chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: VARZOS
Symptoms: Blister, Decreased immune responsiveness, Herpes zoster, 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 19-MAY-2014, 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 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 05-APR-2016, the patient was treated by a physician for a blistering vesicular outbreak and decreased immune symptoms, which was then diagnosed as severe herpes zoster, or shingles. 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 outcome of the events is unknown. Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Blister, Decreased immune responsiveness, Herpes zoster, Rash vesicular
Clinical narrative: Information has been received on 09-MAR-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. During 2012, the patient was inoculated with ZOSTAVAX (lot number and expiration unknown) unknown route, 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. During 2016, the patient was treated by a physician for a blistering vesicular outbreak and decreased immune symptoms which was then diagnosed as herpes zoster, or shingles. 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, Decreased immune responsiveness, Herpes zoster, Rash vesicular
Clinical narrative: Information has been received on 09-MAR-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. On or about 01-MAY-2015, the patient was inoculated with ZOSTAVAX (lot number and expiration unknown) unknown route, 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. During 2016, the patient was treated at a medical facility for a blistering vesicular outbreak and decreased immune symptoms which was then diagnosed as herpes zoster, or shingles. 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, 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 an unknown date during 2016, the patient was inoculated with ZOSTAVAX (lot number, dosage and route of administration not provided) administered by a physician, 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. On an unspecified date during 2016, the patient was treated by a physician for a blistering vesicular outbreak which was then diagnosed as herpes zoster, or shingles. 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 outcome of the events is unknown. Additional information has been requested.
Sex: M
Vaccine: VARZOS
Symptoms: Blister, Herpes zoster, 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 an unknown date during 2015, 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 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 an unspecified date during 2016, the patient was treated for a blistering vesicular outbreak which was then diagnosed as herpes zoster, or shingles. 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 outcome of the events is unknown. Additional information has been requested.
Age: 80.0
Sex: F
Vaccine: FLU4, PNC13
Symptoms: Blood test normal, Injected limb mobility decreased, Injection site pain, Pain in extremity
Clinical narrative: This is a spontaneous report from a contactable consumer (office practice manager reporting on behalf of the patient). A 80-year-old female patient received PREVNAR 13, (Lot Number: R56671, Expire Date: 01Apr2018), via an unspecified route of administration on 31Oct2017 16:00 at deltoid right at 0.5 ml, single for immunisation. Medical history was none. Concomitant medication included FLUARIX, (Manufacturer: GSK, Lot Number: CX775, Expiry Date: 30 Jun 2018) on 31Oct2017 at left deltoid, route: IM. The patient previously received first dose of FLUARIX in 2014. The patient experienced right arm and shoulder pain and limited range of motion in right arm on 12Dec2017 with outcome of recovering. On 12Dec2017, patient called the office and reported right arm and shoulder pain with no redness or swelling at the injection site. Also reported limited range of motion in the right arm. Scheduled the patient for an office visit three weeks later and the provider offered to send her to the physical therapy and to take Ibuprofen which the patient declined. Another three weeks past and the patient came in for a physical still admits to right arm and shoulder pain with limited range of motion and accepted the physical therapy offer which she did three times. Patient called today because she is still having right arm pain with limited range of motion. It has improved but she has not fully healed. Patient had regular blood work at her appointment on 03Jan2018 having to do with other reasons, but all results were normal.
Age: 11.0
Sex: M
Vaccine: MNQ, TDAP
Symptoms: Dyspnoea, Periorbital oedema, Rhinorrhoea
Clinical narrative: Initial unsolicited report received from a physician on 27-Feb-2018. This case involves a 11-year-old male patient who was vaccinated with a 0.5 ml of single intramuscular dose of ADACEL (Batch number: C5228AA) and MENACTRA (batch number- not reported) (expiry date, dose in series, site was not reported for both the vaccine) on 17-Jan-2018. The patient's medical history were unknown and concomitant medications was not reported. On an unknown date, 15 minutes following vaccination, the patient had developed runny nose and periorbital edema. On an unknown date, following vaccination patient had developed trouble breathing and shortness of breath over next several hours. Lab investigations not reported and corrective treatments were unknown. On an unknown date patient was recovered from all the events. List of documents held by sender: none.
