chrisvoncsefalvay/vaers-outcomes huggingface dataset:
RIGHT AWAY MY NECK STARTED SPASMING, MY EYES STARTED TO TWITCH, MY VISION WAS BLURRED, MY SKULL HAD VERY STRANGE WAVES MOVING THROUGH IT. MY LEFT ARM GOT STIFF, MY LEFT HAND GOT MORE COMPRIMISED.
Administration of an expired dose; This case was reported by a pharmacist via call center representative and described the occurrence of expired vaccine used in a female patient who received Flu Seasonal QIV (FluLaval Quadrivalent 2021-2022 season) (batch number N959G, expiry date 30th June 2022) for prophylaxis.   Co-suspect products included flu seasonal qiv pre-filled syringe device (Flulaval Tetra Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 14th September 2022, the patient received FluLaval Quadrivalent 2021-2022 season and Flulaval Tetra Pre-Filled Syringe Device. On 14th September 2022, unknown after receiving FluLaval Quadrivalent 2021-2022 season and Flulaval Tetra Pre-Filled Syringe Device, the patient experienced expired vaccine used. On an unknown date, the outcome of the expired vaccine used 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: 21-Sep-2022 Reporter's Comments:  The pharmacist reported the administration of an expired dose of Flulaval to a patient. Dose was given on 14th Sep 2022 and vaccine expiration date was June 30th 2022, The reporter give consent to follow up. Additional Supportive Information: The patient received expire vaccine which leads to expire vaccine used.
Patient received flu shot 8-28-17 and on 8-29-17 Pt came into pharmacy and arm was bruised and purple.
Patient states that they have had no side effects or adverse events.  Vaccine was given from vial that had been in the refrigerator longer than 30 days.
Lost consciousness after the vaccine. 911 call was made. He was taken to the Hospital Emergency Room by the EMS.
S/s of "cold w/3 days absence from school no meds. Than cough and chest pain began on 11/27/2009 low grade fever began on 11/30 on 12/4/09 was diagnosed with pneumonia was treated w/AZITHRO than on 12/8/09 was put on PO AUGMENTIN
Patient is a 24 y.o. female who was seen at COVID Vaccine Clinic today for her second dose of the COVID 19 vaccination.    She denied any history of previous adverse reactions to vaccines. Denies any adverse effects after receiving her first COVID vaccine.    She was given the Pfizer vaccination in the right deltoid muscle.   During her 15 minute waiting period after the injection, the patient began to experience throat scratchiness and cough.  She denied difficulty breathing, difficulty swallowing, throat tightness, dizziness and facial swelling.   This provider was notified of patient reaction and she was then assessed in the emergency bay area.   Monitored patient for severe reaction symptoms, including but not limited to rapid progression of symptoms.
Pt reports he had approximately 2 hours of chills without fever. He states he felt poor and fatigue for approximately 18 hours. Pt feels fine as of today, 10/12/12.
vaccine was expired, no temperature excursion occurred and Moderna determined the vial "maintained the activity necessary to protect against the SARS CoV-2 Virus at the time of administration".  Patient reported no adverse reactions.
Myocardial infarction (left descending) 45 days after vaccine (2nd)
-Client's mother called to report her daughter is having some increased tenderness at HPV vaccine site 10 days post injection - daughter required IBP & it woke her up - not decrease in pain level.
Patient hasn't received 2nd dose yet past 42 days; This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (Patient hasn't received 2nd dose yet past 42 days) in an 81-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No Adverse Event (No medical history was reported.).    On 04-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .5 milliliter. On 29-Mar-2021, the patient experienced PRODUCT DOSE OMISSION ISSUE (Patient hasn't received 2nd dose yet past 42 days). On 29-Mar-2021, PRODUCT DOSE OMISSION ISSUE (Patient hasn't received 2nd dose yet past 42 days) had resolved.        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.
