chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 23.0
Sex: F
Vaccine: CHOL
Symptoms: Anxiety, Fatigue, Pyrexia, Rash, Vomiting
Clinical narrative: This spontaneous case report was received from caregiver (PVX2017-2909) on 13-Sep-2017. The report describes a 23-year-old adult female consumer who experienced fatigue, hot like fever, vomiting, anxiety and small rash on elbow following the intake of VAXCHORA for an unknown indication. It was reported that the consumer took VAXCHORA two days ago and developed adverse events an hour ago. The consumer vomited once, felt fatigued, and had a small rash on elbow. The consumer also felt hot like a fever, but the caregiver could not take her temperature. The caregiver stated the adverse events were not severe. The patient does not take any other medications but takes medications on an as needed basis. The action taken with VAXCHORA with respect to the events fatigue, hot like fever, vomiting, anxiety and small rash on elbow was not applicable. The clinical outcome of the events fatigue, hot like fever, vomiting, anxiety and small rash on elbow was unknown. Sender's Comments: Company's comments: In view of a temporal relationship between administration of VAXCHORA and the onset of the events, causality of the events with VAXCHORA was assessed as possible.
Sex: U
Vaccine: CHOL
Symptoms: Labelled drug-food interaction medication error
Clinical narrative: This spontaneous case report was received from nurse (PVX2017-3193) on 13-Oct-2017. The report describes a 54-year-old male consumer who "ate chips 30 minutes after taking VAXCHORA". The consumer was receiving oral VAXCHORA for an unknown indication. It was reported that the consumer ate chips 30 minutes after taking VAXCHORA. The action taken with VAXCHORA with respect to the event "ate chips 30 minutes after taking VAXCHORA" was not applicable. The clinical outcome of the event "ate chips 30 minutes after taking VAXCHORA" was unknown. Sender's Comments: Company's comment: The causality of the event "ate chips 30 minutes after taking VAXCHORA" was considered as not applicable.
Age: 25.0
Sex: F
Vaccine: CHOL
Symptoms: Labelled drug-food interaction medication error
Clinical narrative: This spontaneous case report was received from consumer (PVX2017-3281) on 24-Oct-2017. The report describes a 25-year-old adult female consumer who "ate food half an hour after VAXCHORA administration". The consumer was receiving VAXCHORA for an unknown indication. It was reported that the consumer ate half an hour after taking VAXCHORA. The consumer took VAXCHORA on 23-Oct-2017. The action taken with VAXCHORA with respect to the event "ate food half an hour after VAXCHORA administration" was not applicable. The clinical outcome of the event "ate food half an hour after VAXCHORA administration" was unknown. Sender's Comments: Company's comment: The causality of the event "ate food half an hour after VAXCHORA administration" was considered as not applicable.
Age: 4.0
Sex: M
Vaccine: MMRV
Symptoms: Extra dose administered, No adverse event
Clinical narrative: This spontaneous report was received from a medical assistant referring to a 4 year old male patient. The patient's pertinent medical history, concurrent conditions, drug reactions/allergies and concomitant medications were not provided. On 13-NOV-2014, the patient was vaccinated with the first dose of PROQUAD for prophylaxis (route, lot # and expiration date were not reported). Then, on 05-SEP-2017, the patient received a second dose of PROQUAD for prophylaxis (route, lot # and expiration date were not reported). Subsequently, on 06-DEC-2017, the patient was inadvertently administered a third dose of PROQUAD Lot # M049122, expired on 13-JUN-2018, for prophylaxis (route, lot # and expiration date were not reported). No adverse effects were reported.
Sex: U
Vaccine: PPV
Symptoms: Extra dose administered, No adverse event
Clinical narrative: This spontaneous report as received from a pharmacist refers to a patient of unknown age and gender. Neither medical history, concurrent conditions nor historical drugs were reported. On 27-OCT-2017, the patient was vaccinated with PNEUMOVAX 23 lot number N013521, expiration date 23-JAN-2019 (dose number and route of administration were not reported) for prophylaxis. The reporter stated that, on an unspecified date in the beginning of 2017 (reported as "earlier this year"), the patient was also administered a dose of PNEUMOVAX 23 (dose number, route of administration, lot number and expiration date were not reported) for prophylaxis. No adverse effects were reported.
