chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Arrived at clinic for HPV #2 on 7/22/08. Mom reports that patient had dizziness, paleness and fever (temp not taken) for 72 hours after first HPV on 4/22/08. Mom kept home from school on 4/23/08. Patient reported brief episode of right hand numbness/tingling at school on 4/24/08. HPV #2 deferred. Series suspended.
coughed so hard that my ribs hurt; felt sick, Patient did not feel well; 2 days after booster patient got head congestion which then went away; Coughing kicked in; wheezing; As the week went on patient got more tired; This spontaneous case was reported by a patient and describes the occurrence of NASAL CONGESTION (2 days after booster patient got head congestion which then went away), COUGH (Coughing kicked in), MALAISE (felt sick, Patient did not feel well), WHEEZING (wheezing) and MUSCULOSKELETAL CHEST PAIN (coughed so hard that my ribs hurt) in a 63-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 016J21-2A, 050C21A and 023C21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient did not had a history or current diagnosis or pericarditis or myocarditis.  Concomitant products included MONTELUKAST, ALBUTEROL [SALBUTAMOL], PROMETHAZINE HYDROCHLORIDE (PROMETH), CEFUROXIME, METHYLPREDNISOLONE, COLECALCIFEROL (VITAMIN D3), MULTIVITAMIN FOR WOMEN, IRBESARTAN, HYDROCHLOROTHIAZIDE (HCTZ), ROSUVASTATIN and AMLODIPINE for an unknown indication.   On 06-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 03-Jun-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 07-Mar-2022, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 09-Mar-2022,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced NASAL CONGESTION (2 days after booster patient got head congestion which then went away). On 12-Mar-2022, the patient experienced MALAISE (felt sick, Patient did not feel well). In March 2022, the patient experienced COUGH (Coughing kicked in), WHEEZING (wheezing) and FATIGUE (As the week went on patient got more tired). On an unknown date, the patient experienced MUSCULOSKELETAL CHEST PAIN (coughed so hard that my ribs hurt). At the time of the report, NASAL CONGESTION (2 days after booster patient got head congestion which then went away) and COUGH (Coughing kicked in) had resolved and MALAISE (felt sick, Patient did not feel well), WHEEZING (wheezing), MUSCULOSKELETAL CHEST PAIN (coughed so hard that my ribs hurt) and FATIGUE (As the week went on patient got more tired) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In March 2022, SARS-CoV-2 test: (Negative) Negative.         Concomitant products included Bausch and Lomb Preservision Areds, Womens Multivitamin and Prometh-D.  The patient received first booster dose of the Moderna Covid-19 vaccine. Cough lingered for 3 to 4 weeks despite the medication that her doctor gave her.  Reportedly, doctor put patient on 5 unspecified medications due to symptoms.   This case was linked to MOD-2022-637066 (Patient Link).
Ten days after the first injection, I developed a red rash on my left arm in the area of the injection. The rash is about 2 inches in diameter with some slight itching.
administered a dose of flublok to a 17 year old in error with no reported adverse event; Initial information received  on 15-Sep-2022 regarding an unsolicited valid  non-serious case received from a other health professional.  This case involves a 17 years old patient of an unknown gender and reported that they administered a dose of Influenza Quadrivalent Recombinant Vaccine [Flublok] to a 17 year old in error with no reported adverse event   The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On 15-Sep-2022, the patient received a  dose of 0.5 ml suspect Influenza Quadrivalent Recombinant Vaccine, once (1X) ( strength, formulation, route, lot number  and expiry date: not reported)  in unknown administration site for immunization. Information regarding batch number details has been requested.  The reporter stated that  they administered a dose of Flublok to a 17 year old in error with no reported adverse event (product administered to patient of inappropriate age) (onset date: 15-Sep-2022; latency: same day).  Action taken : not applicable.  Outcome: unknown   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.
fever 103-105 x 2 days, sleeping alot when awake extremely irritable & crying for 2 hrs @ a time; holding arm-screams everytime arm is moved;
Patient reported feeling tingling in lips and itchiness in spots on body. Patient reported symptoms 10 mins after vaccine administration. Patient refused epi pen and asked for liquid benadryl. Patient was administered Benadryl 25 mg PO liquid. Patient monitored for 30 mins following and reported feeling better.
Local redness and swelling of site. Symptoms of body aches, nausea and increased sensitivity of skin.
