chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This case was reported by a nurse via call center representative and described the occurrence of neuropathy peripheral in a 60-year-old male patient who received SHINGRIX (batch number HG4P3, expiry date 13th July 2020) for prophylaxis. The patient's past medical history included neuropathy (idiopathic Neuropathy). On 5th June 2018, the patient received the 1st dose of SHINGRIX (intramuscular). On 6th June 2018, 1 days after receiving SHINGRIX, the patient experienced neuropathy peripheral (serious criteria GSK medically significant). On an unknown date, the outcome of the neuropathy peripheral was unknown. It was unknown if the reporter considered the neuropathy peripheral to be related to SHINGRIX. Additional details were provided as follows: The patient had not an occurrence of idiopathic Neuropathy for many years. The patient received SHINGRIX and the next day the patient presented with symptoms.
Information has been received from a physician concerning a 26 month old Caucasian male patient with no known drug allergies or no known medical conditions who on 12DEC2002 was vaccinated subcutaneously in the left thigh with a first dose of varicella virus vaccine live (lot number 640090/1147L). There was no illness at the time of vaccination and no symptoms following prior vaccinations. Concomitant therapy on 12DEC2002 included a subcutaneous first dose in the right thigh of measles virus vaccine live+mumps virus vaccine live+rubella virus vaccine live+, second generation (MSD) (lot number 640910/1049L) and an intramuscular third dose in the left thigh of hepatitis B vaccine, recomb ENGERIX B, batch number 5230A2. There were no other concomitant medications. On 16APR2003 the patient developed a small, red rash that started on the neck and face and spread to the arms, leg and chest, described as yellow, cloudy, fluid filled, itchy and more than 50 spots. There were no adverse events following prior vaccinations of the patient or his siblings. Additional follow up information indicated that on 26APR2003 the patient recovered. No further information is expected.
Since my shot I have had a sudden  increase in sore itchy Discoid Lupus  lesions (arms, head, chest, shoulders, back) from about 2 or 3 to 20 or 25. I have had an increase in a rash and hives around my armpits that started before my shot. I saw the doctor 3 days after my shot. where I recieved a prednisone and a toradol shot. I saw the dermatologist yesterday and am now on mupirocin and  a steroid cream along with clobetasol. It occured to me suddenly last night that these lesions appeared and got worse since my shot. The shot is the only difference in my routine recently. This is just a possibility but maybe this outbreak of lupus lesions and rashy hives is connected to my shot. Just in case other people with lupus start to crop up.
The night of the shot I got very little sleep due to my entire right arm which took the shot aching and hurting all night til I got up the next morning. Have had not other symptoms but it did scare me that night.  My husband experienced soreness of the arm and fatigue.
This case was reported by a pharmacist and described the occurrence of not responding to therapy in a currently 18-year-old female subject who was vaccinated with ENGERIX B (GlaxoSmithKline), Hepatitis B vaccine. In July 2013 the subject received 4th dose of ENGERIX B (unknown details) and experienced extra dose administered. The ENGERIX B series is indicated for 3 doses. In February 1996 and December 1995 the subject received the 3rd and 2nd doses of hepatitis B vaccine (unknown details) and experienced drug administration interval too long. In May 1995 the subject received 1st dose of Hepatitis B vaccine (unknown details). In 2013, 17 years after vaccination with 3rd dose of Hepatitis B vaccine, 18 years after vaccination with 2nd and 1st dose of Hepatitis B vaccine, the subject experienced not responding to therapy. The pharmacist reported that the subject was "not seroprotected."
Pt states that about 8 days after receiving the vaccine he developed an itchy rash on both of his wrists. It did seem to grow in size to cover a little less than the size a dollar bill.
pt recv vax & exp polyarthritis;pt was referred to a rheumatologist;sx resolved;
Post vax the patient stated the left deltoid was itching and red. The patient was treated with Benadryl. The patient also complained of tightness in her throat, a rash and shortness of breath. The patient became anxious, stated she needs air and wheezing started. The patient was treated with Albuterol Nebulizer. The patient's coughing decreased with the nebulizer treatment. The patient's chest and back were itching. The patient experienced hives on her neck and chest. The wheezing cleared and the patient's throat was dry.
The morning after I got the vaccine, I woke up with strong and different smelling body odor. This different odor has continued but has lessened about 50% since April.
