chrisvoncsefalvay/vaers-outcomes huggingface dataset:
From initial information received on 14Jan05 from a health care professional regarding an adverse event occurring, it was reported that a five month old male pt received his second dose of IPOL, lot number X1006, as well as his second dose of Comvax (haemophilus b conjugate and hep B), lot number 0223, administered on 15Nov04. The following day, the pt became lethargic. Per the pt's mother, this lasted four to five days. Reportedly, the pt was not evaluated by a physician at that time.  the pt also previously received a dose of Infanrix, as well as a dose of Pneumovax, lot number A57560B, administered on an unspecified date. He recovered from this event. From additional information received on 25Apr05 from a health care professional, it was reported by the pt's parent that no treatment was provided for symptoms. Per the reporter, the pt did not have any illness at the time of vaccination. The site of the other vaccinations given on 14Oct04 were provided. Infanrix, administered in the right thigh, and Prevnar, administered in the left thigh. Reportedly, this adverse event has not been reported previously. Also the name of the vaccine administrator was provided. No further information is anticipated, this case is considered closed.
Received vaccine I also got the shingles/ Suspected vaccination failure; Shingles; This serious case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine, the patient experienced vaccination failure (Verbatim: Received vaccine I also got the shingles/ Suspected vaccination failure) (serious criteria GSK medically significant) and shingles (Verbatim: Shingles). The outcome of the vaccination failure was unknown and the outcome of the shingles was not reported.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine.     It was unknown if the company considered the vaccination failure and shingles to be related to Shingles vaccine.   Additional Information: GSK Receipt Date: 10-JUN-2023 This case was reported by a patient via interactive digital media. The patient reported that he or she received Shingles vaccine and experienced shingles. The patient stated that he or she never take another vaccine again. This case was considered as suspected vaccination failure as details regarding completion of primary schedule, time to onset for shingles and laboratory confirmation regarding shingles were unknown at the time of reporting. Follow-up would not possible as no contact details were available.
Initial information received on 22-Feb-2019 regarding an unsolicited valid non-serious case received from a nurse. This case involves a 18 years old female patient who Day 0 of vaccine IMOVAX RABIES on 05-Feb-2019 but the day 7 dose was given late, on day 17 (22-Feb-2019). The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. On 05-Feb-2019, the patient received 1 ml of suspect RABIES (HDC) VACCINE lot NIK30 via intramuscular route in the left deltoid. On 22-Feb-2019 she also received 1 ml of the same vaccine lot NIK30 via intramuscular route in the right deltoid. It was a case of actual medication error due to Inappropriate schedule of vaccine administered. It was unknown of any 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.
ED to Hosp-Admission Discharged  4/6/2021 - 4/8/2021 (2 days) Last attending ? Treatment team V-tach (CMS/HCC) Principal problem Discharge Summary Admission diagnosis:     Primary Admission Diagnosis    Hospital Problems          POA   * (Principal) V-tach (CMS/HCC) Yes               Disposition: Home CODE STATUS (LOI): Full Code   Consulted Services: cardiology Operative Procedures Performed   _ Active Issues Requiring Follow-up needs to follow-up with the cardiology      Test Results Pending at Discharge      Referrals and Follow-ups to Schedule    Patient to schedule follow-up appointment with Primary Care Physician     Schedule follow-up appointment in: 1 week        Hospital Course   HPI: Admitted with episode of ventricular tachycardia with ICD firing x2.  Patient was also found to have COVID-19 positive.       Hospital Course:    Following issues were addressed during this hospitalization   Episode of ventricular tachycardia, with ICD firing x2 Ischemic cardiomyopathy with ejection fraction 26% Hypokalemia Seen by cardiology, most likely V. tach triggered in the setting of hypokalemia.  His potassium was repleted during this hospitalization.  He was discharged with 40 mEq of potassium daily. Currently on amiodarone 200 mg twice daily for 2 weeks and after that 100 mg daily Device interrogation was done     Chronic systolic CHF Continue Lasix at home dose Does not appear to be in exacerbation   COVID-19 Saturating well on room air Patient completed COVID-19 vaccination on March 11 th   Diabetes mellitus type 2 Hemoglobin A1c 5.6   Troponin elevation Most likely due to demand ischemia from V. tach in the setting of chronic troponin elevation.    On the day of the discharge patient without any symptoms.  Patient was discharged home in stable condition.  Advised the patient to take 40 mg of potassium instead of 10 as he is on Lasix 40 twice daily.  Patient understood the instructions
Started sneezing approx 2-5min p/immun; progressed to wheezing, coughing, c/o difficulty breathing, pulse 140, sweating; Pt given Adrenalin, DPH; called pvt MD told to take Ventolin x 2 days;
7 days after vaccination my arm around the injection site turned red, felt warm and itched. Itching and heat stopped the next afternoon. Today is day 5 since it started and the redness is very pale now.
