chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Follow-up report received from a HCP on 26 Feb 2010: This patient (2 year old) was inadvertently administered a dose of FLUVIRIN (batch no. 102125P1) on 26 Feb 2010. No adverse reaction had occurred. After an internal review done on 08 May 2010 to the information received on 26 Feb 2010, the following significant correction was made: The suspect product FLUVIRIN was recoded to S-OIV FLUVIRIN. It was also identified that the report received on 26 Feb 2010 was an initial report and not a follow-up report, as previously reported.
Starting mid June, I started having daily headaches and nausea and blurry vision. I went to my PCP because they were not controlled by Tylenol, Advil, or excedrin. The PCP prescribed Eletriptan and Zofran and that did not work either. She then prescribed Topamax which also did not work. She then ordered a brain MRI and spine MRI which both showed non-specific spots. A lumbar puncture was ordered but my BP spiked to 240/140 so I went to the ER. I was admitted and treated for HTN. I received gabapentin for my headaches which helped some and I was given Nifedipine and Clonidine for my BP which helped some. A lumbar puncture and many other tests were completed and they have all come back negative. I have since been discharged on the medicine listed above. My vision is still blurry (I can't drive or work), and I am still following up with multiple doctors. My blood pressure also remains high. I used to be completely healthy and had always had normal BP (including when I went to see my PCP initially about my headaches). A retinologist mentioned that this may be due to the covid vaccine since it can affect the vascular system. My diagnosis has yet to be determined.
Approx 15 min after vaccine administration, patient had a vasovagal and near-syncopal event - felt dizzy and flushed, became pale and diaphoretic, low BP (88/62), low HR (45). Quickly recovered after being laid supine. Was brought to urgent care for continued monitoring and evaluation where she continued to improve and was discharged in stable condition and feeling baseline at approximately 15:30.
Patient fainted, appeared to also be having a small seizure. Uncontrollable shaking of body when alert. Very pale, sleepy after episode.
lt thigh w/large hive where inj was given;rt thigh w/small red area;DPH given;
Patient stated DOB as 10/14/2009 on the consent release forms. So we trusted the parent not realize the child is under 12
Patient feeling fatigued, unable to walk easily, patient also has dementia which could be causing the issue
Initial report was received from a consumer, who was also the patient's parent, on 06 February 2012. A 2-month-old patient (gender not reported) had received a dose 1 injection of DAPTACEL, Sanofi Pasteur Ltd. (lot number, route, date and site of administration unknown). The patient cried for more than three hours after the vaccination. It was unknown if the patient had any illness at the time of vaccination, had any medical history or took any concomitant medications. No further information was available at the time of the report. The patient's outcome was unknown. Documents held by sender: None.
Excruciating Pain in left Arm, Neck, and back along with Swollen left neck, back, and shoulder,
tested positive for Covid-19 after receiving the vaccine; tested positive for Covid-19 after receiving the vaccine; This is a spontaneous report from a contactable consumer (Pfizer employee). An adult female patient received BNT162b2 (PFIZER BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot number and Expiration date was unknown), via an unspecified route of administration on an unspecified date as dose number unknown, single for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. Patient was believed to have received the Pfizer vaccine to completion, but on an unspecified date, patient was still tested positive for Covid-19 after receiving the vaccine. Patient believed she had a sinus infection, but then tested positive for the COVID-19. The events were reported as non-serious by the reporter. This information was received second hand (not from impacted individual) from individual's friend who happens to be a healthcare professional. Since the vaccination, the patient has been tested for COVID-19.The outcome of the events was unknown.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
pt recvd vax; high pitched screaming beginning aapprox 7 hrs p/ vax;lasting intermitently thru noc; no tx;
Pain in the arm; It was hard to walk; Feeling poorly/ like beat up; Redness all of that; Extreme tiredness; Maybe a slight headache; Body aches; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Pain in the arm), GAIT DISTURBANCE (It was hard to walk), FEELING ABNORMAL (Feeling poorly/ like beat up), ERYTHEMA (Redness all of that) and FATIGUE (Extreme tiredness) in an 86-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 012A21A and 012L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 12-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 12-Mar-2021, 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 PAIN IN EXTREMITY (Pain in the arm) and ERYTHEMA (Redness all of that). an unknown date, the patient experienced GAIT DISTURBANCE (It was hard to walk), FEELING ABNORMAL (Feeling poorly/ like beat up), FATIGUE (Extreme tiredness), HEADACHE (Maybe a slight headache) and MYALGIA (Body aches). The patient was treated with PARACETAMOL (TYLENOL) for Adverse event, at an unspecified dose and frequency. At the time of the report, PAIN IN EXTREMITY (Pain in the arm), GAIT DISTURBANCE (It was hard to walk), FEELING ABNORMAL (Feeling poorly/ like beat up), ERYTHEMA (Redness all of that), FATIGUE (Extreme tiredness), HEADACHE (Maybe a slight headache) and MYALGIA (Body aches) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 13-Mar-2021, Body temperature: low (Low) Low. On an unknown date, Antibody test: positive (Positive) Tested for antibodies at six months from vaccination.         Concomitant products included cholesterol medication for an unknown indication. On Friday (unspecified date) pain in the arm, redness, all of that; Saturday: low temperature, feeling poorly, body aches like beat up, extreme tiredness, it was hard to walk, maybe a slight headache.  On Sunday (unspecified date) it was a little better and by Monday she was fine.