Left arm is itchy; Swelling; Local pain; Triceps pain; A spontaneous report was received from a consumer concerning a 60years old, male patient who developed/experienced local pain injection site joint pain), triceps pain(myalgia), itchy left arm (pruritus) and swelling (swelling).  The patient's medical history was not provided.  Products known to have been used by the patient, within two weeks prior to the event, included Cholesterol pills, Aspirin, Vitamins.  On 11-Jan-2021, the patient received their first of two planned doses of mRNA-1273 (Batch number: 013L20A) intramuscularly for prophylaxis of COVID-19 infection.   On 11-Jan-2021, the patient experienced local pain and triceps pain. On 19-Jan-2021,  the patient experienced his left arm was itchy and swelling.No treatment was received for the events.   Action taken with mRNA-1273 in response to the events was not provided.  The outcome of the events were not reported.
In first 48 hours - bad long-lasting headache (kept me from sleeping), nausea, diarrhea, fatigue, chills. Five days after first dose - swollen lymph node in left armpit, increasing pain/tenderness, two days later, swollen lymph node in left part of neck. Swollen and tender lymph nodes lasted for over two weeks off and on; experienced difficulty swallowing. Workplace nurse said my throat was incredibly dry but there was also congestion. All of these adverse affects have made me hesitant to get the second dose.
No adverse event; Patient inadvertently received 0.25mL instead of 0.5mL of the Moderna Bivalent Booster; This spontaneous case was reported by a pharmacist and describes the occurrence of ACCIDENTAL UNDERDOSE (Patient inadvertently received 0.25mL instead of 0.5mL of the Moderna Bivalent Booster) and NO ADVERSE EVENT (No adverse event) in a 53-year-old female patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 059F22A) for COVID-19 vaccination.     No Medical History information was reported.    On 14-Oct-2022, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Intramuscular) .25 milliliter. On 14-Oct-2022, the patient experienced ACCIDENTAL UNDERDOSE (Patient inadvertently received 0.25mL instead of 0.5mL of the Moderna Bivalent Booster). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, ACCIDENTAL UNDERDOSE (Patient inadvertently received 0.25mL instead of 0.5mL of the Moderna Bivalent Booster) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Intramuscular), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for ACCIDENTAL UNDERDOSE (Patient inadvertently received 0.25mL instead of 0.5mL of the Moderna Bivalent Booster).    No concomitant medication information was provided.  No treatment medication was provided.
Twelve days after the vaccine I got a severe headache with blurry vision. I was also short of breath and my legs were swollen. I was dizzy and had body aches mostly on my left side. My left kidney was inflamed. The pain went all the way on the left side of my body from my ribs to my legs. My left leg was the most swollen. Many of the symptoms lasted for two and a half weeks. The headache lasted for three days. The first week was the worst. When I went to the ER  after a week they did not find any blood clots. The aches pains and swelling in my legs came and went over the course of three weeks. I was very tired when the symptoms were present.
Small red raised area around the site of injection.  Injection puncture has a scab.  The patient noticed the next day.  She reports it does not hurt but itches a bit.  She has been self treating by rubbing an alcohol swab on it.  I told her to wash the area with soap and warm water instead because the alcohol may be contributing to dryness and itchiness.
Patient broke out in raised, itchy blister type rash on injected arm and slightly on other arm. Started a couple days after vaccination .
Caller reports no additional AEs; Clinical Administrator called to report administration of expired MMR II vaccine. Caller reports that MMR II lot expired on 10/08/22 and was administered on 10/11/22. Caller reports no additional AEs, no PQCs. Consent granted to contact HCP. MMR II T; This spontaneous report has been received from a clinical administrator, referring to a 9-year-old patient of unknown gender.   The patient's pertinent medical history,current conditions, drugs reactions or allergies and concomitant medications were not provided.  On 11-OCT-2022, the patient was vaccinated with an expired dose of measles, mumps, and rubella (wistar RA 27-3) virus vaccine, live recombinant human albumin (rHA) (M-M-R II) injection 0.5 milliliter once, lot number T034391 has been verified to be a valid lot number with expiration date on 08-OCT-2022, administered as prophylaxis (route of administration and anatomical site of injection were not provided) (expired vaccine used). No additional adverse events were reported.  This is one of several cases from the same reporter.; Sender's Comments:  US-009507513-2210USA004126: US-009507513-2210USA004126: US-009507513-2210USA003600: US-009507513-2210USA003603: US-009507513-2210USA003897:
A day and a half after: Hives, tightness in chest, cough; day after: extreme fatigue; steroid to treat: methylprednisolone
heavy feeling on left side of chest. Went to care facility, they did a chest xray and EKG and gave me an aspirin then sent me to the ER. At the ER they did and EKG and blood work, did not find anything of concern. They sent me for a stress test, no problems found.
