chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a contactable reporter(s) (Physician).  A 42-year-old male patient received BNT162b2 (BNT162B2), on 25Feb2021 as dose 1, single (Batch/Lot number: unknown), on 18Mar2021 as dose 2, single (Batch/Lot number: unknown) and on 13Jan2022 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 41 years for covid-19 immunisation. The patient's relevant medical history included: "Bipolar disorder" (unspecified if ongoing), notes: Other medical history: Bipolar disorder. The patient's concomitant medications were not reported. Past drug history included: Gabapentin, reaction(s): "Known allergies: gabapentin"; Cyclobenzaprine, reaction(s): "Known allergies: cyclobenzaprine". The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (unspecified date) Positive, notes: Paxlovid rebound; (14Aug2022) Positive, notes: positive COVID test on 14Aug2022. Therapeutic measures were taken as a result of vaccination failure, covid-19.   Clinical course: Antiviral details included COVID 19 Treatment, Brand was Paxlovid started on 30Jul2022 to 03Aug2022 administered orally. Paxlovid rebound, developed URI (Upper respiratory infection) symptoms and positive COVID test on 14Aug2022.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.; Sender's Comments: Based on the information currently available,The casual association between the reported events and suspected vaccine BNT162B2 cannot be completely excluded.
This spontaneous report as received from a licensed vocational nurse refers to a 4 year old male patient. The patient had no illness at time of vaccination. No information on patient's medical history or concomitant medications was provided. On 18-NOV-2015, the patient was vaccinated with the first dose of PROQUAD (Merck) (subcutaneously, in right thigh, lot # K008185, albumin status HSA; dose and expiration date were not reported) that was improperly stored. On the same day, the patient was also concomitantly vaccinated with the first dose of KINRIX (intramuscularly, in left thigh, lot # 5412R; dose and expiration date were not reported) and with the fourth dose of PREVNAR 13 (intramuscularly, in right thigh, lot # J80528; dose and expiration date were not reported). No adverse effects were reported. This is one of the several reports from the same source. Additional information is not expected as all correspondence was received.
After the injection I stayed on a recliner for 15 min before returning to work, nothing happened, I felt good. After I arrived home, about 3 hours later when I was home I felt a mild headache. The next day I felt muscle pains/body aches, specially on the right side of my body, my right shoulder was hurting really bad. after 48 hours the symptoms went away.
THE DAUGTHER CALLED AND SAID PATIENT GOT SWEELING ON LEFT HAND SIDE DOWN TO ELBOW AND GOT FEVER.
Information has been received from a 70 year old female patient reporting on herself.  The patient's drug reactions/allergies include allergy to penicillin. The patient's pertinent medical history included open heart surgery in 2005. The patient's concomitant medication included medication for "immune system" and an unspecified flu shot. On 02-NOV-2017, the patient received an unspecified dose of PNEUMOVAX 23 intramuscular in her right arm for prevention of pneumococcal disease (strength, lot number and expiration date were not reported). On 02-NOV-2017, one hour and a half after the patient received the injection, the patient experienced burning sensation on the right side of her face, prickling (injection site paraesthesia) and numbness (injection site hypoaesthesia)/pain where she received the injection and she had no energy on the right side of her body". The patient received treatment for the adverse events; the patient did not seek medical attention and no lab diagnostics/studies were performed. All of the patient's symptoms lasted for about 4-5 days (stop date of the events 06-NOV-2017); they had resolved at the time of the reporting. The causal relationship between the events burning sensation, asthenia, injection site hypoaesthesia, injection site paraesthesia and injection site pain and therapy with PNEUMOVAX 23 were not reported.
Severe nausea, chills, joint pain, headache, racing pounding heartbeat, severe weakness and fatigue, loss of appetite. Symptoms persisted 2+ days.
