chrisvoncsefalvay/vaers-outcomes huggingface dataset:
a male patient of 16 year, was given Flublok Quadrivalent with no adverse event; Initial information regarding an unsolicited valid non-serious case was received from a pharmacist via agency (reference number: 00334480) and transmitted to Sanofi on 27-Oct-2020.  This case involved a 16-year-old male patient who received INFLUENZA QUADRIVALENT RECOMBINANT VACCINE [FLUBLOK QIV] (lot UJ445AA and expiration date 17-MAR-2021) via intramuscular route in the right deltoid for prophylactic vaccination on 27-Oct-2020.  Medical history, medical treatment, vaccination and family history of the patient were not provided. Concomitant medication was not reported.   It was  a case of an actual medication error due to Inappropriate age at vaccine administration.  At the time of reporting, patient had no adverse event.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holders compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.  There will be no information available on the batch number for this case.
Started itching all over body on 12/1/21. Broke out in rash and hives all over body on 12/2/21. Hands and feet experienced severe swelling. Started taking prednisone on 12/2/21. Pain/swelling/hives/rash were still severe on 12/4/21. Received prednisone injection on 12/4/21. Full bloodwork panel completed on 12/4/21 with normal results. As of 12/23/21, rash and hives are less severe, but pop up spontaneously on different parts of the body.  I experienced ?covid arm? after first dose, so I think this reaction could possibly be from the booster.
This spontaneous report as received from a pharmacist refers to a 54 year old female patient. The patient's relevant medical history and past drugs were unknown. On 11-JUN-2015 the patient was vaccinated with ZOSTAVAX injection 0.65 ml lot # L028280 with an expiry date of 28-OCT-2016, subcutaneously for prevention of shingles. Concomitant therapies included acetaminophen, polyethylene glycol, ondansetron hydrochloride, metoprolol succinate, atorvastatin, Lisinopril, pantoprazole, calcium 600 plus vitamin D 400, docusate sodium, tramadol hydrochloride, clonazepam, chondroitin sulfate sodium and glucosamine sulfate, minerals (unspecified), CENTRUM SILVER, citalopram, buspirone hydrochloride and diclofenac diethylamine. On 30-OCT-2015, she inadvertently received a second injection of ZOSTAVAX (extra dose administered). It was unknown if there was any relevant lab data. As of 31-OCT-2015, patient did not receive ZOSTAVAX and is not experiencing any problems from receiving doses of ZOSTAVAX. Additional information has been requested.
MORE PERSISTENT FATIGUE THAN NORMAL; This spontaneous report received from a patient via a company representative concerned a 68 year old male. The patient's height, and weight were not reported. The patient's past medical history included major stroke, and concurrent conditions included aortic st. jude valve, cholesterol, thyroid, hypertension, low blood pressure, extremes of heat, and cold weather effec.The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unk) dose was not reported, administered on 27-MAY-2021 for prophylactic vaccination. The batch number was not reported and has been requested. Concomitant medications included warfarin for cholesterol. On 06-JUN-2021, the subject experienced more persistent fatigue than normal. Laboratory data (dates unspecified) included: Blood pressure (NR: not provided) Often below 120/70. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of more persistent fatigue than normal was not reported. This report was non-serious.
My daughter started feeling off around 8 p.m the evening of her 2nd covid vaccine. She woke up around 3 a.m with sever nausea and a fever 0f 102.5. Shortly after she began vomiting which continued throughout the night. By morning she still had a fever of about 102 and could not hold down fluids. We called in to our pediatricians office and told them of our situation. The Dr called in some ONDANSETRON to control the vomiting. She also developed a sore throat, cough, runy nose and eye infection. We saw another Dr to treat the eye infection which started a few days later.  She still isn't feeling well and it has been almost 2 weeks.
Moderna COVID 19 vaccine EUA  Had first dose on Wednesday 3/10/21 and evening of 3/17/21 right deltoid where injection was giving broke out it what looked like hives with a red ring around it. Itchy, hot and swollen. Every day since rash felt better and red ring spread farther apart. Itching and swelling was done after 12-24 hours.
