chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Baby couldn't put any pressure on the leg the shot was given in without crying.  After speaking with the nurses at the pediatrician's office we gave Motrin and put a warm compress  on the shot area,  as well as massaged the area.  After about an hour baby was able to crawl with less pain. After about 30 more minutes, baby was able to crawl without any pain.
Macular rash around eyes including eyelids, on cheeks and around mouth.  Itching and tingling of lips.  Treated with Benadryl 25mg x 2 doses.  Duration of 1 day.
fatigue; arms and legs feel heavy; insomnia; restless legs; body aches; high fever; nausea; feeling malaise; This case was reported by a consumer and described the occurrence of fatigue in a 57-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   On 20th April 2021 09:00, the patient received the 2nd dose of Shingrix. In April 2021, an unknown time after receiving Shingrix, the patient experienced fatigue, heaviness in extremities, insomnia, restless legs, general body pain, fever, nausea and malaise. On an unknown date, the outcome of the fatigue, heaviness in extremities, insomnia, restless legs, general body pain, fever, nausea and malaise were recovering/resolving.   It was unknown if the reporter considered the fatigue, heaviness in extremities, insomnia, restless legs, general body pain, fever, nausea and malaise to be related to Shingrix.  Additional details were provided as follows: The patient reported that, he received 2nd dose of Shingrix. The patient experience adverse events such as, Feeling malaise, nausea, high fever, body aches, restless legs, insomnia, arms and legs feel heavy, and fatigue about 12 hours later. The patient reports he was doing a bit better at time of this report. Lot number and formulation was not known. The reporter consented to follow up.; Sender's Comments:  US-GLAXOSMITHKLINE-US2020250685:Same reporter
h/a, chills, low grade fever (99.0), nausea, vomiting, muscle aches; given APAP remained on bedrest x 3 hrs, felt better; 20OCT93: reports afebrile, overall feels better,sl nauseous;
Severe chills; headache; Dizziness; short of breath; This is a spontaneous report received from a contactable consumer or other non-HCP (patient herself). A 57-year-old female patient received BNT162b2 (PFIZER BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot Number- EL9265) via an unspecified route of administration in left arm on 23Feb2021 07:00 as dose 2, single (at the age of 57-years-old) for COVID-19 immunization. Patient was not pregnant at the time of vaccination. Patient medical history was not reported. The patient had no known allergies. Facility where the most recent COVID-19 vaccine was administered was reported as Hospital. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The concomitant medications included lisinopril, atorvastatin. The patient did not receive any other vaccines within four weeks prior to the vaccination. Historical vaccine included BNT162b2 (PFIZER BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot number- EL3249) via an unspecified route of administration in left arm on 02Feb2021 07:00 as dose 1, single for COVID-19 immunization. The patient experienced severe chills, headache, dizziness, short of breath on 23Feb2021 20:00. The patient did not receive any treatment for the adverse events. The adverse events resulted in Doctor or other healthcare professional office/clinic visit. The patient underwent lab tests and procedures which included Sars-cov-2 test (reported as Rapid test Covid test) (Nasal Swab) with result as negative on 26Feb2021. The outcome of the event was recovering.  No follow-up attempts are possible; Information about lot/batch number cannot be obtained.  Follow-up (17May2021): Follow-up attempts completed. No further information expected.
4/5/21 Rash on legs near and near elbow 4/6/21 Rash covering legs, hips and arms around elbows (no itching or pain)- Doctor visit prescribed Triamcinolone Acetonide .1% and Benedryl if needed. Return to urgent care if gets worse. (Used cream on bad spots) 4/8/21 Rash worse on legs, whole arm including hands and wrists, on stomach - urgent care visit where lab tests were done. Discontinue using cream and benedryl if not itchy or have no other symptoms 4/10/21 Rash started to fade Today rash still resolving with a small amount of rash evidence still remaining on legs
Immunizations given - client walked to a chair and fainted, fell to the floor. 911 called. EMS, our nurses, safety office evaluated client, BP and pulse were normal. Client woke quickly within 1-2 minutes. Sat up alert and oriented, took nourishment as he had not eaten that day.
Administration error: 12 children, including this patient, at a recent community vaccination event erroneously received ~25.7mcg of the adult Pfizer formulation instead of the intended 10mcg dose. In this case, the vaccine mixer pulled the Pfizer vaccine for adults/adolescents (purple top; for 12 years +) from the cooler instead of the intended Pfizer Pediatric (orange top; for 5-11 years). He proceeded to prepare the adult Pfizer vials following the pediatric Pfizer instructions (diluted with 1.3mL diluent and prepared 0.2mL into syringe). These doses administered to 12 patients before the error was identified. Patients did not report any adverse effects during the immediate observation phase, or during phone call follow-up several days following the event.  All patients/parents have been notified of the error, advised them this is a valid 1st dose, and will proceed to receive the 2nd dose as scheduled. Mixing procedures and workflows have been evaluated and adjusted per our safety action plan as a result of this error.
