chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Inadvertently given a dose of Infanrix instead of Boostrix / 24 yo; Inadvertently given a dose of Infanrix instead of Boostrix / 24 yo; This case was reported by a other health professional via call center representative and described the occurrence of inappropriate age at vaccine administration in a 24-year-old male patient who received DTPa (Infanrix) (batch number 7EC55, expiry date 29th April 2023) for prophylaxis.   Co-suspect products included dtpa vaccine pre-filled syringe device (Infanrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 6th August 2021, the patient received Infanrix and Infanrix Pre-Filled Syringe Device. On 6th August 2021, unknown after receiving Infanrix and Infanrix Pre-Filled Syringe Device, the patient experienced inappropriate age at vaccine administration and wrong vaccine administered. On an unknown date, the outcome of the inappropriate age at vaccine administration and wrong vaccine administered were unknown.     This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.  Additional details provided were as follows: The age at vaccination was not reported. Office administrator reported that patient was inadvertently administered a dose of Infanrix instead of Boostrix which led to wrong vaccine administered and inappropriate age at vaccine administration. No further details provided at time of call. Consent given for safety to follow up via letter in the mail. The reporter Consented to follow up. This case was linked with the case US2021168394 and US2021168395 by same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021168394:same reporter US-GLAXOSMITHKLINE-US2021168395:same reporter
vaccinator drew pt's 0.3 mL dose prior to her seating. As I was penetrating pt's skin with the needle, the hub malfunctioned and the needle independently retracted partway. Vaccinator withdrew the needle without finishing the administration of the dose, and pt reported feeling the vaccine running down her arm as needle was withdram. Half of the dose remained in the syringe, which then was placed in the sharps container. Vaccinator wiped a few drops of the vaccine from pt's arm with a tissue, and then prepared another 0.3 mL dose, which was administered to pt thereafter. Patient sent pt to the EMT for 15 minutes of observation. I informed Lead RN  what occurred. Lead RN spoke with pt to assess how she was feeling before she left
Seizure with fever of 99.6, vomiting, heavy sweating, ct scan, U/A lab done.  Dilantin 100 mg given. Seizure activity started at 12:00 a.m. until morning.  Pt doesn't remember.
uncontrolable screaming for greater than 2 1/2 hrs; family had given APAP didn't help; MD ok'd Motrin;
Iowa Department of Health called today 9/10 - to notify us that on March 24th, 2021 patient had received a dose of the Johnson and Johnson Covid shot.
At the time of injection there was severe burning and stinging pain, also upon removing the needle it was still burning and stinging and it caused me to scream. Following that I had pain and swelling at the injection site as well as pain and swelling in my arm pit as well as pain in my neck and left jaw. I also had a headache. This was ongoing and I called for  medical help on 08/04/2022 and I was off work from 08/01/2022 to 08/08/2022. Then on 08/08/2022 I experienced shortness of breath talking, and then on 08/10/2022 I had a sore throat on right side and my right nostril was running, and I took off work on that day as well, but it got better that day. I gargled with peroxide and felt better, I was just fatigued, but did not go in the office. I returned to work on August 11, 2022 symptom free but at night the symptoms started again and then today 08/12/2022, the sore throat on the right side returned and I am off work again. I will be taking an at home COVID-19 test or going to urgent care.  I just wanted to also update you to say that I may have been exposed to COVID-19 due to my job being a hot spot and cluster for the COVID 19 virus in the office itself and it has been that way since July of 2022.
Patient reported on 11/16/18 that he has had soreness in left arm since 10/15/18.
Got Tdap at Physical 1-17-2018 No adverse reaction. Got Tdap 8-29-2017 ADACEL U5748AA Sanofi.
