chrisvoncsefalvay/vaers-outcomes huggingface dataset:
No additional AE reported; Temperature excursion 47.9 degrees Farenheit; This spontaneous report has been received from an office manager, regarding a 3-years-old male patient. The patient's pertinent medical history, previous drug reactions or allergies and concomitant medications were not reported.  On 01-DEC-2022, a dose of Hepatitis A Vaccine, Inactivated (VAQTA) underwent a temperature excursion of 47.9 degrees Fahrenheit (F) (storage in clinical practice) for 47 minutes. Digital data logger was involved.  On 20-DEC-2022, the patient was vaccinated with the improperly storage dose of Hepatitis A Vaccine, Inactivated (VAQTA) Intramuscular Injection, intramuscularly at the right tight as prophylaxis (lot number: W017343, which was determined to be valid, with an expiration date on 13-DEC-2023) (product storage error) (dose was not reported).  The operator of the vaccine was a healthcare professional, and the vaccine was used according to the instruction leaflet. No adverse event was reported.  This is one of several reports received from the same reporter.
BP 169/96 (pulse 75). Given crackers, apple juice. Advised to drink water. BP trended down and stabilized.
My arm was a little sore; 5-6 big bumps; This is a spontaneous report from a contactable consumer or other non hcp. A 85-years-old female patient received BNT162B2 (BNT162B2, solution for injection, Batch/Lot number was not reported), via an unspecified route of administration on 28Jan2021 09:30 (at the age of 85-year-old) as 1st dose, single for covid-19 immunisation. The patient medical history and concomitant medications were not reported. On 28Jan2021 17:30, the patient experienced 5-6 big bumps on the left side of her forehead, next to her eye and biggest one was the size of a milk dud. They were protruding like a gumdrop. These lasted about 3-4 days. Now she can push on the area with her hands on her forehead and feels 1 indention. The bumps have now went away for the most part. The reporter stated that she didn't know whether it was a clot or something else happened. On an unknown date, patient experienced, arm was a little sore. Patient was due for the second shot 18Feb and so worried about it. The outcome of the event bumps was recovering, however the outcome of the event arm was little sore was unknown.   Information on the Lot/batch number has been requested.  Follow-up attempts are completed. No further information is expected.
fever, unconsolable crying 3hrs; mom states pt did not look well & was taken to ER; mom stated ER MD recommended no further DTP shot, alternate form preferable;
Onset the day after administration of pain at the site of injection as well as itchy rash on the trunk. Rash has not resolved after more than 1 month.
Varicella-like rash, developed 06/06/2003.  Vaccine given 05/20/2003.
I expected some swelling, however (and I work out so my arm muscles are well defined).  First, the upper arm muscle was hardened and tender. By 10:15 PM, the area was surrounded by redness (and "outlined" too). By the next day (02/06/2017), the redness had spread down over the bicep muscle and it also was very sensitive. By 6:12 PM (02/06/2017) the redness and tenderness had spread around the arm slightly to the triceps, as well as down to the inner elbow. Am I going to do my workout?  Heck, no.  Also, the night of 2/05, I was slightly dizzy and had a headache. These effects are more than I expected. Along with the spread of the redness, the right arm (site of injection) is much warmer to the touch than the untouched arm.  Never had a reaction like this before.
Night of 2/19/21 mild soreness of arm. Day and Night of 2/20/21, no symptoms. Night of 2/21/21 Tiredness and slight chills, body aches.
