chrisvoncsefalvay/vaers-outcomes huggingface dataset:
INAPPROPRIATELY STORED VACCINE ADMINISTERED; OUT OF SPECIFICATION PRODUCT USE; This spontaneous report received from a pharmacist 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 admin, and batch number were not reported) dose was not reported, administered on 09-APR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On 09-APR-2021, the patient experienced out of specification product use. On an unspecified date, the patient experienced inappropriately stored vaccine administered. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the inappropriately stored vaccine administered and out of specification product use was not reported. This report was non-serious.
Initially felt lightheaded, and "weird" sensations throughout head/neck area, intermittent headache, legs were elevated, fluid intake, all symptoms had improved, and client ambulated on her own to front office, 2 hrs later she complained of chest pain, initally sharp, mid/left anterior chest with radiation to mid back, no shortness of breath, diaphoresis, jaw/neck pain, or difficulty breathing.  All vital signs stable, emergency services called for further evaluation, client take to nearest hospital via EMS.
Systemic itching - head to toe and mild overall muscle fatigue. I started using BENADRYL about 12 hours after injection. By day three I was using maximum dose printed on OTC label. By day four the itching was subsiding but I still have mild itching on arms, legs and torso.
Hard lump formed in the arm as well as red non-raised rash radiating from the injection site.
THE COOLER WENT OUT OF RANGE A COUPLE OF TIMES (IT DROPPED DOWN FROM 3 TO 4 AM TO JUST BELOW 2 C FOR 5 TO 10 MINUTES, THEN FROM 6 TO 8 AM, IT WENT DOWN TO 0C FOR 30 MINUTES TO 1 HOUR, THEN AROUND 10 TO 11 AM, IT DROPPED TO -0.8 C ANOTHER 20 MINUTES,; OUT OF SPECIFICATION PRODUCT USE; This spontaneous report received from a pharmacist concerned multiple patients.  No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1821286, and expiry: UNKNOWN) dose was not reported, administered on 27-AUG-2021 for prophylactic vaccination. No concomitant medications were reported. On 27-AUG-2021, the patient experienced the cooler went out of range a couple of times (it dropped down from 3 to 4 am to just below 2 c for 5 to 10 minutes, then from 6 to 8 am, it went down to 0c for 30 minutes to 1 hour, then around 10 to 11 am, it dropped to -0.8 c another 20 minutes, then around 8 pm it went below 2c. total duration of out of range is 2 hours and 11 minutes). On 27-AUG-2021, the patient experienced out of specification product use. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the the cooler went out of range a couple of times (it dropped down from 3 to 4 am to just below 2 c for 5 to 10 minutes, then from 6 to 8 am, it went down to 0c for 30 minutes to 1 hour, then around 10 to 11 am, it dropped to -0.8 c another 20 minutes, then around 8 pm it went below 2c. total duration of out of range is 2 hours and 11 minutes) and out of specification product use was not reported. This report was non-serious.
Break through rash secondary to immunization. Treatment rec. Benadryl 1/2 tsp po QID. Approx. 6 lesions noted on patient.
severe, aches, chills, felt feverish, h/a, stomach upset. Took tylenol.
This spontaneous report was received from a other health professional referring to a patient of unknown age and gender. Medical history and current conditions were not reported. On 10-MAR-2016, the patient was vaccinated with improperly stored dose of RECOMBIVAX HB (dose, frequency, route of administration and indication were not reported; lot # L023387 with expiration date: 22-JUN-2017). Concomitant therapy was not reported. No adverse effect reported. This is one of several reports received from the same reporter. Additional information has been requested.
