient's outcome was unknown. Additional information has been requested.
Pt presented on 14 Aug 2009 for clinic visit for adverse reaction to immunization.  Right thigh from hip to just above knee red, swollen, and hot to touch. Pt denies pain, parent denies fever.  No fever noted during clinic visit.  Oral Benadryl and Motrin given to pt during visit.  Cool compress applied to the thigh.
Aching after 2nd dose; Feverish after 2nd dose; feel aching; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (Aching after 2nd dose), PYREXIA (Feverish after 2nd dose) and MYALGIA ( feel aching ) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 026D21A and 013F21A) for COVID-19 vaccination.     No medical history was provided by the reporter.    On 21-Oct-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 18-Nov-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 18-Nov-2021, the patient experienced PAIN (Aching after 2nd dose) and PYREXIA (Feverish after 2nd dose). 18-Nov-2021, the patient experienced MYALGIA ( feel aching ). The patient was treated with PARACETAMOL (TYLENOL [PARACETAMOL]) for Adverse event, at a dose of 2 Tylenol and IBUPROFEN (ADVIL [IBUPROFEN]) for Adverse event, at a dose of 2 Advil. At the time of the report, PAIN (Aching after 2nd dose), PYREXIA (Feverish after 2nd dose) and MYALGIA ( feel aching ) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In November 2021, Body temperature: 101 (High) High, 101F at 14:30pm, 102.7 (High) High, 102.7F she and 101.6 (High) High, 101.6F..         The patient used v-safe as treatment. No concomitant medications were reported.   This case was linked to MOD-2021-392172 (Patient Link).; Sender's Comments: Non-serious Case.
This spontaneous report as received from a medical assistant refers to 5 year old patient of unknown gender. On an unknown date in April 2014, between 12-APR-2014 and 24-APR-2014, the patient was vaccinated with a dose of VARIVAX lot # J012210, expiry 28-SEP-2015 ("VFC" stock), 0.5 ml, once intramuscular. The medical assistant stated there was  a  power outage on 12-APR-2014 and the (Oka/Merck) VARIVAX doses from the freezer needed to be transported to unspecified hospital for proper storage. She stated (Oka/Merck) VARIVAX was exposed to 46F for 1 hour, at worst. There were no prior excursions. There was a site visit from local health department on an unspecified date. No adverse effects reported. This is one of several reports received from the same reporter. Additional information has been requested.
Left ear - fluttering sound when exposed to any type of sound; This is a spontaneous report from a contactable consumer, the patient. A 52-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8727) via an unspecified route of administration in the left arm on 26Mar2021 at 09:00 (at the age of 52-year-old) as a single dose for COVID-19 immunisation. Medical history included hashimotos disease and penicillin allergy. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. Concomitant medications included lisinopril (MANUFACTURER UNKNOWN), atorvastatin (MANUFACTURER UNKNOWN), vitamin b nos (VITAMIN B) and folic acid (MANUFACTURER UNKNOWN); all on unknown date for unspecified indication. On 19Apr2021, the patient experienced left ear fluttering sound when exposed to any type of sound. No therapeutic measures were taken as a result of reported events. The adverse event did not result in a visit to the doctors or other healthcare professional office/clinic visit, and emergency room/department or urgent care. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the event left ear fluttering sound when exposed to any type of sound was not recovered at the time of this report.  No follow-up attempts are needed. No further information is expected.
period starting with heavy bleeding within 4 hours of the vaccination (5 days early).; period starting with heavy bleeding within 4 hours of the vaccination (5 days early).; Uterine cramping; Headache; This is a spontaneous report from a contactable other health care professional (patient). A 37-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection; lot number: 301308A and expiration date: not reported), via an unspecified route of administration, in Left Arm, on Sep2021 at 11:00 (at the age of 37-year-old) as DOSE 1, SINGLE for covid-19 immunization in Pharmacy or Drug Store.  Medical history included depression, constipation and covid-19. The patient had no known allergies. Concomitant medications included venlafaxine and docusate. The patient was not pregnant at time of vaccination. The patient didn't receive any other vaccines within 4 weeks prior to the COVID -19 vaccine. The Patient had been diagnosed with COVID-19 prior to vaccination and had not been tested since the vaccination. On Sep2021, at 03:45 reported as within 4 hours of the vaccination, The patient experienced Uterine cramping and period starting with heavy bleeding (5 days early). Headache that has been daily for one week, comes back when medications wear off, does improve on tylenol and ibuprofen. The outcome of the events was recovering at time of report.
The vial was punctured at 1551 on 2/8/21. The patient received their dose after the 6-hour time frame. The patient received her dose at 2230 on the same day. The patient has had no reaction since receiving the vaccine.
Numb/ tingling tongue, lips, fingers, & toes. Lasted 3, 4, & 5 March- subsided. Reoccured 16 Mar- ongoing.
The site of the injection started to raise on my arm and change color to red. Every day the site is getting larger in area . Today it is about 15 cm x 8 cm raised, erythematous and itchy. I am a dentist myself, and it is a well known delayed type IV sensitivity. I contacted my physician in which I added his information in your forms. He immediately placed me on Steroid medication (Medrol Dose pack) orally, as well as topical. It is spreading on my arm and growing by the minute.
Red square rash right below the injection site appeared 5-6 days after I received my shot & it's still there two weeks after my first shot
Vaccination given 1314 and sent to waiting room for monitoring.  Began to have itching at 1325. PO benadryl administered.   Then with throat swelling. Epinephrine administered by EMS/Fire at 1:32pm: 0.5mg IM right arm.   1342 improving  1350 itching/throat swelling returning while EMS/Fire on phone with medical director.   1352 second dose of epinephrine administered by De Pere EMS/Fire: 0.5mg IM left arm  Medical Director on site for evaluation. Client given option to transport to hospital or stay for monitoring with EMS/Dr.  Condition improving, chose to stay for monitoring.   Client improved and up walking halls   1513 Client cleared to be released home via private transport
reaction 5 mins after shot. large welt came up and it was red; reaction 5 mins after shot. large welt came up and it was red; Initial information received on 26-Sep-2019 regarding an unsolicited valid non-serious case received from a nurse.  This case was linked to 2019SA271040 (same reporter).  This case involves a 70 years old female patient who experienced large welt came up (urticarial) and it was red (erythema), while she received vaccine INFLUENZA QUADRIVALENT RECOMBINANT VACCINE [FLUBLOK QIV].  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   No concomitant medication received.  On 24-Sep-2019, the patient received a single dose of suspect INFLUENZA QUADRIVALENT RECOMBINANT VACCINE lot number not reported in the left deltoid.  On an unknown date, The patient developed a non-serious large welt came up and it was red (urticaria) (erythema) 5 minutes following the administration of INFLUENZA QUADRIVALENT RECOMBINANT VACCINE.  No lab test reported. . Final diagnosis was reaction large welt came up and it was red.   It was not reported if the patient received a corrective treatment.  The patient outcome is reported as Unknown for the events.  Information on the batch number was requested.