chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: MMRV, TDAP
Symptoms: Muscular weakness, Musculoskeletal stiffness
Clinical narrative: This spontaneous report has been received from a nurse, via a company representative, referring to a 37 years old female patient. Information about the patient's pertinent medical history, previous drug reactions, allergies and concomitant medications was unknown by the reporter. On 28-SEP-2018, the patient was vaccinated with PROQUAD (recombinant Human albumin [rHA]) injection, 1 dosage form (DF), for prophylaxis (dose number, route and anatomical location of vaccination were unknown by the reporter; lot number R003294, expiration date 31-JUL-2019). Other suspect therapies included diphtheria toxoid, pertussis acellular vaccine (unspecified), tetanus toxoid, 1 DF, administered to the patient on the same day at a different injection site (dose number, frequency, route of administration, lot number and expiration date were not provided). On 30-SEP-2018, the patient experienced symptoms of weakness in both arms and legs and stiffness in her neck for which she sought for medical attention. On 02-OCT-2018, the patient went back to the clinic with "the same symptoms". On 03-OCT-2018, the patient went back to the clinic and "the symptoms were starting to spontaneously resolve". It was unknown by the reporter if the patient was given any treatment or performed any laboratory or other diagnostic studies for the adverse events. No product quality complaints were involved. The reporter's causality assessment between the occurrence of the adverse events and vaccination with PROQUAD and diphtheria toxoid, pertussis acellular vaccine (unspecified), tetanus toxoid was not provided.
Age: 59.0
Sex: F
Vaccine: FLU4
Symptoms: Dehydration, Diarrhoea, Feeling cold, Headache, Skin burning sensation
Clinical narrative: Very cold which caused severe shaking. Resting heart rate of 103 to 105 bpm. Vomiting. Loose stools. Felt like I had something hot burning me inside my skin. Headache which I think was caused by the dehydration caused by vomiting and loose stools.
Age: 59.0
Sex: F
Vaccine: FLU4
Symptoms: Tremor, Vomiting
Clinical narrative: Very cold which caused severe shaking. Resting heart rate of 103 to 105 bpm. Vomiting. Loose stools. Felt like I had something hot burning me inside my skin. Headache which I think was caused by the dehydration caused by vomiting and loose stools.
Age: 80.0
Sex: M
Vaccine: FLU3
Symptoms: Rash, Rash erythematous
Clinical narrative: Red rash appeared down arm roughyl 1 week later.
Age: 71.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Pyrexia, Swelling
Clinical narrative: Patient ran fever of 100 degrees, and swelling and redness were about 6 inches spread.
Age: 85.0
Sex: F
Vaccine: PPV
Symptoms: Injection site erythema, Injection site warmth, Pyrexia
Clinical narrative: Patient says injection site is warm to the touch and is red, and reaction has moved to the back of the arm, fever.
Age: 52.0
Sex: M
Vaccine: FLU4
Symptoms: Blister, Hypersensitivity, Pruritus, Rash, Urticaria
Clinical narrative: Allergic reaction, hives, rash, itching, blisters that developed on bottom of feet approx. 6 hours after vaccination.
Age: 32.0
Sex: F
Vaccine: FLU4
Symptoms: Furuncle, Rash
Clinical narrative: Boils and rash on hands and arms.
Age: 76.0
Sex: F
Vaccine: VARZOS
Symptoms: Joint fluid drainage, Pain in extremity, Peripheral swelling
Clinical narrative: Patient reported swollen and painful arm, fluid drained from shoulder, 2 days in hospital.
Age: 70.0
Sex: F
Vaccine: FLU3, PPV, VARZOS
Symptoms: Erythema, Peripheral swelling, Pyrexia
Clinical narrative: The patient received a PPSV23 and flu shot on October 15, 2018 in the left arm and a SHINGRIX shot in the right arm. On October 18, 2018, she came back to the pharmacy to report that on the night of the 15th, she had started running a fever of 102 and her left arm began to present with redness and swelling. She ran a fever for 2 days, but is now fever free. She has been treating her arm with ice packs and TYLENOL and Ibuprofen. The pharmacist, advised her to continue with the ice packs and ibuprofen and acetaminophen. The patient was made aware upon the administration of the vaccine that an injection site reaction and fever are side effects of the vaccines, but that this is the body's immune response to an immunization. The patient reports that the swelling and redness has already begun to decrease. Pharmacist will follow up with the patient on Monday.