Painful Hardened red area mid clavicular, left side, pea-sized.  Vaccinatiion site, left deltoid, erythematous.Keflex 500 mg 1 tab 4Xday  X10 dys
This spontaneous report as received from a nurse practitioner regarding a patient of unknown age and gender. The patient's concurrent condition, medical history and concomitant medications were not reported. On 12-MAY-2014, patient received improperly stored VARIVAX dose 2, from batch/lot # H018451 (expiry date, dose units, route and anatomical location were not specified) (incorrect product storage). No adverse effects were reported. The reporter stated that inconsistencies in storage temperature were identified on extensive review and records. The reporter stated that vaccine was not thawed. The nurse practitioner reported that there was insufficient data to provide 100 percent assurance on vaccine stability. This is one of the several reports received from the same reporter. Additional information has been requested.
Fungal infection in the Lungs; Rash and raised reaction at the site of Pfizer booster; Vaccination site papule; Inflammation with joint; This is a solicited report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. Other Case identifier(s): 22K-163-4434822-00 (Agency).  A 58-year-old female patient received BNT162b2 (BNT162B2), as dose number unknown (booster), single (Batch/Lot number: unknown) for 1 day intramuscular for covid-19 immunisation; adalimumab (HUMIRA), first regimen (Batch/Lot number: unknown) and second regimen (Batch/Lot number: unknown) at unk (citrate free), all subcutaneous for crohn's disease. The patient's relevant medical history included: "Pulmonary illness" (unspecified if ongoing), notes: Pulmonary illness. The patient's concomitant medications were not reported. Vaccination history included: Bnt162b2 (Primary Immunization series: Unknown, Intramuscular), for COVID-19 Immunization. The following information was reported: PNEUMONIA FUNGAL (medically significant), outcome "recovered", described as "Fungal infection in the Lungs"; VACCINATION SITE RASH (non-serious), outcome "recovered", described as "Rash and raised reaction at the site of Pfizer booster"; VACCINATION SITE PAPULE (non-serious), outcome "recovered"; ARTHRITIS (non-serious), outcome "recovering", described as "Inflammation with joint". The action taken for adalimumab was temporarily withdrawn.  The reporter's assessment of the causal relationship of "fungal infection in the lungs" and "inflammation with joint" with the suspect product(s) BNT162b2 was not provided at the time of this report. Since no determination has been received, the case is managed based on the company causality assessment. The reporter considered "rash and raised reaction at the site of pfizer booster" and "vaccination site papule" related to BNT162b2.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Based on the current available limited information in the case provided, the causal association between the events and the use of suspect product BNT162B2 cannot be fully excluded.  The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
Patient describes feeling "woozy" immediately following the injection, followed by severe pain in R hand and 3 fingers (index, middle, and ring finger) went numb. All symptoms resolved on their own.  She did not receive medical care, nor did she follow-up with her pcp.
had shot 1 in 2018 but didn't return for the booster / had the first dose a 2nd time in June 2020; This case was reported by a consumer via interactive digital media and described the occurrence of drug dose administration interval too long in a patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st dose of shingrix on 2018).   In June 2020, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced drug dose administration interval too long. On an unknown date, the outcome of the drug dose administration interval too long was unknown.  Additional details provided as follows: Age at vaccination was not reported. The patient had enquired about re-vaccination. The patient received 1st dose in 2018 but did not return for booster dose and received first dose a second time in june 2020 which led to drug dose administration interval too long. No further information received.
MUSCLE PAIN; LEFT ARM PAIN; PAIN TRAVELED TO OTHER PARTS OF  BODY; This spontaneous report received from a patient concerned a 74 year old male. The patient's weight was 195 kilograms, and height was 67 inches. The patient's concurrent conditions included no alcohol use, non smoker, hypertension, cholesterol, and myasthenia gravis, and other pre-existing medical conditions included the patient had no known allergies. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, and batch number: 180518 expiry: 25-MAY-2021) dose was not reported, administered on 12-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On MAR-2021, the subject experienced pain traveled to other parts of body. On 12-MAR-2021, the subject experienced left arm pain. On 16-MAR-2021, the subject experienced muscle pain. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from muscle pain, left arm pain, and pain traveled to other parts of body. This report was non-serious.
Cold symptoms beginning April 27th with cough, sore throat, runny nose and fatigue. Treated with Augmentin, nose spray and cough caplets  beginning April 30th for sinus infection. Symptoms continued with a forceful cough, treated with steroids beginning May 11th, no change then treated for bronchitis with Z-Pack, nose spray and Albuterol inhaler on May 19th. Had x-rays and lungs were clear but very forceful cough continued. Developed vertigo on June 7th which has cleared up and cough has gradually decreased.
