chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 7.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: Headache, high fever, body aches and weakness, nausea, chills
Age: 37.0
Sex: M
Vaccine: COVID19
Symptoms: Headache, Palpitations
Clinical narrative: Heart palpitations occur randomly throughout day. Severe headaches while commuting to work.
Age: 84.0
Sex: F
Vaccine: COVID19
Symptoms: Atrial fibrillation, Blood test, Cerebral haemorrhage, Cerebral thrombosis, Cerebrovascular accident
Clinical narrative: Sometime during the early hours of the morning, Patient started A-Fib and threw a brain-blood clot/stroke.  Surgery was performed to remove blood clot. A bleed then occurred in the area of the clot. Medication given to control A-fib.  Hospitalization/Acute Rehab/Out-patient OT/PT/Speech therapy bi-weekly.  Currently has little language and requires full-time assistance.
Age: 84.0
Sex: F
Vaccine: COVID19
Symptoms: Computerised tomogram, Language disorder, Magnetic resonance imaging, Thrombectomy
Clinical narrative: Sometime during the early hours of the morning, Patient started A-Fib and threw a brain-blood clot/stroke.  Surgery was performed to remove blood clot. A bleed then occurred in the area of the clot. Medication given to control A-fib.  Hospitalization/Acute Rehab/Out-patient OT/PT/Speech therapy bi-weekly.  Currently has little language and requires full-time assistance.
Age: 25.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Hypoaesthesia, Malaise, Nausea
Clinical narrative: Patient experienced dizziness, nausea, and numbness in her arm following her vaccination during the 15 minute observation period. She was assisted to the floor to lay down on her back and elevate her feet. We applied cold compress to her neck and she began to feel better within a few minutes and was able to return to a seated position with symptoms resolving back to normal within 30 minutes.
Age: 43.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Fatigue, Headache, Pain, Pyrexia
Clinical narrative: Fever, fatigue, congestion, headache, chills, body aches. Tested at home for 2 days to recover.  Slowly recovering.
Age: 43.0
Sex: M
Vaccine: COVID19
Symptoms: Respiratory tract congestion
Clinical narrative: Fever, fatigue, congestion, headache, chills, body aches. Tested at home for 2 days to recover.  Slowly recovering.
Age: 9.0
Sex: F
Vaccine: COVID19
Symptoms: Eye pain, Eye swelling, Swelling of eyelid
Clinical narrative: Child had swollen eyelid on left eye and pain similar to a headache behind her swollen eye. Treated with OTC eye drops, ibuprofen for pain, and a cool pack on the eye. The swelling lasted for five days, and subsequently resolved. Parents declined to continue the vaccine series fearing a more significant reaction with a second  dose.
Age: 31.0
Sex: F
Vaccine: COVID19
Symptoms: Amenorrhoea
Clinical narrative: Missing period
Age: 46.0
Sex: F
Vaccine: UNK
Symptoms: Pain, Pain in extremity
Clinical narrative: I continue to experience sharp shooting pain in my leg and arms on the left side. It truly is terrible pain after I got the vaccine.
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Computerised tomogram normal, Disorientation, Disturbance in attention, Dysarthria, Epistaxis
Clinical narrative: It started with lots of ringing in my ears to the point that it took over my hearing,  then came the tingling in left arm that traveled down to the tips of my fingers, changes in ability to walk, extreme muscle pain throughout body, some sort of feeling like a not in my left arm, then came the sever migraine on the left side of my head accompanied with lots of pressure with loss of touch on the top of my head, sever nose bleed in the middle of the night and included what appeared to be clots and dark red in color, disorientation, the inability to focus, regular noise levels seemed to became louder and slurring with loss of feelings in the left side of my face.
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Gait disturbance, Head discomfort, Hyperacusis, Migraine, Myalgia
Clinical narrative: It started with lots of ringing in my ears to the point that it took over my hearing,  then came the tingling in left arm that traveled down to the tips of my fingers, changes in ability to walk, extreme muscle pain throughout body, some sort of feeling like a not in my left arm, then came the sever migraine on the left side of my head accompanied with lots of pressure with loss of touch on the top of my head, sever nose bleed in the middle of the night and included what appeared to be clots and dark red in color, disorientation, the inability to focus, regular noise levels seemed to became louder and slurring with loss of feelings in the left side of my face.
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Nodule, Paraesthesia, Sensory loss, Thrombosis, Tinnitus
Clinical narrative: It started with lots of ringing in my ears to the point that it took over my hearing,  then came the tingling in left arm that traveled down to the tips of my fingers, changes in ability to walk, extreme muscle pain throughout body, some sort of feeling like a not in my left arm, then came the sever migraine on the left side of my head accompanied with lots of pressure with loss of touch on the top of my head, sever nose bleed in the middle of the night and included what appeared to be clots and dark red in color, disorientation, the inability to focus, regular noise levels seemed to became louder and slurring with loss of feelings in the left side of my face.
Age: 68.0
Sex: M
Vaccine: COVID19, VARZOS
Symptoms: Apathy, Asthenia, Dizziness, Dysstasia, Gait disturbance
Clinical narrative: whole body ache, weakness, light-headed, mild headache, no motivation, hard to walk or stand, back of neck hurts
Age: 68.0
Sex: M
Vaccine: COVID19, VARZOS
Symptoms: Headache, Neck pain, Pain
Clinical narrative: whole body ache, weakness, light-headed, mild headache, no motivation, hard to walk or stand, back of neck hurts
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Lymph node pain, Lymphadenopathy
Clinical narrative: pain and swollen lymph nodes in armpit for 3 days/nights.  Normal now.