Narrative:  Patient is a resident of the nursing home since 11/1/22 - short rehab admission. 01/2/23 - Pt spiked fever overnight 1/1-1/2 = 100.8 and report of cough, congestion (couple of days), and runny nose. Isolation and Signs/Symptoms Assessment following exposure to a confirmed case with a communicable pathogen. Pt admitted to hospital medical floor on 1/2/23 d/t agency institutional policy. Upon admission to medical floor: Pt admits to cough (non productive, started within 24 hours), congestion, fatigue, chills. Pt denies CP, SOB, abd pain, N/V/D. Principal diagnosis (Reason for admission after study) = 1. acute mild COVID infection; 2. acute osteomyelitis of the left foot/TMA on 12/8/22. Additional diagnosis include: 3. PAD - 10/19/2022 S/P Angioplasty; Hx Stents x 2 4. ESRD on HD 5. Diabetes Mellitus, Type 2: 6. HTN: 7. HD: 8. H/O Stroke: 9. GERD: 10. Chronic PTSD: 11. Leukocytopenia: 12. Constipation: HOSPITAL COURSE: Hemodynamically stable. Patient remains with asymptomatic COVID on resp isolation until 1/13/22. 10 day resp isolation from 1/2/23. Pt is returning further tx at nursing home for continued care for mgmt of acute osteo of the left foot/ s/p TMA on 12/8/22. 1. Acute Mild Covid Infection: - Hemodynamically, remains asymptomatic on RA. Resp Isolation will be completed as of today. Continue with the plan for the patient to be transferred back to nursing home to continue hyperbaric treatment s/p TMA 2/2 to VRE. 2. Acute Osteomyelitis of the Left Foot/TMA on 12/8/22: - Followed by ID - Pt is on IV dapto/cefepime until 2/7/23. Pt received abtx with HD sessions - T/TH/S. CPK and LFTs monitored closely 2/2 to pt being on dapto - CPK has stayed elevated but essentially unchanged. Pt denies any muscle pain, chest pain, sob or general discomfort. - See #1 for plan of care for d/c status - Related hx: 10/20/2022 S/P amputation of left hallux 10/15/2022 S/P Left foot sichemia with gangrene of hallux - Ct supportive care, monitoring, prn pain med (lortab 5/325 mg daily prn)and wound/dsg care by WCN. - Ct hyperbaric treatment w/ wound vac as per vascular surgery - Ct monitoring screening labs with PRN supplementation CHRONIC MEDICAL CONDITIONS 3. PAD - 10/19/2022 S/P Angioplasty cont apixiban, asa, gabapentin. Hx Stents x 2 4. ESRD on HD - managed by renal - tu/thus/sat 5. Diabetes Mellitus, Type 2: Ct 32 units glargine qhs and 9 units aspart with meals. ssi - <10 units use noted. 6. HTN: Ct amlodipine 10 mgpo daily 7. HD: Ct to hold lipitor held due to being on dapto/ drug interaction 8. hx of stroke on asa and doac 9. GERD: Ct Prilosec 10. Chronic PTSD: Ct on prozosin 4mg po 11. Leukocytopenia: RESOLVED 12. Constipation: Ct miralax daily, s/p 1 dose of Senna Patient discharged back to nursing home on 1/13/23.
Patient experienced paraesthesia; This spontaneous case was reported by a consumer and describes the occurrence of PARAESTHESIA (Patient experienced paraesthesia) in a female patient of an unknown age who received mRNA-1273 (Spikevax) for COVID-19 prophylaxis.     No Medical History information was reported.   On an unknown date, the patient received dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On an unknown date, the patient experienced PARAESTHESIA (Patient experienced paraesthesia). At the time of the report, PARAESTHESIA (Patient experienced paraesthesia) outcome was unknown.      The action taken with mRNA-1273 (Spikevax) (Unknown) was unknown.   No concomitant medications were reported. No treatment medications were reported.
