chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Previously healthy 2 yr old, no wheezing previously noted. She rec'd H1N1 FLUMIST on 11/3/09. Later that night began coughing & wheezing. Seen 11/4/09 in office, given albuterol tx & hospitalized overnight for aggressive respiratory tx. She did require O2 on hosp. admission. Seen in office 11/6/09 with improvement in Sx. Advised to complete steroid course & use albuterol q 4 hr prn. Follow-up if sx persist. 11/10/2009 hospital records from 11/4-11/5/2009. Patient with c/o's rash, cough loose stools and abnormal breathing. Tx: IVF, IV steroids, Resp tx's with bronchodilators. DC DX" Acute bronchitis. ICD-9 code 485.19
dizziness, room tilting  filling, no room spinning, very bad headache and nausea when moving
itching on the vagina; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 05-Apr-2021 and was forwarded to Moderna on 05-Apr-2021.    This spontaneous case was reported by a consumer and describes the occurrence of VULVOVAGINAL PRURITUS (itching on the vagina) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included No adverse event (No medical history or known allergies reported.).    On 01-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced VULVOVAGINAL PRURITUS (itching on the vagina). At the time of the report, VULVOVAGINAL PRURITUS (itching on the vagina) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) was unknown.       No concomitant or treatment medications reported. Reporter did not provide any other information regarding events and hung up the phone before any other information could be obtained.
Sleepy and diificulty concentrating -- need afternoon sleep and early bed (a bout 7pm). Usually  wake up at 7.00 am feeling very good
PT STATES THAT ONE DAY AFTER VACCINATION SHE NOTED URTICARIA FOLLOWED BY A RASH ON UPPER AND LOWER EXTREMITIES IN ADDITION TO THE ABDOMEN.
Chest pains since day 4 of receiving second dose of Moderna COVID-19 vaccine. On June 4, 2021 went to Health Clinic for physical; conducted EKG and was slightly abnormal. Within twenty minutes of leaving the Clinic, RN from Clinic called and advised the cardiologist reviewed the EKG and recommended going to emergency room for a blood draw and heart enzyme test.
little bit of a blurry eye; blurry eye which got worse; This spontaneous case was reported by a consumer and describes the occurrence of VISION BLURRED (little bit of a blurry eye) and CONDITION AGGRAVATED (blurry eye which got worse) in an 87-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History was provided by the reporter.    On 15-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 15-Feb-2021, the patient experienced VISION BLURRED (little bit of a blurry eye) and CONDITION AGGRAVATED (blurry eye which got worse). At the time of the report, VISION BLURRED (little bit of a blurry eye) and CONDITION AGGRAVATED (blurry eye which got worse) was resolving.      Concomitant product use was not provided by the reporter. No treatment information was provided.   Reporter did not allow further contact   Most recent FOLLOW-UP information incorporated above includes: On 26-Apr-2021: NNI
Administer Expired vaccine; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Administer Expired vaccine) in a 28-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 11-Nov-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 11-Nov-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Administer Expired vaccine). On 11-Nov-2021, EXPIRED PRODUCT ADMINISTERED (Administer Expired vaccine) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant product information was not provided. Reporter stated that no treatment was given to patients.  Reporter also stated that the vaccines were stored in freezer and they took out one to two vials and placed in fridge each day as needed.
This spontaneous report was received from a medical assistant concerning, multiple, unspecified patients of unknown age and gender. The patients' medical history, concurrent conditions and concomitant therapies were not reported. On an unknown dates, the patients were vaccinated with an improperly stored doses of ROTATEQ orally (lot number: M002254, expiration date: 15-NOV-2017) (dose was not reported). No adverse effects were reported and no product quality complaint (PQC) was involved. This is one of several reports from the same reporter. Additional information has been requested.
soreness 16APR96 arm ache x/resolved 17APR96 @ recheck;17APR96 cough, fatigue, bronchitis rx Zithromax;22APR96 seen body aches
Headaches ,nausea ,  fatigue,  body aches on March 8,2021 -  March 9 2021
Approx 24 hrs after receiving Fluzone injection; pt developed a "strawberry-type "rash that appeared to look like "windburn". very pruritic. Area effected included injection site left deltoid, left face, neck and hairline. Pt denied any respiratory compromise or hives; denied fever. Benadryl topical helpful in alleviating itch. All S/S resolved 24 hrs after onset.
I had swelling in my left knee and upper leg. I went into the urgent care a few days ago to get it checked out to make sure it was not a blood clot. I was told it is bursitis. It has been going on for 2 weeks and has been off and on. Some days it is okay and some days it is worse. I has an ultrasound and CT Scan done. Both showed bursitis. They said to rest, ice it and take over the counter Motrin. Also, if the swelling continues I need to see an orthopedist. My knee and upper leg are basically full of water. I have never had bursitis before. If I rest, it is not as unbearable but once I put weight on it, it bothers me. It also bothers me at night.