Arm stiffness/ Legs are stiff and heavy/ muscle stiffness; Joint pain; This spontaneous case was reported by a consumer and describes the occurrence of MUSCULOSKELETAL STIFFNESS (Arm stiffness/ Legs are stiff and heavy/ muscle stiffness) and ARTHRALGIA (Joint pain) in a 72-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 040B21A and 047A21A) for COVID-19 vaccination.     The patient's past medical history included COVID-19 (caught COVID two other times) in November 2019 and Brain inflammation (Inflammation in the brain from COVID).   On 15-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 12-Apr-2021, the patient experienced MUSCULOSKELETAL STIFFNESS (Arm stiffness/ Legs are stiff and heavy/ muscle stiffness) and ARTHRALGIA (Joint pain). At the time of the report, MUSCULOSKELETAL STIFFNESS (Arm stiffness/ Legs are stiff and heavy/ muscle stiffness) and ARTHRALGIA (Joint pain) outcome was unknown.            No relevant concomitant medications were reported. No treatment information was provided.   This case was linked to US-MODERNATX, INC.-MOD-2021-127553 (E2B Linked Report).   Most recent FOLLOW-UP information incorporated above includes: On 13-May-2021: Follow up information was received on 13 May 2021 and included no new information.; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-127553:husband case
This spontaneous report as received from a nurse refers to a 11 year old patient. On 22-JUL-2016 the patient was vaccinated with GARDASIL 9 dose 1 for prophylaxis. On 01-SEP-2016 the patient was vaccinated with GARDASIL 9 dose 2 for prophylaxis (inappropriate schedule of drug administration). No adverse event was reported.
I tested positive for COVID-19 on 5/31/2023. I had a headache, sore throat, cough, runny nose, chills, and a fever. I contacted my doctor and was prescribed Paxlovid. I also took Tylenol for the fever. I am still dealing with this at this time.
Difficulty swallowing, headache, felt flushed, about 2 hours after vaccination. Denies struggle to breathe. Sought treatment at ED. Woke up the next morning with swollen eyes. I'm not informed of the treatments provided at the ED.
COVID positive on 11/9/2021.  Admission dx: chest pain, UTI, positive blood culture.  Patient was admitted after having a positive blood culture for gram negatives bacilli in the setting of a UTI. Patient was also found to be Covid-19 positive. She was given IV antibiotics during her admission with transition to oral antibiotics. As her most recent blood cultures have shown no growth today, She will be discharged on oral Levaquin. Given her Covid 19 infection, She was given instruction to be reevaluated if she were to develop shortness of breath or other symptoms related to Covid 19. She was also instructed to self quarantine until 11/23/21 which is 2 weeks after her positive Covid result. Patient was also informed of the option of monoclonal antibody therapy as an outpatient for her Covid 19.  Discharged to home.
Narrative: 48 y/o male with h/o of alcohol dependence, htn, obesity, and h/o DVT (RLE) come to SARTP program for alcohol dependence. Patient given pneumococcal injection on 5/2/08 (4pm)- on 5/3/09 (12am), patient complains of soreness & painful L upper arm. Redness was noted  & warm to touch. Patient given on dose of hydroxyzine 50mg. Redness continues (5/4/08@5pm), acetaminophen and hydrocortisone 2.5% cream ordered. Symptoms: 1. Other 2. redness, soreness, and burning of area
tested positive for Covid after first dose of vaccine; tested positive for Covid after first dose of vaccine; This is a spontaneous report from a contactable consumer (patient). A male patient of an unspecified age received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) (Lot number and expiration date unknown), via an unspecified route of administration on 30Dec2020 at single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient receive the COVID-19 vaccine in 30Dec2020 and on 05Jan2021 he tested positive for COVID-19. He got the first dose of the vaccine on 30Dec2020 and was COVID-19 positive on 01Jan2021 and then tested negative on 08Jan2021. He was supposed to take the second dose on 19Jan2021, if he had COVID-19, he wanted to know if he needs to get the second dose or skip it. The outcome of the events was unknown.
