chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 72.0
Sex: F
Vaccine: PNC13
Symptoms: Injection site pruritus, Injection site swelling, Nausea, Rash
Clinical narrative: This is a spontaneous report received from a contactable physician (patient's husband). A 72-year-old female patient received pneumococcal 13-valent conjugate vaccine (diphtheria crm197 protein) (PREVNAR 13), intramuscular in the left deltoid on 05Jun2018 at single dose to prevent pneumonia. There were no medical history and concomitant medications reported. On 05Jun2018, it was reported that the patient had a side reaction on her left deltoid which despite a BENADRYL and steroid ointment on it, it was spreading. It was described as like the diameter of half a tennis ball and about half of the half of a tennis ball size that was quiet raised, tender and very red. The husband was asking for treatment that the patient can take for the rash that she was having. It was reported that the area of redness is not as red as it was but it is spreading upwards, all the way up above the shoulder and downwards towards the patient's elbow, around the back and all. The husband added that through the next few days it was less tender but itchy and firm only in one three or four centimeter area right around the injection site. On 05Jun2018, the patient also had nausea, lack of appetite and chills. The outcome of events 'quiet raised, tender and very red' (vaccination site erythema and pain) was recovering; events 'nausea' and 'chills' recovered on unspecified date; all other events was unknown.
Age: 8.0
Sex: U
Vaccine: DTAPIPV
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: Initial unsolicited report received from a nurse on 30-May-2018. This case involves an eight-year-old patient (gender not reported) who was vaccinated a dose of ADACEL) Batch number, expiration date, dose, route and site of administration was not reported for both vaccines) on an unspecified date. The patient's medical history and concomitant medications were not reported. It was an actual medication error due to inappropriate age at vaccine administration. It was reported that patient had received four doses of PENTACEL on board and did not received 5th DTaP and is now 8 years old and just received a QUADRACEL. No adverse event reported. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error. List of documents held by sender: none.
Sex: U
Vaccine: DTAPIPVHIB
Symptoms: No adverse event, Product preparation error
Clinical narrative: Initial unsolicited report received from Nurse on 31-May-2018. This case involves a patient (age and gender not reported) who was administered only with PENTACEL was not given HIB (Batch number, expiration date, dose, dose in series, route and site of administration were not reported) on an unspecified date. It was a case of actual medication error due to inappropriate reconstitution technique. No adverse event was reported. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error. Documents held by sender: none.
Sex: U
Vaccine: DTAPIPVHIB
Symptoms: No adverse event, Wrong drug administered
Clinical narrative: Initial unsolicited report received from a nurse on 31-May-2018. This case involves a child patient (age and gender was not reported) who was vaccinated dose of PENTACEL instead of DAPTACEL (batch number, expiry date, dose series, route and site of administration were not reported) on an unspecified date. It was a case of actual medication error due to wrong vaccine administered. No adverse event was reported. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error. Documents held by sender: none.
Sex: U
Vaccine: DTAPIPVHIB
Symptoms: Expired product administered, No adverse event
Clinical narrative: Initial unsolicited report received from an office staff on 06-Jun-2018. This case involves a patient (age and gender were not reported) who was vaccinated with an expired dose of PENTACEL (Batch number, expiration date: 04-Jun-2018, dose, dose in series, route and site of administration were not reported) on 05-Jun-2018. It was a case of actual medication error due to expired vaccine used. No adverse event was reported. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error. Documents held by sender: none.
Age: 68.0
Sex: F
Vaccine: VARZOS
Symptoms: Dizziness
Clinical narrative: Profound dizziness. Patient felt like she was going to fall over and had to be taken home from work.
Age: 74.0
Sex: F
Vaccine: VARZOS
Symptoms: Cough, Feeling abnormal, Injection site pain, Muscle spasms, Pain
Clinical narrative: In general did not feel good, pain @ injection site when moving arm up and down, muscle cramp in arm and nick area on left side, coughing (lead to chest pain), denies fever. Patient presented with above symptoms, injection site appeared normal, no treatment needed but monitored.
Age: 59.0
Sex: M
Vaccine: FLU4, VARZOS
Symptoms: Lip swelling, Urticaria
Clinical narrative: Pt states that about 5 days after receiving the vaccines he developed hives all over his body and his lips even swelled. He said he took BENADRYL for this reaction. It lasted for about 7 days.
Age: 74.0
Sex: M
Vaccine: VARZOS
Symptoms: Abdominal discomfort, Asthenia, Dizziness
Clinical narrative: Dizzy/woozy/weak/slight upset stomach - began 1-2 hours after receiving vaccine and lasted about 12 hours, pt felt better next day.
Age: 1.0
Sex: F
Vaccine: VARCEL
Symptoms: Rash vesicular, Varicella post vaccine
Clinical narrative: Patient seen approximately 2 weeks post vaccination for blistering rash and Dx with vaccine induced Varicella.