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Dyskinesia, Feeling cold, Urine output increased
Clinical narrative: I was awakened by intense jerking of my arms and legs, and possibly my torso.  I couldn't control these.  I also had felt very cold but it was to decide if I was cold or not because the jerking was so intense it blocked out other sensations.  I also had to get up and urinate a large amount which was unusual as I had urinated just before going to bed about 1-2 hours before this started.  The jerking lasted about 30 minutes.  After another hour I had to get up again to urinate a large amount.
Age: 30.0
Sex: F
Vaccine: COVID19
Symptoms: Breast pain, Lymphadenopathy, Pain in extremity, Peripheral swelling
Clinical narrative: Baseball sized swollen area under right arm with pain throughout underarm and right breast. Swollen lymphnodes. Lasted 1 week,
Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: Chest pain
Clinical narrative: Chest pain
Age: 22.0
Sex: F
Vaccine: COVID19
Symptoms: Heavy menstrual bleeding, Oligomenorrhoea, Thrombosis
Clinical narrative: Increase in heaviness of menstrual bleeding and passing blood clots the size of or larger than a golf ball, soaking through a super tampon within less than an hour.  Days of period increased by 5 days.
Age: 25.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Fatigue, Pain, Tenderness
Clinical narrative: On the evening of getting the vaccine, I experienced chills, fatigue, and body aches. These symptoms were mostly resolved within 24 hours. 5 days later, I noticed a tender lump in my arm on the opposite side of the vaccine injection site.
Age: 43.0
Sex: M
Vaccine: COVID19
Symptoms: Incorrect dose administered
Clinical narrative: Pt. received wrong booster dose of vaccine.  Should have gotten 0.3ml, received 0.25ml instead.  Pt. was notified by me and will be offered a re-booster vaccine as soon as possible.
Age: 58.0
Sex: M
Vaccine: COVID19
Symptoms: Incorrect dose administered
Clinical narrative: Pt. received wrong booster dose of vaccine.  Should have gotten 0.3ml, received 0.25ml instead.  Pt. was notified by me and will be offered a re-booster vaccine as soon as possible.
Age: 56.0
Sex: M
Vaccine: COVID19
Symptoms: Incorrect dose administered
Clinical narrative: Pt. given the wrong booster dose of Pfizer vaccine.  Should have gotten 0.3ml, received 0.25ml instead.  Pt. already informed by me and will be offered a re-booster Pfizer vaccine as soon as possible.
Age: 57.0
Sex: M
Vaccine: COVID19
Symptoms: Incorrect dose administered
Clinical narrative: Pt. given the wrong booster dose of Pfizer vaccine.  Should have gotten 0.3ml, received 0.25ml instead.  Pt. already informed by me and will be offered a re-booster Pfizer vaccine as soon as possible.
Age: 58.0
Sex: M
Vaccine: COVID19
Symptoms: Incorrect dose administered
Clinical narrative: Pt. given the wrong booster dose of Pfizer vaccine.  Should have gotten 0.3ml, received 0.25ml instead.  Pt. already informed by me and will be offered a re-booster Pfizer vaccine as soon as possible.
Age: 47.0
Sex: M
Vaccine: COVID19
Symptoms: Incorrect dose administered
Clinical narrative: Pt. given the wrong booster dose of Pfizer vaccine.  Should have gotten 0.3ml, received 0.25ml instead.  Pt. already informed by me and will be offered a re-booster Pfizer vaccine as soon as possible.
Age: 33.0
Sex: F
Vaccine: COVID19
Symptoms: Chest pain, Fatigue, Musculoskeletal chest pain
Clinical narrative: Chest pain near left rib cage and extreme tiredness
Age: 29.0
Sex: M
Vaccine: COVID19
Symptoms: Incorrect dose administered
Clinical narrative: Pt. given the wrong booster dose of Pfizer vaccine.  Should have gotten 0.3ml, received 0.25ml instead.  Pt. already informed by me and will be offered a re-booster Pfizer vaccine as soon as possible.
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Cardiac murmur, Swelling
Clinical narrative: Swelling from middle of neck to right. New onset heart murmur.
Age: 63.0
Sex: M
Vaccine: COVID19
Symptoms: Incorrect dose administered
Clinical narrative: Pt. given the wrong booster dose of Pfizer vaccine.  Should have gotten 0.3ml, received 0.25ml instead.  I have attempted to contact this pt., and will continue to do so so I can offer a re-booster Pfizer vaccine as soon as possible.
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Arteriogram, Computerised tomogram, Pericarditis, Ultrasound scan, X-ray
Clinical narrative: Pericarditis
Age: 45.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Breast pain, Chest pain, Chills, Headache
Clinical narrative: Post Vaccnation symptoms. Muscle aches, injection site pain,  chest pain continues third day at same intensity, headaches, nausea, weakness, chills.  All symptoms started following morning after vaccination and majority disappeared by day 3 except for chest pain left side chest and mid sternum under left breast and left arm pain with on and off numbness.  Underarm dwelling one side only.
