chrisvoncsefalvay/vaers-outcomes huggingface dataset:
No additional AE reported; Medical assistant reporting that a patient was administered PROQUAD after a temperature excursion. No additional information provided. Additional AE cases: 02177149, 02177160, 02177161, 02177162, 02177163, 02177164, 02177165, 02177166, 02177167. No a; This spontaneous report was received from a medical assistant and refers to a patient of unknown age and gender.  The patient's medical history was not reported. The patient's concurrent conditions were not reported. Concomitant therapies were not reported.  On 31-MAY-2022, the patient was vaccinated with a dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) subcutaneous injection, lot #U024508, expiration date: 02-FEB-2023, administered subcutaneously for prophylaxis (strength and exact dose were not provided).  The measles, mumps, rubella and varicella (Oka Merck) virus vaccine live (PROQUAD) was administered after a temperature excursion (8.3F) in a time frame of 15 Minutes. No additional adverse event (AE) and no PQC were reported.
Information has been received from a registered nurse (R.N.) concerning a 15-month-old male with no pertinent medical history or allergies, who on 05-JUL-2006 was vaccinated subcutaneously one time with a 0.5 ml dose of Varivax (lot# 654330/0492F). Concomitant therapy included TYLENOL given prior to the vaccination for the prevention of pain and fever and a vaccination with a dose of MMR. On 30-JUL-2006 the patient started breaking out with what looked like large pimples that were red and raised that blistered then broke and scabbed over within 24 hours. The patient's mother treated him with DIMETAPP (new formula). More breakouts occurred over more areas. The areas with the breakouts were itchy. The nurse mentioned that the child ran a fever before the breakouts occurred. As of 02-AUG-2006 the patient was still having breakouts. As of 09-AUG-2006 the patient was recovered. This was considered to be a non-serious report. No product quality complaint was involved. The nurse indicated in follow-up that the event did not require intervention to prevent serious criteria. Additional information has been requested.
Patient's wife called on 2/10/21 and stated about 30 minutes after receiving the vaccine on 2/5/21 that her husband stated the left side of his face and his forehead went numb. He stated it felt like when you get an injection in your gum before having a dental procedure. Patient's wife stated it has improved some, but the feeling still has not completely come back.
Pt c/o of vaccine lump and redness -ATARAZ 10 mg 1 tsp tid  4 oz - KEFLEX 280 1 1/2 tsp tid
Significant swelling in left arm from proximal shoulder to below left elbow, indurated, warm, non tender. Treated with 12 day steroid course.
Shortness of breath, severe muscle aches, eyesight impacted, impacted thought processes.  This shot is NOT SAFE!!!!
Mother of patient (MOP) describes  patient received two vaccines without any immediate adverse event, one to each thigh. He was a little uncooperative about receipt but then was fine. She denies urticaria, flushing, restlessness, oral/face/throat/tongue swelling, voice change, wheezing, cough, watery eyes, n/v/d within first 2 hours of vaccine receipt. She states he was fine all day. The next day or day after she noted onset of a dermatitis characterized by small erythematous papules that were transient and new lesions formed. The initially presented on his back then spread to his chest and belly over the next week.  She states he had some pruritis, no vesicles or pustules. She noted an erythematous circular macule about dime sized at the injection site on his right thigh and it resolved at the same time as the urticaria  about 3 weeks later. She did not take any pictures. PCP was contacted day 23 and lesions were noted as resolved at that time.
Severe chest pain, shortness of breath, nausea, fever, fainting (did not go unconscious), arm and armpit pain
Idiopathic thrombocytopenic purpura. Admitted to hospital on 05/07/2002. Annual report follow up adds: This child has been followed at hospital for chronic ITP.
gave booster dose to a 17 year old/primary series completead by a 17 year old; This spontaneous case was reported by a pharmacist and describes the occurrence of PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (gave booster dose to a 17 year old/primary series completead by a 17 year old) in a 17-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 008c21, 008c21 and 022j21) for COVID-19 vaccination.     No Medical History information was reported.   On 22-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 19-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 11-Feb-2022, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 22-Apr-2021, the patient experienced PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (gave booster dose to a 17 year old/primary series completead by a 17 year old). At the time of the report, PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (gave booster dose to a 17 year old/primary series completead by a 17 year old) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Patient height was reported as F feet 11 Inches.  The patient had no known allergies. Patient never tested positive/ diagnosed for COVID. Other vaccines given within 1 month prior to Moderna COVID-19 vaccine was reported as no.   No concomitant medications were provided.  Reporter stated that the patient was fine.  No treatment medications were provided.