Fever, extreme fatigue, headache, generalized body aches despite tylenol 650 mg every 6 hours. Symptoms lasted 24 hours.
Case completed the 2 dose Covid vaccine series on 2/6/21, then was admitted to hospital for Covid disease on 7/31/2021.
This spontaneous report was received from a Registered nurse regarding an 11 year old patient of unknown gender. The patient's medical history, concurrent conditions and concomitant medications were not reported. On 24-JUN-2017, the patient was vaccinated with improperly stored dose of GARDASIL 9 lot# N004798 with expiration date: 31-OCT-2019 (dosing details and route of administration was not reported) for prophylaxis (product storage error). No adverse effects were reported. The storage temperature was 47 degrees Fahrenheit to 77 degrees Fahrenheit (49F) and time frame was 14 hours. There was no previous temperature excursion. Digital data logger was involved. No product quality complaint was involved. This is one of the several reports received from the same reporter. Sender's Comments: US-009507513-1804USA005153:
48 HOURS PUNCTURED VIAL; This spontaneous report received from a health care professional concerned a 58 year old female. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included: The patient did not have any known drug allergies. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 204A21A and expiry: 21-SEP-2021) dose was not reported, administered on 17-AUG-2021 for prophylactic vaccination. No concomitant medications were reported. On 17-AUG-2021, the patient experienced 48 hours punctured vial. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of 48 hours punctured vial was not reported. This report was non-serious.
Patient's left arm turned red and is warm to the touch in area of vaccine (upper left arm). Patient stated the red area kept spreading so she went to see a doctor.  He told her that it was nothing to worry about but he gave her a Medrol dose pak to help with the inflammation.  Doctor advised her that since she is over age 65, she will not need another pneumonia shot again in the future.
they both administered ACTHIB & VAXELIS to a patient with no reported adverse event; Initial information received on 19-Apr-2023 regarding an unsolicited valid  non-serious case received from a other health professional.  This case involves a 1 years old male patient and is reported they both administered HIB (PRP/T) vaccine [ACT-HIB] & vaxelis to a patient with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included diphtheria vaccine toxoid, hepatitis B vaccine RHBSAG (YEAST), HIB vaccine CONJ (menigococcal protein), pertussis vaccine acellular 5-component, polio VACCINE INACT 3V (VERO), tetanus vaccine toxoid (Vaxelis) for Prophylactic vaccination.  On 22-Mar-2023, the patient received a dose 0.5 ml of suspect HIB (PRP/T) vaccine Powder and solvent for solution for injection lot UJ796AA via intramuscular route in the left thigh for immunization.  On an unknown date the patient developed a non-serious event "they both administered acthib & vaxelis to a patient with no reported adverse event" (Extra dose administered) latency unknown following the administration of HIB (PRP/T) Vaccine.  Action taken was not applicable.  At time of reporting, the outcome was Recovered / Resolved on an unknown date for the event they both administered acthib & vaxelis to a patient with no reported adverse event.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the guidelines. 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.
Itching and a morbilliform rash of bilateral hands starting the evening of the injection.   No anaphylaxis, pustular rash, difficulty breathing, etc.   Started on clopidogrel 2 weeks prior.  No rash or itching until the vaccine administered but clopidogrel has a 6% listed incidence of rash.
Two of the five vaccines, it kind of like exploded when we were mixing them; The initial case was missing the following minimum criteria: [No adverse effect]. Upon receipt of follow-up information on (16Oct2023), this case now contains all required information to be considered valid. This is a spontaneous report received from contactable reporter(s) (Pharmacist and Consumer or other non HCP) from product quality group.  A patient (no qualifiers provided) received rsv vaccine prot.subunit pref 2v (ABRYSVO), as dose number unknown, single (Lot number: HF5023, Expiration Date: Feb2025) for immunisation; for immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DEVICE BREAKAGE (non-serious), outcome "unknown", described as "Two of the five vaccines, it kind of like exploded when we were mixing them".  The information on the batch/lot number for rsv vaccine prot.subunit pref 2v  has been requested and will be submitted if and when received.