Sex: M
Vaccine: FLU3
Symptoms: Computerised tomogram normal, Cough, Electrocardiogram normal, Malaise, Rhinorrhoea
Clinical narrative: This serious initial spontaneous case, was received from Other Non-Health Professional on 30-Oct-2017, concerning a male of unspecified age. On 01-Oct-2017, the patient was administered with FLUVIRIN (dose: 0.5 ml, route of administration: intramuscular, anatomical location: left deltoid, batch number, expiry date: not reported). On an unspecified date, within 2 weeks of vaccination, the patient developed vertigo and was hospitalized for 3 days. The patient underwent CT (computed tomography) scan, EKG (electrocardiogram) with all other tests were performed. The results were found to be okay and thought that it could be from the vaccine. The patient got sick with runny nose, sneezing, coughing after the vertigo and he was put on antibiotics amoxicillin. For the event vertigo he was put on meclizine. At the time of this report, the patient recovered from the events. The reporter assessed the event vertigo as serious due to hospitalization.
Sex: M
Vaccine: FLU3
Symptoms: Sneezing, Vertigo
Clinical narrative: This serious initial spontaneous case, was received from Other Non-Health Professional on 30-Oct-2017, concerning a male of unspecified age. On 01-Oct-2017, the patient was administered with FLUVIRIN (dose: 0.5 ml, route of administration: intramuscular, anatomical location: left deltoid, batch number, expiry date: not reported). On an unspecified date, within 2 weeks of vaccination, the patient developed vertigo and was hospitalized for 3 days. The patient underwent CT (computed tomography) scan, EKG (electrocardiogram) with all other tests were performed. The results were found to be okay and thought that it could be from the vaccine. The patient got sick with runny nose, sneezing, coughing after the vertigo and he was put on antibiotics amoxicillin. For the event vertigo he was put on meclizine. At the time of this report, the patient recovered from the events. The reporter assessed the event vertigo as serious due to hospitalization.
Age: 50.0
Sex: F
Vaccine: VARZOS
Symptoms: Pyrexia
Clinical narrative: Fever from appx. 2:10 AM 'til 5:30 AM.
Age: 1.0
Sex: F
Vaccine: VARCEL
Symptoms: Rash, Varicella post vaccine
Clinical narrative: Patient presented to the office with spreading rash approximately 2 weeks post vaccination and Dx with Varicella post vaccination.
Age: 1.0
Sex: M
Vaccine: HEPA, MMR, VARCEL
Symptoms: Irritability, Rash generalised, Varicella post vaccine
Clinical narrative: Child presented to the office today 06/13/2018 with a chickenpox rash over entire body. TYLENOL given at home by parent since child was very irritable prior to coming to the office. Advised to follow up in the office should the childs temp elevate greater than 100.4. Advised parents to contact office immediately.
Age: 1.42
Sex: M
Vaccine: MMR
Symptoms: Rash, Rash generalised
Clinical narrative: Rash began on face at 11 days post vaccine and spread to whole body.
Age: 63.0
Sex: M
Vaccine: VARZOS
Symptoms: Fatigue, Headache, Pain
Clinical narrative: Note: Pt was told by his Spouse's doctor to report these symptoms. The day after receiving the vaccine, the patient developed body aches, headache, and fatigue for about 48 hours. The symptoms resolved since then.
Sex: M
Vaccine: FLUX
Symptoms: Paralysis
Clinical narrative: This serious spontaneous case was initially received on 11-Apr-2018, reported by other non-health professional, concerns a male patient of unspecified age. The patient's medical history and concomitant medications were not reported. On an unspecified date in 2017 (reported as September or October of 2017), the patient was administered with INN flu vaccine seasonal (dose, anatomical location, route of administration, batch number, expiry date, manufacturer, trade name was not reported). On an unspecified date in Jan-2018, about 3 months after vaccination, the patient became paralyzed from the waist down. The reporter did not know if the event was related to the vaccine. It was reported that, the patient was seen at hospital due to event. The outcome of the event paralysis was not reported.
Sex: F
Vaccine: FLUX
Symptoms: Condition aggravated, Dystonia, Haematoma, Muscle spasms, Muscle tightness
Clinical narrative: This literature case, initially received on 26-Mar-2018, was reported by other health professional and concerns female patient of unspecified age. The aim of the article was to enhance understanding of the pathology of hematologic derangements in Hermansky-Pudlak syndrome for which literature and case reports of Hermansky-Pudlak syndrome were reviewed. The patient had a history of anaphylactic allergy during platelet transfusion for the treatment hematoma. The current conditions of the patient included, Hermansky-Pudlak syndrome, idiopathic dystonia and hematoma. On an unspecified date, the patient was administered with INN Flu Vaccine Seasonal (dose, route of administration, anatomical location, batch number, expiry date, trade name, manufacturer: not reported). On an unspecified date, after vaccination, the patient developed expanding hematoma over the course of 5 days. The platelet count was found to be normal with a count of 337. The patient also experienced dystonic episode characterised by sudden sensation of tightness/spasm in various parts of body (episode present upon admission began in her neck) which radiated into lower back, sacrum and bilateral upper extremities. The patient described spasms as a pulling sensation after which the body collapsed and was folded (as reported). The pain was expressed as 10/10 in severity. The patient was given pre-treatment with unspecified glucocorticoids and BENADRYL. The patient was transfused with 2 units of platelets without any complications. At the time of this report, the patient had recovered from dystonia and the outcome of the event expanding hematoma was not reported.
