chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 44.0
Sex: M
Vaccine: COVID19
Symptoms: Disturbance in attention, Dizziness, Feeling abnormal, Headache, Hyperhidrosis
Clinical narrative: Symptoms presented 10 days after 1st Dose. Acute Vertigo, followed by vomiting, followed by fever and sweats. Lasted 2 days all the above.. Then we had a  moderate to sever headache that never went away for two weeks. Dizziness.  Went to bed with a headache. Woke up with one. Treated with moderate and consistent 400-1200 Ibuprofin daily. During this time very difficult to think and concentrate, I guess you could say I had brain fog as it were, and slept most of the time. Headache symptoms started to fade after two weeks, but even after all this time I don't feel right and haven't felt like a can resume normal physical activity. I still had symptoms 3 weeks later when I was supposed to get the second dose so I didn't. I am in the military and now I have been ordered to get fully vaccinated. I am scared and don't know what to do.
Age: 44.0
Sex: M
Vaccine: COVID19
Symptoms: Mental impairment, Pyrexia, SARS-CoV-2 test negative, Sleep apnoea syndrome, Vertigo
Clinical narrative: Symptoms presented 10 days after 1st Dose. Acute Vertigo, followed by vomiting, followed by fever and sweats. Lasted 2 days all the above.. Then we had a  moderate to sever headache that never went away for two weeks. Dizziness.  Went to bed with a headache. Woke up with one. Treated with moderate and consistent 400-1200 Ibuprofin daily. During this time very difficult to think and concentrate, I guess you could say I had brain fog as it were, and slept most of the time. Headache symptoms started to fade after two weeks, but even after all this time I don't feel right and haven't felt like a can resume normal physical activity. I still had symptoms 3 weeks later when I was supposed to get the second dose so I didn't. I am in the military and now I have been ordered to get fully vaccinated. I am scared and don't know what to do.
Age: 44.0
Sex: M
Vaccine: COVID19
Symptoms: Vomiting
Clinical narrative: Symptoms presented 10 days after 1st Dose. Acute Vertigo, followed by vomiting, followed by fever and sweats. Lasted 2 days all the above.. Then we had a  moderate to sever headache that never went away for two weeks. Dizziness.  Went to bed with a headache. Woke up with one. Treated with moderate and consistent 400-1200 Ibuprofin daily. During this time very difficult to think and concentrate, I guess you could say I had brain fog as it were, and slept most of the time. Headache symptoms started to fade after two weeks, but even after all this time I don't feel right and haven't felt like a can resume normal physical activity. I still had symptoms 3 weeks later when I was supposed to get the second dose so I didn't. I am in the military and now I have been ordered to get fully vaccinated. I am scared and don't know what to do.
Age: 63.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Epistaxis, Headache, Lethargy, Muscle spasms
Clinical narrative: Headache, joint ache, muscle soreness, nosebleeds, lathargic,  spasms in the chest area
Age: 63.0
Sex: M
Vaccine: COVID19
Symptoms: Myalgia
Clinical narrative: Headache, joint ache, muscle soreness, nosebleeds, lathargic,  spasms in the chest area
Age: 34.0
Sex: M
Vaccine: COVID19
Symptoms: Chest pain, Dyspnoea, Dyspnoea exertional, Fatigue, Inflammation
Clinical narrative: Events: Shortness of breath, chest pain, fatigue, severe shortness of breath while laying down, severe shortness of breath of while exercising, chest pain,  foot and ankle swelling.   Time course: Symptoms appeared 6 days after first dose, continued for approximately 3 months and increased inflammation in severity after second dose. Resolved completely after approximately 6 months
Age: 34.0
Sex: M
Vaccine: COVID19
Symptoms: Joint swelling, Peripheral swelling
Clinical narrative: Events: Shortness of breath, chest pain, fatigue, severe shortness of breath while laying down, severe shortness of breath of while exercising, chest pain,  foot and ankle swelling.   Time course: Symptoms appeared 6 days after first dose, continued for approximately 3 months and increased inflammation in severity after second dose. Resolved completely after approximately 6 months
Age: 41.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal pain, Biopsy, Blood test, Colitis microscopic, Colonoscopy
Clinical narrative: Two weeks after receiving the vaccine, I experienced abdominal cramping that I would compare to being in labor. It was violent. Severe, unpredictable diarrhea. I didn?t associate it with the shot so I proceeded assuming I had eaten something bad etc. A few weeks later I ended up in urgent care and all tests were perfect. The doctor suggested I had an autoimmune response to the vaccine. My PCP concurred and tried me on a dose of prednisone and I had some relief until the prednisone ran out. Ultimately the cramps and diarrhea continued until I had to take short term disability from my job to get it under control. The ultimate diagnosis is that I now have microscopic colitis, which has a known trigger of medications.
Age: 41.0
Sex: F
Vaccine: COVID19
Symptoms: Diarrhoea, Impaired work ability, Stool analysis, X-ray
Clinical narrative: Two weeks after receiving the vaccine, I experienced abdominal cramping that I would compare to being in labor. It was violent. Severe, unpredictable diarrhea. I didn?t associate it with the shot so I proceeded assuming I had eaten something bad etc. A few weeks later I ended up in urgent care and all tests were perfect. The doctor suggested I had an autoimmune response to the vaccine. My PCP concurred and tried me on a dose of prednisone and I had some relief until the prednisone ran out. Ultimately the cramps and diarrhea continued until I had to take short term disability from my job to get it under control. The ultimate diagnosis is that I now have microscopic colitis, which has a known trigger of medications.