Age: 45.0
Sex: F
Vaccine: COVID19
Symptoms: Hypoaesthesia, Injection site pain, Myalgia, Nausea, Pain in extremity
Clinical narrative: Post Vaccnation symptoms. Muscle aches, injection site pain,  chest pain continues third day at same intensity, headaches, nausea, weakness, chills.  All symptoms started following morning after vaccination and majority disappeared by day 3 except for chest pain left side chest and mid sternum under left breast and left arm pain with on and off numbness.  Underarm dwelling one side only.
Age: 45.0
Sex: F
Vaccine: COVID19
Symptoms: Peripheral swelling
Clinical narrative: Post Vaccnation symptoms. Muscle aches, injection site pain,  chest pain continues third day at same intensity, headaches, nausea, weakness, chills.  All symptoms started following morning after vaccination and majority disappeared by day 3 except for chest pain left side chest and mid sternum under left breast and left arm pain with on and off numbness.  Underarm dwelling one side only.
Sex: F
Vaccine: COVID19
Symptoms: Depression, Drug ineffective, Suspected COVID-19
Clinical narrative: Covid-19; Covid-19; depressed; FACILITATED COLLECT  This is a solicited report received from contactable reporter(s) (Consumer or other non HCP) for a sponsored program. The reporter is the patient.  An adult female patient received bnt162b2 (BNT162B2), intramuscular, administration date 30Apr2021 (Batch/Lot number: unknown) as dose 2, single and intramuscular, administration date 07Apr2021 (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation; adalimumab (HUMIRA), subcutaneous, administration date 13Apr2014 (ongoing) (Batch/Lot number: unknown) as 40 mg (1 in 2 wk) for rheumatoid arthritis. Relevant medical history included: "Rheumatoid Arthritis" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: SUSPECTED COVID-19 (medically significant), DRUG INEFFECTIVE (medically significant) all with onset Aug2021, outcome "recovered" (2021) and all described as "Covid-19"; DEPRESSION (non-serious) with onset 2021, outcome "not recovered", described as "depressed". The action taken for adalimumab was dosage not changed. It was unknown if patient was enrolled in a COVID-19 Vaccine Trial. Causality for HUMIRA 40MG/0.8ML (Adalimumab): The reporter's causality for the event(s), depressed, covid 19 with Humira 40mg/0.8ml(Adalimumab) was no Reasonable possibility. Causality for BNT162B2: The reporter's causality for the event(s) depressed, covid 19 with BNT162B2 was not provided at the time of this report. Since no determination has been received, the case is managed based on the company causality assessment.  The lot number for bnt162b2 was not provided and will be requested during follow up.; Sender's Comments: Based on the currently available information the possibility of causal association between the reported events and the suspect drug BNT162B2  cannot be ruled out. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate,Linked Report(s) : 21K-131-4185304-00
Sex: U
Vaccine: PPV
Symptoms: Product storage error
Clinical narrative: No additional AE's or PQC's were reported; improperly stored dose of Pneumovax was administered to a patient; This spontaneous report was received from a nurse and refers to a patient of unknown age and gender. No information regarding the patient's concurrent conditions, medical history, drug reactions or allergies and concomitant medications was provided.  On 18-NOV-2021, the patient was vaccinated with first dose of improperly stored (temperature excursion occured on 04-NOV-2021) pneumococcal vaccine, polyvalent (23-valent)(PNEUMOVAX23) lot# U018309, expiration date: 08-JAN-2023 (exact dose, route of administration, anatomical location were not reported) for prophylaxis. Administered dose of vaccine has been stored in the temperature of 70 Fahrenheit (F) for 16 hours. There were no previous temperature excursions reported. No adverse event was reported.
Sex: U
Vaccine: MMR
Symptoms: Expired product administered
Clinical narrative: No additional AE; Patient was administered expired MMRII; This spontaneous report was received from an other healthcare business professional referring to a patient of unknown age and gender. The patient's pertinent medical history, previous drug reactions or allergies, and concomitant medications were not reported.     On 19-NOV-2021, the patient was vaccinated with expired measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) for prophylaxis (strength, dose, route of administration and anatomical location were not reported; lot number S035352 had been verified to be a valid number; expiration date 05-NOV-2021). No additional adverse event.
Age: 65.0
Sex: M
Vaccine: HPV9
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: No additional AEs; a 65 year old male patient was administered GARDASIL 9 on today; This spontaneous report has been received from a pharmacist referring to a 65-year-old male patient. No information regarding the patient's medical history, previous drug reactions or allergies, concurrent conditions or concomitant medications was provided.  On 07-DEC-2021, the patient was vaccinated with hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) (product administered to patient of inappropriate age) dose and frequency reported as 1 time dose (dose, route of administration and anatomical site of vaccination were not reported; lot number T036442 has been verified to be valid, expiration date reported and established as 09-APR-2023) as prophylaxis.   No additional adverse events were reported (no adverse event).