Sex: F
Vaccine: FLUX
Symptoms: Pain, Platelet count normal, Platelet transfusion, Syncope
Clinical narrative: This literature case, initially received on 26-Mar-2018, was reported by other health professional and concerns female patient of unspecified age. The aim of the article was to enhance understanding of the pathology of hematologic derangements in Hermansky-Pudlak syndrome for which literature and case reports of Hermansky-Pudlak syndrome were reviewed. The patient had a history of anaphylactic allergy during platelet transfusion for the treatment hematoma. The current conditions of the patient included, Hermansky-Pudlak syndrome, idiopathic dystonia and hematoma. On an unspecified date, the patient was administered with INN Flu Vaccine Seasonal (dose, route of administration, anatomical location, batch number, expiry date, trade name, manufacturer: not reported). On an unspecified date, after vaccination, the patient developed expanding hematoma over the course of 5 days. The platelet count was found to be normal with a count of 337. The patient also experienced dystonic episode characterised by sudden sensation of tightness/spasm in various parts of body (episode present upon admission began in her neck) which radiated into lower back, sacrum and bilateral upper extremities. The patient described spasms as a pulling sensation after which the body collapsed and was folded (as reported). The pain was expressed as 10/10 in severity. The patient was given pre-treatment with unspecified glucocorticoids and BENADRYL. The patient was transfused with 2 units of platelets without any complications. At the time of this report, the patient had recovered from dystonia and the outcome of the event expanding hematoma was not reported.
Sex: U
Vaccine: HEPA, HPV9, RV5
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report as received from a medical assistant refers to an unspecified number of patients of unknown age and gender. From 01-MAY-2018 to 31-MAY-2018, the patients were vaccinated with improperly stored ROTATEQ lot # R002052, expiration date 22-MAY-2019; GARDASIL 9 lot # N022583, expiration date 20-JUN-2020; VAQTA lot # R002086, expiration date 22-APR-2019. The vaccines underwent a temperature excursion of 0 to -9.8 degrees Celsius for 15 minutes. There was no previous temperature excursion. Data logger was involved. No adverse effects were reported.
Sex: U
Vaccine: MMR
Symptoms: Incorrect route of drug administration, No adverse event
Clinical narrative: This spontaneous report was received from a pharmacist concerning a patient of unknown age and gender. The patient's historical condition, concurrent condition, concomitant therapy, historical drugs or allergies were not reported. On an unknown date, the patient was vaccinated with M-M-R II via the intramuscular route, rather than the subcutaneous route. Lot # M039914 and expiry date 26-SEP-2018 (strength, dose and frequency were not reported) for prophylaxis. No adverse effects were reported.  No product quality complaint was filed.
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster, Pain, Rash vesicular
Clinical narrative: This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a female patient of unknown age.  No information was provided regarding concomitant medications, concurrent conditions or medical history. In 2015, the patient was inoculated with ZOSTAVAX at an internal medicine office as recommended for routine adult health maintenance and for the prevention of shingles (dose, route, and lot # not provided). The vaccine did not prevent shingles as intended, and the patient subsequently contracted a persistent strain of herpes zoster. On or about 05-JAN-2016, the patient was treated at the same internal medicine office for a persistent and severe vesicular rash, which was diagnosed as shingles. She was treated with valacyclovir (VALTREX) for management of her painful symptoms and chronic pain. As a direct and proximate result of ZOSTAVAX vaccine, and/or despite receiving ZOSTAVAX for long-term prevention of shingles, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages. The outcome of the events was unknown. Causality assessment was related. Additional information has been requested.
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster, Rash vesicular
Clinical narrative: This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a male patient of unknown age. No information was provided regarding concomitant medications, concurrent conditions or medical history. On or about 19-SEP-2012, the patient was inoculated with ZOSTAVAX at a pharmacy as recommended for routine adult health maintenance and for the prevention of shingles (dose, route, and lot # not provided). The vaccine did not prevent shingles as intended, and the patient subsequently contracted a persistent strain of herpes zoster. On or about 18-DEC-2014, the patient was treated at a medical center for the onset of a severe vesicular rash, which was diagnosed as shingles. As a direct and proximate result of ZOSTAVAX vaccine, and/or despite receiving ZOSTAVAX for long-term prevention of shingles, the patient suffered painful injuries and damages, and required extensive medical care and treatment.  As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages. The outcome of the events was unknown. Causality assessment was related. Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Herpes virus infection, Rash vesicular
Clinical narrative: This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a female patient of unknown age. No information was provided regarding concomitant medications, concurrent conditions or medical history. On or about 16-JAN-2014, the patient was inoculated with ZOSTAVAX at a pharmacy as recommended for routine adult health maintenance and for the prevention of shingles (dose, route, and lot # not provided). The vaccine did not prevent shingles as intended, and the patient subsequently contracted a persistent strain of herpes zoster. Later in 2014, the patient was treated by a Dermatologist for a persistent and severe vesicular rash, which was diagnosed as herpes zoster or shingles. As a direct and proximate result of ZOSTAVAX vaccine, and/or despite receiving ZOSTAVAX for long-term prevention of shingles, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages. The outcome of the events was unknown. Causality assessment was related. Additional information has been requested.