Age: 37.0
Sex: F
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration, Injection site induration, Injection site mass, Injection site pruritus, Injection site warmth
Clinical narrative: Woke up on Sep 30, 2021 with a large swollen lump at injection site. Lump is hard, warm to the touch, and slightly itchy. No visible bite mark to suggest bug bite, and no recollection of incident that could have caused lump (e.g., no recent trauma to the area that could explain the lump). Unsure if related to AE, but started menstrual period on Sep 29, 2021. No lump has appeared at injection site during other menstrual periods between vaccine and now.
Age: 37.0
Sex: F
Vaccine: COVID19
Symptoms: Menstrual disorder
Clinical narrative: Woke up on Sep 30, 2021 with a large swollen lump at injection site. Lump is hard, warm to the touch, and slightly itchy. No visible bite mark to suggest bug bite, and no recollection of incident that could have caused lump (e.g., no recent trauma to the area that could explain the lump). Unsure if related to AE, but started menstrual period on Sep 29, 2021. No lump has appeared at injection site during other menstrual periods between vaccine and now.
Age: 21.0
Sex: F
Vaccine: VARCEL
Symptoms: Dizziness, Dyspnoea, Lip swelling, Syncope
Clinical narrative: Patient was initially showing sings of vasovagal syncope, then started t feel dizzy and stated that she could not breath well. Patient's vitals were taken: BP:86/54 HR: 82 Spo2: 97% RR:16  Provider was consulted and noticed that patient's lip was swelling, then administered an Epi pen.
Age: 12.0
Sex: F
Vaccine: COVID19
Symptoms: Heavy menstrual bleeding, Menstruation irregular
Clinical narrative: Pt has experienced extremely long and extremely heavy menstrual periods.  Her 1st shot was given on 6/2/21, same location, Lot # EW 0217.  Her first irregular period began in early July and lasted 3 weeks.  Then she had two weeks with a period before the current one started again.  This was has been going on for 9 weeks.  A doctor has finally prescribed a birth control pill to attempt to stop this current pill.
Age: 69.0
Sex: F
Vaccine: FLU4
Symptoms: Anticoagulant therapy, Back pain, Cold sweat, Dizziness, Fear
Clinical narrative: Within 2 minutes - severe dizziness, nausea, cold sweat, muscle weakness and very severe lower back pain.  I could not walk out of the pharmacy for fear of falling. I could not drive home. After approximately 45 minutes was able to walk and had to have my husband take me home.  Fever continued to worsen thru the night, and I took aspirin to help with aches and fever.  Fever escalated to 101.8.  At this writing 6:45 am. Fever has subsided, still have achy muscles. Slight headache. I have never had a reaction like this before. Received the flu shot for 65+ last year with no reaction like this.  This was a very scary event.
Age: 69.0
Sex: F
Vaccine: FLU4
Symptoms: Gait inability, Headache, Impaired driving ability, Muscular weakness, Myalgia
Clinical narrative: Within 2 minutes - severe dizziness, nausea, cold sweat, muscle weakness and very severe lower back pain.  I could not walk out of the pharmacy for fear of falling. I could not drive home. After approximately 45 minutes was able to walk and had to have my husband take me home.  Fever continued to worsen thru the night, and I took aspirin to help with aches and fever.  Fever escalated to 101.8.  At this writing 6:45 am. Fever has subsided, still have achy muscles. Slight headache. I have never had a reaction like this before. Received the flu shot for 65+ last year with no reaction like this.  This was a very scary event.
Age: 69.0
Sex: F
Vaccine: FLU4
Symptoms: Nausea, Pain, Pyrexia
Clinical narrative: Within 2 minutes - severe dizziness, nausea, cold sweat, muscle weakness and very severe lower back pain.  I could not walk out of the pharmacy for fear of falling. I could not drive home. After approximately 45 minutes was able to walk and had to have my husband take me home.  Fever continued to worsen thru the night, and I took aspirin to help with aches and fever.  Fever escalated to 101.8.  At this writing 6:45 am. Fever has subsided, still have achy muscles. Slight headache. I have never had a reaction like this before. Received the flu shot for 65+ last year with no reaction like this.  This was a very scary event.
Age: 59.0
Sex: M
Vaccine: COVID19
Symptoms: Abdominal pain, Arthralgia, Back pain, Chest pain, Dysgeusia
Clinical narrative: Rash on neck,metallic taste,ears ringing,severe chest and abdominal pain,leg and back pain severe headache,fatigue and joint pain. Hospitalized 2 days, left eye blurred vision
Age: 59.0
Sex: M
Vaccine: COVID19
Symptoms: Fatigue, Headache, Pain in extremity, Rash, Tinnitus
Clinical narrative: Rash on neck,metallic taste,ears ringing,severe chest and abdominal pain,leg and back pain severe headache,fatigue and joint pain. Hospitalized 2 days, left eye blurred vision
Age: 59.0
Sex: M
Vaccine: COVID19
Symptoms: Vision blurred
Clinical narrative: Rash on neck,metallic taste,ears ringing,severe chest and abdominal pain,leg and back pain severe headache,fatigue and joint pain. Hospitalized 2 days, left eye blurred vision
Age: 41.0
Sex: F
Vaccine: HPV9
Symptoms: Pain in extremity, Vaccination site discomfort, Vaccination site pain
Clinical narrative: Pain in arm; Soreness and discomfort in arm at site of injection; Soreness and discomfort in arm at site of injection; This spontaneous report was received from a nurse prescriber, referring to a 41 year old female patient. The patient had no pertinent medical history and was not taking any concomitant medication.  On 21-JUL-2021, the patient was vaccinated with hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) 0.5 milliliter, intramuscularly, lot # T028583 (expiration date not provided, but upon internal validation established as 04-MAR-2023) for prevention of human papilloma virus.   On the same day, the patient experienced soreness and discomfort in the arm at site of vaccination. Additionally, per the reporting nurse, the patient's only complaint was pain in arm. The patient sought for medical attention and the reporting nurse denied redness or swelling; however, the patient started treatment with over the counter non-steroidal antiinflammatory drugs (NSAIDS) for the events. No laboratory diagnostic tests or studies were performed, and no intervention to prevent serious criteria was reported.  At the time of the report, the patient had not recovered from the events.  The reporter's causality assessment between the event's and hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) was unknown. combinationproductreport: Yes; brandname: GARDASIL 9 SYRINGE (DEVICE); commondevicename: HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast); productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp & Dohme Corp.; devicelotnumber: T028583; expirationdate: 04-MAR-2023; deviceage and unit: 0 ; malfunction: Unknown; deviceusage: Initial; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not suggest a causal association with the device or device constituent
Age: 69.0
Sex: M
Vaccine: COVID19
Symptoms: Diarrhoea, Haematochezia
Clinical narrative: Appearance of blood in loose stool on waking.
