chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: M
Vaccine: COVID19-2
Symptoms: SARS-CoV-2 test positive, Sputum culture positive, Upper gastrointestinal haemorrhage
Clinical narrative: Reported Symptoms: 10011906:DEATH; 10054112:HOSPITALISATION; 10067923:VACCINE BREAKTHROUGH INFECTION; 10084268:COVID-19; Narrative:  80-year-old male with a PMH of HTN, HLD, CAD, T2DM , memory impairment, presenting to the ED for weakness and hypotension after PICC line  removal in ID clinic.  Patient admitted on 10/5 for Acute hypoxic respiratory  failure 2/2 to severe COVID pneumonia requiring supplemental oxygenation.  Continued on 5 doses of Remdesavir (10/6-10/10) and 10-day course of  dexamethasone (10/7-10/16) for COVID pneumonia.  Patient transferred to MICU for  higher oxygen supplementation with possibility of progression to CPAP or  intubation. Discussed with patient of risks/benefits of escalation to intubation; patient understood with confirmation of CODE status FULL  and MPOA as  roommate if unable to communicate cares. Additional MPOA identified on AD from 2015.  Sputum speciated ESBL Klebsiella, treated  with ertapenem per ID.  C diff positive,  treated with PO vanc through Duotube.  Hospitalization complicated by UGIB,  endoscopy by GI on 10/12 with multiple  duodenal ulcers s/p cliping. S/p 2u RBC. No recurrence of bleeding, even after  Duotube replacement. Continued mechanical ventilation increasing Fi02  requirements for prolonged duration. Encephalopathy and hypoactive delirium with  inability to follow commands while off sedation. Atempted high dose steroid  ARDS NET protocol on 10/18 with improvement in Fi02 levels.  10/18 sputum CX  concerning for possible carbapenemase resistance however discussed with ID and  since
Age: 71.0
Sex: M
Vaccine: COVID19-2, FLUA4
Symptoms: Immunisation reaction, Pruritus, Rash, Urticaria
Clinical narrative: Reporter Symptoms: 10037087:PRURITUS; 10037844: RASH;  Narrative: Nursing documentation has reviewed and the following timeline is noted. He was in the woods on Tuesday 11/1 Wednesday 11/2 in the morning he was received both his influenza and covid booster (Moderna). Wednesday 11/2 in the evening (about 12 hours later) he developed hives on arms and legs. Of note, he has received influenzas vaccine and Moderna Covid vaccination on multiple occasions in the past without documentation of reaction. Also noted history of reaction (rash) to Tegaderm Transparent dressings. Nurse note indicates reaction to get from Tegaderm. It is unclear what kind of Tegaderm dressing caused the reaction. Transparent dressings do not appear to contain polyethylene glycol, but other Tegaderm dressings may contain polyethylene glycol, (which is in Moderna and Pfizer covid vaccine) Unsure how accessible allergy testing is to polyethylene glycol, but that could be considered if desired. Polyethylene glycol is also in MiraLAX and Systane eye drops. Reaction to either of those products would increase suspicion of polyethylene glycol related reaction to covid vaccine. Adverse reaction to both vaccines will be added to his profile; however, based on successful past use and type of reaction, it is reasonable to consider future vaccination.
Age: 79.0
Sex: M
Vaccine: COVID19
Symptoms: Syncope
Clinical narrative: Reported Symptoms: 10042772:SYNCOPE; Narrative: Other Relevant HX:
Sex: F
Vaccine: COVID19
Symptoms: Lip swelling
Clinical narrative: Reported Symptoms: 10024570:LIP SWELLING; Narrative: Submitted on behalf of a employee so no records to review. Other Relevant HX: Other: LIP SWELLING
Sex: M
Vaccine: FLU4
Symptoms: Dizziness, Syncope
Clinical narrative: Reported Symptoms:  10013573:DIZZINESS:  10042772:SYNCOPE;     Narrative: Other Relevant HX:   Other:
Age: 65.0
Sex: M
Vaccine: FLUA4
Symptoms: No adverse event
Clinical narrative: Reported Symptoms:  10067462:NO ADVERSE EVENT;     Narrative:   Other Relevant HX:  Other:  None
Age: 60.0
Sex: M
Vaccine: COVID19-2
Symptoms: Pruritus, Rash, Rash erythematous, Rash pruritic, Tenderness
Clinical narrative: Reported Symptoms: 10037087:PRURITUS; 10037844:RASH; Narrative: Received COIVD booster 10/31/2022. Woke up morning of 11/2/22 with localized rash on low back. No fever, chills or drainage. Described as very itchy, on fire, sore to touch, pure red and bumpy. No new products or medications. He was outside doing yardwork day prior but skin was covered. No difficulty breathing or wheezing. No reaction to prior COVID vaccinations. Provider determined reaction may be related to COVID vaccination and prescribed a medrol dose pack along with as needed antihistamines. No additional follow up completed after reaction. Other Relevant HX: Other:
Age: 38.0
Sex: F
Vaccine: COVID19
Symptoms: Rash
Clinical narrative: Reported Symptoms: 10037844:RASH; Narrative: Other Relevant HX: Other: RASH
Age: 58.0
Sex: M
Vaccine: COVID19
Symptoms: Influenza like illness
Clinical narrative: Reported Symptoms: 10016797:FLU-LIKE SYMPTOMS; Narrative: Other Relevant HX: Patient received vaccination outside of facility from pharmacy, no vaccination records/details available in chart. Other: INFLUENZA-LIKE ILLNESS (6/16/22@11:59:37)
Sex: M
Vaccine: COVID19
Symptoms: Product administration error, Wrong product administered
Clinical narrative: Reported Symptoms: 10063978:WRONG VACCINE ADMINISTERED; Narrative: patient received the bivalent booster as his primary series first vaccination, instead of monovalent formulation. We notified the patient and will proceed as recommended by the CDC Vaccination Errors and Deviations guidance. Other Relevant HX: Other: vaccine administration error, should have been monovalent
