chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Itching; Rash; Redness; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 25-May-2021 and was forwarded to Moderna on 25-May-2021.    This spontaneous case was reported by a patient family member or friend and describes the occurrence of PRURITUS (Itching), RASH (Rash) and ERYTHEMA (Redness) in an 80-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included Asthma. Concurrent medical conditions included Penicillin allergy (chest rash,itching), Drug allergy (allergic to sulfa drug), Shellfish allergy (raw throat), Allergy (allergic to grass -tearing eyes, runny nose) and Drug allergy (allergic to topical steroids-raw throat). Concomitant products included ATENOLOL, ATORVASTATIN, TERAZOSIN, DUTASTERIDE and ASPIRIN [ACETYLSALICYLIC ACID] for an unknown indication.    On 08-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 15-Mar-2021, the patient experienced PRURITUS (Itching), RASH (Rash) and ERYTHEMA (Redness). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL A) (oral) at a dose of 50 milligram three times a day. On 19-Mar-2021, PRURITUS (Itching) and RASH (Rash) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       This case was linked to MOD-2021-044285 (Patient Link).
Pt here today in COVID vaccination clinic for 2nd dose of Moderna vaccine. During screening questions, pt states that after her first dose of Moderna on 9/1/21 after she left the clinic, at about 20 min after vaccination, that she felt her throat become dry and tight "like I didn't have any saliva" and that she became nauseous. Pt states that she did not seek medical care at that time, but went home. After sx did not resolve, pt states she went to the ED at about four hours post vaccination. In the ED she said she was given motrin and morphine and was observed over night. She did discuss with her PCP whether she should get a 2nd dose and was told by her PCP that she should proceed with both her 2nd and 3rd doses of Moderna. Today she presents for the 2nd dose. Pt had not been instructed by PCP  to  premedicate with Benadryl.  2nd dose given in right deltoid at 1330 and instructed to wait in obs for 30 min. At 1347 pt stated that she was feeling lightheaded, was mentating and speaking without difficulty, no pallor noted. VS 112/70, pulse 64. Pulse ox not obtainable due to length of pt's fingernails. Water and crackers given, with patient stating that she felt better after about 5 minutes. Pt escorted out by friend/family member in patient's wheelchair that she presented in. Advised pt that should she develop any sx of anaphylaxis to call 911/present to ED.
patient fell , landed on head, got dizziness, lighheadness, trembling , 911 was already here for sister, they check on her, took her to hospital
pt devel itching & mild chemosis of eyelids 10 mins p/vax; no resp distress; no anaphylaxis;
This spontaneous report was received from a pharmacist concernig to a unspecified patient with unspecified demographics. The patient's concurrent conditions, medical history, drug reactions and/ or allergies.  On 07-MAR-2017, the patient was indavertanly administered an expired ZOSTAVAX 19400 PFU,lot # L044530/expiration date 09-FEB-2017, 0.65 ml, subcutaneous for prophylaxis. It was also reported that the vaccine was reconstituted with sterile diluent (DILUENT MRK) lot number as reported (K023742/ and expiration date 23-SEP-2017). No adverse effects were reported. Additional information has been requested.
This spontaneous report was received from a pharmacist referring to an unspecified number of patients of unknown age and gender. The patients' pertinent medical history, drug reactions/allergies, concurrent conditions and concomitant medications were not reported. On an unknown date, the patients were vaccinated with doses of ZOSTAVAX, subcutaneously, for prophylaxis (dose, lot # and expiration date were not reported). It was stated that the patients developed rash at injection site (no dates reported). It was stated that no treatment was given for the adverse event. At the time of reporting, the outcome of the event was unknown. A product quality complaint was not involved. The causality assessment between the event and ZOSTAVAX was not provided. Additional information has been requested.
After eating immediately felt like vomiting. Breathing hard and had chills and slight fever. Lasted about 2 hours.