Age: 33.0
Sex: M
Vaccine: COVID19
Symptoms: Injection site paraesthesia, Nausea
Clinical narrative: Systemic: Tingling (specify: facial area, extemities)-Medium, Additional Details: Pt has reported tingling in arm of where vaccine was administered. Told to F/U with provider. Pt was worried about effect but other than tingling heis feeling completly fine. had a little bit of nauseau. Will call if there is any update
Age: 41.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test positive, Vaccine breakthrough infection
Clinical narrative: Breakthrough COVID
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19 immunisation
Clinical narrative: Systemic: already received J and J and did not tell pharmacy, Additional Details: pt received dose of J & J in April 2021 from another pharmacy.  Did not report when making appointment for Pfizer
Age: 32.0
Sex: M
Vaccine: COVID19
Symptoms: Abdominal pain, Arthralgia, Asthenia, Burning sensation, Chest discomfort
Clinical narrative: Site: Bruising at Injection Site-Medium, Site: Pain at Injection Site-Medium, Site: Redness at Injection Site-Medium, Site: Swelling at Injection Site-Severe, Systemic: Allergic: Rash Generalized-Severe, Systemic: Abdominal Pain-Medium, Systemic: Chest Tightness / Heaviness / Pain-Medium, Systemic: Chills-Medium, Systemic: Exhaustion / Lethargy-Medium, Systemic: Joint Pain-Medium, Systemic: Lymph Node Swelling-Medium, Systemic: Nausea-Medium, Systemic: Numbness (specify: facial area, extremities)-Medium, Systemic: Tingling (specify: facial area, extemities)-Severe, Systemic: Weakness-Medium, Additional Details: Patient came in pharmacy on 09/29/21 around 9am and shared with pharmacist he experienced severed bilateral arm pain, enlarged rash localized to arm site where vaccine was administered, neurologic pain , burning/ tingling of extermities, inflammation/swollen lymph nodes, and pericarditis symptoms. pharmacist instructed him to contact dr and share symptoms and adverse reaction to moderna vaccine given on sunday. He shared he would and would follow up. patient stated better feelin
Age: 32.0
Sex: M
Vaccine: COVID19
Symptoms: Chest pain, Chills, Fatigue, Hypoaesthesia, Injection site bruising
Clinical narrative: Site: Bruising at Injection Site-Medium, Site: Pain at Injection Site-Medium, Site: Redness at Injection Site-Medium, Site: Swelling at Injection Site-Severe, Systemic: Allergic: Rash Generalized-Severe, Systemic: Abdominal Pain-Medium, Systemic: Chest Tightness / Heaviness / Pain-Medium, Systemic: Chills-Medium, Systemic: Exhaustion / Lethargy-Medium, Systemic: Joint Pain-Medium, Systemic: Lymph Node Swelling-Medium, Systemic: Nausea-Medium, Systemic: Numbness (specify: facial area, extremities)-Medium, Systemic: Tingling (specify: facial area, extemities)-Severe, Systemic: Weakness-Medium, Additional Details: Patient came in pharmacy on 09/29/21 around 9am and shared with pharmacist he experienced severed bilateral arm pain, enlarged rash localized to arm site where vaccine was administered, neurologic pain , burning/ tingling of extermities, inflammation/swollen lymph nodes, and pericarditis symptoms. pharmacist instructed him to contact dr and share symptoms and adverse reaction to moderna vaccine given on sunday. He shared he would and would follow up. patient stated better feelin
Age: 32.0
Sex: M
Vaccine: COVID19
Symptoms: Injection site erythema, Injection site pain, Injection site rash, Injection site swelling, Lethargy
Clinical narrative: Site: Bruising at Injection Site-Medium, Site: Pain at Injection Site-Medium, Site: Redness at Injection Site-Medium, Site: Swelling at Injection Site-Severe, Systemic: Allergic: Rash Generalized-Severe, Systemic: Abdominal Pain-Medium, Systemic: Chest Tightness / Heaviness / Pain-Medium, Systemic: Chills-Medium, Systemic: Exhaustion / Lethargy-Medium, Systemic: Joint Pain-Medium, Systemic: Lymph Node Swelling-Medium, Systemic: Nausea-Medium, Systemic: Numbness (specify: facial area, extremities)-Medium, Systemic: Tingling (specify: facial area, extemities)-Severe, Systemic: Weakness-Medium, Additional Details: Patient came in pharmacy on 09/29/21 around 9am and shared with pharmacist he experienced severed bilateral arm pain, enlarged rash localized to arm site where vaccine was administered, neurologic pain , burning/ tingling of extermities, inflammation/swollen lymph nodes, and pericarditis symptoms. pharmacist instructed him to contact dr and share symptoms and adverse reaction to moderna vaccine given on sunday. He shared he would and would follow up. patient stated better feelin
Age: 32.0
Sex: M
Vaccine: COVID19
Symptoms: Lymphadenopathy, Nausea, Pain, Pain in extremity, Paraesthesia
Clinical narrative: Site: Bruising at Injection Site-Medium, Site: Pain at Injection Site-Medium, Site: Redness at Injection Site-Medium, Site: Swelling at Injection Site-Severe, Systemic: Allergic: Rash Generalized-Severe, Systemic: Abdominal Pain-Medium, Systemic: Chest Tightness / Heaviness / Pain-Medium, Systemic: Chills-Medium, Systemic: Exhaustion / Lethargy-Medium, Systemic: Joint Pain-Medium, Systemic: Lymph Node Swelling-Medium, Systemic: Nausea-Medium, Systemic: Numbness (specify: facial area, extremities)-Medium, Systemic: Tingling (specify: facial area, extemities)-Severe, Systemic: Weakness-Medium, Additional Details: Patient came in pharmacy on 09/29/21 around 9am and shared with pharmacist he experienced severed bilateral arm pain, enlarged rash localized to arm site where vaccine was administered, neurologic pain , burning/ tingling of extermities, inflammation/swollen lymph nodes, and pericarditis symptoms. pharmacist instructed him to contact dr and share symptoms and adverse reaction to moderna vaccine given on sunday. He shared he would and would follow up. patient stated better feelin
Age: 32.0
Sex: M
Vaccine: COVID19
Symptoms: Rash