Patient was administered 0.5 ml instead of 0.3 ml. No adverse reaction. No complaints from patient.
high fever (104) Difficulty breathing fast heart beat Cold Hands Cold feet Paleness Blue lips Wheezing red eyes weakness runny nose dizziness
broke out in hives really bad; very bad pain in her arm for 5 or 6 days; itchy/ itching in all her body; arm swelling/each day got swollen; being really hot; each day got redder; This spontaneous case was reported by a consumer and describes the occurrence of PRURITUS (itchy/ itching in all her body), PERIPHERAL SWELLING (arm swelling/each day got swollen), FEELING HOT (being really hot), ERYTHEMA (each day got redder) and URTICARIA (broke out in hives really bad) in a 69-year-old female patient who received mRNA-1273 (Spikevax) (batch no. 003j21-2a) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included COVID-19 (positive and very bad) in November 2021, Epstein-Barr virus infection and Fibromyalgia. Concurrent medical conditions included Drug allergy (some medicines bother) and Milk allergy (milk constipate). Concomitant products included LISINOPRIL and METOPROLOL for an unknown indication.    On 01-Apr-2022, the patient received first dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On 04-Apr-2022, the patient experienced PRURITUS (itchy/ itching in all her body), PERIPHERAL SWELLING (arm swelling/each day got swollen), FEELING HOT (being really hot) and ERYTHEMA (each day got redder). On an unknown date, the patient experienced URTICARIA (broke out in hives really bad) and PAIN IN EXTREMITY (very bad pain in her arm for 5 or 6 days). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) ongoing since an unknown date for Itchy, at an unspecified dose and frequency. At the time of the report, PRURITUS (itchy/ itching in all her body) and URTICARIA (broke out in hives really bad) had not resolved, PERIPHERAL SWELLING (arm swelling/each day got swollen), FEELING HOT (being really hot) and ERYTHEMA (each day got redder) outcome was unknown and PAIN IN EXTREMITY (very bad pain in her arm for 5 or 6 days) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In November 2021, SARS-CoV-2 test: positive (Positive) Positive, very bad.     The action taken with mRNA-1273 (Spikevax) (Unknown) was unknown.       Patient went to urgent care for hives, quitted steroids then for every 5 hours patient got hives.  Patient had bad pain in arm for 5 or 6 days.  Patient used prednisone and made itchiness, so patient started Benadryl. It was reported that the Benadryl runs out and then the hives came back.
BLOOD SUGAR ISSUES; This spontaneous report received from a patient concerned a patient of unspecified age and sex. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported. On an unspecified date, the subject experienced blood sugar issues. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of blood sugar issues was not reported. This report was non-serious.
Patient was admitted to the Hospital on 11/27/2021 for COVID related symptoms. This is considered a breakthrough case.
fever; chills; nausea; headache; myalgias; This is a spontaneous report from a non-contactable healthcare professional. A 25-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number and expiry date: unknown), via an unspecified route of administration on unspecified date at single dose for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. Patient was not pregnant at the time of vaccination. There were no other vaccine received within 4 weeks prior to COVID vaccination. The patient experienced fever, chills, nausea, headache and myalgias. No treatment was received. Outcome of the events was unknown. The event was reported non-serious. It was unknown if patient was diagnosed with COVID-19 prior to vaccination and has not been tested since the vaccination.   No follow-up attempts are possible; information about lot/batch number cannot be obtained.