BRIEF OVERVIEW: Admission Date: 8/2/2023 Discharge Date: 8/4/2023 Discharge Disposition:  home health care svc      Active Issues Requiring Follow-up: Hyponatremia ?  No future appointments.   DETAILS OF HOSPITAL STAY: PRESENTING PROBLEM: Generalized weakness [R53.1] COVID-19 [U07.1]   HOSPITAL COURSE: Patient presented to the ED on 8/2/2023 with concerns for brief loss of consciousness, bilateral lower limb weakness, seizure like activity and possible facial droop on the left side. Blood pressure at presentation was 194/76. NIH 4.    We admitted for Loss of consciousness with possible left sided facial drop and seizure like activity: CT of the head showed no acute process. CTA showed high grade stenosis of the proximal right ICA and left common carotid and vertebral artery.  We consulted neurology they recommended aspirin 81mg, permissive hypertension,  MRI of the brain with and without contrast and continuous EEG. Both showed no acute process. We started patient on continuous telemetry and echo which shows LVEF of 62%. We also started patient on ASA + Plavix x 90 days, then ASA thereafter.   Patient also complained of Generalized weakness and multiple falls at home. We ordered MRI lumber spine to rule out stenosis. No high-grade spinal canal stenosis was seen but there was multiple Mild to moderate stenosis of the neural foramina. PT/OT /SLP were consulted. They saw patient and recommended patient be discharged into skilled nursing facility. Patient preferred to be home with family.   Patient has Hyponatremia on admission we discontinue the HCTZ medication he uses at home and we gave saline bolus and it improved. Blood sodium dropped the next day so we discharged patient home with sodium chloride salt and ordered a repeat lab in 2 days. We cc the PCP so that result could be followed-up. Patient examined today and discharged in stable condition. Follow-up instruction given to patient
pain at the injection site; rash at the injection site; heat at the injection site; oral herpes simplex virus; Fever; tremors; shivers, chills; mylasis; joint pain; muscle soreness; loss of appetite; diarrhea; upset stomach; weakness; tiredness; This case was reported by a consumer via call center representative and described the occurrence of injection site pain in a 55-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   The patient's past medical history included herpes simplex oral. Previously administered products included Shingrix with an associated reaction of pyrexia (received 1st dose on 28th July 2022 and also experienced nausea, appetite absent, muscle pain, pain in arm, swollen lymph nodes, headache and malaise, refer case US2022112840).   On 21st October 2022, the patient received the 2nd dose of Shingrix. In October 2022, less than a week after receiving Shingrix, the patient experienced injection site pain, injection site rash, injection site warmth, herpes simplex oral, fever, tremor, shivers, malaise, joint pain, myalgia, appetite lost, diarrhea, upset stomach, weakness and tiredness. Rechallenge with Shingrix was positive. On an unknown date, the outcome of the injection site pain, injection site rash, injection site warmth, herpes simplex oral, fever, tremor, shivers, malaise, joint pain, myalgia, appetite lost, diarrhea, upset stomach, weakness and tiredness were not recovered/not resolved.   It was unknown if the reporter considered the injection site pain, injection site rash, injection site warmth, herpes simplex oral, fever, tremor, shivers, malaise, joint pain, myalgia, appetite lost, diarrhea, upset stomach, weakness and tiredness to be related to Shingrix.     Linked case(s) involving the same patient:  US2022112840   Additional Information: GSK Receipt Date: 25-Oct-2022 Reporter's Comments: The patient stated that she had her second dose of Shingrix and had been experiencing fever, tremors, shivers, chills, malaise, joint pain, muscle soreness, loss of appetite, pain at the injection site, rash at the injection site, heat at the injection site, diarrhea, upset stomach, weakness, tiredness. The patient further stated that she had a history of oral herpes simplex virus and that she had been having outbreaks since having this second dose. The reporter consented to reach out to the pharmacy that she received this second dose.; Sender's Comments:  US-GSK-US2022112840:Same patient
Redding below injection site over full bicep. Hardening and swelling below injection site.
Vaccinated patient became symptomatic on 9/7/21 and tested positive for Covid -19 on 9/8/21.
pt reportedly fell from bed @ home & appeared to be unconscious about 24hr p/vax;pt transferred to ER by amb & making purposeful movements then when examined by MD in was alert & following commands properly;no sz activity noted;
Rash, warm, swollen skin at injection site, oozing pus, painful joints.