Sex: U
Vaccine: MMRV
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a Licensed Nurse and refers to a patient of unknown age and gender. No information was provided regarding the patient's medical history, concurrent conditions or concomitant medications. On an unknown date (reported as "on unknown recent dates") the patient was administered an improperly stored dose of PROQUAD injection, subcutaneously, for prophylaxis (dose and anatomical location were not reported). The lot number was reported as N014366 with expiration date on 09-MAY-2019, which is not a valid lot number for the product. No adverse effects were reported for the patient after the administration of PROQUAD.  The vaccine underwent a temperature excursion of 14.9F for 12 hours and 6 minutes and no previous temperature excursions were reported. The reporter stated that the call was because of a data logger.   This is one of two reports received from the same reporter (MARRS #1801USA001507); Sender's Comments:  US-009507513-1801USA001507:
Age: 66.0
Sex: F
Vaccine: PPV
Symptoms: Injection site discolouration, Injection site erythema, Mobility decreased, Pain in extremity
Clinical narrative: This spontaneous report as received from a pharmacist and also from a patient, refers to a 66 year old female patient. She did not have pertinent medical history, drug reactions or allergies and concomitant therapies. On 09-DEC-2017, the patient was vaccinated with PNEUMOVAX 23, intramuscularly, lot # N024385, expiration date 18-MAY-2019 (dose and site of administration were not reported) for prophylaxis. On 09-DEC-2017, the patient was unable to raise her arm above her head, towards the end of that day, due to the pain in her arm. On unknown date in December 2017, the patient experienced redness around injection site. Furthermore, redness turned yellow. The outcome of pain in extremity was unknown. The outcome of vaccination site erythema and yellow skin was reported as not recovered. The relatedness between the events and PNEUMOVAX 23 was unknown. The patient did not seek medical attention. No treatment was given for the adverse events. There were no lab diagnostic studies performed. No product quality complaint (PQC) was involved.
Age: 60.0
Sex: M
Vaccine: VARZOS
Symptoms: Chronic obstructive pulmonary disease, Condition aggravated
Clinical narrative: This spontaneous report was received from a pharmacist, concerning a 60 year old male patient. The patient's medical history was not reported. His concurrent conditions included Chronic Obstructive Pulmonary Disease (COPD). The patient's concomitant medications were reported by the pharmacist as "an extensive list". The reporter informed that on 18-DEC-2017, the patient received a dose of ZOSTAVAX administered with sterile diluent (MERCK), both subcutaneously, for prophylaxis, lot #N020852 and expiration date 31-JUL-2018 and lot #N013283 expiration date 03-OCT-2019, respectively (strength, dose and frequency were not reported). It was informed that on 19-DEC-2017, the patient developed a "COPD flair up". On the same date, the patient went to an unspecified physician and was prescribed MEDROL and Z-PACK. At the time of reporting, the outcome of COPD flair up was unknown. The causal relationship between the vaccination with ZOSTAVAX and COPD flair up, was not provided by the reporter.
Age: 21.0
Sex: F
Vaccine: HPV9
Symptoms: Exposure during pregnancy, Ultrasound scan
Clinical narrative: This spontaneous prospective pregnancy report was received from a medical assistant concerning a 21 year old female patient. The patient's medical history included syndactyly, low grade squamous intraepithelial lesion (LGSIL), cervical dysplasia (CIN 1) and CIN 2. On 16-NOV-2017, the patient was vaccinated with GARDASIL 9 lot # N012093 dose 1 for prophylaxis (dose, route of administration and expiration date were not reported). Concomitant therapies included nitrofurantoin(manufacturer unknown) for urinary tract infection (UTI). The patient became pregnant with last menstrual period (LMP) of 20-OCT-2017, and estimated date of delivery (EDD) of 27-JUL-2018. Initial exposure to GARDASIL 9 was at 4 week(s). On 16-NOV-2017, the patient experienced exposure during pregnancy (first trimester of pregnancy). On 12-DEC-2017 an ultrasound was performed, results were not provided.
Sex: U
Vaccine: HPV9
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a nurse, referring to a patient of unspecified age and gender. Information regarding patient's historical drugs, medical history, concomitant therapies, drugs allergies and concurrent conditions were not reported. On 21-DEC-2017, the patient was inadvertently vaccinated with improperly stored doses of GARDASIL 9 lot # N022584, expiration date 15-JUN-2020, for prophylaxis (strength, dose, route and frequency were not reported). The following temperature excursions were reported: temperature below 32°F during 6 hours 9 minutes, 30.8°F during 2 hours 57 minutes and 31.9°F during 3 hours 12 minutes. Temperature excursion was of 32°F to 35°F during 3 hours 4 minutes, multiple excursions were reported. Previous temperature excursion was not reported. A digital data logger was involved. No adverse effects were reported. This is one of the multiple reports received from the same reporter.; Sender's Comments: US-009507513-1801USA001528: US-009507513-1801USA002100: US-009507513-1801USA002098: US-009507513-1801USA002097: US-009507513-1801USA002099:
Age: 2.0
Sex: U
Vaccine: HIBV
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report as received from a consumer via Clinic refers to a currently 3 year old patient of unknown gender. The patient's medical history, concurrent conditions and concomitant medications were not reported. On 14-APR-2017, the patient was vaccinated with improperly stored dose of LIQUID PEDVAXHIB 1 dose unit (lot # M025193, Expiry date : 21-MAR-2019 ) for prophylaxis (product storage error). There were no previous temperature excursions recorded. It was unknown if data logger was involved. No adverse effects were reported. There was no product quality complaint involved. This is one of the several reports received from the same reporter.; Sender's Comments: US-009507513-1801USA000166:
Age: 1.0
Sex: U
Vaccine: HIBV
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report as received from a consumer via Clinic refers to a currently 19 month old patient of unknown gender. The patient's medical history, concurrent conditions and concomitant medications were not reported. On 16-JUN-2017, the patient was vaccinated with improperly stored dose of PEDVAXHIB 1 dose unit (lot # M025193, Expiry date: 21-MAR-2019) for prophylaxis. There were no previous temperature excursions recorded. It was unknown if data logger was involved. No adverse effects were reported. There was no product quality complaint involved. This is one of the several reports received from the same reporter. Sender's Comments: US-009507513-1801USA000166.