Clinical narrative: Site: Bruising at Injection Site-Medium, Site: Pain at Injection Site-Medium, Site: Redness at Injection Site-Medium, Site: Swelling at Injection Site-Severe, Systemic: Allergic: Rash Generalized-Severe, Systemic: Abdominal Pain-Medium, Systemic: Chest Tightness / Heaviness / Pain-Medium, Systemic: Chills-Medium, Systemic: Exhaustion / Lethargy-Medium, Systemic: Joint Pain-Medium, Systemic: Lymph Node Swelling-Medium, Systemic: Nausea-Medium, Systemic: Numbness (specify: facial area, extremities)-Medium, Systemic: Tingling (specify: facial area, extemities)-Severe, Systemic: Weakness-Medium, Additional Details: Patient came in pharmacy on 09/29/21 around 9am and shared with pharmacist he experienced severed bilateral arm pain, enlarged rash localized to arm site where vaccine was administered, neurologic pain , burning/ tingling of extermities, inflammation/swollen lymph nodes, and pericarditis symptoms. pharmacist instructed him to contact dr and share symptoms and adverse reaction to moderna vaccine given on sunday. He shared he would and would follow up. patient stated better feelin
Sex: F
Vaccine: HPV9
Symptoms: Abortion spontaneous, Exposure during pregnancy, Infertility female
Clinical narrative: miscarriage; vaccinated with GARDASIL-9 and subsequently had fertility issues/She had a miscarriage; This spontaneous prospective pregnancy report was received from a medical student via a company representative referring to a female patient of unknown age. The patient's concurrent conditions, medical history and concomitant therapies were not reported.    On an unknown date, the patient was vaccinated with hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) (dose, route, strength, lot # and expiration date were not reported) for prophylaxis.  Subsequently the patient had fertility issues. She had a miscarriage (vaccine exposure during pregnancy). The last menstrual period (LMP) the estimated date of delivery (EDD) was not provided. The pregnancy outcome was miscarriage and the fetal outcome was congenital anomaly.  The causality between hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) and abortion induced was not provided.  Upon internal review, the miscarriage was determined to be medically significant.  The case is cross referenced to the case 2109USA006148 due to Parent-Child Link.  ; Sender's Comments:  US-009507513-2109USA006148:
Age: 2.0
Sex: U
Vaccine: VARCEL
Symptoms: Product storage error
Clinical narrative: No additional AE's/PQC's reported.; temperature excursion for VARlVAX/an excursion of 4 Celsius degrees for 20 minutes during transport and 4 Celsius degrees for 20 minutes during transport/administered on 09-SEP-2021; This spontaneous report was received from a registered nurse (also reported as medical assistant) and refers to a 2-year-old patient of unknown gender. No information regarding the patient's pertinent medical history, drug reactions or allergies and concomitant therapies was provided.   On 07-SEP-2021 during transport, the varicella virus vaccine live (oka/merck) (VARIVAX) lot# U015682, expiration date: 18-MAY-2023, lot# U002394, expiration date: 22-JAN-2023 and lot # U010400, expiration date: 01-APR-2023, experienced an excursion of 4 Celsius degrees (C) for 20 minutes. On 09-SEP-2021, the patient was vaccinated with an improperly stored dose of varicella virus vaccine live (oka/merck) (VARIVAX) lot# U015682, expiration date reported as 18-MAY-2023 (formulation, dose, anatomical location, and route of administration were not reported) for prophylaxis (product storage error). Administered dose of vaccine experienced the temperature excursion of -10 (C) to 8C (4C) for 20 minutes and -10C to 8C (4C) for 20 minutes. Previous temperature excursion: -10C to 8C (4C) for 7 hours and 30 minutes. No additional adverse event was reported (no adverse event).  This is one of several reports from the same reporter concerning this vaccine.; Sender's Comments:  US-009507513-2109USA005628: US-009507513-2109USA005618: US-009507513-2109USA005632: US-009507513-2109USA005742: US-009507513-2109USA005744: US-009507513-2109USA005758: US-009507513-2109USA005776: US-009507513-2109USA005902: US-009507513-2109USA005945: US-009507513-2109USA005964:
Sex: U
Vaccine: HEPA
Symptoms: Product storage error
Clinical narrative: No additional AEs; Caller reports vaccine administered after temperature excursion; This spontaneous report was received from a licensed vocational nurse referring to a patient of unknown age or gender. No information regarding the patient's pertinent medical history, concurrent conditions, concomitant medication, previous drug reactions, or allergies was provided.  On an unreported date, a temperature excursion involving Hepatitis A Vaccine, Inactivated (VAQTA) (lot number T035720 has been verified to be valid as syringe formulation, expiration date reported and validated as 15-APR-2022) occurred. The vaccine was improperly stored at a temperature of 48.9 degrees Fahrenheit for a time frame of 30 minutes. There wasn't a previous temperature excursion.   On 23-SEP-2021, Hepatitis A Vaccine, Inactivated (VAQTA) was administered to the patient after the temperature excursion occurred (administered dose, and vaccination scheme were unknown by the reporter; dose number, route of administration, and anatomical location of vaccination were not reported) (product storage error). No additional adverse events (AEs) were reported. combinationproductreport: Yes; brandname: VAQTA SYRINGE (DEVICE); commondevicename: Hepatitis A Vaccine, Inactivated; productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck; devicelotnumber: T035720; expirationdate: 15-APR-2022; deviceage and unit: 0 ; malfunction: Unknown; deviceusage: Initial; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not meet criteria for reportability
Sex: F