dose administered to patient after more than 1 temperature excursion; dose administered to patient after more than 1 temperature excursion/vial stored at cooler storage during high-pace COVID-19 vaccination clinic at the time of the excursion; This spontaneous case was reported by an other health care professional and describes the occurrence of POOR QUALITY PRODUCT ADMINISTERED (dose administered to patient after more than 1 temperature excursion/vial stored at cooler storage during high-pace COVID-19 vaccination clinic at the time of the excursion) and PRODUCT TEMPERATURE EXCURSION ISSUE (dose administered to patient after more than 1 temperature excursion) in a 54-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031L20A) for COVID-19 vaccination.     No Medical History information was reported.    On 13-Feb-2021 at 1:05 PM, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On 13-Feb-2021 at 1:05 PM, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (dose administered to patient after more than 1 temperature excursion/vial stored at cooler storage during high-pace COVID-19 vaccination clinic at the time of the excursion). On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (dose administered to patient after more than 1 temperature excursion). At the time of the report, POOR QUALITY PRODUCT ADMINISTERED (dose administered to patient after more than 1 temperature excursion/vial stored at cooler storage during high-pace COVID-19 vaccination clinic at the time of the excursion) and PRODUCT TEMPERATURE EXCURSION ISSUE (dose administered to patient after more than 1 temperature excursion) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported.  The vial was initially stored in the fridge on 09-Feb-2021, moved to clinic on 13-Feb-2021 and proposed beyond use date was 10-Mar-2021.  The vials were only punctured right before administration and all doses were drawn from the vial due to high-pace clinic.  It was reported that each time a vial was put into a cooler, sometimes there was a period of time of 1 hour or 1 hour and a half approximately, when temperature data logger registered a temperature of 34 or 35 degree Fahrenheit.  On 12-Feb-2021, at 09:00 A.M., the temperature recorded was 29 degree Fahrenheit, at 10:00 A.M and at 11:00 A.M., the temperature recorded was 35 degree Fahrenheit that has been reached by the vial.  On 13-Feb-2021, at 09:00 A.M., the temperature recorded was 32 degree Fahrenheit, that has been reached by the vial.  Temperature recordings were taken using a traceable temperature monitor at every hour.  The vial was not in a frozen state at the time of vaccine administration.  After administration, the vial was returned to the freezer/refrigerator, or maintained at room temperature.  No treatment information was provided.   This case was linked to MOD-2022-566976 (Patient Link).
This literature-non-study case was reported in a literature article and describes the occurrence of ENDOCRINE OPHTHALMOPATHY (TED reactivation) in a 45-year-old female patient who received mRNA-1273 (Spikevax) for COVID-19 vaccination. LITERATURE REFERENCE: Concurrent medical conditions included Thyroid eye disease (Patient had stable disease for 5 years). On an unknown date, the patient received first dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On an unknown date,  after starting mRNA-1273 (Spikevax), the patient experienced ENDOCRINE OPHTHALMOPATHY (TED reactivation) (seriousness criterion medically significant). At the time of the report, ENDOCRINE OPHTHALMOPATHY (TED reactivation) was resolving. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Thyroid function test: stable Stable. The action taken with mRNA-1273 (Spikevax) (Unknown) was unknown. For mRNA-1273 (Spikevax) (Unknown), the reporter considered ENDOCRINE OPHTHALMOPATHY (TED reactivation) to be related. No treatment and concomitant medication reported. Three female patients over 18 years of age (range 4566 years) received either the Moderna or Pfizer COVID-19 vaccine presented with symptoms of thyroid eye disease (TED) within 24 h to 21 days of receiving their first or second dose. None of the patients had previous infections with severe acute respiratory syndrome coronavirus 2. Patient presented with proptosis. And was not a current smoker. Symptoms in patient was improving at 4 to 8 months. Company Comment: This literature case concerns a 45-year-old female patient with Concurrent medical conditions of Thyroid eye disease (Patient had stable disease for 5 years), who experienced the unexpected serious event of Endocrine Ophthalmopathy (TED reactivation) (seriousness criterion medically significant) which occurred 3 weeks after receiving the first dose of mRNA-1273 vaccine. Patients with Concurrent medical conditions of Thyroid eye disease could be confounder for the event. The benefit-risk relationship of mRNA-1273 Vaccine is not affected by this report. This case was linked to MOD-2022-538683 (Patient Link). Sender's Comments: This literature case concerns a 45-year-old female patient with Concurrent medical conditions of Thyroid eye disease (Patient had stable disease for 5 years), who experienced the unexpected serious event of Endocrine Ophthalmopathy (TED reactivation) (seriousness criterion medically significant) which occurred 3 weeks after receiving the first dose of mRNA-1273 vaccine. Patients with Concurrent medical conditions of Thyroid eye disease could be confounder for the event. The benefit-risk relationship of mRNA-1273 Vaccine is not affected by this report.