This is a spontaneous case, initially received from other non-health professional on 18-Oct-2018, concerning a 65-year-old, elderly female patient. The patient received an unspecified flu vaccine and had not experienced any adverse reactions in the past. On 16-Oct-2018, the patient was administered FLUAD TIV [dose: 0.5 ml, route of administration: intramuscular, anatomical location: left arm, batch number: 250794 and expiry date: 30-Apr-2019]. On the same day after vaccination, the patient experienced extreme soreness in her arm. After 1 hour or several hours, the arm soreness diminished. On 17-Oct-2018 (reported as following day), the patient experienced headache which lasted for 12 hours. The patient also noticed a swollen lymph node under her right arm. On an unspecified date in Oct-2018, the patient experienced pain from the bottom to the top of her head. It was reported that the patient had scheduled a medical appointment on an unspecified date. It was the first time that the patient received FLUAD, but she used to receive flu vaccines before and that was the first time the patient had a reaction after receiving the flu shot. The outcome of the event headache was recovered on an unspecified date in Oct-2018. The outcome of the event arm soreness was recovering and the outcome of other events general body pain and swollen lymph nodes was not reported. The reporter assessed this case as non-serious and the events related to the suspect vaccine.
Patient reported (L) arm soreness and redness day after vaccination administered denies H/A pain.
Systemic: Confusion-Medium, Systemic: Fainting / Unresponsive-Medium, Systemic: Seizure-Medium
severe rash all over her back, down her side and down her leg; First dose: 16Mar2021 and  Second dose: 21Jul2021; she broke out in a rash; rash blisters all over her body; This is a spontaneous report from a contactable consumer. This consumer (patient husband) reported for a female patient that:   A 79-years-old female patient received bnt162b2 (COMIRNATY, Formulation; Solution for Injection), dose 2 via an unspecified route of administration, administered in Arm Right on 21Jul2021 13:00 (Age at vaccination was 79 years) (Batch/Lot number was not reported) as DOSE 2, SINGLE for covid-19 immunisation. The patient medical history not reported.concomitant medications: None. The patient previously received (BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) Formulation; Solution for Injection, Batch/Lot Number: EN6206 and Expiry date was not provided) via unspecified route of administration as Dose 1, on 16Mar2021 on Arm Right for (age at vaccination 79 years) COVID-19 immunisation. Vaccine was not Administered at Military Facility. There were no prior Vaccinations (within 4 weeks) list any other vaccinations within four weeks prior to the first administration date of the suspect vaccine. The patient experienced She broke out in a rash on 21Jul2021, Severe rash all over her back and down her side and down her leg on an unspecified date, Rash blisters all over her body on 21Jul2021.Patient visited physician office for reported events. The events were assessed as Non serious. The outcome of events was not recovered for events She broke out in a rash, for Severe rash all over her back, Down her side and down her leg It was recovered on 2021 and Rash blisters all over her body it was Unknown.
Allergic Reaction, Unspecified, Initial Encounter. Swelling of lips. Treatment Children's Zyrtec in AM, Benadryl at night.
Narrative:  Patient admitted for severe case of COVID-19 despite being receiving both vaccines in the series on 03/10/2021 and 04/07/2021.
DTaP and Varicella vaccines administered. Child was crying and then vomited yellow fluid. Redness noted Left leg and face. EMS was called. Epinephrine 0.10 mg SC RL administered. Redness spread to Right leg. Transported to hospital.
Pt developed redness, swelling & induration of R thigh approximately 48 hrs after receiving vaccines.  Minimally tender, no fever or other systemic symptoms. Placed on Augmentin 400mg BID x10d.
Bright red rash from injection site down arm to elbow (approx.  4 inches x 5 inches); pt also said she has felt badly (fever, general malaise) reported 12/01/2016- assuming onset 11/29 or 11/30.
swollen from temple to cheek; hard time hearing in left ear; left ear was twice the size as her right ear; face was very round from swelling/looked like a water balloon on the left side of her face; This spontaneous case was reported by a consumer and describes the occurrence of SWELLING FACE (face was very round from swelling/looked like a water balloon on the left side of her face), SWELLING FACE (swollen from temple to cheek), HYPOACUSIS (hard time hearing in left ear) and EAR SWELLING (left ear was twice the size as her right ear) in a 70-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 104A21A) for COVID-19 vaccination.     Concurrent medical conditions included Rheumatoid arthritis.    On 12-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-Mar-2021, the patient experienced SWELLING FACE (face was very round from swelling/looked like a water balloon on the left side of her face). On 13-Mar-2021, the patient experienced SWELLING FACE (swollen from temple to cheek), HYPOACUSIS (hard time hearing in left ear) and EAR SWELLING (left ear was twice the size as her right ear). On 15-Mar-2021, SWELLING FACE (face was very round from swelling/looked like a water balloon on the left side of her face), SWELLING FACE (swollen from temple to cheek), HYPOACUSIS (hard time hearing in left ear) and EAR SWELLING (left ear was twice the size as her right ear) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No relevant concomitant medications were reported.  No treatment information was provided.