Pfizer BioNTech COVID-19 Vaccine EUA: COVID-19 case resulting in Hospitalization / Death. Patient received Pfizer Vaccines on 1/24/2021 and 2/19/2021. Presented to ED on 8/4/2021 with 4 day history of feeling ill, and diagnosis of COVID on 8/3/2021. Presented with worsening shortness of breath and cough, also weakness, and vomiting.  Initially admitted to telemetry unit requiring 15 L O2, and within 24 hours of presentation was requiring Airvo 60L/90%. Patient quickly decompensated further and was transferred to the ICU on 08/06 on BiPAP.  He required intubation overnight on 08/06. Patient treated with convalescent plasma, remdesivir x5 days, dexamethasone, ascorbic acid, and zinc. Family requested comfort care on 8/21/2021, patient was extubated and expired 8/21/2021.
Spitting the dose out, regurgitation; Spitting the dose out, regurgitation; This non-serious case was reported by a other health professional via call center representative and described the occurrence of regurgitation of medication in an unspecified number of patients who received Rota (Rotarix lyophilized formulation) for prophylaxis.   On an unknown date, the patients received Rotarix lyophilized formulation. On an unknown date, an unknown time after receiving Rotarix lyophilized formulation, the patients experienced regurgitation of medication (Verbatim: Spitting the dose out, regurgitation) and accidental underdose (Verbatim: Spitting the dose out, regurgitation). The outcome of the regurgitation of medication and accidental underdose were 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: 05-MAY-2023 Health care professional reported, it was noticing that a large portion of patients were spitting the dose out compared with the old formulation, which led to regurgitation of medication and accidental underdose. The reporter wondered if other institutions had the same issues or if this had been reported in the clinical studies.
I am experiencing a little bit of muscle spasm around the injection site and I have a large red bump that is horribly itchy and sore. The first 24 hours after the injection, I could not lift my arm without pain, however, Ibuprofen took care of the pain I was having. It has been very itchy and still slightly sore since then. I'm not sure if this is normal so thought I would report it. No need to contact me, just wanted to add to the side effect reports in case this is unusual.
shingles; This spontaneous report as received from an attorney and refers to an elderly, currently 71-year-old patient of an unknown gender. There was no information about the patient's pertinent medical history, concomitant therapies or drug reactions and allergies provided.  On an unknown date, the patient was prescribed zoster vaccine live (ZOSTAVAX) (dose, route of administration, anatomical location, lot# and expiration date were not reported) by a healthcare provided for long-term prevention of shingles and zoster-related conditions.  On an unknown date in 2012, the vaccine was administrated by a healthcare provider.  On an unknown date, the patient experienced shingles, which was treated by a registered nurse. The outcome of the event was unknown. The reporter considered herpes zoster to be related to zoster vaccine live (ZOSTAVAX).
This case was reported by a healthcare professional and described the occurrence of sneezing in a female subject in her 40's who was vaccinated with FLUARIX (GlaxoSmithKline). On 11 October 2011 at 13:30 the subject received a dose of FLUARIX. On 12 October 2011, 1 day after vaccination with FLUARIX, the subject experienced sneezing. On 22 October 2011, 11 days after vaccination with FLUARIX, the subject developed chills, a sore throat, body pain, cough, nausea, vomiting, headache and eye pain. At the time of reporting, sneezing and body pain were improved and chills and sore throat were resolved. According to the reporter, all four of these events were probably related to vaccination with FLUARIX. The outcome and FLUARIX attribution of cough, nausea, vomiting, headache and eye pain were not known, although a note was made that these symptoms lasted several days. It was indicated that a coworker who did not receive the FLUARIX vaccination, but had been exposed to the subject had not gotten sick; therefore, the reporter believes the subject's symptoms were not a contagious illness, but rather a reaction to the vaccine. Two additional subjects experienced events following vaccination with FLUARIX. Linked cases are A0951445A and A0951452A. Follow-up information was received from the healthcare professional on 6 December 2011. Immediately after the subject received FLUARIX on 11 October 2011, she experienced mild runny nose and sneezing. No others who came in contact with the subject became ill. The events "caused loss of work". On unspecified date(s), all events resolved.