Sex: M
Vaccine: COVID19
Symptoms: Rash
Clinical narrative: Reported Symptoms: 10037844:RASH; Narrative: Other Relevant HX: Other:
Sex: M
Vaccine: COVID19
Symptoms: Lymphadenopathy
Clinical narrative: Reported Symptoms: 10025197:LYMPHADENOPATHY;  Narrative: Other Relevant HX: Other LYMPADENOPATHY
Sex: M
Vaccine: FLUX
Symptoms: Adverse drug reaction, Pain in extremity
Clinical narrative: Reported Symptoms: 10052536:ADVERSE DRUG REACTION NOS;   Narrative: A 54yo female who established care fro a scheduled visit regarding main concern of RT. foot pain The unit RN reported the patient had a historical ADR of influenza vaccine reaction. No ther detailed information regarding the vaccine was provided (type of reaction whe, where and who administered the vaccine, product info, Lot# , Expiration date, etc - were not provided) Other Relevant HX: Other: Not specified
Sex: M
Vaccine: FLUX
Symptoms: Injection site erythema, Peripheral swelling
Clinical narrative: Reported Symptoms:  10023698:LARGE ARM SWELLING;    Narrative:   Other Relevant HX:  Patient reported 12/2/21 having erythema to injection site, 3 x 4 cm per NP documentation.  Received outside clinic, no vaccine records/documentation available.    Other: SWELLING OF ARM
Age: 71.0
Sex: M
Vaccine: COVID19-2
Symptoms: Azotaemia
Clinical narrative: Reported Symptoms: 10003886:AZOTEMIA; 10003889:AZOTEMIA RENAL; Narrative: Other Relevant HX: Other: RENAL AZOTEMIA
Age: 39.0
Sex: F
Vaccine: COVID19
Symptoms: Cerebrovascular accident, Infection, Transient ischaemic attack
Clinical narrative: Reported Symptoms: 10042244:STROKE; 10044391:TRANSIENT ISCHEMIC ATTACKS; Narrative: Patient saw provider on 9/28/2022 and pt reports tia after covid shot/infection. No information in Health Info database or EMR to support TIA diagnosis. Unclear when TIA was, reports taking ASA per note on 9/28/2022. Most recent dose given Jan 2022 of pfizer. Previous dose of Janssen given March 2021 Other Relevant HX: Other: TRANSIENT ISCHEMIC ATTACK
Sex: F
Vaccine: FLUX
Symptoms: Neuropathy peripheral
Clinical narrative: Reported Symptoms: 10029328:NEUROPATHY; Narrative: neuropathy after administration Other Relevant HX: Other: NEUROPATHY
Age: 54.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Arthritis
Clinical narrative: Reported Symptoms: 10083239:ARTHRALGIA;  10003246:ARTHRITIS;     Narrative: Pt is a 56 yoM with PMH of constipation, IBS, low back pain, ED, GERD and HTN. Pt was seen in clinic 9/8/22 for f/u on HTN management, at visit pt reported that when he received his 3rd dose of COVID Pfizer vaccine on 1/26/22 he later experienced arthritis. Pt did not report same or similar reaction with first two COVID Pfizer injections. It is unknown what the vaccine lot number was for this vaccination.   Other Relevant HX:   Other:  ARTHRITIS (9/8/22@8:54:54)
Age: 52.0
Sex: M
Vaccine: FLUX
Symptoms: Nausea, Vomiting
Clinical narrative: Reported Symptoms: 10028813:NAUSEA; 10047700:VOMITING; Narrative: Other Relevant HX: Other: NAUSEA; VOMITING
Age: 76.0
Sex: M
Vaccine: COVID19
Symptoms: Cellulitis, Erythema, Pruritus, Rash, Rash pruritic
Clinical narrative: Reported Symptoms:  10037097:PRURITS;  10046735:URTICARIA;     Narrative:    Other Relevant HX:  Patient got COVID vaccine 5/24/21. Prior to this, noted to have h/o BL leg swelling. At PC RN visit 6/23/21, patient reported having itchy rash to left arm for cellulitis in BL lower legs on 6/23, and ceftriaxone cream w/o relief. PCP was notified and patient was given ceftriaxone 500mg IM to left arm for cellulitis in BL lower leg on 6/23, and ceftriaxone 1000mg IH to right arm for same indication on 6/24 and again to left arm on 6/25, and a prescription for cephalexin 250mg capsule by mouth four times a day for 10 days was given 6/25 alone with a prescription for hydrocerin. On 7/7/2021, triamcinolone acetonide 40mg was administered IM to left arm for rash with the following documentation; Reports BUE and BLE rash that was treated 2 weeks ago with antibiotics is still present and troublesome. Itchy, skin is red and thickened, extends to lateral trunk. Seen in lab by Dr. Rx ordered, RTC tomorrow for repeat Kenalog injection and to p/u Rx. Triamcinolone was given again on 7/8. Per PC visit 7/12/21, the rash improved with the Kenalog. Unclear if rash from the COVID vaccine vs. other underlying issue  documentation did not consider COVID vaccine; reaction was documented a year later 6/2022. Other: URTICARIA (7/21/2022@13:00:12)
Age: 76.0
Sex: M
Vaccine: COVID19
Symptoms: Skin hypertrophy, Urticaria
Clinical narrative: Reported Symptoms:  10037097:PRURITS;  10046735:URTICARIA;     Narrative:    Other Relevant HX:  Patient got COVID vaccine 5/24/21. Prior to this, noted to have h/o BL leg swelling. At PC RN visit 6/23/21, patient reported having itchy rash to left arm for cellulitis in BL lower legs on 6/23, and ceftriaxone cream w/o relief. PCP was notified and patient was given ceftriaxone 500mg IM to left arm for cellulitis in BL lower leg on 6/23, and ceftriaxone 1000mg IH to right arm for same indication on 6/24 and again to left arm on 6/25, and a prescription for cephalexin 250mg capsule by mouth four times a day for 10 days was given 6/25 alone with a prescription for hydrocerin. On 7/7/2021, triamcinolone acetonide 40mg was administered IM to left arm for rash with the following documentation; Reports BUE and BLE rash that was treated 2 weeks ago with antibiotics is still present and troublesome. Itchy, skin is red and thickened, extends to lateral trunk. Seen in lab by Dr. Rx ordered, RTC tomorrow for repeat Kenalog injection and to p/u Rx. Triamcinolone was given again on 7/8. Per PC visit 7/12/21, the rash improved with the Kenalog. Unclear if rash from the COVID vaccine vs. other underlying issue  documentation did not consider COVID vaccine; reaction was documented a year later 6/2022. Other: URTICARIA (7/21/2022@13:00:12)
