chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Patient passed the recommend time frame for second dose; This spontaneous case was reported by a consumer and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Patient passed the recommend time frame for second dose) in a 60-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 027A21A) for COVID-19 vaccination.     No Medical History information was reported.   On 09-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 13-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 13-Apr-2021, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Patient passed the recommend time frame for second dose). At the time of the report, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Patient passed the recommend time frame for second dose) had resolved.            Duration between first shot and second shot: typing error: 35 days instead of 41 days  Concomitant product use was not provided.  Treatment information was unknown.
Patient called today, July 29, 2019 @ 10AM stating his arm is still sore from the injection administered on April 12, 2019. He states there is a lump and he has been to the doctor a number of times regarding other issues and all MD told him was to take anti-inflammatories and heat therapy.
Patient died unrelated to covid vaccine Narrative: The patient had advanced Alzheimer's disease and severe dementia. Patient received the first dose of Moderna vaccine on 1/7/2021 and no adverse reaction was reported. Placed in hospice care and passed away on 1/29/2021. Cause of death not documented. No indication that death was related to COVID 19 vaccination.
Sore arm Small headache  Exhausted  Nauseous  Fever  Runny nose  Congestion
severe lower back pain; pain going into hips; pain going into knees; A spontaneous report was received from a consumer concerning a patient who received the mRNA-1273 and experienced severe lower back pain going into hips and knees.   The patient's medical history was not provided. Concomitant product use was not provided by the reporter.   The patient received their first of two planned doses of mRNA-1273 on 29-Dec-2020 intramuscularly for prophylaxis of COVID-19 infection.   Patient reported that they received the Moderna vaccine on 29-Dec-2020 at 8 a.m.  She said that by midnight that night, she began to experience severe lower back pain going into hips and knees.  Patient reported that they had been taking paracetamol, naproxen and ibuprofen along with application of a heating pad; none of which provided any relief.    Treatment for the event included paracetamol, naproxen, ibuprofen and application of a heating pad.   Action taken with mRNA-1273 in response to the events, severe lower back pain going into hips and knees, was not provided.    The outcome of the events, severe lower back pain going into hips and knees, was not reported.   The reporter did not provide a causality assessment of the events, severe lower back pain going into hips and knees.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
After vaccination in the medical office building adjacent to the hospital, the hospital employee felt palpitations (within 30 minutes of shot).  Employee went to the ED at the hospital and was evaluated by medical personnel.  Employee was SOB but did not have difficulty breathing.  No other untoward reactions were observed.  All other ROS was unremarkable.  Sinus tachycardia of 140bpm observed in the ED, repeated ECG was sinus tachycardia of 119bpm, no other abnormalities.  IVF, 50mg IV diphenhydramine, 40mg IV famotidine, and 125mg IV methylprednisolone given.  Symptoms of palpitations and SOB resolved.  Discharged with instruction to return to the ED if any symptoms returned.
Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 48-year-old male patient received BNT162b2 (BNT162B2), on 01Aug2021 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 47 years for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown) and as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Unknown results, notes: Indication: Covid-19 treatment. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical course: Anti-viral details: Product: COVID 19 Treatment, Brand: Paxlovid, Treatment start date: 19Jun2022, Treatment stop date: 23Jun2022, lot number: Unknown, Indication: Treatment of COVID-19.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
9-28-16 7:30 AM woke up, head hurt all over, neck felt swollen and spine felt swollen between shoulder blades. Extreme headache, nausea.
Corona Breakthrough, 2-2 1/2 days fever 100.9, Loss of taste and smell, cold sweat, chest congestion, coughing. Flu-like symptoms. No treatment given.
02/07/22 presents to ED for "SOB". PMHx of "AF on coumadin, ischemic cardiomyopathy (EF 20%) s/p AICD, MVR, CKD stage III, HLD, HTN, hypothyroidism"
Child has chickenpox. Has vesicles in face, ears, arms, hands, abdomen, back, etc.
Within 9 minutes hives  began, face began to swell up, body felt hot, palpitations began and itching. Her neck was blotchy red. 10 minutes later her mouth began to itch
Sore arm, headache, fatigue, muscle aches, nausea and vomiting
Full-body hives, starting at scalp and upper back and now moving all around my body; a feeling of a lump in my throat/occasionally behind my sternum.  Treatment: Benadryl every 4 hours; 5 Prednisone steroid pills; over-the-counter topical creams.  Outcome: symptoms have not improved since onset four days ago.
