chrisvoncsefalvay/vaers-outcomes huggingface dataset:
male patient received the 1st dose of Engerix on 27Mar2023 and is late for the 2nd dose; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in a 24-year-old male patient who received HBV (Engerix B) for prophylaxis.   Previously administered products included Engerix B (received 1st dose on 27th March 2023 and batch number:9255P).   On an unknown date, the patient did not receive the 2nd dose of Engerix B. On an unknown date, an unknown time after receiving Engerix B, the patient experienced incomplete course of vaccination (Verbatim: male patient received the 1st dose of Engerix on 27Mar2023 and is late for the 2nd dose). The outcome of the incomplete course of vaccination was unknown.   Additional Information: GSK Receipt Date: 11-JUL-2023 The reporter reported that a patient was late for the 2nd dose of Engerix B. The Vaccine Administration Facility was the same as Primary Reporter. The healthcare professional did not have the expiration date. The reporter consented to follow up via postal mail. Till the time of reporting, the patient did not receive the 2nd dose of Engerix B, which led to incomplete course of vaccination.
1 INCH DIAMETER WARM ERYTHEMATOUS RING ON L ARM NEAR SITE WHERE VARICELLA VACCINE WAS GIVEN.  PER MOM APPEARED ABOUT 5 HOURS AFTER ADMINISTRATION.
Large red, hard area on arm around vaccination site. Blister like bumps in the middle of red area.
Immediate pain at site of injection as well as throughout shoulder. Pain still present about 6 weeks after vaccine was given, description of pain and exam consistent with rotator cuff tendinitis.
When giving her the second Pfizer vaccine, patient stated that a couple days after receiving the first Pfizer, she had red spots on her arm and stomach. She didn't think she had got bitten by a bug and hadn't changed laundry detergent. She discussed with her doctor and her doctor advised her to get the second Pfizer vaccine.  He wasn't sure if the spots could be from pregnancy.
Started hurting in mid of night after day of shot. Woke up to itchy, oval, red, warm to touch, and raised/swollen.  Felt fatigued evening after shot and following day, not sick, just tired. The shot location stayed bothersome, red, swollen, warm all weekend and went away by Monday morning. Following Friday, week to the day of original shot, woke up and arm was itchy, lifted shirt and realized the red, hot circle on my arm was back but took up  larger area. Much bigger than first weekend. So odd that it came back exactly a week later for the entire weekend again. All same symptoms but shot location was much bigger, itchy and hot to touch, swollen and raised. Noticed faint yellowish bruise under skin for up to two weeks after second weekend of swelling. Kind of afraid to see what happens with the second shot, if  the first did this.
Dizziness, Headache, Myalgia, Arthralgia & Fever Narrative:
Patient received KINRIX (Dtap, IPV) in error on 11/27/13. Returned to office 12/5/13. Diagnosed w/AGE, viral. Symptoms = vomit x 1, slightly loose back at office on 12/20/13. Diagnosed w/(+) RSV/Bronchiolitis. Hospitalized 12/21/13-1/1/14. Respiratory symptoms include crackles, rales, substernal refractions, tachypnea, low O2 sats. Back to office on 1/8/14 w/same symptoms, only worse. CX Ray indicates perihilar interstitial infiltrates increased WOB. Child referred to pulmonology. Child now re-hospitalized at clinic.
Trouble breathing, both eyes were full of matter, terrible headache, diarrhea, lasted all night long, tapered off the next morning after 8:00 AM.  Used Primatene Mist for breathing and eye drops for eyes.
Rash over entire body  Thursday 12/16 - itching over entire body, no visible signs (other than redness from itching) Sunday 12/19 - bumps noticed (like small mosquito bites, with no discoloration) on both elbows, knees, abdomen, neck Monday, 12/20 - area of intense bumps noticed on lower back/butt, saw the doctor  Prescribed Medrol (Pak) 4 mg tablets, 1 dose pk orally per package directions, for redness/rash over entire body, with instructions to contact dermatologist if symptoms don't improve--particularly if symptoms return after Medrol is done.  As of submission, patient has not yet begun treatment.