Age: 79.0
Sex: M
Vaccine: COVID19
Symptoms: Syncope
Clinical narrative: Reported Symptoms: 10042772:SYNCOPE; Narrative: Other Relevant HX: Other: SYNCOPE
Sex: M
Vaccine: COVID19
Symptoms: Blood glucose normal, Pyrexia, Syncope
Clinical narrative: Reported Symptoms:  10042772:SYNCOPE;    Narrative: 41 year old male who reported a severe reaction to Pfizer monovalent booster where he experienced syncope at work as well as low grade fever of 100.4 and blood glucose of 115. Patient was evaluated at a local ER with negative work up however issues a heart monitor and recommended the patient follow up with a local cardiologist.  Other Relevant HX:  Other: SYNCOPE
Age: 77.0
Sex: M
Vaccine: COVID19-2
Symptoms: Death, Dyspnoea, Insulin therapy, Product use issue, Type 2 diabetes mellitus
Clinical narrative: Reported Symptoms:  10011906:DEATH;     Narrative:  Patient received Moderna bivalent booster on 10/19/22 while at clinic for f/u after hospital discharge on 10/12/22. Hospitalization was for new onset T2DM.  Patient was started on metformin, insulin glargine and insulin aspart sliding scale prior to hospital discharge.  Patient called EMS from his home on 11/10/22 at 23:37 to report trouble breathing.  Patient diet at his home. Cause of death unknown at this time.  Relevant information:  patient takes rivaroxaban 2.5mg BID for PVD. He reported running out for a few days, 10/25 and 10/26, based chart review, it appears he restarted it on 10/27. Other comorbidities: CKD, stage 3, parkinsons disease, OSA. No prior reaction documented to previous covid vaccination.  Other Relevant HX:  Other: Death
Sex: M
Vaccine: COVID19-2
Symptoms: Injection site nodule
Clinical narrative: Reported Symptoms: 10029492:NODULE INJECTION SITE; Narrative: Other Relevant HX: nodule size of marble at vaccination site left deltoid. No COVID vaccine records available on chart, unable to submit vaccination details. Other: Nodule at vaccination site
Age: 43.0
Sex: M
Vaccine: COVID19
Symptoms: Rash
Clinical narrative: Reported Symptoms:     Narrative:   Other Relevant HX:  Other: RASH
Sex: M
Vaccine: FLUX
Symptoms: Rash
Clinical narrative: Reported Symptoms:  10037044: RASH;     Narrative: A 70yo male with PMH of Crohn's Disease and Exposure to potentially Hazardous Substance. On January 22, 2024 , PCC - RN reported the patient had a historical ADR of Influenza Virus vaccine induced rash. (No other detailed information was provided on the vaccine (which vaccine, Lot #, Exp. date. who administered the vaccine , where, when and by who, were not proved. Other Relevant HX:  Other: RASH
Sex: M
Vaccine: FLUX
Symptoms: Guillain-Barre syndrome
Clinical narrative: Reported Symptoms:  10018767: GUILLAIN-BARRE SYNDROME;     Narrative:  GUILLAIN BARRE  Other Relevant HX:  Other:  GUILLAIN BARRE
Age: 63.0
Sex: M
Vaccine: FLUX
Symptoms: Abdominal pain, Anger, Chills, Frustration tolerance decreased, Headache
Clinical narrative: Reported Symptoms: HEADACHE; VOMITING; Other Revelant HX: Patient presented to clinic via telephone on 11/10/2021, primarily due to frustration/anger over reaction to flu shot. Patient received shot on 10/29/21. He reported ongoing headache, chills, and abdominal pain. However, patient declined ER evaluation and also declined clinic evaluation at time of call. Of note, He reported previous adverse reaction to flu shot in 2018 (although unclear what reaction patient experienced then). Other: HEADACHE; NAUSEA (11/10/21@11:11:59)
Age: 63.0
Sex: M
Vaccine: FLUX
Symptoms: Vomiting
Clinical narrative: Reported Symptoms: HEADACHE; VOMITING; Other Revelant HX: Patient presented to clinic via telephone on 11/10/2021, primarily due to frustration/anger over reaction to flu shot. Patient received shot on 10/29/21. He reported ongoing headache, chills, and abdominal pain. However, patient declined ER evaluation and also declined clinic evaluation at time of call. Of note, He reported previous adverse reaction to flu shot in 2018 (although unclear what reaction patient experienced then). Other: HEADACHE; NAUSEA (11/10/21@11:11:59)
Age: 59.0
Sex: M
Vaccine: VARZOS
Symptoms: Pyrexia
Clinical narrative: Reported Symptoms: 10016558:FEVER; Narrative: Other Relevant HX: Other: FEVER
Sex: M
Vaccine: COVID19
Symptoms: Wrong product administered
Clinical narrative: Reported Symptoms: 10006021:BOOSTER; 10063976:WRONG VACCINE ADMINISTERED;   Narrative: Patient was informed that he was given BIVALENT booster by mistake instead of Monovalent vaccine intended for primary series. Writer consulted with physicians regarding error and confirmed that pt does not require repeat of shot #1, and pt was scheduled for shot # 2 of primary series, with plans to administer monovalent vaccine. Clinic nurses were informed of error and re-educated. Other Relevant HX: RN administered Moderna Bivalent Booster RN realized her error and consulted with Clinical Pharmacy Practitioner.  Other: Pt received Bivalent Booster instead on Monovalent vaccine
Age: 73.0
Sex: M
Vaccine: FLU4
Symptoms: Diarrhoea, Dizziness, Vomiting