Patient presented 3 days after her second DuoNeb vaccine with weakness dizziness chest pain or shortness of breath and was initially diagnosed with a pneumonia by chest x-ray obtained with antibiotics without improvement.  Subsequently she was hospitalized and CT of the chest showed left lower lobe segmental pulmonary embolism.  The patient never had history of venous thromboembolism in the past. She had weakly positive anticardiolipin antibody of IgG type of unknown significance. She was treated initially with antibiotics but after diagnosis of the blood clot she was started on anticoagulation with apixaban with improvement
Hospitalized: NSTEMI  intubated and ventilated for respiratory failure  pneumonia
Ongoing left shoulder pain around vaccine injection site. Complains of area hurting to touch and increased pain with use of left shoulder.
Case number PHEH2015US000935, is an initial spontaneous report from a pharmacist received on 09 Jan 2015. This report refers to a 20-year-old female patient. Historical conditions were not reported. No concomitant medication was reported. She was administered only MenCYW-135 liquid component of MENVEO (batch number: X14045) without being reconstituted with MenA, intramuscularly on 09 Jan 2015. No adverse event or complications was reported following the administration error.
This spontaneous case was reported by a consumer and describes the occurrence of FEELING ABNORMAL (her brain was kind fuzzy/ just felt odd), ERYTHEMA (a weird reaction: underneath her fingernails and toes there was a red strip), PAIN (Body aches), PARAESTHESIA (hands tingling) and PARAESTHESIA (all her body is tingling) in a 54-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 010M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concomitant products included METFORMIN, INSULIN and LOSARTAN for an unknown indication.    On 12-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-Feb-2021, the patient experienced FEELING ABNORMAL (her brain was kind fuzzy/ just felt odd), ERYTHEMA (a weird reaction: underneath her fingernails and toes there was a red strip), PARAESTHESIA (hands tingling) and CHILLS (Chills). On 27-Feb-2021, the patient experienced PAIN (Body aches), PARAESTHESIA (all her body is tingling), INFLAMMATION (inflammed), PAIN IN EXTREMITY (hurts a lot in her hands/hurtful) and ARTHRALGIA (all her joints aches). At the time of the report, FEELING ABNORMAL (her brain was kind fuzzy/ just felt odd), ERYTHEMA (a weird reaction: underneath her fingernails and toes there was a red strip), PAIN (Body aches), PARAESTHESIA (hands tingling), PARAESTHESIA (all her body is tingling), INFLAMMATION (inflammed), PAIN IN EXTREMITY (hurts a lot in her hands/hurtful), ARTHRALGIA (all her joints aches) and CHILLS (Chills) outcome was unknown.
Sore arm, which she felt was normal, then back pain starting the morning after vaccine, still lasting on and off the full week after.
Presented with SOB/cough x 2 weeks, intubated in ED; + covd PNA; Patient was admitted to the ICU treated for ARDS and Covid-19pneumonia.  She received antibiotics for sepsis with septic shock, for UTI treatment;  also had NSTEMIl; Tx: Maxipime, decadron, lovenox; extubated 10/17; to tele 10/19; home on baseline O2
Pt experienced a fairly significant local reaction, described as firm, warm, erythematous area measuring from 60-80 mm in diameter. Pt's symptoms resolved, time to onset and duration not reported.
she was diagnosed with Covid; This is a spontaneous report from a contactable consumer (patient's daughter). A 93-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration on 21Feb2021 (Batch/Lot number was not reported) as single dose for COVID-19 immunisation. Relevant medical history and concomitant medications were not reported. The patient was diagnosed with COVID on 24Feb2021. She had an antibody infusion and her doctor said that she should wait 90 days to get the second dose. The event was considered serious as medically significant. The outcome of the event was unknown.  The information on the batch number has been requested.
Patient stated prior to vaccination he has a tendency to get lightheaded and even pass out when given a flu shot. I gave him the shot and after about 5 minutes (while sitting on the ground) the patient passed out. The patient lost consciousness for about 30 seconds then came back. I had the patient lay down with his feet up and when he was ready I sat him up and gave him some water. After several minutes he stood up and I stayed with him for another 5 minutes. He then proceeded to walk around the store for about 10 minutes until he told me he felt better and left.
Within a week of the 2nd vaccine, the pt started to "feel less well." She was aching, tired, "gloomy of outlook" and "too exhausted to go to the gym". Her arthritic symptoms became worse. In late May, the symptoms of numbness, and wide-spread tingling returned. She was seen by a neurologist. The neurologist reportedly said that he thinks she has and antibody reaction to the vaccine. Apparently he feels that the antibodies in the vaccine have triggered her body to be overactive in its production of antibodies and so they are not content with attacking the bad guys, but are also attacking the nerves and joints. She self-medicated with round the clock ibuprofen for two weeks. The ibuprofen partially alleviated the arthritic symptoms but did not relieve the numbness and tingling. As of 2/1/01, the outcome of these events is unknown.