Resident was given the Pfizer vaccine on January 22, 2021, nausea and shortness of breath was taken to the Hospital on the 23rd of January and passed on the 24, 2021
After about 5 hrs, I was very fatigued, had nausea, arm swelling and a red spot on my arm that was raised and hot. Later that night, I had a low grade fever, body aches. After sleeping for 12 hrs,  all of the symptoms were gone accept for being fatigued and my arm swelling which lasted for about 10 days.
I experienced prickling in my mouth, swelling in my throat to the point I felt like my throat was closing up. These symptoms lasted for 2 and a half hours, and I took antihistamines before going to the ER where I was given antihistamine and nausea medication.
I inadvertently gave patientan adult dose of the Hepatitis A Vaccination. No adverse reactions have been reported to date.
Woke to daughter screaming/crying oddly. Viewed on monitor child jerking. Entered room - child actively seizing. Total time 1-2 min. Observed. Ambulance called. Child unresponsive, taken to ER. Fever 102.4. (+) UTI.
Appx 2-3 mins following vaccine administration pt had generalized Tonic-clonic seizure with apnea. Seizure lasted appx 30-45 seconds. Pt gently laid on floor by mother and clinic staff. Pt with very brief post-ictal period. Pt evaluated by EMS and pt's mother requested discharge home and follow with neurologist.  Pt with history of epilepsy,no rescue medication, last seizure appx 2 years PTA.
fever 101 ax;persistent crying;myoclonic jerks (infantile spasms);
Case number PHEH2014US014947 is an initial spontaneous report from the pharmacist (consumer) received on 24 Jul 2014. This report refers to a female patient of an unknown age. The patient was vaccinated with FLUCELAX (batch number: not reported) on 22 Jul 2014, intramuscularly. It was reported that the vaccine taken by the patient went above the recommended temperature, before it was administered. It was reported that FLUCELVAX was shipped on 20 Jul 2014. The vaccines were warm to the touch upon arrival at the facility on 21 Jul 2014 and the ice pack was slushy. No adverse event reported following this medication error (incorrect storage of drug).
Patient received Flucelvax and Arexvy on 10/1/23 in the left arm. She noticed redness and swelling the next day which continued to worsen over the next several days. She described the reddened area as having a diameter of 4-5 inches and very swollen, tender and painful. On day 3 she was seen by a physician and was prescribed a 5 day prednisone course. This helped reduce the swelling and patient is feeling better now. Patient has never had a reaction to the flu vaccine before and has only ever experienced side effects from Covid vaccines.
Patient given bivalent moderna as the first dose of the primary series. No issues noted by patietn or care giver, was noticed when patient came back to clinic on 11/4/22 to get his second dose of Moderna that it was noted. Medical director advised per CDC guidelines, to start the series over with Moderna monvalent
approx 4 days after 2nd dose of vaccine, had sudden hearing loss. Initially improved with oral steroid for a few weeks.  Subsequently permanent hearing loss.
G62.0 CHEMOTHERAPY INDUCED PERIPHERAL NEUROPATHY, SEQUELA 10/7/2022 INTRAABDOMINAL ABSCESS J96.01 ACUTE HYPOXEMIC RESPIRATORY FAILURE 10/7/2022 INTRAABDOMINAL ABSCESS R09.02 HYPOXIA 4/16/2022 INTRAABDOMINAL ABSCESS G62.0 CHEMOTHERAPY INDUCED PERIPHERAL NEUROPATHY, SEQUELA 10/7/2022 DYSLIPIDEMIA J96.01 ACUTE HYPOXEMIC RESPIRATORY FAILURE 10/7/2022 DYSLIPIDEMIA R09.02 HYPOXIA 4/16/2022 DYSLIPIDEMIA G62.0 CHEMOTHERAPY INDUCED PERIPHERAL NEUROPATHY, SEQUELA 10/7/2022 ANEMIA J96.01 ACUTE HYPOXEMIC RESPIRATORY FAILURE 10/7/2022 ANEMIA R09.02 HYPOXIA 4/16/2022 ANEMIA G62.0 CHEMOTHERAPY INDUCED PERIPHERAL NEUROPATHY, SEQUELA 10/7/2022 ANEMIA J96.01 ACUTE HYPOXEMIC RESPIRATORY FAILURE 10/7/2022 ANEMIA R09.02 HYPOXIA 4/16/2022 ANEMIA G62.0 CHEMOTHERAPY INDUCED PERIPHERAL NEUROPATHY, SEQUELA 10/7/2022 HOSPITAL ACQUIRED PNEUMONIA J96.01 ACUTE HYPOXEMIC RESPIRATORY FAILURE 10/7/2022 HOSPITAL ACQUIRED PNEUMONIA R09.02 HYPOXIA 4/16/2022 HOSPITAL ACQUIRED PNEUMONIA
Noticed one month after the injection was given that arm had indention and has gotten worse over the past months. Her personal trainer told her it was from injection. Per patient nothing initial after immunization.