Clinical narrative: Reported Symptoms:   10012727:DIARRHEA;  10013573:DIZZINESS; 10047700:VOMITING;    Narrative:  Other Relevant HX:  Other:
Age: 71.0
Sex: M
Vaccine: COVID19
Symptoms: Rash
Clinical narrative: Reported Symptoms:  10037844:RASH;  Narrative: Described rash over arms and body, no issues with breathing.  Other Relevant HX:  describes rash over arms and body, no issues with breathing. Other: RASH (18/3/22@13:37:33)
Sex: M
Vaccine: FLUX
Symptoms: Chills
Clinical narrative: Reported Symptoms: 10008531:CHILLS;  Narrative: Other Relevent hx:
Sex: F
Vaccine: FLUX
Symptoms: Arthralgia
Clinical narrative: Reported Symptoms:  10003239:ARTHRALGIA; 10023222:JOINT PAIN; Narrative: Other Relevant HX: Patient reported left-shoulder pain after influenza vaccine 11/2/21. Patient vaccinated outside facility, no vaccine records/documentation availabe. Other: JOINT PAIN
Age: 65.0
Sex: F
Vaccine: VARZOS
Symptoms: Pruritus, Urticaria
Clinical narrative: Reported Symptoms:   10037087:PRURITUS;  10046735:URTICARIA;   Narrative:  Other Relevant HX:   Other:  URTICARIA
Age: 86.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Myalgia, Pyrexia
Clinical narrative: Reported Symptoms: 10003239:ARTHRALGIA; 10016558:FEVER; 10028411:MYALGIA; Narrative: Other Relevant HX: Other:
Age: 74.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Arthralgia, Myalgia
Clinical narrative: Reported Symptoms:  10023222:JOINT PAIN;  10028411:MYALGIA;    Narrative: Patient had joint pain with both covid shots. Worse with second vaccine. Still had joint pain a year and a half after shots.    Other Relevant HX: Other: JOINT PAIN
Age: 73.0
Sex: M
Vaccine: COVID19
Symptoms: No adverse event
Clinical narrative: Reported Symptoms: 10067481:NO ADVERSE DRUG REACTION; Narrative: Other Relevant HX: Other: no signs and symptoms noted
Sex: M
Vaccine: COVID19
Symptoms: Chills, Dizziness
Clinical narrative: Reported Symptoms:  10008531:CHILLS; 10013573:DIZZINESS;    Narrative: Other Relevant HX:  Other Chills
Age: 51.0
Sex: M
Vaccine: VARZOS
Symptoms: Erythema, Erythema multiforme, Rash
Clinical narrative: Reported Symptoms:   10015150: ERYTHEMA;  10015218:ERYTHEMA MULTIFORME; 10037844:RASH;   Narrative:  Other Relevant HX:  Other:  ERYTHEMA
Sex: M
Vaccine: FLUX
Symptoms: Angina pectoris, Chest pain
Clinical narrative: Reported Symptoms: 10002391:ANGINAL PAIN; 10008479:CHEST PAIN; Narrative:  Other Relevant HX:  Other: Chest PAIN
Age: 42.0
Sex: M
Vaccine: FLUX
Symptoms: Conjunctival oedema, Eye swelling, Neck pain, Ocular hyperaemia, Swelling of eyelid
Clinical narrative: Reported Symptoms: 10014216:EDEMA CONJUNTIVAL;  Narrative: Per December 5, 223. Clinical Triage nurse's note, to patient called to report he had his COVID - 19 and Influenza vaccine shots the previous day and woke up  the next morning with swelling around the eyes including the eye lids and wondering it it's associated with the vaccines.  He also reported having mild redness to the eyes and pain in the right side of his neck.  The traige nurse made a recommendation to be seen in the ER and that a note would be sent to his PCP. The patient agreed to go to urgent care. The patient also contacted the clinic and reported his symptoms and getting relief from taking Benadryl OTC sleeping. Since symptoms improved monitoring was recommended and for shoulder/arm pain, ibuprofen was ordered for prn use. The PCP reported the historical ADR and added influenza vaccine to the paitent's ADER profile as possible allergy. Other Relevant HX: Other: SWELLING (EYE)
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Mouth swelling, Oedema
Clinical narrative: Reported Symptoms: 10014210:EDEMA; 10030993:ORAL MUCOSA SWOLLEN; Narrative: 60 YO reported edema and oral swelling during NP appointment on 12/15/2022. This was attributed to recent COVID-19 vaccine administration, which was given on 09/21/2022. This was entered as an adverse vaccine reaction. Other Relevant HX: Other: Edema, oral swelling
Sex: M
Vaccine: COVID19
Symptoms: Pruritus, Urticaria
Clinical narrative: Reported Symptoms:  10037087:PRURITUS;  10046735:URTICARIA;    Narrative:  COVID vaccine administration notes not in records system, leading me to believe vaccine was administered outside of heathcare system. Thus I do not have any lot or expiration or other administration data.  Other Relevant HX: Other: URTICARIA
Age: 63.0
Sex: M
Vaccine: COVID19
Symptoms: Dizziness
Clinical narrative: Reported Symptoms: 10013573:DIZZINESS; Narrative: Other Relevant HX:
Sex: M
Vaccine: FLUA4
Symptoms: Rash, Urticaria
Clinical narrative: Reported Symptoms: 10037844:RASH; 10046735:URTICARIA;  Narrative: hives on back and arms 40 min after vaccination. has received flu shot before with no reaction Other Relevant Hx: Other: URTICARIA
Sex: M
Vaccine: PNC20
Symptoms: Injection site pain, Injection site swelling
Clinical narrative: Reported Symptoms:  10022086:INJECTION SITE PAIN;  10053425:INJECTION SITE SWELLING;    Narrative:   Other Relevant HX:    Other:  swelling and pain at injection site
Sex: M
Vaccine: FLUX
Symptoms: Dyspnoea
Clinical narrative: Reported Symptoms: 10006338:BREATHING DIFFICULT; 10013963:DYSPNEA; Narrative:  Other Relevant HX: Patient reported past reaction to influenza of "problems breathing". No vaccination records available, unsure when it occurred. Other: DYSPNEA, problems breathing
Age: 85.0
Sex: M
Vaccine: COVID19
Symptoms: Rash
Clinical narrative: Reported Symptoms:  10037844:RASH;     Narrative:   Other Relevant HX:
Age: 63.0
Sex: M
Vaccine: FLU4
Symptoms: Dizziness, Dyspnoea, Rash, Vomiting