I asked her to wait 30 minutes due to her other allergies and right at 30 minutes after the vaccine injection she reported "feeling strange with a little pressure in her chest.  11:30  B?P 180/100 pulse 80 resp 20 she was alert and oriented 11:40 B/P   170/100 pulse 80 Resp 16 alert and oriented.  11:43 she too Nitroglycerine 0.4mg sublingual - She had this in her purse and followed it up with 2 aspirin 81mg and she chewed these. Ambulance had been called due to the history of CAD and HTN and they arrived at 11:47 . They took her B?P and it was 160/110 and the decision was made to transport her to the hospital for further assessment.
vaccine given 10/19 and lot expired 10/13. moderna cofirmed after investigation the lot should give full coverage. no adverse event was reported
Pt states that she has developed Lupus and fibromyalgia from receiving a Hepatitis B vaccine in 07/2015.
Very weak; Very disjointed thought processes and motor function that day; Very disjointed thought processes and motor function that day; feeling like my knees were going to collapse; Passed out; I began to feel pain radiating from the center of my torso.; I became nauseated,; I fell to the floor; Dizzy and disoriented; disoriented; Began violent vomiting; Worst diarrhea I´ve ever had; Exhausted/tired; This is a spontaneous report from a contactable consumer (patient). A 62-year-old male patient received dose 1 of BNT162B2 (Pfizer-BIONTECH COVID-19 Vaccine), via an unspecified route of administration, administered in the left arm on 19Jul2021 at 18:15 (62-years-old at the time of vaccination) (Batch/Lot Number: FA7484) single, for COVID-19 immunization. Medical history included Penicillin allergy. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient had concomitant medications (unspecified; reported as medications that the patient received within 2 weeks of vaccination). The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 19Jul2021, about 1 hour and 15 minutes after receiving the vaccine, at 19:30, the patient began to feel pain radiating from the center of his torso. The pain intensified rapidly to severe. He became nauseated and tried to walk to the bathroom but he fell to the floor. Dizzy and disoriented, he started crawling, passed out, and started again. He began violent vomiting, passed out, woke up, and dragged himself up on the commode. Stated that it was the worst diarrhea he'd ever had. Stated that everything in his digestive system left his body. He then passed out on the commode, woke up, crawled back to the living room, and went to sleep. He woke up in a few minutes feeling better but exhausted. The patient woke up the next morning, very weak, and was still somewhat disoriented. He had a very disjointed thought processes and motor function that day. He kept feeling like his knees were going to collapse. The next day, he was still weak but almost clear headed. Next day, he was tired but ok. The initial severe sequence of events lasted maybe an hour or a little more. Since the vaccination, the patient has not been tested for COVID-19. The patient received no treatment for the events. Outcome of the events was recovered in Jul2021. The case was reported as non-serious.  Follow-up attempts are completed. No further information is expected.
abdominal mesenteric aneurysm; This is a spontaneous report from a contactable healthcare professional (patient). A 54-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) dose 1 via an unspecified route of administration, administered in arm left on 05Feb2021 15:00 (Lot Number: EL9269) as single dose for covid-19 immunisation. Medical history was reported as none. The patient did not have covid prior vaccination and no covid tested post vaccination. No known allergies. Concomitant medications in two weeks included ibuprofen (ADVIL); cetirizine hydrochloride, pseudoephedrine hydrochloride (ZYRTEC DUO). No other vaccine in four weeks. The patient had an abdominal mesenteric aneurysm 19 days after the first vaccine on 24Feb2021. He had no way of knowing if it was linked to the vaccine but did not know if there had been any other reports of this type of event. He spent 5 days in the hospital and then recovered. The event resulted in Emergency room/department or urgent care, Hospitalization, Life threatening illness (immediate risk of death from the event). It was unknown if treatment received. The outcome of event was recovered. He received the second vaccine without issues.; Sender's Comments: The causal relationship between BNT162B2 and the event abdominal mesenteric aneurysm cannot be excluded as 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.