Age: 1.58
Sex: U
Vaccine: HIBV
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report as received from a consumer via Clinic refers to a currently 2 year old patient of unknown gender. The patient's medical history, concurrent conditions and concomitant medications were not reported. On 16-MAR-2017, the patient was vaccinated with improperly stored dose of LIQUID PEDVAXHIB 1 dose unit (lot # M025193, Expiry date : 21-MAR-2019) for prophylaxis (product storage error). There were no previous temperature excursions recorded. It was unknown if data logger was involved. No adverse effects were reported. There was no product quality complaint involved.  This is one of the several reports received from the same reporter.; Sender's Comments: US-009507513-1801USA000166:
Age: 11.0
Sex: U
Vaccine: HIBV
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report as received from a consumer via Clinic refers to a currently 12 year old patient of unknown gender. The patient's medical history, concurrent conditions and concomitant medications were not reported. On 05-JUL-2017, the patient was vaccinated with improperly stored dose of PEDVAXHIB 1 dose unit (lot # M025193, Expiry date: 21-MAR-2019) for prophylaxis. There were no previous temperature excursions recorded. It was unknown if data logger was involved. No adverse effects were reported. There was no product quality complaint involved. This is one of the several reports received from the same reporter. Sender's Comments: US-009507513-1801USA000166.
Age: 1.5
Sex: U
Vaccine: HIBV
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report as received from a consumer via Clinic refers to a currently 22 month old patient of unknown gender. The patient's medical history, concurrent conditions and concomitant medications were not reported. On 18-AUG-2017, the patient was vaccinated with improperly stored dose of LIQUID PEDVAXHIB 1 dose unit ( lot # M047666, Expiry date was not reported) for prophylaxis (product storage error). There were no previous temperature excursions recorded. It was unknown if data logger was involved. No adverse effects were reported. There was no product quality complaint involved. This is one of the several reports received from the same reporter.; Sender's Comments:  US-009507513-1801USA000166:
Age: 14.0
Sex: F
Vaccine: HPV4
Symptoms: Colitis ulcerative, Laboratory test
Clinical narrative: This spontaneous report was received from a patient's father via a company representative (also the father's friend) and refers to a 18-year-old female patient. The patient's medical history, concurrent conditions and concomitant therapies were not reported. Since approximately 2014 (reported as "3-4 years ago"), the patient was vaccinated with 3 doses in series of GARDASIL, 0.5 ml (route of administration, lot# and expiration date were not reported) to prevent HPV related cancers. In January 2017 (reported as "1 year ago"), the patient was diagnosed with ulcerative colitis. The patient sought for an unspecified medical attention. All diagnostic tests needed to be done for ulcerative colitis were performed in January 2017. At the time of this report, the patient was being treated with HUMIRA.The outcome of the event was unknown. The relatedness between the event and GARDASIL was not reported. Upon internal review, the event of ulcerative colitis was considered to be medically significant.
Sex: U
Vaccine: MMRV
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a Licensed Nurse and refers to a patient of unknown age and gender. No information was provided regarding the patient's medical history, concurrent conditions or concomitant medications. On an unknown date (reported as "on unknown recent dates") the patient was administered an improperly stored dose of PROQUAD injection, subcutaneously, for prophylaxis (dose and anatomical location were not reported). The lot number was reported as N014366 with expiration date on 09-MAY-2019, which is not a valid lot number for the product. No adverse effects were reported for the patient after the administration of PROQUAD. The vaccine underwent a temperature excursion of 14.9F for 12 hours and 6 minutes and no previous temperature excursions were reported. The reporter stated that the call was because of a data logger. This is one of two reports received from the same reporter (MARRS # 1712USA005251). Sender's Comments: US-009507513-1712USA005251.