Itching around mouth within 10 minutes of receiving vaccine, received benadryl injection. Within 25 minutes of receiving vaccine started having heaviness in throat. Was taken to Emergency Dept. Within 1 hour of receiving vaccine, heaviness/tightness in throat worsened, started feeling short of breath. Received epinephrine. Monitored in the emergency dept with EKG for 4 hours and released.
Pt noted red spots and soreness on side of arm (not at area of injection).  No itching, just tender to the touch.  slightly red in appearance (almost like hives but sore, not itchy).  99 fever
20 minutes after injection muscle twitching in right calf muscle and left eyebrow. 2 hours following injection, constant muscle twitching in neck, forearm, upper back, stomach, calves, thigh, hamstring, glutes, hands and eyebrow and lower lip
Klebsiella Pneumonia: 11/26/99 pt coughed up copious amts of dark red blood twice. 11/27 pt hospitalized. Diag w/ bleeding Klebsiella pneumonia. Xray showed blood clot on lung. Treated w/ Ceftin (Roche). Had rxn. Treated w/ Benadryl.
12/1/13 LIMPING ON SAME LEG THAT SHE RECEIVED INJECTION, CAN'T WALK, CLINGY TO MOTHER, TEMP 100.7; DEC 2 TEMP 101, LIMPING, CLINGY TO MOTHER; DEC 3 LATE AFTERNOON 100.3 OR 100.5 TEMP, 10:45 P.M. TEMP 103.5, VOMITED, CRANKY, EXHAUSTED, CLINGY, HOMEOPATHY REMEDY SILICA 30, 12 A.M. GAVE HOMEOPATHY REMEDY BELLADONNA 200C; DEC 4 7:45 A.M. HOMEOPATHIC REMEDY PULSATILLA 200C; 8:45 A.M. TEMP 102, LIMITED FOOD & LIQUID INTAKE, SIPPING WATER THROUGHOUT THE DAY WITH HOMEOPATHIC REMEDY PULSATILLA 200C, 2:30 P.M. CRANKY, CLINGY, NOT SLEEPING WELL, TEMP 101.5; DEC 5 A.M. TEMP 101.7, SOME CLINGY, GAVE SILICA 30C; DEC 6 8 A.M. SPIRITS BETTER, RASH, MOTTLED SKIN ON ENTIRE FACE & BODY, BRIDGE OF NOSE & EYES RED, NO FEVER, 9 A.M. HOMEOPATHIC REMEDY SULPHUR 30C, DIDN'T EAT WELL THROUGHOUT THE DAY, MINIMAL LIQUID INTAKE; DEC 9 EXHAUSTED THROUGHOUT THE DAY; DEC 10 TOOK HOMEOPATHIC REMEDY HIB 30C; DEC 11 BETTER ALTHOUGH STILL CLINGY
dizziness is reported in pt who recvd fluogen; dizziness appeared 3 days p/fluogen inject was given; pt has a h/o hypertenison, which is well controlled; pt recovered from dizziness;
The pt developed red, swollen, warm to touch, palpate knot at injection site for 24 hrs.
Patient received the vaccine intended for patients age 5 through 11 years. Patient was 14 years old at the time. Incorrect vaccine administered.
This spontaneous report has been received from a pharmacist referring to a patient of unknown age and gender. Information about concurrent condition, concomitant medication and medical history was not provided. On an unknown date, the patient was vaccinated with improperly stored GARDASIL 9 (strength, dose, route, lot# and expiration date were not reported) for prophylaxis. The vaccines were exposed to temperature excursion of 47 degrees Fahrenheit to 77 degrees Fahrenheit for 16 hours and 28 degrees Fahrenheit for 4 hours. Data logger was not involved. There was no previous temperature excursion. No adverse effect was reported.