Clinical narrative: Reported Symtoms: 10013573:DIZZINESS; 10013963:DYSPNEA; 10037644:RASH; 10047780:VOMITING;  Narrative: Patient reported symptoms on follow-up call Other Relevant HX:  Other: DYSPNEA
Age: 75.0
Sex: M
Vaccine: TDAP
Symptoms: Rash
Clinical narrative: Reported Symptoms: 10037844:RASH; Narrative: Other Relevant HX: Other:
Age: 60.0
Sex: F
Vaccine: FLUC4
Symptoms: Mouth swelling, Oedema
Clinical narrative: Reported Symptoms: 10014210:EDEMA; 10030993:ORAL MUCOSA SWOLLEN; Narrative: 60 YO reported edema and oral swelling during NP appointment on 12/15/2022. This was attributed to recent influenza vaccine administration, which was given on 12/19/2022. This was entered as an adverse vaccine reaction. Other Relevant HX: Other: Edema, oral swelling
Sex: M
Vaccine: FLUX
Symptoms: Nausea, Pyrexia, Swelling, Vomiting
Clinical narrative: Reported Symptoms: 10016558:FEVER; 10028813:NAUSEA;  10042674:SWELLING; 10047700:VOMITING;  Narrative: States the influenza vaccine causes him to swell, hae a fever and nausea with vomiting  Historical reaction, no details provided  Other Relevant HX:  Other SWELLING; FEVER; NAUSEA AND VOMITING
Age: 83.0
Sex: M
Vaccine: COVID19
Symptoms: Influenza like illness, Pyrexia
Clinical narrative: Reported Symptoms:  10016558:FEVER; 10016797:FLU-LIKE SYMPTOMS; Narrative:  Other Relevant DX:   Other: FEVER; INFLUENZA LIKE ILLNESS
Age: 70.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Fatigue, Myalgia, Oropharyngeal pain
Clinical narrative: Reported Symptoms: 10003239:ARTHRALGIA; 10016256:FATIGUE; 10028411:MYALGIA; 10041367:SORE THROAT; Narrative: Other Relevant HX: Other: Sore throat, fatigue
Age: 67.0
Sex: M
Vaccine: FLUA4
Symptoms: Chills, Headache, Pyrexia, Tremor
Clinical narrative: Reported Symptoms: 10016558:FEVER; 10019211:HEADACHE;  Narrative: Has not had reaction before. Patient experienced uncontrollable shaking, fever, chills and headache.  Other Relevant HX: Has not had reaction before. Patient experienced uncontrollable shaking, fever, chills, headache. Other: FEVER; HEADACHE
Age: 61.0
Sex: M
Vaccine: FLU4
Symptoms: Angioedema, Hypersensitivity, Swollen tongue, Tongue oedema
Clinical narrative: Reported Symptoms: 10002424:ANGIOEDEMA; 10014257:EDEMA TONGUE;  Narrative: Pt reported tongue swelling after getting influenza vaccine, However, pt reported to PCP that he experiences tongue swelling 2-3x per year with the cause being unknown. Due to this, unable to determine if vaccine is what caused allergic reaction. Pt reported he took Benadryl after experiencing tongue swelling from vaccine.  Other Relevant HX:  Other: SWELLING OF TONGUE
Age: 47.0
Sex: M
Vaccine: COVID19
Symptoms: Chest pain, Headache
Clinical narrative: Reported Symptoms: 10008479:CHEST PAIN; 10019211:HEADACHE; Narrative: Other Relevant HX: Other: HEADACHE; CHEST PAIN
Age: 73.0
Sex: M
Vaccine: FLU4
Symptoms: Injection site pain, Swelling
Clinical narrative: Reported Symptoms: 10022086:INJECTION SITE PAIN; 10049568:NECK SWELLING; Narrative: Other Relevant HX:  Other: neck swelling/pain injection site
Sex: F
Vaccine: COVID19
Symptoms: Nausea, Vomiting
Clinical narrative: Reported Symptoms: 10028813:NAUSEA;  10047700: VOMITING;    Narrative:   Other Relevant HX:   Other: NAUSEA AND VOMITING
Age: 26.0
Sex: M
Vaccine: COVID19, COVID19-2
Symptoms: No adverse event
Clinical narrative: Reported Symtpoms: 10029436:NO ADVERSE EFFECT; Narrative: Other Relevant HX: Other: No symptoms
Age: 72.0
Sex: M
Vaccine: FLU4
Symptoms: Pruritus
Clinical narrative: Reported Symptoms: 10037087:PRURITUS;  Narrative: Other Relevant HX:
Age: 82.0
Sex: M
Vaccine: COVID19-2
Symptoms: Amyotrophic lateral sclerosis, Asthenia, Body temperature increased, Breakthrough COVID-19, COVID-19 pneumonia
Clinical narrative: Reported Symptoms: 10054112:HOSPITALISATION; 10067923:VACCINE BREAKTHROUGH INFECTION; 10084268:COVID-19; Narrative: Patient initially presented to ED 11/25/23 with dislodged G tube, which was corrected and patient was discharged. He was brought back to ER by daughter 11/29/23 with worsening generalized weakness, lethargy, and poor appetite. Starting 11/28/23, patient began exhibiting signs of significant secretions resulting in a distressing "gurgline sound." He also had a fall prior to being brought in without LOC. In the ED, temp elevated to 100.7F. COVID-19 swab was positive. Patient admitted to ICU 11/30/23 and given 3 days of remdesivir even though COVID PNA mild as patient at increased risk of complications due to progressive worsening ALS. Patient improved, discharged to SNF 12/7/23. Other Relevant HX: Patient with PMH: amyotrophic lateral sclerosis (ALS), chronic kidney disease, non-verbal, G-tube dependent, interstitial lung disease, Meniere disease, aphasia, BPH Other: Hospitalization due to Covid-19 infection after having received Covid-19 vaccination
Age: 82.0
Sex: M
Vaccine: COVID19-2
Symptoms: Chest X-ray abnormal, Condition aggravated, Decreased appetite, Device dislocation, Fall
Clinical narrative: Reported Symptoms: 10054112:HOSPITALISATION; 10067923:VACCINE BREAKTHROUGH INFECTION; 10084268:COVID-19; Narrative: Patient initially presented to ED 11/25/23 with dislodged G tube, which was corrected and patient was discharged. He was brought back to ER by daughter 11/29/23 with worsening generalized weakness, lethargy, and poor appetite. Starting 11/28/23, patient began exhibiting signs of significant secretions resulting in a distressing "gurgline sound." He also had a fall prior to being brought in without LOC. In the ED, temp elevated to 100.7F. COVID-19 swab was positive. Patient admitted to ICU 11/30/23 and given 3 days of remdesivir even though COVID PNA mild as patient at increased risk of complications due to progressive worsening ALS. Patient improved, discharged to SNF 12/7/23. Other Relevant HX: Patient with PMH: amyotrophic lateral sclerosis (ALS), chronic kidney disease, non-verbal, G-tube dependent, interstitial lung disease, Meniere disease, aphasia, BPH Other: Hospitalization due to Covid-19 infection after having received Covid-19 vaccination
