chrisvoncsefalvay/vaers-outcomes huggingface dataset:
patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion); patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion); This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion)) and POOR QUALITY PRODUCT ADMINISTERED (patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion)) in a 40-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion)) and POOR QUALITY PRODUCT ADMINISTERED (patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion)). At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion)) and POOR QUALITY PRODUCT ADMINISTERED (patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion)) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication was reported. The reporter was an internal medicine manager. It was reported that, there had been no power outages that would have impacted the Moderna vaccine. However, the healthcare professional reiterates that because her facility was unable to download the digital data logger, they would need to treat this issue as a temperature excursion. The data logger was unable to download for the months of Dec-2021, Jan-2022, and Feb-2022. They were filling out a temperature excursion assessment with the State at this time. It was reported that, no adverse reactions were reported by the patient. The reporter mentioned that the patient had been administered dose while the temperature excursion assessment was ongoing. The reporter also reported that, no adverse reactions were reported by the patient. No treatment medication was reported.
This prospective pregnancy case was reported by a nurse via call center representative and described the occurrence of vaccine exposure during pregnancy in a 27-year-old female patient who received BOOSTRIX (batch number 5MG55, expiry date 10th October 2016. On 15th June 2015, the patient received BOOSTRIX (intramuscular) .5 ml. The subject's estimated date of delivery was 19th July 2015. The subject received BOOSTRIX during the third trimester of pregnancy. On 15th June 2015, an unknown time after receiving BOOSTRIX, the patient experienced vaccine exposure during pregnancy and fever. In June 2015, the patient experienced injection site erythema and injection site induration. On an unknown date, the outcome of the vaccine exposure during pregnancy was unknown and the outcome of the fever and injection site erythema were recovered/resolved and the outcome of the injection site induration was not recovered/not resolved. The pregnancy was ongoing. It was unknown if the reporter considered the fever, injection site erythema and injection site induration to be related to BOOSTRIX. Additional information provided: the nurse reported that the patient received a dose of BOOSTRIX and experienced fever on the same day. Then the subject experienced redness at the injection site and a hard know at injection site (1 1/2 inch from the injection site). Patient went to the doctors office and was recovering. The AEs subsided except the hard knot that was not recovered.
I received the shot on Friday, by Saturday morning I had chills, sweats, temp-100.2 and achy leg and back muscles, mild headache too. After 5-6 days went to ER.
Pt claims she didn't remember leaving the Health Department after receiving her vaccinations. She went out to eat with a friend who stated she was acting different. Also she became very short of breath and couldn't breath. Son took her to the ER where they did a CT scan and found nothing wrong. She was unable to lay flat in bed for 5 days without feeling like she was drowning.
This spontaneous report was received from a healthcare professional referring to a 12 months old male patient. Information about the patient's medical history and concurrent conditions was not reported. On 23-SEP-2015, the patient was vaccinated with an improperly stored dose of VARIVAX lot # L008270, expiration date 11-MAR-2017, (dose and route of administration were not provided). Concomitant medication was not reported. No adverse effects were reported. This is one of several reports received from the same source. Additional information is not expected as all scheduled follow up information was received.
Hallucinations - vomiting - sweating - nausea - chills - muscle aches occurred about 24 hours after vaccination - fever.
Initial report was received 28 February 2011 from a health care professional. A 46-year-old female patient with no past medical history and no concurrent illness, had received an intramuscular right deltoid booster dose of IMOVAX Rabies, lot number E-0393-1 on 23 February 2011 during the AM, and four days later on 27 February 2011 during the AM, she developed leg and back aches, and a headache. Her temperature was 96 degrees. At the time of the report, the event did not require a doctor's visit and no corrective treatments were reported. Diagnostic and laboratory testing was not performed. Concomitant medications consisted of diet medications (not specified). The patient had previously received IMOVAX rabies vaccines in the past (number of doses not reported). Outcome was reported as unknown. Documents held by sender: None.
15 minutes after inoculation she developed obvious cutaneous flushing, pruritus, and hives with no other symptoms. She was initially given 50mg diphenhydramine PO. Approximately 45 minutes later she reported chest pain and her vital signs were checked and she was tachycardia at 102 BPM. Her BP was 128/74. EMS was activated and she was given 0.3mg of epinephrine IM after which her flushing  and pruritus immediately resolved. She described continued mild chest tightness but over stated that she felt much better.