This spontaneous report was received from a healthcare professional who reported that in January 2014, 21 improperly stored doses of ROTATEQ, (oral, dose, batch and lot number not reported) were administered by a clinic to an unspecified number of patients (age and gender were not reported). No adverse effects were reported. This is one of several reports from the same source. Follow up information has been received on 17-MAR-2014. All telephone attempts to obtain follow-up information had been unsuccessful. Follow up information has been received on 22-SEP-2014. Demographic details for each patient were provided. This report referred to a 16-year-old female patient, who had no known drug allergies had no illness at time of vaccination. This report did not correspond to a patient vaccinated with ROTATEQ. Instead, the reporter informed that this patient was vaccinated with the third dose of GARDASIL (intramuscular injection, batch/lot # J008423, expiration date 21-JAN-2016, in the left arm, route not reported, on 10-FEB-2014 at 5:00 PM. It was reported that this dose was spoiled since the refrigerator was too cold (onset of event also reported as 27-FEB-2014 at 10:00 AM). Parents were informed and declined to revaccinated. No adverse event was reported for the patient. The outcome was reported by the reporter as recovered. This is one of several reports from the same source. Additional information is not expected since all follow ups requested to complete the case were received.
Cold feet; Pounding headache; This is a spontaneous report received from a contactable reporter(s) (Nurse). The reporter is the patient.  A 39-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 06Dec2022 at 10:00 as dose 3 (booster), single (Lot number: GJ6742) at the age of 39 years intramuscular, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Anaemia" (unspecified if ongoing), notes: Other medical history: Anemia; "Known allergies: Penicillin" (unspecified if ongoing), notes: Known allergies: Penicillin, Sulfur drugs. There were no concomitant medications. Past drug history included: Sulfur drugs, reaction(s): "known allergies: Sulfur drugs", notes: Known allergies: Penicillin, Sulfur drugs. Vaccination history included: BNT162b2 (Dose 1, Single, Batch/Lot No: EL3247, Location of injection: Arm Left, Route of Administration: Intramuscular, Facility type vaccine: Workplace clinic), administration date: 22Feb2021, when the patient was 37-year-old, for covid-19 immunization; BNT162b2 (Dose 2, Single, Batch/Lot No: EL3247, Location of injection: Arm Left, Route of Administration: Intramuscular), administration date: 15Mar2021, when the patient was 37-year-old, for covid-19 immunization. The following information was reported: PERIPHERAL COLDNESS (non-serious) with onset 07Dec2022, outcome "recovered" (07Dec2022 at 08:00), described as "Cold feet"; HEADACHE (non-serious) with onset 07Dec2022, outcome "recovered" (07Dec2022 at 08:00), described as "Pounding headache". Therapeutic measures were taken as a result of peripheral coldness, headache.  Additional information: Patient is a Pfizer employee and registered nurse (DNP). Patient received her COVID-19 booster shot yesterday morning and around 12am this morning she experienced extremely cold feet and a pounding headache. The events resolved as of 8am this morning. AE treatment was took Motrin for the headache. Patient did not received other vaccine in four weeks and other medication in two weeks. Patient did not had covid Prior vaccination and was not tested for covid post vaccination.
Sx started night after receiving vaccine and got progressively worse for a week after.  I had the shakes low blood pressure, back and forth low and high heart rate, chills and shakes, unable to stay awake, nausea. Unable to drink or eat, unable to walk due to extreme weakness and fatigue.
hx of peripheral artery disease, multiple sclerosis, CHF; presented with SOB, decrease O2 saturation, positive for COVID; pt requested do not intubate, pt's condition worsened where he died in the hospital; Acute hypoxemic respiratory failure secondary to COVID pneumonia
Right leg numbness, and an ocular migraine. This happened with both dose 2 and 3.
This case was reported by a pharmacist via call center representative and described the occurrence of influenza-like symptoms in a adult patient who received SHINGRIX for prophylaxis. On an unknown date, the patient received the 2nd dose of SHINGRIX. On an unknown date, unknown after receiving SHINGRIX, the patient experienced influenza-like symptoms. On an unknown date, the outcome of the influenza-like symptoms was unknown. It was unknown if the reporter considered the influenza-like symptoms to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. The health care professional requested Safety Department reach out to her to obtain details about the patient and their experience. The health care professional did not have time to stay on call. This case has been linked with case US2018181706, reported by the same reporter.