Fever for 3 days, severe upper right arm pain, cough, headache, edema of right axilla area 6 days post injection.
Pt stated he had history of fainting during shots. Upon receiving the shot the patient stated he was beginning to faint. He became non-responsive for a few seconds and diaphoretic. Pharmacist examined patient and he began to arouse but continued to complain of feeling light headed. Vitals taken and his BP 98/33 P 41 and R 30 and shallow. Pt continued to be diaphoretic. Patient laid on floor and feet elevated. After 5 minutes his pallor improved and his vitals were BP 98/68 P 68 R 14 and regular. Patient was no longer diaphoretic. Patient remained in waiting room for 15 minutes for continued observation and continued to show improvement. Patient was directed to talk to physician regarding BP and reaction to shots. Patient also directed to go to ER or Urgent Care if symptoms returned.
pt recvd vax & 24 hrs p/inject had diarrhea, rash & severe h/a was seen by a MD; sx have not subsided;
injection site tiching; This spontaneous case was reported by a physician (subsequently medically confirmed) and describes the occurrence of INJECTION SITE PRURITUS (injection site tiching) in a 74-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product UPADACITINIB (RINVOQ) for an unknown indication.    No Medical History information was reported.   On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) at an unspecified dose and UPADACITINIB (RINVOQ) (Oral) at an unspecified dose. On an unknown date, the patient experienced INJECTION SITE PRURITUS (injection site tiching). At the time of the report, INJECTION SITE PRURITUS (injection site tiching) had not resolved.        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.   Reporter did not allow further contact
This patient presented with fussiness and blood in the stool 24 hrs after administration of ROTATEQ vaccine. Intermittent fussiness persisted with vomiting and then another bloody stool this one described as currant jelly stool. The baby was sent to the ER where an intussusception was diagnosed by ultrasound and then reduced by air enema. The baby was hospitalized for 24 hrs of observation with no recurrence and then discharged the following day.
Information has been received from the grandmother of an 11 year old female who on 21-JUN-2007, was vaccinated with a first dose of Gardasil. On 28-JUN-2007, the patient developed a rash on her arm and stomach area. On 29-JUN-2007, the patient sought medical attention at the Health Department in which she received the vaccine. At the time of this report, the patient's outcome was unknown. No product quality complaint was involved. Additional information has been requested. This is in follow-up to report(s) previously submitted on 7/16/2007. Information has been received from a registered nurse concerning an 11 year old female patient who on 21-JUN-2007 at 15:15 PM, was vaccinated into the right deltoid with a first dose of GARDASIL (Lot# 655849/0263U). Concomitant therapy included a first dose into the left deltoid of BOOSTRIX (Lot# AC528008BA). On 28-JUN-2007, the patient developed a rash on her arm and stomach area. On 29-JUN-2007, the patient sought medical attention at the health department in which she received the vaccine. At the time of this report, the patient's outcome was unknown. No product quality complaint was involved. Additional information is not expected.
She was given her two month old vaccines around 930am. Around 6pm the same day exhibited signs of a fever (101.2) and was lethargic - parent called doctors office and was told to take her to the ER. At the ER her fever went to 102.2, and had tachycardia.
Day after Gardasil and Adacel (R) arm (deltoid). Numbness/tingling in right forearm/index finger and right lower leg/foot.
No additional AEs were reported; Nurse practitioner reported that a pregnant patient received GARDASIL 9; pregnant patient received GARDASIL 9 (u032636 10/26/2023) on 2/1/2023. The first dose was given on 12/29/2021; This spontaneous prospective pregnancy report has been received from a nurse prescriber referring to a 21-year-old female patient. The patient's medical history included preeclampsia. Concurrent conditions included asthma and penicillin allergy. Concomitant medications included sertraline hydrochloride (ZOLOFT) and acetylsalicylic acid (ASPIRIN).  On 29-DEC-2021, the patient was vaccinated with the first dose of human papillomavirus (hpv) rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) (exact dose, route of administration, anatomical location, lot# and expiry date were not reported) for prophylaxis.   The patient became pregnant with last menstrual period (LMP) date of 18-JUL-2022 and estimated date of delivery (EDD) of 24-APR-2023.  On 01-FEB-2023, the patient was vaccinated with the second dose of human papillomavirus (hpv) rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9)  lot #U032636, expiry date 26-OCT-2023 (exact dose, route of administration and anatomical location were not reported) for prophylaxis (inappropriate schedule of vaccine administered, maternal exposure during pregnancy).   The pregnancy outcome was outcome pending. Fetal outcome was unknown. No additional adverse event (AE) was reported (no adverse event).