After vaccination, pt stated he felt light-headed and heart/chest was fluttering.  BP 152/98 (pt normally runs 110/60) and pulse 109-112 (pt states is normal for him).  O2 sat 95-97% R16.  Pt also c/o headache.  Pt monitored for 20 minutes and states still some "feeling funny", but no worsening of s/s.  Last BP 146/90 P105.  Pt refused transport, continued nurse monitoring or EMS evaluation, even with cardiac history.  Advised to call EMS if he continued to have any problems.  Phoned pt on 1/14 to check status and said he was "extremely sick" with cough, body aches, possible fever.  Advised pt to have medical evaluation asap.
non-immunity on a recent titer test and had a negative titer; This spontaneous report was received from a registered nurse concerning a 40 years old female patient. Her current conditions included bipolar disorder, polycystic ovaries, major depression, attention deficit hyperactivity disorder, dyslipidaemia, headache, vitamin D deficiency and naproxen caused nausea. Historical drug included naproxen. Concomitant therapies included buspirone, clonazepam (KLONOPIN), bupropion hydrochloride (WELLBUTRIN XL), atorvastatin, ethinylestradiol (+) levonorgestrel (SRONYX), colecalciferol (VITDERA D), hydroxyzine, risperidone (RISPERDAL) and topiramate (TROKENDI XR).     On 09-NOV-2005, the patient was vaccinated with first dose of varicella virus vaccine live (oka/merck)(VARIVAX) (dose, route and lot# were not reported) for prophylaxis. The patient never returned for her second dose.   On 10-DEC-2020, the patient showed non-immunity on a recent titer test and had a negative titer (antibody test negative). The outcome of the event was not resolved. Action taken with varicella virus vaccine live (oka/merck)(VARIVAX) was not applicable.   The causality between the event and suspect vaccine was not reported.
This case was reported by a consumer via call center representative and described the occurrence of pneumonia in a adult female patient who received Influenza vaccine Quadrivalent. Co-suspect products included ADVAIR DISKUS inhalation powder (batch number 5ZP2021, expiry date 28th February 2017) for chronic obstructive pulmonary disease. In January 2017, the patient received Influenza vaccine Quadrivalent. In 2007, the patient started ADVAIR DISKUS (inhaled) at an unknown dose and frequency. In January 2017, less than a month after receiving Influenza vaccine Quadrivalent and unknown after starting ADVAIR DISKUS, the patient experienced pneumonia (serious criteria GSK medically significant), urinary tract infection and expired vaccine used. The action taken with ADVAIR DISKUS was unknown. On an unknown date, the outcome of the pneumonia was not recovered/not resolved and the outcome of the urinary tract infection and expired vaccine used were unknown. It was unknown if the reporter considered the pneumonia and urinary tract infection to be related to Influenza vaccine Quadrivalent and ADVAIR DISKUS. Additional details were reported as follows: The age at vaccination was not reported. In January 2017, the patient received Influenza vaccine Quadrivalent which was already expired. The patient reported that, she developed pneumonia from a flu shot which she received while seeking treatment for an urinary tract infection (UTI). The patient had denied permission to contact their physician.
Weakness, fever, headaches, vomiting, body aches, and fatigue for 3 days.
I had right side facial pausing and my right side of my eye brow and eye lid were having facial drooping. I also experienced facial hemiparesis and I had lost of muscle tone of right side of my mouth. I lost taste in certain parts of my tongue. I went to my PCP for treatment and was prescribed medicine for 7 days 1000mg Valtrex 3xday and prednisone 80mg 1xday. I was diagnosed with facial paralysis/ bell palsy.