Diabetes went to the roof, ended in the hospital; This spontaneous case was reported by a consumer and describes the occurrence of DIABETES MELLITUS (Diabetes went to the roof, ended in the hospital) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No medical history was reported.     On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced DIABETES MELLITUS (Diabetes went to the roof, ended in the hospital) (seriousness criteria hospitalization and medically significant). At the time of the report, DIABETES MELLITUS (Diabetes went to the roof, ended in the hospital) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were reported. No treatment medications were reported.  Very limited information regarding this event has been provided at this time. Further information has been requested.; Sender's Comments: Very limited information regarding this event has been provided at this time. Further information has been requested.
Patient began to feel dizziness, sense of her throat tightening, clearing throat, stated she could not "hear" us talking to her., vomiting following Epipen .3 mg  administration, right leg, SQ,     911 was called and patient was transported by ambulance  to  Medical Center ER
Breakthrough case after Covid vaccination. Dose #1 12/31/2020 Dose # 2 1/22/2021. C/O fever, runny nose, and headache, onset 8/21/2021
Administered vaccine had been in the refrigerator > 30days and was expired; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Administered vaccine had been in the refrigerator > 30days and was expired) in a 37-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 036B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 07-Jul-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 07-Jul-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Administered vaccine had been in the refrigerator > 30days and was expired). On 07-Jul-2021, EXPIRED PRODUCT ADMINISTERED (Administered vaccine had been in the refrigerator > 30days and was expired) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No Concomitants and treatment medications were reported.
red sport about 2 inches around; swelling in the same area as the redness; my arm felt a little bit achy; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (my arm felt a little bit achy), VACCINATION SITE ERYTHEMA (red sport about 2 inches around) and VACCINATION SITE SWELLING (swelling in the same area as the redness) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 007M20A) for COVID-19 vaccination.     No Medical History information was reported.    On 12-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 21-Feb-2021, the patient experienced VACCINATION SITE PAIN (my arm felt a little bit achy). On 22-Feb-2021, the patient experienced VACCINATION SITE ERYTHEMA (red sport about 2 inches around) and VACCINATION SITE SWELLING (swelling in the same area as the redness). At the time of the report, VACCINATION SITE PAIN (my arm felt a little bit achy), VACCINATION SITE ERYTHEMA (red sport about 2 inches around) and VACCINATION SITE SWELLING (swelling in the same area as the redness) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Upon in internal review on 21 May 2021, the age was corrected to unknown age.  No concomitant medications reported by investigator No treatment medications provided by the reporter.  Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded   Most recent FOLLOW-UP information incorporated above includes: On 23-Feb-2021: Upon internal review on 07 Jun 2021, it was discovered that the patient age was incorrectly captured , which was a MI error. The patient age and narrative has been updated to unknown age with reports re-submission and significant amendment is performed for the correction.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded
Information has been received from a physician concerning a 23 year old female with a history of cervical intraepithelial neoplasia who on 03-JAN-2007 was vaccinated intramuscularly into the left arm with a first dose of GARDASIL vaccine (lot#655165/1425F)). There was no concomitant medication. On 03-JAN-2007 the patient experienced hives all over her body after vaccination with GARDASIL vaccine. The hives appeared all over her body on the day of vaccination. BENADRYL was prescribed to the patient and she fully recovered 48 hours after the vaccination. Additional information has been requested.  This is in follow-up to report (s) previously submitted on 4/13/2007. No laboratory diagnositic studies were performed. The patient fully recovered 48 hours after the vaccination (also reported as 04-JAN-2007). No further information is available.
p/vax pt devel rash under both arms w/intense itching x 3wk w/small knot that took 2mo to disappear;1st 4 days area red, hot & swollen;
This spontaneous report as received from a nurse refers to an unspecified patients of unknown age and gender. On an unknown date, the unspecified patients were vaccinated with an improperly stored (Oka/Merck) VARIVAX (therapy type: digital data logger). No adverse effects were reported. No product quality complaint (PQC) was reported for (Oka/Merck) VARIVAX. The vaccine for stored at -14 Celsius for an unspecified time and data logger was involved. This is one of the two reports from the same reporter. Additional information has been requested.