Sex: F
Vaccine: HPV9
Symptoms: Anxiety, Back pain, Fatigue, Headache, Pain in extremity
Clinical narrative: bad anxiety which hinders her ability to function around people/ hindered her ability to finish school; experience aches/pain over her back and legs; experience aches/pain over her back and legs; headaches; fatigue; This spontaneous report has been received from a consumer referring to his daughter, a currently 19-year-old, non-pregnant female patient. The patient had no medical history, concomitant medications nor previous drug reactions/allergies.   On an unspecified date, the patient was vaccinated with the first dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) (dose, lot number and expiration date were not reported). On an unspecified date, the patient was vaccinated with the second dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) route of administration reported as "shot her arm" (dose, anatomical site of vaccination, lot number and expiration date were not reported). Both doses were administered to prevent human papillomavirus (HPV).   On an unspecified date, the patient began to experience aches or pains over her back and legs (back pain, pain in extremity), headaches, fatigue, and "bad" anxiety (severe) which hindered her ability to function around people. Moreover, the patient's anxiety hindered her ability to finish school and the reporter was worried that in the future the patient's anxiety would affect her ability to work, and he thought she may be affected for life. Due to the events, the patient did not receive the third dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9).   It was reported that the patient did not seek medical attention, no treatment was given for the events and no lab diagnostics or studies were performed.   The reporter stated that he reached out to an attorney's office to see if he would have a case.    At the time of reporting, the patient had not recovered from the events. Therapy with hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) was withdrawn. The causal relationship between hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) and the events was not reported.   This is one of two reports received from the same source.; Sender's Comments:  US-009507513-2112USA003013:
Sex: F
Vaccine: HPV9
Symptoms: Social problem
Clinical narrative: bad anxiety which hinders her ability to function around people/ hindered her ability to finish school; experience aches/pain over her back and legs; experience aches/pain over her back and legs; headaches; fatigue; This spontaneous report has been received from a consumer referring to his daughter, a currently 19-year-old, non-pregnant female patient. The patient had no medical history, concomitant medications nor previous drug reactions/allergies.   On an unspecified date, the patient was vaccinated with the first dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) (dose, lot number and expiration date were not reported). On an unspecified date, the patient was vaccinated with the second dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) route of administration reported as "shot her arm" (dose, anatomical site of vaccination, lot number and expiration date were not reported). Both doses were administered to prevent human papillomavirus (HPV).   On an unspecified date, the patient began to experience aches or pains over her back and legs (back pain, pain in extremity), headaches, fatigue, and "bad" anxiety (severe) which hindered her ability to function around people. Moreover, the patient's anxiety hindered her ability to finish school and the reporter was worried that in the future the patient's anxiety would affect her ability to work, and he thought she may be affected for life. Due to the events, the patient did not receive the third dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9).   It was reported that the patient did not seek medical attention, no treatment was given for the events and no lab diagnostics or studies were performed.   The reporter stated that he reached out to an attorney's office to see if he would have a case.    At the time of reporting, the patient had not recovered from the events. Therapy with hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) was withdrawn. The causal relationship between hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) and the events was not reported.   This is one of two reports received from the same source.; Sender's Comments:  US-009507513-2112USA003013:
Age: 22.0
Sex: M
Vaccine: HPV4, HPV9
Symptoms: Inappropriate schedule of product administration
Clinical narrative: no adverse event; Patient received one dosage of the HPV vaccine on 24-AUG-2011. Now received Gardasil-9; The patient received only one dosage of the HPV vaccine on 8/24/2011. His mother called to see if it possible for him to finish the series despite the long gap in time period; This spontaneous report was received from a registered nurse referring to a 32-year-old male patient.  Information regarding the patient's concurrent conditions, medical history or concomitant medications was not provided.  On 24-AUG-2021, the patient was vaccinated with quadrivalent human papillomavirus (types 6,11,16,18) recomb. vaccine (manufacturer unknown) for prophylaxis (dose, route of administration, vaccination scheme frequency, anatomical location, lot number and expiration date were not reported).   The patient's mother wanted to know if it was possible for the patient to finish the series despite the long gap in time period (inappropriate schedule of product administration). Therefore, on 03-AUG-2021, the patient was vaccinated with single dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) intramuscular as prophylaxis (interchange of vaccine products). The vaccine was administered by a healthcare professional at private doctor's office/hospital, and it was purchased with private funds. There was no temperature excursion. No adverse events were reported.
Sex: M
Vaccine: HPV4, HPV9
Symptoms: Inappropriate schedule of product administration
Clinical narrative: first dose of Gardasil in early 2019 and has yet to get additional doses; no additional AE information provided; This spontaneous report has been received from a consumer referring to himself, a currently 44-year-old male patient. No information regarding the patient's medical history, previous drug reactions or allergies, concurrent conditions or concomitant medications was provided.  On an unspecified date in 2019, the patient was vaccinated with the first dose of quadrivalent human papillomavirus (types 6,11,16,18) recomb. vaccine (GARDASIL) (dose, route of administration, anatomical site of vaccination, lot number and expiration date were not provided) as prophylaxis. The patient was unsure if he received quadrivalent human papillomavirus (types 6,11,16,18) recomb. vaccine (GARDASIL) or hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9). It was reported that the patient had yet to get additional doses (inappropriate schedule of product administration).   No additional adverse event was reported (no adverse event).
Age: 29.0
Sex: F
Vaccine: MMRV
Symptoms: Viral titre decreased
Clinical narrative: No aditional AE details; An adult who was administered a PROQUAD dose due to "low titers" of mumps and varicella.; This spontaneous report has been received from a nurse practitioner referring to a 29-years-old female patient. The patient's pertinent medical history, concomitant therapies, and previous drug reactions or allergies were not reported.  On 10-DEC-2021, the adult patient was vaccinated with measles, mumps, rubella and varicella (oka-merck) virus vaccine live (rHA) (PROQUAD), 0.5 ml (milliliter) subcutaneous for prophylaxis (Product administered to patient of inappropriate age) (lot number U016975 has been verified to be a valid lot number, the expiration date was reported and established as 24-NOV-2022; dose number, vaccination scheme, and anatomical site of vaccination were not reported) due to low titers of mumps and varicella.  No additional AE details reported.  .