yesterday high fever, coghing, fever, hard to swallow, cant stay awake, vommitting
Information has been received from two healthcare workers referring to a patient of unknown age and gender. The patient's medical history was not reported. On 07-MAY-2015 the patient was received improperly stored VARIVAX (Merck) (lot # K026385, exp date 15-DEC-2016, dose and route unknown). Concomitant medication was not reported. No adverse effects were reported. No product quality issue (PQC) was involved. This is one of several reports received from the same source. Additional information is not expected since the reporter don't wish us to contact.
arm sore; arm is burning and hot; arm is burning and hot; Headache; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (arm sore), BURNING SENSATION (arm is burning and hot), FEELING HOT (arm is burning and hot) and HEADACHE (Headache) in a 77-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 23-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PAIN IN EXTREMITY (arm sore), BURNING SENSATION (arm is burning and hot), FEELING HOT (arm is burning and hot) and HEADACHE (Headache). At the time of the report, PAIN IN EXTREMITY (arm sore), BURNING SENSATION (arm is burning and hot), FEELING HOT (arm is burning and hot) and HEADACHE (Headache) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant and treatment medications were reported.
Patient reported muscle pain at the site of injection that began 2 days after receiving the vaccine. The pain has persisted for almost 2 weeks with little relief with ibuprofen 800 mg at bedtime. Patient reports the pain is sharp and radiates down the arm and up the neck and that pain intensifies when pressure is applied. Patient is unable to lay on the arm and described his arm as "numb" when lifting his arm for extended period of times. No redness or swelling at the injection site, denies other signs of infection such as fever.
A non-serious spontaneous report of administered of expired FLUMIST that was two days old was received from a health professional concerning an 18-year-old female. Neither the patient's medical history nor the concomitant medications were reported. The product expired on 25-Dec-2011. On 27-Dec-2011, the patient received expired product. There was no adverse event associated with this medication error; therefore, treatment and reporter causality assessments are not applicable, and the event is considered resolved. Additional information was received on 21-Mar-2012: There were no adverse events following administration of expired FLUMIST.
intermittent radiating pain initially; Cant sleep because of arm pain; radiating pain from injection site to elbow; This spontaneous case was reported by a pharmacist and describes the occurrence of PAIN (intermittent radiating pain initially), SLEEP DISORDER (Cant sleep because of arm pain) and INJECTION SITE PAIN (radiating pain from injection site to elbow) in a 60-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 037K20A) for COVID-19 vaccination.     No Medical History information was reported.    On 26-Jan-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 26-Jan-2021, the patient experienced PAIN (intermittent radiating pain initially), SLEEP DISORDER (Cant sleep because of arm pain) and INJECTION SITE PAIN (radiating pain from injection site to elbow). At the time of the report, PAIN (intermittent radiating pain initially), SLEEP DISORDER (Cant sleep because of arm pain) and INJECTION SITE PAIN (radiating pain from injection site to elbow) outcome was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) was not applicable. No relevant concomitant medications were reported. Treatment information was not provided. This case was linked to MOD-2021-057900 (Patient Link).
This spontaneous report was received from a female consumer of an unknown age, who is also a company representative, via company representative. Medical history was not reported. On 17-NOV-2014 the patient was vaccinated with M-M-R II injection (strength, dosage, route, lot # and expiration were not reported). Other suspect therapies included influenza virus vaccine (Manufacturer unknown). (Strength, dosage, route, lot # and expiration were not reported). The consumer informed that on an unknown date in November 2014 she experienced itching, feeling feverish, nausea and redness. The outcome of feeling feverish, nausea, redness and the patient experienced itching was unknown. Additional information has been requested.
Seen in our office on 04/23/2002. Mother states child had chicken pox 2-3 weeks ago.
No problems immediately - took 2 Benadryl given me at the vaccination clinic 2 hours later (after driving home.)  No sore arm or other obvious reactions until woke up on day 5 with hives.  Raised itchy individual bumps on face, back and both arms.