I took my first flight in 2 years and I always seem to get sick afterwards. When I got back Sunday night, I didn't feel great. By Monday, I felt sick. I took an at home test on Tuesday and it was negative. I made an appointment for the minute clinic for Thursday (05/19/2022) and was tested and it was Positive for COVID. I have had congestion and a constant runny nose for 2 days. On Wednesday, I started taking Mucinex FastMax. I have taken Mucinex night time and Advil PM at bedtime. I feel a little out of it from the congestion today but that's it. I no longer have a fever and, I contacted my PCP, who recommended Paxlovid. However, she requested a video visit to discuss it but her only availability was a week out which is outside the recommended time to use Paxlovid. So I messaged her and am waiting for a response. I did not have a fever Monday but I had one Tuesday for about 2 hours and haven't had one since.
Day 1could not sleep after receiving the first night and felt unwell with muscle aches all night.    Day two morning had racing heart for half an hour and had difficulty stopping the fibrillation  and felt ill. Took 325 bufferin. During day rested but had severe diarreaha for five hours during night.  Used pedialyte to help electrolytes.  Day three felt like myself and began eating regularly.
Pain when breathing; Chills; Felt like she was having a fever; Very tired; Intense pain all over her body; Felt like her face was about to get facial palsy; Felt very bad; Terribly dizzy on her head; hard to stand; Pain on her right leg, specially when pressure on it; Joint pain; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of FACIAL DISCOMFORT (Felt like her face was about to get facial palsy), FEELING ABNORMAL (Felt very bad), DIZZINESS POSTURAL (Terribly dizzy on her head; hard to stand), PAIN IN EXTREMITY (Pain on her right leg, specially when pressure on it) and DYSPNOEA (Pain when breathing) in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 014M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Fibromyalgia, Sjogren's syndrome, Rheumatoid arthritis and Breast cancer (remission). Concomitant products included EZETIMIBE for Cholesterol blood excessive, DULOXETINE for Fibromyalgia, BACOPA MONNIERI, CITICOLINE, PHOSPHATIDYL SERINE (CEREBRA) for Memory impaired, ACETYLCYSTEINE (N-ACETILCISTEINA) for Muscle disorder, PILOCARPINE and CEVIMELINE for Sjogren's syndrome, FOLIC ACID for an unknown indication.    On 03-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 03-Mar-2021, the patient experienced FACIAL DISCOMFORT (Felt like her face was about to get facial palsy), FEELING ABNORMAL (Felt very bad), DIZZINESS POSTURAL (Terribly dizzy on her head; hard to stand), PAIN IN EXTREMITY (Pain on her right leg, specially when pressure on it), ARTHRALGIA (Joint pain) and MYALGIA (Intense pain all over her body). On 04-Mar-2021, the patient experienced CHILLS (Chills), PYREXIA (Felt like she was having a fever) and FATIGUE (Very tired). On 21-Mar-2021, the patient experienced DYSPNOEA (Pain when breathing). On 23-Mar-2021, DYSPNOEA (Pain when breathing) had resolved. At the time of the report, FACIAL DISCOMFORT (Felt like her face was about to get facial palsy), FEELING ABNORMAL (Felt very bad), DIZZINESS POSTURAL (Terribly dizzy on her head; hard to stand), PAIN IN EXTREMITY (Pain on her right leg, specially when pressure on it), ARTHRALGIA (Joint pain), CHILLS (Chills), PYREXIA (Felt like she was having a fever), FATIGUE (Very tired) and MYALGIA (Intense pain all over her body) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment drugs included - acetaminophen, zinc and multivitamins. Based on the current available information and temporal association between the use of the product and the start date of the events a causal relationship cannot be excluded.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events a causal relationship cannot be excluded.
Developed redness of skin (trunk/face) approximately 20 mins after injection. Lasted approximately 20 mins. No fever, cough, irritability, V, crying.