Age: 32.0
Sex: F
Vaccine: FLU4
Symptoms: Injection site hypersensitivity, Injection site hypoaesthesia, Injection site pain, Injection site paraesthesia
Clinical narrative: Numbness, tingling, burning, yet extreme sensitivity to my left Antecubital area. It feels as if someone left a tourniquet on too long and keep trying to draw blood from the area. The sensitivity is to the skin only. It started the day after My flu shot. I thought it was because I had my long sleeves rolled up, but the feeling did not resolve after I rolled them down. This is day two, the feeling persists constantly. It is numbing, yet oddly painful to the touch.
Age: 63.0
Sex: F
Vaccine: FLUC4
Symptoms: Bedridden, Chills, Dehydration, Fatigue, Nausea
Clinical narrative: Extreme chilling, fever, fatigue, nausea. Was bed ridden from Sunday, 10-7-18 with chills and fever. Those symptoms ran through the night both Sunday and through Monday into Tuesday, 10-9-18. Light nausea subsided on Tuesday and I was able to eat soup at that point. Dealt with slight dehydration due to extreme symptoms. Symptoms subsided later on Tuesday but slight fever returned at night for two more nights. Returned to normal activity on Saturday morning 10-13/18.
Age: 63.0
Sex: F
Vaccine: FLUC4
Symptoms: Pyrexia
Clinical narrative: Extreme chilling, fever, fatigue, nausea. Was bed ridden from Sunday, 10-7-18 with chills and fever. Those symptoms ran through the night both Sunday and through Monday into Tuesday, 10-9-18. Light nausea subsided on Tuesday and I was able to eat soup at that point. Dealt with slight dehydration due to extreme symptoms. Symptoms subsided later on Tuesday but slight fever returned at night for two more nights. Returned to normal activity on Saturday morning 10-13/18.
Age: 21.0
Sex: M
Vaccine: SMALL
Symptoms: Arthralgia, Brain natriuretic peptide normal, C-reactive protein normal, Chest X-ray normal, Chest pain
Clinical narrative: Pt first became viremic on day 9 after vaccination with myalgia, arthralgia, swollen lymphnodes and malaise. Day 10 chest pain onset substernal sharp constant in nature, exacerbated with deep breaths. Pt went to the ER. Where Troponin I elevated at 4.66, BNP wnl, ESR wnl, CRP wnl, Chest PA/Lat unremarkable. Ketoralac given with resolution. Pain returned next day. Pt was.
Age: 21.0
Sex: M
Vaccine: SMALL
Symptoms: Electrocardiogram abnormal, Lymphadenopathy, Malaise, Myalgia, Painful respiration
Clinical narrative: Pt first became viremic on day 9 after vaccination with myalgia, arthralgia, swollen lymphnodes and malaise. Day 10 chest pain onset substernal sharp constant in nature, exacerbated with deep breaths. Pt went to the ER. Where Troponin I elevated at 4.66, BNP wnl, ESR wnl, CRP wnl, Chest PA/Lat unremarkable. Ketoralac given with resolution. Pain returned next day. Pt was.
Age: 21.0
Sex: M
Vaccine: SMALL
Symptoms: Red blood cell sedimentation rate normal, Sinus arrhythmia, Sinus bradycardia, Troponin I increased, Viraemia
Clinical narrative: Pt first became viremic on day 9 after vaccination with myalgia, arthralgia, swollen lymphnodes and malaise. Day 10 chest pain onset substernal sharp constant in nature, exacerbated with deep breaths. Pt went to the ER. Where Troponin I elevated at 4.66, BNP wnl, ESR wnl, CRP wnl, Chest PA/Lat unremarkable. Ketoralac given with resolution. Pain returned next day. Pt was.
Age: 30.0
Sex: F
Vaccine: FLUC4
Symptoms: Injected limb mobility decreased, Injection site bruising, Injection site haemorrhage, Injection site pain, Pain
Clinical narrative: Received influenza vaccination in left deltoid, small amount of blood noted after injection but nothing else out of the ordinary. Noticed a bruise the next day and that the injection site was high and close to acromion process. Left upper arm/shoulder started to ache and had limited ROM, applied heat and took ibuprofen. Continued to ache and have limited ROM (particularly with abduction - pain). As of 10/18/18 not aching or bothering at night, but still have some limited ROM, although has improved. Will visit with healthcare professional next week if not improved.
Age: 30.0
Sex: F
Vaccine: FLUC4
Symptoms: Product administered at inappropriate site
Clinical narrative: Received influenza vaccination in left deltoid, small amount of blood noted after injection but nothing else out of the ordinary. Noticed a bruise the next day and that the injection site was high and close to acromion process. Left upper arm/shoulder started to ache and had limited ROM, applied heat and took ibuprofen. Continued to ache and have limited ROM (particularly with abduction - pain). As of 10/18/18 not aching or bothering at night, but still have some limited ROM, although has improved. Will visit with healthcare professional next week if not improved.