Vaccine: MMR
Symptoms: Abdominal pain, Autopsy, Biopsy, Chemotherapy, Chest X-ray abnormal
Clinical narrative: Disseminated Measles; This literature marketed information has been received from the authors in a published article title as stated below and refers to a 17-year-old female patient. The patient's concurrent conditions included Hodgkin's lymphoma.   On an unknown date, the patient was vaccinated with measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (MMR) (Manufacturer unknown) (lot #, expiration date, dose, strength, route of administration and anatomical location of vaccine were not reported) a for prophylaxis.  In 2019, she was admitted into the hospital for febrile neutropenia that developed during her third cycle of chemotherapy. A neck mass was noted on examination, and chest radiography showed a mediastinal mass. She was transferred to another hospital, where a biopsy led to a diagnosis of Hodgkin's lymphoma of the nodular sclerosing type. Because her mother lived away, she was transferred to our institution for further evaluation and treatment. Her lymphoma was stage IIA, and doxorubicin hydrochloride (ADRIAMYCIN) (+) bleomycin (+) vincristine sulfate (+) etoposide phosphate (+) prednisone (+) and cyclophosphamide (ABVE-PC) chemotherapy was initiated urgently, owing to tracheal compression from the mediastinal mass. She received three rounds of chemotherapy at 17, 40, and 62 days after vaccination, and her clinical course was complicated by febrile neutropenia, diffuse abdominal pain, varicellazoster infection, recurrent rash and respiratory distress. Extensive infectious workup, including next-generation sequencing of microbial cell-free DNA, was negative. Imaging showed worsening bilateral ground-glass opacities in the lungs as well as hepatic and splenic nodules. Unfortunately, her respiratory status declined rapidly, leading to her death 3 months after the vaccinations. An autopsy was performed. Microscopic examination of the lungs, liver, and pituitary gland showed multinucleated giant cells with cytoplasmic and intranuclear inclusions, which were confirmed as measles viral inclusions by immunohistochemical assay for measles virus. Furthermore, measles virus RNA was detected by reverse transcriptase polymerase-chain-reaction (RT-PCR) assay in lung tissue and characterized by vaccine-specific RT-PCR assay. The presence of a vaccine strain of measles was confirmed by sequence analysis and genotyping. No evidence of secondary infection or active lymphoma was found. It was described that this was a fatal case of vaccine-associated measles in a teenager with immune compromise secondary to lymphoma, with the diagnosis made post mortem.  The reporter considered the event to be related to Measles, Mumps, and Rubella (Wistar RA 27-3) Virus Vaccine, Live (MMR) (manufacturer unknown).      A copy of the published article is attached as further documentation of the patient's experience.; Reported Cause(s) of Death: Disseminated Measles
Sex: F
Vaccine: MMR
Symptoms: Condition aggravated, Death, Febrile neutropenia, Hepatic mass, Hodgkin's disease nodular sclerosis stage II
Clinical narrative: Disseminated Measles; This literature marketed information has been received from the authors in a published article title as stated below and refers to a 17-year-old female patient. The patient's concurrent conditions included Hodgkin's lymphoma.   On an unknown date, the patient was vaccinated with measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (MMR) (Manufacturer unknown) (lot #, expiration date, dose, strength, route of administration and anatomical location of vaccine were not reported) a for prophylaxis.  In 2019, she was admitted into the hospital for febrile neutropenia that developed during her third cycle of chemotherapy. A neck mass was noted on examination, and chest radiography showed a mediastinal mass. She was transferred to another hospital, where a biopsy led to a diagnosis of Hodgkin's lymphoma of the nodular sclerosing type. Because her mother lived away, she was transferred to our institution for further evaluation and treatment. Her lymphoma was stage IIA, and doxorubicin hydrochloride (ADRIAMYCIN) (+) bleomycin (+) vincristine sulfate (+) etoposide phosphate (+) prednisone (+) and cyclophosphamide (ABVE-PC) chemotherapy was initiated urgently, owing to tracheal compression from the mediastinal mass. She received three rounds of chemotherapy at 17, 40, and 62 days after vaccination, and her clinical course was complicated by febrile neutropenia, diffuse abdominal pain, varicellazoster infection, recurrent rash and respiratory distress. Extensive infectious workup, including next-generation sequencing of microbial cell-free DNA, was negative. Imaging showed worsening bilateral ground-glass opacities in the lungs as well as hepatic and splenic nodules. Unfortunately, her respiratory status declined rapidly, leading to her death 3 months after the vaccinations. An autopsy was performed. Microscopic examination of the lungs, liver, and pituitary gland showed multinucleated giant cells with cytoplasmic and intranuclear inclusions, which were confirmed as measles viral inclusions by immunohistochemical assay for measles virus. Furthermore, measles virus RNA was detected by reverse transcriptase polymerase-chain-reaction (RT-PCR) assay in lung tissue and characterized by vaccine-specific RT-PCR assay. The presence of a vaccine strain of measles was confirmed by sequence analysis and genotyping. No evidence of secondary infection or active lymphoma was found. It was described that this was a fatal case of vaccine-associated measles in a teenager with immune compromise secondary to lymphoma, with the diagnosis made post mortem.  The reporter considered the event to be related to Measles, Mumps, and Rubella (Wistar RA 27-3) Virus Vaccine, Live (MMR) (manufacturer unknown).      A copy of the published article is attached as further documentation of the patient's experience.; Reported Cause(s) of Death: Disseminated Measles