Age: 64.0
Sex: F
Vaccine: UNK
Symptoms: Erythema, Pain, Swelling
Clinical narrative: Redness, swelling, pain. Patient seen by FNP. Was prescribed cephalexin 500mg and prednisone 20mg.
Age: 0.25
Sex: M
Vaccine: DTAPIPVHIB, HEP, PNC13, RV5
Symptoms: Injection site rash, Rash
Clinical narrative: Rash progressively spreading from face to trunk to legs over the time period of about 5 minutes.
Age: 18.0
Sex: F
Vaccine: MENB
Symptoms: Body temperature increased, Headache, Immediate post-injection reaction, Injected limb mobility decreased, Injection site pain
Clinical narrative: The injection was given at 2 pm. Adverse outcomes began shortly after the injection: severe pain at the point of injection: immediately after the injection. Severe pain in the arm so that by 7pm (five hours after the injection) the arm could not be raised. Severe headache (7pm - 5 am). Temperature 102 degrees Fahrenheit (1 am - 5 am). Cramping legs (10pm - 5am). Severe nausea (3 am - 5 am).
Age: 18.0
Sex: F
Vaccine: MENB
Symptoms: Muscle spasms, Nausea, Pain in extremity
Clinical narrative: The injection was given at 2 pm. Adverse outcomes began shortly after the injection: severe pain at the point of injection: immediately after the injection. Severe pain in the arm so that by 7pm (five hours after the injection) the arm could not be raised. Severe headache (7pm - 5 am). Temperature 102 degrees Fahrenheit (1 am - 5 am). Cramping legs (10pm - 5am). Severe nausea (3 am - 5 am).
Age: 67.0
Sex: F
Vaccine: PNC13, VARZOS
Symptoms: Rash, Rash pruritic, Varicella
Clinical narrative: Patient was administered ZOSTAVAX vaccine on March 5, 2018. Patient mentioned she developed rash on day 3 post-vaccination. Patient sought medical treatment on March 12. Patient arrived to pharmacy on March 12 with prescriptions from medical treatment. Patient explained what occurred. Her emergency room doctor diagnosed her with varicella. She received treatment for varicella. Patient explained her rash was itchy.
Age: 11.0
Sex: M
Vaccine: HPV9, MNQ, TDAP
Symptoms: Cold sweat, Disorientation, Dizziness, Erythema, Flushing
Clinical narrative: Client received shots at approximately 1030 without incident. He was chatting and walking around following administration. While standing at the back door at checkout speaking with his grandmother, client's sister said "he's seeing black." Client appeared flushed with pink cheeks. Client advised to sit down immediately, seemed disoriented and needed assistance from EMT to get down to the floor. Client then laid down on a mat at 1044. Client grew pale when lying down. Cool damp paper was applied to the back of the client's neck. Juice given, client sat up to consume. Client reported "feeling better" and moved to a chair. Client reported feeling "light headed and clammy" again and was moved back down to prone position on the mat with feet elevated on chair. Client declined more juice. Since client received vaccines at 1030 and was still unable to progress from sitting to standing at 1055, 911 care was initiated. Since the clinic was at a local fire station and staff were present, they were able to begin care without formally making the 911 call. EMTs attended to client until 1130 when ambulance transport to the Hospital occurred.
Age: 11.0
Sex: M
Vaccine: HPV9, MNQ, TDAP
Symptoms: Pallor, Visual impairment
Clinical narrative: Client received shots at approximately 1030 without incident. He was chatting and walking around following administration. While standing at the back door at checkout speaking with his grandmother, client's sister said "he's seeing black." Client appeared flushed with pink cheeks. Client advised to sit down immediately, seemed disoriented and needed assistance from EMT to get down to the floor. Client then laid down on a mat at 1044. Client grew pale when lying down. Cool damp paper was applied to the back of the client's neck. Juice given, client sat up to consume. Client reported "feeling better" and moved to a chair. Client reported feeling "light headed and clammy" again and was moved back down to prone position on the mat with feet elevated on chair. Client declined more juice. Since client received vaccines at 1030 and was still unable to progress from sitting to standing at 1055, 911 care was initiated. Since the clinic was at a local fire station and staff were present, they were able to begin care without formally making the 911 call. EMTs attended to client until 1130 when ambulance transport to the Hospital occurred.