Age: 82.0
Sex: M
Vaccine: COVID19-2
Symptoms: Increased bronchial secretion, Intensive care, Interstitial lung disease, Lethargy, SARS-CoV-2 test positive
Clinical narrative: Reported Symptoms: 10054112:HOSPITALISATION; 10067923:VACCINE BREAKTHROUGH INFECTION; 10084268:COVID-19; Narrative: Patient initially presented to ED 11/25/23 with dislodged G tube, which was corrected and patient was discharged. He was brought back to ER by daughter 11/29/23 with worsening generalized weakness, lethargy, and poor appetite. Starting 11/28/23, patient began exhibiting signs of significant secretions resulting in a distressing "gurgline sound." He also had a fall prior to being brought in without LOC. In the ED, temp elevated to 100.7F. COVID-19 swab was positive. Patient admitted to ICU 11/30/23 and given 3 days of remdesivir even though COVID PNA mild as patient at increased risk of complications due to progressive worsening ALS. Patient improved, discharged to SNF 12/7/23. Other Relevant HX: Patient with PMH: amyotrophic lateral sclerosis (ALS), chronic kidney disease, non-verbal, G-tube dependent, interstitial lung disease, Meniere disease, aphasia, BPH Other: Hospitalization due to Covid-19 infection after having received Covid-19 vaccination
Age: 82.0
Sex: M
Vaccine: COVID19-2
Symptoms: Vaccine breakthrough infection
Clinical narrative: Reported Symptoms: 10054112:HOSPITALISATION; 10067923:VACCINE BREAKTHROUGH INFECTION; 10084268:COVID-19; Narrative: Patient initially presented to ED 11/25/23 with dislodged G tube, which was corrected and patient was discharged. He was brought back to ER by daughter 11/29/23 with worsening generalized weakness, lethargy, and poor appetite. Starting 11/28/23, patient began exhibiting signs of significant secretions resulting in a distressing "gurgline sound." He also had a fall prior to being brought in without LOC. In the ED, temp elevated to 100.7F. COVID-19 swab was positive. Patient admitted to ICU 11/30/23 and given 3 days of remdesivir even though COVID PNA mild as patient at increased risk of complications due to progressive worsening ALS. Patient improved, discharged to SNF 12/7/23. Other Relevant HX: Patient with PMH: amyotrophic lateral sclerosis (ALS), chronic kidney disease, non-verbal, G-tube dependent, interstitial lung disease, Meniere disease, aphasia, BPH Other: Hospitalization due to Covid-19 infection after having received Covid-19 vaccination
Sex: M
Vaccine: VARZOS
Symptoms: Guillain-Barre syndrome
Clinical narrative: He was impacted by Guillain-Barré syndrome; This serious case was reported by a consumer via interactive digital media and described the occurrence of guillain barre syndrome in a male patient who received Herpes zoster (Shingrix) for prophylaxis.   In SEP-2019, the patient received Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced guillain barre syndrome (Verbatim: He was impacted by Guillain-Barré syndrome) (serious criteria hospitalization and GSK medically significant). The outcome of the guillain barre syndrome was not resolved.   It was unknown if the reporter considered the guillain barre syndrome to be related to Shingrix.     It was unknown if the company considered the guillain barre syndrome to be related to Shingrix.   Additional Information: GSK Receipt Date: 18-MAR-2024 This case was reported by a patient via (Shingles) interactive digital media. The patient reported that he spent most of the 2020 year in and out of the hospital, not battling COVID-19 but fighting for his life after taking the shingles vaccine months prior to our trip plan. The patient was impacted by Guillain-Barre syndrome as a result of the shingles vaccine in September 2019. The patient was still recovering from the vaccine.
Sex: U
Vaccine: MMRV
Symptoms: No adverse event, Product storage error
Clinical narrative: no adverse event; Nurse reported that a dose of PROQUAD was administered to a patient on 27FEB2024 after it had experience two temperature excursions on 19FEB2024 and 27FEB2024.; This spontaneous report was received from a registered nurse (R.N.) and refers to a patient of unknown age and gender. No information regarding the patient's pertinent medical history, concomitant therapies, current conditions, and drug reactions or allergies was provided.  On 27-FEB-2024, the patient was vaccinated with an improperly stored dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live Albumin status rHA (recombinant Human albumin) (PROQUAD) injection, (strength, dose quantity, dose number, vaccination scheme frequency, anatomical location of application, and route of administration we not provided; lot number X021758 that was verified to be valid with an expiration date reported and established as 23-FEB-2025) for prophylaxis (product storage error). No additional adverse event reported  (no adverse event).   The temperature excursions were:minus 14.3 degree Celsius (C) and the time frame was 18 minutes; and minus 11.1 C for 14 hours and 50 minutes.