He had a sore neck with the first 2 doses.; This spontaneous case was reported by a consumer and describes the occurrence of NECK PAIN (He had a sore neck with the first 2 doses.) in a 70-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No medical history was reported by the patient.  Concomitant products included ATORVASTATIN, MULTIVITAMINS [VITAMINS NOS] and ACETYLSALICYLIC ACID (BABY ASPIRIN) for an unknown indication.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced NECK PAIN (He had a sore neck with the first 2 doses.). At the time of the report, NECK PAIN (He had a sore neck with the first 2 doses.) outcome was unknown.        mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) dosing remained unchanged.       No treatment details were reported.   This case was linked to MOD-2021-386839, MOD-2021-386949 (Patient Link).
Patient was inadvertently administered the Moderna vaccine before the age of 18. Patient and parent did not report any adverse effects following vaccination.
pt recv vax; adm to hosp w/ severe pain and inc neurological sx; after numerous testing , spinal tap confirmed GBS; transferred to hosp;spinal tab reveal inc protein;
after receiving the 1st dose of the COVID-19 vaccine,it was about 9 hours later before her right shoulder hurt; This is a spontaneous report from a Pfizer-sponsored program from a contactable nurse. A 42-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EJ1685), intramuscular in her right deltoid on 18Dec2020 at a single dose for COVID-19 immunization. Medical history was reported as none. There were no concomitant medications. It was reported that the patient received her first COVID-19 vaccine dose, the person who administered the shot used a 3-finger width distance from her right shoulder bone when administering the COVID-19 vaccine into her right deltoid muscle. She said after receiving the first dose of the COVID-19 vaccine, it was about 9 hours later before her right shoulder hurt. The outcome of the event was recovered on an unspecified date.
Left upper arm - swollen and red, warm to touch and tender. Client stated it hurts to use arm.
first dose/October 2020/ second dose December 2020/last week/HCP diagnosed her with shingles/ Suspected Vaccination failure; HCP diagnosed her with shingles; developed wet blisters on her right face/ have started to crust over and heal/not resolved completely.; crust over; This case was reported by a consumer via call center representative and described the occurrence of suspected vaccination failure in a 82-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis.   In December 2020, the patient received the 2nd dose of Shingrix. In October 2020, the patient received the 1st dose of Shingrix. On an unknown date, between 5 and 6 months after receiving Shingrix and between 7 and 8 months after receiving Shingrix, the patient experienced vaccination failure (serious criteria GSK medically significant), shingles, blister and crust. The patient was treated with valaciclovir hydrochloride (Valtrex). On an unknown date, the outcome of the vaccination failure was unknown and the outcome of the shingles was not recovered/not resolved and the outcome of the blister and crust were recovering/resolving.   It was unknown if the reporter considered the vaccination failure, shingles, blister and crust to be related to Shingrix and Shingrix.  Additional details were reported as follows: This case was reported by patient herself. Last week before reporting date, the patient developed wet blisters on her right face. The healthcare professional diagnosed her with shingles and started her on Valtrex. The patient stated that the blisters had started to crust over and heal but had not resolved completely. The reporter did not consent to follow-up. This case was considered as suspected vaccination failure as detail regarding laboratory test confirming herpes zoster was unknown at the time of reporting.
I have had muscle aches and tiredness since I had Covid-19 in April of 2020. The symptoms have gotten worse since I got the vaccine. The muscle aches were unbearable and I had a fever for the first two days. The aches and pains are still present after three months and they come and go at the moment. I have a constant ache in my legs as well as tiredness. These symptoms were present since my Covid-19 but they are worse than they were before the vaccine.
This spontaneous pregnancy report was received from a nurse refers to a 21 year old female patient. No concurrent condition or medical history was reported. On 26-MAY-2015, the patient was inadvertently vaccinated with M-M-R II (lot # K015374) (dose and route of administration not provided) when she was 20 weeks into her pregnancy (Last menstruation period was 05-JAN-2015). No treatment was given for the event. The patient was now 32 weeks pregnant. The outcome of the event was unknown. No product quality issue was involved. Additional information has been requested.