Sex: U
Vaccine: MMR
Symptoms: Expired product administered, Product preparation issue
Clinical narrative: No additional adverse event; Expired Merck Sterile Diluent used to reconstitute vaccine that was administered; Expired Merck Sterile Diluent used to reconstitute vaccine that was administered; This spontaneous information was received from a nurse concerning a patient of unknown age and gender. The patient's concurrent conditions, medical history and concomitant medications were not provided.  On 18-NOV-2021 the patient was vaccinated with measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live recombinant human albumin (rHA) (M-M-R II) lot # T025927 with expiration date on 30-JUL-2022, for prophylaxis that was reconstitute with an expired sterile diluent (STERILE DILUENT) lot number S002625 with expiration date on 09-NOV-2021, for prophylaxis (strength, dose, frequency, route of administration and anatomical location were not provided) (expired product administered/ product preparation issue).  No additional adverse event reported.  This is one of several cases from the same reporter.; Sender's Comments:  US-009507513-2112USA004666:
Age: 1.17
Sex: M
Vaccine: VARCEL
Symptoms: Anti-RNA polymerase III antibody, Antibody test normal, B-lymphocyte count, Bacterial test negative, Blood immunoglobulin A normal
Clinical narrative: This literature marketed report has been received from the authors of a published literature article, titled as stated below and refers to a 12-year-old male patient. No information regarding patient's pertinent medical history, drug reactions, allergies and concomitant medications. On an unknown date, at age of 14 months, the patient was vaccinated with his first dose of varicella virus vaccine live (oka/merck) (VARIVAX) for prophylaxis (exact dose, route, anatomical location, lot# and expiration date were not reported). On an unknown date at age of 30 months, he received second dose of varicella virus vaccine live (oka/merck) (VARIVAX) (exact dose, route, anatomical location, lot# and expiration date were not reported) for prophylaxis. On an unknown date, the previously healthy patient, presented to the emergency department with a 1-day history of fever, headache, phonophobia and photophobia. Because he had neck stiffness, a lumbar puncture was performed. Laboratory analysis of cerebrospinal fluid (CSF) revealed 83 white cells/mm3 (88% lymphocytes). The CSF was tested by the meningitis panel and found to be positive for varicella zoster virus (VZV) and negative for enterovirus, herpes simplex virus, and HHV6, as well as bacteria. The patient was hospitalized, and acyclovir intravenous (IV) (30 mg/kg/day) was initiated. No radiologic studies were ordered. On day 5, he was discharged home; his acyclovir was switched to oral administration for a total treatment course of 14 days. The virus in the CSF was confirmed to be the VZV vaccine strain by Sanger sequencing. Polymerase chain reaction (PCR) analysis for HHV-7 DNA on the CSF was performed; that test was negative. The patient had an extensive immunology evaluation, which showed normal serum immunoglobulin (IG) IgG, IgA, and IgM levels and normal serum levels of vaccine antibodies for all tested antigens (measles, varicella, tetanus, and diphtheria). An extended immunophenotyping showed normal subpopulations of B, T, and NK cells. Finally, genetic analysis was performed by immunology exome sequencing, which included a panel of 356 genes of primary immunodeficiency. However, no errors in innate immune genes or other rare primary immunodeficiencies were discovered; specifically, there were no errors in RNA polymerase III genes. The child had undergone a complete recovery when seen at 1 and 12 months after his hospitalization. A copy of the published article is attached as further documentation of the patient's experience. This is one of three cases derived from the same literature article (cross referenced with MARRS# 2112USA003020 and 2007USA012025).; Sender's Comments:  US-009507513-2112USA003020: S-009507513-2007USA012025.
Age: 1.17
Sex: M
Vaccine: VARCEL
Symptoms: Blood immunoglobulin G normal, Blood immunoglobulin M normal, CSF lymphocyte count increased, CSF white blood cell count increased, Cytogenetic analysis
Clinical narrative: This literature marketed report has been received from the authors of a published literature article, titled as stated below and refers to a 12-year-old male patient. No information regarding patient's pertinent medical history, drug reactions, allergies and concomitant medications. On an unknown date, at age of 14 months, the patient was vaccinated with his first dose of varicella virus vaccine live (oka/merck) (VARIVAX) for prophylaxis (exact dose, route, anatomical location, lot# and expiration date were not reported). On an unknown date at age of 30 months, he received second dose of varicella virus vaccine live (oka/merck) (VARIVAX) (exact dose, route, anatomical location, lot# and expiration date were not reported) for prophylaxis. On an unknown date, the previously healthy patient, presented to the emergency department with a 1-day history of fever, headache, phonophobia and photophobia. Because he had neck stiffness, a lumbar puncture was performed. Laboratory analysis of cerebrospinal fluid (CSF) revealed 83 white cells/mm3 (88% lymphocytes). The CSF was tested by the meningitis panel and found to be positive for varicella zoster virus (VZV) and negative for enterovirus, herpes simplex virus, and HHV6, as well as bacteria. The patient was hospitalized, and acyclovir intravenous (IV) (30 mg/kg/day) was initiated. No radiologic studies were ordered. On day 5, he was discharged home; his acyclovir was switched to oral administration for a total treatment course of 14 days. The virus in the CSF was confirmed to be the VZV vaccine strain by Sanger sequencing. Polymerase chain reaction (PCR) analysis for HHV-7 DNA on the CSF was performed; that test was negative. The patient had an extensive immunology evaluation, which showed normal serum immunoglobulin (IG) IgG, IgA, and IgM levels and normal serum levels of vaccine antibodies for all tested antigens (measles, varicella, tetanus, and diphtheria). An extended immunophenotyping showed normal subpopulations of B, T, and NK cells. Finally, genetic analysis was performed by immunology exome sequencing, which included a panel of 356 genes of primary immunodeficiency. However, no errors in innate immune genes or other rare primary immunodeficiencies were discovered; specifically, there were no errors in RNA polymerase III genes. The child had undergone a complete recovery when seen at 1 and 12 months after his hospitalization. A copy of the published article is attached as further documentation of the patient's experience. This is one of three cases derived from the same literature article (cross referenced with MARRS# 2112USA003020 and 2007USA012025).; Sender's Comments:  US-009507513-2112USA003020: S-009507513-2007USA012025.