Rapid resting heart beat, low O2 level, fever, chills, body aches and fatigue from 1 am to ongoing.
BODY ACHES; CHILLS; FEVER; This spontaneous report received from a health care professional via another pharmaceutical company (Pfizer) concerned a female of an unspecified age, race and ethnicity. The patient's weight, height, and medical history were not reported. The patient previously received covid-19 vaccine ad26.cov2.s (Dose number in series 1) (suspension for injection, route of admin, batch number and expiry date were not reported) dose, start therapy date were not reported, 1 in total was administered for covid-19 prophylaxis. The patient experienced body aches, chills and fever (Dose number in series 1). The patient recovered from body aches, chills, and fever. The patient received covid-19 vaccine ad26.cov2.s (Dose number in series 2) (suspension for injection, route of admin, batch number and expiry date were not reported) dose, start therapy date were not reported, 1 in total was administered for covid-19 prophylaxis. The batch number was not reported and has been requested. No concomitant medications were reported.  On an unspecified date, the patient was ill and was feeling sick and experienced body aches, chills, and fever for 10-12 hours following vaccine administration (Dose number in series 2). The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from body aches, chills, and fever. This report was non-serious. This case, involving the same patient is linked.
Fainted twice after receiving the vaccine.   First time 5 days after receding the vaccine, the second time about 6 weeks later.  First time I was dehydrated, and fainted at the gym while exercising.  The second time I fainted while walking the dog.  Both times I broke out in hives, the second time more severely (all over my body).  Both times I fell, hit head head and had to get stitches or staples.
Within less than five minutes aft4er receiving the influenza injection in the left arm I lost most the hearing in the left ear. I used a cell phone before leaving my car in the parking lot and could hear fine. I went into the building, got the shot, returned to my car and tried to use the cell phone again but couldn't understand the other party as the voice seemed distorted or muffled. Prior to this event, I have always had excellent hearing. I have received flu shots for many years probably since they were first available with no reactions. After losing hearing in the left ear I immediately made an appointment with doctor. He conducted test and then referred me to another doctor. He conducted tests, gave me drugs to take and made injections through the ear drum. None of these things helped. The 60 day follow up received on 12/16/03 states loss of hearing in the left ear. This occurred immediately upon receiving the innoculation, 2nd there has been no improvement since then. More info concerning this incident is in the report sent 10/1/03.
On 06/11/2022 I had my second booster shot. On 09/04/2022 I started to experience a severe sore throat and nasal congestion. My son had tested COVID-19 positive earlier in the week. I had chills muscle aches and has settled into my chest the following Sunday with a severe cough. I tested COVID-19 positive on 09/07/2022. They did offer medication but I declined due to my blood pressure issues. This is the second time I have had COVID-19.