Time of injection1:05 pm, pt then had lunch (pizza), began with palpitations in chest, feels short of breath 5X began 1:20pm. Patient felt much improved by 2:15
Patient reported extreme malaise, high fever and drenching sweats. Dr's described it as a severe rare allergic reaction.  She also had localized swelling, redness and itchiness at the injection site.  She thought her life was going to end.
pt recv vax & mom states child fussy & screamed;T99.6;mom was on phone w/friend when states child foamed @ mouth & stopped breathing;friend called the amb;
I don't know if it was the vaccine or I have the flu, but I have flu symptoms and a fever which started Friday. Can barely make it out of bed.
Dizziness and sore arm. Later in afternoon, developed headache and fever (did not take temperature).  Took Tylenol.
I'm breastfeeding and have MTHFR gene mutation; I'm breastfeeding and have MTHFR gene mutation; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the parent.  A patient (no qualifiers provided) was exposed to bnt162b2 (BNT162B2), transmammary, administration date 30Aug2021 12:00 (Lot number: FC3181) as dose 1, single for covid-19 immunisation. The mother of the patient was 33 years old at the time of vaccination. The patient's relevant medical history was not reported. Concomitant medication(s) included: ASPIRINE. The following information was reported: EXPOSURE VIA BREAST MILK (non-serious), METHYLENETETRAHYDROFOLATE REDUCTASE GENE MUTATION (non-serious) all with onset 01Sep2021, outcome "not recovered" and all described as "I'm breastfeeding and have MTHFR gene mutation". The event "i'm breastfeeding and have mthfr gene mutation" and "i'm breastfeeding and have mthfr gene mutation" was evaluated at the physician office visit. Therapeutic measures were taken as a result of exposure via breast milk, methylenetetrahydrofolate reductase gene mutation.  No follow-up attempts are possible. No further information is expected.  Additional Information: This is a spontaneous report from a contactable consumer. This consumer (mother) reported information for herself and infant. This is infant report. This report included: Facility type vaccine: Pharmacy or Drug Store. The patient mother was breastfeeding and had MTHFR gene mutation, so she was advised to double her aspirin for 90 days. Adverse event start date: 01Sep2021, AE resulted in: [Doctor or other healthcare professional office/clinic visit]. The patient mother had received treatment for the adverse events. Patient mother was not diagnosed with COVID-19 prior vaccination. Patient has not been tested for COVID-19 since vaccination.  Follow-up #01 (13Sep2021): Follow-up attempts are completed. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202101170073 mother case
have symptoms and have been exposed to covid; Having upper respiratory symptoms; 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 EXPOSURE TO SARS-COV-2 (have symptoms and have been exposed to covid) and RESPIRATORY SYMPTOM (Having upper respiratory symptoms) 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, the patient experienced EXPOSURE TO SARS-COV-2 (have symptoms and have been exposed to covid) and RESPIRATORY SYMPTOM (Having upper respiratory symptoms). At the time of the report, EXPOSURE TO SARS-COV-2 (have symptoms and have been exposed to covid) and RESPIRATORY SYMPTOM (Having upper respiratory symptoms) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       no treatment information was provided no concomitant medication were reported
Allergic reaction; This spontaneous report was received from a physician and a vaccine provider referring to a 17 years old female patient. The patient's medical history included lump removed from neck. The patient had no concomitant medication, no illness at time of vaccination or pre-existing physician-diagnosed allergies, birth defects, medical conditions (specify). The patient's drug reactions/ allergies was unknown.  On 02-AUG-2020 (it was also reported as 02-AUG-2018), the patient was vaccinated with the first dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) (lot # R002344 with expiration date 16-NOV-2020; dose was not reported) intramuscularly in the left arm for prophylaxis.    The patient had no immediate problems on the first day or the second day after the vaccine was administered. On 04-AUG-2020 late in the evening after eating and showering, the patient developed itching to the lower abdomen. The patient applied some sort of gel to the area but did not know the name of the gel. The patient had no further problems that night and went to bed. On 05-AUG-2020, the patient developed swelling and rash to the neck, lower back and thighs (It was also reported on 05-AUG-2018, 3 days after the vaccination, the patient developed hives, the patient might have had snack prior to developing hives heat was passed due date). On 06-AUG-2020, the patient awoke with a worsening rash and was now on both arms as well. The patient contacted his physician and was treated with hydroxyzine (25 mg, q6h, po). On 07-AUG-2020, the patient went in to see his physician who felt like it episode was caused by hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9). It was reported that the rash was widely spread, erythematous, purely macular with irregular edges to the extremities, face and trunk. On 09-AUG-2020 (reported as by day 8), the patient was improved. It was reported that the physician wanted to know if additional doses of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) should be given after the patient had experienced an allergic reaction. The outcome of the event was recovered on an unknown date in 2020. The causality between the event and hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) was unknown. combinationproductreport: Yes; brandname: GARDASIL 9 SYRINGE (DEVICE); commondevicename: HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast); productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp & Dohme Corp.; devicelotnumber: R002344; expirationdate: 16-NOV-2020; deviceage and unit: 0 ; operatorofdevice: Health Care Professional; malfunction: Unknown; deviceusage: Initial; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not suggest a causal association with the device or device constituent