Not feeling great at night and sleepy. 2nd day Chills achey headache slight fever of 99.
My dad received the Pfizer vaccination on 2/5/21.  He was admitted into the hospital the next day for C-Diff bacterial infection.  He had been on dialysis treatments for kidney failure treatment since 2017 and had recently been diagnosed with stage 3 colon cancer in June 2020.  He had completed his final treatment of chemotherapy on 2/4/21 and several weeks prior had been determined cancer free.  On Tuesday 2/9/21 he was released from the hospital and went home.  Early Thursday morning 2/11/21 @ approximately 1:30 am CST his eyes rolled back in head and he stopped breathing and was non responsive.  My mother called 911 and attempted CPR.  Paramedics arrived and were able to successfully get a pulse then transferred him to the hospital.  He was put on a ventilator @ the hospital and then transferred to a different hospital a few hours later.  He lost pulse/heartbeat several times @ the 2nd hospital he was transferred to.  We were not allowed to travel with him or see him b/c of all of the COVID restrictions.  We were communicating with the ICU doctor by phone who ultimately communicated to us that there was nothing further that could be done to save his life. He subsequently passed away @ approximately 8:55 am CST on 2/11/21.
Medical assistant diluting covid vaccines diluted the vaccine with sterile water instead of sodium chloride. She followed the rest of the steps of preparing the vaccine correctly other than what to dilute the vaccine with. It was not caught until a few month later that this MA had been diluting the covid vaccines with the incorrect diluent. Therefore many patients, including this patient, received the covid vaccine with the incorrect diluent. Pfizer, the manufacturer, was contact regarding this and no data is available if the incorrect diluent type is supported to be stable. Therefore this dose with the incorrect diluent should be considered invalid and should be repeated. Patient was seen in acute care on 08/31/2022 for cough and sore throat. She was tested for covid and it was negative. She was also seen on 10/12/2022 for sore throat, cough, and fever. She was tested for covid and that was negative. Patient otherwise did not show any signs or symptoms of adverse reaction from the vaccine. Family is being notified and being advised to bring patient in for revaccination from the incident.
Called call center to reoirt the day  after she got her second dose of Pfizer vaccine she has swelling in her left armpit.   Patient denies fever, chills, cough.  Patient reports she feels tired and has body ache.  Patient denies redness or ulceration Advised pt if emergency symptoms arise to go to ED or call emergency responders.Scheduled pt with telephone appt for 5/1/21.
Pt in office for routine 15 yr old physical. Not ill, felt great. Has had 2 previous GARDASIL vaccines. About 2 hrs after vaccine, pt felt nauseous, febrile, severe  myalgias, headache. Could not attend school or cross country practice. Sx resolved in 24 hrs.
Chills. Nausea vomiting. Muscle aches headache joint pain. Extremely exhausted.
Patient was given original Pfizer Covid 19 vaccine instead of requested bivalent Pfizer Covid-19 vaccine
opened vial for ipol is to be stored at 2 Celsius to 8 Celsius.  Temperature excursion for this opened vial at 46.9 F converted to Celsius is 8.28 Celsius for 30 minutes while door was opened to store vaccines in fridge unit.  After the temperature excursion the ipol was administered to the patient.
Within 14 days of immuization (03/31/08) a severe and very painfull rash appeared on upper right knee/thigh area spreading to inside of thigh and back of thigh area.  Another severe and painfull rash appeared on the right upper buttock a day latter. Same day I was seen by PCP and diagnosised with a full-blown case of shingles. I was given Rx for Acyclovir Tab 800 mgm to be taken 4 times daily of which I had to refill for additional treatment because the shingles were not gone in 7days but were in 14 days.  I was also given Rx/PROPO-N/APAP TAB 100/650 for the pain that helped make the pain bearable.  At the end of 16 days the rash was completely gone but there are scars where the rash/blisters were.
Redness at injection site on (L) leg, about 2" in diameter, somewhat warm to the touch.