Sex: F
Vaccine: MMR
Symptoms: Lung opacity, Measles, Mediastinal mass, Morbillivirus test positive, Neck mass
Clinical narrative: Disseminated Measles; This literature marketed information has been received from the authors in a published article title as stated below and refers to a 17-year-old female patient. The patient's concurrent conditions included Hodgkin's lymphoma.   On an unknown date, the patient was vaccinated with measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (MMR) (Manufacturer unknown) (lot #, expiration date, dose, strength, route of administration and anatomical location of vaccine were not reported) a for prophylaxis.  In 2019, she was admitted into the hospital for febrile neutropenia that developed during her third cycle of chemotherapy. A neck mass was noted on examination, and chest radiography showed a mediastinal mass. She was transferred to another hospital, where a biopsy led to a diagnosis of Hodgkin's lymphoma of the nodular sclerosing type. Because her mother lived away, she was transferred to our institution for further evaluation and treatment. Her lymphoma was stage IIA, and doxorubicin hydrochloride (ADRIAMYCIN) (+) bleomycin (+) vincristine sulfate (+) etoposide phosphate (+) prednisone (+) and cyclophosphamide (ABVE-PC) chemotherapy was initiated urgently, owing to tracheal compression from the mediastinal mass. She received three rounds of chemotherapy at 17, 40, and 62 days after vaccination, and her clinical course was complicated by febrile neutropenia, diffuse abdominal pain, varicellazoster infection, recurrent rash and respiratory distress. Extensive infectious workup, including next-generation sequencing of microbial cell-free DNA, was negative. Imaging showed worsening bilateral ground-glass opacities in the lungs as well as hepatic and splenic nodules. Unfortunately, her respiratory status declined rapidly, leading to her death 3 months after the vaccinations. An autopsy was performed. Microscopic examination of the lungs, liver, and pituitary gland showed multinucleated giant cells with cytoplasmic and intranuclear inclusions, which were confirmed as measles viral inclusions by immunohistochemical assay for measles virus. Furthermore, measles virus RNA was detected by reverse transcriptase polymerase-chain-reaction (RT-PCR) assay in lung tissue and characterized by vaccine-specific RT-PCR assay. The presence of a vaccine strain of measles was confirmed by sequence analysis and genotyping. No evidence of secondary infection or active lymphoma was found. It was described that this was a fatal case of vaccine-associated measles in a teenager with immune compromise secondary to lymphoma, with the diagnosis made post mortem.  The reporter considered the event to be related to Measles, Mumps, and Rubella (Wistar RA 27-3) Virus Vaccine, Live (MMR) (manufacturer unknown).      A copy of the published article is attached as further documentation of the patient's experience.; Reported Cause(s) of Death: Disseminated Measles
Sex: F
Vaccine: MMR
Symptoms: Rash, Respiratory distress, Respiratory failure, Spleen disorder, Varicella zoster virus infection
Clinical narrative: Disseminated Measles; This literature marketed information has been received from the authors in a published article title as stated below and refers to a 17-year-old female patient. The patient's concurrent conditions included Hodgkin's lymphoma.   On an unknown date, the patient was vaccinated with measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (MMR) (Manufacturer unknown) (lot #, expiration date, dose, strength, route of administration and anatomical location of vaccine were not reported) a for prophylaxis.  In 2019, she was admitted into the hospital for febrile neutropenia that developed during her third cycle of chemotherapy. A neck mass was noted on examination, and chest radiography showed a mediastinal mass. She was transferred to another hospital, where a biopsy led to a diagnosis of Hodgkin's lymphoma of the nodular sclerosing type. Because her mother lived away, she was transferred to our institution for further evaluation and treatment. Her lymphoma was stage IIA, and doxorubicin hydrochloride (ADRIAMYCIN) (+) bleomycin (+) vincristine sulfate (+) etoposide phosphate (+) prednisone (+) and cyclophosphamide (ABVE-PC) chemotherapy was initiated urgently, owing to tracheal compression from the mediastinal mass. She received three rounds of chemotherapy at 17, 40, and 62 days after vaccination, and her clinical course was complicated by febrile neutropenia, diffuse abdominal pain, varicellazoster infection, recurrent rash and respiratory distress. Extensive infectious workup, including next-generation sequencing of microbial cell-free DNA, was negative. Imaging showed worsening bilateral ground-glass opacities in the lungs as well as hepatic and splenic nodules. Unfortunately, her respiratory status declined rapidly, leading to her death 3 months after the vaccinations. An autopsy was performed. Microscopic examination of the lungs, liver, and pituitary gland showed multinucleated giant cells with cytoplasmic and intranuclear inclusions, which were confirmed as measles viral inclusions by immunohistochemical assay for measles virus. Furthermore, measles virus RNA was detected by reverse transcriptase polymerase-chain-reaction (RT-PCR) assay in lung tissue and characterized by vaccine-specific RT-PCR assay. The presence of a vaccine strain of measles was confirmed by sequence analysis and genotyping. No evidence of secondary infection or active lymphoma was found. It was described that this was a fatal case of vaccine-associated measles in a teenager with immune compromise secondary to lymphoma, with the diagnosis made post mortem.  The reporter considered the event to be related to Measles, Mumps, and Rubella (Wistar RA 27-3) Virus Vaccine, Live (MMR) (manufacturer unknown).      A copy of the published article is attached as further documentation of the patient's experience.; Reported Cause(s) of Death: Disseminated Measles