Chest pain, short of breath, feeling unwell for 3 days...went to ER...CT scan and Doppler in legs. CT scan showed small blood clots in lung. Medication changed from Xarelto to Eliquis and increased for a week and then on maintenance level.
Hives that started 2d after vaccine, tongue swelling 4d later and redness and swelling at injection site.  Discussed with Allergy-do not take Moderna 2nd vaccine.
accidentally administered Fluzone High Dose to 7 patient between the ages of 36-54 with no AE; accidentally administered Fluzone High Dose to 7 patient between the ages of 36-54 with no AE; Initial information received on 22-Oct-2019 regarding an unsolicited valid non-serious case received from other health professional.  This case involves a 40 years old female patient who received a 0.5 ml dose of vaccine vaccine INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE [FLUZONE HIGH DOSE] Prefilled Syringe (lot: UJ285AA, expiry date: 02-Jun-2020), via intramuscular route in the right arm on 21-Oct-2019.  The patient past medical history, medical treatment(s), vaccination(s) and family history were not provided.  It was an actual medication error due to product administered to patient of inappropriate age and overdose. It was reported that the medical Assistant accidentally administered Fluzone High Dose to 7 patient between the ages of 36-54 year.  At the time of reporting, the 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 holder's 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.
A non-serious spontaneous report of temperature of 102.3, lethargy, headache and sore throat has been received from a physician concerning a six-year-old male, subsequent to H1N1. The patient's medical history includes mild asthma which is well controlled. The patient uses albuterol inhaler as a rescue medication for his asthma but has not needed to use it in over a year. The patient received H1N1 on 22-Oct-2009 along with a seasonal flu shot. During the night of 22-Oct-2009 the patient woke with a temperature of 101.2, lethargy, headache and sore throat. By 3 PM the following day the child had a fever of 102.3, all his other symptoms resolved. The event of fever is ongoing while the events of lethargy, headache and sore throat all resolved on 23-Oct-2009.
Fever NOS on 2013-12-16. Clinician comment: Non focal fever symptoms.
Cold feeling in both feet within half hour of injection. Both of my feet are numb and tingling. Very difficult to move my toes. When sitting my feet go completley numb. I had no issues at all with this befor the injection.
Pt recv vax in 2/20/98; post vax pt exp worsened personality changes of agitation, hysteria, anger & hostility
Contractions and severe stomach pain, followed by a placenta abruption on 5/4/2015 and a preterm 33 week baby.
Had fever and chills beginning about 10  hours after injection. Could not get warm under blankets and socks, shivering for a few hours. Nausea started around same time. Vomited a few times. Couldn?t walk around house without feeling fatigued or nauseous.  Symptoms subsided about 16 hours after they began. Still fatigued for another eight hours after. Symptoms completely gone 24 hours after injection.
This spontaneous report as received from a registered nurse refers to a 5 year old male patient. Nurse stated that patient inadvertently received 3 doses of pediatric VAQTA. First dose of VAQTA was administered on 14-JUN-2010 (dose: 0.5 ml, intramuscularly, lot# reported as AHA VB 362AA expiration date: 23-FEB-2012), second dose was administered on 14-JUN-2011 (dose: 0.5 ml, intramuscularly, lot# reported as: AHA VB481AA expiration date: 05-MAY-2013) and third dose administered on 14-AUG-2014 (dose: 0.5 ml, intramuscularly, lot# J014584, expiration date: 16-JAN-2016). The patient did not seek medical attention. No adverse effects reported. Lot numbers AHA VB362AA and AHA VB481AA are invalid lot numbers for VAQTA. Additional information has been requested.
Patient said she felt the pain right after she had the shot, but a rash occurred right after next day. The rash is on the left are where the injection was done. It is about one inch below the site. It is also red & swelling.
Constant headaches; This is a spontaneous report from a contactable consumer, the patient. A 62-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration on 05Feb2021 at 16:00 (at the age of 62-years-old) as a single dose for COVID-19 immunisation and second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in left arm on 01Mar2021 at 16:00 (at the age of 62-years-old) as a single dose for COVID-19 immunisation. Medical history included COVID-19 and sulfonamide allergy. Prior to the vaccination, the patient was diagnosed with COVID-19. Concomitant medications included calcium (MANUFACTURER UNKNOWN), daily vitamin (MANUFACTURER UNKNOWN) and pravastatin (MANUFACTURER UNKNOWN); all from an unknown start date, for an unknown indication and unknown if ongoing. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 10Feb2021 the patient experienced constant headaches usually in one spot in the back of head on left side, started after first dose about 5 days after vaccination. No therapeutic measures were taken as a result of the event. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the event constant headaches usually in one spot in the back of head on left side was not recovered at the time of this report.   No follow-up attempts are required; information about lot/batch number cannot be obtained. No further information is expected.