Shortness of breath; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 10-May-2021 and was forwarded to Moderna on 10-May-2021.    This spontaneous case was reported by a consumer and describes the occurrence of DYSPNOEA (Shortness of breath) in a 76-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 007B21A,) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concomitant products included OXYGEN and DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) for an unknown indication.    On 25-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 26-Mar-2021, the patient experienced DYSPNOEA (Shortness of breath). The patient was treated with HEXYLRESORCINOL (LISTERINE [HEXYLRESORCINOL]) for Rash, at an unspecified dose and frequency. At the time of the report, DYSPNOEA (Shortness of breath) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment provided include Oxygen for SOB ,Benadryl .
headache, sore throat, arm pain, fever, runny nose, fatigue, brain fog, nausea, vomiting, constipation, diarrhea, muscle aches
Systemic: Dizziness / Lightheadness-Medium, Systemic: TINGLING-Mild, Additional Details: HAD PATIENT PUT HIS HEAD IN BETWEEN HIS LEGS, GAVE WATER, CHOCOLATE AND A CLIFF BAR. PATIENT STILL WAS NOT FEELING BETTER SO HAD PATIENT LAY DOWN AND HAD LEGS ON CHAIR ABOVE HEAR LEVEL. GAVE PATIENT WATER AND STILL WAS NOT FEELING BETTER SO HAD PATIENT PUT LEGS DOWN ON GROUND. I GRABBED NURSE PRACTITIONER FROM CLINIC AND SHE CHECKED HIM OUT. VITALS WERE NORMAL ACCORDING TO NP. SHE ADVISED TO CALL 911 DUE TO TINGLING IN FINGERS AND NOT GETTING BETTER. WE CALLED AND PATIENT WENT WITH EMS.
Pulse raised between 90 and 100; Fever; Fatigue; This spontaneous case was reported by a consumer and describes the occurrence of TACHYCARDIA (Pulse raised between 90 and 100), PYREXIA (Fever) and FATIGUE (Fatigue) in a 70-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 030A21A and 038K20A) for COVID-19 vaccination.     The patient had no allergies, never had COVID-19 positive test or diagnosis. And patient was on diuretic therapy.  The patient's past medical history included Heart disease, unspecified (Since 30 years ago and no recent change in status such as improvement or worsening) and Open heart surgery. Previously administered products included for Product used for unknown indication: INFLUENZA VACCINE. Past adverse reactions to the above products included No adverse event with INFLUENZA VACCINE. Concurrent medical conditions included Type II diabetes mellitus (Since 4 years ago and no recent change in status such as improvement or worsening) and Blood pressure high (Since 30 years ago and no recent change in status such as improvement or worsening). Concomitant products included METFORMIN and DAPAGLIFLOZIN PROPANEDIOL MONOHYDRATE (FARXIGA) for Diabetes, HYDROCHLOROTHIAZIDE for Diuretic therapy.   On 05-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 05-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 05-Mar-2021, the patient experienced TACHYCARDIA (Pulse raised between 90 and 100), PYREXIA (Fever) and FATIGUE (Fatigue). On 07-Mar-2021, TACHYCARDIA (Pulse raised between 90 and 100), PYREXIA (Fever) and FATIGUE (Fatigue) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 05-Mar-2021, Heart rate: 90 to 100 Pulse raised between 90 and 100 for 3 days.         Other concomitant medication includes: Beta Blockers for an unknown indication. Patient stated that AE did not caused patient to seek medical care and the patient did not experienced similar events in the past. No treatment was given to the patient.   This case was linked to MOD-2022-535597, MOD-2022-535624, MOD-2022-535625 (Patient Link).
localized edema, erythema, itching at vaccine site; starting approx 24h after injection
high fever; This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (high fever) 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 16-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 an unknown date, the patient experienced PYREXIA (high fever). At the time of the report, PYREXIA (high fever) had resolved.            Concomitant product use was not provided. No treatment was reported. Action taken in response to mRNA-1273 was not applicable
No fever. Tingling in hand, neck and back. Pain on nerve endings, pale, no appetite, and weak.
1st dose then because of Covid missed 2nd, over a year; This case was reported by a consumer via interactive digital media and described the occurrence of social problem in a patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (1st dose received over a year prior to the reporting).   On an unknown date, the patient did not receive the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced social problem. On an unknown date, the outcome of the social problem was unknown.     Additional Information: GSK Receipt Date: 11-JUN-2022 Reporter's comment: This case was reported by a patient via interactive digital media. The patient had first dose of Shingrix then because of Covid missed second dose. It was over a year asked could he/she get the second dose now. Additional supportive information: Follow-up would not possible as no contact details were available.