Patient received her COVID vaccine booster ( Moderna Lot: 084J21A and expiration: 2/4/22) at 11:30am. Client reported that she felt blurry vision after receiving her vaccine. Vitals taken at 11:40am were as follows: O2sat: 100, HR: 62, Blood pressure: 221/77. Blood pressure was retaken with a manual blood pressure cuff and was 190/80. Client denied chest pain, head ache but reported she still had blurry vision. Client was sitting in chair unassisted with no apparent signs of distress. Client reported she had not eaten this morning At 11:42am client was given a juice and a snack. Client reported a history of diabetes, hypertension, and dry eyes. Client reported taking glipizide, aspirin, and atenolol. Client denied a history of allergies. Client denied a history of a heart attack or stroke. 911 was called at 11:44am. Ambulance arrived at 11:53am. At 1155AM vitals were taken by fire department were as follows: BP: 177/75, O2 Sat: 100%, and HR: 59. At 1157am client refused to go to Emergency department. At 1200 client left building unassisted with a steady gait. Client refused to go wait full 30 min. Client reported her husband was going to drive her home.
Woke up at 3 AM with nausea so went to sit in the bathroom, alternated between feeling better and feeling just about to puke for about an hour. At about 4 AM I was going to the bathroom and then felt about to puke again. I then began to get tinnitus in both my ears and my left eye went black and I thought I was going to pass out. I laid on the bathroom floor for another 30 minutes before going back to sleep. Other symptoms that started on 4/18/21 included chills and fever which lasted until about 6 AM on 4/19/21.
Approximately 1 hour after receiving booster dose pf pfizer covid vaccine felt like heart was going to beat out of her chest and was short of breath.  Patient's HR 190 and patient diagnosed with SVT and cardioverted with adenosine.
Nausea evening after injection. Headache  Very tired  Strange dreams Feeling warm (no fever) Site soreness
CONFIRMED COVID-19 INFECTION; CONFIRMED CLINICAL VACCINATION FAILURE; This spontaneous report received from a patient via a company representative concerned a male of unspecified age. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of administration, batch number and expiry were not reported) dose was not reported,1 total, dose number in series was 1, administered on OCT-2021 (The location of vaccination in which arm was unknown) for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported. Patient experienced chest pain recently and felt bad. On DEC-2021, Laboratory data included: COVID-19 virus test (NR: not provided) positive. the patient had confirmed covid-19 infection and confirmed clinical vaccination failure (dose number in series was 1). The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the confirmed covid-19 infection and confirmed clinical vaccination failure was not reported. This report was serious (Other Medically Important Condition). his report was associated with a regulatory authority: 90000209387; Sender's Comments: V0: 20211264034-Covid-19 vaccine ad26.cov2.s - confirmed covid-19 infection. This event(s) is considered unassessable. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s). 20211264034-covid-19 vaccine ad26.cov2.s- confirmed clinical vaccination failure. This event is considered not related. The event has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event than the drug. Specifically: SPECIAL SITUATIONS
The day after receiving his COVID vaccination, the patient was found unresponsive in his driveway in respiratory distress by his neighbors.  EMSA was called and pt transported to ED, where he was intubated and placed on mechanical ventilation.  Patient extubated 3/4, but remains critically ill at this time.  Neurologic causes are being investigated.