This is a spontaneous report from a contactable consumer (patient) or other non-HCP. A 52-year-old female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID -19 VACCINE, formulation: solution for injection via an unspecified route of administration on 28Mar2021, at 13:45 (Batch/Lot number was not reported, expiry date: unknown) as dose 2, single (age at time of vaccination in years: 52-years-old) for COVID-19 immunisation. Medical history included ongoing Complex partial seizures. There were no concomitant medications. The patient previously received first dose of bnt162b2 (PFIZER-BIONTECH COVID -19 VACCINE, formulation: solution for injection, (Batch/Lot Number: unknown , expiry date: unknown) via unspecific route of administration on 07Mar2021 as dose 1, single for COVID-19 immunisation. There was no history of all previous immunization with the Pfizer vaccine considered as suspect, and Additional Vaccines Administered on Same Date of the Pfizer Suspect. On 29Mar2021, 1 day after vaccination the patient experienced itching, rash, and arm hurting. She woke at 4 woke up itching. She also had a rash. Her arm doesn't hurt as much as it did yesterday. She was also itching in other parts of her body such as her shoulder. The rash started on left side of neck. She also had it on the right jaw. She was going to drive herself to urgent care. When she lifted her arm she realized she was unable to drive. She got prescribed for prednisone ointment by her family doctor. She asked if the rash is normal or is it a documented side effect. The events did not result in doctor or other healthcare professional office/clinic visit. The outcome of arm hurting: recovering, and outcome of others events: not recovered. No follow-up attempts are possible. Information about lot/batch number cannot be obtained.
chest pain; This spontaneous case was reported by a consumer and describes the occurrence of CHEST PAIN (chest pain) in a 43-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 006B21A and 011A21A) for COVID-19 vaccination.     Concurrent medical conditions included Asthma (pre-existing asthma, well controlled) since 1994, Blood pressure high (well controlled) since 2012, Type II diabetes mellitus (well controlled) since 2012, Anxiety, High cholesterol since 2012, Drug allergy (Lisinopril allergy), Immune system disorder NOS (hypersensitive immune system) and Allergic reaction to analgesics (codeine allergy). Concomitant products included ALBUTEROL [SALBUTAMOL] for Asthma, METFORMIN HYDROCHLORIDE (METFORMIN ER) for Diabetes, ROSUVASTATIN for High cholesterol, AMLODIPINE for Hypertension, ALPRAZOLAM (XANAX), BUDESONIDE, FORMOTEROL FUMARATE (SYMBICORT), TIOTROPIUM BROMIDE MONOHYDRATE (SPIRIVA) and IRON for an unknown indication.   On 05-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 02-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 02-Apr-2021, the patient experienced CHEST PAIN (chest pain). The patient was treated with ASPIRIN [ACETYLSALICYLIC ACID] at an unspecified dose and frequency and DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) at an unspecified dose and frequency. On 02-Apr-2021, CHEST PAIN (chest pain) had resolved.      It was reported that 15 minutes after first dose patient experienced chest pain that resolved and also after the second dose.   This case was linked to MOD-2021-369443, MOD-2021-370380 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 03-Nov-2021: Follow up information received on 03 Nov 2021 includes updated Medical history, anatomical location of vaccine administration updated. On 04-Nov-2021: follow up received included no new information. On 05-Nov-2021: Significant follow up (stop date of event updated)
numbness of arms and hands, muscle shakiness, rash on shoulder of injected arm, nausea, diarrhea, abdominal pain, chills, weakness--all symptoms still exist today
Patient received three IM immunizations at once. Patient immediately reached for his throat due to apparent laryngeal spasm at approximately 12:00.  Oxygen administered immediately, 25mg IV diphenhydramine given. Epinephrine not required. Discharged to home after abservation period. Later that night 05/05/06 @ 02:48 patient presented to the ED with fever to 102, vomiting for 90 minutes. Diphenhydramine and prednisone given in ED at approximately 04:43. Patient discharged from ED with Epipen, prednisone prescription and instructions to take diphenhydramine.
Received the 2nd Moderna vaccine 2/02/2021 with fatigue and chills noted 4 hours later. On 2/03/2021 rash and hives noted which resolved without treatment. On 2/13/2021 the rash w/ hives returned, and he noted dizziness. He went to see his PCP on 2/15/2021 as the rash was not resolving. He was prescribed Hydroxyzine and Dramamine.