Age: 68.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Fatigue, Feeling abnormal, Malaise, Neck pain
Clinical narrative: Saturday morning, tremendous chills, shivering, fever over 100 degrees, bad body aches including neck pain. The malaise was so bad that had to stay in bed all day.  By 9 PM fever finally broke, took ibuprofen for pain and fever--took a couple of doses and lots of fluids. Had no stomach problems or congestion. By Sunday much improved--felt really bad 12 hours after vaccination only; recovered completely except for being exhausted. Recovered completely by late Sunday.
Age: 68.0
Sex: F
Vaccine: VARZOS
Symptoms: Pain, Pyrexia
Clinical narrative: Saturday morning, tremendous chills, shivering, fever over 100 degrees, bad body aches including neck pain. The malaise was so bad that had to stay in bed all day.  By 9 PM fever finally broke, took ibuprofen for pain and fever--took a couple of doses and lots of fluids. Had no stomach problems or congestion. By Sunday much improved--felt really bad 12 hours after vaccination only; recovered completely except for being exhausted. Recovered completely by late Sunday.
Age: 62.0
Sex: M
Vaccine: VARZOS
Symptoms: Chills, Dizziness, Feeling abnormal, Impaired work ability, Injection site swelling
Clinical narrative: Several hours after patient received SHINGRIX he felt unwell, achy, shaky, took Tylenol, went to be, woke up around 10 pm shivering. Went back to sleep and about 8 am woke up still feeling achy and lightheaded, went to work but had to leave as he didn't feel right. He was asymptomatic by the time I spoke to him ~ 1.5 days later. He almost went to the ER given convulsing shivering. Also had swelling at site of injection.
Age: 62.0
Sex: M
Vaccine: VARZOS
Symptoms: Malaise, Pain, Tremor
Clinical narrative: Several hours after patient received SHINGRIX he felt unwell, achy, shaky, took Tylenol, went to be, woke up around 10 pm shivering. Went back to sleep and about 8 am woke up still feeling achy and lightheaded, went to work but had to leave as he didn't feel right. He was asymptomatic by the time I spoke to him ~ 1.5 days later. He almost went to the ER given convulsing shivering. Also had swelling at site of injection.
Age: 0.25
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC13
Symptoms: Crying, Erythema, Hypersensitivity, Injection site erythema, Injection site reaction
Clinical narrative: While Mom was nursing patient, about 15 minutes after receiving immunizations, approximately 10:25 AM, Mom noticed that patient's face was really red and she brought him out to the nurse's station. RN noticed that patient's face was red and blotching, resembling hives with what appears to be an allergic reaction. The blotching and developing hives appeared to be spreading down to his upper chest. By the time RN got patient back in the room, the blotching had spread to his abdomen. Redness and swelling at the injection site to the right thigh was also noticed. Epinephrine 0.15 mg auto injector was administered to right vastus lateralis by RN at 10:35 AM. During this time, patient is awake, responding to Mom, and crying/breathing without difficulty. Lungs are clear to auscultation in all lobes. At 10:38, blood pressure in L leg is 106/64, respiration rate is 66/min, heart rate is 144 bpm, capillary refill is less than 2 seconds, blotching in face and trunk as well as in right thigh is diminishing. Patient continues to respond appropriately to Mom and is interacting with her; calms down and is no longer crying. Lungs remain clear to auscultation. At 10:50 lungs remain clear in all lobes, respirations are even and unlabored at 24/min, heart rate is 146 bpm, capillary refill less than 2 seconds, redness to the face and trunk as well as in right thigh is almost completely gone, patient is smiling, alert and calm in Mom's lap. RNs and office manager, discuss with Mom the options of having EMS transport patient to either his doctor's office or the ED, or Mom could transport patient directly to his doctor's office on her own as patient is much improved and has not needed any repeat doses of epinephrine. Mom decides to transport patient to her doctor's office. Patient is a patient of Dr. RN notified Dr.'s nurse of the situation and that Mom is transporting patient to their clinic to be assessed. Nurse says Dr. is out all week, but that patient will be seen by one of the other providers. RN also requested that the notes and plan from patient's visit from today at clinic be faxed so that we will know how to vaccinate patient moving forward. Mom left clinic with patient at 11:05 AM to head to his doctor's office. RN called doctor's office around 11:30 AM to check if patient made it to their clinic, which he had and was checked in.