I gave meningococcal menactra instead of meningococcal bexsero. There was no adverse reaction from the patient. I called and verified with the patients mom and she stated there was no reactions patient was experiencing. Patient will be following up in the office to get the correct vaccine.
Myalgia, Arthralgia, Left arm axilla lumpe noted, eraser head to pea in size, warmth at left upper arm injections site Narrative:
1st dose 19Oct2021, 2nd never; This case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in a 56-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received first dose on 19th October 2021).   On an unknown date, the patient did not receive the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the incomplete course of vaccination was unknown.   Additional Information: GSK receipt date: 30-Jan-2023 Reporter's comment: A pharmacist was looking for additional information for patient who wants to received Shingrix second dose after recommended Shingrix schedule. The reporter declined for the follow-up. This is for 1 of 2 linked patients reported by same reporter. Additional supportive information: Till the time of reporting, the patient did not receive second dose of Shingrix, which led to incomplete course of vaccination.; Sender's Comments:  US-GSK-US2023014284:Same reporter
Received Pneumovax vaccine on 3/8/07 and called on 3/9/07 c/o Lt arm swelling at injection site and rash at site w/ some discomfort. Took Tylenol and slept well.  Woke up on 3/9/07 and had increased swelling of entire left arm from shoulder to elbow, skin on arm was red and splotchy. Instructed patient to come to office for doctor to evaluate.  He assessed patient and instructed patient to use ice, elevate, and use tylenol and benadryl and to contact us if no improvement.
This spontaneous report as received from a pharmacist refers to a 55 year old female patient. The patient's drug reactions/allergies included macrolide antibiotics, fluoroquinolones, sulfa antibiotics, lidocaine, and codeine. On 13-NOV-2013, the patient was vaccinated with a dose of PNEUMOVAX23 (lot # J007786, exp date 25-SEP-2014), (route, dose and strength not reported). On 13-NOV-2013, approximately 30 to 45 seconds after the PNEUMOVAX23 was administered the patient "slumped over in a chair and exhibited seizure like activity". The seizure like activity lasted about 1 minute and patient was in and out of consciousness. The patient then exhibited seizure like activity again for an unspecified period of time at which point an unspecified ambulance was called and the patient was taken to hospital. The pharmacist stated that the patient was given oxygen by the ambulance squad. It is unknown if the patient was admitted to the hospital. The outcome of the events was unknown. The patient had unspecified adverse reactions to unspecified flu vaccines in the past (Captured in MARRS#1311USA008340). Additional information has been requested.
Patient is immunocompromised and did not receive his third full dose; Heart attack; Legs went out from under him could not get out of bed; Soreness in left arm injection site; This spontaneous case was reported by a consumer and describes the occurrence of MYOCARDIAL INFARCTION (Heart attack) in a 68-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 013A21A and 021M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Immunocompromised and Fibromyalgia (Chronic fatigue syndrome with fibromyalgia).   On 04-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 04-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 04-Mar-2021, the patient experienced MOBILITY DECREASED (Legs went out from under him could not get out of bed) and INJECTION SITE PAIN (Soreness in left arm injection site). On 07-Mar-2021, the patient experienced MYOCARDIAL INFARCTION (Heart attack) (seriousness criterion medically significant). On an unknown date, the patient experienced PRODUCT DOSE OMISSION ISSUE (Patient is immunocompromised and did not receive his third full dose). At the time of the report, MYOCARDIAL INFARCTION (Heart attack), MOBILITY DECREASED (Legs went out from under him could not get out of bed) and INJECTION SITE PAIN (Soreness in left arm injection site) outcome was unknown and PRODUCT DOSE OMISSION ISSUE (Patient is immunocompromised and did not receive his third full dose) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medication list was not provided. Treatment information was not provided.  Patient was not hospitalized. Patient was not diagnosed with myocarditis or pericarditis. Patient did not have a history of a COVID-19 infection.  Patient was immunocompromised and did not receive third full dose of the Moderna COVID-19 vaccine as third dose in primary Moderna COVID-19 series.  COMPANY COMMENT ; This spontaneous case concerns a 68-year-old male patient with no medical history reported, who experienced the serious unexpected AESI event of myocardial infraction which occurred 3 days after second dose of mRNA-1273.At the time of report event outcome unknown. The benefit-risk relationship of the mRNA-1273 vaccine is not affected by this report.   This case was linked to MOD-2022-473727 (Patient Link).; Sender's Comments: This spontaneous case concerns a 68-year-old male patient with no medical history reported, who experienced the serious unexpected AESI event of myocardial infraction which occurred 3 days after second dose of mRNA-1273.At the time of report event outcome unknown. The benefit-risk relationship of the mRNA-1273 vaccine is not affected by this report.