Sex: U
Vaccine: HPV9
Symptoms: Foetal exposure during pregnancy, Human papilloma virus test positive
Clinical narrative: tested a sample from the fetus and that there was GARDASIL-9 vaccine in the sample results; the mother vaccinated with GARDASIL-9 and subsequently had fertility issues/She had a miscarriage; This spontaneous report has been received from a medical student via a company representative referring to a foetus. Information about medical history, concurrent conditions and concomitant therapies was not provided.   On an unknown date, the patient's mother was vaccinated with hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) (dose, route, strength, lot # and expiration date were not reported) for prophylaxis. Subsequently the patient's mother had fertility issues. The patient's mother had a miscarriage (fetal exposure during pregnancy).   The doctor tested a sample from the fetus and there was hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) (human papilloma virus test positive) in the sample results. The outcome of human papilloma virus test positive was unknown.  The causality between human papilloma virus test positive and hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) was not provided.  The case is cross referenced to the case 2109USA005831 due to Parent-Child Link.; Sender's Comments:  US-009507513-2109USA005831:
Sex: U
Vaccine: PPV
Symptoms: No adverse event, Product storage error
Clinical narrative: no adverse event; the excursion occurred; This spontaneous report was received from a nurse and refers to a patient of unknown age and gender. The patient's concurrent conditions, medical history and concomitant medications were not reported.  On 21-SEP-2021, the patient was vaccinated with an improperly stored dose of pneumococcal vaccine, polyvalent (23-valent)(PNEUMOVAX23) (lot # T040202, expiry date 11-SEP-2022) for prophylaxis.  The suspect vaccine was stored in a temperature of 26.1 degrees Celsius (C) for 2 hours and 23 minutes. There was no previous temperature excursion. The patient did not report any symptoms after administration. combinationproductreport: Yes; brandname: PNEUMOVAX23 SYRINGE (DEVICE); commondevicename: Pneumococcal Vaccine, Polyvalent (23-valent); productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp & Dohme Corp.; devicelotnumber: T040202; expirationdate: 11-SEP-2022; deviceage and unit: 0 ; malfunction: Unknown; deviceusage: Initial; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not meet criteria for reportability
Age: 52.0
Sex: F
Vaccine: PPV
Symptoms: Inappropriate schedule of product administration
Clinical narrative: inappropriate schedule of vaccine administration; inappropriate schedule of vaccine administration; This spontaneous report has been received from a lawyer, from a case in litigation for zoster vaccine live (ZOSTAVAX) (MARRS # 1810USA005788), concerning a 54-year-old female patient.  On 01-JAN-2005 and 15-OCT-2006, the patient was vaccinated with pneumococcal vaccine, polyvalent (23-valent) (reported as pneumococcal polysaccharide PPV23) (manufacturer unknown) (strengths, doses, routes, anatomical locations, lot numbers and expiration dates were not reported) as prophylaxis (inappropriate schedule of product administration).  On 13-JAN-2017, the patient was vaccinated with pneumococcal vaccine conj 13V (CRM197) (reported as pneumococcal conjugated PCV 13) (manufacturer unknown) (strength, dose, route, anatomical location, lot number and expiration date were not reported) as prophylaxis; then, on 17-JUL-2017, the pt received another dose of pneumococcal vaccine, polyvalent (23-valent) (reported as pneumococcal polysaccharide PPV23) (manufacturer unknown) (strength, dose, route, anatomical location, lot number and expiration date were not reported) as prophylaxis (inappropriate schedule of product administration).; Sender's Comments:  US-009507513-1810USA005788:
Age: 25.0
Sex: F
Vaccine: HEPA, VARCEL
Symptoms: Administration site erythema, Administration site pain, Administration site rash
Clinical narrative: erythema, rash and pain on the administration site; erythema, rash and pain on the administration site; erythema, rash and pain on the administration site; This spontaneous report was received from a consumer, via a company representative, concerning a 25-years-old female patient. The patient's concurrent conditions, medical history, concomitant therapies, and drug allergies were not reported.   On 21-SEP-2021, the patient received one dose of varicella virus vaccine live (oka/merck)(VARIVAX), lot number T038830, with an expiration date not reported but, upon internal validation stablished as 17-NOV-2022, at the dose of 1 milliliter (ml) via subcutaneous (strength, vaccination scheme, and anatomical location were not reported) and one dose of hepatitis a vaccine, inactivated (manufacturer unknown) (route of administration, strength, exact dose, vaccination scheme, anatomical location, lot number, and expiration date were not reported), both for prophylaxis.   Subsequently, on 22-SEP-2021 (reported as "one day after vaccination"), the patient presented erythema, rash and pain on the administration site (vaccination site erythema, vaccination site rash and vaccination site pain). No other symptoms were developed, no treatment received.   At the reporting time, the outcome of the events, as well as the causal relationship between the events and the suspect vaccines were unknown.