Age: 0.25
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC13
Symptoms: Injection site swelling, Rash macular, Urticaria
Clinical narrative: While Mom was nursing patient, about 15 minutes after receiving immunizations, approximately 10:25 AM, Mom noticed that patient's face was really red and she brought him out to the nurse's station. RN noticed that patient's face was red and blotching, resembling hives with what appears to be an allergic reaction. The blotching and developing hives appeared to be spreading down to his upper chest. By the time RN got patient back in the room, the blotching had spread to his abdomen. Redness and swelling at the injection site to the right thigh was also noticed. Epinephrine 0.15 mg auto injector was administered to right vastus lateralis by RN at 10:35 AM. During this time, patient is awake, responding to Mom, and crying/breathing without difficulty. Lungs are clear to auscultation in all lobes. At 10:38, blood pressure in L leg is 106/64, respiration rate is 66/min, heart rate is 144 bpm, capillary refill is less than 2 seconds, blotching in face and trunk as well as in right thigh is diminishing. Patient continues to respond appropriately to Mom and is interacting with her; calms down and is no longer crying. Lungs remain clear to auscultation. At 10:50 lungs remain clear in all lobes, respirations are even and unlabored at 24/min, heart rate is 146 bpm, capillary refill less than 2 seconds, redness to the face and trunk as well as in right thigh is almost completely gone, patient is smiling, alert and calm in Mom's lap. RNs and office manager, discuss with Mom the options of having EMS transport patient to either his doctor's office or the ED, or Mom could transport patient directly to his doctor's office on her own as patient is much improved and has not needed any repeat doses of epinephrine. Mom decides to transport patient to her doctor's office. Patient is a patient of Dr. RN notified Dr.'s nurse of the situation and that Mom is transporting patient to their clinic to be assessed. Nurse says Dr. is out all week, but that patient will be seen by one of the other providers. RN also requested that the notes and plan from patient's visit from today at clinic be faxed so that we will know how to vaccinate patient moving forward. Mom left clinic with patient at 11:05 AM to head to his doctor's office. RN called doctor's office around 11:30 AM to check if patient made it to their clinic, which he had and was checked in.
Age: 28.0
Sex: F
Vaccine: HPV9
Symptoms: Arthralgia, Confusional state, Fatigue, Gait disturbance, Grip strength decreased
Clinical narrative: Chronic pain in limbs; weakness in limbs; blurred and darkened eyesight in left eye; joint and muscle pain; irregular gait; tremors in hands and legs; weakened grip strength; fatigue; mental confusion.
Age: 28.0
Sex: F
Vaccine: HPV9
Symptoms: Muscular weakness, Myalgia, Pain in extremity, Tremor, Vision blurred
Clinical narrative: Chronic pain in limbs; weakness in limbs; blurred and darkened eyesight in left eye; joint and muscle pain; irregular gait; tremors in hands and legs; weakened grip strength; fatigue; mental confusion.
Sex: F
Vaccine: MMR, VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report has been received from a licensed practical nurse referring to a 15 month old female patient. The patient did not have pertinent medical history, drug reactions or allergies, concurrent conditions or concomitant medications. On 02-MAR-2018, the patient was vaccinated with improperly stored doses of VARIVAX lot # N021719 with expiration date of 10-AUG-2019, 5 ml (anatomical location and route were not provided) for prevention of varicella. Other suspect therapies included M-M-R II lot # N013867 with expiration date of 04-MAY-2019, 0.5 ml (anatomical location and route were not provided) for prevention from measles, mumps and rubella. No adverse events were reported. The patient did not sought medical attention and none laboratory studies were performed.