Information has been received from a 70 years old male patient with schizophrenia, seborrhoeic dermatitis and unspecified thyroid problem referring to himself. The patient had no drug allergies or reactions. In early 2015, the patient was vaccinated with a dose of ZOSTAVAX ("1 shot", route and lot# unknown). Concomitant therapies included "thyroxine", unidentified antipsychotics, several unidentified medications and corticosteroids lotion. In early 2015, the patient experienced shingles from the vaccine. He had redness in face and upper body with "minute blood spots all over the body", which tended to be aggravated by stress or excitement. The event had been persistent for several months. The patient did not have a regular physician to see and did not seek medical attention. He also did not receive any treatment and no lab test was performed. ZOSTAVAX was not re-introduced. The outcome of the events was not recovered. Additional information is not expected since there is no consent to contact the physician.
COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 69-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 24Jun2022 at 15:00 as dose 4 (booster), single (Lot number: FJ4991), in left arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Osteoporosis" (unspecified if ongoing); "slipped discs" (unspecified if ongoing); "kidney stones" (unspecified if ongoing). There were no concomitant medications. Past drug history included: Amoxicillin, reaction(s): "Known allergy: Amoxicillin causes a severe stomach ache", notes: Amoxicillin causes a severe stomach ache. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive. Therapeutic measures were taken as a result of drug ineffective, covid-19. Clinical course: The patient treated with Paxlovid (anti-viral) for COVID-19 treatment from 30Nov2022 to unknown date. She did not take other medication in 2 weeks.
pt recvd dose of Engerix-B 30JUN92 evening had urticaria; took oral DPH; spontaneous resolution;
leg pain as a side effect of the COVID booster; This spontaneous case was reported by an other health care professional and describes the occurrence of PAIN IN EXTREMITY (leg pain as a side effect of the COVID booster) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PAIN IN EXTREMITY (leg pain as a side effect of the COVID booster). At the time of the report, PAIN IN EXTREMITY (leg pain as a side effect of the COVID booster) had not resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medication of the patient was not reported.  No treatment information was provided by the reporter.  The patient wanted to know how long the adverse event would last.
About 36 hours post injection of the second dose of the Moderna COVID vaccine, the patient experienced body aches and a headache that felt like a hangover. Such effect lasted until 2 PM of the date of onset then resolved spontaneously.
bad headache,fever 101.3, vomiting & diarrhea along with bodyshakes. But two days later my daughter wiped & something that she said looked like a grape skin & blood came from vagina.
Expired Vaccine used; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Expired Vaccine used) in a 70-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 038C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 28-Oct-2021 at 8:45 AM, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced EXPIRED PRODUCT ADMINISTERED (Expired Vaccine used). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Expired Vaccine used) had resolved. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant medications were not provided. Treatment information was not provided. Client did not have any adverse reaction that was noted. we notified the client and asked them to receive a redosing with un expired vial(lot 037C21A) per our supervisors instructions. All questions and concerns were discussed with the client,
Severe allergies. Trouble breathing itchy everywhere. Never had allergies in my life. Nothing is helping I've tried benadryl and cortisone cream benadryl cream Zyrtec. Otmeal baths everything it's been goin on for 5 months daily ..help
Approximately five days after receiving the vaccine, I had a strange feeling in the left side of my chest as if something was swollen. It was not pain, but rather a feeling as if something inside was "enlarged" or heavy. Shortly after, I also had sharp pains on the left side which would come once or twice a day and last 1-2 seconds at most. As of now (day 13), I either do not feel the heaviness anymore or I am not noticing it anymore. The sharp pains have become very infrequent but I do often feel a mild soreness in the left side of my chest which lasts for about half an hour and gradually subsides.
1 of 3 pts who exp a rxn following vax from the same lot exp a large inj site rxn which included redness & induration;this was a booster dose;uncertain as to date of original dose
Arm swelled within 1 hour to 4 times original size, by end of day could not walk, within 3 days paralyzed from neck down. After 2 weeks was administered a lower lumbar puncture and given 5 days worth of IVIG in 2 days because the paralysis was spreading to lungs and Neurologist stated I did not have 5 days to live.
1) Migraines; 2) Severe Flank Pain on Right Side; 3) Severe Back Pain; 4) Chest Pain; 5) Rhabdomyolysis; 6) Dilated Aortic Root (Thoracic Aneurysm); 7) Biatrial Enlargement; 8) Pulmonic Regurgitation; 9) Atrial Fibrillation; 10) Supraventricular tachycardia
Patient was scheduled for a Pfizer Primary dose but was instead given Pfizer Booster Adult dose her left deltiod.