Sex: U
Vaccine: HPV9
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a nurse, referring to a patient of unspecified age and gender. Information regarding patient's historical drugs, medical history, concomitant therapies, drugs allergies and concurrent conditions were not reported. On 22-DEC-2017, the patient was inadvertently vaccinated with improperly stored doses of GARDASIL 9 lot # N022584, expiration date 15-JUN-2020, for prophylaxis (strength, dose, route and frequency were not reported). The following temperature excursions were reported: temperature below 32°F during 6 hours 9 minutes, 30.8°F during 2 hours 57 minutes and 31.9°F during 3 hours 12 minutes. Temperature excursion was of 32°F to 35°F during 3 hours 4 minutes, multiple excursions were reported. Previous temperature excursion was not reported. A digital data logger was involved. No adverse effects were reported. This is one of the multiple reports received from the same reporter. Sender's Comments: US-009507513-1712USA013720.
Sex: F
Vaccine: VARZOS
Symptoms: Coma, Encephalitis, Herpes zoster, Memory impairment, Tremor
Clinical narrative: Information has been received on 03-JAN-2018 regarding a case in litigation from a lawyer and a female consumer of unknown age and her husband. The patient's concurrent conditions, medical history and concomitant medications are unknown. On or about 2014, the patient was inoculated with ZOSTAVAX (lot number and expiration unknown) subcutaneous for routine health maintenance and for the prevention of shingles. The vaccine did not prevent shingles, but rather caused the patient to contract a persistent strain of herpes zoster. Shortly after receiving ZOSTAVAX, the patient developed tremors and memory issues. Thereafter, the patient was diagnosed with encephalitis, which resulted in the patient being in a coma for two weeks. As a direct and proximate result of these malfunctions, 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 patient suffered serious, progressive, permanent and incurable injuries, as well as significant conscious pain and suffering, mental anguish, emotional distress, loss of enjoyment of life, physical impairment and injury. Upon internal review, encephalitis and coma were considered to be medically significant. Encephalitis, persistent strain of herpes zoster, coma, tremors, and memory issues were considered to be disabling. Additional information has been requested.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Asthenia, Decreased appetite, Fatigue, Headache, Influenza like illness
Clinical narrative: Severe soreness of upper left arm where shot was given - time frame/ beginning Saturday early morning 1-6 to Sunday night 1-7. Beginning on Saturday (1-6) early morning around 1:00 am, experienced a severe headache, weakness of entire body and extremely tired. I could not get out of bed the entire day and could not eat any food. I took one Advil Saturday morning which helped my headache a little but it continued for the rest of the day. I slept until 5:00 Sunday morning and although still weak I felt better and continued to feel better throughout the day. This morning (1-8) I am feeling normal. During the time frame that I mentioned being sick it felt like I had a version of the flu so I thought I would  report these side effects even though they were listed on the paperwork the Pharmacy provided me.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site pain
Clinical narrative: Severe soreness of upper left arm where shot was given - time frame/ beginning Saturday early morning 1-6 to Sunday night 1-7. Beginning on Saturday (1-6) early morning around 1:00 am, experienced a severe headache, weakness of entire body and extremely tired. I could not get out of bed the entire day and could not eat any food. I took one Advil Saturday morning which helped my headache a little but it continued for the rest of the day. I slept until 5:00 Sunday morning and although still weak I felt better and continued to feel better throughout the day. This morning (1-8) I am feeling normal. During the time frame that I mentioned being sick it felt like I had a version of the flu so I thought I would  report these side effects even though they were listed on the paperwork the Pharmacy provided me.
Age: 17.0
Sex: F
Vaccine: HPV9
Symptoms: Computerised tomogram, Dizziness, Drug screen, Electrocardiogram, Electroencephalogram
Clinical narrative: Patient stated she got dizzy, lightheaded and had seizure lasting 60 seconds (1st seizure occurred 12/11/17) and had 2 seizures following that occurred on 12/13/17.
Age: 17.0
Sex: F
Vaccine: HPV9
Symptoms: Nuclear magnetic resonance imaging, Seizure
Clinical narrative: Patient stated she got dizzy, lightheaded and had seizure lasting 60 seconds (1st seizure occurred 12/11/17) and had 2 seizures following that occurred on 12/13/17.
Age: 62.0
Sex: M
Vaccine: FLU3
Symptoms: Injection site erythema, Injection site pustule, Injection site scab, Injection site swelling
Clinical narrative: Deltoid of right arm is red and swollen. Area appears to have scabbed over and scab is now gone leaving area exposed. Patient says that there has been pus in area. Pharmacy called Dr. about patient's arm and Dr. prescribed KEFLEX. Patient has now finished dose of KEFLEX and area is not any better.
Age: 7.0
Sex: M
Vaccine: FLU4
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Per history pt had swollen left shoulder and erythema 4 days later when PA checked the patient erythema and swelling of left shoulder had resolved.