Sex: F
Vaccine: MMR, VARCEL
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report was received from a nurse concerning a female patient of unknown age. The patient's historical condition, concurrent condition, concomitant therapy, historical drugs or allergies were not reported. On 08-SEP-2017, the patient was vaccinated with VARIVAX lot # M004326 (strength, dose, route, frequency and expiration date were not reported) for prophylaxis. On 15-SEP-2017, the patient was vaccinated with M-M-R II lot # L037356 and expiry date 28-SEP-2017 (strength, dose, route and frequency were not reported) for prophylaxis. No adverse effects were reported and no product quality complaint was filed.
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: Information has been received from a lawyer regarding a case in litigation concerning a female patient of unknown age. No information was received regarding the patient's past medical history, concurrent conditions, or concomitant medication. On or about 01-MAY-2016, the patient was inoculated with the ZOSTAVAX (lot number, dosage and route of administration not provided), as recommended by her physicians for the long-term prevention of shingles. The ZOSTAVAX did not prevent shingles as intended. Instead the patient contracted a persistent strain of shingles, or herpes zoster. On or about 12-JUN-2016, the patient was treated at a hospital center for the development of herpes zoster and was prescribed valacyclovir hydrochloride (VALTREX), acetaminophen (+) oxycodone hydrochloride (PERCOCET), and gabapentin by a physician for management of her shingles-related symptoms. The outcome of the events is unknown. As a direct and proximate result of the defective ZOSTAVAX, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, pain and suffering, and other damages. Additional information has been requested.
Age: 84.0
Sex: F
Vaccine: VARZOS
Symptoms: Post herpetic neuralgia, Vertebral foraminal stenosis
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of cervical foraminal stenosis in a 84-year-old female patient who received SHINGRIX for prophylaxis. Concurrent medical conditions included allergic reaction to analgesics (morphine allergy) and sulfonamide allergy. On 16th March 2018, the patient received the 1st dose of SHINGRIX (intramuscular) .5 ml. In May 2018, 61 days after receiving SHINGRIX, the patient experienced cervical foraminal stenosis (serious criteria disability). On an unknown date, the patient experienced post herpetic neuralgia (serious criteria disability). On an unknown date, the outcome of the cervical foraminal stenosis and post herpetic neuralgia were unknown. The reporter considered the cervical foraminal stenosis to be unrelated to SHINGRIX. It was unknown if the reporter considered the post herpetic neuralgia to be related to SHINGRIX. Additional details were provided as follows: The patient's concomitant medications included unspecified other medications. The patient received SHINGRIX vaccine on an unknown deltoid and less than a year post vaccination with SHINGRIX experienced post herpetic neuralgia (PHN). The reporting pharmacist might have additional information on the patient consent form.
Sex: F
Vaccine: VARZOS
Symptoms: Injection site pain, Product administered at inappropriate site
Clinical narrative: This case was reported by an other health professional via sales rep and described the occurrence of injection site pain in a female patient who received SHINGRIX for prophylaxis. On an unknown date, the patient received the 1st dose of SHINGRIX. On an unknown date, less than a year after receiving SHINGRIX, the patient experienced injection site pain and vaccine administered at inappropriate site. On an unknown date, the outcome of the injection site pain and vaccine administered at inappropriate site were unknown. It was unknown if the reporter considered the injection site pain to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. The caller was GSK field representative reporting that she heard from a pharmacy employee about a patient who received her first shot of SHINGRIX at a pharmacy and thought the injection may had been into a tendon and not the deltoid muscle which led to vaccine administered at inappropriate site and also patient experienced pain at injection site. The caller reported that no other details were available. The caller was unable to provide full demographics for the reporter.
Age: 84.0
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Asthenia, Fall, Guillain-Barre syndrome, Lumbar puncture abnormal, Nuclear magnetic resonance imaging
Clinical narrative: This case was reported by a physician via sales rep and described the occurrence of Guillain Barre syndrome in a elderly male patient who received SHINGRIX for prophylaxis. In May 2018, the patient received SHINGRIX. In June 2018, 7 days after receiving SHINGRIX, the patient experienced Guillain Barre syndrome (serious criteria GSK medically significant), fall and weakness generalized. On an unknown date, the outcome of the Guillain Barre syndrome, fall and weakness generalized were unknown. It was unknown if the reporter considered the Guillain Barre syndrome, fall and weakness generalized to be related to SHINGRIX. Additional details were provided as follows: The age at the vaccination was not reported. The patient was administered SHINGRIX in retail a pharmacy. One week post SHINGRIX, the patient felt weakness from head towards legs, collapsed in shower and went to emergency room then released. On 5th June 2018, the patient had MRI (Nuclear magnetic resonance imaging) performed and results expected by early next week. The physician performed a spinal tap and confirmed that the patient has Guillain-Barre syndrome that was believed to be due to the SHINGRIX vaccination.