Age: 14.0
Sex: F
Vaccine: RAB, TDAP
Symptoms: Chest pain, Eye movement disorder, Musculoskeletal stiffness
Clinical narrative: Pt given rabies immunoglobulin 2ml around wound site. Tdap and then vaccine...pt stated her chest hurt and then eyes rolled back and pt stiffened (poss seizure vs syncopal episode).
Age: 0.33
Sex: F
Vaccine: DTAPIPVHIB, PNC13, RV5
Symptoms: Pyrexia
Clinical narrative: Patient developed fever of 103 on 10/16/18. Patient went to ED, came down to 98 degrees without medication.
Age: 13.0
Sex: M
Vaccine: HEPA, MNQ, TDAP, VARCEL
Symptoms: Lymphadenopathy, Rash, Skin warm
Clinical narrative: Patient returned to clinic, complaining of localized rash on left arm and swollen lymph nodes. Rash was localized on left arm warm to touch. Patient states it did not itch and was only visible on left arm. Patient did not have fever and lymph nodes was not painful. Mother states patient had similar reactions growing up, stating he was allergic to many things but did not know what. Mother was advised to let patient stay home from school and to watch for worsening symptoms and report to PCP if symptoms got worse. Mother was also advised to give patient OTC children's antihistamines to help symptoms.
Age: 7.0
Sex: F
Vaccine: FLU4
Symptoms: Erythema, Swelling
Clinical narrative: Red and swollen.
Age: 81.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Erythema, Swelling
Clinical narrative: Local redness and swelling.
Age: 23.0
Sex: F
Vaccine: FLU4, VARCEL
Symptoms: Injection site erythema, Injection site induration, Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: On 10/16/18 patient noticed her arm was sore when changing her clothes that night; site was sore to touch; no medication that night; on 10/17/18 patient took 50 mg BENADRYL po in the morning; site was warm to touch and swelling; that night patient took another 50 mg BENADRYL po and used BENADRYL topical cream to the site, patient also reports using ice for approximately 10-15 minutes that night; on 10/18/18 patient reports redness area; has enlarged, warm to the touch; patient reports using BENADRYL topical cream to site; patient now at health department to report adverse reaction. Right posterior arm with erythema at site of varicella injection; site measures 90mm X 50mm or erythema and 30mm X 18mm of induration. Patient reports that she feels that the site is getting larger. Patient denies having any anaphylactic reaction since receiving her vaccinations. FNP-C in office to look at site. Site is marked with surgical marker to monitor any changes in size. Patient to report to the Emergency Room if the site worsens or she has any breathing difficulties. Patient also given an appointment to return to the Health Department on Monday to assess reaction site.
Age: 23.0
Sex: F
Vaccine: FLU4, VARCEL
Symptoms: Pain in extremity
Clinical narrative: On 10/16/18 patient noticed her arm was sore when changing her clothes that night; site was sore to touch; no medication that night; on 10/17/18 patient took 50 mg BENADRYL po in the morning; site was warm to touch and swelling; that night patient took another 50 mg BENADRYL po and used BENADRYL topical cream to the site, patient also reports using ice for approximately 10-15 minutes that night; on 10/18/18 patient reports redness area; has enlarged, warm to the touch; patient reports using BENADRYL topical cream to site; patient now at health department to report adverse reaction. Right posterior arm with erythema at site of varicella injection; site measures 90mm X 50mm or erythema and 30mm X 18mm of induration. Patient reports that she feels that the site is getting larger. Patient denies having any anaphylactic reaction since receiving her vaccinations. FNP-C in office to look at site. Site is marked with surgical marker to monitor any changes in size. Patient to report to the Emergency Room if the site worsens or she has any breathing difficulties. Patient also given an appointment to return to the Health Department on Monday to assess reaction site.
Age: 1.67
Sex: F
Vaccine: FLU4, HEPA
Symptoms: Inappropriate schedule of product administration
Clinical narrative: Hep A dose given 6 days too soon. First dose 04/23/2018.
Age: 82.0
Sex: F
Vaccine: FLU3, PNC13
Symptoms: Rash, Rash pruritic
Clinical narrative: Patient presented to pharmacy 1 week after injection with a circular rash on arm that itched, patient had been applying rubbing alcohol, told patient to use hydrocortisone cream and/or BENADRYL, patient stated rash was starting to look better.
Age: 22.0
Sex: F
Vaccine: MNQ
Symptoms: Injection site erythema, Injection site pruritus, Injection site swelling
Clinical narrative: Red, swollen area to left upper arm area size of woman's open hand. Per patient area also itches. Advised patient to take, pain fever reliever and antihistamine for itching use cold or warm compresses as needed. Follow up with PVT MD or ER if symptoms continue.