Age: 64.0
Sex: F
Vaccine: FLU4
Symptoms: Abdominal distension, Axillary mass, Tenderness
Clinical narrative: Lump in right armpit noted the following day-swollen & tender.
Age: 4.0
Sex: M
Vaccine: DTAP, HEP, HPV9, MNQ
Symptoms: Wrong patient received medication
Clinical narrative: 4 year old child and 16 year old child in room 4 year old child inadvertently given MCV4 and HPV intended for 16 year old sibling. Guardian present at time of vaccination and notified of med error. Educated r/t common side effects and when to follow up with primary care. Child left clinic happy, playful and appropriate for age. Follow up phone call to guardian, guardian denies any problems or concerns states child doing well. Discussion with supervisor to ensure avoiding future medication error. Will ensure two pt identifiers and label pt vaccines with appropriate pt name.
Age: 70.0
Sex: M
Vaccine: VARCEL
Symptoms: Erythema multiforme, Rash
Clinical narrative: Rash and erythema multiform.
Age: 30.0
Sex: M
Vaccine: HEP
Symptoms: Arthralgia, Autoimmune disorder, Computerised tomogram, Confusional state, Dizziness
Clinical narrative: Autoimmune inflammatory polyneuropathy, Lupus. Muscle/joint pain, chronic fatigue, muscle twitching. neurological problems (forgetfulness, confusion, dizziness), ears ringing, digestive problems, malaise etc.
Age: 30.0
Sex: M
Vaccine: HEP
Symptoms: Fatigue, Gastrointestinal disorder, Malaise, Memory impairment, Muscle twitching
Clinical narrative: Autoimmune inflammatory polyneuropathy, Lupus. Muscle/joint pain, chronic fatigue, muscle twitching. neurological problems (forgetfulness, confusion, dizziness), ears ringing, digestive problems, malaise etc.
Age: 30.0
Sex: M
Vaccine: HEP
Symptoms: Myalgia, Neurological symptom, Nuclear magnetic resonance imaging, Polyneuropathy, Systemic lupus erythematosus
Clinical narrative: Autoimmune inflammatory polyneuropathy, Lupus. Muscle/joint pain, chronic fatigue, muscle twitching. neurological problems (forgetfulness, confusion, dizziness), ears ringing, digestive problems, malaise etc.
Age: 30.0
Sex: M
Vaccine: HEP
Symptoms: Tinnitus
Clinical narrative: Autoimmune inflammatory polyneuropathy, Lupus. Muscle/joint pain, chronic fatigue, muscle twitching. neurological problems (forgetfulness, confusion, dizziness), ears ringing, digestive problems, malaise etc.
Age: 1.25
Sex: F
Vaccine: FLU3
Symptoms: Drug administered to patient of inappropriate age
Clinical narrative: Patient received the high dose flu vaccine instead of pediatric 6-36 mos.
Age: 1.25
Sex: M
Vaccine: FLU3
Symptoms: Drug administered to patient of inappropriate age
Clinical narrative: Patient received high dose flu instead of pediatric 6-36 mos.
Age: 15.0
Sex: F
Vaccine: HPV4, MNQ, TDAP
Symptoms: Abdominal pain, Vomiting
Clinical narrative: Pt's mother called at 4:30pm on 1/3/18, had received these 3 vaccinations at her visit about 3 hours prior. Pt was experiencing 7/10 abdominal pain, had 1 episode of emesis and denied nausea after that first episode. Pt began her period that day but had never experienced abdominal pain like this with previous periods.
Age: 66.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site rash
Clinical narrative: This spontaneous report as received from a 66 year old female patient, referring to herself. The patient's concurrent conditions included penicillin allergy, unspecified skin conditions and fibromyalgia. Her concomitant therapies included Lisinopril (manufacturer unknown) and estradiol. The patient's medical history included shingles twice before. On 08-DEC-2017, the patient was vaccinated with ZOSTAVAX subcutaneously (dose, lot# and expiration date were not provided) for prophylaxis. On 09-DEC-2017 (24 hours later), she experienced a "rash and redness at the injection site, the rash and redness was approximately 2 1/2 inches long and the shape was oblong. At the time of the report, "the rash and redness was two circles, smaller in size and they were next to each other". The outcome of injection site erythema and injection site rash was reported as not recovered. The causal relationship between the above mentioned events and ZOSTAVAX was not provided.