Age: 1.17
Sex: M
Vaccine: VARCEL
Symptoms: Cytokine test, Enterovirus test negative, Gene sequencing, Headache, Herpes simplex test negative
Clinical narrative: This literature marketed report has been received from the authors of a published literature article, titled as stated below and refers to a 12-year-old male patient. No information regarding patient's pertinent medical history, drug reactions, allergies and concomitant medications. On an unknown date, at age of 14 months, the patient was vaccinated with his first dose of varicella virus vaccine live (oka/merck) (VARIVAX) for prophylaxis (exact dose, route, anatomical location, lot# and expiration date were not reported). On an unknown date at age of 30 months, he received second dose of varicella virus vaccine live (oka/merck) (VARIVAX) (exact dose, route, anatomical location, lot# and expiration date were not reported) for prophylaxis. On an unknown date, the previously healthy patient, presented to the emergency department with a 1-day history of fever, headache, phonophobia and photophobia. Because he had neck stiffness, a lumbar puncture was performed. Laboratory analysis of cerebrospinal fluid (CSF) revealed 83 white cells/mm3 (88% lymphocytes). The CSF was tested by the meningitis panel and found to be positive for varicella zoster virus (VZV) and negative for enterovirus, herpes simplex virus, and HHV6, as well as bacteria. The patient was hospitalized, and acyclovir intravenous (IV) (30 mg/kg/day) was initiated. No radiologic studies were ordered. On day 5, he was discharged home; his acyclovir was switched to oral administration for a total treatment course of 14 days. The virus in the CSF was confirmed to be the VZV vaccine strain by Sanger sequencing. Polymerase chain reaction (PCR) analysis for HHV-7 DNA on the CSF was performed; that test was negative. The patient had an extensive immunology evaluation, which showed normal serum immunoglobulin (IG) IgG, IgA, and IgM levels and normal serum levels of vaccine antibodies for all tested antigens (measles, varicella, tetanus, and diphtheria). An extended immunophenotyping showed normal subpopulations of B, T, and NK cells. Finally, genetic analysis was performed by immunology exome sequencing, which included a panel of 356 genes of primary immunodeficiency. However, no errors in innate immune genes or other rare primary immunodeficiencies were discovered; specifically, there were no errors in RNA polymerase III genes. The child had undergone a complete recovery when seen at 1 and 12 months after his hospitalization. A copy of the published article is attached as further documentation of the patient's experience. This is one of three cases derived from the same literature article (cross referenced with MARRS# 2112USA003020 and 2007USA012025).; Sender's Comments:  US-009507513-2112USA003020: S-009507513-2007USA012025.
Age: 1.17
Sex: M
Vaccine: VARCEL
Symptoms: Human herpes virus 6 serology negative, Immunology test, Immunology test normal, Immunophenotyping, Lumbar puncture abnormal
Clinical narrative: This literature marketed report has been received from the authors of a published literature article, titled as stated below and refers to a 12-year-old male patient. No information regarding patient's pertinent medical history, drug reactions, allergies and concomitant medications. On an unknown date, at age of 14 months, the patient was vaccinated with his first dose of varicella virus vaccine live (oka/merck) (VARIVAX) for prophylaxis (exact dose, route, anatomical location, lot# and expiration date were not reported). On an unknown date at age of 30 months, he received second dose of varicella virus vaccine live (oka/merck) (VARIVAX) (exact dose, route, anatomical location, lot# and expiration date were not reported) for prophylaxis. On an unknown date, the previously healthy patient, presented to the emergency department with a 1-day history of fever, headache, phonophobia and photophobia. Because he had neck stiffness, a lumbar puncture was performed. Laboratory analysis of cerebrospinal fluid (CSF) revealed 83 white cells/mm3 (88% lymphocytes). The CSF was tested by the meningitis panel and found to be positive for varicella zoster virus (VZV) and negative for enterovirus, herpes simplex virus, and HHV6, as well as bacteria. The patient was hospitalized, and acyclovir intravenous (IV) (30 mg/kg/day) was initiated. No radiologic studies were ordered. On day 5, he was discharged home; his acyclovir was switched to oral administration for a total treatment course of 14 days. The virus in the CSF was confirmed to be the VZV vaccine strain by Sanger sequencing. Polymerase chain reaction (PCR) analysis for HHV-7 DNA on the CSF was performed; that test was negative. The patient had an extensive immunology evaluation, which showed normal serum immunoglobulin (IG) IgG, IgA, and IgM levels and normal serum levels of vaccine antibodies for all tested antigens (measles, varicella, tetanus, and diphtheria). An extended immunophenotyping showed normal subpopulations of B, T, and NK cells. Finally, genetic analysis was performed by immunology exome sequencing, which included a panel of 356 genes of primary immunodeficiency. However, no errors in innate immune genes or other rare primary immunodeficiencies were discovered; specifically, there were no errors in RNA polymerase III genes. The child had undergone a complete recovery when seen at 1 and 12 months after his hospitalization. A copy of the published article is attached as further documentation of the patient's experience. This is one of three cases derived from the same literature article (cross referenced with MARRS# 2112USA003020 and 2007USA012025).; Sender's Comments:  US-009507513-2112USA003020: S-009507513-2007USA012025.