Sex: U
Vaccine: HPV9
Symptoms: Extra dose administered, No adverse event
Clinical narrative: This spontaneous report as received from nurse via company representative refers to a patient of unknown age and gender. The patient's pertinent medical history, concurrent conditions and concomitant medications were not reported. No previous drug reactions or allergies were reported. On unknown dates, the patient was vaccinated with four doses of GARDASIL 9 (dosing details were not reported), intramuscularly for prophylaxis. No known adverse effects reported. No product quality complaint involved.
Sex: F
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 female patient of unknown age. No information was received concerning the patient's past medical history, concurrent conditions, or concomitant medication. On or about 03-MAY-2010, the patient was inoculated at a County Health Department 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. During 2016, the patient was treated at physician office for persistent and severe vesicular rash accompanied by weakened immune symptoms, which was diagnosed as herpes zoster, or shingles. 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. During 2015, the patient was inoculated at a Veteran's outpatient 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 condition of herpes zoster. During 2016, the patient was treated at Outpatient Clinic, for a blistering vesicular outbreak, and decreased immune symptoms which was then diagnosed as severe herpes zoster, or shingles. 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, 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. During 2012, the patient was inoculated at physician's office 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 condition of herpes zoster. On or about 09-MAR-2016, the patient was treated by a physician for a blistering vesicular outbreak and decreased immune symptoms which was then diagnosed as severe herpes zoster, or shingles. 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, Decreased immune responsiveness, Herpes zoster, Rash vesicular
Clinical narrative: Information has been received from a lawyer regarding a case in litigation concerning a male patient (age unknown). The patient's medical history, concurrent conditions and concomitant medication use were not provided. On or about "December or 01-JAN-2009", the patient was vaccinated with ZOSTAVAX, (lot# and route unknown) as recommended for routine adult health maintenance and for the prevention of shingles. The vaccine did not prevent shingles as intended, but rather caused the patient to contract a persistent strain of herpes zoster. On or about 01-APR-2016, the patient was treated by a physician for a blistering vesicular outbreak and decreased immune symptoms which was then diagnosed as severe herpes zoster, or shingles. 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, Decreased immune responsiveness, Herpes zoster, Rash vesicular
Clinical narrative: Information has been received from a lawyer regarding a case in litigation concerning a female patient (age unknown). The patient's medical history, concurrent conditions and concomitant medication use were not provided. During 2012, the patient was vaccinated with ZOSTAVAX, (lot# and route unknown) as recommended for routine adult health maintenance and for the prevention of shingles. The vaccine did not prevent shingles as intended, but rather caused the patient to contract a persistent strain of herpes zoster. During 2016, the patient was treated at a care center for a blistering vesicular outbreak and decreased immune symptoms which was then diagnosed as severe herpes zoster, or shingles. 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, Decreased immune responsiveness, Herpes zoster, 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. During 2008, the patient was inoculated 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 vaccine did not prevent shingles as intended, but rather caused the patient to contract a persistent strain condition of herpes zoster. During 2016, the patient was treated by a physician, for a blistering vesicular outbreak and decreased immune symptoms which was then diagnosed as severe herpes zoster, or shingles. 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, 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. During 2014, the patient was inoculated 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 vaccine did not prevent shingles as intended, but rather caused the patient to contract a persistent strain condition of herpes zoster. During 2016, the patient was treated at physician office, for a blistering vesicular outbreak and decreased immune symptoms which was then diagnosed as herpes zoster, or shingles. 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, Decreased immune responsiveness, Herpes zoster, Rash vesicular
Clinical narrative: Information has been received from a lawyer regarding a case in litigation concerning a female patient (age unknown). The patient's medical history, concurrent conditions and concomitant medication use were not provided. During 2013, the patient was vaccinated with ZOSTAVAX, (lot# and route unknown) as recommended for routine adult health maintenance and for the prevention of shingles. The vaccine did not prevent shingles as intended, but rather caused the patient to contract a persistent strain of herpes zoster. During 2016, the patient was treated by a physician for a blistering vesicular outbreak and decreased immune symptoms which was then diagnosed as severe herpes zoster, or shingles. 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, Decreased immune responsiveness, Herpes zoster, Rash vesicular