18 year old patient who received an adult dose of Engerix-B; 18 year old patient who received an adult dose of Engerix; pain at the injection site/ Soreness at the injection site/ tenderness at the injection site; This case was reported by a pharmacist via call center representative and described the occurrence of injection site pain in a 18-year-old male patient who received HBV (Engerix B adult) (batch number 239TF, expiry date 4th June 2022) for prophylaxis.  On 5th February 2020, the patient received Engerix B adult. On 5th February 2020, unknown after receiving Engerix B adult, the patient experienced overdose and adult product administered to child. On an unknown date, the outcome of the overdose and adult product administered to child were unknown.  Additional information was provided as follows: The patient received an adult dose of Engerix B vaccine, which led to overdose and adult product administered to child. The reporter consented to follow up.   Follow-up information received from pharmacist on 10th February 2020: The reporter spoke to the patient , the patient did not experienced any additional adverse events besides topical soreness, tenderness and pain at injection site. The reporter stated that overdose and adult product administered to child were due to erroneous administration. It was unknown if the reporter considered the injection site pain to be related to Engerix B adult. The VAERS details were updated.
After receiving 2nd Gardasil pt c/o body aching and tingling in her extremities. Symptoms so apparent that pt's writing is not the same and had difficulty typing. Took 800 mg of Advil with minimal relief. Pt states similar symptoms after 1st Gardasil 10/13/13. When she was then worked up for a pinched nerve all tests were normal.
pt passed out following vax of MMR on 25JUL91; pt recovered w/in a few minutes; pt was also given Mantous test; no further details were provided;
Vaccine was administered and within the first 15 minutes of observation her lips started tingling, developed a headache, felt like she was in a "fog".  She was transported to the local emergency room via ambulance and said at that point she felt like her throat was starting to close.  She received Benadryl in the ER and reported having a sore throat for a couple of days.  She followed up with her local medical provider on 3/4 and was advised to not receive any additional doses.
Headache; All over body pain(joint and Muscular); All over body pain(joint and Muscular); All over body pain(joint and Muscular); Fever; GI issues; Fatigue; This is a spontaneous report from a contactable consumer other hcp. A 48-years-old female patient received second dose of bnt162b2 (Pfizer-BioNTech COVID-19 mRNA vaccine, Formulation: Solution for injection, Batch/Lot Number: EL0142 intramuscular), administered in Arm Left on 18Jan2021 09:00 as SINGLE DOSE for covid-19 immunization. Medical history included migraine from an unknown date and unknown if ongoing , covid-19 from an unknown date and unknown if ongoing. Prior to vaccination, was the patient diagnosed with COVID-19. Historical vaccination was that the patient previously received first dose of bnt162b2 (Pfizer-BioNTech COVID-19 mRNA vaccine, Formulation: Solution for injection, Batch/Lot Number: EL1284 intramuscular), administered in Arm Left on 31Dec2020 08:30 AM as sing for covid-19 immunisation. The patient was not pregnant at the time of vaccination. The patient has not been tested for Covid-19 after the vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. COVID-19 vaccine was administered at Hospital. Vaccine Facility, Ethnicity and Race information was available. There were no seriousness criteria for Results in death, Life threatening Seriousness criteria, Caused/prolonged hospitalization, Congenital anomaly/birth defect. Concomitant medications included zolmitriptan (ZOMIG) taken for an unspecified indication, start and stop date were not reported; prednisone (PREDNISONE) taken for an unspecified indication, start and stop date were not reported; diphenhydramine hydrochloride (BENADRYL) taken for an unspecified indication, start and stop date were not reported; naproxen sodium (ALEVE) taken for an unspecified indication, start and stop date were not reported. The patient experienced drug hypersensitivity, zofran [ondansetron hydrochloride] and codeine. On 18Jan2021 at 15:30, the patient experienced headache, all over body pain, fever, gastrointestinal issues and fatigue. Therapeutic measures were taken, patient was treated with OTC motrin, Aleve. The outcome of events was recovering. Follow-up attempts are completed. No further information is expected.
pt recv vax 3JAN97 & 1OCT97 pt devel chickenpox from thigh recovered;
50-year-old female with a past medical history significant for asthma, hypertension, hyperlipidemia presenting to ER with complaints of subjective dysphagia. Patient describes dysphagia to solids and liquids. Describes this as being an ongoing chronic issue. Has tried but been unable to obtain consultation as an outpatient with a gastroenterologist. Is very anxious and upset. Would like to see a GI specialist. States that she is unable to tolerate solids or liquids. She was observed to be drinking liquids in the ER.