Dose administered >12(US)/24(CA) hours post puncture; administer  over 5000 doses, after the12 hours limit on open vials/administering past the BUD date; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (administer  over 5000 doses, after the12 hours limit on open vials/administering past the BUD date) and PRODUCT STORAGE ERROR (Dose administered >12(US)/24(CA) hours post puncture) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011F21A) for COVID-19 vaccination.     No Medical History information was reported.    On 07-Nov-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 07-Nov-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (administer  over 5000 doses, after the12 hours limit on open vials/administering past the BUD date). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Dose administered >12(US)/24(CA) hours post puncture). At the time of the report, EXPIRED PRODUCT ADMINISTERED (administer  over 5000 doses, after the12 hours limit on open vials/administering past the BUD date) and PRODUCT STORAGE ERROR (Dose administered >12(US)/24(CA) hours post puncture) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication information provided. No treatment medication information provided. BUD is 01-Nov-2021   Most recent FOLLOW-UP information incorporated above includes: On 27-Apr-2022: Live significant follow up- Date of administration update
Information has been received from a pharmacy intern referring to 2 patients of unknown age and gender. On unknown dates in 2016 the patients were vaccinated with expired PNEUMOVAX 23 lot # L002310 (expiration date 08-JUL-2016). No adverse effect reported. This is one of several reports received from the same reporter. Additional information has been requested.
On Tuesday, 12/28/21, Patient came to Covid-19 Vaccination Site for his pediatric Pfizer Covid-19 second dose. Per CDC guidelines, pediatric Pfizer is eligible for ages 5 to 11. Client is 11 years old and eligible for a Pfizer pediatric dose. At approximately 11:30 AM, client was vaccinated with adult Pfizer dose (LOT #: FL3197) in his left arm by LVN. After vaccination, LVN realized client was given an adult Pfizer dose of 0.3 ml instead of a pediatric Pfizer dose of 0.2 ml. Lead RN was made aware of situation who elevated to Vaccine Operations Lead. Per Lead, situation to be explained to parents, no further interventions needed. Lead RN  explained situation to client's parents who verbally understood. Client denied any allergies or medications and was to be a 15 minute observation. Client and client's parents was educated by Lead RN on signs and symptoms of adverse reactions and when to go to the ED/call MD. Client's parents were also encouraged to sign-up on v-safe. Client experienced no adverse reaction while waiting in Observation Area and left vaccination site with a steady gait at 12:00 PM. VAERs completed on 12/28/21.
Lethargic, 102.2 fever, rash on chest/abdomen/back, heavy breathing
Information has been received on 19-JUL-2016 from a registered nurse who refers to an anonymous female patient. The patient's medical history and/or concurrent conditions and concomitant medications were unknown. In May 2015 the patient was vaccinated with one dose of GARDASIL. The patient then received one dose of GARDASIL 9 in March 2016. No further doses of either vaccine were administered. No symptoms were reported. No further information was provided. Additional information has been requested.
6 days after Mist, elevated T 100 cough + nasal congestion. Was seen on 10/20/2009.
Head ache, fatigue, GI upset(nausea) onset 15 minutes post Flumist
Dose administered after more than 1 temperature excursions; dose administered to patient after more than 1 temperature excursion/vial stored at cooler storage during high-pace COVID-19 vaccination clinic at the time of the excursion; This spontaneous case was reported by an other health care professional and describes the occurrence of POOR QUALITY PRODUCT ADMINISTERED (dose administered to patient after more than 1 temperature excursion/vial stored at cooler storage during high-pace COVID-19 vaccination clinic at the time of the excursion) and PRODUCT TEMPERATURE EXCURSION ISSUE (Dose administered after more than 1 temperature excursions ) in a 39-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 041L20A) for COVID-19 vaccination.     No Medical History information was reported.  On 11-Jan-2021 at 11:01 AM, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On 11-Jan-2021 at 11:01 AM,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced POOR QUALITY PRODUCT ADMINISTERED (dose administered to patient after more than 1 temperature excursion/vial stored at cooler storage during high-pace COVID-19 vaccination clinic at the time of the excursion). On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Dose administered after more than 1 temperature excursions ). At the time of the report, POOR QUALITY PRODUCT ADMINISTERED (dose administered to patient after more than 1 temperature excursion/vial stored at cooler storage during high-pace COVID-19 vaccination clinic at the time of the excursion) and PRODUCT TEMPERATURE EXCURSION ISSUE (Dose administered after more than 1 temperature excursions ) outcome was unknown. Not Provided    For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Patient age was reported as 39.25.  No concomitant medication was reported by reporter.  On 11-JAN-2021, Excursion time was 2 PM, temp was 35, condition of vaccine prior to vaccination was not frozen, vaccine was moved to fridge on 08-Jan-2021, vial was moved to clinic on 11-jan-2021. Vaccine BUD date was 07-feb-2021. Number of vials sent to clinic 9.  It was reported that patient was administered with vaccine that experienced more than 1 temperature excursion during 33 weeks on 2021. The HCP explained that each time a vial was put into a cooler, there was a period of time of 1 hour or 1 hour and a half approximately, when the temperature data logger registered 34 or 35 degree F.    Vial was punctured right before administration.   No treatment medication was reported by reporter.  This case was linked to MOD-2022-566976 (Patient Link).