Age: 1.17
Sex: M
Vaccine: VARCEL
Symptoms: Meningitis, Musculoskeletal stiffness, Natural killer cell count, Phonophobia, Photophobia
Clinical narrative: This literature marketed report has been received from the authors of a published literature article, titled as stated below and refers to a 12-year-old male patient. No information regarding patient's pertinent medical history, drug reactions, allergies and concomitant medications. On an unknown date, at age of 14 months, the patient was vaccinated with his first dose of varicella virus vaccine live (oka/merck) (VARIVAX) for prophylaxis (exact dose, route, anatomical location, lot# and expiration date were not reported). On an unknown date at age of 30 months, he received second dose of varicella virus vaccine live (oka/merck) (VARIVAX) (exact dose, route, anatomical location, lot# and expiration date were not reported) for prophylaxis. On an unknown date, the previously healthy patient, presented to the emergency department with a 1-day history of fever, headache, phonophobia and photophobia. Because he had neck stiffness, a lumbar puncture was performed. Laboratory analysis of cerebrospinal fluid (CSF) revealed 83 white cells/mm3 (88% lymphocytes). The CSF was tested by the meningitis panel and found to be positive for varicella zoster virus (VZV) and negative for enterovirus, herpes simplex virus, and HHV6, as well as bacteria. The patient was hospitalized, and acyclovir intravenous (IV) (30 mg/kg/day) was initiated. No radiologic studies were ordered. On day 5, he was discharged home; his acyclovir was switched to oral administration for a total treatment course of 14 days. The virus in the CSF was confirmed to be the VZV vaccine strain by Sanger sequencing. Polymerase chain reaction (PCR) analysis for HHV-7 DNA on the CSF was performed; that test was negative. The patient had an extensive immunology evaluation, which showed normal serum immunoglobulin (IG) IgG, IgA, and IgM levels and normal serum levels of vaccine antibodies for all tested antigens (measles, varicella, tetanus, and diphtheria). An extended immunophenotyping showed normal subpopulations of B, T, and NK cells. Finally, genetic analysis was performed by immunology exome sequencing, which included a panel of 356 genes of primary immunodeficiency. However, no errors in innate immune genes or other rare primary immunodeficiencies were discovered; specifically, there were no errors in RNA polymerase III genes. The child had undergone a complete recovery when seen at 1 and 12 months after his hospitalization. A copy of the published article is attached as further documentation of the patient's experience. This is one of three cases derived from the same literature article (cross referenced with MARRS# 2112USA003020 and 2007USA012025).; Sender's Comments:  US-009507513-2112USA003020: S-009507513-2007USA012025.
Age: 1.17
Sex: M
Vaccine: VARCEL
Symptoms: Polymerase chain reaction, Pyrexia, Roseolovirus test, T-lymphocyte count, Varicella virus test positive
Clinical narrative: This literature marketed report has been received from the authors of a published literature article, titled as stated below and refers to a 12-year-old male patient. No information regarding patient's pertinent medical history, drug reactions, allergies and concomitant medications. On an unknown date, at age of 14 months, the patient was vaccinated with his first dose of varicella virus vaccine live (oka/merck) (VARIVAX) for prophylaxis (exact dose, route, anatomical location, lot# and expiration date were not reported). On an unknown date at age of 30 months, he received second dose of varicella virus vaccine live (oka/merck) (VARIVAX) (exact dose, route, anatomical location, lot# and expiration date were not reported) for prophylaxis. On an unknown date, the previously healthy patient, presented to the emergency department with a 1-day history of fever, headache, phonophobia and photophobia. Because he had neck stiffness, a lumbar puncture was performed. Laboratory analysis of cerebrospinal fluid (CSF) revealed 83 white cells/mm3 (88% lymphocytes). The CSF was tested by the meningitis panel and found to be positive for varicella zoster virus (VZV) and negative for enterovirus, herpes simplex virus, and HHV6, as well as bacteria. The patient was hospitalized, and acyclovir intravenous (IV) (30 mg/kg/day) was initiated. No radiologic studies were ordered. On day 5, he was discharged home; his acyclovir was switched to oral administration for a total treatment course of 14 days. The virus in the CSF was confirmed to be the VZV vaccine strain by Sanger sequencing. Polymerase chain reaction (PCR) analysis for HHV-7 DNA on the CSF was performed; that test was negative. The patient had an extensive immunology evaluation, which showed normal serum immunoglobulin (IG) IgG, IgA, and IgM levels and normal serum levels of vaccine antibodies for all tested antigens (measles, varicella, tetanus, and diphtheria). An extended immunophenotyping showed normal subpopulations of B, T, and NK cells. Finally, genetic analysis was performed by immunology exome sequencing, which included a panel of 356 genes of primary immunodeficiency. However, no errors in innate immune genes or other rare primary immunodeficiencies were discovered; specifically, there were no errors in RNA polymerase III genes. The child had undergone a complete recovery when seen at 1 and 12 months after his hospitalization. A copy of the published article is attached as further documentation of the patient's experience. This is one of three cases derived from the same literature article (cross referenced with MARRS# 2112USA003020 and 2007USA012025).; Sender's Comments:  US-009507513-2112USA003020: S-009507513-2007USA012025.