Developed atrial fibrillation, palpitations and hr of 150. 1 month prior to vaccine pacemaker was checked. Result was normal sinus rhythm. Now on blood thinners permanently
Swelling and pain with large red cicely on deltoid where shot administered. I did not have symptoms post shot as described . This started today and my arm hurts and fingers feel swallen. Also pain goes into my left shoulder and axillla
This patient was a 34 year old male Officer with no medical problems prior to receiving anthrax vaccination #5 in Apr 1999. In Aug and Sept of that year while stationed abroad he had 2 episodes of diarrhea, nausea and weakness where he was diagnosed with viral gastroenteritis and dehydration. In early Oct he had severe chest pain for which cardiac causes were ruled out and he was given H2 blockers. In late Oct he received Anthrax #6 and rapidly developed diarrhea and more severe reflux pain. Within 2 weeks the symptoms worsened and he began having sharp abdominal pains related to eating and lost weight. He was treated with antibiotics and proton pump inhibitors but symptoms continued. In Jan 00 he was aerovaced where an UGI and small bowel series were performed. Findings suggested duodenitis and jejunitis but biopsies of the antrum, duodenum and random colon were all normal following the corresponding EGD and colonoscopy. A gastric emptying study revealed some delayed emptying, however no treatment was started. In the summer of '00 he was referred to behavioral health for continued chest pains, difficulty sleeping, anxiety and fatigue. Symptoms continued and he developed rectal bleeding secondary to chronic constipation, continued wt loss and weakness. He had multiple flexible sigmoidoscopies, continued where hemorrhoids and anal fissures were found. In 2003 he had another EGD to r/o Barrett's esophagus but tissue pathology was not diagnostic. It was determined that he had a mild non-erosive gastropathy and was treated with pantoprazole. In late 2004 a gastric emptying study demonstrated 85% retention of food at 90 minutes. By the time of this diagnosis he had lost 32 lb and had developed chronic fatigue, myalgias, fasciculations, tremors, paresthesias, poor sleep, short term memory loss and migraine headaches. Medications included metoclopromide which was changed to tegaserod which greatly improved symptoms. In 2007 an abdominal X-ray showed a dilated stomach and distention of the splenic flexure of the colon. He was then changed to domperidone. Currently his symptoms are controlled on domperidone along with a strict bland diet and he remains on active duty. Diagnosis: Gastroparesis/Hypogonadism.   1/23/09 Received medical records. FINAL DX:gastroparesis, testicular hypofunction, depressive disorder, Migraine, GERD, insomnia, amnesia, malaise, fatigue Records reveal patient experienced dizziness, almost passed out, weakness, trembling, heart rate increased, BP elevated.  Dx w/dehydration & tx w/IVF.  Recovered but later developed trembling, diarrhea, difficulty sleeping, fatigue, nausea, decreased appetite & disorientation.  Tx multiple times for dehydration, viral gastroenteritis & kidney stone. Developed chest pain, tingling, chronic diarrhea, weight loss, inability to sleep lying down, testicular pain.  Symptoms currently controlled w/meds.
Patient developed mild case of Guillain Barre Syndrome 34 hours after injection of the Johnson and Johnson vaccine. Patient has severe extremity pains. The patient has a personal history of being diagnosed with Guillain-Barre after a yellow fever vaccination.
10/1/16 achy, slight fever, terrible headache, very dizzy and tired. Took DAYQUIL and Ibuprofen. Headaches became worse with vomiting and body aches. 10/14 Dr. Visit, 10/17 Blood work, 10/19 CT Scan of brain. As of 10/28 still queasy with continuous slight headache.