Pfizer Dose 1 3/6/21 (EN6199) Pfizer Dose 2 3/27/21 (EN6207) COVID Positive 1/10/22  1/14/22: A 70-year-old male with a past medical history of type 2 DM, hypertension, hyperlipidemia and gout brought to ED by ambulance for worsening shortness of breath and hypoxia.  Patient states that he has been feeling sick for 1 week, with generalized weakness, cough, SOB and body aches. Patient states he got tested for COVID 19 about 4 days ago, and was reported positive.  Patient was seen by family physician, was asked to monitor pulse ox.  Patient states his pulse ox has been mostly in 70s, but he did not come to the emergency room.  He received monoclonal antibody infusion yesterday.  Patient says he is vaccinated against COVID-19 x2 doses, but no booster.  His friend who lives with him also has mild symptoms.  Denies nausea or vomiting, but had some loose stools.   Per EMS his oxygen saturation was 74% on room air.  In the ED, he was afebrile, blood pressure stable, pulse ox 92% on 15 L oxygen by mask.  Blood work shows leukocytosis with neutrophilia and lymphopenia.  Mild hyponatremia and elevated BUN and creatinine noted.  Chest x-ray showed extensive bilateral infiltrates, with left hemidiaphragm elevation with mass effect.   Patient was given IV dexamethasone 6 mg in the ED.  1/30/22: 70 year old male with hypertension presented for dyspnea and hospitalized for acute hypoxic respiratory failure secondary to COVID 19. Patient's oxygen requirement progressively increased and ended up getting intubated and requiring progressively increasing support on the ventilator. Patient received Actemra, Remdesivir, Dexamethasone and later Solu-Medrol. Patient was treated for superimposed bacterial pneumonia with course of antibiotics including ceftazidime and vancomycin. Patient developed afib w RVR which was appropriately treated medically and converted after synchronized cardioversion for hypotension. Patient's oxygen requirement worsened requiring maximal oxygenation support on the ventilator and developed septic shock with multiorgan failure which was refractory to vasopressors. Gaols of care was discussed with the family by the critical care attending and they decided on DNR/DNI and patient died on 1/30/2022 at 1836. Cause of death COVID 19.
T 102  with 3in erythema surrounding pustules. Take on 10 Feb 03. Red streak leading around biceps. Likely lymphangitis, but will Tx with Diclox secondary to high fever.  Missed 2 days of work.
Patient has reported that he has had pain in his arm since he received his flu shot on October 27,2020. Patient cannot sleep on his right side due to pain in the arm.
pt recv vax 12NOV95 & devel a large area of cellulitis around the inj site & a fever of 102;pt had been d/c from the hosp & had to be readmitted d/t a recurrence of ITP;
Initially, extreme sleepiness with high fever, then high-pitched screams and later abnormal behavior such as head banging, hand flapping, not responding to his name, loss of speech and playing in closets. PDD dx'd by developmental pediatrician at 2 1/2 years old (5/30/00). Heavy metal urine analysis reports indicate severe mercury poisoning, 1st report on 3/23/01.