Age: 1.17
Sex: M
Vaccine: VARCEL
Symptoms: Varicella zoster virus infection
Clinical narrative: This literature marketed report has been received from the authors of a published literature article, titled as stated below and refers to a 12-year-old male patient. No information regarding patient's pertinent medical history, drug reactions, allergies and concomitant medications. On an unknown date, at age of 14 months, the patient was vaccinated with his first dose of varicella virus vaccine live (oka/merck) (VARIVAX) for prophylaxis (exact dose, route, anatomical location, lot# and expiration date were not reported). On an unknown date at age of 30 months, he received second dose of varicella virus vaccine live (oka/merck) (VARIVAX) (exact dose, route, anatomical location, lot# and expiration date were not reported) for prophylaxis. On an unknown date, the previously healthy patient, presented to the emergency department with a 1-day history of fever, headache, phonophobia and photophobia. Because he had neck stiffness, a lumbar puncture was performed. Laboratory analysis of cerebrospinal fluid (CSF) revealed 83 white cells/mm3 (88% lymphocytes). The CSF was tested by the meningitis panel and found to be positive for varicella zoster virus (VZV) and negative for enterovirus, herpes simplex virus, and HHV6, as well as bacteria. The patient was hospitalized, and acyclovir intravenous (IV) (30 mg/kg/day) was initiated. No radiologic studies were ordered. On day 5, he was discharged home; his acyclovir was switched to oral administration for a total treatment course of 14 days. The virus in the CSF was confirmed to be the VZV vaccine strain by Sanger sequencing. Polymerase chain reaction (PCR) analysis for HHV-7 DNA on the CSF was performed; that test was negative. The patient had an extensive immunology evaluation, which showed normal serum immunoglobulin (IG) IgG, IgA, and IgM levels and normal serum levels of vaccine antibodies for all tested antigens (measles, varicella, tetanus, and diphtheria). An extended immunophenotyping showed normal subpopulations of B, T, and NK cells. Finally, genetic analysis was performed by immunology exome sequencing, which included a panel of 356 genes of primary immunodeficiency. However, no errors in innate immune genes or other rare primary immunodeficiencies were discovered; specifically, there were no errors in RNA polymerase III genes. The child had undergone a complete recovery when seen at 1 and 12 months after his hospitalization. A copy of the published article is attached as further documentation of the patient's experience. This is one of three cases derived from the same literature article (cross referenced with MARRS# 2112USA003020 and 2007USA012025).; Sender's Comments:  US-009507513-2112USA003020: S-009507513-2007USA012025.
Sex: U
Vaccine: MMRV, VARCEL
Symptoms: Incorrect dose administered
Clinical narrative: No Additional AR reported; 19 months old infant was accidently administered a dose of both PROQUAD and VARIVAX; This spontaneous report was received from a nurse referring to a 19-months-old patient of unknown gender. Patient's concurrent conditions, medical history and concomitant medications were not provided.   On 15-DEC-2021 the patient was accidently vaccinated with both measles, mumps, rubella and varicella (oka-merck) virus vaccine live(PROQUAD) and varicella virus vaccine live (oka/merck)(VARIVAX) (dose, route of administration, Lot# and expiration date were not provided) for prophylaxis on same day (accidental overdose). Nurse unwilling to provide any more information. No further information provided. No additional AE or PQC reported.
Age: 58.0
Sex: U
Vaccine: VARZOS
Symptoms: Body temperature increased, Gene mutation, Pain
Clinical narrative: Bodyaches; low-grade temp; This case was reported by a consumer via interactive digital media and described the occurrence of general body pain in a 58-year-old patient who received Herpes zoster (Shingrix) for prophylaxis.   On 2nd December 2021, the patient received the 2nd dose of Shingrix. In December 2021, 1 week after receiving Shingrix, the patient experienced general body pain and slight temperature. On an unknown date, the outcome of the general body pain and slight temperature were unknown.   It was unknown if the reporter considered the general body pain and slight temperature to be related to Shingrix.  Additional details were provided as follows: The case was reported by the patient. The reporter asked if it was possible to had side effects a week after getting a second shingles shot. The reporter asked if it was possible to have body aches and a low-grade temperature from the shingles shot a week after receiving the shot. The reporter came to know that safety team like to be informed of any side effects from GlaxoSmithKline vaccination. The reporter was not sure that the thing he/she was not sure if it was a side effect or a cold or exposure to covid, could be anything but he/she thought to check.