Janssen COVID19 Vaccine EUA Fever of 102, chills, body aches. lasted about 6 hours, resolved with sleep and tylenol PM.
can't move my arm."/I can't swim; This spontaneous case was reported by a consumer and describes the occurrence of MOBILITY DECREASED (can't move my arm."/I can't swim) in a 23-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 20-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 20-Mar-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced MOBILITY DECREASED (can't move my arm."/I can't swim). At the time of the report, MOBILITY DECREASED (can't move my arm."/I can't swim) had resolved.        mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosing remained unchanged.       No concomitant medications reported  Treatment information was not provided.   This case was linked to MOD-2021-267751 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 27-Jul-2021: Event outcome updated.
Day of vaccine - cold chills withing hours, followed by 103-106 body fever and only 99 forehead fever, flu like symptoms for 3 days. Within a month from the vaccine started experiencing mild nausea and motion sickness while driving to work, and eyesight focusing issues. Symptoms were mild enough, didn't go to doctor. Saw an eye doctor in 2022 and found no issues. Symptoms continued to get worse and be more consistent (motion sickness and nausea). Starting summer 2022 until Jan 2023 started experiencing "pulled muscle feeling" in the back, lats and chest with pain and shortness of breath. Thought it was due to workouts. Pain worsened in Jan/Feb 2023, diagnosed with irregular heartbeats and 31% PVC. Had heart ablation in April 2023 with no prior family history of heart issues. Since then, continued having worse, debilitating motion sickness, nausea during drivers and flights. Also started having anxiety, claustrophobia, tinitus and headaches. Continued having dizziness, eye focusing issues, body shakes for no reason. Seeing various specialists (GI, neurologist, ENT) with no answers and no treatment.
PATIENT RECEIVED JANSSEN VACCINE AT 17 YEARS AND 8 MONTHS OLD.
mild headache; arm soreness; swelling; pain; This spontaneous case was reported by a consumer and describes the occurrence of HEADACHE (mild headache), MYALGIA (arm soreness), SWELLING (swelling) and PAIN (pain) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event.   On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1. On an unknown date, the patient experienced HEADACHE (mild headache), MYALGIA (arm soreness), SWELLING (swelling) and PAIN (pain). The patient was treated with IBUPROFEN at an unspecified dose and frequency. At the time of the report, HEADACHE (mild headache), MYALGIA (arm soreness), SWELLING (swelling) and PAIN (pain) outcome was unknown.            Concomitant medications were not provided   Reporter did not allow further contact
Physician ordered HPV9 but immunization nurse administered Hep A. This error became evident during documentation. Dr. contacted patient's guardian to inform her of administration error and advised  guardian to RTC with patient to get HPV9 vaccine.
Swelling to 10 cm 1 - 3 days post vaccine.  Day four 2.5 cm lump noted in sub Q.
I went to bed at 9:00 pm on May 7th feeling ok.  Then at about 1:00 am I woke up and felt like I was buzzing, I ached all over and I was wide awake and could not sleep for about 3 hours.  I took some IBProfin and went to bed.  I slept until 8:30 in the morning.  At that time the buzzing had stopped and but I still felt achy all over.  I was also tired.  I felt like that all  the rest of the day on May 8th.  That night I went to bed around 9:00 pm and slept in until 7:00 am.  This whole time my left arm where vaccine was given was sore when I lifted my arm. On May 9th I felt fine.
I had an arthritis flare on 10/16/2021 that was extremely more severe than any I have had during 20 years of diagnosis.  All my joins became inflamed and swollen.  My Rheumatologist had to inject steroids in both knees and left shoulder.  Extreme fatigue and body aches.  This affected joints that had never been inflames before.  It lasted almost 2 months. Usual pain medication did not help at all.  The is the first time I have and an event this severe.
vax was given in lt deltoid on 13DEC93; pt was seen on 16DEC93 w/reddish, sl swollen area @ the inject site; site was sl warm to touch; dx DTP react;
Starting 2 Weeks after the 3 shot (Booster).  Hands began to itch, then arms and up the back of the scalp.  Hives like symptoms appeared.  Lightheadedness.  A feeling of spasm in the esophagus at the throat and upper abdomen like something like a pill stuck in the esophagus.  Went to Urgent care for Hives and lightheadedness.  Was told to take an antihistamine for hives.  Esophagus progressed later that day and was more persistent than in the morning.  Went to the hospital for evaluation.  Blood work, EKG, Sonogram, Chest x-ray.  All looked normal.  Was given Prilosec and Lidocaine and was sent home.  Spasms seem to subside after this.  Hives and itching and hyperpigmentation of skin lasted for another 5-6 weeks but, was managed by antihistamines.