In June 1999, the pt developed shingles. Eight months later, the pt developed another case of shingles. The child recovered with only a few dried lesions remaining at the time of the report.
pt recvd vax & 3 days later devel flu-like sx which included chills, elevated temp, general malaise, fatigue, stiff joints, hemoptysis, diarrhea, abdo cramps, upper resp distress, shaking, chills, cough w/white to yellow sputum w/blood;
Initial misuse report received from a healthcare professional on 26 August 2014. A patient (gender and age not provided) received a fifth dose of FLUZONE. It was reported that expired vaccine used that expired on 06.30.14 was administered to the patient. No adverse event was reported. List of documents held by sender: none.
She was diagnosed with SSLR due to routine vaccinations; This literature marketed report was received from the authors of a published literature, referring to a 4-year-old female patient. No information was provided regarding the patient's medical history, concurrent conditions, drug reactions, allergies or concomitant medications.   On an unknown date, the patient was vaccinated with Measles, Mumps, and Rubella (Wistar RA 27-3) Virus Vaccine, Live (manufacturer unknown) and varicella virus vaccine live (Oka/Merck) (manufacturer unknown) for prophylaxis (strength, dose number, anatomical location, route of administration, lot number and expiration date were not reported). Additional suspect vaccines administered the same day, included diphtheria toxoid (+) pertussis acellular vaccine (unspecified) (+) tetanus toxoid and poliovirus vaccine inactivated (strength, dose number, anatomical location, route of administration, lot number and expiration date were not reported).  On an unspecified date, six days after vaccination, the patient developed a generalized urticarial rash with swelling of her joints. She was started on prednisolone by her pediatrician for presumed Serum sickness-like reaction (SSLR) however was subsequently admitted with high fevers and worsening arthralgia. Her C-reactive protein (CRP), procalcitonin and erythrocyte sedimentation rate (ESR) were all elevated and her respiratory viral panel was positive for adenovirus. Her complement levels (C3, C4) were normal. Intravenous methylprednisolone was started with dramatic improvement. She was diagnosed with SSLR and was discharged on a prednisone taper with instructions to space out vaccinations in the future to elicit the causal vaccine.  On an unspecified date, resolution in symptomatology over the course of 48 hours occurred. The author assessed the causal relationship between suspect vaccines and the events as related as they stated that the patient was diagnosed with SSLR due to routine vaccinations.  A copy of the published article is attached as further documentation of the patient's experience.
don't feel right since his booster dose; feels heavy; Stretching from his left side up to his heart & face feels different; His left side feels different/Stretching from his left side up to his heart; Things are a blur; feels like his heart is fat & engorged; arm feels different; This spontaneous case was reported by a consumer and describes the occurrence of MALAISE (don't feel right since his booster dose), FEELING ABNORMAL (feels heavy), FACIAL DISCOMFORT (Stretching from his left side up to his heart & face feels different), DISCOMFORT (His left side feels different/Stretching from his left side up to his heart) and VISION BLURRED (Things are a blur) in a 37-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 031H21A, 028A21A and 025A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medical history was provided by the reporter.  Concurrent medical conditions included Hypertension (high blood pressure). Concomitant products included LOSARTAN and CARVEDILOL for Hypertension.   On 03-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 31-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 10-Dec-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 10-Dec-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced MALAISE (don't feel right since his booster dose). In December 2021, the patient experienced FEELING ABNORMAL (feels heavy), FACIAL DISCOMFORT (Stretching from his left side up to his heart & face feels different), DISCOMFORT (His left side feels different/Stretching from his left side up to his heart), VISION BLURRED (Things are a blur), CARDIAC DISCOMFORT (feels like his heart is fat & engorged) and LIMB DISCOMFORT (arm feels different). At the time of the report, MALAISE (don't feel right since his booster dose), FEELING ABNORMAL (feels heavy), FACIAL DISCOMFORT (Stretching from his left side up to his heart & face feels different), DISCOMFORT (His left side feels different/Stretching from his left side up to his heart), VISION BLURRED (Things are a blur), CARDIAC DISCOMFORT (feels like his heart is fat & engorged) and LIMB DISCOMFORT (arm feels different) outcome was unknown.            Treatment information was not provided by the reporter.   This case was linked to MOD-2021-411093 (Patient Link).
Shingles occurred three days after second shot. Now, 25 days later, my joints are swelling and fingers are getting rashes.
Patient neglected to tell staff about already receiving his booster on 7/26/2021.  So, he received another booster today and it was before the 6 months recommended time.
I informed the mother that I gave her 9 year old her dose which is the adult Pfizer covid of 0.3ml. I spoke with the mother this morning and she said that her son is fine.