Date the vial was initially stored in the refrigerator on 25-May-2022 and the vaccine was administered on 27-Jun-2022.; administer a vaccine to a patient past the 30 day use by date; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (administer a vaccine to a patient past the 30 day use by date) and PRODUCT STORAGE ERROR (Date the vial was initially stored in the refrigerator on 25-May-2022 and the vaccine was administered on 27-Jun-2022.) in a 69-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 059A22A, 034F21A, 010M20A and 012L20A) for COVID-19 vaccination.     Patient never had COVID positive test or diagnosis. No medical history relating to mentioned AE and both Acute and Chronic illnesses at the time of vaccination.  Concurrent medical conditions included Allergy (Allergy to estrogens) and Drug allergy (Allergy to Toradol).   On 21-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 20-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 13-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 27-Jun-2022, received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 27-Jun-2022,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced EXPIRED PRODUCT ADMINISTERED (administer a vaccine to a patient past the 30 day use by date). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Date the vial was initially stored in the refrigerator on 25-May-2022 and the vaccine was administered on 27-Jun-2022.). At the time of the report, EXPIRED PRODUCT ADMINISTERED (administer a vaccine to a patient past the 30 day use by date) and PRODUCT STORAGE ERROR (Date the vial was initially stored in the refrigerator on 25-May-2022 and the vaccine was administered on 27-Jun-2022.) outcome was unknown.  For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. No concomitant medications was reported. Patient did not receive any other vaccine one month prior to Moderna COVID-19 Vaccine. It was reported that use by date was on the 24-JUN-2022. Number of vials is 10 vials. Vial did not undergone any temperature excursions. AE does not cause patient to seek medical care. No treatment medication was reported.
High fever; This spontaneous case was reported by a patient and describes the occurrence of PYREXIA (High fever) in a 25-year-old male patient who received mRNA-1273.815 (SPIKEVAX 2023-2024) for COVID-19 prophylaxis.     No Medical History information was reported.    On 18-Oct-2023, the patient received dose of mRNA-1273.815 (SPIKEVAX 2023-2024) (Intramuscular use) .5 microgram. On 18-Oct-2023,  after starting mRNA-1273.815 (SPIKEVAX 2023-2024), the patient experienced PYREXIA (High fever). At the time of the report, PYREXIA (High fever) outcome was unknown.            Concomitant medication was not provided. Treatment information was not reported.   This case was linked to US-MODERNATX, INC.-MOD-2022-474092 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2022-474092:Same patient, different vaccine
Vaccine brand other: Moderna/ Vaccine dose number: 3; COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the  patient.  An adult female patient (not pregnant) received BNT162b2 (BNT162B2), as dose 1, single (Batch/Lot number: unknown) and as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation; elasomeran (COVID-19 VACCINE MODERNA), as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history was not reported. There were no concomitant medications within 2 weeks. The following information was reported: INTERCHANGE OF VACCINE PRODUCTS (medically significant), outcome "unknown", described as "Vaccine brand other: Moderna/ Vaccine dose number: 3"; DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive. Therapeutic measures were taken as a result of drug ineffective, covid-19 with Paxlovid from 07Oct2022 to 12Oct2022.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Fever up to 105.2, chills, right shoulder pain, body aches, hypotension, pt admitted to medical center to ICU. 11/14/06-DC DX: Reaction to Pneumovax. Hypertension. Rheumatoid arthritis. Iron deficiency anemia. Hypothyroidism. Fevers up to 105 prior to admission.