Clinical narrative: Information has been received on 09-MAR-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. During 2006, the patient was inoculated with ZOSTAVAX (lot number and expiration unknown) unknown route, 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. During 2016, the patient was treated for a blistering vesicular outbreak and decreased immune symptoms which was then diagnosed as herpes zoster, or shingles. 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, 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. During 2011, the patient was inoculated with ZOSTAVAX (lot number, dosage and route of administration not provided) administered by a physician, 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. During 2016 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 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 expense, and pain and suffering, and other damages. Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Blister, Herpes zoster, 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 an unknown date during 2015, 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 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 an unspecified date during 2016, 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 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 outcome of the events is unknown. Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Blister, Decreased immune responsiveness, Herpes zoster, 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 02-MAY-2015, the patient was inoculated with ZOSTAVAX (lot number, dosage and route of administration not provided) at a pharmacy, 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 13-APR-2016, the patient was treated for a blistering vesicular outbreak and decreased immune symptoms which was then diagnosed as herpes zoster, or shingles. The patient was prescribed acyclovir and was administered an unspecified steroid injection 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. The outcome of the events is unknown. Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Blister, Herpes zoster, 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 an unknown date during 2012, the patient was inoculated with ZOSTAVAX (lot number, dosage and route of administration not provided) at a pharmacy, 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 an unspecified date during 2016, the patient was treated at a medical center for a blistering vesicular outbreak which was then diagnosed as herpes zoster, or shingles. 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 outcome of the events is unknown. Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Blister, 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 30-MAR-2016, the patient was inoculated with ZOSTAVAX (lot number, dosage and route of administration not provided) at a pharmacy, 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 08-APR-2016, the patient was treated by a physician for a blistering vesicular outbreak which was then diagnosed as herpes zoster, or shingles. The patient was prescribed valacyclovir 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. The outcome of the events is unknown. Additional information has been requested.
Sex: M
Vaccine: VARZOS
Symptoms: Blister, Decreased immune responsiveness, Herpes zoster, Rash vesicular
Clinical narrative: This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a male patient of unknown age. Information regarding medical history, concurrent conditions and concomitant medications was not provided. During 2014, the patient was inoculated with ZOSTAVAX at a pharmacy for routine adult health maintenance and for the prevention of shingles (lot #, dose and route not provided). The vaccine did not prevent shingles as intended, but rather caused the patient to contract a persistent strain of herpes zoster. During 2016, the patient was treated by a family physician for a blistering vesicular outbreak and decreased immune symptoms which was then diagnosed as severe herpes zoster, or shingles. 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 outcomes of the events were unknown at the time of reporting. Causality assessment was related. Additional information has been requested.
Age: 10.0
Sex: F
Vaccine: DTAP, FLU4
Symptoms: Blood test, Eye swelling, Laboratory test, Skin test negative
Clinical narrative: As of 12/28/17 we had a blood work and awaiting results. Pls. read paper attached. My daughter started having reactions Friday into Saturday morning 08/25/17 - 08/26/2017, I notice her eyes were swollen. But before the end of the weekend it disappeared, and again Tuesday morning 8/29/17 I noticed her eyes were swollen again which I called the doc's office and was given an appointment. We were advised to give her ZYRTEC and a prescription of Prednisone was given too. But her reactions occurred weekly, which ended up taking her to see a specialist for skin testing and she came out negative on all test performed on her. Though the skin test proved negative, she still had an episode of swollen eyes. We had a follow up 12/27/17 and lab work was done 12/28/17 and had to do another lab work which we are still waiting for the results.
Age: 2.0
Sex: M
Vaccine: FLU4, HEPA
Symptoms: Incorrect dose administered
Clinical narrative: Father reported age as 3 yrs. Given 0.5 ml FLUZONE rather than 0.25 ml. According to records patient is 2 yrs, 9 mos. Child wt. - 40 pounds 10 oz.
Age: 62.0
Sex: F
Vaccine: VARZOS
Symptoms: Computerised tomogram, Injection site erythema, Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: Patient reported having a high grade fever (102.4) starting the day after injection; she also reported redness and swelling all the way around the injection site, with pain and heat; she visited the ER regarding this reaction.