Breast heaviness; chest pain; Breast swelling; Sprain; This spontaneous case was reported by a nurse and describes the occurrence of BREAST DISCOMFORT (Breast heaviness), MUSCULOSKELETAL CHEST PAIN (chest pain), BREAST SWELLING (Breast swelling) and LIGAMENT SPRAIN (Sprain) in a 55-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011J20A) for COVID-19 vaccination.     Concurrent medical conditions included Hypertension.    On 30-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .5 milliliter. On 09-Jan-2021, the patient experienced BREAST DISCOMFORT (Breast heaviness), MUSCULOSKELETAL CHEST PAIN (chest pain), BREAST SWELLING (Breast swelling) and LIGAMENT SPRAIN (Sprain). At the time of the report, BREAST DISCOMFORT (Breast heaviness), MUSCULOSKELETAL CHEST PAIN (chest pain), BREAST SWELLING (Breast swelling) and LIGAMENT SPRAIN (Sprain) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Blood pressure measurement: Hypertension. On an unknown date, Computerised tomogram: negative (Negative) Unclear. On an unknown date, Fibrin D dimer: d-dimer Elevated, rule out DVT. On an unknown date, X-ray: x-ray Not clear.     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.   Treatment included motrin and Lidoderm patch.  No concomitant medication was provided.
incorrect product storage; No adverse affects reported; This spontaneous report as received from an office manager refers to a patient of unknown age and gender. No information on patient's pertinent medical history, concomitant medications and drug reaction or allergies was provided.      On an unknown date, the patient was vaccinated with improperly stored hepatitis a vaccine, inactivated (VAQTA) (lot # S009562 has been verified to be a valid lot number, expiration date reported as 26-JUL-2020, but upon internal validation established as 05-MAY-2019 (dose and route of administration were not provided) for prophylaxis. The vaccine underwent temperature excursion of 35.1 Fahrenheit degrees for 5 hours. There was no previous excursion. Data logger was involved. No adverse affects were reported.
Cerebral venous sinus thrombosis following third dose (booster shot) of BNT162B2 vaccine; This is a literature report for the following literature source(s):    A 52-year-old female patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "ER" (unspecified if ongoing); "Headache" (unspecified if ongoing), notes: Pressure like headache; "ear/sinus infection" (unspecified if ongoing), notes: Initially treated with NSAIDs and antibiotics.; "ear/sinus infection" (unspecified if ongoing), notes: Initially treated with NSAIDs and antibiotics. The patient's concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Primary immunization series completed,, Unknown manufacturer), for Covid-19 Immunization. The following information was reported: CEREBRAL VENOUS SINUS THROMBOSIS (medically significant), 7 weeks after the suspect product(s) administration, outcome "recovering", described as "Cerebral venous sinus thrombosis following third dose (booster shot) of BNT162B2 vaccine". The patient underwent the following laboratory tests and procedures: Blood thromboplastin: Normal; Computerised tomogram venography head: abnormal signal in the, notes: superior sagittal, left transverse and sigmoid sinus-concern for CVST; Full blood count: Normal; International normalised ratio: Normal; Thombophilia: Negative; Magnetic resonance imaging: improving recanalization, notes: of the sinus and patient  3 months later; Magnetic resonance imaging head: which showed no stroke or, notes: parenchymal abnormality but raised concern for abnormal signal in the superior sagittal, left transverse and sigmoid sinus-concern for CVST; Metabolic function test: Normal; Prothrombin time: Normal. Therapeutic measures were taken as a result of cerebral venous sinus thrombosis.; Sender's Comments: Based on the available information in the case, the causal association between the event  Cerebral venous sinus thrombosis and the suspect drug BNT162B2 cannot be 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.
Redness, swelling, bruising at the injection site. Swelling throughout upper left arm. Edema throughout upper left arm. Swollen left elbow. Patient reports that arm is very tender and that she was not able to play golf after receiving her vaccination.
Patient states that approx 15 minutes after injection site had small knot and was red.  It progressively got worse until mom called to bring him in at 2:00 the following day. Patient was seen 3:30 on 1/7/11 and given antibiotics and oral steriods.