received a Moderna vaccine from a vial that should have been discarded; 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 EXPIRED PRODUCT ADMINISTERED (received a Moderna vaccine from a vial that should have been discarded) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 035C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 19-Aug-2021 at 11:17 AM, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 19-Aug-2021 at 11:17 AM, the patient experienced EXPIRED PRODUCT ADMINISTERED (received a Moderna vaccine from a vial that should have been discarded). At the time of the report, EXPIRED PRODUCT ADMINISTERED (received a Moderna vaccine from a vial that should have been discarded) had resolved.            The patient received a Moderna vaccine from the vial that should have been discarded at 2:00 AM. She had received the vaccine 9 hours after the expiration date.  No concomitant product information was provided.  Treatment information was not provided.   Reporter did not allow further contact
This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. A 52-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 20Mar2021 as dose 1, single (Lot number: EN6208), in left arm and on 10Apr2021 as dose 2, single (Lot number: ER8729), in left arm for Covid-19 immunisation; CoviD-19 vaccine miRNA (miRNA 1273) (MODERNA COVID-19 VACCINE), on 12Nov2021 as dose 3 (booster), single (Lot number: 034F21A), in left arm for Covid-19 immunisation. The patient's relevant medical history included: "Crohn's Disease (asymptomatic)" (unspecified if ongoing), notes: other medical history- Crohn's Disease (asymptomatic); "Known allergies: Kiwi" (unspecified if ongoing), notes: known allergies- kiwi; "sulfa drugs" (unspecified if ongoing), notes: sulfa drugs. There were no concomitant medications. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID 19 Treatment". Therapeutic measures were taken as a result of drug ineffective, Covid-19. No follow-up attempts are possible. No further information is expected.
Severe projectile vomiting, shaking and hands and feet turning purple. Took her to the ER, they administered Zofran and told us to ride it out basically.
Patient had reported to Dr. in mid June routine office visit symptoms she had noted some six weeks or more prior (possibly April) of dyspnea on exertion and awareness of irregular heart beats. An EKG revealed non-specific ST-T wave abnormalities. She was advised to follow up with this consultant. She was subsequently noted to have a new S4 on auscultation and echocardiogram revealed mild left ventricular systolic functional impairment with EF 48% with inferolateral wall motion abnormality.    She underwent right and left heart catheterization which disclosed non-flow limiting disease, preserved right heart pressures with normal cardiac index. The cardiac magnetic resonance imaging subsequently revealed EF 35% without specific etiology supported by the scan. The inferolateral wall motion abnormality was confirmed. No specific etiology for the cardiomyopathy is found but is notable to have been discovered after vaccination for SARS-CoV-2 and with symptoms about six weeks after second vaccine administration.
12-year-old patients that received the FLUZONE High-Dose Quadrivalent accidentlywith no reported AE; 12-year-old patients that received the FLUZONE High-Dose Quadrivalent that is for 65 plus age group with no reported AE; Initial information received on 25-Oct-2022 regarding an unsolicited valid non-serious case from a nurse.  This case is linked to case 2022SA443948(CLUSTER).  This case involves a 12 years old and unknown gender patient who received the INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE [FLUZONE HIGH-DOSE QUADRIVALENT] accidently that was for 65 plus age group with no reported adverse event (AE).  The patient's past medical history, medical treatment(s), vaccination(s), concomitant medication and family history were not provided.   On an unknown date, the patient received suspect INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE at a dose of 0.7 ml once (lot number, expiry date: not reported) via intramuscular route in unknown administration site for immunisation.  On an unknown date 12-year-old patients received the fluzone high-dose quadrivalent accidently with no reported ae that is for 65 plus age group (accidental exposure to product, product administered to patient of inappropriate age) (same day latency).  Action taken: Not applicable.  Outcome: Unknown for both the events.   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 the 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.
The patient became very weak, unable to follow commands and was alert and oriented x1.  Within 1 minute of the event the patient became very stiff, his eyes started to roll in the back of his head and he was unresponsive.  Pt was placed in a wheelchair, full set of vitals obtained,sternum rub performed, cold compress applied to the forehead, and the nurse begin to ask a series of questions to try and keep the patient conscious. Patient begin to respond, no food or drinks given, EMS arrived and took control of the scene.
This case was reported by a consumer and described the occurrence of adverse drug reaction in a adult patient who received SHINGRIX for prophylaxis. In November 2018, the patient received the 1st dose of SHINGRIX. On an unknown date, less than a year after receiving SHINGRIX, the patient experienced adverse drug reaction. On an unknown date, the outcome of the adverse drug reaction was unknown. It was unknown if the reporter considered the adverse drug reaction to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. The patient had first dose of SHINGRIX at doctor's office in November 2018 and no side effects except expected ones. For tolerance to the 2nd dose of SHINGRIX, refer case US2019GSK001365.