Age: 17.0
Sex: M
Vaccine: MNQ
Symptoms: Urticaria
Clinical narrative: Hives that started on his chest and progressed to all over his body by next morning.
Age: 67.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Injection site erythema, Injection site pain
Clinical narrative: Patient said that she had never had any problems with any vaccinations in the past. No problems after vaccine administration on 10/16/18. The following morning, patient noticed she had a red spot on her arm (about 2 inches down from the injection site on the inner part of her arm). Throughout the course of the day, she said the spot was growing. She experienced a burning sensation and said it hurt when anything brushed up against her inner arm. On 10/18/18, she presented to urgent care. The provider called the pharmacy to find out which vaccination patient had received in her right arm. Provider ruled out cellulitis and the patient never developed a fever. She was prescribed a 3 day course of prednisone.
Age: 28.0
Sex: F
Vaccine: FLU4
Symptoms: Crying, Immediate post-injection reaction, Injection site pain, Insomnia, Loss of personal independence in daily activities
Clinical narrative: Terrible sharp pain while getting the shot, very sore immediately after receiving the shot, and not able to move shoulder as of Tuesday night. Was in tears several times due to pain, and not able to sleep for the 2nd night in a row due to pain, Not able to extend shoulder very much at all. Not able to lift arm to wash hair, etc.
Age: 28.0
Sex: F
Vaccine: FLU4
Symptoms: Mobility decreased
Clinical narrative: Terrible sharp pain while getting the shot, very sore immediately after receiving the shot, and not able to move shoulder as of Tuesday night. Was in tears several times due to pain, and not able to sleep for the 2nd night in a row due to pain, Not able to extend shoulder very much at all. Not able to lift arm to wash hair, etc.
Age: 67.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site bruising, Injection site discolouration, Injection site pain, Injection site swelling, Pain
Clinical narrative: Swelling and Bruising of L Upper Arm. Pt stated arm swelled up and throbbed. Upon examination 10/18/18 at 3pm - still noted quite a bit of bruising and yellowing. Still tinder and sore. Pt stated that dose last year did NOT have any problems. Pt will follow up if conditions worsens.
Age: 77.0
Sex: F
Vaccine: FLU3
Symptoms: Body temperature increased, Fatigue, Musculoskeletal pain
Clinical narrative: Tiredness, elevated temp, achiness to shoulders bilaterally x 2 days. Temp 99.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Rash vesicular
Clinical narrative: This spontaneous report as received from a lawyer regarding a case in litigation concerning a patient of unknown age and gender. There was no information about the patient's medical history, concurrent conditions and concomitant medication provided. On an unknown date in 2011, the patient was vaccinated with a dose of ZOSTAVAX as recommended for routine adult health maintenance and for the prevention of shingles (dose, route of administration, anatomical location, lot# and expiration date were unknown). The vaccine did not prevent shingles as intended, and the patient subsequently contracted a persistent strain of herpes zoster or shingles (onset date was not provided). On an unknown date in 2011 (reported as later in 2011), the patient was treated for a vesicular outbreak, 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 significant medical expenses, and pain and suffering, and other damages. The outcome of the events was unknown. The reporter considered the events to be related to the ZOSTAVAX.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Rash vesicular
Clinical narrative: This spontaneous report as received from a lawyer regarding a case in litigation concerning a patient of unknown age and gender. There was no information about the patient's medical history, concurrent conditions and concomitant medication provided. On an unknown date in August 2016 (reported as on or about 20-AUG-2016), the patient was vaccinated with a dose of ZOSTAVAX as recommended for routine adult health maintenance and for the prevention of shingles (dose, route of administration, anatomical location, lot# and expiration date were unknown). The vaccine did not prevent shingles as intended, and the patient subsequently contracted a persistent strain of herpes zoster or shingles (onset date was not provided). On an unknown date in August 2016 (reported as on or about 26-AUG-2016), the patient was treated for a vesicular outbreak, 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 significant medical expenses, and pain and suffering, and other damages. The outcome of the events was unknown. The reporter considered the events to be related to the ZOSTAVAX.
Sex: U
Vaccine: VARZOS
Symptoms: Blister, Herpes zoster, Rash vesicular
Clinical narrative: This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a patient of unknown age. No information was provided regarding concomitant medications, concurrent conditions or medical history. On or about 01-NOV-2012, the patient was inoculated with ZOSTAVAX as recommended for routine adult health maintenance 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 condition of herpes zoster. In 2015, the patient was treated by a physician assistant for a blistering vesicular outbreak which was diagnosed as herpes zoster or shingles. 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. The outcome of the events was unknown. Causality assessment was related. Additional information has been requested.