This case was reported by a nurse and described the occurrence of wrong vaccine administered in a 7-year-old male patient who received KINRIX (batch number 23MJ17, expiry date 22nd October 2015). On an unknown date, the patient inadvertently received KINRIX. On an unknown date, an unknown time after receiving KINRIX, the patient experienced wrong vaccine administered and inappropriate age at vaccine administration. On an unknown date, the outcome of the wrong vaccine administered and inappropriate age at vaccine administration were unknown.
Mar90 pt vax w/ 2nd hepta B; 1 wk later exp syncope w/ blurred vision + falling, weakness on awakening, fever, chills, diaphoresis, + diarrhea.  Phy exam neg.
The orange cap pfizer bottle was diluted twice, injection was given to patient before this was realized. Parent of patient was informed while still in office and patient had  no further symptoms.
Pain radiating from injection site to shoulder and neck. Patient stayed for 45 minutes after injection and states that after the initial intense pain the pain has remained the same and has gotten no worse. Advised patient to apply heat and ice and take an anti inflammatory to help with pain and to seek medical attention in pain worsens, she loses movement in neck, or loss of hearing.
Patient reported a red, swollen, itchy area that was warm to touch at the injection site. The area was approximately 4 inches in diameter.
got the 2 shots in Feb2021, was known to have gotten covid-19; got the 2 shots in Feb2021, was known to have gotten covid-19; This is a spontaneous report from a Pfizer. A contactable consumer reported for an 88-year-old female patient received bnt162b2 (COMIRNATY, lot unknown), via an unspecified route of administration on Feb2021 as DOSE 1,  SINGLE; received bnt162b2 (COMIRNATY, lot unknown) via an unspecified route of administration on Feb2021 as DOSE 2, SINGLE for Covid-19 immunisation. The patient's medical history and concomitant medications were not reported. It was reported that the patient had 2 shots in Feb2021 and was known to have gotten Covid-19 on unspecified date in 2021. The outcome of event was unknown.  The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.
Patients  received doses 1 week after expiration; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Patients  received doses 1 week after expiration) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No medical history was provided by the reporter.     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, the patient experienced EXPIRED PRODUCT ADMINISTERED (Patients  received doses 1 week after expiration). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Patients  received doses 1 week after expiration) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Treatment details were not provided.   Reporter did not allow further contact
My blood pressure dropped, started getting heart palpitations, feeling short of breath at times, body (arms/legs) would go numb easy. Would see "stars" at times. Lasted for a good 10-14 days and still don't feel 100% back to normal, but most has subsided.
Patient received a dose of our Moderna COVID-19 vaccine at the age of 15 years and zero months. The patients age was realized during the patients return to our clinic for his second dose. At such time, the guardians, clinics physician and Medical Director was informed. We then proceeded to call the CDC  general questions about COVID-19 or the COVID-19 vaccine helpline at for further guidance. Additionally, reviewing of the literature had revealed that MOderna could be administered to n ages 11-17 as off label use. This was then supported by the guidance given by the CDC during our call. We inquired with the patient his tolerance of his first administration. Pateint reported no post vaccination side -effects and stated he "was fine".
Initial information received on 21-Sep-2018 regarding an unsolicited valid non-serious case received from a nurse. This case involves a 14 years old male patient who was vaccinated with 0.5 ml (once) dose of FLUBLOK QIV (Batch number: QFAA1819 and expiry date: 30-Jun-2019) via intramuscular route in the left deltoid on 21-Sep-2018. The patients past medical history, medical treatment(s), vaccination(s) and family history were not provided. Concomitant medications were not reported. It was a case of actual medication error due to inappropriate age at vaccine administration because the following vaccine should be used for 18 years age or older. It was unknown if any adverse event occurred or not following the vaccination. 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 and Module VI of the 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. Documents held by the sender: none.
Patient had headache, fever, chills (at night). Arm and leg pain after getting shot at 3 PM on Monday, Oct 13, 2008.
This spontaneous report was received from a nurse refers to a 30 year old patient of unknown gender. Information regarding patient's medical history, concurrent condition, drug reactions/allergies and concomitant therapy were not provided. On an unknown date, the patient was inadvertently vaccinated with a dose of PROQUAD (lot # M006102, expiry date: 01-AUG-2018). Nurse reported that it was outside the recommendations per prescribing information. No adverse effects were reported. Additional information has been requested.
Patient fully vaccinated and double boosted with Pfizer. Last booster dose was 7/22/22. Patient admitted to hospital for workup of significant muscle weakness/inability to walk on 7/23/22. Discharged on 7/26/22.