The patient received dose from vial beyond 30-day use by date; The patient received dose from vial beyond 30-day use by date; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (The patient received dose from vial beyond 30-day use by date) and PRODUCT STORAGE ERROR (The patient received dose from vial beyond 30-day use by date) in a 41-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 037C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 11-Jun-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 11-Jun-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (The patient received dose from vial beyond 30-day use by date) and PRODUCT STORAGE ERROR (The patient received dose from vial beyond 30-day use by date). On 11-Jun-2021, EXPIRED PRODUCT ADMINISTERED (The patient received dose from vial beyond 30-day use by date) and PRODUCT STORAGE ERROR (The patient received dose from vial beyond 30-day use by date) had resolved. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Date of refrigeration was on 7-may-2021 Concomitant medication use was unknown Treatment information was unknown
Seizure had one on 8/23/08 Varicella/MMR given 8/26/08. 2nd seizure on 9/1/08
Systemic: Allergic: Swelling of Face / Eyes / Mouth / Tongue-Medium, Systemic: Headache-Mild, Systemic: Joint Pain-Medium, Systemic: Tinnitus-Medium, Additional Details: PER THE PT HER FACE SWELL AND LIPS STILL NOT 100% RESOLVED ,BUT NO DIFFICULTY BREATHING , VERY BAD HEADACHE, SHOOTING SHARP PAIN IN THE EAR EVERY ONCE A WHILE, PER THE PT SHE IS ASTHMA MEDICATION FOR ALLERGIES SHE THIMK THIS LIMITED THE ADVERSE EFFECTS
fever 102 deg F after 8 hrs of vaccine HA prior to onset of fever vomited x 1. Pt was in Er in the clinic 24 hr later asymptomatic body aches.
I received the vaccine in my right arm and within 3 days I noticed some painless swelling around my right areola scar line where I had a breast lift and implants 11 months prior. This progressed to two open wounds where sutures began to surface and had to be removed. After my second dose of the Moderna vaccine I developed another area on my right areola scar line that opened up to reveal another suture that required removal.
soreness by the injection site; headache; muscle ache; This case was reported by a consumer via interactive digital media and described the occurrence of injection site pain in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   On 17th November 2020, the patient received the 2nd dose of Shingrix. On 17th November 2020, less than a day after receiving Shingrix, the patient experienced injection site pain, headache and muscle pain. On an unknown date, the outcome of the injection site pain, headache and muscle pain were unknown.   It was unknown if the reporter considered the injection site pain, headache and muscle pain to be related to Shingrix.  Additional details were reported as follows: The age at vaccination was not reported. The age group was not reported but was selected adult as per vaccine indication.
January 15th, I started getting a minor sore throat that increased on the 16th and 17th, by the 18th it was severe and pain was going up in my right ear, scratchy throat and ear pain. I went to urgent care on 01.18.2022 and tested positive for COVID-19, between the 18th-20th pain was really bad. I had no fever or congestion did have a runny nose. I called on the 19th received some oral lidocaine. I woke up on the 21st all symptoms were gone. I did stay fatigued for about 3 weeks after.
I received the first vaccine around 10:00 in the morning.   Symptoms hit about Midnight.  Started with a headache,  a mild sore throat, fever 100.1, body and joint aches, chills, and then a few times the next day of being extremely tired, only lasted for about 24 hours.  After the second vaccine,  I had all of the previous symptoms again but this time the chills lasted for about 3 hours which was a lot longer.  Lasted again about 24 hours and then a few times of feeling extremely tired the next couple of days.  I should also let you know that I did test positive for COVID around November 6, 2020, and had mild symptoms for a full week.
Entire left arm sore, fatigued,, Slight swelling in all body, increased thirst, Left eye experiencing subconjunctive hemorrage, taking ibuprofen and Benadryl, low discomfort
Information has been received from a pharmacist concerning an adult male who was vaccinated with MMRII. Subsequently, the pt failed to sero-convert for rubella. No other information was provided. Additional information has been requested.