Age: 84.0
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Syncope
Clinical narrative: This case was reported by a physician via sales rep and described the occurrence of Guillain Barre syndrome in a elderly male patient who received SHINGRIX for prophylaxis. In May 2018, the patient received SHINGRIX. In June 2018, 7 days after receiving SHINGRIX, the patient experienced Guillain Barre syndrome (serious criteria GSK medically significant), fall and weakness generalized. On an unknown date, the outcome of the Guillain Barre syndrome, fall and weakness generalized were unknown. It was unknown if the reporter considered the Guillain Barre syndrome, fall and weakness generalized to be related to SHINGRIX. Additional details were provided as follows: The age at the vaccination was not reported. The patient was administered SHINGRIX in retail a pharmacy. One week post SHINGRIX, the patient felt weakness from head towards legs, collapsed in shower and went to emergency room then released. On 5th June 2018, the patient had MRI (Nuclear magnetic resonance imaging) performed and results expected by early next week. The physician performed a spinal tap and confirmed that the patient has Guillain-Barre syndrome that was believed to be due to the SHINGRIX vaccination.
Age: 84.0
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Blood test, Computerised tomogram, Hypoaesthesia, Muscular weakness, Nuclear magnetic resonance imaging
Clinical narrative: This case was reported by a physician via sales rep and described the occurrence of Guillain Barre syndrome in a elderly male patient who received SHINGRIX for prophylaxis. In May 2018, the patient received SHINGRIX. In June 2018, 7 days after receiving SHINGRIX, the patient experienced Guillain Barre syndrome (serious criteria GSK medically significant), fall and weakness generalized. On an unknown date, the outcome of the Guillain Barre syndrome, fall and weakness generalized were unknown. It was unknown if the reporter considered the Guillain Barre syndrome, fall and weakness generalized to be related to SHINGRIX. Additional details were provided as follows: The age at the vaccination was not reported. The patient was administered SHINGRIX in retail a pharmacy. One week post SHINGRIX, the patient felt weakness from head towards legs, collapsed in shower and went to emergency room then released. On 5th June 2018, the patient had MRI (Nuclear magnetic resonance imaging) performed and results expected by early next week. The physician performed a spinal tap and confirmed that the patient has Guillain-Barre syndrome that was believed to be due to the SHINGRIX vaccination.
Age: 46.0
Sex: M
Vaccine: FLUX
Symptoms: Dyspnoea, Oxygen saturation decreased, Tachycardia
Clinical narrative: This is a spontaneous case, initially received from other non-health professional on 24-Jan-2018, concerning a male patient of an unspecified age of body weight 260 lbs and height 72 inches. The patient's concomitant medication included ketoconazole shampoo, Iron, CALTRATE, SPIRIVA, ADVAIR, SYNTHROID, CENTRUM, furosemide, Aspirin, Vitamin D3, potassium chloride, losartan, Clobetasol, Atorvastatin, oxygen for unknown indications. On an unspecified date, the patient was administered with INN Flu Vaccine Seasonal (dose, route of administration, anatomical location, batch number, manufacturer, trade name and expiry date: not reported). On 27-Apr-2010, the patient started ZEMAIRA 966 mg Vial (alpha-1-antitrypsin, dose: 60 mg/kg, weekly) (ongoing), route of administration: Intravenous, batch number: X408809 and expiry date: 09-Sep-2020) for alpha-1-antitrypsin deficiency. On an unspecified date, the patient had shortness of air, low O2 saturation (reported as, in 70's), tachycardia and hospitalized on 21-Jan-2018. At the time of this report, the outcome of the events was not reported. The reporter assessed the events as serious due to hospitalization.