Events:  12:00 PM Fatigue and fever of 100.2  10:00 PM Covid Rash (red splotch on injection arm) that is 10 degrees warmer than the rest of my arm - symptom continues 10:00 PM Observed enlarged underarm lymph node under injection arm - symptom continues  Treatments:   Fatigue & fever = Sleep Rash & lymph node = nothing at recommendation of physician  Outcomes: Fatigue & fever = gone in 4 hours after sleep Rash & lymph node = wait 2 weeks after injection to determine next steps if they are still an issue
flu like symptoms; problems with vision seemed blurry at time for a couple days; lymph's were swollen in neck and even more swollen after shots; arm is a mess; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of INFLUENZA LIKE ILLNESS (flu like symptoms), VISION BLURRED (problems with vision seemed blurry at time for a couple days), LYMPHADENOPATHY (lymph's were swollen in neck and even more swollen after shots) and LIMB DISCOMFORT (arm is a mess) in a 69-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 040A21A and 026B21A) for COVID-19 vaccination.     Concurrent medical conditions included Migraine. Concomitant products included BUDESONIDE (PULMICORT), NITROGLYCERIN, TRAMADOL and FLUTICASONE PROPIONATE (FLUTINASE [FLUTICASONE PROPIONATE]) for an unknown indication.   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 an unknown date, the patient experienced INFLUENZA LIKE ILLNESS (flu like symptoms), VISION BLURRED (problems with vision seemed blurry at time for a couple days), LYMPHADENOPATHY (lymph's were swollen in neck and even more swollen after shots) and LIMB DISCOMFORT (arm is a mess). At the time of the report, INFLUENZA LIKE ILLNESS (flu like symptoms) and LIMB DISCOMFORT (arm is a mess) outcome was unknown and VISION BLURRED (problems with vision seemed blurry at time for a couple days) and LYMPHADENOPATHY (lymph's were swollen in neck and even more swollen after shots) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.    Action taken with mRNA-1273 in response to the event was not applicable.   This case was linked to MOD-2021-110469 (Patient Link).
Extreme Fatigue, muscle aches, headache, soar arm. Lasting 3 days after I got my second shot.
This is a spontaneous report received from a non-contactable reporter(s) (Pharmacist). An elderly male patient received BNT162b2 (BNT162B2), in Jan2022 as dose 3 (booster), single (Batch/Lot number: unknown) 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's relevant medical history was not reported. There were no concomitant medications. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "tested positive for COVID on Apr24". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (24Apr2022) Positive, notes: My Father-In-Law tested positive for COVID on Apr24; (04May2022) Negative, notes: On Day 10 after testing positive, he tested negative and symptoms resolved; (08May2022) Positive, notes: On around Day 14, he started having symptoms again (e.g. sore throat, runny nose) and tested positive for COVID again. Therapeutic measures were taken as a result of drug ineffective, Covid-19. Additional information: If vaccine received reported as Yes. Other medication in 2weeks reported- No. My Father-In-Law tested positive for COVID on Apr24. He is in his late 70s. Symptoms were generally mild. He started a course of Paxlovid as directed the next day. On Day 10 after testing positive, he tested negative and symptoms resolved. On around Day 14, he started having symptoms again (e.g. sore throat, runny nose) and tested positive for COVID again. I would suggest you re-evaluate the narrative that rebound COVID after Paxlovid use is "rare". No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected. Sender's Comments: As there is limited information in the case provided, the causal association between the events Drug ineffective and Covid 19 and the suspect drug cannot be excluded. The case will be reassessed once new information is available.
Nausea within 2 hours. By 8/21, major sinus congestion, leading to muscle aches, body fatigue, diarrhea, disorientation hog sweats etc.
Itching, redness, burning at site of injection. Seems to be a delayed reaction.
Patient received shot and returned 20 minutes later saying their face was numb. Nurse took vitals and recommended patient go to doctor.
Ears always ringing; This spontaneous case was reported by a consumer and describes the occurrence of TINNITUS (Ears always ringing) in a 30-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Undifferentiated connective tissue disease and Depression. Concomitant products included BUPROPION for Depression.    On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 01-Jun-2021, the patient experienced TINNITUS (Ears always ringing). On 22-Jun-2021, TINNITUS (Ears always ringing) had resolved.            No treatment information was provided.
I felt my face swelling and at the same time when I started to eat something found it hard to swallow. Also had side effects of extremely tired fever nausea and cold chills
I had a headache starting at 5 Pm same day. Body aches/muscle aches in chest and back and a little bit fatigued. Symptoms lasted about 24 hours. I had a little arm soreness too and that lasted two. Pregnancy: May 4 expected due date and totally normal pregnancy.