Age: 62.0
Sex: F
Vaccine: VARZOS
Symptoms: Laboratory test, Pyrexia
Clinical narrative: Patient reported having a high grade fever (102.4) starting the day after injection; she also reported redness and swelling all the way around the injection site, with pain and heat; she visited the ER regarding this reaction.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Erythema, Injection site erythema, Injection site pain, Myalgia
Clinical narrative: She was given SHINGRIX at her pharmacy 4 days ago. The night of receiving the vaccine she started having fever, muscle aches, chills, pain, and redness at injection site. By the next day she felt feverish and achey. Her arm became very sore and red and swollen. She has been taking ibuprofen and tylenol throughout the day and does take pepcid and xyzal normally. She has continued to have arm pain and redness and swelling. She has been marking the margins of erythema and found that they are expanding.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Pain, Pain in extremity, Peripheral swelling, Pyrexia
Clinical narrative: She was given SHINGRIX at her pharmacy 4 days ago. The night of receiving the vaccine she started having fever, muscle aches, chills, pain, and redness at injection site. By the next day she felt feverish and achey. Her arm became very sore and red and swollen. She has been taking ibuprofen and tylenol throughout the day and does take pepcid and xyzal normally. She has continued to have arm pain and redness and swelling. She has been marking the margins of erythema and found that they are expanding.
Age: 24.0
Sex: F
Vaccine: FLU4
Symptoms: Injected limb mobility decreased, Sensory loss
Clinical narrative: PATIENT REPORTED THAT AFTER A FEW HOURS, THE PATIENT LOST FEELING IN HER LEFT ARM (THE ARM THAT WAS INJECTED). SHE REPORTED THAT SHE CANNOT MOVE HER ARM, AND AS OF TODAY (3/13/18) SHE STILL HAS NO FEELING IN HER ARM.
Age: 55.0
Sex: M
Vaccine: FLUC4
Symptoms: Feeding disorder, Headache, Pyrexia, Seizure
Clinical narrative: Patient called me (Pharmacist) to state that 24 hours after his shot he experienced convulsions, high temperatures and no ability to eat. He called 3 weeks after the shot, he did not go to the doctor. He said that he was better but still had headaches. I very much encouraged him to go to the doctor, I don't know if he will. He said as a kid he was allergic to eggs but was sensitive now. He never stated this on his consent.
Age: 80.0
Sex: F
Vaccine: VARZOS
Symptoms: Dry skin, Erythema, Exfoliative rash
Clinical narrative: After 5 days of receiving vaccination, pt developed round patch skin condition on her chest. The patches look like scaly, dry and red ( similar to ringworm). Pt believed the rash is from the vaccine but will check by her primary care dr and will inform us.
Age: 1.0
Sex: M
Vaccine: HIBV, MMRV, PNC13
Symptoms: Injection site erythema, Injection site induration, Injection site nodule, Injection site pain, Injection site swelling
Clinical narrative: Mom reports noticing swelling on right thigh. No rash noted but tender to touch, redness at site, and hard knot palpated.
Age: 17.0
Sex: F
Vaccine: HPV9
Symptoms: Joint range of motion decreased, Limb discomfort, Mobility decreased
Clinical narrative: This spontaneous report was received from a physician refers to a female patient of currently 17 years old. The patient's concurrent condition included asthma. The patient's medical history, drug reactions and allergies were not reported. The patient's concomitant medication included PROAIR and norgestin (further unspecified). On 14-FEB-2018, the patient was vaccinated with one dose of GARDASIL 9 (dose, units and frequency not reported) (lot # N019103 and expiration date: 03-FEB-2020) as routine immunization. On an unknown date, patient experienced worsening discomfort where the patient cannot lift their arm without redness. The physician also stated that the patient has decreased range of motion. The patient seek medical attention but did not receive any treatment. The outcome of the events was not recovered/not resolved. The reporter did not provide the causal relationship for the events with suspect therapy GARDASIL 9. No product quality complaint was involved.
Sex: F
Vaccine: VARZOS
Symptoms: Blister, Herpes zoster, 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. During 2015, 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. The vaccine did not prevent shingles as intended, but rather caused the patient to contract a persistent strain condition of herpes zoster. During 2016, the patient was treated at physician office for a blistering vesicular outbreak and 'decreased" (unspecified) which was then diagnosed as herpes zoster, or shingles. 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.