MA had inafnt patients for COVID vaccines in the morning and did not realize a different vaccine is needed for the afternoon as that age group is 5-11 years ols. MA gave the 5 year old a Pfizer vaccine that is reccomended for 6months-4 years old. Per CDC dose will need to be repeated if parent wants to due to low dose given. Parent aware and agrees to bring pt back. Informed MA about COVID vaccines for different age groups. Showed her handout on dosing schedule for COVID vaccines
This spontaneous report was received from a nurse, referring to a patient of unknown age and gender. The patient's medical history, concurrent conditions or concomitant medication were not informed. On 09-APR-2018, the patient received an expired dose of M-M-R II lot # M016233, expiration date 31-MAR-2018, subcutaneously, for prophylaxis (dosage information was not informed). No known adverse effects.
(Moderna) Vaccine was given beyond the refrigeration use; (Moderna) Vaccine was given beyond the refrigeration use; This spontaneous case was reported by a health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED ((Moderna) Vaccine was given beyond the refrigeration use) and PRODUCT STORAGE ERROR ((Moderna) Vaccine was given beyond the refrigeration use) in a 65-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 014B22A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 11-Jul-2022, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 11-Jul-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED ((Moderna) Vaccine was given beyond the refrigeration use). On an unknown date, the patient experienced PRODUCT STORAGE ERROR ((Moderna) Vaccine was given beyond the refrigeration use). At the time of the report, EXPIRED PRODUCT ADMINISTERED ((Moderna) Vaccine was given beyond the refrigeration use) and PRODUCT STORAGE ERROR ((Moderna) Vaccine was given beyond the refrigeration use) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications was reported. No treatment medications was reported.  The vial was initially stored in the refrigerator on 02-Jun-2022. The vial does not undergo any temperature excursions.
T.C. 6/22, 1pm mother, telephoned to report (L) arm sore, child crying, unable to bend at elbow with thick, red, hard, hot to touch from upper arm to elbow. By afternoon of 6/21, arm not painful but remaining thick, red, hard. On 6/23, follow-up call, shoulder and upper arm less red, less swollen. Can bend elbow. Is playing today.
This spontaneous report was received from a registered nurse and refers to a patient of unknown age. No information regarding the patient's medical history, concurrent conditions or concomitant medications was provided. On 13-APR-2018, the patient was vaccinated with an expired dose of VAQTA injection, lot # N005605 with expiration date on 08-APR-2018 (dose and route of administration were not reported). No adverse effects were reported.
THINNING BLOOD; TACHYPNEA; MUSCLE PAIN; WEAKNESS; This spontaneous report received from a patient concerned a 68 year old male. The patient's weight was 166 pounds, and height was 72 inches. The patient's past medical history included diabetic right foot neuropathy, and concurrent conditions included hypertension, type 2 diabetes mellitus, non smoker, and no alcohol use, and other pre-existing medical conditions included the patient has no known allergies. no drug abuse or illicit drug usage. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: 206A21A, expiry: 07-AUG-2021) dose was not reported, administered on 02-JUL-2021 for prophylactic vaccination. Concomitant medications included insulin detemir for diabetes mellitus, insulin lispro for diabetes mellitus 2, enalapril for hypertension, and hydrochlorothiazide for hypertension. On 02-JUL-2021, the subject experienced thinning blood. On 02-JUL-2021, the subject experienced tachypnea. On 02-JUL-2021, the subject experienced muscle pain. On 02-JUL-2021, the subject experienced weakness. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from weakness, muscle pain, and thinning blood, and the outcome of tachypnea was not reported. This report was non-serious.