This case was reported by a consumer and described the occurrence of intestinal problems in a female patient who received ADVAIR unspecified inhaler device for an unknown drug indication. A physician or other health care professional has not verified this report. Co-suspect included unknown (Concurrent medications). On an unknown date, the patient started Fluticasone propionate+salmeterol xinafoate (inhaled), unknown dosing. At an unknown time after starting Fluticasone propionate+salmeterol xinafoate, the patient experienced intestinal problems, digestion problem, urinary infection, cramp and decreased bowel movements. At the time of reporting, the outcome of the events was unknown. The report was received via monitoring of online GSK. The patient said she has a lot of problems with digestion and bowels and feels there is a huge problem there. She had a "scope" performed and no obstruction was found but she was still having severe cramps and weeks without a bowel movement. The patient said her physician discusses all her conditions with her. The physician said the medications that she takes causes urinary infections which she has quite frequently. She said a urologist said the medications were causing the infections. Follow-up information was received via the consumer (the patient) via GSK on 30 December 2012. The patient reported that she "had a very bad episode of exaspiration (exasperation: unspecified event) which placed me into the hospital for eight days." No further detail was provided. Follow-up information was received via the consumer (the patient) via GSK on 21 February 2013. The patient reported "my husband and I both got the flu shot in November and I got the pneumonia shot three years ago. Well, I went into the hospital two weeks ago with pneumonia for eight days and came home and was home for three days and he came down with the flu. He is not allowed around me at all. If I get the flu I am going to get it ten times worse so, we are really trying to avoid it as much as possible this year has been really bad because of this crazy weather pattern". For the husband's case please see case A1014087A.
itching in her body; very very itchy and keeps getting worse; She wakes up 28 times in the night, scratching; This spontaneous case was reported by a consumer and describes the occurrence of PRURITUS (itching in her body), CONDITION AGGRAVATED (very very itchy and keeps getting worse) and INSOMNIA (She wakes up 28 times in the night, scratching) in a 40-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 053C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 22-Jul-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PRURITUS (itching in her body), CONDITION AGGRAVATED (very very itchy and keeps getting worse) and INSOMNIA (She wakes up 28 times in the night, scratching). At the time of the report, PRURITUS (itching in her body), CONDITION AGGRAVATED (very very itchy and keeps getting worse) and INSOMNIA (She wakes up 28 times in the night, scratching) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant product use was not provided. Treatment information was not provided.
Entire right arm hot, red with sharp demarcation of erythema consistently with cellulitis (right arm).
On 09/04/2002 got DPTa right ant. thigh- that evening mom noted knot at site. child scratching site- has 12cm x 12cm area of induration on right thigh with 13cm x 15cm area of erythema. Warmth + tenderness multiple areas of excoration. Full range of motion/no joint swelling. Examined by DR. seen in ER 09/05/2002. Treated with Keflex and Motrin. Admitted to hospital for right thigh cellulitis.
Tinnitus & 12% hearing loss in the left ear and 24% hearing loss in the right ear.
pt recv vax 29APR99 & 3MAY99 report T9.5 & local rxn @ inj site;prescribed APAP;pt mom called back later-pt had temp 104.5 MD prescribed tepid bath& start alternating Ibuprofen & APAP;
Narrative: Veteran is a 78 year old male who received his first dose of the Moderna COVID-19 vaccine on 2/9/2021 without repot of complications. He received his second dose of the Moderna COVID-19 vaccine on 3/6/2021. On 3/9/2021, the patient reported having a severe nose bleed the previous night from both nares. He reported that he packed his nose without much benefit and felt as  though the blood was "draining down the back of his throat." Bleeding has subsided by the morning and he was able to breath through both nares at the time of the call with RN. He denied a significant history of epistaxis, stating he has only had 4 events in his lifetime that he can remember. He utilizes Clopidogrel 75mg daily but no other medication with significant increase in bleeding risk.
pt recvd vax 20APR94 & acute torticollis 27APR94;sx ataxia around on JUN94