vomiting; severe headache; This is a spontaneous report from a contactable nurse. A 50-years-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot number EH9899, expiry date not reported), intramuscular on 30Dec2020 16:00 at a single dose in the left arm as Covid vaccine. The patient's medical history was not reported. The patient was not pregnant at the time of vaccination. The patient had no known allergies; no allergies to medications, food, or other products. Prior to vaccination, the patient was not diagnosed with COVID-19. There were no concomitant medications. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient had no other medications the patient received within 2 weeks of vaccination. Patient received vaccine on 30Dec2020 at 4pm. On 01Jan2021, at approximately 3am, patient woke up with a severe headache, and approximately 6am, patient started vomiting which lasted until after 7pm. The headache was not as intense but it was still there today. Since the vaccination, the patient has not been tested for COVID-19. No treatments received in response to the events reported. The events were reported as not serious (did not result in death, not life-threatening, did not cause/prolonged hospitalization, not disabling/incapacitating and not a congenital anomaly/birth defect). The outcome of the events headache and vomiting was reported as recovering.
first dose in March 2020; Body aches; This case was reported by a consumer via call center representative and described the occurrence of general body pain in a 59-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis.   The patient's past medical history included renal cancer, nephrectomy and covid-19. Previously administered products included COVID vaccine and Flu vaccine.   In March 2020, the patient received the 1st dose of Shingrix. On an unknown date, the patient received the 2nd dose of Shingrix. In March 2020, less than a day after receiving Shingrix and not applicable after receiving Shingrix, the patient experienced general body pain. On an unknown date, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the general body pain was recovered/resolved and the outcome of the incomplete course of vaccination was unknown.   It was unknown if the reporter considered the general body pain to be related to Shingrix.  Additional details were provided as follows: The reporter was the patient. The age at vaccination was not reported. The patient experienced body aches starting at midnight the day of the vaccination. The reporter inquired about Shingles vaccine 2nd dosing.  Till the time of reporting, the patient did not receive 2nd dose which led to incomplete course of vaccination. The reporter consented to follow up. The reporter provided limited information of the health care professional. This case is linked to the case US2021225709 and US2021225710, reported by the same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021225709:same reporter US-GLAXOSMITHKLINE-US2021225710:same reporter
Breakthrough COVID infection. Patient fully vaccinated on March 13, 2021. Patient tested positive for COVID on August 23, 2021
Sore arm; when she moves her arm, it hurts; This is a spontaneous report from a contactable consumer or other non hcp. A 29-year-old Female patient received BNT162B2 (BNT162B2, PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection, Batch/Lot number was not reported) via intramuscular route of administration in Arm Left on 28Jan2021 15:55 as SINGLE DOSE for COVID-19 immunization. (Age at vaccination is 29-Year-old). Medical history included ongoing fibromyalgia, hypersensitivity from an unknown date and unknown if ongoing. Concomitant medications included mometasone furoate (FLONASE [MOMETASONE FUROATE]) taken for hypersensitivity, start and stop date were not reported. Within an hour of receiving the vaccine, her arm was becoming sore and she took 400mg of Advil. patient wants to know is the efficacy of the vaccine effected by taking the Advil. Patient stated that she had to wait 15 minutes after receiving the vaccine. It started hurting like a normal vaccine would but within the hour when she got home, her arm started hurting more. She also has fibromyalgia, so she doesn't know if this contributed to the soreness. Patient stated she honestly does not know if the Advil helped. The soreness kind of stayed the same and moving her arm, hurts. She tried to move her arm because it says to exercise it, but it hurts. The patient stated that soreness has remained the same. Therapeutic measures were taken as a result of sore arm when she moves her arm, it hurts with Advil. The outcome for the events were reported as Not Resolved.   Information about lot/batch number has been requested.  Follow-up (16Apr2021): This follow-up is being submitted to notify that the lot/batch number is not available despite the follow-up attempts made. Follow-up attempts have been completed and no further information is expected.