Sex: U
Vaccine: MMR
Symptoms: Expired product administered, No adverse event
Clinical narrative: confirmed no reports of medical concerns or symptoms from patient involved / No additional AE/PQC reported; An expired measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) vaccine was applied to the patient; This spontaneous report was received from an office manager refers to a patient of unknown age and gender.  The patient's medical history, concurrent conditions , previous drug reaction or allergies, and concomitant therapies were not reported.   On 28-FEB-2024, the patient received measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (recombinant human albumin) (M-M-R II) injection, 0.5 milliliter, lot #W001518, (expiration date: reported and established as: 13-JAN-2024), administered as prophylaxis by a health professional (strength, and route of administration and anatomical location were not provided) (dose number was not provided, it was reported as two dose series). It was confirmed that there were no reports of medical concerns of symptoms from patient involvement.   Therefore, according to the expiration date, an expired measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) vaccine was applied to the patient (Expired vaccine used) in the facility. At the time of reporting, the outcome of the event was not provided.
Sex: U
Vaccine: MMRV, VARCEL
Symptoms: Extra dose administered, No adverse event
Clinical narrative: No adverse event; inadvertent concomitant administration of VARIVAX with PROQUAD instead of MMRII.; inadvertent concomitant administration of VARIVAX with PROQUAD instead of MMRII.; This spontaneous report was received from a registered nurse concerning to a patient of unspecified age and gender. The patient's medical history, historical drugs, known allergies, concurrent conditions, and concomitant therapies were not reported.  On 10-MAR-2024, the patient was inadvertently vaccinated with varicella virus vaccine live (oka/merck) (VARIVAX) injection, lot #X021280, expiration date: 20-AUG-2025 (strength, dose, anatomical location and route of administration were not provided), concomitantly with measles, mumps, rubella and varicella (oka-merck) virus vaccine live recombinant human albumin (rHA) (PROQUAD) injection, lot #X020572, expiration date: 03-FEB-2025 (strength, dose, anatomical location and route of administration were not provided), both administered for prophylaxis, instead of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) injection (Wrong product administered) (Extra dose administered). No additional information or adverse events were provided.
Age: 16.0
Sex: U
Vaccine: MMRV
Symptoms: Extra dose administered, No adverse event, Product administered to patient of inappropriate age, Wrong product administered
Clinical narrative: No additional AE; Nurse called and reported that a dose of PROQUAD was administered to a 16 year old patient instead of VARIVAX on 1/30/2024.; Nurse called and reported that a dose of PROQUAD was administered to a 16 year old patient instead of VARIVAX on 1/30/2024.; Nurse called and reported that a dose of PROQUAD was administered to a 16 year old patient instead of VARIVAX on 1/30/2024.; This spontaneous report was received from a nurse and refers to a 16-year-old patient of unknown gender. The patient's medical history, concurrent conditions, and concomitant therapies were not reported.  On 30-JAN-2024, the patient was vaccinated with measles, mumps, rubella, and varicella (OKA-MERCK) virus vaccine live (PROQUAD) injection, 1 dose, lot #X021759, expiration date: 23-FEB-2025, administered for prophylaxis (strength, and route of administration were not provided) (Product administered to patient of inappropriate age) instead of varicella virus vaccine live (OKA/MERCK) (VARIVAX) injection (Wrong product administered) (Extra dose administered). Reporter stated the patient was already up to date on their measles, mumps, and rubella (MMR) vaccination prior to receiving the dose of measles, mumps, rubella, and varicella (OKA-MERCK) virus vaccine live (PROQUAD. No patient symptoms were reported.
Age: 1.0
Sex: F
Vaccine: MMRV
Symptoms: No adverse event, Product storage error
Clinical narrative: No  adverse event occurred; Inbound call from medical assistant calling to report temperature excursion for PROQUAD.  Caller states one dose of PROQUAD was administered to a patient on 21-MAR-2024 following the temperature excursion.  HCP confirmed no symptomatic adverse events; This spontaneous report was received from a medical assistant concerning a 12-month-old female patient.   The patient's medical history, concurrent conditions and concomitant medication were not reported.  On 21-MAR-2024, the patient was vaccinated with an improperly stored dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) injection, 0.5 milliliter, quantity: 1, once, (lot #X023876, has been verified to be valid, expiration date: 27-MAR-2025) (albumin status: recombinant human albumin) administered for prophylaxis (strength, and route of administration were not provided). The operator of the device was health professional. No adverse event reported.  Names of vaccines involved (including lot/expiration)  measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) Temperature: -13.4C Time frame: 22 minutes Was it administered (AE)? Yes Previous temperature excursion? Yes -11.8C / (-14 degrees Celsius (C) to -10 C) for 0 hours 34 minutes 0 seconds; -4.2C / (-10 C to 8 C) for 0 hours 45 minutes 0 seconds; -7.9C / (-10 C to 8C) for 0 hours 46 minutes 0 seconds; -5.6C / (-10 C to 8 C) for 0 hours 56 minutes 0 seconds -4.5C / (-10 C to 8 C) for 3 hours 57 minutes 0 seconds -13.9C / (-14 C to -10 C) for 0 hours 17 minutes 0 seconds Was call because of a "data logger"? No
Sex: F
Vaccine: HPV9
Symptoms: No adverse event, Product dose omission issue
Clinical narrative: The patient missed her second dose on an unspecified date; The patient has had no symptoms or side effects; This spontaneous report was received from a pharmacist and refers to a female patient of unknown age.  The patient's medical history, concurrent conditions, and concomitant therapies were not reported.  On an unknown date in October 2023, the patient received the first dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) injection, 0.5 milliliter, once, lot #U019412, which had been verified to be a valid lot number, expiration date reported and confirmed as 30-OCT-2023, administered for prophylaxis (strength, route of administration, and anatomical location were not provided).  On an unknown date, the patient experienced missed her second dose of the suspect vaccine (product dose omission issue). I t was mentioned that she had no symptoms or side effects (no adverse event).