On 10/16/01 Diagnosed with shingles by PMD preceded on 10/14/01 fever and painful rash for 2 days. Isolates offered by Merck to do testing to determine wild virus vs varicella vaccine per nurse at Dr's office. No further plan-discussed with mother.
Vaccine #1 3/31/21 at 7pm at pharmacy: 10 minutes after vaccine was administered a sensation traveled up my right arm into my throat leaving a "full sensation" in the back of my throat.  Sent to urgent care.  Assessed for anaphylaxis.  No swelling in throat or breathing issues.  Dr. recommended Benadryl.  Sensation resolved within 4 hours.  Vaccine #2 4/21/21 at 7:30pm :  That same "full sensation" in my throat returned at minute 4 post vaccine.  I was monitored for 45 minutes.  No issues arose, just the stable sensation.  Was sent home.  No medications taken.  The "full sensation" in my throat had resolved about 14 hours post vaccine.  Within 15 hours I had flu-like symptoms.  Mild fever of 99.9*F, chills, headache & muscle aches.  I continued my 10hr shift at work.  When I got home, I took an Aleve for the headache & within an hour I was back to normal. I was tired for about 24 hour after this but nothing that I couldn't do my day to day stuff from.  I started my period on 4/26 & on 4/27- mid-July I got full paresthesia in my arms, legs & torso.  Nothing in my hands, feet or face.  Torso was very sensitive to heat.
Feels dizzy every time he gets the vaccine. BP 125/70; HR 97; Temp 98.1; O2 Sat 97%
Sleep deprivation; Low appetite; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of SLEEP DEFICIT (Sleep deprivation) and DECREASED APPETITE (Low appetite) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced SLEEP DEFICIT (Sleep deprivation) and DECREASED APPETITE (Low appetite). At the time of the report, SLEEP DEFICIT (Sleep deprivation) and DECREASED APPETITE (Low appetite) outcome was unknown.            No concomitants were reported. No treatment was reported.
body rash/back and arms were covered with rash; face flushed; This is a spontaneous report from a contactable consumer (patient). A female patient of an unspecified age received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number and expiry date: unknown), via an unspecified route of administration on 06Jan2021 at a single dose for COVID-19 immunization. Medical history was reported as none. There were no concomitant medications. The patient received the vaccine in, health department. On 06Jan2021, patient had a body rash as soon as she got the shot. Her back and arms were covered with rash and her face flushed, it's been six hours. The patient has been taking Benadryl as treatment for the events. The outcome of the events was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
there was a little sensation but it may have been in her head; This is a spontaneous report from a contactable consumer (patient). A 71-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number, expiration date unknown) , via an unspecified route of administration in her arm on 13Jan2021 at a single dose for  COVID-19 immunisation .  The patient's medical history and concomitant medications were not reported. On 13Jan2021, the patient reported that she received the COVID vaccine today and did not feel a thing, she did not feel the needle or the shot. She said other people have sore arm so she wanted to check if she should be feeling anything. She said she removed the bandaid to see the needle puncture but she did not see it. She felt like the nurse didn't give it to her in her arm. Her arm is not sore. She had to wait 15 minutes after she got the vaccine. There was a little sensation from it but maybe it was in her head on 13Jan2021. The nurse pinched her arm when she gave it. The patient  stated her next dose is scheduled on 03Feb2021. The outcome of the event was unknown.  Information on Lot/batch number has been requested.
No additional AEs were reported; The medical assistant is reporting that a patient received improperly stored vaccine; This spontaneous report was received from a medical assistant and referred to a patient with unknown age and gender. The patient's concurrent conditions, concomitant medication, pertinent medical history and drug reactions/ allergies were not provided.  The hepatitis a vaccine, inactivated (VAQTA) was improperly stored during a temperature excursion. Temperature was 46.74 Fahrenheit degree (F). Time frame was 2 minutes. Previous temperature excursion did not occur. On 03-MAY-2023, the patient was vaccinated with improperly stored hepatitis a vaccine, inactivated (VAQTA) (0.5 milliliter (ml), lot # was reported as X004813, expiration date was reported as 28-JUL-2024, route and anatomical location were not provided) for prophylaxis (product storage error). No additional adverse event (AE) was reported (no adverse event).
Body aches and chills in the first 24 hours. Body  aches the second day. Woke up with rash on body and a low grade fever
Severe fatigue (7/10), Headache (5/10), Muscle Cramps (4-6/10). Rapid onset. Consistent duration for ~ 6 hours.