Age: 23.0
Sex: F
Vaccine: HPV9
Symptoms: Inappropriate schedule of product administration
Clinical narrative: Nurse reported no other adverse events; Patient received first and second dose of Gardasil 9 on 12-SEP-2018 and 24-FEB-2020 respectively. On 24-SEP-2021, the patient was scheduled to received third dose; Patient received first and second dose of Gardasil 9 on 12-SEP-2018 and 24-FEB-2020 respectively. On 24-SEP-2021, the patient was scheduled to received third dose; This spontaneous report was received from a registered nurse and refers to a 23-year-old female patient. The patient's concurrent conditions, drug reactions or allergies, pertinent medical history and concomitant therapy were not reported.     On 12-SEP-2018 and on 24-FEB-2020, the patient was vaccinated respectively with  a first and second dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) (dose, lot #, expiration date and route were not reported) for prophylaxis (inappropriate schedule of product administration). Registered nurse also reported, that there were no other adverse events and no product quality complain.   On 24-SEP-2021 (also reported as today),the patient was scheduled to receive third dose of  hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) (dose, lot #, expiration date and route were not reported) for prophylaxis.
Sex: U
Vaccine: HPV4
Symptoms: No adverse event
Clinical narrative: no adittional AE; had missed Brand Name GARDASIL doses specific to the Brand Name GARDASIL dose series; This spontaneous report as received from a pharmacist refers to a 9-year-old patient of unknown gender.  The patient's concurrent conditions, medical history and concomitant therapies were not provided.   Approximately in 2009 (reported as 12 years ago) the patient was vaccinated with the first dose of quadrivalent human papillomavirus (types 6,11,16,18) recomb. Vaccine (GARDASIL) (route and dosage information were unknown) for prophylaxis.   At the reporting time, the patient had not received the other doses for quadrivalent human papillomavirus (types 6,11,16,18) recomb. Vaccine (GARDASIL) (inappropriate schedule of drug administration). No adverse event was reported.
Sex: U
Vaccine: MMR
Symptoms: Expired product administered
Clinical narrative: additional AE reported; patient was inadvertently administered an expired dose of M-M-R II; This spontaneous report as received from a physician assistant refers to a patient of unknown age and gender. The patient's medical history and concomitant therapies were not reported. Concomitant therapies included sterile diluent.   On 23-SEP-2021, the patient was inadvertently vaccinated with an expired dose of  measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live(M-M-R II) lot # S010704 with expiration date of 08-APR-2021, 0.5 milliliter for prophylaxis (route was not provided); which had not been previously exposed to any temperature excursions. No additional events were reported.
Sex: F
Vaccine: HPV4
Symptoms: Autoimmune disorder
Clinical narrative: issue with autoimmune disease; This spontaneous report was received from a consumer concerning a female patient of unknown age. No information about the current condition, medical history or concomitant therapy was reported.   On an unknown date, the patient was vaccinated with quadrivalent human papillomavirus (types 6,11,16,18) recomb. Vaccine (GARDASIL) (dose, route and lot# were not reported) for prophylaxis.  On an unknown date, the patient felt that ever since then she had issues with autoimmune disease (autoimmune disorder). The outcome of the event was not reported. Action taken with quadrivalent human papillomavirus (types 6,11,16,18) recomb. Vaccine (GARDASIL) was not applicable.   The causality between the event and quadrivalent human papillomavirus (types 6,11,16,18) recomb. Vaccine (GARDASIL) was not reported. Upon internal review, the event of autoimmune disorder was considered as medically significant.
Sex: U
Vaccine: VARZOS
Symptoms: Fatigue, Headache, Nausea, Pyrexia
Clinical narrative: Fever; Nausea; Bad headache; Tired; This case was reported by a consumer via interactive digital media and described the occurrence of fever in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   In September 2021, the patient received Shingles vaccine. In September 2021, less than a week after receiving Shingles vaccine, the patient experienced fever, nausea, headache and tiredness. In September 2021, the outcome of the fever, nausea, headache and tiredness were recovered/resolved.   It was unknown if the reporter considered the fever, nausea, headache and tiredness to be related to Shingles vaccine.  Additional details were reported as follows: This case was reported by the patient for herself/himself. The age at vaccination was not reported. The patient had the shingles vaccine last week and had a fever and nausea, tired, bad headache , doctor said that's normal and would pass on about two days. The patient stated that still better than the actual shingles. The patient had next shot in 2 months. The follow-up would not possible as contacts information was not reported.