Age: 25.0
Sex: F
Vaccine: HPV9
Symptoms: Exposure during pregnancy, No adverse event
Clinical narrative: No additional AE; HCP called to report inadvertent administration of GARDASIL 9 to a pregnant patient; This prospective spontaneous report was received from a nurse concerning a 25-year-old female patient. The patient's medical history, concurrent conditions and concomitant therapies were not reported.  On 25-MAR-2024, a pregnant patient (27 weeks and 5 days of gestation) was inadvertently vaccinated with the first dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) injection, 0.5 milliliter, once (strength, lot #, expiry date, route of administration and anatomical location were not provided) administered for prophylaxis (Exposure during pregnancy).  The last menstrual period (LMP) and estimated date of delivery (EDD) were not reported but were estimated to be 13-SEP-2023 and 19-JUN-2024, respectively. The pregnancy outcome was pending, and fetal outcome was unknown. Moreover, health care professional (HCP) would like the Annual Pregnancy Registry sent via email. No additional adverse event (AE) was reported (no adverse event). The operator of the device was an HCP.  Lot # is being requested and will be submitted if received.
Sex: U
Vaccine: MMR
Symptoms: Expired product administered, No adverse event
Clinical narrative: No additional AE, no PQC; HCP called to report inadvertent administration of expired MMR-II to a patient. Product expired on 22MAR2024 and was administered to a patient on 25MAR2024. Limited demographics provided. No additional AE/PQC.; This spontaneous report was received from other health care professional, concerning a patient of unknown age and gender.   The patient's medical history, concurrent conditions and concomitant medication were not reported.   On 25-MAR-2024, the patient was vaccinated inadvertent with an expired dose of with measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) injection, (lot #W009750, has been verified to be valid expiration date: 22-MAR-2024) (albumin status: recombinant human albumin (rHa)) administered for prophylaxis (strength, and route of administration were not provided). No adverse event reported. The operator of device was health professional.
Sex: U
Vaccine: VARZOS
Symptoms: Contusion, Erythema, Pain, Pain in extremity
Clinical narrative: arm is so sore; Big red bruise; red bruise; painful; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of pain in arm in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   The patient's past medical history included pain and blister (Worst pain and blisters lasted a month).   On an unknown date, the patient received Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine, the patient experienced pain in arm (Verbatim: arm is so sore), contusion (Verbatim: Big red bruise), erythema (Verbatim: red bruise) and pain (Verbatim: painful). The outcome of the pain in arm, contusion, erythema and pain were not reported.   It was unknown if the reporter considered the pain in arm, contusion, erythema and pain to be related to Shingles vaccine.     It was unknown if the company considered the pain in arm, contusion, erythema and pain to be related to Shingles vaccine.   Additional Information: GSK Receipt Date: 12-MAR-2024 This case was reported by a patient via interactive digital media. The patient just got the shingles shot and the arm was so sore with a big red bruise around it, it was painful too.
Sex: U
Vaccine: MNQ
Symptoms: Expired product administered
Clinical narrative: administered an expired vaccine; This non-serious case was reported by a other health professional via call center representative and described the occurrence of expired vaccine used in a patient who received Men ACWY-CRM NVS (Menveo) (expiry date 30-JAN-2024) for prophylaxis.   On 20-MAR-2024, the patient received Menveo. On 20-MAR-2024, an unknown time after receiving Menveo, the patient experienced expired vaccine used (Verbatim: administered an expired vaccine). The outcome of the expired vaccine used was unknown.   Additional Information: GSK Receipt Date: 20-MAR-2024 The health care provider reported that they administered an expired Menveo vaccine to the patient on the day of reporting, which led to an expired vaccine used. The reporter wanted to know does Menveo has an extended expiration date which was the case with some vaccine. Does the patient required to get and unexpired vaccine as soon as possible. The reporter thought there was not a wait requirement since Menveo was a non-lived vaccine. No other information available since this was message left after hours as a form.
Age: 70.0
Sex: M
Vaccine: VARZOS
Symptoms: Chills, Cough, Headache, Night sweats, Paraesthesia
Clinical narrative: Night sweats/shivers; Tingling sensation on left side of hairline/tingling on the left side of his head; Night-time headaches/worsened his headache; Coughing, feels like head will explode when coughing; shivers; This non-serious case was reported by a consumer via call center representative and described the occurrence of night sweat in a 70-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   The patient's past medical history included shingles (had in the 90s), nocturnal headache, nerve pain (optical nerve pain that also affected his teeth) and tingling. Concurrent medical conditions included tumor ablation (had a tumor ablation in his left kidney) and cold (had undiagnosed cold).   On 17-JAN-2024, the patient received Shingrix (left arm). On 17-JAN-2024, less than a day after receiving Shingrix, the patient experienced night sweat (Verbatim: Night sweats/shivers), tingling sensation (Verbatim: Tingling sensation on left side of hairline/tingling on the left side of his head), nocturnal headache (Verbatim: Night-time headaches/worsened his headache), cough (Verbatim: Coughing, feels like head will explode when coughing) and shivers (Verbatim: shivers). The outcome of the night sweat, tingling sensation, nocturnal headache and shivers were not resolved and the outcome of the cough was resolved.   It was unknown if the reporter considered the night sweat, tingling sensation, nocturnal headache, cough and shivers to be related to Shingrix.     It was unknown if the company considered the night sweat, tingling sensation, nocturnal headache, cough and shivers to be related to Shingrix.   Additional Information: GSK receipt date: 11-MAR-2024 The reporter was the patient. The patient did not remember if he got a cold before or after vaccination. It was unknown if he had was diagnosed with the kidney tumor before or after receiving Shingrix. The medical history include shingles in the 90s and his experience was hard to diagnose because it was an internal case with night headaches, optical nerve pain that also affected his teeth, and tingling of the head/hairline.  When he experienced the nerve pain, he found relief by brushing his teeth. After receiving the vaccine, the patient experienced coughing that worsened his headache (felt like his head could explode), shivers, night sweats, nighttime headaches and tingling on the left side of his head. All symptoms resolved until he had tumor ablation in his left kidney then the headaches came roaring back, the tingling in his hairline, night sweats and shivers came back. The coughing had now mostly resolved on its own but other symptoms are unresolved.  The reporter states that his ear, nose and throat doctor is more familiar with his care than his primary care physician.
Age: 88.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Injection site pain, Injection site swelling
Clinical narrative: Novavax COVID-19 Vaccine, Adjuvanted (2023-2024 Formula) EUA. Adverse events: pain/swelling at injection site; headache.