pt recvd vax & lab eval revealed a neg varicella antibody titer;no further details were provided;
This spontaneous case was initially received on 30-Nov-2015. The case report was received from a(n) Health Professional and concerns a(n) 78 year old female patient. The patient does not have any drug allergies. The patient received Influenza vaccine on unknown dates, Batch no: not provided, Route of administration: Unknown, Site: Left arm. Additional suspect drug(s): KEYTRUDA, Route: Central intravenous, Dose: 2 mg/kg, Indication: Stage IV melanoma, Site: Right arm. On an unknown date, after starting treatment with Influenza vaccine the patient experienced Rash on her upper right arm. The pharmacist reports that one week after the first dose of pembrolizumab, the patient returned to her physician because she had developed a rash on her upper right arm. No treatment was given. The patient returned to her physician's office on 18-Nov-2015 to receive her second dose of pembrolizumab. Prior to the infusion it was noted by the physician that the rash looked worse, however, the pembrolizumab was still administered. The patient will be treated with hydrocortisone cream and diphenhydramine. The pharmacist also reported that the patient received an influenza vaccination "a couple of weeks ago" in the left arm (unspecified manufacturer, unspecified date). The pharmacist reports the patient's rash is a pre-existing condition which periodically appears then disappears. Pharmacist further explained that prior to starting pembrolizumab therapy, the patient "has always had a rash that comes and goes on her arm". On the day the patient was scheduled to received her first dose of pembrolizumab, she did not have a rash. The first dose was administered and at an unspecified time the rash "reappeared" on her arm and "it currently seems to be getting worse". Reporter's assessment: Not reported. The pharmacist does not believe the reaction (rash) is from the flu shot. The pharmacist states the flu shot was administered in the left arm, but the rash is in the right arm. The right arm is also where the patient gets her KEYTRUDA, which may cause rash. He states he last spoke to the patient 28-Nov-15 and the rash has not gotten any worse. He believes the rash is from the KEYTRUDA or the patient's disease state of melanoma.
Information has been received from a female consumer concerning her child who "over 10 years ago" was vaccinated with a dose of MMR II. The patient died after being given the vaccine. No further information is available.
NAUSEA; FATIGUE; BODY ACHES; HEADACHE; DIZZINESS; LOST APPETITE; This spontaneous report received from a female patient of unspecified age. The patient's height, and weight were not reported. The patient's concurrent conditions included mild headache. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: 1805020, and  expiry: not reported) dose was not reported, administered on 04-MAR-2021 at 03:30 pm to Left Arm for prophylactic vaccination. No concomitant medications were reported.  On an unspecified date, the patient experienced nausea, fatigue, body aches, headache, dizziness, and lost appetite. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from nausea, fatigue, and body aches, had not recovered from headache, and the outcome of dizziness and lost appetite was not reported. This report was non-serious. This case, from the same reporter is linked to 20210314196.
VOMITING; WEAKNESS; CHILLS; HEADACHE; NAUSEA; This spontaneous report received from a consumer concerned a 64 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included migraine. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1808609, expiry: UNKNOWN) dose was not reported, administered on 12-APR-2021 for prophylactic vaccination. Concomitant medications included topiramate for migraine. On 13-APR-2021, the subject experienced vomiting. On 13-APR-2021, the subject experienced weakness. On 13-APR-2021, the subject experienced chills. On 13-APR-2021, the subject experienced headache. On 13-APR-2021, the subject experienced nausea. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from headache, chills, vomiting, nausea, and weakness. This report was non-serious.
Confirmed Breakthrough  1st dose - 4/14/2021 Moderna 2nd dose 5/10/2021 Moderna
Headache within first 15 minutes, treated with OTC medication, lasted 3 days 1st day- headache, dizziness, nausea 2nd day- stomachache, headache, joint and muscle soreness, sinus congestion 3rd day- severe headache, mild soreness in muscles, sinus drainage cough 4th day- very mild headache  5th day- increased sinus congestion and drainage scratchy throat 6th day- same, plus mild headache 7th- 10th day- symptoms mostly resolved some lingering drainage and fatigue
/p receiving DPT #2 @ 1:30pm on 6JUL90, pt had a T 103 & screaming by evening.
Day 5 after vaccine, developed 2 inch itchy rash below injection site. Rash progressed over 24 hours to a large 5inch area. Itchy urticaria rash progressed to entire torso, front and back, pubic areas, both upper arms daily up to day 10 (today) when began to move up neck. Benadryl at night helped itch, topical Benadryl and topical hydrocortisone not helpful. Seen in Urgent Care clinic today by NP. Prescribed methylprednisolone dose pak 4mg for 6 days. Started dose at 4pm today (2/28/2021).