mom stated 13MAR96 p/6PM rt thigh redness & swelling littler larger than a half dollar;14MAR96 same during am;14MAR96 6PM larger called clinic;715PM rt thigh red,warm,sl edema 4 1/2in cir;instructed to give pt APAP;
Systemic: Dizziness / Lightheadness-Severe, Systemic: Fainting / Unresponsive-Severe, Systemic: Nausea-Medium, Systemic: Vomiting-Mild
got the shingle shot and still got the shingles/Suspected vaccination failure; shingles; This case was reported by a consumer via media and described the occurrence of suspected vaccination failure in a adult patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure and shingles were unknown.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine.  Additional details were provided as follows: Age group was captured as adult as per vaccine indication. The age at vaccination was not reported. The reporter knew someone who got the shingle shot and still got the shingles, what's up with that. This case was considered as suspected vaccination failure since details regarding completion of primary vaccination schedule, time to onset and laboratoy test confirming shingles were not provided.
Mucular pain Achy Joint pain Headache Injection site pain that radiated whole right arm
Adverse reaction to the vaccine started with variable weakness beginning 1/29/2021.  On 1/30/21 around 8:30pm, he needed assistance in the bathroom related to weakness and had what was later identified as a stroke with left side weakness and slurred speech.  In accordance with his wishes, he had care at home.  Due to his advanced age and frailty, a CT scan was not pursued.  The 325 mg of aspirin that he was previously taking daily was discontinued.  After the stroke, he needed total care. Hospice was established at home.  Nursing assistant care was delivered by daughter.  Death followed 9 days later (2/9/2021).
Left arm is warm, tight and itchy, from shoulder down to elbow. Has red welts. Started itching after injection given. Other signs started that night.
Pt reports after one week below injection site (L) deltoid that radiates down to index finger & middle finger is painful and tingling and this makes it difficult for him to sleep.
Diarrhea; Weakness; High and low blood pressure; High and low blood pressure; This spontaneous case was reported by a consumer and describes the occurrence of DIARRHOEA (Diarrhea), ASTHENIA (Weakness), HYPERTENSION (High and low blood pressure) and HYPOTENSION (High and low blood pressure) in an 86-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 004M20A) for COVID-19 vaccination.     The patient's past medical history included No adverse event.    On 17-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 24-Feb-2021, the patient experienced DIARRHOEA (Diarrhea), ASTHENIA (Weakness), HYPERTENSION (High and low blood pressure) and HYPOTENSION (High and low blood pressure). At the time of the report, DIARRHOEA (Diarrhea), ASTHENIA (Weakness), HYPERTENSION (High and low blood pressure) and HYPOTENSION (High and low blood pressure) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       The patient's medical history was not provided.Concomitant medications was not provided by the reporter. Treatment details included Pedialyte 1L per day, Loperamide 2mg.
feels cold; weak; chills; nauseated this morning; This spontaneous case was reported by a consumer and describes the occurrence of NAUSEA (nauseated this morning), CHILLS (chills), NASOPHARYNGITIS (feels cold) and ASTHENIA (weak) in a 70-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 024M20A) for COVID-19 vaccination.     The patient's past medical history included No adverse event.    On 28-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 29-Mar-2021, the patient experienced NAUSEA (nauseated this morning), CHILLS (chills), NASOPHARYNGITIS (feels cold) and ASTHENIA (weak). At the time of the report, NAUSEA (nauseated this morning), CHILLS (chills), NASOPHARYNGITIS (feels cold) and ASTHENIA (weak) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant product use was not provided by the reporter. Treatment information was not provided.
Pt administered Pneumovax PPV 23 vaccine 0.5mL SC x 1. Pt experienced local reactions outside of normal. Pt experienced severe redness and pain at inj site. Malaise and increased temp reported. Temp was not recorded.
I only had hives and I decided to go to the doctor. I had it for 4 days and it stopped and I also changed fabric softeners and I was going to school and working two jobs so they did not know if it was only because of too much stress. But they said they were 100% sure it was not because of the vaccine. They only prescribed amoxicillin and another antibiotic.