Sex: F
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 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 by a pharmacist as recommended for routine adult health maintenance for the long-term prevention of shingles (dose, route, and lot # not provided). The vaccine did not prevent shingles and the patient subsequently contracted a persistent strain condition of herpes zoster. On or about 05-AUG-2016, the patient was treated by a physician for the onset of a vesicular rash, which was diagnosed as herpes zoster or shingles. 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. The outcome of the events was unknown. Causality assessment was related. Additional information has been requested.
Sex: U
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 patient of unknown age and gender. Information regarding medical history, concurrent conditions and concomitant medications was not provided. On or about 07-APR-2014, the patient was inoculated with ZOSTAVAX at a pharmacy as recommended for routine adult health maintenance and for the prevention of shingles. The vaccine did not prevent shingles as intended, and the patient subsequently contracted a persistent strain of herpes zoster. On or about 05-AUG-2016, the patient was treated by a physician for the onset of a vesicular rash, which was diagnosed as herpes zoster. As a direct and proximate result of ZOSTAVAX, 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.
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster, Pain, Rash vesicular
Clinical narrative: Information has been received from a lawyer regarding a case in litigation concerning a male patient of unknown age. No information was received regarding the patient's past medical history, concurrent conditions, or concomitant medication. On or about 03-APR-2013, the patient was inoculated with the ZOSTAVAX (lot number, dosage and route of administration not provided), as recommended for routine adult health maintenance and for the long-term prevention of shingles. The ZOSTAVAX did not prevent shingles as intended, and the patient subsequently contracted a persistent strain of herpes zoster. On or about 06-AUG-2016, the patient was treated for the onset of a vesicular rash, which was diagnosed as severe herpes shingles. The patient was prescribed acyclovir and prednisone for management of his painful symptoms and chronic pain. The outcome of the events is unknown. 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.
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster, Pain, Rash vesicular
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 13-JUL-2007, the patient was inoculated with the ZOSTAVAX (lot number, dosage and route of administration not provided) at a clinic, as recommended for routine adult health maintenance and for the long-term prevention of shingles. The ZOSTAVAX did not prevent shingles as intended, and the patient subsequently contracted a persistent strain of herpes zoster. On or about 06-AUG-2016, the patient was treated by a physician for the onset of a severe vesicular rash, which was diagnosed as shingles. The patient was prescribed methyl-prednisone for management of her painful symptoms and chronic pain. The outcome of the events is unknown. 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 significant medical expenses, and pain and suffering, and other damages. Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster, Pain, Rash vesicular
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 06-NOV-2008, the patient was inoculated with the ZOSTAVAX (lot number, dosage and route of administration not provided) at a pharmacy, as recommended for routine adult health maintenance and for the long-term prevention of shingles. The ZOSTAVAX did not prevent shingles as intended, and the patient subsequently contracted a persistent strain of herpes zoster. On or about 20-SEP-2016, the patient was treated by a nurse practitioner for the onset of a severe vesicular rash, which was diagnosed as herpes zosters. The patient was prescribed acyclovir for management of her painful symptoms and chronic pain. The outcome of the events is unknown. 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.
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster, Pain, Rash vesicular, Vaccination failure
Clinical narrative: This initial spontaneous report as received from a lawyer regarding a case in litigation refers to a female patient of unknown age. The patient's medical history, concurrent conditions, and concomitant medications were not provided. On or about 22-OCT-2015, the patient was vaccinated with ZOSTAVAX (dose, route, and lot number not provided) at a pharmacy as recommended for routine adult health maintenance and for the long-term prevention of shingles. The vaccine did not prevent shingles as intended and, on an unspecified date, the patient contracted a persistent strain of herpes zoster. On or about 24-JUN-2016, the patient was treated at urgent care for a persistent and severe vesicular rash which was diagnosed as shingles. The patient was prescribed VALTREX for management of her painful symptoms and chronic pain. As a direct and proximate result of ZOSTAVAX, 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, pain, suffering, and other damages. The outcome of vaccination failure and herpes zoster was unknown. The reporter considered vaccination failure and herpes zoster to be related to ZOSTAVAX. Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster, Rash vesicular, Vaccination failure