Child received 0.5cc dose of FLUZONE instead of 0.25cc appropriate for age. Mother informed of vaccine error at time of visit on 12/2/10. On 12/3/10 at 5:30pm red welts began on legs and then hives on top of them. Used hydrocortisone but hives spread to arms, hands, neck within 30 minutes. Went to Emergency. Doctor told mother it was an allergic reaction to vaccine. Prescribed Prednisone & BENADRYL for 3 days. Symptoms gone after 4th dose of meds.
Pt received the Moderna dose 1 vaccine today and 5 minutes post vaccine administration, reported feeling very sweaty/clammy.  Pt appeared pale upon assessment. VS as follows @ 0915: BP 114/54, HR 48, O2: 98% 0920: 130/75, HR 64, O2: 98% 0925: 127/95, HR 62, O2: 98% 0930: 109/72, HR 59, O2: 98% Pt was observed for approximately 25 minutes. Symptoms improved and pt discharged home in stable condition.
Dizziness, Headache, Myalgia, HYPERtension, Syncope, Bradycardia, had flulike symptoms and rash with 1st dose, 2nd dose: during 15min observation period, felt weak, tingling all over body and felt weak on her right side and dizziness. lightheadedness, dizziness, and generalized weakness. slow to respond to questions, co Narrative:  Other Relevant History:
Pharmacist administered Zostavax vaccine IM instead of SQ. I called the Merck info line & was told that this was not a problem.
Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from Regulatory Authority. The reporter is the patient.  A 41-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 08Nov2021 at 19:00 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 40 years, in left arm for covid-19 immunisation; coviD-19 vaccine mrna (mrna 1273) (COVID-19 VACCINE MODERNA), on 05Mar2021 at 18:00 as dose 1, single (Batch/Lot number: unknown), in left arm and on 02Apr2021 at 09:00 as dose 2, single (Batch/Lot number: unknown), in left arm for covid-19 immunisation. The patient's relevant medical history included: "High blood pressure" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 05May2022, outcome "unknown" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (05May2022) Positive; (09May2022) Negative; (14May2022) Negative; (15May2022) Positive; (20May2022) Negative. Therapeutic measures were taken as a result of drug ineffective, covid-19.   Clinical course- The patient receive any other vaccines within 4 weeks prior to the COVID vaccine. There was list of other medications the patient received within 2 weeks of vaccination.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
localized hives, turned widespread hives 24 hours after injection and lasted 72+ hours.
No additional AE; Nurse reported AE for improperly stored administered MMRII. Declined full patient demographics. No additional AE/PQC.; This spontaneous report was received from Other Health Professional 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 30-MAY-2023, the patient started therapy with measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) injection, 1 dose, lot #W034592, expiration date: 10-MAY-2024, administered for prophylaxis (strength, and route of administration were not provided).  On 30-MAY-2023, nurse reported AE for improperly stored administered measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II). Declined full patient demographics. No additional AE/PQC.
Initial information has been received from a pharmacist refers to a female patient with unspecified age with nonsteroidal anti-inflammatory drug (NSAIDS) allergy, sulfa allergy and cephalosporin allergy, who, on 23-NOV-2012 ("6 days ago") was vaccinated with ZOSTAVAX (dose, route and lot # were not reported). No other co-suspects were reported. Concomitant medications included DIOVAN, letrozole, simvastatin (manufacturer unknown), tramadol hydrochloride, fluticasone, ipratropium bromide, PRILOSEC, hydrochlorothiazide (+) triamterene and cetirizine hydrochloride. In November 2012, the patient experienced swelling, redness and itching around injection site after receiving ZOSTAVAX. The patient was treated with a moisturizer to affected area. The patient's outcome was unknown. The patient sought medical attention by speaking to the pharmacist. Additional information is not expected.
Patient felt dizziness, weakness, and a fast heartbeat immediately after receiving injection.  Patient was observed by EMS onsite and then went to ED for visit.  Patient discharged from ED with no issues.
Adverse event after 1st shot was on 4/29/2021. Had typical muscle aches day of and day after, then nausea and bad headaches started. I was admitted to the hospital a couple later as a possible stroke patient- paralysis of complete left side while at work in the late afternoon.