Pain at site after initial injection, which resolved after about 4 days (on the 16th). On night of 1/20 (8 days after vaccination site became erythematous, pruritic, and felt "like a mosquito bite, but it was deep." The sensation of swelling has decreased but erythema and pruritis remain. No respiratory s/s, no GI s/s. No other rashes.  Only med taken was ibuprofen the day of the vaccination.  Referred to PCP for further eval; vaccination was completed at work clinic.
Vaccine stored in refrigerator on 11/17/2021, expired product 12/19/2021, administered date on 01/11/2022; 606 doses were given after expiration date; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (606 doses were given after expiration date) and PRODUCT STORAGE ERROR (Vaccine stored in refrigerator on 11/17/2021, expired product 12/19/2021, administered date on 01/11/2022) in a 45-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 004C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 11-Jan-2022, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 11-Jan-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (606 doses were given after expiration date). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Vaccine stored in refrigerator on 11/17/2021, expired product 12/19/2021, administered date on 01/11/2022). At the time of the report, EXPIRED PRODUCT ADMINISTERED (606 doses were given after expiration date) and PRODUCT STORAGE ERROR (Vaccine stored in refrigerator on 11/17/2021, expired product 12/19/2021, administered date on 01/11/2022) outcome was unknown.  For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. No concomitant medications were reported. On 17-Nov-2021, the vial was initially stored in the refrigerator. The Vial did not go undergo any temperature excursion. The patient had no any adverse event post administration of expired vaccine.  Treatment information was not provided.
syncope event; anaphylaxis; profuse sweating; low BP (63/42),; heart rate was in the 150 range; vomitting; This case was reported by a nurse via sales rep and described the occurrence of presyncope in a adult male patient who received Men B NVS (Bexsero) for prophylaxis.   On an unknown date, the patient received the 1st dose of Bexsero. On an unknown date, 15 min after receiving Bexsero, the patient experienced presyncope (serious criteria GSK medically significant), anaphylaxis (serious criteria GSK medically significant), sweating, low blood pressure, heart rate increased and vomiting. The patient was treated with epinephrine. On an unknown date, the outcome of the presyncope was recovering/resolving and the outcome of the anaphylaxis, sweating, low blood pressure, heart rate increased and vomiting were unknown.   It was unknown if the reporter considered the presyncope, anaphylaxis, sweating, low blood pressure, heart rate increased and vomiting to be related to Bexsero.  Additional case details were reported as follows: The age at vaccination was not reported. The patient had a near syncope event accompanied by vomiting, profuse sweating, very low BP (63/42), heart rate was in the 150 range. The physician administered 0.3 mg of epinephrine intramuscularly and administered oxygen and patient started to recover and eventually transferred to hospital.  The patient was treated for anaphylaxis in the emergency department (ED) and discharged.      Lab Comments: The lab testes were performed on an unknown date.
This case was reported by a nurse via sales rep and described the occurrence of vomiting in a 16-year-old male patient who received BEXSERO (batch number 169821, expiry date unknown). Concomitant products included FLUZONE. On 6th November 2017, the patient received BEXERO (intramuscular) .5 ml. On 7th November 2017, 1 days after receiving BEXSERO, the patient experienced vomiting and chills. On an unknown date, the outcome of the vomiting and chills were unknown. The reporter considered the vomiting and chills to be unlikely related to BEXSERO. Additional details were reported as follows: The age at vaccination was not reported. The patient received BEXSERO on right arm and FLUZONE on left arm. The patient experienced vomiting and chills approximately 24 hours after vaccination with BEXSERO and FLUZONE. The patient's physician did not thaught that this was related to BEXSERO. No follow-up visit was required.