DPT #3: admitted to hospital on 8/9/99 because of left side hemiplegia (18 days after DPT #3). DPT #5: exacerbated known seizure disorder. Patient is a five year old boy. On 3/16/04, the parents consulted me about reporting an adverse effect of a DPT given both at six months and at five years of age and requested i report these events to VAERS. Patient was a healthy term infant born on 2/3/99. He received a DPT #3 on 7/22/99. On 8/9/99, two hours after falling out of bed and 18 days after the DPT, he was admitted to hospital for spontaneous paralysis of left arm and dysphagia with discharge diagnosis of left hemiparesis secondary to infarction of the putamen posterior capsule and tail of caudate nucleus. He was under care of a neurologist. At age three and a half years, he had several episodes of becoming limp, weak and pale, which was diagnosed as atypical seizure disorder by the doctor presumably associated with stroke sustained at age six months of age. He has been treated with seizure medication. Ten days after his DPT #5, he had an atypical seizure with paralysis of facial muscles and excessive drooling, which was again diagnosed as a probable seizure. Follow up medical record on 05/14/04 states: completed. Nurse follow up on 06/10/04 states: Complete.
Information has been received from a registered nurse concerning her 13 month old son with no past medical history and no allergies who on 10/23/2001 in the AM was vaccinated with the first dose of varicella vaccine SC. There was no concomitant medication or illness at the time of vaccination. On 11/22/2001, the pt's mother noticed a rash that looked like chicken pox on the child. The rash was described as a "flat red rash on cheek; over the next day or two, some filled with fulid," and progressed down the legs and out the arms, and was also located on the chest and back. The mother estimated the child had about 100 lesions. On 11/26/2001, it was reported that "some of the areas have crusted over." It was reported that the rash resolved in about 1 week. Follow-up info reported that the pt was exposed to shingles. It was also  noted that a varicella titer was done and was negative. No further info is expected.
temp and upper arm soreness; temp and upper arm soreness; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  An elderly female patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 13Oct2022 as dose 5 (booster), single (Lot number: GH9693, Expiration Date: 30Jun2023) at the age of 73 years for covid-19 immunisation. The patient's relevant medical history included: "covid-19", start date: Apr2022 (unspecified if ongoing), notes: Date: Apr2022, Result: Positive, Date: Apr2022, Result: Negative. There were no concomitant medications. Vaccination history included: BNT162b2 (Vaccine: 1st dose, single covid-19, Product name/Manufacturer lot number: Pfizer Lot EN6200), administration date: 27Feb2021, when the patient was 71-year-old, for Covid-19 Immunization, reaction(s): "temp and upper arm soreness", "temp and upper arm soreness"; BNT162b2 (Vaccine: 2nd dose, single covid-19, Product name / Manufacturer lot number: Pfizer Lot ER8730, Time: 9:25AM), administration date: 23Mar2021, when the patient was 72-year-old, for Covid-19 Immunization, reaction(s): "temp and upper arm soreness", "temp and upper arm soreness"; BNT162b2 (Vaccine: dose 3, single, Pfizer Lot: FE3590, Expiration: 30Nov2021), administration date: 15Oct2021, when the patient was 72-year-old, for Covid-19 Immunization, reaction(s): "temp and upper arm soreness", "temp and upper arm soreness"; BNT162b2 (Vaccine: dose 4, single, Pfizer Lot: FK9894), administration date: 02May2022, when the patient was 73-year-old, for Covid-19 Immunization, reaction(s): "temp and upper arm soreness", "temp and upper arm soreness". The following information was reported: BODY TEMPERATURE INCREASED (non-serious), PAIN IN EXTREMITY (non-serious), outcome "unknown" and all described as "temp and upper arm soreness". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were taken as a result of body temperature increased, pain in extremity.  Additional information: no meds other than Tylenol taken day 1 02 of vaccine; Sender's Comments: Linked Report(s) : US-PFIZER INC-PV202300101946 same patient, different vaccine dose/event;US-PFIZER INC-202300259177 same patient, different vaccine dose/event;US-PFIZER INC-202300259176 same patient, different vaccine dose/event;US-PFIZER INC-202300259180 same patient, different vaccine dose/event;US-PFIZER INC-202300259179 same patient, different vaccine dose/event;US-PFIZER INC-PV202300128433 same patient, different vaccine dose/event;US-PFIZER INC-202300259178 same patient, different vaccine dose/event;US-PFIZER INC-202300259180 same patient, different vaccine dose/event;
pt had 2nd Moderna vaccine on 2/10/2021 lot # 013M20A.   Pt became Ill on 5/10/2021, test covid-19 positive on 5/17/2021 and treated with BAM, Intubated on vent 6/1/2021 deceased 6/13/2021
Severe Headaches; This spontaneous case was reported by an other health care professional and describes the occurrence of HEADACHE (Severe Headaches) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On 27-Jan-2022, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In January 2022, the patient experienced HEADACHE (Severe Headaches). At the time of the report, HEADACHE (Severe Headaches) had not resolved.      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No Concomitant Drug details were reported.  No Treatment information was provided.