Clinical narrative: This initial spontaneous report as received from a lawyer regarding a case in litigation refers to a female patient of unknown age. The patient's medical history, concurrent conditions, and concomitant medications were not provided. On or about 28-SEP-2011, the patient was vaccinated with ZOSTAVAX (dose, route, and lot number not provided) at a pharmacy as recommended for routine adult health maintenance and for the long-term prevention of shingles. The vaccine did not prevent shingles as intended and, on an unspecified date, the patient contracted a persistent strain of herpes zoster. On or about 09-AUG-2016, the patient was treated at a medical center for a persistent and severe vesicular rash which was diagnosed as herpes zoster or shingles. As a direct and proximate result of ZOSTAVAX, 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, pain, suffering, and other damages. The outcome of vaccination failure and herpes zoster was unknown. The reporter considered vaccination failure and herpes zoster to be related to ZOSTAVAX. Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Blister, Herpes zoster, Rash vesicular
Clinical narrative: This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a patient of unknown age and gender. No information was provided regarding concomitant medications, concurrent conditions or medical history. In 2010, the patient was inoculated with ZOSTAVAX by a physician as recommended for routine adult health maintenance 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 condition of herpes zoster. In 2015, the patient was treated at a hospital for a blistering vesicular outbreak which was diagnosed as herpes zoster or shingles. 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. The outcome of the events was unknown. Causality assessment was related. Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Blister, Herpes zoster, 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 01-May-2013, the patient was inoculated with ZOSTAVAX by a healthcare professional as recommended for routine adult health maintenance 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 condition of herpes zoster. On or about 30-Nov-2015, the patient was treated at the same medical office for a blistering vesicular outbreak which was diagnosed as herpes zoster or shingles. 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. The outcome of the events was unknown. Causality assessment was related. Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Blister, Herpes zoster, 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 07-Aug-2012, the patient was inoculated with ZOSTAVAX by a pharmacist as recommended for routine adult health maintenance 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 condition of herpes zoster. On or about 01-Nov-2015, the patient was treated at a medical office for a blistering vesicular outbreak which was diagnosed as herpes zoster or shingles. 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. The outcome of the events was unknown. Causality assessment was related. Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Blister, Herpes zoster, 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 2010, the patient was inoculated with ZOSTAVAX by a physician as recommended for routine adult health maintenance 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 condition of herpes zoster. In 2011, the patient was treated by a physician for a blistering vesicular outbreak which was diagnosed as herpes zoster or shingles.  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. The outcome of the events was unknown. Causality assessment was related. Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster, Pain, Rash vesicular, Vaccination failure
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. There was no information about the patient's concurrent conditions, medical history or concomitant medication. On or about 11-FEB-2010, the patient was inoculated with ZOSTAVAX by a physician as recommended for routine adult health maintenance for the prevention of shingles (dose, frequency, route of administration, lot number and expiration date were not reported). The vaccine did not prevent shingles as intended and the patient subsequently contracted a persistent strain condition of herpes zoster. On or about 04-AUG-2012, according to the report, the patient was treated in the hospital, for a persistent and severe vesicular rash, which was diagnosed as herpes zoster or shingles. The patient was prescribed with LORTAB and Acyclovir for management of the painful symptoms and chronic pain. According to the report, 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 did suffer and was going to continue to suffer significant medical expenses, and pain and suffering, and other damages. The outcome of vaccination failure, herpes zoster, emotional distress, injury and pain was unknown. The reporter considered vaccination failure, herpes zoster, emotional distress, injury and pain to be related to ZOSTAVAX. Additional information has been requested.
Sex: U
Vaccine: RV5
Symptoms: No adverse event, Product storage error
Clinical narrative: The report was first received from a practice manager on 07-SEP-2018, and it was recognized as non-valid because report did not obtain any patient identify. Follow-up information has been received from the practice manager on 18-SEP-2018. This spontaneous report refers to a patient of unknown age and gender. Information of concurrent condition, medical history and concomitant therapy was not provided. On 24-JAN-2018 and 10-APR-2018, the patient was vaccinated with an improperly stored dose of ROTATEQ (strength were unknown) (lot# N003984 and expiration date 19-NOV-2018; lot# N024295 and expiration date 24-MAR-2019) orally for prophylaxis, respectively. The sterile diluent (MERCK) (lot# and expiration date were unknown) was properly stored. No adverse event was reported. The excursion temperature on 08-NOV-2017, 16-NOV-2017, 23-JAN-2018, 06-JUN-2018, 03-JUL-2018 and 14-AUG-2018 was 47 degree Celsius for maximize 15 hours. The excursion temperature on 07-DEC-2017 was 50 degree Celsius for maximize 8.75 hours. The call was not because of data logger. This is one of several reports received from the same reporter. Sender's Comments: US-009507513-1809USA003709: US-009507513-1810USA001951: US-009507513-1810USA001952: US-009507513-1810USA001953: US-009507513-1810USA001954: US-009507513-1810USA001955: US-009507513-1810USA001956: US-009507513-1810USA001957: US-009507513-1810USA001958.