Moderna Covid-19 Vaccine  red bump at injection site, itchy and very tender to touch, sore arm, body aches
Description: Developed chest pain several weeks after receipt of SPV.  Was seen in the ER.  He saw a civilian cardiologist a few days later and was cleared.  He is currently asymptomatic.  Symptom: Chest Pain Start: 03/11/2003; Symptom: Dyspnea (shortness of breath) Start: 03/11/2003; Symptom: Dizziness Start: 03/11/2003; Symptom: Chills Start: 03/11/2003.
soreness in arm; stiffness in joints, shoulders and knees; left leg swelling; feeling horrible; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (soreness in arm), MUSCULOSKELETAL STIFFNESS (stiffness in joints, shoulders and knees), PERIPHERAL SWELLING (left leg swelling) and FEELING ABNORMAL (feeling horrible) in an adult male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 002A21A) for COVID-19 vaccination.     No Medical History information was reported.   On 02-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 05-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to at an unspecified dose. On an unknown date, the patient experienced PAIN IN EXTREMITY (soreness in arm), MUSCULOSKELETAL STIFFNESS (stiffness in joints, shoulders and knees), PERIPHERAL SWELLING (left leg swelling) and FEELING ABNORMAL (feeling horrible). The patient was treated with PREDNISONE at an unspecified dose and frequency and MONTELUKAST at an unspecified dose and frequency. At the time of the report, PAIN IN EXTREMITY (soreness in arm), MUSCULOSKELETAL STIFFNESS (stiffness in joints, shoulders and knees), PERIPHERAL SWELLING (left leg swelling) and FEELING ABNORMAL (feeling horrible) outcome was unknown. Not Provided
Exactly 3 weeks to the day of the second shot I lost all hearing in my left ear. Ear had been perfect until this day. 2 ear tests have revealed that the ear is useless.
Migraine with visual disturbance. Patient has had them before in response to new medication ex escitalopram.
Local symptoms- Pain-discomfort, swelling. Genera symptoms- muscle pains ,fatigue, heavier than usual periods. Narrative:
Information has been received from a registered nurse referring to a 9 year old male patient. There's no pertinent medical history. The drug reactions or allergies were unspecified. In 2007, the patient was vaccinated with PROQUAD (lot number, dose and route were unknown). On 16-MAR-2011 the patient was vaccinated with (Oka/Merck) VARIVAX (lot number and dose were unknown) subcutaneously. There were no concomitant medications. On 13-MAY-2015 the patient developed chicken pox. The patient sought medical attention via office visit. No treatment was given for the event. At the time of the report, the patient did not recover from the event. The relationship between th event and suspect therapies were not reported. Additional information has been requested.
felt cold; This spontaneous case was reported by a consumer and describes the occurrence of CHILLS (felt cold) in a male patient of an unknown age 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 second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 09-Feb-2021, the patient experienced CHILLS (felt cold). At the time of the report, CHILLS (felt cold) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No relevant concomitant medications were reported.  No treatment information was provided.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.
Patient was administered a dose of Infanrix instead of a Td vaccine for a dog bite.; Adult patient was administered a dose of Infanrix; This case was reported by a nurse via call center representative and described the occurrence of wrong vaccine administered in a adult patient who received DTPa (Infanrix) for prophylaxis.   Co-suspect products included dtpa vaccine pre-filled syringe device (Infanrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 15th May 2022, the patient received Infanrix and Infanrix Pre-Filled Syringe Device. On 15th May 2022, unknown after receiving Infanrix and Infanrix Pre-Filled Syringe Device, the patient experienced wrong vaccine administered and inappropriate age at vaccine administration. On an unknown date, the outcome of the wrong vaccine administered and inappropriate age at vaccine administration were unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK Receipt Date: 16-MAY-2022 Reporter's Comment: The reporter reported that, a patient was administered a dose of Infanrix instead of a Td vaccine for a dog bite. The lot number was not available. The reporter declined to have contact information stored.  The reporter declined follow-up from safety in escalated call to 2nd line agent. The reporter did not consent to follow-up. Additional Supportive Information: The reporter reported that, a patient was administered a dose of Infanrix instead of a Td vaccine for a dog bite, which led to wrong vaccine administered and inappropriate age at vaccine administration.
Had MMR and flu vaccine on 10-7-10. On 10-8-10 developed full body rash and N and V. Developed fever on 10-10-10 of 101. Taken to ER and had to have fluid replacement. Cont with full body rash on 10-11-10.