Pt came in and had 2 high dose flu shots given about 20 minutes apart.
shoulder injury related to vaccine administration (SIRVA); 55 year old male complaining of right shoulder pain s/p influenza vaccine. Received influenza vaccine through flu clinic 10/05/2020. EE reports that when he received vaccine, he felt immediate, sharp, 10/10, pain in his right shoulder "joint space". EE reports that he is aware vaccines can sometimes cause soreness, but after 5-7 days noted that shoulder still continued to be sore. Ecchymosis formed over injection site and is still slightly visible.  EE has been taking OTC brand NSAID with relief, okay per PCP. EE notes sharp pain with certain movements, ~6-7/10, mostly when reaching arm out or up. EE has no pain in his shoulder at rest. EE denies pain radiating up into neck or clavicle. EE denies pain radiating down into upper arm, lower arm, or hand. EE denies numbness/tingling/weakness in right upper extremity. EE denies posterior shoulder or back pain.
fever 100.2, rash rt upper arm;h/a, chills;treated w/APAP 2 x 24hr;improved 5NOV97;redness @ site persists;
heart rate going faster (ka-bunk, ka-bunk); muscles and bones aching; muscles and bones aching; very very very very tired; slight headache; A spontaneous report was received from a consumer who was a 68-year-old, male patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced muscles and bones aching, slight headache, heart rate going faster (ka-bunk, ka-bunk) and felt very tired.  The patient's medical history was not provided. No concomitant medications were reported.   On 06 Jan 2021, approximately one day prior to the onset of the events, the patient received his first of two planned doses of mRNA-1273 (Lot number: 026L20A) intramuscularly on the left arm for prophylaxis of COVID-19 infection.   On the morning of 07 Jan 2021, the patient woke up feeling very tired with muscles and bones aching and a slight headache. He also noticed that his heart rate was going faster (ka-bunk, ka-bunk) one hour prior to reporting the events. Treatment for the events included ibuprofen.   Action taken with mRNA-1273 in response to the events was not reported.  The outcome for the events, very tired, muscles and bones aching, slight headache and heart rate going faster was not reported.; Reporter's Comments: This case concerns a 68 year old male who experienced nonserious  unexpected events of heart rate increase and bone pain, as wells as nonserious listed events of fatigue, myalgia, and headache. The events occurred approximately 1 day after first dose of mRNA-1273 administration. Treatment for the events included ibuprofen.  Based on the current available information and temporal association between the use of mRNA-1273 and the start date of the events, a causal relationship cannot be excluded.
RN was called to room after pt experienced syncope post vaccination. Felt nauseous - emesis bag was provided. Pallor noted. Normal cognition.  Pt was placed supine with knees lifted.  Vitals checked and rechecked. BP noted to be low. Pt rested for a few minutes then was able to come to a sitting position without issue.  Verified vitals returned to normal. Skin color improved. Pt reported he was feeling much better.  Pt was then able to stand without issue - then ambulated normally.  Pt's mother felt comfortable with going home after pt had improved.    Of note - pt/parent would like to move forward with only doing 1 immunization at a time.  He has done well with that plan previously.
Patient reported full body urticaria 12 hrs after receiving injection. Urticaria lasted 36 hrs. Patient reported to Urgent Care  on 4 Apr 21, managed symptoms with Benadryl and Zyrtec, provider determined not anaphylaxis. Patient made appointment with primary care provider on 13 May 21, who determined patient should not receive second dose of Moderna. On 23 Aug 21, patient was reassessed for 2nd dose, provider determined again that previous reaction was not classified as an immediate reaction per CDC classifications. Provider recommended getting a dose of Janssen, to have a complete series.  Provider directed patient to  starting taking  Zyrtec 2 days prior to receiving Janssen vaccine and continue for 1 week post vaccination. Patient has not reported any adverse reaction post Janssen vaccine. Patient received Janssen dose on 26 Aug 21.