Pfizer vaccine was administered outside of our facility - reported by patient  I95.9 HYPOTENSION 5/29/2021 PRESENCE OF SUPRAPUBIC CATHETER I95.9 HYPOTENSION 5/29/2021 URINARY RETENTION I95.9 HYPOTENSION 5/29/2021 ATRIAL FIBRILLATION, UNSPECIFIED I95.9 HYPOTENSION 5/29/2021 ATRIAL FIBRILLATION W RAPID VENTRICULAR RESPONSE I95.9 HYPOTENSION 5/29/2021 ATRIAL FIBRILLATION, UNSPECIFIED
No adverse symptoms from vaccination.  Decedent died day after 2nd vaccination, death not related to vaccination
Patient got anxious  then dizze and nauseated 1 min post vaccination Provided water and crackers Discharged to home
DEVELOPED FEVER ON 4/23/09. TOTAL BODY RASH(MORBILIFORM) DEVELOPED ON OR ABOUT 4/24/09.
Came in with 3 in x 3 in red circular welt on arm at site of injection. Stated it was warm to the touch but not painful. No other problems to report.
I had a fever of 103.8 8-12 hours after the vaccine. After the first 24 hours all normal side effects went away. Yesterday (day 5), I started having leg discomfort and it continues today. Could easily be a pulled muscle but I?m also concerned about blood clots so I?m watching my symptoms and if anything worsens, I will get seen by patient first.
Had CT scan for lung nodules checkup.  Result was:  Subpleural ill-defined opacification in the lingula, may be infectious or inflammatory etiology.  Did this come from the  shot??  Was supposed to be called by Respiratory Dr. but that didn't happen yet.
The patient presented to the pharmacy several days after administration and informed us that she had severe inflammation and redness at the injection site, along with extreme soreness. She had already visited a physician and been given a steroid shot and steroid tablets (exact drug unknown to pharmacy). As of 10/10/2016, the patient has improved significantly and no longer complains of soreness, redness, or inflammation at the site of injection.
Baby died from SIDS, according to pathologist. Autopsy also showed diffuse patchy lymphocytic pneumonitis, found unresponsive, lung congestion, pulmonary edema
Pain at left Under Arm, Chest pain and neck area And Both Calves behind knee.
Fever, headache and eye pain and neck pain - 24 hours after vaccine. Went to ER - normal lumbar puncture and CBC and chemistry rapid flu (-) in office.
arrhythmias/arrhythmias got worse over the last few days; low grade fevers; flushing; This is a spontaneous report from a contactable nurse (patient). A 37-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 2 via an unspecified route of administration administered on arm left on 01Feb2021 15:00 (Batch/Lot Number: EL9263) as SINGLE DOSE for COVID-19 immunization at the hospital. Medical history included hypothyroidism and hypertension. Concomitant medications included levothyroxine sodium (SYNTHROID) and nifedipine (NIFEDIPINE) taken from unknown dates and indications. The patient had the first dose of PFIZER-BIONTECH COVID-19 VACCINE (batch# el1284) on 14Jan2021 02:00 PM on the left arm as COVID-19 immunization. On 08Feb2021 (about one week after receiving the vaccine), the patient began having arrhythmias. The arrhythmias got worse over the last few days, so she went to urgent care and followed up with her MD who stated he has heard others with this same complaint. Additionally, she has been experiencing low grade fevers and flushing periodically which also started on 08Feb2021. The patient went to doctor or other healthcare professional office/clinic visit and emergency room/department or urgent care due to the events. The patient received treatment of potassium chloride (KCL) replacement and labs (unspecified results)- as reported. The patient had no if COVID prior vaccination and not tested post vaccination. Outcome of the events were not recovered.   No follow-up attempts are possible. No further information is expected.; Sender's Comments: Based on temporal association, the causal relationship between bnt162b2 and the event arrhythmia cannot be excluded. The information available in this report is limited and does not allow a medically meaningful assessment. This case will be reassessed once additional information becomes available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees, and Investigators, as appropriate.,Linked Report(s) : US-PFIZER INC-2021231701 Same reporter/ drug/ event for different patients
inconsolable crying for more than 3hr, loss of appetite, vomit, fussiness;
Sore, constant aching arm still 2 months after shot. Patient did not call us till 9/30/11 to inform us.
Severe abdominal pain unable to eat or sleep for 36 hours. He went by ambulance to the Hospital emergency room. They tried to pump his stomach but he aspirated and and went into cardiac arrest. He was revived but never regained consciousness. (The ICU Dr said that he had blood clots in his abdomen from a recent stroke. We were unaware of him having a stroke other than in 2026. The same Dr. said that he had necrosis in his lungs from aspirating. The necrosis was from his bowel dying) He was put on a ventilator and given drugs to increase his heart rate. On 3-5-21  the heart drugs were reduced and he died. I was with him when he recieved the vaccination and he was healthy, just old. I think that the shot killed him.