Age: 58.0
Sex: F
Vaccine: FLU4
Symptoms: Ureteritis, Urine output decreased
Clinical narrative: This spontaneous case, was initially received on 08-Dec-2017, from a consumer, concerning a 58-year-old female, adult patient. The patient's historical condition included stones in right kidney (on an unspecified date) and it was removed (on an unspecified date in Sep-2017). It was reported that no stones found in left kidney. The patient's current conditions included, diabetes, obstructive sleep apnea and atherosclerosis since and unspecified date. The concomitant medications included CRESTOR, Diltiazem, valsartan, glipizide, omeprazole for unknown indications. The patient had history of flu shot in the past without any adverse events. On 24-Nov-2017, the patient was administered with AFLURIA QUADRIVALENT (dose: 0.5 ml, route of administration: intramuscular, anatomical location: left deltoid, batch number: XF34509, expiry date: 30-Jun-2018). On 25-Nov-2017, the patient experienced sudden flank pain on left side (reported as bad) thus, on the same day, the patient went to the ER. On the same day, the patient was hospitalized and underwent CT scan, which revealed inflammation of kidney and kidney stones were unchanged. No other tests were done. The patient was unable to void even for urine specimen; hence a Foley catheter was placed, but there was no urine output for 18 hours. Creatinine level was 1.5 initially and went up to 3.5 and potassium level was 5.9 (baseline value was unknown) on 25-Nov-2017. On 26-Nov-2017, the patient underwent bilateral stent insertion for ureter inflammation and urine flow (for obstruction). The patient was given IV. On 04-Dec-2017, creatinine level was 1.3, potassium was normal (value was not provided). Protein was observed in patient's urine. On 14-Dec-2017, the renal stents were planned to remove. At the time of this report, the patient had recovered from the event Inflammation of kidney and urine obstruction. The reporter considered the event inflammation of kidney as serious due to hospitalization and assessed the causality between the events and suspect vaccine as related. The reporter did not provided the seriousness and causality of the events creatinine increased, and potassium increased. Follow-up received from consumer on 09-Jan-2018: The current condition kidney stone was change to historical condition right kidney stone (which was removed in Sep-2017). The concomitant drug valsartan (started in Aug-2017, no dose changed) was withdrawn by the patient on an unknown date. It was reported that no tests other than CT was performed (ANCA antibody titer was not done) in ER and the consumer had no details of the diagnosis. Added events ureter inflammation and obstruction. The stents were placed for ureter inflammation and obstruction. Narrative was amended accordingly. Follow-up received from consumer on 25-Jan-2018: The consumer confirmed that patient had stones in right kidney only and reported that no stones were found in left kidney and it was confirmed that stents were placed due to ureter inflammation and obstruction. Narrative was amended accordingly.
Age: 71.0
Sex: M
Vaccine: VARZOS
Symptoms: Headache, Influenza like illness, Injection site pain, Pyrexia
Clinical narrative: On first day after getting second dose of SHINGRIX, had fever, headache and flu-like symptoms for 1 day. Soreness at injection site lasted for 5 days. Symptoms got better every day. As of today (6/12/2018). felt normal.
Age: 64.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Headache, Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: On first day after getting SHINGRIX, having headache and shivering, which lasted for only 1 day. About 3 inches below the injection site on the arm, swelling, sore, and felt hot about 1 week.
Age: 74.0
Sex: F
Vaccine: VARZOS
Symptoms: Fatigue, Herpes zoster, Myalgia, Peripheral swelling, Rash
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of shingles in a 74-year-old female patient who received SHINGRIX for prophylaxis. Concomitant products included famotidine, omeprazole, Thyroxine and ZETIA. On 7th May 2018, the patient received the 1st dose of SHINGRIX .5 ml. On 8th May 2018, 1 days after receiving SHINGRIX, the patient experienced shingles, swelling arm, tiredness, rash and muscle soreness. On 4th June 2018, the outcome of the shingles and rash were recovered/resolved. On an unknown date, the outcome of the swelling arm, tiredness and muscle soreness were recovered/resolved. The reporter considered the shingles, swelling arm, tiredness, rash and muscle soreness to be related to SHINGRIX. Additional details were provided as follows: The reporter was reporting this case for herself. Concomitant medications also included vitamins. The patient received SHINGRIX on the right arm. The patient reported that her arm became swollen to about the size of a baseball and she developed a rash. The patient reported that the day after the injection, she hurt all over (muscle soreness) and felt like a truck hit her (tiredness). On Saturday, 12th May 2018, after the dose she had symptoms on her head and around her temple area and she went to urgent care (emergency room) and was diagnosed with shingles outbreak. The patient reported, about a week later she developed shingles outbreak around her kneecap area. The patient had denied permission to contact their physician.
Age: 56.0
Sex: F
Vaccine: VARZOS
Symptoms: Abdominal pain upper, Chills, Pain, Pyrexia
Clinical narrative: This case was reported by a nurse via call center representative and described the occurrence of chills in a 56-year-old female patient who received SHINGRIX (batch number L7F7E, expiry date unknown) for prophylaxis. On 25th May 2018, the patient received SHINGRIX (intramuscular). On 26th May 2018, 1 days after receiving SHINGRIX, the patient experienced chills, general body pain, stomach cramps and fever. On an unknown date, the outcome of the chills, general body pain, stomach cramps and fever were recovered/resolved. The reporter considered the chills, general body pain, stomach cramps and fever to be possibly related to SHINGRIX. Additional details were provided as follows: The healthcare provider (HCP) reported that, the patient developed chills, fever, body aches, and stomach cramps after receiving the SHINGRIX vaccine. The patient stated that, she "felt like she was hit by a truck" for 48 hours starting the day after receiving the vaccine. The healthcare provider did not have the expiration date.