I had a major flare up of Crohn?s 1 week after my second shot
hit her like a ton of bricks; This non-serious case was reported by a consumer via call center representative and described the occurrence of pain in a 73-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   The patient's past medical history included intestinal resection (In 2015), peridiverticular abscess (on colon) and diverticulitis. Previously administered products included Proton pump inhibitors (for years). Concurrent medical conditions included renal disease (3rd stage kidney disease in 2016) and hypothyroidism. Concomitant products included famotidine (Pepcid).   In JUL-2018, the patient received the 1st dose of Shingrix. On an unknown date, 18 hrs after receiving Shingrix, the patient experienced pain (Verbatim: hit her like a ton of bricks).The outcome of the pain was resolved (duration 1 day).   It was unknown if the reporter considered the pain to be related to Shingrix.     It was unknown if the company considered the pain to be related to Shingrix.   Linked case(s) involving the same patient:US2023149435, US2023AMR149797   Additional Information: GSK Receipt Date: 27-OCT-2023 The patient also mentioned having received the Shingrix and that shot hit her like a ton of bricks. This started about 18 hours after receiving Shingrix, and lasted for about a day.  No further information was provided about these events. A diverticulitis abscess on her colon all pre-existing. The Shingrix was being monitored for all of this. The patient was on proton pump Inhibitors for years but no longer took these medications (no drug information provided).  The patient currently took Pepcid the smallest dose (no product information provided). The reporter consented to follow up. The case had been linked to US2023AMR149797 and US2023149435, reported by the same reporter, for a different product.; Sender's Comments:  US-GSK-US2023AMR149797:Shingrix Dose 2 US-GSK-US2023AMR149797:same patient US-GSK-US2023149435:same patient
Information has been received from a registered nurse concerning a 29 year old male who had been given "at least one dose of MMR II in the past and now had negative titers." At the time of the report, the patient's outcome was unknown. Follow up has been received from the registered nurse who stated that the patient had documentation of two doses of MMR II (lot# not reported) and negative serum titers. He stated that there was no adverse experience besides negative titers: no evidence of disease or any other disorder. Additional information is not expected.
Non-stop hot flashes (day and night) since the jab; Headache; Warmth  at the injection site; Soreness at the injection site; This is a spontaneous report from a contactable consumer, the patient. A 52-yeasr-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 arm left on 20Mar2021 at 15:00 (at the age of 52-years-old) as a single dose for COVID-19 immunisation. The patient did not have any relevant medical history. The concomitant medication were not reported. The patient did not receive any other vaccines within four weeks prior to the vaccination. Prior to the vaccination, the patient was not diagnosed with COVID-19.  On 25Sep2020, the patient underwent COVID test (nasal swab test) and resulted negative. On 17Dec2020, the patient underwent COVID test (nasal swab test) and resulted negative. Since the vaccination, on an unknown date in 2021, the patient had been tested for COVID-19 and result was unknown. On 20Mar2021 the patient experienced non-stop hot flashes (day and night) since the jab, headache on the day of the vaccine, warmth and soreness at the injection site for a couple days. Therapeutic measures and treatments were not 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. The clinical outcome of the events hot flashes, headache, warmth and soreness were not recovered. at the time of this report.  No follow-up attempts are needed. No further information is expected.
Injection spot became red, swollen and large for a month. After a month thigh was a quarter bruised for almost 6 months. Also  same day as injection, red swollen spots broke out all over the body and no longer was speaking.  There is as no treatment as doctor explained it was a ?normal? reaction.
COLD SWEATS; PAIN ALL OVER THE BODY; COULD FEEL EACH ONE OF BONES BECAUSE THEY WERE HURTING SO BAD; FEVER THAT WOULD NOT GO DOWN; EXTREME HEADACHE (SWOLLEN BRAIN); This spontaneous report received from a patient via a company representative concerned a patient of unspecified age and sex. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported.  On an unspecified date, the patient experienced cold sweats, pain all over the body, could feel each one of bones because they were hurting so bad, fever that would not go down, and extreme headache (swollen brain). The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the cold sweats, pain all over the body, could feel each one of bones because they were hurting so bad, fever that would not go down and extreme headache (swollen brain) was not reported. This report was non-serious.
shortness of breath; heart palpitations; fatigue; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of DYSPNOEA (shortness of breath) in a 57-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 032B21 and 002B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medical history was reported.  Concomitant products included VITAMINS NOS (DAILY VITAMINS) for an unknown indication.   On 23-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 20-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 21-Apr-2021, the patient experienced DYSPNOEA (shortness of breath) (seriousness criterion hospitalization), PALPITATIONS (heart palpitations) and FATIGUE (fatigue). At the time of the report, DYSPNOEA (shortness of breath), PALPITATIONS (heart palpitations) and FATIGUE (fatigue) had not resolved.        mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosing remained unchanged.       On known date, cardiology, pulmonary and blood work were performed with negative results.  Patient was hospitalized for observation over night.   No treatment information was provided.  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.