Age: 73.0
Sex: M
Vaccine: PPV
Symptoms: Erythema, Peripheral swelling, Tenderness, Vaccination complication
Clinical narrative: This spontaneous report was received from a patient's wife and refers to a 73-year-old male patient. The patient did not have any pertinent medical history or any known drug reactions or allergies. On 15-DEC-2017, the patient was vaccinated with PNEUMOVAX 23 for prophylaxis (dose, route of administration, anatomical location, lot# and expiration date were not reported). The patient concomitant therapies included unspecified blood pressure and cholesterol medicine. On 16-DEC-2017, the patient developed redness, swelling and tenderness from his shoulder down to his elbow (also reported as "reaction to PNEUMOVAX 23. The patient did not seek medical attention, did not have any laboratory test performed and did not receive any treatment for the events. On 18-DEC-2017, the patient recovered form the events. The reporter considered the events to be related to PNEUMOVAX 23.
Sex: F
Vaccine: VARZOS
Symptoms: Decreased immune responsiveness, Herpes zoster, Pain, Rash vesicular
Clinical narrative: Information was received from a lawyer regarding a case in litigation concerning a female patient of unknown age. No information was received concerning the patient's past medical history, concurrent conditions, or concomitant medication. On or about 19-DEC-2015, the patient was vaccinated at a pharmacy with ZOSTAVAX (lot number, dosage, and route of administration not provided), as recommended for routine adult health maintenance and for the prevention of shingles. The ZOSTAVAX vaccine did not prevent shingles as intended, but rather caused the patient to contract a persistent strain of herpes zoster. On or about 06-JAN-2016, the patient was treated for the onset of a severe vesicular rash accompanied by weakened immune symptoms, which was diagnosed as severe herpes zoster or shingles. The patient has been prescribed ibuprofen, oxycodone and valacyclovir for management of her painful condition. As a direct and proximate result of these malfunctions, the patient has suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, she has suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages. Additional information has been requested.
Sex: M
Vaccine: VARZOS
Symptoms: Decreased immune responsiveness, 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 provided regarding the patient's past medical history, concurrent conditions, or concomitant medication. The patient was inoculated with ZOSTAVAX (lot number, dosage, and route of administration not provided) on or about 11-MAR-2015, at a pharmacy as recommended for routine adult health maintenance and for the prevention of shingles. ZOSTAVAX did not prevent shingles as intended, but rather caused the patient to contract a persistent strain of herpes zoster. On or about 15-JUL-2016, the patient was treated at an urgent care clinic for the onset of a severe vesicular rash accompanied by weakened immune symptoms, which was diagnosed as severe herpes zoster, or shingles. The patient was prescribed valacyclovir hydrochloride (VALTREX) for management of his painful symptoms. As a direct and proximate result of these malfunctions, 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: Decreased immune responsiveness, 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. Information regarding medical history, concurrent conditions and concomitant medications was not provided. On or about 11-NOV-2014, the patient was inoculated with ZOSTAVAX at a family health center for routine 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 25-OCT-2016, the patient was treated at the same family health center for painful symptoms and for the onset of a severe vesicular rash accompanied by weakened immunity, which was diagnosed as herpes zoster, or shingles. The patient was prescribed valacyclovir for management of her painful condition. As a direct and proximate result of these malfunctions, 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, Skin lesion
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. Information regarding medical history, concurrent conditions and concomitant medications was not provided. On or about 01-NOV-2014, the patient received ZOSTAVAX for its intended purpose: the prevention of shingles. As a direct result of this vaccine, on 31-DEC-2015, the patient suffered from a shingles outbreak, in addition to chronic pain, rash and lesions to various parts of her body. As a direct result of the vaccine, the patient suffered mental and emotional distress resulting in physical limitations and seriousness of her condition. As a result of the manufacture, advertising, promotion, distribution and/or sale of ZOSTAVAX, the patient sustained severe and permanent personal injuries. The patient suffered serious, progressive, permanent, and incurable injuries, as well as significant conscious pain and suffering, mental anguish, emotional distress, loss of enjoyment of life, physical impairment and injury. The patient has incurred medical expenses and other economic harms as a direct result of the use of ZOSTAVAX. The lawyer considered shingles outbreak to be disabling. Additional information has been requested.
Age: 1.5
Sex: M
Vaccine: DTAP, FLU4, HEPA
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: Red, swollen injection sites both legs warm to the touch.
Age: 1.0
Sex: M
Vaccine: VARCEL
Symptoms: Erythema, Immediate post-injection reaction, Skin warm, Swelling
Clinical narrative: 2.5 x 4 cm Red, raised area. Warm to touch. Area developed immediately after giving vaccine.
Age: 66.0
Sex: F
Vaccine: FLUR3, PPV, VARZOS
Symptoms: Injection site erythema, Injection site reaction, Staphylococcal infection
Clinical narrative: LARGE REDNESS AROUND THE INJECTION SITE, DOCTOR SAID IT WAS A STAPH INFECTION AND PRESCRIBED BACTRIM DS.
Age: 64.0
Sex: F
Vaccine: FLU4, FLU4
Symptoms: Injected limb mobility decreased, Injection site pain
Clinical narrative: Chronic ache at injection site. Restricted mobility in right arm.