This case was reported by a nurse via call center representative and described the occurrence of anaphylactic reaction in a patient who received FLULAVAL QUADRIVALENT. This case was associated with pharmaceutical product complaint. On an unknown date, the patient received FLULAVAL QUADRIVALENT at an unknown dose. On an unknown date, unknown after receiving FLULAVAL QUADRIVALENT, the patient experienced anaphylactic reaction (serious criteria GSK medically significant), wrong injection technique, syringe leak and pharmaceutical product complaint. On an unknown date, the outcome of the anaphylactic reaction, wrong injection technique, syringe leak and pharmaceutical product complaint were unknown. It was unknown if the reporter considered the anaphylactic reaction to be related to FLULAVAL QUADRIVALENT. Additional details were provided as follows: The patient had to receive the shot three times (due to leakage), which led to wrong injection technique. The patient developed an unspecified anaphylactic reaction although they received the flu vaccine yearly. This case was associated with pharmaceutical product complaint. No further information was reported regarding the event.
This spontaneous report as received from a healthcare worker (certified medical assistant) refers to a patient of unknown demographics. No concurrent conditions or medical history were provided. On an unknown date, the patient was vaccinated with a dose of PEDVAXHIB injection (strength, dose, frequency, route of administration, indication, lot# and expiry date unspecified), that was exposed to temperatures outside of the proper storage range. No concomitant medications were reported. No adverse effect was reported. Additional information has been requested.
No significant history Of throwing up. 30 minutes after the shot I threw up on the way home and have been nauseous since
w/in 24 hrs of inject, pt spiked fever of 104.4; mom states ached all over & had h/a; examined ears, throat, chest clear; no rash;
This case was reported by a other health professional and described the occurrence of inappropriate age at vaccine administration in a 5-year-old female patient who received HAVRIX adult (batch number 59D74, expiry date 5th February 2016). On 15th May 2014, the patient received HAVRIX adult. On an unknown date, an unknown time after receiving HAVRIX adult, the patient experienced inappropriate age at vaccine administration and accidental overdose. On an unknown date, the outcome of the inappropriate age at vaccine administration and accidental overdose were unknown.
Uncontrolled cough over a week come in night and it's hard and dry; Lethargic feeling no desire to do anything; Congestion in head; No desire to eat; Sore throat; Sore arm; Fever on and off around 98 degree; Chill on and off; Headache; This spontaneous case was reported by a consumer and describes the occurrence of COUGH (Uncontrolled cough over a week come in night and it's hard and dry), LETHARGY (Lethargic feeling no desire to do anything), HEAD DISCOMFORT (Congestion in head), DECREASED APPETITE (No desire to eat) and OROPHARYNGEAL PAIN (Sore throat) in a 68-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011421A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medical history was provided by the reporter. .  Concomitant products included HYDROCHLOROTHIAZIDE for Hypertension, VITAMINS NOS for an unknown indication.    On 26-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 27-Feb-2021, the patient experienced COUGH (Uncontrolled cough over a week come in night and it's hard and dry), LETHARGY (Lethargic feeling no desire to do anything), HEAD DISCOMFORT (Congestion in head), DECREASED APPETITE (No desire to eat), OROPHARYNGEAL PAIN (Sore throat), PAIN IN EXTREMITY (Sore arm), PYREXIA (Fever on and off around 98 degree), CHILLS (Chill on and off) and HEADACHE (Headache). At the time of the report, COUGH (Uncontrolled cough over a week come in night and it's hard and dry), LETHARGY (Lethargic feeling no desire to do anything), HEAD DISCOMFORT (Congestion in head), DECREASED APPETITE (No desire to eat), OROPHARYNGEAL PAIN (Sore throat), PAIN IN EXTREMITY (Sore arm), PYREXIA (Fever on and off around 98 degree), CHILLS (Chill on and off) and HEADACHE (Headache) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No treatment information was provided.
Narrative:  Per note on 8-12-21, "Patient declined scheduled  shingles vaccine stating he ran a fever of 102 with the last one".
Mother called, patient had nausea and abdominal pain x 2 days after recieving injection.
Headache, dizziness, nausea, diarrhea, exhaustion the injection was at approximately 11:00 a.m. and symptoms started at approximately 2:00 p.m. gradually getting worse until 10:00 a.m. the next day and symptoms then started subsiding and we're non-existent at approximately 6:00 p.m.