This young man was seen at the clinic where the itinerant Public Health Nurse administered the 2 injections.  Later in the early evening he was found outside hanging by the neck - apparent suicide. 2/4/09-Medical Examiner report: COD Hanging.
pt states on 2/27/2021 after he got the vax he had a high fever.  On 2/28/2021 he was weak and was getting out of the shower when he fell.  He was to weak to get up.  He stayed on the floor for four hours before he was able to get to a phone to call 911.  Paramedics took him to Medical Center he was directly admitted. His temp was 103.  He stayed for four days before he was stabilized enough to be able to go home. They ran numerous test, CT, EKG, Labs, Covid (negative).  He has a nurse and PT coming to his house 2 times weekly.  He states he now how control over his bowels and bladder and can take short walks w/ walker.  He has a FU apt w/his PCP on 3/29/2021.  He is scheduled for his 2nd Covid dose on 3/25/2021.
Increased Mucus Production/post nasal drip; Increased Mucus Production/post nasal drip; Increased Mucus Production/post nasal drip with expiratory wheezing since the shot; Causes coughing on and off daily and gets worse with physical exertion; Causes coughing on and off daily and gets worse with physical exertion which also causes fatigue; Shortness of breath with increased coughing; This is a spontaneous report from a contactable healthcare professional. A 36-year-old male patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8727) via an unspecified route of administration in the right arm on 25Mar2021 at 16:00 (at the age of 36-years-old) as a single dose for COVID-19 immunisation. Medical history included hyperthyroidism and COVID-19. The patient was allergic to penicillin. Prior to the vaccination, the patient was diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. Concomitant medications included thiamazole (METHIMAZOLE) taken for an unspecified indication from an unknown date and unknown if ongoing. On 01Apr2021 at 16:00, the patient experienced increased mucus production/post nasal drip with expiratory wheezing since the shot, about a month and a half time, caused coughing on and off daily and got worse with physical exertion which also caused fatigue, shortness of breath with increased coughing. The events did not result in a visit to the doctors or other healthcare professional office/clinic visit, and emergency room/department or urgent care. Therapeutic measures were not taken as a result of the events. Since the vaccination, the patient had been tested for COVID-19. On 02May2021, the patient underwent SARS-COV-2 test (nasal swab) and the result was negative. The clinical outcome of the events increased mucus production/post nasal drip with expiratory wheezing since the shot, about a month and a half time, caused coughing on and off daily and got worse with physical exertion which also caused fatigue, shortness of breath with increased coughing was not resolved at the time of this report.  No follow-up attempts are needed. No further information is expected.
Patient started by complaining of a metallic taste in their mouth shortly after administration. a few minutes later it had evolved into numbness and tingling across the entire mouth and down the throat. Physical exam presented mild swelling
On April 25th, I woke up with my upper left arm extremely itchy and covered in hives at the injection site (approximately a 2" by 1" area).  I took Allegra and used Cortizone cream, but did not get relief.  My arm was also slightly warm and sore to touch.  That night, I took Benadryl before going to sleep.  On April 26th, my arm is still very red and tender, but the itchiness and hives seem to be a little better.
Pt received 2nd dose of this season's influenza immunization. Minutes later while walking to check out pt had episode of syncope. Pt quickly regained consciousness. Pt then had episode of emesis.  BP quickly improved to baseline. Glucose was also checked and was normal. No previous history  of adverse reaction to immunizations. Pt is a previously healthy 3year old. Dr.
15 minutes after vaccination, patient started presenting with a cough.  Patient was asked to stay for observation, but left the pharmacy upon her own free will.  I was able to make contact with the patient 45 min later. She was doing ok but said she had a headache, sore throat, cough, and mildly swollen cheeks. No report of trouble breathing, wheezing or swollen lips or tongue.  After 1 hour and 45 min, patient had not reported any worsening or new symptoms. Assessed through phone as patient left pharmacy.
Some of the vaccine had come out after the injection with some blood / A little fluid came out of her arm after getting the injection; Some of the vaccine had come out after the injection with some blood / A little fluid came out of her arm after getting the injection; This is a spontaneous report from a contactable consumer (patient). This 35-year-old female consume received the first single dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on an unspecified date, in the arm, for COVID-19 immunization. Medical history and concomitant medications were not reported. The patient noticed that some of the vaccine had come out after the injection with some blood. A little fluid came out of her arm after getting the injection. She stated she had no side effects to report or anything like that. Events outcome was unknown.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.