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site inflammation, Injection site pain
Clinical narrative: This case was reported by a consumer and described the occurrence of injection site erythema in a adult female patient who received SHINGRIX for prophylaxis. On 1st June 2018, the patient received SHINGRIX. In June 2018, less than a week after receiving SHINGRIX, the patient experienced injection site erythema, injection site inflammation and injection site pain. On an unknown date, the outcome of the injection site erythema, injection site inflammation and injection site pain were unknown. It was unknown if the reporter considered the injection site erythema, injection site inflammation and injection site pain to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. The patient received SHINGRIX vaccine on Friday at 10.40 am at his primary care doctor's office. The patient's injection site had been red, inflamed, and very sore since then. The size of the redness was about the size of a cell phone or about 5 inches by 2 to 3 inches on his right upper arm.
Sex: M
Vaccine: VARZOS
Symptoms: Injection site swelling
Clinical narrative: This case was reported by a physician via sales rep and described the occurrence of injection site swelling in an adult male patient who received SHINGRIX for prophylaxis. On an unknown date, the patient received SHINGRIX at an unknown dose. On an unknown date, less than a year after receiving SHINGRIX, the patient experienced injection site swelling. On an unknown date, the outcome of the injection site swelling was unknown. It was unknown if the reporter considered the injection site swelling to be related to SHINGRIX. Additional information reported as follows: The age at vaccination was not reported. The patient reported that it was not been informed, if the dose was administered subcutaneously instead of intramuscularly.
Sex: M
Vaccine: VARZOS
Symptoms: Fatigue, Injection site erythema, Injection site urticaria, Myalgia
Clinical narrative: This case was reported by a physician via sales rep and described the occurrence of injection site erythema in a male patient who received SHINGRIX for prophylaxis. On an unknown date, the patient received the 1st dose of SHINGRIX. On an unknown date, less than a year after receiving SHINGRIX, the patient experienced injection site erythema, injection site wheal, myalgia and fatigue. On an unknown date, the outcome of the injection site erythema, injection site wheal, myalgia and fatigue were recovering/resolving. It was unknown if the reporter considered the injection site erythema, injection site wheal, myalgia and fatigue to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. The patient had experienced injection site reaction, redness, whelps, and myalgia or fatigue. The reporting physician asked the patient to go to the pharmacy where he was vaccinated and let them know of the adverse events. The patient came back after 4 to 5 days for recheck and was better.
Sex: M
Vaccine: VARZOS
Symptoms: Cellulitis, Erythema, Peripheral swelling
Clinical narrative: This case was reported by a physician via sales rep and described the occurrence of cellulitis in a adult male patient who received SHINGRIX for prophylaxis. On an unknown date, the patient received SHINGRIX at an unknown dose. On an unknown date, less than a year after receiving SHINGRIX, the patient experienced cellulitis (serious criteria GSK medically significant), erythema of extremities and swelling arm. On an unknown date, the outcome of the cellulitis, erythema of extremities and swelling arm were unknown. It was unknown if the reporter considered the cellulitis, erythema of extremities and swelling arm to be related to SHINGRIX. Additional details were provided as follows: This patient received SHINGRIX from a pharmacy. The patient then called physician's office and told his arm was red with swelling. The patient was diagnosed with a cellulitis according to physician. The physician said that this was different in his estimation than redness and swelling. The reporter did not agreed upon follow up from GlaxoSmithKline.
Age: 72.0
Sex: F
Vaccine: VARZOS
Symptoms: Asthenia, Feeling cold, Feeling hot, Headache, Myalgia
Clinical narrative: Intense muscle pain; excruciating headaches that wouldn't respond to aspirin/caffeine powders; felt feverish, although temperature was normal. Overnight began trembling with cold, despite room temperature above 80 degrees. Felt extremely weak, and occasionally nauseous. Duration approximately 36 hours. Felt absolutely normal by 4:00 am 6/13.
Age: 72.0
Sex: F
Vaccine: VARZOS
Symptoms: Nausea, Tremor
Clinical narrative: Intense muscle pain; excruciating headaches that wouldn't respond to aspirin/caffeine powders; felt feverish, although temperature was normal. Overnight began trembling with cold, despite room temperature above 80 degrees. Felt extremely weak, and occasionally nauseous. Duration approximately 36 hours. Felt absolutely normal by 4:00 am 6/13.
Age: 46.0
Sex: F
Vaccine: TDAP
Symptoms: Amnesia, Anxiety, Hallucinations, mixed, Panic reaction, Pyrexia
Clinical narrative: 3 day sustained fever of 103 - 104 with very little relief from fever reducing medicine. 2 additional days of a fever of 99.5. Hallucinations both auditory and visual. Overwhelming anxiety and panic that has persisted since. Changes in eyesight (everything had a pink hue). Memory lapses.