Sex: U
Vaccine: RV5
Symptoms: No adverse event, Product storage error
Clinical narrative: The report was first received from a practice manager on 07-SEP-2018, and it was recognized as non-valid because report did not obtain any patient identify. Follow-up information has been received from the practice manager on 18-SEP-2018. This spontaneous report refers to a patient of unknown age and gender. Information of concurrent condition, medical history and concomitant therapy was not provided. On 11-JAN-2018 and 05-APR-2018, the patient was vaccinated with an improperly stored dose of ROTATEQ (strength were unknown) (lot# N003984 and expiration date 19-NOV-2018; lot# N024295 and expiration date 24-MAR-2019) orally for prophylaxis, respectively (Incorrect product storage). The Merck Sterile Diluent (lot# and expiration date were unknown) was properly stored. No adverse event was reported. The excursion temperature on 08-NOV-2017, 16-NOV-2017, 23-JAN-2018, 06-JUN-2018, 03-JUL-2018 and 14-AUG-2018 was 47 degree Celsius for maximize 15 hours. The excursion temperature on 07-DEC-2017 was 50 degree Celsius for maximize 8.75 hours. The call was not because of data logger. This is one of several reports received from the same reporter. Sender's Comments: US-009507513-1809USA003709; US-009507513-1810USA001951; US-009507513-1810USA001952; US-009507513-1810USA001953; US-009507513-1810USA001954; US-009507513-1810USA001955; US-009507513-1810USA001956; US-009507513-1810USA001957; US-009507513-1810USA001958.
Sex: U
Vaccine: RV5
Symptoms: No adverse event, Product storage error
Clinical narrative: The report was first received from a practice manager on 07-SEP-2018, and it was recognized as non-valid because report did not obtain any patient identify. Follow-up information has been received from the practice manager on 18-SEP-2018. This spontaneous report refers to a patient of unknown age and gender. Information of concurrent condition, medical history and concomitant therapy was not provided. On 02-JAN-2018, 22-MAR-2018 and 24-MAY-2018, the patient was vaccinated with an improperly stored dose of ROTATEQ (strength were unknown) (lot# N003984 and expiration date 19-NOV-2018; lot# M022173 and expiration date 15-MAR-2019; lot# N024295 and expiration date 24-MAR-2019) orally for prophylaxis, respectively. The sterile diluent (MERCK) (lot# and expiration date were unknown) was properly stored. No adverse event was reported. The excursion temperature on 08-NOV-2017, 16-NOV-2017, 23-JAN-2018, 06-JUN-2018, 03-JUL-2018 and 14-AUG-2018 was 47 degree Celsius for maximize 15 hours. The excursion temperature on 07-DEC-2017 was 50 degree Celsius for maximize 8.75 hours. The call was not because of data logger. This is one of several reports received from the same reporter. Sender's Comments: US-009507513-1809USA003709: US-009507513-1810USA001951: US-009507513-1810USA001952: US-009507513-1810USA001953: US-009507513-1810USA001954: US-009507513-1810USA001955: US-009507513-1810USA001956: US-009507513-1810USA001957: US-009507513-1810USA001958.
Sex: U
Vaccine: RV5
Symptoms: No adverse event, Product storage error
Clinical narrative: The report was first received from a practice manager on 07-SEP-2018, and it was recognized as non-valid because report did not obtain any patient identify. Follow-up information has been received from the practice manager on 18-SEP-2018. This spontaneous report refers to a patient of unknown age and gender. Information of concurrent condition, medical history and concomitant therapy was not provided. On 06-FEB-2018, 19-APR-2018 and 22-JUN-2018, the patient was vaccinated with an improperly stored dose of ROTATEQ (strength were unknown) (lot# N003984 and expiration date 19-NOV-2018; lot# N024295 and expiration date 24-MAR-2019; lot# N028258 and expiration date 30-MAY-2019) orally for prophylaxis, respectively. The sterile diluent (MERCK) (lot# and expiration date were unknown) was properly stored. No adverse event was reported. The excursion temperature on 08-NOV-2017, 16-NOV-2017, 23-JAN-2018, 06-JUN-2018, 03-JUL-2018 and 14-AUG-2018 was 47 degree Celsius for maximize 15 hours. The excursion temperature on 07-DEC-2017 was 50 degree Celsius for maximize 8.75 hours. The call was not because of data logger. This is one of several reports received from the same reporter. Sender's Comments: US-009507513-1809USA003709: US-009507513-1810USA001951: US-009507513-1810USA001952: US-009507513-1810USA001953: US-009507513-1810USA001954: US-009507513-1810USA001955: US-009507513-1810USA001956: US-009507513-1810USA001957: US-009507513-1810USA001958.