After 1st dose - slight soreness at injection site, no other symptoms After 2nd dose - after 4 hours, extreme fatigue, whole body soreness, injection site soreness, after 12 hours, all of the above, after 24 hours, all plus injection site swelling and redness, 36 hours, only more injection site swelling and more redness, 48 hours, more swelling and redness, and now itchiness
At 24hr after shots, patient began developing redness and swelling at shot sites. On day of exam (approximately 48hr after shots), she had a 10cm x 12cm area of induration and redness around (R) shot site and a 8.5cm x 10.25c, area of induration and redness around (L) shot site.
Report 20010039331 describes a rash on a 1 month old male who received an injection of hepatitis B vaccine (Engerix-B). Concurrent medical conditions and medications were not provided. The infant received his first injection of Engerix-B on 02/05/2001. On 02/06/2001, one day post-immunization, the infant developed a rash on his face, hands, neck, trunk, and knees. He was seen in the local ER on 02/08/2001. The outcome of this event is unknown.
Information has been received from a pharmacist concerning a 67 year old female patient with no allergies and a history of being very thin, who on 20-MAY-2008 was vaccinated SC in the left arm with a 0.65 mL dose of zoster vaccine live (Oka/Merck) (Lot # 659323/0164X). On 22-MAY-2008, the patient developed a red, painful, hot and swollen rash at the injection site, which was hard and warm to the touch. No diagnostic laboratory tests were performed. At the time of this report, the injection site reaction persisted. No product quality complaint was reported. Additional information has been requested. This is in follow-up to report(s) previously submitted on 6/24/2008. In information received from the physician's office it was reported that the office was not contacted and the patient was not seen in that office. It was reported that the vaccine was administered at a pharmacy. Additional information has been requested.
TINGLING AND NUMBNESS VACCINATED ARM IMMEDIATELY RIGHT ARM; TINGLING AND NUMBNESS AND WEAKENING OF RIGHT HAND AND OVER 6 MONTHS TO LEFT ARM AND HAND EVENTUALLY CAUSING PARALYSIS OF BOTH ARMS AND HANDS; EVOLVING MYOPATHY/NEUROPATHY BOTH LEGS.
Client came through the line.  11yrs old.  Should not have received the above product.  She received the 12-adult product instead of the 5-11.  Spoke with her mother 10/24/22.  Stated child's only complaint was both arms were sore.  She received flu in L arm and COVID Bivalent in right arm
Pain in upper left arm, just below where shot was given, and elbow when moving arm laterally up and when reaching up, and when reaching up and over to the right. Also mental cloudiness and extreme fatigue. All this still continues up to this date (11/12/2012) and is all at the same rate. No decrease or increase of pain or fatigue or confusion. Haven't sought Dr. yet. Similar happened last year (2011) with shot...but not as bad as this 2012 shot and eventually it went away. Thought 2011 was from shot in bad spot and delivered poorly, but the same is happening this year, only worse.