Age: 46.0
Sex: F
Vaccine: TDAP
Symptoms: Visual impairment
Clinical narrative: 3 day sustained fever of 103 - 104 with very little relief from fever reducing medicine. 2 additional days of a fever of 99.5. Hallucinations both auditory and visual. Overwhelming anxiety and panic that has persisted since. Changes in eyesight (everything had a pink hue). Memory lapses.
Age: 4.0
Sex: M
Vaccine: DTAPIPV, MMRV
Symptoms: Injection site erythema, Injection site streaking, Injection site warmth, Peripheral swelling
Clinical narrative: According to patient's Mom his right arm had a "goose egg" yesterday, but it went away. She reports that today patient's right arm has a square "patch" below the site of the injection that is "a little bigger than a 50 cent piece" and is warm to touch. She reports that today patient's left arm has red streaks near the injection site. Denies any fever or chills. Denies lethargy, nausea, vomiting, or any changes in behavior. Patient has plans to go to swimming lessons later today. Advised Mom to put cool compresses on the sites, give patient ibuprofen and continue monitoring closely. If no improvement today or any worsening at the sites described, advised Mom to take patient to his physician or to ER for further evaluation. Offered for Mom to bring patient in and let me assess the sites. She said she will try the cool compresses and ibuprofen first.
Age: 77.0
Sex: F
Vaccine: PPV
Symptoms: Blood pressure decreased, Dizziness, Injected limb mobility decreased, Pain in extremity, Peripheral swelling
Clinical narrative: I have a rather severe reaction to the shot. A few hours after the shot my arm welled a lot and was very painful. I had trouble raising my arm even an inch. I took an ADVIL PM so I hopefully could sleep last night. That worked fairly well. This morning my arm was extremely painful. The swelling had moved from the vaccination site toward my inner arm and went down to my elbow. In addition, right after I got up I walked to the kitchen and started to feel faint. My husband was there and he took me to a chair. My blood pressure had dropped to 105/56. I gradually began to feel better. My arm is still very sore and swollen. I thought you should know my reaction so others can be informed. I am only glad the shot was in my left arm instead of my right arm.
Age: 77.0
Sex: F
Vaccine: PPV
Symptoms: Vaccination site swelling
Clinical narrative: I have a rather severe reaction to the shot. A few hours after the shot my arm welled a lot and was very painful. I had trouble raising my arm even an inch. I took an ADVIL PM so I hopefully could sleep last night. That worked fairly well. This morning my arm was extremely painful. The swelling had moved from the vaccination site toward my inner arm and went down to my elbow. In addition, right after I got up I walked to the kitchen and started to feel faint. My husband was there and he took me to a chair. My blood pressure had dropped to 105/56. I gradually began to feel better. My arm is still very sore and swollen. I thought you should know my reaction so others can be informed. I am only glad the shot was in my left arm instead of my right arm.
Age: 17.0
Sex: F
Vaccine: MENB
Symptoms: Injection site erythema, Injection site pain, Local reaction, Pain in extremity
Clinical narrative: Per mom patient complained of arm hurting and being sore post vaccine administration at night around 2000 hours. Mom states that next day area of vaccine administration was red and tender to the touch. MD examination on 06/13/2018: Local reaction to MenB vaccine to left deltoid. 2.5x4cm redness in diameter noted. Provider Rx 20 mg of Prednisone. Instructions of medication: take 2 tabs  by mouth once a day for four days. Patient will return in 5 days for follow up.
Age: 72.0
Sex: F
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination, Influenza like illness, Myalgia
Clinical narrative: Severe myalgia, flu like symptoms, Patient refuses to take 2nd vaccine.
Sex: F
Vaccine: HEPA
Symptoms: Incorrect dose administered, No adverse event
Clinical narrative: This spontaneous report was received from an office manager; reporting on a 17 year old female patient. The patient's medical history, concurrent conditions and concomitant medications were not provided. On an unknown date, the patient was vaccinated by the medical assistant with an adult dose of VAQTA 50/1.0 U/ml, lot # N016805 and expiration date 04-SEP-2018, for prophylaxis (route of administration was not reported). No adverse effect was reported. No further information was obtained.
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster, Pain, Post herpetic neuralgia, Rash vesicular
Clinical narrative: Information has been received from a lawyer regarding a case in litigation concerning a male patient (age unknown). The patient's medical history, concurrent conditions and concomitant medication use were not provided. On or about 13-AUG-2012, the patient was vaccinated with ZOSTAVAX, (lot# and route unknown) as recommended for routine adult health maintenance and for the prevention of shingles. The vaccine did not prevent shingles as intended, but rather caused the patient to contract a persistent strain of herpes zoster. On or about 30-JUN-2016, the patient was treated by a physician for a vesicular outbreak, which was diagnosed as shingles and other post-herpetic nervous system involvement. The patient has been prescribed capsaicin cream for management of his painful symptoms. As a direct and proximate result of the ZOSTAVAX vaccine, and/or despite receiving ZOSTAVAX for long-term prevention of shingles, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages. Additional information has been requested.