Sex: U
Vaccine: RV5
Symptoms: No adverse event, Product storage error
Clinical narrative: The report was first received from a practice manager on 07-SEP-2018, and it was recognized as non-valid because report did not obtain any patient identify. Follow-up information has been received from the practice manager on 18-SEP-2018. This spontaneous report refers to a patient of unknown age and gender. Information of concurrent condition, medical history and concomitant therapy was not provided. On 22-FEB-2018, 26-APR-2018 and 28-JUN-2018, the patient was vaccinated with an improperly stored dose of ROTATEQ (strength were unknown) (lot# N003984 and expiration date 19-NOV-2018; lot# N024295 and expiration date 24-MAR-2019; lot# N028258 and expiration date 30-MAY-2019) orally for prophylaxis, respectively (Incorrect product storage). The Merck Sterile Diluent (lot# and expiration date were unknown) was properly stored. No adverse event was reported. The excursion temperature on 08-NOV-2017, 16-NOV-2017, 23-JAN-2018, 06-JUN-2018, 03-JUL-2018 and 14-AUG-2018 was 47 degree Celsius for maximize 15 hours. The excursion temperature on 07-DEC-2017 was 50 degree Celsius for maximize 8.75 hours. The call was not because of data logger. This is one of several reports received from the same reporter. Sender's Comments:  US-009507513-1809USA003709; US-009507513-1810USA001951; US-009507513-1810USA001952; US-009507513-1810USA001953; US-009507513-1810USA001954; US-009507513-1810USA001955; US-009507513-1810USA001956; US-009507513-1810USA001957; US-009507513-1810USA001958.
Sex: U
Vaccine: RV5
Symptoms: No adverse event, Product storage error
Clinical narrative: The report was first received from a practice manager on 07-SEP-2018, and it was recognized as non-valid because report did not obtain any patient identify. Follow-up information has been received from the practice manager on 18-SEP-2018. This spontaneous report refers to a patient of unknown age and gender. Information of concurrent condition, medical history and concomitant therapy was not provided. On 01-MAR-2018, 03-MAY-2018 and 05-JUL-2018, the patient was vaccinated with an improperly stored dose of ROTATEQ (strength were unknown) (lot# N003984 and expiration date 19-NOV-2018; lot# N024295 and expiration date 24-MAR-2019; lot# N028258 and expiration date 30-MAY-2019) orally for prophylaxis, respectively (Incorrect product storage). The Merck Sterile Diluent (lot# and expiration date were unknown) was properly stored. No adverse event was reported. The excursion temperature on 08-NOV-2017, 16-NOV-2017, 23-JAN-2018, 06-JUN-2018, 03-JUL-2018 and 14-AUG-2018 was 47 degree Celsius for maximize 15 hours. The excursion temperature on 07-DEC-2017 was 50 degree Celsius for maximize 8.75 hours. The call was not because of data logger. This is one of several reports received from the same reporter. Sender's Comments: US-009507513-1809USA003709; US-009507513-1810USA001951; US-009507513-1810USA001952; US-009507513-1810USA001953; US-009507513-1810USA001954; US-009507513-1810USA001955; US-009507513-1810USA001956; US-009507513-1810USA001957; US-009507513-1810USA001958.
Sex: U
Vaccine: RV5
Symptoms: No adverse event, Product storage error
Clinical narrative: The report was first received from a practice manager on 07-SEP-2018, and it was recognized as non-valid because report did not obtain any patient identify. Follow-up information has been received from the practice manager on 18-SEP-2018. This spontaneous report refers to a patient of unknown age and gender. Information of concurrent condition, medical history and concomitant therapy was not provided. On 23-APR-2018, 25-JUN-2018 and 29-AUG-2018, the patient was vaccinated with an improperly stored dose of ROTATEQ (strength were unknown) (lot# N024295 and expiration date 24-MAR-2019; lot# N028258 and expiration date 30-MAY-2019; lot# N030175 and expiration date 16-JUN-2019) orally for prophylaxis, respectively. The sterile diluent (MERCK) (lot# and expiration date were unknown) was properly stored. No adverse event was reported. The excursion temperature on 08-NOV-2017, 16-NOV-2017, 23-JAN-2018, 06-JUN-2018, 03-JUL-2018 and 14-AUG-2018 was 47 degree Celsius for maximize 15 hours. The excursion temperature on 07-DEC-2017 was 50 degree Celsius for maximize 8.75 hours. The call was not because of data logger. This is one of several reports received from the same reporter. Sender's Comments: US-009507513-1809USA003709: US-009507513-1810USA001951: US-009507513-1810USA001952: US-009507513-1810USA001953: US-009507513-1810USA001954: US-009507513-1810USA001955: US-009507513-1810USA001956: US-009507513-1810USA001957: US-009507513-1810USA001958.