Age: 64.0
Sex: F
Vaccine: FLU4, FLU4
Symptoms: Pain, Pain in extremity
Clinical narrative: Chronic ache at injection site. Restricted mobility in right arm.
Age: 64.0
Sex: F
Vaccine: FLU4, FLU4
Symptoms: Injected limb mobility decreased, Injection site pain
Clinical narrative: The patient received the injection about 1.5 -2 inches below the acromion process in the right deltoid muscle. She says that she has experienced pain when raising and lowering her arm since the injection. The pain has not eased up with time. It has currently been 3 months since the immunization was administered. She has not been to see her doctor as of 1/8/18.
Age: 64.0
Sex: F
Vaccine: FLU4, FLU4
Symptoms: Pain, Pain in extremity
Clinical narrative: The patient received the injection about 1.5 -2 inches below the acromion process in the right deltoid muscle. She says that she has experienced pain when raising and lowering her arm since the injection. The pain has not eased up with time. It has currently been 3 months since the immunization was administered. She has not been to see her doctor as of 1/8/18.
Age: 61.0
Sex: F
Vaccine: FLU4
Symptoms: Asthenia, Fall, Impaired driving ability, Injected limb mobility decreased, Injection site pain
Clinical narrative: Pain and soreness started in the area of the shot within a few hours. I normally sleep on my left side and have been unable to do so since the injection. The pain increased to a throbbing level over the next three weeks, and is so intense as to restrict left arm motion vertically and rearward. I went to see my PCP at week five, but there was nothing she could offer. The soreness has decreased some, but returns at the end of a day of normal activity such as grocery shopping or light housekeeping. My left arm?s vertical and rearward motion are still limited so it is very difficult if not impossible to back up my car looking over my right shoulder and trying to steer with my left arm. I also am losing strength in my left arm to the point that last week it caused me to fall. I was standing one step up, reached with my right arm, became a little off balance and reached up with my left arm to steady myself on the wall, and could not do so, causing me to then fall to the floor. I am anticipating requiring physical therapy.
Age: 61.0
Sex: F
Vaccine: FLU4
Symptoms: Insomnia, Pain
Clinical narrative: Pain and soreness started in the area of the shot within a few hours. I normally sleep on my left side and have been unable to do so since the injection. The pain increased to a throbbing level over the next three weeks, and is so intense as to restrict left arm motion vertically and rearward. I went to see my PCP at week five, but there was nothing she could offer. The soreness has decreased some, but returns at the end of a day of normal activity such as grocery shopping or light housekeeping. My left arm?s vertical and rearward motion are still limited so it is very difficult if not impossible to back up my car looking over my right shoulder and trying to steer with my left arm. I also am losing strength in my left arm to the point that last week it caused me to fall. I was standing one step up, reached with my right arm, became a little off balance and reached up with my left arm to steady myself on the wall, and could not do so, causing me to then fall to the floor. I am anticipating requiring physical therapy.
Age: 1.0
Sex: F
Vaccine: MMR
Symptoms: Laboratory test, Pharyngeal oedema, Seizure
Clinical narrative: Patient had a very bad seizure. It lasted about 15 min and she ended up in ER on 10/15/2013 with the seizure. A day or two prior to it patient had her throat swollen. We called dr and she said we could seek medical assistance.
Age: 1.5
Sex: M
Vaccine: DTAP, HEPA
Symptoms: Febrile convulsion, Pyrexia
Clinical narrative: Child went down for nap day of event. Child had been acting and feeling fine all week and all day leading up to event. Child woke up from nap with fever of 104, 2 minutes after waking, child experiences an 8 minute febrile seizure.
Age: 1.08
Sex: F
Vaccine: DTAPIPVHIB, FLU4, HEPA, MMRV, PNC13, VARCEL
Symptoms: Extra dose administered
Clinical narrative: Infant was accidentally given a MMR-V as well as varicella.