Information has been received from a medical assistant referring to multiple patients of unknown age and gender. The medical assistant reported that on multiple unspecified dates these patients were administered with doses of GARDASIL (dose, route not reported, lot # H021608 with expiration date 13-AUG-2015, lot# K006191 with expiration date 02-FEB-2017, lot # K007828 with expiration date 02-MAR-2017, lot # K023432 with expiration date 18-JUN-2016) that were exposed to a supported temperature excursion of 32F for 8 hours on six different occasions. The medical assistant stated that these vaccines were not exposed to temperatures below 32F. No adverse effect was reported. This is one of two reports from the same reporter (other linked MARRS# 1505USA001498). Additional information has been requested.
Narrative: Pt was a 72 YO male with PMH of severe bullous emphysema, COPD on oxygen therapy 6 L/min at nighttime, HFpEF (EF = 5%), hx of SVT admitted to hospital for increased sputum production, shortness of air, and afib. Cause of death was reported as hypoxic and hypercapnic respiratory failure secondary to end stage COPD. Family declined autopsy.
Patient experience shortness of breath, hives, itching approx 8-12 hours post vaccination. No reaction reported within 4 hours post-injection
This spontaneous report was received from a health care worker concerning an unspecified number of patients of unknown age and gender. The patients' medical history, concurrent conditions, concomitant medications and drug reactions/allergies were not reported. On an unspecified date in April 2017, the patients were vaccinated with improperly stored doses of ROTATEQ orally, lot # L037924 with expiration date: 22-JUN-2017 and lot # M002254 with expiration date: 15-NOV-2017, as prophylaxis (Strength, dose and route were not reported), which experienced a temperature excursion of 12.7 Celsius degrees for 2 hours and 15 minutes. There were no previous temperature excursions reported. Data logger was involved. No symptoms were reported. Additional information has been requested.
pt recv vax 3APR98 & 13APR98 pt exp dizziness, n/v & joint pain intermittently;child came to the office & found nothing on exam;
Covid arm:  started itching-swelling started 2-24-2021.  Reddened area & swelling is still enlarging .
Case PHHY2015US124679 is an initial literature case report received on 08 Oct 2015. The author in the article discussed about the risk of anaphylaxis after vaccination in children and adults. This report refers to an 11 years old male patient. Medical history was reported as none. Concomitant medications were not reported. The patient was vaccinated with Hep A vaccine (manufacturer and batch number: not reported) along with MCV4 vaccine (manufacturer and batch number: not reported), Tdap (manufacturer and batch number: not reported) and varicella vaccine (manufacturer and batch number: not reported) on an unknown date. On an unknown date after vaccination the patient experienced injection site urticaria and erythema. Further the patient had decreased blood pressure. The patient was sent to the clinic. The pediatrician attributed vaccines as trigger for the events (vaccine triggered anaphylaxis). The patient was treated with oral antihistamine. Final outcome of the events was reported as complete recovery. Seriousness of the events was not reported. Seriousness of the event anaphylactic reaction was upgraded based on Novartis Important Medical Events (NVS-IME) list. The author described the case as Brighton Level 2 of diagnostic certainty. The author concluded that the present study was based on a very large population receiving currently used vaccines and confirmed the rarity of post-vaccination anaphylaxis overall and after specific vaccines. Although anaphylaxis after immunization was rare; its immediate onset (usually within minutes) and life-threatening nature require that all personnel and facilities providing vaccinations have procedures in place for anaphylaxis management. Additional provider education concerning current recommendations for treatment and follow-up appears to be warranted.
I first lost my nail. It was unusual because there was no trauma to the nail. I was reaching for something across my bed, and I started experiencing radiating pain across my chest as well as pressure. I stayed very still and then it spread through my left arm and up into my shoulder, neck ear and jaw. I remained still and tried breathing the best I could. This lasted a minute or two and then it released and was over. About a month later, I was diagnosed with RSV which ran down into my lungs and soon my blood pressure was going up because my heart was working so hard to breathe. It was over 200/175 which is abnormal for me. I had to end up calling an ambulance because I was having trouble breathing. I was prescribed blood pressure medication, steroids, antibiotics, prednisone and oxygen. I was not allowed to get out of bed, I couldn't walk. They told me it would take baby steps.