Day 2 post vaccine, I experienced severe chills throughout the day.  Onset upon waking up.  I felt like I could not get warm at all, and flu-like symptoms up until around 4pm day 2.  Then it turned to a fever and felt very flushed.  I was irritable and lack of patience.  Day 3 I was back to about 95%.  I did take acetaminophen to ease the day.
Suspect COVID breakthrough case Admitted for Left PICA aneurysm rupture- positive for COVID as well
Case number PHEH2013US021426 is an initial spontaneous report received from a physician on 08 Oct 2013: This report refers to a 29-year-old female patient. Her vaccination history included administration of two flu vaccines following which she experienced aches and pains (see related cases: PHEH2013US021218 and PHEH2013US021425). She was further on vaccinated with another seasonal influenza vaccine (manufacturer and batch number: unknown) on an undetermined date the following year and experienced aches and pains. The patient recovered on an unknown date. No further information about seriousness and causality was mentioned.
Itching started on the right side of the body from shoulder to foot; having no energy and could hardly move; felt not his best/terrible and sick described as having no energy and could hardly move; headache suspected as migraine headache; sore arm muscle near the injection site; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (sore arm muscle near the injection site), ILLNESS (felt not his best/terrible and sick described as having no energy and could hardly move), MIGRAINE (headache suspected as migraine headache), PRURITUS (Itching started on the right side of the body from shoulder to foot) and ASTHENIA (having no energy and could hardly move) in a 75-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Drug allergy (Allergic to Benadryl), Penicillin allergy and Blood pressure (Patient is taking bloodpressure medication.). Concomitant products included FINASTERIDE and TAMSULOSIN for an unknown indication.    On 26-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 26-Feb-2021, the patient experienced PAIN IN EXTREMITY (sore arm muscle near the injection site). On 27-Feb-2021, the patient experienced ILLNESS (felt not his best/terrible and sick described as having no energy and could hardly move), MIGRAINE (headache suspected as migraine headache) and ASTHENIA (having no energy and could hardly move). On 28-Feb-2021, the patient experienced PRURITUS (Itching started on the right side of the body from shoulder to foot). On 28-Feb-2021, MIGRAINE (headache suspected as migraine headache) had resolved. On 04-Mar-2021, ILLNESS (felt not his best/terrible and sick described as having no energy and could hardly move) and ASTHENIA (having no energy and could hardly move) had resolved. On 05-Mar-2021, PAIN IN EXTREMITY (sore arm muscle near the injection site) and PRURITUS (Itching started on the right side of the body from shoulder to foot) had resolved. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant Product includes Blood Pressure Medication.   Treatment includes rubbing alcohol to the itching areas.   Reporter did not allow further contact
I had muscle spasms and trouble walking before I got the vaccine. I gave it some time. The morning before I had a light headache. After the vaccine my headache, and muscle spasms  got worse. It lasted for days. Yesterday the headache was a little less. As of this morning my neck was hurting. Thursday and Friday the headache did not go away at out. Saturday it was coming and going. I was trying to put ice on it and run the water from the shower on it. Thursday , Friday and Saturday I was vomiting.  Friday I went to Urgent Care, the doctor said a lot of patients were complaining about headaches. She gave it a few days. On the 15th of this week I seen my primary doctor, she said the same thing.
Fever spiked unexpectedly, treated with Tylenol only at first.  Had febrile seizure that lasted 1 minute at 6:30 PM on Jan. 1.  Stopped breathing due to aspiration from vomit during seizure.  Taken by ambulance to hospital where he recovered normally and, to date, is fine although still with high fever to treat.
Extreme pain at injection site for two days after shot, now has diminished.  Extreme tiredness for several days after the shot, general feeling  like I'm coming down with something since about 8 hours after the injection.  On Saturday broke out in cold sores.  No fever, slight chills.  Feel slightly better today but wanted to report this as I have never had any reaction to any vaccine before.  This was my first dose; I go back for my second shot on 28 April.