Sex: M
Vaccine: VARZOS
Symptoms: Decreased immune responsiveness, Herpes zoster, Pain, Post herpetic neuralgia, Rash vesicular
Clinical narrative: Information was received from a lawyer regarding a case in litigation concerning a male patient of unknown age. No information was received concerning the patient's past medical history, concurrent conditions, or concomitant medication. On or about 10-OCT-2015, the patient was vaccinated at a pharmacy with ZOSTAVAX (lot number, dosage, and route of administration not provided), as recommended for routine adult health maintenance and for the prevention of shingles. The ZOSTAVAX vaccine did not prevent shingles as intended, but rather caused the patient to contract a persistent strain of herpes zoster. On or about 15-DEC-2015, the patient was treated at Medical group for onset of a severe vesicular rash accompanied by weakened immune symptoms, which was diagnosed as severe herpes zoster, or shingles. On or about 17-JUL- 2016, the patient required subsequent treatment for continued and worsening symptoms of shingles pain, at which time he was diagnosed as post-herpetic neuralgia, a condition of chronic pain and nerve damage secondary to shingles infections. On or about  18-OCT-2016, the patient sought additional treatment  for continued symptoms and post-herpetic neuralgia. The patient was prescribed topical ointment for management of his painful symptoms. As a direct and proximate result of these malfunctions, the patient has suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, he 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: Decreased immune responsiveness, Herpes zoster, Pain, Rash vesicular
Clinical narrative: Information has been received on 04-JAN-2018 regarding a case in litigation from a lawyer and a female consumer of unknown age. The patient's concurrent conditions, medical history and concomitant medications are unknown. The patient was inoculated with ZOSTAVAX (lot number and expiration unknown) subcutaneous on or about 28-FEB-2014, 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 11-JUL-2016, the patient was treated by a physician at a hospital emergency room for the onset of a severe vesicular rash accompanied by weakened immune symptoms, which was diagnosed as severe herpes zoster or 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: Decreased immune responsiveness, 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 provided regarding the patient's past medical history, concurrent conditions, or concomitant medication. On or about 16-APR-2012, the patient was inoculated with ZOSTAVAX (lot number, dosage and route of administration not provided) as recommended for routine adult health maintenance and for the prevention of shingles. ZOSTAVAX 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 at urgent care for the onset of a severe vesicular rash accompanied by weakened immune symptoms, which was diagnosed as severe herpes zoster, or shingles with complications. The patient was prescribed valacyclovir hydrochloride (VALTREX) and acetaminophen/codeine for management of her painful symptoms. As a direct and proximate result of these malfunctions, 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: M
Vaccine: VARZOS
Symptoms: Decreased immune responsiveness, Herpes zoster, Rash vesicular
Clinical narrative: Information was received from a lawyer regarding a case in litigation concerning a male patient of unknown age. No information was received concerning the patient's past medical history, concurrent conditions, or concomitant medication. On or about 06-JUN-2008, the patient was vaccinated at a community clinic with ZOSTAVAX (lot number, dosage, and route of administration not provided), 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-MAY-2014, the patient was treated by a physician, for the onset of a severe vesicular rash accompanied by weakened immune symptoms, which was diagnosed as severe herpes zoster, or shingles. As a direct and proximate result of these malfunctions, the patient has 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: Decreased immune responsiveness, 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 provided regarding the patient's past medical history, concurrent conditions, or concomitant medication. On or about 12-OCT-2012, the patient was inoculated with ZOSTAVAX (lot number, dosage and route of administration not provided) at a pharmacy, as recommended for routine adult health maintenance and for the prevention of shingles. ZOSTAVAX did not prevent shingles as intended, but rather caused the patient to contract a persistent strain of herpes zoster. On or about 07-APR-2016, the patient was treated at a hospital for the onset of a severe vesicular rash accompanied by weakened immune symptoms, which was diagnosed as severe herpes zoster or shingles. The patient was prescribed tramadol and acyclovir for management of her painful symptoms. As a direct and proximate result of these malfunctions, 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: Blister, Herpes zoster, Pain, Post herpetic neuralgia, 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 provided regarding the patient's past medical history, concurrent conditions, or concomitant medication. On or about 01-OCT-2007, the patient was inoculated with ZOSTAVAX (lot number, dosage and route of administration not provided) at a physician's office, as recommended for routine adult health maintenance for the prevention of shingles. ZOSTAVAX did not prevent shingles as intended, but rather caused the patient to contract a persistent strain of herpes zoster, also known as shingles and other complications. On or about 10-JUN-2016, the patient was treated by a physician for a blistering vesicular outbreak that was diagnosed as severe herpes zoster and severe zoster dermatitis, or shingles. On or about 13-JUL-2016, the patient sought subsequent treatment from a physician for ongoing and worsening symptoms of pain, which was diagnosed as post-herpetic neuralgia. The patient was prescribed gabapentin and acetaminophen/hydrocodone bitartrate (NORCO) for management of her painful symptoms and neuralgia. As a direct and proximate result of these malfunctions, 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: M
Vaccine: VARZOS
Symptoms: Blister, 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 male patient of unknown age. Information regarding medical history, concurrent conditions and concomitant medications was not provided. On or about 24-MAY-2013, the patient was inoculated with ZOSTAVAX at a physician's office, 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, also known as shingles. On or about 08-DEC-2015, the patient was treated at the same physician's office for a blistering vesicular outbreak that was diagnosed as severe herpes zoster, or shingles. The patient was prescribed valacyclovir and silver sulfadiazine for management of his painful and persistent symptoms. As a direct and proximate result of these malfunctions, 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.